🇺🇸 TDM1 in United States

13 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: 13

Most-reported reactions

1. Atypical Femur Fracture — 3 reports (23.08%)
2. Osteonecrosis Of Jaw — 2 reports (15.38%)
3. Depression — 1 report (7.69%)
4. Liver Function Test Abnormal — 1 report (7.69%)
5. Mood Swings — 1 report (7.69%)
6. Off Label Use — 1 report (7.69%)
7. Pruritus — 1 report (7.69%)
8. Rash — 1 report (7.69%)
9. Thinking Abnormal — 1 report (7.69%)
10. Thrombocytopenia — 1 report (7.69%)

Source database →

Frequently asked questions

Is TDM1 approved in United States?

TDM1 does not currently have US marketing authorisation in our dataset.

Who is the marketing authorisation holder for TDM1 in United States?

David Garcia Cinca is the originator. The local marketing authorisation holder may differ — check the official source linked above.