Sovaldi Side Effects

Generic name: sofosbuvir

Medically reviewed by Philip Thornton, DipPharm. Last updated on Jan 23, 2024.

Note: This document provides detailed information about Sovaldi Side Effects associated with sofosbuvir. Some dosage forms listed on this page may not apply specifically to the brand name Sovaldi.

Applies to sofosbuvir: oral packet, oral tablet.

Important warnings This medicine can cause some serious health issues

Oral route (tablet)

Test all patients for evidence of current or prior hepatitis B virus (HBV) infection before initiating treatment with sofosbuvir.

HBV reactivation has been reported in HCV/HBV coinfected patients who were undergoing or had completed treatment with HCV direct acting antivirals and were not receiving HBV antiviral therapy.

Some cases have resulted in fulminant hepatitis, hepatic failure, and death.

Monitor HCV/HBV coinfected patients for hepatitis flare or HBV reactivation during HCV treatment and post-treatment follow-up.

Initiate appropriate patient management for HBV infection as clinically indicated.

Serious side effects of Sovaldi

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

• chest pain or discomfort
• lightheadedness, dizziness, or fainting
• shortness of breath
• slow or irregular heartbeat
• unusual tiredness

Other side effects of Sovaldi

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 pellet, 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 up to 4% of subjects using placebo, up to 1% of subjects using sofosbuvir and ribavirin for 12 weeks, less than 1% of subjects using sofosbuvir and ribavirin for 24 weeks, 11% of subjects using peginterferon alfa and ribavirin for 24 weeks, and 2% 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

• 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]

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]

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
• Frequency not reported: Stevens-Johnson syndrome
• Postmarketing reports: Skin rashes (sometimes with blisters or angioedema-like swelling), angioedema^[Ref]

Psychiatric

• 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]

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

Cardiovascular

• Frequency not reported: Severe bradycardia, heart block
• Postmarketing reports: Symptomatic bradycardia (including cases requiring pacemaker intervention)^[Ref]

Severe bradycardia and heart block have been reported when sofosbuvir-containing regimens were used in combination with 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]

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

• Common (1% to 10%): Increased total bilirubin
• Postmarketing reports: Hepatitis B reactivation^[Ref]

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]

Ocular

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

Frequently asked questions

• What is the difference between hepatitis B and C?
• What are the new drugs for the treatment of hepatitis C?
• Does Sovaldi cure hepatitis C?
• How well does Sovaldi work?
• What is the cost of Sovaldi? Why is it so expensive?
• What is the difference between Sovaldi and Harvoni?

Further information

Sovaldi side effects can vary depending on the individual. 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.

Medical Disclaimer