Flumadine Side Effects

Generic Name: rimantadine

Please note - some side effects for Flumadine may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Flumadine - for the Consumer

Flumadine

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Flumadine:

Dizziness; dry mouth; headache; loss of appetite; nausea; nervousness; stomach pain; tiredness; trouble sleeping; vomiting; weakness.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); confusion; depression; fast or irregular heartbeat; hallucinations; seizures; swelling of the hands, ankles, or feet; tremor; trouble walking.

Flumadine Syrup

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Flumadine Syrup:

Dizziness; dry mouth; headache; loss of appetite; nausea; nervousness; stomach pain; tiredness; trouble sleeping; vomiting; weakness.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); confusion; depression; fast or irregular heartbeat; hallucinations; seizures; swelling of the hands, ankles, or feet; tremor; trouble walking.

Flumadine Side Effects - for the Professional

Flumadine

In 1,027 patients treated with Flumadine in controlled clinical trials at the recommended dose of 200 mg daily, the most frequently reported adverse events involved the gastrointestinal and nervous systems.

Incidence >1%: Adverse events reported most frequently (1-3%) at the recommended dose in controlled clinical trials are shown in the table below.

Less frequent adverse events (0.3 to 1%) at the recommended dose in controlled clinical trials were: Gastrointestinal System: diarrhea, dyspepsia; Nervous System: impairment of concentration, ataxia, somnolence, agitation, depression; Skin and Appendages: rash; Hearing and Vestibular: tinnitus; Respiratory: dyspnea.

Additional adverse events (less than 0.3%) reported at recommended doses in controlled clinical trials were: Nervous System: gait abnormality, euphoria, hyperkinesia, tremor, hallucination, confusion, convulsions; Respiratory: bronchospasm, cough; Cardiovascular: pallor, palpitation, hypertension, cerebrovascular disorder, cardiac failure, pedal edema, heart block, tachycardia, syncope; Reproduction: non-puerperal lactation; Special Senses: taste loss/change, parosmia.

Rates of adverse events, particularly those involving the gastrointestinal and nervous systems, increased significantly in controlled studies using higher than recommended doses of Flumadine. In most cases, symptoms resolved rapidly with discontinuation of treatment. In addition to the adverse events reported above, the following were also reported at higher than recommended doses: increased lacrimation, increased micturition frequency, fever, rigors, agitation, constipation, diaphoresis, dysphagia, stomatitis, hypesthesia and eye pain.

Adverse Reactions in Trials of Rimantadine and Amantadine: In a six-week prophylaxis study of 436 healthy adults comparing rimantadine with amantadine and placebo, the following adverse reactions were reported with an incidence >1 %.

GERIATRIC USE: Approximately 200 patients over the age of 64 were evaluated for safety in controlled clinical trials with Flumadine® (rimantadine hydrochloride). Geriatric subjects who received either 200 mg or 400 mg of rimantadine daily for 1 to 50 days experienced considerably more central nervous system and gastrointestinal adverse events than comparable geriatric subjects receiving placebo. Central nervous system events including dizziness, headache, anxiety, asthenia, and fatigue, occurred up to two times more often in subjects treated with rimantadine than in those treated with placebo. Gastrointestinal symptoms, particularly nausea, vomiting, and abdominal pain occurred at least twice as frequently in subjects receiving rimantadine than in those receiving placebo. The gastrointestinal symptoms appeared to be dose related. In patients over 64, the recommended dose is 100 mg, daily.

Side Effects by Body System

General

Gastrointestinal and nervous system side effects are most frequently reported. In a prophylaxis trial, 6.9% of subjects discontinued treatment due to adverse reactions. In geriatric patients, gastrointestinal and nervous system adverse effects occurred twice as often with rimantadine than with placebo.

Nervous system

Seizures were reported in a few patients during clinical trials with rimantadine. In two patients, seizure activity had been absent for greater than 10 years. However, their anticonvulsant medications had been withdrawn in the previous few months.

Nervous system side effects have included dizziness, jitteriness, insomnia, headache, nervousness, and fatigue in 1% to 3% of patients. Ataxia, impairment of concentration, somnolence, agitation, and depression have been reported in 0.3% to 1% of patients. Gait abnormality, euphoria, hyperkinesia, tremor, hallucination, confusion, and convulsions have occurred in less than 0.3% of patients.

Gastrointestinal

Gastrointestinal side effects have included nausea, vomiting, anorexia, dry mouth, and abdominal pain in 1% to 3% of patients. Diarrhea and dyspepsia have been reported in 0.3% to 1% of patients. Tolerance may be improved by giving the drug in two divided daily doses.

Cardiovascular

Cardiovascular side effects have included cardiac failure, cerebrovascular disorder, heart block, hypertension, pallor, palpitation, pedal edema, syncope, and tachycardia in less than 0.3% of patients.

Respiratory

Respiratory side effects have included dyspnea (0.3% to 0.1%), bronchospasm (<0.3%), and cough (<0.3%).

Other

Other side effects have included asthenia (1.4%), tinnitus (0.3% to 1%), taste loss/change (<0.3%), and parosmia (<0.3%).

Dermatologic

Dermatologic side effects have included rash in less than 1% of patients,

Endocrine

Endocrine side effects have included nonpuerperal lactation in less than 0.3% of patients.

Other

Increased lacrimation, increased micturition frequency, fever, rigors, agitation, constipation, diaphoresis, dysphagia, stomatitis, hypesthesia, and eye pain have occurred with higher than recommended doses of rimantadine.

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