Medication Guide — Oxycodone Hcl

Patient-friendly FDA guidance and safety information.

Last updated · May 13, 2026Source: DailyMed ↗

Boxed Warning

Addiction, Abuse, and Misuse

OXYCODONE HCl EXTENDED-RELEASE TABLETS, 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 OXYCODONE HCl EXTENDED-RELEASE TABLETS and monitor all patients regularly for the development of these behaviors and conditions .

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 . 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 OXYCODONE HCl EXTENDED-RELEASE TABLETS. Monitor for respiratory depression, especially during initiation of OXYCODONE HCl EXTENDED-RELEASE TABLETS or following a dose increase. Instruct patients to swallow OXYCODONE HCl EXTENDED-RELEASE TABLETS whole; crushing, chewing, or dissolving OXYCODONE HCl EXTENDED-RELEASE TABLETS can cause rapid release and absorption of a potentially fatal dose of oxycodone .

Accidental Ingestion

Accidental ingestion of even one dose of OXYCODONE HCl EXTENDED-RELEASE TABLETS , especially by children, can result in a fatal overdose of oxycodone .

Neonatal Opioid Withdrawal Syndrome

Prolonged use of OXYCODONE HCl EXTENDED-RELEASE TABLETS 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.

Cytochrome P450 3A4 Interaction

The concomitant use of OXYCODONE HCl EXTENDED-RELEASE TABLETS with all cytochrome P450 3A4 inhibitors may result in an increase in 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 cytochrome P450 3A4 inducer may result in an increase in oxycodone plasma concentration. Monitor patients receiving OXYCODONE HCl EXTENDED-RELEASE TABLETS and any CYP3A4 inhibitor or inducer .

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 and Precautions, Drug Interactions (7)].

Reserve concomitant prescribing of OXYCODONE HCl EXTENDED-RELEASE TABLETS 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.

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; and RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS

See full prescribing information for complete boxed warning .

OXYCODONE HCl EXTENDED-RELEASE TABLETS exposes users to risks of addiction, abuse and misuse, which can lead to overdose and death. Assess patient’s risk before prescribing and monitor regularly for these behaviors and conditions.
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 Risk Evaluation and Mitigation Strategy (REMS) for these products.
Serious, life-threatening, or fatal respiratory depression may occur. Monitor closely, especially upon initiation or following a dose increase. Instruct patients to swallow OXYCODONE HCl EXTENDED-RELEASE TABLETS whole to avoid exposure to a potentially fatal dose of oxycodone.
Accidental ingestion of OXYCODONE HCl EXTENDED-RELEASE TABLETS especially by children, can result in a fatal overdose of oxycodone.
Prolonged use of OXYCODONE HCl EXTENDED-RELEASE TABLETS during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated. If prolonged opioid use is required in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available.
Concomitant use with CYP3A4 inhibitors (or discontinuation of CYP3A4 inducers) can result in a fatal overdose of oxycodone. (5.5, 7, 12.3)
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. Reserve concomitant prescribing for use in patients for whom alternative treatment options are inadequate; limit dosages and durations to the minimum required; and follow patients for signs and symptoms of respiratory depression and sedation. (5.6, 7)

Poison Help

If you suspect an overdose or accidental ingestion, call Poison Control: 1-800-222-1222 (free, 24/7, U.S.). For life-threatening symptoms, call 911.

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MEDICATION GUIDE

This Medication Guide has been approved by the U.S. Food and Drug Administration. Revised: 03/2021

Medication Guide

OXYCODONE (OX-ee-KON-dohn) HCl EXTENTED-RELEASE TABLETS, CII

OXYCODONE HCl EXTENDED-RELEASE TABLETS ARE:

A strong prescription pain medicine that contains an opioid (narcotic) that is used to manage pain severe enough to require daily around-the-clock, long-term treatment with an opioid, when other pain treatments such as non-opioid pain medicines or immediate-release opioid medicines do not treat your pain well enough or you cannot tolerate them.
A long-acting (extended-release) 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.
Not for use to treat pain that is not around-the-clock.
Not for use in children less than 11 years of age and who are not already using opioid pain medicines regularly to manage pain severe enough to require daily around-the-clock long-term treatment of pain with an opioid.

Important information about oxycodone HCl extended-release tablets:

Get emergency help or call 911 right away if you take too much OXYCODONE HCl EXTENDED-RELEASE TABLETS (overdose). When you first start taking oxycodone HCl extended-release tablets, 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 OXYCODONE HCl EXTENDED-RELEASE TABLETS 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 oxycodone HCl extended-release tablets. They could die from taking it. Selling or giving away OXYCODONE HCl EXTENDED-RELEASE TABLETS is against the law.
Store OXYCODONE HCl EXTENDED-RELEASE TABLETS securely, out of sight and reach of children, and in a location not accessible by others, including visitors to the home.

Do not take OXYCODONE HCl EXTENDED-RELEASE TABLETS if you have:

severe asthma, trouble breathing, or other lung problems.
a bowel blockage or have narrowing of the stomach or intestines.

Before taking oxycodone HCl extended-release tablets, tell your healthcare provider if you have a history of:

head injury, seizures
problems urinating
liver, kidney, thyroid problems
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 OXYCODONE HCl EXTENDED-RELEASE TABLETS during pregnancy can cause withdrawal
symptoms in your newborn baby that could be life-threatening if not recognized and treated.
breastfeeding. Not recommended during treatment with oxycodone HCl extended-release tablets. It 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 OXYCODONE HCl EXTENDED-RELEASE TABLETS with certain other medicines can cause serious side effects that could lead to death.

When taking OXYCODONE HCl EXTENDED-RELEASE TABLETS:

Do not change your dose. Take OXYCODONE HCl EXTENDED-RELEASE TABLETS exactly as prescribed by your healthcare provider.Use the lowest dose possible for the shortest time needed.
Take your prescribed dose every 12 hours at the same time every day. Do not take more than your prescribed dose in 12
hours. If you miss a dose, take your next dose at your usual time.
Swallow OXYCODONE HCl EXTENDED-RELEASE TABLETS whole. Do not cut, break, chew, crush, dissolve, snort, or inject OXYCODONE HCl EXTENDED-RELEASE TABLETS because this may cause you to overdose and die.
OXYCODONE HCl EXTENDED-RELEASE TABLETS should be taken 1 tablet at a time. Do not pre-soak, lick, or wet the tablet before placing in your mouth to avoid choking on the tablet.
Call your healthcare provider if the dose you are taking does not control your pain.
Do not stop taking OXYCODONE HCl EXTENDED-RELEASE TABLETS without talking to your healthcare provider.

Dispose of expired, unwanted, or unused OXYCODONE HCl EXTENDED-RELEASE TABLETS 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 OXYCODONE HCl EXTENDED-RELEASE TABLETS DO NOT:

Drive or operate heavy machinery until you know how OXYCODONE HCl EXTENDED-RELEASE TABLETS affects you. OXYCODONE HCl EXTENDED-RELEASE TABLETS 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 OXYCODONE HCl EXTENDED-RELEASE TABLETS may cause you to overdose and die.

The possible side effects of OXYCODONE HCl EXTENDED-RELEASE TABLETS are:

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 oxycodone HCl extended-release tablets. 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

Manufactured by:

Purdue Pharmaceuticals L.P.

Wilson, NC 27893

Distributed by:

Amneal Pharmaceuticals LLC

Bridgewater, NJ 08807

Sources

RxCUI: 1860129

NDC: 69238-2294

Last fetched: May 13, 2026

Source: DailyMed ↗

⚠️ Disclaimer

This information is for educational purposes only and is not medical advice. Always consult your doctor, pharmacist, or other licensed healthcare professional before starting, stopping, or changing any medicine. Read full medical disclaimer.