Azacitidine Side Effects

Brand Names: Vidaza

Please note - some side effects for Azacitidine may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Azacitidine - for the Consumer

Azacitidine

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Azacitidine:

Anxiety; constipation; cough; diarrhea; dizziness; dry skin; headache; joint or muscle pain; loss of appetite; nausea; pain, swelling, or redness at the injection site; tiredness or weakness; trouble sleeping; vomiting.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); black, tarry stools; bleeding at the injection site; blood in the urine; changes in vision; chest pain; confusion; dark urine; decreased or painful urination; fainting; fever, chills, or persistent sore throat; irregular heartbeat; numbness of an arm or leg; seizures; shortness of breath; stomach or leg pain; sudden severe headache; swelling of the hands, arms, ankles, feet, or legs; unusual bruising or bleeding; unusual or severe tiredness or weakness; vision changes; weight loss; yellowing of skin or eyes.

Side Effects by Body System

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.

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.

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.

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.

Oncologic

Oncologic side effects including leukemia cutis have been reported.

Psychiatric

Psychiatric side effects including confusion have been reported.

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