🇺🇸 Vicodin in United States

FDA authorised Vicodin on 25 May 1984 · 34,183 US adverse-event reports

Marketing authorisations

FDA — authorised 25 May 1984

  • Application: ANDA085667
  • Marketing authorisation holder: ABBOTT
  • Local brand name: VICODIN
  • Indication: TABLET — ORAL
  • Status: approved

Read official source →

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 Dependence — 6,844 reports (20.02%)
  2. Pain — 6,124 reports (17.92%)
  3. Emotional Distress — 3,367 reports (9.85%)
  4. Nausea — 3,036 reports (8.88%)
  5. Overdose — 2,897 reports (8.47%)
  6. Drug Withdrawal Syndrome — 2,551 reports (7.46%)
  7. Anxiety — 2,444 reports (7.15%)
  8. Fatigue — 2,420 reports (7.08%)
  9. Drug Ineffective — 2,383 reports (6.97%)
  10. Depression — 2,117 reports (6.19%)

Source database →

Vicodin in other countries

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Other Other approved in United States

Frequently asked questions

Is Vicodin approved in United States?

Yes. FDA authorised it on 25 May 1984; FDA has authorised it.

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

ABBOTT holds the US marketing authorisation.