ABACAVIR SULFATE

N/A

Manufactured by ViiV Healthcare Company

29,564 FDA adverse event reports analyzed

Last updated: 2026-04-14

About ABACAVIR SULFATE

ABACAVIR SULFATE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by ViiV Healthcare Company. The most commonly reported adverse reactions for ABACAVIR SULFATE include PAIN, PYREXIA, NAUSEA, RASH, VOMITING. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for ABACAVIR SULFATE.

Top Adverse Reactions

PAIN846 reports
PYREXIA829 reports
NAUSEA615 reports
RASH576 reports
VOMITING549 reports
FATIGUE534 reports
EXPOSURE DURING PREGNANCY527 reports
OFF LABEL USE527 reports
HEPATIC ENZYME INCREASED515 reports
HYPERTENSION511 reports
HEADACHE507 reports
DRUG INTERACTION487 reports
VIROLOGIC FAILURE484 reports
HYPERSENSITIVITY481 reports
TREATMENT FAILURE476 reports
ANXIETY474 reports
EMOTIONAL DISTRESS465 reports
FOETAL EXPOSURE DURING PREGNANCY438 reports
RENAL FAILURE434 reports
DRUG INEFFECTIVE432 reports
THROMBOCYTOPENIA413 reports
ANHEDONIA412 reports
DIARRHOEA401 reports
CHRONIC KIDNEY DISEASE382 reports
ANAEMIA371 reports
PATHOGEN RESISTANCE360 reports
RENAL IMPAIRMENT360 reports
VIRAL MUTATION IDENTIFIED356 reports
DRUG RESISTANCE352 reports
HYPERHIDROSIS344 reports
PRODUCT USE ISSUE342 reports
ACUTE KIDNEY INJURY334 reports
IMMUNODEFICIENCY330 reports
OVERDOSE329 reports
JOINT SWELLING325 reports
PNEUMONIA317 reports
DRUG HYPERSENSITIVITY315 reports
RASH ERYTHEMATOUS315 reports
UPPER RESPIRATORY TRACT INFECTION312 reports
INFUSION RELATED REACTION309 reports
FOOD ALLERGY308 reports
PRESCRIBED OVERDOSE306 reports
ASTHMA305 reports
INTENTIONAL PRODUCT MISUSE305 reports
RHEUMATOID ARTHRITIS304 reports
CONDITION AGGRAVATED287 reports
LIPODYSTROPHY ACQUIRED286 reports
BACK PAIN283 reports
DEATH268 reports
DRUG INTOLERANCE266 reports
DEPRESSION257 reports
FLUID RETENTION251 reports
FOETAL DEATH249 reports
ERYTHEMA243 reports
ASTHENIA240 reports
CONSTIPATION239 reports
PSORIASIS236 reports
TREATMENT NONCOMPLIANCE235 reports
INFECTION233 reports
TEMPERATURE REGULATION DISORDER228 reports
CHOLELITHIASIS225 reports
BLOOD CREATININE INCREASED224 reports
IMMUNE RECONSTITUTION INFLAMMATORY SYNDROME222 reports
OSTEOPOROSIS220 reports
CONTRAINDICATED PRODUCT ADMINISTERED218 reports
SCHIZOPHRENIA209 reports
ABDOMINAL PAIN208 reports
BLOOD BILIRUBIN INCREASED206 reports
BURSITIS205 reports
COELIAC DISEASE204 reports
HEPATOTOXICITY198 reports
ECONOMIC PROBLEM194 reports
MATERNAL EXPOSURE DURING PREGNANCY193 reports
DYSPNOEA182 reports
MALAISE182 reports
END STAGE RENAL DISEASE178 reports
WEIGHT DECREASED177 reports
PSYCHOTIC DISORDER174 reports
MYOCARDIAL INFARCTION171 reports
HYPOMANIA155 reports
BONE DENSITY DECREASED146 reports
JAUNDICE CHOLESTATIC145 reports
EYELID PTOSIS141 reports
TOXICITY TO VARIOUS AGENTS141 reports
OEDEMA PERIPHERAL140 reports
OSTEOPENIA140 reports
MITOCHONDRIAL TOXICITY138 reports
MYALGIA138 reports
RENAL FAILURE ACUTE133 reports
ALANINE AMINOTRANSFERASE INCREASED132 reports
NEUTROPENIA129 reports
DIZZINESS128 reports
GASTROOESOPHAGEAL REFLUX DISEASE128 reports
NEUROPATHY PERIPHERAL126 reports
DECREASED APPETITE120 reports
DIPLOPIA120 reports
COUGH118 reports
GAIT DISTURBANCE116 reports
ASPARTATE AMINOTRANSFERASE INCREASED113 reports
PREMATURE BABY112 reports

Report Outcomes

Out of 9,555 classified reports for ABACAVIR SULFATE:

Serious 93.3%Non-Serious 6.7%

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

Male4,869 (63.0%)
Female2,815 (36.4%)
Unknown42 (0.5%)

Reports by Age

Age 52434 reports
Age 36250 reports
Age 58178 reports
Age 47164 reports
Age 48163 reports
Age 45160 reports
Age 44153 reports
Age 50148 reports
Age 54148 reports
Age 55143 reports
Age 39141 reports
Age 43139 reports
Age 49139 reports
Age 56136 reports
Age 40132 reports
Age 42130 reports
Age 51130 reports
Age 46129 reports
Age 53128 reports
Age 35120 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 ABACAVIR SULFATE?

This profile reflects 29,564 FDA FAERS reports that mention ABACAVIR SULFATE. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for ABACAVIR SULFATE?

Frequently reported terms in FAERS include PAIN, PYREXIA, NAUSEA, RASH, VOMITING, FATIGUE. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures ABACAVIR SULFATE?

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