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Sofosbuvir / velpatasvir Side Effects

For the Consumer

Applies to sofosbuvir / velpatasvir: oral tablet

As well as its needed effects, sofosbuvir / velpatasvir may cause unwanted side effects that require medical attention.

Major Side Effects

If any of the following side effects occur while taking sofosbuvir / velpatasvir, check with your doctor immediately:

Incidence not known:
  • Chest pain or discomfort
  • lightheadedness, dizziness or fainting
  • shortness of breath
  • slow or irregular heartbeat
  • unconsciousness
  • unusual tiredness

Minor Side Effects

Some sofosbuvir / velpatasvir side effects may not need any medical attention. As your body gets used to the medicine these side effects may disappear. Your health care professional may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue, or if you are concerned about them:

More common:
  • Fatigue
  • headache
Less common:
  • Diarrhea
  • discouragement
  • feeling sad or empty
  • irritability
  • lack of appetite, nausea
  • lack or loss of strength
  • loss of interest or pleasure
  • rash
  • tiredness
  • 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 and headache. When this drug was studied with ribavirin, the most common side effects were fatigue, anemia, nausea, headache, insomnia, and diarrhea.

The manufacturer product information for ribavirin should be consulted, if applicable.[Ref]

Other

Very common (10% or more): Fatigue (up to 32%)
Common (1% to 10%): Asthenia, irritability[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]

Nervous system

Very common (10% or more): Headache (up to 22%)[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]

Psychiatric

Very common (10% or more): Insomnia (up to 11%)
Uncommon (0.1% to 1%): Depressed mood[Ref]

Cardiovascular

Serious symptomatic bradycardia has been reported in patients taking amiodarone who started therapy with sofosbuvir in combination with another hepatitis C virus (HCV) direct-acting antiviral.[Ref]

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

Dermatologic

Common (1% to 10%): Rash[Ref]

Musculoskeletal

Common (1% to 10%): Increased creatine kinase[Ref]

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

Hepatic

Frequency not reported: Increased indirect bilirubin[Ref]

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]

References

1. "Product Information. Epclusa (sofosbuvir-velpatasvir)." Gilead Sciences, Foster City, CA.

It is possible that some side effects of sofosbuvir / velpatasvir may not have been reported. These can be reported to the FDA here. Always consult a healthcare professional for medical advice.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

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