🇺🇸 cyclosporine microemulsion in United States

21 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. Pneumonia — 3 reports (14.29%)
  2. Pyelonephritis — 3 reports (14.29%)
  3. Cytomegalovirus Infection — 2 reports (9.52%)
  4. Diabetes Mellitus — 2 reports (9.52%)
  5. Osteonecrosis — 2 reports (9.52%)
  6. Pneumocystis Jirovecii Pneumonia — 2 reports (9.52%)
  7. Post Transplant Lymphoproliferative Disorder — 2 reports (9.52%)
  8. Sepsis — 2 reports (9.52%)
  9. Transplant Rejection — 2 reports (9.52%)
  10. Aspergillus Infection — 1 report (4.76%)

Source database →

cyclosporine microemulsion 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 cyclosporine microemulsion approved in United States?

Yes. FDA has authorised it.

Who is the marketing authorisation holder for cyclosporine microemulsion in United States?

Astellas Pharma Inc is the originator. The local marketing authorisation holder may differ — check the official source linked above.