ELVITEGRAVIR, COBICISTAT, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE

N/A

Manufactured by Gilead Sciences, Inc.

45,551 FDA adverse event reports analyzed

Last updated: 2026-04-14

About ELVITEGRAVIR, COBICISTAT, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE

ELVITEGRAVIR, COBICISTAT, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Gilead Sciences, Inc.. The most commonly reported adverse reactions for ELVITEGRAVIR, COBICISTAT, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE include BONE DENSITY DECREASED, RENAL INJURY, SKELETAL INJURY, CHRONIC KIDNEY DISEASE, TOOTH LOSS. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for ELVITEGRAVIR, COBICISTAT, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE.

Top Adverse Reactions

BONE DENSITY DECREASED4,550 reports
RENAL INJURY3,304 reports
SKELETAL INJURY3,020 reports
CHRONIC KIDNEY DISEASE2,482 reports
TOOTH LOSS2,455 reports
BONE LOSS2,134 reports
OSTEONECROSIS2,095 reports
RENAL FAILURE2,052 reports
TOOTH INJURY1,970 reports
MULTIPLE FRACTURES1,957 reports
PAIN1,843 reports
EMOTIONAL DISTRESS1,810 reports
OSTEOPOROSIS1,729 reports
ANXIETY1,693 reports
ANHEDONIA1,635 reports
OSTEOPENIA1,072 reports
ECONOMIC PROBLEM680 reports
ACUTE KIDNEY INJURY591 reports
BLOOD CREATININE INCREASED542 reports
RENAL IMPAIRMENT476 reports
VITAMIN D DEFICIENCY396 reports
NEPHROPATHY345 reports
FRACTURE300 reports
DEPRESSION287 reports
BONE DENSITY ABNORMAL276 reports
BONE DISORDER216 reports
FOOT FRACTURE205 reports
TOOTH FRACTURE187 reports
OSTEOARTHRITIS178 reports
BONE DEMINERALISATION173 reports
ARTHRALGIA155 reports
END STAGE RENAL DISEASE155 reports
FATIGUE154 reports
ANKLE FRACTURE153 reports
DRUG INTERACTION136 reports
HAND FRACTURE133 reports
RIB FRACTURE132 reports
PROTEINURIA119 reports
LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES118 reports
WRIST FRACTURE110 reports
GAIT DISTURBANCE109 reports
DRUG INEFFECTIVE101 reports
HIP ARTHROPLASTY99 reports
HIP FRACTURE99 reports
BACK PAIN98 reports
DIARRHOEA96 reports
NEPHROLITHIASIS95 reports
NAUSEA94 reports
ASTHENIA92 reports
BONE PAIN89 reports
INTERVERTEBRAL DISC DEGENERATION86 reports
DENTAL CARIES82 reports
PROTEIN TOTAL ABNORMAL81 reports
GLOMERULAR FILTRATION RATE DECREASED79 reports
UPPER LIMB FRACTURE79 reports
RENAL DISORDER75 reports
QUALITY OF LIFE DECREASED71 reports
DEATH69 reports
LOWER LIMB FRACTURE66 reports
RASH66 reports
SPINAL FRACTURE66 reports
HEADACHE63 reports
INSOMNIA63 reports
OSTEOMALACIA62 reports
SPINAL OSTEOARTHRITIS59 reports
DECREASED ACTIVITY58 reports
FANCONI SYNDROME ACQUIRED58 reports
MOBILITY DECREASED57 reports
VOMITING57 reports
DYSSTASIA54 reports
WEIGHT INCREASED54 reports
VIRAL LOAD INCREASED51 reports
ARTHRITIS48 reports
OFF LABEL USE48 reports
PAIN IN EXTREMITY48 reports
FEMUR FRACTURE47 reports
GLOMERULAR FILTRATION RATE ABNORMAL47 reports
RENAL CYST47 reports
TEETH BRITTLE45 reports
HYPERTENSION44 reports
ANAEMIA43 reports
IMPAIRED WORK ABILITY42 reports
PROTEIN TOTAL INCREASED42 reports
MYALGIA41 reports
NEUROPATHY PERIPHERAL41 reports
WEIGHT DECREASED41 reports
DIZZINESS38 reports
SOMNOLENCE38 reports
SPINAL COMPRESSION FRACTURE38 reports
TIBIA FRACTURE38 reports
FOETAL EXPOSURE DURING PREGNANCY36 reports
DRUG DOSE OMISSION35 reports
CLAVICLE FRACTURE33 reports
MALAISE33 reports
RHABDOMYOLYSIS33 reports
TOOTH DISORDER33 reports
FALL32 reports
HAEMATURIA32 reports
POLLAKIURIA31 reports
SPINAL STENOSIS31 reports

Report Outcomes

Out of 8,912 classified reports for ELVITEGRAVIR, COBICISTAT, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE:

Serious 85.7%Non-Serious 14.3%

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 Breakdown

Reports by Sex

Male5,948 (74.9%)
Female1,988 (25.0%)
Unknown6 (0.1%)

Reports by Age

Age 53243 reports
Age 50229 reports
Age 51218 reports
Age 49204 reports
Age 55204 reports
Age 52197 reports
Age 48186 reports
Age 47182 reports
Age 54180 reports
Age 44176 reports
Age 56171 reports
Age 57169 reports
Age 46158 reports
Age 43150 reports
Age 45147 reports
Age 38146 reports
Age 42141 reports
Age 39132 reports
Age 59132 reports
Age 41128 reports

Demographics reflect voluntary FDA adverse event reporting patterns and may not represent the full patient population.

Frequently Asked Questions

How many FDA adverse event reports are associated with ELVITEGRAVIR, COBICISTAT, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE?

This profile reflects 45,551 FDA FAERS reports that mention ELVITEGRAVIR, COBICISTAT, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for ELVITEGRAVIR, COBICISTAT, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE?

Frequently reported terms in FAERS include BONE DENSITY DECREASED, RENAL INJURY, SKELETAL INJURY, CHRONIC KIDNEY DISEASE, TOOTH LOSS, BONE LOSS. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures ELVITEGRAVIR, COBICISTAT, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE?

Labeling and FAERS entries often list Gilead Sciences, Inc. in connection with ELVITEGRAVIR, COBICISTAT, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE. Always verify the specific product and NDC with your pharmacist.

Important Disclaimer: This content is generated by AI analysis of FDA adverse event reports and is provided for informational purposes only. It is not medical advice. Adverse event reports submitted to the FDA do not prove that a medication caused the reported side effect. Always consult your healthcare provider before starting, stopping, or changing any medication. If you experience a serious side effect, contact your doctor or call 911 immediately.