What the label lists and what reports show
Sofosbuvir and velpatasvir and voxilaprevir side effects
Sofosbuvir and velpatasvir and voxilaprevir's FDA label: “The most common adverse reactions (incidence greater than or equal to 10%, all grades) observed with treatment with VOSEVI for 12 weeks were headache, fatigue, diarrhea, and nausea.” FAERS holds 1,084 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is fatigue (197 reports).
- No generic listed
- Boxed warning
Check it at the source: the sofosbuvir and velpatasvir and voxilaprevir FDA label on DailyMed (effective July 14, 2025, Gilead Sciences, Inc.); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are the possible side effects of VOSEVI?VOSEVI may cause serious side effects, including: Hepatitis B virus (HBV) reactivation. See " What is the most important information I should know about VOSEVI? " In people who had or have advanced liver problems before starting treatment with VOSEVI: rare risk of worsening liver problems, liver failure and death. Your healthcare provider will check you for signs and symptoms of worsening liver problems during treatment with VOSEVI. […]
Source: FDA drug label, Gilead Sciences, Inc., effective July 14, 2025 (SPL set 17ffc094-8ca7-45d2-80d8-fd043bc9a221), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsThe most common adverse reactions (incidence greater than or equal to 10%, all grades) observed with treatment with VOSEVI for 12 weeks were headache, fatigue, diarrhea, and nausea.
Table 2 Adverse Reactions (All Grades) Reported in ≥5% of Subjects With HCV Without Cirrhosis or With Compensated Cirrhosis Receiving VOSEVI in POLARIS-1 and POLARIS-4
| Reaction | VOSEVI 12 weeks (N=263) | Placebo 12 weeks (N=152) | VOSEVI 12 weeks (N=182) | SOF/VEL 12 weeks (N=151) |
|---|---|---|---|---|
| Headache | 21% | 14% | 23% | 23% |
| Fatigue | 17% | 15% | 19% | 23% |
| Diarrhea | 13% | 9% | 14% | 3% |
| Nausea | 13% | 7% | 10% | 3% |
| Asthenia | 6% | 4% | 4% | 6% |
| Insomnia | 6% | 3% | 3% | 1% |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedThe following serious adverse reactions are described below and elsewhere in labeling: Serious Symptomatic Bradycardia When Coadministered with Amiodarone [see Warnings and Precautions (5.3) ]. The most common adverse reactions (incidence greater than or equal to 10%, all grades) observed with treatment with VOSEVI for 12 weeks were headache, fatigue, diarrhea, and nausea. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Gilead Sciences, Inc. at 1-800-GILEAD-5 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Adverse Reactions in HCV-Infected Subjects without Cirrhosis or with Compensated Cirrhosis The adverse reactions data for VOSEVI were derived from two Phase 3 clinical trials (POLARIS-1 and POLARIS-4) that evaluated a total of 445 subjects infected with genotype 1, 2, 3, 4, 5, or 6 HCV, without cirrhosis or with compensated cirrhosis (Child-Pugh A), who received VOSEVI for 12 weeks. VOSEVI was studied in placebo- and active-controlled (sofosbuvir/velpatasvir) trials [see Clinical Studies (14.1 and 14.2) ]. …
Source: FDA drug label, Gilead Sciences, Inc., effective July 14, 2025 (SPL set 17ffc094-8ca7-45d2-80d8-fd043bc9a221), via openFDA; the full label on DailyMed
What do FAERS reports show?
1,084 reports list sofosbuvir and velpatasvir and voxilaprevir among the medicines taken, each a report of something that happened, not proof the medicine caused it; 35 are coded as a death and 81 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 17 reactions below, 8 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Sofosbuvir and velpatasvir and voxilaprevir: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions