🇺🇸 Crinone in United States

FDA authorised Crinone on 31 July 1997 · 3,314 US adverse-event reports

Marketing authorisations

FDA — authorised 31 July 1997

  • Application: NDA020701
  • Marketing authorisation holder: ABBVIE
  • 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. Exposure During Pregnancy — 383 reports (11.56%)
  2. Off Label Use — 370 reports (11.16%)
  3. Headache — 346 reports (10.44%)
  4. Product Use Issue — 321 reports (9.69%)
  5. Hyperhidrosis — 319 reports (9.63%)
  6. Hepatic Enzyme Increased — 318 reports (9.6%)
  7. Immunodeficiency — 317 reports (9.57%)
  8. Food Allergy — 314 reports (9.47%)
  9. Hypersensitivity — 314 reports (9.47%)
  10. Pain — 312 reports (9.41%)

Source database →

Crinone 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 Crinone approved in United States?

Yes. FDA authorised it on 31 July 1997; FDA has authorised it.

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

ABBVIE holds the US marketing authorisation.