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AZATHIOPRINE SODIUM

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Azathioprine Sodium Adverse Events Reported to the FDA Over Time

How are Azathioprine Sodium adverse event reports trending over time?

This graph shows volume of adverse events submitted to the FDA by quarter for Azathioprine Sodium, as well as related generic and/or brandname drugs containing the same primary active ingredients. Adverse events are counted if Azathioprine Sodium is flagged as the suspect drug causing the adverse event.

Most Common Azathioprine Sodium Adverse Events Reported to the FDA

What are the most common Azathioprine Sodium adverse events reported to the FDA?

Pyrexia
407 (1.68%)
Pancytopenia
269 (1.11%)
Diarrhoea
227 (.94%)
Leukopenia
227 (.94%)
Sepsis
227 (.94%)
Pneumonia
226 (.93%)
Drug Ineffective
221 (.91%)
Vomiting
204 (.84%)
Nausea
203 (.84%)
Anaemia
193 (.8%)
Drug Interaction
171 (.71%)
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Drug Exposure During Pregnancy
159 (.66%)
Fatigue
141 (.58%)
Weight Decreased
141 (.58%)
Abdominal Pain
133 (.55%)
Basal Cell Carcinoma
131 (.54%)
Epstein-barr Virus Infection
129 (.53%)
Thrombocytopenia
125 (.52%)
Cytomegalovirus Infection
122 (.5%)
Condition Aggravated
119 (.49%)
Haemoglobin Decreased
119 (.49%)
Pancreatitis
118 (.49%)
Dyspnoea
117 (.48%)
Malaise
115 (.47%)
Asthenia
114 (.47%)
Respiratory Failure
110 (.45%)
Renal Failure
105 (.43%)
Neutropenia
104 (.43%)
Renal Impairment
100 (.41%)
Blood Creatinine Increased
99 (.41%)
Herpes Zoster
97 (.4%)
Arthralgia
96 (.4%)
Hepatosplenic T-cell Lymphoma
95 (.39%)
Multi-organ Failure
95 (.39%)
Bone Marrow Failure
94 (.39%)
Squamous Cell Carcinoma
91 (.38%)
Platelet Count Decreased
89 (.37%)
White Blood Cell Count Decreased
88 (.36%)
Renal Failure Acute
87 (.36%)
Epstein-barr Virus Associated Lymph...
83 (.34%)
Headache
83 (.34%)
Histiocytosis Haematophagic
83 (.34%)
Progressive Multifocal Leukoencepha...
83 (.34%)
Rash
80 (.33%)
Hypotension
79 (.33%)
Lymphoproliferative Disorder
78 (.32%)
Pleural Effusion
74 (.31%)
Pneumocystis Jiroveci Pneumonia
73 (.3%)
Myalgia
72 (.3%)
Chills
70 (.29%)
Liver Function Test Abnormal
70 (.29%)
Ascites
69 (.28%)
Colitis Ulcerative
66 (.27%)
Death
65 (.27%)
Aspartate Aminotransferase Increase...
64 (.26%)
C-reactive Protein Increased
64 (.26%)
Septic Shock
64 (.26%)
Hepatitis
62 (.26%)
Alanine Aminotransferase Increased
60 (.25%)
Aspergillosis
60 (.25%)
Dehydration
59 (.24%)
Pancreatitis Acute
59 (.24%)
Oedema Peripheral
58 (.24%)
Urinary Tract Infection
58 (.24%)
Infection
57 (.24%)
Lymphadenopathy
57 (.24%)
Staphylococcal Infection
57 (.24%)
Cough
56 (.23%)
Drug Hypersensitivity
56 (.23%)
Muscular Weakness
56 (.23%)
Pain
56 (.23%)
Premature Baby
56 (.23%)
Transplant Rejection
55 (.23%)
Blood Alkaline Phosphatase Increase...
53 (.22%)
Jaundice
53 (.22%)
Bronchiectasis
52 (.21%)
Hypertension
51 (.21%)
Liver Disorder
51 (.21%)
Interstitial Lung Disease
50 (.21%)
Disease Recurrence
49 (.2%)
Cholestasis
48 (.2%)
Hepatitis Cholestatic
48 (.2%)
Nodular Regenerative Hyperplasia
48 (.2%)
Tachycardia
48 (.2%)
Acute Myeloid Leukaemia
47 (.19%)
Acute Febrile Neutrophilic Dermatos...
46 (.19%)
Diffuse Large B-cell Lymphoma
46 (.19%)
Hepatic Enzyme Increased
46 (.19%)
Hypogammaglobulinaemia
46 (.19%)
Abdominal Pain Upper
45 (.19%)
Skin Lesion
45 (.19%)
White Blood Cell Count Increased
45 (.19%)
Alopecia
44 (.18%)
Colitis
44 (.18%)
Haemodialysis
44 (.18%)
Back Pain
43 (.18%)
Blood Lactate Dehydrogenase Increas...
43 (.18%)
Lymphoma
43 (.18%)
Transaminases Increased
43 (.18%)
Convulsion
42 (.17%)
General Physical Health Deteriorati...
42 (.17%)

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This graph shows the top adverse events submitted to the FDA for Azathioprine Sodium, as well as related generic and/or brandname drugs containing the same primary active ingredients, from Q1 2004 to Q3 2012. Adverse events are counted if Azathioprine Sodium is flagged as a suspect drug causing the adverse event. For each adverse event listed, percent (%) represents percentage of the adverse event to all adverse events reported for the drug. Percent does not represent a rate related to drug utilization.

Adverse Event Categories for Azathioprine Sodium

What are the most common Azathioprine Sodium adverse events reported to the FDA?

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This graph shows the top categories of adverse events submitted to the FDA for Azathioprine Sodium, as well as related generic and/or brandname drugs containing the same primary active ingredients, from Q1 2004 to Q3 2012. Adverse events are counted if Azathioprine Sodium is flagged as a suspect drug causing the adverse event. For each adverse event listed, percent (%) represents percentage of the adverse event to all adverse events reported for the drug. Percent does not represent a rate related to drug utilization.

Common Uses of Azathioprine Sodium According to Those Reporting Adverse Events

Why are people taking Azathioprine Sodium, according to those reporting adverse events to the FDA?

Crohns Disease
3646
Product Used For Unknown Indication
1167
Colitis Ulcerative
941
Drug Use For Unknown Indication
854
Immunosuppression
615
Rheumatoid Arthritis
589
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Renal Transplant
555
Systemic Lupus Erythematosus
275
Immunosuppressant Drug Therapy
206
Lung Transplant
191
Heart Transplant
155
Prophylaxis Against Transplant Reje...
122
Autoimmune Hepatitis
100
Liver Transplant
100
Myasthenia Gravis
92
Pemphigus
78
Colitis
78
Multiple Sclerosis
77
Idiopathic Thrombocytopenic Purpura
70
Arthritis
68
Behcets Syndrome
65
Inflammatory Bowel Disease
65
Wegeners Granulomatosis
60
Organ Transplant
52
Drug Exposure During Pregnancy
47
Lupus Nephritis
47
Polymyositis
45
Vasculitis
44
Interstitial Lung Disease
35
Dermatomyositis
31
Idiopathic Pulmonary Fibrosis
27
Dermatitis Atopic
26
Psoriasis
24
Relapsing-remitting Multiple Sclero...
22
Sarcoidosis
22
Uveitis
21
Pemphigoid
21
Ankylosing Spondylitis
20
Psoriatic Arthropathy
19
Ill-defined Disorder
18
Connective Tissue Disorder
18
Prophylaxis
18
Nephrotic Syndrome
18
Juvenile Arthritis
18
Heart And Lung Transplant
17
Foetal Exposure During Pregnancy
16
Allergic Granulomatous Angiitis
16
Anti-neutrophil Cytoplasmic Antibod...
16
Transplant
15
Immune System Disorder
15
Autoimmune Disorder
15

Drug Labels

LabelLabelerEffective
Azathioprine SodiumBedford Laboratories26-MAR-10

Azathioprine Sodium Case Reports

What Azathioprine Sodium safety concerns are being reported by doctors and researchers in the medical literature?

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About Results

This report contains aggregated drug side effects and adverse events for Azathioprine Sodium. The data has been pulled from the United States Food and Drug Administration's (US FDA) Adverse Event Reporting System (AERS), a database containing more than 4,000,000 adverse event reports.

DrugCite expands your query using the Unified Medical Language System (UMLS) to include generic drugs and primary active ingredients. While the core of DrugCite's advanced drug filtering algorithm is based on the industry standard UMLS, DrugCite's proprietary filtering system also includes dozens of additional steps to reconcile malformed drug names in the FDA's data.

DrugCite only counts a drug if the submitter of the adverse event indicates that the drug is suspected to have caused the adverse event.

Depending on how the data is aggregated, different counts may occur. When someone submits an adverse event to the FDA, the submitter can attribute multiple adverse events to one or more drugs. For example, an individual taking Paxil could submit the adverse events "anxiety" and "suicidal ideation" for the same individual safety report (ISR). This means when DrugCite aggregates by adverse event, two distinct adverse events are counted in the adverse event graph; once for "anxiety" and again for "suicidal ideation". However, when DrugCite aggregates by individual safety reports irrespective of the details of the adverse events contained within the safety report, the report is only counted once.

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