🇺🇸 Provigil in United States

FDA authorised Provigil on 24 December 1998 · 9,523 US adverse-event reports

Marketing authorisations

FDA — authorised 24 December 1998

  • Application: NDA020717
  • Marketing authorisation holder: NUVO PHARMS
  • Local brand name: PROVIGIL
  • 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. Fatigue — 1,587 reports (16.66%)
  2. Nausea — 1,188 reports (12.48%)
  3. Drug Ineffective — 1,096 reports (11.51%)
  4. Headache — 959 reports (10.07%)
  5. Fall — 932 reports (9.79%)
  6. Depression — 840 reports (8.82%)
  7. Pain — 743 reports (7.8%)
  8. Dizziness — 730 reports (7.67%)
  9. Anxiety — 726 reports (7.62%)
  10. Somnolence — 722 reports (7.58%)

Source database →

Provigil 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 Provigil approved in United States?

Yes. FDA authorised it on 24 December 1998; FDA has authorised it.

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

NUVO PHARMS holds the US marketing authorisation.