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Roxiprin Side Effects

Generic Name: aspirin / oxycodone

Note: This document contains side effect information about aspirin / oxycodone. Some of the dosage forms listed on this page may not apply to the brand name Roxiprin.

For the Consumer

Applies to aspirin / oxycodone: oral tablet

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
  • Abdominal pain, cramping, or tenderness
  • 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
  • constipation
  • convulsions
  • coughing or vomiting blood
  • dark-colored urine
  • decrease in urine volume or frequency
  • decreased appetite
  • depression
  • difficult, fast, noisy breathing, sometimes with wheezing
  • difficulty in passing urine (dribbling)
  • 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 in the skin
  • large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
  • loss of consciousness
  • muscle cramping, weakness, or tremors
  • muscle pain or stiffness
  • nausea or vomiting
  • nosebleeds
  • numbness or tingling in the hands, feet, or lips
  • 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
  • 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
  • shivering
  • sleepiness
  • sunken eyes
  • sweating
  • swelling of face, ankles, hands, feet, or lower legs
  • thirst
  • tightness in the chest
  • unusual bleeding or bruising
  • unusual tiredness or weakness
  • 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
  • sleepiness or unusual drowsiness
  • 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

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

3. 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

4. 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

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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

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29. 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

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

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

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

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36. 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

37. 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

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. 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

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

42. 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

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

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

Some side effects of Roxiprin may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

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