ADVERSE REACTIONS Table 2 reports the incidence rate of treatment-emergent adverse events over five days of ULTRACET use in clin-ical trials (subjects took an average of at least 6 tablets per day). Table 2: Incidence of Treatment-Emergent Adverse Events ( 2.0%)  Incidence at least 1%, causal relationship at least pos-sible or greater: the following lists adverse reactions that occurred with an incidence of at least 1% in single-dose or repeated-dose clinical trials of ULTRACET. Body as a Whole Asthenia, fatigue, hot flushes Central and Peripheral Nervous System Ð Dizziness, headache, tremor Gastrointestinal System Abdominal pain, consti-pation, diarrhea, dyspepsia, flatulence, dry mouth, nausea, vomiting Psychiatric Disorders Ð Anorexia, anxiety, confusion, euphoria, insomnia, nervousness, somnolence Skin and Appendages Pruritus, rash, increased sweating. Selected Adverse events occurring at less than 1%: the following lists clinically relevant adverse reactions that occurred with an incidence of less than 1% in ULTRACET clinical trials. Body as a Whole Chest pain, rigors, syncope, with-drawal syndrome Cardiovascular Disorders Hypertension, aggra-vated hypertension, hypotension Central and Peripheral Nervous System Ataxia, convulsions, hypertonia, migraine, aggravated migraine, involuntary muscle contractions, paraesthesia, stupor, vertigo Gastrointestinal System Dysphagia, melena, tongue edema Hearing and Vestibular Disorders Tinnitus Heart Rate and Rhythm Disorders Arrhythmia, palpitation, tachycardia Liver and Biliary System Hepatic function abnormal Metabolic and Nutritional Disorders Weight decrease Psychiatric Disorders Amnesia, depersonalization, depression, drug abuse, emotional lability, hallucination, impotence, paroniria, abnormal thinking | ||||
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