Drug Safety Information for SOVALDI (Sofosbuvir)

Safety-related Labeling Changes for SOVALDI (SOFOSBUVIR) Rx Drug: FDA Link

Safety-related Labeling Changes for SOVALDI (SOFOSBUVIR) Rx Drug: FDA Link

Safety-related Labeling Changes for EPCLUSA (SOFOSBUVIR AND VELPATASVIR) Rx Drug: FDA Link

Safety-related Labeling Changes for VOSEVI (SOFOSBUVIR; VELPATASVIR; VOXILAPREVIR) Rx Drug: FDA Link

Safety-related Labeling Changes for SOVALDI (SOFOSBUVIR) Rx Drug: FDA Link

Required post-approval safety study:

Collect and analyze long-term safety data for subjects enrolled in the pediatric SOVALDI (sofosbuvir) pharmacokinetic, safety and efficacy trial described in 2110-1. Data collected should include at least 3 years of follow-up in order to characterize the long-term safety of sofosbuvir in pediatric subjects, including growth assessment, sexual maturation and characterization of sofosbuvir resistance-associated substitutions in viral isolates from subjects failing therapy. Due Date: 2023-08-31

Original FDA Drug Approval Date for SOVALDI: 2013-12-06

Adverse Drug Reactions for SOVALDI* (Sofosbuvir)

These charts and graphs are based on reports received through the FDA Adverse Event Reporting System (FAERS) program (see below).

Top 20 Adverse Effects Associated with SOVALDI
(reported in FDA Medwatch/FAERS Reports)

  Side Effect # of FDA Reports
1Off label use1009
2Fatigue672
3Nausea447
4Headache437
5Drug ineffective392
6Anaemia289
7Insomnia288
8Rash244
9Dyspnoea231
10Hepatitis c227
11Vomiting207
12Depression193
13Dizziness181
14Asthenia179
15Pyrexia171
16Pruritus168
17Death147
18Diarrhoea146
19Decreased appetite145
20Blood bilirubin increased143

* This side effect also appears in "Top 10 Side Effects of SOVALDI " in the drug's Review Summary based on AskaPatient reviews.

Top 10 Reasons for Taking SOVALDI
(associated with FDA Medwatch/FAERS Reports)

Reason # of FDA Reports
1Hepatitis c12660
2Product used for unknown indication2471
3Hepatic cirrhosis168
4Hepatitis125
5Hepatitis c virus test positive45
6Chronic hepatitis35
7Liver disorder20
8Hepatitis infectious20
9Hiv infection16
10Hepatitis viral10

*Also a top-10 reason in AskaPatient Review Summary.


Types of Adverse Events for SOVALDI

Total Reports Filed with FDA: 17443


Number of FDA Adverse Event Reports by Patient Age for SOVALDI

Total Reports Filed with FDA: 17443*


* Reports for drugs with the same active ingredients have been aggregated in this analysis: Sofosbuvir (Sovaldi)

Charts are based on 17443 reports filed with the FDA between 2004 and June 2015.

Adverse Event Reports are submitted to the FDA by pharmaceutical companies (mandatory reporting is required by manufacturers, distributors, or importers), health care providers such as doctors (voluntary reporting), and by patients themselves (voluntary reporting). More Information on FDA MedWatch (FDA Safety Information and Adverse Event Reporting Program)Voluntary reporting takes place under the FDA's MedWatch program, where health care professionals and consumers submit reports to FDA when they find a problem with a drug, medical device, biologic, or other FDA-regulated product. An adverse event is any undesirable experience or extreme side effect associated with the use of a medical product. Adverse events include: death, life threatening event, hospitalization, disability or permanent damage, congenital anomaly or birth defect, medical product use requiring a surgical or other intervention, or other serious medical situation believed to be caused by the drug.

Click to go back to search results and SOVALDI Reviews and Review Summary .

Historical Analytics of FDA Adverse Event Reports Provided by Druginformer.com. FDA Drug Safety Information, including safety-related labeling updates, required post-approval safety studies, risk evaluation management strategies (REMS), alerts, and recalls are compiled by AskaPatient.com from the U.S. Food and Drug Administration.