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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