pharmacopeia
GET
/api/v1/drug/amantadine
2D structure
adamantan-1-amine
SMILES C1C2CC3CC1CC(C2)(C3)N
InChIKey DKNWSYNQZKUICI-UHFFFAOYSA-N

Mechanism of action

Sourced from openFDA

Mechanism-of-action classes: Dopamine Receptor Interactions; Ion Channel Interactions; M2 Protein Inhibitors.

M2 Protein

Indications

Sourced from openFDA
  • Amantadine hydrochloride capsules, USP are indicated for the prophylaxis and treatment of signs and symptoms of infection caused by various strains of influenza A virus. Amantadine hydrochloride capsules, USP are also indicated in the treatment of parkinsonism and drug-induced extrapyramidal reactions.ICD-10: J11.1

Contraindications

Sourced from openFDA
  • Amantadine hydrochloride capsules, USP are contraindicated in patients with known hypersensitivity to amantadine hydrochloride or to any of the other ingredients in amantadine hydrochloride capsules, USP.contraindicated

Dosage & administration

Sourced from openFDA

The dose of amantadine hydrochloride capsules may need reduction in patients with congestive heart failure, peripheral edema, orthostatic hypotension, or impaired renal function (see Dosage for Impaired Renal Function ).

Warnings & precautions

Sourced from openFDA

Deaths Deaths have been reported from overdose with amantadine. The lowest reported acute lethal dose was 1 gram. Acute toxicity may be attributable to the anticholinergic effects of amantadine. Drug overdose has resulted in cardiac, respiratory, renal or central nervous system toxicity. Cardiac dysfunction includes arrhythmia, tachycardia and hypertension (see OVERDOSAGE ). Deaths due to drug accumulation (overdosage) have been reported in patients with renal impairment, who were prescribed higher than recommended doses of amantadine hydrochloride for their level of renal function [see DOSAGE AND ADMINISTRATION: Dosage of Impaired Renal Function and OVERDOSAGE ]. Suicide Attempts Suicide attempts, some of which have been fatal, have been reported in patients treated with amantadine, many of whom received short courses for influenza treatment or prophylaxis. The incidence of suicide attempts is not known and the pathophysiologic mechanism is not understood. Suicide attempts and suicidal ideation have been reported in patients with and without prior history of psychiatric illness. Amantadine can exacerbate mental problems in patients with a history of psychiatric disorders or substance abuse. Patients who attempt suicide may exhibit abnormal mental states which include disorientation, confusion, depression, personality changes, agitation, aggressive behavior, hallucinations, paranoia, other psychotic reactions, and somnolence or insomnia.

Adverse reactions

Sourced from openFDA

The adverse reactions reported most frequently at the recommended dose of amantadine (5 to 10%) are: nausea, dizziness (lightheadedness), and insomnia. Less frequently (1 to 5%) reported adverse reactions are: depression, anxiety and irritability, hallucinations, confusion, anorexia, dry mouth, constipation, ataxia, livedo reticularis, peripheral edema, orthostatic hypotension, headache, somnolence, nervousness, dream abnormality, agitation, dry nose, diarrhea and fatigue. Infrequently (0.1 to 1%) occurring adverse reactions are: congestive heart failure, psychosis, urinary retention, dyspnea, skin rash, vomiting, weakness, slurred speech, euphoria, thinking abnormality, amnesia, hyperkinesia, hypertension, decreased libido, and visual disturbance, including punctate subepithelial or other corneal opacity, corneal edema, decreased visual acuity, sensitivity to light, and optic nerve palsy. Rare (less than 0.1%) occurring adverse reactions are: instances of convulsion, leukopenia, neutropenia, eczematoid dermatitis, oculogyric episodes, suicidal attempt, suicide, and suicidal ideation (see WARNINGS ). Other adverse reactions reported during postmarketing experience with amantadine usage include: Nervous System/Psychiatric coma, stupor, delirium, hypokinesia, hypertonia, delusions, aggressive behavior, paranoid reaction, manic reaction, involuntary muscle contractions, gait abnormalities, paresthesia, EEG changes, and tremor.

Use in specific populations

Sourced from openFDA

Use in the Elderly Because amantadine is primarily excreted in the urine, it accumulates in the plasma and in the body when renal function declines. Thus, the dose of amantadine should be reduced in patients with renal impairment and in individuals who are 65 years of age or older. The dose of amantadine hydrochloride capsules may need reduction in patients with congestive heart failure, peripheral edema, or orthostatic hypotension (see DOSAGE AND ADMINISTRATION ).

Pharmacokinetics

Sourced from openFDA
Metabolism
Amantadine is well absorbed orally. Maximum plasma concentrations are directly related to dose for doses up to 200 mg/day.

Overdosage

Sourced from openFDA

Deaths have been reported from overdose with amantadine. The lowest reported acute lethal dose was 1 gram. Because some patients have attempted suicide by overdosing with amantadine, prescriptions should be written for the smallest quantity consistent with good patient management. Acute toxicity may be attributable to the anticholinergic effects of amantadine. Drug overdose has resulted in cardiac, respiratory, renal or central nervous system toxicity. Cardiac dysfunction includes arrhythmia, tachycardia and hypertension. Pulmonary edema and respiratory distress (including adult respiratory distress syndrome – ARDS) have been reported; renal dysfunction including increased BUN, decreased creatinine clearance and renal insufficiency can occur. Central nervous system effects that have been reported include insomnia, anxiety, agitation, aggressive behavior, hypertonia, hyperkinesia, ataxia, gait abnormality, tremor, confusion, disorientation, depersonalization, fear, delirium, hallucinations, psychotic reactions, lethargy, somnolence and coma. Seizures may be exacerbated in patients with prior history of seizure disorders.

Approval history

Sourced from openFDA
  • Jan 7, 1987ANDAANDA070589Upsher Smith Labs
  • Jun 28, 1993ANDAANDA074028Chartwell Rx
  • Jul 17, 1995ANDAANDA074509Pharm Assoc
  • Dec 24, 1998ANDAANDA075060Pharmobedient
  • Sep 11, 2002ANDAANDA075819Adaptis
  • Dec 16, 2002ANDAANDA076186Upsher Smith Labs
  • May 29, 2008ANDAANDA078720Bionpharma
  • Aug 24, 2017NDANDA208944Supernus Pharms

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.
19,798 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. 1Fall2,10811%
  2. 2Hallucination1,5087.6%
  3. 3Drug Ineffective1,4977.6%
  4. 4Fatigue1,3887.0%
  5. 5Dyskinesia1,2506.3%
  6. 6Gait Disturbance1,1565.8%
  7. 7Dizziness1,1185.6%
  8. 8Tremor1,0065.1%
  9. 9Death9825.0%
  10. 10Nausea8414.2%
  11. 11Asthenia8384.2%
  12. 12Balance Disorder7753.9%
  13. 13Condition Aggravated7753.9%
  14. 14Urinary Tract Infection7673.9%
  15. 15Confusional State7533.8%

Literature

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Recent PubMed references pinned to Amantadine 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 337 ClinicalTrials.gov registrations naming Amantadine as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Structural analogs

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Ranked by 2D fingerprint (Tanimoto) similarity over PubChem structures. Structural proximity only — not a claim of therapeutic equivalence.

Frequently asked questions

How does Amantadine work?
Mechanism-of-action classes: Dopamine Receptor Interactions; Ion Channel Interactions; M2 Protein Inhibitors.
What is Amantadine used for?
According to FDA labeling, Amantadine carries indications including: Amantadine hydrochloride capsules, USP are indicated for the prophylaxis and treatment of signs and symptoms of infection caused by various strains of influenza A virus. Amantadine hydrochloride capsules, USP are also indicated in the treatment of parkinsonism and drug-induced extrapyramidal reactions.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Amantadine?
Amantadine is classified as Adamantane derivatives, Influenza A M2 Protein Inhibitor, Dopamine Receptor Interactions, Ion Channel Interactions, M2 Protein Inhibitors, Decreased RNA Replication, Increased Central Nervous System Dopamine Activity.
What are the brand names for Amantadine?
Amantadine is marketed under brand names including Gocovri, Osmolex.
What are the contraindications for Amantadine?
Amantadine labeling lists contraindications including: Amantadine hydrochloride capsules, USP are contraindicated in patients with known hypersensitivity to amantadine hydrochloride or to any of the other ingredients in amantadine hydrochloride capsules, USP.. Always consult the full prescribing information and a clinician.
Note. Data for amantadine 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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