🇺🇸 DELAMANID in United States

1,648 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. Electrocardiogram Qt Prolonged — 256 reports (15.53%)
  2. Off Label Use — 231 reports (14.02%)
  3. Vomiting — 228 reports (13.83%)
  4. Anaemia — 214 reports (12.99%)
  5. Neuropathy Peripheral — 161 reports (9.77%)
  6. Dyspnoea — 160 reports (9.71%)
  7. Nausea — 117 reports (7.1%)
  8. Haemoglobin Decreased — 97 reports (5.89%)
  9. Intentional Product Use Issue — 92 reports (5.58%)
  10. Tuberculosis — 92 reports (5.58%)

Source database →

DELAMANID 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 DELAMANID approved in United States?

Yes. FDA has authorised it.

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

Marketing authorisation holder not available in our data.