ELVITEGRAVIR, COBICISTAT, EMTRICITABINE, AND TENOFOVIR ALAFENAMIDE

N/A

Manufactured by Gilead Sciences, Inc.

43,023 FDA adverse event reports analyzed

Last updated: 2026-04-14

About ELVITEGRAVIR, COBICISTAT, EMTRICITABINE, AND TENOFOVIR ALAFENAMIDE

ELVITEGRAVIR, COBICISTAT, EMTRICITABINE, AND TENOFOVIR ALAFENAMIDE 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 ALAFENAMIDE include BONE DENSITY DECREASED, CHRONIC KIDNEY DISEASE, BONE LOSS, OSTEONECROSIS, 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 ALAFENAMIDE.

Top Adverse Reactions

BONE DENSITY DECREASED4,492 reports
CHRONIC KIDNEY DISEASE2,605 reports
BONE LOSS2,410 reports
OSTEONECROSIS2,378 reports
TOOTH LOSS2,247 reports
MULTIPLE FRACTURES2,131 reports
RENAL FAILURE2,086 reports
OSTEOPOROSIS1,928 reports
RENAL INJURY1,916 reports
PAIN1,857 reports
EMOTIONAL DISTRESS1,803 reports
SKELETAL INJURY1,646 reports
ANXIETY1,635 reports
ANHEDONIA1,562 reports
OSTEOPENIA1,199 reports
ECONOMIC PROBLEM684 reports
BLOOD CREATININE INCREASED570 reports
RENAL IMPAIRMENT554 reports
ACUTE KIDNEY INJURY525 reports
TOOTH INJURY405 reports
DEPRESSION328 reports
FRACTURE321 reports
BONE DENSITY ABNORMAL298 reports
NEPHROPATHY278 reports
DRUG INTERACTION263 reports
VITAMIN D DEFICIENCY245 reports
FOOT FRACTURE228 reports
FATIGUE224 reports
BONE DEMINERALISATION197 reports
WEIGHT INCREASED187 reports
OSTEOARTHRITIS171 reports
ARTHRALGIA168 reports
BONE DISORDER159 reports
TOOTH FRACTURE158 reports
GAIT DISTURBANCE149 reports
ANKLE FRACTURE148 reports
NAUSEA146 reports
ASTHENIA135 reports
DIARRHOEA135 reports
LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES135 reports
DRUG INEFFECTIVE134 reports
RIB FRACTURE127 reports
END STAGE RENAL DISEASE122 reports
BACK PAIN120 reports
HAND FRACTURE115 reports
WRIST FRACTURE108 reports
RASH105 reports
PROTEINURIA104 reports
HEADACHE103 reports
PROTEIN TOTAL ABNORMAL100 reports
VOMITING98 reports
NEPHROLITHIASIS96 reports
DEATH92 reports
HIP FRACTURE91 reports
DIZZINESS89 reports
UPPER LIMB FRACTURE87 reports
VIRAL LOAD INCREASED85 reports
INSOMNIA84 reports
BONE PAIN81 reports
HYPERTENSION80 reports
INTERVERTEBRAL DISC DEGENERATION80 reports
PRODUCT STORAGE ERROR77 reports
RENAL DISORDER77 reports
SPINAL FRACTURE75 reports
OFF LABEL USE73 reports
PAIN IN EXTREMITY73 reports
MOBILITY DECREASED71 reports
HIP ARTHROPLASTY70 reports
GLOMERULAR FILTRATION RATE DECREASED69 reports
GLOMERULAR FILTRATION RATE ABNORMAL68 reports
QUALITY OF LIFE DECREASED67 reports
LOWER LIMB FRACTURE66 reports
BLOOD HIV RNA INCREASED65 reports
CUSHING^S SYNDROME64 reports
OSTEOMALACIA63 reports
PRODUCT DOSE OMISSION62 reports
TREATMENT NONCOMPLIANCE61 reports
ANAEMIA58 reports
PRODUCT USE ISSUE56 reports
WEIGHT DECREASED54 reports
MYALGIA53 reports
PYREXIA53 reports
FEMUR FRACTURE52 reports
PRODUCT DOSE OMISSION ISSUE51 reports
SPINAL OSTEOARTHRITIS51 reports
DYSPNOEA50 reports
INTENTIONAL DOSE OMISSION50 reports
ARTHRITIS49 reports
DECREASED ACTIVITY48 reports
DENTAL CARIES48 reports
PRURITUS47 reports
DYSSTASIA46 reports
PERIPHERAL SWELLING46 reports
PROTEIN TOTAL INCREASED45 reports
FANCONI SYNDROME ACQUIRED44 reports
ABDOMINAL PAIN43 reports
DRUG DOSE OMISSION43 reports
DRUG RESISTANCE43 reports
MATERNAL EXPOSURE DURING PREGNANCY43 reports
BLOOD CHOLESTEROL INCREASED42 reports

Report Outcomes

Out of 9,896 classified reports for ELVITEGRAVIR, COBICISTAT, EMTRICITABINE, AND TENOFOVIR ALAFENAMIDE:

Serious 77.8%Non-Serious 22.2%

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

Male7,214 (75.0%)
Female2,405 (25.0%)
Unknown3 (0.0%)

Reports by Age

Age 53280 reports
Age 51272 reports
Age 55269 reports
Age 52268 reports
Age 54253 reports
Age 50251 reports
Age 48233 reports
Age 49221 reports
Age 58221 reports
Age 56219 reports
Age 47217 reports
Age 45201 reports
Age 59199 reports
Age 57194 reports
Age 46177 reports
Age 43175 reports
Age 60160 reports
Age 42159 reports
Age 44154 reports
Age 38151 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 ALAFENAMIDE?

This profile reflects 43,023 FDA FAERS reports that mention ELVITEGRAVIR, COBICISTAT, EMTRICITABINE, AND TENOFOVIR ALAFENAMIDE. 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 ALAFENAMIDE?

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

Who manufactures ELVITEGRAVIR, COBICISTAT, EMTRICITABINE, AND TENOFOVIR ALAFENAMIDE?

Labeling and FAERS entries often list Gilead Sciences, Inc. in connection with ELVITEGRAVIR, COBICISTAT, EMTRICITABINE, AND TENOFOVIR ALAFENAMIDE. 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.