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AZULFIDINE

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Azulfidine Adverse Events Reported to the FDA Over Time

How are Azulfidine adverse event reports trending over time?

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

Most Common Azulfidine Adverse Events Reported to the FDA

What are the most common Azulfidine adverse events reported to the FDA?

Pyrexia
163 (4.04%)
Liver Disorder
82 (2.03%)
Rash
81 (2.01%)
Interstitial Lung Disease
80 (1.99%)
Pancytopenia
69 (1.71%)
Agranulocytosis
62 (1.54%)
Pneumonia
62 (1.54%)
Drug Eruption
59 (1.46%)
Drug Rash With Eosinophilia And Sys...
59 (1.46%)
Hepatic Function Abnormal
58 (1.44%)
Sepsis
41 (1.02%)
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Arthralgia
40 (.99%)
Malaise
40 (.99%)
Erythema
38 (.94%)
Diarrhoea
34 (.84%)
Disseminated Intravascular Coagulat...
34 (.84%)
Platelet Count Decreased
33 (.82%)
White Blood Cell Count Decreased
32 (.79%)
Rheumatoid Arthritis
31 (.77%)
Vomiting
31 (.77%)
Drug Hypersensitivity
30 (.74%)
Dizziness
29 (.72%)
Hypersensitivity
29 (.72%)
Nausea
29 (.72%)
Pleural Effusion
29 (.72%)
Dyspnoea
27 (.67%)
Stomatitis
27 (.67%)
Headache
24 (.6%)
Leukopenia
23 (.57%)
Lymphadenopathy
22 (.55%)
Thrombocytopenia
22 (.55%)
Glomerulonephritis Membranous
21 (.52%)
Granulocytopenia
21 (.52%)
Decreased Appetite
20 (.5%)
Infection
20 (.5%)
Lymphoma
20 (.5%)
Rash Generalised
20 (.5%)
Weight Decreased
20 (.5%)
Multi-organ Failure
19 (.47%)
Oedema
19 (.47%)
Septic Shock
19 (.47%)
Anti-neutrophil Cytoplasmic Antibod...
18 (.45%)
Bone Marrow Failure
18 (.45%)
Cough
18 (.45%)
Neutropenia
18 (.45%)
Toxic Skin Eruption
18 (.45%)
Dehydration
17 (.42%)
Drug Ineffective
17 (.42%)
Fatigue
17 (.42%)
Histiocytosis Haematophagic
17 (.42%)
Anaphylactic Shock
16 (.4%)
Condition Aggravated
16 (.4%)
Oropharyngeal Pain
16 (.4%)
Anaemia
15 (.37%)
Eczema
15 (.37%)
Generalised Erythema
15 (.37%)
Nasopharyngitis
15 (.37%)
Pruritus
15 (.37%)
Respiratory Failure
15 (.37%)
Anorexia
14 (.35%)
Asthenia
14 (.35%)
Haemoglobin Decreased
14 (.35%)
Liver Function Test Abnormal
14 (.35%)
Tachycardia
14 (.35%)
Alanine Aminotransferase Increased
13 (.32%)
Blood Lactate Dehydrogenase Increas...
13 (.32%)
Cardiomegaly
13 (.32%)
Nephrotic Syndrome
13 (.32%)
Pericardial Effusion
13 (.32%)
Aplastic Anaemia
12 (.3%)
Asthma
12 (.3%)
C-reactive Protein Increased
12 (.3%)
Cardiac Failure
12 (.3%)
Infectious Mononucleosis
12 (.3%)
Loss Of Consciousness
12 (.3%)
Oculomucocutaneous Syndrome
12 (.3%)
Lymphoproliferative Disorder
11 (.27%)
Oedema Peripheral
11 (.27%)
Renal Failure
11 (.27%)
White Blood Cell Count Increased
11 (.27%)
Convulsion
10 (.25%)
Face Oedema
10 (.25%)
Hypertension
10 (.25%)
Pneumonia Bacterial
10 (.25%)
Aspartate Aminotransferase Increase...
9 (.22%)
Dysgeusia
9 (.22%)
Enterocolitis
9 (.22%)
Epstein-barr Virus Infection
9 (.22%)
Hepatic Enzyme Increased
9 (.22%)
Lung Disorder
9 (.22%)
Myelodysplastic Syndrome
9 (.22%)
Neutrophil Count Decreased
9 (.22%)
Pain
9 (.22%)
Paraesthesia
9 (.22%)
Pericarditis
9 (.22%)
Renal Impairment
9 (.22%)
Surgery
9 (.22%)
Toxic Epidermal Necrolysis
9 (.22%)
Abdominal Pain
8 (.2%)
Abdominal Pain Upper
8 (.2%)
Acute Tonsillitis
8 (.2%)

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This graph shows the top adverse events submitted to the FDA for Azulfidine, 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 Azulfidine 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 Azulfidine

What are the most common Azulfidine adverse events reported to the FDA?

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This graph shows the top categories of adverse events submitted to the FDA for Azulfidine, 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 Azulfidine 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 Azulfidine According to Those Reporting Adverse Events

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

Rheumatoid Arthritis
1245
Product Used For Unknown Indication
107
Colitis Ulcerative
57
Drug Use For Unknown Indication
49
Crohns Disease
49
Musculoskeletal Pain
45
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Ankylosing Spondylitis
25
Psoriatic Arthropathy
25
Arthritis
24
Arthralgia
14
Juvenile Arthritis
10
Colitis
10
Spondylitis
10
Seronegative Arthritis
10
Ill-defined Disorder
9
Psoriasis
7
Polyarthritis
6
Inflammatory Bowel Disease
5
Osteoarthritis
5
Spondyloarthropathy
4
Arthropathy
4
Polymyalgia Rheumatica
4
Interstitial Lung Disease
3
Gastrointestinal Disorder
3
Exostosis
3
Caplans Syndrome
3
Inflammation
3
Pain
2
Diarrhoea
2
Sapho Syndrome
2
Scleroderma
2
Spinal Cord Disorder
2
Antiinflammatory Therapy
2
Irritable Bowel Syndrome
2
Vasculitis
2
Tendon Disorder
2
Uveitis
2
Sjogrens Syndrome
2
Borrelia Test Positive
2
Arrhythmia
2
Gastric Disorder
1
Prophylaxis
1
Fatigue
1
Major Depression
1
Spinal Osteoarthritis
1
Rosacea
1
Joint Swelling
1
Swelling
1
Rheumatoid Vasculitis
1
Neoplasm
1
Myositis
1

Drug Labels

LabelLabelerEffective
Azulfidine En-tabsPharmacia and Upjohn Company LLC03-DEC-12
AzulfidinePharmacia and Upjohn Company LLC03-DEC-12

Azulfidine Case Reports

What Azulfidine 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 Azulfidine. 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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