Prescription medication · Opioid Analgesic
oxycodone
Also sold as OxyContin, Roxicodone. Oxycodone is used to manage severe pain.
Data updated 2026-05-15
- 180,422
- FDA reportsHeavily reported
- 28
- InteractionsSeveral interactions
- 97% less
- Generic vs brandHuge savings
- In shortage
- FDA status
What the data shows
oxycodone (OxyContin) is a prescription Opioid Analgesic, more reported than roughly 9 in 10 tracked drugs (180,422 FDA reports), whose generic costs a fraction of the brand (about 97% less).
Reporting volume reflects how widely a drug is used and studied, not how dangerous it is, a FAERS report documents a temporal association, never proof of cause.
oxycodone (OxyContin) is a prescription Opioid Analgesic. Oxycodone is used to manage severe pain.
Oxycodone is a strong pain medicine. It is used to treat severe pain that is not helped by other treatments.
Verify with FDA → · CMS NADAC pricing →
Drug Shortage Alert
oxycodone is currently listed as to be discontinued by the FDA. Affected manufacturer: Hikma Pharmaceuticals USA, Inc..
View all drug shortages →Drug Pricing (NADAC)
Brand Price
$4.99/unit
Generic Price
$0.14/unit
Generic Savings
97%
Generic Available
Yes (43 manufacturers)
Pricing data from NADAC (CMS), effective December 18, 2024. Compare all drug costs →
What it does
Oxycodone is used to manage severe pain.
Common side effects
Feeling sick to your stomach, Constipation, Throwing up
Key warnings
Oxycodone can cause serious, life-threatening risks: * Addiction, abuse, and misuse can lead to overdose and death.
The sections below are summarized in plain English from oxycodone's FDA-approved prescribing information. They describe what the official label says, and are not personal medical advice.
How It Works
Oxycodone works by changing how your brain and nervous system respond to pain. It attaches to certain receptors in the brain. This helps to block pain signals and reduce pain.
How to Take It
Take oxycodone exactly as your doctor tells you. The usual dose is 5 to 15 mg every 4 to 6 hours as needed for pain. Your doctor may change your dose to best control your pain. You can take it with or without food.
This is a plain-language summary of oxycodone's FDA labeling, not individualized dosing advice. Ask a pharmacist or prescriber before changing how you take this medication.
Pregnancy & Breastfeeding
Using oxycodone for a long time during pregnancy can cause withdrawal symptoms in the baby after birth. Talk to your doctor about the risks if you are pregnant or plan to become pregnant. Oxycodone is not recommended during labor, as it can cause breathing problems in the newborn.
This is a plain-language summary of oxycodone's FDA labeling, not individualized advice. Ask a pharmacist or prescriber about pregnancy or breastfeeding on this medication.
Missed Dose
If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and take your next dose at the regular time.
This is a plain-language summary of oxycodone's FDA labeling, not individualized advice. Ask a pharmacist or prescriber what to do about your specific missed dose.
Storage
Store oxycodone at room temperature, away from moisture and light. Keep it in a safe place where others cannot access it.
Side Effects (from patient reports)
Based on 180,422 FDA adverse event reports.
Most-reported reactions
Adverse reactions in FAERS for oxycodone, by number of reports
- Addiction to the drug
Addiction to the drug
27,480 reports
- Pain
Pain
26,410 reports
- Death
Death
19,598 reports
- Taking too much of the drug
Taking too much of the drug
19,081 reports
- Harmful effects from different substances
Harmful effects from different substances
16,254 reports
- Emotional suffering
Emotional suffering
15,630 reports
- Feeling tired
Feeling tired
11,870 reports
- Feeling sick to your stomach 10,629
Feeling sick to your stomach
10,629 reports
- Symptoms when stopping the drug 10,451
Symptoms when stopping the drug
10,451 reports
- Loose stools 8,216
Loose stools
8,216 reports
What this shows Bars show how often each reaction was reported, not how likely it is to happen, a report records a temporal association, never proof that the drug caused it.
Reports over time
Adverse-event reports filed for oxycodone each year to the FDA Adverse Event Reporting System (FAERS).
Year-to-year volume tracks usage, prescribing, and scrutiny, not a change in per-patient risk. Source: FDA FAERS.
Where oxycodone sits
oxycodone has more FDA adverse-event reports than 93% of the drugs FAERS tracks. A high position reflects how widely a drug is used and watched, not how dangerous it is.
Percentile across all drugs PlainMeds tracks by FAERS report volume. The dot is oxycodone; the line is the median (50th percentile).
FDA Adverse Event Report Analysis
Detailed analysis of 180,422 reports from the FDA Adverse Event Reporting System (FAERS). Reports span 2002–2025.
Total Reports
180,422
Reports Mentioning Death
51,490
28.5% of reports — not proof of cause
Hospitalization Reports
49,832
Top Indication
Product Used For Unknown Indication
Gender Distribution
Age Distribution
Most Reported Adverse Reactions (FAERS)
| # | Reaction | Reports |
|---|---|---|
| 1 | DRUG DEPENDENCE | 27,480 |
| 2 | PAIN | 26,409 |
| 3 | DEATH | 19,598 |
| 4 | OVERDOSE | 19,081 |
| 5 | TOXICITY TO VARIOUS AGENTS | 16,253 |
| 6 | EMOTIONAL DISTRESS | 15,630 |
| 7 | FATIGUE | 11,870 |
| 9 | NAUSEA | 10,630 |
| 10 | DRUG WITHDRAWAL SYNDROME | 10,451 |
| 11 | DIARRHOEA | 8,216 |
| 13 | DYSPNOEA | 7,699 |
| 14 | VOMITING | 7,490 |
| 15 | RASH | 7,264 |
| 16 | ARTHRALGIA | 7,185 |
| 17 | DRUG ABUSE | 7,150 |
Reactions in Death Reports
Reactions in Hospitalization Reports
Source: FDA FAERS (Adverse Event Reporting System) FDA FAERS (Adverse Event Reporting System) Reports are voluntary and do not establish causation
Serious Warnings
Oxycodone can cause serious, life-threatening risks: * Addiction, abuse, and misuse can lead to overdose and death. Your doctor will check your risk before prescribing and during treatment. * It can cause very slow or stopped breathing, especially when you start taking it or after a dose increase. * If a child accidentally takes even one dose, it can cause a fatal overdose. * Taking it with benzodiazepines (like Xanax) or other depressants (like alcohol) can cause sleepiness, slowed breathing, coma, and death. * Using oxycodone for a long time during pregnancy can cause withdrawal symptoms in the newborn. * Taking oxycodone with certain other medicines can cause dangerous side effects.
Known Drug Interactions
Examples: Rifampin, carbamazepine, phenytoin Benzodiazepines and Other Central Nervous System (CNS) Depressants Clinical Impact: Due to additive pharmacologic effect, the concomitant use of benzodiazepines or other CNS depressants, including alcohol, can increase the risk of hypotension, respiratory depression, profound sedation, coma, and death [see Warnings and Precautions (5.3)] .
Mechanism: Both of these medications can slow down your brain and body functions. When used together, they can cause dangerously low blood pressure, extreme sleepiness, or breathing problems.
What to do: Use these drugs together only if necessary and watch closely for signs of severe drowsiness or slow breathing.
Examples: Rifampin, carbamazepine, phenytoin Benzodiazepines and Other Central Nervous System (CNS) Depressants Clinical Impact: Due to additive pharmacologic effect, the concomitant use of benzodiazepines or other CNS depressants, including alcohol, can increase the risk of hypotension, respiratory depression, profound sedation, coma, and death [see Warnings and Precautions (5.3)] .
Mechanism: Combining these drugs can cause their effects to stack up, which may lead to a dangerous drop in blood pressure or breathing rate. This additive effect can result in severe sedation or even a coma.
What to do: Talk to your healthcare provider about the risks and monitor for any signs of extreme tiredness or difficulty breathing.
Intervention: Avoid concomitant use Examples: Butorphanol, nalbuphine, pentazocine, buprenorphine Muscle Relaxants Clinical Impact: Oxycodone may enhance the neuromuscular blocking action of skeletal muscle relaxants and produce an increased degree of respiratory depression.
Mechanism: Oxycodone can make the muscle-weakening effects of other drugs stronger and can cause your breathing to slow down significantly. This combination can be very dangerous for your lungs and muscles.
What to do: You should avoid using these two medications together to prevent serious breathing or muscle problems.
Intervention: Avoid concomitant use Examples: Butorphanol, nalbuphine, pentazocine, buprenorphine Muscle Relaxants Clinical Impact: Oxycodone may enhance the neuromuscular blocking action of skeletal muscle relaxants and produce an increased degree of respiratory depression.
Mechanism: These drugs both slow down your breathing and can make your muscles very weak when taken together.
What to do: You should avoid using these two medications at the same time.
Intervention: Avoid concomitant use Examples: Butorphanol, nalbuphine, pentazocine, buprenorphine Muscle Relaxants Clinical Impact: Oxycodone may enhance the neuromuscular blocking action of skeletal muscle relaxants and produce an increased degree of respiratory depression.
Mechanism: Combining these medications can lead to a dangerous increase in breathing problems and muscle weakness.
What to do: Do not take these drugs together as it can be unsafe.
This is a plain-language summary of interactions documented in FDA labeling, not individualized advice. Ask a pharmacist or prescriber before combining medications.
Common Questions
Can I drive while taking oxycodone?
Can I drink alcohol while taking oxycodone?
What should I do if I think I'm having a side effect?
Can I stop taking oxycodone suddenly?
Is oxycodone addictive?
What should I do if someone takes too much oxycodone?
Can I take other medicines with oxycodone?
How long does oxycodone stay in my system?
What is a REMS program?
Can I share my oxycodone with someone else?
What are the common side effects of oxycodone?
Does oxycodone interact with other medications?
What drug class is oxycodone?
Is there a generic version of oxycodone?
Is oxycodone safe during pregnancy?
Has oxycodone been recalled?
Is oxycodone currently in shortage?
Active Recalls
Defective container: card seal defects (weak/non-existent seals), leading to the tablets falling out of their cavities.
Amerisource Health Services LLC
Failed Tablet/Capsule Specification: There is a potential for the imprint to be missing on tablets.
SpecGx, LLC
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Medication Guides
Understanding Drug Interactions
How CYP450 enzymes, inhibitors, and inducers affect your medications
Generic vs Brand Name Drugs
FDA requirements, cost savings, and when the difference matters
Narrow Therapeutic Index Drugs
Why some drugs demand precise dosing and monitoring
Common Drug Interactions
Dangerous medication combinations and how to protect yourself
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What the FDA Data Shows for oxycodone
The FDA label for oxycodone (sold under brand names such as OxyContin, Roxicodone) classifies it as a prescription-only medication in the Opioid Analgesic class. Oxycodone is used to manage severe pain. Official labeling lists 9 commonly reported side effects, including Feeling sick to your stomach, Constipation, Throwing up.
Post-market surveillance from the FDA Adverse Event Reporting System (FAERS) captures real-world experience. For this drug, FAERS contains 180,422 voluntary reports. The database also lists 28 documented drug interactions derived from FDA labeling, with the top-flagged interaction rated moderate severity. NADAC pricing from CMS shows a generic unit cost of $0.14 versus $4.99 for the brand - a 97% generic savings.
Report counts do not establish causation, a FAERS entry documents a temporal association, not proof that the drug produced the outcome. Widely prescribed medications naturally accumulate more reports than niche therapies, so raw totals must be interpreted alongside total exposure. Shortage status, recall history (currently 2 recall records on file), and patent information further shape supply and switching decisions. This page summarizes public FDA data for educational purposes only and is not a substitute for professional medical advice, always consult a licensed healthcare provider before starting, stopping, or changing any medication.
Data Sources
Drug labeling: FDA Drug Labels (SPL/DailyMed). Adverse events: FDA Adverse Event Reporting System (FAERS). Pricing: CMS National Average Drug Acquisition Cost (NADAC). Shortage status: FDA Drug Shortages Database.
FAERS reports are voluntary and do not establish causation. Drug interactions are derived from FDA labeling and clinical references. Always consult a healthcare professional before making medication decisions.
Last updated: January 14, 2026
Read our methodology - how this data is sourced, computed, and verified.
Data currency: FDA FAERS adverse-event reports through 2025, CMS NADAC acquisition-cost pricing effective December 2024, compiled and last refreshed May 2026. See our methodology for per-source dates and refresh cadence. Spot a figure that looks wrong? Report a correction.
All federal data sources used on this page
- FDA Orange Book - approved drug products with therapeutic equivalence. accessdata.fda.gov/cder/ob
- FDA DailyMed - NIH-hosted drug labeling for FDA-approved meds. dailymed.nlm.nih.gov
- FDA Adverse Event Reporting System (FAERS) - post-marketing safety surveillance. fda.gov/drugs/faers
- NLM RxNorm - standardized clinical drug nomenclature. nlm.nih.gov/research/umls/rxnorm
- CMS Medicare Part B Drug Average Sales Price Files - federal drug pricing data. cms.gov/medicare/part-b-drugs/asp
- FDA Drug Shortages Database - current and resolved drug shortage tracking. accessdata.fda.gov/drugshortages