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Blinatumomab Side Effects

The most commonly reported side effects of blinatumomab include pyrexia, acute lymphocytic leukaemia recurrent, and cytokine release syndrome, based on 9,864 FDA adverse event reports from 2012 to 2025. 4.1% of reports found the drug to be ineffective.

Blinatumomab side effects

Percentages show how often each reaction appears relative to total reports for blinatumomab.

1
Pyrexia11.3%1,110
2
Acute Lymphocytic Leukaemia Recurrent10.6%1,041
3
Cytokine Release Syndrome10.3%1,014
4
Off Label Use7.0%689
5
Death6.4%627
6
Neurotoxicity5.7%560
7
Drug Ineffective4.1%408
8
Headache3.6%352
9
Febrile Neutropenia3.0%300
10
Neutropenia3.0%298
11
Therapy Non-responder2.8%274
12
Tremor2.6%260
13
Infection2.5%246
14
Seizure2.5%245
15
Acute Lymphocytic Leukaemia2.4%238

These are voluntary reports and do not establish that blinatumomab caused these reactions.

Report severity

79.3%Serious7,824 reports
26.9%Hospitalizations2,655 reports
18.3%Fatal1,809 reports

Seriousness is determined by the reporter, not by OpenClaim.

Blinatumomab drug interactions

Other drugs that appear in adverse event reports alongside blinatumomab. Drugs flagged as a suspected cause appear in the first column. Drugs taken at the same time but not suspected appear in the second.

Also suspected

1
Methotrexate9.8%969
2
Vincristine-sulfate8.7%860
3
Dexamethasone7.9%776
4
Cytarabine7.4%727
5
Cyclophosphamide7.1%704
6
Inotuzumab-ozogamicin3.9%388
7
Ponatinib-hydrochloride3.6%354
8
Rituximab3.4%333
9
Doxorubicin-hydrochloride3.3%322
10
Prednisone3.2%314
11
Mercaptopurine2.9%290
12
Fludarabine-phosphate2.5%251
13
Etoposide2.3%223
14
Pegaspargase2.1%205
15
Daunorubicin1.9%189

Taken alongside

1
Dexamethasone7.9%779
2
Methotrexate4.7%462
3
Acyclovir4.0%397
4
Cyclophosphamide3.8%375
5
Cytarabine3.7%368
6
Vincristine-sulfate3.4%331
7
Inotuzumab-ozogamicin2.8%276
8
Sulfamethoxazole2.6%259
9
Trimethoprim2.5%247
10
Acetaminophen2.2%217
11
Ponatinib-hydrochloride2.1%207
12
Allopurinol2.0%195
13
Fludarabine-phosphate1.8%181
14
Fluconazole1.8%178
15
Prednisone1.8%174

Co-occurrence in adverse event reports does not establish a drug interaction. Patients often take multiple medications, and these lists reflect prescribing patterns rather than causal relationships. Consult a healthcare provider about potential drug interactions.

Who reports blinatumomab side effects

34.1% of blinatumomab adverse event reports involve female patients and 38.9% involve male patients. The largest age group is adult at 59%. These figures reflect who reports side effects, not underlying risk.

Sex

Female34.1%
Male38.9%
Unknown27.0%

Age group

< 22.8%
2–1113.3%
12–177.3%
18–6458.5%
65+18.1%

What is blinatumomab used for

Conditions and purposes for which patients were taking blinatumomab when the adverse event was reported.

Acute Biphenotypic LeukaemiaAcute LeukaemiaAcute Leukaemia In RemissionAcute Lymphocytic LeukaemiaAcute Lymphocytic Leukaemia (in Remission)Acute Lymphocytic Leukaemia RecurrentAcute Lymphocytic Leukaemia RefractoryAcute Myeloid LeukaemiaAllogenic Stem Cell TransplantationAcute Biphenotypic LeukaemiaAcute LeukaemiaAcute Leukaemia In RemissionAcute Lymphocytic LeukaemiaAcute Lymphocytic Leukaemia RecurrentAcute Lymphocytic Leukaemia Refractory

Showing 15 of 199 indications

Blinatumomab brand names and reporting trend

Blinatumomab is sold under the brand name Blincyto.

Brand names

Blincyto5,165

Quarterly reports (20122025)

20122016202020242025

An upward trend reflects increased FAERS reporting overall, not necessarily increased risk.

Taking blinatumomab with another medication?

Ask OpenClaim about your specific drug combination. Get a sourced report using FDA data, drug labels, and medical literature.