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Epclusa Side Effects

Generic Name: sofosbuvir / velpatasvir

Note: This page contains information about the side effects of sofosbuvir / velpatasvir. Some of the dosage forms included on this document may not apply to the brand name Epclusa.

For the Consumer

Applies to sofosbuvir / velpatasvir: oral tablet

In addition to its needed effects, some unwanted effects may be caused by sofosbuvir / velpatasvir. In the event that any of these side effects do occur, they may require medical attention.

Major Side Effects

You should check with your doctor immediately if any of these side effects occur when taking sofosbuvir / velpatasvir:

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 of the side effects that can occur with sofosbuvir / velpatasvir may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

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.

Not all side effects for Epclusa may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

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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