Nalocet Side Effects

Generic name: acetaminophen / oxycodone

Medically reviewed by Drugs.com. Last updated on Sep 9, 2023.

Note: This document provides detailed information about Nalocet Side Effects associated with acetaminophen / oxycodone. Some dosage forms listed on this page may not apply specifically to the brand name Nalocet.

Applies to acetaminophen / oxycodone: oral solution, oral tablet.

Precautions

It is very important that your doctor check your progress while you are taking this medicine, especially within the first 24 to 72 hours of treatment. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it. Blood and urine tests may be needed to check for unwanted effects.

It is against the law and dangerous for anyone else to use your medicine. Keep your unused medicine in a safe and secure place. People who are addicted to drugs might want to steal it.

Check with your doctor before using this medicine with alcohol or other medicines that affect the central nervous system (CNS). This medicine will add to the effects of alcohol and other CNS depressants (medicines that can make you drowsy or less alert). Some examples of CNS depressants are antihistamines or medicine for allergies or colds, sedatives, tranquilizers, or sleeping medicine, other prescription pain medicine or narcotics, medicine for seizures or barbiturates, muscle relaxants, or anesthetics, including some dental anesthetics. Also, there may be a greater risk of liver damage if you drink three or more alcoholic beverages while you are taking acetaminophen. Do not drink alcoholic beverages.

If you think you or someone else may have taken an overdose of this medicine, get emergency help at once. Your doctor may also give naloxone to treat an overdose. Signs of an overdose include: extreme dizziness or weakness, slow heartbeat or breathing, seizures, trouble breathing, and cold, clammy skin. Call your doctor right away if you notice these symptoms.

This medicine may be habit-forming. If you feel that the medicine is not working as well, do not use more than your prescribed dose. Call your doctor for instructions.

Do not use this medicine if you are using or have used an MAO inhibitor (eg, isocarboxazid [Marplan®], linezolid [Zyvox®], phenelzine [Nardil®], selegiline [Eldepryl®], tranylcypromine [Parnate®]) within the past 14 days. Using these medicine together may cause serious unwanted effects.

This medicine may cause sleep-related breathing problems (eg, sleep apnea, sleep-related hypoxemia). Your doctor may decrease your dose if you have sleep apnea (stop breathing for short periods during sleep) while using this medicine.

Dizziness, lightheadedness, or fainting may occur when you get up suddenly from a lying or sitting position. Getting up slowly may help lessen this problem. Also, lying down for a while may relieve the dizziness or lightheadedness.

This medicine may make you dizzy, drowsy, or lightheaded. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.

Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, unusual tiredness or weakness, or yellow eyes or skin. These could be symptoms of a serious liver problem.

Serious skin reactions (eg, acute generalized exanthematous pustulosis, Stevens-Johnson syndrome, and toxic epidermal necrolysis) can occur with this medicine. Check with your doctor right away if you have blistering, peeling, or loosening of the skin, chills, cough, diarrhea, itching, joint or muscle pain red irritated eyes, red skin lesions, often with a purple center, sore throat, sores, ulcers, or white spots in the mouth or on the lips, or unusual tiredness or weakness while you are using this medicine.

This medicine may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and requires immediate medical attention. Call your doctor right away if you have a rash, itching, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth while you are using this medicine.

Using narcotics for a long time can cause severe constipation. To prevent this, your doctor may direct you to take laxatives, drink a lot of fluids, or increase the amount of fiber in your diet. Be sure to follow the directions carefully, because continuing constipation can lead to more serious problems.

If you have been using this medicine regularly for several weeks or longer, do not change your dose or suddenly stop using it without checking with your doctor. Your doctor may want you to gradually reduce the amount you are using before stopping it completely. This may help prevent worsening of your condition and reduce the possibility of withdrawal symptoms, including stomach cramps, anxiety, fever, irritability, nausea, restlessness, runny nose, sweating, tremors, or trouble with sleeping.

Using this medicine while you are pregnant may cause serious unwanted effects, including neonatal withdrawal syndrome in your newborn baby. Tell your doctor right away if you think you are pregnant or if you plan to become pregnant while using this medicine.

For nursing mothers:

• Talk to your doctor if you have any questions about taking oxycodone or about how this medicine may affect your baby.
• Call your doctor if you become extremely tired and have difficulty caring for your baby.
• Your baby should generally nurse every 2 to 3 hours and should not sleep for more than 4 hours at a time.
• Check with your doctor or hospital emergency room immediately if your baby shows signs of increased sleepiness (more than usual), difficulty breastfeeding, difficulty breathing, or limpness. These may be symptoms of an overdose and need immediate medical attention.

Before you have any medical tests, tell the medical doctor in charge that you are taking this medicine. The results of some tests may be affected by this medicine.

Check with your doctor right away if you have anxiety, restlessness, a fast heartbeat, fever, sweating, muscle spasms, twitching, nausea, vomiting, diarrhea, or see or hear things that are not there. These may be symptoms of a serious condition called serotonin syndrome. Your risk may be higher if you also take certain other medicines that affect serotonin levels in your body.

Using too much of this medicine may cause infertility (unable to have children). Talk with your doctor before using this medicine if you plan to have children.

This medicine may cause adrenal gland problems. Check with your doctor right away if you have darkening of the skin, diarrhea, dizziness, fainting, loss of appetite, mental depression, nausea, skin rash, unusual tiredness or weakness, or vomiting.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Serious side effects of Nalocet

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:

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

Other side effects of Nalocet

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:

For healthcare professionals

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

General adverse events

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

Opioids:

• Postmarketing reports: Adrenal insufficiency, androgen deficiency

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

See also:

Further information

Nalocet side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

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