🇺🇸 Ledipasvir/Sofosbuvir in United States

2,862 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: 2,862

Most-reported reactions

1. Headache — 477 reports (16.67%)
2. Fatigue — 476 reports (16.63%)
3. Drug Ineffective — 297 reports (10.38%)
4. Death — 285 reports (9.96%)
5. Nausea — 253 reports (8.84%)
6. Hepatocellular Carcinoma — 242 reports (8.46%)
7. Asthenia — 225 reports (7.86%)
8. Hepatitis C — 215 reports (7.51%)
9. Vomiting — 201 reports (7.02%)
10. Insomnia — 191 reports (6.67%)

Source database →

Frequently asked questions

Is Ledipasvir/Sofosbuvir approved in United States?

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

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

Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections is the originator. The local marketing authorisation holder may differ — check the official source linked above.