🇺🇸 Yasmin in United States

FDA authorised Yasmin on 11 May 2001 · 47,177 US adverse-event reports

Marketing authorisations

FDA — authorised 11 May 2001

  • Application: NDA021098
  • Marketing authorisation holder: BAYER HLTHCARE
  • 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. Pain — 8,582 reports (18.19%)
  2. Injury — 7,480 reports (15.86%)
  3. Pulmonary Embolism — 5,614 reports (11.9%)
  4. Deep Vein Thrombosis — 5,409 reports (11.47%)
  5. Anxiety — 4,485 reports (9.51%)
  6. Emotional Distress — 4,417 reports (9.36%)
  7. Cholecystitis Chronic — 3,614 reports (7.66%)
  8. Cholelithiasis — 2,691 reports (5.7%)
  9. Gallbladder Disorder — 2,629 reports (5.57%)
  10. General Physical Health Deterioration — 2,256 reports (4.78%)

Source database →

Yasmin 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 Yasmin approved in United States?

Yes. FDA authorised it on 11 May 2001; FDA has authorised it.

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

BAYER HLTHCARE holds the US marketing authorisation.