Rydapt (midostaurin) is a prescription drug used to treat certain leukemias and blood cell disorders. Rydapt can cause side effects that range from mild to serious. Examples include nausea, vomiting, and headache.

Specifically, Rydapt is used to treat the following conditions in adults:

The active ingredient in Rydapt is midostaurin. The drug comes as an oral capsule.

Keep reading to learn about the common, mild, and serious side effects Rydapt can cause. For a general overview of the drug, including details about its uses, see this article.

* For this condition, Rydapt must be combined with chemotherapy drugs such as cytarabine and daunorubicin.

Some people may experience mild to serious side effects during Rydapt treatment. Below are just a few of the more common side effects reported by people taking Rydapt in studies. Side effects can vary depending on the condition the drug is being used to treat.

More common side effects in people taking Rydapt for AML include:

More common side effects in people taking Rydapt for mastocytosis include:

Mild side effects have been reported with Rydapt. These include:

  • muscle and bone pain
  • swelling of the arms, hands, legs, or feet from fluid buildup
  • diarrhea
  • constipation
  • abdominal pain
  • headache
  • nausea and vomiting
  • fever
  • fatigue
  • painful sores in the mouth or throat
  • bruises or tiny red spots on the skin
  • nosebleeds

In most cases, these side effects should be temporary. And some may be easily managed. But if you have symptoms that are ongoing or bothersome, talk with your doctor or pharmacist. And do not stop taking Rydapt unless your doctor recommends it.

Rydapt may cause mild side effects other than those listed above. See the drug’s prescribing information for details.

Serious side effects have been reported with Rydapt. These include:

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

* To learn more about this side effect, see the “Side effects explained” section below.

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

Allergic reaction

For some people, Rydapt can cause an allergic reaction. In studies, some people had reactions such as:

  • shortness of breath
  • flushing (temporary warmth, redness, or deepening of skin color)
  • chest pain
  • swelling of the face, eyes, lips, tongue, or throat
  • shock (rare)

In general, symptoms of allergic reaction can be mild or serious. You can learn more about possible symptoms in this article.

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 a treatment to manage your symptoms and can determine whether you should keep taking Rydapt.

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’ve had a serious allergic reaction to Rydapt, they may have you switch to a different treatment.

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

Severe stomach and intestinal problems

Severe stomach and intestinal problems were uncommon side effects reported in studies of Rydapt. These side effects may cause symptoms such as:

Factors that can increase the risk of severe stomach and intestinal problems when taking this drug include:

  • consumption of raw, acidic, spicy, greasy, or contaminated food
  • a history of immune system problems
  • age of 65 years or older
  • group living conditions (such as in a hospital or nursing center)
  • excessive alcohol consumption
  • use of other medications that may cause stomach problems, including nonsteroidal anti-inflammatory drugs (NSAIDs)

What might help

To help avoid stomach and intestinal problems during Rydapt treatment, consider the following tips:

  • Wash your hands and sanitize surfaces regularly.
  • Stay hydrated by drinking plenty of water and avoiding alcohol.
  • Avoid close contact with people who are ill.
  • Eat a balanced diet of fruits, vegetables, whole grains, and lean meats.
  • Clean vegetables and fruits well before eating them.
  • Cook food thoroughly (and avoid raw or undercooked foods).
  • If you have severe symptoms, eat bland foods that can be mashed with a fork.

If you have any of the following symptoms, contact your doctor right away or get an urgent medical evaluation:

  • fever
  • blood or mucus in your stool
  • an inability to keep fluids down

If left untreated, severe stomach and intestinal problems can lead to life threatening kidney problems, intestinal rupture, or sepsis (blood infection).

Inflammation of the lungs

Pneumonitis (inflammation of the lungs) was a rare side effect reported in studies of Rydapt. This condition may cause symptoms such as:

Factors that can increase the risk of pneumonitis when taking Rydapt include:

  • a history of lung disease or immune system disorders
  • use of other medications that may cause inflammation of the lungs (such as certain chemotherapy drugs or amiodarone)
  • previous radiation treatment to the lungs
  • exposure to reptile, bird, or cat feces
  • age of 65 years or older
  • a history of smoking or exposure to inhaled chemicals
  • exposure to environments with unsanitized humidifiers or air conditioning units

What might help

To avoid inflammation of the lungs during Rydapt treatment, consider the following tips:

  • Ask your pharmacist to review your current medications for pneumonitis-causing drugs.
  • Avoid cleaning cat boxes or bird or reptile cages.
  • Avoid smoking.
  • Have window-mounted air conditioning units and humidifiers serviced and cleaned regularly.

If you develop the above symptoms of lung inflammation, especially fever or chills, call your doctor right away or seek an urgent medical evaluation. Permanent lung damage or death can result from severe pneumonitis.

Serious infection

Serious infections were common side effects reported in studies of Rydapt. Common infections included:

Serious infections may cause symptoms such as:

Factors that can increase the risk of serious infection when taking Rydapt include:

  • low white blood cell counts
  • a history of immune system problems
  • a history of viral infections such as shingles or cold sores

What might help

Before starting Rydapt, tell your doctor if you have an active infection or have had one recently. To help avoid serious infection during Rydapt treatment, you can:

  • Wash your hands and sanitize surfaces regularly.
  • Avoid close contact with people who are ill.
  • Avoid razors, knives, and other sharp tools that can cause skin injuries.

If you develop symptoms of a serious infection, call your doctor right away or seek an urgent medical evaluation.

Keeping track of side effects

During your Rydapt treatment, consider taking notes on any side effects you’re having. You can then share this information with your doctor. This is especially helpful when you first start a new drug or combination of treatments.

Your side effect notes can include things such as:

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

Taking notes and sharing them with your doctor will help them learn more about how Rydapt affects you. They can then use this information to adjust your treatment plan if needed.

Below is important information you should consider before taking Rydapt.

Warnings

Rydapt can sometimes cause harmful effects in people with certain conditions. This is known as a drug-condition interaction. Other factors may also affect whether this drug is a good treatment option for you.

Talk with your doctor about your health history before starting Rydapt. Be sure to tell them if any of the following factors apply to you:

  • active or recent infection
  • lung problems
  • heart problems
  • diabetes
  • a history of smoking
  • previous allergic reaction to Rydapt
  • use of other prescription medications, over-the-counter drugs, herbs, nutritional supplements, or vitamins
  • pregnancy
  • breastfeeding

Alcohol and Rydapt

There are no known interactions between alcohol and Rydapt. But alcohol may make certain Rydapt side effects worse, such as:

  • nausea, vomiting, and diarrhea
  • inflammation or bleeding of the stomach or intestine
  • infection
  • high blood sugar

If you have questions about consuming alcohol during Rydapt treatment, talk with your doctor or pharmacist.

Pregnancy and breastfeeding with Rydapt

Before starting Rydapt treatment, it’s essential to talk with your doctor if you’re pregnant, breastfeeding, or planning for either.

Pregnancy

Rydapt is not safe to take during pregnancy because it can harm a fetus. Notify your doctor right away if you become pregnant or think you’re pregnant while taking Rydapt.

If you can get pregnant, your doctor may order a pregnancy test up to 7 days before you start Rydapt. During treatment, they’ll likely recommend frequent pregnancy tests. They’ll also recommend that you use a reliable form of birth control throughout treatment and for at least 4 months after your last Rydapt dose.

Also, males with female* partners who can get pregnant must use effective birth control during and for at least 4 months after Rydapt treatment.

If you take or are exposed to Rydapt during pregnancy (through a partner who is taking the drug), consider notifying the Novartis Pharmaceuticals Corporation. You can do this by visiting the website or calling 888-669-6682. A pregnancy registry collects information about the safety of certain drugs when taken during pregnancy.

* In this article, we use the terms “male” and “female” to refer to someone’s sex assigned at birth. For information about the difference between sex and gender, see this article

Breastfeeding

It’s not known whether Rydapt passes into breast milk. Breastfeeding is not recommended while taking Rydapt and for up to 4 months after your last dose. If you’re breastfeeding or planning to do so, talk with your doctor about your options.

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.