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| __NOTOC__
| | #REDIRECT [[Captopril#Adverse Reactions]] |
| {{Captopril}}
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| {{CMG}}; {{AE}} {{AM}}
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| ==Adverse Reactions==
| | [[Category: Cardiovascular Drugs]] |
| | | [[Category: Drug]] |
| Reported incidences are based on clinical trials involving approximately 7000 patients.
| | [[Category:ACE inhibitors]] |
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| ====Renal====
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| About one of 100 patients developed [[proteinuria]].
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| 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]].
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| ====Hematologic====
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| [[Neutropenia]]/[[agranulocytosis]] has occurred. Cases of [[anemia]], [[thrombocytopenia]], and [[pancytopenia]] have been reported.
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| ====Dermatologic====
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| 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 [[antihistamine]] 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.
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| Flushing or pallor has been reported in 2 to 5 of 1000 patients.
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| ====Cardiovascular====
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| [[]Hypotension]] may occur; for discussion of hypotension with captopril therapy.
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| [[Tachycardia], [[chest pain]], and [[palpitations]] have each been observed in approximately 1 of 100 patients.
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| [[Angina pectoris]], [[myocardial infarction]], [[Raynaud's syndrome]], and [[congestive heart failure]] have each occurred in 2 to 3 of 1000 patients.
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| ====Dysgeusia====
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| 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.
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| ====Angioedema====
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| [[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.)
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| ====Cough====
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| [[Cough]] has been reported in 0.5 to 2% of patients treated with captopril in clinical trials.
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| 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]].
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| 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.
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| ====Body As A Whole====
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| [[Anaphylactoid reactions] (see WARNINGS, Anaphylactoid and possible Related Reactions and PRECAUTIONS, Hemodialysis).
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| ====General====
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| [[Asthenia]], [[gynecomastia]].
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| ====Cardiovascular====
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| [[Cardiac arrest]], [[cerebrovascular accident]]/insufficiency, [[rhythm disturbances]], [[orthostatic hypotension]], [[syncope]].
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| ====Dermatologic====
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| [[Bullous pemphigus]], [[erythema multiforme]] (including [[Stevens-Johnson syndrome]]), [[exfoliative dermatitis]].
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| ====Gastrointestinal====
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| [[Pancreatitis]], [[glossitis]], [[dyspepsia]].
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| ====Hematologic====
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| [[Anemia]], including [[aplastic]] and [[hemolytic]].
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| ====Hepatobiliary====
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| [[Jaundice]], [[hepatitis]], including rare cases of [[necrosis]], [[cholestasis]].
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| ====Metabolic====
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| Symptomatic [[hyponatremia]].
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| ====Musculoskeletal====
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| [[Myalgia]], [[myasthenia]].
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| ====Nervous/Psychiatric====
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| [[Ataxia]], [[confusion]], [[depression]], [[nervousness]], [[somnolence]].
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| ====Respiratory====
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| [[Bronchospasm]], [[eosinophilic pneumonitis]], [[rhinitis]].
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| ====Special Senses====
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| [[Blurred vision]].
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| ====Urogenital====
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| [[Impotence]].
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| 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]].
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| ====Altered Laboratory Findings====
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| Serum Electrolytes
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| ======Hyperkalemia======
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| Small increases in serum potassium, especially in patients with renal impairment.
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| ======Hyponatremia======
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| Particularly in patients receiving a low sodium diet or concomitant [[diuretics]].
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| ====BUN/Serum Creatinine====
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| 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.
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| ====Hematologic====
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| A positive ANA has been reported.
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| ====Liver Function Tests====
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| Elevations of [[liver transaminases]], [[alkaline phosphatase]], and [[serum bilirubin]] have occurred.<ref name="dailymed.nlm.nih.gov">{{Cite web | last = | first = | title = CAPTOPRIL (CAPTOPRIL ) TABLET CAPTOPRIL TABLET [APOTEX CORP.] | url = http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=2c0f1ee3-b2b7-a1bc-059a-d65bea6cd0ef | publisher = | date = | accessdate =}}</ref>
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| ==References==
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| {{Reflist}}
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| {{FDA}}
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| [[Category:Cardiovascular Drugs]] | |
| [[Category:Drugs]] | |