FDA label 45d8575d-1969-4175-e054-00144ff8d46c

WARNINGS

ADVERSE REACTIONS Table 2 reports the incidence rate of treatment-emergent adverse events over five days of tramadol hydrochloride and acetaminophen tablets use in clinical trials (subjects took an average of at least 6 tablets per day). Table 2: Incidence of Treatment-Emergent Adverse Events (Body System Preferred TermTramadol Hydrochloride and Acetaminophen Tablets (N=142) %Gastrointestinal System DisordersConstipation6Nausea3Diarrhea3Dry Mouth2Psychiatric DisordersSomnolence6Anorexia3Insomnia2Central & Peripheral Nervous SystemDizziness3Skin and AppendagesSweating Increased4Pruritus2Reproductive Disorders, Male *Prostatic Disorder2* Number of males = 62 Incidence at least 1%, causal relationship at least possible 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 tramadol hydrochloride and acetaminophen tablets Body as a Whole Asthenia, fatigue, hot flushes Central and Peripheral Nervous System Dizziness, headache, tremor Gastrointestinal System Abdominal pain, constipation, diarrhea, dyspepsia, flatulence, dry mouth, nausea, vomiting Psychiatric Disorders 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 tramadol hydrochloride and acetaminophen tablets clinical trials. Body as a Whole Chest pain, rigors, syncope, withdrawal syndrome Cardiovascular Disorders Hypertension, aggravated hypertension, hypotension Central and Peripheral Nervous System Ataxia, convulsions, hypertonia, migraine, aggravated migraine, involuntary muscle contractions, paresthesias, stupor, vertigo Gastrointestinal System Dysphagia, melena, tongue edema Hearing and Vestibular Disorders Tinnitus Heart Rate and Rhythm DisordersArrhythmia, 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. Other events which have been reported with the use of tramadol products and for which a causal association has not been determined include: vasodilation, orthostatic hypotension, myocardial ischemia, pulmonary edema, allergic reactions (including anaphylaxis and urticaria, Stevens-Johnson syndrome/TENS), cognitive dysfunction, difficulty concentrating, depression, suicidal tendency, hepatitis liver failure and gastrointestinal bleeding. Reported laboratory abnormalities included elevated creatinine and liver function tests. Serotonin syndrome (whose symptoms may include mental status change, hyperreflexia, fever, shivering, tremor, agitation, diaphoresis, seizures and coma) has been reported with tramadol when used concomitantly with other serotonergic agents such as SSRIs and MAOIs. Other clinically significant adverse experiences previously reported with acetaminophen. Allergic reactions (primarily skin rash) or reports of hypersensitivity secondary to acetaminophen are rare and generally controlled by discontinuation of the drug and, when necessary, symptomatic treatment.