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Sofosbuvir / velpatasvir Side Effects

For the Consumer

Applies to sofosbuvir / velpatasvir: oral tablet

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
  • unconsciousness
  • unusual tiredness

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:

More Common

  • Headache
  • unusual tiredness or weakness

Less Common

  • Diarrhea
  • discouragement
  • feeling sad or empty
  • irritability
  • lack of appetite, nausea
  • lack or loss of strength
  • loss of interest or pleasure
  • rash
  • trouble concentrating
  • trouble sleeping

For Healthcare Professionals

Applies to sofosbuvir / velpatasvir: oral tablet

General

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.

If this drug is used with ribavirin, the manufacturer product information for ribavirin should be consulted for associated side effects.[Ref]

Other

Very common (10% or more): Fatigue (up to 32%)

Common (1% to 10%): Asthenia, irritability[Ref]

Nervous system

Very common (10% or more): Headache (up to 29%)[Ref]

Hematologic

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]

Gastrointestinal

Very common (10% or more): Nausea (up to 15%)

Common (1% to 10%): Diarrhea, increased lipase[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]

Respiratory

Very common (10% or more): Nasopharyngitis (up to 12%)

Common (1% to 10%): Cough

Psychiatric

Very common (10% or more): Insomnia (up to 11%)

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

Cardiovascular

Severe bradycardia and heart block have been reported when sofosbuvir plus another direct-acting antiviral was used with concomitant 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]

Frequency not reported: Severe bradycardia, heart block

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

Dermatologic

Common (1% to 10%): Rash

Postmarketing reports: Skin rashes (sometimes with blisters or angioedema-like swelling), angioedema[Ref]

Musculoskeletal

Common (1% to 10%): Back pain, arthralgia, increased creatine kinase[Ref]

Isolated, asymptomatic creatine kinase elevations (at least 10 x ULN) were reported in up to 2% of subjects.[Ref]

Hepatic

Increased indirect bilirubin (up to 3 mg/dL above baseline) was reported in HIV-1/HCV-coinfected patients using this drug and an atazanavir/ritonavir-based antiretroviral regimen.[Ref]

Frequency not reported: Increased indirect bilirubin[Ref]

References

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.

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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