What the label lists and what reports show

Ponatinib side effects

Ponatinib's FDA label: “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 …” FAERS holds 5,180 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is rash (271 reports).

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 FDA FAERS public dashboard.

What does the patient leaflet say about side effects?

From the patient leaflet: What are the possible side effects of ICLUSIG?
ICLUSIG may cause serious side effects, including: See " What is the most important information I should know about ICLUSIG? " High blood pressure (hypertension). High blood pressure is common during treatment with ICLUSIG and can also be serious or severe. ICLUSIG can cause new or worsening high blood pressure. Your blood pressure should be checked regularly, and any high blood pressure should be treated during treatment with ICLUSIG. Tell your healthcare provider right away if you get confusion, headaches, dizziness, chest pain or shortness of breath. Inflammation of the pancreas (pancreatitis). Pancreatitis is common during treatment with ICLUSIG and can also be serious or severe. Tell your healthcare provider right away if you get any of the following symptoms: sudden stomach-area pain or discomfort, nausea, and vomiting. […]

Source: FDA drug label, 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 label list?

From the label: adverse reactions
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.

Table 4: Adverse Reactions (>10%) in Patients with Newly Diagnosed Ph+ ALL in PhALLCON

Reaction	All Grades (%)	Grade 3 or 4 (%)	All Grades (%)	Grade 3 or 4 (%)
Hepatotoxicity	66	30	57	14
Arthralgia Includes arthralgia, arthritis, back pain, flank pain, intervertebral disc…	47	4.3	35	1.2
Myalgia	13	1.2	10	1.2
Headache	45	1.8	43	1.2
Neuropathy peripheral	33	1.2	24	1.2
Paresthesia	22	0	10	0
Peripheral sensory neuropathy	12	0	12	0
Rash and related conditions	47	1.2	33	1.2
Abdominal pain Includes abdominal discomfort, abdominal distension, abdominal pain,…	43	4.9	28	0
Constipation	41	0.6	21	1.2
Nausea	37	3.1	52	7
Oral mucositis	35	4.9	30	10
Pancreatitis/lipase elevation	34	15	37	20
Vomiting	24	1.2	40	2.5
Diarrhea	20	0	35	2.5
Pyrexia	44	4.3	26	2.5
Fatigue or asthenia	40	2.5	38	3.7
Fluid retention and edema	24	0.6	48	3.7
Hypertension	34	14	15	7
Hemorrhage	31	1.8	30	7
Venous thromboembolic events	12	3.1	10	2.5
Febrile neutropenia	28	25	22	20
Impaired glucose tolerance	20	4.9	20	9
Hyperlipidemia	16	1.2	15	1.2
Decreased appetite	10	0	19	3.7

Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.

From the label: adverse reactions, continued
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. …

Source: FDA drug label, 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?

5,180 reports list ponatinib among the medicines taken, 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. Of the 21 reactions below, 19 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.

Reports received each year

The 25 most reported reactions

Death (an outcome recorded in the report)742
Off Label Use (a use or a product term, not a reaction)345
Rash (named in the label)271
Headache (named in the label)267
Fatigue (named in the label)257
Pyrexia (named in the label)254
Neoplasm Progression197
Hypertension (named in the label)194
Nausea (named in the label)194
Constipation (named in the label)192
Drug Ineffective (a use or a product term, not a reaction)191
Platelet Count Decreased (named in the label)166
Arthralgia (named in the label)165
Abdominal Pain (named in the label)160
Dry Skin (named in the label)148
Chronic Myeloid Leukaemia (named in the label)147
Thrombocytopenia (named in the label)146
Pneumonia (named in the label)141
Chest Pain (named in the label)137
Hospitalisation (an outcome recorded in the report)137
Diarrhoea (named in the label)133
Asthenia (named in the label)129
Acute Lymphocytic Leukaemia Recurrent128
Dyspnoea (named in the label)123
Pain In Extremity (named in the label)122

Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms

What next?

Ponatinib: the full record: label, generics, price, shortages, recalls
Report a side effect to the FDA: MedWatch
Side effects hub: the most reported medicines and reactions