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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.

TELBIVUDINE: 434 Adverse Event Reports & Safety Profile

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434
Total FAERS Reports
27 (6.2%)
Deaths Reported
106
Hospitalizations
434
As Primary/Secondary Suspect
5
Life-Threatening
14
Disabilities
Apr 28, 2009
FDA Approved
Discontinued
Status

FDA Application: 022011 ·

First Report: 2004 · Latest Report: 20200629

What Are the Most Common TELBIVUDINE Side Effects?

#1 Most Reported
Drug resistance
103 reports (23.7%)
#2 Most Reported
Blood creatine phosphokinase increased
84 reports (19.4%)
#3 Most Reported
Foetal exposure during pregnancy
58 reports (13.4%)

All TELBIVUDINE Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Drug resistance 103 23.7% 0 10
Blood creatine phosphokinase increased 84 19.4% 2 43
Foetal exposure during pregnancy 58 13.4% 13 3
Myalgia 49 11.3% 2 22
Drug ineffective 37 8.5% 0 6
Pathogen resistance 37 8.5% 0 6
Muscular weakness 33 7.6% 1 19
Maternal exposure during pregnancy 31 7.1% 0 3
Treatment failure 31 7.1% 0 0
Asthenia 26 6.0% 3 18
Viral mutation identified 25 5.8% 0 0
Rhabdomyolysis 24 5.5% 3 12
Hepatic cirrhosis 20 4.6% 5 16
Myopathy 20 4.6% 0 12
Vomiting 20 4.6% 5 14
Hypoaesthesia 19 4.4% 0 11
Gait disturbance 18 4.2% 0 10
Pain in extremity 18 4.2% 1 11
Alanine aminotransferase increased 17 3.9% 1 8
Fatigue 17 3.9% 1 11

Who Reports TELBIVUDINE Side Effects? Age & Gender Data

Gender: 37.4% female, 62.6% male. Average age: 43.4 years. Most reports from: CN. View detailed demographics →

Is TELBIVUDINE Getting Safer? Reports by Year

YearReportsDeathsHosp.
2004 11 6 1
2007 8 0 2
2008 6 1 5
2010 4 0 1
2011 5 0 2
2012 21 1 11
2013 25 0 10
2014 35 0 8
2015 16 0 11
2016 25 0 13
2017 12 0 8
2018 13 2 3
2019 9 2 1
2020 2 0 1

View full timeline →

What Is TELBIVUDINE Used For?

IndicationReports
Chronic hepatitis b 153
Hepatitis b 111
Product used for unknown indication 52
Foetal exposure during pregnancy 30
Hiv infection 20
Hepatic cirrhosis 12
Antiviral treatment 11
Viral infection 9
Hepatitis viral 8

TELBIVUDINE vs Alternatives: Which Is Safer?

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

Official FDA Label for TELBIVUDINE

Official prescribing information from the FDA-approved drug label.