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Gemtuzumab Side Effects

The most commonly reported side effects of gemtuzumab include febrile neutropenia, febrile neutropenia, and platelet count decreased, based on 3,938 FDA adverse event reports from 2004 to 2025. 3.9% of reports found the drug to be ineffective.

Gemtuzumab side effects

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

1
Febrile Neutropenia11.5%452
2
Febrile Neutropenia6.4%251
3
Platelet Count Decreased4.7%185
4
Pyrexia4.6%182
5
Off Label Use4.6%180
6
Sepsis4.2%167
7
Pyrexia4.2%167
8
Drug Ineffective3.9%153
9
White Blood Cell Count Decreased3.9%152
10
Aspartate Aminotransferase Increased3.7%147
11
Venoocclusive Liver Disease3.7%145
12
Sepsis3.6%141
13
Venoocclusive Liver Disease3.5%139
14
Thrombocytopenia3.4%134
15
Neutropenia3.2%127

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

Report severity

97.1%Serious3,825 reports
46.7%Hospitalizations1,840 reports
30.8%Fatal1,212 reports

Seriousness is determined by the reporter, not by OpenClaim.

Gemtuzumab drug interactions

Other drugs that appear in adverse event reports alongside gemtuzumab. 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
Cytarabine36.6%1,441
2
Daunorubicin19.4%763
3
Mitoxantrone-hydrochloride15.0%592
4
Fludarabine-phosphate8.7%344
5
Etoposide8.6%338
6
Idarubicin-hydrochloride6.9%271
7
Methotrexate4.7%185
8
Azacitidine4.6%183
9
Cyclophosphamide3.7%144
10
Busulfan3.1%123
11
Hydrocortisone2.9%114
12
Venetoclax2.5%100
13
Vancomycin2.2%88
14
Amphotericin-b2.2%86
15
Midostaurin2.0%78

Taken alongside

1
Cytarabine9.2%361
2
Acetaminophen8.8%346
3
Acyclovir7.3%286
4
Ondansetron7.1%281
5
Vancomycin5.9%233
6
Fluconazole5.8%230
7
Allopurinol5.5%217
8
Amphotericin-b4.7%185
9
Daunorubicin4.2%167
10
Furosemide4.0%159
11
Meropenem3.9%154
12
Diphenhydramine3.8%148
13
Pantoprazole-sodium3.7%147
14
Methylprednisolone3.7%146
15
Levofloxacin3.7%144

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 gemtuzumab side effects

39.2% of gemtuzumab adverse event reports involve female patients and 43.2% involve male patients. The largest age group is adult at 56%. These figures reflect who reports side effects, not underlying risk.

Sex

Female39.2%
Male43.2%
Unknown17.6%

Age group

< 22.1%
2–117.4%
12–176.5%
18–6456.3%
65+27.8%

What is gemtuzumab used for

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

Acute Biphenotypic LeukaemiaAcute LeukaemiaAcute Lymphocytic LeukaemiaAcute Megakaryocytic LeukaemiaAcute Monocytic LeukaemiaAcute Myeloid LeukaemiaAcute Myeloid Leukaemia (in Remission)Acute Myeloid Leukaemia RecurrentAcute Myeloid Leukaemia RefractoryAcute Myeloid LeukemiaAcute Myeloid Leukemia NosAcute Myelomonocytic LeukaemiaAcute Promyelocytic LeukaemiaAcute Promyelocytic LeukemiaAllogenic Stem Cell Transplantation

Showing 15 of 110 indications

Gemtuzumab brand names and reporting trend

Gemtuzumab is sold under the brand name Mylotarg.

Brand names

Mylotarg2,348

Quarterly reports (20042025)

20052010201520202025

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

Taking gemtuzumab with another medication?

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