Azacitidine Side Effects

Medically reviewed by Drugs.com. Last updated on Dec 3, 2024.

Applies to azacitidine: oral tablet.

Other dosage forms:

• injection powder for suspension

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:

More common side effects

• black, tarry stools
• bleeding gums
• blood in urine or stools
• chest pain or tightness
• chills
• cough
• decreased appetite
• diarrhea
• difficulty in moving
• dizziness
• fever
• lack or loss of strength
• lower back or side pain
• muscle pain or stiffness
• nausea
• pain in the arms or legs
• pain in joints
• painful or difficult urination
• pale skin
• pinpoint red spots on skin
• sneezing
• sore throat
• stomach pain
• trouble breathing
• ulcers, sores, or white spots in the mouth
• unusual bleeding or bruising
• unusual tiredness or weakness
• vomiting

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:

More common side effects

• constipation
• decreased appetite

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]

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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