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Cautions

Contraindications

• Known hypersensitivity to aspirin or any ingredient in the formulation.
• History of asthma, urticaria, or other sensitivity reaction precipitated by other NSAIAs.
• Syndrome of asthma, rhinitis, and nasal polyps.
• Children or adolescents with viral infections (with or without fever) because of the possibility that the infection may be one associated with an increased risk of Reye’s syndrome. (See Pediatric Use under Cautions.)

Warnings/Precautions

Warnings

Alcohol

Long-term heavy alcohol use (≥3 alcoholic beverages daily) associated with an increased risk of aspirin-induced bleeding. (See Advice to Patients.)

Hematologic Effects

Inhibits platelet aggregation and may prolong bleeding time. These effects may be particularly important in patients with inherited (e.g., hemophilia) or acquired (e.g., liver disease, vitamin K deficiency) bleeding disorders.

Because of the increased risk of bleeding, avoid aspirin-containing chewing gum tablets or gargles for ≥1 week after tonsillectomy or oral surgery.

GI Effects

Serious GI toxicity (e.g., bleeding, ulceration, perforation) can occur with or without warning symptoms. Increased risk in those with a history of GI bleeding or ulceration, geriatric patients, those receiving an anticoagulant, receiving prolonged therapy, taking multiple NSAIAs concomitantly, and consuming ≥3 alcohol-containing beverages daily.

Avoid in patients with active peptic ulcer disease; can cause gastric mucosal irritation and bleeding.

Thrombosis Associated with Drug-eluting Stents

Stent thrombosis with potentially fatal sequelae, particularly with drug-eluting stents (DES), associated with premature discontinuance (<12 months) of dual-drug therapy with a thienopyridine derivative and aspirin. (See Percutaneous Coronary Intervention and Revascularization Procedures under Uses.) For non-elective procedures that mandate premature discontinuance of thienopyridine-derivative therapy, continue aspirin therapy if at all possible. Restart thienopyridine therapy as soon as possible after the procedure. (See Advice to Patients.)

Sensitivity Reactions

Anaphylactoid reactions, severe urticaria, angioedema, or bronchospasm reported.

Immediate medical intervention and discontinuance for anaphylaxis.

Contraindicated in patients with syndrome of asthma, rhinitis, and nasal polyps; caution in patients with asthma.

General Precautions

Sodium Content

Avoid highly buffered aspirin preparations in patients with CHF, renal failure, or other conditions in which high sodium content would be harmful.

Individuals with Phenylketonuria

Some preparations contain aspartame (NutraSweet^®), which is metabolized in the GI tract to phenylalanine.

Use of Fixed Combinations

When aspirin is used in fixed combination with other agents, consider the cautions, precautions, and contraindications associated with the other agent(s).

Specific Populations

Pregnancy

Category C (Category D in third trimester).

Use only if clearly needed. Avoid use in the third trimester because of possible premature closure of the ductus arteriosus. Avoid 1 week prior to and during labor and delivery; aspirin use prior to and during labor associated with excessive blood loss at delivery.

Maternal and fetal hemorrhagic complications observed with maternal ingestion of large doses (e.g., 12–15 g daily) of aspirin generally have not been observed in studies in which low doses (60–150 mg daily) of the drug were used for prevention of complications of pregnancy†.

Lactation

Distributed into milk; use not recommended. High doses may result in adverse effects (rash, platelet abnormalities, bleeding) in nursing infants.

Pediatric Use

Dosing recommendations for juvenile rheumatoid arthritis based on well controlled clinical studies. High dosages that result in plasma concentrations >200 mcg/mL associated with an increased incidence of toxicity.

Use in children with varicella infection or influenza-like illnesses reportedly is associated with an increased risk of developing Reye’s syndrome. US Surgeon General, AAP Committee on Infectious Diseases, FDA, and other authorities advise that salicylates not be used in children and teenagers with varicella or influenza, unless directed by a clinician. Generally avoid salicylates in children and teenagers with suspected varicella or influenza and during presumed outbreaks of influenza, since accurate diagnosis of these diseases may be impossible during the prodromal period; use of salicylates in the management of viral infections in children or adolescents is contraindicated, since the infection may be one associated with an increased risk of Reye’s syndrome.

Use with caution in pediatric patients who are dehydrated (increased susceptibility to salicylate intoxication).

Safety and efficacy of aspirin in fixed combination with extended-release dipyridamole not established.

Risk of overdosage and toxicity (including death) in children <2 years of age receiving preparations containing antihistamines, cough suppressants, expectorants, and nasal decongestants alone or in combination for relief of symptoms of upper respiratory tract infection. Limited evidence of efficacy for these preparations in this age group; appropriate dosages not established. Use such preparations in children <2 years of age with caution and only as directed by clinician. Clinicians should ask caregivers about use of OTC cough/cold preparations to avoid overdosage.

Hepatic Impairment

Avoid in patients with severe hepatic impairment.

Renal Impairment

Avoid in patients with GFR <10 mL/minute.

Common Adverse Effects

Minor upper GI symptoms (dyspepsia).