Oxycodone is a prescription opioid medication used to treat moderate to severe pain. It works by binding to opioid receptors in the brain and spinal cord, altering the perception of and response to pain. Oxycodone is often prescribed for conditions such as post-surgical pain, injuries, or chronic pain that doesn’t respond well to non-opioid treatments.
US Brand Name
- Endocet
- Magnacet
- Narvox
- Percocet
- Perloxx
- Primalev
- Roxicet
- Roxilox
- Tylox
- Xartemix XR
- Xolox
Canadian Brand Name
- oxyCODONEACET
- Rivacocet
- Teva-Oxycocet
Descriptions
Oxycodone and acetaminophen combination is used to relieve pain severe enough to require opioid treatment and when other pain medicines did not work well enough or cannot be tolerated.
Oxycodone belongs to the group of medicines called opioid analgesics (pain medicines). It acts on the central nervous system (CNS) to relieve pain, and stops or prevents cough.
When oxycodone is used for a long time, it may become habit-forming, causing mental or physical dependence. However, under the close supervision of healthcare providers, people who have continuing pain should not let the fear of dependence keep them from using opioids to relieve their pain. Mental dependence (addiction) is less likely to occur when opioids are used for this purpose. Physical dependence may lead to withdrawal symptoms if treatment is stopped suddenly. However, severe withdrawal symptoms can usually be prevented by gradually reducing the dose over a period of time before treatment is stopped completely.
This medicine is available only with your doctor’s prescription. Percocet® and Xartemis™ are available only under a restricted distribution program called the Opioid Analgesic REMS (Risk Evaluation and Mitigation Strategy) program.
This product is available in the following dosage forms:
- Tablet
- Solution
Oxycodone is a potent semisynthetic opioid agonist prescription medication with agonistic properties on mu-, kappa-, and delta-type opioid receptors. This drug is beneficial when used judiciously for pain management, yet it carries the risk of inducing physical dependence and addiction.
FDA-Approved Indications
The immediate-release formulation of oxycodone is approved by the US Food and Drug Administration (FDA) for managing acute or chronic moderate-to-severe pain when opioid medication is considered suitable and alternative pain management strategies are inadequate. The extended-release formulation is FDA-approved for managing severe pain that necessitates continuous (24 hours per day) long-term opioid treatment when no alternative options are available to address the pain.
The oxycodone to morphine dose equivalent ratio is approximately 1:1.5 for immediate-release and 1:2 for extended-release formulations. The FDA has also approved an abuse-deterrent formulation of oxycodone, containing inactive ingredients to render the formulation resistant to misuse and abuse.
IMPORTANT WARNING:
Oxycodone may be habit-forming. Take oxycodone exactly as directed. Do not take more of it, take it more often, or take it in a different way than directed by your doctor. While taking oxycodone, discuss with your healthcare provider your pain treatment goals, length of treatment, and other ways to manage your pain. Tell your doctor if you or anyone in your family drinks or has ever drunk large amounts of alcohol, uses or has ever used street drugs, or has overused prescription medications, or has had an overdose, or if you have or have ever had depression or another mental illness. There is a greater risk that you will overuse oxycodone if you have or have ever had any of these conditions. Talk to your healthcare provider immediately and ask for guidance if you think that you have an opioid addiction or call the U.S. Substance Abuse and Mental Health Services Administration (SAMHSA) National Helpline at 1-800-662-HELP.
Oxycodone may cause serious or life-threatening breathing problems, especially during the first 24 to 72 hours of your treatment and any time your dose is increased. Your doctor will monitor you carefully during your treatment. Tell your doctor if you have or have ever had slowed breathing or asthma. Your doctor will probably tell you not to take oxycodone. Also tell your doctor if you have or have ever had lung disease such as chronic obstructive pulmonary disease (COPD; a group of diseases that affect the lungs and airways), a head injury a brain tumor, or any condition that increases the amount of pressure in your brain. The risk that you will develop breathing problems may be higher if you are an older adult or are weak or malnourished due to disease. If you experience any of the following symptoms, call your doctor immediately or get emergency medical treatment: slowed breathing, long pauses between breaths, or shortness of breath.
Do not allow anyone else to take your medication. Oxycodone may harm or cause death to other people who take your medication, especially children. Keep oxycodone in a safe place so that no one else can take it accidentally or on purpose. Be especially careful to keep oxycodone out of the reach of children. Keep track of how many capsules, tablets, or oral solution is left so you will know if any medication is missing.
Taking certain other medications with oxycodone may increase the risk of serious or life-threatening breathing problems, sedation, or coma. Tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Your doctor may need to change the doses of your medication and will monitor you carefully. If you take oxycodone with other medications and you develop any of the following symptoms, call your doctor immediately or seek emergency medical care: unusual dizziness, lightheadedness, extreme sleepiness, slowed or difficult breathing, or unresponsiveness. Be sure that your caregiver or family members know which symptoms may be serious so they can call the doctor or emergency medical care if you are unable to seek treatment on your own.
Drinking alcohol, taking prescription or nonprescription medications that contain alcohol, or using street drugs during your treatment with oxycodone increases the risk that you will experience serious, life-threatening side effects. Do not drink alcohol, take prescription or nonprescription medications that contain alcohol, or use street drugs during your treatment.
If you are taking the oxycodone extended-release tablets, swallow them whole; do not chew, break, divide, crush, or dissolve them. Do not presoak, lick or otherwise wet the tablet prior to placing in the mouth. Swallow each tablet right after you put it in your mouth. If you swallow broken, chewed, crushed, or dissolved extended-release tablets, you may receive too much oxycodone at once instead of slowly over 12 hours. This may cause serious problems, including overdose and death.
Oxycodone comes as a regular solution (liquid) and as a concentrated solution that contains more oxycodone in each milliliter of solution. Be sure that you know whether your doctor has prescribed the regular or concentrated solution and the dose in milliliters that your doctor has prescribed. Use the dosing cup, oral syringe, or dropper provided with your medication to carefully measure the number of milliliters of solution that your doctor prescribed. Read the directions that come with your medication carefully and ask your doctor or pharmacist if you have any questions about how to measure your dose or how much medication you should take. You may experience serious or life threatening side effects if you take an oxycodone solution with a different concentration or if you take a different amount of medication than prescribed by your doctor.
Store oxycodone in a safe place so that no one else can take it accidentally or on purpose. Be especially careful to keep oxycodone out of the reach of children. Keep track of how many tablets or capsules, or how much liquid is left so you will know if any medication is missing. Dispose of unwanted capsules, tablets, extended-release tablets, extended-release capsules, and liquid properly according to instructions. (See STORAGE and DISPOSAL).
Tell your doctor if you are pregnant or plan to become pregnant. If you take oxycodone regularly during your pregnancy, your baby may experience life-threatening withdrawal symptoms after birth. Tell your baby’s doctor right away if your baby experiences any of the following symptoms: irritability, hyperactivity, abnormal sleep, high-pitched cry, uncontrollable shaking of a part of the body, vomiting, diarrhea, or failure to gain weight.
Talk to your doctor about the risks of taking oxycodone.
Your doctor or pharmacist will give you the manufacturer’s patient information sheet (Medication Guide) when you begin your treatment with oxycodone and each time you fill your prescription. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website (https://www.fda.gov/Drugs/DrugSafety/ucm085729.htm) or the manufacturer’s website to obtain the Medication Guide.
Why is Oxycodone Prescribed?
Oxycodone immediate-release tablets, capsules, and oral solution are used to relieve severe, acute pain (pain that begins suddenly, has a specific cause, and is expected to go away when the cause of the pain is healed) in people who are expected to need an opioid pain medication and who cannot be treated with other pain medications. Oxycodone extended-release tablets and extended-release capsules are used to relieve severe pain in people who are expected to need pain medication around the clock for a long time and who cannot be treated with other medications. Oxycodone extended-release tablets and extended-release capsules should not be used to treat pain that can be controlled by medication that is taken as needed. Oxycodone concentrated solution should only be used to treat people who are tolerant (used to the effects of the medication) to opioid medications because they have taken this type of medication for at least one week. Oxycodone is in a class of medications called opiate (narcotic) analgesics. It works by changing the way the brain and nervous system respond to pain.
Oxycodone is also available in combination with acetaminophen (Oxycet, Percocet, others) and aspirin (Percodan). This monograph only includes information about the use of oxycodone alone. If you are taking an oxycodone combination product, be sure to read information about all the ingredients in the product you are taking and ask your doctor or pharmacist for more information.
Mechanism of Action of Oxycodone
Oxycodone is a semisynthetic opioid with agonistic properties on mu, kappa, and delta-type opioid receptors, with the strongest affinity for mu-type receptors. Upon binding to these G-protein–coupled receptors, oxycodone stimulates the exchange of guanosine diphosphate (GDP) on the G-alpha subunit for guanosine triphosphate (GTP), inhibiting adenylate cyclase and decreasing intracellular cyclic adenosine monophosphate (cAMP). This signal cascade leads to a consequent inhibition of the nociceptive neurotransmitters acetylcholine, dopamine, gamma-aminobutyric acid (GABA), noradrenaline, and substance P and the hormones glucagon, insulin, somatostatin, and vasopressin.
As with other opioids, oxycodone causes hyperpolarization and reduced excitability of neurons in the central nervous system (CNS). This generalized CNS depression results from the agonistic effect on kappa-type receptors, leading to N-type voltage-gated calcium channel closure. In contrast, stimulation of the mu and delta-type receptors opens calcium-dependent inward-rectifying potassium channels.
Pharmacokinetics
Absorption: The onset of action is 10 to 30 minutes for the immediate-release formulation and about 1 hour for the controlled release. The plasma half-life is 3 to 5 hours, and stable plasma levels are reached within 24 to 36 hours. The duration ranges from 3 to 6 hours for immediate release or 12 hours for controlled-release formulations.
Distribution: Oxycodone exhibits a distribution volume of 2.6 L/kg. The plasma protein binding of oxycodone is approximately 45%.
Metabolism: Oxycodone is metabolized by the hepatic enzymes CYP3A4 and CYP2D6, producing the metabolites nor-oxycodone and oxymorphone, respectively. Oxymorphone has a greater affinity for μ-opioid receptors compared to oxycodone.
Elimination: Metabolites get excreted from the body via the kidneys.[8] The clearance is 0.8 L/min.
How Should Oxycodone be Used?
Oxycodone comes as a solution (liquid), a concentrated solution, a tablet, a capsule, an extended-release (long-acting) tablet (Oxycontin), and an extended-release capsule (Xtampza ER) to take by mouth. The solution, concentrated solution, tablet, and capsule are taken usually with or without food every 4 to 6 hours, either as needed for pain or as regularly scheduled medications. The extended-release tablets (Oxycontin) are taken every 12 hours with or without food. The extended-release capsules (Xtampza ER) are taken every 12 hours with food; eat the same amount of food with each dose. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take oxycodone exactly as directed.
If you are taking the extended-release tablets (Oxycontin), swallow the tablets one at a time with plenty of water. Swallow the tablet or right after putting it in your mouth. Do not presoak, wet, or lick the tablets before you put them in your mouth. Do not chew or crush extended-release tablets.
If you have trouble swallowing extended-release capsules (Xtampza ER), you can carefully open the capsule and sprinkle the contents on soft foods such as applesauce, pudding, yogurt, ice cream, or jam, then consume the mixture immediately. Dispose of the empty capsule shells right away by flushing them down a toilet. Do not store the mixture for future use.
If you have a feeding tube, the extended-release capsule contents can be poured into the tube. Ask your doctor how you should take the medication and follow these directions carefully.
Your doctor may adjust your dose of oxycodone during your treatment, depending on how well your pain is controlled and on the side effects that you experience. Talk to your doctor about how you are feeling during your treatment with oxycodone. Tell your doctor if you feel that your pain is not controlled or if your pain increases, becomes worse, or if you have new pain or an increased sensitivity to pain during your treatment with oxycodone. Do not take more of it or take it more often than prescribed by your doctor.
Do not stop taking oxycodone without talking to your doctor. If you stop taking oxycodone suddenly, you may experience withdrawal symptoms such as restlessness, watery eyes, runny nose, sneezing, yawning, sweating, chills, muscle or joint aches or pains, weakness, irritability, anxiety, depression, difficulty falling asleep or staying asleep, cramps, nausea, vomiting, diarrhea, loss of appetite, fast heartbeat, and fast breathing. Your doctor will probably decrease your dose gradually.
Other Uses for Oxycodone
This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.
What Special Precautions Should I Follow?
Before taking oxycodone,
- tell your doctor and pharmacist if you are allergic to oxycodone, any other medications, or any of the ingredients in the oxycodone product you plan to take. Ask your pharmacist or check the Medication Guide for a list of the ingredients.
- tell your doctor or pharmacist if you are taking the following medications or have stopped taking them within the past two weeks: isocarboxazid (Marplan), linezolid (Zyvox), methylene blue, phenelzine (Nardil), selegiline (Emsam, Zelapar), or tranylcypromine (Parnate).
- The following nonprescription or herbal products may interact with oxycodone: St. John’s wort and tryptophan. Be sure to let your doctor and pharmacist know that you are taking these medications before you start taking oxycodone. Do not start these medications while taking oxycodone without discussing it with your healthcare provider.
- tell your doctor if you have or have ever had any of the conditions mentioned in the IMPORTANT WARNING section, a blockage or narrowing of your stomach or intestines, or paralytic ileus (condition in which digested food does not move through the intestines). Your doctor may tell you not to take oxycodone.
- Also tell your doctor if you have or have ever had low blood pressure; seizures; adrenal insufficiency (condition in which the adrenal glands do not produce enough of certain hormones needed for important body functions); seizures; urethral stricture (blockage of the tube that allows urine to leave the body), problems urinating; or heart, kidney, liver, pancreas, thyroid, or gall bladder disease. If you will be taking the extended-release tablets or extended-release capsules, also tell your doctor if you have or have ever had difficulty swallowing, diverticulitis (condition in which small pouches form in the intestines and become swollen and infected), colon cancer (cancer that begins in the large intestine), or esophageal cancer (cancer that begins in the tube that connects the mouth and stomach).
- tell your doctor if you are breastfeeding. You should not breastfeed while you are taking oxycodone. Oxycodone can cause shallow breathing, difficulty or noisy breathing, confusion, more than usual sleepiness, trouble breastfeeding, or limpness in breastfed infants.
- you should know that this medication may decrease fertility in men and women. Talk to your doctor about the risks of taking oxycodone.
- if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking oxycodone.
- you should know that this medication may make you drowsy. Do not drive a car, operate heavy machinery, or participate in any other possibly dangerous activities until you know how this medication affects you.
- you should know that oxycodone may cause dizziness, lightheadedness, and fainting when you get up too quickly from a lying position. To help avoid this problem, get out of bed slowly, resting your feet on the floor for a few minutes before standing up.
- you should know that oxycodone may cause constipation. Talk to your doctor about changing your diet or using other medications to prevent or treat constipation while you are taking oxycodone.
What Special Dietary Instructions Should I Follow?
Unless your doctor tells you otherwise, continue your normal diet.
What Should I do if I Forget a Dose?
If you are taking oxycodone on a regular schedule, take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one. Do not take more than one dose of the extended-release tablets or capsules in 12 hours.
What Side Effects Can Oxycodone Cause?
Nausea, vomiting, constipation, lightheadedness, dizziness, or drowsiness may occur. Some of these side effects may decrease after you have been using this medication for a while. If any of these effects last or get worse, tell your doctor or pharmacist promptly.
To prevent constipation, eat dietary fiber, drink enough water, and exercise. You may also need to take a laxative. Ask your pharmacist which type of laxative is right for you.
To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.
Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Tell your doctor right away if you have any serious side effects, including: interrupted breathing during sleep (sleep apnea), mental/mood changes (such as agitation, confusion, hallucinations), severe stomach/abdominal pain, difficulty urinating, signs of your adrenal glands not working well (such as loss of appetite, unusual tiredness, weight loss).
Get medical help right away if you have any very serious side effects, including: fainting, seizure, slow/shallow breathing, severe drowsiness/difficulty waking up.
A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US –
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.
In Canada – Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Oxycodone may cause side effects. Tell your doctor if any of these symptoms, are severe or do not go away:
- dry mouth
- stomach pain
- drowsiness
- flushing
- headache
- mood changes
Some side effects can be serious. If you experience any of these symptoms or those mentioned in the IMPORTANT WARNING section, call your doctor immediately or get emergency medical help:
- changes in heartbeat
- agitation, hallucinations (seeing things or hearing voices that do not exist), fever, sweating, confusion, fast heartbeat, shivering, severe muscle stiffness or twitching, loss of coordination, or diarrhea
- nausea, vomiting, loss of appetite, weakness, or dizziness
- inability to get or keep an erection
- irregular menstruation
- decreased sexual desire
- chest pain
- rash; itching; hives; hoarseness; difficulty breathing or swallowing; or swelling of the face, mouth, tongue, lips, or throat
- swelling of the hands, feet, ankles, or lower legs
- seizures
- extreme drowsiness
If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration’s (FDA) MedWatch Adverse Event Reporting program online (https://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).
Oxycodone may cause other side effects. Call your doctor if you have any unusual problems while you are taking this medication.
What Should I Know About Storage and Disposal of Oxycodone?
Keep this medication in the container it came in, tightly closed, and out of reach of children, and in a location that is not easily accessible by others, including visitors to the home. Store it at room temperature and away from light and excess heat and moisture (not in the bathroom). You must immediately dispose of any medication that is outdated or no longer needed through a medicine take-back program. If you do not have a take-back program nearby or one that you can access promptly, flush any medication that is outdated or no longer needed down the toilet so that others will not take it. Talk to your pharmacist about the proper disposal of your medication.
It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. https://www.upandaway.org
In case of emergency/overdose
In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can’t be awakened, immediately call emergency services at 911.
While taking oxycodone, you should talk to your doctor about having a rescue medication called naloxone readily available (e.g., home, office). Naloxone is used to reverse the life-threatening effects of an overdose. It works by blocking the effects of opiates to relieve dangerous symptoms caused by high levels of opiates in the blood. Your doctor may also prescribe you naloxone if you are living in a household where there are small children or someone who has abused street or prescription drugs. You should make sure that you and your family members, caregivers, or the people who spend time with you know how to recognize an overdose, how to use naloxone, and what to do until emergency medical help arrives. Your doctor or pharmacist will show you and your family members how to use the medication. Ask your pharmacist for the instructions or visit the manufacturer’s website to get the instructions. If symptoms of an overdose occur, a caregiver or family member should give the first dose of naloxone, call 911 immediately, and stay with you and watch you closely until emergency medical help arrives.Your symptoms may return within a few minutes after you receive naloxone. If your symptoms return, the person should give you another dose of naloxone. Additional doses may be given every 2 to 3 minutes, if symptoms return before medical help arrives.
Symptoms of overdose may include the following:
- difficulty breathing
- slowed or shallow breathing
- excessive sleepiness
- limp or weak muscles
- narrowing or widening of the pupils (dark circle in the eye)
- cold, clammy skin
- unable to respond or wake up
- slowed heartbeat
- unusual snoring
What Other Information Should I Know?
Keep all appointments with your doctor. Your doctor may order certain lab tests to check your body’s response to oxycodone.
Before having any laboratory test (especially those that involve methylene blue), tell your doctor and the laboratory personnel that you are taking oxycodone.
This prescription is not refillable. If you continue to have pain after you finish the oxycodone, call your doctor.
It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.
Oxycodone Drug Interaction
Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor’s approval.
Some products that may interact with this drug include: certain pain medications (mixed opioid agonist/antagonists such as butorphanol, nalbuphine, pentazocine), naltrexone, samidorphan.
The risk of serious side effects (such as slow/shallow breathing, severe drowsiness/dizziness) may be increased if this medication is taken with other products that may also cause drowsiness or breathing problems. Tell your doctor or pharmacist if you are taking other products such as other opioid pain or cough relievers (such as codeine, hydrocodone), alcohol, marijuana (cannabis), drugs for sleep or anxiety (such as alprazolam, lorazepam, zolpidem), muscle relaxants (such as carisoprodol, cyclobenzaprine), or antihistamines (such as cetirizine, diphenhydramine).
Check the labels on all your medicines (such as allergy or cough-and-cold products) because they may contain ingredients that cause drowsiness. Ask your pharmacist about using those products safely.
Other medications can affect the removal of oxycodone from your body, which may affect how oxycodone works. Examples include azole antifungals (such as ketoconazole), macrolide antibiotics (such as erythromycin), mifepristone, HIV medications (such as tipranavir), rifamycins (such as rifabutin, rifampin), ritonavir, certain drugs used to treat seizures (such as carbamazepine, phenytoin), among others.
This medication may interfere with certain lab tests (such as amylase/lipase levels), possibly causing false test results. Make sure lab personnel and all your doctors know you use this drug.
Brand names
- Oxaydo®
- Oxycontin®
- Roxicodone®
- Roxybond®
- Xtampza® ER
- Targiniq® ER (as a combination product containing naloxone, oxycodone)
- Xartemis XR® (as a combination product containing Acetaminophen, Oxycodone)
Brand names of combination products
- Combunox® (containing Ibuprofen, Oxycodone)
- Narvox® (containing Acetaminophen, Oxycodone)
- Oxycet® (containing Acetaminophen, Oxycodone)
- Percocet® (containing Acetaminophen, Oxycodone)
- Percodan® (containing Aspirin, Oxycodone)
- Roxicet® (containing Acetaminophen, Oxycodone)
- Roxilox® (containing Acetaminophen, Oxycodone)
- Roxiprin® (containing Aspirin, Oxycodone)
- Troxyca ER® (containing Naltrexone, Oxycodone)
- Tylox® (containing Acetaminophen, Oxycodone)