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Ponatinib Side Effects

In Summary

Commonly reported side effects of ponatinib include: arterial thrombosis, venous thrombosis, cardiac failure, congestive heart failure, pleural effusion, bone marrow depression, conjunctival irritation, dizziness, dyspnea, eye pain, fluid retention, gastrointestinal hemorrhage, headache, hyperesthesia, hypertension, increased serum alanine aminotransferase, increased serum aspartate aminotransferase, increased serum lipase, paresthesia, peripheral edema, peripheral neuropathy, and xerophthalmia. Other side effects include: myocardial infarction, pancreatitis, severe bone marrow depression, supraventricular tachycardia, blurred vision, coronary artery disease, hemorrhage, hyperuricemia, and tachyarrhythmia. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to ponatinib: oral tablet

As well as its needed effects, ponatinib may cause unwanted side effects that require medical attention.

Major Side Effects

If any of the following side effects occur while taking ponatinib, check with your doctor immediately:

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
  • 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 or skin rash
  • loss of appetite
  • nausea and vomiting
  • sensitivity of the eyes to light
  • severe vomiting, sometimes with blood
  • unusual tiredness or weakness
  • yellow eyes or skin

Minor Side Effects

Some ponatinib side effects may not need any medical attention. As your body gets used to the medicine these side effects may disappear. Your health care professional may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue, or if you are concerned about them:

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.

It is possible that some side effects of ponatinib may not have been reported. These can be reported to the FDA here. Always consult a healthcare professional for medical advice.

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