Hepatitis C Virus NS5A Inhibitor side effects compared: 3 drugs, 36,115 FDA adverse event reports
Members
| Drug | FAERS reports | Serious | Death outcome | Boxed warning | Top labeled signals | Unlabeled (unassessed) |
|---|---|---|---|---|---|---|
| Ledipasvir and Sofosbuvir | 19,115 | 39% | 779 | boxed | Fatigue; Headache; Hepatic cirrhosis | Hepatocellular carcinoma; Ascites |
| Velpatasvir and Sofosbuvir (Sofosbuvir And Velpatasvir) | 12,757 | 30% | 587 | boxed | Fatigue; Headache; Insomnia | Dyspepsia; Hepatocellular carcinoma |
| Elbasvir and Grazoprevir (Zepatier) | 4,243 | 34% | 123 | boxed | Fatigue; Headache; Insomnia | Joint swelling; Dyspepsia |
Class-wide signals (flagged in at least 2 of 3 members)
| Reaction | Members flagged | Median PRR | Reports (sum) | In label |
|---|---|---|---|---|
| Hepatitis c | 3/3 | 57.4 | 1,434 | 0/3 members' labels |
| Hepatic cirrhosis | 3/3 | 8.3 | 282 | 3/3 members' labels |
| Headache | 3/3 | 6.0 | 6,676 | 3/3 members' labels |
| Fatigue | 3/3 | 5.9 | 7,712 | 3/3 members' labels |
| Hepatocellular carcinoma | 2/3 | 43.4 | 520 | 0/2 members' labels |
| Oesophageal varices haemorrhage | 2/3 | 22.6 | 75 | 0/2 members' labels |
| Hepatorenal syndrome | 2/3 | 13.2 | 32 | 0/2 members' labels |
| Liver transplant | 2/3 | 12.7 | 68 | 1/2 members' labels |
| Hepatic encephalopathy | 2/3 | 12.4 | 180 | 0/2 members' labels |
| Varices oesophageal | 2/3 | 11.7 | 52 | 0/2 members' labels |
| Hepatitis b reactivation | 2/3 | 9.8 | 50 | 2/2 members' labels |
| Hepatic pain | 2/3 | 9.7 | 61 | 2/2 members' labels |
| Portal vein thrombosis | 2/3 | 7.0 | 35 | 0/2 members' labels |
| Ascites | 2/3 | 6.8 | 310 | 0/2 members' labels |
| Energy increased | 2/3 | 5.1 | 47 | 0/2 members' labels |
| Dyspepsia | 2/3 | 4.5 | 322 | 0/2 members' labels |
| Insomnia | 2/3 | 4.4 | 818 | 2/2 members' labels |
| Hepatic cancer | 2/3 | 3.7 | 144 | 0/2 members' labels |
Member-specific signals (flagged in exactly one drug)
No strong single-member signals (n ≥ 50) in this class.
Common questions
Which hepatitis c virus ns5a inhibitor has the most FDA adverse event reports?
Ledipasvir and Sofosbuvir has the most FAERS co-reports in this class (19,115), followed by Velpatasvir and Sofosbuvir (12,757). Report volume tracks how widely and how long a drug has been used, and how much attention it has had, far more than its risk.
Which side effects are shared across hepatitis c virus ns5a inhibitor drugs?
Reaction terms flagged in at least half of the 3 members include hepatitis c, hepatic cirrhosis, headache, fatigue, hepatocellular carcinoma. A term shared across a class usually reflects the shared mechanism (or the shared patient population) rather than one product.
Does a FAERS signal mean the drug causes the reaction?
No. These are disproportionality signals from voluntary reports with no denominator. Each is screened against the FDA label (known vs unlabeled) on the drug pages; causality needs temporality, dose-response, plausibility and trial or cohort evidence.
Sources: openFDA FAERS pair statistics (OpenPV build 2026-09-14), FDA labels via openFDA, seriousness and death counts from openFDA count queries. Generated 2026-10-08. Not medical advice.