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Ivosidenib Side Effects

The most commonly reported side effects of ivosidenib include off label use, fatigue, and diarrhoea, based on 1,868 FDA adverse event reports from 2017 to 2025. 3.9% of reports found the drug to be ineffective.

#1 Reported: Off Label UseAll side effects ↓Top Co-Medication: AzacitidineDrug interactions ↓60% of Reports Are ElderlyDemographics ↓

Ivosidenib side effects

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

1
Off Label Use34.6%646
2
Fatigue8.4%156
3
Diarrhoea6.0%113
4
Nausea5.9%110
5
Disease Progression4.7%88
6
Differentiation Syndrome4.4%83
7
Drug Ineffective3.9%73
8
Product Dose Omission Issue3.8%71
9
Platelet Count Decreased3.4%64
10
Electrocardiogram Qt Prolonged3.3%62
11
Death3.1%58
12
Vomiting3.1%58
13
Asthenia2.9%54
14
Pneumonia2.8%53
15
Pyrexia2.8%53

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

Report severity

57.1%Serious1,067 reports
29.5%Hospitalizations551 reports
8.7%Fatal162 reports

Seriousness is determined by the reporter, not by OpenClaim.

Ivosidenib drug interactions

Other drugs that appear in adverse event reports alongside ivosidenib. 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
Azacitidine6.3%117
2
Venetoclax5.1%95
3
Cytarabine2.7%50
4
Posaconazole1.5%28
5
Daunorubicin1.2%23
6
Decitabine1.0%19
7
Bevacizumab0.9%16
8
Olutasidenib0.7%14
9
Enasidenib-mesylate0.7%13
10
Idarubicin-hydrochloride0.6%11
11
Ruxolitinib0.6%11
12
Levetiracetam0.4%8
13
Nivolumab0.4%8
14
Fluorouracil0.4%7
15
Temozolomide0.4%7

Taken alongside

1
Acyclovir6.2%116
2
Ondansetron4.4%82
3
Acetaminophen4.3%80
4
Pantoprazole-sodium3.7%69
5
Levothyroxine-sodium3.3%62
6
Posaconazole3.2%60
7
Metoprolol2.9%54
8
Amlodipine2.9%54
9
Azacitidine2.8%52
10
Ergocalciferol2.7%51
11
Furosemide2.7%50
12
Lorazepam2.5%46
13
Allopurinol2.5%46
14
Prochlorperazine2.4%45
15
Atorvastatin-calcium2.2%42

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 ivosidenib side effects

7.8% of ivosidenib adverse event reports involve female patients and 8.2% involve male patients. The largest age group is elderly at 60%. These figures reflect who reports side effects, not underlying risk.

Sex

Female7.8%
Male8.2%
Unknown83.9%

Age group

< 20.4%
2–110.4%
12–170.4%
18–6438.7%
65+60.1%

What is ivosidenib used for

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

Acute LeukaemiaAcute Leukaemia In RemissionAcute Lymphocytic LeukaemiaAcute Megakaryocytic LeukaemiaAcute Monocytic LeukaemiaAcute Myeloid LeukaemiaAcute Myeloid Leukaemia (in Remission)Acute Myeloid Leukaemia RecurrentAcute Myeloid Leukaemia RefractoryAcute Myelomonocytic LeukaemiaAcute Promyelocytic LeukaemiaAcute Undifferentiated LeukaemiaAdenocarcinomaAnaemiaAnaplastic Astrocytoma

Showing 15 of 139 indications

Ivosidenib brand names and reporting trend

Ivosidenib is sold under the brand name Tibsovo.

Brand names

Tibsovo404

Quarterly reports (2017–2025)

20172020202220242025

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

Taking ivosidenib with another medication?

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