Flumadine Side Effects

Generic Name: rimantadine

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

Not all side effects for Flumadine may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

For the Consumer

Applies to rimantadine: oral syrup, oral tablet

In addition to its needed effects, some unwanted effects may be caused by rimantadine (the active ingredient contained in Flumadine). In the event that any of these side effects do occur, they may require medical attention.

You should check with your doctor immediately if any of these side effects occur when taking rimantadine:

Less common
  • Difficult or labored breathing
  • shortness of breath
  • tightness in the chest
  • wheezing

If any of the following symptoms of overdose occur while taking rimantadine, get emergency help immediately:

Symptoms of overdose
  • Anxiety
  • chest pain or discomfort
  • dizziness
  • dry mouth
  • fainting
  • fast, slow, or irregular heartbeat
  • hyperventilation
  • irregular heartbeats
  • irritability
  • lightheadedness
  • nervousness
  • pounding or rapid pulse
  • restlessness
  • seeing, hearing, or feeling things that are not there
  • shaking
  • trouble with sleeping

Some of the side effects that can occur with rimantadine may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

Less common
  • Abdominal or stomach pain
  • acid or sour stomach
  • belching
  • continuing ringing or buzzing or other unexplained noise in the ears
  • diarrhea
  • difficulty with concentrating
  • headache
  • hearing loss
  • heartburn
  • impaired concentration
  • indigestion
  • lack or loss of strength
  • loss of appetite
  • nausea
  • rash
  • shakiness and unsteady walk
  • sleepiness or unusual drowsiness
  • stomach discomfort, upset, or pain
  • unsteadiness, trembling, or other problems with muscle control or coordination
  • unusual tiredness or weakness
  • vomiting

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.[Ref]

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.[Ref]

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.[Ref]

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.[Ref]

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.[Ref]

Respiratory

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

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.[Ref]

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) [Ref]

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)

References

1. Centers for Disease Control and Prevention "Prevention and control of influenza: recommendations of the advisory committee on immunization practices (ACIP)." MMWR Morb Mortal Wkly Rep 47(RR-6) (1998): 1-26

2. "Product Information. Flumadine (rimantadine)." Forest Pharmaceuticals, St. Louis, MO.

3. Brady MT, Sears SD, Pacini DL, Samorodin R, DePamphilis J, Oakes M, Soo W, Clements ML "Safety and prophylactic efficacy of low-dose rimantadine in adults during an influenza A epidemic." Antimicrob Agents Chemother 34 (1990): 1633-6

4. Jefferson T, Demicheli V, Rivetti D, Jones M, Di Pietrantonj C, Rivetti A "Antivirals for influenza in healthy adults: systematic review." Lancet 367 (2006): 303-13

5. "Rimantadine for prevention and treatment of influenza." Med Lett Drugs Ther 35 (1993): 109-10

6. Patriarca PA, Kater NA, Kendal AP, Bregman DJ, Smith JD, Sikes RK "Safety of prolonged administration of rimantadine hydrochloride in the prophylaxis of influenza A virus infections in nursing homes." Antimicrob Agents Chemother 26 (1984): 101-3

7. Dolin R, Reichman RC, Madore HP, et al "A controlled trial of amantadine and rimantadine in the prophylaxis of influenza A infection." N Engl J Med 307 (1982): 580-4

8. Bentley DW, Karki SD, Betts RF "Rimantadine and seizures." Ann Intern Med 110 (1989): 323-4

9. Millet VM, Dreisbach M, Bryson YJ "Double-blind controlled study of central nervous system side effects of amantadine, rimantadine, and chlorpheniramine." Antimicrob Agents Chemother 21 (1982): 1-4

10. Keyser LA, Karl M, Nafziger AN, Bertino JS "Comparison of central nervous system adverse effects of amantadine and rimantadine used as sequential prophylaxis of influenza A in elderly nursing home patients." Arch Intern Med 160 (2000): 1485-8

11. Hayden FG, Hoffman HE, Spyker DA "Differences in side effects of amantadine hydrochloride and rimantadine hydrochloride relate to differences in pharmacokinetics." Antimicrob Agents Chemother 23 (1983): 458-64

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