🇺🇸 Itraconazole capsule in United States

17 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. Platelet Count Decreased — 3 reports (17.65%)
  2. Back Pain — 2 reports (11.76%)
  3. Disease Progression — 2 reports (11.76%)
  4. Disseminated Intravascular Coagulation — 2 reports (11.76%)
  5. Graft Versus Host Disease — 2 reports (11.76%)
  6. Infection In An Immunocompromised Host — 2 reports (11.76%)
  7. Abdominal Distension — 1 report (5.88%)
  8. Abdominal Tenderness — 1 report (5.88%)
  9. Activated Partial Thromboplastin Time Prolonged — 1 report (5.88%)
  10. Agranulocytosis — 1 report (5.88%)

Source database →

Itraconazole capsule 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 Itraconazole capsule approved in United States?

Yes. FDA has authorised it.

Who is the marketing authorisation holder for Itraconazole capsule in United States?

Advenchen Laboratories Nanjing Ltd. is the originator. The local marketing authorisation holder may differ — check the official source linked above.