Oxycodone and acetaminophen is a combination medication for moderate to severe pain. Oxycodone is an opioid pain reliever that belongs to the group of medicines called narcotic analgesics. Acetaminophen  is used for pain relief and to reduce fever.  Oxycodone and acetaminophen were originally marketed under the brand name Percocet. Other brands have also been available Nalocet, Primlev, Endocet (discontinued), Roxicet (discontinued), Xartemis XR (discontinued), and generic oxycodone and acetaminophen products are available.

Due to the risks of addiction, abuse, and misuse, even at recommended doses, oxycodone and acetaminophen is only prescribed when treatment with non-opioid pain-relieving medication has not been tolerated or has not provided adequate pain relief.

Is oxycodone with acetaminophen a controlled substance?

Yes, oxycodone with acetaminophen is a controlled substance. Under the Controlled Substances Act (CSA) oxycodone (which includes oxycodone with acetaminophen) is a schedule 2 controlled substance.  This means oxycodone has a high potential for abuse, it currently has an accepted medical use which may include severe restrictions. Abuse may lead to severe psychological or physical dependence.

What strengths are available for oxycodone and acetaminophen tablets and solution?

Oxycodone and acetaminophen tablets:

• Oxycodone and acetaminophen 2.5mg/325mg tablets
• Oxycodone and acetaminophen 5mg/325mg tablets
• Oxycodone and acetaminophen 7.5mg/325mg tablets
• Oxycodone and acetaminophen 10mg/325mg tablets

Oxycodone and acetaminophen solution:

• Oxycodone and acetaminophen 5mg/325mg in 5ml
• Oxycodone and acetaminophen 10mg/300mg in 5 ml 

Sometimes oxycodone with acetaminophen strengths get abbreviated to oxycodone acetaminophen 5-325 or oxycodone acetaminophen 5 325, but is important to use the correct names and strengths (oxycodone and acetaminophen 5mg/325mg tablets) to avoid confusion and dosing errors.

MISUSE OF OPIOID MEDICINE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH. Keep the medication in a place where others cannot get to it.

An overdose of acetaminophen can damage your liver or cause death. Call your doctor at once if you have pain in your upper stomach, loss of appetite, dark urine, or jaundice (yellowing of your skin or eyes).

Stop taking oxycodone with acetaminophen and call your doctor right away if you have skin redness or a rash that spreads and causes blistering and peeling.

Taking opioid medicine during pregnancy may cause life-threatening withdrawal symptoms in the newborn.

Oxycodone may be habit-forming and should be used only by the person it was prescribed for. Keep the medication in a secure place where others cannot get to it. Oxycodone with acetaminophen can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.

Fatal side effects can occur if you use opioid medicine with alcohol, or with other drugs that cause drowsiness or slow your breathing.

Take oxycodone with acetaminophen exactly as it was prescribed for you. Follow all directions on your prescription label. Never take oxycodone with acetaminophen in larger amounts, or for longer than prescribed. An overdose can damage your liver or cause death. Tell your doctor if the medicine seems to stop working as well in relieving your pain.

Never share oxycodone with acetaminophen with another person, especially someone with a history of drug abuse or addiction. MISUSE CAN CAUSE ADDICTION, OVERDOSE, OR DEATH. Keep the medicine in a place where others cannot get to it. Selling or giving away oxycodone with acetaminophen is against the law.

Measure liquid medicine carefully. Use the dosing syringe provided, or use a medicine dose-measuring device (not a kitchen spoon).

If you need surgery or medical tests, tell the doctor ahead of time that you are using this medicine.

You should not stop using oxycodone with acetaminophen suddenly. Follow your doctor's instructions about tapering your dose.

Store at room temperature away from moisture and heat. Keep track of your medicine. You should be aware if anyone is using it improperly or without a prescription.

Do not keep leftover opioid medication. Just one dose can cause death in someone using this medicine accidentally or improperly. Ask your pharmacist where to locate a drug take-back disposal program. If there is no take-back program, flush the unused medicine down the toilet.

Use: For the management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.

Usual Adult Dose for Pain:

Oxycodone 2.5 mg/acetaminophen 300 or 325 mg tablets:

• 1 to 2 tablets every 6 hours
• Maximum dose: 12 tablets in 24 hours

Oxycodone 5 mg/acetaminophen 300 or 325 mg: 

• 1 tablet orally every 6 hours as needed for pain
• Maximum dose: 12 tablets in 24 hours

Oxycodone 7.5 mg/acetaminophen 300 or 325 mg tablets: 

• 1 tablet orally every 6 hours as needed for pain
• Maximum dose: 8 tablets in 24 hours

Oxycodone 10 mg/acetaminophen 300 or 325 mg:

•  1 tablet orally every 6 hours as needed for pain
• Maximum dose: 6 tablets in 24 hours

Oxycodone 5 mg/acetaminophen 325 mg per 5 mL Oral Solution:

• Oxycodone 5 mg/acetaminophen 325 mg (5 mL) orally every 6 hours as needed for pain
• Maximum dose: Oxycodone 60 mg/acetaminophen 3900 mg (60 mL) in 24 hours
• Always verify dose in mg and mL prior to administration

Comments:

• Doses should be individually titrated to provide adequate analgesia while minimizing adverse reactions.
• Because of the risks of addiction, abuse and misuse, the lowest effective dose for the shortest duration consistent with individual patient treatment goals should be used.
• Monitor patients closely for respiratory depression within the first 24 to 72 hours of initiating therapy and following any increase in dose.

You should not use this medicine if you are allergic to acetaminophen, or oxycodone or any inactive ingredients, or if you have:

• severe asthma or breathing problems; or
• a blockage in your stomach or intestines.

To make sure oxycodone with acetaminophenis safe for you, tell your doctor if you have ever had:

• liver disease;
• a drug or alcohol addiction;
• kidney disease;
• a head injury or seizures;
• urination problems; or
• problems with your thyroid, pancreas, or gallbladder.

Pregnancy 

If you use opioid medicine while you are pregnant, your baby could become dependent on the drug. This can cause life-threatening withdrawal symptoms in the baby after it is born. Babies that are born dependent on opioids may need medical treatment for several weeks.

Breastfeeding

Do not breastfeed. Oxycodone with acetaminophen can pass into breast milk and cause drowsiness, breathing problems, or death in a nursing baby.

Since this medicine is used for pain, you are not likely to miss a dose. Skip any missed dose if it is almost time for your next dose. Do not use two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of this medicine can be fatal, especially in a child or other person using the medicine without a prescription. Overdose symptoms may include nausea, vomiting, sweating, severe drowsiness, pinpoint pupils, slow breathing, or no breathing.

Your doctor may recommend you get naloxone (a medicine to reverse an opioid overdose) and keep it with you at all times. A person caring for you can give the naloxone if you stop breathing or don't wake up. Your caregiver must still get emergency medical help and may need to perform CPR (cardiopulmonary resuscitation) on you while waiting for help to arrive.

Anyone can buy naloxone from a pharmacy or local health department. Make sure any person caring for you knows where you keep naloxone and how to use it.

Avoid driving or operating machinery until you know how oxycodone with acetaminophen will affect you. Dizziness or drowsiness can cause falls, accidents, or severe injuries.

Do not drink alcohol. Dangerous side effects or death could occur.

Ask a doctor or pharmacist before using any other medicine that may contain acetaminophen which sometimes abbreviated as APAP and also known as paracetamol. Taking certain medications together can lead to a fatal overdose.

Serious side effects of oxycodone with acetaminophen may include:

Get emergency medical help if you have signs of an allergic reaction to acetaminophen and oxycodone: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Opioid medicine can slow or stop your breathing, and death may occur. A person caring for you should seek emergency medical attention if you have slow breathing with long pauses, blue-colored lips, or if you are hard to wake up.

In rare cases, acetaminophen may cause a severe skin reaction that can be fatal. This could occur even if you have taken acetaminophen in the past and had no reaction. Stop taking this medicine and call your doctor right away if you have skin redness or a rash that spreads and causes blistering and peeling.

Call your doctor at once if you have:

• noisy breathing, sighing, shallow breathing;
• a light-headed feeling, like you might pass out;
• weakness, tiredness, fever, unusual bruising or bleeding;
• confusion, unusual thoughts or behavior;
• problems with urination;
• liver problems - nausea, upper stomach pain, tiredness, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or
• low cortisol levels - nausea, vomiting, loss of appetite, dizziness, worsening tiredness or weakness.

Seek medical attention right away if you have symptoms of serotonin syndrome, such as: agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, vomiting, or diarrhea.

Serious breathing may be more likely in older adults and those who are overweight, malnourished, or debilitated.

Long-term use of opioid medication may affect fertility (ability to have children) in men or women. It is not known whether opioid effects on fertility are permanent.

Common oxycodone with acetaminophen side effects include:

• dizziness, drowsiness, feeling tired;
• headache;
• constipation, nausea, vomiting, stomach pain;
• blurred vision;
• itching, red eyes, or flushing;
• feelings of extreme happiness or sadness; or
• dry mouth.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

You may have breathing problems or withdrawal symptoms if you start or stop taking certain other medicines. Tell your doctor if you also use an antibiotic, antifungal medication, heart or blood pressure medication, seizure medication, or medicine to treat HIV or hepatitis C.

Opioid medication can interact with many other drugs and cause dangerous side effects or death. Be sure your doctor knows if you also use:

• cold or allergy medicines, bronchodilator asthma/COPD medication, or a diuretic ("water pill");
• medicines for motion sickness, irritable bowel syndrome, or overactive bladder;
• other narcotic medications - opioid pain medicine or prescription cough medicine;
• a sedative like Valium - diazepam, alprazolam, lorazepam, Xanax, Klonopin, Versed, and others;
• drugs that make you sleepy or slow your breathing - a sleeping pill, muscle relaxer, medicine to treat mood disorders or mental illness;
• drugs that affect serotonin levels in your body - a stimulant, or medicine for depression, Parkinson's disease, migraine headaches, serious infections, or nausea and vomiting.

This list is not complete. Other drugs may interact with acetaminophen and oxycodone, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here.  To check for interactions with oxycodone with acetaminophen click the link below.