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Bayer Women's Aspirin With Calcium Side Effects

Generic name: aspirin

Note: This document contains side effect information about aspirin. Some of the dosage forms listed on this page may not apply to the brand name Bayer Women's Aspirin With Calcium.

Some side effects of Bayer Women's Aspirin With Calcium 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: oral delayed release capsule, oral delayed release tablet, oral gum, oral powder for reconstitution, oral tablet, oral tablet chewable, oral tablet disintegrating, oral tablet extended release

Get emergency medical help if you have any of these signs of an allergic reaction while taking aspirin (the active ingredient contained in Bayer Women's Aspirin With Calcium) hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using this medication and call your doctor at once if you have any of these serious side effects:

  • black, bloody, or tarry stools;

  • coughing up blood or vomit that looks like coffee grounds;

  • severe nausea, vomiting, or stomach pain;

  • fever lasting longer than 3 days;

  • swelling, or pain lasting longer than 10 days; or

  • hearing problems, ringing in your ears.

Less serious side effects of aspirin may include:

  • upset stomach, heartburn;

  • drowsiness; or

  • headache.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

Applies to aspirin: rectal suppository

Get emergency medical help if you have any of these signs of an allergic reaction while taking aspirin (the active ingredient contained in Bayer Women's Aspirin With Calcium) hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using this medicine and call your doctor at once if you have a serious side effect such as:

  • black, bloody, or tarry stools;

  • blood in your urine;

  • coughing up blood or vomit that looks like coffee grounds;

  • pale skin, easy bruising or bleeding;

  • wheezing, chest tightness, trouble breathing;

  • decreased hearing or ringing in the ears;

  • seizure (convulsions); or

  • dizziness, confusion, or hallucinations.

Less serious side effects of aspirin may include:

  • nausea, vomiting, stomach pain; or

  • rectal irritation.

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: compounding powder, oral delayed release capsule, oral delayed release tablet, oral gum, oral powder for reconstitution, oral tablet, oral tablet chewable, oral tablet disintegrating, oral tablet dispersible, oral tablet extended release, rectal suppository

Gastrointestinal

Endoscopically identifiable gastric mucosal lesions occur in most patients who receive a single dose of aspirin (the active ingredient contained in Bayer Women's Aspirin With Calcium) 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 (the active ingredient contained in Bayer Women's Aspirin With Calcium) 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 (the active ingredient contained in Bayer Women's Aspirin With Calcium) 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 (the active ingredient contained in Bayer Women's Aspirin With Calcium) 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 (the active ingredient contained in Bayer Women's Aspirin With Calcium) 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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