Drug Information



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Brand Name
Onureg
Common Name
azacitidine oral
How does this medication work? What will it do for me?

Azacitidine oral belongs to the class of medications called antineoplastics. It is used to prevent the return of acute myeloid leukemia (AML), a type of blood cancer, for adults who have been successfully treated for this disease. It is used when bone marrow transplant is not an option.

For people with leukemia, it works by preventing the growth of cancer cells, thereby killing the cells.

This medication may be available under multiple brand names and/or in several different forms. Any specific brand name of this medication may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of this medication may not be used for all of the conditions discussed here.

Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.

Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor has not prescribed it.

How should I use this medication?

The recommended dose of azacitidine oral tablets is 300 mg taken by mouth once daily for the first 14 days of every 28 day cycle.

This medication may be taken with food or on an empty stomach. Swallow the tablets whole with some water. Do not chew or crush the tablets. Try to take this medication at approximately the same time every day. Your doctor may recommend that you take a medication to prevent nausea before your dose of azacitidine.

If a tablet is broken and the powder comes into contact with skin, thoroughly wash the area with soap and water. If the powder comes into contact with the inside of your mouth, rinse it away with plenty of water.

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

It is important to take this medication exactly as prescribed by your doctor. If you vomit after taking a dose, do not take another dose. Continue with the next dose at your regular time. If you miss a dose, take it as soon as possible and continue with your regular schedule. If it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Store this medication at room temperature, protect it from light and moisture, and keep it out of the reach of children.

What form(s) does this medication come in?

Azacitidine oral belongs to the class of medications called antineoplastics. It is used to prevent the return of acute myeloid leukemia (AML), a type of blood cancer, for adults who have been successfully treated for this disease. It is used when bone marrow transplant is not an option.

For people with leukemia, it works by preventing the growth of cancer cells, thereby killing the cells.

This medication may be available under multiple brand names and/or in several different forms. Any specific brand name of this medication may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of this medication may not be used for all of the conditions discussed here.

Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.

Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor has not prescribed it.

Who should NOT take this medication?

Do not take this medication if you:

  • are allergic to azacitidine or any ingredients of the medication
  • have advanced liver cancer
  • have a blood cancer called myelodysplastic syndrome
What side effects are possible with this medication?

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

  • constipation
  • decreased appetite
  • diarrhea
  • dizziness
  • gas
  • joint, back, arm, or leg pain
  • nausea
  • stomach pain
  • tiredness
  • vomiting
  • weakness

Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

  • anxiety
  • fainting
  • increased frequency of infection symptoms (symptoms may include fever or chills, severe diarrhea, shortness of breath, prolonged dizziness, headache, stiff neck, weight loss, or listlessness)
  • signs of anemia (low red blood cells; e.g., dizziness, pale skin, unusual tiredness or weakness, shortness of breath)
  • signs of clotting problems (e.g., unusual nosebleeds, bruising, blood in urine, coughing blood, bleeding gums, cuts that don't stop bleeding)
  • symptoms of an upper respiratory tract infection (colds or flus; runny or stuffy nose, sore throat, cough, nasal congestion, body aches, headache, sneezing, fever, general feeling of being unwell)
  • symptoms of a urinary tract infection (e.g. pain when urinating, urinating more often than usual, low back or flank pain)

Stop taking the medication and seek immediate medical attention if any of the following occur:

  • symptoms of a lung infection (e.g., chest pain when you breathe or cough, confusion, cough producing phlegm, nausea, shortness of breath)

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.

Are there any other precautions or warnings for this medication?

Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.

Bleeding: Azacitidine may cause a reduced number of platelets in the blood, which can make it difficult to stop cuts from bleeding. If you notice any signs of bleeding, such as frequent nosebleeds, unexplained bruising, or black and tarry stools, notify your doctor as soon as possible. Your doctor will order routine blood tests to make sure potential problems are caught early.

Drowsiness/reduced alertness: Azacitidine may affect the mental or physical abilities needed to drive or operate machinery. Avoid driving, operating machinery, or performing other potentially hazardous tasks until you have determined how this medication affects you.

Infection: As well as killing cancer cells, azacitidine can reduce the number of cells that fight infection in the body (white blood cells). If possible, avoid contact with people with contagious infections. Tell your doctor immediately if you notice signs of an infection, such as fever or chills, severe diarrhea, shortness of breath, prolonged dizziness, headache, stiff neck, weight loss, or listlessness. Your doctor will do blood tests regularly to monitor the number of specific types of blood cells in your blood.

Kidney function: If you have kidney problems, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Pregnancy: Azacitidine may cause harm to the developing baby if it is taken by the mother during pregnancy or it is being taken by either the man or the woman at the time of conception.

If you or your partner become pregnant while taking this medication, contact your doctor immediately. Effective birth control should be practiced by both men and women while using this medication and for at least 6 months after taking the last dose.

Breast-feeding: It is not known if azacitidine passes into breast milk. Avoid breast feeding while taking azacitidine and for at least 1 week after taking your last dose of azacitidine.

Children: The safety and effectiveness of using this medication have not been established for children.

What other drugs could interact with this medication?

There may be an interaction between azacitidine and any of the following:

  • baricitinib
  • BCG
  • cladribine
  • clozapine
  • deferiprone
  • denosumab
  • echinacea
  • fingolimod
  • leflunomide
  • mesalamine
  • natalizumab
  • ocrelizumab
  • olsalazine
  • ozanimod
  • pimecrolimus
  • roflumilast
  • sulfasalazine
  • tacrolimus
  • tofacitinib
  • upadacitinib
  • vaccines

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

  • stop taking one of the medications,
  • change one of the medications to another,
  • change how you are taking one or both of the medications, or
  • leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

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