🇺🇸 Raloxifene HCL in United States

FDA authorised Raloxifene HCL on 9 December 1997 · 278 US adverse-event reports

Marketing authorisations

FDA — authorised 9 December 1997

  • Application: NDA020815
  • Marketing authorisation holder: LILLY
  • Local brand name: EVISTA
  • Indication: TABLET — ORAL
  • Status: approved

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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 — 40 reports (14.39%)
  2. Asthenia — 34 reports (12.23%)
  3. Fall — 31 reports (11.15%)
  4. Dizziness — 28 reports (10.07%)
  5. Diarrhoea — 27 reports (9.71%)
  6. Fatigue — 27 reports (9.71%)
  7. Drug Ineffective — 26 reports (9.35%)
  8. Erythema — 22 reports (7.91%)
  9. Headache — 22 reports (7.91%)
  10. Arthralgia — 21 reports (7.55%)

Source database →

Raloxifene HCL 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 Raloxifene HCL approved in United States?

Yes. FDA authorised it on 9 December 1997; FDA has authorised it.

Who is the marketing authorisation holder for Raloxifene HCL in United States?

LILLY holds the US marketing authorisation.