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Mercaptopurine (Mercaptopurine) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Mercaptopurine and submitted to the FDA during the sample period of about a year. The information is not vetted and should not be considered as verified clinical evidence.

Reports by Event Outcome

All Cases (419)
Death (80)
Life Threatening Events (15)
Disability (12)

Reports by Reaction Type

Osteonecrosis (35)Pyrexia (32)Acute Myeloid Leukaemia (26)Off Label Use (24)Infection (21)Diarrhoea (17)Rash (16)Headache (15)Maternal Exposure During Pregnancy (15)Hepatosplenic T-Cell Lymphoma (15)Abdominal Pain (14)Multi-Organ Failure (14)

Below are a few examples of reports where side effects / adverse reactions may be related to Mercaptopurine. For a complete list or a specific selection of reports, please use the links above.

Possible Mercaptopurine side effects in 10 year old male

Reported by a physician from United States on 2012-08-27

Patient: 10 year old male, weighing 76.1 kg (167.4 pounds)

Reactions: Hypersensitivity, Hyperglycaemia, Peripheral Motor Neuropathy

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Cyclophosphamide
    Dosage: 1000mgm2 cyclic
    Indication: T-Cell Type Acute Leukaemia

Cytarabine
    Dosage: 75mgm2 cyclic
    Indication: T-Cell Type Acute Leukaemia

Mercaptopurine
    Dosage: 60mgm2 cyclic
    Administration route: Oral
    Indication: T-Cell Type Acute Leukaemia

Methotrexate
    Indication: T-Cell Type Acute Leukaemia
    Start date: 2012-06-06

Nelarabine
    Dosage: 650mgm2 cyclic
    Indication: T-Cell Type Acute Leukaemia
    Start date: 2012-05-22

PEG-Asparaginase
    Indication: T-Cell Type Acute Leukaemia
    Start date: 2012-06-13

Vincristine
    Dosage: 1.5mgm2 cyclic
    Indication: T-Cell Type Acute Leukaemia
    Start date: 2012-06-13

Other drugs received by patient: Radiation



Possible Mercaptopurine side effects in male

Reported by a physician from Germany on 2012-08-24

Patient: male, weighing 48.0 kg (105.6 pounds)

Reactions: Memory Impairment

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Amphotericin B
    Dosage: 6x60 mg/d
    Administration route: Oral
    Start date: 2012-06-24

Cytarabine
    Dosage: 110 mg, per day
    Start date: 2012-08-08
    End date: 2012-08-11

Cytarabine
    Dosage: 110 mg, per day
    Start date: 2012-08-16

Furosemide
    Dosage: 2x10mg/d
    Start date: 2012-08-09
    End date: 2012-08-11

Granisetron
    Dosage: 3 mg, per day
    Start date: 2012-08-08
    End date: 2012-08-11

Granisetron
    Dosage: 3 mg, per day
    Start date: 2012-08-16

Imatinib Mesylate
    Dosage: 450 mg, per day
    Administration route: Oral
    Indication: Acute Lymphocytic Leukaemia
    Start date: 2012-07-13

Mercaptopurine
    Dosage: 1x87.5mg/d average
    Administration route: Oral
    Start date: 2012-08-06

Pantoprazole
    Dosage: 40 mg, per day
    Administration route: Oral
    Start date: 2012-06-24
    End date: 2012-08-15

Sulfamethoxazole and Trimethoprim
    Dosage: 2x120mg every sat, sun and mon
    Administration route: Oral



Possible Mercaptopurine side effects in female

Reported by a physician from United States on 2012-08-23

Patient: female

Reactions: Febrile Neutropenia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Cyclophosphamide
    Indication: Acute Lymphocytic Leukaemia
    Start date: 2012-07-21

Cytarabine
    Indication: Acute Lymphocytic Leukaemia
    Start date: 2012-07-17
    End date: 2012-07-20

Dasatinib
    Dosage: 40 milligram daily;
    Administration route: Oral
    Indication: Acute Lymphocytic Leukaemia
    Start date: 2012-05-29

Mercaptopurine
    Indication: Acute Lymphocytic Leukaemia
    Start date: 2012-07-13
    End date: 2012-07-21

Other drugs received by patient: Zofran; Miralax



Possible Mercaptopurine side effects in

Reported by a health professional (non-physician/pharmacist) from Canada on 2012-08-23

Patient:

Reactions: Neoplasm Malignant

Drug(s) suspected as cause:
Entocort EC
    Administration route: Oral
    Indication: Crohn's Disease

Infliximab, Recombinant
    Indication: Crohn's Disease

Mercaptopurine
    Indication: Crohn's Disease



Possible Mercaptopurine side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-22

Patient: female, weighing 37.2 kg (81.9 pounds)

Reactions: Tooth Loss, Respiratory Rate Increased, Pain, Off Label Use, Thinking Abnormal, Malaise, Euphoric Mood, Palpitations, Heart Rate Increased, Pancreatitis, Dizziness

Drug(s) suspected as cause:
Actiq
    Indication: Pain

Actiq
    Indication: Crohn's Disease

Mercaptopurine

Other drugs received by patient: Ciprofloxacin HCL; Morphine; Flagyl; Pentasa



Possible Mercaptopurine side effects in male

Reported by a physician from United States on 2012-08-22

Patient: male, weighing 55.2 kg (121.4 pounds)

Reactions: Unresponsive To Stimuli, Moaning, Neutropenia, Septic Shock, Cardiac Arrest

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Mercaptopurine
    Start date: 2009-08-21

Methotrexate Sodium

Prednisone

Vincristine
    End date: 2012-08-10



Possible Mercaptopurine side effects in male

Reported by a pharmacist from United States on 2012-08-21

Patient: male, weighing 81.7 kg (179.6 pounds)

Reactions: Neuropathy Peripheral, Lung Neoplasm, Hepatosplenic T-Cell Lymphoma, Nervous System Disorder, Muscle Rupture, Postoperative Abscess

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Mercaptopurine
    Start date: 2002-01-01

Mercaptopurine
    Indication: Crohn's Disease
    Start date: 2002-10-01

Mercaptopurine
    Dosage: decreased to 50 mg/day after 6-tg levels were found to be elevated
    Start date: 2004-01-01
    End date: 2006-08-01

Prednisone TAB
    Indication: Crohn's Disease
    Start date: 2003-08-01

Remicade
    Dosage: in 2006, the patient received 3 doses; 24 total doses over total treatment period
    Indication: Crohn's Disease
    Start date: 2002-10-01
    End date: 2006-08-01

Other drugs received by patient: Nexium; Folic Acid; Singulair; Asacol; Calcium; Nystatin; Balsalazide Disodium



Possible Mercaptopurine side effects in 8 year old female

Reported by a health professional (non-physician/pharmacist) from Turkey on 2012-08-21

Patient: 8 year old female

Reactions: Mucoepidermoid Carcinoma

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Cyclophosphamide
    Indication: Acute Lymphocytic Leukaemia

Cytarabine
    Indication: Acute Lymphocytic Leukaemia

Doxorubicin HCL
    Indication: Acute Lymphocytic Leukaemia

Elspar
    Dosage: unk
    Indication: Acute Lymphocytic Leukaemia

Mercaptopurine
    Indication: Acute Lymphocytic Leukaemia

Methotrexate

Methotrexate
    Indication: Acute Lymphocytic Leukaemia

Prednisone TAB
    Dosage: unk
    Indication: Acute Lymphocytic Leukaemia

Vincristine
    Indication: Acute Lymphocytic Leukaemia



Possible Mercaptopurine side effects in male

Reported by a physician from United Kingdom on 2012-08-21

Patient: male

Reactions: Pelvic Pain, Pyrexia, Anal Fistula, C-Reactive Protein Increased, Splenomegaly, Rectal Abscess, Lethargy, Hepatosplenic T-Cell Lymphoma, Crohn's Disease, Sepsis, Platelet Count Decreased, Diabetic Ketoacidosis, Neutropenia, Rectal Discharge, Leukopenia, Influenza Like Illness

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Azathioprine Sodium
    Dosage: 2.5 mg/kg
    Indication: Crohn's Disease

Azathioprine Sodium
    Start date: 2002-01-01
    End date: 2006-09-01

Azathioprine Sodium
    Start date: 2001-06-01

Mercaptopurine
    Indication: Crohn's Disease

Prednisolone
    Indication: Product Used FOR Unknown Indication

Remicade
    Indication: Crohn's Disease
    End date: 2005-09-29

Remicade
    Dosage: stopped in february - march (3rd infusion)
    End date: 2006-02-01

Other drugs received by patient: Metronidazole; Vitamin B-12



Possible Mercaptopurine side effects in male

Reported by a physician from United States on 2012-08-21

Patient: male

Reactions: Multi-Organ Failure, Hepatosplenic T-Cell Lymphoma, Staphylococcal Abscess

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Mercaptopurine
    Indication: Crohn's Disease

Remicade
    Dosage: date also reported as 5-may-2005
    Start date: 2005-04-01

Remicade
    Dosage: second dose
    Indication: Crohn's Disease
    Start date: 2005-03-21

Remicade
    Start date: 2000-01-01

Other drugs received by patient: Prednisone TAB; Mesalamine



Possible Mercaptopurine side effects in 66 year old female

Reported by a consumer/non-health professional from United States on 2012-08-21

Patient: 66 year old female, weighing 83.0 kg (182.6 pounds)

Reactions: Diplopia, Diarrhoea, Rash

Drug(s) suspected as cause:
Mercaptopurine
    Administration route: Oral
    Indication: Crohn's Disease
    Start date: 2010-08-01
    End date: 2010-03-01

Mercaptopurine
    Administration route: Oral
    Start date: 2011-03-01
    End date: 2011-06-01

Mercaptopurine
    Administration route: Oral
    Start date: 2011-06-01

Metoprolol Succinate
    Administration route: Oral
    Indication: Blood Pressure Increased
    Start date: 2006-01-01
    End date: 2011-06-01

Other drugs received by patient: Omeprazole; Simvastatin; Amitriptyline HCL; Lisinopril



Possible Mercaptopurine side effects in male

Reported by a physician from United States on 2012-08-21

Patient: male, weighing 92.1 kg (202.6 pounds)

Reactions: T-Cell Lymphoma

Adverse event resulted in: death

Drug(s) suspected as cause:
Mercaptopurine
    Start date: 1999-04-01

Mercaptopurine
    Indication: Crohn's Disease
    Start date: 1999-05-01
    End date: 2002-05-12

Mesalamine
    Indication: Crohn's Disease

Remicade

Remicade
    Indication: Crohn's Disease
    Start date: 1999-04-17
    End date: 1999-04-17

Other drugs received by patient: Prednisone TAB



Possible Mercaptopurine side effects in male

Reported by a physician from United States on 2012-08-21

Patient: male, weighing 81.2 kg (178.6 pounds)

Reactions: Mechanical Ventilation, Renal Failure, Hepatosplenic T-Cell Lymphoma, Sinus Disorder, Pneumothorax

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Mercaptopurine
    Administration route: Oral

Mercaptopurine
    Administration route: Oral
    Indication: Crohn's Disease

Mercaptopurine
    Administration route: Oral
    Start date: 2005-02-01

Remicade
    Dosage: started in oct or nov-2005
    Indication: Crohn's Disease
    Start date: 2005-10-01

Remicade
    Dosage: once every 6 to 7 weeks
    End date: 2007-11-20

Other drugs received by patient: Steroids NOS; Allopurinol; Ambien; Wellbutrin; Doxycycline HCL; Protonix; Bentyl; Claritin; Mesalamine; Zoloft



Possible Mercaptopurine side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-21

Patient: female

Reactions: Malaise

Drug(s) suspected as cause:
Mercaptopurine



Possible Mercaptopurine side effects in male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-21

Patient: male, weighing 63.5 kg (139.7 pounds)

Reactions: Night Sweats, Cellulitis, Hepatosplenic T-Cell Lymphoma, Pyrexia, Thirst, Laryngitis, Leukocytoclastic Vasculitis, Epstein-Barr Virus Infection, Fatigue, Sinus Headache, Bacterial Infection, Vision Blurred, Pharyngitis

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Mercaptopurine
    Dosage: 25mg am, 25mg pm
    Indication: Crohn's Disease
    Start date: 1999-11-01
    End date: 2001-02-01

Mercaptopurine
    Dosage: 25mg am, 25mg pm
    Start date: 1998-05-01

Mercaptopurine
    Dosage: 25mg am, 25mg pm
    Start date: 1997-12-01

Mercaptopurine
    Dosage: 25mg am, 25mg pm
    Start date: 1997-07-01

Remicade
    Start date: 2000-06-16

Remicade
    Start date: 2000-02-03

Remicade
    Start date: 2003-01-06

Remicade
    Start date: 2002-11-15

Remicade
    Start date: 2002-09-27

Remicade
    Start date: 1999-12-03

Remicade
    Start date: 1999-09-01

Remicade
    Start date: 2002-06-21

Remicade
    Indication: Crohn's Disease
    Start date: 2000-08-17

Remicade
    Start date: 2000-11-05

Remicade
    Start date: 2002-08-09

Remicade
    Start date: 2002-02-22

Remicade
    Start date: 2002-02-11

Other drugs received by patient: Prilosec; Azathioprine Sodium; Imuran; Prednisone TAB; Corticosteroids; Fosamax



Possible Mercaptopurine side effects in female

Reported by a physician from United States on 2012-08-21

Patient: female, weighing 53.0 kg (116.6 pounds)

Reactions: Hepatosplenic T-Cell Lymphoma, Neutropenic Sepsis

Adverse event resulted in: death

Drug(s) suspected as cause:
Mercaptopurine

Mercaptopurine
    Indication: Crohn's Disease

Mesalamine
    Indication: Crohn's Disease

Remicade
    Dosage: summer 2003
    Indication: Crohn's Disease
    Start date: 2001-01-15
    End date: 2003-08-15

Other drugs received by patient: Metronidazole; Hydrocortisone; Prednisone TAB



Possible Mercaptopurine side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-21

Patient: female

Reactions: Night Sweats, Hot Flush

Drug(s) suspected as cause:
Mercaptopurine

Other drugs received by patient: Vitamin TAB



Possible Mercaptopurine side effects in male

Reported by a physician from United States on 2012-08-17

Patient: male, weighing 31.5 kg (69.3 pounds)

Reactions: Pancreatitis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Cyclophosphamide
    Dosage: 1000mgm2 cyclic
    Indication: T-Cell Type Acute Leukaemia

Cytarabine
    Dosage: 75mgm2 cyclic
    Indication: T-Cell Type Acute Leukaemia

Mercaptopurine
    Dosage: 60mgm2 cyclic
    Administration route: Oral
    Indication: T-Cell Type Acute Leukaemia

Methotrexate
    Indication: T-Cell Type Acute Leukaemia

Nelarabine
    Dosage: 650mgm2 cyclic
    Indication: T-Cell Type Acute Leukaemia
    Start date: 2012-06-06

PEG-Asparaginase
    Indication: T-Cell Type Acute Leukaemia

Vincristine
    Dosage: 1.5mgm2 cyclic
    Indication: T-Cell Type Acute Leukaemia

Other drugs received by patient: Radiation



Possible Mercaptopurine side effects in female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-17

Patient: female

Reactions: Off Label Use, Ileostomy, Intestinal Operation, Pelvic Pouch Procedure, Pouchitis, Treatment Failure

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Humira
    Dosage: 40 mg/0.8 ml pre-filled syringe
    Start date: 2009-08-01

Humira
    Indication: Pouchitis
    Start date: 2012-06-06

Humira
    Dosage: 40 mg/0.8 ml pre-filled syringe
    Indication: Colitis Ulcerative
    Start date: 2009-08-01

Humira
    Start date: 2012-06-06

Mercaptopurine
    Dosage: 40 mg/0.8 ml pre-filled syringe
    Indication: Product Used FOR Unknown Indication

Remicade
    Indication: Colitis Ulcerative



Possible Mercaptopurine side effects in 13 year old male

Reported by a health professional (non-physician/pharmacist) from Japan on 2012-08-17

Patient: 13 year old male, weighing 40.0 kg (88.0 pounds)

Reactions: Pancreatitis Acute

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Azathioprine Sodium
    Indication: Colitis Ulcerative

Mercaptopurine
    Indication: Colitis Ulcerative



Possible Mercaptopurine side effects in female

Reported by a consumer/non-health professional from United States on 2012-08-16

Patient: female, weighing 37.2 kg (81.9 pounds)

Reactions: Respiratory Rate Increased, Tooth Loss, Pain, Off Label Use, Thinking Abnormal, Malaise, Euphoric Mood, Palpitations, Heart Rate Increased, Dizziness, Pancreatitis

Drug(s) suspected as cause:
Actiq
    Indication: Pain

Actiq
    Indication: Crohn's Disease

Mercaptopurine

Other drugs received by patient: Pentasa; Ciprofloxacin HCL; Flagyl



Possible Mercaptopurine side effects in

Reported by a health professional (non-physician/pharmacist) from Canada on 2012-08-13

Patient:

Reactions: Neoplasm Malignant

Drug(s) suspected as cause:
Budesonide
    Indication: Crohn's Disease

Infliximab, Recombinant
    Indication: Crohn's Disease

Mercaptopurine
    Indication: Crohn's Disease



Possible Mercaptopurine side effects in 56 year old female

Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-08-09

Patient: 56 year old female

Reactions: Angiocentric Lymphoma, Renal Mass

Drug(s) suspected as cause:
Mercaptopurine



Possible Mercaptopurine side effects in 18 year old male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-08

Patient: 18 year old male

Reactions: Hodgkin's Disease Stage IV

Drug(s) suspected as cause:
Mercaptopurine
    Indication: Colitis Ulcerative

Mesalamine
    Indication: Colitis Ulcerative



Possible Mercaptopurine side effects in 9 year old female

Reported by a physician from Australia on 2012-08-08

Patient: 9 year old female, weighing 38.9 kg (85.6 pounds)

Reactions: Upper Respiratory Tract Infection, Alanine Aminotransferase Increased

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Cyclophosphamide
    Dosage: 1000mgm2 cyclic
    Indication: T-Cell Type Acute Leukaemia

Cytarabine
    Dosage: 75mgm2 cyclic
    Indication: T-Cell Type Acute Leukaemia

Mercaptopurine
    Dosage: 60mgm2 cyclic
    Administration route: Oral
    Indication: T-Cell Type Acute Leukaemia

Methotrexate
    Indication: T-Cell Type Acute Leukaemia

Nelarabine
    Dosage: 650mgm2 cyclic
    Indication: T-Cell Type Acute Leukaemia
    Start date: 2012-05-10

PEG-Asparaginase
    Indication: T-Cell Type Acute Leukaemia

Vincristine
    Dosage: 1.5mgm2 cyclic
    Indication: T-Cell Type Acute Leukaemia



Possible Mercaptopurine side effects in 12 year old male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-08

Patient: 12 year old male

Reactions: non-Hodgkin's Lymphoma

Drug(s) suspected as cause:
Mercaptopurine
    Indication: Crohn's Disease

Mesalamine
    Indication: Crohn's Disease



Possible Mercaptopurine side effects in female

Reported by a physician from United States on 2012-08-07

Patient: female, weighing 44.9 kg (98.8 pounds)

Reactions: Small Intestinal Obstruction

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Humira

Humira
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-07-01

Mercaptopurine
    Indication: Product Used FOR Unknown Indication

Remicade
    Indication: Inflammatory Bowel Disease
    Start date: 2009-11-14
    End date: 2010-07-02



Possible Mercaptopurine side effects in male

Reported by a physician from United States on 2012-08-07

Patient: male, weighing 75.2 kg (165.4 pounds)

Reactions: Clostridium Difficile Colitis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Dexamethasone
    Dosage: 12 mg

Mercaptopurine
    Dosage: 150 mg

Methotrexate
    Dosage: 40 mg receives once weekly

Vincristine Sulfate
    Dosage: 2 mg



Possible Mercaptopurine side effects in 5 year old male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-07

Patient: 5 year old male

Reactions: Alanine Aminotransferase Increased, Aspartate Aminotransferase Increased

Drug(s) suspected as cause:
Mercaptopurine
    Dosage: 2800 milligram total
    Administration route: Oral
    Indication: B Precursor Type Acute Leukaemia
    Start date: 2010-06-11

Methotrexate
    Dosage: 110 milligram total
    Administration route: Oral
    Indication: B Precursor Type Acute Leukaemia
    Start date: 2010-06-11

Prednisone
    Dosage: 270 milligram total
    Administration route: Oral
    Indication: B Precursor Type Acute Leukaemia
    Start date: 2010-06-11

Sprycel
    Dosage: 1120 milligram total
    Administration route: Oral
    Indication: B Precursor Type Acute Leukaemia
    Start date: 2010-06-11

Vincristine
    Dosage: 2 milligram total
    Indication: B Precursor Type Acute Leukaemia
    Start date: 2010-06-11



Possible Mercaptopurine side effects in female

Reported by a pharmacist from United States on 2012-08-06

Patient: female

Reactions: Drug Ineffective

Drug(s) suspected as cause:
Mercaptopurine

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