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Important: This site presents data from the FDA Adverse Event Reporting System (FAERS). A report does not mean the drug caused the event. Full disclaimer.

SOFOSBUVIR\VELPATASVIR: 18,042 Adverse Event Reports & Safety Profile

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18,042
Total FAERS Reports
978 (5.4%)
Deaths Reported
2,342
Hospitalizations
18,042
As Primary/Secondary Suspect
143
Life-Threatening
289
Disabilities

First Report: 1985 · Latest Report: 20250912

What Are the Most Common SOFOSBUVIR\VELPATASVIR Side Effects?

#1 Most Reported
Fatigue
3,666 reports (20.3%)
#2 Most Reported
Headache
3,084 reports (17.1%)
#3 Most Reported
Nausea
1,637 reports (9.1%)

All SOFOSBUVIR\VELPATASVIR Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Fatigue 3,666 20.3% 15 129
Headache 3,084 17.1% 5 110
Nausea 1,637 9.1% 3 98
Diarrhoea 882 4.9% 10 55
Insomnia 715 4.0% 2 34
Drug ineffective 694 3.9% 17 54
Product dose omission issue 625 3.5% 1 69
Death 597 3.3% 591 59
Hepatitis c 510 2.8% 14 38
Vomiting 507 2.8% 9 94
Intentional dose omission 474 2.6% 3 112
Dizziness 427 2.4% 6 42
Treatment failure 380 2.1% 3 18
Product dose omission 364 2.0% 0 31
Abdominal discomfort 356 2.0% 5 23
Rash 321 1.8% 3 28
Pain 310 1.7% 4 31
Asthenia 306 1.7% 16 77
Dyspepsia 301 1.7% 1 9
Decreased appetite 279 1.6% 4 30

Who Reports SOFOSBUVIR\VELPATASVIR Side Effects? Age & Gender Data

Gender: 42.5% female, 57.5% male. Average age: 54.5 years. Most reports from: US. View detailed demographics →

Is SOFOSBUVIR\VELPATASVIR Getting Safer? Reports by Year

YearReportsDeathsHosp.
2008 1 1 1
2009 1 0 0
2012 1 0 0
2014 2 0 1
2016 439 10 58
2017 2,113 77 241
2018 1,917 103 221
2019 2,752 95 299
2020 1,539 68 189
2021 672 61 152
2022 477 54 120
2023 306 28 95
2024 222 39 45
2025 122 14 39

View full timeline →

What Is SOFOSBUVIR\VELPATASVIR Used For?

IndicationReports
Chronic hepatitis c 6,405
Hepatitis c 4,956
Product used for unknown indication 2,083
Hepatic cirrhosis 368
Hepatitis viral 99
Hepatitis c virus test positive 88
Hepatitis b 46
Essential hypertension 33
Acute hepatitis c 29
Chronic hepatitis 28

SOFOSBUVIR\VELPATASVIR vs Alternatives: Which Is Safer?

SOFOSBUVIR\VELPATASVIR vs SOFOSBUVIR\VELPATASVIR\VOXILAPREVIR SOFOSBUVIR\VELPATASVIR vs SOLIFENACIN SOFOSBUVIR\VELPATASVIR vs SOLIRIS SOFOSBUVIR\VELPATASVIR vs SOLOSTAR SOFOSBUVIR\VELPATASVIR vs SOLRIAMFETOL SOFOSBUVIR\VELPATASVIR vs SOLU-MEDROL SOFOSBUVIR\VELPATASVIR vs SOMATREM SOFOSBUVIR\VELPATASVIR vs SOMATROPIN SOFOSBUVIR\VELPATASVIR vs SONIDEGIB SOFOSBUVIR\VELPATASVIR vs SORAFENIB

Official FDA Label for SOFOSBUVIR\VELPATASVIR

Official prescribing information from the FDA-approved drug label.