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

Applies to azacitidine: oral tablet. Other dosage forms:

• injection powder for suspension

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

More common

• Black, tarry stools
• bleeding gums
• blood in urine or stools
• chest pain or tightness
• chills
• cough
• decreased appetite
• diarrhea
• difficulty in moving
• dizziness
• fever
• lack or loss of strength
• lower back or side pain
• muscle pain or stiffness
• nausea
• pain in the arms or legs
• pain in joints
• painful or difficult urination
• pale skin
• pinpoint red spots on skin
• sneezing
• sore throat
• stomach pain
• trouble breathing
• ulcers, sores, or white spots in the mouth
• unusual bleeding or bruising
• unusual tiredness or weakness
• 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

• Constipation
• decreased appetite

For Healthcare Professionals

Applies to azacitidine: injectable powder for injection, oral tablet, subcutaneous powder for injection.

Gastrointestinal

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]

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, bone marrow failure^[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^[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: Injection site necrosis, catheter site hemorrhage^[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 (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]

Musculoskeletal

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]

Metabolic

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]

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]

General

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]