🇺🇸 Hyoscine butylbromide in United States

692 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. Nausea — 104 reports (15.03%)
  2. Diarrhoea — 88 reports (12.72%)
  3. Vomiting — 81 reports (11.71%)
  4. Abdominal Pain — 79 reports (11.42%)
  5. Malaise — 70 reports (10.12%)
  6. Headache — 63 reports (9.1%)
  7. Dyspnoea — 60 reports (8.67%)
  8. Dizziness — 54 reports (7.8%)
  9. Pyrexia — 49 reports (7.08%)
  10. Hypotension — 44 reports (6.36%)

Source database →

Hyoscine butylbromide 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 butylbromide approved in United States?

Yes. FDA has authorised it.

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

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