Skip to Content

Aspirin / oxycodone Side Effects

For the Consumer

Applies to aspirin / oxycodone: oral tablet

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 .

Along with its needed effects, aspirin / oxycodone 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 while taking aspirin / oxycodone:

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 or discomfort
  • chills
  • clay-colored stools
  • confusion
  • constipation
  • 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 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 cramping, weakness, or tremors
  • muscle pain or stiffness
  • 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
  • tightness in the chest
  • 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 while taking aspirin / oxycodone:

Symptoms of Overdose

  • Continuing ringing or buzzing or other unexplained noise in the ears
  • decreased awareness or responsiveness
  • diarrhea
  • drowsiness
  • enlarged pupils
  • extremely high fever or body temperature
  • fast, weak heartbeat
  • hearing loss
  • increase in heart rate
  • restlessness
  • severe sleepiness

Some side effects of aspirin / oxycodone 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

For Healthcare Professionals

Applies to aspirin / oxycodone: oral tablet

General

The most commonly reported adverse events have included lightheadedness, dizziness, drowsiness, sedation, nausea, and vomiting.[Ref]

Gastrointestinal

Oxycodone-Aspirin:

Frequency not reported: Nausea, vomiting, constipation

Postmarketing reports: Hemorrhagic gastric/duodenal ulcer, gastric/peptic ulcer, dyspepsia, abdominal pain, diarrhea, eructation, dry mouth, gastrointestinal bleeding, intestinal perforation, pancreatitis, intestinal obstruction, ileus, thirst, aspiration

Aspirin:

Frequency not reported: Anorexia[Ref]

Nervous system

Frequency not reported: Lightheadedness, dizziness, drowsiness, sedation

Postmarketing reports: Stupor, paresthesia, cerebral edema, coma, subdural or intracranial hemorrhage, seizures

Opioids:

Postmarketing reports: Serotonin syndrome[Ref]

Renal

Postmarketing reports: Renal insufficiency and failure[Ref]

Hematologic

Oxycodone-aspirin:

Postmarketing reports: Unspecified hemorrhage, purpura, reticulocytosis, prolongation of prothrombin time, disseminated intravascular coagulation, ecchymosis, thrombocytopenia

Aspirin:

Frequency not reported: Leukopenia, thrombocytopenia, purpura, decreased iron concentration, shortened erythrocyte survival time[Ref]

Hypersensitivity

Postmarketing reports: Anaphylaxis, allergic reaction, angioedema[Ref]

Cardiovascular

Frequency not reported: Hypotension

Postmarketing reports: Tachycardia, dysrhythmias, orthostatic hypotension, bradycardia, palpitations[Ref]

Metabolic

Postmarketing reports: Hypoglycemia, hyperglycemia, acidosis, alkalosis, dehydration, hyperkalemia[Ref]

Other

Postmarketing reports: Malaise, asthenia, hypothermia, accidental overdose, non-accidental overdose, hearing loss, tinnitus[Ref]

Hepatic

Oxycodone-aspirin:

Postmarketing reports: Transient elevations of hepatic enzymes, hepatitis, Reye syndrome

Aspirin:

Frequency not reported: Reversible hepatotoxicity[Ref]

Psychiatric

Frequency not reported: Euphoria, dysphoria

Postmarketing reports: Agitation, confusion, anxiety, mental impairment, drug dependence, drug abuse, depression, nervousness, hallucination[Ref]

Dermatologic

Frequency not reported: Pruritus

Postmarketing reports: Urticaria, rash, flushing, increased sweating[Ref]

Musculoskeletal

Postmarketing reports: Rhabdomyolysis

Ocular

Postmarketing reports: Miosis, visual disturbances, red eye

Genitourinary

Frequency not reported: Urinary retention, interstitial nephritis, proteinuria

Respiratory

Frequency not reported: Apnea, respiratory arrest, respiratory depression

Postmarketing reports: Bronchospasm, dyspnea, hyperpnea, pulmonary edema, tachypnea, hypoventilation, laryngeal edema

Endocrine

Adrenal insufficiency and androgen deficiency have been reported with opioid use, most often with chronic use.

Opioids:

Postmarketing reports: Adrenal insufficiency, androgen deficiency

References

1. Leow KP, Smith MT, Watt JA, Williams BE, Cramond T "Comparative oxycodone pharmacokinetics in humans after intravenous, oral, and rectal administration." Ther Drug Monit 14 (1992): 479-84

2. Glare P, Walsh D "Dose-ranging study of oxycodone for advanced cancer pain (meeting abstract)." Proc Annu Meet Am Soc Clin Oncol 10 (1991): a1201

3. Roderick PJ, Wilkes HC, Meade TW "The gastrointestinal toxicity of aspirin: an overview of randomised controlled trials." Br J Clin Pharmacol 35 (1993): 219-26

4. Thirlby RC "More problems with aspirin: it may cause appendicitis." Gastroenterology 104 (1993): 1571-3

5. Naschitz JE, Yeshurun D, Odeh M, Bassan H, Rosner I, Stermer E, Levy N "Overt gastrointestinal bleeding in the course of chronic low-dose aspirin administration for secondary prevention of arterial occlusive disease." Am J Gastroenterol 85 (1990): 408-11

6. Bergmann JF, Chassany O, Geneve J, Abiteboul M, Caulin C, Segrestaa JM "Endoscopic evaluation of the effect of ketoprofen, ibuprofen and aspirin on the gastroduodenal mucosa." Eur J Clin Pharmacol 42 (1992): 685-8

7. Levy M, Miller DR, Kaufman DW, Siskind V, Schwingl P, Rosenberg L, Strom B, Shapiro S "Major upper gastrointestinal tract bleeding. Relation to the use of aspirin and other nonnarcotic analgesics." Arch Intern Med 148 (1988): 281-5

8. Silagy CA, McNeil JJ, Donnan GA, Tonkin AM, Worsam B, Campion K "Adverse effects of low-dose aspirin in a healthy elderly population." Clin Pharmacol Ther 54 (1993): 84-9

9. Sabesin SM, Boyce HW Jr, King CE, Mann JA, Ruoff G, Wall E "Comparative evaluation of gastrointestinal intolerance produced by plain and tri-buffered aspirin tablets." Am J Gastroenterol 83 (1988): 1220-5

10. Sunshine A, Olson NZ, Zighelboim I, Decastro A "Ketoprofen, acetaminophen plus oxycodone, and acetaminophen in the relief of postoperative pain." Clin Pharmacol Ther 54 (1993): 546-55

11. Prichard PJ, Kitchingman GK, Walt RP, Daneshmend TK, Hawkey CJ "Human gastric mucosal bleeding induced by low dose aspirin, but not warfarin." BMJ 298 (1989): 493-6

12. Mehta S, Dasarathy S, Tandon RK, Mathur M, Malaviya AN "A prospective randomized study of the injurious effects of aspirin and naproxen on the gastroduodenal mucosa in patients with rheumatoid arthritis." Am J Gastroenterol 87 (1992): 996-1000

13. Wilcox CM, Shalek KA, Cotsonis G "Striking prevalence of over-the-counter nonsteroidal anti- inflammatory drug use in patients with upper gastrointestinal hemorrhage." Arch Intern Med 154 (1994): 42-6

14. Glare PA, Walsh TD "Dose-ranging study of oxycodone for chronic pain in advanced cancer." J Clin Oncol 11 (1993): 973-8

15. Leow KP, Smith MT, Williams B, Cramond T "Single-dose and steady-state pharmacokinetics and pharmacodynamics of oxycodone in patients with cancer." Clin Pharmacol Ther 52 (1992): 487-95

16. Graham DY, Smith JL "Aspirin and the stomach." Ann Intern Med 104 (1986): 390-8

17. D'Haens G, Breysem Y, Rutgeerts P, van Besien B, Geboes K, Ponette E, Vantrappen G "Proctitis and rectal stenosis induced by nonsteroidal antiinflammatory suppositories." J Clin Gastroenterol 17 (1993): 207-12

18. Boettcher FA, Salvi RJ "Salicylate ototoxicity: review and synthesis." Am J Otolaryngol 12 (1991): 33-47

19. Carlyon RP, Butt M "Effects of aspirin on human auditory filters." Hear Res 66 (1993): 233-44

20. Halla JT, Hardin JG "Salicylate ototoxicity in patients with rheumatoid arthritis: a controlled study." Ann Rheum Dis 47 (1988): 134-7

21. Muther RS, Potter DM, Bennett WM "Aspirin-induced depression of glomerular filtration rate in normal humans: role of sodium balance." Ann Intern Med 94 (1981): 317-21

22. Maher JF "Analgesic nephropathy. Observations, interpretations, and perspective on the low incidence in America." Am J Med 76 (1984): 345-8

23. Kimberly RP, Plotz PH "Aspirin-induced depression of renal function." N Engl J Med 296 (1977): 418-24

24. Riegger GA, Kahles HW, Elsner D, Kromer EP, Kochsiek K "Effects of acetylsalicylic acid on renal function in patients with chronic heart failure." Am J Med 90 (1991): 571-5

25. Carmichael J, Shankel SW "Effects of nonsteroidal anti-inflammatory drugs on prostaglandins and renal function." Am J Med 78 (1985): 992-1000

26. Wen SF, Parthasarathy R, Iliopoulos O, Oberley TD "Acute renal failure following binge drinking and nonsteroidal antiinflammatory drugs." Am J Kidney Dis 20 (1992): 281-5

27. Williams JO, Mengel CE, Sullivan LW, Haq AS "Megaloblastic anemia associated with chronic ingestion of an analgesic." N Engl J Med 280 (1969): 312-3

28. Eldar M, Aderka D, Shoenfeld Y, Livni E, Pinkhas J "Aspirin-induced aplastic anaemia." S Afr Med J 55 (1979): 318

29. Sutor AH "Thrombocyturia after aspirin." N Engl J Med 288 (1973): 794-5

30. Fausa O "Salicylate-induced hypoprothrombinemia: a report of four cases." Acta Med Scand 188 (1970): 403-8

31. Barrow MV, Quick DT, Cunningham RW "Salicylate hypoprothrombinemia in rheumatoid arthritis with liver disease. Report of two cases." Arch Intern Med 120 (1967): 620-4

32. Moroz LA "Increased blood fibrinolytic activity after aspirin ingestion." N Engl J Med 296 (1977): 525-9

33. Wijnja L, Snijder JA, Nieweg HO "Acetylsalicylic acid as a cause of pancytopenia from bone-marrow damage." Lancet 2 (1966): 768-70

34. Katz Y, Goldberg N, Kivity S "Localized periorbital edema induced by aspirin." Allergy 48 (1993): 366-9

35. Lee TH "Mechanism of bronchospasm in aspirin-sensitive asthma." Am Rev Respir Dis 148 (1993): 1442-3

36. Kowalski ML, Sliwinska-Kowalska M, Igarashi Y, White MV, Wojciechowska B, Brayton P, Kaulbach H, Rozniecki J, Kaliner MA "Nasal secretions in response to acetylsalicylic acid." J Allergy Clin Immunol 91 (1993): 580-98

37. Israel E, Fischer AR, Rosenberg MA, Lilly CM, Callery JC, Shapiro J, Cohn J, Rubin P, Drazen JM "The pivotal role of 5-lipoxygenase products in the reaction of aspirin-sensitive asthmatics to aspirin." Am Rev Respir Dis 148 (1993): 1447-51

38. Mukerji V, Alpert MA, Flaker GC, Beach CL, Weber RD "Cardiac conduction abnormalities and atrial arrhythmias associated with salicylate toxicity." Pharmacotherapy 6 (1986): 41-3

39. Al-Abbasi AH "Salicylate-induced variant angina." Am Heart J 106 (1983): 1450

40. Berg KJ "Acute acetylsalicylic acid poisoning: treatment with forced alkaline diuresis and diuretics." Eur J Clin Pharmacol 12 (1977): 111-6

41. David DS, Steere AC Jr, Pi-Sunyer XF, Sakai S, Clark SB "Aspirin-induced hypoglycaemia in a patient on haemodialysis." Lancet 2 (1971): 1092-3

42. Gardos G "Dyskinesia after discountinuation of compound analgesic containing oxycodone ." Lancet 1 (1977): 759-60

43. Fishbain DA, Goldberg M, Rosomoff RS, Rosomoff H "Atypical withdrawal syndrome (organic delusional syndrome) secondary to oxycodone detoxification ." J Clin Psychopharmacol 8 (1988): 441-2

44. Peters LJ, Wiener GJ, Gilliam J, Van Noord G, Geisinger KR, Roach ES "Reye's syndrome in adults. A case report and review of the literature." Arch Intern Med 146 (1986): 2401-3

45. Epidemiology Office, Divisiion of Viral and Rickettsial Diseasses, Center for Infectious Diseases, Centers for Disease Control. "Leads from the MMWR. Reye syndrome surveillance--United States, 1987 and 1988." JAMA 261 (1989): 3520,

46. Sbarbaro JA, Bennett RM "Aspirin hepatotoxicity and disseminated intravascular coagulation." Ann Intern Med 86 (1977): 183-5

47. Wolfe JD, Metzger AL, Goldstein RC "Aspirin hepatitis." Ann Intern Med 80 (1974): 74-6

48. Pearson RE, Salter FJ "Drug interaction? Orphenadrine with propoxyphene." N Engl J Med 282 (1970): 1215

49. Seaman WE, Ishak KG, Plotz PH "Aspirin-induced hepatotoxicity in patients with systemic lupus erythematosus." Ann Intern Med 80 (1974): 1-8

50. Analysis of Reports to the Spontaneous Reporting System of the Gruppo Italiano Studi Epidemiiologici in Dermatologia. "Cutaneous reactions to analgesic-antipyretics and nonsteroidal anti- inflammatory drugs." Dermatology 186 (1993): 164-9

51. Bharija SC, Belhaj MS "Acetylsalicylic acid may induce a lichenoid eruption." Dermatologica 177 (1988): 19

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

Hide