RALTEGRAVIR

N/A

Manufactured by Merck Sharp & Dohme LLC

29,953 FDA adverse event reports analyzed

Last updated: 2026-04-14

About RALTEGRAVIR

RALTEGRAVIR is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Merck Sharp & Dohme LLC. The most commonly reported adverse reactions for RALTEGRAVIR include DRUG INTERACTION, FOETAL EXPOSURE DURING PREGNANCY, DEPRESSION, ANXIETY, PAIN. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for RALTEGRAVIR.

Top Adverse Reactions

DRUG INTERACTION1,203 reports
FOETAL EXPOSURE DURING PREGNANCY1,075 reports
DEPRESSION1,015 reports
ANXIETY964 reports
PAIN916 reports
EMOTIONAL DISTRESS788 reports
EXPOSURE DURING PREGNANCY733 reports
MATERNAL EXPOSURE DURING PREGNANCY724 reports
ANHEDONIA707 reports
VIROLOGIC FAILURE580 reports
RENAL FAILURE555 reports
CHRONIC KIDNEY DISEASE545 reports
FATIGUE528 reports
DIARRHOEA523 reports
NAUSEA468 reports
OFF LABEL USE467 reports
DEATH464 reports
ANAEMIA451 reports
RENAL IMPAIRMENT441 reports
OSTEOPOROSIS429 reports
DRUG INEFFECTIVE415 reports
PYREXIA412 reports
ACUTE KIDNEY INJURY395 reports
PATHOGEN RESISTANCE389 reports
NO ADVERSE EVENT356 reports
LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES350 reports
RASH341 reports
DRUG RESISTANCE340 reports
ASTHENIA339 reports
VOMITING336 reports
BONE DENSITY DECREASED317 reports
HEADACHE308 reports
VIRAL MUTATION IDENTIFIED303 reports
ECONOMIC PROBLEM299 reports
PREMATURE BABY289 reports
BLOOD CREATININE INCREASED286 reports
ABORTION SPONTANEOUS269 reports
INSOMNIA265 reports
OSTEOPENIA252 reports
IMMUNE RECONSTITUTION INFLAMMATORY SYNDROME249 reports
ALANINE AMINOTRANSFERASE INCREASED238 reports
DYSPNOEA227 reports
NEUTROPENIA218 reports
LIPODYSTROPHY ACQUIRED217 reports
PRODUCT USE IN UNAPPROVED INDICATION217 reports
TREATMENT FAILURE217 reports
ARTHRALGIA216 reports
TREATMENT NONCOMPLIANCE216 reports
DIZZINESS215 reports
PNEUMONIA214 reports
BLOOD HIV RNA INCREASED212 reports
SUICIDAL IDEATION209 reports
ASPARTATE AMINOTRANSFERASE INCREASED207 reports
PRURITUS201 reports
GAIT DISTURBANCE200 reports
WEIGHT DECREASED200 reports
THROMBOCYTOPENIA199 reports
DYSPHAGIA198 reports
MALAISE198 reports
MYALGIA195 reports
ABDOMINAL PAIN192 reports
WEIGHT INCREASED192 reports
HYPERTENSION188 reports
OSTEONECROSIS187 reports
END STAGE RENAL DISEASE182 reports
DRUG REACTION WITH EOSINOPHILIA AND SYSTEMIC SYMPTOMS174 reports
NEUROPATHY PERIPHERAL172 reports
PANCYTOPENIA172 reports
ADVERSE EVENT170 reports
MYOCARDIAL INFARCTION163 reports
CONDITION AGGRAVATED161 reports
FALL155 reports
DECREASED APPETITE153 reports
PSYCHOTIC DISORDER152 reports
DIABETES MELLITUS147 reports
PARANOIA141 reports
PREMATURE DELIVERY141 reports
PSYCHIATRIC DECOMPENSATION139 reports
RENAL FAILURE ACUTE136 reports
BACK PAIN135 reports
PAIN IN EXTREMITY133 reports
MULTIPLE FRACTURES132 reports
SEPSIS132 reports
BLOOD CREATINE PHOSPHOKINASE INCREASED128 reports
TOXICITY TO VARIOUS AGENTS127 reports
COUGH124 reports
INTENTIONAL PRODUCT USE ISSUE124 reports
DEPRESSIVE SYMPTOM120 reports
RENAL DISORDER120 reports
CAESAREAN SECTION119 reports
VIRAL LOAD INCREASED119 reports
NEPHROLITHIASIS118 reports
TEARFULNESS117 reports
DRUG EXPOSURE DURING PREGNANCY116 reports
HYPERSENSITIVITY116 reports
RHABDOMYOLYSIS116 reports
DEPRESSION SUICIDAL111 reports
BLOOD BILIRUBIN INCREASED110 reports
BONE DEMINERALISATION110 reports
HEPATITIS C109 reports

Report Outcomes

Out of 16,316 classified reports for RALTEGRAVIR:

Serious 83.1%Non-Serious 16.9%

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

Male9,222 (64.9%)
Female4,861 (34.2%)
Unknown128 (0.9%)

Reports by Age

Age 54691 reports
Age 50349 reports
Age 53340 reports
Age 52305 reports
Age 47292 reports
Age 49286 reports
Age 55284 reports
Age 45283 reports
Age 40281 reports
Age 43277 reports
Age 44277 reports
Age 46272 reports
Age 51261 reports
Age 48255 reports
Age 57246 reports
Age 42217 reports
Age 58214 reports
Age 59205 reports
Age 41203 reports
Age 39198 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 RALTEGRAVIR?

This profile reflects 29,953 FDA FAERS reports that mention RALTEGRAVIR. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for RALTEGRAVIR?

Frequently reported terms in FAERS include DRUG INTERACTION, FOETAL EXPOSURE DURING PREGNANCY, DEPRESSION, ANXIETY, PAIN, EMOTIONAL DISTRESS. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures RALTEGRAVIR?

Labeling and FAERS entries often list Merck Sharp & Dohme LLC in connection with RALTEGRAVIR. 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.