🇺🇸 DIFELIKEFALIN ACETATE in United States

22 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. Death — 7 reports (31.82%)
  2. Somnolence — 5 reports (22.73%)
  3. Fatigue — 3 reports (13.64%)
  4. Abnormal Behaviour — 1 report (4.55%)
  5. Aggression — 1 report (4.55%)
  6. Anxiety — 1 report (4.55%)
  7. Bronchial Carcinoma — 1 report (4.55%)
  8. Cardiac Arrest — 1 report (4.55%)
  9. Cerebral Haemorrhage — 1 report (4.55%)
  10. Face Oedema — 1 report (4.55%)

Source database →

DIFELIKEFALIN ACETATE 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 DIFELIKEFALIN ACETATE approved in United States?

Yes. FDA has authorised it.

Who is the marketing authorisation holder for DIFELIKEFALIN ACETATE in United States?

Marketing authorisation holder not available in our data.