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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.

LEDIPASVIR\SOFOSBUVIR: 23,616 Adverse Event Reports & Safety Profile

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23,616
Total FAERS Reports
1,371 (5.8%)
Deaths Reported
4,031
Hospitalizations
23,616
As Primary/Secondary Suspect
384
Life-Threatening
303
Disabilities

First Report: 1970 · Latest Report: 20241027

What Are the Most Common LEDIPASVIR\SOFOSBUVIR Side Effects?

#1 Most Reported
Fatigue
4,609 reports (19.5%)
#2 Most Reported
Headache
4,203 reports (17.8%)
#3 Most Reported
Nausea
1,471 reports (6.2%)

All LEDIPASVIR\SOFOSBUVIR Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Fatigue 4,609 19.5% 38 205
Headache 4,203 17.8% 24 222
Nausea 1,471 6.2% 31 167
Drug ineffective 1,397 5.9% 31 87
Hepatitis c 1,076 4.6% 23 81
Diarrhoea 1,065 4.5% 39 134
Insomnia 1,021 4.3% 14 95
Hepatocellular carcinoma 640 2.7% 76 136
Vomiting 623 2.6% 44 208
Dizziness 604 2.6% 21 140
Asthenia 558 2.4% 43 173
Drug dose omission 553 2.3% 5 140
Treatment failure 511 2.2% 6 20
Death 471 2.0% 470 65
Arthralgia 407 1.7% 3 37
Dyspnoea 405 1.7% 26 171
Rash 402 1.7% 6 26
Constipation 389 1.7% 11 49
Anaemia 384 1.6% 57 163
Pain 372 1.6% 6 66

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

Gender: 42.9% female, 57.1% male. Average age: 57.9 years. Most reports from: US. View detailed demographics →

Is LEDIPASVIR\SOFOSBUVIR Getting Safer? Reports by Year

YearReportsDeathsHosp.
2000 1 0 0
2002 2 0 1
2004 7 0 7
2005 1 0 1
2006 3 0 1
2008 2 0 0
2009 1 1 1
2011 1 0 1
2012 4 1 2
2013 8 0 1
2014 201 14 63
2015 3,247 260 1,146
2016 4,515 248 824
2017 3,878 140 422
2018 2,143 76 276
2019 1,040 41 157
2020 266 20 47
2021 86 10 31
2022 35 3 14
2023 17 3 3
2024 6 2 0

View full timeline →

What Is LEDIPASVIR\SOFOSBUVIR Used For?

IndicationReports
Hepatitis c 8,924
Chronic hepatitis c 6,621
Product used for unknown indication 3,087
Hepatic cirrhosis 552
Hepatitis c virus test positive 116
Hepatitis 70
Essential hypertension 64
Chronic hepatitis 47
Gastrooesophageal reflux disease 44
Hepatitis b 43

LEDIPASVIR\SOFOSBUVIR vs Alternatives: Which Is Safer?

LEDIPASVIR\SOFOSBUVIR vs LEFLUNOMIDE LEDIPASVIR\SOFOSBUVIR vs LEMBOREXANT LEDIPASVIR\SOFOSBUVIR vs LENACAPAVIR LEDIPASVIR\SOFOSBUVIR vs LENALIDOMIDE LEDIPASVIR\SOFOSBUVIR vs LENIOLISIB LEDIPASVIR\SOFOSBUVIR vs LENOGRASTIM LEDIPASVIR\SOFOSBUVIR vs LENVATINIB LEDIPASVIR\SOFOSBUVIR vs LEPONEX LEDIPASVIR\SOFOSBUVIR vs LERCANIDIPINE LEDIPASVIR\SOFOSBUVIR vs LETAIRIS

Official FDA Label for LEDIPASVIR\SOFOSBUVIR

Official prescribing information from the FDA-approved drug label.