🇺🇸 RIMANTADINE in United States

FDA authorised RIMANTADINE on 30 August 2002 · 69 US adverse-event reports

Marketing authorisations

FDA — authorised 30 August 2002

  • Application: ANDA076132
  • Marketing authorisation holder: IMPAX LABS
  • Status: approved

FDA

  • Status: approved

Safety signals — FAERS

Adverse reaction reports describe suspected side effects. A report does not mean the drug caused the event — co-medications, underlying disease and coincidence all contribute.

Most-reported reactions

  1. Drug Ineffective — 10 reports (14.49%)
  2. Asthenia — 7 reports (10.14%)
  3. Cough — 7 reports (10.14%)
  4. Dyspnoea — 7 reports (10.14%)
  5. Headache — 7 reports (10.14%)
  6. Malaise — 7 reports (10.14%)
  7. Arthralgia — 6 reports (8.7%)
  8. Death — 6 reports (8.7%)
  9. Dizziness — 6 reports (8.7%)
  10. Pneumonia — 6 reports (8.7%)

Source database →

RIMANTADINE in other countries

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Frequently asked questions

Is RIMANTADINE approved in United States?

Yes. FDA authorised it on 30 August 2002; FDA has authorised it.

Who is the marketing authorisation holder for RIMANTADINE in United States?

IMPAX LABS holds the US marketing authorisation.