Oxycodon Accord

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Oxycodon Accord

Method of action: Analgesic

Treatment option: Pain, Cancer

Medically reviewed

Marina Burgos

Last updated on 10/01/2026

This page provides general, reference-level information compiled from official medical sources. It is not a substitute for professional medical advice, diagnosis, or treatment. For decisions about your health, please consult a qualified healthcare professional.

Overview of Oxycodon Accord

Here is a quick overview of the key properties of this medicine.

Property Description
Active ingredient Oxycodone Hydrochloride (Oxycodone)
Form Prolonged-release tablet
Pharmacological class Strong opioid analgesic
General purpose Management of severe pain
Origin Semi-synthetic (derived from thebaine)

What Type of Medicine is Oxycodon Accord?

Oxycodon Accord is a potent, prescription-only medicine containing the active substance Oxycodone Hydrochloride, which classifies it as a strong opioid analgesic. This medication is specifically intended for the pain management of individuals experiencing severe pain that is not adequately controlled by less potent pain relievers. The clinical recognition of its efficacy is supported by pharmacological studies, which confirm its ability to powerfully modulate pain signaling. The classification as a strong opioid places it within the highest tier of medications used to address pain, due to its powerful effects on the central nervous system. Its general therapeutic purpose is to mitigate intense physical suffering, often used in scenarios where continuous, round-the-clock pain relief is required for a prolonged illness.


Composition, Origin, and Dosage Form

The core active ingredient, Oxycodone, is a semi-synthetic chemical compound, meaning it is derived from thebaine, a natural alkaloid found in the opium poppy. Oxycodone is classified as a Schedule II controlled substance in the United States. Oxycodon Accord is typically presented as prolonged-release tablets, a specialized oral dosage form designed for controlled administration. This specific formulation is a distinguishing feature from immediate-release oxycodone products. The extended-release formulation provides around-the-clock pain relief. This confirms that the prolonged-release format is engineered for sustained and steady pain relief throughout the day, ensuring continuous pain management compared to immediate-release formulations of the substance.

Regulatory References

  1. Opioids | National Institute on Drug Abuse (NIDA)
  2. Controlled Substance Schedules - DEA
  3. Oxycodone: MedlinePlus Drug Information

What side effects are possible with Oxycodon Accord?

Possible Side Effects and Safety Information

The medicine's safety profile, as documented in official regulatory sources, involves specific adverse reactions classified by frequency and impact on organ systems. The most common documented adverse reactions, classified as Very Common (ge 1/10), include constipation, nausea, vomiting, somnolence (drowsiness), dizziness, headache, and pruritus (itching). Other frequently documented effects (Common, ge 1/100 to < 1/10) affect the gastrointestinal tract (e.g., dry mouth, abdominal pain) and the nervous system (e.g., anxiety, insomnia, nervousness).


Serious Adverse Reactions and Key Safety Constraints

Regulatory information highlights several serious and potentially life-threatening risks. The most critical documented risk is respiratory depression, which can be fatal and is highest when starting treatment or increasing the dosage. The medicine is associated with the serious risks of addiction, abuse, and misuse (Opioid Use Disorder). Prolonged use during pregnancy carries the risk of Neonatal Opioid Withdrawal Syndrome (NOWS). Documented, less frequent serious reactions include adrenal insufficiency and severe hypotension.


Population-Specific and Duration-Related Safety Notes

The safety label includes specific considerations for certain patient groups. Older adults and individuals with impaired renal or hepatic function have an increased risk of adverse effects, including respiratory depression, due to slower clearance. Use is generally contraindicated in conditions such as significant respiratory depression, acute bronchial asthma, or known or suspected paralytic ileus (gastrointestinal obstruction). The label also notes that chronic use is associated with the development of opioid tolerance and physical dependence, and abrupt cessation can lead to a withdrawal syndrome.

Overdose and Emergency Response

Overdose and when to seek help

Official regulatory sources specify that an overdose of oxycodone, the active substance in Oxycodon Accord, primarily presents as life-threatening respiratory depression and profound Central Nervous System (CNS) depression. This can be characterized by slowed, shallow, or stopped breathing, extreme sleepiness progressing to unresponsiveness, and pinpoint pupils (miosis).

Circulatory disturbances such as severe hypotension and slowed heartbeat are also documented clinical signs. The most severe outcomes include coma and death.

Immediate emergency action is mandated for any suspected overdose. Regulator-mandated instructions are to seek immediate medical attention and call emergency services immediately upon the recognition of these symptoms. If available, an opioid antagonist (such as Naloxone) should be administered as an emergency measure.

Due to the prolonged-release nature of the tablet, prolonged monitoring in a hospital setting is necessary, as the effects of the overdose may recur after initial reversal. Accidental ingestion of even one dose is explicitly stated to result in a fatal overdose, particularly in children. Management involves symptomatic and supportive treatment.

Therapeutic Uses of Oxycodon Accord

What Oxycodon Accord Treats: Main Uses and Benefits

The medication is commonly used to help with the management of severe pain in situations requiring continuous, supportive symptom management. This treatment is generally applied when symptoms are not adequately controlled by less potent pain relievers.

Oxycodon Accord is relevant for easing symptom clusters that become intense or disruptive, often associated with conditions characterized by periods of heightened, persistent symptoms, such as certain types of cancer pain or severe chronic non-malignant pain, including persistent low back pain and severe osteoarthritis pain. The treatment is applied in addressing symptoms related to heightened physiological activity that interfere with daily functioning.

The medication's role is to provide supportive, sustained analgesia. It contributes to improved comfort during periods of heightened symptoms, helping to maintain a sense of stability when symptoms are more noticeable. It is also considered relevant in clinical settings that involve acute or disruptive symptom patterns, such as the management of severe acute pain following major surgery or trauma.


Quick Fact: Use is relevant for symptoms of Severe, Resistant Pain

Regulatory References

  1. NIH MedlinePlus overview

Eligibility and Restrictions for Use

Who can and cannot use Oxycodon Accord?

The population eligibility for Oxycodone prolonged-release tablets is strictly defined by regulatory authorities based on patient age, concurrent health status, and physiological function.

Eligibility Statuses

Status Population/Condition
Contraindicated Patients with significant respiratory depression, acute severe bronchial asthma, paralytic ileus, or known hypersensitivity to oxycodone.
Not Recommended Children under 11 years of age; high-strength tablets for opioid non-tolerant patients; women who are pregnant or breastfeeding.
Conditional Use Older adults; patients with hepatic or renal impairment; patients with hypothyroidism or adrenal insufficiency.

Key Restrictions

Use is prohibited for patients receiving Monoamine Oxidase Inhibitors (MAOIs) or within 14 days of stopping MAOI treatment. Use requires caution and a potential initial dose reduction in patients with impaired liver or kidney function. The safety and effectiveness of the medicine are not established for use in children under 11 years old. Prolonged use during pregnancy is not recommended due to the risk of Neonatal Opioid Withdrawal Syndrome.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Official regulatory documents detail specific drug interactions based on pharmacokinetic (metabolism) and pharmacodynamic (additive effects) mechanisms.

Interacting Product Category Regulatory Constraint or Risk
Central Nervous System (CNS) Depressants (e.g., alcohol, benzodiazepines, other opioids, sedatives) Concomitant use may result in profound sedation, respiratory depression, coma, and death. Prescribing together is reserved for patients when alternatives are inadequate.
CYP3A4 Inhibitors (e.g., macrolide antibiotics, azole-antifungals) Inhibition of the CYP3A4 enzyme increases oxycodone plasma concentration, which can lead to a potentially fatal overdose. Patients must be monitored closely, especially upon initiation.
CYP3A4 Inducers (e.g., rifampin, carbamazepine, phenytoin) Discontinuation of these inducers can increase oxycodone plasma concentration, also raising the risk of fatal overdose. Patient monitoring is required.
Serotonergic Drugs (e.g., SSRIs, SNRIs) May result in Serotonin Syndrome, a potentially life-threatening condition. If suspected, the drug must be discontinued.
MAOIs (Monoamine Oxidase Inhibitors) Avoid concomitant use or use within 14 days of stopping MAOI treatment due to the risk of potentiating opioid effects.
Mixed Agonist/Antagonist Opioids (e.g., buprenorphine, pentazocine) Avoid use, as these agents may reduce the analgesic effect or precipitate withdrawal symptoms.

These interactions are formally classified to manage the risks of respiratory depression, Serotonin Syndrome, and fatal overdose, requiring specific management instructions, close patient monitoring, or avoidance of the combination.

Mechanism of Action

mu-Opioid Receptor Agonism

Oxycodone acts as an agonist of the mu-opioid receptor (MOR), a type of inhibitory G protein-coupled receptor distributed throughout the central nervous system (CNS) and peripheral nervous system (PNS). It also exhibits high affinity for kappa-opioid receptors (KOR).


Cellular and Ionic Cascade

The binding of Oxycodone to MOR initiates an intracellular signaling cascade. This agonism primarily causes hyperpolarization of the neuron membrane by activating potassium ( K^+) conductance and inhibiting voltage-dependent calcium ( Ca^2+) channels. This process is functionally linked to inhibiting the release of gamma-aminobutyric acid ( GABA) from inhibitory neurons.


Modulation of Nociceptive Pathways

These cellular changes collectively modulate the activity within the descending pain modulation pathway. The resulting reduction in neuronal excitability limits the release of neurotransmitters involved in signal transmission. This ultimately reduces the transmission of nociceptive signals and alters the neuronal perception of afferent signals at a system level.

Dosage and Administration Information

Oxycodon Accord is administered orally as a prolonged-release tablet, a dosage form explicitly designed for sustained, continuous symptom management. The medication is used on a fixed schedule for around-the-clock pain control and is not intended for intermittent or pro re nata (as-needed) use. The tablets must be swallowed whole and should never be chewed, crushed, cut, or dissolved, as altering the form permits the rapid release of the entire dose, thereby disrupting the controlled-release mechanism.

The standard administration schedule requires the medicine to be taken exactly every 12 hours, with the dose adjusted (titrated) as needed. For opioid-naïve adults, a starting dose is often 10 mg every 12 hours, though some regimens begin at 5 mg every 12 hours. Dosage adjustments proceed cautiously in increments typically ranging from 25% to 50% of the previous dose. This medication can be taken with or without food.

Specific adjustments to the dosing regimen are required for certain populations. For patients with established hepatic or renal impairment, and for frail, non-tolerant older adults, initial treatment typically begins at a reduced dose, often one-third to one-half the usual adult starting amount. If a scheduled dose is missed, the standard approach is to skip the missed dose and return to the regular schedule if the time for the next dose is near; double doses are prohibited.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Oxycodon Accord

Evidence for Use in Severe Cancer-Related Pain

The research for prolonged-release oxycodone was evaluated in settings of severe cancer-related pain, primarily utilizing Systematic Reviews and Randomized Controlled Trials (RCTs). These studies explored measured changes in symptom intensity in adult patients whose pain requires continuous treatment. Research describes patterns where the measured pain scores were studied for comparability against those measured for other strong opioid analgesics. This evidence is structurally considered to provide a High level of research insight when evaluating comparative measured outcomes against other studied strong opioids.

Evidence for Use in Severe Chronic Non-Cancer Pain

Research was studied for severe chronic non-cancer pain (CNCP), including conditions like severe osteoarthritis and chronic low back pain, using Meta-analyses of RCTs and long-term observational patient registry studies. Studies were conducted to examine outcomes related to physical discomfort and changes in daily functioning. In short-term controlled trials, data show patterns related to small but measurable changes in pain severity scores when studied against a placebo. The structural evidence for these short-term changes against placebo is generally described as Moderate.

Long-Term Evidence and Research Gaps

Long-term, uncontrolled patient registry studies have been conducted, with some follow-up durations running up to 3 years, documenting patterns related to dose stability and function. However, the majority of controlled trials had follow-up durations that were limited, restricting conclusions about sustained long-term results. Comparative evidence is lacking for certain chronic pain conditions against all available non-opioid alternatives, and subgroup findings are uncertain for patients with renal (kidney) impairment.

Evidence in Special Populations

Research in opioid-tolerant pediatric and adolescent patients (ages 6 to le 17 years) was primarily limited to pharmacokinetic (PK) studies, which monitored the drug’s processing in the body. The research base in this group remains a Low level of evidence; regulators have noted that the necessary evidence for use is not established in children younger than 11 years of age. The geriatric population (aged ge 70 years) was also observed in certain open-label studies focused on chronic pain.

Key Studies & References

  1. Efficacy and safety of combined prolonged-release oxycodone and naloxone in the management of moderate/severe chronic non-malignant pain: results of a prospectively designed pooled analysis of two randomised, double-blind clinical trials. BMC Clin Pharmacol. 2010.
  2. Oxycodone Pathway, Pharmacokinetics (Including metabolism and comparison to morphine). ClinPGx.
  3. Oxycodone - StatPearls (Including renal impairment and general PK/dosing considerations). NIH Bookshelf.
  4. Population Pharmacokinetics and Pharmacogenomics of Oral Oxycodone in Pediatric Surgical Patients (Focusing on PK studies in children). ClinicalTrials.gov NCT02044497.

Frequently Asked Questions (FAQ)

Common questions about Oxycodon Accord (FAQ)

Q: What is the best time of day to take Oxycodon Accord?

The medication is generally recommended to be taken at the same time each day to help maintain consistent blood levels. It is important to follow the specific instructions provided by a healthcare professional, as the required time of day may depend on the condition being treated. Some product information may suggest taking it with a meal.

Q: If I miss a dose of Oxycodon Accord, what should I do?

Official product labeling provides specific guidance on what to do if a dose is missed, which may vary depending on the length of time since the missed dose. Patients are typically advised not to double a dose, as this may increase the risk of side effects. If there are difficulties adhering to the dosing schedule, consulting a healthcare provider is the appropriate action to determine a suitable plan.

Q: Can I drink grapefruit juice while taking Oxycodon Accord?

Product information often indicates that grapefruit juice can interfere with the metabolism of Oxycodon Accord by inhibiting certain liver enzymes. This process could potentially lead to higher-than-expected levels of the drug in the bloodstream. Because of this potential interaction, patients are usually advised to limit or avoid consuming grapefruit and grapefruit juice. Consulting the prescribing information or a healthcare professional is recommended for specific dietary restrictions.

How should Oxycodon Accord be stored and disposed of?

How to Store and Dispose of Oxycodon Accord

Official regulatory documents define strict rules for the storage and disposal of Oxycodone Accord to maintain its efficacy and ensure safety.

Storage Requirements

Condition Requirement
Temperature Do not store above 25°C.
Protection Protect from light and moisture.
Packaging Store in the original container.
Child Safety Keep safely out of the sight and reach of children.

Disposal Instructions

Expired or unused Oxycodone Accord must be disposed of in accordance with local regulatory requirements. The medicine must not be discarded into household waste or wastewater, but should instead be taken to a pharmacy or an approved drug take-back location to prevent environmental contamination and misuse.

Attention! Always consult to a doctor or pharmacist before using pills or medicines.

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