Oxycodone

Oxycodone is a strong opioid pain medicine used to manage pain that is severe enough to need an opioid, and only when other pain treatments, such as non-opioid medicines or other combinations, have not worked well enough, are not tolerated, or are not expected to control the pain.

• Immediate-release forms (tablets, capsules, and oral solution) are usually used for short-term, severe pain, such as pain after surgery or an injury. They are taken only when other options are not enough.
• Extended-release forms (extended-release tablets and Xtampza ER capsules) are used for severe, around-the-clock pain that needs daily, long-term treatment. They are not for use "as needed." Extended-release tablets are approved for adults and for opioid-tolerant children aged 11 years and older who are already taking and tolerating at least 20 mg of oxycodone a day, or the equivalent.

Oxycodone is a full mu-opioid receptor agonist. In plain terms, it attaches to specific opioid receptors in the brain and spinal cord (the central nervous system) to reduce the feeling of pain. Because it is a full agonist, there is no "ceiling" on its pain-relieving effect, which means higher doses keep adding effect but are limited by side effects such as slowed breathing and heavy sedation. The exact way oxycodone relieves pain is not fully understood.

Oxycodone first gained FDA approval on October 26, 1998. It is a Schedule II controlled substance, meaning it has an accepted medical use but a high potential for misuse, abuse, and dependence.

Oxycodone 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, which can lead to death. These risks can happen at any dose and at any point during treatment.

The FDA requires a Risk Evaluation and Mitigation Strategy (REMS) for opioid pain medicines. As part of this program, prescribers are strongly encouraged to complete opioid safety education, counsel patients and caregivers on safe use, storage, and disposal, make sure patients read the Medication Guide with each prescription, and consider tools such as patient-prescriber agreements.

Get emergency help or call 911 right away if you take too much oxycodone (overdose). Serious or life-threatening breathing problems that can lead to death may occur, especially when you first start oxycodone, when your dose is changed, or if you take too much. Ask your healthcare provider about medicines such as naloxone or nalmefene that can be used in an emergency to reverse an opioid overdose. These medicines are available by prescription, over the counter, or through some community programs. Keep an overdose reversal medicine where family or friends can reach it, and learn how to use it before an emergency happens.

Do not combine oxycodone with certain other medicines or substances. Taking oxycodone with other opioid medicines, benzodiazepines, gabapentinoids (gabapentin or pregabalin), alcohol, or other central nervous system depressants (including street drugs) can cause severe drowsiness, decreased awareness, breathing problems, coma, and death.

Taking oxycodone with medicines that affect certain liver enzymes (CYP3A4) can raise the level of oxycodone in your body to a dangerous or even fatal level. Always tell your healthcare provider and pharmacist about every medicine you take.

Never give anyone else your oxycodone. They could die from taking it. Selling or giving away oxycodone is against the law. Store oxycodone securely, out of sight and reach of children, and in a place not accessible by others, including visitors to the home.

Do not take oxycodone if you have:

• Severe asthma, trouble breathing, or other serious lung problems
• A bowel blockage, or a narrowing of the stomach or intestines
• An allergy to oxycodone or to any of the ingredients in your oxycodone product

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

• Head injury or seizures
• Liver, kidney, or thyroid problems
• Problems urinating
• Pancreas or gallbladder problems
• Breathing problems or lung disease, including sleep apnea
• Low blood pressure or fainting spells
• Misuse of street or prescription drugs, alcohol addiction, a past opioid overdose, or mental health problems such as depression

Also, tell your healthcare provider if you are:

• Pregnant or planning to become pregnant. Using oxycodone for a long time during pregnancy can cause withdrawal in your newborn (neonatal opioid withdrawal syndrome), which can be life-threatening if not recognized and treated. Oxycodone may also cause harm to an unborn baby.
• Breastfeeding. Oxycodone passes into breast milk and may harm your baby. Extended-release forms (extended-release tablets and Xtampza ER) are not recommended while breastfeeding. If you use an immediate-release form, watch your baby closely for increased sleepiness (more than usual), breathing difficulties, or limpness, and seek immediate medical care if you notice these signs.
• Living in a household with small children or with someone who has misused street or prescription drugs. Oxycodone must be stored securely to prevent accidental ingestion, theft, and misuse.
• Taking any prescription or over-the-counter medicines, vitamins, or herbal supplements. Taking oxycodone with certain other medicines can cause serious side effects that could lead to death. This includes medicines that affect serotonin, such as some antidepressants and migraine medicines.

Common side effects

The most common side effects of oxycodone are:

• Constipation
• Nausea and vomiting
• Sleepiness and tiredness
• Headache
• Itching
• Dizziness
• Trouble sleeping
• Dry mouth
• Abdominal pain

Many of these effects are more likely when you first start oxycodone or when your dose is increased. Constipation is common and often continues with ongoing use, so ask your healthcare provider how to prevent and manage it. Call your healthcare provider if any side effect is severe.

Serious side effects and warnings

Call 911 or get emergency medical help right away if you have:

• Trouble breathing, shortness of breath, or very slow or shallow breathing
• Extreme drowsiness, or being hard to wake up
• Fast heartbeat or chest pain
• Swelling of your face, tongue, or throat (signs of a serious allergic reaction)
• Light-headedness or feeling faint when changing positions
• Agitation, high body temperature, trouble walking, stiff muscles, or mental changes such as confusion (possible signs of a serious drug reaction called serotonin syndrome)

Oxycodone can also cause other serious problems. Talk to your healthcare provider promptly if you notice any of the following:

• Worsening or new pain. In some people, opioids can make pain worse or increase sensitivity to pain (called opioid-induced hyperalgesia). If your pain increases, if ordinary touch becomes painful, or if you have new pain, do not take more oxycodone on your own. Talk to your healthcare provider first.
• Adrenal insufficiency. This is a potentially life-threatening hormone problem that has been reported with opioid use, more often after more than a month of use. Signs can include nausea, vomiting, loss of appetite, tiredness, weakness, dizziness, and low blood pressure.
• Low blood pressure. Oxycodone can cause a drop in blood pressure, including when you stand up, which may lead to dizziness or fainting. Rise slowly from sitting or lying down.
• Breathing problems during sleep. Opioids can cause sleep apnea (pauses in breathing while asleep) and low oxygen levels during sleep. Tell your provider if you or others notice new or worsening breathing problems during sleep.
• Trouble swallowing or severe constipation. Opioids can cause swallowing problems, regurgitation, or chest pain that is not related to your heart. This risk may increase with higher doses or longer use. With extended-release tablets, there is also a rare risk of tablets becoming stuck in the throat. Severe constipation can also become a serious bowel problem.
• Seizures. Oxycodone may increase the risk of seizures, especially in people who already have a seizure disorder.
• Reduced fertility, missed periods, or low sex drive. Long-term opioid use may affect hormone levels and fertility in both women and men.

These are not all the possible side effects of oxycodone. Call your healthcare provider for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Take oxycodone exactly as prescribed by your healthcare provider. Do not change your dose on your own. Your provider will use the lowest effective dose for the shortest time needed to manage your pain. For short-term (acute) pain, many people need an opioid for only a few days.

Oxycodone immediate-release tablets or capsules

• Take your prescribed dose every 4 to 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. Do not double up.
• You may have some oxycodone left over. See the disposal information below for how to safely throw away unused medicine.

Oxycodone extended-release tablets

• Take your prescribed dose every 12 hours at the same times each day.
• Swallow extended-release tablets whole. Do not cut, break, chew, crush, dissolve, snort, or inject them, because this can release a dangerous or fatal dose all at once.
• Take one tablet at a time with enough water to swallow it right away. Do not pre-soak, lick, or wet the tablet before placing it in your mouth, to avoid choking.
• Do not take more than your prescribed dose in 12 hours. If you miss a dose, take your next dose at your usual time.

Oxycodone extended-release (ER) capsules (Xtampza ER)

• Take your prescribed dose every 12 hours at the same times each day.
• Always take Xtampza ER with food, and with about the same amount of food each time, so the right amount of medicine is absorbed.
• Swallow the capsules whole. Do not snort or inject the contents, because this can cause overdose and death.
• If you cannot swallow the capsules, the contents may be sprinkled onto soft food, placed from a cup directly into the mouth, or given through a nasogastric or gastrostomy (feeding) tube. Follow the detailed Instructions for Use.
• If you miss a dose, take your next dose at your usual time.

Oxycodone oral solution

• Take your prescribed dose every 4 to 6 hours as needed for pain. Do not take more than your prescribed dose.
• Always use the dosing device that comes with your medicine (a measuring cup for the 5 mg/5 mL strength, or an oral syringe for the 100 mg/5 mL strength). Never use a household teaspoon or tablespoon, because this can cause an overdose.
• The oral solution comes in two very different strengths. Be sure you know which strength you have, and measure every dose carefully.
• If you miss a dose, take your next dose at your usual time.

Important for all forms

• Call your healthcare provider if the dose you are taking does not control your pain. Do not increase your dose on your own.
• If you have been taking oxycodone regularly, do not stop suddenly. Stopping or lowering the dose too quickly can cause serious withdrawal symptoms, uncontrolled pain, and, in some cases, thoughts of suicide. Your provider will help you taper (lower the dose slowly) using a plan that is right for you.

Dispose of expired, unwanted, or unused oxycodone capsules, tablets, extended-release tablets, ER capsules, or oral solution promptly. If a drug take-back option is not readily available, the FDA advises flushing these medicines down the toilet because of the serious risk they pose to others in the home. Visit www.fda.gov/drugdisposal for more information on disposing of unused medicines.

While taking oxycodone, do not:

• Drive or operate heavy machinery until you know how oxycodone affects you. It can make you sleepy, dizzy, or lightheaded.
• Drink alcohol or use prescription or over-the-counter medicines that contain alcohol. Combining alcohol with oxycodone can cause you to overdose and die.

Oxycodone can interact with many medicines, sometimes causing serious side effects or death. Always tell your healthcare provider and pharmacist about all the medicines you take, including:

• Other opioids, pain medicines, or prescription cough medicines
• Benzodiazepines, such as Xanax, Valium, Ativan, Klonopin, or Restoril
• Sleeping pills, muscle relaxants, or tranquilizers
• Medicines for depression, anxiety, or other mental health conditions, and other medicines that affect serotonin (such as certain antidepressants, migraine medicines, and the muscle relaxants cyclobenzaprine and metaxalone)
• Medicines for Parkinson's disease, migraines, or seizures
• Monoamine oxidase inhibitors (MAOIs), which should not be used with oxycodone or within 14 days of stopping an MAOI
• Antibiotics, antifungals, or HIV or hepatitis C medicines, which can change how oxycodone is broken down in the body
• Heart or blood pressure medicines, including diuretics (water pills)
• Cold, allergy, or asthma medicines
• Medicines for nausea, motion sickness, or bladder problems (anticholinergic medicines)

Some medicines can slow down how oxycodone is cleared from the body and raise it to dangerous levels, while others can lower its effect or trigger withdrawal. This list is not complete. Always check with your doctor or pharmacist before starting or stopping any medicine, including over-the-counter products, vitamins, and herbal supplements.