Endodan 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 Endodan.
Some side effects of Endodan may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.
For the Consumer
Applies to aspirin / oxycodone: oral tablet
Get emergency medical help if you have any of these signs of an allergic reaction while taking aspirin / oxycodone: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have a serious side effect such as:
severe stomach pain or constipation, vomiting;
black, bloody, or tarry stools, coughing up blood or vomit that looks like coffee grounds;
weak or shallow breathing, fast or slow heartbeats;
confusion, hallucinations, feeling like you might pass out;
easy bruising or bleeding;
decreased hearing, ringing in your ears.
Less serious side effects of aspirin / oxycodone may include:
headache, dizziness, drowsiness;
constipation, heartburn, upset stomach, bloating, gas, diarrhea; or
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.
For Healthcare Professionals
Applies to aspirin / oxycodone: oral tablet
Psychosis has also been reported during withdrawal from oxycodone.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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).
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.
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.
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.
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.
Reye's syndrome (associated with aspirin therapy) typically involves vomiting, neurologic dysfunction, and hepatic dysfunction during or shortly after an acute viral infection.
Cases of aspirin induced hepatotoxicity and cholestatic hepatitis, particularly at high doses, have been reported rarely.
Psychiatric adverse effects of oxycodone reported include paranoia, psychosis, and hallucinations.
Oxycodone may produce pruritus. Other dermatologic effects have been reported rarely with aspirin and include Stevens-Johnson syndrome and lichenoid eruption.
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