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Azacitidine Side Effects

In Summary

Commonly reported side effects of azacitidine include: pneumonia, upper respiratory tract infection, febrile neutropenia, vomiting, petechia, peripheral edema, abdominal tenderness, weight loss, hypokalemia, neutropenia, leukopenia, pharyngitis, thrombocytopenia, abdominal pain, anemia, dyspnea on exertion, back pain, nausea, upper abdominal pain, injection site reaction, rigors, productive cough, heart murmur, nasopharyngitis, limb pain, skin lesion, arthralgia, weakness, dyspnea, anxiety, chest pain, rhinorrhea, depression, epistaxis, skin rash, fatigue, cough, pain, pruritus, diarrhea, fever, constipation, insomnia, dizziness, myalgia, headache, pain at injection site, ecchymoses, bruise, bruising at injection site, decreased appetite, erythema at injection site, pallor, erythema, anorexia, diaphoresis, and malaise. Other side effects include: atelectasis, pleural effusion, urinary tract infection, syncope, herpes simplex infection, sinusitis, dysphagia, abdominal distention, muscle cramps, loose stools, tongue ulcer, dysuria, rales, lymphadenopathy, hemorrhoids, oral hemorrhage, hypoesthesia, oral mucosal petechiae, exacerbation of anemia, chest wall pain, exacerbation of dyspnea, injection site granuloma, transfusion reaction, hemorrhage, gingival hemorrhage, swelling of extremities, rhonchi, night sweats, abnormal breath sounds, wheezing, nasal congestion, urticaria, lethargy, tachycardia, hypotension, stomatitis, dyspepsia, cutaneous nodule, postoperative pain, hematoma, itching at injection site, skin discoloration at a injection site, post nasal drip, swelling at injection site, and xeroderma. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to azacitidine: subcutaneous powder for suspension

In addition to its needed effects, some unwanted effects may be caused by azacitidine. In the event that any of these side effects do occur, they may require medical attention.

Also, because of the way these medicines act on the body, there is a chance that they might cause other unwanted effects that may not occur until months or years after the medicine is used. These may include certain types of cancer, such as leukemia or bladder cancer. Discuss these possible effects with your doctor.

Major Side Effects

You should check with your doctor immediately if any of these side effects occur when taking azacitidine:

More common:
  • Black, tarry stools
  • bladder pain
  • bleeding gums
  • blood in urine or stools
  • cloudy urine
  • body aches or pain
  • burning or stinging of skin
  • chest pain
  • chills
  • congestion
  • cough
  • difficult breathing
  • difficulty swallowing
  • dizziness
  • ear congestion
  • fast heartbeat
  • fever
  • frequent urge to urinate
  • headache
  • hives
  • hoarseness
  • itching
  • loss of voice
  • lower back or side pain
  • muscle aches
  • nasal congestion
  • nausea
  • pain or tenderness around eyes and cheekbones
  • painful cold sores or blisters on lips, nose, eyes, or genitals
  • painful or difficult urination
  • pain, redness, swelling, tenderness, warmth on skin
  • pale skin
  • pinpoint red spots on skin
  • puffiness or swelling of the eyelids or around the eyes, face, lips or tongue
  • rapid heartbeat
  • runny nose
  • shortness of breath
  • skin rash
  • sneezing
  • sore throat
  • sores, ulcers, or white spots on lips or in mouth
  • stuffy nose
  • swollen glands;
  • tender, swollen glands in neck
  • tightness in chest
  • troubled breathing with exertion
  • unusual bleeding or bruising
  • unusual tiredness or weakness
  • voice changes
  • vomiting
  • wheezing
Less common:
  • Change in consciousness
  • convulsions
  • decreased urine
  • drowsiness
  • dry mouth
  • increased blood creatinine
  • increased blood pressure
  • increased thirst
  • irregular heartbeat
  • loss of appetite
  • mood changes
  • muscle pain or cramps
  • numbness or tingling in hands, feet, or lips
  • loss of consciousness
Symptoms of overdose:

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

  • Diarrhea
  • nausea
  • vomiting

Minor Side Effects

Some of the side effects that can occur with azacitidine may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

More common:
  • Acid or sour stomach
  • appetite decreased
  • belching
  • bleeding after defecation
  • bloody nose
  • blurred vision
  • bruise
  • bumps on skin
  • burning, crawling, itching, numbness, prickling, "pins and needles"; or tingling feelings
  • burning while urinating
  • confusion
  • diarrhea
  • difficulty having a bowel movement (stool)
  • difficulty in moving
  • discouragement
  • dizziness, faintness, or lightheadedness when getting up from a lying or sitting position suddenly
  • 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 site of injection
  • 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 joints
  • postnasal drip
  • post procedural hemorrhage
  • redness of skin
  • shivering
  • sleeplessness
  • 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 mouth
  • soreness or discomfort to touch or pressure on stomach
  • stomach discomfort upset or pain
  • sweating
  • swelling of abdominal or stomach area
  • swelling of hands, ankles, feet, or lower legs
  • swelling or inflammation of the mouth
  • swelling with pits or depressions visible on skin
  • swollen joints
  • tongue ulceration
  • trouble concentrating
  • trouble sleeping
  • uncomfortable swelling around anus
  • unusual drowsiness
  • unusually warm skin
  • upper abdominal pain
  • weight loss

For Healthcare Professionals

Applies to azacitidine: injectable powder for injection, subcutaneous powder for injection


Gastrointestinal side effects including nausea (70.5%), vomiting (54.1%), diarrhea (36.4%), constipation (33.6%), anorexia (20.5%), pharyngitis (20.0%), appetite decreased (12.7%), gingival bleeding (9.5%), oral mucosal petechiae (7.7%), stomatitis (7.7%), dyspepsia (6.8), hemorrhoids (6.8%), loose stools (5.5%), dysphagia (5.0%), mouth hemorrhage (5.0%), tongue ulceration (5.0%), diverticulitis, gastrointestinal hemorrhage, melena, and perirectal abscess have been reported.[Ref]


Hematologic side effects including anemia (69.5%), thrombocytopenia (65.5%), leukopenia (48.2%), neutropenia (32.3%), febrile neutropenia (16.4%), hypokalemia (12.7%), post procedural hemorrhage (5.9%), aggravated anemia (5.5%), agranulocytosis, bone marrow depression, bone marrow failure, pancytopenia, and splenomegaly have been reported.[Ref]


General side effects including pyrexia (51.8%), fatigue (35.9%), weakness (29.1%), rigors (25.5%), pain in limb (20%), back pain (18.6%), contusion (18.6%), dizziness (18.6%), erythema (16.8%), chest pain (16.4%), epistaxis (16.4%), myalgia (15.9%), decreased weight (15.9%), abdominal pain (15.5%), aggravated fatigue (12.7%), abdominal tenderness (11.8%), insomnia (10.9%), malaise (10.9%), pain (10.9%), upper abdominal pain (10.5%), night sweats (8.6%), lethargy (7.7%), peripheral swelling (7.3%), transfusion reaction (6.8%), abdominal distension (5.9%), syncope (5.9%), chest wall pain (5.0%), hypoesthesia (5.0%), post procedural pain (5.0%), general physical health deterioration, and systemic inflammatory response syndrome have been reported.[Ref]


Local side effects including injection site erythema (35%), injection site pain (22.7%), injection site bruising (14.1%), injection site reaction (13.6%), injection site pruritus (6.8%), injection site granuloma (5.0%), injection site pigmentation changes (5.0%), injection site swelling (5.0%), and catheter site hemorrhage have been reported. Postmarketing reports of injection site necrosis have been received.[Ref]


Dermatologic side effects including ecchymosis (30.5%), petechiae (23.6%), skin lesions (14.5%), rash (14.1%), pruritus (12.3%), increased sweating (10.5%), urticaria (5.9%), dry skin (5.0%), skin nodule (5.0%), pyoderma gangrenosum, pruritic rash, and skin induration have been reported. Postmarketing reports of Sweet's syndrome (acute febrile neutrophilic dermatosis) have been received.[Ref]


Respiratory side effects including cough (29.5%), dyspnea (29.1%), nasopharyngitis (14.5%), exertional dyspnea (14.1%), productive cough (11.4%), pneumonia (10.9%), lung crackles (10.5%), rhinorrhea (10.0%), rales (8.6%), wheezing (8.6%), decreased breath sounds (7.7%), pleural effusion (6.4%), postnasal drip (5.9%), rhonchi (5.9%), nasal congestion (5.5%), atelectasis (5.0%), exacerbated dyspnea (5.0%), sinusitis (5.0%), hemoptysis, lung infiltration, pneumonitis, and respiratory distress have been reported. Postmarketing reports of interstitial lung disease have been received.[Ref]


Musculoskeletal side effects including arthralgia (22.3%), muscle cramps (5.9%), aggravated bone pain, muscle weakness, and neck pain have been reported.[Ref]

Nervous system

Nervous system side effects including headache (21.8%), convulsions, and intracranial hemorrhage have been reported.[Ref]


Cardiovascular side effects including peripheral edema (18.6%), cardiac murmur (10.0%), tachycardia (8.6%), hypotension (6.8%), atrial fibrillation, cardiac failure, congestive cardiac failure, orthostatic hypotension, cardiorespiratory arrest, cerebral hemorrhage, and congestive cardiomyopathy have been reported.[Ref]


Other side effects including pallor (15.5%), pitting edema (14.5%), lymphadenopathy (9.5%), hematoma (8.6%), cellulitis (8.2%), and cholecystectomy have been reported.

Infections and infestations including herpes simplex (9.1%), limb abscess, bacterial infection, blastomycosis, injection site infection, Klebsiella sepsis, streptococcal pharyngitis, Klebsiella pneumonia, sepsis, Staphylococcal bacteremia, Staphylococcal infection, neutropenic sepsis, septic shock, and toxoplasmosis have been reported.[Ref]


Genitourinary side effects including urinary tract infection (7.7%), hematuria, and loin pain have been reported.[Ref]


Renal side effects including renal failure have been reported.[Ref]


Hepatic side effects including cholecystitis have been reported.[Ref]


Immunologic side effects including anaphylactic shock and hypersensitivity have been reported.[Ref]


Metabolic side effects including dehydration have been reported. Postmarketing reports of tumor lysis syndrome have been received.[Ref]


Oncologic side effects including leukemia cutis have been reported.[Ref]


Psychiatric side effects including confusion have been reported.[Ref]


Ocular side effects including eye hemorrhage have been reported.[Ref]


1. "Product Information. Vidaza (azacitidine)." Pharmion Corporation, Boulder, CO.

Not all side effects for azacitidine may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

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.