This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Rowasa (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 (10)
Disability (2)
Reports by Reaction Type
Vitamin D Decreased (7),
Central Nervous System Lesion (5),
Deafness Unilateral (5),
Diplopia (4),
Multiple Sclerosis (4),
Vertigo (3),
Lung Disorder (2),
Productive Cough (1),
Weight Decreased (1),
General Physical Condition Abnormal (1),
Obliterative Bronchiolitis (1),
Dizziness (1)
Possible Rowasa side effects in male
Reported by a physician from United States on 2012-07-11
Patient: male, weighing 83.0 kg (182.6 pounds)
Reactions: Weight Decreased, Vomiting, Nausea, Eating Disorder, Diplopia, Viral Upper Respiratory Tract Infection, Acute Sinusitis, Vitamin D Decreased, Ear Pain, Dizziness, Multiple Sclerosis
Adverse event resulted in: disablity
Drug(s) suspected as cause:
Rowasa
Indication: Colitis Ulcerative
Start date: 2012-02-01
Remicade
Indication: Colitis Ulcerative
End date: 2012-04-12
Remicade
Start date: 2007-05-11
End date: 2012-01-03
Other drugs received by patient: Nexium; Pentasa; Multi-Vitamins; ALL Other Therapeutic Products
Possible Rowasa side effects in 54 year old female
Reported by a health professional (non-physician/pharmacist) on 2012-06-26
Patient: 54 year old female
Reactions: Night Sweats, Productive Cough, General Physical Condition Abnormal, Lung Disorder, Colitis Ulcerative, Obliterative Bronchiolitis
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Rowasa
Possible Rowasa side effects in male
Reported by a consumer/non-health professional from United States on 2012-06-18
Patient: male, weighing 83.0 kg (182.6 pounds)
Reactions: Vitamin D Decreased, Multiple Sclerosis
Adverse event resulted in: disablity
Drug(s) suspected as cause:
Remicade
Indication: Colitis Ulcerative
Start date: 2007-05-11
End date: 2012-01-03
Rowasa
Indication: Colitis Ulcerative
Start date: 2012-02-01
Other drugs received by patient: ALL Other Therapeutic Products; Pentasa; Multi-Vitamins
Possible Rowasa side effects in female
Reported by a health professional (non-physician/pharmacist) from France on 2012-06-18
Patient: female
Reactions: Lung Disorder
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Rowasa
Possible Rowasa side effects in male
Reported by a consumer/non-health professional from United States on 2012-06-08
Patient: male, weighing 83.0 kg (182.6 pounds)
Reactions: Central Nervous System Lesion, Vitamin D Decreased, Deafness Unilateral, Multiple Sclerosis
Drug(s) suspected as cause:
Rowasa
Indication: Colitis Ulcerative
Start date: 2012-02-01
Remicade
Indication: Colitis Ulcerative
Start date: 2007-05-11
End date: 2012-01-03
Other drugs received by patient: Multi-Vitamins; ALL Other Therapeutic Products; Pentasa
Possible Rowasa side effects in male
Reported by a consumer/non-health professional from United States on 2012-05-29
Patient: male, weighing 83.0 kg (182.6 pounds)
Reactions: Vitamin D Decreased, Deafness Unilateral, Central Nervous System Lesion, Multiple Sclerosis
Drug(s) suspected as cause:
Rowasa
Indication: Colitis Ulcerative
Start date: 2012-02-01
Remicade
Indication: Colitis Ulcerative
Start date: 2007-05-11
End date: 2012-01-03
Other drugs received by patient: ALL Other Therapeutic Products; Pentasa; Multi-Vitamins
Possible Rowasa side effects in male
Reported by a consumer/non-health professional from United States on 2012-05-29
Patient: male
Reactions: Diplopia, Deafness Unilateral, Central Nervous System Lesion, Vitamin D Decreased, Vertigo
Drug(s) suspected as cause:
Rowasa
Dosage: 1 application, at night
Indication: Colitis Ulcerative
Start date: 2012-02-01
Remicade
Indication: Colitis Ulcerative
Start date: 2007-04-01
End date: 2012-01-01
Other drugs received by patient: Multivitamins (Vitamins, Minerals)
Possible Rowasa side effects in 37 year old male
Reported by a consumer/non-health professional from United States on 2012-05-25
Patient: 37 year old male, weighing 83.0 kg (182.6 pounds)
Reactions: Diplopia, Central Nervous System Lesion, Deafness Unilateral, Vitamin D Decreased, Vertigo, Paraesthesia
Drug(s) suspected as cause:
Rowasa
Dosage: 1 application (dose) (at night)
Indication: Colitis Ulcerative
Start date: 2012-02-01
Remicade
Dosage: iv
Indication: Colitis Ulcerative
Start date: 2007-04-01
End date: 2012-01-01
Other drugs received by patient: Multivitamins (Vitamins, Minerals)
Possible Rowasa side effects in male
Reported by a consumer/non-health professional from United States on 2012-05-11
Patient: male, weighing 83.0 kg (182.6 pounds)
Reactions: Diplopia, Central Nervous System Lesion, Deafness Unilateral, Vitamin D Decreased, Vertigo
Drug(s) suspected as cause:
Rowasa
Indication: Colitis Ulcerative
Start date: 2012-02-01
Remicade
Indication: Colitis Ulcerative
Start date: 2007-04-01
End date: 2012-01-01
Other drugs received by patient: Multi-Vitamins; ALL Other Therapeutic Products
Possible Rowasa side effects in male
Reported by a consumer/non-health professional from United States on 2011-10-05
Patient: male, weighing 67.6 kg (148.7 pounds)
Reactions: Restlessness, Gastrointestinal Disorder, Flatulence, Abdominal Distension, Inflammation
Drug(s) suspected as cause:
Rowasa
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