Sofosbuvir / velpatasvir Side Effects
Medically reviewed by Drugs.com. Last updated on July 24, 2020.
For the Consumer
Applies to sofosbuvir / velpatasvir: oral tablet
Oral route (Tablet)
Test all patients for evidence of current or prior hepatitis B virus (HBV) infection before initiating treatment with sofosbuvir / velpatasvir. HBV reactivation has been reported in HCV/HBV coinfected patients who were undergoing or had completed treatment with HCV direct acting antivirals and were not receiving HBV antiviral therapy. Some cases have resulted in fulminant hepatitis, hepatic failure, and death. Monitor HCV/HBV coinfected patients for hepatitis flare or HBV reactivation during HCV treatment and post-treatment follow-up. Initiate appropriate patient management for HBV infection as clinically indicated.
Side effects requiring immediate medical attention
Along with its needed effects, sofosbuvir / velpatasvir may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur while taking sofosbuvir / velpatasvir:
Incidence not known
- Chest pain or discomfort
- large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
- lightheadedness, dizziness or fainting
- skin rash, sometimes with blisters or hive-like swelling
- slow or irregular heartbeat
- trouble breathing
- unusual tiredness
Side effects not requiring immediate medical attention
Some side effects of sofosbuvir / velpatasvir may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.
Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
- unusual tiredness or weakness
- feeling sad or empty
- lack of appetite, nausea
- lack or loss of strength
- loss of interest or pleasure
- trouble concentrating
- trouble sleeping
For Healthcare Professionals
Applies to sofosbuvir / velpatasvir: oral tablet
The most common side effects reported with this drug were fatigue, headache, nausea, and nasopharyngitis. When this drug was studied with ribavirin, the most common side effects were fatigue, anemia, nausea, headache, insomnia, and diarrhea.
The most common side effect in patients with hepatitis C virus (HCV) with compensated liver disease (with or without cirrhosis) and end-stage renal disease requiring dialysis was nausea.
If this drug is used with ribavirin, the manufacturer product information for ribavirin should be consulted for associated side effects.[Ref]
Very common (10% or more): Fatigue (up to 32%)
Common (1% to 10%): Asthenia, irritability[Ref]
Very common (10% or more): Headache (up to 29%)[Ref]
Very common (10% or more): Anemia (26%), decreased hemoglobin (up to 23%)[Ref]
Decreases in hemoglobin to less than 10 g/dL and 8.5 g/dL during combination therapy were reported in 23% and 7% of subjects, respectively.[Ref]
Isolated, asymptomatic lipase elevations (greater than 3 times the upper limit of normal [3 x ULN]) were reported in up to 6% of subjects.[Ref]
Very common (10% or more): Nausea (up to 15%)
Common (1% to 10%): Diarrhea, increased lipase[Ref]
Very common (10% or more): Nasopharyngitis (up to 12%)
Common (1% to 10%): Cough
Very common (10% or more): Insomnia (up to 11%)
Uncommon (0.1% to 1%): Depressed mood[Ref]
Serious symptomatic bradycardia has been reported in patients taking amiodarone who started therapy with a regimen containing sofosbuvir.[Ref]
Frequency not reported: Severe bradycardia, heart block
Common (1% to 10%): Rash
Frequency not reported: Stevens-Johnson syndrome
Isolated, asymptomatic creatine kinase elevations (at least 10 x ULN) were reported in up to 2% of subjects.[Ref]
Frequency not reported: Increased indirect bilirubin[Ref]
1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
2. Cerner Multum, Inc. "Australian Product Information." O 0
3. "Product Information. Epclusa (sofosbuvir-velpatasvir)." Gilead Sciences, Foster City, CA.
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More about sofosbuvir / velpatasvir
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Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Some side effects may not be reported. You may report them to the FDA.