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Bayer ASA Side Effects, and Drug Interactions - Aspirin
SIDE EFFECTS
Antiarthritic Effect
In MI Prophylaxis
Gastrointestinal reactions: Doses of 1,000 mg per day of aspirin caused gastrointestinal symptoms and bleeding that, in some cases, were clinically significant. In the largest postinfarction study (the Aspirin Myocardial Infarction Study (AMIS) with 4,500 people), the percentage of incidences of gastrointestinal symptoms for the aspirin (1,000 mg of a standard, solid-tablet formulation) and placebo-treated subjects, respectively, were stomach pain (14.5%, 4.4%), heartburn (11.9%, 4.8%), nausea and/or vomiting (7.6%, 2.1%), hospitalization for GI disorder (4.9%, 3.5%). In the A.I. and other trials, aspirin-treated patients had increased rates of gross gastrointestinal bleeding. Symptoms and signs of gastrointestinal irritation were not significantly increased in subjects treated for unstable angina with buffered aspirin in solution.
Cardiovascular and Biochemical: In the A.I. trial, the dosage of 1,000 mg per day of aspirin was associated with small increases in systolic blood pressure (BP) (average 1.5 to 2.1 mm) and diastolic BP (0.5 to 0.6 mm), depending upon whether maximal or last available readings were used. Blood urea nitrogen and uric acid levels were also increased but by less than 1.0 mg percent. Subjects with marked hypertension or renal insufficiency had been excluded from the trial so that the clinical importance of these observations for such subjects or for any subjects treated over more prolonged periods is not known. It is recommended that patients placed on long-term aspirin treatment, even at doses of 300 mg per day, be seen at regular intervals to assess changes in these measurements.
In Transient Ischemic Attacks
At dosages of 1,000 milligrams or higher of aspirin per day, gastrointestinal side effects include stomach pain, heartburn, nausea and/or vomiting, as well as increased rates of gross gastrointestinal bleeding.
DRUG INTERACTIONS
Anticoagulants: See WARNINGS
section.
Hypoglycemic Agents: See WARNINGS
section.
Uricosuric Agents: Aspirin may decrease the effects
of probenecid, sulfinpyrazone, and phenylbutazone.
Spironolactone: See PRECAUTIONS
section.
Alcohol: Has a synergistic
effect with aspirin
in causing gastrointestinal bleeding.
Corticosteroids: Concomitant administration
with aspirin may increase
the risk of gastrointestinal
ulceration and may
reduce serum
salicylate levels.
Pyrazolone Derivatives (phenylbutazone, oxyphenbutazone, and
possibly dipyrone): Concomitant administration
with aspirin may increase
the risk of gastrointestinal
ulceration.
Nonsteroidal Antiinflammatory Agents: Aspirin is contraindicated
in patients who are hypersensitive
to nonsteroidal antiinflammatory agents.
Urinary Alkalinizers: Decrease aspirin
effectiveness
by increasing the rate of salicylate
renal excretion.
Phenobarbital: Decreases aspirin
effectiveness
by enzyme induction.
Phenytoin: Serum phenytoin
levels may be increased by aspirin.
Propranolol: May decrease aspirin's antiinflammatory
action by competing for
the same receptors. Antacids: Enteric Coated Aspirin
should not be given concurrently with antacids, since an increase
in the pH of the stomach
may effect the enteric
coating of the tablets.
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