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Role of pharmacist
Its side effects are mainly gastric disorders and allergies
Endoscopically identifiable gastric mucosal lesions occur in most patients who receive a single dose of aspirin (the active ingredient contained in Acetylsalicylic Acid) 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.
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 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.
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).
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).
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 Acetylsalicylic Acid) therapy.
Hepatic side effects have included hepatotoxicity and cholestatic hepatitis.
Oncologic side effects have included reports of pancreatic cancer. Several epidemiologic studies have suggested that chronic aspirin (the active ingredient contained in Acetylsalicylic Acid) use may decrease the risk of large bowel neoplasms. However, other studies have not found such a beneficial effect.
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
A 29-year-old female with a history of migraine developed chest pain, tachycardia and orthopnea following aspirin (the active ingredient contained in Acetylsalicylic Acid) 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.
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.
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 side effects have included rhabdomyolysis
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 side effects have included hypoglycemia (which has been reported in children) and hyperglycemia
Ocular side effects have included cases of localized periorbital edema
Indomethacin Side EffectsVery common (10% or more): Nausea (up to 34%), vomiting (up to 12%)Common (1% to 10%): Constipation, diarrhea, dyspepsia, upper abdominal pain, abdominal pain/distress, indigestion, heartburn, epigastric pain, gastrointestinal (GI) bleeding, gastrointestinal perforation, necrotizing enterocolitis Uncommon (0.1% to 1%): Anorexia, bloating/distention, flatulence, peptic ulcer, gastroenteritis, rectal bleeding, proctitis, ulcerations/perforations/hemorrhage of the esophagus, stomach, duodenum, or small and large intestines, intestinal ulceration, stenosis, obstruction, development of ulcerative colitis, development of regional ileitis, ulcerative stomatitis, intestinal strictures Frequency not reported: Gastric perforation, gastritis, bleeding from sigmoid colon, perforation of existing sigmoid lesions, tenesmus, irritation of rectal mucosa, rectal burning/pain, rectal itching/discomfort, glossitis, esophageal lesions, tenesmusPatent Ductus Arteriosus:Common (1% to 10%): GI bleeding, GI perforation, necrotizing enterocolitisFrequency not reported: Gross/microscopic bleeding into gastrointestinal tract, vomiting, abdominal distention, transient ileus, gastric perforation, localized perforations of small/large intestines, melena
Borderline elevations of 1 or more liver function tests can occur in up to 15% of patients taking NSAIDs, including this drug. These elevations may progress, remain unchanged, or may be transient with continued treatment. Elevations of ALT or AST of 3 or more times the upper limit of normal have been reported in about 1% of patients in clinical trials with NSAIDs. Rare cases of severe hepatic reactions, including jaundice, fatal fulminant hepatitis, liver necrosis, and hepatic failure, some with fatal outcomes, have been reported.Pediatric patients: There have been cases of hepatotoxicity, including fatalities, in pediatric patients with juvenile rheumatoid arthritis.[Ref]
Uncommon (0.1% to 1%): Toxic hepatitis, jaundice, elevated ALT/ASTFrequency not reported: Cholestasis, abnormal liver function[Ref]
In controlled clinical trials, renal dysfunction occurred statistically significantly more frequently during IV use in neonates than in those treated with placebo. Renal dysfunction has been reported in 41% of neonates and included at least 1 of the following: reduced urinary output, reduced urine sodium, chloride, or potassium; reduced urine osmolality, free water clearance, or GFR; elevated serum creatinine or BUN; or uremia.
Uncommon (0.1% to 1%): Nephrotic syndrome, interstitial nephritis, elevated BUN, renal insufficiency, renal failurePatent Ductus Arteriosus:Very common (10% or more): Renal dysfunction (41%)Frequency not reported: Elevated serum creatinine, renal failure, elevated BUN
Common (1% to 10%): Decreased appetiteUncommon (0.1% to 1%): Hyperglycemia, hyperkalemia, glycosuria, weight gain, fluid retentionPatent Ductus Arteriosus:Common (1% to 10%): Hyponatremia, elevated serum potassiumFrequency not reported: Reduction in blood sugar/hypoglycemia, weight gain/fluid retention, metabolic acidosis, metabolic alkalosis
Uncommon (0.1% to 1%): Leukopenia, bone marrow depression, anemia secondary to obvious or occult GI bleeding, aplastic anemia, hemolytic anemia, agranulocytosis, thrombocytopenic purpura, disseminated intravascular coagulationFrequency not reported: Leukemia, blood dyscrasias/hematopoietic disorders, neutropeniaPatent Ductus Arteriosus:Common (1% to 10%): BleedingFrequency not reported: Disseminated intravascular coagulation, decreased platelet aggregation, thrombocytopenia
In a double blind placebo controlled trial of 405 premature infants weighing less than or equal to 1750 g with evidence of large ductal shunting, there was statistically significant greater incidence of bleeding problems, including gross or microscopic bleeding in GI tract, oozing from skin after needle stick, pulmonary hemorrhage, and disseminated intravascular coagulopathy in infants treated with this drug (n=206). There was no statistically significant difference between treatment groups of intracranial hemorrhage
Very common (10% or more): Headache (up to 16%), dizziness (up to 15%)Common (1% to 10%): Presyncope, somnolence, syncope, intracranial bleeding, faintingUncommon (0.1% to 1%): Drowsiness, lightheadedness, paresthesia, aggravation of epilepsy and Parkinsonism, coma, peripheral neuropathy, convulsion, dysarthria, aseptic meningitis, optic neuritis Patent Ductus Arteriosus:Very common (10% or more): Intraventricular hemorrhage (up to 14.3%), intracranial hemorrhage (up to 10.5%)Common (1% to 10%): Intracranial bleeding, periventricular leukomalacia
Common (1% to 10%): Depression, listlessness Uncommon (0.1% to 1%): Anxiety, nervousness, insomnia, muzziness, psychic disturbances, psychotic episodes, mental confusion, depersonalizationFrequency not reported: Hallucinations
Common (1% to 10%): Hot flushUncommon (0.1% to 1%): Congestive heart failure, hypertension, hypotension, tachycardia, chest pain, arrhythmia, palpitations, angiitisFrequency not reported: Thrombophlebitis, rapid fall in blood pressure resembling shock, cardiac failure, thrombotic eventsPatent Ductus Arteriosus:Frequency not reported: Bradycardia, hypertension, cardiac failure
Common (1% to 10%): Pruritus, rash, sweating/hyperhidrosis, flushing, urticariaUncommon (0.1% to 1%): Petechiae, ecchymosis, exfoliative dermatitis, erythema nodosum, loss of hair/alopecia, Stevens-Johnson syndrome, erythema multiforme, toxic epidermal necrolysis, angioedema, purpuraVery rare (less than 0.01%): EczemaFrequency not reported: Fulminant necrotizing fasciitis, photosensitivity
Uncommon (0.1% to 1%): Acute anaphylaxisVery rare (less than 0.01%): Allergy-induced vasculitisFrequency not reported: Hypersensitivity reactionsPatent Ductus Arteriosus:Frequency not reported: Hypersensitivity reactions
Uncommon (0.1% to 1%): Corneal deposits, retinal disturbances, blurred vision, diplopiaFrequency not reported: Orbital/periorbital pain, double visionPatent Ductus Arteriosus:Very common (10% or more): Retinopathy of prematurity (up to 21.1%)Common (1% to 10%): Retrolental fibroplasiaUncommon (0.1% to 1%): Blindness
Very common (10% or more): Post-procedural edema (up to 26%), post-procedural hemorrhage (up to 11%)Common (1% to 10%): Post-procedural swelling, vertigo, fatigue, malaise, tinnitus, asthenia, exhaustionUncommon (0.1% to 1%): Hearing disturbances, deafness, edema, feverPostmarketing reports: Exacerbation of infectionPatent Ductus Arteriosus:Frequency not reported: Exacerbation of infection, edema
The most frequently reported adverse effects were nausea, headache, dizziness, vomiting, constipation, pruritus, diarrhea, dyspepsia, presyncope, rash, upper abdominal pain, somnolence, pruritus, hyperhidrosis, decreased appetite, hot flush, and syncope.Patent Ductus Arteriosus: The most frequently reported adverse effects were bleeding problems, transient oliguria, and elevated serum creatinine
Uncommon (0.1% to 1%): Hematuria, vaginal bleeding, proteinuria, breast enlargement/tenderness, gynecomastiaFrequency not reported: Urinary frequency Patent Ductus Arteriosus:Very common (10% or more): Oliguria (44%)Frequency not reported: Transient oliguria
Information from various medical literature states that 44% of infants treated with this drug had oliguria. Renal dysfunction appears to be dose related; renal function usually returns to normal 24 hours following discontinuation.
Patent Ductus Arteriosus:Frequency not reported: Bleeding/oozing from skin following needle puncture
Uncommon (0.1% to 1%): Muscle weakness, involuntary muscle movementsFrequency not reported: Hypercreatininemia, acceleration of cartilage degeneration
Uncommon (0.1% to 1%): Dyspnea, acute respiratory distress, asthma, pulmonary edema, epistaxisFrequency not reported: Bronchospasm, pulmonary eosinophilia, alveolitisPatent Ductus Arteriosus:Frequency not reported: Pulmonary hemorrhage, pneumothorax, pulmonary hypertension, apnea, exacerbation of preexisting pulmonary infection
