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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.

TELAPREVIR: 6,420 Adverse Event Reports & Safety Profile

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6,420
Total FAERS Reports
195 (3.0%)
Deaths Reported
1,040
Hospitalizations
6,420
As Primary/Secondary Suspect
104
Life-Threatening
22
Disabilities
May 23, 2011
FDA Approved
Discontinued
Status

FDA Application: 201917 ·

Patent Expires: May 30, 2028 · First Report: 1994 · Latest Report: 20171128

What Are the Most Common TELAPREVIR Side Effects?

#1 Most Reported
Anaemia
1,124 reports (17.5%)
#2 Most Reported
Rash
918 reports (14.3%)
#3 Most Reported
Nausea
823 reports (12.8%)

All TELAPREVIR Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Anaemia 1,124 17.5% 48 280
Rash 918 14.3% 30 164
Nausea 823 12.8% 2 106
Fatigue 793 12.4% 8 76
Pruritus 652 10.2% 5 69
Headache 506 7.9% 1 28
Pyrexia 435 6.8% 8 86
Insomnia 399 6.2% 3 27
Vomiting 376 5.9% 6 62
Diarrhoea 337 5.3% 3 44
Thrombocytopenia 316 4.9% 26 102
Decreased appetite 315 4.9% 4 53
Dyspnoea 312 4.9% 0 58
Asthenia 295 4.6% 10 63
White blood cell count decreased 288 4.5% 0 35
Chills 281 4.4% 2 10
Influenza like illness 271 4.2% 3 13
Depression 269 4.2% 4 31
Haemoglobin decreased 257 4.0% 4 69
Pain 251 3.9% 1 18

Who Reports TELAPREVIR Side Effects? Age & Gender Data

Gender: 45.4% female, 54.6% male. Average age: 53.9 years. Most reports from: US. View detailed demographics →

Is TELAPREVIR Getting Safer? Reports by Year

YearReportsDeathsHosp.
2001 1 0 0
2003 2 0 1
2004 6 0 1
2006 3 0 0
2007 1 0 0
2008 2 0 0
2009 4 0 0
2010 12 1 0
2011 107 2 37
2012 542 9 152
2013 514 13 215
2014 404 31 181
2015 7 1 3
2016 2 0 2
2017 10 1 1

View full timeline →

What Is TELAPREVIR Used For?

IndicationReports
Chronic hepatitis c 3,103
Hepatitis c 2,604
Product used for unknown indication 491
Hepatic cirrhosis 60
Hepatitis c virus test positive 35
Antiviral treatment 30
Hiv infection 20
Hepatitis 10
Chronic hepatitis 9
Hepatitis cholestatic 9

TELAPREVIR vs Alternatives: Which Is Safer?

TELAPREVIR vs TELBIVUDINE TELAPREVIR vs TELMISARTAN TELAPREVIR vs TELOTRISTAT ETHYL TELAPREVIR vs TEMAZEPAM TELAPREVIR vs TEMODAR TELAPREVIR vs TEMOZOLOMIDE TELAPREVIR vs TEMSIROLIMUS TELAPREVIR vs TENAMFETAMINE TELAPREVIR vs TENAPANOR TELAPREVIR vs TENECTEPLASE

Official FDA Label for TELAPREVIR

Official prescribing information from the FDA-approved drug label.