Oxycodone (ox-i-KOE-done)

Treats moderate to severe pain. This medicine is an opioid pain reliever.

Brand Name(s):

OxyCONTIN, Xtampza ER

When This Medicine Should Not Be Used:

How to Use This Medicine:

Long Acting Capsule, Long Acting Tablet

• Take your medicine as directed. Your dose may need to be changed several times to find what works best for you. An overdose can be dangerous. Follow directions carefully so you do not get too much medicine at one time. Your doctor may also give naloxone to treat an overdose. Naloxone is a medicine that temporarily reverses the effects of an overdose. If you have been prescribed naloxone, make sure household members know how to use this on you in the event of an overdose or suspected overdose. Emergency medical attention is still needed after naloxone is used because the reversal effects are only temporary.
• Extended-release capsule:
  • It is best to take this medicine with food or milk.
  • Swallow the extended-release capsule whole. Do not crush, break, or chew it.
  • If you have trouble swallowing the capsule, you may open it and sprinkle the contents on soft foods (including applesauce, pudding, ice cream, or jam) or into a cup. Eat the mixture or swallow the contents immediately. Drink a glass of water after you take the medicine to make sure you get a full dose.
• Extended-release tablet:
  • Swallow the extended-release tablet whole. Do not crush, break, or chew it. Do not take a tablet that is chipped or broken.
  • Do not soak, lick, or wet the tablet before you place it in your mouth. Take 1 tablet at a time with enough water to swallow it completely.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
• Missed dose: If you miss a dose, skip the missed dose and take your next dose at the regular time.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Store the medicine in a safe and secure place. Drop off any unused opioid medicine at a drug take-back location right away. If you do not have a drug take-back location near you, flush any unused opioid medicine down the toilet. Check your local drug store and clinics for take-back locations. You can also check the DEA web site for locations. Here is the link to the FDA safe disposal of medicines website: www.fda.gov/drugs/resourcesforyou/consumers/buyingusingmedicinesafely/ensuringsafeuseofmedicine/safedisposalofmedicines/ucm186187.htm

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Do not use this medicine if you are using or have used an MAO inhibitor within the past 14 days.
• Some medicines can affect how oxycodone works. Tell your doctor if you are using any of the following:
  • Carbamazepine, cyclobenzaprine, erythromycin, ketoconazole, metaxalone, mirtazapine, phenytoin, rifampin, ritonavir, tramadol, or trazodone
  • Benzodiazepine medicine
  • Diuretic (water pill)
  • Medicine to treat depression or mental health problems (including SNRIs, SSRIs, TCAs)
  • Medicine to treat migraine headaches
  • Phenothiazine medicine
• Tell your doctor if you use anything else that makes you sleepy. Some examples are allergy medicine, narcotic pain medicine, and alcohol. Tell your doctor if you are also using buprenorphine, butorphanol, nalbuphine, pentazocine, or a muscle relaxer.
• Do not drink alcohol while you are using this medicine.

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding, or if you have kidney disease, liver disease, breathing problems or lung disease (including asthma, COPD, sleep apnea), low blood pressure, stomach problems, an enlarged prostate, gallbladder disease, pancreas disease, or trouble swallowing or urinating. Tell your doctor if you have a history of head injury, brain tumor, depression, seizures, or alcohol or drug use disorder.
• This medicine may cause the following problems:
  • High risk of overdose, which can lead to death
  • Respiratory depression (serious breathing problem that can be life-threatening)
  • Sleep-related breathing problems (including sleep apnea, sleep-related hypoxemia)
  • Worsening of pain
  • Adrenal gland problems
  • Low blood pressure
  • Serotonin syndrome, when used with certain medicines
  • Seizures
• This medicine may make you dizzy, drowsy, or faint. Do not drive or do anything else that could be dangerous until you know how this medicine affects you. Sit or lie down if you feel dizzy. Stand up carefully.
• This medicine can be habit-forming. Do not use more than your prescribed dose. Call your doctor if you think your medicine is not working.
• Do not stop using this medicine suddenly. Your doctor will need to slowly decrease your dose before you stop it completely.
• This medicine may cause constipation, especially with long-term use. Ask your doctor if you should use a laxative to prevent and treat constipation.
• Tell any doctor or dentist who treats you that you are using this medicine. This medicine may affect certain medical test results.
• This medicine could cause infertility. Talk with your doctor before using this medicine if you plan to have children.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Anxiety, restlessness, fast heartbeat, fever, sweating, muscle spasms, twitching, nausea, vomiting, diarrhea, seeing or hearing things that are not there
• Blue lips, fingernails, or skin, trouble breathing
• Changes in skin color, dark freckles, cold feeling, tiredness, weight loss
• Extreme dizziness or weakness, shallow breathing, slow or uneven heartbeat, sweating, cold or clammy skin, seizures
• Lightheadedness, dizziness, fainting
• Worsening of pain, increased sensitivity to pain

If you notice these less serious side effects, talk with your doctor:

• Constipation, stomach pain
• Sleepiness

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088