Azacitidine Side Effects

Some side effects of azacitidine may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to azacitidine: injectable powder for injection

Get emergency medical help if you have any of these signs of an allergic reaction while taking azacitidine: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• pale skin, feeling light-headed or short of breath, easy bruising, unusual bleeding;

• fever, chills, body aches, flu symptoms, sores in your mouth and throat;

• redness, swelling, warmth, oozing, or other signs of skin infection;

• sudden chest pain or discomfort, wheezing, dry cough or hack;

• severe ongoing nausea, vomiting, or diarrhea;

• burning or skin changes where the injection was given;

• lower back pain, blood in your urine, little or no urinating;

• numbness or tingly feeling around your mouth;

• muscle weakness, tightness, or contraction, overactive reflexes;

• fast or slow heart rate, weak pulse, confusion, fainting; or

• low potassium (extreme thirst, increased urination, leg discomfort, muscle weakness or limp feeling).

Common side effects may include:

• mild nausea, vomiting, loss of appetite;

• stomach pain, diarrhea, constipation;

• feeling weak or tired;

• pain, redness, bruising, or other irritation where the injection was given;

• headache, dizziness, anxiety;

• joint or muscle pain; or

• cold symptoms such as stuffy nose, sneezing, sore throat.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

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

Gastrointestinal

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.

Hematologic

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.

General

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.

Local

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.

Dermatologic

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.

Respiratory

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.

Musculoskeletal

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

Nervous system

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

Cardiovascular

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.

Other

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.

Genitourinary

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

Renal

Renal side effects including renal failure have been reported.

Hepatic

Hepatic side effects including cholecystitis have been reported.

Immunologic

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

Metabolic

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

Oncologic

Oncologic side effects including leukemia cutis have been reported.

Psychiatric

Psychiatric side effects including confusion have been reported.

Ocular

Ocular side effects including eye hemorrhage have been reported.

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