NELARABINE

N/A

Manufactured by Novartis Pharmaceuticals Corporation

2,208 FDA adverse event reports analyzed

Last updated: 2026-04-15

About NELARABINE

NELARABINE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Novartis Pharmaceuticals Corporation. The most commonly reported adverse reactions for NELARABINE include FEBRILE NEUTROPENIA, DRUG INEFFECTIVE, NEUROTOXICITY, NEUROPATHY PERIPHERAL, SEPSIS. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for NELARABINE.

Top Adverse Reactions

FEBRILE NEUTROPENIA75 reports
DRUG INEFFECTIVE61 reports
NEUROTOXICITY59 reports
NEUROPATHY PERIPHERAL55 reports
SEPSIS55 reports
MUSCULAR WEAKNESS54 reports
PERIPHERAL SENSORY NEUROPATHY54 reports
MYELOPATHY51 reports
OFF LABEL USE48 reports
NEUTROPENIA47 reports
GUILLAIN BARRE SYNDROME41 reports
HYPOAESTHESIA39 reports
GAIT DISTURBANCE38 reports
THROMBOCYTOPENIA36 reports
PERIPHERAL MOTOR NEUROPATHY35 reports
PLATELET COUNT DECREASED35 reports
PYREXIA35 reports
RESPIRATORY FAILURE35 reports
MALIGNANT NEOPLASM PROGRESSION34 reports
ANAEMIA33 reports
SEPTIC SHOCK30 reports
RHABDOMYOLYSIS28 reports
WHITE BLOOD CELL COUNT DECREASED28 reports
ALANINE AMINOTRANSFERASE INCREASED27 reports
DIARRHOEA26 reports
SOMNOLENCE26 reports
PARAESTHESIA25 reports
POLYNEUROPATHY25 reports
ENCEPHALOPATHY24 reports
ASPARTATE AMINOTRANSFERASE INCREASED23 reports
ATAXIA23 reports
BONE MARROW FAILURE23 reports
DEATH23 reports
DISEASE PROGRESSION23 reports
HYPERTRIGLYCERIDAEMIA23 reports
ASPERGILLUS INFECTION22 reports
NERVOUS SYSTEM DISORDER22 reports
PANCYTOPENIA22 reports
COVID 1921 reports
NAUSEA21 reports
T CELL TYPE ACUTE LEUKAEMIA21 reports
LEUKOENCEPHALOPATHY20 reports
PNEUMONIA20 reports
PRODUCT USE IN UNAPPROVED INDICATION20 reports
ASTHENIA19 reports
PNEUMOCYSTIS JIROVECII PNEUMONIA19 reports
SENSORY LOSS19 reports
MYELOSUPPRESSION18 reports
PULMONARY HAEMORRHAGE18 reports
VOMITING18 reports
HEADACHE17 reports
PLEURAL EFFUSION17 reports
SCEDOSPORIUM INFECTION17 reports
STENOTROPHOMONAS INFECTION17 reports
ACUTE KIDNEY INJURY16 reports
HYPOTENSION16 reports
PSEUDOMONAL BACTERAEMIA16 reports
HAEMOGLOBIN DECREASED15 reports
NEUTROPHIL COUNT DECREASED15 reports
BACTERAEMIA14 reports
BRONCHOPULMONARY ASPERGILLOSIS14 reports
CONDITION AGGRAVATED14 reports
COUGH14 reports
FIBRINOUS BRONCHITIS14 reports
SPINAL CORD DISORDER14 reports
BLOOD CREATINE PHOSPHOKINASE INCREASED13 reports
DECREASED APPETITE13 reports
HEPATOTOXICITY13 reports
MYALGIA13 reports
SEIZURE13 reports
SENSORY DISTURBANCE13 reports
THERAPY NON RESPONDER13 reports
DEPRESSED LEVEL OF CONSCIOUSNESS12 reports
HYPERBILIRUBINAEMIA12 reports
PAIN IN EXTREMITY12 reports
PRODUCT USE ISSUE12 reports
TOXICITY TO VARIOUS AGENTS12 reports
ACUTE GRAFT VERSUS HOST DISEASE IN INTESTINE11 reports
ACUTE LYMPHOCYTIC LEUKAEMIA RECURRENT11 reports
BRONCHIECTASIS11 reports
HEPATIC FUNCTION ABNORMAL11 reports
INFUSION RELATED REACTION11 reports
STOMATITIS11 reports
TOXIC LEUKOENCEPHALOPATHY11 reports
ABDOMINAL PAIN10 reports
ALTERED STATE OF CONSCIOUSNESS10 reports
ANORECTAL DISORDER10 reports
CARDIOTOXICITY10 reports
DYSPNOEA10 reports
HISTIOCYTOSIS HAEMATOPHAGIC10 reports
PAIN10 reports
THERAPY PARTIAL RESPONDER10 reports
TREMOR10 reports
ABASIA9 reports
ACUTE GRAFT VERSUS HOST DISEASE IN SKIN9 reports
BLADDER DISORDER9 reports
CONFUSIONAL STATE9 reports
CYTOPENIA9 reports
DISSEMINATED INTRAVASCULAR COAGULATION9 reports
FATIGUE9 reports

Report Outcomes

Out of 937 classified reports for NELARABINE:

Serious 96.5%Non-Serious 3.5%

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

Male560 (70.2%)
Female235 (29.4%)
Unknown3 (0.4%)

Reports by Age

Age 431 reports
Age 1227 reports
Age 1426 reports
Age 1626 reports
Age 1325 reports
Age 923 reports
Age 722 reports
Age 1121 reports
Age 2419 reports
Age 2118 reports
Age 1516 reports
Age 815 reports
Age 4015 reports
Age 5015 reports
Age 513 reports
Age 1013 reports
Age 2013 reports
Age 2313 reports
Age 2513 reports
Age 3613 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 NELARABINE?

This profile reflects 2,208 FDA FAERS reports that mention NELARABINE. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for NELARABINE?

Frequently reported terms in FAERS include FEBRILE NEUTROPENIA, DRUG INEFFECTIVE, NEUROTOXICITY, NEUROPATHY PERIPHERAL, SEPSIS, MUSCULAR WEAKNESS. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures NELARABINE?

Labeling and FAERS entries often list Novartis Pharmaceuticals Corporation in connection with NELARABINE. 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.