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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