Onureg Side Effects

Generic name: azacitidine

Medically reviewed by Drugs.com. Last updated on Dec 3, 2024.

Note: This document provides detailed information about Onureg Side Effects associated with azacitidine. Some dosage forms listed on this page may not apply specifically to the brand name Onureg.

Applies to azacitidine: injection powder for suspension.

Other dosage forms:

• oral tablet

Serious side effects of Onureg

Along with its needed effects, azacitidine (the active ingredient contained in Onureg) 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 side effects

• 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 side effects

• 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

• diarrhea
• nausea
• vomiting

Other side effects of Onureg

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 side effects

• 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.

General adverse events

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.

Most common adverse reactions (greater than 10%) by oral route included nausea, vomiting, diarrhea, fatigue or asthenia, constipation, pneumonia, abdominal pain, arthralgia, decreased appetite, neutropenia, respiratory tract infection, thrombocytopenia, leucopenia, febrile neutropenia, dizziness, back pain and pain in extremity.^[Ref]

Hematologic

• 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 splenomegaly, bone marrow failure
• Frequency not reported: Agranulocytosis^[Ref]

Other

• 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
• Postmarketing reports: Differentiation syndrome^[Ref]

Local

• 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: Catheter site hemorrhage
• Postmarketing reports: Injection site necrosis^[Ref]

Dermatologic

• 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]

Respiratory

• Very common (10% or more): Dyspnea (29%), cough (19%), nasopharyngitis (15%), epistaxis (17%), upper respiratory tract infection (13%), pneumonia (11%)
• Common (1% to 10%): Rhinitis, bronchitis, influenza. 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]

Pneumonia include pneumonia, bronchopulmonary aspergillosis, lung infection, Pneumocystis jirovecii pneumonia, atypical pneumonia, pneumonia bacterial, and pneumonia fungal.

Respiratory tract infection include upper respiratory tract infection, respiratory tract infection, and respiratory tract infection viral.^[Ref]

Musculoskeletal

• Very common (10% or more): Arthralgia (22%), myalgia (16%), musculoskeletal pain (11%), back pain (11.9%), pain in extremity (10.6%)
• Common (1% to 10%): Muscle spasms
• Frequency not reported: Aggravated bone pain, muscle weakness, neck pain, loin pain, abscess limb, chest wall pain
• 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]

Metabolic

• Very common (10% or more): Anorexia (21%), hyperuricemia (17%), decreased appetite (13%)
• Common (1% to 10%): Decreased weight, hypokalemia, dehydration, fluid retention
• 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
• Postmarketing reports: Pericardial effusion, pericarditis^[Ref]

Ocular

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

Psychiatric

• Very common (10% or more): Anxiety (13%), insomnia (11%)
• Common (1% to 10%): 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
• Frequency not reported: Renal toxicity^[Ref]

Urinary tract infection include urinary tract infection, urinary tract infection bacterial, Escherichia urinary tract infection, and cystitis.^[Ref]

Hepatic

• Uncommon (0.1% to 1%): Hepatic failure, hepatic coma
• Frequency not reported: Cholecystitis, cholecystectomy, hepatotoxicity^[Ref]

Hypersensitivity

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

Immunologic

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

Gastrointestinal

• Very common (10% or more): Nausea (71%), vomiting (54%), constipation (50%), diarrhea (36%), abdominal pain (13%), abdominal tenderness (12%), ascites (11%), leucopenia (10.6%)
• 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]

Abdominal pain include abdominal pain, abdominal pain upper, abdominal discomfort, and gastrointestinal pain.^[Ref]

Further information

Onureg side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

Medical Disclaimer