Percocet, Nalocet, Oxycodone Hydrochloride Acetaminophen, Prolate, Oxycodone And Acetaminophen

Introduction

Written by Patricia Weiser, PharmD
Medically reviewed by Melissa Badowski, PharmD, MPH, FCCP 
Updated on November 7, 2023

Oxycodone/acetaminophen (oks i KOE done & a seet a MIN oh fen) is a generic medication prescribed for severe pain. Oxycodone/acetaminophen belongs to a group of drugs called opioids/pain relievers.

Boxed warnings

Oxycodone/acetaminophen has boxed warnings, which are the most serious warnings from the Food and Drug Administration (FDA). For the oral tablet and oral solution forms these warnings include risk of:

• addiction and misuse
• serious respiratory depression
• someone accidentally taking the drug, especially children
• serious harm if taken with certain other medications
• neonatal opioid withdrawal syndrome
• liver failure

The oral solution form also has a boxed warning for risk of serious harm from medication errors.

For details, see the “Interactions and warnings for oxycodone/acetaminophen” section.

Uses of oxycodone/acetaminophen

The Food and Drug Administration (FDA) approves prescription drugs such as oxycodone/acetaminophen for certain conditions. Approved uses for oxycodone/acetaminophen are described below.

Use for pain

Doctors may prescribe oxycodone/acetaminophen oral tablet or oral liquid solution for treating severe pain. The drug is used for this purpose in adults. It’s usually used for short-term pain relief, but in some cases, it may be used long term.

Pain can be acute (sudden or short term) or chronic (long term or keeps coming back). Severe pain may occur due to injury, surgery, or an underlying health condition.

Due to risks of misuse and addiction* with oxycodone/acetaminophen, doctors may only prescribe the drug in certain situations. These include:

• when your pain is too severe to be relieved by other medications, such as non-opioid pain relievers
• when you can’t take other pain medications (due to side effects, allergies, or other reasons)

In general, oxycodone/acetaminophen isn’t prescribed long term unless your pain remains severe enough that you need an opioid analgesic and other medications aren’t an option. Talk with your doctor for more information about this.

*Oxycodone/acetaminophen has boxed warnings due to these risks, among others. A boxed warning is the most serious warning from the Food and Drug Administration (FDA). For more details, see the “Interactions and warnings for oxycodone/acetaminophen” section.

Side effects of oxycodone/acetaminophen

Oxycodone/acetaminophen may cause mild or serious side effects. More common mild side effects of oxycodone/acetaminophen and its serious side effects are listed below. This article doesn’t include all possible side effects of the drug. Side effects can vary based on your age, overall health, and any other medications you take.

To learn more about oxycodone/acetaminophen’s side effects, ask your doctor or pharmacist. You can also refer to the prescribing information listed in the “Resources” section.

Mild side effects

More common mild side effects reported with some forms of oxycodone/acetaminophen are listed below.

This article doesn’t include all possible mild side effects of the drug. To learn more about oxycodone/acetaminophen’s side effects based on the form, refer to the prescribing information listed in the “Resources” section.

With many drugs, mild side effects may go away within a few days or a couple of weeks. If the side effects are bothersome, tell your doctor or pharmacist. They may be able to suggest ways to manage them.

Oxycodone/acetaminophen oral tablet’s and oral solution’s mild side effects include:

• constipation
• dizziness
• drowsiness
• nausea or vomiting
• mild allergic reaction*

* For details about this side effect, see the “Interactions and warnings for oxycodone/acetaminophen” section.

Serious side effects

Serious side effects of oxycodone/acetaminophen are listed below.

This article doesn’t include all possible serious side effects of the drug. To learn more about oxycodone/acetaminophen’s side effects based on the form, refer to the prescribing information listed in the “Resources” section.

With many drugs, serious side effects are possible but not common. If you have serious side effects from this drug, call your doctor right away. If you’re having severe symptoms or a medical emergency, call 911 or a local emergency number.

In general, oxycodone/acetaminophen’s serious side effects include: 

• low blood pressure
• mood changes, such as euphoria (feeling “high”) or dysphoria (feeling down)
• boxed warnings* for the risk of:
  • addiction and misuse
  • serious respiratory depression
  • someone accidentally taking the drug, especially children
  • serious harm if taken with certain other medications
  • neonatal opioid withdrawal syndrome
  • liver failure
  • serious harm from medication errors
• severe allergic reaction*

* For details about this side effect, see the “Interactions and warnings for oxycodone/acetaminophen” section.

Interactions and warnings for oxycodone/acetaminophen

Below, you’ll find information about oxycodone/acetaminophen’s possible interactions and warnings.

Interactions of oxycodone/acetaminophen

Certain things may affect how a drug works. These include getting vaccines, consuming alcohol or certain foods, or taking the drug with other medications. This effect is called a drug interaction.

Before you take oxycodone/acetaminophen, ask your doctor to check for possible interactions. Be sure to tell them about any of the following you take or use:

• prescription or over-the-counter drugs 
• vitamins, herbs, or supplements

To learn about drug-condition interactions, see the “Warnings for oxycodone/acetaminophen” section below.

Warnings for oxycodone/acetaminophen

Some people should not take oxycodone/acetaminophen, and others should take it cautiously.

Boxed warnings

Oxycodone/acetaminophen has several boxed warnings. Boxed warnings are the most serious warnings from the Food and Drug Administration (FDA).

To learn more about these warnings, read below. You can also talk with your doctor or pharmacist.

Risk of addiction and misuse. With addiction, a drug is used even if it’s causing harmful outcomes. With misuse, a drug is taken in a way other than how a doctor prescribes it. While addiction and misuse were not reported in studies* of oxycodone/acetaminophen, these are well-known risks of taking opioids. (Oxycodone is an opioid.)

If you have concerns about misuse and addiction with oxycodone/acetaminophen, tell your doctor. They’ll likely limit your prescription to a low dosage and give you only a few days’ supply. Or they may recommend a non-opioid pain reliever instead.

Your doctor may recommend a different treatment option if you have a personal or family history of substance use disorder or other mental health conditions. These factors may increase your risk of misuse and addiction with oxycodone/acetaminophen.

* For details about oxycodone/acetaminophen‘s studies, see the prescribing information for each form in the “Resources” section below.

Risk of serious respiratory depression. With serious respiratory depression, your breathing may become very slow or irregular. This side effect was not common in studies* of oxycodone/acetaminophen. But serious breathing difficulties are a known risk of opioids, including oxycodone.

Respiratory depression is a life threatening medical emergency. Symptoms may include:

• slowed, shallow breathing
• shortness of breath
• whistling or other unusual sounds while breathing
• loss of consciousness (passing out)

Taking certain other medications and drinking alcohol may increase your risk of respiratory depression with oxycodone/acetaminophen. Having certain breathing problems may also increase this risk. Your doctor can advise you on your risk of this side effect.

If you have respiratory depression while taking oxycodone/acetaminophen, you or someone near you should call 911 or a local emergency number right away.

While waiting for emergency services to arrive, someone can give you naloxone (Narcan). Naloxone is used to help restore typical breathing. It’s available without a prescription. Your doctor may recommend keeping naloxone with you (such as in your pocket or bag) in the event of serious respiratory depression. To learn more about this, talk with your doctor or pharmacist.

* For details about oxycodone/acetaminophen‘s studies, see the prescribing information for each form in the “Resources” section below.

Risk of accidental ingestion. Taking oxycodone/acetaminophen by accident may cause an overdose. This may lead to death, especially in children.

Due to this risk, it’s important to store oxycodone/acetaminophen in a place where children can’t get to it.

For more information about this, including advice on how to safely store and get rid of medications, talk with your doctor or pharmacist.

* For details about oxycodone/acetaminophen‘s studies, see the prescribing information for each form in the “Resources” section below.

Risk of serious harm if taken with certain other medications. Taking oxycodone/acetaminophen with medications or substances that slow the activity of the brain and spinal cord may be dangerous or even life threatening. Examples include other opioids, benzodiazepines such as diazepam (Valium), and alcohol.

Taking oxycodone/acetaminophen with these types of drugs may cause severe side effects. These side effects may include severe drowsiness or respiratory depression (slowed, shallow breathing). It isn’t known whether this occurred in studies* of oxycodone/acetaminophen, but it’s a known risk of taking opioids. (Oxycodone is an opioid.)

In addition, oxycodone is broken down in the body by a certain enzyme (protein). Certain other drugs can interact with oxycodone by affecting the way this enzyme works. This may increase your body’s exposure to oxycodone, raising the risk of serious side effects.

If you take other drugs, tell your doctor before starting oxycodone/acetaminophen. Sharing this information can help prevent or lessen the risk of harmful interactions. Your doctor may recommend changes to your treatment plan.

* For details about oxycodone/acetaminophen‘s studies, see the prescribing information for each form in the “Resources” section below.

Risk of neonatal opioid withdrawal syndrome. To learn more about this risk, see the “Pregnancy or breastfeeding and oxycodone/acetaminophen” section below.

Risk of liver failure. Taking too much acetaminophen can damage your liver and lead to liver failure.

It isn’t known if this occurred in studies* of oxycodone/acetaminophen. But it’s a well-known risk of taking acetaminophen, especially in amounts above 4,000 milligrams (mg) per day.

Symptoms of liver failure may include:

• abdominal pain
• nausea
• vomiting
• yellowing of the eyes or skin

If you have concerns about your risk of liver failure, tell your doctor. They’ll likely recommend limiting your dosage and how long you take the medication.

If you take other medications that contain acetaminophen, such as Tylenol or other over-the-counter drugs, keep track of how much acetaminophen you take each day. This can help prevent you from taking more than your doctor recommends.

* For details about oxycodone/acetaminophen‘s studies, see the prescribing information for each form in the “Resources” section below.

Risk of serious harm from medication errors. Taking a high dosage of oxycodone/acetaminophen by accident could lead to serious and life threatening side effects. The risk of making a dosing error is especially high with oxycodone/acetaminophen oral liquid solution.

It isn’t known if dosing errors occurred in studies* of the drug. But it’s a common risk with liquid medications in general.

Because of this risk, it’s important to carefully measure out each of your doses. To do this, use only a dosing cup or oral syringe from your pharmacy. Avoid using methods that may not be accurate, such as a household spoon.

If you have concerns about dosing errors with oxycodone/acetaminophen oral solution, talk with your doctor or pharmacist. They’ll show you how to use the proper tools to accurately measure your dose.

* For details about oxycodone/acetaminophen‘s studies, see the prescribing information for each form in the “Resources” section below.

Other warnings

Oxycodone/acetaminophen could cause harm to people with certain health conditions. This effect is called a drug-condition interaction. Other factors can also affect whether this drug is a safe option for you. These warnings may differ based on the form of oxycodone/acetaminophen you take.

Ask your doctor about specific warnings for oxycodone/acetaminophen, and be sure to tell your doctor about your:

• current health, including any allergies to medications
• past health conditions or surgeries

Allergic reaction

Oxycodone/acetaminophen can cause an allergic reaction in some people. Severe allergic reactions are rare but possible.

If you’ve had an allergic reaction to oxycodone/acetaminophen or any of its ingredients, your doctor will likely not prescribe it. They can tell you about medications that are safer options for you.

A mild allergic reaction may cause the following symptoms:

• skin rash
• itchiness
• flushing (temporary warmth, redness, or deepening of skin color)

A severe allergic reaction may cause the following symptoms:

• swelling under your skin, usually in your hands, feet, eyelids, or lips
• swelling of your mouth, throat, or tongue, which can cause difficulty breathing

If you have an allergic reaction to oxycodone/acetaminophen, call your doctor right away. If you have severe symptoms, call 911 or a local emergency number.

Overdose of oxycodone/acetaminophen

You should not take more oxycodone/acetaminophen than your doctor prescribes. For some drugs, doing so may lead to harmful effects or overdose.

If you think you’ve taken too much oxycodone/acetaminophen, call your doctor or pharmacist right away. Or you could call 800-222-1222 to speak with someone at America’s Poison Centers. You can also use its online resource. If you have concerning symptoms, call 911 or a local emergency number immediately. You can also go to the closest emergency room.

Pregnancy or breastfeeding and oxycodone/acetaminophen

Information about oxycodone/acetaminophen and pregnancy and breastfeeding is described below.

Oxycodone/acetaminophen and pregnancy

There are risks to taking oxycodone/acetaminophen during pregnancy. But there are also risks with having untreated severe pain during this time. (Keep in mind that this medication is used for treating severe pain.)

If you’re planning a pregnancy or can become pregnant, talk with your doctor about treatment options for pain management. Together, you can discuss the risks and benefits of your treatment options and decide whether or not you should take oxycodone/acetaminophen while pregnant.

Boxed warning: Risk of neonatal opioid withdrawal syndrome

Oxycodone/acetaminophen has a boxed warning about the risk of neonatal opioid withdrawal syndrome (NOWS). Boxed warnings are serious warnings from the FDA.

Taking oxycodone/acetaminophen for a long time during pregnancy can lead to NOWS, which causes withdrawal symptoms in a newborn. (Withdrawal symptoms are side effects that can happen when someone stops taking a drug their body needs in order to function like usual.) NOWS was not reported in studies* of oxycodone/acetaminophen. But it’s a known risk of opioid use during pregnancy. (Oxycodone is an opioid.)

In a newborn, withdrawal from opioids can become life threatening. Symptoms may include:

• diarrhea
• vomiting
• tremors
• excessive irritability
• high pitched crying
• difficulty gaining weight

Because of this risk, doctors may recommend other ways to manage pain during pregnancy. If you have questions about the risk of NOWS, talk with your doctor.

* For details about oxycodone/acetaminophen‘s studies, see the prescribing information for each form in the “Resources” section below.

Oxycodone/acetaminophen and breastfeeding

There are risks to taking oxycodone/acetaminophen while breastfeeding. But there are also risks with having untreated severe pain during this time. (Keep in mind that this medication is used for treating severe pain.)

For instance, oxycodone/acetaminophen may cause excessive sleepiness or difficulty breathing in a breastfed child.

If you’re planning to breastfeed, talk with your doctor about treatment options for pain management. Together, you can discuss the risks and benefits of your treatment options and decide whether or not you should take oxycodone/acetaminophen during this time. Your doctor may recommend other ways to feed your child.

Common questions about oxycodone/acetaminophen

Below you’ll find answers to a few commonly asked questions about oxycodone/acetaminophen.

Is oxycodone/acetaminophen safe for older adults?

Older adults should be cautious about taking oxycodone/acetaminophen. In general, older adults refers to people ages 65 years and older. Older adults can be more sensitive to oxycodone/acetaminophen. When prescribing this drug for older adults, doctors usually give a low dosage. This is because the drug is removed from your body through your kidneys and liver, and the function of these organs may slow with age.

Also, older adults may be more likely to fall or get injured if they experience certain side effects from this drug, such as drowsiness, dizziness, or low blood pressure.

If you’re 65 years of age or older, your doctor can help determine whether oxycodone/acetaminophen is a safe treatment option for you.

How does oxycodone/acetaminophen work? And how long does it take to start working?

Oxycodone/acetaminophen contains two drugs that work differently to help relieve pain: oxycodone and acetaminophen.

Oxycodone is an opioid analgesic. It works by blocking opioid receptors on nerve cells. This stops pain signals from traveling between your nerves and your brain. As a result, it helps to lower the sensation of pain.

Acetaminophen is a non-opioid pain reliever as well as a fever reducer. It’s thought to work by blocking a certain signaling pathway in the central nervous system (your brain and spinal cord).

Oxycodone/acetaminophen usually starts working to provide pain relief within 30–60 minutes after you take it.

To learn more about what to expect while taking oxycodone/acetaminophen, talk with your doctor or pharmacist.

What to ask your doctor

Let your doctor know if you have questions about oxycodone/acetaminophen or would like more details about it.

Here’s a list of some possible questions you may want to ask your doctor:

• What should I know about how to take oxycodone/acetaminophen safely to reduce the risks of side effects?
• What’s the best way for me to help prevent and manage constipation due to oxycodone/acetaminophen?
• What should I know about naloxone (Narcan) while taking oxycodone/acetaminophen?
• How long after taking a dose of oxycodone/acetaminophen is it safe for me to drive?

Resources

• Food and Drug Administration. (2023). Orange Book: Approved drug products with therapeutic equivalence evaluations. https://www.accessdata.fda.gov/scripts/cder/ob/index.cfm 
• Marco C, et al. (2008). Comparison of oxycodone and hydrocodone for the treatment of acute pain associated with fractures: A double-blind, randomized, controlled trial. https://onlinelibrary.wiley.com/doi/10.1197/j.aem.2004.12.005
• Oxycodone and acetaminophen tablets, USP CII. (2023). https://nctr-crs.fda.gov/fdalabel/services/spl/set-ids/f9cf218c-af5e-4249-aa3b-a8555ed02278/spl-doc
• Oxycodone hydrochloride and acetaminophen oral solution, CII. (2023). https://nctr-crs.fda.gov/fdalabel/services/spl/set-ids/9986aa04-c976-4654-8ad7-b97d2eecea93/spl-doc

Disclaimer: Optum Perks has made every effort to make certain that all information is factually correct, comprehensive, and up to date. However, this article should not be used as a substitute for the knowledge and expertise of a licensed healthcare professional. You should always consult your doctor or another healthcare professional before taking any medication. The drug information contained herein is subject to change and is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. The absence of warnings or other information for a given drug does not indicate that the drug or drug combination is safe, effective, or appropriate for all patients or all specific uses.