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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
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.
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:
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:
For Healthcare Professionals
Applies to sofosbuvir: oral tabletGeneral
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.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 painNervous system
Very common (10% or more): Headache (up to 36%), dizziness
Common (1% to 10%): Disturbance in attention, migraine, memory impairmentGastrointestinal
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.
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 refluxHematologic
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
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/L: up to 15%; less than 0.5 x 10/L: up to 5%), and decreased platelets (25 to less than 50 x 10/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.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), angioedemaPsychiatric
Severe depression was reported, particularly in patients with history of psychiatric illness.
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)Cardiovascular
Severe bradycardia and heart block have been reported when sofosbuvir-containing regimens were used with 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.
Frequency not reported: Severe bradycardia, heart block
Postmarketing reports: Symptomatic bradycardia (including cases requiring pacemaker intervention)Metabolic
Very common (10% or more): Decreased appetite (up to 18%)
Common (1% to 10%): Decreased weightMusculoskeletal
Very common (10% or more): Myalgia (up to 14%), arthralgia
Common (1% to 10%): Increased creatine kinase, back pain, muscle spasms
Increased creatine kinase (at least 10 x ULN) was reported in up to 2% of patients. Creatine kinase elevation was isolated and asymptomatic.Respiratory
Very common (10% or more): Dyspnea, cough
Common (1% to 10%): Nasopharyngitis, exertional dyspneaHepatic
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.
Common (1% to 10%): Increased total bilirubin
Postmarketing reports: Hepatitis B reactivationOcular
Common (1% to 10%): Blurred vision
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