85/100 · Critical
Manufactured by Gilead Sciences, Inc
High Safety Concerns with EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE
167,978 FDA adverse event reports analyzed
Last updated: 2026-05-12
EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Gilead Sciences, Inc. Based on analysis of 167,978 FDA adverse event reports, EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE has a safety score of 85 out of 100. This score indicates a relatively favorable safety profile, with fewer or less severe adverse events compared to many other tracked medications. The most commonly reported adverse reactions for EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE include BONE DENSITY DECREASED, CHRONIC KIDNEY DISEASE, OSTEONECROSIS, BONE LOSS, RENAL FAILURE. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE.
Emtricitabine And Tenofovir Disoproxil Fumarate has a safety concern score of 85 out of 100, placing it in the high concern category based on analysis of FDA adverse event data. The FDA has received approximately 167,978 adverse event reports for this medication, which is primarily manufactured by Gilead Sciences, Inc.
The most commonly reported adverse events include Bone Density Decreased, Chronic Kidney Disease, Osteonecrosis. Of classified reports, 84.4% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Significant reports of bone density decrease and chronic kidney disease, indicating potential long-term health risks.
Multiple fractures and osteoporosis are common, suggesting a high risk of bone-related issues. Renal impairment and failure are frequent, highlighting the need for regular kidney function monitoring.
Patients taking Emtricitabine And Tenofovir Disoproxil Fumarate should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Caution is advised when using this drug with other nephrotoxic or bone-damaging medications, as it may increase the risk of adverse reactions. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Emtricitabine And Tenofovir Disoproxil Fumarate received a safety concern score of 85/100 (high concern). This is based on a 84.4% serious event ratio across 44,920 classified reports. The score accounts for 167,978 total adverse event reports and 100 distinct reaction types. This high score reflects a significant proportion of serious adverse events in the reporting data.
Adverse event reports by sex: Male: 29,335, Female: 12,195, Unknown: 120. The most frequently reported age groups are age 50 (1,071 reports), age 51 (1,010 reports), age 53 (985 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 44,920 classified reports for EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE:
The FDA classifies an adverse event as “serious” if it results in death, hospitalization, disability, congenital anomaly, or requires intervention to prevent permanent damage.
Demographics reflect voluntary FDA adverse event reporting patterns and may not represent the full patient population.
Caution is advised when using this drug with other nephrotoxic or bone-damaging medications, as it may increase the risk of adverse reactions.
If you are taking Emtricitabine And Tenofovir Disoproxil Fumarate, here are important things to know. The most commonly reported side effects include bone density decreased, chronic kidney disease, osteonecrosis, bone loss, renal failure. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Regularly monitor bone density and kidney function, especially if taking this medication long-term. Inform your healthcare provider about any existing bone or kidney conditions before starting this treatment. If you experience a serious adverse reaction, seek emergency medical attention immediately or call 911. You can report side effects to the FDA's MedWatch program at 1-800-FDA-1088.
The FDA closely monitors the safety of this drug, and any new or severe adverse events should be reported to the agency promptly.
The FDA has received approximately 167,978 adverse event reports associated with Emtricitabine And Tenofovir Disoproxil Fumarate. These reports come from healthcare professionals, consumers, and manufacturers through the FDA Adverse Event Reporting System (FAERS). Note that the number of reports does not directly indicate the frequency of side effects, as adverse events are voluntarily reported and may be underrepresented.
The most frequently reported adverse events for Emtricitabine And Tenofovir Disoproxil Fumarate include Bone Density Decreased, Chronic Kidney Disease, Osteonecrosis, Bone Loss, Renal Failure. By volume, the top reported reactions are: Bone Density Decreased (16,432 reports), Chronic Kidney Disease (10,262 reports), Osteonecrosis (9,075 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Emtricitabine And Tenofovir Disoproxil Fumarate.
Out of 44,920 classified reports, 37,902 (84.4%) were classified as serious and 7,018 as non-serious. The FDA classifies an event as "serious" if it results in death, hospitalization, disability, or other medically significant outcomes. A higher serious-event ratio warrants closer attention but does not necessarily mean the drug is unsafe.
Adverse event reports for Emtricitabine And Tenofovir Disoproxil Fumarate break down by patient sex as follows: Male: 29,335, Female: 12,195, Unknown: 120. This distribution reflects reporting patterns rather than actual risk differences between groups. Reporting rates can be influenced by prescribing patterns, disease demographics, and reporting behavior.
The most frequently reported age groups for Emtricitabine And Tenofovir Disoproxil Fumarate adverse events are: age 50: 1,071 reports, age 51: 1,010 reports, age 53: 985 reports, age 52: 937 reports, age 48: 915 reports. Age-related reporting patterns can reflect both the demographics of the patient population and potential age-related susceptibility to certain side effects.
The primary manufacturer associated with Emtricitabine And Tenofovir Disoproxil Fumarate adverse event reports is Gilead Sciences, Inc. Multiple manufacturers may produce generic versions of this drug. The manufacturer listed reflects the most frequently reported brand in FDA adverse event data.
Beyond the most common reactions, other reported adverse events for Emtricitabine And Tenofovir Disoproxil Fumarate include: Multiple Fractures, Tooth Loss, Renal Injury, Osteoporosis, Skeletal Injury. Less common side effects can still be clinically significant. Patients should report any unusual symptoms to their healthcare provider.
You can report adverse events from Emtricitabine And Tenofovir Disoproxil Fumarate to the FDA through their MedWatch program at www.fda.gov/medwatch, by calling 1-800-FDA-1088, or by completing Form FDA 3500. Healthcare professionals, consumers, and manufacturers can all submit reports. Reporting helps the FDA monitor drug safety after approval.
Emtricitabine And Tenofovir Disoproxil Fumarate has a safety concern score of 85 out of 100 (high concern). This score is calculated from the ratio of serious to non-serious adverse events, the diversity of reported reactions, and the overall volume of reports relative to usage. Significant reports of bone density decrease and chronic kidney disease, indicating potential long-term health risks.
Key safety signals identified in Emtricitabine And Tenofovir Disoproxil Fumarate's adverse event data include: Bone density decreased and osteoporosis are among the most reported reactions.. Chronic kidney disease and renal failure are also highly prevalent.. Multiple fractures and osteopenia are frequent, indicating potential skeletal health risks.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Caution is advised when using this drug with other nephrotoxic or bone-damaging medications, as it may increase the risk of adverse reactions. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Emtricitabine And Tenofovir Disoproxil Fumarate.
Regularly monitor bone density and kidney function, especially if taking this medication long-term. Inform your healthcare provider about any existing bone or kidney conditions before starting this treatment.
Emtricitabine And Tenofovir Disoproxil Fumarate has 167,978 adverse event reports on file with the FDA. Multiple fractures and osteoporosis are common, suggesting a high risk of bone-related issues. The volume of reports for Emtricitabine And Tenofovir Disoproxil Fumarate reflects both the drug's usage level and the vigilance of the reporting community.
The FDA closely monitors the safety of this drug, and any new or severe adverse events should be reported to the agency promptly. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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