🇺🇸 ella in United States

FDA authorised ella on 13 August 2010 · 433 US adverse-event reports

Marketing authorisations

FDA — authorised 13 August 2010

  • Application: NDA022474
  • Marketing authorisation holder: LAB HRA PHARMA
  • Local brand name: ELLA
  • 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. Unintended Pregnancy — 125 reports (28.87%)
  2. Abortion Spontaneous — 83 reports (19.17%)
  3. Vaginal Haemorrhage — 57 reports (13.16%)
  4. Drug Ineffective — 47 reports (10.85%)
  5. Nausea — 30 reports (6.93%)
  6. Abdominal Pain — 20 reports (4.62%)
  7. Exposure During Pregnancy — 19 reports (4.39%)
  8. Dizziness — 18 reports (4.16%)
  9. Headache — 18 reports (4.16%)
  10. Pregnancy After Post Coital Contraception — 16 reports (3.7%)

Source database →

ella 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 ella approved in United States?

Yes. FDA authorised it on 13 August 2010; FDA has authorised it.

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

LAB HRA PHARMA holds the US marketing authorisation.