CABOTEGRAVIR

N/A

Manufactured by ViiV Healthcare Company

11,616 FDA adverse event reports analyzed

Last updated: 2026-04-14

About CABOTEGRAVIR

CABOTEGRAVIR is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by ViiV Healthcare Company. The most commonly reported adverse reactions for CABOTEGRAVIR include PRODUCT DOSE OMISSION ISSUE, OFF LABEL USE, INJECTION SITE PAIN, VIRAL LOAD INCREASED, PAIN. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for CABOTEGRAVIR.

Top Adverse Reactions

PRODUCT DOSE OMISSION ISSUE1,109 reports
OFF LABEL USE1,030 reports
INJECTION SITE PAIN889 reports
VIRAL LOAD INCREASED430 reports
PAIN389 reports
VIROLOGIC FAILURE264 reports
PYREXIA248 reports
PATHOGEN RESISTANCE243 reports
PRODUCT USE IN UNAPPROVED THERAPEUTIC ENVIRONMENT239 reports
INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION237 reports
PRODUCT COMPLAINT216 reports
DRUG INEFFECTIVE186 reports
FATIGUE184 reports
PRODUCT STORAGE ERROR183 reports
INJECTION SITE NODULE174 reports
VIRAL MUTATION IDENTIFIED161 reports
BLOOD HIV RNA INCREASED158 reports
HEADACHE153 reports
EXPOSURE DURING PREGNANCY146 reports
DEPRESSION144 reports
INJECTION SITE SWELLING143 reports
CONDITION AGGRAVATED134 reports
RASH134 reports
WRONG TECHNIQUE IN DEVICE USAGE PROCESS131 reports
HIV INFECTION130 reports
PRODUCT ADMINISTERED AT INAPPROPRIATE SITE115 reports
NAUSEA114 reports
INCORRECT DOSE ADMINISTERED112 reports
INJECTION SITE REACTION111 reports
MYALGIA108 reports
ARTHRALGIA107 reports
DIARRHOEA99 reports
PRODUCT USE IN UNAPPROVED INDICATION96 reports
PAIN IN EXTREMITY95 reports
INJECTION SITE MASS94 reports
MALAISE91 reports
DIZZINESS88 reports
ANXIETY87 reports
GAIT DISTURBANCE87 reports
INFLUENZA LIKE ILLNESS85 reports
TREATMENT FAILURE85 reports
NODULE81 reports
WEIGHT DECREASED81 reports
CHILLS80 reports
BACK PAIN78 reports
DYSPNOEA78 reports
INJECTION SITE ERYTHEMA74 reports
PRODUCT USE ISSUE73 reports
PRURITUS72 reports
WRONG TECHNIQUE IN PRODUCT USAGE PROCESS65 reports
TREATMENT NONCOMPLIANCE57 reports
VOMITING57 reports
INJECTION SITE DISCOMFORT55 reports
INSOMNIA53 reports
MUSCULOSKELETAL PAIN53 reports
WEIGHT INCREASED52 reports
INJECTION SITE DISCHARGE50 reports
URTICARIA50 reports
DEATH47 reports
MUSCLE SPASMS46 reports
PRODUCT ADMINISTRATION ERROR46 reports
ASTHENIA45 reports
GAIT INABILITY45 reports
INCORRECT ROUTE OF PRODUCT ADMINISTRATION45 reports
HYPERSENSITIVITY44 reports
ILLNESS42 reports
ERYTHEMA41 reports
INJECTION SITE INDURATION41 reports
LABELLED DRUG DRUG INTERACTION MEDICATION ERROR39 reports
COUGH38 reports
FEELING ABNORMAL38 reports
INJECTION SITE ABSCESS37 reports
INJECTION SITE WARMTH37 reports
OCCUPATIONAL EXPOSURE TO PRODUCT37 reports
ABDOMINAL PAIN36 reports
COVID 1936 reports
FLUSHING36 reports
HYPOAESTHESIA36 reports
PRODUCT DISPENSING ERROR35 reports
PSYCHOTIC DISORDER35 reports
PARAESTHESIA34 reports
CD4 LYMPHOCYTES DECREASED33 reports
HYPERHIDROSIS33 reports
SUICIDAL IDEATION32 reports
AGGRESSION31 reports
DISCOMFORT31 reports
SWELLING31 reports
ACCIDENTAL EXPOSURE TO PRODUCT30 reports
CHEST PAIN30 reports
PRODUCT PREPARATION ISSUE30 reports
NASOPHARYNGITIS29 reports
PNEUMONIA29 reports
SCIATICA29 reports
UNDERDOSE29 reports
VIRAEMIA29 reports
ADVERSE DRUG REACTION28 reports
CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR27 reports
DECREASED APPETITE27 reports
FEELING HOT27 reports
HYPERTENSION27 reports

Report Outcomes

Out of 7,654 classified reports for CABOTEGRAVIR:

Serious 18.7%Non-Serious 81.3%

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

Male4,018 (75.4%)
Female1,308 (24.6%)
Unknown1 (0.0%)

Reports by Age

Age 35124 reports
Age 34113 reports
Age 40109 reports
Age 30104 reports
Age 3699 reports
Age 3295 reports
Age 3382 reports
Age 4282 reports
Age 5078 reports
Age 3777 reports
Age 3877 reports
Age 3174 reports
Age 2972 reports
Age 4370 reports
Age 2668 reports
Age 2867 reports
Age 5466 reports
Age 3965 reports
Age 4461 reports
Age 2559 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 CABOTEGRAVIR?

This profile reflects 11,616 FDA FAERS reports that mention CABOTEGRAVIR. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for CABOTEGRAVIR?

Frequently reported terms in FAERS include PRODUCT DOSE OMISSION ISSUE, OFF LABEL USE, INJECTION SITE PAIN, VIRAL LOAD INCREASED, PAIN, VIROLOGIC FAILURE. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures CABOTEGRAVIR?

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