Ultracet Side Effects

Please note - some side effects for Ultracet may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Ultracet - for the Consumer

Ultracet

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Ultracet:

Constipation; diarrhea; dizziness; drowsiness; increased sweating; loss of appetite; nausea.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); severe seizures (convulsions).

Ultracet Side Effects - for the Professional

Ultracet

Table 2 reports the incidence rate of treatment-emergent adverse events over five days of Ultracet® use in clinical trials (subjects took an average of at least 6 tablets per day).

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 Ultracet®.

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 Ultracet® 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 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.

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.

Side Effects by Body System

Gastrointestinal

Gastrointestinal side effects including constipation (6%), diarrhea (3%), nausea (3%) dry mouth (2%), abdominal pain, dyspepsia, flatulence, dysphagia, melena, and tongue edema have been reported. Gastrointestinal bleeding has been reported with the use of tramadol but a causal association has not been determined.

Gastrointestinal side effects of acetaminophen are rare, except in alcoholics and after overdose. Cases of acute pancreatitis have been reported rarely with acetaminophen use.

One study has suggested that acetaminophen may precipitate acute biliary pain and cholestasis. The mechanism of this effect may be related to inhibition of prostaglandin and alterations in the regulation of the sphincter of Oddi.

Psychiatric

Psychiatric side effects including somnolence (6%), anorexia (3%), insomnia (2%), anxiety, confusion, euphoria, amnesia, depersonalization, depression, drug abuse, emotional lability, hallucination, impotence, paroniria (morbid dreaming), abnormal thinking, and nervousness have been reported. Suicidal tendency has been reported with the use of tramadol but a causal association has not been determined.

Dermatologic

Dermatologic side effects including increased sweating (4%), pruritus (2%), and rash have been reported.

Nervous system

Nervous system side effects including dizziness (3%), headache, tremor, ataxia, convulsions, hypertonia, migraine, aggravated migraine, involuntary muscle contractions, paraesthesia, stupor, and vertigo have been reported. Cognitive dysfunction and difficulty concentrating have been reported with the use of tramadol but a causal association has not been determined.

Genitourinary

Genitourinary side effects including prostatic disorder (2%), albuminuria, micturition disorder, oliguria, and urinary retention have been reported.

General

General side effects including asthenia, fatigue, hot flushes, chest pain, rigors, syncope, and withdrawal syndrome have been reported.

Cardiovascular

Cardiovascular side effects including hypertension, aggravated hypertension, arrhythmia, palpitation, tachycardia, and hypotension have been reported. Vasodilation, orthostatic hypotension, and myocardial ischemia have been reported with the use of tramadol but a causal association has not been determined.

Other

Other side effects including tinnitus and weight decrease have been reported. Serotonin syndrome has been reported with the use of tramadol when taken concomitantly with other serotonergic agents (such as SSRIs and MAOIs).

Hepatic

Hepatic side effects including abnormal hepatic function have been reported. Hepatitis, liver failure, and elevated liver function test have been reported with the use of tramadol but a causal association has not been determined.

Hepatic side effects of acetaminophen including severe and sometimes fatal dose dependent hepatitis have been reported in alcoholic patients. Hepatotoxicity has been increased during fasting. Several cases of hepatotoxicity from chronic acetaminophen therapy at therapeutic doses have also been reported despite a lack of risk factors for toxicity.

Alcoholic patients may develop hepatotoxicity after even modest doses of acetaminophen. In healthy patients, approximately 15 grams of acetaminophen is necessary to deplete liver glutathione stores by 70% in a 70 kg person. However, hepatotoxicity has been reported following smaller doses. Glutathione concentrations may be repleted by the antidote N-acetylcysteine. One case report has suggested that hypothermia may also be beneficial in decreasing liver damage during overdose.

In a recent retrospective study of 306 patients admitted for acetaminophen overdose, 6.9% had severe liver injury but all recovered. None of the 306 patients died.

A 19-year-old female developed hepatotoxicity, reactive plasmacytosis and agranulocytosis followed by a leukemoid reaction after acute acetaminophen toxicity.

Hematologic

Hematologic side effects including anemia have been reported.

Hematologic side effects including rare cases of thrombocytopenia associated with acetaminophen have been reported. Acute thrombocytopenia has also been reported as having been caused by sensitivity to acetaminophen glucuronide, the major metabolite of acetaminophen. Methemoglobinemia with resulting cyanosis has been observed in the setting of acute overdose.

Respiratory

Respiratory side effects including dyspnea have been reported. Pulmonary edema has been reported with the use of tramadol but a causal association has not been determined.

Ocular

Ocular side effects including abnormal vision have been reported.

Hypersensitivity

Hypersensitivity side effects including anaphylaxis, urticaria, Stevens-Johnson syndrome/TENS have been reported with the use of tramadol but a causal association has not been determined. Allergic reaction including primarily skin rash and hypersensitivity secondary to acetaminophen have rarely been reported.

Allergic reactions and hypersensitivity secondary to acetaminophen have generally been controlled by discontinuation of the drug and, if necessary, symptomatic treatment.

Renal

Renal side effects including elevated creatinine has been reported with the use of tramadol but a causal association has not been determined.

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