Endocet

Note: This document contains side effect information about acetaminophen / oxycodone. Some of the dosage forms listed on this page may not apply to the brand name Endocet.

Applies to acetaminophen / oxycodone: oral solution, oral tablet

Along with its needed effects, acetaminophen / oxycodone 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 / oxycodone:

More common

• Black, tarry stools
• chills
• dark urine
• dizziness
• fever
• headache
• itching, skin rash
• light-colored stools
• loss of appetite
• nausea
• stomach pain
• unpleasant breath odor
• unusual tiredness or weakness
• vomiting of blood
• yellow eyes or skin

Rare

• Cough
• fever with or without chills
• general feeling of tiredness or weakness
• hoarseness
• 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
• cloudy urine
• clumsiness
• confusion
• constipation
• coughing that sometimes produces a pink frothy sputum
• decreased awareness or responsiveness
• decreased frequency or amount of urine
• difficult or labored breathing
• difficult, fast, noisy breathing
• 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
• feeling of warmth
• general body swelling
• hives or welts
• increased sweating
• increased thirst
• indigestion
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or genitals
• lightheadedness
• muscle aches, tremors, or weakness
• nervousness
• nosebleeds
• 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 or shallow breathing
• redness of the face, neck, arms, and occasionally, upper chest
• restlessness
• seizures
• severe constipation
• severe sleepiness
• severe vomiting
• skin blisters
• sleepiness
• stomach cramps
• sunken eyes
• sweating
• swelling of the face, fingers, lower legs, or ankles
• thirst
• tightness in the chest
• tiredness
• vomiting
• weakness or heaviness of the legs
• weight gain

Get emergency help immediately if any of the following symptoms of overdose occur while taking acetaminophen / oxycodone:

Symptoms of overdose

• Bluish lips or skin
• change in consciousness
• cold, clammy skin
• extreme sleepiness
• general feeling of discomfort or illness
• loss of consciousness
• low blood pressure or pulse
• slow breathing
• unconsciousness

Some side effects of acetaminophen / oxycodone 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:

More common

• Relaxed and calm feeling

Incidence not known

• Agitation
• bad, 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 bowels
• 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 urination
• indigestion
• joint pain
• lack or loss of strength
• muscle cramps, spasms, pain, or stiffness
• night blindness
• nightmares
• overbright appearance of lights
• seeing, hearing, or feeling things that are not there
• seizures
• shakiness
• slurred speech
• stomach discomfort, upset, or pain
• swollen joints
• trouble sleeping
• tunnel vision
• unexplained weight loss
• unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness

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

The most commonly reported adverse events have included lightheadedness, dizziness, drowsiness, sedation, nausea, and vomiting.

Common (1% to 10%): Cough

Frequency not reported: Apnea, respiratory arrest, respiratory depression, hiccups

Postmarketing reports: Bronchospasm, dyspnea, hyperpnea, pulmonary edema, tachypnea, hypoventilation, laryngeal edema

Oxycodone-acetaminophen:

Postmarketing reports: Transient elevations of hepatic enzymes, increased bilirubin, hepatic failure, jaundice, hepatotoxicity, hepatic disorder, hepatitis

Acetaminophen:

Frequency not reported: Hepatic necrosis

At high doses, the most serious acetaminophen related adverse event is a dose-dependent, potentially fatal hepatic necrosis.

Frequency not reported: Skin eruptions, urticaria, erythematous skin reactions

Postmarketing reports: Anaphylaxis, allergic reaction, angioedema

Common (1% to 10%): Rash, blister, excoriation, pruritus, erythema

Frequency not reported: Dermatitis, ecchymosis, hyperhidrosis

Postmarketing reports: Urticaria, flushing, increased sweating

Very common (10% or more): Dizziness (up to 13%)

Common (1% to 10%): Headache, somnolence

Frequency not reported: Lightheadedness, dizziness, drowsiness, sedation, migraine, myoclonus, paresthesia, tremor

Postmarketing reports: Stupor, cerebral edema, coma, subdural or intracranial hemorrhage, seizures

Opioids:

Postmarketing reports: Serotonin syndrome

Frequency not reported: Euphoria, dysphoria, insomnia, altered mood, sleep disorder, withdrawal syndrome

Postmarketing reports: Agitation, confusion, anxiety, mental impairment, drug dependence, drug abuse, depression, nervousness, hallucination, suicide

Very common (10% or more): Nausea (up to 31%)

Common (1% to 10%): Vomiting, constipation, dry mouth, dyspepsia, diarrhea

Frequency not reported: Esophageal spasm, oropharyngeal pain, throat irritation

Postmarketing reports: Abdominal pain, abdominal distention, flatulence, gastrointestinal disorder, pancreatitis, intestinal obstruction, ileus, thirst

Oxycodone-acetaminophen:

Frequency not reported: Thrombocytopenia, neutropenia, pancytopenia, hemolytic anemia

Acetaminophen:

Rare (0.01% to 0.1%): Agranulocytosis

Postmarketing reports: Renal insufficiency and failure

Common (1% to 10%): Edema

Frequency not reported: Hypotension, chest discomfort

Postmarketing reports: Tachycardia, dysrhythmias, orthostatic hypotension, bradycardia, palpitations, hypertension

Frequency not reported: Decreased appetite

Postmarketing reports: Hypoglycemia, hyperglycemia, acidosis, alkalosis, hyperkalemia, dehydration

Postmarketing reports: Rhabdomyolysis, myalgia

Postmarketing reports: Miosis, visual disturbances, red eye

Common (1% to 10%): Dysuria

Frequency not reported: Urinary retention, interstitial nephritis, proteinuria, decreased urine flow

Postmarketing reports: Malaise, asthenia, fatigue, fever, hypothermia, accidental overdose, non-accidental overdose, hearing loss, tinnitus

Adrenal insufficiency and androgen deficiency have been reported with opioid use, most often with chronic use.

Opioids:

Postmarketing reports: Adrenal insufficiency, androgen deficiency