🇺🇸 DOXY in United States

FDA authorised DOXY on 9 December 1983 · 188 US adverse-event reports

Marketing authorisations

FDA — authorised 9 December 1983

  • Application: ANDA062475
  • Marketing authorisation holder: FRESENIUS KABI USA
  • 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. Fatigue — 28 reports (14.89%)
  2. Pain — 22 reports (11.7%)
  3. Pyrexia — 21 reports (11.17%)
  4. Nausea — 20 reports (10.64%)
  5. Arthralgia — 19 reports (10.11%)
  6. Asthenia — 18 reports (9.57%)
  7. Dermatitis Acneiform — 17 reports (9.04%)
  8. Drug Ineffective — 15 reports (7.98%)
  9. Constipation — 14 reports (7.45%)
  10. Infection — 14 reports (7.45%)

Source database →

DOXY 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 DOXY approved in United States?

Yes. FDA authorised it on 9 December 1983; FDA has authorised it.

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

FRESENIUS KABI USA holds the US marketing authorisation.