Xtampza ER
Xtampza ER is an extended-release form of oxycodone and it's an opioid medication. It's used in adults to treat long-term pain that isn't relieved by non-opioid pain medications. Xtampza ER (oxycodone) is a capsule that's taken by mouth every 12 hours. Xtampza ER (oxycodone) is available as a brand-name medication only; there's no lower-cost generic yet. Common side effects include nausea, headache, and constipation. Xtampza ER (oxycodone) is a controlled substance because it has a warning for misuse and dependence.
What is Xtampza ER (oxycodone)?
What is Xtampza ER (oxycodone) used for?
Long-term pain that isn't relieved by non-opioid pain medications alone
How Xtampza ER (oxycodone) works
Xtampza ER (oxycodone) is an opioid. It attaches to certain mu-opioid receptors in your brain to lower how much pain you feel.
Drug Facts
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What are the risks and warnings for Xtampza ER (oxycodone)?
Xtampza ER (oxycodone) can cause some serious health issues. This risk may be even higher for certain groups. If this worries you, talk to your doctor or pharmacist about other options.
Potential for addiction and misuse
Risk factors: Personal or family history of alcohol or substance use disorder | Personal or family history of mental health problems
Xtampza ER (oxycodone) is a controlled substance that has a risk for misuse and addiction. Take the medication exactly as prescribed. Don't change how much or how often you take it without talking to your prescriber first.
Misusing Xtampza ER (oxycodone) can raise the risk for serious and possibly life-threatening side effects, such as dangerously slow breathing, not able to stay awake, addiction, and opioid overdose. You'll be prescribed the lowest amount of Xtampza ER (oxycodone) that's necessary to manage your pain for the shortest period of time possible.
Because of the risk for misuse and addiction, Xtampza ER (oxycodone) is only available through a Risk Evaluation and Mitigation Strategy (REMS) program called the Opioid Analgesic REMS program. Your prescriber and pharmacy must register with the program, receive training on proper medication use, and discuss with you about how to safely take Xtampza ER (oxycodone).
Dangerously slow breathing (respiratory depression)
Risk factors: Taking medications that can cause slow breathing | Drinking alcohol | Older age | Being frail | Medical conditions that cause breathing problems (e.g., COPD, asthma, head injury) | Taking too much Xtampza ER (oxycodone)
Xtampza ER (oxycodone) can cause dangerously slow breathing, which can be life-threatening. This can happen to anyone and at recommended doses. But the risk is greatest when you first start treatment or when your prescriber raises your dose.
Don't drink alcohol while you're taking Xtampza ER (oxycodone). Also don't take Xtampza ER (oxycodone) with medications that slow your body down (e.g., benzodiazepines, other opioids, muscle relaxants). This can put you at risk for having dangerously slow breathing.
Your prescriber will recommend that you have naloxone (Narcan) to carry with you at all times. Naloxone is a medication that can reverse slowed breathing from opioids. Use naloxone, call 911, and get medical help right away if you or your loved one notices that you have trouble breathing or have bluish-colored lips, fingers, or toes.
Risk for opioid overdose
Risk factors: History of opioid use disorder | Previous opioid overdose | Taking high doses of Xtampza ER (oxycodone) | Taking more opioids than prescribed | Alcohol use
Take Xtampza ER (oxycodone) exactly as prescribed. Taking too much medication or taking it more often than prescribed can lead to an overdose. It can be very dangerous if someone accidentally swallows the medication. Be sure to keep Xtampza ER (oxycodone) out of reach from children, pets, and visitors to prevent accidental exposure or overdose.
Symptoms of an opioid overdose include not responding to sound or touch, extremely slow breathing, slow heartbeat, extreme sleepiness, and cold or clammy skin. Be sure you and your loved ones know how to recognize an overdose. Your prescriber will recommend getting naloxone (Narcan) — either by prescription or over the counter. Naloxone can help treat an opioid overdose. Carry naloxone with you at all times; use it and call 911 right away if an overdose happens.
Difficulty concentrating and extreme sleepiness
Risk factors: Taking high doses of Xtampza ER (oxycodone) | Age 65 years or older | Drinking alcohol | Taking other medications that can cause sleepiness
Xtampza ER (oxycodone) can cause extreme sleepiness and lower your ability to think, react, and focus. Don't drink alcohol with Xtampza ER (oxycodone). Also don't take Xtampza ER (oxycodone) with other medications that can cause sleepiness or "brain fog" (e.g., benzodiazepines, muscle relaxants, sleep medications). Otherwise, these side effects might worsen.
Make sure you know how Xtampza ER (oxycodone) affects you before driving a car or doing activities that require your concentration. Talk to your prescriber right away if you feel too sleepy from the medication.
Drug interactions
Xtampza ER (oxycodone) interacts with several medications. Let your care team know what medications you're taking to make sure they're safe for you to take together. Also speak with your care team first before making any changes to your medications because sudden dose adjustments can be harmful.
Some medications can raise the level of Xtampza ER (oxycodone) in your body, which can raise your risk for serious side effects like potentially life-threatening slowed breathing. Medications that can lead to this type of interaction include erythromycin and ritonavir (Norvir), among others.
Other interactions, such as with rifampin (Rifadin) or carbamazepine (Tegretol), can lower the levels of Xtampza ER (oxycodone) in your body. This can cause the opioid medication to work less well to manage your pain. These interactions might also lead to withdrawal symptoms.
Harm to newborn babies
Long-term use of Xtampza ER (oxycodone) during pregnancy can cause your unborn baby to become dependent on the medication. This is because Xtampza ER (oxycodone) can pass through the placenta to your unborn baby.
Once your baby is born, they can experience withdrawal symptoms, such as high-pitched crying, poor feeding behavior, trembling, abnormal sleep patterns, and even seizures. This condition is called neonatal opioid withdrawal syndrome and can be life-threatening if not recognized and treated in time. Let your healthcare professional (HCP) know if you've taken Xtampza ER (oxycodone) during pregnancy or if you notice these symptoms in your baby.
Physical dependence and withdrawal
Risk factors: Long-term use of Xtampza ER (oxycodone)
If taken regularly for a long time, Xtampza ER (oxycodone) can cause physical dependence. This means that your body relies on the medication to function. And you might experience withdrawal if you lower your dose too quickly or suddenly stop taking the medication. Withdrawal symptoms include anxiety, restlessness, irritability, runny nose, yawning, sweating, and chills.
Don't suddenly lower your dose or stop taking Xtampza ER (oxycodone) suddenly without talking to your prescriber first. If needed, your prescriber will slowly lower your dose over time to prevent withdrawal symptoms. Talk to an HCP if you have concerns about taking Xtampza ER (oxycodone) because of the risk for withdrawal.
Low blood pressure
Xtampza ER (oxycodone) can cause extremely low blood pressure. For example, your blood pressure might suddenly drop when you stand from a sitting or lying down position. This can lead to dizziness and fainting. To avoid falling, get up slowly if you've been sitting or lying down. Talk to an HCP if dizziness or lightheadedness doesn't go away.
Low adrenal hormone levels
Risk factors: Taking Xtampza ER (oxycodone) for longer than 1 month
Some people taking opioids like Xtampza ER (oxycodone) have had low adrenal hormone levels. This can be more likely to happen after taking opioids for longer than 1 month. Tell your HCP if you have symptoms of low adrenal hormone levels, such as tiredness, dizziness, weakness, not feeling hungry, nausea, and vomiting. If your adrenal hormone levels are too low, you might need to stop Xtampza ER (oxycodone) and get treated with corticosteroids.
Seizures
Risk factors: History of seizure conditions
If you've had a seizure in the past, Xtampza ER (oxycodone) can raise the risk of having seizures more often. Opioids can also raise your risk of seizures in certain situations. Get medical help immediately if you have a seizure while you're taking Xtampza ER (oxycodone).
What are the side effects of Xtampza ER (oxycodone)?
Common Side Effects
- Nausea (17%)
- Headache (14%)
- Constipation (13%)
- Sleepiness (9%)
- Itching (7%)
- Vomiting (6%)
- Dizziness (6%)
Other Side Effects
- Blurry vision
- Stomach pain
- Low appetite
- Rash
Serious Side Effects
- Dangerously slow breathing: trouble breathing; bluish-colored lips, fingers, or toes
- Accidentally taking too much (overdose): not responding to sound or touch, slowed breathing, slow heartbeat, extreme sleepiness, cold or clammy skin
- Opioid withdrawal: anxiety, suicidal thoughts, restlessness, irritability, runny nose, yawning, sweating, chills, wide pupils
- Serious allergic reaction: itchy, red rash (hives); shortness of breath; chest tightness; swelling of lips, tongue, throat, face, or eyes
Source: DailyMed
More on Xtampza ER (oxycodone) side effects
The following side effects have also been reported
Side effects that you should report to your care team as soon as possible:
- Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
- CNS depression—slow or shallow breathing, shortness of breath, feeling faint, dizziness, confusion, difficulty staying awake
- Low adrenal gland function—nausea, vomiting, loss of appetite, unusual weakness or fatigue, dizziness
- Low blood pressure—dizziness, feeling faint or lightheaded, blurry vision
Side effects that usually do not require medical attention (report to your care team if they continue or are bothersome):
- Constipation
- Dizziness
- Drowsiness
- Dry mouth
- Headache
- Nausea
- Vomiting
Pros and cons of Xtampza ER (oxycodone)
Pros
Might help with long-term pain that's not completely relieved with non-opioid pain relievers
Continues to relieve pain for up to 12 hours after a dose
Can open the capsules and sprinkle contents onto soft food or into an empty cup for people who can't swallow capsules whole
Cons
Taken every 12 hours
Not meant to be used to treat sudden pain because it takes 1 hour to start working
Must slowly lower the dose to stop the medication after long-term use to avoid withdrawal symptoms
Pharmacist tips for Xtampza ER (oxycodone)
Take Xtampza ER (oxycodone) with food, about the same amount each time so that the medication levels in your body stay consistent. Taking Xtampza ER (oxycodone) on an empty stomach causes your body to absorb less medication, which might make it work less well to relieve your pain.
You can open the Xtampza ER capsule if you're having trouble swallowing them whole. Sprinkle all the contents over one tablespoon of soft food (e.g., applesauce, yogurt, ice cream) or into an empty cup. Then, swallow all the capsule contents right away. Rinse your mouth with water to make sure you've taken your full dose. Flush the empty capsule down the toilet to throw it away.
Take Xtampza ER (oxycodone) exactly as your prescriber instructed you to. Don't change your dose or stop taking the medication without talking to your prescriber first. They might need to slowly lower your dose before you can stop taking it completely. This lowers your risk of having uncomfortable withdrawal symptoms like sweating, chills, irritability, anxiety, and trouble sleeping.
Xtampza ER (oxycodone) can make you sleepy and affect your ability to think, react, and focus. Don't drive or do anything that you need to focus for until you know how this medication affects you.
Don't drink alcohol while you're taking Xtampza ER (oxycodone). Mixing them together can make you very sleepy or dizzy.
Constipation is a common side effect of Xtampza ER (oxycodone). Some lifestyle changes, like staying hydrated throughout the day and getting more fiber into your diet, might help with this side effect. But speak to your care team if you're still getting constipated. They can suggest medications or a change in your pain treatment to help.
Make sure to tell your care team about all the medications you're taking with Xtampza ER (oxycodone). They'll also review your medication list to make sure your medications are safe to take together. Xtampza ER (oxycodone) can interact with other medications, like certain antidepressants, benzodiazepines, and sleep medications, among others.
Always carry naloxone (Narcan) with you at all times. Naloxone is a medication that reverses the effects of Xtampza ER (oxycodone) in situations like an accidental overdose. Teach your loved ones about how to give naloxone to you if you can't do it yourself. Be sure to call for emergency help if you need to use naloxone because its effects are temporary.
Keep Xtampza ER (oxycodone) out of reach from children, pets, and visitors. There are a few drug take-back options to safely get rid of the medication if you don't need to take it anymore. This lessens the risk for accidental overdose and medication misuse.
More on Xtampza ER (oxycodone) tips
Frequently asked questions about Xtampza ER (oxycodone)
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Xtampza ER (oxycodone) dosage forms
Typical dosing for Xtampza ER (oxycodone)
Your prescriber will work with you to find the right dose for your individual needs. It's recommended to take the lowest dose possible for the shortest duration of time to manage your pain.
The typical starting dose is 9 mg by mouth every 12 hours with food.
Your dose might differ if you have liver problems.
How much does Xtampza ER (oxycodone) cost?
Xtampza ER (oxycodone) contraindications
Severely slowed breathing (respiratory depression)
Severe asthma
Conditions that cause blockage of the stomach passageway
Allergy to oxycodone
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References
Best studies we foundAmerican College of Obstetricians and Gynecologists. (2017). Opioid use and opioid use disorder in pregnancy.
American College of Obstetricians and Gynecologists. (2021). Breastfeeding challenges: ACOG committee opinion, number 820. Obstetrics & Gynecology.
Anesthesia Patient Safety Foundation. (n.d.). Respiratory depression and opioids.
Center for Disease Control and Prevention. (2024). About opioid use during pregnancy.
Collegium Pharmaceutical, Inc. (2023). Xtampza ER- oxycodone capsule, extended release [package insert]. DailyMed.
Dowell, D., et al. (2022). CDC clinical practice guideline for prescribing opioids for pain — United States, 2022. Morbidity and Mortality Weekly Report.
Drugs and Lactation Database (LactMed®). (2024). Oxycodone. National Institute of Child Health and Human Development.
Jansson, L. M., et al. (2019). Neonatal abstinence syndrome. Pediatric Clinics of North America.
McNicol, E., et al. (2003). Management of opioid side effects in cancer-related and chronic noncancer pain: A systematic review. The Journal of Pain.
National Institute of Diabetes and Digestive and Kidney Diseases. (2018). Adrenal insufficiency & Addison’s disease.
National Institute of Diabetes and Digestive and Kidney Diseases. (2018). Symptoms & causes of adrenal insufficiency & Addison's disease.
Sadiq, N. M., et al. (2024). Oxycodone. StatPearls.
U.S. Food and Drug Administration. (2022). Drug disposal: Drug take back locations.
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