BLINATUMOMAB

N/A

Manufactured by Amgen, Inc

16,815 FDA adverse event reports analyzed

Last updated: 2026-04-14

About BLINATUMOMAB

BLINATUMOMAB is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Amgen, Inc. The most commonly reported adverse reactions for BLINATUMOMAB include PYREXIA, ACUTE LYMPHOCYTIC LEUKAEMIA RECURRENT, CYTOKINE RELEASE SYNDROME, OFF LABEL USE, DEATH. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for BLINATUMOMAB.

Top Adverse Reactions

PYREXIA1,108 reports
ACUTE LYMPHOCYTIC LEUKAEMIA RECURRENT1,041 reports
CYTOKINE RELEASE SYNDROME1,014 reports
OFF LABEL USE689 reports
DEATH627 reports
NEUROTOXICITY560 reports
DRUG INEFFECTIVE408 reports
HEADACHE352 reports
FEBRILE NEUTROPENIA298 reports
NEUTROPENIA298 reports
THERAPY NON RESPONDER274 reports
TREMOR260 reports
INFECTION246 reports
SEIZURE245 reports
ACUTE LYMPHOCYTIC LEUKAEMIA238 reports
THROMBOCYTOPENIA215 reports
CONFUSIONAL STATE212 reports
ACCIDENTAL EXPOSURE TO PRODUCT196 reports
PRODUCT STORAGE ERROR196 reports
PNEUMONIA186 reports
DISEASE PROGRESSION180 reports
LEUKAEMIC INFILTRATION EXTRAMEDULLARY180 reports
SEPSIS179 reports
IMMUNE EFFECTOR CELL ASSOCIATED NEUROTOXICITY SYNDROME174 reports
CENTRAL NERVOUS SYSTEM LEUKAEMIA168 reports
B PRECURSOR TYPE ACUTE LEUKAEMIA157 reports
NERVOUS SYSTEM DISORDER156 reports
HYPOTENSION155 reports
ANAEMIA150 reports
NAUSEA150 reports
CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR149 reports
PANCYTOPENIA148 reports
PLATELET COUNT DECREASED146 reports
VOMITING144 reports
WRONG TECHNIQUE IN PRODUCT USAGE PROCESS140 reports
RASH137 reports
ENCEPHALOPATHY135 reports
FATIGUE135 reports
APHASIA131 reports
B CELL TYPE ACUTE LEUKAEMIA128 reports
HEPATOTOXICITY124 reports
ALANINE AMINOTRANSFERASE INCREASED118 reports
MYELOSUPPRESSION112 reports
ACUTE GRAFT VERSUS HOST DISEASE111 reports
BLAST CELL COUNT INCREASED111 reports
INTERCEPTED PRODUCT PREPARATION ERROR111 reports
NEUROPATHY PERIPHERAL111 reports
NEUTROPHIL COUNT DECREASED111 reports
ASTHENIA110 reports
PRODUCT PREPARATION ERROR107 reports
WHITE BLOOD CELL COUNT DECREASED107 reports
DIARRHOEA106 reports
VENOOCCLUSIVE LIVER DISEASE104 reports
MULTIPLE ORGAN DYSFUNCTION SYNDROME100 reports
COVID 1999 reports
CHILLS98 reports
GRAFT VERSUS HOST DISEASE97 reports
MINIMAL RESIDUAL DISEASE97 reports
CYTOPENIA95 reports
TACHYCARDIA94 reports
DYSPNOEA91 reports
PLEURAL EFFUSION91 reports
SOMNOLENCE91 reports
TOXICITY TO VARIOUS AGENTS89 reports
ACUTE KIDNEY INJURY88 reports
DEVICE RELATED INFECTION88 reports
MALAISE88 reports
CYTOMEGALOVIRUS INFECTION87 reports
ADVERSE EVENT86 reports
TUMOUR LYSIS SYNDROME86 reports
HOSPITALISATION85 reports
HYPERTENSION85 reports
ASPARTATE AMINOTRANSFERASE INCREASED81 reports
ACUTE LYMPHOCYTIC LEUKAEMIA REFRACTORY80 reports
UNEVALUABLE EVENT79 reports
RESPIRATORY FAILURE78 reports
ARTHRALGIA75 reports
PAIN75 reports
DISEASE RECURRENCE74 reports
HEPATIC ENZYME INCREASED74 reports
BLOOD BILIRUBIN INCREASED72 reports
GRAFT VERSUS HOST DISEASE IN SKIN72 reports
CHRONIC GRAFT VERSUS HOST DISEASE70 reports
PAIN IN EXTREMITY69 reports
SEPTIC SHOCK68 reports
TREATMENT FAILURE68 reports
VENOOCCLUSIVE DISEASE68 reports
INFUSION SITE HAEMORRHAGE67 reports
BONE MARROW FAILURE66 reports
TRANSAMINASES INCREASED66 reports
DISORIENTATION65 reports
OCCUPATIONAL EXPOSURE TO PRODUCT65 reports
WHITE BLOOD CELL COUNT INCREASED64 reports
ABDOMINAL PAIN63 reports
DISSEMINATED INTRAVASCULAR COAGULATION63 reports
DYSARTHRIA63 reports
HYPOXIA62 reports
MALIGNANT NEOPLASM PROGRESSION62 reports
STOMATITIS62 reports
MENTAL STATUS CHANGES61 reports

Report Outcomes

Out of 9,855 classified reports for BLINATUMOMAB:

Serious 79.3%Non-Serious 20.7%

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

Male3,837 (53.3%)
Female3,362 (46.7%)
Unknown1 (0.0%)

Reports by Age

Age 19138 reports
Age 6121 reports
Age 5114 reports
Age 4109 reports
Age 9106 reports
Age 20105 reports
Age 64102 reports
Age 21101 reports
Age 23101 reports
Age 1898 reports
Age 1597 reports
Age 6097 reports
Age 796 reports
Age 2695 reports
Age 2594 reports
Age 6893 reports
Age 892 reports
Age 6392 reports
Age 3291 reports
Age 1190 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 BLINATUMOMAB?

This profile reflects 16,815 FDA FAERS reports that mention BLINATUMOMAB. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for BLINATUMOMAB?

Frequently reported terms in FAERS include PYREXIA, ACUTE LYMPHOCYTIC LEUKAEMIA RECURRENT, CYTOKINE RELEASE SYNDROME, OFF LABEL USE, DEATH, NEUROTOXICITY. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures BLINATUMOMAB?

Labeling and FAERS entries often list Amgen, Inc in connection with BLINATUMOMAB. 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.