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SYMMETREL (AMANTADINE HCL) TABLETS AND SYRUP: ADVERSE REACTIONS / SIDE EFFECTS

The adverse reactions reported most frequently at the recommended dose of Symmetrel (510%) are: dizziness (lightheadedness), nausea, and insomnia.

Less frequently (1-5%) reported adverse reactions are: depression, anxiety and irritability, confusion, hallucinations, anorexia, constipation, dry mouth, ataxia, peripheral edema, livedo reticularis, orthostatic hypotension, somnolence, headache, nervousness, agitation, dream abnormality, dry nose, diarrhea and fatigue.

Infrequently (0.1-1%) occurring adverse reactions are: psychosis, congestive heart failure, urinary retention, skin rash, dyspnea, vomiting, slurred speech, weakness, euphoria, amnesia, thinking abnormality, hyperkinesia, decreased libido, hypertension, 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: leukopenia, instances of convulsion, neutropenia, oculogyric episodes, eczematoid dermatitis, suicidal attempt, suicide, and suicidal ideation.

Other adverse reactions reported during postmarketing experience with Amantadine (Symmetrel) tablets and syrup usage include:

Nervous System/Psychiatric: stupor, coma, delirium, hypertonia, hypokinesia, delusions, paranoid reaction, aggressive behavior, manic reaction, gait abnormalities, involuntary muscle contractions, paresthesia, EEG changes, and tremor. Abrupt discontinuation may also precipitate agitation, delirium, delusions, paranoid reaction, hallucinations, stupor, anxiety, depression and slurred speech.

Cardiovascular: arrhythmias including malignant arrhythmias, cardiac arrest, hypotension, and tachycardia.

Respiratory: pulmonary edema, acute respiratory failure, and tachypnea.

Gastrointestinal: dysphagia.

Hematologic: agranulocytosis, leukocytosis.

Special Senses: keratitis and mydriasis.

Skin and Appendages: pruritus and diaphoresis.

Miscellaneous: neuroleptic malignant syndrome, edema, fever, allergic reactions including anaphylactic reactions, pathological gambling, increased libido including hypersexuality, and impulse control symptoms.

Laboratory Test

Elevated: BUN, CPK, serum creatinine, LDH, alkaline phosphatase, bilirubin, SGOT, GGT, and SGPT.

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