🇺🇸 TMC-114 in United States

23 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: 23

Most-reported reactions

1. Abortion Induced — 3 reports (13.04%)
2. Hepatitis — 3 reports (13.04%)
3. Pregnancy — 3 reports (13.04%)
4. Blood Creatine Phosphokinase Increased — 2 reports (8.7%)
5. Cholestasis — 2 reports (8.7%)
6. Constipation — 2 reports (8.7%)
7. Cytolytic Hepatitis — 2 reports (8.7%)
8. Drug Interaction — 2 reports (8.7%)
9. Drug Toxicity — 2 reports (8.7%)
10. Foetal Growth Retardation — 2 reports (8.7%)

Source database →

Frequently asked questions

Is TMC-114 approved in United States?

TMC-114 does not currently have US marketing authorisation in our dataset.

Who is the marketing authorisation holder for TMC-114 in United States?

Tibotec Pharmaceuticals, Ireland is the originator. The local marketing authorisation holder may differ — check the official source linked above.