Axotal Side Effects
Generic Name: aspirin / butalbital
Note: This document contains side effect information about aspirin / butalbital. Some of the dosage forms listed on this page may not apply to the brand name Axotal.
Applies to aspirin/butalbital: oral tablet
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 treated elderly patients. Anorectal ulceration and rectal stenosis have been reported in patients who abuse aspirin-containing rectal suppositories. One case-controlled study has suggested that an association between aspirin (and other NSAID) consumption and appendicitis may exist.[Ref]
Gastrointestinal side effects have been common and have included 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 have included hemorrhage, peptic ulcers, perforation, and esophageal ulcerations.
Nausea, vomiting, and abdominal pain have been reported frequently with the use of butalbital.[Ref]
Renal side effects of aspirin have included 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]
The mechanism of an 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]
Hematologic side effects of aspirin (in addition to predictable antiplatelet effects which may result in hemorrhage) have included increased blood fibrinolytic activity. In addition, hypoprothrombinemia, thrombocytopenia, thrombocyturia, megaloblastic anemia, and pancytopenia have been reported rarely. Aplastic anemia has also been reported.[Ref]
Regarding the use of aspirin, some investigators have suggested that tinnitus may be a less reliable indicator of salicylate toxicity than previously believed. Patients with high frequency hearing loss may have difficulty perceiving tinnitus. In a study of rheumatoid arthritis patients, those with tinnitus had no greater salicylate levels than those without tinnitus. Elderly patients may be less likely to perceive tinnitus than younger patients.[Ref]
Nervous system side effects in patients receiving aspirin have included agitation, cerebral edema, coma, confusion, dizziness, headache, cranial hemorrhage, lethargy, and seizures. Tinnitus and subjective hearing loss (or both) may occur. Some investigators have reported that modest doses may result in decreased frequency selectivity and may therefore impair hearing performance, particularly in the setting of background noise.
Drowsiness, lightheadedness, dizziness, sedation, and an intoxicated feeling have been reported frequently from the use of butalbital. Headache and seizures have been reported infrequently. Mental confusion, excitement, or depression have also been reported due to either intolerance (primarily in elderly or debilitated patients) or due to an overdose of butalbital.[Ref]
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).[Ref]
Hypersensitivity side effects of aspirin have included 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]
Dermatologic side effects from the use of aspirin have been reported rarely and included Stevens-Johnson syndrome and a lichenoid eruption.[Ref]
Hepatic side effects including cases of aspirin-induced hepatotoxicity and cholestatic hepatitis, particularly at high doses, have been reported rarely.[Ref]
Oncologic side effects of decreased risk have been reported. Several epidemiologic studies have suggested that chronic aspirin use may decrease the risk of large bowel neoplasms. Other studies have not found such a beneficial effect.[Ref]
Metabolic side effects of aspirin have included dehydration and hyperkalemia. Respiratory alkalosis and metabolic acidosis, particularly during salicylate toxicity, have been reported. 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]
Cardiovascular side effects of aspirin including salicylate-induced variant angina, ventricular ectopy, conduction abnormalities, and hypotension (particularly during salicylate toxicity) have been reported rarely.[Ref]
Other side effects have included Reye's syndrome. 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.
Prolonged labor and pregnancy, decreased infant birth weight and stillborn births, antepartum and postpartum bleeding have occurred due to aspirin use by women during the third trimester of pregnancy.[Ref]
Reye's syndrome typically involves vomiting, neurologic dysfunction, and hepatic dysfunction during or shortly after an acute viral infection.[Ref]
In general, side effects noted with aspirin use are dose-related.[Ref]
Musculoskeletal side effects including rhabdomyolysis have occurred in patients receiving aspirin.[Ref]
Endocrine side effects of aspirin use have been reported to include hypoglycemia (children) and hyperglycemia.[Ref]
Ocular side effects including cases of localized periorbital edema have been reported rarely in patients receiving aspirin.[Ref]
1. Petty GW, Brown RD, Whisnant JP, Sicks JD, O'Fallon WM, Wiebers DO "Frequency of major complications of aspirin, warfarin, and intravenous heparin for secondary stroke prevention: a population study." Ann Intern Med 130 (1999): 14-22
2. Lanas A, Serrano P, Bajador E, Esteva F, Benito R, Sainz R "Evidence of aspirin use in both upper and lower gastrointestinal perforation." Gastroenterology 112 (1997): 683-9
3. Dickinson JP, Prentice CRM "Aspirin: benefit and risk in thromboprophylaxis." Qjm Mon J Assoc Physician 91 (1998): 523-38
4. He J, Whelton PK, Vu B, Klag MJ "Aspirin and risk of hemorrhagic stroke: a meta-analysis of randomized controlled trials." JAMA 280 (1998): 1930-35
5. Boissel JP "Individualizing aspirin therapy for prevention of cardiovascular events." JAMA 280 (1998): 1949-50
6. Surks MI, Sievert R "Drugs and thyroid function." N Engl J Med 333 (1995): 1688-94
7. "Product Information. Bayer aspirin (aspirin)." Bayer, West Haven, CT.
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Some side effects may not be reported. You may report them to the FDA.