🇺🇸 Ortho Cyclen in United States

FDA authorised Ortho Cyclen on 9 January 2004 · 319 US adverse-event reports

Marketing authorisations

FDA — authorised 9 January 2004

  • Application: ANDA076334
  • Marketing authorisation holder: PH HEALTH
  • Local brand name: PREVIFEM
  • Indication: TABLET — ORAL-28
  • 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. Nausea — 46 reports (14.42%)
  2. Headache — 42 reports (13.17%)
  3. Anxiety — 37 reports (11.6%)
  4. Fatigue — 33 reports (10.34%)
  5. Depression — 30 reports (9.4%)
  6. Pain — 29 reports (9.09%)
  7. Inappropriate Schedule Of Drug Administration — 26 reports (8.15%)
  8. Vomiting — 26 reports (8.15%)
  9. Dizziness — 25 reports (7.84%)
  10. Metrorrhagia — 25 reports (7.84%)

Source database →

Ortho Cyclen in other countries

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

Frequently asked questions

Is Ortho Cyclen approved in United States?

Yes. FDA authorised it on 9 January 2004; FDA has authorised it.

Who is the marketing authorisation holder for Ortho Cyclen in United States?

PH HEALTH holds the US marketing authorisation.