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Captopril (Captopril) - Side Effects and Adverse Reactions

 
 



ADVERSE REACTIONS

Reported incidences are based on clinical trials involving approximately 7000 patients.

Renal: About one of 100 patients developed proteinuria (see WARNINGS).

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 (see WARNINGS). 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; see WARNINGS and PRECAUTIONS: Drug Interactions 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 (see PRECAUTIONS: General: Cough).

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.

To report SUSPECTED ADVERSE REACTIONS, contact West-Ward Pharmaceutical Corp. at 1-877-233-2001, or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.



REPORTS OF SUSPECTED CAPTOPRIL SIDE EFFECTS / ADVERSE REACTIONS

Below is a sample of reports where side effects / adverse reactions may be related to Captopril. The information is not vetted and should not be considered as verified clinical evidence.

Possible Captopril side effects / adverse reactions in 56 year old female

Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2011-07-05

Patient: 56 year old female weighing 84.0 kg (184.8 pounds)

Reactions: Chest Discomfort, Chest Pain, Tachycardia, Headache, Hypertension, Rash Pruritic, Infusion Related Reaction

Adverse event resulted in: hospitalization

Suspect drug(s):
Gammaplex
    Dosage: 30g
    Indication: Chronic Inflammatory Demyelinating Polyradiculoneuropathy
    Start date: 2010-09-06

Symbicort

Captopril

Ezetimibe

Other drugs received by patient: Bendroflumethazide; Metformin HCL; Insulin; Gliclazide



Possible Captopril side effects / adverse reactions in 44 year old female

Reported by a individual with unspecified qualification from Brazil on 2011-10-12

Patient: 44 year old female weighing 84.0 kg (184.8 pounds)

Reactions: Mitral Valve Incompetence, Left Ventricular Hypertrophy, Diastolic Dysfunction, Blood Pressure Abnormal, Hepatic Steatosis

Suspect drug(s):
Hydrochlorothiazide
    Dosage: 12.5 mg, unk

Diovan
    Dosage: 160 mg, unk
    Indication: Hypertension

Simvastatin
    Dosage: 40 mg, daily
    Indication: Hypercholesterolaemia

Captopril
    Dosage: 50 mg, tid



Possible Captopril side effects / adverse reactions in 47 year old male

Reported by a individual with unspecified qualification from Brazil on 2011-10-12

Patient: 47 year old male

Reactions: Blood Pressure Increased, Oedema Peripheral, Varicose Vein

Suspect drug(s):
Captopril
    Dosage: 25 mg, bid

Glyburide
    Dosage: 5 mg, qd



See index of all Captopril side effect reports >>

Drug label data at the top of this Page last updated: 2014-08-04

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