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Lialda (Mesalamine) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Lialda (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 (66)
Death (7)
Life Threatening Events (2)

Reports by Reaction Type

Inappropriate Schedule of Drug Administration (12)Diarrhoea (12)Colitis Ulcerative (11)Off Label Use (9)Abdominal Pain (6)Drug Ineffective (6)Condition Aggravated (6)Colitis (6)Weight Decreased (5)Pyrexia (5)Abdominal Pain Upper (5)Clostridial Infection (5)

Below are a few examples of reports where side effects / adverse reactions may be related to Lialda (Mesalamine). For a complete list or a specific selection of reports, please use the links above.

Possible Lialda side effects in male

Reported by a physician from United States on 2012-08-15

Patient: male, weighing 163.3 kg (359.2 pounds)

Reactions: Inappropriate Schedule of Drug Administration, Colitis Ulcerative

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Lialda

Other drugs received by patient: Albuterol; Lasix; Amlodipine; Aspirin; Lisinopril; Humulin R; Hydrocodone Bitartrate; Carvedilol; Diazepam



Possible Lialda side effects in 60 year old female

Reported by a consumer/non-health professional from United States on 2012-08-06

Patient: 60 year old female, weighing 65.8 kg (144.7 pounds)

Reactions: Chromaturia

Drug(s) suspected as cause:
Lialda



Possible Lialda side effects in female

Reported by a consumer/non-health professional from Italy on 2012-07-20

Patient: female, weighing 72.1 kg (158.6 pounds)

Reactions: Abdominal Pain, Colitis Ulcerative, Arthralgia, Diarrhoea Haemorrhagic, Drug Prescribing Error

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Lialda
    Dosage: 2.4 g, 1x/day:qd (two, 1.2g tablets)
    Administration route: Oral
    Indication: Colitis Ulcerative
    Start date: 2010-11-01

Lialda
    Dosage: unk, 1x/day:qd
    Administration route: Oral
    End date: 2012-07-10

Lialda
    Dosage: 2.4 g, 2x/day:bid
    Administration route: Oral
    Start date: 2012-07-11

Other drugs received by patient: Probiotics NOS



Possible Lialda side effects in 62 year old male

Reported by a consumer/non-health professional from United States on 2012-07-18

Patient: 62 year old male, weighing 99.8 kg (219.5 pounds)

Reactions: Diarrhoea, Abdominal Pain Upper

Drug(s) suspected as cause:
Lialda



Possible Lialda side effects in male

Reported by a consumer/non-health professional from United States on 2012-07-18

Patient: male, weighing 81.2 kg (178.6 pounds)

Reactions: Haematochezia, Drug Ineffective, Chest Pain, Drug Prescribing Error, Fall, Myocardial Infarction

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Lialda
    Dosage: 1.2 g, 2x/day:bid
    Administration route: Oral
    Indication: Colitis Ulcerative
    Start date: 2012-06-01
    End date: 2012-06-21

Lialda
    Dosage: 1.2 g, 4x/day:qid
    Administration route: Oral
    Start date: 2012-06-22
    End date: 2012-06-01

Lialda
    Dosage: 1.2 g, 2x/day:bid
    Administration route: Oral
    Start date: 2012-06-01
    End date: 2012-07-01

Other drugs received by patient: Cetirizine DI-HCL; Fluticasone Propionate; Advair HFA



Possible Lialda side effects in 24 year old male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-16

Patient: 24 year old male, weighing 61.2 kg (134.7 pounds)

Reactions: Abdominal Pain, Colitis Ulcerative, Diarrhoea Haemorrhagic

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Lialda
    Dosage: 4.8 g, 1x/day:qd (four-1.2g tablets)
    Administration route: Oral
    Start date: 2012-04-01

Lialda
    Dosage: 2.4 g, 1x/day:qd (two- 1.2g tablets)
    Administration route: Oral
    Indication: Colitis Ulcerative
    End date: 2012-04-01



Possible Lialda side effects in male

Reported by a physician from United States on 2012-07-13

Patient: male, weighing 81.2 kg (178.6 pounds)

Reactions: Haematochezia, Drug Ineffective, Chest Pain, Myocardial Infarction, Drug Prescribing Error, Fall

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Lialda
    Dosage: 1.2 g, 2x/day:bid
    Administration route: Oral
    Indication: Colitis Ulcerative
    Start date: 2012-06-01
    End date: 2012-06-21

Lialda
    Dosage: 1.2 g, 2x/day:bid
    Administration route: Oral
    Start date: 2012-06-01
    End date: 2012-07-01

Lialda
    Dosage: 1.2 g, 4x/day:qid
    Administration route: Oral
    Start date: 2012-06-22
    End date: 2012-06-01

Other drugs received by patient: Advair HFA; Cetirizine DI-HCL; Fluticasone Propionate



Possible Lialda side effects in 20 year old male

Reported by a physician from United States on 2012-07-12

Patient: 20 year old male

Reactions: Meningitis Viral

Drug(s) suspected as cause:
Lialda
    Administration route: Oral
    Indication: Colitis Ulcerative

Remicade
    Indication: Colitis Ulcerative



Possible Lialda side effects in female

Reported by a consumer/non-health professional from United States on 2012-07-06

Patient: female, weighing 47.6 kg (104.8 pounds)

Reactions: Weight Decreased, Hospitalisation, Clostridium Difficile Colitis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Lialda

Other drugs received by patient: Levoxyl; Singulair; Albuterol; Metamucil / 00091301 /; Align; Multi-Vitamins



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 30 year old male

Reported by a physician from United States on 2012-06-21

Patient: 30 year old male

Reactions: Swollen Tongue

Drug(s) suspected as cause:
Lialda



Possible Lialda side effects in 18 year old female

Reported by a consumer/non-health professional from United States on 2012-06-01

Patient: 18 year old female

Reactions: Migraine, Depression, Suicidal Ideation

Drug(s) suspected as cause:
Lialda
    Dosage: 1.2 g, 1x/day:qd
    Administration route: Oral
    Start date: 2012-01-01

Lialda
    Dosage: 4.8 g, 1x/day:qd (four 1.2 g tablets)
    Administration route: Oral
    Indication: Colitis Ulcerative
    Start date: 2012-01-01
    End date: 2012-01-01

Other drugs received by patient: Methotrexate



Possible Lialda side effects in male

Reported by a consumer/non-health professional from United States on 2012-05-29

Patient: male, weighing 85.3 kg (187.6 pounds)

Reactions: Renal Impairment

Drug(s) suspected as cause:
Lialda
    Dosage: 4.8 g; 1x/day:qd (four 1.2 g tablets in the am)
    Administration route: Oral
    Indication: Diverticulitis
    Start date: 2012-03-01
    End date: 2012-04-06

Lialda
    Dosage: 2.4 g; 1x/day:qd (two 1.2 g tablets in the pm)
    Administration route: Oral
    Indication: Colitis Ulcerative
    Start date: 2012-03-01
    End date: 2012-04-06

Pentasa
    Dosage: 2000 mg; 2x/day:bid (four 500 mg capsules)
    Administration route: Oral
    Indication: Colitis Ulcerative
    Start date: 2012-04-07

Other drugs received by patient: Butalbital; Metoprolol Tartrate; Prilosec; Enalapril Maleate; Flovent; Unspecified Nebulizer; Benzonatate; Combivent; Clonidine; Pravastatin Sodium



Possible Lialda side effects in male

Reported by a physician from United States on 2012-05-28

Patient: male, weighing 85.3 kg (187.6 pounds)

Reactions: Renal Impairment

Drug(s) suspected as cause:
Lialda
    Dosage: 4.8 g; 1x/day:qd (four 1.2 g tablets in the am)
    Administration route: Oral
    Indication: Diverticulitis
    Start date: 2012-03-01
    End date: 2012-04-06

Lialda
    Dosage: 2.4 g; 1x/day:qd (two 1.2 g tablets in the pm)
    Administration route: Oral
    Indication: Colitis Ulcerative
    Start date: 2012-03-01
    End date: 2012-04-06

Pentasa
    Dosage: 2000 mg; 2x/day:bid (four 500 mg capsules)
    Administration route: Oral
    Indication: Colitis Ulcerative
    Start date: 2012-04-07

Other drugs received by patient: Prilosec; Butalbital; Benzonatate; Metoprolol Tartrate; Pravastatin Sodium; Enalapril Maleate; Unspecified Nebulizer; Clonidine; Combivent; Flovent



Possible Lialda side effects in female

Reported by a physician from United States on 2012-05-18

Patient: female, weighing 56.7 kg (124.7 pounds)

Reactions: Nephrolithiasis, Abdominal Pain, Vomiting, Diarrhoea, Nausea

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Lialda
    Dosage: 3.6 g, 1x/day:qd
    Administration route: Oral
    Indication: Colitis
    Start date: 2012-04-07
    End date: 2012-04-08

Lialda
    Dosage: 1.2 g, 1x/day:qd
    Administration route: Oral
    Start date: 2012-04-11
    End date: 2012-04-12

Other drugs received by patient: Toprol-XL; Lisinopril; Xanax; Phenergan; Norvasc; Aciphex; Hydrocodone



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 69 year old male

Reported by a consumer/non-health professional from United States on 2012-04-26

Patient: 69 year old male

Reactions: Death

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 2012-04-19

Patient: male

Reactions: Hepatitis C

Drug(s) suspected as cause:
Lialda



Possible Lialda side effects in 29 year old male

Reported by a health professional (non-physician/pharmacist) from United States on 2012-04-19

Patient: 29 year old male, weighing 83.4 kg (183.5 pounds)

Reactions: Pancreatitis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Lialda

Other drugs received by patient: Iron (Iron); Multivitamins / 0097801 / (Ascorbic Acid, Calcium Pantothenate, Ergocalc; Fish OIL (Fish Oil); Folic Acid; Prednisone TAB



Possible Lialda side effects in 29 year old female

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

Patient: 29 year old female

Reactions: Pericarditis

Drug(s) suspected as cause:
Lialda



Possible Lialda side effects in 19 year old female

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

Patient: 19 year old female, weighing 62.6 kg (137.7 pounds)

Reactions: Colitis Ulcerative, Pancreatitis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Lialda
    Dosage: 4.8 g, 1x/day:qd, oral
    Administration route: Oral
    Indication: Colitis Ulcerative
    Start date: 2008-08-16
    End date: 2008-12-26

Prednisone TAB
    Dosage: (two 20 mg tablets daily), oral
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Other drugs received by patient: Albuterol



Possible Lialda side effects in 35 year old female

Reported by a consumer/non-health professional from United States on 2012-04-19

Patient: 35 year old female, weighing 49.9 kg (109.8 pounds)

Reactions: Colitis Ulcerative, Drug Ineffective

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Lialda



Possible Lialda side effects in 26 year old female

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

Patient: 26 year old female

Reactions: Nephritis

Drug(s) suspected as cause:
Lialda

Other drugs received by patient: Humira; Remicade



Possible Lialda side effects in 46 year old female

Reported by a consumer/non-health professional from United States on 2012-04-19

Patient: 46 year old female, weighing 79.4 kg (174.7 pounds)

Reactions: Inappropriate Schedule of Drug Administration, Diabetes Mellitus, Colitis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Lialda

Other drugs received by patient: Lomotil; Hydrochlorothiazide; Metoprolol Tartrate; Ranitidine Hydrochloride; Celexa



Possible Lialda side effects in 48 year old male

Reported by a consumer/non-health professional from United States on 2012-04-19

Patient: 48 year old male, weighing 93.0 kg (204.6 pounds)

Reactions: Hepatitis Viral, Headache, Biliary Tract Disorder

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Lialda



Possible Lialda side effects in male

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

Patient: male

Reactions: Pancreatitis

Drug(s) suspected as cause:
Lialda



Possible Lialda side effects in female

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

Patient: female

Reactions: Pancreatitis

Drug(s) suspected as cause:
Lialda



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 28 year old male

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

Patient: 28 year old male, weighing 68.0 kg (149.6 pounds)

Reactions: Myocarditis

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Lialda

Other drugs received by patient: Prednisone TAB

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