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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.

TENOFOVIR: 4,066 Adverse Event Reports & Safety Profile

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4,066
Total FAERS Reports
600 (14.8%)
Deaths Reported
803
Hospitalizations
4,066
As Primary/Secondary Suspect
110
Life-Threatening
43
Disabilities

First Report: 19960101 · Latest Report: 20250821

What Are the Most Common TENOFOVIR Side Effects?

#1 Most Reported
Foetal exposure during pregnancy
509 reports (12.5%)
#2 Most Reported
Virologic failure
409 reports (10.1%)
#3 Most Reported
Drug resistance
317 reports (7.8%)

All TENOFOVIR Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Foetal exposure during pregnancy 509 12.5% 95 41
Virologic failure 409 10.1% 10 10
Drug resistance 317 7.8% 9 26
Exposure during pregnancy 292 7.2% 10 21
Death 225 5.5% 224 17
Immune reconstitution inflammatory syndrome 177 4.4% 33 75
Maternal exposure during pregnancy 173 4.3% 17 28
Treatment failure 163 4.0% 2 7
Drug interaction 141 3.5% 13 48
Premature baby 126 3.1% 22 6
Drug ineffective 125 3.1% 46 23
Acute kidney injury 122 3.0% 33 68
Premature delivery 110 2.7% 0 8
Treatment noncompliance 105 2.6% 4 21
Renal impairment 90 2.2% 6 23
Pathogen resistance 86 2.1% 0 15
Condition aggravated 80 2.0% 51 29
Fanconi syndrome 80 2.0% 8 46
Lipodystrophy acquired 75 1.8% 0 4
Csf hiv escape syndrome 73 1.8% 5 14

Who Reports TENOFOVIR Side Effects? Age & Gender Data

Gender: 43.2% female, 56.8% male. Average age: 43.9 years. Most reports from: US. View detailed demographics →

Is TENOFOVIR Getting Safer? Reports by Year

YearReportsDeathsHosp.
2001 2 0 0
2002 4 0 0
2003 5 1 1
2004 6 0 5
2005 14 0 1
2006 12 0 3
2007 4 0 3
2008 7 0 4
2009 11 1 2
2010 36 7 27
2011 22 1 5
2012 34 8 17
2013 31 5 15
2014 73 17 41
2015 56 6 33
2016 33 2 11
2017 50 14 22
2018 124 21 38
2019 64 1 13
2020 45 14 12
2021 51 6 10
2022 28 2 6
2023 38 11 3
2024 32 1 10
2025 13 1 6

View full timeline →

What Is TENOFOVIR Used For?

IndicationReports
Hiv infection 2,192
Product used for unknown indication 466
Antiretroviral therapy 243
Hepatitis b 200
Chronic hepatitis b 187
Prophylaxis against hiv infection 155
Acquired immunodeficiency syndrome 37
Prophylaxis 31
Antiviral prophylaxis 28
Hiv infection who clinical stage iii 25

TENOFOVIR vs Alternatives: Which Is Safer?

TENOFOVIR vs TENOFOVIR ALAFENAMIDE TENOFOVIR vs TENOFOVIR DISOPROXIL TENOFOVIR vs TEPLIZUMAB-MZWV TENOFOVIR vs TEPOTINIB TENOFOVIR vs TEPROTUMUMAB TENOFOVIR vs TEPROTUMUMAB-TRBW TENOFOVIR vs TERAZOSIN TENOFOVIR vs TERAZOSIN\TERAZOSIN TENOFOVIR vs TERBINAFINE TENOFOVIR vs TERBINAFINE\TERBINAFINE

Official FDA Label for TENOFOVIR

Official prescribing information from the FDA-approved drug label.