Azacitidine Side Effects
Medically reviewed by Drugs.com. Last updated on Apr 30, 2023.
Commonly reported side effects of azacitidine include: febrile neutropenia, pneumonia, upper respiratory tract infection, abdominal pain, abdominal tenderness, anemia, anxiety, arthralgia, asthenia, back pain, chest pain, constipation, cough, depression, diarrhea, dizziness, dyspnea, dyspnea on exertion, epistaxis, fatigue, fever, headache, heart murmur, hypokalemia, injection site reaction, insomnia, leukopenia, limb pain, myalgia, nasopharyngitis, nausea, neutropenia, pain, peripheral edema, petechia, pharyngitis, productive cough, pruritus, rhinorrhea, rigors, skin lesion, skin rash, thrombocytopenia, upper abdominal pain, vomiting, weight loss, anorexia, bruise, bruising at injection site, decreased appetite, diaphoresis, ecchymoses, erythema at injection site, erythema of skin, malaise, pain at injection site, and pallor. Other side effects include: atelectasis, herpes simplex infection, pleural effusion, syncope, urinary tract infection, abdominal distention, abnormal breath sounds, chest wall pain, dyspepsia, dysphagia, dysuria, exacerbation of anemia, exacerbation of dyspnea, gingival hemorrhage, hemorrhage, hemorrhoids, hypoesthesia, hypotension, injection site granuloma, lethargy, loose stools, lymphadenopathy, muscle cramps, nasal congestion, night sweats, oral hemorrhage, oral mucosal petechiae, rales, rhonchi, sinusitis, stomatitis, swelling of extremities, tachycardia, tongue ulcer, transfusion reaction, urticaria, wheezing, cutaneous nodule, hematoma, injection-site pigmentation changes, itching at injection site, post nasal drip, postoperative pain, swelling at injection site, and xeroderma. Continue reading for a comprehensive list of adverse effects.
Applies to azacitidine: oral tablet. Other dosage forms:
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:
- Black, tarry stools
- bleeding gums
- blood in urine or stools
- chest pain or tightness
- decreased appetite
- difficulty in moving
- lack or loss of strength
- lower back or side pain
- muscle pain or stiffness
- pain in the arms or legs
- pain in joints
- painful or difficult urination
- pale skin
- pinpoint red spots on skin
- sore throat
- stomach pain
- trouble breathing
- ulcers, sores, or white spots in the mouth
- unusual bleeding or bruising
- unusual tiredness or weakness
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:
- decreased appetite
For Healthcare Professionals
Applies to azacitidine: injectable powder for injection, oral tablet, subcutaneous powder for injection.
Very common (10% or more): Nausea (71%), vomiting (54%), constipation (50%), diarrhea (36%), abdominal pain (13%), abdominal tenderness (12%)
Frequency not reported: Melena, perirectal abscess[Ref]
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[Ref]
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: Injection site necrosis, catheter site hemorrhage[Ref]
Very common (10% or more): Ecchymosis (31%), petechiae (24%), erythema (17%), rash (14%), pruritus (12%)
Uncommon (0.1% to 1%): Sweet's syndrome, pyoderma gangrenosum
Frequency not reported: Pruritic rash, skin induration[Ref]
Rare (less than 0.1%): Interstitial lung disease
Frequency not reported: Hemoptysis, lung infiltration, pneumonitis, respiratory distress, Streptococcal pharyngitis, Klebsiella pneumonia[Ref]
Very common (10% or more): Arthralgia (22%), myalgia (16%)
Common (1% to 10%): Musculoskeletal pain, muscle spasms
Frequency not reported: Aggravated bone pain, muscle weakness, neck pain, loin pain, abscess limb
Postmarketing reports: Necrotizing fasciitis[Ref]
Very common (10% or more): Headache (22%), dizziness (19%)
Very common (10% or more): Anorexia (21%)
Very common (10% or more): Acute myeloid leukemia (14.3%)
Common (1% to 10%): Eye hemorrhage, conjunctival hemorrhage[Ref]
Uncommon (0.1% to 1%): Renal tubular acidosis[Ref]
Uncommon (0.1% to 1%): Hepatic failure, hepatic coma
Uncommon (0.1% to 1%): Hypersensitivity reactions[Ref]
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.[Ref]
More about azacitidine
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Related treatment guides
1. Product Information. Vidaza (azacitidine). Celgene Corporation. 2004.
2. Cerner Multum, Inc. UK Summary of Product Characteristics.
3. Cerner Multum, Inc. Australian Product Information.
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Some side effects may not be reported. You may report them to the FDA.