Drug Information for SYMMETREL (Amantadine Hydrochloride, USP) Tablets and SyrupRx only (Endo Pharmaceuticals Inc.): ADVERSE REACTIONS

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  • The adverse reactions reported most frequently at the recommended dose of SYMMETREL (5-10%) are: nausea, dizziness (lightheadedness), and insomnia.

    Less frequently (1-5%) 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 (0.1-1%) 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 SYMMETREL usage include:

    Nervous System/Psychiatriccoma, 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;

    Cardiovascularcardiac arrest, arrhythmias including malignant arrhythmias, hypotension, and tachycardia; Respiratoryacute respiratory failure, pulmonary edema, and tachypnea; Gastrointestinaldysphagia; Hematologicleukocytosis; agranulocytosisSpecial Senseskeratitis and mydriasis; Skin and Appendagespruritus and diaphoresis; Miscellaneousneuroleptic malignant syndrome (see WARNINGS), allergic reactions including anaphylactic reactions, edema, fever, pathological gambling, increased libido including hypersexuality, and impulse control symptoms.Laboratory Testelevated: CPK, BUN, serum creatinine, alkaline phosphatase, LDH, bilirubin, GGT, SGOT, and SGPT.

  • Drug Information Provided by National Library of Medicine (NLM).
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