Ultracet Side Effects
Generic Name: acetaminophen / tramadol
Note: This document contains side effect information about acetaminophen / tramadol. Some of the dosage forms listed on this page may not apply to the brand name Ultracet.
Some side effects of Ultracet may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.
For the Consumer
Applies to acetaminophen / tramadol: oral tablet
Along with its needed effects, acetaminophen / tramadol may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur while taking acetaminophen / tramadol:Rare
- Burning, itching, and redness of the skin
- chest pain
- difficulty with swallowing
- fast heartbeat
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- shortness of breath
- skin rash, hives, or itching skin
- tightness in the chest
- unusual tiredness or weakness
- Blistering, peeling, or loosening of the skin
- joint or muscle pain
- large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
- noisy breathing
- red skin lesions, often with a purple center
- red, irritated eyes
- sore throat
- sores, ulcers, or white spots in the mouth or on the lips
Get emergency help immediately if any of the following symptoms of overdose occur while taking acetaminophen / tramadol:Symptoms of overdose
- Abdominal or stomach pain
- black, tarry stools
- chest pain or discomfort
- dark urine
- difficulty with sleeping
- drowsiness to profound coma
- irregular, fast or slow, or shallow breathing
- light-colored stools
- loss of appetite
- mood or other mental changes
- pale or blue lips, fingernails, or skin
- seeing, hearing, or feeling things that are not there
- unpleasant breath odor
- vomiting of blood
- yellow eyes or skin
Some side effects of acetaminophen / tramadol may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:Less common
- Acid or sour stomach
- bloated or full feeling
- dry mouth
- excess air or gas in the stomach or intestines
- false or unusual sense of well-being
- feeling of warmth
- increase in bowel movements
- increased sweating
- loose stools
- loss of strength or energy
- muscle pain or weakness
- numbness or tingling of the hands, legs, and feet
- painful or difficult urination
- redness of the face, neck, arms, and occasionally the upper chest
- sleepiness or unusual drowsiness
- soft stools
- stomach discomfort
- weight loss
- Abnormal thinking
- blurred vision
- change in vision
- clumsiness, unsteadiness, trembling, or problems with muscle control or coordination
- cold sweats
- continuing ringing, buzzing, or unexplained noise in the ears
- decrease in the frequency or amount of urination
- decreased awareness or responsiveness
- decreased interest in sexual intercourse
- difficulty in passing urine (dribbling)
- dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
- fast, pounding, or irregular heartbeat or pulse
- feeling of constant movement of self or surroundings
- feeling unusually cold
- headache, severe or continuing
- increased muscle tone
- involuntary muscle contractions
- loss of memory
- loss of sense of reality
- loss of sexual ability, desire, drive, or performance
- migraine headache
- morbid dreaming
- pounding in the ears
- problems with memory
- quick to react or overreact emotionally
- rapidly changing moods
- sensation of spinning
- severe stomach pain
- shakiness and unsteady walk
- swelling of the tongue
- vomiting of blood or material that looks like coffee grounds
For Healthcare Professionals
Applies to acetaminophen / tramadol: oral tablet
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 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 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 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 side effects including prostatic disorder (2%), albuminuria, micturition disorder, oliguria, and urinary retention have been reported.
General side effects including asthenia, fatigue, hot flushes, chest pain, rigors, syncope, and withdrawal syndrome have been reported.
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 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 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 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 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 side effects including abnormal vision have been reported.
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 side effects including elevated creatinine has been reported with the use of tramadol but a causal association has not been determined.
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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