🇺🇸 Botulinum Toxin in United States

12,572 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. Off Label Use — 2,360 reports (18.77%)
  2. Drug Ineffective — 1,917 reports (15.25%)
  3. Drug Intolerance — 1,268 reports (10.09%)
  4. Product Use In Unapproved Indication — 1,204 reports (9.58%)
  5. Headache — 1,112 reports (8.85%)
  6. Migraine — 1,064 reports (8.46%)
  7. Nausea — 1,011 reports (8.04%)
  8. Pain — 928 reports (7.38%)
  9. Hypoaesthesia — 883 reports (7.02%)
  10. Hypertension — 825 reports (6.56%)

Source database →

Botulinum 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 Toxin approved in United States?

Yes. FDA has authorised it.

Who is the marketing authorisation holder for Botulinum Toxin in United States?

University Health Network, Toronto is the originator. The local marketing authorisation holder may differ — check the official source linked above.