85/100 · Critical
Manufactured by Gilead Sciences, Inc.
High Safety Concerns with Tenofovir Disoproxil Fumarate, Particularly for Bone and Renal Health
123,510 FDA adverse event reports analyzed
Last updated: 2026-05-12
TENOFOVIR DISOPROXIL FUMARATE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Gilead Sciences, Inc.. Based on analysis of 123,510 FDA adverse event reports, 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 TENOFOVIR DISOPROXIL FUMARATE include BONE DENSITY DECREASED, RENAL INJURY, SKELETAL INJURY, CHRONIC KIDNEY DISEASE, OSTEONECROSIS. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for TENOFOVIR DISOPROXIL FUMARATE.
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 123,510 adverse event reports for this medication, which is primarily manufactured by Gilead Sciences, Inc..
The most commonly reported adverse events include Bone Density Decreased, Renal Injury, Skeletal Injury. Of classified reports, 94.0% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Bone density decreased and renal injury are the most frequent and serious adverse reactions.
Multiple fractures and chronic kidney disease are also significant concerns. Osteoporosis and osteopenia are common, indicating long-term bone health risks.
Patients taking Tenofovir Disoproxil Fumarate should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Tenofovir disoproxil fumarate can cause bone and renal toxicity, and patients should be monitored for these conditions. Drug interactions, particularly with other nephrotoxic or bone toxic agents, should be avoided. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Tenofovir Disoproxil Fumarate received a safety concern score of 85/100 (high concern). This is based on a 94.0% serious event ratio across 32,657 classified reports. The score accounts for 123,510 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: 19,216, Female: 9,209, Unknown: 78. The most frequently reported age groups are age 54 (795 reports), age 50 (790 reports), age 52 (692 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 32,657 classified reports for 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.
Tenofovir disoproxil fumarate can cause bone and renal toxicity, and patients should be monitored for these conditions. Drug interactions, particularly with other nephrotoxic or bone toxic agents, should be avoided.
If you are taking Tenofovir Disoproxil Fumarate, here are important things to know. The most commonly reported side effects include bone density decreased, renal injury, skeletal injury, chronic kidney disease, osteonecrosis. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Patients should inform their healthcare provider about any existing bone or kidney conditions before starting Tenofovir disoproxil fumarate. Regular bone density and kidney function tests are recommended during 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 has issued warnings regarding the potential for bone and renal toxicity with Tenofovir disoproxil fumarate. Healthcare providers should closely monitor patients for these adverse events and adjust treatment as necessary.
The FDA has received approximately 123,510 adverse event reports associated with 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 Tenofovir Disoproxil Fumarate include Bone Density Decreased, Renal Injury, Skeletal Injury, Chronic Kidney Disease, Osteonecrosis. By volume, the top reported reactions are: Bone Density Decreased (10,625 reports), Renal Injury (9,276 reports), Skeletal Injury (8,327 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Tenofovir Disoproxil Fumarate.
Out of 32,657 classified reports, 30,705 (94.0%) were classified as serious and 1,952 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 Tenofovir Disoproxil Fumarate break down by patient sex as follows: Male: 19,216, Female: 9,209, Unknown: 78. 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 Tenofovir Disoproxil Fumarate adverse events are: age 54: 795 reports, age 50: 790 reports, age 52: 692 reports, age 51: 664 reports, age 55: 641 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 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 Tenofovir Disoproxil Fumarate include: Bone Loss, Multiple Fractures, Renal Failure, Osteoporosis, Tooth Loss. 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 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.
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. Bone density decreased and renal injury are the most frequent and serious adverse reactions.
Key safety signals identified in Tenofovir Disoproxil Fumarate's adverse event data include: Bone density decreased and osteoporosis are reported in a significant number of cases.. Renal injury and chronic kidney disease are among the top reported adverse reactions.. Multiple fractures and osteopenia are also key safety signals.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Tenofovir disoproxil fumarate can cause bone and renal toxicity, and patients should be monitored for these conditions. Drug interactions, particularly with other nephrotoxic or bone toxic agents, should be avoided. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Tenofovir Disoproxil Fumarate.
Patients should inform their healthcare provider about any existing bone or kidney conditions before starting Tenofovir disoproxil fumarate. Regular bone density and kidney function tests are recommended during treatment.
Tenofovir Disoproxil Fumarate has 123,510 adverse event reports on file with the FDA. Multiple fractures and chronic kidney disease are also significant concerns. The volume of reports for Tenofovir Disoproxil Fumarate reflects both the drug's usage level and the vigilance of the reporting community.
The FDA has issued warnings regarding the potential for bone and renal toxicity with Tenofovir disoproxil fumarate. Healthcare providers should closely monitor patients for these adverse events and adjust treatment as necessary. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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