Oxycodone

Generic name: oxycodone hydrochloride · Brand names: Roxicodone, Roxybond, Oxaydo (no longer on the market per MedlinePlus), Oxycontin (extended-release; not covered by this record), Xtampza ER (extended-release capsule; not covered by this record)

Quick facts

Drug class
Oxycodone is an opioid agonist (opioid pain medicine).
Section
Highlights, Indications and Usage
Source
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=928227bf-89c5-4c64-9823-0e84cc669388&type=display
Source text (exact source wording)
Oxycodone hydrochloride tablets are an opioid agonist indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.
Rx or otc
Rx - source: https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=928227bf-89c5-4c64-9823-0e84cc669388&type=display
Controlled schedule
Schedule II (CII) controlled substance.
Section
5.1 Addiction, Abuse, and Misuse; Highlights title
Source
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=928227bf-89c5-4c64-9823-0e84cc669388&type=display
Source text (exact source wording)
Oxycodone hydrochloride tablets contain oxycodone, a Schedule II controlled substance. (Title line: for oral use, CII.)
Forms and strengths
  • Immediate-release tablets: 5 mg, 10 mg, 15 mg, 20 mg, 30 mg. (3)
  • SpecGx: 5 mg white round convex; 10 mg mottled pink round convex; 15 mg light green round convex; 20 mg mottled gray round convex; 30 mg light blue round convex. (3)
Generic available
Value
yes - this record uses the SpecGx LLC generic label
Source
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=928227bf-89c5-4c64-9823-0e84cc669388&type=display
Common use one line
Management of pain severe enough to require an opioid analgesic when alternative treatments are inadequate (label Indications).

What it is used for

Oxycodone treats pain that is severe enough to need an opioid when other treatments are not enough. Because of the risks of addiction, abuse, misuse, overdose and death, it is reserved for people for whom other treatments do not work, are not tolerated or are inadequate. It is the generic of Roxicodone.
Section
1 INDICATIONS AND USAGE
Source
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=928227bf-89c5-4c64-9823-0e84cc669388&type=display
Source text (exact source wording)
Oxycodone hydrochloride tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use: Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration and persist over the course of therapy [see Warnings and Precautions (5.1)], reserve opioid analgesics, including oxycodone hydrochloride tablets for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.

How it works

The label calls oxycodone an opioid agonist. MedlinePlus says it works by changing the way the brain and nervous system respond to pain.
Section
Highlights; MedlinePlus Why is this medication prescribed?
Source
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=928227bf-89c5-4c64-9823-0e84cc669388&type=display ; https://medlineplus.gov/druginfo/meds/a682132.html

Dosage: adults

For a first opioid, the label's starting range is 5 to 15 mg every 4 to 6 hours as needed for pain, using the lowest dose that works and the shortest time. The dose is adjusted for each person. Do not stop suddenly if you are physically dependent.
Section
2.3 Initial Dosage; 2.1; 2.5 (sentences joined)
Source
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=928227bf-89c5-4c64-9823-0e84cc669388&type=display
Source text (exact source wording)
Initiate treatment with oxycodone hydrochloride tablets 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 of oxycodone hydrochloride tablets. [2.3] Use the lowest effective dosage for the shortest duration of time consistent with individual patient treatment goals. [2.1] Do not rapidly reduce or abruptly discontinue oxycodone hydrochloride tablets in patients who may be physically dependent on opioids. [2.5]

Dosage: children

The safety and efficacy in children have not been evaluated.
Section
8.4 Pediatric Use
Source
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=928227bf-89c5-4c64-9823-0e84cc669388&type=display
Source text (exact source wording)
The safety and efficacy of oxycodone hydrochloride tablets in pediatric patients have not been evaluated.

Dosage adjustments

Drug interaction caps
With CYP3A4 inhibitors, or after stopping a CYP3A4 inducer, the doctor should check you often and may lower the dose.
Section
5.6
Source
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=928227bf-89c5-4c64-9823-0e84cc669388&type=display
Source text (exact source wording)
When using oxycodone hydrochloride tablets with CYP3A4 inhibitors or discontinuing CYP3A4 inducers in oxycodone hydrochloride tablets-treated patients, evaluate patients at frequent intervals and consider dosage reduction of oxycodone hydrochloride tablets until stable drugs effects are achieved [see Drug Interactions (7)].
Kidney
With kidney problems, start with a lower than usual dose and adjust carefully.
Section
8.7 Renal Impairment
Source
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=928227bf-89c5-4c64-9823-0e84cc669388&type=display
Source text (exact source wording)
Because oxycodone is known to be substantially excreted by the kidney, its clearance may decrease in patients with renal impairment. Initiate therapy with a lower than usual dosage of oxycodone hydrochloride tablets and titrate carefully. Regularly evaluate for adverse events such as respiratory depression, sedation, and hypotension [see Clinical Pharmacology (12.3)].
Liver
With liver problems, start with a lower than usual dose and adjust carefully.
Section
8.6 Hepatic Impairment
Source
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=928227bf-89c5-4c64-9823-0e84cc669388&type=display
Source text (exact source wording)
Because oxycodone is extensively metabolized in the liver, its clearance may decrease in patients with hepatic impairment. Initiate therapy in these patients with a lower than usual dosage of oxycodone hydrochloride tablets and titrate carefully. Regularly evaluate for adverse events such as respiratory depression, sedation, and hypotension [see Clinical Pharmacology (12.3)].
Elderly
Older adults (65 and over) may be more sensitive. Start at the low end of the dose range.
Section
8.5 Geriatric Use
Source
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=928227bf-89c5-4c64-9823-0e84cc669388&type=display
Source text (exact source wording)
Elderly patients (aged 65 years or older) may have increased sensitivity to oxycodone. In general, use caution when selecting a dosage for an elderly patient, usually starting at the low end of the dosing range

Missed dose

Label
Section
n/a
Source
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=928227bf-89c5-4c64-9823-0e84cc669388&type=display
Medlineplus
On a regular schedule, take a missed dose when you remember unless it is almost time for the next one. Never double up.
Source
https://medlineplus.gov/druginfo/meds/a682132.html
Source text (exact source wording)
If you are taking oxycodone on a regular schedule, take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one. Do not take more than one dose of the extended-release tablets or capsules in 12 hours.

Overdose

Label
Overdose can cause slow or stopped breathing, extreme sleepiness progressing to coma, cold clammy skin, small pupils, slow heartbeat, low blood pressure and death. The first priority is to open the airway and support breathing.
Section
10 OVERDOSAGE (Clinical Presentation and start of Treatment of Overdose; the rest of the Treatment text was not read)
Source
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=928227bf-89c5-4c64-9823-0e84cc669388&type=display
Source text (exact source wording)
Acute overdose with oxycodone can be manifested by respiratory depression, somnolence progressing to stupor or coma, skeletal muscle flaccidity, cold and clammy skin, constricted pupils, and in some cases, pulmonary edema, bradycardia, hypotension, hypoglycemia, partial or complete airway obstruction, atypical snoring, and death. Marked mydriasis rather than miosis may be seen with hypoxia in overdose situations [see Clinical Pharmacology (12.2)]. Toxic leukoencephalopathy has been reported after opioid overdose and can present hours, days, or weeks after apparent recovery from the initial intoxication. In case of overdose, priorities are the re-establishment of a patent and protected airway and institution of assisted or controlled ventilation, if needed.
Medlineplus
Call poison control at 1-800-222-1222, or 911 if the person has collapsed, had a seizure, has trouble breathing or cannot be awakened.
Source
https://medlineplus.gov/druginfo/meds/a682132.html
Source text (exact source wording)
In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Storage

Store at 20° to 25°C (68° to 77°F) in a tight, light-resistant container, protected from moisture. Store securely and dispose of properly. SpecGx label detail; other labelers may differ.
Section
16 HOW SUPPLIED/STORAGE AND HANDLING
Source
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=928227bf-89c5-4c64-9823-0e84cc669388&type=display
Source text (exact source wording)
Dispense in a tight, light-resistant container with child-resistant closure. Protect from moisture. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Store oxycodone hydrochloride tablets securely and dispose of properly [see Patient Counseling Information (17)].

Boxed warning

Oxycodone can cause addiction, abuse and misuse, which can lead to overdose and death. It can cause serious, life-threatening or fatal slowed breathing, especially when starting or after a dose increase. Even one dose taken by accident, especially by a child, can be fatal. Using it with benzodiazepines or other CNS depressants, including alcohol, can cause profound sedation, slowed breathing, coma and death. Long use in pregnancy can cause neonatal opioid withdrawal syndrome. Providers are encouraged to complete a REMS-compliant education program. CYP3A4 inhibitors can raise oxycodone levels and may cause fatal breathing problems.
Heading
WARNING: SERIOUS AND LIFE-THREATENING RISKS FROM USE OF OXYCODONE HYDROCHLORIDE TABLETS
Section
WARNING: SERIOUS AND LIFE-THREATENING RISKS FROM USE OF OXYCODONE HYDROCHLORIDE TABLETS (full Boxed Warning; each subheading followed by its text, in original order)
Source
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=928227bf-89c5-4c64-9823-0e84cc669388&type=display
Source text (exact source wording)
Addiction, Abuse, and Misuse: Because the use of oxycodone hydrochloride tablets expose patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death, assess each patient’s risk prior to prescribing and reassess all patients regularly for the development of these behaviors and conditions [see Warnings and Precautions (5.1)]. Life-Threatening Respiratory Depression: Serious, life-threatening, or fatal respiratory depression may occur with use of oxycodone hydrochloride tablets, especially during initiation or following a dosage increase. To reduce the risk of respiratory depression, proper dosing and titration of oxycodone hydrochloride tablets are essential [see Warnings and Precautions (5.2)]. Accidental Ingestion: Accidental ingestion of even one dose of oxycodone hydrochloride tablets, especially by children, can result in a fatal overdose of oxycodone [see Warnings and Precautions (5.2)]. Risks from Concomitant Use with Benzodiazepines or Other CNS Depressants: Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing of oxycodone hydrochloride tablets and benzodiazepines or other CNS depressants for use in patients for whom alternative treatment options are inadequate [see Warnings and Precautions (5.3), Drug Interactions (7)]. Neonatal Opioid Withdrawal Syndrome (NOWS): Advise pregnant women using opioids for an extended period of time of the risk of Neonatal Opioid Withdrawal Syndrome, which may be life-threatening if not recognized and treated. Ensure that management by neonatology experts will be available at delivery [see Warnings and Precautions (5.4)]. Opioid Analgesic Risk Evaluation and Mitigation Strategy (REMS): Healthcare providers are strongly encouraged to complete a REMS-compliant education program and to counsel patients and caregivers on serious risks, safe use, and the importance of reading the Medication Guide with each prescription [see Warnings and Precautions (5.5)]. Cytochrome P450 3A4 Interaction: The concomitant use of oxycodone hydrochloride tablets with all cytochrome P450 3A4 inhibitors may result in an increase in oxycodone plasma concentrations, which could increase or prolong adverse reactions and may cause potentially fatal respiratory depression. In addition, discontinuation of a concomitantly used cytochrome P450 3A4 inducer may result in an increase in oxycodone plasma concentration. Regularly evaluate patients receiving oxycodone hydrochloride tablets and any CYP3A4 inhibitor or inducer [see Warnings and Precautions (5.6), Drug Interactions (7), Clinical Pharmacology (12.3)].

Contraindications

Do not use with significant slowed breathing.
Section
4 CONTRAINDICATIONS
Source
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=928227bf-89c5-4c64-9823-0e84cc669388&type=display
Source text (exact source wording)
Significant respiratory depression [see Warnings and Precautions (5.2)].
Do not use with acute or severe asthma unless monitored with resuscitation equipment.
Section
4
Source
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=928227bf-89c5-4c64-9823-0e84cc669388&type=display
Source text (exact source wording)
Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment or hypercarbia [see Warnings and Precautions (5.8)].
Do not use with a known or suspected bowel blockage.
Section
4
Source
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=928227bf-89c5-4c64-9823-0e84cc669388&type=display
Source text (exact source wording)
Known or suspected gastrointestinal obstruction, including paralytic ileus [see Warnings and Precautions (5.12)].
Do not use if allergic to oxycodone.
Section
4
Source
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=928227bf-89c5-4c64-9823-0e84cc669388&type=display
Source text (exact source wording)
Known hypersensitivity (e.g., anaphylaxis) to oxycodone [see Adverse Reactions (6.2)].

Warnings and precautions

Addiction can happen even when taken as prescribed. Overdose risk rises with higher doses.
Heading
5.1 Addiction, Abuse, and Misuse
Source
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=928227bf-89c5-4c64-9823-0e84cc669388&type=display
Source text (exact source wording)
Although the risk of addiction in any individual is unknown, it can occur in patients appropriately prescribed oxycodone hydrochloride tablets. Addiction can occur at recommended dosages and if the drug is misused or abused. The risk of opioid-related overdose or overdose-related death is increased with higher opioid doses, and this risk persists over the course of therapy.
Slowed breathing can be fatal and is most likely when starting or raising the dose. Even one accidental dose can be fatal for a child.
Heading
5.2 Life-Threatening Respiratory Depression
Source
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=928227bf-89c5-4c64-9823-0e84cc669388&type=display
Source text (exact source wording)
Serious, life-threatening, or fatal respiratory depression has been reported with the use of opioids, even when used as recommended. Respiratory depression, if not immediately recognized and treated, may lead to respiratory arrest and death. While serious, life-threatening, or fatal respiratory depression can occur at any time during the use of oxycodone hydrochloride tablets, the risk is greatest during the initiation of therapy or following a dosage increase. Accidental ingestion of even one dose of oxycodone hydrochloride tablets, especially by children, can result in respiratory depression and death due to an overdose of oxycodone.
Using it with benzodiazepines, alcohol, sleep medicines, muscle relaxants, gabapentin, pregabalin or other opioids can cause heavy sedation, slowed breathing, coma and death.
Heading
5.3 Risks from Concomitant Use with Benzodiazepines or Other CNS Depressants
Source
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=928227bf-89c5-4c64-9823-0e84cc669388&type=display
Source text (exact source wording)
Profound sedation, respiratory depression, coma, and death may result from the concomitant use of oxycodone hydrochloride tablets with benzodiazepines and/or other CNS depressants, including alcohol (e.g., non-benzodiazepine sedatives/hypnotics, anxiolytics, tranquilizers, muscle relaxants, general anesthetics, antipsychotics, gabapentinoids [gabapentin or pregabalin], and other opioids). Because of these risks, reserve concomitant prescribing of these drugs for use in patients for whom alternative treatment options are inadequate.
Long use in pregnancy can cause life-threatening withdrawal in the newborn.
Heading
5.4 Neonatal Opioid Withdrawal Syndrome
Source
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=928227bf-89c5-4c64-9823-0e84cc669388&type=display
Source text (exact source wording)
Use of oxycodone hydrochloride tablets for an extended period of time during pregnancy can result in withdrawal in the neonate. Neonatal opioid withdrawal syndrome, unlike opioid withdrawal syndrome in adults, may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts.
FDA requires a REMS program for opioid pain medicines.
Heading
5.5 Opioid Analgesic Risk Evaluation and Mitigation Strategy (REMS)
Source
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=928227bf-89c5-4c64-9823-0e84cc669388&type=display
Source text (exact source wording)
To ensure that the benefits of opioid analgesics outweigh the risks of addiction, abuse, and misuse, the Food and Drug Administration (FDA) has required a Risk Evaluation and Mitigation Strategy (REMS) for these products.
Erythromycin-type antibiotics, ketoconazole-type antifungals and ritonavir-type drugs can raise oxycodone levels and cause dangerous breathing problems. Stopping rifampin, carbamazepine or phenytoin can do the same.
Heading
5.6 Risks of Concomitant Use or Discontinuation of Cytochrome P450 3A4 Inhibitors and Inducers
Source
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=928227bf-89c5-4c64-9823-0e84cc669388&type=display
Source text (exact source wording)
Concomitant use of oxycodone hydrochloride tablets with a CYP3A4 inhibitor, such as macrolide antibiotics (e.g., erythromycin), azole-antifungal agents (e.g., ketoconazole), and protease inhibitors (e.g., ritonavir), may increase plasma concentrations of oxycodone and prolong opioid adverse reactions, which may cause potentially fatal respiratory depression [see Warnings and Precautions (5.3)], particularly when an inhibitor is added after a stable dose of oxycodone hydrochloride tablets is achieved. Similarly, discontinuation of a CYP3A4 inducer, such as rifampin, carbamazepine, and phenytoin, in oxycodone hydrochloride tablets-treated patients may increase oxycodone plasma concentrations and prolong opioid adverse reactions.
An opioid can sometimes make pain or pain sensitivity worse.
Heading
5.7 Opioid-Induced Hyperalgesia and Allodynia
Source
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=928227bf-89c5-4c64-9823-0e84cc669388&type=display
Source text (exact source wording)
Opioid-Induced Hyperalgesia (OIH) occurs when an opioid analgesic paradoxically causes an increase in pain, or an increase in sensitivity to pain.
Breathing problems are more likely in older, very thin or weakened people and people with chronic lung disease.
Heading
5.8 Life-Threatening Respiratory Depression in Patients with Chronic Pulmonary Disease or in Elderly, Cachectic, or Debilitated Patients
Source
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=928227bf-89c5-4c64-9823-0e84cc669388&type=display
Source text (exact source wording)
Life-threatening respiratory depression is more likely to occur in elderly, cachectic, or debilitated patients because they may have altered pharmacokinetics or altered clearance compared to younger, healthier patients [see Warnings and Precautions (5.2)].
Adrenal insufficiency has been reported, more often after more than one month of use.
Heading
5.9 Adrenal Insufficiency
Source
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=928227bf-89c5-4c64-9823-0e84cc669388&type=display
Source text (exact source wording)
Cases of adrenal insufficiency have been reported with opioid use, more often following greater than one month of use.
It can cause severe low blood pressure and fainting.
Heading
5.10 Severe Hypotension
Source
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=928227bf-89c5-4c64-9823-0e84cc669388&type=display
Source text (exact source wording)
Oxycodone hydrochloride tablets may cause severe hypotension including orthostatic hypotension and syncope in ambulatory patients.
Avoid in people with impaired consciousness or coma. Use extra monitoring with raised pressure in the head or brain tumors.
Heading
5.11 Risks of Use in Patients with Increased Intracranial Pressure, Brain Tumors, Head Injury, or Impaired Consciousness
Source
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=928227bf-89c5-4c64-9823-0e84cc669388&type=display
Source text (exact source wording)
Avoid the use of oxycodone hydrochloride tablets in patients with impaired consciousness or coma.
Do not use with a bowel blockage. It may cause spasm of the sphincter of Oddi and raise amylase.
Heading
5.12 Risks of Gastrointestinal Complications
Source
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=928227bf-89c5-4c64-9823-0e84cc669388&type=display
Source text (exact source wording)
Oxycodone hydrochloride tablets are contraindicated in patients with gastrointestinal obstruction, including paralytic ileus. The oxycodone in oxycodone hydrochloride tablets may cause spasm of the sphincter of Oddi. Opioids may cause increases in serum amylase.
It may increase seizures in people with seizure disorders.
Heading
5.13 Increased Risk of Seizures in Patients with Seizure Disorders
Source
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=928227bf-89c5-4c64-9823-0e84cc669388&type=display
Source text (exact source wording)
The oxycodone in oxycodone hydrochloride tablets may increase the frequency of seizures in patients with seizure disorders, and may increase the risk of seizures occurring in other clinical settings associated with seizures.
Do not stop suddenly if physically dependent. The dose should be tapered gradually.
Heading
5.14 Withdrawal
Source
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=928227bf-89c5-4c64-9823-0e84cc669388&type=display
Source text (exact source wording)
Do not rapidly reduce or abruptly discontinue oxycodone hydrochloride tablets in a patient physically dependent on opioids. When discontinuing oxycodone hydrochloride tablets in a physically dependent patient, gradually taper the dosage.
It may impair driving and machine use.
Heading
5.15 Risks of Driving and Operating Machinery
Source
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=928227bf-89c5-4c64-9823-0e84cc669388&type=display
Source text (exact source wording)
Oxycodone hydrochloride tablets may impair the mental or physical abilities needed to perform potentially hazardous activities such as driving a car or operating machinery.

Pregnancy and breastfeeding

Pregnancy
Long use in pregnancy may cause withdrawal in the newborn. There is not enough data to tell whether it raises the risk of major birth defects or miscarriage.
Section
8.1 Pregnancy (Risk Summary)
Source
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=928227bf-89c5-4c64-9823-0e84cc669388&type=display
Source text (exact source wording)
Use of opioid analgesics for an extended period of time during pregnancy may cause neonatal opioid withdrawal syndrome [see Warnings and Precautions (5.4)]. Available data with oxycodone hydrochloride tablets in pregnant women are insufficient to inform a drug-associated risk for major birth defects and miscarriage or adverse maternal outcomes.
Lactation
Oxycodone passes into breast milk. At doses under 60 mg/day of immediate-release, clinically relevant exposure is unlikely. Infants should be watched for too much sleepiness and slowed breathing. MedlinePlus says you should not breastfeed while taking oxycodone.
Section
8.2 Lactation (Risk Summary; sentences joined, middle sentences omitted; last sentence is cut where the slice ended)
Source
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=928227bf-89c5-4c64-9823-0e84cc669388&type=display
Source text (exact source wording)
Available data from lactation studies indicate that oxycodone is present in breastmilk and that doses of less than 60 mg/day of the immediate-release formulation are unlikely to result in clinically relevant exposures in breastfed infants. ... However, based on known adverse effects in adults, infants should be monitored for signs of excess sedation and respiratory depression (see Clinical Con

Side effects

Common
The most common reactions (3% or more) were nausea, constipation, vomiting, headache, itching, trouble sleeping, dizziness, weakness and sleepiness.
Threshold
incidence ≥ 3% (in all patients with dosing information available, n=191)
Section
Highlights Adverse Reactions; 6.1 Clinical Trials Experience
Source
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=928227bf-89c5-4c64-9823-0e84cc669388&type=display
Source text (exact source wording)
Most common adverse reactions (≥3%) were nausea, constipation, vomiting, headache, pruritus, insomnia, dizziness, asthenia, and somnolence. (6.1) / In all patients for whom dosing information was available (n=191) from the open-label and double-blind studies involving oxycodone hydrochloride tablets, the following adverse events were recorded in oxycodone hydrochloride tablets-treated patients with an incidence ≥ 3%. In descending order of frequency they were: nausea, constipation, vomiting, headache, pruritus, insomnia, dizziness, asthenia, and somnolence.
Less common
The label lists less frequent reactions by body system, including anemia, fast heartbeat, abdominal pain, dry mouth, diarrhea, chills, swelling, infections and decreased appetite. Only part of this list was read.
Section
6.1 Clinical Trials Experience
Source
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=928227bf-89c5-4c64-9823-0e84cc669388&type=display
Source text (exact source wording)
Other less frequently observed adverse reactions from opioid analgesics, including oxycodone hydrochloride tablets included: Blood and lymphatic system disorders: anemia, leukopenia. Cardiac disorders: cardiac failure, palpitation, tachycardia. Gastrointestinal disorders: abdominal pain, dry mouth, diarrhea, dyspepsia, dysphagia, glossitis, nausea, vomiting. General disorders and administration site conditions: chills, edema, edema peripheral, pain, pyrexia. Immune system disorders: hypersensitivity. Infections and infestations: bronchitis, gingivitis, infection, pharyngitis, rhinitis, sepsis, sinusitis, urinary tract infection. Injury, poisoning and procedural complications: injury. Metabolism and nutrition disorders: decreased appetite, gout, hyperglycemia. (List is partial: the label continues with further body systems that were past the page-text cap and not read. This label gives no placebo-controlled percentage table.)
Serious
Label
Serious reactions include slowed or stopped breathing, circulatory depression, cardiac arrest, low blood pressure and shock, plus addiction, withdrawal, adrenal insufficiency, seizures and stomach problems.
Section
6 ADVERSE REACTIONS; 6.1
Source
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=928227bf-89c5-4c64-9823-0e84cc669388&type=display
Source text (exact source wording)
Serious adverse reactions associated with oxycodone hydrochloride tablets use included: respiratory depression, respiratory arrest, circulatory depression, cardiac arrest, hypotension, and/or shock. The following serious adverse reactions are described, or described in greater detail, in other sections: Addiction, Abuse, and Misuse; Life-Threatening Respiratory Depression; Interactions with Benzodiazepines or Other CNS Depressants; Neonatal Opioid Withdrawal Syndrome; Opioid-Induce Hyperalgesia and Allodynia; Adrenal Insufficiency; Severe Hypotension; Gastrointestinal Adverse Reactions; Seizures; Withdrawal. (Postmarketing section 6.2 was past the page-text cap and not read.)
Medlineplus
MedlinePlus says to call your doctor right away or get emergency help for these symptoms.
Section
What side effects can this medication cause?
Source
https://medlineplus.gov/druginfo/meds/a682132.html
Source text (exact source wording)
chest pain, changes in heartbeat; agitation, hallucinations (seeing things or hearing voices that do not exist), fever, sweating, confusion, fast heartbeat, shivering, severe muscle stiffness or twitching, loss of coordination, or diarrhea; nausea, vomiting, loss of appetite, weakness, or dizziness; new pain or pain from touch or doing ordinary tasks such as combing your hair; rash; itching; hives; hoarseness; difficulty breathing or swallowing; or swelling of the face, mouth, tongue, lips, or throat; difficulty swallowing, regurgitation (bringing up swallowed food into throat and mouth), pain in the chest area; seizures; extreme drowsiness; unusual snoring or long pauses during breaths during sleep
Led to discontinuation
Section
n/a
Source
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=928227bf-89c5-4c64-9823-0e84cc669388&type=display

Interactions

Drugs
Dangerous combination: heavy sedation, slowed breathing, coma and death. Use only when other options are inadequate, with the lowest doses and shortest time.
Name
Benzodiazepines and other CNS depressants (sedatives/hypnotics, anxiolytics, tranquilizers, muscle relaxants, general anesthetics, antipsychotics, gabapentinoids, other opioids)
Section
7 DRUG INTERACTIONS; Boxed Warning
Source
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=928227bf-89c5-4c64-9823-0e84cc669388&type=display
Source text (exact source wording)
Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing of oxycodone hydrochloride tablets and benzodiazepines or other CNS depressants for use in patients for whom alternative treatment options are inadequate. Limit dosages and durations to the minimum required. Examples: Benzodiazepines and other sedatives/hypnotics, anxiolytics, tranquilizers, muscle relaxants, general anesthetics, antipsychotics, gabapentinoids (gabapentin or pregabalin), other opioids, alcohol.
These drugs can raise oxycodone levels and cause fatal breathing problems.
Name
CYP3A4 inhibitors (macrolide antibiotics such as erythromycin, azole-antifungals such as ketoconazole, protease inhibitors such as ritonavir)
Section
5.6
Source
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=928227bf-89c5-4c64-9823-0e84cc669388&type=display
Source text (exact source wording)
Concomitant use of oxycodone hydrochloride tablets with a CYP3A4 inhibitor, such as macrolide antibiotics (e.g., erythromycin), azole-antifungal agents (e.g., ketoconazole), and protease inhibitors (e.g., ritonavir), may increase plasma concentrations of oxycodone and prolong opioid adverse reactions, which may cause potentially fatal respiratory depression
Stopping these drugs can raise oxycodone levels.
Name
CYP3A4 inducers (rifampin, carbamazepine, phenytoin)
Section
5.6
Source
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=928227bf-89c5-4c64-9823-0e84cc669388&type=display
Source text (exact source wording)
Similarly, discontinuation of a CYP3A4 inducer, such as rifampin, carbamazepine, and phenytoin, in oxycodone hydrochloride tablets-treated patients may increase oxycodone plasma concentrations and prolong opioid adverse reactions.
Can cause serotonin syndrome.
Name
Serotonergic drugs
Section
Highlights, Drug Interactions (7)
Source
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=928227bf-89c5-4c64-9823-0e84cc669388&type=display
Source text (exact source wording)
Serotonergic Drugs: Concomitant use may result in serotonin syndrome. Discontinue oxycodone hydrochloride tablets if serotonin syndrome is suspected. (7)
Avoid; they may weaken pain relief or trigger withdrawal.
Name
Mixed agonist/antagonist and partial agonist opioid analgesics
Section
Highlights, Drug Interactions (7)
Source
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=928227bf-89c5-4c64-9823-0e84cc669388&type=display
Source text (exact source wording)
Mixed Agonist/Antagonist and Partial Agonist Opioid Analgesics: Avoid use with oxycodone hydrochloride tablets because they may reduce analgesic effect of oxycodone hydrochloride tablets or precipitate withdrawal symptoms. (7)
Avoid with MAOIs or within 14 days of stopping one.
Name
Monoamine oxidase inhibitors (MAOIs)
Section
Highlights, Drug Interactions (7)
Source
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=928227bf-89c5-4c64-9823-0e84cc669388&type=display
Source text (exact source wording)
Monoamine Oxidase Inhibitors (MAOIs): Can potentiate the effects of morphine. Avoid concomitant use in patients receiving MAOIs or within 14 days of stopping treatment with an MAOI. (7)
Food and alcohol
Alcohol with oxycodone can cause profound sedation, slowed breathing, coma and death.
Name
Alcohol
Section
Boxed Warning
Source
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=928227bf-89c5-4c64-9823-0e84cc669388&type=display
Source text (exact source wording)
Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death.
Ask your doctor about grapefruit and grapefruit juice.
Name
Grapefruit (MedlinePlus)
Section
What special dietary instructions should I follow?
Source
https://medlineplus.gov/druginfo/meds/a682132.html
Source text (exact source wording)
Talk to your doctor about eating grapefruit and drinking grapefruit juice while taking this medication.
Other
These may interact with oxycodone. Talk to your doctor first.
Name
St. John's wort and tryptophan (MedlinePlus)
Section
What special precautions should I follow?
Source
https://medlineplus.gov/druginfo/meds/a682132.html
Source text (exact source wording)
the following nonprescription or herbal products may interact with oxycodone: St. John's wort and tryptophan.

Patient tips

Medlineplus
Take it exactly as directed, every 4 to 6 hours as needed for pain, with or without food. Do not stop suddenly. Ask about naloxone or nalmefene. Avoid alcohol and driving until you know how it affects you. Lock it up away from others, especially children.
Section
IMPORTANT WARNING; How should this medicine be used?; precautions; storage
Source
https://medlineplus.gov/druginfo/meds/a682132.html
Source text (exact source wording)
Oxycodone may be habit-forming. ... Do not take more or less of it, take it more often, stop taking it suddenly, or take it in a different way than directed by your doctor. ... Take the solution, tablet, and capsule with or without food every 4 to 6 hours as needed for pain. ... Talk to your doctor or pharmacist about access to rescue medicines, naloxone or nalmefene, while taking oxycodone. ... you should know to not drink alcoholic beverages while you are taking oxycodone products. ... Do not drive a car, operate heavy machinery, or participate in any other possibly dangerous activities until you know how this medication affects you. ... Keep oxycodone in a safe place so that no one else can take it accidentally or on purpose. (Ellipses join separate sentences of the same page.)

Alternatives

Class from label
opioid agonist (label Highlights, Indications)
Source
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=928227bf-89c5-4c64-9823-0e84cc669388&type=display

Frequently asked questions

Question
What is oxycodone used for?
Answer
It treats pain that is severe enough to need an opioid when other treatments are not enough or not tolerated.
Source section
1 INDICATIONS AND USAGE
Source
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=928227bf-89c5-4c64-9823-0e84cc669388&type=display
Question
How often can I take it?
Answer
The label's starting range for a first opioid is 5 to 15 mg every 4 to 6 hours as needed for pain, at the lowest dose that works. MedlinePlus says tablets can be taken with or without food every 4 to 6 hours as needed.
Source section
2.3 Initial Dosage; MedlinePlus How should this medicine be used?
Source
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=928227bf-89c5-4c64-9823-0e84cc669388&type=display ; https://medlineplus.gov/druginfo/meds/a682132.html
Question
Is oxycodone addictive?
Answer
Yes, it can be. The label says addiction can occur at recommended doses and if the drug is misused or abused, which can lead to overdose and death. Do not stop suddenly if you are physically dependent. Your doctor should lower the dose gradually.
Source section
Boxed Warning; 5.1; 5.14
Source
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=928227bf-89c5-4c64-9823-0e84cc669388&type=display
Question
Can I drink alcohol with oxycodone?
Answer
No. The boxed warning says using opioids with alcohol or other CNS depressants may cause profound sedation, slowed breathing, coma and death. MedlinePlus also says not to drink alcohol.
Source section
Boxed Warning; MedlinePlus precautions
Source
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=928227bf-89c5-4c64-9823-0e84cc669388&type=display ; https://medlineplus.gov/druginfo/meds/a682132.html
Question
What are the common side effects?
Answer
The most common (3% or more) were nausea, constipation, vomiting, headache, itching, trouble sleeping, dizziness, weakness and sleepiness.
Source section
6.1
Source
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=928227bf-89c5-4c64-9823-0e84cc669388&type=display
Question
What should I do if I miss a dose?
Answer
The label has no missed-dose instruction. MedlinePlus says on a regular schedule take it when you remember unless it is almost time for the next dose, and never take a double dose.
Source section
MedlinePlus What should I do if I forget a dose?
Source
https://medlineplus.gov/druginfo/meds/a682132.html
Question
What if someone takes it by accident?
Answer
Even one dose taken by accident, especially by a child, can be fatal. For an overdose call poison control at 1-800-222-1222, or 911 if the person has collapsed, had a seizure, has trouble breathing or cannot be awakened.
Source section
Boxed Warning; MedlinePlus In case of emergency/overdose
Source
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=928227bf-89c5-4c64-9823-0e84cc669388&type=display ; https://medlineplus.gov/druginfo/meds/a682132.html
Question
Is it safe in pregnancy?
Answer
Long use during pregnancy can cause life-threatening withdrawal in the newborn. Tell your doctor right away if you are pregnant or plan to be.
Source section
Boxed Warning; 8.1
Source
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=928227bf-89c5-4c64-9823-0e84cc669388&type=display

Sources

Information is taken from the cited sources and is for general reference only. It is not medical advice. Report side effects to FDA MedWatch at 1-800-FDA-1088. For a poison emergency call 1-800-222-1222. See prices for this drug