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Rimantadine Side Effects

For the Consumer

Applies to rimantadine: oral syrup, oral tablet

Along with its needed effects, rimantadine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking rimantadine:

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

Get emergency help immediately if any of the following symptoms of overdose occur while taking rimantadine:

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 side effects of rimantadine may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

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 than with placebo.[Ref]

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.[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. 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 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. 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.[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.

Ocular

Ocular side effects have included increased lacrimation and eye pain with higher than recommended doses of rimantadine.

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

5. 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

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

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

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