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Oxycodone

Oxycodone is an opioid pain medicine used for pain severe enough to need an opioid, in immediate-release forms (tablets, capsules, oral solution) and in extended-release forms for around-the-clock, long-term pain.

Brand names OxaydoOxyContinXtampza ErDazidoxEndocodone +8 more
Drug class Opioid Agonist
Rx Schedule CII Forms 5
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 2026 Content updated Oct 2, 2026
🧬 Where this information comes from Click to expand

The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 100 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →

How we combine label and product data →
✓No current FDA shortage listed · checked Oct 4, 2026 🚨Recall on record · 2
Oxycodone at a glance The quick version — the full detail is in the Patient Information Guide below.
Dr. Brian Staiger, PharmD, BCPS
The Pharmacist’s Take By · Clinical pharmacist · Written

Oxycodone is a strong opioid, on the U.S. market since about 1950 and available generically, that acts on opioid receptors in the brain and spinal cord to dull pain and is reserved for pain severe enough to need an opioid when other treatments have not worked or cannot be used. Early nausea, sleepiness and dizziness often ease as the body adjusts, but constipation, which almost everyone gets, tends to stay. Its boxed warning includes addiction and misuse, life-threatening slowed breathing and fatal overdose, risks that rise sharply with alcohol, benzodiazepines or other sedating drugs, and one accidental dose can kill a child, so keep it locked away.

Clinical pearls

  • Never cut, crush, chew or dissolve OxyContin or other extended-release oxycodone, since that can release a potentially fatal dose at once.
  • Keep naloxone, an overdose reversal medicine, at home and teach family to use it and call 911 for slow breathing.
  • Tell every prescriber you take it, since erythromycin, ketoconazole, ritonavir, gabapentin and pregabalin can all make its breathing risks more dangerous.
  • With the oral solution, check the dose in mL and the strength every refill, since mg and mL mix-ups cause overdoses.
How we write & review this content — our editorial policy →
⚠️ FDA Boxed Warning — the FDA’s strongest safety alert ▾

Oxycodone can cause addiction, life-threatening slowed breathing, and fatal overdose, especially in children who take it by accident.

  • Addiction and misuse: These can lead to overdose and death. Your prescriber should assess your risk and check in with you regularly.
  • Slowed breathing: This is most likely when starting or raising the dose.
  • Accidental ingestion: Even one dose can be fatal for a child.
  • Pregnancy: Prolonged use can cause life-threatening withdrawal in a newborn.
  • Drug interactions: CYP3A4 inhibitors can raise oxycodone levels, and stopping a CYP3A4 inducer can also raise them, potentially causing fatal breathing problems.
  • Sedatives and alcohol: Benzodiazepines, other CNS depressants and alcohol can cause profound sleepiness, coma and death.
  • Oral solution: Mix-ups between mg and mL, or between solution strengths, can cause accidental overdose.
  • Opioids are covered by an FDA safety program (REMS), so you should get counseling and a Medication Guide each time.
Read the full warning on DailyMed →
How you get itPrescription only
Comes asTablet, Oral solution, Extended-release tablet +2
Earliest FDA record1950
Companies listing it with the FDA34
FDA label last updatedDec 30, 2025
FDA’s strongest warning (boxed)Yes, read the warning

Patient information guide — a plain-language walkthrough of Oxycodone, written from its FDA label.

What Oxycodone is used for

▾

Oxycodone is used for severe pain when other treatments are not enough.

  • Oxycodone tablets, capsules and oral solution: pain severe enough to need an opioid when alternatives are inadequate.
  • Oxycodone Hydrochloride Oral Solution 100 mg per 5 mL (20 mg/mL): pain in opioid-tolerant patients only.
  • OxyContin and oxycodone extended-release tablets: severe, persistent pain needing around-the-clock treatment, in adults and opioid-tolerant children 11 and older.
  • Xtampza ER: severe, persistent pain not controlled by other options, including immediate-release opioids.
  • Oxaydo: acute and chronic pain severe enough to need an opioid.
  • Extended-release products are not for as-needed use.

How Oxycodone works

▾

Oxycodone is a full opioid agonist. It mostly binds to mu opioid receptors in the brain and spinal cord, which changes how pain is perceived.

Its exact pain-relieving mechanism is not fully known. Pain relief has no ceiling effect, but doses are limited by side effects such as slowed breathing and drowsiness. The same receptor action can cause euphoria.

Oxycodone dosage

▾

Oxycodone is taken by mouth. Immediate-release forms are taken as prescribed, sometimes as needed every few hours. Extended-release forms work over about 12 hours and are taken on a regular schedule.

  • Use the lowest effective dose for the shortest time.
  • Do not cut, chew, crush or dissolve extended-release tablets.
  • With the oral solution, check mg versus mL and the strength.
  • Food does not significantly change absorption of oxycodone extended-release tablets.
  • Do not stop suddenly if you have been taking it regularly. Follow your prescriber and label.

Dosing details from the FDA-approved label

From the Oxycodone prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.

  • Use of Oxycodone Hydrochloride Tablets as the First Opioid Analgesic (initial dosage)
    • Initiate treatment in a dosing range of 5 to 15 mg every 4 to 6 hours as needed for pain, and at the lowest dose necessary to achieve adequate analgesia
    • Titrate the dose based upon the individual patient's response to their initial dose
  • Oxycodone Hydrochloride Oral Solution (initial dosage)
    • Initiate dosing with a range of 5 to 15 mg every 4 to 6 hours as needed for pain, and at the lowest dose necessary to achieve adequate analgesia
    • Titrate the dose based upon the individual patient's response to their initial dose
Read the label’s full dosing text

2 DOSAGE AND ADMINISTRATION Oxycodone Hydrochloride Oral Solution 100 mg per 5 mL (20 mg/mL) is for opioid-tolerant patients only ( 2.1 ) Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals. ( 2.1 ) Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals. ( 2.1 ) Individualize dosing based on the severity of pain, patient response, prior analgesic experience, and risk factor for addiction, abuse, and misuse. ( 2.1 ) Discuss availability of naloxone with the patient and caregiver and assess each patient’s need for access to naloxone, both when initiating and renewing treatment with Oxycodone Hydrochloride Oral Solution. Consider prescribing naloxone based on the patient’s risk factors for overdose ( 2.2 , 5.2 , 5.4 , 5.7 ). Initiate dosing with a range of 5 to 15 mg every 4 to 6 hours as needed for pain. ( 2.3 ) For control of chronic pain, administer Oxycodone Hydrochloride Oral Solution on a regularly scheduled basis, at the lowest dosage level to achieve adequate analgesia. ( 2.3 ) Individually titrate Oxycodone Hydrochloride Oral Solution to a dose that provides adequate analgesia and minimizes adverse reactions. ( 2.4 ) Do not abruptly discontinue Oxycodone Hydrochloride Oral Solution in a physically dependent patient because rapid discontinuation of opioid analgesics has resulted in serious withdrawal symptoms, uncontrolled pain, and suicide. ( 2.5 ) 2.1 Important Dosage and Administration Instructions Oxycodone Hydrochloride Oral Solution is available in two concentrations: 5 mg per 5 mL (1 mg/mL), and 100 mg per 5 mL (20 mg/mL). Oxycodone Hydrochloride Oral Solution 100 mg per 5 mL (20 mg/mL) is for use in opioid-tolerant patients only who have already been receiving opioid therapy. Use this strength only for patients who have already been titrated to a stable analgesic regimen using lower strengths of oxycodone hydrochloride and who can benefit from use of a smaller volume of oral solution. Patients considered to be opioid tolerant are those who are receiving, for one week or longer, at least 60 mg oral morphine per day, 25 mcg transdermal fentanyl per hour, 30 mg oral oxycodone per day, 8 mg oral hydromorphone per day, 25 mg oral oxymorphone per day, 60 mg oral hydrocodone per day, or an equianalgesic dose of another opioid.

Excerpted — the section continues on the label. Read the full Dosage and Administration section on DailyMed →

Oxycodone side effects

▾

Common side effects

  • Constipation
  • Nausea
  • Sleepiness (somnolence)
  • Dizziness
  • Vomiting
  • Itching
  • Headache
  • Dry mouth

When to get medical help

  • Call 911 right away for slow or shallow breathing, extreme sleepiness, or trouble waking someone. These can be signs of overdose.
  • Get emergency help if a child or anyone else takes oxycodone by accident.
  • Call for emergency help for signs of a severe allergic reaction (anaphylaxis).
  • Tell your doctor if you notice signs of addiction, abuse or misuse, such as using it in ways not prescribed.
  • Tell your doctor if your pain gets worse or you become more sensitive to pain.
  • Get help for fainting, severe dizziness on standing, or very low blood pressure.
  • Report agitation, fever, sweating, shaking or other signs of serotonin syndrome if you take other serotonin-affecting drugs.
  • Contact your doctor about ongoing weakness, tiredness, nausea or vomiting, which can be signs of adrenal insufficiency.

Common side effects include:

  • Constipation
  • Nausea and vomiting
  • Sleepiness
  • Dizziness
  • Itching
  • Headache
  • Dry mouth
  • Weakness and sweating

Seek help for slowed breathing, severe allergic reaction, fainting, signs of serotonin syndrome, or signs of addiction or misuse.

Oxycodone warnings and precautions

▾
  • Addiction, abuse and misuse can happen even at recommended doses.
  • Slowed breathing can be fatal, especially at the start or after a dose increase.
  • Accidental ingestion by children can be fatal.
  • Sedatives and alcohol greatly raise the risk of coma and death.
  • Long-term use may cause hormone changes, worsened pain sensitivity, and adrenal insufficiency.
  • Ask about naloxone and store and dispose of the medicine safely.

Oxycodone interactions

▾

Several drug types can change how oxycodone works or add to its risks.

  • Benzodiazepines, sleep aids, muscle relaxants, gabapentin, pregabalin, other opioids: more sedation and slowed breathing.
  • Alcohol: adds to sedation and breathing risk.
  • CYP3A4 inhibitors (erythromycin, ketoconazole, ritonavir): higher oxycodone levels.
  • CYP3A4 inducers (rifampin, carbamazepine, phenytoin): lower levels, and higher levels when stopped.
  • Serotonergic drugs: serotonin syndrome risk.
  • MAO inhibitors: not recommended during use or within 14 days of stopping.
  • Mixed agonist/antagonist opioids: may weaken pain relief or trigger withdrawal.
  • Anticholinergics: urinary retention and severe constipation.

Interactions listed in the FDA-approved label

From the Oxycodone prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.

  • Inhibitors of CYP3A4 and CYP2D6 (e.g., erythromycin, ketoconazole, ritonavir): Can increase the plasma concentration of oxycodone, resulting in increased or prolonged opioid effects; stopping a CYP3A4 inhibitor will decrease oxycodone concentration, causing decreased efficacy or withdrawal syndrome in physically dependent patients. If concomitant use is necessary, consider dosage reduction until stable drug effects are achieved and evaluate patients at frequent intervals for respiratory depression and sedation. If a CYP3A4 inhibitor is discontinued, consider increasing the dosage and evaluate for signs of opioid withdrawal.
  • CYP3A4 inducers (e.g., rifampin, carbamazepine, phenytoin): Can decrease the plasma concentration of oxycodone, resulting in decreased efficacy or withdrawal syndrome in physically dependent patients; after stopping an inducer, oxycodone concentration will increase and may cause serious respiratory depression. If concomitant use is necessary, consider increasing the dosage until stable drug effects are achieved and evaluate for signs of opioid withdrawal. If an inducer is discontinued, consider dosage reduction and evaluate at frequent intervals for respiratory depression and sedation.
  • Benzodiazepines and other CNS depressants (including alcohol): Due to additive pharmacologic effect, can increase the risk of hypotension, respiratory depression, profound sedation, coma, and death. Reserve concomitant prescribing for patients for whom alternative treatment options are inadequate; limit dosages and durations to the minimum required; inform patients and caregivers; if concomitant use is warranted, consider recommending or prescribing an opioid overdose reversal agent.
  • Serotonergic drugs (e.g., SSRIs, SNRIs, TCAs, triptans, mirtazapine, trazodone, tramadol, linezolid, intravenous methylene blue): Concomitant use with opioids has resulted in serotonin syndrome. If concomitant use is warranted, frequently evaluate the patient, particularly during treatment initiation and dose adjustment. Discontinue oxycodone if serotonin syndrome is suspected.
  • Monoamine oxidase inhibitors (MAOIs) (e.g., phenelzine, tranylcypromine, linezolid): MAOI interactions with opioids may manifest as serotonin syndrome or opioid toxicity (e.g., respiratory depression, coma). Use is not recommended for patients taking MAOIs or within 14 days of stopping such treatment. If urgent use of an opioid is necessary, use test doses and frequent titration of small doses while closely monitoring blood pressure and signs of CNS and respiratory depression.
  • Mixed agonist/antagonist opioid analgesics (butorphanol, nalbuphine, pentazocine, buprenorphine): May reduce the analgesic effect of oxycodone and/or may precipitate withdrawal symptoms. Avoid concomitant use.
  • Muscle relaxants (e.g., cyclobenzaprine, metaxalone): Oxycodone may enhance the neuromuscular blocking action of skeletal muscle relaxants and produce an increased degree of respiratory depression. Decrease the dosage of oxycodone and/or the muscle relaxant as necessary; consider recommending or prescribing an opioid overdose reversal agent.
  • Diuretics: Opioids can reduce the efficacy of diuretics by inducing the release of antidiuretic hormone. Evaluate patients for signs of diminished diuresis and/or effects on blood pressure and increase the dosage of the diuretic as needed.
  • Anticholinergic drugs: May result in increased risk of urinary retention and/or severe constipation, which may lead to paralytic ileus. Evaluate patients for signs of urinary retention or reduced gastric motility when used concurrently.
Read the label’s full interactions text

7 DRUG INTERACTIONS Table 1 includes clinically significant drug interactions with oxycodone hydrochloride tablets. Table 1: Clinically Significant Drug Interactions with Oxycodone Hydrochloride Tablets Inhibitors of CYP3A4 and CYP2D6 Clinical Impact: The concomitant use of oxycodone hydrochloride tablets and CYP3A4 inhibitors can increase the plasma concentration of oxycodone, resulting in increased or prolonged opioid effects. These effects could be more pronounced with concomitant use of oxycodone hydrochloride tablets and CYP2D6 and CYP3A4 inhibitors, particularly when an inhibitor is added after a stable dose of oxycodone hydrochloride tablets is achieved [see Warnings and Precautions (5.3) ] . After stopping a CYP3A4 inhibitor, as the effects of the inhibitor decline, the oxycodone plasma concentration will decrease [see Clinical Pharmacology (12.3) ] , resulting in decreased opioid efficacy or a withdrawal syndrome in patients who had developed physical dependence to oxycodone. Intervention: If concomitant use is necessary, consider dosage reduction of oxycodone hydrochloride tablets until stable drug effects are achieved. Evaluate patients at frequent intervals for respiratory depression and sedation. If a CYP3A4 inhibitor is discontinued, consider increasing the oxycodone hydrochloride tablets dosage until stable drug effects are achieved. Evaluate for signs of opioid withdrawal. Examples: Macrolide antibiotics (e.g., erythromycin), azole-antifungal agents (e.g., ketoconazole), protease inhibitors (e.g., ritonavir). CYP3A4 Inducers Clinical Impact: The concomitant use of oxycodone hydrochloride tablets and CYP3A4 inducers can decrease the plasma concentration of oxycodone [see Clinical Pharmacology (12.3) ] , resulting in decreased efficacy or onset of a withdrawal syndrome in patients who have developed physical dependence to oxycodone [see Warnings and Precautions (5.6) ] .

Excerpted — the section continues on the label. Read the full Drug Interactions section on DailyMed →

Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.

🌿145 supplements and herbs with documented Oxycodone interactions, ranked by severity Check Oxycodone against a supplement or herb →

Before taking Oxycodone

▾
  • Do not use with significant breathing problems, severe asthma without monitoring, or known or suspected GI blockage.
  • Do not use if allergic to oxycodone.
  • Tell your prescriber about substance misuse or mental illness history.
  • Be cautious with chronic lung disease or if you are elderly or debilitated.
  • Pregnancy: prolonged use can cause newborn withdrawal.
  • Breastfeeding is not recommended.
  • Kidney or liver problems may need lower doses.
  • Long-term use may reduce fertility.

Oxycodone overdose

▾

Overdose can cause slowed breathing, extreme sleepiness progressing to stupor or coma, limp muscles, cold clammy skin, and small pupils. It can lead to death. Get emergency help immediately. Naloxone or nalmefene reverse opioid effects, and extended-release products may need prolonged monitoring.

What Oxycodone does in the body

▾

Oxycodone slows breathing by acting on the brainstem. It also constricts pupils, slows the gut (causing constipation), and widens blood vessels, which can lower blood pressure on standing. Long-term use may lower sex hormones. Side effects increase as blood levels rise.

How your body processes Oxycodone

▾

About 60% to 87% of an oral dose is absorbed. The extended-release tablets are designed to release oxycodone over 12 hours, and food does not significantly change absorption. Steady levels build within 24 to 36 hours. The liver breaks oxycodone down, mainly through CYP3A, and the kidneys remove it.

How to store Oxycodone

▾

Dispense in a tight, light-resistant container. Protect from moisture. Store at 25°C (77°F); excursions are permitted to 15° to 30°C (59° to 86°F) .

Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

145

Supplements & herbs that interact with Oxycodone

145 supplements and herbal products have documented interactions with Oxycodone in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.

Severity mix
  • Major · 8
  • Moderate · 114
  • Minor · 23
1,4-BUTANEDIOL Major ACTIVATED CHARCOAL Major BEER Major GAMMA-HYDROXYBUTYRATE (GHB) Major KAVA Major L-TRYPTOPHAN Major ST. JOHN'S WORT Major WINE Major +137 more
Every supplement checked against Oxycodone — ranked by severity The full interaction hub: 8 major · 114 moderate · 23 minor · every one linked to its full report. Check Oxycodone against your exact supplements

Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.

Oxycodone: pharmacist answers to common questions

Quick, plain-English answers to the questions patients ask most about Oxycodone — the kind of thing our pharmacy team would talk through with you at the counter.

What is oxycodone used for?

▾
It treats pain severe enough to need an opioid when other treatments aren’t enough. Some forms, like OxyContin and Xtampza ER, are for around-the-clock, long-term pain and are not for as-needed use.

How should I take it?

▾
Take it by mouth exactly as prescribed. Never crush, chew or dissolve extended-release tablets. If you use the liquid, double-check the dose in mL and the strength on your bottle.

What side effects should I expect?

▾
Constipation, nausea, drowsiness, dizziness and itching are common. Call 911 for slow or shallow breathing or if someone can’t be woken. Tell your doctor if you notice signs of misuse or addiction.

Can I drink alcohol or take sleep or anxiety medicines with it?

▾
No, not without your prescriber’s approval. Alcohol, benzodiazepines and other sedating drugs can cause extreme sleepiness, slowed breathing, coma and death. Tell us about everything you take.

Is it safe in pregnancy or while breastfeeding?

▾
Prolonged use in pregnancy can cause withdrawal in the newborn and may harm the baby, so talk with your doctor. Breastfeeding isn’t recommended because the medicine passes into breast milk.

How should I store it?

▾
Keep it locked up and away from children, since even one accidental dose can be fatal. Dispose of leftovers properly, and ask about having naloxone at home.

Is Oxycodone available over the counter?

▾
No. Oxycodone is a prescription medicine: every Oxycodone product listed with the FDA is prescription only, so it is not sold over the counter. Your prescriber decides whether it is appropriate for you, and your pharmacist dispenses it.

Is Oxycodone a controlled substance?

▾
Yes — Oxycodone is a federally controlled substance (Schedule II) in the United States, so how it is prescribed, refilled and dispensed is regulated by the DEA.

When was Oxycodone first available?

▾
The earliest FDA record we hold for Oxycodone is from 1950: its first approval in Drugs@FDA or its earliest product listing in the NDC Directory, whichever is older. Many older medicines were in use before their first formal FDA approval, so this is the earliest date on record, not necessarily when Oxycodone was first used.

Who makes Oxycodone?

▾
34 companies currently list Oxycodone products in the FDA's NDC Directory, including Bryant Ranch Prepack, Asclemed USA, Inc., SpecGx LLC. That count includes repackagers and distributors as well as manufacturers (companies that sell only the raw ingredient are not counted), so fewer companies actually make it; the label on your bottle names the one that supplied yours.

Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

More about Oxycodone on HelloPharmacist

📊Oxycodone supplement interactions145 checked — ranked by severity 🌿Drug & Supplement CheckerOxycodone vs. vitamins & herbs 💬Ask a PharmacistFree answer, usually < 24h 🔎NDC & pricing lookupFind Oxycodone NDCs & costs 🅰️Browse Drugs A–ZLook up any medication
Detailed data & references for Oxycodone Forms & strengths, pricing, billing codes, manufacturers, safety reports and sourcing — the data behind the page. Most people can stop here. Each section below opens on a tap.

Oxycodone forms and strengths (how it comes)

Oxycodone is available in 5 forms. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.

Tablet

By mouth
Brands Oxaydo Oxycodone Hydchloride RoxyBond
How this form is used
What it may be used for
  • Oxaydo is for acute and chronic pain severe enough to need an opioid when alternatives are inadequate.
  • Roxicodone and Oxycodone Hydrochloride Tablets are for pain severe enough to need an opioid when alternatives are inadequate.
Important instructions
  • Roxicodone and Oxaydo should be used at the lowest effective dose for the shortest time.
  • Oxycodone Hydrochloride Tablets should not be used long term unless pain stays severe and other options remain inadequate.
Available strengths 6 strengths
5 mg 7.5 mg 10 mg 15 mg 20 mg 30 mg
267 FDA-listed product records ⓘ

Oral solution

By mouth
How this form is used
What it may be used for
  • Oxycodone Hydrochloride Oral Solution is for pain severe enough to need an opioid when alternatives are inadequate.
  • Oxycodone Hydrochloride Oral Solution 100 mg per 5 mL (20 mg/mL) is only for opioid-tolerant patients.
Important instructions
  • Oxycodone Hydrochloride Oral Solution: confusion between mg and mL, or between strengths, can cause accidental overdose, so check your dose carefully.
Available strengths 3 strengths
5 mg/5 mL 20 mg/mL 100 mg/5 mL
62 FDA-listed product records ⓘ

Extended-release tablet

By mouth
Brands OxyContin
How this form is used
What it may be used for
  • OxyContin is for severe, persistent pain in adults and in opioid-tolerant children 11 and older.
  • Oxycodone HCl extended-release tablets are for around-the-clock, long-term pain in adults and opioid-tolerant children 11 and older.
Important instructions
  • Oxycodone HCl extended-release tablets are designed to deliver oxycodone over 12 hours, and cutting, chewing, crushing or dissolving them can release a potentially fatal dose.
  • OxyContin and oxycodone HCl extended-release tablets are not for as-needed use.
Available strengths 7 strengths
10 mg 15 mg 20 mg 30 mg 40 mg 60 mg
Show 1 more strength Show fewer strengths
80 mg
30 FDA-listed product records ⓘ

Extended-release capsule

By mouth
Brands Xtampza
How this form is used
What it may be used for
  • Xtampza ER is for severe, persistent pain that needs an opioid and cannot be treated with other options, including immediate-release opioids.
Important instructions
  • Xtampza ER is not for as-needed use.
  • Xtampza ER at higher doses is only for patients already tolerant to opioids.
Available strengths 5 strengths
9 mg 13.5 mg 18 mg 27 mg 36 mg
15 FDA-listed product records ⓘ

Capsule

By mouth
How this form is used
What it may be used for
  • Oxycodone Hydrochloride Capsules are for adults with pain severe enough to need an opioid when alternative treatments are inadequate.
Important instructions
  • Oxycodone Hydrochloride Capsules should be prescribed at the lowest effective dose for the shortest time.
Available strengths 1 strength
5 mg
6 FDA-listed product records ⓘ

Oxycodone on the U.S. market: products, makers and brands

How Oxycodone appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.

34 companies list 160 Oxycodone product records with the FDA, mostly as tablet, oral solution, extended-release tablet; the earliest marketing or approval year on record is 1950. Brand names on the directory include Oxaydo, OxyContin, Xtampza Er and 10 more; the rest are generics.

5
Dose forms ⓘ
34
Labelers (makers, repackagers, distributors)
10
Brand names
160
FDA-listed product records ⓘ
1950
Earliest FDA record ⓘ

FDA-listed product records by dose form (tablet variants merged) — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

Also listed with the FDA, not a patient dose form: Powder (16) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.

Bryant Ranch Prepack15%
Asclemed USA, Inc.8%
SpecGx LLC6%
Kvk-tech,inc5%
Direct_Rx4%
Knoa Pharma LLC4%
Other makers58%

Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

How widely Oxycodone is used (Medicaid data)

A general measure of how commonly Oxycodone is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.

Think of this as a proxy for how widely Oxycodone is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.

3,037,434
Medicaid prescriptions filled (Q1–Q4 2025)
$107.8M gross Medicaid reimbursement (before mandatory rebates — net cost is lower)

How commonly is Oxycodone prescribed? Of the 1,601 medications we measure, Oxycodone ranks #73 by Medicaid prescriptions — more than 95% of them.

Where Oxycodone ranks among the drugs we measure · Q1–Q4 2025 · neighbors ±5
Total prescriptions — #73 of 1,601
#68 Hydrocortisone 3,162,599 Rx #69 Divalproex 3,122,967 Rx #70 Tirzepatide injection 3,083,095 Rx #71 Tirzepatide 3,083,095 Rx #72 Levetiracetam 3,055,070 Rx #73 Oxycodone 3,037,434 Rx #74 Clindamycin 3,018,439 Rx #75 Hydrocortisone Topical 2,941,220 Rx #76 Mupirocin 2,929,179 Rx #77 Empagliflozin 2,905,773 Rx #78 Venlafaxine 2,819,501 Rx

Utilization by Oxycodone product

Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.

The 5 mg oral tablet is the most-dispensed Oxycodone product — about 59% of these Medicaid prescriptions.

oxycodone hydrochloride 5 MG Oral Tablet Most dispensed

1,798,299 Medicaid prescriptions (Q1–Q4 2025) 59% of Oxycodone prescriptions shown $15.6M gross reimbursement (before rebates) ≈ $8.69 per prescription (gross)

Summed across the 16 of 135 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1049621

oxycodone hydrochloride 10 MG Oral Tablet

604,462 Medicaid prescriptions (Q1–Q4 2025) 20% of Oxycodone prescriptions shown $10.3M gross reimbursement (before rebates) ≈ $17 per prescription (gross)

Summed across the 10 of 69 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1049683

oxycodone hydrochloride 15 MG Oral Tablet

235,541 Medicaid prescriptions (Q1–Q4 2025) 8% of Oxycodone prescriptions shown $5.3M gross reimbursement (before rebates) ≈ $23 per prescription (gross)

Summed across the 14 of 130 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1049611

oxycodone hydrochloride 30 MG Oral Tablet

99,611 Medicaid prescriptions (Q1–Q4 2025) 3% of Oxycodone prescriptions shown $3.6M gross reimbursement (before rebates) ≈ $37 per prescription (gross)

Summed across the 11 of 129 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1049618

oxycodone hydrochloride 20 MG Oral Tablet

85,106 Medicaid prescriptions (Q1–Q4 2025) 3% of Oxycodone prescriptions shown $2.6M gross reimbursement (before rebates) ≈ $30 per prescription (gross)

Summed across the 6 of 45 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1049686

oxycodone hydrochloride 1 MG/ML Oral Solution

79,754 Medicaid prescriptions (Q1–Q4 2025) 3% of Oxycodone prescriptions shown $1.2M gross reimbursement (before rebates) ≈ $15 per prescription (gross)

Summed across the 12 of 49 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1049604

Abuse-Deterrent 12 HR oxycodone hydrochloride 10 MG Extended Release Oral Tablet

40,307 Medicaid prescriptions (Q1–Q4 2025) 1% of Oxycodone prescriptions shown $10.6M gross reimbursement (before rebates) ≈ $262 per prescription (gross)

Summed across the 2 of 8 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1860157

Abuse-Deterrent 12 HR oxycodone hydrochloride 20 MG Extended Release Oral Tablet

28,330 Medicaid prescriptions (Q1–Q4 2025) <1% of Oxycodone prescriptions shown $15.3M gross reimbursement (before rebates) ≈ $541 per prescription (gross)

Summed across the 2 of 9 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1860129

Abuse-Deterrent 12 HR oxycodone hydrochloride 15 MG Extended Release Oral Tablet

17,194 Medicaid prescriptions (Q1–Q4 2025) <1% of Oxycodone prescriptions shown $7.3M gross reimbursement (before rebates) ≈ $427 per prescription (gross)

Summed across the 2 of 2 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1860154

oxycodone hydrochloride 5 MG Oral Capsule

16,813 Medicaid prescriptions (Q1–Q4 2025) <1% of Oxycodone prescriptions shown $308,906 gross reimbursement (before rebates) ≈ $18 per prescription (gross)

Summed across the 2 of 11 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1049696

Abuse-Deterrent 12 HR oxycodone hydrochloride 30 MG Extended Release Oral Tablet

13,730 Medicaid prescriptions (Q1–Q4 2025) <1% of Oxycodone prescriptions shown $10.7M gross reimbursement (before rebates) ≈ $781 per prescription (gross)

Summed across the 2 of 2 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1860151

Abuse-Deterrent 12 HR oxycodone hydrochloride 40 MG Extended Release Oral Tablet

8,291 Medicaid prescriptions (Q1–Q4 2025) <1% of Oxycodone prescriptions shown $8.5M gross reimbursement (before rebates) ≈ $1,020 per prescription (gross)

Summed across the 2 of 13 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1860137

Abuse-Deterrent 12 HR oxycodone hydrochloride 60 MG Extended Release Oral Tablet

4,193 Medicaid prescriptions (Q1–Q4 2025) <1% of Oxycodone prescriptions shown $6.2M gross reimbursement (before rebates) ≈ $1,469 per prescription (gross)

Summed across the 1 of 3 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1860127

Abuse-Deterrent 12 HR oxycodone hydrochloride 80 MG Extended Release Oral Tablet

3,444 Medicaid prescriptions (Q1–Q4 2025) <1% of Oxycodone prescriptions shown $7M gross reimbursement (before rebates) ≈ $2,034 per prescription (gross)

Summed across the 1 of 8 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1860148

Abuse-Deterrent oxycodone hydrochloride 10 MG Oral Tablet

678 Medicaid prescriptions (Q1–Q4 2025) <1% of Oxycodone prescriptions shown $1.2M gross reimbursement (before rebates) ≈ $1,705 per prescription (gross)

Summed across the 1 of 2 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 2693194

Abuse-Deterrent oxycodone hydrochloride 5 MG Oral Tablet

487 Medicaid prescriptions (Q1–Q4 2025) <1% of Oxycodone prescriptions shown $562,696 gross reimbursement (before rebates) ≈ $1,155 per prescription (gross)

Summed across the 1 of 2 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1944541

Abuse-Deterrent oxycodone hydrochloride 15 MG Oral Tablet

425 Medicaid prescriptions (Q1–Q4 2025) <1% of Oxycodone prescriptions shown $794,303 gross reimbursement (before rebates) ≈ $1,869 per prescription (gross)

Summed across the 1 of 2 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1944529

oxycodone hydrochloride 20 MG/ML Oral Solution

400 Medicaid prescriptions (Q1–Q4 2025) <1% of Oxycodone prescriptions shown $78,068 gross reimbursement (before rebates) ≈ $195 per prescription (gross)

Summed across the 2 of 21 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1049615

Abuse-Deterrent oxycodone hydrochloride 30 MG Oral Tablet

251 Medicaid prescriptions (Q1–Q4 2025) <1% of Oxycodone prescriptions shown $658,386 gross reimbursement (before rebates) ≈ $2,623 per prescription (gross)

Summed across the 1 of 2 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1944538

Abuse-Deterrent 12 HR oxycodone 9 MG Extended Release Oral Capsule

74 Medicaid prescriptions (Q1–Q2 2025) <1% of Oxycodone prescriptions shown $23,467 gross reimbursement (before rebates) ≈ $317 per prescription (gross)

Summed across the 1 of 2 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1790527

Abuse-Deterrent 12 HR oxycodone 13.5 MG Extended Release Oral Capsule

44 Medicaid prescriptions (Q1–Q3 2025) <1% of Oxycodone prescriptions shown $20,001 gross reimbursement (before rebates) ≈ $455 per prescription (gross)

Summed across the 1 of 3 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1791558

Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.

Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Oxycodone, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 91 of 647 listed Oxycodone NDCs with Medicaid activity.

Compare Oxycodone products

A representative set of FDA-listed product records for Oxycodone — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)

Showing 87 of 160 products — FDA National Drug Code Directory. See every product, package size and price: browse all 160 Oxycodone NDCs →

Oxycodone recall history

A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.

The FDA’s enforcement reports list 5 Oxycodone recalls since July 2021. Two of them are still ongoing or began in the last six months and are listed first. A recall names specific lots from one company, so check the lot number on your own bottle rather than assuming every product is affected; your pharmacist can check whether your supply came from an affected lot.

Ongoing Class II Jan 14, 2026 · Amerisource Health Services LLC
Defective container: card seal defects (weak/non-existent seals), leading to the tablets falling out of their cavities.
  • Oxycodone Hydrochloride Tablets, USP (CII), 5 mg, 100-Count (10 x 10) blister cards per carton, Rx Only, The drug product contained in this package is from NDC # 10702-018, KVK-Tech Inc. Distributed… Lots: Lots #: 1027932, Exp Date 06/30/2027, 1028360, Exp Date 08/31/2027 FDA record D-0338-2026 →
Ongoing Class III Oct 20, 2023 · Zyla Life Sciences US Inc.
Sub-potent Drug: Lower potency than labeled.
  • Oxaydo (oxycodone HCl, USP) tablets, 7.5 mg, 100 Tablets per bottle, Rx only, Distributed by: Zyla Life Sciences US Inc., Wayne, PA 19087. NDC: 69344-213-11 Lots: Lot 22W02, Exp 01/31/2025 FDA record D-0094-2024 →
Class II Feb 22, 2022 · Terminated · American Health Packaging
Impurity failure at 0-time of the repackaged lot.
  • Oxycodone Hydrochloride Oral Solution, USP (C-II), 5 mg/5 mL, Delivers 5 mL per Cup, 1 Tray of 10 Cups, Rx Only, For Institutional Use Only, American Health Packaging, Columbus, OH 43217. UPC (01) 00… Lots: Lot# 1004276, Exp 11/30/2022 FDA record D-0652-2022 →
Class III Dec 29, 2021 · Terminated · Lupin Pharmaceuticals Inc.
Out-of-specification impurity test result observed at 18-month long term stability time point.
  • Oxycodone Hydrochloride Tablets, USP C-II, 5 mg, 100 count bottles, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202. Manufactured by: Novel Laboratories, Inc. Somerset, NJ… Lots: Lot # S000268, Exp. date January 2022 FDA record D-0358-2022 →
Class II Aug 19, 2021 · Terminated · Rhodes Pharmaceuticals, L.P.
Presence of Foreign Tablets/Capsules; A single foreign tablet Hydrochlorothiazide/Lisinopril 25/20 was found in one bottle
  • Oxycodone Hydrochloride Tablets, USP, 10 mg, 100 count bottle, Rx only, Marketed by: Rhodes Pharmaceuticals L.P., Coventry RI 02816, Manufactured by: Purdue Pharma L.P., Stanford, CT 06901 NDC 42858-… Lots: Lot # WP5K0Y, exp. date 02/28/2023 FDA record D-0794-2021 →

Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.

RxNorm Concept Web — From Ingredient to Every Form and Strength

This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.

Ingredient (IN) Oxycodone RxCUI 7804 6 dose forms · 37 strengths
  2. Dose form (SCDF) Extended Release Oral Tablet RxCUI 385094 In current FDA listings
    Clinical drug / strength (SCD) Abuse-Deterrent 12 HR oxycodone hydrochloride 10 MG RxCUI 1860157 Abuse-Deterrent 12 HR oxycodone hydrochloride 15 MG RxCUI 1860154 Abuse-Deterrent 12 HR oxycodone hydrochloride 20 MG RxCUI 1860129 Abuse-Deterrent 12 HR oxycodone hydrochloride 30 MG RxCUI 1860151 Abuse-Deterrent 12 HR oxycodone hydrochloride 40 MG RxCUI 1860137 Abuse-Deterrent 12 HR oxycodone hydrochloride 60 MG RxCUI 1860127 Abuse-Deterrent 12 HR oxycodone hydrochloride 80 MG RxCUI 1860148 hydrochloride 5 MG RxCUI 1049727 12 HR oxycodone hydrochloride 10 MG RxCUI 1049502 12 HR oxycodone hydrochloride 15 MG RxCUI 1049543 12 HR oxycodone hydrochloride 20 MG RxCUI 1049563 12 HR oxycodone hydrochloride 30 MG RxCUI 1049574 12 HR oxycodone hydrochloride 40 MG RxCUI 1049584 12 HR oxycodone hydrochloride 60 MG RxCUI 1049593 12 HR oxycodone hydrochloride 80 MG RxCUI 1049599
  3. Dose form (SCDF) Injectable Solution RxCUI 402341 No current FDA listing
    Clinical drug / strength (SCD) hydrochloride 10 MG/ML RxCUI 1049719
  4. Dose form (SCDF) Oral Capsule RxCUI 373195 In current FDA listings
    Clinical drug / strength (SCD) hydrochloride 10 MG RxCUI 1049717 hydrochloride 20 MG RxCUI 1049721 hydrochloride 5 MG RxCUI 1049696
  5. Dose form (SCDF) Oral Solution RxCUI 373196 In current FDA listings
    Clinical drug / strength (SCD) hydrochloride 1 MG/ML RxCUI 1049604 hydrochloride 10 MG/ML RxCUI 1049720 hydrochloride 20 MG/ML RxCUI 1049615
  6. Dose form (SCDF) Oral Tablet RxCUI 373198 In current FDA listings
    Clinical drug / strength (SCD) Abuse-Deterrent oxycodone hydrochloride 10 MG RxCUI 2693194 Abuse-Deterrent oxycodone hydrochloride 15 MG RxCUI 1944529 Abuse-Deterrent oxycodone hydrochloride 30 MG RxCUI 1944538 Abuse-Deterrent oxycodone hydrochloride 5 MG RxCUI 1944541 hydrochloride 10 MG RxCUI 1049683 hydrochloride 15 MG RxCUI 1049611 hydrochloride 20 MG RxCUI 1049686 hydrochloride 30 MG RxCUI 1049618 hydrochloride 5 MG RxCUI 1049621 hydrochloride 7.5 MG RxCUI 1113314

Look up RxCUI 7804 in the RxCUI Atlas →

RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.

Oxycodone brand names

Oxycodone is sold under 13 brand names in the FDA directory — Oxaydo, OxyContin, Xtampza Er, Dazidox and others. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.

Oxaydo OxyContin Xtampza Er Dazidox Endocodone ETH-Oxydose Oxecta Oxyfast OxyIR Percolone Xtampza RoxyBond Oxycodone Hydchloride

Who makes Oxycodone: manufacturers and labelers

34 companies list Oxycodone products with the FDA. By number of product records, the largest are Bryant Ranch Prepack, Asclemed USA, Inc., SpecGx LLC. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.

Bryant Ranch Prepack 24 Asclemed USA, Inc. 13 SpecGx LLC 9 Kvk-tech,inc 8 Direct_Rx 7 Knoa Pharma LLC 7 Lupin Pharmaceuticals,Inc. 6 St. Mary's Medical Park Pharmacy 6 American Health Packaging 5 Amneal Pharmaceuticals LLC 5 Aurolife Pharma, LLC 5 Camber Pharmaceuticals Inc 5 Collegium Pharmaceutical, Inc. 5 Epic Pharma, LLC 5 Rhodes Pharmaceuticals LLC 5 Strides Pharma Science Limited 5 Major Pharmaceuticals 4 Protega Pharmaceuticals Inc 4 Redpharm Drug 4 Alvogen, Inc. 3 NuCare Pharmaceuticals,Inc. 3 Quality Care Products LLC 3 ANI Pharmaceuticals, Inc. 2 Ascent Pharmaceuticals Inc 2

…and 10 more on the FDA NDC directory.

Oxycodone drug class (RxNorm)

Oxycodone belongs to the Opioid Agonist class.

Pharmacologic class Opioid Agonist
Drug family (ATC) Natural opium alkaloids
How it works Full Opioid Agonists

Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.

Sources for this Oxycodone page

Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.

📄
FDA-filed drug labels (SPL) Uses, dosing, warnings & side effects from SPL records retrieved through openFDA; the linked representative set can be verified on DailyMed. ✓ Linked label effective Dec 30, 2025
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Oxycodone.
📈
Real-world reportsThe FDA Adverse Event Reporting System (FAERS), served through openFDA.
🚨
Recalls & shortagesopenFDA drug-enforcement reports and the FDA drug-shortage database.
🧾 Clinical label set — FDA-filed SPL labels retained for Oxycodone after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
100
Finished products in the current FDA directory
160
Companies listing them (makers, repackagers, distributors)
34
FDA labeler codes behind them ⓘ
40
Linked representative label ⓘ
Collegium Pharmaceutical, Inc.
Linked label effective
Dec 30, 2025
Composite sections available
28
Linked SPL Set ID
b0a5ded2-8ee2-49ca-a86c-2b28ae40f60c
Linked SPL Document ID
fda0989d-9319-4e35-af83-fca1ec66878e
Open the linked representative label on DailyMed ↗

How this page is built

HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. Collegium Pharmaceutical, Inc. is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →