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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.

EMTRICITABINE\TENOFOVIR: 2,967 Adverse Event Reports & Safety Profile

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2,967
Total FAERS Reports
365 (12.3%)
Deaths Reported
612
Hospitalizations
2,967
As Primary/Secondary Suspect
94
Life-Threatening
90
Disabilities

First Report: 20000101 · Latest Report: 20250919

What Are the Most Common EMTRICITABINE\TENOFOVIR Side Effects?

#1 Most Reported
Foetal exposure during pregnancy
404 reports (13.6%)
#2 Most Reported
Death
205 reports (6.9%)
#3 Most Reported
Maternal exposure during pregnancy
196 reports (6.6%)

All EMTRICITABINE\TENOFOVIR Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Foetal exposure during pregnancy 404 13.6% 57 35
Death 205 6.9% 203 10
Maternal exposure during pregnancy 196 6.6% 7 17
Drug ineffective 175 5.9% 1 5
Hiv infection 172 5.8% 3 6
Exposure during pregnancy 164 5.5% 9 21
Abortion spontaneous 141 4.8% 12 13
Virologic failure 129 4.4% 6 3
Neurodevelopmental disorder 80 2.7% 0 0
Nausea 67 2.3% 2 18
No adverse event 62 2.1% 0 2
Immune reconstitution inflammatory syndrome 60 2.0% 3 32
Treatment noncompliance 60 2.0% 1 11
Drug resistance 55 1.9% 0 5
Premature baby 55 1.9% 9 13
Off label use 53 1.8% 14 23
Drug interaction 52 1.8% 1 15
Diarrhoea 49 1.7% 2 14
Diabetes mellitus 47 1.6% 0 10
Fatigue 47 1.6% 5 14

Who Reports EMTRICITABINE\TENOFOVIR Side Effects? Age & Gender Data

Gender: 31.3% female, 68.7% male. Average age: 40.9 years. Most reports from: US. View detailed demographics →

Is EMTRICITABINE\TENOFOVIR Getting Safer? Reports by Year

YearReportsDeathsHosp.
2000 1 0 0
2002 1 0 1
2008 3 0 0
2009 16 0 0
2010 11 8 10
2011 4 0 0
2012 9 3 5
2013 7 1 2
2014 8 0 4
2015 23 3 2
2016 20 0 10
2017 108 16 51
2018 169 13 62
2019 122 10 32
2020 115 13 49
2021 109 21 32
2022 133 20 28
2023 101 7 15
2024 68 8 12
2025 25 0 10

View full timeline →

What Is EMTRICITABINE\TENOFOVIR Used For?

IndicationReports
Hiv infection 1,459
Prophylaxis against hiv infection 635
Product used for unknown indication 470
Antiretroviral therapy 131
Maternal exposure timing unspecified 35
Acquired immunodeficiency syndrome 21
Prophylaxis 18
Foetal exposure during pregnancy 17
Hepatitis c 14
Hepatitis b 12

EMTRICITABINE\TENOFOVIR vs Alternatives: Which Is Safer?

EMTRICITABINE\TENOFOVIR vs EMTRICITABINE\TENOFOVIR ALAFENAMIDE EMTRICITABINE\TENOFOVIR vs EMTRICITABINE/TENOFOVIR DISOPROXIL EMTRICITABINE\TENOFOVIR vs EMTRICITABINE\TENOFOVIR DISOPROXIL EMTRICITABINE\TENOFOVIR vs ENALAPRIL EMTRICITABINE\TENOFOVIR vs ENALAPRIL\HYDROCHLOROTHIAZIDE EMTRICITABINE\TENOFOVIR vs ENALAPRIL\LERCANIDIPINE EMTRICITABINE\TENOFOVIR vs ENASIDENIB EMTRICITABINE\TENOFOVIR vs ENBREL EMTRICITABINE\TENOFOVIR vs ENCORAFENIB EMTRICITABINE\TENOFOVIR vs ENDOXAN

Official FDA Label for EMTRICITABINE\TENOFOVIR

Official prescribing information from the FDA-approved drug label.