🇺🇸 Belladonna and Opium in United States

24 US adverse-event reports

Marketing authorisation

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. Urticaria — 4 reports (16.67%)
  2. Drug Hypersensitivity — 3 reports (12.5%)
  3. Pruritus — 3 reports (12.5%)
  4. Abdominal Pain Lower — 2 reports (8.33%)
  5. Anaemia — 2 reports (8.33%)
  6. Anosmia — 2 reports (8.33%)
  7. Asthenia — 2 reports (8.33%)
  8. Blood Pressure Decreased — 2 reports (8.33%)
  9. Chest Pain — 2 reports (8.33%)
  10. Chronic Spontaneous Urticaria — 2 reports (8.33%)

Source database →

Belladonna and Opium 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 Belladonna and Opium approved in United States?

Yes. FDA has authorised it.

Who is the marketing authorisation holder for Belladonna and Opium in United States?

University of Washington is the originator. The local marketing authorisation holder may differ — check the official source linked above.