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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.

SIMEPREVIR: 6,029 Adverse Event Reports & Safety Profile

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6,029
Total FAERS Reports
372 (6.2%)
Deaths Reported
1,165
Hospitalizations
6,029
As Primary/Secondary Suspect
146
Life-Threatening
53
Disabilities
Nov 22, 2013
FDA Approved
Discontinued
Status

FDA Application: 205123 ·

Patent Expires: Sep 5, 2029 · First Report: 2008 · Latest Report: 202001

What Are the Most Common SIMEPREVIR Side Effects?

#1 Most Reported
Off label use
1,166 reports (19.3%)
#2 Most Reported
Anaemia
999 reports (16.6%)
#3 Most Reported
Platelet count decreased
833 reports (13.8%)

All SIMEPREVIR Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Off label use 1,166 19.3% 51 146
Anaemia 999 16.6% 52 144
Platelet count decreased 833 13.8% 11 86
White blood cell count decreased 581 9.6% 6 51
Hepatitis c 537 8.9% 7 12
Blood bilirubin increased 467 7.8% 18 81
Drug ineffective 440 7.3% 7 12
Pyrexia 429 7.1% 8 83
Rash 388 6.4% 19 46
Haemoglobin decreased 385 6.4% 10 62
Pruritus 341 5.7% 23 42
Fatigue 315 5.2% 30 40
Neutrophil count decreased 308 5.1% 5 38
Headache 303 5.0% 29 43
Nausea 299 5.0% 20 65
Malaise 247 4.1% 14 59
Hyperbilirubinaemia 237 3.9% 34 57
Insomnia 215 3.6% 10 15
Photosensitivity reaction 197 3.3% 9 19
Decreased appetite 196 3.3% 16 49

Who Reports SIMEPREVIR Side Effects? Age & Gender Data

Gender: 43.0% female, 57.0% male. Average age: 60.6 years. Most reports from: US. View detailed demographics →

Is SIMEPREVIR Getting Safer? Reports by Year

YearReportsDeathsHosp.
2008 4 0 1
2012 5 0 3
2013 20 0 8
2014 2,563 101 587
2015 687 78 272
2016 146 16 47
2017 28 3 4
2018 4 0 4
2019 13 0 0
2020 1 0 0

View full timeline →

What Is SIMEPREVIR Used For?

IndicationReports
Chronic hepatitis c 2,735
Hepatitis c 2,300
Product used for unknown indication 731
Hepatic cirrhosis 124
Hepatitis c virus test positive 32
Hepatitis 23
Antiviral treatment 22
Hepatocellular carcinoma 22
Hiv infection 22
Hepatitis c antibody positive 6

SIMEPREVIR vs Alternatives: Which Is Safer?

SIMEPREVIR vs SIMPONI SIMEPREVIR vs SIMVASTATIN SIMEPREVIR vs SINGULAIR SIMEPREVIR vs SINTILIMAB SIMEPREVIR vs SIPONIMOD SIMEPREVIR vs SIPULEUCEL-T SIMEPREVIR vs SIROLIMUS SIMEPREVIR vs SIRUKUMAB SIMEPREVIR vs SITAGLIPTIN SIMEPREVIR vs SOAP

Official FDA Label for SIMEPREVIR

Official prescribing information from the FDA-approved drug label.