Ecotrin Side Effects

Generic Name: aspirin

Please note - some side effects for Ecotrin may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Side Effects of Ecotrin - for the Consumer

Ecotrin Delayed-Release Tablets

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Ecotrin Delayed-Release Tablets:

Heartburn; nausea; upset stomach.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); black or bloody stools; confusion; diarrhea; dizziness; drowsiness; hearing loss; ringing in the ears; severe stomach pain; vomiting.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

Side Effects by Body System - for Healthcare Professionals

Gastrointestinal

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.

The risk of developing dyspeptic events (i.e., epigastric pain, heartburn, nausea, ulcers) is low in rheumatic patients with no prior gastrointestinal symptoms who receive low-dose (less than 650 mg/day) aspirin therapy.

Gastrointestinal side effects 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 include hemorrhage, peptic ulcers, perforation, small bowel enteropathy, and esophageal ulcerations.

Renal

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.

Renal side effects 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.

Hematologic

Hematologic side effects have included increased blood fibrinolytic activity. In addition, hypoprothrombinemia, thrombocytopenia, thrombocyturia, megaloblastic anemia, and pancytopenia have been reported rarely. Aplastic anemia and eosinophilia have also been reported.

Hypersensitivity

Hypersensitivity side effects 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).

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).

Dermatologic

Dermatologic side effects have included Stevens-Johnson syndrome and a lichenoid eruption. In addition, isolated cases of unilateral aquagenic wrinkling of the palms and papuloerythroderma have been associated with aspirin therapy.

Hepatic

Hepatic side effects have included hepatotoxicity and cholestatic hepatitis.

Oncologic

Oncologic side effects have included reports of pancreatic cancer. 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.

Metabolic

Metabolic side effects 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.

Cardiovascular

A 29-year-old female with a history of migraine developed chest pain, tachycardia and orthopnea following aspirin consumption at doses of 1500 mg per day for several days. After discontinuation of aspirin therapy, the patient's symptoms promptly resolved. The patient consented to a pharmacological challenge test which once again triggered the symptoms.

Cardiovascular side effects have included salicylate-induced variant angina, ventricular ectopy, conduction abnormalities, and hypotension, particularly during salicylate toxicity. In addition, at least one case of fluid retention simulating acute congestive heart failure has been reported during aspirin therapy. Antiplatelet therapy has also been associated with acute deterioration of intracerebral hemorrhage.

Nervous system

Central nervous system side effects 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.

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.

Other

Reye's syndrome typically involves vomiting, neurologic dysfunction, and hepatic dysfunction during or shortly after an acute viral infection.

Other side effects have included Reye's syndrome with aspirin use in children with an acute viral illness. Reye's syndrome has also been reported even more rarely in adults.

Musculoskeletal

Musculoskeletal side effects have included rhabdomyolysis.

Respiratory

Respiratory side effects have included hyperpnea, pulmonary edema, and tachypnea.

Aspirin desensitization has been used to decrease disease activity and reduce the need for systemic corticosteroids in patients with aspirin-exacerbated respiratory disease.

Endocrine

Endocrine side effects have included hypoglycemia (which has been reported in children) and hyperglycemia.

Ocular

Ocular side effects have included cases of localized periorbital edema.

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