PEGASPARGASE

N/A

Manufactured by Servier Pharmaceuticals LLC

23,600 FDA adverse event reports analyzed

Last updated: 2026-04-14

About PEGASPARGASE

PEGASPARGASE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Servier Pharmaceuticals LLC. The most commonly reported adverse reactions for PEGASPARGASE include FEBRILE NEUTROPENIA, PYREXIA, FEBRILE BONE MARROW APLASIA, VOMITING, NEUTROPENIA. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for PEGASPARGASE.

Top Adverse Reactions

FEBRILE NEUTROPENIA1,556 reports
PYREXIA758 reports
FEBRILE BONE MARROW APLASIA676 reports
VOMITING597 reports
NEUTROPENIA559 reports
SEPSIS558 reports
ABDOMINAL PAIN506 reports
HYPOTENSION462 reports
HYPERTRIGLYCERIDAEMIA405 reports
PANCREATITIS405 reports
THROMBOCYTOPENIA400 reports
NAUSEA399 reports
HYPERBILIRUBINAEMIA363 reports
PNEUMONIA357 reports
BACTERIAL INFECTION337 reports
SEPTIC SHOCK333 reports
HYPERSENSITIVITY330 reports
TACHYCARDIA330 reports
MUCOSAL INFLAMMATION328 reports
OFF LABEL USE327 reports
ANAEMIA303 reports
HYPOFIBRINOGENAEMIA298 reports
PANCYTOPENIA273 reports
ALANINE AMINOTRANSFERASE INCREASED269 reports
CLOSTRIDIUM DIFFICILE COLITIS267 reports
VIRAL INFECTION257 reports
HEADACHE256 reports
ACUTE KIDNEY INJURY245 reports
DIARRHOEA245 reports
ANAPHYLACTIC REACTION235 reports
SECONDARY IMMUNODEFICIENCY221 reports
DYSPNOEA218 reports
PANCREATITIS ACUTE218 reports
PLATELET COUNT DECREASED212 reports
HYPERGLYCAEMIA207 reports
BLOOD BILIRUBIN INCREASED206 reports
PSEUDOMONAL SEPSIS206 reports
SEIZURE206 reports
MYELOSUPPRESSION205 reports
DEATH203 reports
PRODUCT USE IN UNAPPROVED INDICATION201 reports
RESPIRATORY FAILURE196 reports
BRONCHOPULMONARY ASPERGILLOSIS195 reports
COUGH195 reports
COLITIS194 reports
DRUG INEFFECTIVE187 reports
FUNGAL INFECTION187 reports
RHINOVIRUS INFECTION180 reports
HEPATOCELLULAR INJURY173 reports
CHOLESTASIS172 reports
MYCOBACTERIUM CHELONAE INFECTION172 reports
ASPERGILLUS INFECTION171 reports
COAGULOPATHY169 reports
MULTIPLE ORGAN DYSFUNCTION SYNDROME169 reports
DRUG HYPERSENSITIVITY166 reports
HEPATOTOXICITY166 reports
PLEURAL EFFUSION165 reports
CELLULITIS164 reports
STOMATITIS163 reports
HEPATIC STEATOSIS154 reports
INFECTION154 reports
HYPERTENSION153 reports
RASH151 reports
RESPIRATORY DISTRESS151 reports
ASTHENIA150 reports
DECREASED APPETITE149 reports
ASCITES146 reports
NEUTROPHIL COUNT DECREASED146 reports
GAMMA GLUTAMYLTRANSFERASE INCREASED145 reports
ENTERITIS143 reports
ENTEROBACTER INFECTION143 reports
ASPARTATE AMINOTRANSFERASE INCREASED142 reports
PNEUMATOSIS INTESTINALIS142 reports
PAIN IN EXTREMITY140 reports
URTICARIA140 reports
WHITE BLOOD CELL COUNT DECREASED140 reports
HUMAN HERPESVIRUS 6 INFECTION139 reports
HEPATIC FAILURE138 reports
PARAINFLUENZAE VIRUS INFECTION137 reports
POSTERIOR REVERSIBLE ENCEPHALOPATHY SYNDROME137 reports
BONE MARROW FAILURE136 reports
FATIGUE136 reports
DEHYDRATION135 reports
HUMAN BOCAVIRUS INFECTION132 reports
HYPOXIA132 reports
VENOOCCLUSIVE LIVER DISEASE129 reports
ORAL HERPES126 reports
BACTERAEMIA123 reports
HYPONATRAEMIA123 reports
LEUKOPENIA120 reports
CHILLS118 reports
TOXICITY TO VARIOUS AGENTS118 reports
CARDIAC ARREST117 reports
HAEMOGLOBIN DECREASED116 reports
HYPOALBUMINAEMIA115 reports
NEUROPATHY PERIPHERAL115 reports
ERYTHEMA114 reports
RENAL FAILURE113 reports
BLOOD CULTURE POSITIVE111 reports
PAIN110 reports

Report Outcomes

Out of 11,959 classified reports for PEGASPARGASE:

Serious 97.9%Non-Serious 2.1%

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

Male4,562 (57.3%)
Female3,368 (42.3%)
Unknown32 (0.4%)

Reports by Age

Age 3513 reports
Age 4458 reports
Age 5366 reports
Age 13301 reports
Age 2286 reports
Age 12283 reports
Age 14268 reports
Age 17264 reports
Age 15262 reports
Age 7257 reports
Age 11252 reports
Age 8245 reports
Age 6237 reports
Age 10235 reports
Age 16223 reports
Age 9220 reports
Age 18166 reports
Age 19161 reports
Age 20103 reports
Age 3198 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 PEGASPARGASE?

This profile reflects 23,600 FDA FAERS reports that mention PEGASPARGASE. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for PEGASPARGASE?

Frequently reported terms in FAERS include FEBRILE NEUTROPENIA, PYREXIA, FEBRILE BONE MARROW APLASIA, VOMITING, NEUTROPENIA, SEPSIS. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures PEGASPARGASE?

Labeling and FAERS entries often list Servier Pharmaceuticals LLC in connection with PEGASPARGASE. 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.