DOLUTEGRAVIR SODIUM

N/A

Manufactured by ViiV Healthcare Company

28,565 FDA adverse event reports analyzed

Last updated: 2026-04-14

About DOLUTEGRAVIR SODIUM

DOLUTEGRAVIR SODIUM is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by ViiV Healthcare Company. The most commonly reported adverse reactions for DOLUTEGRAVIR SODIUM include PAIN, ANXIETY, EMOTIONAL DISTRESS, ANHEDONIA, CHRONIC KIDNEY DISEASE. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for DOLUTEGRAVIR SODIUM.

Top Adverse Reactions

PAIN1,425 reports
ANXIETY1,051 reports
EMOTIONAL DISTRESS1,048 reports
ANHEDONIA942 reports
CHRONIC KIDNEY DISEASE701 reports
FATIGUE628 reports
EXPOSURE DURING PREGNANCY606 reports
HEADACHE566 reports
OFF LABEL USE553 reports
RENAL FAILURE539 reports
RASH487 reports
FOETAL EXPOSURE DURING PREGNANCY478 reports
PYREXIA445 reports
HYPERTENSION428 reports
OSTEOPOROSIS425 reports
DRUG INEFFECTIVE412 reports
DEPRESSION406 reports
BONE DENSITY DECREASED400 reports
DEATH396 reports
ECONOMIC PROBLEM388 reports
RENAL IMPAIRMENT359 reports
PRODUCT USE ISSUE357 reports
HEPATIC ENZYME INCREASED353 reports
BACK PAIN344 reports
THROMBOCYTOPENIA341 reports
PRODUCT DOSE OMISSION ISSUE337 reports
HYPERSENSITIVITY327 reports
MATERNAL EXPOSURE DURING PREGNANCY324 reports
HYPERHIDROSIS320 reports
ACUTE KIDNEY INJURY317 reports
NAUSEA316 reports
JOINT SWELLING315 reports
ASTHMA304 reports
IMMUNODEFICIENCY304 reports
OVERDOSE295 reports
FOETAL DEATH294 reports
UPPER RESPIRATORY TRACT INFECTION294 reports
RASH ERYTHEMATOUS292 reports
RHEUMATOID ARTHRITIS292 reports
OSTEOPENIA290 reports
INTENTIONAL PRODUCT MISUSE289 reports
FOOD ALLERGY288 reports
BLOOD CREATININE INCREASED276 reports
END STAGE RENAL DISEASE276 reports
INFUSION RELATED REACTION273 reports
PRESCRIBED OVERDOSE271 reports
CONSTIPATION254 reports
DRUG INTOLERANCE247 reports
TREATMENT FAILURE235 reports
FLUID RETENTION231 reports
PSORIASIS229 reports
DRUG HYPERSENSITIVITY227 reports
ASTHENIA226 reports
TEMPERATURE REGULATION DISORDER223 reports
ERYTHEMA222 reports
DIARRHOEA221 reports
GAIT DISTURBANCE212 reports
INFECTION212 reports
CONTRAINDICATED PRODUCT ADMINISTERED211 reports
INSOMNIA203 reports
COELIAC DISEASE201 reports
BURSITIS198 reports
ARTHRALGIA195 reports
WEIGHT INCREASED173 reports
LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES172 reports
DYSPNOEA166 reports
ABORTION SPONTANEOUS161 reports
BONE DEMINERALISATION159 reports
HOSPITALISATION159 reports
ANAEMIA156 reports
OSTEONECROSIS154 reports
MALAISE153 reports
DIZZINESS141 reports
VOMITING140 reports
MULTIPLE FRACTURES134 reports
CONDITION AGGRAVATED131 reports
DRUG INTERACTION129 reports
IMMUNE RECONSTITUTION INFLAMMATORY SYNDROME122 reports
TOOTH LOSS122 reports
BLOOD HIV RNA INCREASED120 reports
QUALITY OF LIFE DECREASED117 reports
PRURITUS115 reports
TREATMENT NONCOMPLIANCE115 reports
PNEUMONIA113 reports
BONE LOSS111 reports
SUICIDAL IDEATION102 reports
RENAL INJURY101 reports
PAIN IN EXTREMITY100 reports
MOBILITY DECREASED99 reports
WEIGHT DECREASED99 reports
ABDOMINAL PAIN98 reports
DRUG RESISTANCE96 reports
DYSSTASIA94 reports
FOOT FRACTURE94 reports
MYALGIA90 reports
DECREASED ACTIVITY88 reports
VIRAL LOAD INCREASED84 reports
FALL80 reports
GENERAL PHYSICAL HEALTH DETERIORATION79 reports
PROTEINURIA79 reports

Report Outcomes

Out of 8,753 classified reports for DOLUTEGRAVIR SODIUM:

Serious 76.2%Non-Serious 23.8%

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

Male4,713 (64.2%)
Female2,600 (35.4%)
Unknown27 (0.4%)

Reports by Age

Age 36233 reports
Age 58194 reports
Age 53145 reports
Age 52143 reports
Age 55143 reports
Age 56133 reports
Age 54130 reports
Age 46125 reports
Age 57124 reports
Age 51122 reports
Age 50116 reports
Age 60112 reports
Age 49107 reports
Age 59105 reports
Age 41104 reports
Age 45101 reports
Age 6199 reports
Age 3598 reports
Age 3497 reports
Age 4896 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 DOLUTEGRAVIR SODIUM?

This profile reflects 28,565 FDA FAERS reports that mention DOLUTEGRAVIR SODIUM. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for DOLUTEGRAVIR SODIUM?

Frequently reported terms in FAERS include PAIN, ANXIETY, EMOTIONAL DISTRESS, ANHEDONIA, CHRONIC KIDNEY DISEASE, FATIGUE. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures DOLUTEGRAVIR SODIUM?

Labeling and FAERS entries often list ViiV Healthcare Company in connection with DOLUTEGRAVIR SODIUM. 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.