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Azacitidine Side Effects

In Summary

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, 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 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

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 or nurse immediately if any of the following side effects occur while taking azacitidine:

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

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

Symptoms of Overdose

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
  • 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

Gastrointestinal

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]

Hematologic

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]

Other

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]

Local

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]

Dermatologic

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]

Respiratory

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]

Musculoskeletal

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]

Metabolic

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]

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[Ref]

Ocular

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

Psychiatric

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

Hepatic

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

Frequency not reported: Cholecystitis, cholecystectomy[Ref]

Hypersensitivity

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

Immunologic

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

References

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.

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.

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