OpenClaim

Decitabine Side Effects

The most commonly reported side effects of decitabine include off label use, febrile neutropenia, and death, based on 6,436 FDA adverse event reports from 2005 to 2025. 5.9% of reports found the drug to be ineffective.

Decitabine side effects

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

1
Off Label Use9.7%623
2
Febrile Neutropenia8.3%532
3
Death7.4%478
4
Pneumonia5.9%382
5
Drug Ineffective5.9%378
6
Neutropenia5.7%365
7
Pyrexia5.1%330
8
Platelet Count Decreased4.7%304
9
Acute Myeloid Leukaemia4.7%303
10
Myelosuppression4.6%295
11
Thrombocytopenia4.6%293
12
Product Use In Unapproved Indication4.5%290
13
Sepsis4.1%262
14
Fatigue3.7%235
15
White Blood Cell Count Decreased3.6%229

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

Report severity

92.4%Serious5,946 reports
39.7%Hospitalizations2,553 reports
28.2%Fatal1,812 reports

Seriousness is determined by the reporter, not by OpenClaim.

Decitabine drug interactions

Other drugs that appear in adverse event reports alongside decitabine. 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
Venetoclax29.8%1,915
2
Cytarabine10.8%693
3
Cedazuridine8.2%530
4
Azacitidine5.4%346
5
Fludarabine-phosphate4.2%268
6
Cyclophosphamide4.0%260
7
Vorinostat3.2%204
8
Filgrastim2.9%185
9
Methotrexate2.7%175
10
Busulfan2.5%158
11
Vincristine-sulfate2.2%143
12
Idarubicin-hydrochloride2.1%137
13
Etoposide2.1%133
14
Lenalidomide2.0%127
15
Mitoxantrone-hydrochloride2.0%126

Taken alongside

1
Acyclovir11.9%764
2
Allopurinol8.6%552
3
Ondansetron8.1%523
4
Acetaminophen7.7%498
5
Levofloxacin6.9%442
6
Metoprolol5.0%320
7
Furosemide4.9%313
8
Ergocalciferol4.6%299
9
Fluconazole4.6%296
10
Levothyroxine-sodium4.6%294
11
Amlodipine4.5%289
12
Pantoprazole-sodium4.5%288
13
Posaconazole4.5%288
14
Omeprazole4.1%264
15
Prochlorperazine4.0%255

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 decitabine side effects

34.7% of decitabine adverse event reports involve female patients and 48.4% involve male patients. The largest age group is elderly at 57%. These figures reflect who reports side effects, not underlying risk.

Sex

Female34.7%
Male48.4%
Unknown16.9%

Age group

< 20.9%
2–113.7%
12–172.4%
18–6435.6%
65+57.4%

What is decitabine used for

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

Accidental ExposureAcquired Chromosomal AbnormalityAcute Myeloid LeukaemiaAcute Erythroid LeukaemiaAcute LeukaemiaAcute Lymphocytic LeukaemiaAcute Lymphocytic Leukaemia RecurrentAcute Lymphocytic Leukaemia RefractoryAcute Megakaryocytic LeukaemiaAcute Monocytic LeukaemiaAcute Myeloid LeukaemiaAcute Myeloid Leukaemia (in Remission)Acute Myeloid Leukaemia RecurrentAcute Myeloid Leukaemia RefractoryAcute Myeloid Leukemia

Showing 15 of 315 indications

Decitabine brand names and reporting trend

Decitabine is sold under the brand name Inqovi.

Brand names

Inqovi6,169

Quarterly reports (20052025)

20052010201520202025

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

Taking decitabine with another medication?

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