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Company LIALDA Group / Shire US Inc. / / Event FDA Phase / Product Issues / / Facility Terminal Phase / Laboratory Tests / Laboratory Tests Use / / IndustryTerm dose / food / / MedicalCondition anaphylactic reaction / cholecystitis / interstitial pneumonitis / pharyngolaryngeal pain General Disorders / headache / seizures / ear and labyrinth disorders / Kawasaki-like syndrome / liver failure / Subcutaneous Tissue Disorders / Moderate Ulcerative Colitis / nausea / pruritis / pericardial effusion / Upper GI Tract Obstruction Pyloric stenosis / Alopecia / colonic inflammation / colitis / Stevens-Johnson syndrome / peripheral neuropathy / prurigo / Administrative Site Disorders / fatigue / drowsiness / eosinophilic pneumonitis / gastritis / renal disease / aplastic anemia Immune System Disorders / chronic inflammatory bowel disease / psoriasis / diarrhea / hypersensitivity / hepatitis / bloody diarrhea / blood disorders / myocarditis / Pruritus / liver disease / renal dysfunction / gastrointestinal disorders / erythema nodosum Urogenital / Back pain / pericarditis / lupus-like syndrome / agranulocytosis / Mesalamine-induced acute intolerance syndrome / skin and subcutaneous tissue disorders / Cardiac Disorder / Mediastinal Disorders / abdominal pain / hypertension / acne / Nervous System Disorders / arthralgia / tachycardia Vascular Disorders / gastroenteritis / dyspnea / Mesalamine-induced cardiac hypersensitivity / drug fever Cardiac Disorders / Carcinogenesis / concurrent disease / pre existing liver disease / Guillain-Barre syndrome / neutropenia / vertigo / ear pain / LIALDA-treated ulcerative colitis / ulcerative colitis / vomiting / acute intolerance syndrome / Hepatic failure / urticaria Gastrointestinal Disorders / Pancreatitis / pyoderma gangrenosum / acute and chronic interstitial nephritis / pre-existing liver disease / minimal change nephropathy / Connective Tissue Disorders / hyperventilation / dizziness / renal failure / inflammation / liver necrosis / acute abdominal pain / hypersensitivity pneumonitis / rash / tinnitus / eosinophilia and systemic symptoms / Disorders / pancytopenia / transverse myelitis Renal Disorders / dehydration / / MedicalTreatment antibiotics / intravenous therapy / induction of remission / drug therapy / / Organization Mesalamine Following Single Dose Administration of LIALDA / **N=46 Administration / DOSAGE AND ADMINISTRATION / FDA / Mesalamine Following Single Dose Administration of LIALDA Under Fasting Conditions Parameter1 of Mesalamine LIALDA / / / Position General / / Product The tablet / trimethoprim / mesalamine / polyethylene glycol / sulfasalazine / LIALDA / Each LIALDA / mercaptopurine / C7H7NO3 153.14 The / talc / metronidazole / amoxicillin / Azathioprine / ciprofloxacin / sulfamethoxazole / Delayed-Release Tablets / fertility / / Technology Pharmacokinetics / Pharmacodynamics / / URL www.fda.gov/medwatch / / SocialTag 
HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use LIALDA safely and effectively. See full prescribing information for LIALDA. LIALDA® (mesalamine) delayed-release ta