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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]] | |