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Ultracet

[Tramadol/Acetaminophen]


Side Effects & Drug Interactions
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%)

Text Continues Below



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

Red Blood Cell Disorders

Anemia

Respiratory System

Dyspnea

Urinary System

Albuminuria, micturition disorder, oliguria, urinary retention

Vision Disorders

Abnormal vision

Other clinically significant adverse experiences previously reported with tramadol hydrochloride.

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