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Reference ID: 2923078 ________________________________________________________________________________ INCIDENCE OF MOST FREQUENT (≥1%) ADVERSE EVENTS IN PATIENTS WITH SPASTICITY OF SPINAL ORIGIN IN PROSPECTIVELY MONITORED CLINICAL TRIALS ________________________________________________________________________________ Percent of Patients Reporting Events Nausea and Vomiting Urinary Retention Accidental Injury Peripheral Edema Urinary Incontinence Urinary Frequency ____________________________________________________________________________________ Following administration of test bolus Two month period following implant Beyond two months following implant N= total number of patients entering each period %=% of patients evaluated In addition to the more common (1% or more) adverse events reported in the prospectively followed 576 domestic patients in pre- and post- marketing studies, experience lioresal from an additional 194 patients exposed to LIORESAL INTRATHECAL (baclofen injection) from foreign studies has been reported .
The Reference ID: lioresal 2923078 following adverse events, not described in the table, and arranged in decreasing order of frequency, and classified by body system, were reported: Nervous System: Abnormal gait, thinking abnormal, tremor, amnesia, twitching, vasodilitation, cerebrovascular accident, nystagmus, personality disorder, psychotic depression, cerebral ischemia, emotional lability, euphoria, hypertonia, ileus, drug dependence, incoordination, paranoid reaction and Digestive System: Flatulence, dysphagia, dyspepsia and gastroenteritis .
Cardiovascular: Postural hypotension, bradycardia, palpitations, syncope, arrhythmia ventricular, deep lioresal thrombophlebitis, pallor and tachycardia .
Respiratory: Respiratory disorder, aspiration pneumonia, hyperventilation, pulmonary embolus and lioresal Urogenital: Hematuria and kidney failure .oral voltaren |
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