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Ponatinib Side Effects

The most commonly reported side effects of ponatinib include death, off label use, and product dose omission issue, based on 11,948 FDA adverse event reports from 2012 to 2025. 4.6% of reports found the drug to be ineffective.

Ponatinib side effects

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

1
Death15.6%1,860
2
Off Label Use9.8%1,168
3
Product Dose Omission Issue7.0%841
4
Fatigue6.6%783
5
Rash6.4%764
6
Headache5.7%684
7
Pyrexia5.6%665
8
Nausea4.7%561
9
Drug Ineffective4.6%555
10
Constipation4.2%507
11
Platelet Count Decreased3.9%462
12
Hospitalisation3.9%460
13
Arthralgia3.8%459
14
Dry Skin3.7%443
15
Hypertension3.7%438

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

Report severity

90.2%Serious10,772 reports
39.9%Hospitalizations4,768 reports
27.1%Fatal3,236 reports

Seriousness is determined by the reporter, not by OpenClaim.

Ponatinib drug interactions

Other drugs that appear in adverse event reports alongside ponatinib. 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
Dasatinib7.0%837
2
Imatinib-mesylate5.3%632
3
Cytarabine4.8%568
4
Nilotinib4.5%532
5
Methotrexate4.3%513
6
Vincristine-sulfate4.2%502
7
Dexamethasone4.1%484
8
Blinatumomab3.6%436
9
Cyclophosphamide3.4%411
10
Bosutinib-monohydrate2.6%305
11
Doxorubicin-hydrochloride2.5%295
12
Fludarabine-phosphate1.5%184
13
Prednisone1.3%154
14
Asciminib-hydrochloride1.0%119
15
Hydroxyurea0.9%106

Taken alongside

1
Acyclovir7.5%897
2
Aspirin7.1%844
3
Amlodipine5.6%668
4
Acetaminophen4.5%535
5
Allopurinol4.3%519
6
Levothyroxine-sodium4.0%473
7
Ergocalciferol3.7%442
8
Furosemide3.6%428
9
Ondansetron3.6%427
10
Metoprolol3.4%408
11
Gabapentin3.4%408
12
Oxycodone3.2%386
13
Fluconazole3.2%380
14
Sulfamethoxazole3.2%380
15
Lisinopril3.1%376

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 ponatinib side effects

39.9% of ponatinib adverse event reports involve female patients and 49.0% involve male patients. The largest age group is adult at 64%. These figures reflect who reports side effects, not underlying risk.

Sex

Female39.9%
Male49.0%
Unknown11.1%

Age group

< 2<0.1%
2–111.2%
12–171.6%
18–6464.1%
65+33.0%

What is ponatinib used for

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

Abdominal NeoplasmAcute Biphenotypic LeukaemiaAcute LeukaemiaAcute Lymphocytic LeukaemiaAcute Lymphocytic Leukaemia (in Remission)Acute Lymphocytic Leukaemia RecurrentAcute Lymphocytic Leukaemia RefractoryAcute Megakaryocytic LeukaemiaAcute Monocytic LeukaemiaAcute Myeloid LeukaemiaAcute Myeloid Leukaemia (in Remission)Acute Myeloid Leukaemia RecurrentAcute Myeloid Leukaemia RefractoryAcute Myelomonocytic LeukaemiaAdenocarcinoma Pancreas

Showing 15 of 293 indications

Ponatinib brand names and reporting trend

Quarterly reports (20122025)

20122016202020242025

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

Taking ponatinib with another medication?

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