Azacitidine Side Effects

Medically reviewed by Drugs.com. Last updated on Feb 17, 2025.

Applies to azacitidine: oral tablet.

Other dosage forms:

• injection powder for suspension

Precautions

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood tests may be needed to check for unwanted effects.

Using this medicine while you are pregnant can harm your unborn baby. If you are a woman who can bear children, your doctor may give you a pregnancy test before you start using this medicine to make sure you are not pregnant. This medicine may also cause birth defects if the father is using it when his sexual partner becomes pregnant. Female patients should use an effective form of birth control during treatment with this medicine and for at least 6 months after the last dose. Male patients who have female partners should use effective birth control during treatment with this medicine and for at least 3 months after the last dose. If you think you have become pregnant or your partner has become pregnant while using this medicine, tell your doctor right away.

Cancer medicines can cause nausea or vomiting in most people, sometimes even after receiving medicines to prevent it. Ask your doctor or nurse about other ways to control these side effects.

This medicine can temporarily lower the number of white blood cells in your blood, increasing the chance of getting an infection. It can also lower the number of platelets, which are necessary for proper blood clotting. If this occurs, there are certain precautions you can take, especially when your blood count is low, to reduce the risk of infection or bleeding:

• If you can, avoid people with infections. Check with your doctor immediately if you think you are getting an infection or if you get a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.
• Check with your doctor immediately if you notice any unusual bleeding or bruising, black, tarry stools, blood in the urine or stools, or pinpoint red spots on your skin.
• Be careful when using a regular toothbrush, dental floss, or toothpick. Your medical doctor, dentist, or nurse may recommend other ways to clean your teeth and gums. Check with your medical doctor before having any dental work done.
• Do not touch your eyes or the inside of your nose unless you have just washed your hands and have not touched anything else in the meantime.
• Be careful not to cut yourself when you are using sharp objects such as a safety razor or fingernail or toenail cutters.
• Avoid contact sports or other situations where bruising or injury could occur.

If you plan to have children, talk with your doctor before using this medicine. Some men and women using this medicine have become infertile (unable to have children).

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or non-prescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Serious side effects of azacitidine

Along with its needed effects, azacitidine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking azacitidine:

Other side effects of azacitidine

Some side effects of azacitidine may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

For healthcare professionals

Applies to azacitidine: injectable powder for injection, oral tablet, subcutaneous powder for injection.

General adverse events

Most common adverse reactions (greater than 30%) by subcutaneous route are: nausea, anemia, thrombocytopenia, vomiting, pyrexia, leukopenia, diarrhea, injection site erythema, constipation, neutropenia, and ecchymosis. Most common adverse reactions by IV route also included petechiae, rigors, weakness, and hypokalemia.

Most common adverse reactions (greater than 10%) by oral route included nausea, vomiting, diarrhea, fatigue or asthenia, constipation, pneumonia, abdominal pain, arthralgia, decreased appetite, neutropenia, respiratory tract infection, thrombocytopenia, leucopenia, febrile neutropenia, dizziness, back pain and pain in extremity.^[Ref]

Hematologic

• Very common (10% or more): Thrombocytopenia (70%), anemia (70%), neutropenia (66%), leukopenia (48%), febrile neutropenia (16%)
• Common (1% to 10%): Aggravated anemia, hematoma, neutropenic sepsis, pancytopenia splenomegaly, bone marrow failure
• Frequency not reported: Agranulocytosis^[Ref]

Other

• Very common (10% or more): Pyrexia (52%), fatigue (24%), chest pain (16%), asthenia (16%), peripheral edema (13%), transfusion reaction (12%)
• Common (1% to 10%): Malaise, chills, post-procedural hemorrhage, sepsis, herpes simplex
• Frequency not reported: General physical health deterioration, bacterial infection, blastomycosis, Klebsiella sepsis, septic shock, Staphylococcal bacteremia, Staphylococcal infection, toxoplasmosis
• Postmarketing reports: Differentiation syndrome^[Ref]

Local

• Very common (10% or more): Injection site erythema (43%), injection site reaction (29%), injection site pain (23%), injection site bruising (14%)
• Common (1% to 10%): Injection site pruritus, injection site granuloma, injection site pigmentation changes, injection site swelling, injection site induration, injection site hematoma, injection site rash, injection site inflammation, injection site discoloration, injection site nodule, injection site hemorrhage, injection site malaise
• Frequency not reported: Catheter site hemorrhage
• Postmarketing reports: Injection site necrosis^[Ref]

Dermatologic

• Very common (10% or more): Ecchymosis (31%), petechiae (24%), erythema (17%), rash (14%), pruritus (12%)
• Common (1% to 10%): Dry skin, urticaria, skin nodule, cellulitis, skin infection, purpura, alopecia, erythema, macular rash
• Uncommon (0.1% to 1%): Sweet's syndrome, pyoderma gangrenosum
• Frequency not reported: Pruritic rash, skin induration^[Ref]

Respiratory

• Very common (10% or more): Dyspnea (29%), cough (19%), nasopharyngitis (15%), epistaxis (17%), upper respiratory tract infection (13%), pneumonia (11%)
• Common (1% to 10%): Rhinitis, bronchitis, influenza. pharyngolaryngeal pain, exertional dyspnea, sinusitis, pharyngitis, pleural effusion
• Rare (less than 0.1%): Interstitial lung disease
• Frequency not reported: Hemoptysis, lung infiltration, pneumonitis, respiratory distress, streptococcal pharyngitis, Klebsiella pneumonia^[Ref]

Pneumonia include pneumonia, bronchopulmonary aspergillosis, lung infection, Pneumocystis jirovecii pneumonia, atypical pneumonia, pneumonia bacterial, and pneumonia fungal.

Respiratory tract infection include upper respiratory tract infection, respiratory tract infection, and respiratory tract infection viral.^[Ref]

Musculoskeletal

• Very common (10% or more): Arthralgia (22%), myalgia (16%), musculoskeletal pain (11%), back pain (11.9%), pain in extremity (10.6%)
• Common (1% to 10%): Muscle spasms
• Frequency not reported: Aggravated bone pain, muscle weakness, neck pain, loin pain, abscess limb, chest wall pain
• Postmarketing reports: Necrotizing fasciitis^[Ref]

Nervous system

• Very common (10% or more): Headache (22%), dizziness (19%)
• Common (1% to 10%): Intracranial hemorrhage, syncope, somnolence, lethargy
• Frequency not reported: Cerebral hemorrhage, convulsions^[Ref]

Metabolic

• Very common (10% or more): Anorexia (21%), hyperuricemia (17%), decreased appetite (13%)
• Common (1% to 10%): Decreased weight, hypokalemia, dehydration, fluid retention
• Rare (less than 0.1%): Tumor lysis syndrome^[Ref]

Oncologic

• Very common (10% or more): Acute myeloid leukemia (14.3%)
• Frequency not reported: Leukemia cutis^[Ref]

Cardiovascular

• Common (1% to 10%): Hypotension, hypertension, orthostatic hypotension
• Frequency not reported: Atrial fibrillation, cardiac failure, congestive cardiac failure, cardio-respiratory arrest, congestive cardiomyopathy
• Postmarketing reports: Pericardial effusion, pericarditis^[Ref]

Ocular

• Common (1% to 10%): Eye hemorrhage, conjunctival hemorrhage^[Ref]

Psychiatric

• Very common (10% or more): Anxiety (13%), insomnia (11%)
• Common (1% to 10%): Confusional state^[Ref]

Renal

• Common (1% to 10%): Renal failure, elevated serum creatinine, hematuria, urinary tract infection
• Uncommon (0.1% to 1%): Renal tubular acidosis
• Frequency not reported: Renal toxicity^[Ref]

Urinary tract infection include urinary tract infection, urinary tract infection bacterial, Escherichia urinary tract infection, and cystitis.^[Ref]

Hepatic

• Uncommon (0.1% to 1%): Hepatic failure, hepatic coma
• Frequency not reported: Cholecystitis, cholecystectomy, hepatotoxicity^[Ref]

Hypersensitivity

• Uncommon (0.1% to 1%): Hypersensitivity reactions^[Ref]

Immunologic

• Frequency not reported: Anaphylactic shock, systemic inflammatory response syndrome^[Ref]

Gastrointestinal

• Very common (10% or more): Nausea (71%), vomiting (54%), constipation (50%), diarrhea (36%), abdominal pain (13%), abdominal tenderness (12%), ascites (11%), leucopenia (10.6%)
• Common (1% to 10%): Gingival bleeding, loose stools, mouth hemorrhage, stomatitis, dyspepsia, diverticulitis, oral fungal infection, gastrointestinal hemorrhage, hemorrhoidal hemorrhage
• Frequency not reported: Melena, perirectal abscess^[Ref]

Abdominal pain include abdominal pain, abdominal pain upper, abdominal discomfort, and gastrointestinal pain.^[Ref]

See also:

Further information

Azacitidine side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

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