Oxycodone

Oxycodone is an opioid medicine or a moderately strong painkiller only available via prescription from your doctor often prescribed for severe pain either alone or in combination with acetaminophen (paracetamol) and anti-inflammatories (nonsteroidal anti-inflammatory drugs [NSAIDs]) when other pain-relief medicines are not effective or cannot be used ¹, ², ³, ⁴, ⁵. Oxycodone alone or in combination with acetaminophen (paracetamol) such as Percocet and/or an anti-inflammatory (nonsteroidal anti-inflammatory drugs [NSAIDs]) aspirin such as Percodan has been shown to be effective in reducing moderate- to moderately severe pain and is widely used for temporary as well as chronic (long-term) management of pain states. Oxycodone should only be used when other forms of pain relief have not been successful in managing your pain or if you are not able to take them (for example, because of side effects or because your doctor says you cannot take it together with another medicine that you are taking). Oxycodone is best used together with acetaminophen (paracetamol) and/or an anti-inflammatory (nonsteroidal anti-inflammatory drugs [NSAIDs]).

Oxycodone is in a class of medications called opioids or opiates or narcotic analgesics. Oxycodone is a semisynthetic derivative of thebaine, which is a natural alkaloid that is derived from resin extracts from the seeds of the opium poppy plant (Papaver somniferum) and is used for pain relief (analgesic) or calming effects ³, ⁴. Oxycodone works by changing the way the brain and nervous system respond to pain. Oxycodone is a controlled substance and classified as a Schedule 2 drug, indicating that oxycodone has medical usefulness, but also a high potential for physical and psychological dependency and abuse. Unfortunately, oxycodone has become one of the most frequently abused prescription medications and some formulations can be dissolved and injected intravenously. Individuals with oxycodone dependence may turn to illegal opiate drug use. Ironically, in some communities, heroin is more available and less expensive than oxycodone by prescription. Newer abuse-deterrent formulations could also be used to prevent the misuse and abuse of oxycodone ⁶.

Oxycodone has been in use since its first synthesis in 1917, but was formally approved for use in the United States in 1991 ³. Since then, it has become one of the most commonly prescribed drugs in medical practice ³. Due to the high misuse potential and possibly fatal results of an oxycodone overdose, prescriptions should be written for the lowest therapeutic dose and only for the therapeutic period.

Oxycodone is available in multiple formulations including oral tablets of 5, 7.5, 10 and 20 mg, as well as capsules of 5 mg, an extended-release (long-acting) tablet (Oxycontin), and an extended-release capsule (Xtampza ER), suppositories of 10 and 20 mg,  and oral solution (liquid) in various concentrations generically. Higher dose oral formulations of 10 to 80 mg are also available generically and under the brand name OxyContin for therapy of persistent, moderate- to moderately severe pain that requires 24 hour opioid therapy. Oxycodone is also available in fixed combinations with other analgesics, including aspirin, ibuprofen, but particularly acetaminophen. These combinations are commonly used and available generically and under the brand names such as Percocet, Tylox and Endocet. The dose of oxycodone is typically 5 to 10 mg and acetaminophen 300 to 600 mg per tablet.

Oxycodone solution, concentrated solution, tablet, and capsule are usually taken 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 pre-soak, 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.

It is very important that your doctor check your progress while you are using oxycodone, especially within the first 24 to 72 hours of treatment. This will allow your doctor to see if oxycodone 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.

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. If oxycodone therapy requires termination, consider decreasing it in increments of 10% to 50% of the dose every few days to a few weeks while monitoring for withdrawal symptoms.

Side effects of oxycodone include sedation, respiratory depression, mental clouding, euphoria, agitation, itching, constipation, diarrhea, abdominal bloating, nausea, vomiting, headache and dizziness. Severe adverse events include life-threatening respiratory depression, addiction, abuse, opioid withdrawal, serotonin syndrome (when used with serotonergic agents) and adrenal insufficiency (a condition that occurs when the adrenal glands don’t produce enough hormones, particularly cortisol and aldosterone). Oxycodone is also linked with acute liver injury, especially in higher doses and in combination with high acetaminophen doses ³.

Oxycodone mechanism of action

Oxycodone is a semisynthetic derivative of thebaine, which is a natural alkaloid that is derived from resin extracts from the seeds of the opium poppy plant (Papaver somniferum). Oxycodone works primarily as an agonist of mu (μ) opioid receptors in the spinal cord and brain ⁷, ¹. Oxycodone has some activity at kappa and delta opioid receptors which are also involved in nociception or analgesia though the importance of this mechanism in the overall analgesic effect of oxycodone is unclear ¹. As with other opioids, oxycodone causes hyperpolarization and reduced excitability of neurons in the central nervous system (brain and spinal cord). This generalized central nervous system (brain and spinal cord) depression results from the agonistic effect on kappa-type opioid receptors, leading to N-type voltage-gated calcium channel closure. In contrast, stimulation of the mu (μ) and delta-type receptors opens calcium-dependent inward-rectifying potassium channels ⁸.

Oxycodone upon binding to these G-protein–coupled opioid receptors 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) ⁹. 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 ⁹.

Oxycodone is metabolized by the hepatic enzymes CYP3A4 and CYP2D6, producing the metabolites nor-oxycodone and oxymorphone, respectively ⁹. Oxymorphone has a greater affinity for mu (μ) opioid receptors compared to oxycodone ¹⁰. Oxycodone metabolites get excreted from the body via the kidneys ¹¹. The clearance is 0.8 L/minute.

Oxycodone special precautions

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For oxycodone, the following should be considered:

Before using 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 oxycodone 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 oxycodone may make you drowsy. Do not drive a car, operate heavy machinery, or participate in any other possibly dangerous activities until you know how oxycodone 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.

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to oxycodone or any other medicines. Also tell your doctor if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children

Appropriate studies have not been performed on the relationship of age to the effects of Oxaydo®, Roxicodone®, Roxybond™, and Xtampza® ER in the pediatric population. Safety and efficacy have not been established.

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of Oxycontin® in children. However, safety and efficacy have not been established in children younger than 11 years of age.

Elderly patients

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of oxycodone in the elderly. However, elderly patients are more likely to have age-related liver, kidney, heart, or lung problems, which may require caution and an adjustment in the dose for patients receiving oxycodone in order to avoid potentially serious side effects.

Pregnancy

Studies involving people who use some opioids frequently during their pregnancy have found an increased chance for poor growth of the baby, low levels of amniotic fluid (fluid that surrounds baby in the uterus), stillbirth, preterm delivery, and C-section. This is more commonly reported in those who are using heroin or who are taking prescribed opioid medication in greater amounts or for longer than recommended by their healthcare provider. Use of an opioid close to the time of delivery can result in withdrawal symptoms in the baby also called Neonatal Abstinence Syndrome (NAS). Studies have reported an increased chance for neonatal abstinence syndrome (NAS) with use of oxycodone during the 3rd trimester.

Neonatal abstinence syndrome (NAS) is the term used to describe withdrawal symptoms in newborns from opioid medication that a person takes during pregnancy. Neonatal abstinence syndrome (NAS) symptoms can include irritability, crying, sneezing, stuffy nose, poor sleep, extreme drowsiness (very tired), yawning, poor feeding, sweating, tremors, seizures, vomiting, and diarrhea. Most often, symptoms of NAS appear 2 days after birth and may last more than 2 weeks. The chance that NAS will occur depends on the length of time and/or the dose of opioid taken during pregnancy, if other medications were also taken, if the baby was born preterm, and/or the size of the baby at birth. If opioids were taken in pregnancy, it is important to let your baby’s healthcare providers know so that they can check for symptoms of NAS and provide the best care for your newborn.

Breastfeeding

Oxycodone product label recommends women who are breastfeeding not use oxycodone. But, the benefit of breastfeeding and treating your condition may outweigh possible risks. Your doctor can talk with you about using oxycodone and what treatment is best for you.

Oxycodone can get into breast milk. Babies might have problems with the amounts of oxycodone in the breast milk. The use of some opioids, including oxycodone, when breastfeeding might cause babies to be very sleepy, have trouble latching on, and have poor feeding. Some opioids can cause trouble with breathing. Talk with your doctor about your specific situation, as information on breastfeeding might change based on the age of your baby, the medication dosage, the length of use, or other factors.

If you are using any opioid while breastfeeding, talk to your doctor about how to use the least amount for the shortest time and how to monitor (watch) your baby for any signs of concern. Contact the baby’s doctor immediately if your baby has any problems such as increased sleepiness (more than usual), trouble feeding, trouble breathing, or limpness.

Drug Interactions

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking oxycodone, it is especially important that your doctor know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using oxycodone with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Levoketoconazole
• Mavorixafor
• Naltrexone
• Safinamide
• Samidorphan

Using oxycodone with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Other Interactions

Using oxycodone with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use oxycodone, or give you special instructions about the use of food, alcohol, or tobacco.

• Ethanol
• Grapefruit Juice

Medical Problems

The presence of these medical problems may affect the use of oxycodone. Make sure you tell your doctor if you have any of these medical problems, especially:

• Addison disease (adrenal gland problem) or
• Alcohol use disorder, or history of or
• Brain tumor, history of or
• Breathing or lung problems (eg, hypoxia, COPD, sleep apnea) or
• Cancer of the esophagus or colon or
• CNS depression or
• Cor pulmonale (serious heart condition) or
• Drug dependence, especially with opioids, or history of or
• Enlarged prostate (eg, BPH, prostatic hypertrophy) or
• Gallbladder disease or gallstones or
• Head injuries, history of or
• Hypothyroidism (an underactive thyroid) or
• Hypovolemia (low blood volume) or
• Increased pressure in the head or
• Kyphoscoliosis (curvature of the spine with breathing problems) or
• Problems with passing urine or
• Psychosis (mental disease) or
• Stomach or bowel problems (eg, esophageal or colon cancer with a small gastrointestinal lumen) or
• Trouble swallowing or
• Weakened physical condition—Use with caution. May increase risk for more serious side effects.
• Asthma, acute or severe or respiratory depression (serious breathing problem) or stomach or bowel blockage (including paralytic ileus): Oxycodone should not be used in patients with these conditions.
• Hypotension (low blood pressure) or pancreatitis (swelling of the pancreas) or seizures, history of: Use oxycodone with caution. May make these conditions worse.
• Kidney disease, severe or liver disease: Use oxycodone with caution. The effects may be increased because of slower removal of oxycodone from the body.

Oxycodone uses

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.

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 ¹². The extended-release oxycodone 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 your pain ¹³.

Oxycodone contraindications

Oxycodone is contraindicated in people with respiratory depression, acute bronchospasm, hypercarbia, hypersensitivity to oxycodone, and known or suspected ileus or gastrointestinal obstruction.

Oxycodone may cause a serious type of allergic reaction called anaphylaxis, which can be life-threatening and requires immediate medical attention. For patients with an opioid allergy, a clear description of the allergic reaction should be explored and documented adequately before considering oxycodone. Patients who have a true allergic reaction to other opioid medications should avoid oxycodone therapy when possible. Call your doctor right away if you have a rash, itching, hoarseness, trouble breathing or swallowing, or any swelling of your hands, face, or mouth while you are using oxycodone.

Oxycodone dosage

The oxycodone to morphine dose equivalent ratio is approximately 1:1.5 for immediate-release and 1:2 for extended-release formulations ¹⁴. Take oxycodone only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. This is especially important for elderly patients, who may be more sensitive to the effects of pain medicines. If too much of oxycodone is taken for a long time, it may become habit-forming causing mental or physical dependence.

• Oxycodone immediate-release tablets: These are available in 5 mg, 10 mg, 15 mg, 20 mg, and 30 mg, while capsules are 5 mg strength. The oral solution is available in 5 mg/5 mL strength, and the oral concentrate is in 100 mg/5 mL strength. Manufacturers discontinued the 160 mg dose in May 2001 due to the high misuse potential.
• Oxycodone extended-release tablets: These are available in 10 mg, 15 mg, 20 mg, 30 mg, 40 mg, 60 mg, and 80 mg strengths. Tablets are not intended to be broken, chewed, crushed, or dissolved in liquid.
• Oxycodone abuse-deterrent tablets: These are available in 9 mg, 13.5 mg, 18 mg, 27 mg, and 36 mg strengths.
• Oxycodone is also available in combination with other analgesics, including acetaminophen, aspirin, or ibuprofen. In some countries, oxycodone may be available in intramuscular and/or intravenous forms.

Oxycodone extended-release capsules or tablets should only be used by patients who have already been taking opioid pain medicines. These patients are called opioid-tolerant. If you are uncertain whether or not you are opioid-tolerant, check with your doctor before using oxycodone.

Measure the oral liquid concentrate with the calibrated dropper that comes with the package. Your doctor may have you mix the concentrate with a small amount of liquid or food. Carefully follow the instructions and take the medicine mixture right away.

Measure the oral liquid with a marked measuring spoon, oral syringe, or medicine cup. The average household teaspoon may not hold the right amount of liquid.

Swallow the Oxaydo® or OxyContin® tablet whole with water. Do not break, crush, cut, chew, or dissolve it. Do not pre-soak, lick, or wet the tablet before placing it in the mouth. Take one tablet at a time. Also, do not give oxycodone through nasogastric or feeding tubes.

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.

If you are using the extended-release (ER) oxycodone capsules:

• Take oxycodone with food and with about the same amount of food each time.
• If you have trouble swallowing, you may open the capsule and sprinkle the contents on soft foods (eg, applesauce, pudding, yogurt, ice cream, or jam) or into a cup and swallow immediately.
• Drink a glass of water to make sure all the medicine has been taken.
• Oxycodone may also be given through a nasogastric or gastrostomy tube.

Oxycodone extended-release capsules or tablets work differently from the regular oxycodone oral solution or tablets, even at the same dose. Do not switch from one brand or form to the other unless your doctor tells you to.

While taking the Roxybond™ tablet, part of it may pass into your stool. This is normal and nothing to worry about.

If you miss a dose of oxycodone, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

If you miss a dose of OxyContin®, Roxicodone®, Roxybond™, or Xtampza® ER, skip the missed dose and go back to your regular dosing schedule.

Adult dose

• Acute pain: Initial recommended doses of oxycodone are in the 5 mg to 15 mg range, every 4 to 6 hours as needed for adequate analgesia of acute pain. Further dosing should be titrated upwards for pain control, with attention and monitoring for adverse effects.
• Chronic pain: The dosage should be slowly titrated upwards, starting at the lowest possible dose for analgesia (2.5 mg to 10 mg every 4 to 6 hours) for patients with chronic pain. However, the medication should be taken at regularly scheduled intervals for chronic pain management to prevent the reoccurrence of pain instead of treating the pain after it has started.

Chilren dose

• Acute pain: Initial recommended doses of oxycodone are 0.05 to 0.15 mg/kg every 4 to 6 hours as needed for adequate analgesia of acute pain. Further dosing should be titrated upwards for pain control, with attention and monitoring for potential adverse effects.
• Chronic pain: It is recommended to titrate dosage slowly upwards, starting at the lowest possible dose for analgesia for patients with chronic pain. However, the medication should be taken at regularly scheduled intervals for chronic pain management to prevent the reoccurrence of pain instead of treating the pain after it has started.

Extended-release oxycodone capsules (oral dosage form)

For severe pain:

• Patients who are not taking opioid medicines or are not opioid tolerant:
  • Adults: At first, 9 milligrams (mg) every 12 hours with food. Your doctor may adjust your dose as needed. However, the dose is usually not more than 288 mg per day.
  • Children: Use and dose must be determined by your doctor.
• Patients switching from other opioid medicines:
  • Adults: The total amount of milligrams (mg) per day will be determined by your doctor and depends on which opioid you were using. Your doctor may adjust your dose as needed.
  • Children: Use and dose must be determined by your doctor.

Oxycodone capsules (oral dosage form)

For moderate to severe pain:

• Patients who are not taking opioid medicines:
  • Adults: At first, 5 to 15 milligrams (mg) every 4 to 6 hours as needed. Your doctor may adjust your dose as needed.
  • Children: Use and dose must be determined by your doctor.
• Patients switching from other opioid medicines:
  • Adults: The total amount of milligrams (mg) per day will be determined by your doctor and depends on which opioid you were using. Your doctor may adjust your dose as needed.
  • Children: Use and dose must be determined by your doctor.

Extended-release oxycodone tablets (oral dosage form)

For moderate to severe pain:

• Patients switching from regular oxycodone forms:
  • Adults: One tablet every 12 hours. The total amount of milligrams (mg) per day is the same as the total amount of regular oxycodone that is taken per day. The total amount per day will be given as 2 divided doses during the day. Your doctor may adjust your dose as needed.
  • Children 11 years of age and older: Dose must be determined by your doctor. The patient must already be receiving and tolerating opioids for at least 5 days in a row with a minimum of 20 mg per day of oxycodone or its equivalent for at least 2 days before taking OxyContin®.
  • Children younger than 11 years of age: Use and dose must be determined by your doctor.
• Patients switching from other opioid medicines:
  • Adults: One tablet every 12 hours. The total amount of milligrams (mg) per day will be determined by your doctor and depends on which opioid you were using. The total amount per day will be given as 2 divided doses during the day. Your doctor may adjust your dose as needed.
  • Children 11 years of age and older: Dose must be determined by your doctor. The patient must already be receiving and tolerating opioids for at least 5 days in a row with a minimum of 20 mg per day of oxycodone or its equivalent for at least 2 days before taking OxyContin®.
  • Children younger than 11 years of age: Use and dose must be determined by your doctor.
• Patients who are not taking opioid medicines:
  • Adults: At first, 10 milligrams (mg) every 12 hours. Your doctor may adjust your dose as needed.
  • Older adults: At first, 3 to 5 milligrams (mg) every 12 hours. Your doctor may adjust your dose as needed.
  • Children: Use and dose must be determined by your doctor.

Oxycodone immediate-release tablets (oral dosage form)

For moderate to severe pain:

• Patients who are not taking opioid medicines:
  • Adults: At first, 5 to 15 milligrams (mg) every 4 to 6 hours as needed. Your doctor may adjust your dose as needed.
  • Children: Use and dose must be determined by your doctor.
• Patients switching from other opioid medicines:
  • Adults: The total amount of milligrams (mg) per day will be determined by your doctor and depends on which opioid you were using. Your doctor may adjust your dose as needed.
  • Children: Use and dose must be determined by your doctor.

Oxycodone liquid concentrate or solution (oral dosage forms)

For moderate to severe pain:

• Adults: 10 to 30 milligrams (mg) every 4 hours as needed. Your doctor may adjust your dose as needed.
• Children: Use and dose must be determined by your doctor.

Oxycodone oral dosage forms (oral solution)

For moderate to severe pain:

• Adults: 5 to15 milligrams (mg) every 4 hours as needed. Your doctor may adjust your dose as needed.
• Children: Use and dose must be determined by your doctor.

Oxycodone tablets (oral dosage form)

For moderate to severe pain:

• Adults: At first, 5 to 15 milligrams (mg) every 4 to 6 hours as needed. Your doctor may adjust your dose as needed and tolerated.
• Children: Use and dose must be determined by your doctor.

Oxycodone side effects

Oxycodone may cause side effects. See 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, see 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

Oxycodone may cause other side effects. See your doctor if you have any unusual problems while you are taking oxycodone.

Oxycodone overdose

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 opioid overdose. Naloxone works by blocking the effects of opiates to relieve dangerous symptoms caused by high levels of opiates in your 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 opioid 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 naloxone.

Symptoms of oxycodone overdose may include the following ¹⁵:

• irregular, fast, or slow, or shallow breathing
• slowed or shallow breathing or trouble breathing
• slow heartbeat
• excessive sleepiness or unusual drowsiness
• limp or weak muscles
• extreme dizziness or weakness
• narrowing or widening of the pupils (dark circle in the eye)
• cold, clammy skin
• pale or blue lips, fingernails, or skin
• unable to respond or wake up
• slowed heartbeat
• unusual snoring
• coughing that sometimes produces a pink frothy sputum
• decreased awareness or responsiveness
• increased sweating
• seizures
• swelling in legs and ankles
• change or loss of consciousness.

1. Schmidt-Hansen M, Bennett MI, Arnold S, Bromham N, Hilgart JS, Page AJ, Chi Y. Oxycodone for cancer-related pain. Cochrane Database Syst Rev. 2022 Jun 9;6(6):CD003870. doi: 10.1002/14651858.CD003870.pub7[↩][↩][↩]
2. WHO Guidelines for the pharmacological and radiotherapeutic management of cancer pain in adults and adolescents. 1 January 2019. https://iris.who.int/bitstream/handle/10665/279700/9789241550390-eng.pdf[↩]
3. LiverTox: Clinical and Research Information on Drug-Induced Liver Injury [Internet]. Bethesda (MD): National Institute of Diabetes and Digestive and Kidney Diseases; 2012-. Oxycodone. [Updated 2020 Nov 24]. Available from: https://www.ncbi.nlm.nih.gov/books/NBK547955[↩][↩][↩][↩][↩]
4. Oxycodone. https://medlineplus.gov/druginfo/meds/a682132.html[↩][↩]
5. Oxycodone (oral route). https://www.mayoclinic.org/drugs-supplements/oxycodone-oral-route/description/drg-20074193[↩]
6. Rauck RL. Mitigation of IV Abuse Through the Use of Abuse-Deterrent Opioid Formulations: An Overview of Current Technologies. Pain Pract. 2019 Apr;19(4):443-454. doi: 10.1111/papr.12760[↩]
7. Riley J, Eisenberg E, Müller-Schwefe G, Drewes AM, Arendt-Nielsen L. Oxycodone: a review of its use in the management of pain. Curr Med Res Opin. 2008 Jan;24(1):175-92. doi: 10.1185/030079908×253708[↩]
8. Inturrisi CE. Clinical pharmacology of opioids for pain. Clin J Pain. 2002 Jul-Aug;18(4 Suppl):S3-13. doi: 10.1097/00002508-200207001-00002[↩]
9. Sadiq NM, Dice TJ, Mead T. Oxycodone. [Updated 2024 Feb 20]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2024 Jan-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK482226[↩][↩][↩]
10. Balyan R, Mecoli M, Venkatasubramanian R, Chidambaran V, Kamos N, Clay S, Moore DL, Mavi J, Glover CD, Szmuk P, Vinks A, Sadhasivam S. CYP2D6 pharmacogenetic and oxycodone pharmacokinetic association study in pediatric surgical patients. Pharmacogenomics. 2017 Mar;18(4):337-348. doi: 10.2217/pgs-2016-0183[↩]
11. Lugo RA, Kern SE. The pharmacokinetics of oxycodone. J Pain Palliat Care Pharmacother. 2004;18(4):17-30. doi: 10.1300/j354v18n04_03[↩]
12. Torabi R, Bourn L, Mundinger GS, Saeg F, Patterson C, Gimenez A, Wisecarver I, St Hilaire H, Stalder M, Tessler O. American Society of Plastic Surgeons Member Post-Operative Opioid Prescribing Patterns. Plast Reconstr Surg Glob Open. 2019 Mar 13;7(3):e2125. doi: 10.1097/GOX.0000000000002125[↩]
13. Kalso E. Oxycodone. J Pain Symptom Manage. 2005 May;29(5 Suppl):S47-56. doi: 10.1016/j.jpainsymman.2005.01.010[↩]
14. Thigpen JC, Odle BL, Harirforoosh S. Opioids: A Review of Pharmacokinetics and Pharmacodynamics in Neonates, Infants, and Children. Eur J Drug Metab Pharmacokinet. 2019 Oct;44(5):591-609. doi: 10.1007/s13318-019-00552-0[↩]
15. Concheiro M, Chesser R, Pardi J, Cooper G. Postmortem Toxicology of New Synthetic Opioids. Front Pharmacol. 2018 Oct 26;9:1210. doi: 10.3389/fphar.2018.01210[↩]