🇺🇸 Sirolimus Tab. in United States

154 US adverse-event reports

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.

• Window: 22 April 2025 – 22 April 2026
• Total reports: 154

Most-reported reactions

1. Off Label Use — 67 reports (43.51%)
2. Death — 15 reports (9.74%)
3. Headache — 13 reports (8.44%)
4. Diarrhoea — 11 reports (7.14%)
5. Lung Transplant — 10 reports (6.49%)
6. Product Dispensing Error — 8 reports (5.19%)
7. Stomatitis — 8 reports (5.19%)
8. Therapy Cessation — 8 reports (5.19%)
9. Nausea — 7 reports (4.55%)
10. Product Substitution Issue — 7 reports (4.55%)

Source database →

Frequently asked questions

Is Sirolimus Tab. approved in United States?

Sirolimus Tab. does not currently have US marketing authorisation in our dataset.

Who is the marketing authorisation holder for Sirolimus Tab. in United States?

Chong Kun Dang Pharmaceutical is the originator. The local marketing authorisation holder may differ — check the official source linked above.