🇺🇸 Amiodarone Hydrochloride 200 MG in United States

FDA authorised Amiodarone Hydrochloride 200 MG on 24 December 1985 · 155 US adverse-event reports

Marketing authorisations

FDA — authorised 24 December 1985

  • Application: NDA018972
  • Marketing authorisation holder: WYETH PHARMS
  • Local brand name: CORDARONE
  • Indication: TABLET — ORAL
  • Status: approved

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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. Fatigue — 25 reports (16.13%)
  2. Dyspnoea — 24 reports (15.48%)
  3. Asthenia — 20 reports (12.9%)
  4. Cough — 19 reports (12.26%)
  5. Off Label Use — 16 reports (10.32%)
  6. Wheezing — 12 reports (7.74%)
  7. Dizziness — 11 reports (7.1%)
  8. Blindness — 10 reports (6.45%)
  9. Pneumonia — 9 reports (5.81%)
  10. Respiratory Failure — 9 reports (5.81%)

Source database →

Amiodarone Hydrochloride 200 MG 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 Amiodarone Hydrochloride 200 MG approved in United States?

Yes. FDA authorised it on 24 December 1985; FDA has authorised it.

Who is the marketing authorisation holder for Amiodarone Hydrochloride 200 MG in United States?

WYETH PHARMS holds the US marketing authorisation.