Capoten Side Effects

Generic Name: captopril

Note: This page contains information about the side effects of captopril. Some of the dosage forms included on this document may not apply to the brand name Capoten.

Not all side effects for Capoten may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

For the Consumer

Applies to captopril: oral liquid, oral tablet

In addition to its needed effects, some unwanted effects may be caused by captopril (the active ingredient contained in Capoten). In the event that any of these side effects do occur, they may require medical attention.

You should check with your doctor immediately if any of these side effects occur when taking captopril:

Less common
  • Chest pain
  • cloudy urine
  • fast, pounding, or irregular heartbeat or pulse
Rare
  • Arm, back, or jaw pain
  • bloody urine
  • chest discomfort
  • chest tightness or heaviness
  • decreased blood pressure
  • decreased or increased frequency or amount of urine
  • dilated neck veins
  • increased thirst
  • irregular breathing
  • large, hive-like swelling on face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
  • loss of appetite
  • low blood pressure
  • lower back or side pain
  • nausea
  • paleness or cold feeling in fingertips and toes
  • sweating
  • swelling of face, fingers, feet, or lower legs
  • tingling or pain in fingers or toes when exposed to cold
  • troubled breathing or wheezing
  • unusual tiredness or weakness
  • vomiting
  • weight gain
Incidence not known
  • Bleeding gums
  • bloody, black, or tarry stools
  • blurred vision
  • chills
  • confusion
  • cough
  • dizziness, faintness, or lightheadedness when getting up from a lying or sitting position suddenly
  • high fever
  • painful or difficult urination
  • pale skin
  • pinpoint red spots on skin
  • sore throat
  • sores, ulcers, or white spots on lips or in mouth
  • swollen glands
  • unusual bleeding or bruising

Some of the side effects that can occur with captopril may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

Less common
  • Change in taste
  • feeling of warmth
  • itching skin
  • loss of taste
  • rash
  • redness of the face, neck, arms, and occasionally, upper chest

For Healthcare Professionals

Applies to captopril: compounding powder, oral tablet

General

The incidence of adverse drug events (ADEs) associated with captopril (the active ingredient contained in Capoten) is related to dose and to preexisting renal disease. Postmarketing surveillance reveals that the incidence of withdrawal from captopril due to ADEs ranges from 5% to 9%. ADEs appear to be more likely in the elderly, in females, and in patients who receive dosages greater than 150 mg per day.[Ref]

Cardiovascular

Cardiovascular side effects have included hypotension (1% to 25%), dizziness (1% to 5%), myocardial infarction (less than 1%), palpitations (less than 1%), angina pectoris (less than 1%), and angioedema (less than 0.1%).[Ref]

Hypotension and presyncopal symptoms are more common in patients with congestive heart failure, hyponatremia, or in patients who are on diuretics. "First dose" hypotension may be minimized by a reduction in diuretic therapy, by starting with a low dose of captopril, and by slowly advancing captopril doses in small increments. Intolerance to a small "test dose" of captopril does not necessarily contraindicate further use of the drug.[Ref]

Respiratory

Respiratory side effects have included a dry, persistent cough in up to 4% of patients. Asthma has been reported rarely. At least two case of interstitial pulmonary infiltrates have been reported.[Ref]

A 79-year-old man with hypertension, heart failure, and atrial fibrillation developed a dry cough and wheezing after starting captopril. Pulmonary function tests revealed findings consistent with mixed obstructive and restrictive lung disease; histamine challenge was markedly positive. There was no history of tobacco use or a family history of asthma. The cough and wheezing persisted after captopril was discontinued. The authors believe that angiotensin-converting enzyme inhibitors may uncover an asthmatic tendency in patients with preexisting bronchial hyperreactivity.

A retrospective study has revealed a significantly higher incidence of discontinuation of angiotensin converting enzyme inhibitor therapy due to cough among black patients compared with non-black patients (9.6% vs. 2.4%).[Ref]

Hematologic

The neutropenia and agranulocytosis associated with captopril (the active ingredient contained in Capoten) typically occur within 3 to 12 weeks after starting therapy, and are usually reversible within 3 weeks after stopping the drug. While most cases are described in patients who are receiving high doses of captopril (600 mg per day), agranulocytosis has been described in patients who were receiving as little as 12.5 to 100 mg per day. Granulocyte colony-stimulating factor (G-CSF) has been reported in one case to be of benefit in treating captopril-induced agranulocytosis.

Hematologic side effects may be more likely in patients with renal dysfunction.[Ref]

Hematologic side effects have included neutropenia, agranulocytosis, aplastic anemia, hemolytic anemia, eosinophilia, and thrombocytopenia.[Ref]

Hypersensitivity

Hypersensitivity side effects have been reported rarely. Intestinal angioedema and angioedema of the face, extremities, lips, tongue, glottis and/or pharynx have been reported rarely in patients receiving ACE inhibitors. Rarely, obstructive laryngeal and glossal angioedema have been reported. Hepatitis, allergic vasculitis, and mild to severe skin rashes have been reported.[Ref]

Patients with intestinal angioedema generally present with abdominal pain (with or without nausea or vomiting) and in some cases there was no prior history of facial angioedema, and C-1 esterase levels were normal. These symptoms resolve after stopping the ACE inhibitor.[Ref]

Hepatic

Hepatic side effects have been reported rarely. Cholestatic changes, cholestatic-hepatocellular changes, and hepatic necrosis have been reported. Jaundice has also been reported.[Ref]

A review of 19 cases of captopril-associated hepatic injury revealed the most common dosage of captopril that was given to affected patients was 450 mg per day, the mean age of affected patients was 61 years, and the most common interval between starting the drug and the onset of symptoms was 14 weeks. Jaundice was the most common presenting symptom, and approximately one third of the patients had concomitant fever, rash, or eosinophilia. Because of these associated findings, the suspected mechanism of injury is hypersensitivity.[Ref]

Dermatologic

A 70-year-old, heterosexual, HIV-negative man with hypertension developed Kaposi's sarcoma (KS) during captopril (the active ingredient contained in Capoten) therapy. The lesions completely resolved within three months after discontinuation of captopril. In another case, a 70-year-old woman with seropositive rheumatoid arthritis and hypertension developed KS within eight months after starting captopril therapy. A full work-up, including HIV antibody testing, was negative. The lesions did not resolve, but became flat, brown, and non-indurated within 15 days after captopril was stopped.

A 47-year-old male was given captopril for hypertension and developed an erythematous eruption on both cheeks within a few hours following the first dose. Positive reactions were obtained during patch testing for captopril at a later time.[Ref]

Dermatologic side effects have included psoriasiform rashes, pemphigus-like lesions, angioedema of the face and mucous membranes, pityriasis-like eruptions, alopecia, exfoliative dermatitis, photosensitivity, bullous or lichenoid eruptions, and erythematous eruptions. Rarely, worsened Kaposi's sarcoma lesions, oncolysis, pemphigus vulgaris, and Henoch-Schonlein Purpura have been reported. A case of toxic epidermal necrolysis has also been reported.[Ref]

Nervous system

Nervous system side effects have included dysgeusia (0.3% to 4.0%) and headache (up to 4%). Cases of Guillain-Barre neuropathy and parkinsonism have been reported.[Ref]

A 57-year-old man with hypertension and moderate alcohol use developed a sensorimotor loss associated with a cerebral spinal fluid pleocytosis three months after starting captopril therapy. A complete work-up was otherwise unremarkable. The patient eventually required mechanical ventilation, at which time captopril was discontinued. The syndrome resolved completely over the next six weeks. Nerve conduction velocity and electromyography findings were consistent with a demyelinating neuropathy of the Guillain-Barre type.

A 75-year-old man with hypertension and heart failure developed a shuffling gait, resting tremors, mask face, and cogwheel rigidity several days after beginning captopril therapy. A full work-up was unremarkable. The parkinsonian symptoms resolved after captopril was discontinued.[Ref]

Renal

Renal side effects have included renal insufficiency (less than 3%) and proteinuria (1%). Allergic nephritis, membranous glomerulonephritis, and nephrotic syndrome have been reported rarely.[Ref]

Risk factors for the development of captopril-induced renal insufficiency are hypovolemia, hypotension, hyponatremia, concomitant use of other potentially nephrotoxic medications, and renal artery stenosis.

Proteinuria associated with captopril therapy is more likely in patients with renal insufficiency.

Captopril-induced hypotension may cause decreased renal blood flow and glomerular filtration in some patients. In addition, captopril may cause an interstitial nephritis (usually associated with rash, eosinophilia, fever, and azotemia), or a membranous glomerulopathy. The histological findings of membranous glomerulonephritis in some patients who have proteinuria suggest the possibility of an immune-complex glomerulopathy. These findings are similar to other cases of drug-induced glomerulopathy.[Ref]

Gastrointestinal

Gastrointestinal side effects have been reported rarely. Nausea has been reported in up to 4% of patients. At least two cases of oral ulceration have been reported. Esophagitis, scalded mouth syndrome, and pancreatitis have been reported rarely. Cases of sialadenitis have also been reported.[Ref]

Scalded mouth syndrome is characterized by a burning sensation of the tongue, throat, lips or palate (similar to drinking coffee which is too hot).[Ref]

Endocrine

Endocrine side effects have been reported rarely. A case of gynecomastia has been reported.[Ref]

A 72-year-old man with hypertension developed painful gynecomastia while taking captopril 75 mg per day. The patient had no history of alcohol abuse, liver disease, diabetes mellitus, and was on no other medications. A complete endocrinologic work-up was unremarkable. The gynecomastia resolved upon substitution with nifedipine. Rechallenge with enalapril resulted in recurrent gynecomastia.[Ref]

Immunologic

A 53-year-old man with diabetes mellitus, hypertension, and heart failure developed arthralgias, fever, and malaise associated with bilateral pleural effusions, elevated liver function tests, a pericardial rub, and elevated C-reactive protein. After other causes of systemic lupus erythematosus were ruled out, captopril (the active ingredient contained in Capoten) was stopped, and these signs and symptoms resolved.

In a study of 78 patients who were treated with captopril for 11 months, 13 developed a positive antinuclear antibody titer. Only one of the 13, however, developed a serum sickness-like illness.[Ref]

Immunologic side effects have rarely included lymphadenopathy, systemic lupus erythematosus, and Henoch-Schonlein Purpura. Serum sickness-like illness has been reported.[Ref]

Psychiatric

Psychiatric side effects have rarely included mania.[Ref]

Metabolic

Metabolic side effects have included hyperkalemia and, less commonly, hyponatremia. Hypoglycemia has been reported rarely.[Ref]

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