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Vidaza Side Effects

Generic name: azacitidine

Medically reviewed by Last updated on Oct 12, 2022.

Note: This document contains side effect information about azacitidine. Some dosage forms listed on this page may not apply to the brand name Vidaza.


Common side effects of Vidaza 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: injection powder for suspension.

Serious side effects of Vidaza

Along with its needed effects, azacitidine (the active ingredient contained in Vidaza) 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 or nurse immediately if any of the following side effects occur while taking azacitidine:

More common

  • Black, tarry stools
  • bladder pain
  • bleeding gums
  • bloating or swelling of the face, arms, hands, lower legs, or feet
  • blood in the urine or stools
  • cloudy urine
  • body aches or pain
  • burning or stinging of the skin
  • chest pain or tightness
  • chills
  • congestion
  • cough
  • difficult breathing
  • difficulty swallowing
  • dizziness
  • ear congestion
  • fast heartbeat
  • fever
  • frequent urge to urinate
  • headache
  • hives, itching, or skin rash
  • hoarseness
  • increased menstrual flow or vaginal bleeding
  • loss of voice
  • lower back or side pain
  • muscle aches
  • nausea
  • nosebleeds
  • pain or tenderness around the eyes and cheekbones
  • painful cold sores or blisters on the lips, nose, eyes, or genitals
  • painful or difficult urination
  • pain, redness, swelling, tenderness, warmth on the skin
  • pale skin
  • paralysis
  • pinpoint red spots on the skin
  • prolonged bleeding from cuts
  • puffiness or swelling of the eyelids or around the eyes, face, lips or tongue
  • rapid heartbeat
  • runny or stuffy nose
  • sneezing
  • sore throat
  • sores, ulcers, or white spots on lips or in mouth
  • swollen glands
  • tender, swollen glands in the neck
  • trouble breathing
  • unusual bleeding or bruising
  • unusual tiredness or weakness
  • voice changes
  • vomiting

Less common

  • Change in consciousness
  • decreased urine
  • drowsiness
  • dry mouth
  • increased thirst
  • irregular heartbeat
  • loss of appetite
  • mood changes
  • muscle pain or cramps
  • numbness or tingling in the hands, feet, or lips
  • loss of consciousness
  • seizures

Incidence not known

  • Chest discomfort
  • coughing or spitting up blood
  • dilated neck veins
  • dizziness, faintness, or lightheadedness when getting up from lying or sitting position
  • red or bloodshot eye
  • seeing gloating spots before the eyes
  • stroke
  • swelling of the face, fingers, feet, or lower legs
  • thickened bronchial secretions
  • vomiting of blood or material that looks like coffee grounds
  • weight gain

Get emergency help immediately if any of the following symptoms of overdose occur while taking azacitidine:

Symptoms of overdose

Other side effects of Vidaza

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

  • Acid or sour stomach
  • appetite decreased
  • belching
  • bleeding after defecation
  • bloody nose
  • blurred vision
  • bone pain
  • bruise
  • bumps on the skin
  • burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
  • burning while urinating
  • diarrhea
  • difficulty having a bowel movement (stool)
  • difficulty with moving
  • discouragement
  • dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  • dry skin
  • fainting
  • fear
  • feeling of discomfort or illness
  • feeling of sluggishness
  • feeling sad or empty
  • feeling unusually cold
  • flushing
  • full or bloated feeling or pressure in the stomach
  • heartburn
  • heart murmur
  • indigestion
  • inflamed tissue from infection at the injection site
  • injection site bruising
  • irritability
  • itching at injection site
  • joint pain
  • lack of appetite
  • large, flat, blue or purplish patches in the skin
  • loss of interest or pleasure
  • mouth hemorrhage
  • muscle stiffness
  • nervousness
  • night sweats
  • pain in the joints
  • postnasal drip
  • post procedural hemorrhage
  • redness of the skin
  • shivering
  • small clicking, bubbling, or rattling sounds in the lung when listening with a stethoscope
  • small lumps under the skin
  • small red or purple spots in the mouth or on the skin
  • soreness or discomfort to touch or pressure on the stomach
  • stomach discomfort upset or pain
  • sweating
  • swelling of abdominal or stomach area
  • swelling of the hands, ankles, feet, or lower legs
  • swelling or inflammation of the mouth
  • swelling with pits or depressions visible on the skin
  • swollen joints
  • tongue ulceration
  • trouble concentrating
  • trouble sleeping
  • uncomfortable swelling around the anus
  • unusual drowsiness
  • unusually warm skin
  • upper abdominal or stomach pain
  • weight loss

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%)

Common (1% to 10%): Gingival bleeding, loose stools, mouth hemorrhage, stomatitis, dyspepsia, diverticulitis, oral fungal infection, GI hemorrhage, hemorrhoidal hemorrhage

Frequency not reported: Melena, perirectal abscess[Ref]


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, bone marrow failure[Ref]


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[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%)

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]


Very common (10% or more): Dyspnea (29%), cough (19%), nasopharyngitis (19%), epistaxis (17%), upper respiratory tract infection (13%), pneumonia (13%)

Common (1% to 10%): Rhinitis, bronchitis, 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]


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]

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]


Very common (10% or more): Anorexia (21%)

Common (1% to 10%): Decreased weight, decreased appetite, hypokalemia, dehydration

Rare (less than 0.1%): Tumor lysis syndrome[Ref]


Very common (10% or more): Acute myeloid leukemia (14.3%)

Frequency not reported: Leukemia cutis[Ref]


Common (1% to 10%): Hypotension, hypertension, orthostatic hypotension

Frequency not reported: Atrial fibrillation, cardiac failure, congestive cardiac failure, cardio-respiratory arrest, congestive cardiomyopathy[Ref]


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


Common (1% to 10%): Anxiety, insomnia, confusional state[Ref]


Common (1% to 10%): Renal failure, elevated serum creatinine, hematuria, urinary tract infection

Uncommon (0.1% to 1%): Renal tubular acidosis[Ref]


Uncommon (0.1% to 1%): Hepatic failure, hepatic coma

Frequency not reported: Cholecystitis, cholecystectomy[Ref]


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


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


1. "Product Information. Vidaza (azacitidine)." Celgene Corporation (2004):

2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

3. Cerner Multum, Inc. "Australian Product Information." O 0

Further 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.