This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Purinethol (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 (29)
Death (3)
Life Threatening Events (4)
Reports by Reaction Type
Diarrhoea (8),
Crohn's Disease (7),
Drug Ineffective (6),
Abdominal Pain (5),
Rectal Haemorrhage (5),
Post Procedural Infection (5),
Hyperbilirubinaemia (4),
Hepatosplenic T-Cell Lymphoma (4),
Weight Decreased (3),
Cholestasis (3),
Hepatic Failure (2),
Change of Bowel Habit (2)
Possible Purinethol side effects in male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-21
Patient: male, weighing 69.0 kg (151.8 pounds)
Reactions: Hepatosplenic T-Cell Lymphoma
Adverse event resulted in: death, life threatening event, hospitalization
Drug(s) suspected as cause:
Humira
Indication: Colitis Ulcerative
Start date: 2007-06-15
Purinethol
Dosage: also reported with start date of 01-oct-1999
Start date: 1999-06-02
Remicade
Dosage: 19 infusions administered between 10-jul-2002 and 7-mar-2006
Indication: Inflammatory Bowel Disease
Start date: 2002-07-10
End date: 2006-03-07
Remicade
Dosage: 19 infusions administered between 10-jul-2002 and 7-mar-2006
Indication: Colitis Ulcerative
Start date: 2002-07-10
End date: 2006-03-07
Humira
Start date: 2007-06-15
Purinethol
Dosage: also reported with start date of 01-oct-1999
Start date: 1999-06-02
Humira
Start date: 2006-11-01
Purinethol
Indication: Inflammatory Bowel Disease
End date: 2007-04-01
Purinethol
Indication: Colitis Ulcerative
End date: 2007-04-01
Remicade
Dosage: 19 infusions administered between 10-jul-2002 and 7-mar-2006
Indication: Crohn's Disease
Start date: 2002-07-10
End date: 2006-03-07
Humira
Indication: Irritable Bowel Syndrome
Start date: 2006-11-01
Other drugs received by patient: Prednisone TAB; Asacol; Prednisone TAB; Asacol
Possible Purinethol side effects in 49 year old female
Reported by a health professional (non-physician/pharmacist) from France on 2012-07-25
Patient: 49 year old female
Reactions: Pancytopenia
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Purinethol
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Start date: 2011-11-15
End date: 2011-12-30
Vesanoid
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Start date: 2011-11-16
End date: 2011-12-30
Methotrexate
Start date: 2012-01-28
Purinethol
Start date: 2012-01-28
Methotrexate
Indication: Product Used FOR Unknown Indication
Start date: 2011-11-15
End date: 2011-12-30
Vesanoid
Start date: 2012-02-07
Possible Purinethol side effects in 26 year old female
Reported by a health professional (non-physician/pharmacist) from Sweden on 2012-06-25
Patient: 26 year old female
Reactions: Pustular Psoriasis, Sacroiliitis
Drug(s) suspected as cause:
Humira
Dosage: week 0 and 2
Start date: 2012-02-21
Purinethol
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Start date: 2012-02-21
Remicade
Dosage: as necessary; 100 mg
Indication: Colitis Ulcerative
Start date: 2011-10-14
End date: 2012-01-12
Humira
Indication: Colitis Ulcerative
End date: 2012-03-06
Other drugs received by patient: Calcium Carbonate / Cholecalciferol
Possible Purinethol side effects in male
Reported by a lawyer from United States on 2012-06-22
Patient: male, weighing 81.6 kg (179.5 pounds)
Reactions: Adenocarcinoma, Osteoporosis, Colitis Ulcerative, Crohn's Disease, Anaemia Macrocytic, Inflammatory Bowel Disease
Drug(s) suspected as cause:
Prednisone TAB
Indication: Crohn's Disease
Accutane
Administration route: Oral
Indication: Acne
Start date: 1984-01-12
End date: 1984-06-03
Purinethol
Indication: Crohn's Disease
Other drugs received by patient: Boniva
Possible Purinethol side effects in female
Reported by a physician from France on 2012-06-13
Patient: female
Reactions: Failed Induction of Labour, Proteinuria, Urinary Tract Infection, Oedema, PRE-Eclampsia, Hypertension
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Humira
Indication: Colitis Ulcerative
Purinethol
Administration route: Oral
Indication: Colitis Ulcerative
End date: 2012-04-03
Other drugs received by patient: Prednisone TAB
Possible Purinethol side effects in female
Reported by a health professional (non-physician/pharmacist) from France on 2012-04-24
Patient: female
Reactions: Weight Decreased, Jaundice, Hyperbilirubinaemia, Diarrhoea, Transaminases Increased, Asthenia
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Methotrexate
Dosage: 25 mg once weekly
Indication: Acute Lymphocytic Leukaemia
End date: 2009-10-28
Micardis
Administration route: Oral
Start date: 2009-08-15
End date: 2009-10-28
Purinethol
Dosage: 100 mg
Administration route: Oral
Indication: Acute Lymphocytic Leukaemia
Start date: 2009-05-12
End date: 2009-10-28
Other drugs received by patient: Zithromax
Possible Purinethol side effects in male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-04-19
Patient: male, weighing 68.0 kg (149.7 pounds)
Reactions: Hepatosplenic T-Cell Lymphoma
Drug(s) suspected as cause:
Purinethol
Other drugs received by patient: Asacol
Possible Purinethol side effects in female
Reported by a physician from Israel on 2012-04-06
Patient: female, weighing 64.7 kg (142.3 pounds)
Reactions: Fistula, Anal Abscess
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Purinethol
Dosage: mercaptopurine 40mg or 80mg or purinethol
Administration route: Oral
Indication: Crohn's Disease
Start date: 2011-11-27
End date: 2012-02-12
Mercaptopurine
Dosage: mercaptopurine 40mg or 80mg or purinethol
Administration route: Oral
Indication: Crohn's Disease
Start date: 2011-06-09
End date: 2012-02-12
Other drugs received by patient: Budesonide; Pentasa
Possible Purinethol side effects in female
Reported by a physician from France on 2012-03-27
Patient: female
Reactions: Hepatic Failure, Hepatitis
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Vesanoid
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Start date: 2011-10-27
End date: 2012-01-25
Purinethol
Dosage: 50 mg
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Start date: 2011-12-21
End date: 2012-01-25
Valacyclovir Hydrochloride
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Start date: 2011-12-21
End date: 2012-01-25
Bactrim
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Start date: 2011-12-21
End date: 2012-01-25
Methotrexate
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Start date: 2011-12-21
End date: 2012-01-25
Baraclude
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Start date: 2011-09-15
End date: 2012-01-25
Possible Purinethol side effects in female
Reported by a physician from France on 2012-03-23
Patient: female
Reactions: Hepatic Failure, Hepatitis
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Vesanoid
Dosage: 900mg every 3 months
Administration route: Oral
Indication: Chemotherapy
Start date: 2011-10-27
End date: 2012-01-25
Baraclude
Dosage: 1tab per day
Administration route: Oral
Indication: Hepatitis B
Start date: 2011-09-15
End date: 2012-01-25
Bactrim
Administration route: Oral
Indication: Prophylaxis
Start date: 2011-12-21
End date: 2012-01-25
Valacyclovir Hydrochloride
Administration route: Oral
Indication: Prophylaxis
Start date: 2011-12-21
End date: 2012-01-25
Purinethol
Dosage: 1tab twice per day
Administration route: Oral
Indication: Chemotherapy
Start date: 2011-12-21
End date: 2012-01-25
Methotrexate
Dosage: 20mg weekly
Administration route: Oral
Indication: Acute Promyelocytic Leukaemia
Start date: 2011-12-21
End date: 2012-01-25
Other drugs received by patient: Viread
Possible Purinethol side effects in 7 year old female
Reported by a health professional (non-physician/pharmacist) from France on 2012-03-08
Patient: 7 year old female
Reactions: Lung Disorder, Neutropenia, Thrombocytopenia, Leukopenia
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Purinethol
Dosage: 50 mg/m2/day
Indication: T-Cell Lymphoma Stage III
Cytarabine
Dosage: 75 mg/m2/day, for 4 days
Indication: T-Cell Lymphoma Stage III
Other drugs received by patient: Cyclophosphamide
Possible Purinethol side effects in male
Reported by a physician from United States on 2012-02-27
Patient: male, weighing 84.0 kg (184.8 pounds)
Reactions: Abdominal Pain, Drug Ineffective, Diarrhoea, Rectal Haemorrhage, Crohn's Disease, Post Procedural Infection
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Humira
Indication: Crohn's Disease
Start date: 2008-01-01
Purinethol
Indication: Crohn's Disease
End date: 2010-11-01
Humira
Start date: 2011-12-01
Possible Purinethol side effects in female
Reported by a physician from Israel on 2012-02-19
Patient: female, weighing 64.7 kg (142.3 pounds)
Reactions: Fistula, Anal Abscess
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Purinethol
Dosage: mercaptopurine 40mg or 80mg or purinethol
Administration route: Oral
Indication: Crohn's Disease
Start date: 2011-11-27
End date: 2012-02-12
Mercaptopurine
Dosage: mercaptopurine 40mg or 80mg or purinethol
Administration route: Oral
Indication: Crohn's Disease
Start date: 2011-06-09
End date: 2011-09-01
Other drugs received by patient: Budesonide; Pentasa
Possible Purinethol side effects in 42 year old male
Reported by a consumer/non-health professional from Germany on 2012-02-15
Patient: 42 year old male, weighing 87.0 kg (191.4 pounds)
Reactions: Hyperbilirubinaemia, Cholestasis
Drug(s) suspected as cause:
Vincristine
Indication: Acute Lymphocytic Leukaemia
Start date: 2011-12-26
Dasatinib
Dosage: interrupted:12jan12 to 17jan12.
Indication: Acute Lymphocytic Leukaemia
Cyclophosphamide
Dosage: also taken on 25jan12
Indication: Acute Lymphocytic Leukaemia
Start date: 2012-01-01
Purinethol
Administration route: Oral
Indication: Acute Lymphocytic Leukaemia
Start date: 2012-01-07
End date: 2012-01-09
Pegaspargase
Dosage: 1df= 4000u
Indication: Acute Lymphocytic Leukaemia
Start date: 2011-12-26
Methotrexate
Dosage: also on 10jan12,18jan12
Indication: Acute Lymphocytic Leukaemia
Start date: 2012-01-03
Possible Purinethol side effects in 42 year old male
Reported by a consumer/non-health professional from Germany on 2012-02-14
Patient: 42 year old male, weighing 87.0 kg (191.4 pounds)
Reactions: Hyperbilirubinaemia, Cholestasis
Drug(s) suspected as cause:
Vincristine
Indication: Acute Lymphocytic Leukaemia
Start date: 2011-12-26
Cyclophosphamide
Dosage: also taken on 25jan12
Indication: Acute Lymphocytic Leukaemia
Start date: 2012-01-01
Purinethol
Administration route: Oral
Indication: Acute Lymphocytic Leukaemia
Start date: 2012-01-07
End date: 2012-01-09
Dasatinib
Dosage: interrupted:12jan12 to 17jan12.
Indication: Acute Lymphocytic Leukaemia
Methotrexate
Dosage: also on 10jan12,18jan12
Indication: Acute Lymphocytic Leukaemia
Start date: 2012-01-03
Pegaspargase
Dosage: 1df= 4000u
Indication: Acute Lymphocytic Leukaemia
Start date: 2011-12-26
Possible Purinethol side effects in female
Reported by a physician from Israel on 2012-02-02
Patient: female, weighing 53.5 kg (117.7 pounds)
Reactions: Pancreatitis Acute
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Purinethol
Dosage: mercaptopurine 40mg or 80mg or purinethol
Administration route: Oral
Indication: Crohn's Disease
Start date: 2011-09-26
End date: 2011-10-02
Mercaptopurine
Dosage: mercaptopurine 40mg or 80mg or purinethol
Administration route: Oral
Indication: Crohn's Disease
Start date: 2011-09-26
End date: 2011-10-02
Other drugs received by patient: Pentasa
Possible Purinethol side effects in male
Reported by a physician from United States on 2012-01-23
Patient: male, weighing 84.0 kg (184.8 pounds)
Reactions: Abdominal Pain, Diarrhoea, Drug Ineffective, Rectal Haemorrhage, Crohn's Disease, Post Procedural Infection
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Humira
Start date: 2011-02-21
End date: 2011-11-15
Humira
Indication: Crohn's Disease
Start date: 2009-01-01
End date: 2010-11-01
Purinethol
Indication: Crohn's Disease
End date: 2010-11-01
Possible Purinethol side effects in male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-01-20
Patient: male, weighing 69.0 kg (151.8 pounds)
Reactions: Hepatosplenic T-Cell Lymphoma
Adverse event resulted in: death, life threatening event, hospitalization
Drug(s) suspected as cause:
Remicade
Dosage: 19 infusions administered between 10-jul-2002 and 7-mar-2006
Indication: Inflammatory Bowel Disease
Start date: 2002-07-10
End date: 2006-03-07
Humira
Start date: 2006-11-01
Remicade
Dosage: 19 infusions administered between 10-jul-2002 and 7-mar-2006
Indication: Colitis Ulcerative
Start date: 2002-07-10
End date: 2006-03-07
Humira
Start date: 2007-06-15
Purinethol
Indication: Colitis Ulcerative
End date: 2007-04-01
Purinethol
Dosage: also reported with start date of 01-oct-1999
Start date: 1999-06-02
Humira
Indication: Irritable Bowel Syndrome
Start date: 2006-11-01
Purinethol
Indication: Inflammatory Bowel Disease
End date: 2007-04-01
Remicade
Dosage: 19 infusions administered between 10-jul-2002 and 7-mar-2006
Indication: Crohn's Disease
Start date: 2002-07-10
End date: 2006-03-07
Humira
Indication: Colitis Ulcerative
Start date: 2007-06-15
Purinethol
Dosage: also reported with start date of 01-oct-1999
Start date: 1999-06-02
Other drugs received by patient: Asacol; Prednisone; Asacol; Prednisone
Possible Purinethol side effects in 42 year old male
Reported by a consumer/non-health professional from Germany on 2012-01-20
Patient: 42 year old male, weighing 87.0 kg (191.4 pounds)
Reactions: Hyperbilirubinaemia, Cholestasis
Drug(s) suspected as cause:
Vincristine
Indication: Acute Lymphocytic Leukaemia
Start date: 2011-12-26
Cyclophosphamide
Indication: Acute Lymphocytic Leukaemia
Start date: 2012-01-01
Purinethol
Administration route: Oral
Indication: Acute Lymphocytic Leukaemia
Start date: 2012-01-07
End date: 2012-01-09
Methotrexate
Dosage: also on 10-jan-2012
Indication: Acute Lymphocytic Leukaemia
Start date: 2012-01-03
Pegaspargase
Dosage: 1df= 4000u
Indication: Acute Lymphocytic Leukaemia
Start date: 2011-12-26
Dasatinib
Dosage: interrupted:12jan2012.
Indication: Acute Lymphocytic Leukaemia
Possible Purinethol side effects in 45 year old male
Reported by a health professional (non-physician/pharmacist) from France on 2012-01-10
Patient: 45 year old male
Reactions: Listeriosis
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Purinethol
Indication: Colitis Ulcerative
Remicade
Indication: Colitis Ulcerative
Start date: 2011-06-01
Prednisolone
Administration route: Oral
Indication: Colitis Ulcerative
Other drugs received by patient: Fivasa; Imuran
Possible Purinethol side effects in male
Reported by a individual with unspecified qualification from United States on 2012-01-10
Patient: male
Reactions: Abdominal Pain, Drug Ineffective, Diarrhoea, Crohn's Disease, Rectal Haemorrhage, Post Procedural Infection
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Humira
Indication: Crohn's Disease
Start date: 2009-01-01
End date: 2010-11-01
Purinethol
Indication: Crohn's Disease
End date: 2010-11-01
Possible Purinethol side effects in male
Reported by a physician from United States on 2012-01-10
Patient: male
Reactions: Abdominal Pain, Diarrhoea, Drug Ineffective, Rectal Haemorrhage, Crohn's Disease, Post Procedural Infection
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Purinethol
Indication: Crohn's Disease
End date: 2010-11-01
Humira
Indication: Crohn's Disease
Start date: 2009-01-01
End date: 2010-11-01
Possible Purinethol side effects in male
Reported by a lawyer from United States on 2012-01-06
Patient: male, weighing 81.6 kg (179.5 pounds)
Reactions: Osteoporosis, Colitis Ulcerative, Adenocarcinoma, Crohn's Disease, Anaemia Macrocytic, Inflammatory Bowel Disease
Drug(s) suspected as cause:
Prednisone TAB
Indication: Crohn's Disease
Accutane
Administration route: Oral
Indication: Acne
Start date: 1984-01-12
End date: 1984-06-03
Purinethol
Indication: Crohn's Disease
Other drugs received by patient: Boniva
Possible Purinethol side effects in male
Reported by a consumer/non-health professional from United States on 2011-12-28
Patient: male
Reactions: Abdominal Pain, Diarrhoea, Drug Ineffective, Rectal Haemorrhage, Crohn's Disease, Post Procedural Infection
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Humira
Indication: Crohn's Disease
Start date: 2009-01-01
End date: 2010-11-01
Purinethol
Indication: Crohn's Disease
End date: 2010-11-01
Possible Purinethol side effects in male
Reported by a consumer/non-health professional from United States on 2011-12-08
Patient: male, weighing 85.3 kg (187.6 pounds)
Reactions: Weight Decreased, Chills, Impaired Work Ability, Pain, Headache, Change of Bowel Habit, Hyperhidrosis, Fatigue, Cough, Polydipsia, Renal Disorder, Vomiting, Pain in Extremity, Muscular Weakness, Rash, Tremor, Eating Disorder, Renal Impairment, Arthralgia, Diarrhoea, Insomnia, Increased Tendency To Bruise, Gait Disturbance, Feeling Abnormal, Disability
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Remicade
Start date: 2011-11-03
Purinethol
Administration route: Oral
Indication: Neoplasm Malignant
Start date: 2011-10-20
Remicade
Indication: Crohn's Disease
Start date: 2011-10-20
Other drugs received by patient: Levothyroxine Sodium
Possible Purinethol side effects in female
Reported by a physician from Israel on 2011-12-02
Patient: female, weighing 53.5 kg (117.7 pounds)
Reactions: Pancreatitis Acute
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Mercaptopurine
Dosage: mercaptopurine 40mg or 80mg or purinethol
Administration route: Oral
Indication: Crohn's Disease
Start date: 2011-09-26
End date: 2011-10-02
Purinethol
Dosage: mercaptopurine 40mg or 80mg or purinethol
Administration route: Oral
Indication: Crohn's Disease
Start date: 2011-09-26
End date: 2011-10-02
Other drugs received by patient: Pentasa
Possible Purinethol side effects in male
Reported by a consumer/non-health professional from United States on 2011-11-24
Patient: male, weighing 85.3 kg (187.6 pounds)
Reactions: Weight Decreased, Chills, Impaired Work Ability, Headache, Hyperhidrosis, Change of Bowel Habit, Fatigue, Cough, Polydipsia, Vomiting, Pain in Extremity, Muscular Weakness, Rash, Tremor, Eating Disorder, Diarrhoea, Arthralgia, Increased Tendency To Bruise, Insomnia, Gait Disturbance, Feeling Abnormal
Drug(s) suspected as cause:
Purinethol
Administration route: Oral
Indication: Neoplasm Malignant
Start date: 2011-10-20
Remicade
Start date: 2011-11-03
Remicade
Indication: Crohn's Disease
Start date: 2011-10-20
Other drugs received by patient: Levothyroxine Sodium
Possible Purinethol side effects in 45 year old male
Reported by a physician from Canada on 2011-10-14
Patient: 45 year old male, weighing 60.0 kg (132.0 pounds)
Reactions: Small Intestine Carcinoma, Drug Ineffective
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Remicade
Indication: Crohn's Disease
Start date: 2010-01-01
End date: 2011-06-01
Purinethol
Indication: Crohn's Disease
Start date: 1995-01-01
End date: 2011-06-01
Corticosteroids
Indication: Product Used FOR Unknown Indication
Possible Purinethol side effects in male
Reported by a lawyer from United States on 2011-10-14
Patient: male, weighing 69.0 kg (151.8 pounds)
Reactions: Hepatosplenic T-Cell Lymphoma
Adverse event resulted in: death, life threatening event, hospitalization
Drug(s) suspected as cause:
Humira
Indication: Irritable Bowel Syndrome
Start date: 2006-11-01
Purinethol
Dosage: also reported with start date of 01-oct-1999
Start date: 1999-06-02
Remicade
Dosage: 19 infusions administered between 10-jul-2002 and 7-mar-2006
Indication: Colitis Ulcerative
Start date: 2002-07-10
End date: 2006-03-07
Humira
Start date: 2007-06-15
Purinethol
Dosage: also reported with start date of 01-oct-1999
Start date: 1999-06-02
Purinethol
Indication: Colitis Ulcerative
End date: 2007-04-01
Humira
Indication: Colitis Ulcerative
Start date: 2007-06-15
Purinethol
Indication: Inflammatory Bowel Disease
End date: 2007-04-01
Remicade
Dosage: 19 infusions administered between 10-jul-2002 and 7-mar-2006
Indication: Inflammatory Bowel Disease
Start date: 2002-07-10
End date: 2006-03-07
Remicade
Dosage: 19 infusions administered between 10-jul-2002 and 7-mar-2006
Indication: Crohn's Disease
Start date: 2002-07-10
End date: 2006-03-07
Humira
Start date: 2006-11-01
Other drugs received by patient: Asacol; Asacol; Prednisone; Prednisone
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