Ponatinib: uses, dosing, side effects & brands
Ponatinib is a kinase inhibitor sold in the U.S. under one brand, for myeloid leukemia. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
Key facts
- Drug class
- Kinase Inhibitor
- Treats
- Myeloid Leukemia
- Available as
- Tablet
- Sold as
- Iclusig
- Prescription?
- Prescription only
- Generic available?
- Not in our catalog
- Boxed warning
- Boxed warning
How ponatinib is dosed
From the FDA label for Iclusig (application NDA203469). Other ponatinib products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
Recommended Dosage in Newly Diagnosed Ph+ ALL : Starting dose is 30 mg orally once daily in combination with chemotherapy, with a reduction to 15 mg once daily upon achievement of MRD-negative (≤0.01% BCR::ABL1/ABL1) CR at the end of induction. ( 2.1 ) Recommended Dosage in Monotherapy for Ph+ ALL for Whom No Other Kinase Inhibitors are Indicated or T315I-positive Ph+ ALL : Starting dose is 45 mg orally once daily. ( 2.1 ) Recommended Dosage in CP-CML : Starting dose is 45 mg orally once daily with a reduction to 15 mg once daily upon achievement of ≤1% BCR::ABL1 IS . ( 2.1 ) Recommended Dosage in AP-CML and BP-CML : Starting dose is 45 mg orally once daily. ( 2.1 ) Hepatic Impairment : See the Full Prescribing Information for dosage modifications for hepatic impairment. ( 2.4 ) ICLUSIG may be taken with or without food. ( 2.1 ) 2.1 Recommended Dosage Newly Diagnosed Ph+ ALL The recommended starting dosage of ICLUSIG in combination with chemotherapy is 30 mg orally once daily with a reduction to 15 mg orally once daily upon achievement of MRD-negative (≤0.01% BCR::ABL1/ABL1) CR at the end of induction. Continue ICLUSIG in combination with chemotherapy for up to 20 cycles until loss of response or unacceptable toxicity [see Clinical Studies (14) ] . For a description of dosing of agents administered in combination with ICLUSIG, [see Clinical Studies (14) ] . Monotherapy for Ph+…
Ponatinib side effects
The following clinically significant adverse reactions are described elsewhere in the labeling: Arterial Occlusive Events [see Warnings and Precautions (5.1) ] Venous Thromboembolic Events [see Warnings and Precautions (5.2) ] Heart Failure [see Warnings and Precautions (5.3) ] Hepatotoxicity [see Warnings and Precautions (5.4) ] Hypertension [see Warnings and Precautions (5.5) ] Pancreatitis [see Warnings and Precautions (5.6) ] Neuropathy [see Warnings and Precautions (5.8) ] Ocular Toxicity [see Warnings and Precautions (5.9) ] Hemorrhage [see Warnings and Precautions (5.10) ] Fluid Retention [see Warnings and Precautions (5.11) ] Cardiac Arrhythmias [see Warnings and Precautions (5.12) ] Myelosuppression [see Warnings and Precautions (5.13) ] Tumor Lysis Syndrome [see Warnings and Precautions (5.14) ] Reversible Posterior Leukoencephalopathy Syndrome [see Warnings and Precautions (5.15) ] Impaired Wound Healing and Gastrointestinal Perforation [see Warnings and Precautions (5.16) ] Most common adverse reactions (occurring in >20% of patients) are: ICLUSIG as a single agent: rash and related conditions, arthralgia, abdominal pain, fatigue, headache, constipation, hypertension, dry skin, hepatotoxicity, fluid retention and edema, pyrexia, pancreatitis/lipase elevation, nausea, hemorrhage, anemia, AOEs, and cardiac arrhythmias. The most common Grade 3 or 4 laboratory…
Who shouldn’t take ponatinib
None. None. ( 4 )
Ponatinib drug interactions
Strong CYP3A Inhibitors : Avoid coadministration or reduce ICLUSIG dose if coadministration cannot be avoided. ( 2.3 , 7.1 ) Strong CYP3A Inducers : Avoid coadministration. ( 7.1 ) 7.1 Effects of Other Drugs on ICLUSIG Strong CYP3A Inhibitors Coadministration of ICLUSIG with a strong CYP3A inhibitor increases ponatinib plasma concentrations [see Clinical Pharmacology (12.3) ] , which may increase the risk of ICLUSIG adverse reactions. Avoid coadministration of ICLUSIG with strong CYP3A inhibitors. If coadministration of ICLUSIG with strong CYP3A inhibitors cannot be avoided, reduce the ICLUSIG dosage [see Dosage and Administration (2.3) ] . Strong CYP3A Inducers Coadministration of ICLUSIG with a strong CYP3A inducer decreases ponatinib plasma concentrations [see Clinical Pharmacology (12.3) ] . Avoid coadministration of ICLUSIG with strong CYP3A inducers unless the benefit outweighs the risk of decreased ponatinib exposure. Monitor patients for reduced efficacy. Selection of concomitant medication with no or minimal CYP3A induction potential is recommended.
Every ponatinib product we track (1)
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
Only one: Iclusig.
What ponatinib pills look like
Imprint codes, colour and shape from the FDA’s labelling data. Match the imprint on your pill — or search any imprint.
| Imprint | Strength | Colour | Shape | Maker |
|---|---|---|---|---|
| A5 | 15 mg | white | round | — |
| AP4 | 45 mg | white | round | — |
| C7 | 30 mg | white | round | — |
| NZ | 10 mg | white | oval | — |
Ponatinib and breastfeeding
From LactMed, the US National Library of Medicine’s Drugs and Lactation Database — quoted, not rewritten.
Full LactMed record for ponatinib: levels in milk, effects in breastfed infants, and the drugs it would consider insteadNo information is available on the clinical use of ponatinib during breastfeeding. Because ponatinib is more than 99% bound to plasma proteins, the amount in milk is likely to be low. However, its half-life is about 24 hours and it might accumulate in the infant. National Comprehensive Cancer Network guidelines recommend avoiding breastfeeding during ponatinib therapy and the manufacturer recommends withholding breastfeeding for 6 days following the last dose.
National Institute of Child Health and Human Development, record revised February 20, 2022. LactMed states its information is not a substitute for professional judgement.
What people report to the FDA about ponatinib
The FDA Adverse Event Reporting System (FAERS) collects reports from patients and clinicians. It holds 50 reports naming ponatinib, and the FDA flagged 88% of those reports as serious. The effects reported most often — leaving out reports about overdose, misuse or the condition being treated, which dominate the raw list for common medicines:
- febrile neutropenia9 reports
- pyrexia8 reports
- diarrhoea7 reports
- nausea7 reports
- abdominal pain6 reports
- headache5 reports
- platelet count decreased5 reports
- syncope5 reports
Read these as a signal, not a rate. A report does not mean ponatinib caused the effect — anyone can file one, and many describe people taking several medicines for several conditions. Crucially there is no denominator: FAERS does not record how many people took the drug, so these counts cannot be turned into “X% of patients” — a bigger number often just means a more widely used or more talked-about drug. Duplicates exist, and publicity drives reporting. For what is actually established, read the FDA label section above.
Source: openFDA drug/event (FAERS), retrieved July 26, 2026.
Related calculators
Frequently asked questions
What is ponatinib?
Iclusig (Ponatinib Hydrochloride) is a kinase inhibitor used to treat Myeloid Leukemia.
What kind of drug is ponatinib?
The FDA classifies ponatinib as a kinase inhibitor. Kinase inhibitors block protein kinases, the enzymes that relay 'grow and divide' signals inside cells. By shutting down the overactive kinase signals that a tumor depends on, they help slow or stop cancer cells from multiplying. If you are checking whether it is safe to combine with something else, the class is what matters — two drugs from the same class usually should not be stacked.
Can you take ponatinib with other medicines?
It depends on the medicine. We check it against the FDA labels rather than guessing: our interaction checker searches each drug's own label for the other and quotes what it says, naming the section it came from. Run ponatinib against whatever else you take — and remember that a label not naming a drug is not the same as that combination being safe.
What forms does ponatinib come in?
Across the brands we track, ponatinib is currently marketed as tablet, per the FDA's National Drug Code Directory. Each form is dosed differently — follow the label for the exact product you were prescribed.
Is there a generic ponatinib?
We do not currently list a generic-labelled ponatinib product. That does not always mean none exists — it means none appears under a generic name in the FDA data we track. Ask your pharmacist.
Cite this page
- APA
- pharmaranks. (2026, July 24). Ponatinib: uses, dosing, side effects & brands. https://pharmaranks.com/drugs/ponatinib
- MLA
- “Ponatinib: uses, dosing, side effects & brands.” pharmaranks, 24 July 2026, https://pharmaranks.com/drugs/ponatinib.
We summarise public FDA and NIH sources — for a clinical claim, cite the primary source we link to as well.
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
Read the full FDA label for ponatinib on DailyMed (NIH) ↗ — including its boxed warning in full.