🇺🇸 Hyoscine N Butylbromide in United States

59 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. Constipation — 7 reports (11.86%)
  2. Aphonia — 6 reports (10.17%)
  3. Cough — 6 reports (10.17%)
  4. Hot Flush — 6 reports (10.17%)
  5. Hyperglycaemia — 6 reports (10.17%)
  6. Neuropathy Peripheral — 6 reports (10.17%)
  7. Upper Respiratory Tract Infection — 6 reports (10.17%)
  8. Vomiting — 6 reports (10.17%)
  9. Depression — 5 reports (8.47%)
  10. Drug Interaction — 5 reports (8.47%)

Source database →

Hyoscine N 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 N Butylbromide approved in United States?

Yes. FDA has authorised it.

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

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