This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Asacol (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 (37)
Death (4)
Life Threatening Events (2)
Reports by Reaction Type
Drug Hypersensitivity (6),
Colitis Ulcerative (4),
Pyrexia (4),
Chest Pain (3),
Dizziness (3),
Diarrhoea (3),
Neutropenia (3),
Headache (2),
Lower Respiratory Tract Infection (2),
Myalgia (2),
Dermatitis (2),
Neuroleptic Malignant Syndrome (2)
Below are a few examples of reports where side effects / adverse reactions may be related to Asacol (Mesalamine). For a complete list or a specific selection of reports, please use the links above.
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 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 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 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 female
Reported by a physician from United States on 2012-06-05
Patient: female
Reactions: Drug Hypersensitivity
Drug(s) suspected as cause:
Stadol
Dosage: unk
Flagyl
Dosage: unk
Potassium Pencillin G
Dosage: unk
Asacol
Dosage: unk
Possible Asacol side effects in female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-05-25
Patient: female
Reactions: Drug Hypersensitivity
Drug(s) suspected as cause:
Flagyl
Dosage: unk
Potassium Penicillin G
Dosage: unk
Stadol
Dosage: unk
Asacol
Dosage: unk
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
Reported by a consumer/non-health professional from United States on 2012-05-10
Patient:
Reactions: Drug Hypersensitivity
Drug(s) suspected as cause:
Morphine Sulfate
Dosage: unk
Asacol
Dosage: unk
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 female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-05-10
Patient: female
Reactions: Drug Hypersensitivity
Drug(s) suspected as cause:
Asacol
Dosage: unk
Flagyl
Dosage: unk
Potassium Penicillin G
Dosage: unk
Stadol
Dosage: unk
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
Reported by a consumer/non-health professional from United States on 2012-03-27
Patient:
Reactions: Drug Hypersensitivity
Drug(s) suspected as cause:
Morphine SUL TAB
Dosage: unk
Asacol
Dosage: unk
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 male
Reported by a consumer/non-health professional from United States on 2012-01-29
Patient: male
Reactions: Drug Ineffective, Crohn's Disease, Incorrect Storage of Drug, Poor Quality Drug Administered
Drug(s) suspected as cause:
Colazal
Indication: Product Used FOR Unknown Indication
Humira
Indication: Crohn's Disease
Asacol
Indication: Product Used FOR Unknown Indication
Possible Asacol side effects in female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-01-29
Patient: female
Reactions: Alopecia
Drug(s) suspected as cause:
Asacol
Indication: Product Used FOR Unknown Indication
End date: 2011-04-01
Humira
Indication: Crohn's Disease
Start date: 2010-01-01
End date: 2011-04-01
Other drugs received by patient: Protonix; Gabapentin; Citalopram Hydrobromide; Bentyl; Prednisone TAB; Lasix; Fluconazole; Chlor-CON; Xanax; Lomotil
Possible Asacol side effects in female
Reported by a consumer/non-health professional from United States on 2012-01-28
Patient: female
Reactions: Weight Increased, Arthralgia
Drug(s) suspected as cause:
Prednisone TAB
Indication: Crohn's Disease
Asacol
Indication: Product Used FOR Unknown Indication
Humira
Indication: Crohn's Disease
Start date: 2011-03-13
Entocort EC
Indication: Crohn's Disease
Other drugs received by patient: Iron
Possible Asacol side effects in 53 year old female
Reported by a physician from United States on 2012-01-13
Patient: 53 year old female
Reactions: Blood Alkaline Phosphatase Increased, Liver Injury, Aspartate Aminotransferase Increased, Alanine Aminotransferase Increased
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 70 year old male
Reported by a consumer/non-health professional from United States on 2011-12-22
Patient: 70 year old male
Reactions: Pyrexia, Rash
Drug(s) suspected as cause:
Asacol
Dosage: asacol 400mg tabs
Administration route: Oral
Indication: Colitis Ulcerative
Start date: 2000-01-01
Pravachol
Administration route: Oral
Indication: Blood Cholesterol Increased
Start date: 2011-01-01
Other drugs received by patient: Multi-Vitamin
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 female
Reported by a health professional (non-physician/pharmacist) from United States on 2011-12-09
Patient: female, weighing 74.0 kg (162.8 pounds)
Reactions: Hyperhidrosis, Tremor
Drug(s) suspected as cause:
Genotropin
Dosage: 0.4 mg, 1x/day
Indication: Dwarfism
Start date: 2011-06-24
Asacol
Dosage: unk
Indication: Abdominal Discomfort
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
|
