Oxycodone and aspirin (Oral route)

Pronunciation:

AS-pir-in, ox-i-KOE-done hye-droe-KLOR-ide

Brand Names:

Endodan
Percodan

Warnings:

Oral route(Tablet)

Addiction, Abuse, and MisuseOxycodone hydrochloride/aspirin exposes 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 oxycodone hydrochloride/aspirin, and monitor all patients regularly for the development of these behaviors or conditions.Opioid Analgesic Risk Evaluation and Mitigation Strategy (REMS)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 REMS for these products. Under the requirements of the REMS, drug companies with approved opioid analgesic products must make REMS-compliant education programs available to healthcare providers. Healthcare providers are strongly encouraged to: complete a REMS-compliant education program, counsel patients and/or their caregivers, with every prescription, on safe use, serious risks, storage, and disposal of these products, emphasize to patients and their caregivers the importance of reading the Medication Guide every time it is provided by their pharmacists, and consider other tools to improve patient, household, and community safety.Life-Threatening Respiratory DepressionSerious, life-threatening, or fatal respiratory depression may occur with use of oxycodone hydrochloride/aspirin. Monitor for respiratory depression, especially during initiation of oxycodone hydrochloride/aspirin or following a dose increase.Accidental IngestionAccidental ingestion of even one dose of oxycodone hydrochloride/aspirin, especially by children, can result in a fatal overdose of oxycodone hydrochloride.Neonatal Opioid Withdrawal SyndromeProlonged use of oxycodone hydrochloride/aspirin during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts. If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available.Cytochrome P450 3A4 InteractionThe concomitant use of oxycodone hydrochloride/aspirin 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. Monitor patients receiving oxycodone hydrochloride/aspirin and any CYP3A4 inhibitor or inducer.Risks from Concomitant Use with Benzodiazepines or Other CNS DepressantsReserve concomitant prescribing of oxycodone hydrochloride/aspirin 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. Follow patients for signs and symptoms of respiratory depression and sedation .

Classifications:

Pharmacologic—

NSAID

Chemical—

Salicylate, Aspirin

Uses of This Medicine:

Oxycodone and aspirin combination is used to relieve pain severe enough to require opioid treatment and when other pain medicines did not work well enough or cannot be tolerated. Oxycodone belongs to the group of medicines called narcotic analgesics (pain medicines). It acts on the central nervous system (CNS) to relieve pain.

Aspirin is used to relieve pain and reduce fever in patients. Aspirin belongs to the group of medicines known as salicylates and acts on the immune system to reduce inflammation. It is also known as an antiinflammatory analgesic.

When oxycodone is used for a long time, it may become habit-forming, causing mental or physical dependence. However, people who have continuing pain should not let the fear of dependence keep them from using narcotics to relieve their pain. Mental dependence (addiction) is not likely to occur when narcotics are used for this purpose. Physical dependence may lead to withdrawal side effects if treatment is stopped suddenly. However, severe withdrawal side effects can usually be prevented by gradually reducing the dose over a period of time before treatment is stopped completely.

This medicine is available only under a restricted distribution program called the Opioid Analgesic REMS (Risk Evaluation and Mitigation Strategy) program.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of oxycodone and aspirin combination in the pediatric population. Because of aspirin's toxicity, use in children is not recommended. Do not give aspirin to a child who has chickenpox or flu symptoms, unless approved by a doctor. Aspirin can cause a life-threatening reaction called Reye syndrome.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of oxycodone and aspirin combination in the elderly. However, elderly patients are more likely to have age-related liver, kidney, or lung problems, which may require caution and an adjustment in the dose for patients receiving oxycodone and aspirin combination.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

Abrocitinib
Defibrotide
Dichlorphenamide
Influenza Virus Vaccine, Live
Ketorolac
Levoketoconazole
Nalmefene
Naltrexone
Safinamide
Samidorphan

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Abiraterone Acetate
Acarbose
Aceclofenac
Acemetacin
Acenocoumarol
Acepromazine
Acetazolamide
Aclidinium
Adagrasib
Alclometasone
Aldosterone
Alfentanil
Alipogene Tiparvovec
Almotriptan
Alosetron
Alprazolam
Alteplase, Recombinant
Alvimopan
Amantadine
Amcinonide
Amifampridine
Amikacin
Amiloride
Amineptine
Amiodarone
Amitriptyline
Amitriptylinoxide
Amobarbital
Amoxapine
Amphetamine
Amphotericin B
Amprenavir
Amtolmetin Guacil
Anagrelide
Anileridine
Anisindione
Apalutamide
Apixaban
Aprepitant
Ardeparin
Argatroban
Aripiprazole
Aripiprazole Lauroxil
Armodafinil
Asciminib
Asenapine
Atazanavir
Atropine
Avacopan
Bacitracin
Baclofen
Beclomethasone
Belladonna
Belzutifan
Bemetizide
Bemiparin
Benazepril
Bendroflumethiazide
Benperidol
Bentazepam
Benzhydrocodone
Benzphetamine
Benzthiazide
Benztropine
Berotralstat
Betamethasone
Betrixaban
Biperiden
Bivalirudin
Boceprevir
Bosentan
Brinzolamide
Bromazepam
Bromfenac
Bromopride
Brompheniramine
Budesonide
Bufexamac
Bumetanide
Buprenorphine
Bupropion
Buspirone
Butabarbital
Butorphanol
Calcium Oxybate
Cannabidiol
Cannabis
Caplacizumab-yhdp
Capreomycin
Captopril
Carbamazepine
Carbinoxamine
Carisoprodol
Carphenazine
Celecoxib
Cenobamate
Ceritinib
Certoparin
Cetirizine
Chloral Hydrate
Chlordiazepoxide
Chlorothiazide
Chlorpheniramine
Chlorpromazine
Chlorpropamide
Chlorthalidone
Chlorzoxazone
Choline Salicylate
Ciclesonide
Cilostazol
Cimetidine
Cinacalcet
Ciprofloxacin
Cisplatin
Citalopram
Clarithromycin
Clemastine
Clidinium
Clobazam
Clobetasol
Clobetasone
Clocortolone
Clomipramine
Clonazepam
Clonixin
Clopamide
Clopidogrel
Clorazepate
Cloxazolam
Clozapine
Cobicistat
Cocaine
Codeine
Conivaptan
Cortisone
Crizotinib
Curcumin
Cyclobenzaprine
Cyclopenthiazide
Cyclopentolate
Cyclosporine
Cyclothiazide
Cyproheptadine
Dabigatran Etexilate
Dabrafenib
Dalteparin
Danaparoid
Dantrolene
Daridorexant
Darifenacin
Darunavir
Deflazacort
Delavirdine
Delorazepam
Desipramine
Desirudin
Desmopressin
Desonide
Desoximetasone
Desvenlafaxine
Dexamethasone
Dexibuprofen
Dexketoprofen
Dexmedetomidine
Dextroamphetamine
Dextromethorphan
Dezocine
Diacetylmorphine
Diazepam
Diazoxide
Dibenzepin
Dichloralphenazone
Diclofenac
Dicumarol
Dicyclomine
Difenoxin
Diflorasone
Diflucortolone
Diflunisal
Difluprednate
Digoxin
Dihydrocodeine
Diltiazem
Dimenhydrinate
Diphenhydramine
Diphenoxylate
Dipyrone
Dolasetron
Donepezil
Dorzolamide
Dothiepin
Doxepin
Doxylamine
Dronedarone
Droperidol
Droxicam
Duloxetine
Edoxaban
Efavirenz
Elagolix
Eletriptan
Emtricitabine
Enalapril
Enalaprilat
Enflurane
Enoxaparin
Enzalutamide
Eplerenone
Eptifibatide
Erdafitinib
Erythromycin
Escitalopram
Esketamine
Eslicarbazepine Acetate
Estazolam
Eszopiclone
Ethacrynic Acid
Ethchlorvynol
Ethopropazine
Ethylmorphine
Etodolac
Etofenamate
Etoricoxib
Etozolin
Etravirine
Fedratinib
Felbinac
Fenfluramine
Fenoprofen
Fentanyl
Fepradinol
Feprazone
Fesoterodine
Feverfew
Fexinidazole
Flavoxate
Flibanserin
Floctafenine
Flucloronide
Fluconazole
Fludrocortisone
Flufenamic Acid
Flumethasone
Flunisolide
Flunitrazepam
Fluocinolone
Fluocinonide
Fluocortin
Fluocortolone
Fluorometholone
Fluoxetine
Fluphenazine
Flurandrenolide
Flurazepam
Flurbiprofen
Fluspirilene
Fluticasone
Fluvoxamine
Fondaparinux
Fosamprenavir
Fosaprepitant
Foscarnet
Fosinopril
Fosnetupitant
Fosphenytoin
Fospropofol
Frovatriptan
Furazolidone
Furosemide
Gabapentin
Gabapentin Enacarbil
Gentamicin
Gepirone
Ginkgo
Glimepiride
Glipizide
Glyburide
Glycopyrrolate
Glycopyrronium Tosylate
Gossypol
Granisetron
Halazepam
Halcinonide
Halobetasol
Haloperidol
Halothane
Heparin
Hexobarbital
Homatropine
Hydrochlorothiazide
Hydrocodone
Hydrocortisone
Hydroflumethiazide
Hydromorphone
Hydroxyamphetamine
Hydroxytryptophan
Hydroxyzine
Hyoscyamine
Ibrutinib
Ibuprofen
Idelalisib
Imatinib
Imipramine
Indapamide
Indinavir
Indomethacin
Inotersen
Ipratropium
Iproniazid
Isocarboxazid
Isoflurane
Itraconazole
Ivacaftor
Kanamycin
Ketamine
Ketazolam
Ketobemidone
Ketoconazole
Ketoprofen
Lacosamide
Lanreotide
Larotrectinib
Lasmiditan
Lefamulin
Lemborexant
Lenacapavir
Lepirudin
Letermovir
Levocetirizine
Levomilnacipran
Levorphanol
Linezolid
Lisdexamfetamine
Lisinopril
Lithium
Lofepramine
Lofexidine
Lomitapide
Lopinavir
Loprazolam
Lorazepam
Lorcaserin
Lorlatinib
Lormetazepam
Lornoxicam
Loteprednol
Loxapine
Loxoprofen
Lumacaftor
Lumiracoxib
Macimorelin
Magnesium Oxybate
Mavacamten
Meclizine
Meclofenamate
Medazepam
Medrysone
Mefenamic Acid
Melitracen
Meloxicam
Melperone
Melphalan
Mepenzolate
Meperidine
Mephobarbital
Meprobamate
Meptazinol
Mesoridazine
Metaclazepam
Metaxalone
Metformin
Methadone
Methamphetamine
Methazolamide
Methdilazine
Methocarbamol
Methohexital
Methotrexate
Methotrimeprazine
Methyclothiazide
Methylene Blue
Methylnaltrexone
Methylprednisolone
Metoclopramide
Metolazone
Mibefradil
Midazolam
Mifepristone
Milnacipran
Mirabegron
Mirtazapine
Mitotane
Mobocertinib
Moclobemide
Modafinil
Moexipril
Molindone
Mometasone
Moricizine
Morniflumate
Morphine
Morphine Sulfate Liposome
Nabumetone
Nadroparin
Nafcillin
Nalbuphine
Nalorphine
Naloxone
Naproxen
Naratriptan
Nateglinide
Nefazodone
Nelfinavir
Neomycin
Nepafenac
Netilmicin
Netupitant
Nevirapine
Nialamide
Nicomorphine
Nicorandil
Niflumic Acid
Nilotinib
Nimesulide
Nimesulide Beta Cyclodextrin
Nitrazepam
Nitrous Oxide
Nordazepam
Nortriptyline
Octreotide
Olanzapine
Omaveloxolone
Ondansetron
Opipramol
Opium
Opium Alkaloids
Orphenadrine
Oxaprozin
Oxazepam
Oxcarbazepine
Oxitropium Bromide
Oxybutynin
Oxymorphone
Oxyphenbutazone
Ozanimod
Palbociclib
Palonosetron
Papaveretum
Paramethasone
Parecoxib
Paregoric
Parnaparin
Paromomycin
Paroxetine
Pemetrexed
Pentazocine
Pentobarbital
Pentosan Polysulfate Sodium
Pentoxifylline
Perampanel
Perazine
Periciazine
Perindopril
Perphenazine
Phenelzine
Phenindione
Phenobarbital
Phenprocoumon
Phenylbutazone
Phenytoin
Piketoprofen
Pimozide
Pinazepam
Pipenzolate Bromide
Piperacetazine
Pipotiazine
Piracetam
Pirenzepine
Piretanide
Piritramide
Piroxicam
Pirtobrutinib
Plazomicin
Polythiazide
Posaconazole
Potassium Citrate
Potassium Oxybate
Pranoprofen
Prasugrel
Prazepam
Prednicarbate
Prednisolone
Prednisone
Pregabalin
Primidone
Procarbazine
Prochlorperazine
Procyclidine
Proglumetacin
Promazine
Promethazine
Propantheline
Propiverine
Propofol
Propyphenazone
Proquazone
Protein C
Protriptyline
Quazepam
Quetiapine
Quinapril
Quinethazone
Quinidine
Quinine
Ramelteon
Ramipril
Ranitidine
Ranolazine
Rasagiline
Remifentanil
Remimazolam
Remoxipride
Repaglinide
Reteplase, Recombinant
Reviparin
Ribociclib
Rifabutin
Rifampin
Rifapentine
Rimexolone
Ritlecitinib
Ritonavir
Rivaroxaban
Rizatriptan
Rofecoxib
Rolapitant
Ropeginterferon Alfa-2b-njft
Salicylic Acid
Salsalate
Saquinavir
Scopolamine
Secobarbital
Selegiline
Selpercatinib
Selumetinib
Sertindole
Sertraline
Sibutramine
Sodium Oxybate
Sodium Salicylate
Solifenacin
Sotorasib
Spectinomycin
Spirapril
Spironolactone
Stramonium
Streptomycin
Sufentanil
Sulindac
Sulodexide
Sulpiride
Sumatriptan
Suvorexant
Tacrolimus
Tapentadol
Taurursodiol
Telaprevir
Telithromycin
Temazepam
Tenofovir Alafenamide
Tenofovir Disoproxil Fumarate
Tenoxicam
Terbinafine
Terodiline
Tetrazepam
Thiethylperazine
Thiopental
Thiopropazate
Thioridazine
Thiothixene
Tianeptine
Tiaprofenic Acid
Ticagrelor
Ticlopidine
Tilidine
Tinzaparin
Tiotropium
Tirofiban
Tizanidine
Tobramycin
Tocilizumab
Tolazamide
Tolbutamide
Tolfenamic Acid
Tolmetin
Tolonium Chloride
Tolterodine
Topiramate
Torsemide
Tramadol
Trandolapril
Tranylcypromine
Trazodone
Treprostinil
Triamcinolone
Triamterene
Triazolam
Trichlormethiazide
Trifluoperazine
Trifluperidol
Triflupromazine
Trihexyphenidyl
Trimeprazine
Trimipramine
Trofinetide
Tropicamide
Trospium
Tryptophan
Tucatinib
Turmeric
Umeclidinium
Valdecoxib
Valproic Acid
Vancomycin
Varicella Virus Vaccine, Live
Venlafaxine
Verapamil
Vilazodone
Voriconazole
Vortioxetine
Voxelotor
Warfarin
Xipamide
Zaleplon
Ziprasidone
Zolmitriptan
Zolpidem
Zopiclone
Zotepine
Zuranolone

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Acebutolol
Atenolol
Betaxolol
Bisoprolol
Carteolol
Carvedilol
Celiprolol
Delapril
Esmolol
Imidapril
Labetalol
Levobunolol
Metipranolol
Metoprolol
Nadolol
Nebivolol
Nitroglycerin
Oxprenolol
Penbutolol
Pindolol
Probenecid
Propranolol
Sotalol
St John's Wort
Streptokinase
Tamarind
Temocapril
Tenecteplase
Timolol

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

Ethanol
Grapefruit Juice

Using this medicine with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

Ethanol

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

Addison disease (adrenal gland problem) or
Alcohol abuse, or history of or
Bleeding problems or
Brain tumor, history of or
Breathing or lung problems (eg, COPD, sleep apnea) or
Cor pulmonale (serious heart condition) or
Drug dependence, especially with narcotics, or history of or
Gallbladder disease or gallstones or
Head injury, history of or
Hypothyroidism (an underactive thyroid) or
Hypovolemia (low blood volume) or
Kyphoscoliosis (curvature of the spine with breathing problems) or
Peptic ulcer disease, active or history of or
Problems with passing urine or
Prostatic hypertrophy (enlarged prostate, BPH) or
Vitamin K deficiency—Use with caution. May increase risk for more serious side effects.

Hemophilia (bleeding problem) or
Kidney disease, severe or
Liver disease, severe or
Lung or breathing problems (eg, asthma, respiratory depression), severe or
Reye's syndrome or
Stomach or bowel blockage (eg, paralytic ileus) or
Viral infection—Should not be used in patients with these conditions.

Hypotension (low blood pressure) or
Pancreatitis (swelling of the pancreas) or
Seizures, history of—Use with caution. May make these conditions worse.

Kidney disease, mild to moderate or
Liver disease, mild to moderate—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

Proper Use of This Medicine:

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. This is especially important for elderly patients, who may be more sensitive to the effects of pain medicines. If too much of this medicine is taken for a long time, it may become habit-forming (causing mental or physical dependence).

It is very important that you understand the rules of the Opioid Analgesic REMS program to prevent addiction, abuse, and misuse of oxycodone and aspirin combination. This medicine should come with a Medication Guide. Read and follow the instructions carefully. Read and follow these instructions carefully. Read it again each time you refill your prescription in case there is new information. Ask your doctor if you have any questions.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For oral dosage form (tablets):
- For moderate to moderately severe pain:
  - Adults—At first, 1 tablet every 6 hours as needed. Your doctor may adjust your dose as needed. However, the dose is usually not more than 12 tablets per day.
  - Children—Use and dose must be determined by your doctor.

Missed dose—

If you miss a dose of this medicine, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Store the medicine in a safe and secure place. Drop off any unused narcotic medicine at a drug take-back location right away. If you do not have a drug take-back location near you, flush any unused narcotic medicine down the toilet. Check your local drug store and clinics for take-back locations. You can also check the DEA web site for locations. Here is the link to the FDA safe disposal of medicines website: www.fda.gov/drugs/resourcesforyou/consumers/buyingusingmedicinesafely/ensuringsafeuseofmedicine/safedisposalofmedicines/ucm186187.htm

Precautions While Using This Medicine:

It is very important that your doctor check your progress while you are using this medicine, especially within the first 24 to 72 hours of treatment. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it. Blood and urine tests may be needed to check for unwanted effects.

Do not use this medicine if you are using or have used an MAO inhibitor (MAOI) such as isocarboxazid [Marplan®], linezolid [Zyvox®], phenelzine [Nardil®], selegiline [Eldepryl®], tranylcypromine [Parnate®]) within the past 14 days.

Using this medicine while you are pregnant, especially during the later part of pregnancy may cause serious unwanted effects, including neonatal withdrawal syndrome in your newborn baby. Tell your doctor right away if you think you are pregnant or if you plan to become pregnant while using this medicine.

Check with your doctor before using Percodan® with alcohol or other medicines that affect the central nervous system (CNS). The use of alcohol or other medicines that affect the CNS with Percodan® may worsen the side effects of this medicine, such as dizziness, poor concentration, drowsiness, unusual dreams, and trouble with sleeping. Some examples of medicines that affect the CNS are antihistamines or medicine for allergies or colds, sedatives, tranquilizers, or sleeping medicines, medicine for depression, medicine for anxiety, prescription pain medicine or narcotics, medicine for attention deficit and hyperactivity disorder, medicine for seizures or barbiturates, muscle relaxants, or anesthetics, including some dental anesthetics.

If you think you or someone else may have taken an overdose of this medicine, get emergency help at once. Your doctor may also give naloxone to treat an overdose. Signs of an overdose include: extreme dizziness or weakness, slow heartbeat or breathing, seizures, trouble breathing, and cold, clammy skin. Call your doctor right away if you notice these symptoms.

This medicine may cause sleep-related breathing problems (eg, sleep apnea, sleep-related hypoxemia). Your doctor may decrease your dose if you have sleep apnea (stop breathing for short periods during sleep) while using this medicine.

Do not change your dose or suddenly stop taking this medicine without first checking with your doctor. Your doctor may want you to gradually reduce the amount you are using before stopping completely. This will decrease your chance of having withdrawal symptoms, including restlessness, chills, muscle pain, runny nose, sweating, tearing of the eyes, or yawning.

Make sure any doctor or dentist who treats you knows that you are using this medicine. You may need to stop using this medicine several days before you have surgery or medical tests.

This medicine may be habit-forming. If you feel that the medicine is not working as well, do not use more than your prescribed dose. Call your doctor for instructions.

Dizziness, lightheadedness, or fainting may occur when you get up suddenly from a lying or sitting position. Getting up slowly may help lessen this problem. Also, lying down for a while may relieve the dizziness or lightheadedness. If this problem continues or gets worse, check with your doctor right away.

This medicine may make you dizzy, drowsy, or lightheaded. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.

This medicine may cause bleeding in your stomach or bowels. This problem can happen without warning signs. This is more likely if you have had a stomach ulcer in the past, if you drink alcohol regularly, if you are over 60 years of age, are in poor health, or are using certain other medicines (eg, NSAIDs).

This medicine may cause adrenal gland problems. Check with your doctor right away if you have darkening of the skin, diarrhea, dizziness, fainting, loss of appetite, mental depression, nausea, skin rash, unusual tiredness or weakness, or vomiting.

This medicine may cause bleeding in your stomach or bowels. Check with your doctor right away if you have bloody or black, tarry stools, heartburn, nausea, vomiting, stomach pain, or vomiting of blood or material that looks like coffee grounds.

This medicine may cause a serious allergic reaction called anaphylaxis, which can be life-threatening and requires immediate medical attention. Call your doctor right away if you have a rash, itching, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth while you are using this medicine.

Check with your doctor right away if you have black, tarry stools, chest pain, chills, cough, fever, painful or difficult urination, sore throat, sores, ulcers, or white spots on the lips or in the mouth, swollen glands, trouble breathing, unusual bleeding or bruising, or unusual tiredness or weakness. These may be symptoms of serious skin reaction including drug reaction with eosinophilia and systemic symptoms (DRESS).

For nursing mothers:

Talk to your doctor if you have any questions about taking oxycodone or about how this medicine may affect your baby.
Call your doctor if you become extremely tired and have difficulty caring for your baby.
Your baby should generally nurse every 2 to 3 hours and should not sleep for more than 4 hours at a time.
Check with your doctor or hospital emergency room immediately if your baby shows signs of increased sleepiness (more than usual), difficulty breastfeeding, difficulty breathing, or limpness. These may be symptoms of an overdose and need immediate medical attention.

Check with your doctor right away if you have anxiety, restlessness, a fast heartbeat, fever, sweating, muscle spasms, twitching, nausea, vomiting, diarrhea, or see or hear things that are not there. These may be symptoms of a serious condition called serotonin syndrome. Your risk may be higher if you also take certain other medicines that affect serotonin levels in your body.

Using too much of this medicine may cause infertility (unable to have children). Talk with your doctor before using this medicine if you plan to have children.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Incidence not known: Agitation; bleeding gums; bloating; blood in the urine or stools; bloody, black, or tarry stools; blue lips, fingernails, or skin; blurred vision; burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings; change in consciousness or confusion; chest pain, tightness, or discomfort; chills; clay-colored stools; confusion; cough; coughing or vomiting blood; dark urine; darkening of the skin; decrease in urine volume or frequency; decreased appetite; depression; difficult, fast, noisy breathing; difficulty in passing urine (dribbling); difficulty having a bowel movement (stool); difficulty with swallowing; dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position; drowsiness; dry mouth; fainting; fast, slow, irregular, pounding, or racing heartbeat or pulse; feeling of hostility or irritability; feeling of warmth; feeling that something terrible will happen; fever; headache, sudden, severe; heartburn; hives, itching, or skin rash; increased menstrual flow or vaginal bleeding; increased sweating; indigestion; irregular, fast, slow, or shallow breathing; large, flat, blue or purplish patches on the skin; large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or genitals; loss of consciousness; muscle cramps, pain, stiffness, weakness, or tremors; nausea; nosebleeds; numbness or tingling in the hands, feet, or lips; overactive reflexes; painful or difficult urination; pains in the stomach, side, or abdomen, possibly radiating to the back; pale skin; pinpoint red or purple spots on the skin; poor coordination; prolonged bleeding from cuts; puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue; red or black, tarry stools or dark urine; restlessness; seizures; shivering; sleepiness; sunken eyes; sweating; swelling of the face, ankles, hands, feet, or lower legs; stomach pain, cramping, or tenderness; talking or acting with excitement you cannot control; thirst; trembling or shaking; twitching; unusual bleeding or bruising; unusual tiredness or weakness; vomiting; vomiting of material that looks like coffee grounds, severe and continuing; weak or feeble pulse; weakness or heaviness of the legs; weight gain; wrinkled skin; yellow eyes or skin

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose: Blue lips and fingernails; blurred vision; change in consciousness; chest pain; cold, clammy skin; confusion; continuing ringing or buzzing or other unexplained noise in the ears; coughing that sometimes produces a pink frothy sputum; decreased awareness or responsiveness; diarrhea; dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position; drowsiness; enlarged pupils; extremely high fever or body temperature; fast, weak heartbeat; hearing loss; increase in heart rate; increased sweating; loss of consciousness; pale skin; restlessness; severe sleepiness; swelling in legs and ankles; unusual tiredness or weakness

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common: Relaxed and calm feeling; sleepiness

Incidence not known: Belching; bloated, full feeling; blurred or loss of vision; change in color perception; cold sweats; constricted, pinpoint, or small pupils (black part of the eye); cool, pale skin; double vision; excess air or gas in the stomach; false or unusual sense of well-being; flushed, dry skin; fruit-like breath odor; halos around lights; increased hunger or thirst; increased urination; lack or loss of strength; night blindness; nightmares; overbright appearance of lights; red eyes; redness of the skin; seeing, hearing, or feeling things that are not there; shakiness; slurred speech; trouble sleeping; tunnel vision; unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness; weight loss

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Last Updated: 11/16/2023

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