pharmacopeia
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Boxed warning

ABUSE, MISUSE, AND ADDICTION Amphetamine sulfate tablets have a high potential for abuse and misuse, which can lead to the development of a substance use disorder, including addiction. Misuse and abuse of CNS stimulants, including amphetamine sulfate, can result in overdose and death ( see OVERDOSAGE ), and this risk is increased with higher doses or unapproved methods of administration, such as snorting or injection. Before prescribing amphetamine sulfate tablets, assess each patient’s risk for abuse, misuse, and addiction. Educate patients and their families about these risks, proper storage of the drug, and proper disposal of any unused drug. Throughout amphetamine sulfate tablets treatment, reassess each patient’s risk of abuse, misuse, and addiction and frequently monitor for signs and symptoms of abuse, misuse, and addiction ( see WARNINGS and DRUG ABUSE AND DEPENDENCE ).

Mechanism of action

Sourced from openFDA

Mechanism-of-action classes: Dopamine Uptake Inhibitors; Monoamine Oxidase Inhibitors; Norepinephrine Uptake Inhibitors.

Dopamine UptakeMonoamine OxidaseNorepinephrine Uptake

Indications

Sourced from openFDA
  • Amphetamine sulfate tablets are indicated for: Narcolepsy Attention Deficit Disorder with Hyperactivity as an integral part of a total treatment program which typically includes other remedial measures (psychological, educational, social) for a stabilizing effect in children with behavioral syndrome characterized by the following group of developmentally inappropriate symptoms: moderate to severe distractibility, short attention span, hyperactivity, emotional lability, and impulsivity. The diagnosis of the syndrome should not be made with finality when these symptoms are only of comparatively recent origin.ICD-10: F90.9, G47.419

Contraindications

Sourced from openFDA
  • Known hypersensitivity to amphetamine products. During or within 14 days following the administration of monoamine oxidase inhibitors (hypertensive crises may result) ( see WARNINGS ).contraindicated

Dosage & administration

Sourced from openFDA

Regardless of indication, amphetamine should be administered at the lowest effective dosage and dosage should be individually adjusted. Late evening doses should be avoided because of resulting insomnia. Narcolepsy Usual dose is 5 to 60 milligrams per day in divided doses depending on the individual patient response. Narcolepsy seldom occurs in children under 12 years of age; however, when it does, amphetamine sulfate tablets may be used. The suggested initial dose for patients aged 6 to 12 is 5 mg daily; daily dose may be raised in increments of 5 mg at weekly intervals until optimal response obtained. In patients 12 years of age and older, start with 10 mg daily; daily dosage may be raised in increments of 10 mg at weekly intervals until optimal response is obtained. If bothersome adverse reactions appear (e.g., insomnia or anorexia) dosage should be reduced. Give the first dose on awakening; additional doses (5 or 10 mg) at intervals of 4 to 6 hours. Attention Deficit Disorder with Hyperactivity Not recommended for children under 3 years of age. In children from 3 to 5 years of age, start with 2.5 mg daily; daily dosage may be raised in increments of 2.5 mg at weekly intervals until optimal response is obtained. In children 6 years of age or older, start with 5 mg once or twice daily; daily dosage may be raised in increments of 5 mg at weekly intervals until optimal response is obtained. Only in rare cases will it be necessary to exceed a total of 40 milligrams per day. With tablets give first dose on awakening; additional doses (1 to 2) at intervals of 4 to 6 hours.

Warnings & precautions

Sourced from openFDA

Abuse, Misuse, and Addiction Amphetamine sulfate tablets have a high potential for abuse and misuse. The use of amphetamine sulfate tablets exposes individuals to the risks of abuse and misuse, which can lead to the development of a substance use disorder, including addiction. Amphetamine sulfate can be diverted for non-medical use into illicit channels or distribution ( see DRUG ABUSE AND DEPENDENCE ). Misuse and abuse of CNS stimulants, including amphetamine sulfate tablets, can result in overdose and death ( see OVERDOSAGE ), and this risk is increased with higher doses or unapproved methods of administration, such as snorting or injection. Before prescribing amphetamine sulfate tablets, assess each patient’s risk for abuse, misuse, and addiction. Educate patients and their families about these risks and proper disposal of any unused drug. Advise patients to store amphetamine sulfate in a safe place, preferably locked, and instruct patients to not give amphetamine sulfate tablets to anyone else. Throughout amphetamine sulfate tablets treatment, reassess each patient’s risk of abuse, misuse, and addiction and frequently monitor for signs and symptoms of abuse, misuse, and addiction. Risks to Patients with Serious Cardiac Disease Sudden death has been reported in patients with structural cardiac abnormalities or other serious cardiac disease who are treated with CNS stimulants at the recommended ADHD dosages.

Adverse reactions

Sourced from openFDA

Cardiovascular Palpitations, tachycardia, elevation of blood pressure. There have been isolated reports of cardiomyopathy associated with chronic amphetamine use. Central Nervous System Psychotic episodes at recommended doses (rare), overstimulation, restlessness, dizziness, insomnia, euphoria, dyskinesia, dysphoria, tremor, headache, exacerbation of motor and verbal tics and Tourette's syndrome. Gastrointestinal Dryness of the mouth, unpleasant taste, diarrhea, constipation, intestinal ischemia and other gastrointestinal disturbances. Anorexia and weight loss may occur as undesirable effects when amphetamines are used for other than the anorectic effect. Allergic Urticaria Endocrine Impotence, changes in libido, and frequent or prolonged erections. Musculoskeletal Rhabdomyolysis

Use in specific populations

Sourced from openFDA

Pregnancy Teratogenic Effects Dextroamphetamine sulfate has been shown to have embryotoxic and teratogenic effects when administered to A/Jax mice and C57BL mice in doses approximately 41 times the maximum human dose. Embryotoxic effects were not seen in New Zealand white rabbits given the drug in doses 7 times the human dose nor in rats given 12.5 times the maximum human dose. There are no adequate and well-controlled studies in pregnant women. Amphetamine sulfate tablets should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Nonteratogenic Effects Infants born to mothers dependent on amphetamines have an increased risk of premature delivery and low birth weight. Also, these infants may experience symptoms of withdrawal as demonstrated by dysphoria, including agitation, and significant lassitude.

Overdosage

Sourced from openFDA

Clinical Effects of Overdose Overdose of CNS stimulants is characterized by the following sympathomimetic effects: Cardiovascular effects including tachyarrhythmias, and hypertension or hypotension. Vasospasm, myocardial infarction, or aortic dissection may precipitate sudden cardiac death. Takotsubo cardiomyopathy may develop. CNS effects including psychomotor agitation, confusion, and hallucinations. Serotonin syndrome, seizures, cerebral vascular accidents, and coma may occur. Life-threatening hyperthermia (temperatures greater than 104°F) and rhabdomyolysis may develop. Overdose Management Consider the possibility of multiple drug ingestion. D-amphetamine is not dialyzable. Consider contacting the Poison Help line (1-800-222-1222) or a medical toxicologist for additional overdose management recommendations.

Approval history

Sourced from openFDA
  • Oct 11, 2001NDANDA021303Takeda Pharms Usa
  • Feb 11, 2002ANDAANDA040422Barr
  • Jun 14, 2002ANDAANDA040439Sandoz
  • Jun 19, 2002ANDAANDA040444Epic Pharma Llc
  • Oct 19, 2015NDANDA208147Tris Pharma Inc
  • Jan 27, 2016NDANDA204326Neos Theraps
  • Jun 20, 2017NDANDA022063Takeda Pharms Usa
  • Nov 4, 2021NDANDA210526Tris Pharma Inc

FAERS reports

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Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
49,302 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Drug Ineffective5,12710%
  2. 2Fatigue3,4357.0%
  3. 3Nausea3,0786.2%
  4. 4Headache2,8785.8%
  5. 5Anxiety2,6675.4%
  6. 6Depression2,2434.5%
  7. 7Toxicity To Various Agents2,2324.5%
  8. 8Feeling Abnormal2,1174.3%
  9. 9Drug Abuse1,9263.9%
  10. 10Somnolence1,8893.8%
  11. 11Pain1,8703.8%
  12. 12Dizziness1,8673.8%
  13. 13Insomnia1,7613.6%
  14. 14Off Label Use1,6893.4%
  15. 15Vomiting1,3942.8%

Literature

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Recent PubMed references pinned to Amphetamine as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

Clinical trials

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The 10 most recently updated of 467 ClinicalTrials.gov registrations naming Amphetamine as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Pharmacogenomics

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CPIC-curated drug–gene pairs for Amphetamine. Levels describe the strength of curated evidence and guideline status — never a recommendation to test or to adjust therapy.

  • CYP2D6CPIC B/C (provisional)FDA label: Informative PGx

Frequently asked questions

How does Amphetamine work?
Mechanism-of-action classes: Dopamine Uptake Inhibitors; Monoamine Oxidase Inhibitors; Norepinephrine Uptake Inhibitors.
What is Amphetamine used for?
According to FDA labeling, Amphetamine carries indications including: Amphetamine sulfate tablets are indicated for: Narcolepsy Attention Deficit Disorder with Hyperactivity as an integral part of a total treatment program which typically includes other remedial measures (psychological, educational, social) for a stabilizing effect in children with behavioral syndrome characterized by the following group of developmentally inappropriate symptoms: moderate to severe distractibility, short attention span, hyperactivity, emotional lability, and impulsivity. The diagnosis of the syndrome should not be made with finality when these symptoms are only of comparatively recent origin.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Amphetamine?
Amphetamine is classified as Centrally acting sympathomimetics, Central Nervous System Stimulant, Dopamine Uptake Inhibitors, Monoamine Oxidase Inhibitors, Norepinephrine Uptake Inhibitors, Bronchodilation, Central Nervous System Stimulation, Increased Blood Pressure, Increased Cerebral Cortex Dopamine Activity, Increased Cerebral Cortex Norepinephrine Activity, Increased Thyroid Hormone Secretion, Vascular Sclerosing Activity.
What are the brand names for Amphetamine?
Amphetamine is marketed under brand names including Adderall, Adzenys, Dyanavel, Evekeo, Mydayis.
What are the contraindications for Amphetamine?
Amphetamine labeling lists contraindications including: Known hypersensitivity to amphetamine products. During or within 14 days following the administration of monoamine oxidase inhibitors (hypertensive crises may result) ( see WARNINGS ).. Always consult the full prescribing information and a clinician.
Note. Data for amphetamine is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

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