🇺🇸 Hidroxicloroquina in United States

457 US adverse-event reports

Marketing authorisation

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. Hepatitis — 103 reports (22.54%)
  2. Off Label Use — 75 reports (16.41%)
  3. Long Qt Syndrome — 61 reports (13.35%)
  4. Condition Aggravated — 50 reports (10.94%)
  5. Drug Interaction — 46 reports (10.07%)
  6. Diarrhoea — 29 reports (6.35%)
  7. Hypertriglyceridaemia — 26 reports (5.69%)
  8. Hypertransaminasaemia — 25 reports (5.47%)
  9. Atrial Fibrillation — 21 reports (4.6%)
  10. Mixed Liver Injury — 21 reports (4.6%)

Source database →

Hidroxicloroquina 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 Hidroxicloroquina approved in United States?

Yes. FDA has authorised it.

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

Instituto de Investigación Marqués de Valdecilla is the originator. The local marketing authorisation holder may differ — check the official source linked above.