🇺🇸 sofosbuvir/ledipasvir in United States
73 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: 73
Most-reported reactions
- Drug Interaction — 24 reports (32.88%)
- Renal Failure Acute — 9 reports (12.33%)
- Anaemia — 8 reports (10.96%)
- Fatigue — 5 reports (6.85%)
- Haemoglobin Decreased — 5 reports (6.85%)
- Nausea — 5 reports (6.85%)
- Pleural Effusion — 5 reports (6.85%)
- Atelectasis — 4 reports (5.48%)
- Blood Bilirubin Increased — 4 reports (5.48%)
- Dehydration — 4 reports (5.48%)
Other Infectious Disease / Virology approved in United States
Frequently asked questions
Is sofosbuvir/ledipasvir approved in United States?
sofosbuvir/ledipasvir does not currently have US marketing authorisation in our dataset.
Who is the marketing authorisation holder for sofosbuvir/ledipasvir in United States?
University of Texas Southwestern Medical Center is the originator. The local marketing authorisation holder may differ — check the official source linked above.