Side Effects of Iclusig: What You Need to Know

If you have certain kinds of leukemia, your doctor might suggest Iclusig (ponatinib) as a treatment option for you.

Iclusig treats some kinds of chronic myeloid leukemia and acute lymphoblastic leukemia in certain adults. It’s used after other treatments haven’t been effective.

Iclusig is a prescription brand-name drug. It comes as a tablet that you swallow.

This drug may be prescribed as a long-term cancer treatment. Your doctor will prescribe Iclusig for the amount of time that’s best for your specific condition.

For more information about Iclusig, including details about its uses, see this in-depth article on the drug. Keep reading to find out more about possible mild and serious Iclusig side effects.

Some people may experience mild or serious side effects during Iclusig treatment. These side effects may be different in each person taking the drug.

Examples of Iclusig’s commonly reported side effects include:

• edema (fluid buildup) that leads to swelling in the arms, legs, hands, or feet
• pain in the legs, arms, muscles, or belly
• skin rash
• weight loss
• infection
• abnormal liver function test results*
• abnormal levels of pancreas enzymes (a kind of protein)
• blood disorders (low levels of certain kinds of blood cells)

* For more information about this, see “Liver damage and liver failure” in the “Side effects explained” section below.

Iclusig may cause mild side effects in some people who take the drug. The side effects you experience will vary.

Examples of mild side effects that have been reported with Iclusig include:

• dry skin
• pain in the legs, arms, muscles, or belly
• headache
• constipation
• fatigue (low energy)

In most cases, these side effects should be temporary. And some may be easily managed, too. But if you have any symptoms that are ongoing or that bother you, talk with your doctor or pharmacist. And don’t stop taking Iclusig unless your doctor recommends it.

Iclusig may cause mild side effects other than the ones listed above. See the Iclusig prescribing information for details.

Note: After the Food and Drug Administration (FDA) approves a drug, it tracks side effects of the medication. If you’d like to notify the FDA about a side effect you’ve had with Iclusig, visit MedWatch.

Iclusig can cause serious side effects. Most of these side effects are rare. Contact your doctor or another healthcare professional if you experience any of these side effects.

Some of these serious side effects are medical emergencies. If you have a side effect that may be life threatening or a medical emergency, call 911 or your local emergency number right away.

Serious side effects that have been reported with Iclusig include:

• slowed wound healing
• pneumonia (a serious lung infection)
• perforations (holes) in the stomach or intestines
• sepsis (a serious blood infection)
• urinary tract infection (UTI)
• fluid buildup in your chest
• abnormal heart rate
• tumor lysis syndrome (a condition in which the breakdown of cancer cells releases harmful chemicals into your blood)
• reversible posterior leukoencephalopathy syndrome (abnormal pressure in the brain)
• blood disorders (low levels of certain kinds of blood cells)
• edema (fluid buildup) that leads to swelling in the arms, legs, hands, or feet
• reduced fertility (decreased ability to conceive a child safely)
• severe bleeding
• peripheral neuropathy (pain or numbness in the legs or arms)
• high blood pressure
• pancreatitis (inflammation of the pancreas)
• liver damage and liver failure*
• heart failure*
• venous thromboembolism*
• blockage in arteries*
• ocular (eye-related) problems†
• allergic reaction†‡

If you develop serious side effects while taking Iclusig, call your doctor right away. If the side effects seem life threatening or if you think you’re having a medical emergency, immediately call 911 or your local emergency number.

* Iclusig has a boxed warning for this side effect. This is the most serious warning from the Food and Drug Administration (FDA). To learn more, see the “Side effects explained” section below.
† To learn more about this side effect, see the “Side effects explained” section below.
‡ An allergic reaction is possible after taking Iclusig. But it’s not clear whether this side effect occurred in studies.

Learn more about some of the side effects Iclusig may cause.

Ocular (eye-related) side effects

Eye problems rarely occurred in studies of Iclusig. In some cases, these eye problems led to blindness.

Below are some eye problems you might notice when you take Iclusig:

• dry eyes
• blurred vision
• sensitivity to light
• watery or itchy eyes
• eye pain or bleeding
• seeing light flashes or floating lights

What might help

Your doctor will monitor your eye function while you’re taking Iclusig. Be sure to talk with them right away if you notice any changes in your vision or pain in your eyes. It’s important to tell your doctor so that any eye problems can be treated before they lead to serious damage.

Depending on how serious your eye symptoms are, your doctor might suggest certain kinds of eye drops. Or they may have you switch to a medication other than Iclusig.

Liver damage and liver failure

Iclusig has a boxed warning for the risk of liver damage and liver failure. A boxed warning is the most serious warning from the Food and Drug Administration (FDA). It alerts doctors and patients about drug effects that may be dangerous.

Liver damage was a common side effect in some studies of Iclusig. Serious liver damage may lead to liver failure, which was less common. In rare cases, liver failure led to death.

Symptoms of liver damage or liver failure may include:

• bruising
• bleeding
• decreased appetite or loss of appetite
• fatigue (low energy)
• tea-colored urine
• yellowing of the white of your eyes
• changes in your skin color
• abnormal liver function test results

What might help

Your doctor will monitor your liver function while you take Iclusig. Be sure to tell your doctor right away if you notice any symptoms of liver problems.

Your doctor may pause your Iclusig treatment or have you switch to a different drug if Iclusig causes damage to your liver.

Blockages in arteries

Iclusig has a boxed warning for the risk of blockages in arteries. Arteries are blood vessels that carry blood away from your heart.

People who take Iclusig can have dangerous blockages that prevent blood from flowing correctly in their arteries. This can lead to life threatening conditions such as heart attack or stroke. Artery blockages were rare in studies of Iclusig.

Some symptoms of an artery blockage include:

• chest pain
• trouble breathing
• weakness on one side of your body
• trouble speaking

Artery blockage is a medical emergency. This condition must be treated at a hospital right away.

What might help

If you notice any symptoms of an artery blockage, contact your doctor or another healthcare professional right away. If your symptoms feel life threatening, go to your nearest emergency room or call 911 (or your local emergency number).

Venous thromboembolism

Iclusig has a boxed warning for venous thromboembolism (VTE). VTE is a dangerous blood clot that starts in your leg and moves through your veins.

VTE was rare in studies of Iclusig. This kind of blood clot can be life threatening in some cases. It is a medical emergency.

Symptoms of VTE may include:

• chest pain
• trouble breathing
• weakness on one side of your body
• leg pain
• swelling in your leg
• trouble speaking

What might help

If you notice any symptoms of a blood clot, contact your doctor right away or call 911. You could also go to your nearest emergency room.

There are a few ways to help prevent VTE. These include exercising regularly, avoiding sitting for long periods at a time, and wearing compression stockings.

In some cases, your doctor may also reduce your Iclusig dose. Or they may prescribe a lower starting dose for you than usual. This can help make VTE less likely.

Heart failure

Iclusig has a boxed warning for heart failure. Heart failure means that the heart can’t pump enough blood to the body.

Heart failure is a serious condition that many people can live with if they take medication. But in some cases, it can be fatal.

Symptoms of heart failure may include:

• trouble breathing
• chest pain
• fainting
• heart palpitations (a feeling of skipped or extra heartbeats)
• dizziness

What might help

New symptoms of heart failure may be a medical emergency. Be sure to contact your doctor right away if you notice any new symptoms. Call 911 or go to your nearest emergency room if your symptoms feel life threatening.

If you develop heart failure with Iclusig, your doctor will prescribe medications to treat it. They may also lower your Iclusig dose or switch you to a different medication.

Be sure to talk with your doctor right away if you notice any symptoms of new or worsening heart failure.

Allergic reaction

Like most drugs, Iclusig can cause an allergic reaction in some people. But it’s not clear whether this side effect occurred in studies.

Symptoms can be mild or serious and can include:

• skin rash
• itchiness
• flushing (temporary warmth, redness, or deepening of skin color)
• swelling under your skin, typically in your eyelids, lips, hands, or feet
• swelling of your mouth, tongue, or throat, which can make it hard to breathe

What might help

If you have mild symptoms of an allergic reaction, such as a mild rash, call your doctor right away. They may suggest an over-the-counter antihistamine that you take by mouth, such as Benadryl (diphenhydramine), or a topical product you apply to your skin, such as hydrocortisone cream, to manage your symptoms.

If your doctor confirms you had a mild allergic reaction to Iclusig, they’ll decide if you should continue taking it.

If you have symptoms of a severe allergic reaction, such as swelling or trouble breathing, call 911 or your local emergency number right away. These symptoms could be life threatening and require immediate medical care.

If your doctor confirms you had a serious allergic reaction to Iclusig, they may have you switch to a different treatment.

Keeping track of side effects

During Iclusig treatment, consider keeping notes on any side effects you’re having. Then, you can share this information with your doctor. This is especially helpful to do when you first start taking new drugs or using a combination of treatments.

Your side effect notes can include things such as:

• what dose you were taking when you had the side effect
• how soon after starting that dose you had the side effect
• what your symptoms were from the side effect
• how it affected your daily activities
• what other medications you were also taking
• any other information you feel is important

Keeping notes and sharing them with your doctor will help your doctor learn more about how Iclusig affects you. And your doctor can use this information to adjust your treatment plan if needed.

Below are answers to some frequently asked questions about Iclusig’s side effects.

Will I lose my hair while I take Iclusig?

It’s possible that you may lose some of your hair during Iclusig treatment. Hair loss was reported in a small number of people in studies of Iclusig.

Talk with your doctor about hair loss. There may be ways to decrease this side effect during Iclusig treatment.

Will I get a rash while taking Iclusig?

You might get a skin rash while you take Iclusig. Mild and serious skin rashes were reported in studies of Iclusig.

Talk with your doctor about treatments for a rash. They may prescribe you medication to help make the rash easier to manage. Or, if the rash is more serious, they may adjust your Iclusig dose.

Can I keep taking Iclusig if my heart failure gets worse during treatment?

Iclusig has a boxed warning for new or worsening heart failure (inability of the heart to pump enough blood to the body).*

If you already have heart failure and it gets worse while you take Iclusig, your doctor may stop your Iclusig treatment. It’s important not to stop taking Iclusig unless your doctor recommends this, though.

* A boxed warning is the most serious warning from the Food and Drug Administration (FDA). See “Side effects explained” above for details.

Can Iclusig cause high blood pressure?

Yes, you may get high blood pressure while you take Iclusig. High blood pressure has been reported in studies of Iclusig.

Your doctor will test your blood pressure during your treatment with Iclusig. If needed, you and your doctor may discuss medications that can lower your blood pressure while you’re taking Iclusig.

You can also help prevent high blood pressure in other ways. For example, a low salt diet and regular exercise may help lower blood pressure.

Iclusig may not be right for you if you have certain conditions. Before starting Iclusig, talk with your doctor about your other medical conditions and past surgeries.

Boxed warnings

Iclusig has four boxed warnings. Boxed warnings are the most serious warnings from the Food and Drug Administration (FDA).

• Liver damage and liver failure. Iclusig can cause liver damage or liver failure.
• Heart failure. It’s possible to have new or worsening heart failure with Iclusig.
• Venous thromboembolism (VTE). Some people who take Iclusig develop VTE (a serious blood clot in a vein).
• Blockage in arteries. Artery blockage is a possible side effect of Iclusig. This means a blood vessel that carries blood away from your heart is blocked from transporting blood.

The above conditions can be life threatening. To learn more, see the “Side effects explained” section above.

Other warnings

Iclusig may not be right for you if you have certain medical conditions or other factors that affect your health. Talk with your doctor about your health history before you take Iclusig. The list below includes a few of the factors to consider.

History of blood clots. Iclusig has a boxed warning for serious blood clots that can lead to death. If you have a medical condition that causes you to develop too many blood clots, talk with your doctor before taking Iclusig.

Bleeding conditions. Iclusig may lead to episodes of uncontrolled bleeding. These are sometimes very serious and can be fatal. If you have any problems with bleeding or clotting, talk with your doctor about this before starting Iclusig.

Diabetes. Iclusig can rarely cause serious blood clots. These clots happen more often in people who already have risk factors that make blood clots more likely, such as diabetes. Talk with your doctor about how to monitor your diabetes and help prevent blood clots while you take Iclusig.

Heart conditions. Iclusig can cause heart problems. If you have a medical condition that involves your heart, such as heart failure, the condition might get worse while you are taking Iclusig. Talk with your doctor about any heart problems in your medical history before starting Iclusig.

Liver problems. Iclusig can sometimes cause increased liver enzymes, which can be a sign of liver damage. Your doctor will do blood tests during your Iclusig treatment to monitor for this. Iclusig can also rarely cause serious liver damage. So if you already have any liver problems, talk with your doctor about them before starting Iclusig.

History of pancreatitis (inflammation of your pancreas). Iclusig has a rare side effect of pancreatitis. If you’ve had pancreatitis in the past, Iclusig may not be the right drug for you. Be sure to tell your doctor about your full medical history before taking Iclusig.

High blood pressure. Since Iclusig can make high blood pressure worse, talk with your doctor about any blood pressure conditions you have or have had in the past. Your doctor may monitor your blood pressure more often than usual. They may also show you how to check your blood pressure during Iclusig treatment. Or they may prescribe a different drug for you.

Lactose intolerance. Iclusig is made with lactose (a byproduct of milk). If you’re lactose intolerant, talk with your doctor before taking Iclusig. They may recommend a medication to decrease symptoms of lactose intolerance while taking Iclusig.

Surgery. Iclusig may slow your body’s wound healing. If you have surgery, your doctor may have you stop taking Iclusig for a certain amount of time before your procedure. You’ll also need to wait a certain amount of time after surgery before restarting Iclusig. This will help your body heal after the surgery. Be sure to follow your doctor’s instructions.

Allergic reaction. If you’ve had an allergic reaction to Iclusig or any of its ingredients, your doctor will likely not prescribe Iclusig. Ask your doctor what other medications are better options for you.

Alcohol and Iclusig

It should be safe to drink alcohol during Iclusig treatment. But Iclusig and alcohol can both cause damage to your liver or pancreas.

If you drink alcohol, talk with your doctor about how much alcohol, if any, is safe for you to have while taking Iclusig.

Pregnancy and breastfeeding while taking Iclusig

Iclusig is not recommended for use during pregnancy or while breastfeeding. If you’re pregnant or breastfeeding, talk with your doctor before starting Iclusig.

Also, talk with your doctor if you’re planning to become pregnant or to breastfeed. Your doctor may advise you to wait a certain amount of time after Iclusig treatment.

Iclusig is a medication prescribed to treat certain kinds of leukemia in adults. People who take Iclusig may experience mild side effects. Rarely, Iclusig can also cause serious side effects such as damage to the liver or heart.

If you have questions about this drug’s side effects, talk with your doctor or pharmacist. Below are examples of a few questions you might want to ask:

• How can I treat any mild side effects I have?
• When is a side effect serious enough for me to call my doctor?
• How can I tell if I am having a side effect or a symptom of leukemia?
• Will my side effects get less severe after I have taken Iclusig for a while?
• Will you prescribe drugs to help make Iclusig’s side effects easier to manage?
• What’s the difference between hives and a skin rash caused by Iclusig?

Disclaimer: Healthline has made every effort to make certain that all information is factually correct, comprehensive, and up to date. However, this article should not be used as a substitute for the knowledge and expertise of a licensed healthcare professional. You should always consult your doctor or another healthcare professional before taking any medication. The drug information contained herein is subject to change and is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. The absence of warnings or other information for a given drug does not indicate that the drug or drug combination is safe, effective, or appropriate for all patients or all specific uses.