What are the most common side effects of SOFOSBUVIR?

Reported side effects vary by individual. The side-effects section on this page lists the events most frequently reported to FDA FAERS for SOFOSBUVIR. FAERS is voluntary reporting, so it reflects what was reported, not absolute incidence.

Is SOFOSBUVIR the same as Vosevi?

Vosevi is a brand name for SOFOSBUVIR. They share the same active ingredient and FDA-approved indications. Biosimilars and authorised generics may differ in inactive ingredients such as buffers or preservatives.

SOFOSBUVIR

Q: What is SOFOSBUVIR used for?

SOFOSBUVIR (brand name Vosevi) is a Other indicated for or 6 infection previously treated with sofosbuvir without an NS5A inhibitor. VOSEVI is a fixed-dose combination of sofosbuvir, a hepatitis C virus (HCV) nucleotide analog NS5B polymerase inhibitor, velpatasvir.

Q: How does SOFOSBUVIR work?

SOFOSBUVIR works through the following mechanism: 12.1 Mechanism of Action VOSEVI is a fixed-dose combination of sofosbuvir, velpatasvir, and voxilaprevir which are DAA agents against the hepatitis C virus [see Microbiology (12.4) ]..

Other

Brand names: Vosevi

Oral

Mechanism of Action

12.1 Mechanism of Action VOSEVI is a fixed-dose combination of sofosbuvir, velpatasvir, and voxilaprevir which are DAA agents against the hepatitis C virus [see Microbiology (12.4) ].

Indications

or 6 infection previously treated with sofosbuvir without an NS5A inhibitor. VOSEVI is a fixed-dose combination of sofosbuvir

a hepatitis C virus (HCV) nucleotide analog NS5B polymerase inhibitor

velpatasvir

an HCV NS5A inhibitor

and voxilaprevir

an HCV NS3/4A protease inhibitor

Contraindications

• 4 CONTRAINDICATIONS VOSEVI is contraindicated with rifampin [see Drug Interactions (7.3)
• and Clinical Pharmacology (12.3) ]. Coadministration with rifampin. ( 4 )

FDA Warnings

5 WARNINGS AND PRECAUTIONS Risk of Hepatitis B Virus Reactivation: Test all patients for evidence of current or prior HBV infection before initiation of HCV treatment
1 ) Risk of Hepatic Decompensation/Failure in Patients with Evidence of Advanced Liver Disease: Hepatic decompensation/failure, including fatal outcomes, have been reported mostly in patients with cirrhosis and baseline moderate or severe liver impairment (Child-Pugh B or C) treated with HCV NS3/4A protease inhibitor-containing regimens
2 ) Bradycardia with Amiodarone Coadministration: Serious symptomatic bradycardia may occur in patients taking amiodarone with VOSEVI, a sofosbuvir-containing regimen, particularly in patients also receiving beta blockers, or those with underlying cardiac comorbidities and/or advanced liver disease
1 Risk of Hepatitis B Virus Reactivation in Patients Coinfected with HCV and HBV Hepatitis B virus (HBV) reactivation has been reported in HCV/HBV coinfected patients who were undergoing or had completed treatment with HCV direct-acting antivirals, and who were not receiving HBV antiviral therapy

Known Side Effects

10 documented side effects by frequency

Fatigue

>10%

Headache

>10%

Nausea

1-10%

Drug Not Working

1-10%

Insomnia

1-10%

Diarrhea

1-10%

Vomiting

0.1-1%

Dizziness

0.1-1%

Weakness

0.1-1%

Shortness of Breath

0.1-1%

Community Discussions

No community discussions found for SOFOSBUVIR yet.

Primary sources

Every figure on this page links back to its primary source. See data sources for full provenance.

DailyMed FDA label search → SOFOSBUVIR openFDA label JSON → SOFOSBUVIR FAERS adverse-event reports → SOFOSBUVIR ClinicalTrials.gov → completed Phase 2+ trials of SOFOSBUVIR

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Formulations

Dosage Forms

Tablet

Route

Oral