Tylox Side Effects

Generic Name: acetaminophen / oxycodone

Note: This page contains side effects data for the generic drug acetaminophen / oxycodone. It is possible that some of the dosage forms included below may not apply to the brand name Tylox.

It is possible that some side effects of Tylox may not have been reported. These can be reported to the FDA here. Always consult a healthcare professional for medical advice.

For the Consumer

Applies to acetaminophen / oxycodone: oral capsule, oral solution, oral tablet, oral tablet extended release

As well as its needed effects, acetaminophen / oxycodone may cause unwanted side effects that require medical attention.

If any of the following side effects occur while taking acetaminophen / oxycodone, check with your doctor immediately:

More common
  • Abdominal or stomach pain
  • black, tarry stools
  • chills
  • dark urine
  • dizziness
  • fever
  • headache
  • itching
  • light-colored stools
  • loss of appetite
  • nausea
  • rash
  • unpleasant breath odor
  • unusual tiredness or weakness
  • vomiting of blood
  • yellow eyes or skin
Rare
  • Cough or hoarseness
  • fever with or without chills
  • general feeling of tiredness or weakness
  • lower back or side pain
  • painful or difficult urination
  • sore throat
  • sores, ulcers, or white spots on the lips or in the mouth
  • unusual bleeding or bruising
Incidence not known
  • Back, leg, or stomach pains
  • bleeding gums
  • bloating
  • blood in the urine or stools
  • blue lips and fingernails
  • blurred vision
  • burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
  • chest pain or discomfort
  • clay-colored stools
  • cloudy urine
  • clumsiness
  • confusion
  • constipation
  • coughing that sometimes produces a pink frothy sputum
  • decrease in the frequency of urination
  • decrease in urine volume
  • decreased awareness or responsiveness
  • decreased frequency or amount of urine
  • decreased urination
  • difficult or labored breathing
  • difficult or painful urination
  • difficult, fast, noisy breathing, sometimes with wheezing
  • difficulty in passing urine (dribbling)
  • difficulty with swallowing
  • dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  • drowsiness
  • dry mouth
  • extremely shallow or slow breathing
  • fainting
  • fast or deep breathing
  • fast, slow, irregular, pounding, or racing heartbeat or pulse
  • feeling of warmth
  • general body swelling
  • greatly decreased frequency of urination or amount of urine
  • increased sweating
  • increased thirst
  • indigestion
  • large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
  • lightheadedness
  • muscle aches
  • muscle tremors
  • muscle weakness
  • nervousness
  • noisy breathing
  • nosebleeds
  • numbness or tingling in the hands, feet, or lips
  • pains in the stomach, side, or abdomen, possibly radiating to the back
  • pale skin
  • pinpoint red spots on the skin
  • pounding in the ears
  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • rapid, deep breathing
  • rapid, shallow breathing
  • redness of the face, neck, arms, and occasionally, upper chest
  • redness of the skin
  • restlessness
  • seizures
  • severe constipation
  • severe sleepiness
  • severe vomiting
  • shivering
  • skin blisters
  • skin rash, hives, or welts
  • sleepiness
  • slow or irregular breathing
  • sore throat
  • stomach cramps
  • stomach pain, continuing
  • sudden decrease in the amount of urine
  • sunken eyes
  • sweating
  • swelling in the legs and ankles
  • swelling of the face, fingers, or lower legs
  • thirst
  • tightness in the chest
  • tiredness
  • troubled breathing
  • unpleasant breath odor
  • upper right abdominal or stomach pain
  • vomiting
  • weak or feeble pulse
  • weakness or heaviness of the legs
  • weight gain
  • wrinkled skin

If any of the following symptoms of overdose occur while taking acetaminophen / oxycodone, get emergency help immediately:

Symptoms of overdose
  • Bluish lips or skin
  • change in consciousness
  • cold, clammy skin
  • extreme sleepiness
  • general feeling of discomfort or illness
  • loss of consciousness
  • no blood pressure or pulse
  • not breathing
  • stopping of heart
  • unconsciousness

Some acetaminophen / oxycodone side effects may not need any medical attention. As your body gets used to the medicine these side effects may disappear. Your health care professional may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue, or if you are concerned about them:

More common
  • Relaxed and calm
Incidence not known
  • Acid or sour stomach
  • agitation
  • bad or unusual or unpleasant (after) taste
  • belching
  • change in taste
  • cold sweats
  • constricted, pinpoint, or small pupils (black part of the eye)
  • continuing ringing or buzzing or other unexplained noise in the ears
  • cool, pale skin
  • depression
  • diarrhea
  • difficulty with moving
  • disturbed color perception
  • double vision
  • excess air or gas in the stomach or intestines
  • false or unusual sense of well-being
  • flushed, dry skin
  • fruit-like breath odor
  • full feeling
  • general feeling of discomfort or illness
  • halos around lights
  • hearing loss
  • heartburn
  • increased hunger
  • increased thirst
  • increased urination
  • indigestion
  • joint pain
  • lack or loss of strength
  • muscle cramps or spasms
  • muscle pain or stiffness
  • night blindness
  • nightmares
  • overbright appearance of lights
  • passing gas
  • red eye
  • seeing, hearing, or feeling things that are not there
  • seizures
  • shakiness
  • sleepiness or unusual drowsiness
  • slurred speech
  • stomach discomfort, upset, or pain
  • stomach fullness
  • sweating
  • swollen joints
  • thirst
  • trouble sleeping
  • tunnel vision
  • unexplained weight loss
  • unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness

For Healthcare Professionals

Applies to acetaminophen / oxycodone: oral capsule, oral solution, oral tablet, oral tablet extended release

General

Psychosis has also been reported during withdrawal from oxycodone.[Ref]

In general, acetaminophen is well tolerated when administered in therapeutic doses. Oxycodone may be habit forming. Withdrawal symptoms after either abrupt cessation or fast tapering may occur and include agitation, restlessness, anxiety, insomnia, tremor, abdominal cramps, piloerection, blurred vision, vomiting, and sweating.[Ref]

Dermatologic

Dermatologic side effects including general erythematous skin rashes associated with acetaminophen have been reported, but are rare. Cases of bullous erythema and purpura fulminans associated with acetaminophen 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). Oxycodone may produce pruritus.[Ref]

Gastrointestinal

Gastrointestinal side effects with acetaminophen are rare except in alcoholics and after overdose. Cases of acute pancreatitis have been reported rarely. Nausea, vomiting, and constipation occur commonly with oxycodone.[Ref]

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.[Ref]

Hematologic

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 also been observed in the setting of acute overdose.[Ref]

Hepatic

Hepatic side effects have included hepatic dysfunction which may occur after overdose. In this setting, severe and sometimes fatal dose-dependent hepatitis has been reported. Several cases of hepatotoxicity from chronic acetaminophen therapy at therapeutic doses have also been reported despite a lack of risk factors for toxicity[Ref]

Hepatotoxicity may be increased by thyroid drugs, zidovudine, fasting, or alcohol use.

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. 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.[Ref]

Hypersensitivity

Hypersensitivity side effects including anaphylaxis and fixed drug eruptions have been reported rarely in association with acetaminophen use.[Ref]

Nervous system

Severe adverse effects of oxycodone, such as respiratory depression, can be treated with the opioid antagonist, naloxone. (The usual adult dose of naloxone is 1 to 2 mg every 5 minutes as necessary to a maximum of 10 mg. The dose is usually administered intravenously, but in an emergency may be given intramuscularly, subcutaneously, or sublingually.)[Ref]

Nervous system side effects with oxycodone containing products are common and include drowsiness, sedation, dizziness, and lightheadedness. Respiratory depression has also been reported.[Ref]

Psychiatric

Psychiatric side effects of oxycodone reported include paranoia, psychosis, and hallucinations.[Ref]

Renal

Acetaminophen related acute tubular necrosis usually occurs in conjunction with liver failure, but has been observed as an isolated finding in rare cases. A possible increase in the risk of renal cell carcinoma has been associated with chronic acetaminophen use.

A recent case-control study of patients with end-stage renal disease suggested that long term consumption of acetaminophen may significantly increase the risk of end-stage renal disease particularly in patients taking more than two tablets per day.[Ref]

Renal side effects of acetaminophen are rare and include acute tubular necrosis and interstitial nephritis. Additional adverse renal effects are most often observed after overdose, after chronic abuse (often with multiple analgesics), or in association with acetaminophen-related hepatotoxicity.[Ref]

Respiratory

Respiratory side effects have included a case of eosinophilic pneumonia which has been associated with acetaminophen.[Ref]

Cardiovascular

Two cases of hypotension have been reported following the administration of acetaminophen. Both patients experienced significant decreases in blood pressure. One of the two patients required pressor agents to maintain adequate mean arterial pressures. Neither episode was associated with symptoms of anaphylaxis. Neither patient was rechallenged after resolution of the initial episode.[Ref]

Cardiovascular side effects have included at least two cases of hypotension which have been reported following the administration of acetaminophen.[Ref]

Metabolic

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

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.

References

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