Amantadine adverse reactions

Amantadine
ZZZZZ® FDA Package Insert
Description
Clinical Pharmacology
Indications and Usage
Contraindications
Warnings and Precautions
Adverse Reactions
Drug Interactions
Overdosage
Dosage and Administration
How Supplied
Labels and Packages

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]

Adverse Reactions

The adverse reactions reported most frequently at the recommended dose of amantadine hydrochloride (5 to10%) 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 hydrochloride 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. Abrupt discontinuation may also precipitate delirium, agitation, delusions, hallucinations, paranoid reaction, stupor, anxiety, depression and slurred speech;

Cardiovascular --cardiac arrest, arrhythmias including malignant arrhythmias, hypotension, and tachycardia;

Respiratory -acute respiratory failure, pulmonary edema, and tachypnea;

Gastrointestinal -dysphagia;

Hematologic -leukocytosis; agranulocytosis

Special Senses -keratitis and mydriasis;

Miscellaneous -neuroleptic malignant syndrome (see WARNINGS), allergic reactions including anaphylactic reactions, edema and fever.

Laboratory Test -elevated: CPK, BUN, serum creatinine, alkaline phosphatase, LDH, bilirubin, GGT, SGOT, and SGPT.

To report SUSPECTED ADVERSE REACTIONS, contact Banner at 1866-231-1749 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

References

Adapted from the FDA Package Insert.