Aspirin / oxycodone Side Effects

Not all side effects for aspirin / oxycodone may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

For the Consumer

Applies to aspirin / oxycodone: oral tablet

In addition to its needed effects, some unwanted effects may be caused by aspirin / oxycodone. In the event that any of these side effects do occur, they may require medical attention.

You should check with your doctor immediately if any of these side effects occur when 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 or itching
  • 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
  • low body temperature
  • 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
  • shortness of breath
  • skin rash
  • 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
  • wheezing
  • wrinkled skin
  • yellow eyes or skin

If any of the following symptoms of overdose occur while taking aspirin / oxycodone, get emergency help immediately:

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 of the side effects that can occur with aspirin / oxycodone may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

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

Psychosis has also been reported during withdrawal from oxycodone.[Ref]

Oxycodone may be habit forming. Withdrawal symptoms after either abrupt cessation or fast tapering may occur and include agitation, restlessness, anxiety, insomnia, tremor, abdominal cramps, piloerection, blurred vision, vomiting, and sweating.[Ref]

Gastrointestinal

Gastrointestinal effects of aspirin are common and include epigastric distress, (in as many as 83% of patients treated with regular aspirin), abdominal discomfort or pain, endoscopically identifiable gastric mucosal lesions, nausea, and vomiting. More serious gastrointestinal effects include hemorrhage, peptic ulcers, perforation, and esophageal ulcerations. Nausea, vomiting, and constipation occur commonly with oxycodone.[Ref]

Endoscopically identifiable gastric mucosal lesions occur in most patients who receive a single dose of aspirin. Clinically evident gastrointestinal bleeding has been reported in as many as 3% of elderly patients taking aspirin.

One case controlled study has suggested that an association between aspirin (and other NSAID) consumption and appendicitis may exist.[Ref]

Nervous system

Severe adverse effects of oxycodone, such as respiratory depression, can be treated with the opioid antagonist naloxone. (The usual adult dose of naloxone is 1 to 2 mg every 5 minutes as necessary. The dose is usually administered intravenously, but in an emergency may be given intramuscularly, subcutaneously, or sublingually.)

Some investigators have suggested that tinnitus may be a less reliable indicator of salicylate toxicity than previously believed. In one study of rheumatoid arthritis patients, those with tinnitus had no greater salicylate levels than those without tinnitus. In addition, elderly patients may be less likely to perceive tinnitus than younger patients.[Ref]

Nervous system side effects of oxycodone containing products are common and include drowsiness, sedation, dizziness, and lightheadedness. Respiratory depression has also been reported. Tinnitus and subjective hearing loss (or both) may occur with aspirin. Some investigators have reported that modest aspirin doses may result in decreased frequency selectivity and may therefore impair hearing performance, particularly in the setting of background noise.[Ref]

Renal

The mechanism of aspirin induced decrease in renal function may be related to inhibition of renal prostaglandin synthesis with consequent decreases in renal blood flow. Vasodilating renal prostaglandins may be particularly important in patients who exhibit arterial underfilling (i.e. heart failure, cirrhosis). The administration of high doses of NSAIDs to such patients has produced acute renal failure in rare instances.[Ref]

Renal effects of aspirin include reduction in glomerular filtration rate (particularly in patients who are sodium restricted or who exhibit diminished effective arterial blood volume, such as patients with advanced heart failure or cirrhosis), interstitial nephritis, papillary necrosis, elevations in serum creatinine, elevations in blood urea nitrogen, proteinuria, hematuria, and renal failure.[Ref]

Hematologic

Hematologic effects of aspirin (in addition to predictable antiplatelet effects which may result in hemorrhage) include increased blood fibrinolytic activity. Hypoprothrombinemia, thrombocytopenia, thrombocyturia, megaloblastic anemia, aplastic anemia, and pancytopenia have been reported rarely.[Ref]

Hypersensitivity

The mechanism of aspirin induced hypersensitivity may be related to an up regulation of the 5-lipoxygenase pathway of arachidonic acid metabolism with a resulting increase in the products of 5-lipoxygenase (such as leukotrienes).

Cases of localized periorbital edema have been reported rarely during aspirin therapy.[Ref]

Aspirin hypersensitivity reactions include bronchospasm, rhinitis, conjunctivitis, urticaria, angioedema, and anaphylaxis. Approximately 10% to 30% of asthmatics are aspirin-sensitive (with the clinical triad of aspirin sensitivity, bronchial asthma and nasal polyps).[Ref]

Cardiovascular

Cardiovascular effects of aspirin have been reported rarely and include salicylate induced variant angina, ventricular ectopy, and conduction abnormalities. These problems are most commonly encountered during salicylate toxicity.[Ref]

Oncologic

Several epidemiologic studies have suggested that chronic aspirin use may decrease the risk of large bowel neoplasms. However, other studies have not found such a beneficial effect. Since aspirin-oxycodone is most commonly used for short term therapy, this effect is unlikely to be seen.[Ref]

Metabolic

Metabolic side effects of aspirin include respiratory alkalosis and metabolic acidosis, particularly during salicylate toxicity. A case of hypoglycemia has been reported in a patient on hemodialysis. Salicylates have also been reported to displace triiodothyronine (T3) and thyroxine (T4) from protein binding sites. The initial effect is an increase in serum free T4 concentrations.[Ref]

Other

Reye's syndrome, although rare, has been associated with aspirin use in children with an acute viral illness. Reye's syndrome has also been reported even more rarely in adults. Full strength aspirin-oxycodone is generally not used in children.[Ref]

Reye's syndrome (associated with aspirin therapy) typically involves vomiting, neurologic dysfunction, and hepatic dysfunction during or shortly after an acute viral infection.[Ref]

Hepatic

Cases of aspirin induced hepatotoxicity and cholestatic hepatitis, particularly at high doses, have been reported rarely.[Ref]

Psychiatric

Psychiatric adverse effects of oxycodone reported include paranoia, psychosis, and hallucinations.[Ref]

Dermatologic

Oxycodone may produce pruritus. Other dermatologic effects have been reported rarely with aspirin and include Stevens-Johnson syndrome and lichenoid eruption.[Ref]

References

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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

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42. Greenberg ER, Baron JA, Freeman DH Jr, Mandel JS, Haile R "Reduced risk of large-bowel adenomas among aspirin users. The Polyp Prevention Study Group." J Natl Cancer Inst 85 (1993): 912-6

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