🇺🇸 Compazine in United States

FDA authorised Compazine on 28 June 2000 · 15,774 US adverse-event reports

Marketing authorisations

FDA — authorised 28 June 2000

  • Application: ANDA040246
  • Marketing authorisation holder: PADAGIS US
  • Local brand name: COMPRO
  • Indication: SUPPOSITORY — RECTAL
  • 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. Nausea — 2,957 reports (18.75%)
  2. Fatigue — 2,222 reports (14.09%)
  3. Diarrhoea — 1,960 reports (12.43%)
  4. Vomiting — 1,848 reports (11.72%)
  5. Asthenia — 1,242 reports (7.87%)
  6. Dyspnoea — 1,241 reports (7.87%)
  7. Death — 1,215 reports (7.7%)
  8. Dehydration — 1,134 reports (7.19%)
  9. Pain — 983 reports (6.23%)
  10. Pyrexia — 972 reports (6.16%)

Source database →

Other Other approved in United States

Frequently asked questions

Is Compazine approved in United States?

Yes. FDA authorised it on 28 June 2000; FDA has authorised it.

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

PADAGIS US holds the US marketing authorisation.