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Vidaza Side Effects

Generic Name: azacitidine

Note: This page contains side effects data for the generic drug azacitidine. It is possible that some of the dosage forms included below may not apply to the brand name Vidaza.

In Summary

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, erythema at injection site, 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, itching at injection site, post nasal drip, postoperative pain, skin discoloration at a injection site, swelling at injection site, and xeroderma. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to azacitidine: injection powder for suspension

As well as its needed effects, azacitidine (the active ingredient contained in Vidaza) may cause unwanted side effects that require medical attention.

If any of the following side effects occur while taking azacitidine, check with your doctor or nurse immediately:

More common:
  • Black, tarry stools
  • bladder pain
  • bleeding gums
  • blood in the urine or stools
  • cloudy urine
  • body aches or pain
  • burning or stinging of the skin
  • chest pain
  • chills
  • congestion
  • cough
  • difficult breathing
  • difficulty swallowing
  • dizziness
  • ear congestion
  • fast heartbeat
  • fever
  • frequent urge to urinate
  • headache
  • hives, itching, or skin rash
  • hoarseness
  • loss of voice
  • lower back or side pain
  • muscle aches
  • nasal congestion
  • nausea
  • 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
  • pinpoint red spots on the skin
  • puffiness or swelling of the eyelids or around the eyes, face, lips or tongue
  • rapid heartbeat
  • runny nose
  • sneezing
  • sore throat
  • sores, ulcers, or white spots on lips or in mouth
  • stuffy nose
  • swollen glands
  • tender, swollen glands in the neck
  • tightness in the chest
  • troubled breathing with exertion
  • unusual bleeding or bruising
  • unusual tiredness or weakness
  • voice changes
  • vomiting
Less common:
  • Change in consciousness
  • convulsions
  • 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

If any of the following symptoms of overdose occur while taking azacitidine, get emergency help immediately:

Symptoms of overdose:
  • Diarrhea
  • nausea
  • vomiting

Minor Side Effects

Some azacitidine side effects may not need any medical attention. As your body gets used to the medicine these side effects may disappear. Your health care professional may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue, or if you are concerned about them:

More common:
  • Acid or sour stomach
  • appetite decreased
  • belching
  • bleeding after defecation
  • bloody nose
  • blurred vision
  • 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
  • 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, subcutaneous powder for injection


Very common (10% or more): Nausea (70.5%), vomiting (54.1%), constipation (50.3%), diarrhea (36.4%), abdominal pain (12.6%), abdominal tenderness (11.8%)
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]


Very common (10% or more): Thrombocytopenia (69.7%), anemia (69.5%), neutropenia (65.7%), leukopenia (48.2%), febrile neutropenia (16.4%)
Common (1% to 10%): Aggravated anemia, hematoma, neutropenic sepsis, pancytopenia, bone marrow failure[Ref]


Very common (10% or more): Pyrexia (51.8%), fatigue (24%), chest pain (16.4%), asthenia (16%), peripheral edema (13.1%), 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 (42.9%), injection site reaction (29.1%), injection site pain (22.7%), injection site bruising (14.1%)
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 (30.5%), petechiae (23.6%), erythema (16.8%), rash (14.1%), 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 (29.1%), cough (19.4%), nasopharyngitis (18.9%), epistaxis (16.6%), upper respiratory tract infection (12.7%), pneumonia (12.6%)
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 (22.3%), myalgia (15.9%)
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 (21.8%), dizziness (18.6%)
Common (1% to 10%): Intracranial hemorrhage, syncope, somnolence, lethargy
Frequency not reported: Cerebral hemorrhage, convulsions[Ref]


Very common (10% or more): Anorexia (20.5%)
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]


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

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

3. "Product Information. Vidaza (azacitidine)." Celgene Corporation, Summit, NJ.

It is possible that some side effects of Vidaza may not have been reported. These can be reported to the FDA here. Always consult a healthcare professional for medical advice.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.