🇺🇸 Vicoprofen in United States

FDA authorised Vicoprofen on 23 September 1997 · 870 US adverse-event reports

Marketing authorisations

FDA — authorised 23 September 1997

  • Application: NDA020716
  • Marketing authorisation holder: ABBVIE
  • Local brand name: VICOPROFEN
  • 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. Pain — 136 reports (15.63%)
  2. Nausea — 102 reports (11.72%)
  3. Fatigue — 97 reports (11.15%)
  4. Anxiety — 92 reports (10.57%)
  5. Drug Ineffective — 88 reports (10.11%)
  6. Depression — 86 reports (9.89%)
  7. Drug Dependence — 86 reports (9.89%)
  8. Pain In Extremity — 64 reports (7.36%)
  9. Vomiting — 60 reports (6.9%)
  10. Headache — 59 reports (6.78%)

Source database →

Vicoprofen 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 Vicoprofen approved in United States?

Yes. FDA authorised it on 23 September 1997; FDA has authorised it.

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

ABBVIE holds the US marketing authorisation.