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Lialda (Mesalamine) - Off Label Use - Suspected Cause - Side Effect Reports

 
 



Index of reports > Cases with Off Label Use (9)

Below is the selection of side effect reports (a.k.a. adverse event reports) related to Lialda (Mesalamine) where reactions include off label use. The selected reports were submitted to the FDA during the sample period of about a year.

Possible Lialda side effects in male

Reported by a pharmacist from United States on 2012-06-22

Patient: male, weighing 163.3 kg (359.2 pounds)

Reactions: Inappropriate Schedule of Drug Administration, Off Label Use, Crohn's Disease

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Lialda



Possible Lialda side effects in female

Reported by a consumer/non-health professional from United States on 2012-05-10

Patient: female, weighing 63.5 kg (139.7 pounds)

Reactions: Abdominal Pain, Inappropriate Schedule of Drug Administration, Vomiting, Lymphadenopathy, Off Label Use, Diarrhoea, Abdominal Distension, Colitis, Clostridial Infection

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Lialda



Possible Lialda side effects in female

Reported by a physician from United States on 2012-05-01

Patient: female, weighing 81.6 kg (179.6 pounds)

Reactions: Off Label Use, Inappropriate Schedule of Drug Administration, Cataract, Hypertrophic Cardiomyopathy, Sleep Apnoea Syndrome

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Lialda

Other drugs received by patient: Vivelle-DOT; Valtrex; Prilosec; Synthroid; Nasonex; Astepro



Possible Lialda side effects in 17 year old male

Reported by a pharmacist from United States on 2012-04-19

Patient: 17 year old male

Reactions: Dyspnoea, Pyrexia, Eosinophil Count Increased, Off Label Use, Heart Rate Increased, Blood Pressure Decreased, Pneumonitis, Cough

Drug(s) suspected as cause:
Lialda
    Dosage: 2.4 g, 1x/day:qd,oral, 4.8g 1xd oral
    Administration route: Oral
    Indication: Crohn's Disease
    Start date: 2011-04-01
    End date: 2011-05-04

Lialda
    Dosage: 2.4 g, 1x/day:qd,oral, 4.8g 1xd oral
    Administration route: Oral
    Indication: Crohn's Disease
    Start date: 2011-05-05
    End date: 2011-05-05



Possible Lialda side effects in 37 year old male

Reported by a physician from United States on 2012-04-19

Patient: 37 year old male, weighing 99.8 kg (219.6 pounds)

Reactions: Off Label Use, Pericarditis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Lialda



Possible Lialda side effects in female

Reported by a consumer/non-health professional from United States on 2012-03-06

Patient: female, weighing 63.5 kg (139.7 pounds)

Reactions: Inappropriate Schedule of Drug Administration, Abdominal Pain, Lymphadenopathy, Vomiting, Off Label Use, Diarrhoea, Abdominal Distension, Colitis, Clostridial Infection

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Lialda



Possible Lialda side effects in female

Reported by a consumer/non-health professional from United States on 2012-01-12

Patient: female, weighing 49.9 kg (109.8 pounds)

Reactions: Off Label Use, Coma, Cerebrovascular Accident

Adverse event resulted in: death

Drug(s) suspected as cause:
Lialda



Possible Lialda side effects in male

Reported by a consumer/non-health professional from United States on 2011-12-13

Patient: male

Reactions: Off Label Use, Multiple Sclerosis

Drug(s) suspected as cause:
Lialda



Possible Lialda side effects in male

Reported by a consumer/non-health professional from United States on 2011-11-10

Patient: male

Reactions: Off Label Use, Death, Post Procedural Complication, Condition Aggravated, Adverse Event, Chronic Hepatic Failure

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Lialda

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