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Pentasa (Mesalamine) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Pentasa (Mesalamine) 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 (91)
Death (9)
Life Threatening Events (5)
Disability (7)

Reports by Reaction Type

Off Label Use (17)Drug Interaction (9)Diarrhoea (9)Abdominal Pain (8)Renal Impairment (8)Erythema (7)Weight Increased (7)Dyspnoea (7)Hypersensitivity (6)Ecchymosis (6)DRY Mouth (6)Oedema Peripheral (6)

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

Possible Pentasa side effects in female

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

Patient: female, weighing 2.2 kg (4.9 pounds)

Reactions: Premature Baby

Drug(s) suspected as cause:
Pentasa
    Indication: Foetal Exposure During Pregnancy
    Start date: 2008-01-01

Prednisone TAB
    Indication: Foetal Exposure During Pregnancy
    Start date: 2008-01-01

Remicade

Remicade
    Start date: 2008-01-01

Remicade
    Indication: Foetal Exposure During Pregnancy



Possible Pentasa side effects in female

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

Patient: female

Reactions: Maternal Exposure During Pregnancy, Premature Labour

Drug(s) suspected as cause:
Pentasa
    Indication: Product Used FOR Unknown Indication
    Start date: 2008-01-01

Prednisolone
    Dosage: 30-40 mg
    Indication: Crohn's Disease
    Start date: 2008-01-01

Remicade
    Dosage: dose: 7.5mg/kg
    Indication: Crohn's Disease
    Start date: 2008-01-01



Possible Pentasa side effects in female

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

Patient: female

Reactions: Maternal Exposure During Pregnancy, Crohn's Disease, Premature Labour

Drug(s) suspected as cause:
Pentasa
    Indication: Product Used FOR Unknown Indication
    Start date: 2008-01-01

Prednisolone
    Indication: Crohn's Disease
    Start date: 2008-01-01

Remicade
    Indication: Crohn's Disease

Remicade
    Dosage: 7.5mg/kg
    Start date: 2008-01-01

Remicade



Possible Pentasa side effects in male

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

Patient: male, weighing 1.7 kg (3.8 pounds)

Reactions: Premature Baby

Drug(s) suspected as cause:
Pentasa
    Indication: Foetal Exposure During Pregnancy
    Start date: 2008-01-01

Prednisolone
    Indication: Foetal Exposure During Pregnancy
    Start date: 2008-01-01

Remicade
    Dosage: (7.5mg/kg)
    Indication: Foetal Exposure During Pregnancy
    Start date: 2008-01-01



Possible Pentasa side effects in male

Reported by a consumer/non-health professional from United States on 2012-08-15

Patient: male, weighing 72.6 kg (159.6 pounds)

Reactions: Photosensitivity Reaction, Off Label Use, Prostate Cancer, Hypertension

Drug(s) suspected as cause:
Pentasa

Other drugs received by patient: Entocort EC; Dilantin



Possible Pentasa side effects in female

Reported by a physician from United States on 2012-08-15

Patient: female, weighing 37.6 kg (82.8 pounds)

Reactions: Nausea, Chest Pain, Constipation, Gastritis

Adverse event resulted in: hospitalization

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

Pentasa
    Dosage: 1000 mg, 3x/day:tid
    Administration route: Oral
    Indication: Colitis Ulcerative

Other drugs received by patient: Zyrtec; Nasonex



Possible Pentasa side effects in female

Reported by a physician from France on 2012-08-14

Patient: female

Reactions: Arthralgia, Bone Fissure, Tibia Fracture

Adverse event resulted in: disablity

Drug(s) suspected as cause:
Actonel
    Administration route: Oral
    Indication: Osteoporosis
    Start date: 2002-06-04
    End date: 2010-06-14

Cytotec
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 1998-12-01

Enbrel
    Indication: Rheumatoid Arthritis
    Start date: 2008-05-01
    End date: 2008-10-01

Humira 40 MG / 0.8 ML PRE-Filled Syringe
    Indication: Rheumatoid Arthritis
    Start date: 2008-10-01
    End date: 2009-03-01

Methotrexate
    Administration route: Oral
    Indication: Rheumatoid Arthritis
    Start date: 1996-02-05

Orencia
    Indication: Rheumatoid Arthritis
    Start date: 2011-02-01

Pentasa
    Administration route: Oral
    Indication: Rheumatoid Arthritis
    Start date: 1996-01-01

Plaquenil
    Administration route: Oral
    Indication: Rheumatoid Arthritis
    Start date: 1994-12-01

Prednisone TAB
    Administration route: Oral
    Indication: Rheumatoid Arthritis
    Start date: 1995-02-20

Prednisone TAB
    Administration route: Oral
    Start date: 1995-02-20

Protelos
    Administration route: Oral
    Indication: Osteoporosis
    Start date: 2011-02-18
    End date: 2011-09-13



Possible Pentasa side effects in female

Reported by a physician from United States on 2012-08-14

Patient: female, weighing 68.0 kg (149.7 pounds)

Reactions: Off Label Use, Drug Ineffective FOR Unapproved Indication, Crohn's Disease, Maternal Exposure Before Pregnancy

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Pentasa

Other drugs received by patient: Prednisone TAB



Possible Pentasa side effects in 54 year old male

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

Patient: 54 year old male

Reactions: Proctocolitis, Rectal Haemorrhage

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Omeprazole
    Administration route: Oral
    Indication: Colitis Ulcerative
    Start date: 2012-01-13
    End date: 2012-03-03

Pentasa
    Administration route: Oral
    Indication: Colitis Ulcerative
    Start date: 2011-01-01

Remicade
    Dosage: seventh infusion
    Indication: Colitis Ulcerative
    Start date: 2012-01-17
    End date: 2012-01-17

Remicade



Possible Pentasa side effects in male

Reported by a physician from Japan on 2012-07-27

Patient: male, weighing 71.0 kg (156.2 pounds)

Reactions: Abdominal Pain, Diarrhoea, Platelet Count Decreased, Lymphocytic Leukaemia, White Blood Cell Count Increased

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Gonadotropins
    Dosage: 3000 units per month
    Indication: Product Used FOR Unknown Indication
    Start date: 2010-02-12
    End date: 2012-01-16

Imuran
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2010-09-07

Imuran
    Administration route: Oral
    Start date: 2011-06-25

Pentasa
    Dosage: start date prior to 16-apr-1999
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Remicade
    Indication: Crohn's Disease
    Start date: 2012-01-06

Remicade
    Start date: 2011-01-26

Remicade
    Dosage: 12 total infusions
    Start date: 2010-06-25

Other drugs received by patient: Elental



Possible Pentasa side effects in female

Reported by a physician from Japan on 2012-07-20

Patient: female, weighing 50.0 kg (110.0 pounds)

Reactions: Upper Respiratory Fungal Infection, Stomatitis, Sensation of Foreign Body, Rectal Ulcer, Type IV Hypersensitivity Reaction, Pyrexia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Pentasa
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Prodif
    Start date: 2012-04-28
    End date: 2012-05-01

Prodif
    Start date: 2012-05-02
    End date: 2012-05-07

Prodif
    Start date: 2012-05-14

Prodif
    Indication: Upper Respiratory Fungal Infection
    Start date: 2012-04-26
    End date: 2012-04-27

Prodif
    Start date: 2012-05-15
    End date: 2012-05-16

Remicade
    Dosage: 5 mg/kg
    Start date: 2012-03-22
    End date: 2012-03-22

Remicade
    Dosage: 5 mg/kg
    Indication: Crohn's Disease
    Start date: 2012-04-05
    End date: 2012-04-05

Remicade
    Start date: 2012-05-23

Other drugs received by patient: Exforge; Miya BM; Sulfasalazine



Possible Pentasa side effects in

Reported by a consumer/non-health professional from United States on 2012-07-19

Patient:

Reactions: Off Label Use, Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Pentasa



Possible Pentasa side effects in 63 year old female

Reported by a health professional (non-physician/pharmacist) from France on 2012-07-19

Patient: 63 year old female

Reactions: Bone Fissure

Adverse event resulted in: disablity

Drug(s) suspected as cause:
Actonel
    Dosage: 35 mg, unk
    Administration route: Oral
    Indication: Osteoporosis
    Start date: 2002-06-04
    End date: 2010-06-14

Cytotec
    Dosage: unk
    Administration route: Oral
    Start date: 1998-12-01

Enbrel
    Dosage: unk
    Indication: Rheumatoid Arthritis
    Start date: 2008-05-01
    End date: 2008-10-01

Humira
    Dosage: unk
    Indication: Rheumatoid Arthritis
    Start date: 2008-10-01
    End date: 2009-03-01

Methotrexate
    Dosage: 7.5 mg, weekly
    Administration route: Oral
    Indication: Rheumatoid Arthritis
    Start date: 1996-02-05

Orencia
    Dosage: unk
    Indication: Rheumatoid Arthritis
    Start date: 2011-02-01

Pentasa
    Dosage: unk
    Administration route: Oral
    Indication: Rheumatoid Arthritis
    Start date: 1996-01-01

Plaquenil
    Dosage: 400 mg, 1x/day
    Administration route: Oral
    Indication: Rheumatoid Arthritis
    Start date: 1994-12-01

Prednisone TAB
    Dosage: 8 mg, 1x/day
    Administration route: Oral
    Start date: 1995-02-20

Prednisone TAB
    Dosage: 5 mg, 1x/day
    Administration route: Oral
    Indication: Rheumatoid Arthritis
    Start date: 1995-02-20

Protelos
    Dosage: unk
    Administration route: Oral
    Indication: Osteoporosis
    Start date: 2011-02-18
    End date: 2011-09-13



Possible Pentasa side effects in 63 year old female

Reported by a consumer/non-health professional from France on 2012-07-18

Patient: 63 year old female

Reactions: Bone Fissure

Adverse event resulted in: disablity

Drug(s) suspected as cause:
Actonel
    Administration route: Oral
    Indication: Osteoporosis
    Start date: 2002-06-04
    End date: 2010-06-14

Cytotec
    Administration route: Oral
    Start date: 1998-12-01

Enbrel
    Start date: 2008-05-01
    End date: 2008-10-01

Humira
    Start date: 2008-10-01
    End date: 2009-03-01

Methotrexate
    Administration route: Oral
    Start date: 1996-02-05

Orencia
    Indication: Rheumatoid Arthritis
    Start date: 2011-02-01

Pentasa
    Administration route: Oral
    Start date: 1996-01-01

Plaquenil
    Administration route: Oral
    Start date: 1994-12-01

Prednisone TAB
    Dosage: also taken 8mg
    Administration route: Oral
    Start date: 1995-02-20

Protelos
    Indication: Osteoporosis
    Start date: 2011-02-18
    End date: 2011-09-13



Possible Pentasa side effects in female

Reported by a physician from France on 2012-07-18

Patient: female

Reactions: Bone Fissure, Tibia Fracture

Adverse event resulted in: disablity

Drug(s) suspected as cause:
Actonel
    Administration route: Oral
    Indication: Osteoporosis
    Start date: 2002-06-04
    End date: 2010-06-14

Cytotec
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 1998-12-01

Enbrel
    Indication: Rheumatoid Arthritis
    Start date: 2008-05-01
    End date: 2008-10-01

Humira
    Indication: Rheumatoid Arthritis
    Start date: 2008-10-01
    End date: 2009-03-01

Methotrexate
    Administration route: Oral
    Indication: Rheumatoid Arthritis
    Start date: 1996-02-05

Orencia
    Indication: Rheumatoid Arthritis
    Start date: 2011-02-01

Pentasa
    Administration route: Oral
    Indication: Rheumatoid Arthritis
    Start date: 1996-01-01

Plaquenil
    Administration route: Oral
    Indication: Rheumatoid Arthritis
    Start date: 1994-12-01

Prednisone TAB
    Administration route: Oral
    Indication: Rheumatoid Arthritis
    Start date: 1995-02-20

Prednisone TAB
    Administration route: Oral
    Start date: 1995-02-20

Protelos
    Administration route: Oral
    Indication: Osteoporosis
    Start date: 2011-02-18
    End date: 2011-09-13



Possible Pentasa side effects in 63 year old female

Reported by a health professional (non-physician/pharmacist) from France on 2012-07-17

Patient: 63 year old female

Reactions: Bone Fissure

Adverse event resulted in: disablity

Drug(s) suspected as cause:
Actonel
    Administration route: Oral
    Indication: Osteoporosis
    Start date: 2002-06-04
    End date: 2010-06-14

Cytotec
    Administration route: Oral
    Start date: 1998-12-01

Etanercept
    Indication: Rheumatoid Arthritis
    Start date: 1998-05-01
    End date: 1998-10-01

Humira
    Indication: Rheumatoid Arthritis
    Start date: 2008-10-01
    End date: 2009-03-01

Methotrexate
    Administration route: Oral
    Indication: Rheumatoid Arthritis
    Start date: 1996-02-05

Orencia
    Indication: Rheumatoid Arthritis
    Start date: 2011-02-01

Pentasa
    Administration route: Oral
    Indication: Rheumatoid Arthritis
    Start date: 1996-01-01

Plaquenil
    Administration route: Oral
    Indication: Rheumatoid Arthritis
    Start date: 1994-12-01

Prednisone TAB
    Administration route: Oral
    Start date: 1995-02-20

Prednisone TAB
    Administration route: Oral
    Indication: Rheumatoid Arthritis
    Start date: 1995-02-20

Strontium Ranelate
    Administration route: Oral
    Indication: Osteoporosis
    Start date: 2011-02-18
    End date: 2011-09-13



Possible Pentasa side effects in 24 year old male

Reported by a consumer/non-health professional from United States on 2012-07-17

Patient: 24 year old male

Reactions: Off Label Use, Renal Impairment

Drug(s) suspected as cause:
Pentasa



Possible Pentasa side effects in 63 year old female

Reported by a health professional (non-physician/pharmacist) from France on 2012-07-17

Patient: 63 year old female

Reactions: Bone Fissure

Adverse event resulted in: disablity

Drug(s) suspected as cause:
Actonel
    Dosage: 35 mg, unk
    Administration route: Oral
    Indication: Osteoporosis
    Start date: 2002-06-04
    End date: 2010-06-14

Cytotec
    Dosage: unk
    Administration route: Oral
    Start date: 1998-12-01

Enbrel
    Dosage: unk
    Indication: Rheumatoid Arthritis
    Start date: 2008-05-01
    End date: 2008-10-01

Humira
    Dosage: unk
    Indication: Rheumatoid Arthritis
    Start date: 2008-10-01
    End date: 2009-03-01

Methotrexate
    Dosage: 7.5 mg, weekly
    Administration route: Oral
    Indication: Rheumatoid Arthritis
    Start date: 1996-02-05

Orencia
    Dosage: unk
    Indication: Rheumatoid Arthritis
    Start date: 2011-02-01

Pentasa
    Dosage: unk
    Administration route: Oral
    Indication: Rheumatoid Arthritis
    Start date: 1996-01-01

Plaquenil
    Dosage: 400 mg, 1x/day
    Administration route: Oral
    Indication: Rheumatoid Arthritis
    Start date: 1994-12-01

Prednisone TAB
    Dosage: 8 mg, 1x/day
    Administration route: Oral
    Start date: 1995-02-20

Prednisone TAB
    Dosage: 5 mg, 1x/day
    Administration route: Oral
    Indication: Rheumatoid Arthritis
    Start date: 1995-02-20

Protelos
    Dosage: unk
    Administration route: Oral
    Indication: Osteoporosis
    Start date: 2011-02-18
    End date: 2011-09-13



Possible Pentasa side effects in female

Reported by a consumer/non-health professional from United States on 2012-07-13

Patient: female, weighing 68.0 kg (149.7 pounds)

Reactions: Off Label Use, Drug Ineffective FOR Unapproved Indication, Crohn's Disease, Maternal Exposure Before Pregnancy

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Pentasa

Other drugs received by patient: Prednisone



Possible Pentasa side effects in female

Reported by a physician from Japan on 2012-07-13

Patient: female, weighing 50.0 kg (110.0 pounds)

Reactions: Upper Respiratory Fungal Infection, Stomatitis, Sensation of Foreign Body, Rectal Ulcer, Type IV Hypersensitivity Reaction, Pyrexia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Pentasa
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Prodif
    Start date: 2012-05-14

Prodif
    Start date: 2012-04-28
    End date: 2012-05-01

Prodif
    Start date: 2012-05-15
    End date: 2012-05-16

Prodif
    Start date: 2012-05-02
    End date: 2012-05-07

Prodif
    Indication: Upper Respiratory Fungal Infection
    Start date: 2012-04-26
    End date: 2012-04-27

Remicade
    Dosage: 5 mg/kg
    Indication: Crohn's Disease
    Start date: 2012-04-05
    End date: 2012-04-05

Remicade
    Dosage: 5 mg/kg
    Start date: 2012-03-22
    End date: 2012-03-22

Remicade
    Start date: 2012-05-23

Other drugs received by patient: Sulfasalazine; Miya BM; Exforge



Possible Pentasa side effects in male

Reported by a physician from Japan on 2012-07-05

Patient: male, weighing 65.0 kg (143.0 pounds)

Reactions: Adenocarcinoma

Adverse event resulted in: death, life threatening event, hospitalization

Drug(s) suspected as cause:
Ensure
    Administration route: Oral
    Indication: Nutritional Support

Lendormin
    Administration route: Oral
    Indication: Insomnia

Miya BM
    Administration route: Oral
    Indication: Flatulence

Pentasa
    Administration route: Oral
    Indication: Crohn's Disease

Posterisan
    Indication: Anal Inflammation

Remicade
    Start date: 2006-03-20

Remicade
    Start date: 2007-01-12

Remicade
    Start date: 2006-11-15

Remicade
    Indication: Crohn's Disease
    Start date: 2006-07-12

Remicade
    Start date: 2005-11-16

Remicade
    Start date: 2005-02-25

Remicade
    Start date: 2004-09-17

Remicade
    Start date: 2006-05-17

Remicade
    Start date: 2005-03-11

Remicade
    Start date: 2004-10-28

Remicade
    Start date: 2004-10-01

Remicade
    Start date: 2006-09-06

Other drugs received by patient: Tsumura DAI Kenchu TO Extract Granules; Claritin; Glucose; Cefazolin Sodium; Iron Sucrose; Roxatidine Acetate HCL



Possible Pentasa side effects in female

Reported by a physician from United States on 2012-07-02

Patient: female, weighing 66.2 kg (145.7 pounds)

Reactions: Vomiting, Nausea, Headache, Blood Pressure Decreased

Drug(s) suspected as cause:
Pentasa
    Dosage: 1500 mg (three 500 mg capsules), 1x/day:qd
    Administration route: Oral
    Indication: Crohn's Disease
    Start date: 2012-01-30
    End date: 2012-01-30

Pentasa
    Indication: Colitis Ulcerative

Other drugs received by patient: Bentyl; Promethazine; Zofran; Tramadol HCL; Omeprazole; Budesonide



Possible Pentasa side effects in 53 year old female

Reported by a physician from Japan on 2012-07-02

Patient: 53 year old female, weighing 54.0 kg (118.8 pounds)

Reactions: Hypomagnesaemia, Hypocalcaemia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Adsorbin
    Administration route: Oral
    Indication: Short-Bowel Syndrome
    Start date: 2011-08-23

Albumin Tannate
    Administration route: Oral
    Indication: Short-Bowel Syndrome
    Start date: 2011-08-23

Berizym
    Administration route: Oral
    Indication: Short-Bowel Syndrome
    Start date: 2011-08-23

Elental
    Administration route: Oral
    Indication: Crohn's Disease
    Start date: 2011-08-23

LAC-B
    Administration route: Oral
    Indication: Short-Bowel Syndrome
    Start date: 2011-08-23

Levothyroxine Sodium
    Administration route: Oral
    Indication: Hypothyroidism
    Start date: 2011-08-23

Loperamide Hydrochloride
    Administration route: Oral
    Indication: Short-Bowel Syndrome
    Start date: 2011-08-23

Nexium
    Administration route: Oral
    Start date: 2012-02-13
    End date: 2012-05-01

Pentasa
    Administration route: Oral
    Indication: Crohn's Disease
    Start date: 2011-08-23

Polyful
    Administration route: Oral
    Indication: Short-Bowel Syndrome
    Start date: 2011-08-23

Warfarin Sodium
    Administration route: Oral
    Indication: Antiphospholipid Syndrome
    Start date: 2011-08-23



Possible Pentasa side effects in 53 year old female

Reported by a physician from Japan on 2012-06-25

Patient: 53 year old female, weighing 54.0 kg (118.8 pounds)

Reactions: Hypomagnesaemia, Hypocalcaemia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Adsorbin
    Administration route: Oral
    Indication: Short-Bowel Syndrome
    Start date: 2011-08-23

Albumin Tannate
    Administration route: Oral
    Indication: Short-Bowel Syndrome
    Start date: 2011-08-23

Berizym
    Administration route: Oral
    Indication: Short-Bowel Syndrome
    Start date: 2011-08-23

Elental
    Administration route: Oral
    Indication: Crohn's Disease
    Start date: 2011-08-23

LAC-B
    Administration route: Oral
    Indication: Short-Bowel Syndrome
    Start date: 2011-08-23

LAC-B
    Administration route: Oral
    Start date: 2011-08-23

Levothyroxine Sodium
    Administration route: Oral
    Indication: Hypothyroidism
    Start date: 2011-08-23

Loperamide Hydrochloride
    Administration route: Oral
    Indication: Short-Bowel Syndrome
    Start date: 2011-08-23

Nexium
    Administration route: Oral
    Indication: Gastric Ulcer
    Start date: 2012-02-13
    End date: 2012-05-01

Pentasa
    Administration route: Oral
    Indication: Crohn's Disease
    Start date: 2011-08-23

Polyful
    Administration route: Oral
    Indication: Short-Bowel Syndrome
    Start date: 2011-08-23

Warfarin Sodium
    Administration route: Oral
    Indication: Antiphospholipid Syndrome
    Start date: 2011-08-23



Possible Pentasa side effects in male

Reported by a physician from United States on 2012-06-20

Patient: male, weighing 72.6 kg (159.6 pounds)

Reactions: Abdominal Pain, Diarrhoea, Adverse Event, Rash Macular

Drug(s) suspected as cause:
Pentasa
    Dosage: 1500 mg (3) 500mg capsules at breakfast other
    Administration route: Oral
    Indication: Colitis Ulcerative

Pentasa
    Dosage: 1000 mg (2) 500 mg capsules at lunch

Pentasa
    Dosage: 1500 mg, other(3) 500mg capsules at dinner
    Administration route: Oral

Other drugs received by patient: Aloe Vera Extract; Dairy AID; Acetaminophen



Possible Pentasa side effects in 15 year old male

Reported by a physician from Japan on 2012-06-13

Patient: 15 year old male, weighing 52.0 kg (114.4 pounds)

Reactions: Pancreatitis Acute, Pneumonia, Drug Ineffective, Colitis Ulcerative

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Pentasa
    Administration route: Oral
    Indication: Colitis Ulcerative
    End date: 2011-12-17

Pentasa
    Administration route: Oral
    Start date: 2012-02-04
    End date: 2012-02-06

Remicade
    Indication: Colitis Ulcerative
    Start date: 2011-04-19

Remicade
    Start date: 2011-03-26

Remicade
    Start date: 2012-02-08

Remicade
    Start date: 2011-06-10

Remicade
    Start date: 2011-11-26

Remicade
    Start date: 2011-03-14

Remicade
    Start date: 2012-01-07

Other drugs received by patient: Asacol; Flagyl; Acetaminophen; Rabeprazole Sodium; Imuran; Rebamipide; Miya BM; Trancolon; Aleroff



Possible Pentasa side effects in female

Reported by a physician from Japan on 2012-06-11

Patient: female, weighing 50.0 kg (110.0 pounds)

Reactions: Upper Respiratory Fungal Infection, Sensation of Foreign Body, Stomatitis, Rectal Ulcer, Type IV Hypersensitivity Reaction, Pyrexia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Pentasa
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Prodif
    Indication: Upper Respiratory Fungal Infection
    Start date: 2012-05-14

Prodif
    Start date: 2012-05-02
    End date: 2012-05-07

Prodif
    Start date: 2012-04-26
    End date: 2012-04-27

Prodif
    Start date: 2012-04-28
    End date: 2012-05-01

Prodif
    Start date: 2012-05-15
    End date: 2012-05-16

Remicade
    Dosage: 5 mg/kg
    Indication: Crohn's Disease
    Start date: 2012-03-22
    End date: 2012-03-22

Remicade
    Dosage: 5 mg/kg
    Start date: 2012-04-05
    End date: 2012-04-05

Other drugs received by patient: Exforge; Miya BM; Salazopyrin



Possible Pentasa side effects in male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-05-31

Patient: male

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Pentasa



Possible Pentasa side effects in 28 year old male

Reported by a physician from Japan on 2012-05-31

Patient: 28 year old male

Reactions: Platelet Count Decreased, Lymphocytic Leukaemia, White Blood Cell Count Increased

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Gonadotropins
    Indication: Product Used FOR Unknown Indication

Imuran
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-06-25

Pentasa
    Indication: Product Used FOR Unknown Indication

Remicade
    Dosage: 12 total infusions
    Indication: Crohn's Disease
    Start date: 2010-06-25

Other drugs received by patient: Elental



Possible Pentasa side effects in female

Reported by a physician from Japan on 2012-05-31

Patient: female, weighing 50.0 kg (110.0 pounds)

Reactions: Sensation of Foreign Body, Oropharyngitis Fungal, Type IV Hypersensitivity Reaction

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Exforge
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Miya BM
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Pentasa
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Remicade
    Indication: Crohn's Disease
    Start date: 2012-03-22
    End date: 2012-03-22

Remicade
    Start date: 2012-04-05
    End date: 2012-04-05

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