Captopril adverse reactions
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Amr Marawan, M.D. [2]
ADVERSE REACTIONS
Reported incidences are based on clinical trials involving approximately 7000 patients.
Renal
About one of 100 patients developed proteinuria.
Each of the following has been reported in approximately 1 to 2 of 1000 patients and are of uncertain relationship to drug use: renal insufficiency, renal failure, nephrotic syndrome, polyuria, oliguria, and urinary frequency.
Hematologic
Neutropenia/agranulocytosis has occurred. Cases of anemia, thrombocytopenia, and pancytopenia have been reported.
Dermatologic
Rash, often with pruritus, and sometimes with fever, arthralgia, and eosinophilia, occurred in about 4 to 7 (depending on renal status and dose) of 100 patients, usually during the first four weeks of therapy. It is usually maculopapular, and rarely urticarial. The rash is usually mild and disappears within a few days of dosage reduction, short-term treatment with an antihistaminic agent, and/or discontinuing therapy; remission may occur even if captopril is continued. Pruritus, without rash, occurs in about 2 of 100 patients. Between 7 and 10 percent of patients with skin rash have shown an eosinophilia and/or positive ANA titers. A reversible associated pemphigoid-like lesion, and photosensitivity, have also been reported.
Flushing or pallor has been reported in 2 to 5 of 1000 patients.
Cardiovascular
Hypotension may occur; for discussion of hypotension with captopril therapy.
Tachycardia, chest pain, and palpitations have each been observed in approximately 1 of 100 patients.
Angina pectoris, myocardial infarction, Raynaud's syndrome, and congestive heart failure have each occurred in 2 to 3 of 1000 patients.
Dysgeusia
Approximately 2 to 4 (depending on renal status and dose) of 100 patients developed a diminution or loss of taste perception. Taste impairment is reversible and usually self-limited (2 to 3 months) even with continued drug administration. Weight loss may be associated with the loss of taste.
Angioedema
Angioedema involving the extremities, face, lips, mucous membranes, tongue, glottis or larynx has been reported in approximately one in 1000 patients. Angioedema involving the upper airways has caused fatal airway obstruction. (See WARNINGS, Head and Neck Angioedema , Intestinal Angioedema and PRECAUTIONS, Information for Patients.)
Cough
Cough has been reported in 0.5 to 2% of patients treated with captopril in clinical trials.
The following have been reported in about 0.5 to 2 percent of patients but did not appear at increased frequency compared to placebo or other treatments used in controlled trials: gastric irritation, abdominal pain, nausea, vomiting, diarrhea, anorexia, constipation, aphthous ulcers, peptic ulcer, dizziness, headache, malaise, fatigue, insomnia, dry mouth, dyspnea, alopecia, paresthesias.
Other clinical adverse effects reported since the drug was marketed are listed below by body system. In this setting, an incidence or causal relationship cannot be accurately determined.
Body As A Whole
Anaphylactoid reactions (see WARNINGS, Anaphylactoid and possible Related Reactions and PRECAUTIONS, Hemodialysis).
General
Asthenia, gynecomastia.
Cardiovascular
Cardiac arrest, cerebrovascular accident/insufficiency, rhythm disturbances, orthostatic hypotension, syncope.
Dermatologic
Bullous pemphigus, erythema multiforme (including Stevens-Johnson syndrome), exfoliative dermatitis.
Gastrointestinal
Pancreatitis, glossitis, dyspepsia.
Hematologic
Anemia, including aplastic and hemolytic.
Hepatobiliary
Jaundice, hepatitis, including rare cases of necrosis, cholestasis.
Metabolic
Symptomatic hyponatremia.
Musculoskeletal
Myalgia, myasthenia.
Nervous/Psychiatric
Ataxia, confusion, depression, nervousness, somnolence.
Respiratory
Bronchospasm, eosinophilic pneumonitis, rhinitis.
Special Senses
Blurred vision.
Urogenital
Impotence.
As with other ACE inhibitors, a syndrome has been reported which may include: fever, myalgia, arthralgia, interstitial nephritis, vasculitis, rash or other dermatologic manifestations, eosinophilia and an elevated ESR.
Altered Laboratory Findings
Serum Electrolytes
Hyperkalemia
Small increases in serum potassium, especially in patients with renal impairment (see PRECAUTIONS).
Hyponatremia
Particularly in patients receiving a low sodium diet or concomitant diuretics.
BUN/Serum Creatinine
Transient elevations of BUN or serum creatinine especially in volume or salt depleted patients or those with renovascular hypertension may occur. Rapid reduction of longstanding or markedly elevated blood pressure can result in decreases in the glomerular filtration rate and, in turn, lead to increases in BUN or serum creatinine.
Hematologic
A positive ANA has been reported.
Liver Function Tests
Elevations of liver transaminases, alkaline phosphatase, and serum bilirubin have occurred.[1]
References
Adapted from the FDA Package Insert.