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Sovaldi Side Effects

Generic Name: sofosbuvir

Note: This document contains side effect information about sofosbuvir. Some of the dosage forms listed on this page may not apply to the brand name Sovaldi.

For the Consumer

Applies to sofosbuvir: oral tablet

Along with its needed effects, sofosbuvir (the active ingredient contained in Sovaldi) 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:

More Common

  • Chills
  • fever
  • lower back or side pain
  • pale skin
  • ulcers, sores, or white spots in the mouth
  • unusual tiredness or weakness

Rare

  • Changes in behavior
  • discouragement
  • feeling sad or empty
  • loss of interest or pleasure
  • thoughts of killing oneself
  • trouble concentrating

Incidence Not Known

Some side effects of sofosbuvir 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

  • Decreased appetite
  • diarrhea
  • difficulty with moving
  • headache
  • irritability
  • lack or loss of strength
  • muscle aching or cramping
  • muscle pains or stiffness
  • nausea
  • rash or itching skin
  • trouble sleeping

For Healthcare Professionals

Applies to sofosbuvir: oral tablet

General

When this drug is used with ribavirin or peginterferon alfa/ribavirin, the respective manufacturer product information should be consulted for associated side effects.

The most common side effects reported with sofosbuvir (the active ingredient contained in Sovaldi) and ribavirin therapy were fatigue and headache. The most common side effects reported with sofosbuvir, peginterferon alfa, and ribavirin therapy were fatigue, headache, nausea, insomnia, and anemia. Therapy was permanently discontinued due to side effects in 1.4% to 4% of subjects using placebo, 0.5% to 1% of subjects using sofosbuvir and ribavirin for 12 weeks, less than 1% of subjects using sofosbuvir and ribavirin for 24 weeks, 11.1% of subjects using peginterferon alfa and ribavirin for 24 weeks, and 2.4% of subjects using sofosbuvir, peginterferon alfa, and ribavirin for 12 weeks.[Ref]

Other

Very common (10% or more): Fatigue (up to 59%), asthenia (up to 21%), pyrexia (up to 18%), chills (up to 17%), influenza-like illness (up to 16%), pain

Common (1% to 10%): Chest pain[Ref]

Nervous system

Very common (10% or more): Headache (up to 36%), dizziness

Common (1% to 10%): Disturbance in attention, migraine, memory impairment[Ref]

Gastrointestinal

Increased lipase (greater than 3 times the upper limit of normal [3 x ULN]) was reported in up to 2% of patients. Lipase elevation was isolated and asymptomatic.[Ref]

Very common (10% or more): Nausea (up to 34%), diarrhea (up to 12%), vomiting

Common (1% to 10%): Increased lipase, abdominal discomfort, constipation, dyspepsia, dry mouth, gastroesophageal reflux[Ref]

Hematologic

Very common (10% or more): Decreased hemoglobin (up to 32.5%), anemia (up to 21%), neutropenia (up to 17%), decreased neutrophils (up to 15%), decreased lymphocyte count, decreased platelet count

Uncommon (0.1% to 1%): Pancytopenia[Ref]

Decreased hemoglobin (less than 10 g/dL: up to 23%; less than 8.5 g/dL: up to 2%), decreased neutrophils (0.5 to less than 0.75 x 10[9]/L: up to 15%; less than 0.5 x 10[9]/L: up to 5%), and decreased platelets (25 to less than 50 x 10[9]/L: up to 1%) have been reported.

In a study in liver transplant recipients, decreased hemoglobin was very common during therapy. Hemoglobin decreased to less than 10 g/dL in 13 of 40 patients (32.5%); hemoglobin decreased to less than 8.5 g/dL in 1 of those patients. Epoetin and/or a blood product was used in 8 patients (20%); 5 patients (12.5%) discontinued, modified, or interrupted therapy due to side effects.

Pancytopenia was reported, particularly in patients using concomitant pegylated interferon.[Ref]

Dermatologic

Very common (10% or more): Pruritus (up to 27%), rash (18%)

Common (1% to 10%): Alopecia, dry skin[Ref]

Psychiatric

Severe depression was reported, particularly in patients with history of psychiatric illness.[Ref]

Very common (10% or more): Insomnia (up to 25%), irritability (up to 13%)

Common (1% to 10%): Depression, anxiety, agitation

Uncommon (0.1% to 1%): Severe depression (including suicidal ideation, suicide)[Ref]

Cardiovascular

Severe bradycardia and heart block have been reported when this drug was used with another direct-acting antiviral (including daclatasvir, simeprevir, ledipasvir) and 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 this drug.[Ref]

Frequency not reported: Severe bradycardia, heart block

Postmarketing reports: Symptomatic bradycardia (including cases requiring pacemaker intervention)[Ref]

Metabolic

Very common (10% or more): Decreased appetite (up to 18%)

Common (1% to 10%): Decreased weight[Ref]

Musculoskeletal

Very common (10% or more): Myalgia (up to 14%), arthralgia

Common (1% to 10%): Increased creatine kinase, back pain, muscle spasms[Ref]

Increased creatine kinase (at least 10 x ULN) was reported in up to 2% of patients. Creatine kinase elevation was isolated and asymptomatic.[Ref]

Respiratory

Very common (10% or more): Dyspnea, cough

Common (1% to 10%): Nasopharyngitis, exertional dyspnea[Ref]

Hepatic

Increased total bilirubin (greater than 1.5 x ULN) was reported in up to 3% of patients. Bilirubin levels peaked during the first 1 to 2 weeks of therapy then decreased and returned to baseline levels by 4 weeks after therapy. These bilirubin elevations were not associated with transaminase elevations.[Ref]

Common (1% to 10%): Increased total bilirubin

Postmarketing reports: Hepatitis B reactivation[Ref]

Ocular

Common (1% to 10%): Blurred vision[Ref]

References

1. "Product Information. Sovaldi (sofosbuvir)." Gilead Sciences, Foster City, CA.

2. Cerner Multum, Inc. "Australian Product Information." O 0

3. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

4. FDA. U.S. Food and Drug Administration "FDA Drug Safety Communicaation: FDA warns of serious slowing of the heart rate when antiarrhythmic drug amiodarone is used with hepatitis C treatments containing sofosbuvir (Harvoni or Sovaldi) in combination with another Direct Acting Antiviral drug. Ava" ([2015 Mar 24]):

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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