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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.

EFAVIRENZ\EMTRICITABINE\TENOFOVIR DISOPROXIL: 18,558 Adverse Event Reports & Safety Profile

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18,558
Total FAERS Reports
429 (2.3%)
Deaths Reported
1,627
Hospitalizations
18,558
As Primary/Secondary Suspect
101
Life-Threatening
89
Disabilities

Active Ingredient: EFAVIRENZ\EMTRICITABINE\TENOFOVIR DISOPROXIL FUMARATE ·

First Report: 10100610 · Latest Report: 20250823

What Are the Most Common EFAVIRENZ\EMTRICITABINE\TENOFOVIR DISOPROXIL Side Effects?

#1 Most Reported
Bone density decreased
9,547 reports (51.4%)
#2 Most Reported
Chronic kidney disease
5,861 reports (31.6%)
#3 Most Reported
Tooth loss
4,937 reports (26.6%)

All EFAVIRENZ\EMTRICITABINE\TENOFOVIR DISOPROXIL Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Bone density decreased 9,547 51.4% 92 486
Chronic kidney disease 5,861 31.6% 128 658
Tooth loss 4,937 26.6% 50 244
Renal injury 4,744 25.6% 62 241
Renal failure 4,596 24.8% 142 665
Bone loss 4,493 24.2% 41 234
Osteonecrosis 4,338 23.4% 44 241
Pain 4,297 23.2% 70 467
Skeletal injury 4,272 23.0% 60 231
Emotional distress 4,249 22.9% 71 458
Multiple fractures 4,102 22.1% 40 266
Osteoporosis 4,029 21.7% 34 283
Anxiety 3,879 20.9% 66 435
Anhedonia 3,754 20.2% 63 421
Osteopenia 2,639 14.2% 17 161
Tooth injury 1,986 10.7% 22 83
Economic problem 1,453 7.8% 41 172
Acute kidney injury 1,291 7.0% 71 499
Renal impairment 1,124 6.1% 20 135
Blood creatinine increased 1,112 6.0% 7 113

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

Gender: 25.7% female, 74.3% male. Average age: 48.7 years. Most reports from: US. View detailed demographics →

Is EFAVIRENZ\EMTRICITABINE\TENOFOVIR DISOPROXIL Getting Safer? Reports by Year

YearReportsDeathsHosp.
2000 8 1 0
2001 13 1 2
2002 29 0 2
2003 37 0 1
2004 68 4 4
2005 135 5 11
2006 200 1 26
2007 297 9 35
2008 464 8 63
2009 561 7 41
2010 784 17 69
2011 680 20 68
2012 901 8 79
2013 997 23 114
2014 1,184 40 154
2015 1,532 50 193
2016 1,447 54 180
2017 1,366 32 122
2018 1,345 19 82
2019 1,287 19 77
2020 431 8 22
2021 188 1 7
2022 74 0 6
2023 47 3 3
2024 24 1 3
2025 4 1 1

View full timeline →

What Is EFAVIRENZ\EMTRICITABINE\TENOFOVIR DISOPROXIL Used For?

IndicationReports
Hiv infection 15,794
Product used for unknown indication 1,522
Acquired immunodeficiency syndrome 536
Prophylaxis against hiv infection 304
Hepatitis b 72
Antiretroviral therapy 59
Kaposi's sarcoma aids related 49
Hiv test positive 16
Maternal exposure timing unspecified 12
Kaposi's sarcoma 10

EFAVIRENZ\EMTRICITABINE\TENOFOVIR DISOPROXIL vs Alternatives: Which Is Safer?

EFAVIRENZ\EMTRICITABINE\TENOFOVIR DISOPROXIL vs EFAVIRENZ\LAMIVUDINE\TENOFOVIR DISOPROXIL EFAVIRENZ\EMTRICITABINE\TENOFOVIR DISOPROXIL vs EFFEXOR EFAVIRENZ\EMTRICITABINE\TENOFOVIR DISOPROXIL vs EFFIENT EFAVIRENZ\EMTRICITABINE\TENOFOVIR DISOPROXIL vs EFGARTIGIMOD ALFA EFAVIRENZ\EMTRICITABINE\TENOFOVIR DISOPROXIL vs EFGARTIGIMOD ALFA-FCAB EFAVIRENZ\EMTRICITABINE\TENOFOVIR DISOPROXIL vs EFGARTIGIMOD ALFA\HYALURONIDASE-QVFC EFAVIRENZ\EMTRICITABINE\TENOFOVIR DISOPROXIL vs EFINACONAZOLE EFAVIRENZ\EMTRICITABINE\TENOFOVIR DISOPROXIL vs EFLORNITHINE EFAVIRENZ\EMTRICITABINE\TENOFOVIR DISOPROXIL vs EFMOROCTOCOG ALFA EFAVIRENZ\EMTRICITABINE\TENOFOVIR DISOPROXIL vs EFTRENONACOG ALFA

Official FDA Label for EFAVIRENZ\EMTRICITABINE\TENOFOVIR DISOPROXIL

Official prescribing information from the FDA-approved drug label.