Prescription medicine

Aspirin and oxycodone

Aspirin and oxycodone is a prescription medicine. FDA's NDC Directory lists it from 1 generic labeler.

Generic listed
Boxed warning
DEA Schedule II

Check it at the source: the aspirin and oxycodone FDA label on DailyMed (effective December 17, 2025, Epic Pharma, LLC); every aspirin and oxycodone label on DailyMed.

Highlights of the record

FDA label of December 17, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026

Boxed warning

SERIOUS AND LIFE-THREATENING RISKS FROM USE OF OXYCODONE AND ASPIRIN TABLETS.

Addiction, Abuse, and Misuse Because the use of oxycodone and aspirin tablets 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 and reassess all patients regularly for the development of these behaviors and conditions (see WARNINGS ). Life-Threatening Respiratory Depression Serious, life-threatening, or fatal respiratory depression may occur with use of oxycodone and aspirin tablets, especially during initiation or following a dosage increase. To reduce the risk of respiratory depression, proper dosing and titration of oxycodone and aspirin tablets are essential (see WARNINGS ). Accidental Ingestion Accidental ingestion of even one dose of oxycodone and aspirin tablets, especially by children, can result in a fatal overdose of oxycodone (see WARNINGS ). Risks From Concomitant Use With Benzodiazepines Or Other CNS Depressants Concomitant use of opioids with benzodiazepines or central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. […]

Used for

From the label: indications and usage
Oxycodone and aspirin tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.

Forms and strengths

4.8355 mg / 325 mg

Tablet.

On the market

Generic approvals: 3 first March 16, 2011; 0 with a marketed status in Drugs@FDA
Labelers listed (NDC): 1 of which 1 under generic applications, 0 under brand applications, repackagers included

Supply and safety

Pharmacy cost (NADAC): Not in the survey
Shortage (FDA): No current entry
Recalls by its makers (FDA): No recall recorded
FAERS reports: 51 through July 30, 2026

What is aspirin and oxycodone used for?

From the label: indications and usage
Oxycodone and aspirin tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. […]

Conditions named in the indications of aspirin and oxycodone's FDA labels, with every medicine labeled for each:

Pain

From other aspirin and oxycodone labels
Pain: INDICATIONS AND USAGE Oxycodone and aspirin tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.

FDA pharmacologic class: Nonsteroidal Anti-inflammatory Drug, Opioid Agonist and Platelet Aggregation Inhibitor.

Source: FDA drug label (Oxycodone and Aspirin), Epic Pharma, LLC, effective December 17, 2025 (SPL set 3292a7c6-5ba3-4563-bc62-e43040634123), via openFDA; the full label on DailyMed

Is there a generic for aspirin and oxycodone?

The FDA approved the first generic aspirin and oxycodone on March 16, 2011. 3 generic applications are approved; 0 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.

FDA's NDC Directory lists aspirin and oxycodone from 1 labeler under a generic (ANDA) application. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.

Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)

What does the aspirin and oxycodone label say about other medicines?

The aspirin and oxycodone label names 19 other medicines in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.

Medicine named	Section	What the label says
Acetazolamide	drug interactions	Acetazolamide: Concurrent use of aspirin and acetazolamide can lead to high serum concentrations of acetazolamide (and toxicity) due to competition at the renal tubule for secretion.
Buprenorphine	warnings	Additionally, avoid the use of mixed agonist/antagonist (i.e., pentazocine, nalbuphine, and butorphanol) or partial agonist (buprenorphine) analgesics in patients who have received or are receiving a course of therapy with a full opioid agonist analgesic, including oxycodone and aspirin tablets.
Butorphanol	warnings	Additionally, avoid the use of mixed agonist/antagonist (i.e., pentazocine, nalbuphine, and butorphanol) or partial agonist (buprenorphine) analgesics in patients who have received or are receiving a course of therapy with a full opioid agonist analgesic, including oxycodone and aspirin tablets.
Carbamazepine	drug interactions	Inducers of CYP450 CYP450 inducers, such as rifampin, carbamazepine, and phenytoin, may induce the metabolism of oxycodone, may cause increased clearance of the drug which could lead to a decrease in oxycodone plasma concentrations.
Divalproex	drug interactions	Anticonvulsants: Salicylate can displace protein-bound phenytoin and valproic acid, leading to a decrease in the total concentration of phenytoin and an increase in serum valproic acid levels.
Erythromycin	drug interactions	Drug -Drug Interactions (see PRECAUTIONS) Inhibitors of CYP3A4 Since the CYP3A4 isoenzyme plays a major role in the metabolism of oxycodone and aspirin tablets, drugs that inhibit CYP3A4 activity, such as macrolide antibiotics (e.g., erythromycin), azole-antifungal agents (e.g., ketoconazole), and protease inhibitors …
Heparin	drug interactions	Anticoagulant Therapy (Heparin and Warfarin): Patients on anticoagulation therapy are at increased risk for bleeding because of drug-drug interactions and the effect on platelets.
Ketoconazole	drug interactions	… inhibit CYP3A4 activity, such as macrolide antibiotics (e.g., erythromycin), azole-antifungal agents (e.g., ketoconazole), and protease inhibitors (e.g., ritonavir), may cause decreased clearance of oxycodone, which could lead to an increase in oxycodone plasma concentrations.
Ketorolac	drug interactions	Aspirin may enhance the serious side effects and toxicity of ketorolac, due to displacement from its plasma protein binding sites and/or reduced renal clearance.
Methotrexate	drug interactions	Methotrexate: Aspirin may enhance the serious side and toxicity of methotrexate due to displacement from its plasma protein binding sites and/or reduced renal clearance.
Nalbuphine	warnings	Additionally, avoid the use of mixed agonist/antagonist (i.e., pentazocine, nalbuphine, and butorphanol) or partial agonist (buprenorphine) analgesics in patients who have received or are receiving a course of therapy with a full opioid agonist analgesic, including oxycodone and aspirin tablets.
Naloxone	warnings	Consider prescribing naloxone, based on the patient’s risk factors for overdose, such as concomitant use of other CNS depressants, a history of opioid use disorder, or prior opioid overdose.
Phenytoin	drug interactions	Inducers of CYP450 CYP450 inducers, such as rifampin, carbamazepine, and phenytoin, may induce the metabolism of oxycodone, may cause increased clearance of the drug which could lead to a decrease in oxycodone plasma concentrations.
Probenecid	drug interactions	Uricosuric Agents: Salicylates antagonize the uricosuric action of probenecid or sulfinpyrazone.

Every other medicine the aspirin and oxycodone label names

Medicine named	Section	What the label says
Rifampin	drug interactions	Inducers of CYP450 CYP450 inducers, such as rifampin, carbamazepine, and phenytoin, may induce the metabolism of oxycodone, may cause increased clearance of the drug which could lead to a decrease in …
Ritonavir	drug interactions	… azole-antifungal agents (e.g., ketoconazole), and protease inhibitors (e.g., ritonavir), may cause decreased clearance of oxycodone, which could lead to an increase in oxycodone plasma concentrations.
Valproic acid	drug interactions	Anticonvulsants: Salicylate can displace protein-bound phenytoin and valproic acid, leading to a decrease in the total concentration of phenytoin and an increase in serum valproic acid levels.
Voriconazole	drug interactions	A published study showed that the co-administration of the antifungal drug, voriconazole, increased oxycodone AUC and Cmax by 3.6 and 1.7 fold, respectively.
Warfarin	drug interactions	Anticoagulant Therapy (Heparin and Warfarin): Patients on anticoagulation therapy are at increased risk for bleeding because of drug-drug interactions and the effect on platelets.

Check aspirin and oxycodone against other medicines

Source: FDA drug label (Oxycodone and Aspirin), Epic Pharma, LLC, effective December 17, 2025 (SPL set 3292a7c6-5ba3-4563-bc62-e43040634123), via openFDA; the full label on DailyMed

What do FAERS reports show for aspirin and oxycodone?

The FDA Adverse Event Reporting System holds 51 reports that list aspirin and oxycodone among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 19 are coded as a death and 13 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.

The most reported reactions

Drug Ineffective (a use or a product term, not a reaction)9
Completed Suicide (an outcome recorded in the report)8
Nausea (named in the label)6
Pain (a use or a product term, not a reaction)6
Fatigue (named in the label)5
Off Label Use (a use or a product term, not a reaction)5
Asthenia4
Back Pain4

Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026

What else is labeled for the same conditions as aspirin and oxycodone?

28 other medicines are given the same way (oral) and in the same FDA class as aspirin and oxycodone or labeled mainly for the same use (pain), the same class first. Pain lists all 80 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.

Medicine	Shared indication	Generic labelers (oral)	Pharmacy cost	Shortage
Ibuprofen	Pain	273 labelers	$0.0573 per tablet 800 mg tablet	No current entry
Naproxen	Pain	146 labelers	$0.0565 per tablet 500 mg tablet	No current entry
Celecoxib	Pain	65 labelers	$0.0762 per capsule 200 mg capsule	No current entry
Acetaminophen and hydrocodone	Pain	38 labelers	$0.152 per tablet 10-325 mg tablet	No current entry
Diclofenac	Pain	67 labelers	$0.0619 per tablet 75 mg tablet	A presentation being discontinued
Meloxicam	Pain	43 labelers	$0.0166 per tablet 7.5 mg tablet	No current entry
Tramadol	Pain	40 labelers	$0.0248 per tablet 50 mg tablet	No current entry
Morphine	Pain	17 labelers	$0.226 per tablet 15 mg tablet	In shortage

Every medicine labeled for the same conditions as aspirin and oxycodone

Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)

What next?

Alternatives to aspirin and oxycodone: 28 medicines for the same use
Other NSAIDs: the pharmacologic class, with prices and generics
Aspirin and oxycodone side effects: the label's list beside FAERS reports
Check an interaction: what two or more labels say about each other