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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

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
  • 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
  • unusual tiredness or weakness

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:

More common Less common
  • Discouragement
  • feeling sad or empty
  • irritability
  • lack of appetite
  • loss of interest or pleasure
  • tiredness
  • trouble concentrating
  • trouble sleeping

For Healthcare Professionals

Applies to sofosbuvir / velpatasvir / voxilaprevir: oral tablet

General

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 0.2% of patients.[Ref]

Nervous system

Very common (10% or more): Headache (up to 23%)[Ref]

Other

Very common (10% or more): Fatigue (up to 19%)
Common (1% to 10%): Asthenia[Ref]

Gastrointestinal

Isolated, asymptomatic lipase elevations (greater than 3 times the upper limit of normal [3 x ULN]) were reported in 2% of subjects.[Ref]

Very common (10% or more): Diarrhea (up to 14%), nausea (up to 13%)
Common (1% to 10%): Elevated lipase[Ref]

Hepatic

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.[Ref]

Very common (10% or more): Increased total bilirubin (up to 13%)[Ref]

Psychiatric

Common (1% to 10%): Insomnia
Uncommon (0.1% to 1%): Depressed mood[Ref]

Cardiovascular

Postmarketing reports: Serious symptomatic bradycardia (including fatal cardiac arrest, cases requiring pacemaker intervention)[Ref]

Serious symptomatic bradycardia has been reported in patients taking amiodarone who started therapy with a sofosbuvir-containing regimen.[Ref]

Dermatologic

Common (1% to 10%): Rash
Postmarketing reports: Skin rashes (sometimes with blisters or angioedema-like swelling), angioedema[Ref]

Musculoskeletal

Uncommon (0.1% to 1%): Elevated creatine kinase[Ref]

Isolated, asymptomatic creatine kinase elevations (at least 10 x ULN) were reported in up to 1% of subjects.[Ref]

References

1. "Product Information. Vosevi (sofosbuvir / velpatasvir / voxilaprevir)." Gilead Sciences, Foster City, CA.

Further information

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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