Acetaminophen and oxycodone

Name: Acetaminophen and oxycodone

What should I discuss with my healthcare provider before taking acetaminophen and oxycodone?

You should not use this medicine if you are allergic to acetaminophen (Tylenol) or oxycodone, or if:

  • you have severe asthma or breathing problems;

  • you have a blockage in your stomach or intestines, including paralytic ileus; or

  • you have recently used alcohol, sedatives, tranquilizers, or other narcotic medications.

Some medicines can interact with oxycodone and cause a serious condition called serotonin syndrome. Be sure your doctor knows if you also take medicine for depression, mental illness, Parkinson's disease, migraine headaches, serious infections, or prevention of nausea and vomiting. Ask your doctor before making any changes in how or when you take your medications.

To make sure this medicine is safe for you, tell your doctor if you have:

  • any type of breathing problem or lung disease;

  • liver disease, cirrhosis, or if you drink alcohol daily;

  • a history of drug abuse, alcohol addiction, or mental illness;

  • kidney disease, urination problems;

  • problems with your gallbladder, pancreas, thyroid, or adrenal gland;

  • a history of head injury, brain tumor, or seizures; or

  • if you use a sedative like Valium (diazepam, alprazolam, lorazepam, Ativan, Klonopin, Restoril, Tranxene, Versed, Xanax, and others).

This medicine is more likely to cause breathing problems in older adults and people who are severely ill, malnourished, or otherwise debilitated.

If you use oxycodone while you are pregnant, your baby could become dependent on the drug. This can cause life-threatening withdrawal symptoms in the baby after it is born. Babies born dependent on habit-forming medicine may need medical treatment for several weeks. Tell your doctor if you are pregnant or plan to become pregnant.

Acetaminophen and oxycodone can pass into breast milk and may harm a nursing baby. You should not breast-feed while using this medicine.

For the Consumer

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

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
  • 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
  • decreased awareness or responsiveness
  • decreased frequency or amount of urine
  • 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
  • feeling of warmth
  • general body swelling
  • 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 or shallow breathing
  • redness of the face, neck, arms, and occasionally, upper chest
  • restlessness
  • seizures
  • severe constipation
  • severe sleepiness
  • severe vomiting
  • skin blisters
  • skin rash, hives, or welts
  • sleepiness
  • sore throat
  • 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
  • Acid or sour stomach
  • 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 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 urination
  • indigestion
  • joint pain
  • lack or loss of strength
  • muscle cramps or spasms
  • muscle pain or stiffness
  • night blindness
  • nightmares
  • overbright appearance of lights
  • seeing, hearing, or feeling things that are not there
  • seizures
  • shakiness
  • sleepiness or unusual drowsiness
  • slurred speech
  • stomach discomfort, upset, or pain
  • 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

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

Respiratory

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[Ref]

Hepatic

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

Acetaminophen:
Frequency not reported: Hepatic necrosis[Ref]

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

Hypersensitivity

Frequency not reported: Skin eruptions, urticaria, erythematous skin reactions
Postmarketing reports: Anaphylaxis, allergic reaction, angioedema[Ref]

Dermatologic

Common (1% to 10%): Rash, blister, excoriation, pruritus, erythema
Frequency not reported: Dermatitis, ecchymosis, hyperhidrosis
Postmarketing reports: Urticaria, flushing, increased sweating[Ref]

Nervous system

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[Ref]

Psychiatric

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[Ref]

Gastrointestinal

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[Ref]

Hematologic

Oxycodone-acetaminophen:
Frequency not reported: Thrombocytopenia, neutropenia, pancytopenia, hemolytic anemia

Acetaminophen:
Rare (0.01% to 0.1%): Agranulocytosis[Ref]

Renal

Postmarketing reports: Renal insufficiency and failure[Ref]

Cardiovascular

Common (1% to 10%): Edema
Frequency not reported: Hypotension, chest discomfort
Postmarketing reports: Tachycardia, dysrhythmias, orthostatic hypotension, bradycardia, palpitations, hypertension[Ref]

Metabolic

Frequency not reported: Decreased appetite
Postmarketing reports: Hypoglycemia, hyperglycemia, acidosis, alkalosis, hyperkalemia, dehydration

Musculoskeletal

Postmarketing reports: Rhabdomyolysis, myalgia

Ocular

Postmarketing reports: Miosis, visual disturbances, red eye

Genitourinary

Common (1% to 10%): Dysuria
Frequency not reported: Urinary retention, interstitial nephritis, proteinuria, decreased urine flow

Other

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

Endocrine

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

Opioids:
Postmarketing reports: Adrenal insufficiency, androgen deficiency

Some side effects of acetaminophen / oxycodone may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Precautions

US BOXED WARNINGS: ADDICTION, ABUSE AND MISUSE; LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; NEONATAL OPIOID WITHDRAWAL SYNDROME; CYP450 3A4 INTERACTION; HEPATOTOXICITY; RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS and RISKS OF MEDICATION ERRORS:
-Addiction, Abuse, and Misuse: This drug exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Assess each patient's risk prior to prescribing and monitor all patients regularly for the development of these behaviors or conditions.
-Life-Threatening Respiratory Depression: Serious, life-threatening, or fatal respiratory depression may occur, especially during initiation or following a dose increase.
-Accidental Ingestion: Accidental ingestion of even 1 dose, especially by children, can result in a fatal overdose of oxycodone.
-Neonatal Opioid Withdrawal Syndrome: Prolonged use during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts. If opioid use is required for a prolonged period in a pregnant woman, the patient should be advised of the risk of neonatal opioid withdrawal syndrome and ensure appropriate treatment will be available.
-CYP450 3A4 Interaction: Concomitant use of CYP450 3A4 inhibitors may result in increased oxycodone plasma concentrations, which could increase or prolong adverse drug effects and may cause potentially fatal respiratory depression. In addition, discontinuation of a concomitantly used CYP450 3A4 inducer may result in increased oxycodone plasma concentrations. Monitor patients concomitantly receiving any CYP450 3A4 inhibitor or inducer.
-Hepatotoxicity: Acetaminophen has been associated with case of acute liver failure, at times resulting in liver transplant and death; most cases of liver injury are associated with the use of acetaminophen at doses that exceed 4000 mg per day, and often involve more than one acetaminophen-containing product.
-Concomitant Use with Benzodiazepines or Other CNS Depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. Concomitant use should be reserved for use in patients for whom alternative treatment options are inadequate. If needed, limit dose and duration to the minimum required and follow patients for signs and symptoms of respiratory depression and sedation.
-Risks of Medication Errors: Ensure accuracy when prescribing, dispensing, and administering oxycodone/acetaminophen oral solution; dosing errors due to confusion between mg and mL, and other oxycodone/acetaminophen oral solutions of different concentrations can result in accidental overdose and death.

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

US Controlled Substance: Schedule II

Dialysis

Data not available

Bottom Line

Acetaminophen/oxycodone may be used to relieve moderate-to-severe pain that is unrelieved by nonopioid analgesics; however, its use is limited by the dependence and addiction potential of the oxycodone component and the risk of respiratory depression (unusually slow and shallow breathing).

Response and Effectiveness

  • The maximum effect of oxycodone component is reached in 1.8 hours and the duration of activity lasts for 3-4 hours. Acetaminophen reaches its maximum effect within 30-60 minutes of administration and its analgesic effect lasts around 3 to 4 hours.

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Acetaminophen / oxycodone Breastfeeding Warnings

Not recommended Excreted into human milk: Yes Comments: -If used, monitor breastfed infants for excess sedation and respiratory depression. -Withdrawal symptoms may occur in breastfed infants when maternal administration of an opioid is stopped or when breast-feeding is stopped.

Maternal use of narcotics during breastfeeding can cause infant drowsiness, central nervous system depression, and even death. Infant sedation is common with maternal use of oxycodone. Newborn infants are particularly sensitive to the effects of even small dosages of narcotic analgesics.

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