Oxycodone-Acetaminophen Risks, Warnings, and Complications

MISUSE, ABUSE, AND ADDICTION: Oxycodone is habit-forming, and taking this opioid medication can lead to misuse, abuse, and addiction (psychological and physical dependence) even when you use it at the recommended doses. Taking oxycodone without a doctor’s prescription or at higher doses than prescribed increases the risk of prescription drug abuse. People who have a history of substance abuse, i.e., abusing street or prescription drugs, are at a greater risk of developing an opioid addiction. Your doctor will prescribe the lowest effective dose of oxycodone and acetaminophen for the shortest time to control your severe pain.

 Before starting oxycodone and acetaminophen, tell your doctor if you have a personal or family history of mental illness or substance abuse. Do not take a higher dose of this medicine or take it more frequently or for a longer duration than prescribed.

 The FDA mandates a Risk Evaluation and Mitigation Strategy (REMS) program for people receiving opioid medications because of their potential for misuse, abuse, and dependence. Licensed healthcare practitioners who prescribe medications from this class of drugs are required to explain to patients how to use these medicines properly, the risks associated with their use, and the proper storage and disposal of opioid medications.

LIFE-THREATENING RESPIRATORY DEPRESSION: Oxycodone can cause dangerously slow breathing or stopped breathing, which can be fatal. The risk of fatal respiratory depression is greatest in the first few days after starting the medication and after a dosage adjustment. People with chronic lung disorders like asthma, chronic obstructive pulmonary disease, chronic bronchitis, and obstructive sleep apnea, older adults, and children under 12 years of age are at a higher risk of this serious complication. Drinking alcohol and taking certain other CNS depressant drugs (for example, benzodiazepines, anti-anxiety medications, sedatives, and certain skeletal muscle relaxants) can raise the risk of serious breathing problems. 

 Give your provider a full list of all your medications to prevent potentially dangerous drug interactions. Talk to your doctor about having naloxone (Narcan) available in case of an accidental overdose of opioid analgesics. Seek emergency medical attention if you or a loved one develops difficulty breathing, slowed breathing, or a bluish discoloration of the lips, fingers, or toes.

NEONATAL OPIOID WITHDRAWAL SYNDROME: If you take oxycodone or other opioids during pregnancy, the medicine can be passed on to your unborn baby, causing the baby to develop a dependence on opioid drugs. After birth, your baby may experience life-threatening withdrawal symptoms. This condition is called neonatal opioid withdrawal syndrome. Seek immediate medical attention if you took oxycodone during pregnancy and your baby exhibits signs and symptoms such as poor feeding, high-pitched crying, poor sleep, irritability, or seizures after birth.

CNS DEPRESSION DUE TO DRUG INTERACTIONS: Taking oxycodone and acetaminophen with other CNS depressants such as sedatives, hypnotics, tranquilizers, anti-anxiety drugs, skeletal muscle relaxants, other opioid drugs, antipsychotics, and alcohol can lead to life-threatening breathing problems. The risk of serious breathing problems is higher in people with chronic lung conditions and in elderly and debilitated individuals.

Doctors reserve concomitant prescribing of these medications for patients only when necessary. Your provider may recommend taking a lower dose if you are on any other CNS depressant drugs. Give your doctor and pharmacist a complete list of your medications. Seek emergency medical care if you develop respiratory distress or slowed breathing while on oxycodone and acetaminophen. 

ADRENAL INSUFFICIENCY: Use of oxycodone and other opioid analgesics for more than one month can lead to a drop in adrenal hormone levels with symptoms such as nausea, vomiting, loss of appetite, dizziness, weakness, tiredness, and low blood pressure. Tell your doctor without delay if you experience these symptoms. You may need to stop taking oxycodone and be treated with corticosteroids.

SEVERE HYPOTENSION: Percocet (oxycodone and acetaminophen) can cause your blood pressure to drop to dangerously low levels. Symptoms of hypotension (low blood pressure) can include dizziness and fainting, especially when going from a sitting or lying position to standing. To reduce your risk of falls, get up slowly out of bed. Tell your doctor if you take a blood pressure medication or experience dizziness or lightheadedness.

HEPATOTOXICITY: High doses of acetaminophen can cause permanent and serious liver damage, which may be life-threatening. Do not exceed the maximum recommended dose of acetaminophen for adults (4,000 mg) in 24 hours. Before taking acetaminophen, tell your doctor if you have a history of liver problems. Avoid drinking alcohol while on this medicine because alcohol can increase your risk of liver injury. Call your doctor immediately if you develop signs of liver damage, such as upper stomach pain, yellowing of the skin or eyes, dark urine, pale stools, nausea, and tiredness.

SEVERE ADVERSE REACTIONS: Rarely can there be a severe allergic reaction to oxycodone and acetaminophen with swelling of the face, anaphylaxis (throat closing), and difficulty breathing. Seek emergency medical help if you develop these signs and symptoms. Serious adverse reactions can also include skin reactions with a rash, hives, itching, blistering, and peeling of the skin. Stop taking oxycodone and acetaminophen, and call your provider right away if you notice any skin changes. 

RISK IN PEOPLE WITH CERTAIN MEDICAL CONDITIONS: People with certain health conditions, such as increased intracranial pressure (pressure inside the head) due to brain tumors or head injuries, gastrointestinal conditions such as paralytic ileus, and seizure disorders are at increased risk of complications from oxycodone and acetaminophen use. Give your healthcare professional a complete medical history before starting this medication.

WITHDRAWAL SYMPTOMS: Stopping oxycodone and acetaminophen suddenly after taking it for a period of time can lead to life-threatening withdrawal symptoms. Do not suddenly stop this medicine without talking to your doctor. Call your doctor right away if you develop restlessness, anxiety, irritability, changes in pupil size, runny nose, sleep problems, excessive sweating, chills, fast breathing, fast heartbeat, stomach cramps, nausea, vomiting, diarrhea, loss of appetite, or muscle aches.

OVERDOSE: Taking higher doses or more frequent doses of oxycodone and acetaminophen can lead to an overdose, which can be fatal. Keep this medication safely out of reach of children to prevent accidental ingestion. Make sure you and other people in your household know how to recognize the signs of an opioid overdose, such as extreme drowsiness, unresponsiveness, slowed breathing, slow heartbeat, and cold or clammy skin. Talk to your provider about having the rescue medicine naloxone (Narcan) available in case of an accidental opioid overdose. Call 911 or emergency medical services in case of a known or suspected overdose.

EXTREME SLEEPINESS AND DIFFICULTY CONCENTRATING: Taking opioid medicines such as oxycodone can make you sleepy and affect your ability to focus, concentrate, and react. The risk is higher if you're taking other medications that also cause drowsiness, such as sedatives, benzodiazepines, skeletal muscle relaxants, and sleep aids. Older adults (age 65 years and above) are at a higher risk of these side effects. Alcohol can make these symptoms worse. Tell your doctor if the acetaminophen oxycodone combination makes you very sleepy.