🇺🇸 DIGITALIS in United States

293 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. Atrial Fibrillation — 40 reports (13.65%)
  2. Cardiac Failure — 37 reports (12.63%)
  3. Dyspnoea — 37 reports (12.63%)
  4. Drug Ineffective — 33 reports (11.26%)
  5. Hypotension — 30 reports (10.24%)
  6. Asthenia — 28 reports (9.56%)
  7. Diarrhoea — 24 reports (8.19%)
  8. Oedema Peripheral — 23 reports (7.85%)
  9. Fatigue — 21 reports (7.17%)
  10. Dehydration — 20 reports (6.83%)

Source database →

DIGITALIS 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 DIGITALIS approved in United States?

Yes. FDA has authorised it.

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

Marketing authorisation holder not available in our data.