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Iclusig Side Effects

Generic name: ponatinib

Medically reviewed by Philip Thornton, DipPharm. Last updated on Sep 27, 2023.

Note: This document contains side effect information about ponatinib. Some dosage forms listed on this page may not apply to the brand name Iclusig.

Applies to ponatinib: oral tablet.


Oral route (Tablet)

Arterial Occlusion Events, Venous Thromboembolic Events, Heart Failure, and HepatotoxicityArterial occlusive events (AOEs), including fatalities, have occurred in ponatinib hydrochloride-treated patients. AOEs included fatal myocardial infarction, stroke, stenosis of large arterial vessels of the brain, severe peripheral vascular disease, and the need for urgent revascularization procedures. Patients with and without cardiovascular risk factors, including patients age 50 years or younger, experienced these events. Monitor for evidence of AOEs. Interrupt or discontinue ponatinib hydrochloride based on severity. Consider benefit-risk to guide a decision to restart ponatinib hydrochloride.Venous thromboembolic events (VTEs) have occurred in ponatinib hydrochloride-treated patients. Monitor for evidence of VTEs. Interrupt or discontinue ponatinib hydrochloride based on severity.Heart failure, including fatalities, occurred in ponatinib hydrochloride-treated patients. Monitor for heart failure and manage patients as clinically indicated. Interrupt or discontinue ponatinib hydrochloride for new or worsening heart failure.Hepatotoxicity, liver failure and death have occurred in ponatinib hydrochloride-treated patients. Monitor liver function tests. Interrupt or discontinue ponatinib hydrochloride based on severity.

Serious side effects of Iclusig

Along with its needed effects, ponatinib (the active ingredient contained in Iclusig) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking ponatinib:

More common

Less common

Incidence not known

Other side effects of Iclusig

Some side effects of ponatinib may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

For Healthcare Professionals

Applies to ponatinib: oral tablet.


-A safety analysis showed a significant increase in grade 3 or greater adverse reactions (thrombocytopenia, neutropenia, rash, elevated ALT/AST, pancreatitis, elevated lipase) with an increase in dose intensity.[Ref]


-Very common (10% or more): Hypertension (74%), elevated blood pressure (68%), arterial ischemia (42%), arterial occlusion (35%), hemorrhage (28%), arrhythmia (19%), heart failure/left ventricular dysfunction (15%)

-Common (1% to 10%): Venous thromboembolism, atrial fibrillation, myocardial infarction, myocardial ischemia, congestive cardiac failure, coronary artery disease, angina pectoris, decreased ejection fraction, acute coronary syndrome, atrial flutter, peripheral arterial occlusive disease, peripheral ischemia, peripheral artery stenosis, intermittent claudication, deep vein thrombosis, hot flush, flushing, palpitations, poor peripheral circulation, splenic infarction

-Uncommon (0.1% to 1%): Hypertensive crisis, renal artery stenosis, cardiac discomfort

Frequency not reported: Ischemic cardiomyopathy, coronary arteriospasm[Ref]


-Very common (10% or more): Rash and related conditions (63%), dry skin (42%), pruritus (13%), alopecia (11%), cellulitis (11%), erythema (10%)

-Common (1% to 10%): Folliculitis, skin exfoliation, night sweats, hyperhidrosis, petechia, ecchymosis, skin pain, exfoliative dermatitis, hyperkeratosis, skin hyperpigmentation[Ref]


-Very common (10% or more): Leukopenia (63%), myelosuppression (59%), neutropenia (59%), febrile neutropenia (25%), anemia (52%), thrombocytopenia (49%), lymphopenia (32%)

-Common (1% to 10%): Pancytopenia[Ref]


-Very common (10% or more): Increased glucose (54%), decreased glucose (13%)

-Common (1% to 10%): Hypothyroidism[Ref]


-Very common (10% or more): Constipation (53%), abdominal pain (48%), increased lipase (42%), nausea (34%), diarrhea (29%), vomiting (27%), oral mucositis (23%), increased amylase (18%)

-Common (1% to 10%): GI hemorrhage, pancreatitis, gastroesophageal reflux disease, stomatitis, dyspepsia, abdominal distention, abdominal discomfort, dry mouth

-Frequency not reported: GI fistula, GI perforation[Ref]


-Very common (10% or more): Asthenia/fatigue (49%), pyrexia (40%), peripheral edema (25%), pain (60%), chills (13%), sepsis (13%)

-Common (1% to 10%): Effusions (pericardial, pleural, ascites), influenza-like illness, peripheral swelling, non-cardiac chest pain, face edema, malaise[Ref]

Nervous system

-Very common (10% or more): Headache (43%), peripheral neuropathy (24%), dizziness (16%)

-Common (1% to 10%): Cranial neuropathy, cerebrovascular accident, cerebral infarction, lethargy, migraine, hyperesthesia, hypoesthesia, paresthesia, transient ischemic attack

-Uncommon (0.1% to 1%): Cerebral artery stenosis, cerebral hemorrhage, intracranial hemorrhage

-Postmarketing reports: Reversible posterior leukoencephalopathy syndrome/posterior reversible encephalopathy syndrome (RPLS/PRES)[Ref]


-Very common (10% or more): Increased ALT (41%), increased alkaline phosphatase (40%), increased AST (35%), hepatotoxicity (29%), decreased albumin (27%), increased bilirubin (13%)

-Common (1% to 10%): Increased gamma-glutamyltransferase

-Uncommon (0.1% to 1%): Hepatic failure, jaundice

-Frequency not reported: Acute liver failure[Ref]


-Very common (10% or more): Decreased phosphorus (33%), decreased calcium (30%), decreased appetite (31%), fluid retention (31%), decreased sodium (27%), increased creatinine (21%), decreased bicarbonate (19%), increased potassium (19%), decreased potassium (18%), decreased weight (13%), increased calcium (12%), increased sodium (10%)

-Common (1% to 10%): Hypertriglyceridemia, dehydration, increased blood cholesterol

-Uncommon (0.1% to 1%): Tumor lysis syndrome[Ref]


-Very common (10% or more): Arthralgia (33%), myalgia (24%), pain in extremity (23%), back pain (21%), bone pain (14%), muscle spasms (14%), musculoskeletal pain (11%)

-Common (1% to 10%): Neck pain, musculoskeletal chest pain[Ref]


-Very common (10% or more): Cough (22%), dyspnea (20%), pleural effusion (19%), nasopharyngitis (18%), pneumonia (16%), upper respiratory tract infection (14%)

-Common (1% to 10%): Epistaxis, dysphonia, pulmonary hypertension, pulmonary embolism[Ref]


-Very common (10% or more): Urinary tract infection (14%)

-Common (1% to 10%): Hyperuricemia[Ref]


-Very common (10% or more): Insomnia (13%)

-Common (1% to 10%): Confusional state, erectile dysfunction[Ref]


-Very common (10% or more): Ocular toxicities (14%; conjunctival irritation, corneal erosion/abrasion, dry eye, conjunctivitis, conjunctival hemorrhage, hyperemia, eye pain)

-Common (1% to 10%): Blurred vision, periorbital edema, eyelid edema, visual impairment, retinal toxicities (macular edema, retinal vein occlusion/thrombosis, retinal artery occlusion, retinal hemorrhage)

-Uncommon (0.1% to 1%): Vision loss[Ref]


1. Cerner Multum, Inc. "UK Summary of Product Characteristics."

2. Cerner Multum, Inc. "Australian Product Information."

3. (2012) "Product Information. Iclusig (ponatinib)." Ariad Pharmaceuticals Inc

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.