Velpatasvir and Sofosbuvir side effects: what 12,757 FDA adverse event reports show
Drug class
Hepatitis C Virus NS5A Inhibitor, Hepatitis C Virus Nucleotide Analog NS5B Polymerase Inhibitor
Brand names
Sofosbuvir And Velpatasvir
Who reports
12,757 reports · 30% serious · 587 with death outcome · 43% female
Used for
Sofosbuvir and velpatasvir is indicated for the treatment of adults and pediatric patients 3 years of age and older with chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5, or 6 infection : without cirrhosis or with compensated cirrhosis with decompensated cirrhosis for use in combination with ribavirin.
What it is
Sofosbuvir and velpatasvir tablets (400 mg/100 mg) are fixed-dose combination tablets containing sofosbuvir and velpatasvir for oral administration. Sofosbuvir is a nucleotide analog HCV NS5B polymerase inhibitor and velpatasvir is an NS5A inhibitor.
Boxed warning
RISK OF HEPATITIS B VIRUS REACTIVATION IN PATIENTS COINFECTED WITH HCV AND HBV Test all patients for evidence of current or prior hepatitis B virus (HBV) infection before initiating treatment with sofosbuvir and velpatasvir.
Causality screen of the 40 strongest signals
What the badges mean
- Labeled — boxed warning The term (or its clinical synonym) appears in the FDA boxed warning: causality is regulator-recognised and considered serious.
- Labeled adverse reaction The exact term appears in the label's warnings or adverse-reactions sections: a known, expected effect. The FAERS signal confirms the label rather than discovering anything.
- Labeled (related wording) The label describes this effect under different wording (e.g. 'neutropenia' for 'neutrophil count decreased'). Treated as known.
- Likely indication confounding The term appears in the label's indications: reports probably describe the disease being treated (or its progression), not a drug effect. Classic confounding by indication.
- Reporting / coding artifact An administrative, monitoring or exposure term (product issue, off-label use, 'test normal', overdose...). Not a biological reaction; a high PRR here reflects how reports are coded.
- Lab value / disease marker A laboratory result, investigation or disease-activity marker (antibody positive, CRP abnormal, swollen joint count) not described in the label. These usually mirror the monitored disease or testing protocol rather than a drug effect; not screened further.
- Not in label — unassessed Not found in the label text, not an artifact pattern. This is a genuine candidate for a formal causality assessment (Bradford Hill / WHO-UMC); it has NOT had one here.
Strongest disproportionality signals
Flagged terms (PRR ≥ 2, χ² ≥ 4, n ≥ 10), ranked by PRR; infinite PRRs (no comparator reports) excluded. The EBGM column is a second, shrinkage-based estimate (MGPS) with its 5th percentile EB05 and the BCPNN IC025; a pair flagged by PRR alone is marked PRR-only and should be read as fragile. The strata column recomputes the PRR on serious reports only and flags pairs whose reports are unusually skewed by sex or come mostly from consumers rather than clinicians. 816 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Hepatitis c virus test positive | 45 | 135.3 99.9–183.3ROR 135.8 · χ² 5,414 / p <1e-300 | 118.8 EB05 92.4 · IC025 +5.2 3/3 methods agree | Lab value / disease marker | serious n=18 | no trial data cached |
| Hepatitis c rna positive | 12 | 121.6 67.6–218.5ROR 121.7 · χ² 1,225 / p 1e-268 | 96.3 EB05 58.7 · IC025 +3.4 3/3 methods agree | Lab value / disease marker | serious n=11 | no trial data cached |
| Genotype drug resistance test positive | 71 | 120.6 94.8–153.4ROR 121.3 · χ² 7,729 / p <1e-300 | 109.1 EB05 89.4 · IC025 +5.6 3/3 methods agree | Lab value / disease marker | serious n=71 · 93% clinician | no trial data cached |
| Hepatitis c rna increased | 13 | 64.4 37.0–112.1ROR 64.5 · χ² 721 / p 4e-159 | 57.1 EB05 35.5 · IC025 +3.3 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious n=11 | no trial data cached |
| Hepatitis c | 412 | 57.4 52.1–63.2ROR 59.2 · χ² 21,992 / p <1e-300 | 55.3 EB05 51.0 · IC025 +5.5 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 110.9 · ♀ 23% (drug 43%) · 90% clinician | no trial data cached |
| Hepatocellular carcinoma | 118 | 25.8 21.5–30.9ROR 26.0 · χ² 2,746 / p <1e-300 | 25.3 EB05 21.7 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious PRR 48.4 · ♀ 21% (drug 43%) · 96% clinician | no trial data cached |
| Oesophageal varices haemorrhage | 26 | 19.9 13.5–29.2ROR 19.9 · χ² 442 / p 2e-98 | 19.4 EB05 13.8 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious n=25 | no trial data cached |
| Hepatorenal syndrome | 17 | 16.6 10.3–26.8ROR 16.6 · χ² 232 / p 1e-52 | 15.9 EB05 10.0 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious n=17 | no trial data cached |
| Liver transplant | 31 | 14.2 10.0–20.2ROR 14.2 · χ² 364 / p 2e-81 | 13.7 EB05 9.9 · IC025 +2.9 3/3 methods agree | Labeled adverse reaction exact term | serious n=29 · ♀ 10% (drug 43%) · 93% clinician | no trial data cached |
| Intentional dose omission | 218 | 13.2 11.6–15.1ROR 13.4 · χ² 2,429 / p <1e-300 | 13.1 EB05 11.7 · IC025 +3.4 3/3 methods agree | Reporting / coding artifact | serious PRR 12.7 | no trial data cached |
| Varices oesophageal | 24 | 13.2 8.8–19.7ROR 13.2 · χ² 256 / p 7e-58 | 12.5 EB05 8.5 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious n=24 | no trial data cached |
| Hepatic pain | 29 | 11.2 7.8–16.1ROR 11.2 · χ² 258 / p 2e-58 | 10.5 EB05 7.4 · IC025 +2.6 3/3 methods agree | Labeled (related wording) related wording | serious n=6 | no trial data cached |
| Hepatic encephalopathy | 59 | 10.4 8.1–13.5ROR 10.5 · χ² 491 / p 4e-109 | 10.1 EB05 8.0 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 19.9 | no trial data cached |
| Intra-abdominal fluid collection | 11 | 10.3 5.7–18.6ROR 10.3 · χ² 82 / p 5e-20 | 8.3 EB05 4.6 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious n=9 | no trial data cached |
| Viral load increased | 24 | 10.2 6.8–15.2ROR 10.2 · χ² 188 / p 5e-43 | 9.3 EB05 6.3 · IC025 +2.4 3/3 methods agree | Lab value / disease marker | serious n=11 | no trial data cached |
| Hepatic cirrhosis | 114 | 10.1 8.4–12.1ROR 10.2 · χ² 918 / p 5e-202 | 9.9 EB05 8.4 · IC025 +3.0 3/3 methods agree | Labeled (related wording) related wording | serious PRR 18.8 | no trial data cached |
| Hepatitis b reactivation | 13 | 6.7 3.9–11.6ROR 6.8 · χ² 58 / p 1e-14 | 5.6 EB05 3.4 · IC025 +1.5 3/3 methods agree | Labeled — boxed warning synonym match | serious n=13 | no trial data cached |
| Treatment failure | 334 | 6.7 6.0–7.5ROR 6.9 · χ² 1,617 / p <1e-300 | 6.6 EB05 6.1 · IC025 +2.5 3/3 methods agree | Reporting / coding artifact | serious PRR 19.7 · 92% clinician | no trial data cached |
| Gastrointestinal tube insertion | 10 | 6.6 3.5–12.3ROR 6.6 · χ² 42 / p 5e-11 | 5.2 EB05 3.0 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious n=9 | no trial data cached |
| Ammonia increased | 20 | 6.5 4.2–10.0ROR 6.5 · χ² 87 / p 6e-21 | 5.7 EB05 3.9 · IC025 +1.8 3/3 methods agree | Lab value / disease marker | serious n=16 | no trial data cached |
| Product use complaint | 58 | 6.2 4.8–8.0ROR 6.2 · χ² 245 / p 1e-55 | 5.9 EB05 4.7 · IC025 +2.1 3/3 methods agree | Reporting / coding artifact | serious n=7 | no trial data cached |
| Portal vein thrombosis | 12 | 6.1 3.5–10.8ROR 6.1 · χ² 46 / p 5e-12 | 5.1 EB05 3.1 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious n=12 | no trial data cached |
| Ascites | 107 | 6.0 5.0–7.2ROR 6.0 · χ² 439 / p 7e-98 | 5.8 EB05 5.0 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 11.2 · 90% clinician | no trial data cached |
| Headache | 2,214 | 5.8 5.6–6.1ROR 6.8 · χ² 9,092 / p <1e-300 | 5.8 EB05 5.6 · IC025 +2.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 1.5 | no trial data cached |
| Fatigue (tiredness) | 2,624 | 5.6 5.4–5.8ROR 6.7 · χ² 10,170 / p <1e-300 | 5.5 EB05 5.4 · IC025 +2.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 1.3 | no trial data cached |
| Portal hypertension | 10 | 5.3 2.9–9.9ROR 5.3 · χ² 31 / p 1e-8 | 4.4 EB05 2.6 · IC025 +1.1 3/3 methods agree | Not in label — unassessed | serious n=10 | no trial data cached |
| Energy increased | 17 | 4.7 2.9–7.6ROR 4.7 · χ² 46 / p 6e-12 | 4.2 EB05 2.8 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | – | no trial data cached |
| Product dose omission | 184 | 4.6 4.0–5.3ROR 4.6 · χ² 511 / p 2e-113 | 4.5 EB05 4.0 · IC025 +1.9 3/3 methods agree | Reporting / coding artifact | serious PRR 3.5 | no trial data cached |
| Hepatic failure | 81 | 4.4 3.6–5.5ROR 4.4 · χ² 210 / p 6e-48 | 4.3 EB05 3.6 · IC025 +1.7 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 8.2 · 91% clinician | no trial data cached |
| Glomerular filtration rate decreased | 31 | 4.2 3.0–6.0ROR 4.2 · χ² 73 / p 8e-18 | 4.0 EB05 2.9 · IC025 +1.4 3/3 methods agree | Lab value / disease marker | serious PRR 7.0 · ♀ 20% (drug 43%) · 94% clinician | no trial data cached |
| Product dose omission in error | 66 | 4.0 3.2–5.1ROR 4.1 · χ² 148 / p 2e-34 | 3.9 EB05 3.2 · IC025 +1.6 3/3 methods agree | Reporting / coding artifact | serious PRR 5.1 · 81% consumer | no trial data cached |
| Dyspepsia (indigestion) | 216 | 3.6 3.2–4.1ROR 3.7 · χ² 409 / p 3e-91 | 3.6 EB05 3.2 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 1.1 | no trial data cached |
| Rash vesicular | 10 | 3.4 1.8–6.4ROR 3.4 · χ² 15 / p 6e-5 | 3.0 EB05 1.8 · IC025 +0.5 | Not in label — unassessed | serious n=5 | no trial data cached |
| Therapy cessation | 100 | 3.2 2.6–3.9ROR 3.2 · χ² 151 / p 5e-35 | 3.2 EB05 2.7 · IC025 +1.3 3/3 methods agree | Reporting / coding artifact | serious PRR 3.7 · 95% clinician | no trial data cached |
| Insomnia (trouble sleeping) | 510 | 3.1 2.9–3.4ROR 3.2 · χ² 753 / p 5e-166 | 3.1 EB05 2.9 · IC025 +1.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 1.0 | no trial data cached |
| Product size issue | 10 | 3.1 1.7–5.8ROR 3.1 · χ² 12 / p 2e-4 | 2.8 EB05 1.7 · IC025 +0.4 | Reporting / coding artifact | – | no trial data cached |
| Peritonitis bacterial | 18 | 2.9 1.9–4.7ROR 2.9 · χ² 21 / p 2e-6 | 2.8 EB05 1.9 · IC025 +0.7 | Not in label — unassessed | serious PRR 5.6 | no trial data cached |
| Initial insomnia | 18 | 2.9 1.8–4.6ROR 2.9 · χ² 21 / p 3e-6 | 2.7 EB05 1.9 · IC025 +0.7 | Not in label — unassessed | – | no trial data cached |
| Hepatic cancer | 41 | 2.8 2.0–3.8ROR 2.8 · χ² 45 / p 1e-11 | 2.7 EB05 2.1 · IC025 +0.9 3/3 methods agree | Not in label — unassessed | serious PRR 4.4 · ♀ 8% (drug 43%) | no trial data cached |
| Chromaturia | 38 | 2.8 2.0–3.8ROR 2.8 · χ² 41 / p 7e-11 | 2.7 EB05 2.1 · IC025 +0.9 3/3 methods agree | Not in label — unassessed | serious PRR 2.6 | no trial data cached |
Trial evidence (ClinicalTrials.gov)
Most frequently reported reactions
By raw co-report count, regardless of disproportionality. Common terms here are often the illness itself or generic outcomes.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Fatigue (tiredness) | 2,624 | 5.6 5.4–5.8ROR 6.7 · χ² 10,170 / p <1e-300 | 5.5 EB05 5.4 · IC025 +2.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 1.3 | no trial data cached |
| Headache | 2,214 | 5.8 5.6–6.1ROR 6.8 · χ² 9,092 / p <1e-300 | 5.8 EB05 5.6 · IC025 +2.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 1.5 | no trial data cached |
| Nausea | 1,174 | 2.4 2.3–2.6ROR 2.6 · χ² 1,042 / p 8e-229 | 2.4 EB05 2.3 · IC025 +1.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 1.0 | no trial data cached |
| Diarrhoea (diarrhea) | 662 | 1.7 1.6–1.8ROR 1.7 · χ² 192 / p 5e-44 | 1.7 EB05 1.6 · IC025 +0.6 | Labeled adverse reaction exact term | serious PRR 0.7 | no trial data cached |
| Drug ineffective (drug did not work) | 553 | 0.7 0.6–0.7ROR 0.7 · χ² 82 / p 8e-20 | 0.7 EB05 0.6 · IC025 -0.7 PRR-only: not supported by EBGM or IC | Reporting / coding artifact | serious PRR 3.3 | no trial data cached |
| Insomnia (trouble sleeping) | 510 | 3.1 2.9–3.4ROR 3.2 · χ² 753 / p 5e-166 | 3.1 EB05 2.9 · IC025 +1.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 1.0 | no trial data cached |
| Hepatitis c | 412 | 57.4 52.1–63.2ROR 59.2 · χ² 21,992 / p <1e-300 | 55.3 EB05 51.0 · IC025 +5.5 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 110.9 · ♀ 23% (drug 43%) · 90% clinician | no trial data cached |
| Treatment failure | 334 | 6.7 6.0–7.5ROR 6.9 · χ² 1,617 / p <1e-300 | 6.6 EB05 6.1 · IC025 +2.5 3/3 methods agree | Reporting / coding artifact | serious PRR 19.7 · 92% clinician | no trial data cached |
| Vomiting | 329 | 1.2 1.0–1.3ROR 1.2 · χ² 7 / p 0.005 | 1.2 EB05 1.1 · IC025 +0.0 | Labeled adverse reaction exact term | serious PRR 0.8 | no trial data cached |
| Death | 308 | 0.6 0.5–0.7ROR 0.6 · χ² 93 / p 3e-22 | 0.6 EB05 0.5 · IC025 -1.0 PRR-only: not supported by EBGM or IC | Outcome field, not a reaction boxed warning mentions mortality | serious PRR 1.1 | no trial data cached |
| Dizziness | 286 | 0.9 0.8–1.1ROR 0.9 · χ² 1 / p 0.170 | 0.9 EB05 0.9 · IC025 -0.3 PRR-only: not supported by EBGM or IC | Labeled adverse reaction exact term | serious PRR 0.7 | no trial data cached |
| Rash | 258 | 1.0 0.9–1.1ROR 1.0 · χ² 0 / p 0.370 | 1.0 EB05 0.9 · IC025 -0.2 PRR-only: not supported by EBGM or IC | Labeled adverse reaction exact term | serious PRR 0.9 | no trial data cached |
| Product dose omission issue | 245 | 1.4 1.2–1.6ROR 1.4 · χ² 30 / p 2e-8 | 1.4 EB05 1.3 · IC025 +0.3 | Reporting / coding artifact | serious PRR 1.9 · 73% consumer | no trial data cached |
| Abdominal discomfort | 239 | 2.4 2.1–2.7ROR 2.4 · χ² 186 / p 1e-42 | 2.3 EB05 2.1 · IC025 +1.0 3/3 methods agree | Not in label — unassessed | serious PRR 1.1 | no trial data cached |
| Intentional dose omission | 218 | 13.2 11.6–15.1ROR 13.4 · χ² 2,429 / p <1e-300 | 13.1 EB05 11.7 · IC025 +3.4 3/3 methods agree | Reporting / coding artifact | serious PRR 12.7 | no trial data cached |
Unlabeled candidate signals
These flagged terms were not found in the FDA label text and do not match an artifact pattern. They are the pairs that would merit a structured assessment (temporality, dose-response, biological plausibility, consistency across databases, trial or cohort evidence). The screen has not done that; string-matching misses label wording, and a strong PRR can still be stimulated reporting, co-medication, or the disease itself.
- Hepatocellular carcinoma — n=118, PRR 25.8
- Oesophageal varices haemorrhage — n=26, PRR 19.9
- Varices oesophageal — n=24, PRR 13.2
- Hepatic encephalopathy — n=59, PRR 10.4
- Ascites — n=107, PRR 6.0
- Dyspepsia — n=216, PRR 3.6
- Hepatic cancer — n=41, PRR 2.8
- Chromaturia — n=38, PRR 2.8
Want to assess one of these properly? The runbook describes the Bradford Hill / trial-evidence workflow used on the assessment page, and handoff_top1000_signals.csv lists the strongest unassessed pairs across all drugs.
Common questions
What are the most reported side effects of Velpatasvir and Sofosbuvir?
In FDA FAERS, the most frequently co-reported reaction terms for Velpatasvir and Sofosbuvir are fatigue, headache, nausea, diarrhoea, insomnia, hepatitis c. These are report counts, not rates: FAERS has no denominator, reporting is voluntary and uneven, and a term can be reported because of the illness being treated rather than the drug.
Does Velpatasvir and Sofosbuvir have an FDA boxed warning?
Yes. The current FDA label carries a boxed warning: RISK OF HEPATITIS B VIRUS REACTIVATION IN PATIENTS COINFECTED WITH HCV AND HBV Test all patients for evidence of current or prior hepatitis B virus (HBV) infection before initiating treatment with sofosbuvir and velpatasvir.
Do FAERS signals prove that Velpatasvir and Sofosbuvir causes these side effects?
No. A disproportionality signal (PRR, ROR) means a reaction is reported more often with this drug than with others in the database. That can reflect a real effect, but also the disease being treated, stimulated reporting after news or litigation, co-medications, or how reports are coded. Causality needs temporality, dose-response, biological plausibility, consistency across data sources and, ideally, trial or cohort evidence. This page screens each term against the FDA label and ClinicalTrials.gov results; it does not establish causation.
Sources & methods
- FDA label via openFDA (set ID d0c1a945-4440-4b5c-81aa-693ed3db597c, effective 20250306; matched on
openfda.generic_name.exact:"VELPATASVIR AND SOFOSBUVIR") - Bayesian shrinkage measures computed offline over all 1,317,300 cached pairs: BCPNN information component (IC, with Norén closed-form IC025) and MGPS empirical-Bayes geometric mean (EBGM, EB05) with a two-component gamma prior fitted by maximum marginal likelihood (α₁=0.57, β₁=0.02, α₂=1.42, β₂=0.70, w=0.17); unstratified
- FAERS pair statistics from the OpenPV build of 2026-09-14 (openFDA
count=aggregation, fieldpatient.drug.openfda.generic_name.exact, 856 reaction terms, min 3 co-reports); PRR/ROR with 95% CI, chi-square with Yates correction - Serious-only and stratified counts (serious:1, patient.patientsex, primarysource.qualification) from openFDA count queries; serious-only PRR uses the drug serious report total and the term global serious total (N_serious=11,882,979); strata shown only when n ≥ 20
- Seriousness and sex counts from openFDA
count=serious,patient.patientsex,seriousnessdeath
Page generated 2026-10-08. Label and PubChem text are retrieved automatically and may lag the current label; always check the current prescribing information. OpenPV is a beta research tool of the Open Source Medicine Foundation.