What the label lists and what reports show
Sofosbuvir side effects
Sofosbuvir's FDA label: “The most common adverse events (incidence greater than or equal to 20%, all grades) observed with SOVALDI in combination with ribavirin were fatigue and headache.” FAERS holds 19,615 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 (2,314 reports).
- No generic listed
- Boxed warning
Check it at the source: the sofosbuvir FDA label on DailyMed (effective December 26, 2024, 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 SOVALDI?SOVALDI can cause serious side effects, including: Hepatitis B virus reactivation. See " What is the most important information I should know about SOVALDI? " Slow heart rate (bradycardia). SOVALDI treatment may result in slowing of the heart rate along with other symptoms when taken with amiodarone (Cordarone ® , Nexterone ® , Pacerone ® ), a medicine used to treat certain heart problems. In some cases bradycardia has led to death or the need for a heart pacemaker when amiodarone is taken with SOVALDI. […]
Source: FDA drug label, Gilead Sciences, Inc., effective December 26, 2024 (SPL set 80beab2c-396e-4a37-a4dc-40fdb62859cf), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsThe most common adverse events (incidence greater than or equal to 20%, all grades) observed with SOVALDI in combination with ribavirin were fatigue and headache.
Table 5 Adverse Events (All Grades and without Regard to Causality) Reported in ≥15% of Subjects with HCV in Any Treatment Arm
| Reaction | PBO 12 weeks N=71 | SOVALDI + RBV Subjects received weight-based ribavirin (1000 mg per day if weighing <75… N=650 | SOVALDI + RBV 24 weeks N=250 | Peg-IFN alfa + RBV Subjects received 800 mg ribavirin per day regardless of weight. 24… N=243 | SOVALDI + Peg-IFN alfa + RBV 12 weeks N=327 |
|---|---|---|---|---|---|
| Fatigue | 24% | 38% | 30% | 55% | 59% |
| Headache | 20% | 24% | 30% | 44% | 36% |
| Nausea | 18% | 22% | 13% | 29% | 34% |
| Insomnia | 4% | 15% | 16% | 29% | 25% |
| Pruritus | 8% | 11% | 27% | 17% | 17% |
| Anemia | 0% | 10% | 6% | 12% | 21% |
| Asthenia | 3% | 6% | 21% | 3% | 5% |
| Rash | 8% | 8% | 9% | 18% | 18% |
| Decreased Appetite | 10% | 6% | 6% | 18% | 18% |
| Chills | 1% | 2% | 2% | 18% | 17% |
| Influenza Like Illness | 3% | 3% | 6% | 18% | 16% |
| Pyrexia | 0% | 4% | 4% | 14% | 18% |
| Diarrhea | 6% | 9% | 12% | 17% | 12% |
| Neutropenia | 0% | <1% | <1% | 12% | 17% |
| Myalgia | 0% | 6% | 9% | 16% | 14% |
| Irritability | 1% | 10% | 10% | 16% | 13% |
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 the labeling: Serious Symptomatic Bradycardia When Coadministered with Amiodarone [see Warnings and Precautions (5.2) ]. The most common adverse events (incidence greater than or equal to 20%, all grades) observed with SOVALDI in combination with ribavirin were fatigue and headache. The most common adverse events observed with SOVALDI in combination with peginterferon alfa and ribavirin were fatigue, headache, nausea, insomnia and anemia. ( 6.1 ). The most common adverse events observed with SOVALDI in combination with ribavirin oral solution in pediatric patients was decreased appetite. ( 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. When SOVALDI is administered with ribavirin or peginterferon alfa/ribavirin, refer to the respective prescribing information for a description of adverse reactions associated with their use.
Source: FDA drug label, Gilead Sciences, Inc., effective December 26, 2024 (SPL set 80beab2c-396e-4a37-a4dc-40fdb62859cf), via openFDA; the full label on DailyMed
What do FAERS reports show?
19,615 reports list sofosbuvir among the medicines taken, each a report of something that happened, not proof the medicine caused it; 1,797 are coded as a death and 4,451 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. Reports rose sharply in 2016 (4,033, against a median of 198 a year): FAERS counts follow reporting, which news, litigation and label changes can drive, not how often a reaction happens. Of the 21 reactions below, 15 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: 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