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Company abnormal AG / PREVACID / Takeda Pharmaceuticals America Inc. / / Country United States / / Event FDA Phase / Product Issues / / Facility Laboratory Values The / Laboratory Values / / IndustryTerm age / aqueous solution / otitis media / treatment of heartburn and other symptoms / / MedicalCondition polyuria / photophobia / Senses - speech disorder / glossitis / vaginitis / leg cramps / enteritis / Active Benign Gastric Ulcer PREVACID / HIV / dementia / cholelithiasis / Duodenal Ulcer / arthritis / esophagitis / hallucinations / convulsion / thrombotic thrombocytopenic purpura / gastrointestinal moniliasis / stomatitis / H. pylori infection / toxic epidermal necrolysis / NSAID-associated gastric ulcers / breast pain / gastrointestinal disorder / penis disorder / gout / albuminuria / gastrointestinal hemorrhage / Active Duodenal Ulcer / Overall GERD Symptoms Nonerosive GERD / hematemesis / angina / diarrhea / Zollinger-Ellison syndrome / otitis media / testis disorder / bone disorder / ear/eye disorder / esophageal stenosis / flu syndrome / Symptomatic GERD Nonerosive GERD / asthma / nail disorder / Pathological Hypersecretory Conditions Including ZollingerEllison Syndrome / asthenia / back pain / adolescent erosive esophagitis / abdominal pain / pneumonia / Nutritional Disorders / hair disorder / hyperglycemia/hypoglycemia / tumors / arthralgia / non-erosive GERD / conservative GERD / dysphagia / chills / NSAID-Associated Gastric Ulcer / Carcinogenesis / sleep disorder / candidiasis / neutropenia / bradycardia / cerebrovascular accident/cerebral infarction / fever / melena / ulcerative colitis / vomiting / esophageal disorder / Treatment-related dizziness / Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome / chronic hepatic impairment / Erosive Esophagitis / weeks Erosive Esophagitis / myositis / pancreatitis / infection / joint disorder / contact dermatitis / dizziness / hyperkinesia / depression / rash / paresthesia / inflammation/infection / tinnitus / eosinophilia / pancytopenia / leukorrhea / skin disorder / glaucoma / GERD Symptomatic GERD / tongue disorder / allergic reaction / Symptomatic GERD / chest pain / Healed Duodenal Ulcers / Headache / urinary retention / duodenitis / retinal degeneration/disorder / leukopenia / bronchitis / urinary tract infection / nausea / hypertension/hypotension / Indication Dose Frequency Duodenal Ulcers / thrombocytopenia / Symptomatic GERD PREVACID / rhinitis / glycosuria / alopecia / carcinoma / hemiplegia / colitis / hemoptysis / Stevens-Johnson syndrome / tremor / syncope / duodenal ulcer disease / Whole Abdominal Pain / conjunctivitis / severe hypersensitivity / Nonerosive GERD / duodenal ulcers / lung fibrosis / fatigue / deafness / gastritis / erythema multiforme / tachycardia / hyperlipemia / sinusitis / aplastic anemia / constipation / neck pain / pruritus / infections / Active Duodenal Ulcer PREVACID / rectal disorder / Erosive Esophagitis PREVACID / gynecomastia / respiratory disorder / mg wks NSAID-associated Gastric Ulcer / arrhythmia / Healed Duodenal Ulcers PREVACID / insomnia / epistaxis / avitaminosis / hemolytic anemia / acne / gastric ulcer / days Benign Gastric Ulcer / kidney calculus / NSAID-Associated Gastric Ulcer PREVACID / carcinoid tumors / gastroenteritis / dyspnea / hoarseness / amnesia / hematuria / shock / pleural disorder / migraine / benign neoplasm / Overall GERD Symptoms Erosive Esophagitis / hypesthesia / menorrhagia / menstrual disorder / pain / amblyopia / maculopapular rash / GERD / myocardial infarction / Lymphatic System agranulocytosis / diabetes mellitus / System - interstitial nephritis / overall GERD / eye pain / hiatal hernia / goiter / skin carcinoma / cough / impotence / cardiospasm / diplopia / Active Benign Gastric Ulcer / pharyngitis / anemia / cataract / documented gastric ulcer / blepharitis / dehydration / / MedicalTreatment hemodialysis / / Organization Oral Administration / DOSAGE AND ADMINISTRATION / FDA / Oral Syringe For administration / Tacrolimus Concomitant administration / Concomitant administration / Administration For administration / / / Position treating physician / investigator / / Product glucagon / ampicillin / Delayed-Release Capsules / theophylline / digoxin / Amoxicillin / Open capsule / The tablet / PREVACID / SoluTab™ Delayed-Release Orally Disintegrating Tablets / polyethylene glycol / Clarithromycin / naproxen / mannitol / talc / SoluTab Delayed-Release Orally Disintegrating Tablets / estradiol / Place / testosterone / lansoprazole / ketoconazole / misoprostol / patients / administration / gastric emptying / fertility / Delayed-Release Orally Disintegrating Tablets / / Technology Pharmacokinetics / Pharmacodynamics / / URL www.fda.gov/medwatch / /
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HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use PREVACID safely and effectively. See full prescribing information for: PREVACID (lansoprazole) Delayed-Release Capsu