Vosevi Side Effects
Generic Name: sofosbuvir / velpatasvir / voxilaprevir
Note: This document contains side effect information about sofosbuvir / velpatasvir / voxilaprevir. Some of the dosage forms listed on this page may not apply to the brand name Vosevi.
For the Consumer
Applies to sofosbuvir/velpatasvir/voxilaprevir: 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 / voxilaprevir. 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 / voxilaprevir 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 / voxilaprevir:
Incidence not known
- Chest pain or discomfort
- dark-colored urine
- large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
- lightheadedness, dizziness, or fainting
- light-colored stools
- skin rash, sometimes with blisters or hive-like swelling
- slow or irregular heartbeat
- stomach pain, continuing
- unusual tiredness or weakness
- yellow eyes or skin
Side effects not requiring immediate medical attention
Some side effects of sofosbuvir / velpatasvir / voxilaprevir 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:
- feeling sad or empty
- lack of appetite
- loss of interest or pleasure
- trouble concentrating
- trouble sleeping
For Healthcare Professionals
Applies to sofosbuvir / velpatasvir / voxilaprevir: oral tablet
The most common side effects reported with this drug were headache, fatigue, diarrhea, and nausea. This drug was permanently discontinued due to side effects in up to 0.2% of patients.[Ref]
Very common (10% or more): Headache (up to 27%)[Ref]
Very common (10% or more): Fatigue (up to 24%)
Common (1% to 10%): Asthenia[Ref]
Very common (10% or more): Diarrhea (up to 20%), nausea (up to 14%)
Isolated, asymptomatic lipase elevations (greater than 3 times the upper limit of normal [3 x ULN]) were reported in 2% of patients.[Ref]
Due to inhibition of OATP1B1 and OATP1B3 by voxilaprevir, increased total bilirubin (up to 1.5 x ULN) occurred with this drug. No jaundice was observed and total bilirubin levels decreased after completion of therapy.
Cases of hepatic decompensation/failure (including fatal outcomes) have been reported during postmarketing experience in patients treated with hepatitis C virus nonstructural protein 3/4A (NS3/4A) protease inhibitor-containing regimens (including this drug). Reported cases occurred in patients with baseline cirrhosis with and without moderate or severe liver dysfunction (Child-Pugh B or C).[Ref]
Very common (10% or more): Increased total bilirubin (up to 13%)
Postmarketing reports: Hepatic decompensation, hepatic failure[Ref]
Common (1% to 10%): Insomnia
Uncommon (0.1% to 1%): Depressed mood[Ref]
Severe bradycardia and heart block have been reported when sofosbuvir-containing regimens were used in combination with amiodarone and/or other agents that lower heart rate.
Serious symptomatic bradycardia has been reported in patients taking amiodarone who started therapy with a regimen containing sofosbuvir.[Ref]
Common (1% to 10%): Rash
Frequency not reported: Stevens-Johnson syndrome
Common (1% to 10%): Back pain, myalgia
Uncommon (0.1% to 1%): Elevated creatine kinase, muscle spasm[Ref]
Common (1% to 10%): Decreased appetite
1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
2. "Product Information. Vosevi (sofosbuvir / velpatasvir / voxilaprevir)." Gilead Sciences, Foster City, CA.
3. Cerner Multum, Inc. "Australian Product Information." O 0
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.
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More about Vosevi (sofosbuvir / velpatasvir / voxilaprevir)
- During Pregnancy
- Dosage Information
- Drug Images
- Drug Interactions
- Pricing & Coupons
- En Español
- Drug class: antiviral combinations
- FDA Alerts (1)
- FDA Approval History