🇺🇸 LEE-011 in United States

14 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: 28 March 2025 – 28 March 2026
• Total reports: 14

Most-reported reactions

1. Malignant Neoplasm Progression — 3 reports (21.43%)
2. Breast Cancer Metastatic — 2 reports (14.29%)
3. Febrile Neutropenia — 2 reports (14.29%)
4. Deep Vein Thrombosis — 1 report (7.14%)
5. Disease Progression — 1 report (7.14%)
6. Gastrointestinal Disorder — 1 report (7.14%)
7. Herpes Zoster — 1 report (7.14%)
8. Menstruation Irregular — 1 report (7.14%)
9. Metastases To Bone — 1 report (7.14%)
10. Metastases To Pelvis — 1 report (7.14%)

Source database →

Frequently asked questions

Is LEE-011 approved in United States?

LEE-011 does not currently have US marketing authorisation in our dataset.

Who is the marketing authorisation holder for LEE-011 in United States?

Melissa K Accordino is the originator. The local marketing authorisation holder may differ — check the official source linked above.