Prescription medicine
Ponatinib Brand names: Iclusig
Ponatinib (Iclusig) is a prescription medicine with an FDA approval on record since 2012. No generic is listed in FDA's NDC Directory.
- No generic listed
- Boxed warning
Check it at the source: the ponatinib FDA label on DailyMed (effective August 14, 2026, Takeda Pharmaceuticals America, Inc.); the NDA 203469 record on Drugs@FDA; every ponatinib label on DailyMed.
Highlights of the record
FDA label of August 14, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
ARTERIAL OCCLUSIVE EVENTS, VENOUS THROMBOEMBOLIC EVENTS, HEART FAILURE,.
and HEPATOTOXICITY WARNING: ARTERIAL OCCLUSIVE EVENTS, VENOUS THROMBOEMBOLIC EVENTS, HEART FAILURE, and HEPATOTOXICITY See full prescribing information for complete boxed warning. Arterial occlusive events (AOEs), including fatalities, have occurred in ICLUSIG-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 ICLUSIG based on severity. Consider benefit-risk to guide a decision to restart ICLUSIG. ( 2.2 , 5.1 ) Venous thromboembolic events (VTEs) have occurred in ICLUSIG-treated patients. Monitor for evidence of VTEs. Interrupt or discontinue ICLUSIG based on severity. ( 2.2 , 5.2 ) Heart failure, including fatalities, occurred in ICLUSIG-treated patients. Monitor for heart failure and manage patients as clinically indicated. Interrupt or discontinue ICLUSIG for new or worsening heart failure. ( 2.2 , 5.3 ) Hepatotoxicity, liver failure and death have occurred in ICLUSIG-treated patients. Monitor liver function tests. Interrupt or discontinue ICLUSIG based on severity. […]
Used for
From the label: indications and usageICLUSIG ® is indicated for the treatment of adult patients with: Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia (Ph+ ALL) Newly diagnosed Ph+ ALL in combination with chemotherapy.
Forms and strengths
- 10 mg
- 15 mg
- 30 mg
- 45 mg
Film-coated tablet.
On the market
- Earliest approval on file
- December 14, 2012 Iclusig, Takeda Pharms Usa; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 1 first July 14, 2023; 0 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- December 12, 2033 Iclusig tablets; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 5,180 through July 30, 2026
What is ponatinib used for?
From the label: indications and usageICLUSIG ® is indicated for the treatment of adult patients with: Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia (Ph+ ALL) Newly diagnosed Ph+ ALL in combination with chemotherapy. This indication is approved under accelerated approval based on minimal residual disease (MRD)-negative complete remission (CR) at the end of induction [see Clinical Studies (14) ]. Continued approval for this indication may be contingent upon verification of clinical benefit in a confirmatory trial(s). As monotherapy in Ph+ ALL for whom no other kinase inhibitors are indicated or T315I-positive Ph+ ALL. […]
Conditions named in the indications of ponatinib's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Kinase Inhibitor.
Source: FDA drug label (Iclusig), Takeda Pharmaceuticals America, Inc., effective August 14, 2026 (SPL set 16d804b6-4957-43ee-b18c-3b36ec37c5ac), via openFDA; the full label on DailyMed
What does the patient leaflet for ponatinib say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about ICLUSIG?ICLUSIG can cause serious side effects, including: Blood clots or blockage in your blood vessels (arteries and veins). Blood clots or blockage in your blood vessels may lead to heart attack, stroke, or death. A blood clot or blockage in your blood vessels can prevent proper blood flow to your heart, brain, bowels (intestines), legs, eyes, and other parts of your body. You may need emergency surgery or treatment in a hospital. Get medical help right away if you get any of the following symptoms: chest pain or pressure pain in your arms, legs, back, neck or jaw shortness of breath numbness or weakness on one side of your body leg swelling trouble talking headache dizziness severe stomach area pain decreased vision or loss of vision Blood clots or blockage in your blood vessels can happen in people with or without risk factors for heart and blood vessel disease, including people 50 years of age or younger. The most common risk factors for these problems are a history of high blood pressure (hypertension), high cholesterol, and heart disease. Blood clots or blockages in your blood vessels happen more often in people as they get older, and in people with a history of decreased blood flow, high blood pressure, diabetes, or high cholesterol. Heart problems. ICLUSIG can cause heart problems, including heart failure which can be serious and may lead to death. Heart failure means your heart does not pump blood well enough. ICLUSIG can also cause irregular, slow, or fast heartbeats and heart attack. Your healthcare provider will check you for heart problems during your treatment with ICLUSIG. Get medical help right away if you get any of the following symptoms: shortness of breath, chest pain, fast or irregular heartbeats, dizziness, or feel faint. Liver problems. […]
From the patient leaflet: How should I store ICLUSIG?Store ICLUSIG at room temperature between 68°F to 77°F (20°C to 25°C). Keep ICLUSIG and all medicines out of the reach of children.
Source: FDA drug label (Iclusig), Takeda Pharmaceuticals America, Inc., effective August 14, 2026 (SPL set 16d804b6-4957-43ee-b18c-3b36ec37c5ac), via openFDA; the full label on DailyMed
Is there a generic for ponatinib (Iclusig)?
The FDA approved the first generic ponatinib on July 14, 2023. 1 generic application is approved; 0 of it carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
The Orange Book lists 6 patents for Iclusig tablets: the compound patent runs to December 12, 2033. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2012 earliest approval on file
- 2023 first generic approved
- 2033 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the ponatinib label say about other medicines?
The ponatinib label names 1 other medicine in its interaction, contraindication or warning sections. The labels of 1 other medicine name ponatinib. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Imatinib | warnings and precautions | Toxicity in Newly Diagnosed Chronic Phase CML In a prospective randomized clinical trial in the first line treatment of newly diagnosed patients with CP-CML, single agent ICLUSIG 45 mg once daily increased the risk of serious adverse reactions 2-fold compared to single agent imatinib 400 mg once daily. |
Other labels that name ponatinib
Source: FDA drug label (Iclusig), Takeda Pharmaceuticals America, Inc., effective August 14, 2026 (SPL set 16d804b6-4957-43ee-b18c-3b36ec37c5ac), via openFDA; the full label on DailyMed
What do FAERS reports show for ponatinib?
The FDA Adverse Event Reporting System holds 5,180 reports that list ponatinib among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 1,453 are coded as a death and 1,659 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as ponatinib?
37 other medicines are given the same way (oral) and in the same FDA class as ponatinib or labeled mainly for the same use (leukemia, lymphoma and myeloma), the same class first. Leukemia, lymphoma and myeloma lists all 98 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Dasatinib | Leukemia, lymphoma and myeloma | 14 labelers | $26.46 per tablet 100 mg tablet | No current entry |
| Imatinib | Leukemia, lymphoma and myeloma | 20 labelers | $0.624 per tablet 100 mg tablet | No current entry |
| Nilotinib | Leukemia, lymphoma and myeloma | 6 labelers | n/a | No current entry |
| Bosutinib | Leukemia, lymphoma and myeloma | 3 labelers | n/a | No current entry |
| Ibrutinib | Leukemia, lymphoma and myeloma | none listed | n/a | No current entry |
| Acalabrutinib | Leukemia, lymphoma and myeloma | none listed | n/a | No current entry |
| Pirtobrutinib | Leukemia, lymphoma and myeloma | none listed | n/a | No current entry |
| Quizartinib | Leukemia, lymphoma and myeloma | none listed | n/a | No current entry |
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to ponatinib
- 37 medicines for the same use
- Other kinase inhibitors
- the pharmacologic class, with prices and generics
- Ponatinib side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other