Acetaminophen / tramadol Side Effects

Not all side effects for acetaminophen / tramadol may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

Applies to acetaminophen / tramadol: oral tablet

Gastrointestinal

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.

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.

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. Acetaminophen has been associated with a risk of rare but potentially fatal serious skin reactions know as Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and acute generalized exanthematous pustulosis (AGEP).

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

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

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.

Renal

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

Metabolic

In the case of metabolic acidosis, causality is uncertain as more than one drug was ingested. The case of metabolic acidosis followed the ingestion of 75 grams of acetaminophen, 1.95 grams of aspirin, and a small amount of a liquid household cleaner. The patient also had a history of seizures which the authors reported may have contributed to an increased lactate level indicative of metabolic acidosis.

Metabolic side effects including metabolic acidosis have been reported following a massive overdose of acetaminophen.

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