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PERCOCET oxycodone hydrochloride and acetaminophen

Get an overview of PERCOCET (oxycodone hydrochloride and acetaminophen tablet), including its generic name, formulation (i.e. pill, oral solution, injection, inhaled medicine) and why it’s used. The medication in PERCOCET can be sold under different names.

Refer to the “Also Known As” section to reference different products that include the same medication as PERCOCET.

Drug Basics

Brand Name: PERCOCET

Generic Name: OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN

Drug Type: HUMAN PRESCRIPTION DRUG

Route: ORAL

Dosage Form: TABLET

Packager: Endo Pharmaceuticals Inc.

Data Current As Of: 2021-02-11

WARNING: ADDICTION, ABUSE, AND MISUSE; RISK EVALUATION AND MITIGATION STRATEGY (REMS); LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; NEONATAL OPIOID WITHDRAWAL SYNDROME, CYTOCHROME P450 3A4 INTERACTION; HEPATOTOXICITY, and RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS

Addiction, Abuse, and Misuse

PERCOCET 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 PERCOCET, and monitor all patients regularly for the development of these behaviors and conditions [see WARNINGS].

Opioid Analgesic Risk Evaluation and Mitigation Strategy (REMS):

To ensure that the benefits of opioid analgesics outweigh the risks of addiction, abuse, and misuse, the Food and Drug Administration (FDA) has required a REMS for these products [ see WARNINGS] . Under the requirements of the REMS, drug companies with approved opioid analgesic products must make REMS-compliant education programs available to healthcare providers. Healthcare providers are strongly encouraged to

  • complete a REMS-compliant education program,

  • counsel patients and/or their caregivers, with every prescription, on safe use, serious risks, storage, and disposal of these products,

  • emphasize to patients and their caregivers the importance of reading the Medication Guide every time it is provided by their pharmacist, and

  • consider other tools to improve patient, household, and community safety.

Life-Threatening Respiratory Depression

Serious, life-threatening, or fatal respiratory depression may occur with use of PERCOCET. Monitor for respiratory depression, especially during initiation of PERCOCET or following a dose increase [see WARNINGS].

Accidental Ingestion

Accidental ingestion of PERCOCET, especially by children, can result in a fatal overdose of PERCOCET [see WARNINGS].

Neonatal Opioid Withdrawal Syndrome

Prolonged use of PERCOCET 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, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available [see WARNINGS].  

Cytochrome P450 3A4 Interaction

The concomitant use of PERCOCET with all cytochrome P450 3A4 inhibitors may result in an increase in oxycodone plasma concentrations, which could increase or prolong adverse reactions and may cause potentially fatal respiratory depression. In addition, discontinuation of a concomitantly used cytochrome P450 3A4 inducer may result in an increase in oxycodone plasma concentration. Monitor patients receiving PERCOCET and any CYP3A4 inhibitor or inducer [see CLINICAL PHARMACOLOGY, WARNINGS, PRECAUTIONS; Drug Interactions].

Hepatotoxicity

Acetaminophen has been associated with cases of acute liver failure, at times resulting in liver transplant and death. Most of the 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.

Risks From Concomitant Use With Benzodiazepines Or Other CNS Depressants

Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death [see WARNINGS, PRECAUTIONS; Drug Interactions].

  • Reserve concomitant prescribing of PERCOCET and benzodiazepines or other CNS depressants for use in patients for whom alternative treatment options are inadequate.

  • Limit dosages and durations to the minimum required.

  • Follow patients for signs and symptoms of respiratory depression and sedation.

Medication Guide
 PERCOCET® (ˈpər-kō-ˌset)
Tablets, CII

PERCOCET is:

  • A strong prescription pain medicine that contains an opioid (narcotic) that is used to manage pain, severe enough to require an opioid analgesic and for which alternative treatments are inadequate and when other pain treatments such as non-opioid pain medicines do not treat your pain well enough or you cannot tolerate them.
  • An opioid pain medicine that can put you at risk for overdose and death. Even if you take your dose correctly as prescribed you are at risk for opioid addiction, abuse, and misuse that can lead to death.

Important information about PERCOCET tablets: 

  • Get emergency help or call 911 right away if you take too much PERCOCET (overdose). When you first start taking PERCOCET, when your dose is changed, or if you take too much (overdose), serious or life-threatening breathing problems that can lead to death may occur.  Talk to your healthcare provider about naloxone, a medicine for the emergency treatment of an opioid overdose.Taking PERCOCET with other opioid medicines, benzodiazepines, alcohol, or other central nervous system depressants (including street drugs) can cause severe drowsiness, decreased awareness, breathing problems, coma, and death.

  • Never give anyone else your PERCOCET. They could die from taking it. Selling or giving away PERCOCET is against the law.

  • Store PERCOCET securely, out of sight and reach of children, and in a location not accessible by others, including visitors to the home.

Do not take PERCOCET if you have:

  • Severe asthma, trouble breathing, or other lung problems.
  • A bowel blockage or have narrowing of the stomach or intestines.
  • Known hypersensitivity to oxycodone, acetaminophen, or any ingredient in PERCOCET.

Before taking PERCOCET , tell your healthcare provider if you have a history of:

  • Head injury, seizures
  • Liver, kidney, thyroid problems
  • Problems urinating
  • Pancreas or gallbladder problems
  • Abuse of street or prescription drugs, alcohol addiction, opioid overdose, or mental health problems

          Tell your healthcare provider if you are:

  • Pregnant or planning to become pregnant. Prolonged use of PERCOCET during pregnancy can cause withdrawal symptoms in your newborn baby that could be life-threatening if not recognized and treated.
  • Breastfeeding. PERCOCET passes into breast milk and may harm your baby. 
  • Living in a household where there are small children or someone who has abused street or prescription drugs.
  • Taking prescription or over-the-counter medicines, vitamins, or herbal supplements. Taking PERCOCET with certain other medicines can cause serious side effects that could lead to death.

When taking PERCOCET:

  • Do not change your dose. Take PERCOCET exactly as prescribed by your healthcare provider. Use the lowest dose possible for the shortest time needed.
  • Take your prescribed dose every 6 hours as needed for pain. Do not take more than your prescribed dose. If you miss a dose, take your next dose at your usual time.
  • Call your healthcare provider if the dose you are taking does not control your pain.
  • If you have been taking PERCOCET regularly, do not stop taking PERCOCET without talking to your healthcare provider.
  • Dispose of expired, unwanted, or unused PERCOCET by promptly flushing down the toilet, if a drug take-back option is not readily available. Visit www.fda.gov/drugdisposal for additional information on disposal of unused medicines.

While taking PERCOCET DO NOT:

  • Drive or operate heavy machinery, until you know how PERCOCET affects you. PERCOCET can make you sleepy, dizzy, or lightheaded.
  • Drink alcohol or use prescription or over-the-counter medicines that contain alcohol. Using products containing alcohol during treatment with PERCOCET  may cause you to overdose and die.
The possible side effects of PERCOCET:
  • Constipation, nausea, sleepiness, vomiting, tiredness, headache, dizziness, abdominal pain. Call your healthcare provider if you have any of these symptoms and they are severe.

Get emergency medical help or call 911 right away if you have:

  • Trouble breathing, shortness of breath, fast heartbeat, chest pain, swelling of your face, tongue, or throat, extreme drowsiness, light-headedness when changing positions, feeling faint, agitation, high body temperature, trouble walking, stiff muscles, or mental changes such as confusion.

These are not all the possible side effects of PERCOCET. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. For more information go to dailymed.nlm.nih.gov.

Distributed by: Endo Pharmaceuticals Inc. Malvern, PA 19355 1-800-462-3636

Manufactured by: Par Pharmaceutical Chestnut Ridge, NY 10977
This Medication Guide has been approved by the U.S. Food and Drug Administration. Revised: 08/2020

also known as
This drug label information is as submitted to the Food and Drug Administration (FDA) and is intended for informational purposes only. If you think you may have a medical emergency, immediately call your doctor or dial 911. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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