🇺🇸 Sofosbuvir / Velpatasvir in United States

3,338 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: 3,338

Most-reported reactions

1. Fatigue — 858 reports (25.7%)
2. Headache — 720 reports (21.57%)
3. Product Dose Omission Issue — 387 reports (11.59%)
4. Nausea — 384 reports (11.5%)
5. Intentional Dose Omission — 206 reports (6.17%)
6. Diarrhoea — 190 reports (5.69%)
7. Death — 168 reports (5.03%)
8. Product Dose Omission — 150 reports (4.49%)
9. Insomnia — 148 reports (4.43%)
10. Vomiting — 127 reports (3.8%)

Source database →

Frequently asked questions

Is Sofosbuvir / Velpatasvir approved in United States?

Sofosbuvir / Velpatasvir does not currently have US marketing authorisation in our dataset.

Who is the marketing authorisation holder for Sofosbuvir / Velpatasvir in United States?

Peking University First Hospital is the originator. The local marketing authorisation holder may differ — check the official source linked above.