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5-azacytidine

More information: STITCH, PubChem (stereo-specific compound: 1) and possibly Wikipedia

ATC Code: L01BC07

Side effects

Options: Hide MedDRA Preferred Terms

MedDRA Preferred Term Side effect Data for drug Placebo Labels
1 2 3 4 5 6 7 8
Thrombocytopenia Thrombocytopenia very common, 3.2% - 69.7% x x x x x x x x
Anaemia Anaemia very common, 2.3% - 69.5% x x x x x x x x
Anaemia NOS aggravated 5.43% - 5.45% x x x x x
Body temperature increased Body temperature increased very common, 0.98% - 51.8% x x x x x x x x
Asthenia Asthenia 20.7% - 29.1% x x x x x x
Fatigue very common, 1.96% - 35.9% x x x x x x x x
Cough Cough 15.2% - 29.5% x x x
Neutropenia Neutropenia very common, 2.7% - 65.7% x x x x x x x x
Chills Rigors 10.9% - 25.5% x x x x x x
Nausea Nausea very common, 0% - 70.5% x x x x x x x x
Ecchymosis Ecchymosis very common, 15.2% - 30.5% x x x x x x x x
Decreased appetite Anorexia very common, 6.52% - 20.5% x x x x x x x x
Decreased appetite 8.7% - 12.7% x x
Arthralgia Arthralgia very common, 3.26% - 22.3% x x x x x x x x
Musculoskeletal discomfort Arthralgia very common, 3.26% - 22.3% x x x x x x x x
Myalgia common, 2.17% - 15.9% x x x x x x x x
Chest pain Chest pain very common, 5.43% - 16.4% x x x x x x x x
Diarrhoea Diarrhoea very common, 14.1% - 36.4% x x x x x x x x
Loose stools 0% - 5.45% x x x x x
Dizziness Dizziness very common, 5.43% - 18.6% x x x x x x x x
Syncope 5.43% - 5.91% x x
Fatigue Fatigue very common, 1.96% - 35.9% x x x x x x x x
Fatigue aggravated 4.35% - 12.7% x x
Headache Headache very common, 10.9% - 21.8% x x x x x x x x
Leukopenia Leukopenia very common, 0.98% - 48.2% x x x x x x x x
Oedema peripheral Oedema peripheral 10.9% - 18.6% x x x
Nasopharyngitis Nasopharyngitis very common, 3.26% - 14.5% x x x x x x x x
Rhinorrhoea 2.17% - 10% x x
Back pain Back pain 7.61% - 18.6% x x
Loin pain x x x x x
Epistaxis Epistaxis 9.78% - 16.4% x x x
Pain in extremity Pain in extremity 5.43% - 20% x x
Abdominal pain Abdominal pain very common, 0% - 15.5% x x x x x x x x
Gastrointestinal pain Abdominal pain very common, 0% - 15.5% x x x x x x x x
Oedema Pitting edema 9.78% - 14.5% x x
Dyspnoea Dyspnoea very common, 1.96% - 29.1% x x x x x x x x
Dyspnoea exacerbated 3.26% - 5% x x
Skin lesion Skin lesion 8.7% - 14.5% x x x x x
Pallor Pallor 7.61% - 15.5% x x
Pneumonia Pneumonia very common, 2.5% - 10.9% x x x x x x x x
Febrile neutropenia Febrile neutropenia very common, 2.7% - 16.4% x x x x x x x x
Contusion Contusion common, 9.78% - 18.6% x x x x x x x x
Dermatitis Rash common — 0% - 14.1% x x x x x x x x
Rash Rash common — 0% - 14.1% x x x x x x x x
Depression Depression 7.61% - 11.8% x x
Cardiac murmur Cardiac murmur 8.7% - 10% x x
Petechiae Petechiae very common, 0% - 23.6% x x x x x x x x
Rales Rales 8.64% - 10.5% x x
Pruritus Pruritus common — 0% - 12.3% x x x x x x x x
Productive cough Productive cough 4.35% - 11.4% x x
Constipation Constipation very common, 0% - 50.3% x x x x x x x x
Pharyngitis Pharyngitis common, 7.61% - 20% x x x x x
Tachycardia Tachycardia 6.52% - 8.64% x x
Pain Pain 3.26% - 10.9% x x x x x
Vomiting Vomiting very common, 0% - 54.1% x x x x x x x x
Abdominal pain upper Abdominal pain upper 3.26% - 10.5% x x
Abdominal tenderness Abdominal tenderness 1.09% - 11.8% x x x x x
Pleural effusion Pleural effusion 6.36% - 6.52% x x
Lymphadenopathy Lymphadenopathy 3.26% - 9.55% x x
Local swelling Peripheral swelling 5.43% - 7.27% x x
Hyperhidrosis Sweating increased 2.17% - 10.5% x x
Cellulitis Cellulitis 4.35% - 8.18% x x x x x x x
Rhinorrhoea Rhinorrhoea 2.17% - 10% x x
Night sweats Night sweats 3.26% - 8.64% x x
Shock Syncope 5.43% - 5.91% x x
Syncope Syncope 5.43% - 5.91% x x
Loss of consciousness Syncope 5.43% - 5.91% x x
Mouth haemorrhage Oral mucosal petechiae 3.26% - 7.73% x x
Mouth haemorrhage 1.09% - 5% x x x x x
Herpes simplex Herpes simplex common, 5.43% - 9.09% x x x x x
Wheezing Wheezing 2.17% - 8.64% x x
Dysuria Dysuria 2.17% - 8.18% x x
Abdominal distension Abdominal distension 4.35% - 5.91% x x
Alopecia Alopecia common x x x
Confusional state Confusional state common x x x x x
Feeling abnormal Confusional state common x x x x x
Malaise common, 1.09% - 10.9% x x x x x x x x
Conjunctival haemorrhage Conjunctival haemorrhage common x x x
Eye haemorrhage Eye haemorrhage common x x x x x x
Gastrointestinal haemorrhage Gastrointestinal haemorrhage common, 0.8% x x x x x x x x
Gingival bleeding Gingival bleeding common, 4.35% - 9.55% x x x x x x x x
Haematoma Haematoma common, 0% - 8.64% x x x x x x x x
Haemorrhage Haemorrhage common x x x x x x x
Haemoglobin Haemorrhage common x x x x x x x
Hypokalaemia Hypokalaemia common, 1.71% - 13% x x x x x x x x
Hypotension Hypotension common, 2.17% - 6.82% x x x x x x x x
Inflammation Inflammation common x x x
Musculoskeletal pain Musculoskeletal pain common x x x
Nodule Nodule common x x x
Pancytopenia Pancytopenia common x x x x x x
Bone marrow depression x x
Purpura Purpura common x x x
Vascular purpura Purpura common x x x
Sinusitis Sinusitis common, 3.26% - 5% x x x x x
Stomatitis Stomatitis common, 0% - 7.73% x x x x x x x x
Urinary tract infection Urinary tract infection common, 0% - 8.57% x x x x x x x x
Weight decreased Weight decreased common, 0% - 15.9% x x x x x x x x
Haemorrhage intracranial Haemorrhage intracranial common, 0.5% x x x x x x x x
Rash macular Rash macular common x x x
Malaise Malaise common, 1.09% - 10.9% x x x x x x x x
Discomfort Malaise common, 1.09% - 10.9% x x x x x x x x
Ill-defined disorder Malaise common, 1.09% - 10.9% x x x x x x x x
Myalgia Myalgia common, 2.17% - 15.9% x x x x x x x x
Dyspnoea exertional Dyspnoea exertional common, 0% - 16.3% x x x x x x x x
Haemorrhoidal haemorrhage Haemorrhoidal haemorrhage common x x x
Induration Induration common x x x
Neutropenic sepsis Neutropenic sepsis common, 0.8% x x x x x x
Muscle spasms Cramp muscle 3.26% - 5.91% x x
Upper-airway cough syndrome Postnasal drip 3.26% - 5.91% x x
Breath sounds abnormal Respiratory sounds decreased 1.09% - 7.73% x x
Dyspepsia Dyspepsia common, 0% - 6.82% x x x x x x x x
Erythema Erythema common, 0% - 16.8% x x x x x x x x
Upper respiratory tract infection Upper respiratory tract infection common, 0% - 12.7% x x x x x x x x
Insomnia Insomnia common, 0% - 10.9% x x x x x x x x
Rhonchi Rhonchi 2.17% - 5.91% x x
Haemorrhoids Haemorrhoids 1.09% - 6.82% x x
Hypertension Hypertension common, 1.14% - 8.57% x x x x x x
Atelectasis Atelectasis 2.17% - 5% x x
Pneumothorax Atelectasis 2.17% - 5% x x
Dysphagia Dysphagia 2.17% - 5% x x
Tongue ulceration Tongue ulceration 2.17% - 5% x x
Procedural pain Post procedural pain 2.17% - 5% x x
Urticaria Urticaria 1.09% - 5.91% x x x x x
Post procedural haemorrhage Post procedural haemorrhage 1.09% - 5.91% x x x x x
Transfusion reaction Transfusion reaction 0% - 6.82% x x x
Injection site pruritus Injection site pruritus 0% - 6.82% x x x x x
Nasal congestion Nasal congestion 1.09% - 5.45% x x
Anxiety Anxiety common, 0% - 13.2% x x x x x x x x
Hypoaesthesia Hypoaesthesia 1.09% - 5% x x
Skin mass Skin nodule 1.09% - 5% x x x x x
Dry skin Dry skin 1.09% - 5% x x x x x
Laryngeal pain Pharyngolaryngeal pain common, 0% - 6.29% x x x x x x
Musculoskeletal chest pain Chest wall pain 0% - 5% x x x x x
Injection site granuloma Injection site granuloma 0% - 5% x x x x x
Injection site swelling Injection site swelling 0% - 5% x x x x x
Injection site discolouration Injection site pigmentation changes 0% - 5% x x x x x
Haematuria Haematuria common, 0.98% - 6.29% x x x x x x x x
Lethargy Lethargy common, 0% - 7.73% x x x x x x x x
Rhinitis Rhinitis common, 0% - 5.71% x x x x x x
Injection site reaction Injection site reaction very common, 0% - 29.1% x x x x x x x x
Hypersensitivity Hypersensitivity uncommon, 0.25% x x x x x x x x
Tumour lysis syndrome Tumour lysis syndrome postmarketing x x x x x x
Acute febrile neutrophilic dermatosis Acute febrile neutrophilic dermatosis postmarketing x x x x
Injection site necrosis Injection site necrosis postmarketing x x x x x x
Interstitial lung disease Interstitial lung disease postmarketing x x x x x x
Renal tubular acidosis Renal tubular acidosis x x x x x x x x
Road traffic accident Renal tubular acidosis x x x x x x x x
Agranulocytosis Agranulocytosis x x x x x
Anaphylactic shock Anaphylactic shock x x x x x
Refractory anaemia with an excess of blasts Refractory anaemia with an excess of blasts x x
Atrial fibrillation Atrial fibrillation x x x x x
Bacterial infection Bacterial infection x x x x x
Mental disorder Mental disorder x x x x x x x x
Blastomycosis Blastomycosis x x x x x
Bronchitis Bronchitis x
Congestive cardiomyopathy Congestive cardiomyopathy x x x x x
Neck pain Neck pain x x x x x
Cholecystitis Cholecystitis x x x x x
Coma Coma x
Infection Infection x x x x x x x x
Connective tissue disorder Connective tissue disorder x x x x x x x x
Cyst Cyst x
Dehydration Dehydration x x x x x
Diverticulitis Diverticulitis x x x x x
Eye disorder Eye disorder x x x x x x
Gastrointestinal disorder Gastrointestinal disorder x x x x x x x x
Cardiac disorder Cardiac disorder x x x x x
Cardiac failure Cardiac failure x x x x x
Cardiac failure congestive Cardiac failure congestive x x x x x
Haemoptysis Haemoptysis x x x x x
Coma hepatic Coma hepatic x x x x x x x x
Orthostatic hypotension Orthostatic hypotension x x x x x
Immune system disorder Immune system disorder x x x x x x x x
Mediastinal disorder Mediastinal disorder x x x x x x x x
Melaena Melaena x x x x x
Neoplasm Neoplasm x x x x x x x x
Nervous system disorder Nervous system disorder x x x x x x x x
Polyp Polyp x
Prurigo Prurigo x x x x x
Renal failure Renal failure x x x x x x x x
Convulsion Convulsion x x x x x
Pharyngitis streptococcal Pharyngitis streptococcal x x x x x
Septic shock Septic shock x x x
Splenomegaly Splenomegaly x x x x x
Staphylococcal infection Staphylococcal infection x x x x x
Toxoplasmosis Toxoplasmosis x x x x x
Urethral disorder Urinary tract disorder x x x x x x x x
Urinary tract disorder Urinary tract disorder x x x x x x x x
Angiopathy Angiopathy x x x x x x x x
Hepatic failure Hepatic failure x
Pyoderma gangrenosum Pyoderma gangrenosum x x x x x
Muscular weakness Muscular weakness x x x x x
Injection site pain Injection site pain very common, 0% - 22.7% x x x x x x x x
Staphylococcal bacteraemia Staphylococcal bacteraemia x x x x x
Malnutrition Malnutrition x x x x x x x x
Skin disorder Unspecified disorder of skin and subcutaneous tissue x x x x x x x x
Injection site infection Injection site infection x x x x x
Lung infiltration Lung infiltration x x x x x
Skin induration Skin induration x x x x x
Systemic inflammatory response syndrome Systemic inflammatory response syndrome x x x x x
Sepsis Sepsis x x x x x
Perirectal abscess Perirectal abscess x x x x x
Hepatobiliary disease Hepatobiliary disease x x x x x x
Myelodysplastic syndrome transformation Refractory anemia with excess blasts in transformation x x
Respiratory distress Respiratory distress x x x x x
Pneumonia klebsiella Pneumonia klebsiella x x x x x
Injection site dermatitis Injection site dermatitis 0% - 5.71% x x x x x x
Injection site haemorrhage Injection site bruising 0% - 14.1% x x x x x
Injection site bruising Injection site bruising 0% - 14.1% x x x x x
Injection site induration Injection site induration 0% - 5.14% x x x
Injection site haematoma Injection site haematoma 0% - 6.29% x x x
Bone pain Bone pain aggravated x x x x x
Abscess limb Abscess limb x x x x x
Cardio-respiratory arrest Cardio-respiratory arrest x x x x x
Klebsiella sepsis Klebsiella sepsis x x x x x
Infestation Infestation NOS x x x x x x x x
Injection site erythema Injection site erythema very common, 0% - 42.9% x x x x x x x x
General physical health deterioration General physical health deterioration x x x x x
Catheter site haemorrhage Catheter site haemorrhage x x x x x
Catheter site erythema Catheter site erythema x
Leukaemia cutis Leukaemia cutis x x x x x
Cerebral haemorrhage Cerebral haemorrhage x x x x
Metastatic neoplasm Metastatic disease x x x

Indications

Information about indications was extracted from the indications and usage sections of the labels.

azacitidine / azacitidine

Side effects:98
Source:EMA

03 October 2013 / Vidaza (azacitidine) Powder for Injection

Side effects:103
Source:medicines.org.au

Azacitidine

Side effects:143
Source:FDA Structured Product Label

AZACITIDINE

Side effects:145
Source:FDA Structured Product Label

AZACITIDINE

Side effects:146
Source:FDA Structured Product Label

AZACITIDINE / VIDAZA

Side effects:170
Source:FDA

AZACITIDINE / VIDAZA

Side effects:172
Source:FDA

Color scheme:

standard – alternative

    100%
    75%
    50%
    10%
    frequent (1% to 100%)
    infrequent (0.1% to 1%)
    rare (<0.1%)
    postmarketing
    0%
    no frequency information
    not found on label