EMTRICITABINE\RILPIVIRINE\TENOFOVIR DISOPROXIL: 7,225 Adverse Event Reports & Safety Profile
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7,225
Total FAERS Reports
141 (2.0%)
Deaths Reported
535
Hospitalizations
7,225
As Primary/Secondary Suspect
46
Life-Threatening
34
Disabilities
Active Ingredient: EMTRICITABINE\RILPIVIRINE HYDROCHLORIDE\TENOFOVIR DISOPROXIL FUMARATE ·
First Report: 199601 · Latest Report: 20250513
What Are the Most Common EMTRICITABINE\RILPIVIRINE\TENOFOVIR DISOPROXIL Side Effects?
#1 Most Reported
Bone density decreased
3,497 reports (48.4%)
#2 Most Reported
Renal injury
2,955 reports (40.9%)
#3 Most Reported
Skeletal injury
2,766 reports (38.3%)
All EMTRICITABINE\RILPIVIRINE\TENOFOVIR DISOPROXIL Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Bone density decreased | 3,497 | 48.4% | 38 | 156 |
| Renal injury | 2,955 | 40.9% | 43 | 133 |
| Skeletal injury | 2,766 | 38.3% | 40 | 127 |
| Tooth injury | 1,969 | 27.3% | 22 | 82 |
| Tooth loss | 1,968 | 27.2% | 21 | 91 |
| Chronic kidney disease | 1,960 | 27.1% | 47 | 194 |
| Renal failure | 1,600 | 22.2% | 47 | 207 |
| Bone loss | 1,530 | 21.2% | 20 | 74 |
| Osteonecrosis | 1,492 | 20.7% | 22 | 78 |
| Multiple fractures | 1,489 | 20.6% | 23 | 80 |
| Osteoporosis | 1,415 | 19.6% | 14 | 78 |
| Pain | 1,371 | 19.0% | 14 | 126 |
| Emotional distress | 1,356 | 18.8% | 14 | 125 |
| Anxiety | 1,251 | 17.3% | 11 | 120 |
| Anhedonia | 1,207 | 16.7% | 10 | 115 |
| Osteopenia | 886 | 12.3% | 8 | 37 |
| Acute kidney injury | 434 | 6.0% | 13 | 135 |
| Blood creatinine increased | 424 | 5.9% | 3 | 34 |
| Economic problem | 403 | 5.6% | 6 | 42 |
| Vitamin d deficiency | 367 | 5.1% | 3 | 20 |
Who Reports EMTRICITABINE\RILPIVIRINE\TENOFOVIR DISOPROXIL Side Effects? Age & Gender Data
Gender: 30.3% female, 69.7% male. Average age: 46.5 years. Most reports from: US. View detailed demographics →
Is EMTRICITABINE\RILPIVIRINE\TENOFOVIR DISOPROXIL Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2000 | 2 | 1 | 0 |
| 2001 | 9 | 1 | 1 |
| 2002 | 14 | 0 | 0 |
| 2003 | 18 | 0 | 1 |
| 2004 | 31 | 1 | 3 |
| 2005 | 60 | 2 | 7 |
| 2006 | 68 | 1 | 11 |
| 2007 | 79 | 3 | 7 |
| 2008 | 110 | 2 | 12 |
| 2009 | 162 | 2 | 10 |
| 2010 | 245 | 3 | 17 |
| 2011 | 212 | 8 | 11 |
| 2012 | 341 | 3 | 32 |
| 2013 | 384 | 8 | 37 |
| 2014 | 529 | 12 | 49 |
| 2015 | 598 | 8 | 66 |
| 2016 | 594 | 8 | 57 |
| 2017 | 570 | 10 | 45 |
| 2018 | 534 | 17 | 30 |
| 2019 | 478 | 6 | 29 |
| 2020 | 186 | 2 | 8 |
| 2021 | 93 | 1 | 7 |
| 2022 | 42 | 3 | 3 |
| 2023 | 23 | 10 | 0 |
| 2024 | 10 | 0 | 1 |
| 2025 | 1 | 0 | 0 |
What Is EMTRICITABINE\RILPIVIRINE\TENOFOVIR DISOPROXIL Used For?
| Indication | Reports |
|---|---|
| Hiv infection | 5,840 |
| Product used for unknown indication | 859 |
| Acquired immunodeficiency syndrome | 427 |
| Prophylaxis against hiv infection | 27 |
| Antiretroviral therapy | 21 |
| Hepatitis b | 21 |
| Hiv test positive | 11 |
| Maternal exposure timing unspecified | 7 |
EMTRICITABINE\RILPIVIRINE\TENOFOVIR DISOPROXIL vs Alternatives: Which Is Safer?
EMTRICITABINE\RILPIVIRINE\TENOFOVIR DISOPROXIL vs EMTRICITABINE\TENOFOVIR
EMTRICITABINE\RILPIVIRINE\TENOFOVIR DISOPROXIL vs EMTRICITABINE\TENOFOVIR ALAFENAMIDE
EMTRICITABINE\RILPIVIRINE\TENOFOVIR DISOPROXIL vs EMTRICITABINE/TENOFOVIR DISOPROXIL
EMTRICITABINE\RILPIVIRINE\TENOFOVIR DISOPROXIL vs EMTRICITABINE\TENOFOVIR DISOPROXIL
EMTRICITABINE\RILPIVIRINE\TENOFOVIR DISOPROXIL vs ENALAPRIL
EMTRICITABINE\RILPIVIRINE\TENOFOVIR DISOPROXIL vs ENALAPRIL\HYDROCHLOROTHIAZIDE
EMTRICITABINE\RILPIVIRINE\TENOFOVIR DISOPROXIL vs ENALAPRIL\LERCANIDIPINE
EMTRICITABINE\RILPIVIRINE\TENOFOVIR DISOPROXIL vs ENASIDENIB
EMTRICITABINE\RILPIVIRINE\TENOFOVIR DISOPROXIL vs ENBREL
EMTRICITABINE\RILPIVIRINE\TENOFOVIR DISOPROXIL vs ENCORAFENIB
Official FDA Label for EMTRICITABINE\RILPIVIRINE\TENOFOVIR DISOPROXIL
Official prescribing information from the FDA-approved drug label.