🇺🇸 Botox in United States

FDA authorised Botox on 9 December 1991 · 62,880 US adverse-event reports

Marketing authorisations

FDA — authorised 9 December 1991

  • Application: BLA103000
  • Marketing authorisation holder: ALLERGAN
  • Status: supplemented

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. Drug Ineffective — 26,154 reports (41.59%)
  2. Off Label Use — 11,063 reports (17.59%)
  3. Therapeutic Response Decreased — 4,501 reports (7.16%)
  4. Headache — 3,979 reports (6.33%)
  5. Product Preparation Error — 3,628 reports (5.77%)
  6. Injection Site Pain — 3,360 reports (5.34%)
  7. Eyelid Ptosis — 3,093 reports (4.92%)
  8. Multiple Use Of Single-Use Product — 2,798 reports (4.45%)
  9. Migraine — 2,233 reports (3.55%)
  10. Nausea — 2,071 reports (3.29%)

Source database →

Other Other approved in United States

Frequently asked questions

Is Botox approved in United States?

Yes. FDA authorised it on 9 December 1991; FDA has authorised it.

Who is the marketing authorisation holder for Botox in United States?

ALLERGAN holds the US marketing authorisation.