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What the label lists and what reports show

Sofosbuvir and velpatasvir side effects

Sofosbuvir and velpatasvir's FDA label: “The most common adverse reactions (incidence greater than or equal to 10%, all grades) observed in adults and pediatric subjects 6 years of age and older with treatment with EPCLUSA for 12 weeks are headache and fatigue.” FAERS holds 12,759 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 (2,624 reports).

  • No generic listed
  • Boxed warning

Check it at the source: the sofosbuvir and velpatasvir FDA label on DailyMed (effective June 5, 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 EPCLUSA?

EPCLUSA can cause serious side effects, including: Hepatitis B virus reactivation. See " What is the most important information I should know about EPCLUSA? " Slow heart rate (bradycardia). EPCLUSA 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 medicines similar to EPCLUSA that contain sofosbuvir. […]

Source: FDA drug label, Gilead Sciences, Inc., effective June 5, 2024 (SPL set 7f30631a-ee3b-4cfe-866b-964df3f0a44f), via openFDA; the full label on DailyMed

What does the label list?

From the label: adverse reactions

The most common adverse reactions (incidence greater than or equal to 10%, all grades) observed in adults and pediatric subjects 6 years of age and older with treatment with EPCLUSA for 12 weeks are headache and fatigue.

From the label: adverse reactions, continued

The following serious adverse reactions are described below and elsewhere in labeling: Serious Symptomatic Bradycardia When Coadministered with Amiodarone [see Warnings and Precautions (5.2) ]. The most common adverse reactions (incidence greater than or equal to 10%, all grades) observed in adults and pediatric subjects 6 years of age and older with treatment with EPCLUSA for 12 weeks are headache and fatigue. ( 6.1 ) The most common adverse reactions (incidence greater than or equal to 10%, grade 1 or 2) observed in pediatric subjects less than 6 years of age are vomiting and product use issue (spitting up the drug). ( 6.1 ) The most common adverse reactions (incidence greater than or equal to 10%, all grades) observed with treatment with EPCLUSA and ribavirin for 12 weeks in adult patients with decompensated cirrhosis are fatigue, anemia, nausea, headache, insomnia, and diarrhea. ( 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. …

Source: FDA drug label, Gilead Sciences, Inc., effective June 5, 2024 (SPL set 7f30631a-ee3b-4cfe-866b-964df3f0a44f), via openFDA; the full label on DailyMed

What do FAERS reports show?

12,759 reports list sofosbuvir and velpatasvir among the medicines taken, each a report of something that happened, not proof the medicine caused it; 587 are coded as a death and 1,426 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, 9 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

  • Fatigue (named in the label)2,624
  • Headache (named in the label)2,214
  • Nausea (named in the label)1,174
  • Diarrhoea (named in the label)662
  • Drug Ineffective (a use or a product term, not a reaction)553
  • Insomnia (named in the label)510
  • Hepatitis C (a use or a product term, not a reaction)412
  • Treatment Failure (a use or a product term, not a reaction)334
  • Vomiting (named in the label)329
  • Death (an outcome recorded in the report)308
  • Dizziness (named in the label)286
  • Rash (named in the label)258
  • Product Dose Omission Issue (a use or a product term, not a reaction)245
  • Abdominal Discomfort239
  • Intentional Dose Omission (a use or a product term, not a reaction)218
  • Dyspepsia216
  • Pain205
  • Drug Dose Omission (a use or a product term, not a reaction)202
  • Asthenia (named in the label)200
  • Pruritus200
  • Product Dose Omission (a use or a product term, not a reaction)184
  • Decreased Appetite178
  • Abdominal Pain Upper176
  • Constipation174
  • Arthralgia171

Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms

What next?

Sofosbuvir and velpatasvir: the full record
label, generics, price, shortages, recalls
Side effects hub
the most reported medicines and reactions