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Index of reports
> Serious Events (26)
Below is the selection of side effect reports (a.k.a. adverse event reports) related to Asacol (Mesalamine) serious events. The selected reports were submitted to the FDA during the sample period of about a year.
Possible Asacol side effects in male
Reported by a consumer/non-health professional from United States on 2012-08-27
Patient: male, weighing 70.3 kg (154.7 pounds)
Reactions: Pneumocystis Jiroveci Pneumonia, Colitis Ulcerative, Immune System Disorder
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Asacol
Indication: Colitis Ulcerative
Remicade
Indication: Colitis Ulcerative
Start date: 2012-05-22
End date: 2012-06-06
Prednisone TAB
Indication: Colitis Ulcerative
Start date: 2011-04-01
Azathioprine Sodium
Indication: Colitis Ulcerative
End date: 2012-01-01
Other drugs received by patient: Acecol
Possible Asacol side effects in 22 year old male
Reported by a consumer/non-health professional from United States on 2012-07-27
Patient: 22 year old male, weighing 56.2 kg (123.7 pounds)
Reactions: Pericarditis, Atrial Flutter
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Asacol
Dosage: 2 tablets 3 times a day po
Administration route: Oral
Indication: Colitis Ulcerative
Start date: 2012-06-22
End date: 2012-07-11
Perrigo 4 G Perrigo
Dosage: 4 grams once a day rectal
Indication: Colitis Ulcerative
Start date: 2012-06-22
End date: 2012-07-08
Possible Asacol side effects in 76 year old male
Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-07-27
Patient: 76 year old male
Reactions: Neuroleptic Malignant Syndrome, Neutropenia, Lower Respiratory Tract Infection
Adverse event resulted in: death, life threatening event
Drug(s) suspected as cause:
Asacol
Possible Asacol side effects in 22 year old male
Reported by a consumer/non-health professional from United States on 2012-07-27
Patient: 22 year old male, weighing 55.3 kg (121.7 pounds)
Reactions: Dyspnoea, Chest Pain, Gait Disturbance
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Asacol
Dosage: 2 tablets, 3 times a day, po
Administration route: Oral
Indication: Colitis Ulcerative
Start date: 2012-06-08
End date: 2012-07-09
Perrigo, 4 G, Perrigo
Dosage: 1 once a day, rectal
Indication: Colitis Ulcerative
Start date: 2012-06-08
End date: 2012-07-09
Possible Asacol side effects in 76 year old male
Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-07-24
Patient: 76 year old male
Reactions: Neutropenia, Neuroleptic Malignant Syndrome, Lower Respiratory Tract Infection
Adverse event resulted in: death, life threatening event
Drug(s) suspected as cause:
Asacol
Possible Asacol side effects in female
Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-07-24
Patient: female
Reactions: Neoplasm Malignant
Drug(s) suspected as cause:
Asacol
Possible Asacol side effects in 7 year old male
Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-07-02
Patient: 7 year old male
Reactions: Off Label Use, Unevaluable Event, Medication Residue
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Asacol
Other drugs received by patient: Tacrolimus; Ursodiol; Nystatin; Piperacillin / Tazobactam; Omeprazole; Prednisolone; Acetaminophen; Valganciclovir HCL
Possible Asacol side effects in female
Reported by a consumer/non-health professional from United States on 2012-06-19
Patient: female
Reactions: Cardiac Failure, Diarrhoea
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Asacol
Possible Asacol side effects in 36 year old female
Reported by a physician from United States on 2012-05-11
Patient: 36 year old female, weighing 52.2 kg (114.8 pounds)
Reactions: Ligament Disorder, Stress Fracture
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Asacol
Possible Asacol side effects in 55 year old female
Reported by a physician from Switzerland on 2012-05-10
Patient: 55 year old female
Reactions: Inappropriate Schedule of Drug Administration, Respiratory Disorder, Nausea, Bronchopneumonia, Colitis Ulcerative, Rhinitis, Headache, Pityriasis Rosea, Diarrhoea, Chest Pain, Lung Infiltration, Asthenia, Rash Maculo-Papular, Cough
Drug(s) suspected as cause:
Estraderm
Dosage: 1 df, per six days
Asacol
Dosage: 1 df, tid
Administration route: Oral
Indication: Colitis Ulcerative
Start date: 2006-02-01
End date: 2011-12-02
Other drugs received by patient: Calperos D3; Progesterone
Possible Asacol side effects in 22 year old male
Reported by a health professional (non-physician/pharmacist) from Denmark on 2012-04-17
Patient: 22 year old male
Reactions: Haemoglobin Decreased, Renal Impairment, Hydronephrosis, Glomerulonephritis Chronic, Blood Creatinine Increased, Haemodialysis
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Asacol
Dosage: oral
Administration route: Oral
Indication: Crohn's Disease
Start date: 2003-02-01
End date: 2007-02-12
Pentasa
Dosage: oral
Administration route: Oral
Indication: Crohn's Disease
Start date: 2001-05-29
Other drugs received by patient: Cortisone (Coritsone); Oxcarbazepine
Possible Asacol side effects in male
Reported by a pharmacist from United States on 2012-02-28
Patient: male, weighing 77.1 kg (169.6 pounds)
Reactions: Atelectasis, Allergic Myocarditis, Bundle Branch Block Right, Cardiomegaly, Pericardial Effusion, Myalgia, Dizziness, Acute Coronary Syndrome, Sinusitis, Myocardial Infarction, Cardiac Failure Congestive, White Blood Cell Count Increased, Jugular Vein Distension, Bundle Branch Block Left, Arrhythmia, Peripancreatic Fluid Collection, Brain Natriuretic Peptide Increased, Cardiac Arrest
Adverse event resulted in: death
Drug(s) suspected as cause:
Asacol
Possible Asacol side effects in 37 year old female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-02-14
Patient: 37 year old female
Reactions: Aortic Aneurysm
Drug(s) suspected as cause:
Asacol
Possible Asacol side effects in 38 year old female
Reported by a consumer/non-health professional from United States on 2011-12-29
Patient: 38 year old female
Reactions: Injury, Asphyxia
Adverse event resulted in: death
Drug(s) suspected as cause:
Asacol
Possible Asacol side effects in female
Reported by a physician from United States on 2011-12-15
Patient: female, weighing 73.9 kg (162.7 pounds)
Reactions: Photosensitivity Reaction, Chest Discomfort, Motor Dysfunction, Paraesthesia, Anxiety, Balance Disorder, Alopecia, Sinus Headache, Visual Impairment, Dizziness, Hypertension, Feeling Abnormal, Cough
Drug(s) suspected as cause:
Remicade
Indication: Colitis Ulcerative
Remicade
Start date: 2011-05-01
Remicade
Start date: 2011-07-13
Asacol
Administration route: Oral
Indication: Colitis Ulcerative
Other drugs received by patient: Paxil; Prevacid; Lialda
Possible Asacol side effects in female
Reported by a consumer/non-health professional from Sweden on 2011-12-12
Patient: female
Reactions: Gastrointestinal Disorder, Anal Haemorrhage, Abdominal Pain Upper
Drug(s) suspected as cause:
Prednisolone
Dosage: 10 mg, unk
Indication: Proctitis Ulcerative
Sulfasalazine
Dosage: unk
Administration route: Oral
Indication: Proctitis Ulcerative
Asacol
Dosage: 500 mg, unk
Indication: Proctitis Ulcerative
Possible Asacol side effects in 55 year old female
Reported by a individual with unspecified qualification from United States on 2011-12-09
Patient: 55 year old female
Reactions: Colitis Ulcerative, Condition Aggravated, Headache, Speech Disorder, Fatigue, Musculoskeletal Stiffness, Dizziness, Meningitis
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Asacol
Other drugs received by patient: Simvastatin; Valium
Possible Asacol side effects in 47 year old male
Reported by a physician from Finland on 2011-12-09
Patient: 47 year old male
Reactions: Colitis Ulcerative, Diarrhoea, Pyrexia, Leukocytosis
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Prednisolone
Dosage: 30 mg, 1x/day
Start date: 2011-10-01
End date: 2011-01-01
Prednisolone
Dosage: 40 mg, qd
Start date: 2011-01-01
End date: 2011-11-08
Prednisolone
Dosage: 35 mg, qwk, dose reduction 5 mg weekly
Start date: 2011-11-09
Asacol
Dosage: 1600+800 mg daily
Start date: 2011-10-24
End date: 2011-11-02
Asacol
Dosage: 800 mg, bid
Start date: 2011-10-01
End date: 2011-10-23
Enbrel
Dosage: 50 mg, weekly
Indication: Juvenile Arthritis
Start date: 2011-07-18
End date: 2011-01-01
Enbrel
Dosage: 50 mg, weekly
Start date: 2011-09-01
Other drugs received by patient: Neoral; Neoral; Oxiklorin; Oxiklorin
Possible Asacol side effects in male
Reported by a pharmacist from United States on 2011-12-01
Patient: male, weighing 85.0 kg (187.0 pounds)
Reactions: Poor Quality Sleep, Myalgia, Dyspnoea, Fibrin D Dimer Increased, Arthralgia, Nausea, Chest Pain, Pyrexia, Asthenia, Leukopenia
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Asacol
Administration route: Oral
Indication: Colitis
End date: 2011-11-03
Methotrexate
Administration route: Oral
Indication: Rheumatoid Arthritis
End date: 2011-11-03
Xarelto
Administration route: Oral
Indication: HIP Arthroplasty
Start date: 2011-10-13
End date: 2011-11-03
Methotrexate
Administration route: Oral
Indication: Crohn's Disease
End date: 2011-11-03
Asacol
Administration route: Oral
Indication: Crohn's Disease
End date: 2011-11-03
Other drugs received by patient: Omeprazole; Prednisone TAB; Enoxaparin; Warfarin Sodium; Prednisone TAB; Glucosamine; Simvastatin; Prednisone TAB; Fish OIL
Possible Asacol side effects in 54 year old female
Reported by a consumer/non-health professional from United States on 2011-11-22
Patient: 54 year old female
Reactions: Drug Effect Decreased, Injection Site Pain, Hepatitis
Drug(s) suspected as cause:
Asacol
Indication: Product Used FOR Unknown Indication
Humira
Indication: Psoriatic Arthropathy
Start date: 2010-05-01
Other drugs received by patient: Pravachol; Vitamin TAB; Colazal
Possible Asacol side effects in 27 year old female
Reported by a health professional (non-physician/pharmacist) from Japan on 2011-10-25
Patient: 27 year old female
Reactions: Back Pain, Pleurisy, Drug Hypersensitivity, Pyrexia
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Asacol
Possible Asacol side effects in 23 year old female
Reported by a physician from United States on 2011-10-19
Patient: 23 year old female, weighing 55.4 kg (121.9 pounds)
Reactions: Dermatitis, Type IV Hypersensitivity Reaction
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Asacol
Dosage: 800 mg. p.o. once
Administration route: Oral
Start date: 2011-09-06
End date: 2011-09-26
Mesalamine
Dosage: 800mg. p.o. once
Administration route: Oral
Start date: 2011-09-16
Possible Asacol side effects in 18 year old female
Reported by a consumer/non-health professional from Denmark on 2011-10-12
Patient: 18 year old female
Reactions: Eosinophilic Pneumonia
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Mesalamine
Dosage: 1 gm (1 gm, daily), rectal
Indication: Colitis Ulcerative
Start date: 2011-08-16
End date: 2011-08-31
Asacol
Dosage: (3600 mg, daily), oral
Administration route: Oral
Indication: Colitis Ulcerative
Start date: 2011-07-25
End date: 2011-08-31
Possible Asacol side effects in 54 year old male
Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2011-10-07
Patient: 54 year old male, weighing 89.9 kg (197.8 pounds)
Reactions: Contusion, Anaemia, Neutropenic Sepsis, Drug Interaction, Rash, Eosinophilia, Neutropenia, Thrombocytopenia, Leukopenia
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Asacol
Dosage: 2 g. 1/day, rectal
Indication: Colitis Ulcerative
Start date: 2007-01-01
End date: 2011-05-27
Mesalamine
Dosage: 800 mg, 3 day, oral
Administration route: Oral
Indication: Colitis Ulcerative
Start date: 2007-01-01
End date: 2011-05-27
Other drugs received by patient: Atenolol; Citalopram; Fexofenadine; Acetaminophen and Codeine Phosphate; Simvastatin; Warfarin Sodium; Ferrous Fumarate; Isosorbide Mononitrate; Desloratadine
Possible Asacol side effects in 23 year old female
Reported by a physician from United States on 2011-10-06
Patient: 23 year old female, weighing 55.4 kg (121.9 pounds)
Reactions: Dermatitis, Rash Erythematous, Blister, Rash Pruritic, Papule
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Asacol
Dosage: 800 mg, p.o. once
Administration route: Oral
Start date: 2011-09-06
End date: 2011-09-26
Mesalamine
Dosage: 800 mg, po, once
Administration route: Oral
Start date: 2011-09-16
Possible Asacol side effects in 37 year old male
Reported by a consumer/non-health professional from United States on 2011-10-05
Patient: 37 year old male, weighing 67.6 kg (148.7 pounds)
Reactions: Restlessness, Insomnia
Drug(s) suspected as cause:
Asacol
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