Flumadine Side Effects

Generic name: rimantadine

Note: This document contains side effect information about rimantadine. Some of the dosage forms listed on this page may not apply to the brand name Flumadine.

Some side effects of Flumadine may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to rimantadine: oral syrup, oral tablet

Get emergency medical help if you have any of these signs of an allergic reaction while taking rimantadine (the active ingredient contained in Flumadine) hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using rimantadine and call your doctor at once if you have a seizure (black-out or convulsions).

Less serious side effects of rimantadine may include:

• nausea, vomiting, diarrhea, loss of appetite, stomach pain;

• dry mouth;

• sleep problems (insomnia);

• dizziness;

• headache; or

• anxiety, trouble concentrating.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect.

For Healthcare Professionals

Applies to rimantadine: oral syrup, oral tablet

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 (the active ingredient contained in Flumadine) than with placebo.

Nervous system

Seizures were reported in a few patients during clinical trials with rimantadine (the active ingredient contained in Flumadine) 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 However, their anticonvulsant medications had been withdrawn in the previous few months.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 insomnia (up to 3.4%), dizziness (up to 1.9%), headache (1.4%), and jitteriness. Ataxia, somnolence, agitation, and tinnitus have been reported in 0.3% to 1% of patients. Gait abnormality, hyperkinesia, tremor, hallucination, confusion, syncope, taste loss/change, parosmia, and convulsions have been reported in less than 0.3% of patients. Agitation and hypesthesia have occurred with higher than recommended doses of rimantadine. Dizziness and headache were reported up to two times more often in geriatric patients receiving rimantadine than in those receiving placebo.

Gastrointestinal

Gastrointestinal side effects have included nausea (2.8%), vomiting (1.7%), anorexia (1.6%), dry mouth (1.5%), and abdominal pain (1.4%). Diarrhea and dyspepsia have been reported in 0.3% to 1% of patients. Constipation, dysphagia, and stomatitis have occurred with higher than recommended doses of rimantadine (the active ingredient contained in Flumadine) Gastrointestinal symptoms (particularly nausea, vomiting, and abdominal pain) were reported at least twice as often in geriatric patients receiving rimantadine than in those receiving placebo. Tolerance may be improved by giving the drug in two divided daily doses.

Psychiatric

Psychiatric side effects have included impaired concentration (up to 2.1%), nervousness (up to 2.1%), depression (up to 1%), and euphoria (less than 0.3%). Anxiety was reported up to two times more often in geriatric patients receiving rimantadine (the active ingredient contained in Flumadine) than in those receiving placebo.

Cardiovascular

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

Respiratory

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

Other

Other side effects have included asthenia (1.4%), fatigue (1%), and pallor (less than 0.3%). Fever and rigors have occurred with higher than recommended doses of rimantadine (the active ingredient contained in Flumadine) Asthenia and fatigue were reported up to two times more often in geriatric patients receiving rimantadine than in those receiving placebo.

Dermatologic

Dermatologic side effects have included rash (0.3% to less than 1%). Diaphoresis has occurred with higher than recommended doses of rimantadine (the active ingredient contained in Flumadine)

Genitourinary

Genitourinary side effects have included nonpuerperal lactation in less than 0.3% of patients. Increased micturition frequency has occurred with higher than recommended doses of rimantadine (the active ingredient contained in Flumadine)

Ocular

Ocular side effects have included increased lacrimation and eye pain with higher than recommended doses of rimantadine (the active ingredient contained in Flumadine)

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