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Rowasa (Mesalamine) - Side Effect Reports to FDA

 
 



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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