ADHD Medication Database

Label-listed forms & strengths

Not recommended doses or confirmation of current supply. Ask a pharmacist about local brand and generic availability; do not substitute products yourself.

Tablet

Indications in US label

ADHD, Narcolepsy

Other indications may have different age limits. Local approvals and prescribing rules may differ.

Mechanism and its limits

Methylphenidate hydrochloride is a CNS stimulant. Its therapeutic mode of action in ADHD and narcolepsy is not known (label section 12.1). Section 12.2 separately reports that methylphenidate blocks norepinephrine and dopamine reuptake and increases release of these monoamines into extraneuronal space.

Selected adverse reactions

Selected reactions reported with Ritalin in label section 6; the label combines clinical trials, spontaneous reports, and literature, and frequency is not established.

• Decreased appetite
• Insomnia
• Headache
• Abdominal pain
• Nausea

Not a complete safety list. An omitted reaction is not evidence of no risk. Trial rates cannot be compared directly between medicines or used to predict your risk; spontaneous reports do not establish frequency or causation. See the cited label and serious warnings below.

Contraindications in cited label

Conditions in the cited label’s contraindications section are listed separately from warnings above. Absence from this list does not mean a medicine is safe for you. Check the complete, current label with your prescriber.

• • Known hypersensitivity to methylphenidate or other components
• • Concurrent use of MAOIs or within 14 days of discontinuing MAOIs

Selected label interactions

Not a complete interaction check. Share all medicines, supplements and planned procedures with your pharmacist or prescriber. Do not change treatment yourself.

• • MAOIs: contraindicated concurrently or within 14 days after discontinuation
• • Antihypertensive drugs: monitor blood pressure and adjust the antihypertensive as needed
• • Halogenated anesthetics: day-of-surgery use may cause a sudden blood pressure and heart-rate increase; the clinician should plan whether to withhold treatment
• • Risperidone: monitor for extrapyramidal symptoms when either drug is started, stopped, or its dosage is changed

Label-listed forms & strengths

Not recommended doses or confirmation of current supply. Ask a pharmacist about local brand and generic availability; do not substitute products yourself.

Oral Solution

Indications in US label

ADHD

Other indications may have different age limits. Local approvals and prescribing rules may differ.

Mechanism and its limits

Methylphenidate hydrochloride is a CNS stimulant. Its therapeutic mode of action in ADHD is not known (label section 12.1). Section 12.2 separately describes norepinephrine and dopamine reuptake blockade and increased monoamine release into extraneuronal space.

Selected adverse reactions

Selected reactions reported for methylphenidate-containing products in Methylin label section 6; sources include clinical studies, postmarketing reports, and literature, and frequency is not established.

• Decreased appetite
• Insomnia
• Headache
• Abdominal pain
• Nausea

Not a complete safety list. An omitted reaction is not evidence of no risk. Trial rates cannot be compared directly between medicines or used to predict your risk; spontaneous reports do not establish frequency or causation. See the cited label and serious warnings below.

Contraindications in cited label

Conditions in the cited label’s contraindications section are listed separately from warnings above. Absence from this list does not mean a medicine is safe for you. Check the complete, current label with your prescriber.

• • Known hypersensitivity to methylphenidate or other components
• • Concurrent use of MAOIs or within 14 days of discontinuing MAOIs

Selected label interactions

Not a complete interaction check. Share all medicines, supplements and planned procedures with your pharmacist or prescriber. Do not change treatment yourself.

• • MAOIs: contraindicated concurrently or within 14 days after discontinuation
• • Antihypertensive drugs: monitor blood pressure and adjust the antihypertensive as needed
• • Halogenated anesthetics: day-of-surgery use may cause a sudden blood pressure and heart-rate increase; the clinician should plan whether to withhold treatment
• • Risperidone: monitor for extrapyramidal symptoms when either drug is started, stopped, or its dosage is changed

Label-listed forms & strengths

Not recommended doses or confirmation of current supply. Ask a pharmacist about local brand and generic availability; do not substitute products yourself.

Tablet

Indications in US label

ADHD

Other indications may have different age limits. Local approvals and prescribing rules may differ.

Mechanism and its limits

Dexmethylphenidate hydrochloride is a CNS stimulant, and its therapeutic mode of action in ADHD is not known (label section 12.1). Section 12.2 separately identifies dexmethylphenidate as the more pharmacologically active d-enantiomer of racemic methylphenidate and describes norepinephrine and dopamine reuptake blockade.

Selected adverse reactions

Focalin label section 6.1: reactions occurring in at least 5% and at least twice placebo in clinical trials of pediatric patients ages 6 to 17 with ADHD.

• Abdominal pain
• Fever
• Nausea
• Anorexia

Not a complete safety list. An omitted reaction is not evidence of no risk. Trial rates cannot be compared directly between medicines or used to predict your risk; spontaneous reports do not establish frequency or causation. See the cited label and serious warnings below.

Contraindications in cited label

Conditions in the cited label’s contraindications section are listed separately from warnings above. Absence from this list does not mean a medicine is safe for you. Check the complete, current label with your prescriber.

• • Known hypersensitivity to methylphenidate or other components
• • Concurrent use of MAOIs or within 14 days of discontinuing MAOIs

Selected label interactions

Not a complete interaction check. Share all medicines, supplements and planned procedures with your pharmacist or prescriber. Do not change treatment yourself.

• • MAOIs: contraindicated concurrently or within 14 days after discontinuation
• • Antihypertensive drugs: monitor blood pressure and adjust the antihypertensive as needed
• • Halogenated anesthetics: day-of-surgery use may cause a sudden blood pressure and heart-rate increase; the clinician should plan whether to withhold treatment
• • Risperidone: monitor for extrapyramidal symptoms when either drug is started, stopped, or its dosage is changed

Label-listed forms & strengths

Not recommended doses or confirmation of current supply. Ask a pharmacist about local brand and generic availability; do not substitute products yourself.

Tablet

Indications in US label

ADHD

Other indications may have different age limits. Local approvals and prescribing rules may differ.

Mechanism and its limits

Methylphenidate is a CNS stimulant. Its therapeutic mode of action in ADHD is not known (label section 12.1); the same section separately describes norepinephrine and dopamine reuptake blockade and increased monoamine release.

Release System

OROS (Osmotic-controlled Release Oral delivery System)

Selected adverse reactions

Concerta label section 6.1: reactions in at least 5% in double-blind clinical trials; pediatric patients were ages 6 to 17 and adults were up to age 65.

• Upper abdominal pain (pediatric patients)
• Decreased appetite (adults)
• Headache (adults)
• Dry mouth (adults)
• Nausea (adults)
• Insomnia (adults)
• Anxiety (adults)
• Dizziness (adults)
• Weight decreased (adults)
• Irritability (adults)
• Tachycardia (adults)
• Hyperhidrosis (adults)

Not a complete safety list. An omitted reaction is not evidence of no risk. Trial rates cannot be compared directly between medicines or used to predict your risk; spontaneous reports do not establish frequency or causation. See the cited label and serious warnings below.

Contraindications in cited label

Conditions in the cited label’s contraindications section are listed separately from warnings above. Absence from this list does not mean a medicine is safe for you. Check the complete, current label with your prescriber.

• • Known hypersensitivity to methylphenidate or other components
• • Concurrent use of MAOIs or within 14 days of discontinuing MAOIs

Selected label interactions

Not a complete interaction check. Share all medicines, supplements and planned procedures with your pharmacist or prescriber. Do not change treatment yourself.

• • MAOIs: contraindicated concurrently or within 14 days after discontinuation
• • Antihypertensive drugs: monitor blood pressure and adjust the antihypertensive as needed
• • Halogenated anesthetics: day-of-surgery use may cause a sudden blood pressure and heart-rate increase; the clinician should plan whether to withhold treatment
• • Risperidone: monitor for extrapyramidal symptoms when either drug is started, stopped, or its dosage is changed

Label-listed forms & strengths

Not recommended doses or confirmation of current supply. Ask a pharmacist about local brand and generic availability; do not substitute products yourself.

Capsule

Indications in US label

ADHD

Other indications may have different age limits. Local approvals and prescribing rules may differ.

Mechanism and its limits

Methylphenidate hydrochloride is a CNS stimulant. Its therapeutic mode of action in ADHD is not known (label section 12.1); section 12.2 separately describes norepinephrine and dopamine reuptake blockade.

Release System

Bimodal bead system (SODAS - Spheroidal Oral Drug Absorption System)

Selected adverse reactions

Ritalin LA label section 6.1: reactions reported in greater than 5% of clinical-trial participants; the clinical program included children ages 6 to 12 with ADHD and healthy adult volunteers.

• Headache
• Insomnia
• Upper abdominal pain
• Decreased appetite
• Anorexia

Not a complete safety list. An omitted reaction is not evidence of no risk. Trial rates cannot be compared directly between medicines or used to predict your risk; spontaneous reports do not establish frequency or causation. See the cited label and serious warnings below.

Contraindications in cited label

Conditions in the cited label’s contraindications section are listed separately from warnings above. Absence from this list does not mean a medicine is safe for you. Check the complete, current label with your prescriber.

• • Known hypersensitivity to methylphenidate or other components
• • Concurrent use of MAOIs or within 14 days of discontinuing MAOIs

Selected label interactions

Not a complete interaction check. Share all medicines, supplements and planned procedures with your pharmacist or prescriber. Do not change treatment yourself.

• • MAOIs: contraindicated concurrently or within 14 days after discontinuation
• • Antihypertensive drugs: monitor blood pressure and adjust the antihypertensive as needed
• • Halogenated anesthetics: day-of-surgery use may cause a sudden blood pressure and heart-rate increase; the clinician should plan whether to withhold treatment
• • Risperidone: monitor for extrapyramidal symptoms when either drug is started, stopped, or its dosage is changed

Label-listed forms & strengths

Not recommended doses or confirmation of current supply. Ask a pharmacist about local brand and generic availability; do not substitute products yourself.

Capsule

Indications in US label

ADHD

Other indications may have different age limits. Local approvals and prescribing rules may differ.

Mechanism and its limits

Methylphenidate hydrochloride is a CNS stimulant. Its therapeutic mode of action in ADHD is not known (label section 12.1); section 12.2 separately describes norepinephrine and dopamine reuptake blockade.

Release System

Diffucaps bimodal bead system (30% IR / 70% ER)

Selected adverse reactions

Metadate CD label section 6.1: reactions in at least 5% and at least twice placebo in pooled three- to four-week trials of pediatric patients ages 6 to 15 with ADHD.

• Anorexia
• Insomnia

Not a complete safety list. An omitted reaction is not evidence of no risk. Trial rates cannot be compared directly between medicines or used to predict your risk; spontaneous reports do not establish frequency or causation. See the cited label and serious warnings below.

Contraindications in cited label

Conditions in the cited label’s contraindications section are listed separately from warnings above. Absence from this list does not mean a medicine is safe for you. Check the complete, current label with your prescriber.

• • Known hypersensitivity to methylphenidate or other components
• • Concurrent use of MAOIs or within 14 days of discontinuing MAOIs
• • Hereditary fructose intolerance, glucose-galactose malabsorption, or sucrase-isomaltase insufficiency because the product contains sucrose
• • Pheochromocytoma or a history of pheochromocytoma

Selected label interactions

Not a complete interaction check. Share all medicines, supplements and planned procedures with your pharmacist or prescriber. Do not change treatment yourself.

• • MAOIs: contraindicated concurrently or within 14 days after discontinuation
• • Antihypertensive drugs: monitor blood pressure and adjust the antihypertensive as needed
• • Halogenated anesthetics: day-of-surgery use may cause a sudden blood pressure and heart-rate increase; the clinician should plan whether to withhold treatment
• • Risperidone: monitor for extrapyramidal symptoms when either drug is started, stopped, or its dosage is changed

Label-listed forms & strengths

Not recommended doses or confirmation of current supply. Ask a pharmacist about local brand and generic availability; do not substitute products yourself.

Capsule

Indications in US label

ADHD

Other indications may have different age limits. Local approvals and prescribing rules may differ.

Mechanism and its limits

Dexmethylphenidate hydrochloride is a CNS stimulant, and its therapeutic mode of action in ADHD is not known (label section 12.1). Section 12.2 separately identifies it as the more pharmacologically active d-enantiomer and describes norepinephrine and dopamine reuptake blockade.

Release System

Bimodal bead system (50% IR / 50% delayed release)

Selected adverse reactions

Focalin XR label section 6.1: reactions in at least 5% and at least twice placebo in controlled ADHD trials, reported separately for pediatric patients ages 6 to 17 and adults.

• Dyspepsia (pediatric patients)
• Decreased appetite (pediatric patients)
• Headache
• Anxiety
• Dry mouth (adults)
• Pharyngolaryngeal pain (adults)

Not a complete safety list. An omitted reaction is not evidence of no risk. Trial rates cannot be compared directly between medicines or used to predict your risk; spontaneous reports do not establish frequency or causation. See the cited label and serious warnings below.

Contraindications in cited label

Conditions in the cited label’s contraindications section are listed separately from warnings above. Absence from this list does not mean a medicine is safe for you. Check the complete, current label with your prescriber.

• • Known hypersensitivity to methylphenidate or other components
• • Concurrent use of MAOIs or within 14 days of discontinuing MAOIs

Selected label interactions

Not a complete interaction check. Share all medicines, supplements and planned procedures with your pharmacist or prescriber. Do not change treatment yourself.

• • MAOIs: contraindicated concurrently or within 14 days after discontinuation
• • Antihypertensive drugs: monitor blood pressure and adjust the antihypertensive as needed
• • Halogenated anesthetics: day-of-surgery use may cause a sudden blood pressure and heart-rate increase; the clinician should plan whether to withhold treatment
• • Risperidone: monitor for extrapyramidal symptoms when either drug is started, stopped, or its dosage is changed

Label-listed forms & strengths

Not recommended doses or confirmation of current supply. Ask a pharmacist about local brand and generic availability; do not substitute products yourself.

Capsule

Indications in US label

ADHD

Other indications may have different age limits. Local approvals and prescribing rules may differ.

Mechanism and its limits

Methylphenidate hydrochloride is a CNS stimulant. Its therapeutic mode of action in ADHD is not known (label section 12.1); section 12.2 separately describes norepinephrine and dopamine reuptake blockade.

Release System

Multilayer bead system (40% IR / 60% ER)

Selected adverse reactions

Aptensio XR label section 6.1: reactions in more than 5% and at least twice placebo in double-blind trials of pediatric patients ages 6 to 17 with ADHD.

• Abdominal pain
• Decreased appetite
• Headache
• Insomnia

Not a complete safety list. An omitted reaction is not evidence of no risk. Trial rates cannot be compared directly between medicines or used to predict your risk; spontaneous reports do not establish frequency or causation. See the cited label and serious warnings below.

Contraindications in cited label

Conditions in the cited label’s contraindications section are listed separately from warnings above. Absence from this list does not mean a medicine is safe for you. Check the complete, current label with your prescriber.

• • Known hypersensitivity to methylphenidate or other components
• • Concurrent use of MAOIs or within 14 days of discontinuing MAOIs

Selected label interactions

Not a complete interaction check. Share all medicines, supplements and planned procedures with your pharmacist or prescriber. Do not change treatment yourself.

• • MAOIs: contraindicated concurrently or within 14 days after discontinuation
• • Antihypertensive drugs: monitor blood pressure and adjust the antihypertensive as needed
• • Halogenated anesthetics: day-of-surgery use may cause a sudden blood pressure and heart-rate increase; the clinician should plan whether to withhold treatment
• • Risperidone: monitor for extrapyramidal symptoms when either drug is started, stopped, or its dosage is changed

Label-listed forms & strengths

Not recommended doses or confirmation of current supply. Ask a pharmacist about local brand and generic availability; do not substitute products yourself.

Capsule

Indications in US label

ADHD

Other indications may have different age limits. Local approvals and prescribing rules may differ.

Mechanism and its limits

Methylphenidate hydrochloride is a CNS stimulant. Its therapeutic mode of action in ADHD is not known (historical label section 12.1); section 12.2 separately describes norepinephrine and dopamine reuptake blockade.

Release System

Multilayer-release bead system containing an immediate-release layer (20% of the dose) and a controlled-release layer (80% of the dose)

Selected adverse reactions

Historical Adhansia XR FDA label section 6.1: selected reactions in at least 5% and at least twice placebo in four-week controlled ADHD trials, with adult and pediatric populations reported separately.

• Insomnia
• Dry mouth (adults)
• Decreased appetite
• Weight decreased

Not a complete safety list. An omitted reaction is not evidence of no risk. Trial rates cannot be compared directly between medicines or used to predict your risk; spontaneous reports do not establish frequency or causation. See the cited label and serious warnings below.

Contraindications in cited label

Conditions in the cited label’s contraindications section are listed separately from warnings above. Absence from this list does not mean a medicine is safe for you. Check the complete, current label with your prescriber.

• • Historical label: known hypersensitivity to methylphenidate or other components
• • Historical label: concurrent use of MAOIs or within 14 days of discontinuing MAOIs

Selected label interactions

Not a complete interaction check. Share all medicines, supplements and planned procedures with your pharmacist or prescriber. Do not change treatment yourself.

• • Historical label: MAOIs were contraindicated concurrently or within 14 days after discontinuation
• • Historical label: gastric pH modulators, such as proton pump inhibitors, H2 blockers and sodium bicarbonate, could change drug release and clinical effects; the prescriber was to monitor response and consider alternatives

Label-listed forms & strengths

Not recommended doses or confirmation of current supply. Ask a pharmacist about local brand and generic availability; do not substitute products yourself.

Oral Suspension

Indications in US label

ADHD

Other indications may have different age limits. Local approvals and prescribing rules may differ.

Mechanism and its limits

Methylphenidate is a CNS stimulant. Its therapeutic mode of action in ADHD is not known; label sections 12.1 and 12.2 separately describe its pharmacology, including norepinephrine and dopamine reuptake blockade.

Release System

Extended-release oral suspension containing approximately 20% immediate-release and 80% extended-release methylphenidate

Selected adverse reactions

Quillivant XR label section 6.1: reactions in at least 2% and greater than placebo during the controlled crossover phase of a Phase 3 trial in 45 children ages 6 to 12 with ADHD.

• Affect lability
• Excoriation
• Initial insomnia
• Tic
• Decreased appetite
• Vomiting
• Motion sickness
• Eye pain
• Rash

Not a complete safety list. An omitted reaction is not evidence of no risk. Trial rates cannot be compared directly between medicines or used to predict your risk; spontaneous reports do not establish frequency or causation. See the cited label and serious warnings below.

Contraindications in cited label

Conditions in the cited label’s contraindications section are listed separately from warnings above. Absence from this list does not mean a medicine is safe for you. Check the complete, current label with your prescriber.

• • Known hypersensitivity to methylphenidate or other components
• • Concurrent use of MAOIs or within 14 days of discontinuing MAOIs

Selected label interactions

Not a complete interaction check. Share all medicines, supplements and planned procedures with your pharmacist or prescriber. Do not change treatment yourself.

• • MAOIs: contraindicated concurrently or within 14 days after discontinuation
• • Antihypertensive drugs: monitor blood pressure and adjust the antihypertensive as needed
• • Halogenated anesthetics: day-of-surgery use may cause a sudden blood pressure and heart-rate increase; the clinician should plan whether to withhold treatment
• • Risperidone: monitor for extrapyramidal symptoms when either drug is started, stopped, or its dosage is changed

Label-listed forms & strengths

Not recommended doses or confirmation of current supply. Ask a pharmacist about local brand and generic availability; do not substitute products yourself.

Chewable Tablet

Indications in US label

ADHD

Other indications may have different age limits. Local approvals and prescribing rules may differ.

Mechanism and its limits

Methylphenidate is a CNS stimulant. Its therapeutic mode of action in ADHD is not known; label sections 12.1 and 12.2 separately describe its pharmacology, including norepinephrine and dopamine reuptake blockade.

Release System

Extended-release chewable tablet containing approximately 30% immediate-release and 70% extended-release methylphenidate

Selected adverse reactions

QuilliChew ER label section 6.1: reactions in at least 2% and greater than placebo during the double-blind phase of a laboratory-classroom trial in children ages 6 to 12 with ADHD.

• Decreased appetite
• Aggression
• Emotional poverty
• Nausea
• Headache
• Weight decreased

Not a complete safety list. An omitted reaction is not evidence of no risk. Trial rates cannot be compared directly between medicines or used to predict your risk; spontaneous reports do not establish frequency or causation. See the cited label and serious warnings below.

Contraindications in cited label

Conditions in the cited label’s contraindications section are listed separately from warnings above. Absence from this list does not mean a medicine is safe for you. Check the complete, current label with your prescriber.

• • Known hypersensitivity to methylphenidate or other components
• • Concurrent use of MAOIs or within 14 days of discontinuing MAOIs

Selected label interactions

Not a complete interaction check. Share all medicines, supplements and planned procedures with your pharmacist or prescriber. Do not change treatment yourself.

• • MAOIs: contraindicated concurrently or within 14 days after discontinuation
• • Antihypertensive drugs: monitor blood pressure and adjust the antihypertensive as needed
• • Halogenated anesthetics: day-of-surgery use may cause a sudden blood pressure and heart-rate increase; the clinician should plan whether to withhold treatment
• • Risperidone: monitor for extrapyramidal symptoms when either drug is started, stopped, or its dosage is changed

Label-listed forms & strengths

Not recommended doses or confirmation of current supply. Ask a pharmacist about local brand and generic availability; do not substitute products yourself.

ODT

Indications in US label

ADHD

Other indications may have different age limits. Local approvals and prescribing rules may differ.

Mechanism and its limits

Methylphenidate is a CNS stimulant. Its therapeutic mode of action in ADHD is not known (label section 12.1); section 12.2 separately describes norepinephrine and dopamine reuptake blockade.

Release System

Extended-release orally disintegrating tablet containing approximately 25% immediate-release and 75% extended-release methylphenidate

Selected adverse reactions

Cotempla XR-ODT label section 6.1 reports limited controlled-trial experience in children with ADHD and does not enumerate a product-specific common-reaction list.

Not a complete safety list. An omitted reaction is not evidence of no risk. Trial rates cannot be compared directly between medicines or used to predict your risk; spontaneous reports do not establish frequency or causation. See the cited label and serious warnings below.

Contraindications in cited label

Conditions in the cited label’s contraindications section are listed separately from warnings above. Absence from this list does not mean a medicine is safe for you. Check the complete, current label with your prescriber.

• • Known hypersensitivity to methylphenidate or other components
• • Concurrent use of MAOIs or within 14 days of discontinuing MAOIs

Selected label interactions

Not a complete interaction check. Share all medicines, supplements and planned procedures with your pharmacist or prescriber. Do not change treatment yourself.

• • MAOIs: contraindicated concurrently or within 14 days after discontinuation
• • Antihypertensive drugs: monitor blood pressure and adjust the antihypertensive as needed
• • Halogenated anesthetics: day-of-surgery use may cause a sudden blood pressure and heart-rate increase; the clinician should plan whether to withhold treatment
• • Risperidone: monitor for extrapyramidal symptoms when either drug is started, stopped, or its dosage is changed
• • Gastric pH modulators, including H2 blockers and proton pump inhibitors: concomitant use is not recommended

Label-listed forms & strengths

Not recommended doses or confirmation of current supply. Ask a pharmacist about local brand and generic availability; do not substitute products yourself.

Capsule

Indications in US label

ADHD

Other indications may have different age limits. Local approvals and prescribing rules may differ.

Mechanism and its limits

Methylphenidate hydrochloride is a CNS stimulant. Its exact therapeutic mode of action in ADHD is not known (label section 12.1); section 12.2 separately describes norepinephrine and dopamine reuptake blockade.

Release System

DR/ER (delayed-release and extended-release) bead system

Selected adverse reactions

Jornay PM label section 6.1: reactions in at least 5% and at least twice placebo in a three-week controlled trial of pediatric patients ages 6 to 12 with ADHD.

• Insomnia
• Decreased appetite
• Headache
• Vomiting
• Nausea
• Psychomotor hyperactivity
• Affect lability
• Mood swings

Not a complete safety list. An omitted reaction is not evidence of no risk. Trial rates cannot be compared directly between medicines or used to predict your risk; spontaneous reports do not establish frequency or causation. See the cited label and serious warnings below.

Contraindications in cited label

Conditions in the cited label’s contraindications section are listed separately from warnings above. Absence from this list does not mean a medicine is safe for you. Check the complete, current label with your prescriber.

• • Known hypersensitivity to methylphenidate or other components
• • Concurrent use of MAOIs or within 14 days of discontinuing MAOIs

Selected label interactions

Not a complete interaction check. Share all medicines, supplements and planned procedures with your pharmacist or prescriber. Do not change treatment yourself.

• • MAOIs: contraindicated concurrently or within 14 days after discontinuation
• • Antihypertensive drugs: monitor blood pressure and adjust the antihypertensive as needed
• • Halogenated anesthetics: day-of-surgery use may cause a sudden blood pressure and heart-rate increase; the clinician should plan whether to withhold treatment
• • Risperidone: monitor for extrapyramidal symptoms when either drug is started, stopped, or its dosage is changed

Label-listed forms & strengths

Not recommended doses or confirmation of current supply. Ask a pharmacist about local brand and generic availability; do not substitute products yourself.

Capsule

Indications in US label

ADHD

Other indications may have different age limits. Local approvals and prescribing rules may differ.

Mechanism and its limits

Serdexmethylphenidate is a prodrug of dexmethylphenidate, and dexmethylphenidate hydrochloride is a CNS stimulant. Their therapeutic mode of action in ADHD is not known (label section 12.1).

Release System

Prodrug technology (serdexmethylphenidate converted to dexmethylphenidate)

Active Metabolite

dexmethylphenidate

Selected adverse reactions

Azstarys label section 6.1: product-specific studies in children ages 6 to 12 used open-label optimization or long-term uncontrolled designs, so reported rates cannot predict clinical-practice rates or establish causality; no product-specific common-reaction list is enumerated.

Not a complete safety list. An omitted reaction is not evidence of no risk. Trial rates cannot be compared directly between medicines or used to predict your risk; spontaneous reports do not establish frequency or causation. See the cited label and serious warnings below.

Contraindications in cited label

Conditions in the cited label’s contraindications section are listed separately from warnings above. Absence from this list does not mean a medicine is safe for you. Check the complete, current label with your prescriber.

• • Known hypersensitivity to serdexmethylphenidate, methylphenidate, or other components
• • Concurrent use of MAOIs or within 14 days of discontinuing MAOIs

Selected label interactions

Not a complete interaction check. Share all medicines, supplements and planned procedures with your pharmacist or prescriber. Do not change treatment yourself.

• • MAOIs: contraindicated concurrently or within 14 days after discontinuation
• • Antihypertensive drugs: monitor blood pressure and adjust the antihypertensive as needed
• • Halogenated anesthetics: day-of-surgery use may cause a sudden blood pressure and heart-rate increase; the clinician should plan whether to withhold treatment
• • Risperidone: monitor for extrapyramidal symptoms when either drug is started, stopped, or its dosage is changed

Label-listed forms & strengths

Not recommended doses or confirmation of current supply. Ask a pharmacist about local brand and generic availability; do not substitute products yourself.

Tablet

Indications in US label

ADHD, Narcolepsy

Other indications may have different age limits. Local approvals and prescribing rules may differ.

Mechanism and its limits

Adderall contains a 3:1 ratio of dextroamphetamine to levoamphetamine. Its label describes amphetamine as a sympathomimetic amine with CNS stimulant activity but does not establish the precise therapeutic mechanism in ADHD; proposed monoamine release and reuptake effects are pharmacology, not a demonstrated explanation of efficacy.

Selected adverse reactions

Selected reactions reported in the Adderall label’s unnumbered ADVERSE REACTIONS section; frequency is not established and these are not a clinical-trial “common reactions” list.

• Insomnia
• Irritability
• Dry mouth
• Diarrhea
• Constipation
• Anorexia
• Weight loss

Not a complete safety list. An omitted reaction is not evidence of no risk. Trial rates cannot be compared directly between medicines or used to predict your risk; spontaneous reports do not establish frequency or causation. See the cited label and serious warnings below.

Contraindications in cited label

Conditions in the cited label’s contraindications section are listed separately from warnings above. Absence from this list does not mean a medicine is safe for you. Check the complete, current label with your prescriber.

• • Known hypersensitivity to amphetamine or other components of Adderall
• • Concurrent use of MAOIs or within 14 days of discontinuing MAOIs

Selected label interactions

Not a complete interaction check. Share all medicines, supplements and planned procedures with your pharmacist or prescriber. Do not change treatment yourself.

• • MAOIs: contraindicated during use and for 14 days after stopping an MAOI because of hypertensive crisis risk.
• • Serotonergic drugs and CYP2D6 inhibitors: increased serotonin syndrome risk; CYP2D6 inhibitors may increase exposure. Prescriber-led dose decisions and monitoring are required.
• • Acidifying agents lower amphetamine blood levels; alkalinizing agents increase them. The label says to avoid gastrointestinal alkalinizing agents.
• • Tricyclic antidepressants may potentiate cardiovascular effects; antihypertensive effects may be reduced.
• • Proton pump inhibitors can change the timing of peak concentration; monitor for changes in clinical effect rather than assuming a coverage window.

Label-listed forms & strengths

Not recommended doses or confirmation of current supply. Ask a pharmacist about local brand and generic availability; do not substitute products yourself.

Tablet

Indications in US label

ADHD, Narcolepsy, Exogenous obesity

Other indications may have different age limits. Local approvals and prescribing rules may differ.

Mechanism and its limits

Evekeo contains racemic amphetamine sulfate (d- and l-amphetamine). Its label describes CNS-stimulant sympathomimetic pharmacology but does not establish the precise therapeutic mechanism in ADHD; pharmacologic monoamine effects should not be read as a demonstrated explanation of efficacy.

Selected adverse reactions

Selected reactions reported in the Evekeo label’s unnumbered ADVERSE REACTIONS section; frequency is not established and these are not a product-specific controlled-trial “common reactions” list.

• Insomnia
• Restlessness
• Dizziness
• Headache
• Dry mouth
• Anorexia
• Weight loss

Not a complete safety list. An omitted reaction is not evidence of no risk. Trial rates cannot be compared directly between medicines or used to predict your risk; spontaneous reports do not establish frequency or causation. See the cited label and serious warnings below.

Contraindications in cited label

Conditions in the cited label’s contraindications section are listed separately from warnings above. Absence from this list does not mean a medicine is safe for you. Check the complete, current label with your prescriber.

• • Known hypersensitivity to amphetamine products
• • Concurrent use of MAOIs or within 14 days of discontinuing MAOIs

Selected label interactions

Not a complete interaction check. Share all medicines, supplements and planned procedures with your pharmacist or prescriber. Do not change treatment yourself.

• • MAOIs: contraindicated during use and for 14 days after stopping an MAOI because of hypertensive crisis risk.
• • Serotonergic drugs and CYP2D6 inhibitors: increased serotonin syndrome risk; CYP2D6 inhibitors may increase exposure. Prescriber-led dose decisions and monitoring are required.
• • Gastrointestinal and urinary acidifying agents lower amphetamine blood levels; alkalinizing agents increase them. Ask the prescriber to check these combinations.
• • Tricyclic antidepressants may potentiate cardiovascular effects; antihypertensive effects may be reduced.

Label-listed forms & strengths

Not recommended doses or confirmation of current supply. Ask a pharmacist about local brand and generic availability; do not substitute products yourself.

Tablet

Indications in US label

ADHD, Narcolepsy

Other indications may have different age limits. Local approvals and prescribing rules may differ.

Mechanism and its limits

Dextroamphetamine is the dextrorotatory amphetamine isomer. The historical 2007 label describes sympathomimetic CNS-stimulant actions but says there is no specific evidence clearly establishing the mechanism by which amphetamines produce mental and behavioral effects in children; proposed catecholamine effects are not a demonstrated explanation of ADHD efficacy.

Selected adverse reactions

Selected reactions reported in the archival 2007 Dexedrine label’s unnumbered ADVERSE REACTIONS section (covering tablets and Spansule capsules); frequency is not established.

• Overstimulation
• Restlessness
• Dizziness
• Insomnia
• Headache
• Dry mouth
• Anorexia
• Weight loss

Not a complete safety list. An omitted reaction is not evidence of no risk. Trial rates cannot be compared directly between medicines or used to predict your risk; spontaneous reports do not establish frequency or causation. See the cited label and serious warnings below.

Contraindications in cited label

Conditions in the cited label’s contraindications section are listed separately from warnings above. Absence from this list does not mean a medicine is safe for you. Check the complete, current label with your prescriber.

• • Known hypersensitivity or idiosyncrasy to sympathomimetic amines (historical label)
• • Concurrent use of MAOIs or within 14 days of discontinuing MAOIs
• • Advanced arteriosclerosis
• • Symptomatic cardiovascular disease
• • Moderate to severe hypertension
• • Hyperthyroidism
• • Glaucoma
• • Agitated states
• • History of drug abuse (historical label)

Selected label interactions

Not a complete interaction check. Share all medicines, supplements and planned procedures with your pharmacist or prescriber. Do not change treatment yourself.

• • Historical label: MAOIs are contraindicated during use and for 14 days after stopping an MAOI; hypertensive crises may result.
• • Historical label: gastrointestinal and urinary acidifying agents lower amphetamine blood levels; alkalinizing agents increase them.
• • Historical label: tricyclic antidepressants may potentiate cardiovascular effects; antihypertensive effects may be reduced.

Label-listed forms & strengths

Not recommended doses or confirmation of current supply. Ask a pharmacist about local brand and generic availability; do not substitute products yourself.

Tablet

Indications in US label

ADHD, Narcolepsy

Other indications may have different age limits. Local approvals and prescribing rules may differ.

Mechanism and its limits

Zenzedi contains dextroamphetamine sulfate. Its label describes sympathomimetic CNS-stimulant actions but does not establish the precise therapeutic mechanism in ADHD; proposed catecholamine effects are pharmacology, not a demonstrated explanation of efficacy.

Selected adverse reactions

Selected reactions reported in the Zenzedi label’s unnumbered ADVERSE REACTIONS section; frequency is not established and these are not a product-specific controlled-trial “common reactions” list.

• Overstimulation
• Restlessness
• Dizziness
• Insomnia
• Headache
• Dry mouth
• Anorexia
• Weight loss

Not a complete safety list. An omitted reaction is not evidence of no risk. Trial rates cannot be compared directly between medicines or used to predict your risk; spontaneous reports do not establish frequency or causation. See the cited label and serious warnings below.

Contraindications in cited label

Conditions in the cited label’s contraindications section are listed separately from warnings above. Absence from this list does not mean a medicine is safe for you. Check the complete, current label with your prescriber.

• • Known hypersensitivity to amphetamine products
• • Concurrent use of MAOIs or within 14 days of discontinuing MAOIs

Selected label interactions

Not a complete interaction check. Share all medicines, supplements and planned procedures with your pharmacist or prescriber. Do not change treatment yourself.

• • MAOIs: contraindicated during use and for 14 days after stopping an MAOI because of hypertensive crisis risk.
• • Serotonergic drugs and CYP2D6 inhibitors: increased serotonin syndrome risk; CYP2D6 inhibitors may increase exposure. Prescriber-led dose decisions and monitoring are required.
• • Gastrointestinal and urinary acidifying agents lower amphetamine blood levels; alkalinizing agents increase them. Ask the prescriber to check these combinations.
• • Tricyclic antidepressants may potentiate cardiovascular effects; antihypertensive effects may be reduced.

Label-listed forms & strengths

Not recommended doses or confirmation of current supply. Ask a pharmacist about local brand and generic availability; do not substitute products yourself.

Capsule

Indications in US label

ADHD

Other indications may have different age limits. Local approvals and prescribing rules may differ.

Mechanism and its limits

Adderall XR contains mixed amphetamine salts in a 3:1 d- to l-amphetamine ratio. Section 12.1 says amphetamines have CNS-stimulant activity but the mode of therapeutic action in ADHD is unknown.

Release System

Two types of drug-containing beads (immediate-release and delayed-release) prolong release compared with Adderall immediate-release tablets; the label does not state a 50/50 split.

Selected adverse reactions

Section 6.1 controlled ADHD trials: reactions occurring in ≥5% and more often than placebo in at least one labeled population (ages 6–12, 13–17, or adults).

• Loss of appetite
• Insomnia
• Abdominal pain
• Emotional lability
• Vomiting
• Nervousness
• Nausea
• Fever
• Weight loss
• Dry mouth
• Headache
• Anxiety
• Agitation
• Dizziness
• Tachycardia
• Diarrhea
• Asthenia
• Urinary tract infection

Not a complete safety list. An omitted reaction is not evidence of no risk. Trial rates cannot be compared directly between medicines or used to predict your risk; spontaneous reports do not establish frequency or causation. See the cited label and serious warnings below.

Contraindications in cited label

Conditions in the cited label’s contraindications section are listed separately from warnings above. Absence from this list does not mean a medicine is safe for you. Check the complete, current label with your prescriber.

• • Known hypersensitivity to amphetamine or other components of Adderall XR
• • Concurrent use of MAOIs or within 14 days of discontinuing MAOIs

Selected label interactions

Not a complete interaction check. Share all medicines, supplements and planned procedures with your pharmacist or prescriber. Do not change treatment yourself.

• • MAOIs: contraindicated during use and for 14 days after stopping an MAOI because of hypertensive crisis risk.
• • Serotonergic drugs and CYP2D6 inhibitors: increased serotonin syndrome risk; CYP2D6 inhibitors may increase exposure. Prescriber-led dose decisions and monitoring are required.
• • Avoid gastrointestinal or urinary alkalinizing agents, which increase amphetamine blood levels. Acidifying agents lower blood levels; the prescriber must assess clinical response.
• • Tricyclic antidepressants may potentiate cardiovascular effects; frequent monitoring and prescriber-led treatment changes may be needed.
• • Proton pump inhibitors can change the timing of peak concentration; monitor for changes in clinical effect rather than assuming a coverage window.

Label-listed forms & strengths

Not recommended doses or confirmation of current supply. Ask a pharmacist about local brand and generic availability; do not substitute products yourself.

Capsule, Chewable Tablet

Indications in US label

ADHD, Binge eating disorder (adults)

Other indications may have different age limits. Local approvals and prescribing rules may differ.

Mechanism and its limits

Lisdexamfetamine is a prodrug converted primarily in blood to dextroamphetamine and l-lysine. Section 12.1 says amphetamines have CNS-stimulant activity but the exact therapeutic mechanism in ADHD and binge eating disorder is unknown; conversion pharmacology does not establish individual onset, duration, or efficacy.

Release System

Prodrug converted primarily in blood by red-blood-cell hydrolytic activity to dextroamphetamine and l-lysine; this is pharmacokinetics, not an extended-release efficacy claim.

Active Metabolite

d-amphetamine

Selected adverse reactions

Section 6.1 controlled ADHD trials in patients ages 6–17 and/or adults: incidence ≥5% and at least twice placebo.

• Anorexia
• Anxiety
• Decreased appetite
• Weight decreased
• Diarrhea
• Dizziness
• Dry mouth
• Irritability
• Insomnia
• Nausea
• Upper abdominal pain
• Vomiting

Not a complete safety list. An omitted reaction is not evidence of no risk. Trial rates cannot be compared directly between medicines or used to predict your risk; spontaneous reports do not establish frequency or causation. See the cited label and serious warnings below.

Contraindications in cited label

Conditions in the cited label’s contraindications section are listed separately from warnings above. Absence from this list does not mean a medicine is safe for you. Check the complete, current label with your prescriber.

• • Known hypersensitivity to amphetamine products or other ingredients of Vyvanse
• • Concurrent use of MAOIs or within 14 days of discontinuing MAOIs

Selected label interactions

Not a complete interaction check. Share all medicines, supplements and planned procedures with your pharmacist or prescriber. Do not change treatment yourself.

• • MAOIs: contraindicated during use and for 14 days after stopping an MAOI because of hypertensive crisis risk.
• • Serotonergic drugs increase serotonin syndrome risk; CYP2D6 inhibitors may increase exposure to the active dextroamphetamine metabolite and this risk. Prescriber-led dose decisions and monitoring are required.
• • Avoid urinary alkalinizing agents, which increase amphetamine blood levels. Urinary acidifying agents lower blood levels; the prescriber must assess clinical response.
• • Tricyclic antidepressants may potentiate cardiovascular effects; frequent monitoring and prescriber-led treatment changes may be needed.

Label-listed forms & strengths

Not recommended doses or confirmation of current supply. Ask a pharmacist about local brand and generic availability; do not substitute products yourself.

Capsule

Indications in US label

ADHD

Other indications may have different age limits. Local approvals and prescribing rules may differ.

Mechanism and its limits

Mydayis contains mixed amphetamine salts in a 3:1 d- to l-amphetamine ratio. Section 12.1 says amphetamines have CNS-stimulant activity but the exact therapeutic mechanism in ADHD is unknown; release phases do not establish an individual symptom-coverage window.

Release System

Three drug-releasing bead types: immediate-release plus two delayed-release beads that release at pH 5.5 and pH 7.0.

Selected adverse reactions

Section 6.1 controlled ADHD trials: incidence ≥5% and at least twice placebo in adolescents ages 13–17 and/or adults.

• Insomnia
• Decreased appetite
• Weight decreased
• Irritability
• Nausea
• Dry mouth
• Heart rate increased
• Anxiety

Not a complete safety list. An omitted reaction is not evidence of no risk. Trial rates cannot be compared directly between medicines or used to predict your risk; spontaneous reports do not establish frequency or causation. See the cited label and serious warnings below.

Contraindications in cited label

Conditions in the cited label’s contraindications section are listed separately from warnings above. Absence from this list does not mean a medicine is safe for you. Check the complete, current label with your prescriber.

• • Known hypersensitivity to amphetamine or other components of Mydayis
• • Concurrent use of MAOIs or within 14 days of discontinuing MAOIs

Selected label interactions

Not a complete interaction check. Share all medicines, supplements and planned procedures with your pharmacist or prescriber. Do not change treatment yourself.

• • MAOIs: contraindicated during use and for 14 days after stopping an MAOI because of hypertensive crisis risk.
• • Serotonergic drugs increase serotonin syndrome risk; CYP2D6 inhibitors may increase amphetamine exposure. Prescriber-led dose decisions and monitoring are required.
• • Gastrointestinal and urinary alkalinizing agents: the label calls for caution because exposure may increase. Acidifying agents lower blood levels; the prescriber must assess clinical response.
• • Tricyclic antidepressants may potentiate cardiovascular effects; frequent monitoring and prescriber-led treatment changes may be needed.
• • Gastric pH modulators may change the pharmacokinetic profile and exposure; monitor changes in clinical effect and use alternative therapy based on clinical response.

Label-listed forms & strengths

Not recommended doses or confirmation of current supply. Ask a pharmacist about local brand and generic availability; do not substitute products yourself.

Capsule

Indications in US label

ADHD, Narcolepsy

Other indications may have different age limits. Local approvals and prescribing rules may differ.

Mechanism and its limits

Dexedrine Spansule contains dextroamphetamine sulfate. The label describes sympathomimetic CNS-stimulant actions but does not establish the precise therapeutic mechanism in ADHD; proposed catecholamine effects are pharmacology, not a demonstrated explanation of efficacy.

Release System

Sustained-release capsule formulation; the label does not establish an individual duration of benefit.

Selected adverse reactions

Selected reactions reported in the Dexedrine Spansule label’s unnumbered ADVERSE REACTIONS section; frequency is not established and these are not a controlled-trial “common reactions” list.

• Overstimulation
• Restlessness
• Dizziness
• Insomnia
• Headache
• Dry mouth
• Anorexia
• Weight loss

Not a complete safety list. An omitted reaction is not evidence of no risk. Trial rates cannot be compared directly between medicines or used to predict your risk; spontaneous reports do not establish frequency or causation. See the cited label and serious warnings below.

Contraindications in cited label

Conditions in the cited label’s contraindications section are listed separately from warnings above. Absence from this list does not mean a medicine is safe for you. Check the complete, current label with your prescriber.

• • Known hypersensitivity to amphetamine or other components of Dexedrine
• • Concurrent use of MAOIs or within 14 days of discontinuing MAOIs

Selected label interactions

Not a complete interaction check. Share all medicines, supplements and planned procedures with your pharmacist or prescriber. Do not change treatment yourself.

• • MAOIs: contraindicated during use and for 14 days after stopping an MAOI because of hypertensive crisis risk.
• • Serotonergic drugs and CYP2D6 inhibitors: increased serotonin syndrome risk; CYP2D6 inhibitors may increase exposure. Prescriber-led dose decisions and monitoring are required.
• • Acidifying agents lower amphetamine blood levels; alkalinizing agents increase them. The label says to avoid gastrointestinal alkalinizing agents.
• • Tricyclic antidepressants may potentiate cardiovascular effects; antihypertensive effects may be reduced.
• • Proton pump inhibitors can change the timing of peak concentration; monitor for changes in clinical effect rather than assuming a coverage window.

Label-listed forms & strengths

Not recommended doses or confirmation of current supply. Ask a pharmacist about local brand and generic availability; do not substitute products yourself.

Oral Suspension, Tablet

Indications in US label

ADHD

Other indications may have different age limits. Local approvals and prescribing rules may differ.

Mechanism and its limits

Dyanavel XR contains amphetamine in an approximately 3.2:1 d- to l-amphetamine ratio. Section 12.1 describes CNS-stimulant sympathomimetic pharmacology but says the therapeutic mode of action in ADHD is unknown.

Release System

Extended-release oral suspension or extended-release tablet; the label does not establish an individual duration of benefit.

Selected adverse reactions

Section 6.1 Phase 3 controlled Dyanavel XR oral-suspension trial in 108 pediatric patients ages 6–12 with ADHD: incidence ≥2% and greater than placebo.

• Epistaxis
• Allergic rhinitis
• Upper abdominal pain

Not a complete safety list. An omitted reaction is not evidence of no risk. Trial rates cannot be compared directly between medicines or used to predict your risk; spontaneous reports do not establish frequency or causation. See the cited label and serious warnings below.

Contraindications in cited label

Conditions in the cited label’s contraindications section are listed separately from warnings above. Absence from this list does not mean a medicine is safe for you. Check the complete, current label with your prescriber.

• • Known hypersensitivity to amphetamine or other components of Dyanavel XR
• • Concurrent use of MAOIs or within 14 days of discontinuing MAOIs

Selected label interactions

Not a complete interaction check. Share all medicines, supplements and planned procedures with your pharmacist or prescriber. Do not change treatment yourself.

• • MAOIs: contraindicated during use and for 14 days after stopping an MAOI because of hypertensive crisis risk.
• • Serotonergic drugs and CYP2D6 inhibitors: increased serotonin syndrome risk; CYP2D6 inhibitors may increase exposure. Prescriber-led dose decisions and monitoring are required.
• • Avoid gastrointestinal or urinary alkalinizing agents, which increase amphetamine blood levels. Gastrointestinal or urinary acidifying agents lower blood levels; the prescriber must assess clinical response.
• • Tricyclic antidepressants may potentiate cardiovascular effects; frequent monitoring and prescriber-led treatment changes may be needed.

Label-listed forms & strengths

Not recommended doses or confirmation of current supply. Ask a pharmacist about local brand and generic availability; do not substitute products yourself.

ODT

Indications in US label

ADHD

Other indications may have different age limits. Local approvals and prescribing rules may differ.

Mechanism and its limits

Adzenys XR-ODT contains amphetamine in an approximately 3.2:1 d- to l-amphetamine ratio. Section 12.1 says its therapeutic mode of action in ADHD is unknown; the label separately describes proposed norepinephrine and dopamine release/reuptake pharmacology.

Release System

Extended-release orally disintegrating tablet; the label does not establish an individual duration of benefit.

Selected adverse reactions

Section 6.1 controlled trials of the referenced single-entity mixed amphetamine salts extended-release capsules, which support Adzenys XR-ODT safety: incidence ≥5% and higher than placebo in at least one labeled age population; these were not direct Adzenys XR-ODT trials.

• Loss of appetite
• Insomnia
• Abdominal pain
• Emotional lability
• Vomiting
• Nervousness
• Nausea
• Fever
• Weight loss
• Dry mouth
• Headache
• Anxiety
• Agitation
• Dizziness
• Tachycardia
• Diarrhea
• Asthenia
• Urinary tract infection

Not a complete safety list. An omitted reaction is not evidence of no risk. Trial rates cannot be compared directly between medicines or used to predict your risk; spontaneous reports do not establish frequency or causation. See the cited label and serious warnings below.

Contraindications in cited label

Conditions in the cited label’s contraindications section are listed separately from warnings above. Absence from this list does not mean a medicine is safe for you. Check the complete, current label with your prescriber.

• • Known hypersensitivity to amphetamine or other components of Adzenys XR-ODT
• • Concurrent use of MAOIs or within 14 days of discontinuing MAOIs

Selected label interactions

Not a complete interaction check. Share all medicines, supplements and planned procedures with your pharmacist or prescriber. Do not change treatment yourself.

• • MAOIs: contraindicated during use and for 14 days after stopping an MAOI because of hypertensive crisis risk.
• • Serotonergic drugs increase serotonin syndrome risk; prescriber-led dose decisions and monitoring are required.
• • Alkalinizing agents increase amphetamine blood levels; section 7 specifically says to avoid gastrointestinal alkalinizing agents. Acidifying agents lower blood levels; the prescriber must assess clinical response.
• • Tricyclic antidepressants may potentiate cardiovascular effects; frequent monitoring and prescriber-led treatment changes may be needed.

Label-listed forms & strengths

Not recommended doses or confirmation of current supply. Ask a pharmacist about local brand and generic availability; do not substitute products yourself.

Patch

Indications in US label

ADHD

Other indications may have different age limits. Local approvals and prescribing rules may differ.

Mechanism and its limits

Xelstrym delivers dextroamphetamine through a transdermal system. Section 12.1 says amphetamines have CNS-stimulant activity but the exact therapeutic mode of action in ADHD is unknown; transdermal delivery does not establish continuous absorption, steady levels, or an individual efficacy window.

Release System

Transdermal system labeled for no more than 9 hours of wear; wear time is an administration limit, not a duration-of-benefit claim.

Selected adverse reactions

Section 6.1 double-blind, placebo-controlled Xelstrym trial phase in pediatric patients ages 6–17 with ADHD: incidence ≥2% and greater than placebo.

• Decreased appetite
• Headache
• Insomnia
• Affect lability
• Tic
• Vomiting
• Abdominal pain
• Nausea
• Irritability
• Blood pressure increased
• Heart rate increased

Not a complete safety list. An omitted reaction is not evidence of no risk. Trial rates cannot be compared directly between medicines or used to predict your risk; spontaneous reports do not establish frequency or causation. See the cited label and serious warnings below.

Contraindications in cited label

Conditions in the cited label’s contraindications section are listed separately from warnings above. Absence from this list does not mean a medicine is safe for you. Check the complete, current label with your prescriber.

• • Known hypersensitivity to amphetamine products or other components of Xelstrym
• • Concurrent use of MAOIs or within 14 days of discontinuing MAOIs

Selected label interactions

Not a complete interaction check. Share all medicines, supplements and planned procedures with your pharmacist or prescriber. Do not change treatment yourself.

• • MAOIs: contraindicated during use and for 14 days after stopping an MAOI because of hypertensive crisis risk.
• • Serotonergic drugs and CYP2D6 inhibitors: increased serotonin syndrome risk; CYP2D6 inhibitors may increase exposure. Prescriber-led dose decisions and monitoring are required.
• • Avoid urinary alkalinizing agents, which increase amphetamine blood levels. Urinary acidifying agents lower blood levels; the prescriber must assess clinical response.
• • Tricyclic antidepressants may potentiate cardiovascular effects; frequent monitoring and prescriber-led treatment changes may be needed.

Label-listed forms & strengths

Not recommended doses or confirmation of current supply. Ask a pharmacist about local brand and generic availability; do not substitute products yourself.

Capsule

Indications in US label

ADHD

Other indications may have different age limits. Local approvals and prescribing rules may differ.

Mechanism and its limits

The precise mechanism by which Strattera produces therapeutic effects in ADHD is unknown. The label states that it is thought to relate to selective inhibition of the presynaptic norepinephrine transporter, based on ex vivo uptake and neurotransmitter-depletion studies (section 12.1).

Selected adverse reactions

Section 6.1 most commonly observed reactions in short-term placebo-controlled ADHD studies: incidence at least 5% and at least twice placebo. Pediatric patients 6 years and older and adults are listed separately.

• Pediatric: nausea, vomiting, fatigue, decreased appetite, abdominal pain, somnolence
• Adults: constipation, dry mouth, nausea, decreased appetite, dizziness, erectile dysfunction, urinary hesitation

Not a complete safety list. An omitted reaction is not evidence of no risk. Trial rates cannot be compared directly between medicines or used to predict your risk; spontaneous reports do not establish frequency or causation. See the cited label and serious warnings below.

Contraindications in cited label

Conditions in the cited label’s contraindications section are listed separately from warnings above. Absence from this list does not mean a medicine is safe for you. Check the complete, current label with your prescriber.

• • Known hypersensitivity to atomoxetine or other constituents of Strattera
• • Concurrent use of MAOIs or within 14 days of discontinuing MAOIs
• • Narrow-angle glaucoma
• • Pheochromocytoma or history of pheochromocytoma
• • Severe cardiac or vascular disorders expected to deteriorate with clinically important increases in blood pressure or heart rate

Selected label interactions

Not a complete interaction check. Share all medicines, supplements and planned procedures with your pharmacist or prescriber. Do not change treatment yourself.

• • MAOIs: contraindicated during use and for 14 days after stopping an MAOI. Also wait at least 14 days after stopping Strattera before starting an MAOI; the prescriber must manage switching.
• • Strong CYP2D6 inhibitors increase atomoxetine exposure and require prescriber-led dosing and titration-interval decisions; CYP2D6 poor metabolizers also need special dosing consideration.
• • Antihypertensives, pressor drugs and other medicines that increase blood pressure: use cautiously with more frequent blood-pressure monitoring.
• • Albuterol or other beta2 agonists: more frequent blood-pressure and heart-rate monitoring may be needed. Systemically administered albuterol can have potentiated cardiovascular effects.

Label-listed forms & strengths

Not recommended doses or confirmation of current supply. Ask a pharmacist about local brand and generic availability; do not substitute products yourself.

Capsule

Indications in US label

ADHD

Other indications may have different age limits. Local approvals and prescribing rules may differ.

Mechanism and its limits

The mechanism of action in ADHD is unclear; the label states that it is thought to be through inhibiting norepinephrine reuptake. Separately, pharmacodynamic studies show norepinephrine-transporter binding and inhibition and partial agonist activity at serotonin 5-HT2C receptors; the label does not establish that the serotonin activity produces the ADHD benefit (sections 12.1–12.2).

Release System

Extended-release capsule

Selected adverse reactions

Section 6.1 most commonly observed reactions in short-term randomized placebo-controlled ADHD trials: incidence at least 5% and at least twice placebo. Pediatric pooled trials (ages 6–17; 6–8 weeks) and the adult flexible-dose trial (ages 18–60; 6 weeks) are listed separately.

• Pediatric: somnolence, decreased appetite, fatigue, nausea, vomiting, insomnia, irritability
• Adults: insomnia, headache, somnolence, fatigue, nausea, decreased appetite, dry mouth, constipation

Not a complete safety list. An omitted reaction is not evidence of no risk. Trial rates cannot be compared directly between medicines or used to predict your risk; spontaneous reports do not establish frequency or causation. See the cited label and serious warnings below.

Contraindications in cited label

Conditions in the cited label’s contraindications section are listed separately from warnings above. Absence from this list does not mean a medicine is safe for you. Check the complete, current label with your prescriber.

• • Concurrent use of MAOIs or within 14 days of discontinuing MAOIs
• • Concurrent use with sensitive CYP1A2 substrates or CYP1A2 substrates with a narrow therapeutic range

Selected label interactions

Not a complete interaction check. Share all medicines, supplements and planned procedures with your pharmacist or prescriber. Do not change treatment yourself.

• • MAOIs: contraindicated during use and for 14 days after stopping an MAOI because of potentially life-threatening hypertensive crisis.
• • Strong CYP1A2 inhibition: sensitive CYP1A2 substrates and those with a narrow therapeutic range are contraindicated. Moderately sensitive CYP1A2 substrates are not recommended; a prescriber may need to reduce the substrate dose if coadministered.
• • Weak CYP2D6 and CYP3A4 inhibition can increase exposure to their substrates; monitor adverse reactions and let the prescriber adjust those medicines as needed.

Label-listed forms & strengths

Not recommended doses or confirmation of current supply. Ask a pharmacist about local brand and generic availability; do not substitute products yourself.

Tablet

Indications in US label

ADHD as monotherapy or adjunctive to stimulants

Other indications may have different age limits. Local approvals and prescribing rules may differ.

Mechanism and its limits

Central alpha-2A adrenergic receptor agonist. The mechanism of action in ADHD is not known.

Release System

Extended-release matrix tablet (section 11)

Selected adverse reactions

Section 6.1 selected reactions from pediatric placebo-controlled ADHD trials. Fixed-dose monotherapy items met at least 5% and at least twice placebo; adjunctive items are the label-highlighted reactions from the flexible dose-optimization trial (ages 6–17), whose highlights do not state that same threshold.

• Fixed-dose monotherapy: hypotension, somnolence, fatigue, nausea, lethargy
• Adjunctive to a psychostimulant: somnolence, fatigue, insomnia, dizziness, abdominal pain

Not a complete safety list. An omitted reaction is not evidence of no risk. Trial rates cannot be compared directly between medicines or used to predict your risk; spontaneous reports do not establish frequency or causation. See the cited label and serious warnings below.

Contraindications in cited label

Conditions in the cited label’s contraindications section are listed separately from warnings above. Absence from this list does not mean a medicine is safe for you. Check the complete, current label with your prescriber.

• • History of hypersensitivity to Intuniv, its inactive ingredients, or other guanfacine products

Selected label interactions

Not a complete interaction check. Share all medicines, supplements and planned procedures with your pharmacist or prescriber. Do not change treatment yourself.

• • Strong or moderate CYP3A4 inhibitors increase guanfacine exposure; strong or moderate CYP3A4 inducers decrease it. Both starting and stopping these medicines may require prescriber-led dose changes.
• • Section 5 cautions: antihypertensives and other drugs that lower blood pressure or heart rate may increase hypotension, bradycardia or syncope; CNS depressants can add to sedation.

Label-listed forms & strengths

Not recommended doses or confirmation of current supply. Ask a pharmacist about local brand and generic availability; do not substitute products yourself.

Tablet

Indications in US label

ADHD as monotherapy or adjunctive to stimulants

Other indications may have different age limits. Local approvals and prescribing rules may differ.

Mechanism and its limits

Clonidine stimulates alpha-2 adrenergic receptors in the brain, but its mechanism of action in ADHD is not known. Its reduction of sympathetic outflow from the brain stem is labeled pharmacology for clonidine as an antihypertensive and is not presented as the explanation for ADHD benefit (sections 12.1–12.2 of the historical label).

Release System

Historical label: extended-release tablet designed to delay absorption and decrease peak-to-trough plasma concentration differences; this describes release and does not establish a clinical advantage (section 11).

Selected adverse reactions

Historical 2010 label section 6.1, pediatric placebo-controlled ADHD trials (ages 6–17): selected treatment-period reactions occurring in at least 5% of Kapvay-treated patients and at least twice placebo. The historical label pooled this threshold across monotherapy and adjunctive trial results rather than supplying a current-product estimate.

• Somnolence
• Fatigue
• Upper respiratory tract infection
• Irritability
• Throat pain
• Insomnia
• Nightmares
• Emotional disorder
• Constipation
• Nasal congestion
• Increased body temperature
• Dry mouth
• Ear pain

Not a complete safety list. An omitted reaction is not evidence of no risk. Trial rates cannot be compared directly between medicines or used to predict your risk; spontaneous reports do not establish frequency or causation. See the cited label and serious warnings below.

Contraindications in cited label

Conditions in the cited label’s contraindications section are listed separately from warnings above. Absence from this list does not mean a medicine is safe for you. Check the complete, current label with your prescriber.

• • Known hypersensitivity to clonidine

Selected label interactions

Not a complete interaction check. Share all medicines, supplements and planned procedures with your pharmacist or prescriber. Do not change treatment yourself.

• • Historical label: no pediatric Kapvay interaction studies; the listed interactions were reported with other oral immediate-release clonidine formulations.
• • Historical label: CNS depressants, including alcohol, can add to sedation. Tricyclic antidepressants may reduce the hypotensive effect.
• • Historical label: use caution with digitalis, calcium channel blockers or beta blockers because of additive bradycardia or AV block, and with antihypertensives because of hypotension or syncope.
• • Historical label: do not use with other clonidine-containing products (sections 5.6 and 7.4). This instruction is not listed as a section 4 contraindication.

Label-listed forms & strengths

Not recommended doses or confirmation of current supply. Ask a pharmacist about local brand and generic availability; do not substitute products yourself.

Oral Suspension

Indications in US label

ADHD as monotherapy or adjunctive to CNS stimulants

Other indications may have different age limits. Local approvals and prescribing rules may differ.

Mechanism and its limits

Clonidine stimulates alpha-2 adrenergic receptors in the brain. Its mechanism of action in ADHD is not known.

Release System

Extended-release oral suspension; most of the clonidine hydrochloride is complexed with sodium polystyrene sulfonate (section 11). This formulation description does not establish a clinical advantage.

Selected adverse reactions

Onyda XR label section 6.1: safety is based on pediatric clonidine hydrochloride extended-release tablet trials in ages 6–17, not trials of the oral suspension. Listed reactions occurred at least 5% and at least twice placebo in the fixed-dose monotherapy trial or flexible-dose adjunctive-to-psychostimulant trial.

• Tablet monotherapy evidence: somnolence, fatigue, irritability, insomnia, nightmare, constipation, dry mouth
• Tablet adjunctive-to-psychostimulant evidence: somnolence, fatigue, decreased appetite, dizziness

Not a complete safety list. An omitted reaction is not evidence of no risk. Trial rates cannot be compared directly between medicines or used to predict your risk; spontaneous reports do not establish frequency or causation. See the cited label and serious warnings below.

Contraindications in cited label

Conditions in the cited label’s contraindications section are listed separately from warnings above. Absence from this list does not mean a medicine is safe for you. Check the complete, current label with your prescriber.

• • Known hypersensitivity to clonidine

Selected label interactions

Not a complete interaction check. Share all medicines, supplements and planned procedures with your pharmacist or prescriber. Do not change treatment yourself.

• • Onyda XR interaction studies have not been conducted; section 7 relies on oral immediate-release clonidine data.
• • CNS depressants add to sedation; the label says to avoid concomitant use. Drugs affecting sinus node function or AV conduction (such as digitalis, calcium channel blockers and beta blockers) can add to bradycardia or AV block; avoid concomitant use.
• • Antihypertensives can potentiate hypotension; monitor blood pressure and heart rate. Tricyclic antidepressants can increase blood pressure and counteract the hypotensive effect. The prescriber may need to adjust treatment.