🇺🇸 Alprazolam (Xanax) in United States

FDA authorised Alprazolam (Xanax) on 16 October 1981 · 45 US adverse-event reports

Marketing authorisation

FDA — authorised 16 October 1981

  • Application: NDA018276
  • Marketing authorisation holder: UPJOHN
  • Local brand name: XANAX
  • Indication: TABLET — ORAL
  • Status: approved

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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. Depression — 6 reports (13.33%)
  2. Fall — 5 reports (11.11%)
  3. Gait Disturbance — 5 reports (11.11%)
  4. Nausea — 5 reports (11.11%)
  5. Osteoporosis — 5 reports (11.11%)
  6. Asthenia — 4 reports (8.89%)
  7. Malaise — 4 reports (8.89%)
  8. Product Substitution Issue — 4 reports (8.89%)
  9. Type 2 Diabetes Mellitus — 4 reports (8.89%)
  10. Anxiety — 3 reports (6.67%)

Source database →

Other Psychiatry/Neurology approved in United States

Frequently asked questions

Is Alprazolam (Xanax) approved in United States?

Yes. FDA authorised it on 16 October 1981.

Who is the marketing authorisation holder for Alprazolam (Xanax) in United States?

UPJOHN holds the US marketing authorisation.