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MERCAPTOPURINE

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Mercaptopurine Adverse Events Reported to the FDA Over Time

How are Mercaptopurine adverse event reports trending over time?

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

Most Common Mercaptopurine Adverse Events Reported to the FDA

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

Pyrexia
151 (1.9%)
Neutropenia
135 (1.7%)
Nausea
108 (1.36%)
Vomiting
93 (1.17%)
Febrile Neutropenia
84 (1.06%)
Headache
84 (1.06%)
Hepatosplenic T-cell Lymphoma
79 (1%)
Diarrhoea
78 (.98%)
Sepsis
75 (.95%)
Acute Myeloid Leukaemia
66 (.83%)
Pancytopenia
65 (.82%)
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Abdominal Pain
62 (.78%)
Alanine Aminotransferase Increased
62 (.78%)
Pancreatitis
60 (.76%)
Fatigue
59 (.74%)
Pneumonia
55 (.69%)
Hypotension
54 (.68%)
White Blood Cell Count Decreased
54 (.68%)
Aspartate Aminotransferase Increase...
53 (.67%)
Blood Bilirubin Increased
49 (.62%)
Haemoglobin Decreased
49 (.62%)
Osteonecrosis
45 (.57%)
Rash
45 (.57%)
Infection
43 (.54%)
Multi-organ Failure
42 (.53%)
Anaemia
41 (.52%)
Leukopenia
41 (.52%)
Convulsion
40 (.5%)
Renal Impairment
40 (.5%)
Dyspnoea
39 (.49%)
Thrombocytopenia
39 (.49%)
Drug Ineffective
38 (.48%)
Glioma
38 (.48%)
Platelet Count Decreased
38 (.48%)
Hyperglycaemia
37 (.47%)
Myelodysplastic Syndrome
36 (.45%)
Drug Toxicity
33 (.42%)
Asthenia
32 (.4%)
Hyperbilirubinaemia
31 (.39%)
Pleural Effusion
31 (.39%)
Weight Decreased
31 (.39%)
Renal Failure
30 (.38%)
Respiratory Distress
30 (.38%)
Treatment Related Secondary Maligna...
30 (.38%)
Pain
29 (.37%)
Muscular Weakness
28 (.35%)
Off Label Use
28 (.35%)
Respiratory Failure
28 (.35%)
Cytogenetic Abnormality
27 (.34%)
Leukoencephalopathy
27 (.34%)
B-cell Lymphoma
26 (.33%)
Back Pain
25 (.32%)
Hypertension
25 (.32%)
Neutrophil Count Decreased
25 (.32%)
Septic Shock
25 (.32%)
Cardio-respiratory Arrest
24 (.3%)
Chills
24 (.3%)
Decreased Appetite
24 (.3%)
Acute Respiratory Distress Syndrome
23 (.29%)
Cough
23 (.29%)
Dehydration
23 (.29%)
Hepatotoxicity
23 (.29%)
Pancreatitis Acute
23 (.29%)
Tachycardia
23 (.29%)
Dizziness
22 (.28%)
Hepatic Failure
22 (.28%)
Malaise
22 (.28%)
Jaundice
21 (.26%)
Ascites
20 (.25%)
Condition Aggravated
20 (.25%)
Depressed Level Of Consciousness
20 (.25%)
Nervous System Disorder
20 (.25%)
Sinus Tachycardia
20 (.25%)
Hemiparesis
19 (.24%)
Herpes Zoster
19 (.24%)
Hypersensitivity
19 (.24%)
Lethargy
19 (.24%)
Mucosal Inflammation
19 (.24%)
Arthralgia
18 (.23%)
Bone Marrow Failure
18 (.23%)
Chronic Myeloid Leukaemia
18 (.23%)
General Physical Health Deteriorati...
18 (.23%)
Splenomegaly
18 (.23%)
Alopecia
17 (.21%)
Anxiety
17 (.21%)
Coagulopathy
17 (.21%)
Hepatic Function Abnormal
17 (.21%)
Hepatic Steatosis
17 (.21%)
Hypophagia
17 (.21%)
Influenza Like Illness
17 (.21%)
Leukaemia Recurrent
17 (.21%)
Mental Status Changes
17 (.21%)
Staphylococcal Infection
17 (.21%)
Abdominal Distension
16 (.2%)
Blood Culture Positive
16 (.2%)
Death
16 (.2%)
Diabetic Ketoacidosis
16 (.2%)
Hepatic Enzyme Increased
16 (.2%)
Hypoxia
16 (.2%)
Loss Of Consciousness
16 (.2%)
Lung Neoplasm
16 (.2%)

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

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

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

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

Crohns Disease
1119
Acute Lymphocytic Leukaemia
399
Product Used For Unknown Indication
369
Colitis Ulcerative
249
Drug Use For Unknown Indication
185
Acute Promyelocytic Leukaemia
80
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Inflammatory Bowel Disease
40
Burkitts Lymphoma
32
Chemotherapy
30
T-cell Type Acute Leukaemia
29
B Precursor Type Acute Leukaemia
24
Colitis
18
Acute Myeloid Leukaemia
17
Autoimmune Hepatitis
12
Non-hodgkins Lymphoma
10
B-cell Type Acute Leukaemia
7
Acute Myelomonocytic Leukaemia
7
Ill-defined Disorder
6
Systemic Lupus Erythematosus
6
Gestational Trophoblastic Tumour
6
Lymphocytic Leukaemia
6
Malignant Histiocytosis
5
Neoplasm Malignant
5
Acute Myeloid Leukaemia Recurrent
5
Immunosuppressant Drug Therapy
5
Precursor B-lymphoblastic Lymphoma
5
Drug Exposure During Pregnancy
5
Leukaemia
4
Rheumatoid Arthritis
4
Chronic Granulomatous Disease
4
Maternal Exposure During Pregnancy
3
Chronic Myeloid Leukaemia
3
Acute Lymphocytic Leukaemia Recurre...
3
Immunosuppression
3
Langerhans Cell Granulomatosis
3
Leukaemia Recurrent
3
Fistula
2
Renal Failure Acute
2
Anal Fistula
2
Gastrointestinal Disorder
2
Precursor T-lymphoblastic Lymphoma/...
2
Anaplastic Large Cell Lymphoma T- A...
2
Haematopoietic Neoplasm
2
Thrombocytopenia
2
Pouchitis
2
Irritable Bowel Syndrome
2
Abdominal Discomfort
2
Leukocytosis
2
Retroperitoneal Fibrosis
2
Diffuse Large B-cell Lymphoma
2
Inflammatory Marker Increased
2

Drug Labels

LabelLabelerEffective
MercaptopurineREMEDYREPACK INC. 03-NOV-11
MercaptopurineTeva Pharmaceuticals USA Inc01-MAY-12
MercaptopurinePar Pharmaceutical Companies, Inc.03-JUL-12
PurinetholGate Pharmaceuticals02-AUG-12
MercaptopurinePhysicians Total Care, Inc.01-OCT-12
MercaptopurineRoxane Laboratories, Inc01-NOV-12
MercaptopurineMylan Pharmaceuticals Inc.14-MAR-13
MercaptopurineAmerican Health Packaging15-MAR-13

Mercaptopurine Case Reports

What Mercaptopurine 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 Mercaptopurine. 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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