BICTEGRAVIR SODIUM, EMTRICITABINE, AND TENOFOVIR ALAFENAMIDE FUMARATE

N/A

Manufactured by Gilead Sciences, Inc.

62,897 FDA adverse event reports analyzed

Last updated: 2026-04-14

About BICTEGRAVIR SODIUM, EMTRICITABINE, AND TENOFOVIR ALAFENAMIDE FUMARATE

BICTEGRAVIR SODIUM, EMTRICITABINE, AND TENOFOVIR ALAFENAMIDE 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 BICTEGRAVIR SODIUM, EMTRICITABINE, AND TENOFOVIR ALAFENAMIDE FUMARATE include BONE DENSITY DECREASED, CHRONIC KIDNEY DISEASE, BONE LOSS, TOOTH LOSS, OSTEONECROSIS. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for BICTEGRAVIR SODIUM, EMTRICITABINE, AND TENOFOVIR ALAFENAMIDE FUMARATE.

Top Adverse Reactions

BONE DENSITY DECREASED6,535 reports
CHRONIC KIDNEY DISEASE3,595 reports
BONE LOSS3,431 reports
TOOTH LOSS3,376 reports
OSTEONECROSIS3,353 reports
MULTIPLE FRACTURES3,121 reports
RENAL FAILURE2,982 reports
OSTEOPOROSIS2,751 reports
PAIN2,531 reports
RENAL INJURY2,478 reports
EMOTIONAL DISTRESS2,425 reports
ANXIETY2,267 reports
ANHEDONIA2,145 reports
SKELETAL INJURY2,113 reports
OSTEOPENIA1,854 reports
ACUTE KIDNEY INJURY803 reports
RENAL IMPAIRMENT799 reports
BLOOD CREATININE INCREASED782 reports
ECONOMIC PROBLEM696 reports
TOOTH INJURY497 reports
WEIGHT INCREASED474 reports
VITAMIN D DEFICIENCY472 reports
BONE DENSITY ABNORMAL466 reports
FRACTURE457 reports
DEATH444 reports
DEPRESSION400 reports
FATIGUE391 reports
NEPHROPATHY357 reports
FOOT FRACTURE344 reports
NAUSEA319 reports
DRUG INEFFECTIVE298 reports
ARTHRALGIA283 reports
BONE DEMINERALISATION279 reports
VIRAL LOAD INCREASED264 reports
OFF LABEL USE262 reports
HEADACHE261 reports
DIARRHOEA257 reports
OSTEOARTHRITIS251 reports
PRODUCT DOSE OMISSION ISSUE231 reports
GAIT DISTURBANCE229 reports
ANKLE FRACTURE226 reports
RASH224 reports
TOOTH FRACTURE211 reports
ASTHENIA208 reports
INSOMNIA197 reports
BACK PAIN192 reports
BONE DISORDER191 reports
PRODUCT STORAGE ERROR190 reports
VOMITING187 reports
RIB FRACTURE181 reports
END STAGE RENAL DISEASE175 reports
HAND FRACTURE175 reports
DYSPNOEA164 reports
MATERNAL EXPOSURE DURING PREGNANCY162 reports
WRIST FRACTURE161 reports
LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES155 reports
PROTEINURIA152 reports
PROTEIN TOTAL ABNORMAL150 reports
DIZZINESS147 reports
HIP FRACTURE143 reports
VIROLOGIC FAILURE139 reports
UPPER LIMB FRACTURE134 reports
PYREXIA130 reports
NEPHROLITHIASIS126 reports
HYPERTENSION125 reports
IMMUNE RECONSTITUTION INFLAMMATORY SYNDROME122 reports
PAIN IN EXTREMITY122 reports
PRURITUS120 reports
TREATMENT NONCOMPLIANCE120 reports
LOWER LIMB FRACTURE115 reports
BONE PAIN111 reports
DRUG INTERACTION110 reports
BLOOD HIV RNA INCREASED109 reports
ANAEMIA104 reports
GLOMERULAR FILTRATION RATE DECREASED104 reports
INTERVERTEBRAL DISC DEGENERATION104 reports
MOBILITY DECREASED104 reports
WEIGHT DECREASED103 reports
PRODUCT DISPENSING ERROR102 reports
PRODUCT USE ISSUE101 reports
HOSPITALISATION100 reports
MYALGIA100 reports
DRUG RESISTANCE96 reports
PATHOGEN RESISTANCE94 reports
DYSPHAGIA93 reports
SPINAL FRACTURE93 reports
HIP ARTHROPLASTY91 reports
RENAL DISORDER90 reports
DYSSTASIA87 reports
PROTEIN TOTAL INCREASED86 reports
CD4 LYMPHOCYTES DECREASED84 reports
ABDOMINAL PAIN82 reports
ALOPECIA82 reports
DECREASED APPETITE80 reports
MALAISE80 reports
WRONG TECHNIQUE IN PRODUCT USAGE PROCESS80 reports
FANCONI SYNDROME ACQUIRED79 reports
INTENTIONAL DOSE OMISSION78 reports
FEMUR FRACTURE77 reports
ABDOMINAL DISCOMFORT76 reports

Report Outcomes

Out of 17,338 classified reports for BICTEGRAVIR SODIUM, EMTRICITABINE, AND TENOFOVIR ALAFENAMIDE FUMARATE:

Serious 73.3%Non-Serious 26.7%

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

Male12,066 (73.6%)
Female4,302 (26.3%)
Unknown19 (0.1%)

Reports by Age

Age 53418 reports
Age 50406 reports
Age 51403 reports
Age 52403 reports
Age 54377 reports
Age 57368 reports
Age 55355 reports
Age 48345 reports
Age 49338 reports
Age 59321 reports
Age 56314 reports
Age 47313 reports
Age 58312 reports
Age 45291 reports
Age 43290 reports
Age 60278 reports
Age 44273 reports
Age 46272 reports
Age 42269 reports
Age 40238 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 BICTEGRAVIR SODIUM, EMTRICITABINE, AND TENOFOVIR ALAFENAMIDE FUMARATE?

This profile reflects 62,897 FDA FAERS reports that mention BICTEGRAVIR SODIUM, EMTRICITABINE, AND TENOFOVIR ALAFENAMIDE FUMARATE. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for BICTEGRAVIR SODIUM, EMTRICITABINE, AND TENOFOVIR ALAFENAMIDE FUMARATE?

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

Who manufactures BICTEGRAVIR SODIUM, EMTRICITABINE, AND TENOFOVIR ALAFENAMIDE FUMARATE?

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