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DIR Classification

Classification:Moderate-DIR concern
Severity Score:2

Description in Drug Labeling: View Full Labeling: SPL in DailyMed | PDF

  • Adverse Reactions from Clinical Trials and Spontaneous Postmarketing Reports of Other Amphetamine Products
  • The following adverse reactions are from clinical trials and spontaneous postmarketing reports of other amphetamine products in pediatric patients and adults with ADHD. Because some of these reactions were reported voluntarily from a population of uncertain size, it is not always possible to estimate their frequency reliably or to establish a causal relationship to drug exposure.
  • Cardiovascular: Palpitations, sudden death, myocardial infarction. There have been isolated reports of cardiomyopathy associated with chronic amphetamine use.
  • Central Nervous System: Restlessness, irritability, euphoria, dyskinesia, dysphoria, depression, tremor, aggression, anger, logorrhea, and paresthesia (including formication).
  • Eye Disorders: Vision blurred, mydriasis.
  • Gastrointestinal: Unpleasant taste, constipation, other gastrointestinal disturbances.
  • Allergic: Urticaria, rash, hypersensitivity reactions including angioedema and anaphylaxis. Serious skin rashes, including Stevens-Johnson Syndrome and toxic epidermal necrolysis have been reported.
  • Endocrine: Impotence, change in libido, frequent or prolonged erections.
  • Skin: Alopecia.
  • Musculoskeletal, Connective Tissue, and Bone Disorders: rhabdomyolysis.
  • Psychiatric Disorders: dermatillomania, bruxism.
  • Vascular Disorders: Raynaud's phenomenon.
  • Consult with a Certified Poison Control Center (1-800-222-1222) for up-to-date guidance and advice for treatment of overdosage. Individual patient response to amphetamines varies widely. Toxic symptoms may occur idiosyncratically at low doses.
  • Manifestations of amphetamine overdose include restlessness, tremor, hyperreflexia, rapid respiration, confusion, assaultiveness, hallucinations, panic states, hyperpyrexia and rhabdomyolysis. Fatigue and depression usually follow the central nervous system stimulation. Other reactions include arrhythmias, hypertension or hypotension, circulatory collapse, nausea, vomiting, diarrhea, and abdominal cramps. Fatal poisoning is usually preceded by convulsions and coma.

Postmarketing Surveillance

Contingency Table:

Current Drug
Other Drugs
Other ADRs

Odds Ratio = 4.471

Drug Property Information

ATC Code(s):
  • N06BA01 - amphetamine
    • N06BA - Centrally acting sympathomimetics
Active Ingredient:amphetamine
Active Ingredient UNII:CK833KGX7E
Drugbank ID:DB00182
PubChem Compound:3007
CAS Number:300-62-9
Dosage Form(s):tablet, orally disintegrating
Route(s) Of Administrator:oral
Daily Dose:
  • 15.0 mg/day N06BA01
Chemical Structure:





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