Oxycodone and aspirin (Oral)

Oxycodone and aspirin combination is used to relieve pain that is severe enough to need opioid treatment, especially when other pain medicines have not worked well enough or cannot be tolerated. Oxycodone is part of a group of medicines called narcotic analgesics (pain medicines) and works on the central nervous system (CNS) to relieve pain.

Aspirin is used to relieve pain and lower fever in patients. Aspirin is part of a group of medicines known as salicylates and works 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, leading to mental or physical dependence. However, people with ongoing pain should not let the fear of dependence stop 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 cause withdrawal side effects if treatment is stopped suddenly. However, severe withdrawal side effects can usually be avoided by gradually lowering the dose over time before stopping treatment completely.

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

It is very important that your doctor checks your progress while you are taking this medicine, especially during the first 24 to 72 hours of treatment. This will help your doctor see if the medicine is effective and decide if you should keep taking it. Blood and urine tests may be needed to check for side effects.

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

Using this medicine during pregnancy, especially in the later stages, may cause serious effects, including neonatal withdrawal syndrome in your newborn. Inform your doctor immediately if you think you are pregnant or 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). Using alcohol or other CNS-affecting medicines with Percodan® may increase side effects like dizziness, poor concentration, drowsiness, unusual dreams, and trouble sleeping. Some examples of these medicines include antihistamines, allergy or cold medicines, sedatives, tranquilizers, sleeping medicines, depression medications, anxiety medications, prescription pain medicines or narcotics, ADHD medications, seizure medications 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, seek emergency help immediately. Your doctor may 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 (e.g., sleep apnea, sleep-related hypoxemia). Your doctor may lower your dose if you have sleep apnea while using this medicine.

Do not change your dose or suddenly stop taking this medicine without first talking to your doctor. Your doctor may want you to gradually reduce your dose before stopping completely. This will lower your chance of experiencing 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 having surgery or medical tests.

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

Dizziness, lightheadedness, or fainting may occur when you get up suddenly from a lying or sitting position. Getting up slowly may help reduce this issue. Lying down for a while may relieve dizziness or lightheadedness. If this problem persists or worsens, contact your doctor immediately.

This medicine may make you dizzy, drowsy, or lightheaded. Do not drive or engage in activities that could be dangerous until you know how this medicine affects you.

This medicine may cause bleeding in your stomach or bowels. This can happen without warning signs and is more likely if you have had a stomach ulcer previously, drink alcohol regularly, are over 60 years old, are in poor health, or are using certain other medicines (e.g., NSAIDs).

This medicine may cause problems with your adrenal glands. Contact your doctor immediately if you experience 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. Contact your doctor immediately if you have bloody or black, tarry stools, heartburn, nausea, vomiting, stomach pain, or vomit 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 experience a rash, itching, hoarseness, trouble breathing, trouble swallowing, or swelling of your hands, face, or mouth while using this medicine.

Contact your doctor immediately 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 a serious skin reaction known as drug reaction with eosinophilia and systemic symptoms (DRESS).

For nursing mothers:

• Talk to your doctor if you have any questions about taking oxycodone or how this medicine may affect your baby.
• Call your doctor if you become extremely tired and have trouble 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.
• Seek immediate help from your doctor or hospital emergency room if your baby shows signs of increased sleepiness (more than usual), difficulty breastfeeding, difficulty breathing, or limpness. These may indicate an overdose and require immediate medical attention.

Contact your doctor right away if you experience 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 lead to infertility (inability to have children). Discuss with your doctor before using this medicine if you plan to have children.

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

In deciding to use a medicine, the chances of using the medication must be weighed against the beneficial it will do. This is a decision you and your clinician will make. For this drug, the following should be considered:

Allergies

Inform your doctor if you have ever had any unusual or allergic reaction to this drug or any other medicines. Additionally 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.

Pediatric

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.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific issues that would limit the usefulness of oxycodone and aspirin combination in the elderly. Nevertheless, elderly patients are more likely to have age-related liver, kidney, or lung issues, 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 medicine during breastfeeding. Weigh the potential benefits against the potential chances before taking this medication while breastfeeding.

Interactions with Medications

Although certain medications should not be used together at all, in other cases two different drugs may be used together even if an interaction might occur. In these cases, your clinician may want to change the dose, or other precautions may be necessary. When you are taking this medication, it is especially critical that your healthcare professional know if you are using 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 drugs is not advised. 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 drug with any of the following medications is usually not recommended, but may be required in some cases. If both drugs 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 medication with any of the following medications may cause an increased chance of certain side effects, but using both drugs may be the best therapy for you. If both drugs are prescribed together, your doctor may change the dose or how frequently 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

Interactions with Food/Tobacco/Alcohol

Certain medications 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 medication with any of the following is normally not advised, but may be unavoidable in some cases. If used together, your clinician may change the dose or how often you use this drug, or give you special instructions about the use of food, alcohol, or tobacco.

• Ethanol
• Grapefruit Juice

Using this medication 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 clinician may change the dose or how frequently you use this drug, or give you special instructions about the use of food, alcohol, or tobacco.

• Ethanol

Other Medical Issues

The presence of other medical problems may affect the use of this medication. Make sure you tell your clinician 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 (severe 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 issues) 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 raise risk for more severe adverse effects.

• Hemophilia (bleeding issue) or
• Kidney disease, severe or
• Liver disease, serious or
• Lung or breathing problems (eg, asthma, respiratory depression), serious 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, slight to moderate or
• Liver disease, slight to moderate—Use with caution. The effects may be increased since of slower removal of the medicine from the body.

Along with its necessary effects, this medicine may cause some unwanted effects. Not all of these side effects will occur, but if they do, they may require 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. Your health care professional may also be able to tell you how 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.

In the U.S.

• Endodan
• Percodan

Pharmacologic Class: NSAID

Chemical Class: Salicylate, Aspirin

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