🇺🇸 Hyoscine bromide in United States

19 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. Malaise — 4 reports (21.05%)
  2. Vomiting — 3 reports (15.79%)
  3. Decreased Appetite — 2 reports (10.53%)
  4. Diarrhoea — 2 reports (10.53%)
  5. Fatigue — 2 reports (10.53%)
  6. Treatment Noncompliance — 2 reports (10.53%)
  7. Abdominal Pain Upper — 1 report (5.26%)
  8. Anaemia — 1 report (5.26%)
  9. Angina Pectoris — 1 report (5.26%)
  10. Asthenia — 1 report (5.26%)

Source database →

Hyoscine bromide 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 Hyoscine bromide approved in United States?

Yes. FDA has authorised it.

Who is the marketing authorisation holder for Hyoscine bromide in United States?

Hospital Clinic of Barcelona is the originator. The local marketing authorisation holder may differ — check the official source linked above.