🇺🇸 botulinum A toxin in United States

13 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. Headache — 2 reports (15.38%)
  2. Migraine — 2 reports (15.38%)
  3. Musculoskeletal Stiffness — 2 reports (15.38%)
  4. Cataplexy — 1 report (7.69%)
  5. Cholangiocarcinoma — 1 report (7.69%)
  6. Dysphagia — 1 report (7.69%)
  7. Fall — 1 report (7.69%)
  8. Gastrointestinal Haemorrhage — 1 report (7.69%)
  9. Malaise — 1 report (7.69%)
  10. Petechiae — 1 report (7.69%)

Source database →

botulinum A toxin 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 botulinum A toxin approved in United States?

Yes. FDA has authorised it.

Who is the marketing authorisation holder for botulinum A toxin in United States?

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