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Enasidenib Side Effects

The most commonly reported side effects of enasidenib include death, off label use, and fatigue, based on 3,631 FDA adverse event reports from 2017 to 2025. 3.2% of reports found the drug to be ineffective.

Enasidenib side effects

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

1
Death18.8%682
2
Off Label Use6.8%246
3
Fatigue6.0%217
4
Nausea5.7%208
5
Hospitalisation4.4%160
6
Acute Myeloid Leukaemia4.1%148
7
Diarrhoea3.9%143
8
Platelet Count Decreased3.5%126
9
Decreased Appetite3.4%123
10
Drug Ineffective3.2%117
11
Asthenia2.6%95
12
Pyrexia2.2%81
13
Full Blood Count Decreased2.2%80
14
Pneumonia2.2%79
15
Differentiation Syndrome2.1%78

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

Report severity

64.1%Serious2,329 reports
27.7%Hospitalizations1,006 reports
25.9%Fatal941 reports

Seriousness is determined by the reporter, not by OpenClaim.

Enasidenib drug interactions

Other drugs that appear in adverse event reports alongside enasidenib. 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
Venetoclax3.7%136
2
Cytarabine2.6%93
3
Azacitidine2.3%84
4
Daunorubicin1.0%36
5
Ruxolitinib0.6%23
6
Idarubicin-hydrochloride0.6%20
7
Decitabine0.5%19
8
Fludarabine-phosphate0.5%18
9
Busulfan0.3%11
10
Ondansetron0.3%11
11
Etoposide0.3%11
12
Mycophenolate0.3%10
13
Thiotepa0.3%10
14
Metronidazole0.3%10
15
Mitoxantrone-hydrochloride0.3%10

Taken alongside

1
Acyclovir11.8%427
2
Ondansetron8.0%290
3
Allopurinol6.7%243
4
Acetaminophen5.9%213
5
Levofloxacin5.1%185
6
Pantoprazole-sodium5.0%180
7
Ergocalciferol4.9%179
8
Metoprolol4.9%177
9
Posaconazole4.3%156
10
Levothyroxine-sodium4.2%151
11
Omeprazole4.0%147
12
Fluconazole3.6%131
13
Amlodipine3.6%129
14
Atorvastatin-calcium3.3%119
15
Prochlorperazine3.1%112

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 enasidenib side effects

39.7% of enasidenib adverse event reports involve female patients and 53.9% involve male patients. The largest age group is elderly at 74%. These figures reflect who reports side effects, not underlying risk.

Sex

Female39.7%
Male53.9%
Unknown6.4%

Age group

< 20.1%
2–110.3%
12–17<0.1%
18–6425.7%
65+73.8%

What is enasidenib used for

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

2-hydroxyglutaric Aciduria5q Minus Syndrome5q Minus SyndromeAcute Graft Versus Host DiseaseAcute LeukaemiaAcute Leukaemia In RemissionAcute Lymphocytic LeukaemiaAcute Monocytic LeukaemiaAcute Monocytic Leukaemia (in Remission)Acute Myeloid LeukaemiaAcute Myeloid Leukaemia (in Remission)Acute Myeloid Leukaemia RecurrentAcute Myeloid Leukaemia RefractoryAcute Myelomonocytic LeukaemiaAnaemia

Showing 15 of 160 indications

Enasidenib brand names and reporting trend

Enasidenib is sold under the brand name Idhifa.

Brand names

Idhifa572

Quarterly reports (20172025)

20182020202220242025

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

Taking enasidenib with another medication?

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