Iclusig Side Effects

Generic Name: ponatinib

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

Not all side effects for Iclusig may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

For the Consumer

Applies to ponatinib: oral tablet

In addition to its needed effects, some unwanted effects may be caused by ponatinib (the active ingredient contained in Iclusig). In the event that any of these side effects do occur, they may require medical attention.

You should check with your doctor immediately if any of these side effects occur when taking ponatinib:

More common
  • Bladder pain
  • bleeding gums
  • bloating or swelling of the face, arms, hands, lower legs, or feet
  • blurred vision
  • chest pain
  • chills
  • cloudy urine
  • confusion
  • constipation
  • cough or hoarseness
  • coughing up blood
  • decreased urine output
  • difficult, burning, or painful urination
  • difficulty with breathing or swallowing
  • dilated neck veins
  • dizziness
  • extreme fatigue
  • fainting
  • frequent urge to urinate
  • increased menstrual flow or vaginal bleeding
  • indigestion
  • irregular breathing
  • joint pain, stiffness, or swelling
  • lightheadedness
  • lower back, side, or stomach pain
  • nervousness
  • nosebleeds
  • pains in the chest, groin, or legs, especially calves of the legs
  • pains in the stomach, side, or abdomen, possibly radiating to the back
  • pale skin
  • paralysis
  • pinpoint red spots on the skin
  • pounding in the ears
  • prolonged bleeding from cuts
  • rapid weight gain
  • rapid, shallow breathing
  • red or black, tarry stools
  • red or dark brown urine
  • severe headaches of sudden onset
  • slow or fast heartbeat
  • sore throat
  • sudden loss of coordination
  • sudden shortness of breath
  • sudden slurred speech
  • sudden vision changes
  • tingling of the hands or feet
  • ulcers, sores, or white spots in the mouth
  • unusual bleeding or bruising
  • unusual weight gain or loss
Less common
  • Anxiety
  • burning, numbness, tingling, or painful sensations
  • chest pain or discomfort
  • fast, pounding, or irregular heartbeat or pulse
  • pain, redness, or swelling in the arms or legs
  • sudden shortness of breath
  • troubled breathing
  • unsteadiness or awkwardness
  • weakness in the arms, hands, legs, or feet
Incidence not known
  • Abdominal or stomach cramps or tenderness
  • blue-green halos seen around objects
  • clay-colored stools
  • dark urine
  • decreased appetite
  • diarrhea
  • dry eyes
  • fever
  • headache
  • itching
  • loss of appetite
  • nausea and vomiting
  • sensitivity of eyes to light
  • severe vomiting, sometimes with blood
  • skin rash
  • swelling of feet or lower legs
  • unusual tiredness or weakness
  • yellow eyes or skin

Some of the side effects that can occur with ponatinib may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

More common
  • Back or bone pain
  • cracked lips
  • difficulty having a bowel movement (stool)
  • difficulty with moving
  • dry skin
  • itching, pain, redness, swelling, tenderness, or warmth on the skin
  • lack or loss of strength
  • muscle aches
  • muscle pain or stiffness
  • sore throat
  • stuffy or runny nose
  • trouble sleeping

For Healthcare Professionals

Applies to ponatinib: oral tablet

Cardiovascular

Very common (10% or more): Hypertension (up to 71%), arterial ischemia (up to 13%), cardiac failure (up to 15%)
Common (1% to 10%): Myocardial infarction or worsening coronary artery disease (5%), cardiac failure (4%), effusions (3%), atrial fibrillation (2%), stroke or TIA (2%), peripheral arterial disease (2%)[Ref]

Dermatologic

Very common (10% or more): Rash and related conditions (up to 54%), dry skin (up to 39%), cellulitis (up to 11%)[Ref]

Endocrine

Very common (10% or more): Lipase increased (41%)
Common (1% to 10%): Amylase increased (3%)[Ref]

Gastrointestinal

Very common (10% or more): Abdominal pain (up to 49%), constipation (up to 47%), nausea (up to 32%), diarrhea (up to 26%), vomiting (up to 24%), oral mucositis (up to 23%), GI hemorrhage (up to 11%)
Common (1% to 10%): Pancreatitis (5%), abdominal pain (4%)[Ref]

General

Very common (10% or more): Fatigue or asthenia (up to 39%), pyrexia (up to 32%), peripheral edema (up to 22%), sepsis (up to 22%), pain (up to 16%), chills (up to 13%)[Ref]

Genitourinary

Very common (10% or more): Urinary tract infection (up to 12%)[Ref]

Hematologic

Very common (10% or more): Neutropenia (up to 63%), leukopenia (up to 63%), thrombocytopenia (up to 57%), anemia (up to 55%), lymphopenia (up to 37%), febrile neutropenia (up to 25%)[Ref]

Hepatic

Very common (10% or more): ALT increased (53%), AST increased (41%), alkaline phosphatase increased (37%), albumin decreased (28%), bilirubin increased (19%)[Ref]

Metabolic

Very common (10% or more): Glucose increased (58%), phosphorous decreased (57%), calcium decreased (52%), decreased appetite (up to 31%), sodium decreased (29%), glucose decreased (24%), potassium decreased (16%), potassium increased (15%), weight decreased (up to 13%), sodium increased (10%)
Common (1% to 10%): Creatinine increased (7%), calcium increased (5%), triglycerides increased (3%)[Ref]

Musculoskeletal

Very common (10% or more): Arthralgia (up to 31%), myalgia (up to 22%), pain in extremity (up to 17%), back pain (up to 17%), back pain (up to 16%), muscle spasms (up to 12%), bone pain (up to 12%)[Ref]

Nervous system

Very common (10% or more): Headache (up to 39%), peripheral neuropathy (up to 13%), dizziness (up to 11%), CNS hemorrhage (up to 2%)[Ref]

Psychiatric

Very common (10% or more): Insomnia (up to 12%)[Ref]

Respiratory

Very common (10% or more): Dyspnea (up to 21%), cough (up to 18%), pneumonia (up to 13%), pleural effusion (up to 13%), nasopharyngitis (up to 12%), upper respiratory tract infection (up to 11%)[Ref]

References

1. "Product Information. Iclusig (ponatinib)." Ariad Pharmaceuticals Inc, Cambridge, MA.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

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