🇺🇸 TMC114 in United States
128 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: 23 April 2025 – 23 April 2026
- Total reports: 128
Most-reported reactions
- Pyrexia — 20 reports (15.62%)
- Immune Reconstitution Syndrome — 19 reports (14.84%)
- Renal Failure — 14 reports (10.94%)
- Dehydration — 13 reports (10.16%)
- Pancreatitis — 13 reports (10.16%)
- Diarrhoea — 12 reports (9.38%)
- Hepatitis — 10 reports (7.81%)
- Pneumonia — 10 reports (7.81%)
- Renal Failure Acute — 9 reports (7.03%)
- Alanine Aminotransferase Increased — 8 reports (6.25%)
Other Infectious Diseases approved in United States
Frequently asked questions
Is TMC114 approved in United States?
TMC114 does not currently have US marketing authorisation in our dataset.
Who is the marketing authorisation holder for TMC114 in United States?
Tibotec Pharmaceuticals, Ireland is the originator. The local marketing authorisation holder may differ — check the official source linked above.