Reply #1: the elderly [View All]

Following is a list of terms that reflect treatment-emergent adverse events reported by patients treated with olanzapine (at multiple doses ³1 mg/day) in clinical trials (8661 patients, 4165 patient-years of exposure). This listing does not include those events already listed in previous tables or elsewhere in labeling, those events for which a drug cause was remote, those event terms which were so general as to be uninformative, and those events reported only once or twice which did not have a substantial probability of being acutely life-threatening.

Events are further categorized by body system and listed in order of decreasing frequency according to the following definitions: frequent adverse events are those occurring in at least 1/100 patients (only those not already listed in the tabulated results from placebo-controlled trials appear in this listing); infrequent adverse events are those occurring in 1/100to 1/1000patients; rare events are those occurring in fewer than 1/1000patients.

Body as a Whole — Frequent: dental pain and flu syndrome; Infrequent: abdomen enlarged, chills, face edema, intentional injury, malaise, moniliasis, neck pain, neck rigidity, pelvic pain, photosensitivity reaction, and suicide attempt; Rare: chills and fever, hangover effect, and sudden death.

Cardiovascular System — Frequent: hypotension; Infrequent: atrial fibrillation, bradycardia, cerebrovascular accident, congestive heart failure, heart arrest, hemorrhage, migraine, pallor, palpitation, vasodilatation, and ventricular extrasystoles; Rare: arteritis, heart failure, and pulmonary embolus.

Digestive System — Frequent: flatulence, increased salivation, and thirst; Infrequent: dysphagia, esophagitis, fecal impaction, fecal incontinence, gastritis, gastroenteritis, gingivitis, hepatitis, melena, mouth ulceration, nausea and vomiting, oral moniliasis, periodontal abscess, rectal hemorrhage, stomatitis, tongue edema, and tooth caries; Rare: aphthous stomatitis, enteritis, eructation, esophageal ulcer, glossitis, ileus, intestinal obstruction, liver fatty deposit, and tongue discoloration.