Captopril

Captopril may be found in some form under the following brand names:

• Capoten

Take captopril exactly as prescribed.

Captopril comes in tablet form and is given either 2 or 3 times a day, at least 1 hour before a meal. It should be taken without food or at least one hour before a meal or snack.

If you miss a dose, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take two doses of captopril at the same time.

Captopril is an ACE inhibitor. ACE stands for angiotensin converting enzyme.

Captopril is used to treat high blood pressure (hypertension), congestive heart failure, kidney problems caused by diabetes, and to improve survival after a heart attack.

Captopril may also be used for purposes not listed in this medication guide.

Get emergency medical help if you have signs of an allergic reaction: hives; severe stomach pain; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• a light-headed feeling, like you might pass out;

• little or no urination, or urinating more than usual;

• shortness of breath (even with mild exertion), swelling, rapid weight gain;

• chest pain or pressure, pounding heartbeats or fluttering in your chest;

• high potassium--nausea, slow or unusual heart rate, weakness, loss of movement; or

• sudden weakness or ill feeling, fever, chills, sore throat, painful mouth sores, pain when swallowing, skin sores, cold or flu symptoms.

Common side effects may include:

• cough;

• flushing (warmth, redness, or tingly feeling);

• numbness, tingling, or burning pain in your hands or feet;

• loss of taste sensation; or

• mild skin itching or rash.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Other drugs may interact with captopril, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

In addition to the use of captopril, treatment for your high blood pressure may include weight control and changes in the types of foods you eat, especially foods high in sodium (salt). Your doctor will tell you which of these are most important for you. You should check with your doctor before changing your diet.

Many patients who have high blood pressure will not notice any signs of the problem. In fact, many may feel normal. It is very important that you take your medicine exactly as directed and that you keep your appointments with your doctor even if you feel well.

Remember that captopril will not cure your high blood pressure but it does help control it. Therefore, you must continue to take it as directed if you expect to lower your blood pressure and keep it down. You may have to take high blood pressure medicine for the rest of your life. If high blood pressure is not treated, it can cause serious problems such as heart failure, blood vessel disease, stroke, or kidney disease.

It is best to take captopril on an empty stomach at least 1 hour before eating any food.

Dosing

The dose of captopril will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of captopril. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (tablets):
  • For high blood pressure:
    • Adults—At first, 25 milligrams (mg) two or three times a day. Your doctor may increase your dose as needed. However, the dose is usually not more than 450 mg per day.
    • Children—Use and dose must be determined by your doctor.
  • For heart failure:
    • Adults—At first, 25 milligrams (mg) three times a day. Your doctor may increase your dose as needed. However, the dose is usually not more than 450 mg per day.
    • Children—Use and dose must be determined by your doctor.
  • For treatment after a heart attack:
    • Adults—At first, 6.25 milligrams (mg) as a single dose, then 12.5 mg three times a day. Your doctor may increase your dose as needed. However, the dose is usually not more than 450 mg per day.
    • Children—Use and dose must be determined by your doctor.
  • For kidney problems caused by diabetes:
    • Adults—25 milligrams (mg) three times a day.
    • Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of captopril, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

• Chest pain
• cloudy urine
• fast, pounding, or irregular heartbeat or pulse

• 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

• 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 side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

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

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

• If you have an allergy to captopril or any other part of this medicine.
• If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
• If you have ever had a very bad or life-threatening reaction called angioedema. Signs may be swelling of the hands, face, lips, eyes, tongue, or throat; trouble breathing; trouble swallowing; unusual hoarseness.
• If you are taking a drug that has aliskiren in it and you also have high blood sugar (diabetes) or kidney problems. Check with your doctor or pharmacist if you are not sure if a drug you take has aliskiren in it.
• If you have taken a drug that has sacubitril in it in the last 36 hours.
• If you are breast-feeding or plan to breast-feed.

This is not a list of all drugs or health problems that interact with captopril.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this medicine with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
• Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about captopril, please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about captopril. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using captopril.

Review Date: October 4, 2017

Competitive inhibitor of angiotensin-converting enzyme (ACE); prevents conversion of angiotensin I to angiotensin II, a potent vasoconstrictor; results in lower levels of angiotensin II which causes an increase in plasma renin activity and a reduction in aldosterone secretion.

Absorption

60% to 75%; rapid

Distribution

Vdss: 0.7 L/kg (Duchin 1982)

Metabolism

50% metabolized

Excretion

Urine (>95%) within 24 hours (40% to 50% as unchanged drug)

Within 15 minutes; Peak effect: Blood pressure reduction: 1 to 1.5 hours after dose; Maximum effect: Antihypertensive: 60 to 90 minutes; may require several weeks of therapy before full hypotensive effect is seen

Time to Peak

Within 1 to 2 hours

Aldosteronism (diagnosis)

Data from a prospective head-to-head study in patients with hypertension who were suspected to have aldosteronism supports the use of captopril in the diagnosis of aldosteronism [Wu 2010]. Additional trials may be necessary to further define the role of captopril in diagnosis of this condition.

Hypertension secondary to scleroderma renal crisis

Data from a limited number of patients studied (single case report) suggest that captopril may be beneficial for the treatment of hypertension secondary to scleroderma renal crisis [Collins 1996]. Additional data may be necessary to further define the role of captopril in this condition.

Hypertensive crisis

Data from one nonrandomized clinical trial, four randomized active comparator trials, and case reports supports the use of captopril (oral or sublingual) for treatment of hypertensive crisis [Angeli 1991], [Castrol del Castilo 1988], [Ceyhan 1990], [Damasceno 1997], [Karakilic 2012], [Tschollar 1985] . Additional trials may be necessary to further define the role of captopril in this setting.

Improve kidney outcomes in hypertensive patients with chronic kidney disease (CKD) (diabetic and nondiabetic population)

Based on the Eighth Joint National Committee (JNC 8) guidelines for the management of high blood pressure in adults, an ACE inhibitor (eg, captopril) or an ARB is effective and recommended to improve kidney outcomes in adult patients with CKD and hypertension. This recommendation applies to hypertensive CKD patients, with and without proteinuria, and regardless of race and diabetes status.

Based on the American Diabetes Association Standards of Medical Care in Diabetes, in CKD patients with diabetes and hypertension, an ACE inhibitor (eg, captopril) or an ARB is effective and strongly recommended in patients with an eGFR <60 mL/min/1.73 m2 and/or a UACR ≥300 mg/g for the prevention of CKD progression. In patients with modestly elevated UACR (30 to 299 mg/g), ACE inhibitors or ARBs are also recommended to reduce the progression to more advanced albuminuria.

Pediatric hypertension

Guidelines for the management of pediatric hypertension generally recommend the same drug classes that are indicated for management of adult hypertension. Particular consideration should be given to medications for which published pediatric experience is available, including appropriate dosing ranges. Similar to adults, prescribers should assess for concomitant disease states that would present a compelling indication for use of a particular drug. ACE inhibitors, such as captopril, were specifically recommended for children with diabetes and microalbuminuria or proteinuric renal diseases. Other factors, such as the potential for a patient to become pregnant while on therapy, may limit selection. All ACE inhibitors, including captopril, are contraindicated in pregnancy. Girls of childbearing age should use reliable contraception if captopril is selected for management of pediatric hypertension. Captopril is among the therapeutic options for pediatric hypertension identified by the National High Blood Pressure Education Program, based on published case series and randomized, controlled trials.

Postmyocardial infarction for prevention of heart failure

Based on the American College of Cardiology Foundation/American Heart Association (ACCF/AHA) guidelines for the management of ST-elevation myocardial infarction and the ACCF/AHA Guideline for the Management of Heart Failure, captopril (among other ACE inhibitors) given for prevention of heart failure after myocardial infarction is effective and recommended in the management of this condition.

Raynaud phenomenon

Initial data from limited trials indicate that captopril may provide minor benefit in patients with Raynaud phenomenon, but results regarding the effect of captopril on the frequency, severity, or duration of vasospasm attacks are conflicting. Larger, controlled trials are needed to establish the role of captopril in the management of Raynaud phenomenon.

Non–ST-elevation acute coronary syndrome

Based on the American Heart Association/American College of Cardiology (AHA/ACC) guidelines for the management of patients with non-ST-elevation acute coronary syndromes (NSTE-ACS) states that an ACE inhibitor (eg, captopril) should be initiated and continued indefinitely after NSTE-ACS in patients with an LVEF ≤0.4 and in those with hypertension, diabetes mellitius, or stable CKD unless contraindicated. Use of an ACE inhibitor may also be useful in all other patients with cardiac or other vascular disease. In patients with stress (Takotsubo) cardiomyopathy, the use of ACE inhibitors (in combination with beta blockers, aspirin and diuretics) is recommended.

Additional Off-Label Uses

Anatomic renal artery stenosis (diagnosis); Bartter's syndrome; Hypertension secondary to Takayasu's disease

Manufacturers recommendations: Reduce initial daily dose and titrate slowly (1- to 2-week intervals) with smaller increments. Slowly back titrate to determine the minimum effective dose once the desired therapeutic effect has been reached.

Alternative recommendations (Aronoff 2007):

Adults:

CrCl 10 to 50 mL/minute: Administer at 75% of normal dose every 12 to 18 hours.

CrCl <10 mL/minute: Administer at 50% of normal dose every 24 hours.

Intermittent hemodialysis (IHD): Administer after hemodialysis on dialysis days

Peritoneal dialysis: Dose for CrCl 10 to 50 mL/minute; supplemental dose is not necessary

Infants, Children, and Adolescents: Note: Renally adjusted dose recommendations are based on doses of 0.1 to 0.5 mg/kg/dose every 6 to 8 hours; maximum daily dose: 6 mg/kg/day.

GFR 10 to 50 mL/minute/1.73 m2: Administer 75% of dose

GFR <10 mL/minute/1.73 m2: Administer 50% of dose

Intermittent hemodialysis: Administer 50% of dose

Peritoneal dialysis (PD): Administer 50% of dose

A 1 mg/mL oral solution may be made by allowing two 50 mg tablets to dissolve in 50 mL of distilled water. Add the contents of one 500 mg sodium ascorbate injection ampul or one 500 mg ascorbic acid tablet and allow to dissolve. Add quantity of distilled water sufficient to make 100 mL. Label “shake well” and “refrigerate”. Stable for 56 days refrigerated.

Concerns related to adverse effects:

• Angioedema: At any time during treatment (especially following first dose) angioedema may occur rarely with ACE inhibitors; it may involve the head and neck (potentially compromising airway) or the intestine (presenting with abdominal pain). African-Americans and patients with idiopathic or hereditary angioedema may be at an increased risk. Risk may also be increased with concomitant use of mTOR inhibitor (eg, everolimus) therapy or a neprilysin inhibitor (eg, sacubitril). Prolonged frequent monitoring may be required especially if tongue, glottis, or larynx are involved as they are associated with airway obstruction. Patients with a history of airway surgery may have a higher risk of airway obstruction. Aggressive early and appropriate management is critical. Use in patients with previous angioedema associated with ACE inhibitor therapy is contraindicated.

• Cholestatic jaundice: A rare toxicity associated with ACE inhibitors includes cholestatic jaundice, which may progress to fulminant hepatic necrosis (some fatal); discontinue if marked elevation of hepatic transaminases or jaundice occurs.

• Cough: An ACE inhibitor cough is a dry, hacking, nonproductive one that usually occurs within the first few months of treatment and should generally resolve within 1 to 4 weeks after discontinuation of the ACE inhibitor. Other causes of cough should be considered (eg, pulmonary congestion in patients with heart failure) and excluded prior to discontinuation.

• Hematologic effects: Captopril has been associated with neutropenia with myeloid hypoplasia and agranulocytosis; anemia and thrombocytopenia have also occurred. Patients with renal impairment are at high risk of developing neutropenia. Patients with both renal impairment and collagen vascular disease (eg, systemic lupus erythematosus) are at an even higher risk of developing neutropenia. Closely monitor CBC with differential for the first 3 months of therapy and periodically thereafter in these patients. Onset of neutropenia is usually within 3 months of captopril initiation. Neutrophil count generally returns to baseline within 2 weeks of discontinuation. If neutropenia develops (neutrophil count <1,000/mm3), discontinue therapy.

• Hyperkalemia: May occur with ACE inhibitors; risk factors include renal dysfunction, diabetes mellitus, concomitant use of potassium-sparing diuretics, potassium supplements, and/or potassium-containing salts. Use cautiously, if at all, with these agents and monitor potassium closely.

• Hypersensitivity reactions: Anaphylactic/anaphylactoid reactions can occur with ACE inhibitors. Severe anaphylactoid reactions may be seen during hemodialysis (eg, CVVHD) with high-flux dialysis membranes (eg, AN69), and rarely, during low density lipoprotein apheresis with dextran sulfate cellulose. Rare cases of anaphylactoid reactions have been reported in patients undergoing sensitization treatment with hymenoptera (bee, wasp) venom while receiving ACE inhibitors.

• Hypotension/syncope: Symptomatic hypotension with or without syncope can occur with ACE inhibitors (usually with the first several doses); effects are most often observed in volume-depleted patients; correct volume depletion prior to initiation; close monitoring of patient is required especially with initial dosing and dosing increases; blood pressure must be lowered at a rate appropriate for the patient's clinical condition. Although dose reduction may be necessary, hypotension is not a reason for discontinuation of future ACE inhibitor use especially in patients with heart failure where a reduction in systolic blood pressure is a desirable observation.

• Proteinuria: Total urinary proteins greater than 1 g per day have been reported (<1%); nephrotic syndrome occurred in about one-fifth of proteinuric patients. In most cases, proteinuria subsided or cleared within six months (whether or not captopril was continued).

• Renal function deterioration: May be associated with deterioration of renal function and/or increases in BUN and serum creatinine, particularly in patients with low renal blood flow (eg, renal artery stenosis, heart failure) whose glomerular filtration rate (GFR) is dependent on efferent arteriolar vasoconstriction by angiotensin II; deterioration may result in oliguria, acute renal failure, and progressive azotemia. Small benign increases in serum creatinine may occur following initiation; consider discontinuation only in patients with progressive and/or significant deterioration in renal function (Bakris 2000).

Disease-related concerns:

• Aortic stenosis: Use with caution in patients with aortic stenosis; may reduce coronary perfusion resulting in ischemia.

• Cardiovascular disease: Initiation of therapy in patients with ischemic heart disease or cerebrovascular disease warrants close observation due to the potential consequences posed by falling blood pressure (eg, MI, stroke). Fluid replacement, if needed, may restore blood pressure; therapy may then be resumed. Discontinue therapy in patients whose hypotension recurs.

• Collagen vascular disease: Use with caution in patients with collagen vascular disease especially with concomitant renal impairment; may be at increased risk for hematologic toxicity.

• Hypertrophic cardiomyopathy (HCM) with outflow tract obstruction: Use with caution in patients with HCM and outflow tract obstruction since reduction in afterload may worsen symptoms associated with this condition (ACCF/AHA [Gersh 2011]).

• Renal artery stenosis: Use with caution in patients with unstented unilateral/bilateral renal artery stenosis. When unstented bilateral renal artery stenosis is present, use is generally avoided due to the elevated risk of deterioration in renal function unless possible benefits outweigh risks.

• Renal impairment: Use with caution in preexisting renal insufficiency; dosage adjustment may be needed. Avoid rapid dosage escalation which may lead to further renal impairment.

Concurrent drug therapy issues:

• Drug-drug interactions: Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information.

Special populations:

• Black patients: ACE inhibitors effectiveness is less in black patients than in non-blacks. In addition, ACE inhibitors cause a higher rate of angioedema in black than in non-black patients.

• Pregnancy: [US Boxed Warning]: Drugs that act on the renin-angiotensin system can cause injury and death to the developing fetus. Discontinue as soon as possible once pregnancy is detected.

Other warnings/precautions:

• Extemporaneous oral solutions: Extemporaneous preparations of liquid formulations may vary; this may affect the rate and extent of absorption causing intrapatient variability regarding dosing and safety profile for the patient; use with caution and monitor closely if dosage formulations are changed (Bhatt 2011, Mulla 2007).

• Surgery: In patients on chronic ACE inhibitor therapy, intraoperative hypotension may occur with induction and maintenance of general anesthesia; use with caution before, during, or immediately after major surgery. Cardiopulmonary bypass, intraoperative blood loss, or vasodilating anesthesia increases endogenous renin release. Use of ACE inhibitors perioperatively will blunt angiotensin II formation and may result in hypotension. However, discontinuation of therapy prior to surgery is controversial. If continued preoperatively, avoidance of hypotensive agents during surgery is prudent (Hillis 2011).

BUN, electrolytes, serum creatinine; blood pressure. In patients with renal impairment and/or collagen vascular disease, closely monitor CBC with differential for the first 3 months of therapy and periodically thereafter.

2013 ACCF/AHA Heart Failure guideline recommendations: Within 1 to 2 weeks after initiation and periodically thereafter, reassess renal function and serum potassium especially in patients with preexisting hypotension, hyponatremia, diabetes mellitus, azotemia, or those taking potassium supplements (ACCF/AHA [Yancy 2013]).

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience change in taste. Have patient report immediately to prescriber signs of infection, signs of kidney problems (urinary retention, hematuria, change in amount of urine passed, or weight gain), signs of high potassium (abnormal heartbeat, confusion, dizziness, passing out, weakness, shortness of breath, or numbness or tingling feeling), signs of liver problems (dark urine, fatigue, lack of appetite, nausea, abdominal pain, light-colored stools, vomiting, or jaundice), severe dizziness, passing out, persistent cough, severe abdominal pain, severe nausea, vomiting, angina, tachycardia, bruising, bleeding, or severe loss of strength and energy (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.

Applies to captopril: oral liquid, oral tablet

Along with its needed effects, captopril may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking captopril:

• Chest pain
• cloudy urine
• fast, pounding, or irregular heartbeat or pulse

• 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

• 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 side effects of captopril may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

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

Applies to captopril: compounding powder, oral tablet

General

The most common side effect is rash.[Ref]

Dermatologic

Very common (10% or more): Rash (up to 13.1%)
Common (1% to 10%): Pruritus, alopecia
Uncommon (0.1% to 1%): Angioedema
Very rare (less than 0.01%): Urticaria, Stevens-Johnson syndrome, erythema multiforme, photosensitivity, erythroderma, pemphigoid reactions, exfoliative dermatitis[Ref]

Gastrointestinal

Common (1% to 10%): Nausea, vomiting, abdominal pain, dry mouth, diarrhea, constipation, gastric irritation
Rare (0.01% to 0.1%): Stomatitis/aphthous ulceration, mouth ulcers, intestinal angioedema
Very rare (less than 0.01%): Glossitis, peptic ulcer, pancreatitis[Ref]

Nervous system

Common (1% to 10%): Dizziness, taste impairment, loss of taste
Rare (0.01% to 0.1%): Paresthesia, headache, drowsiness
Very rare (less than 0.01%): Cerebrovascular incidents
Frequency not reported: Syncope, ataxia, somnolence[Ref]

Respiratory

Common (1% to 10%): Cough, dyspnea
Rare (0.01% to 0.1%): Bronchospasm
Very rare (less than 0.01%): Rhinitis, allergic alveolitis/eosinophilic pneumonia[Ref]

Cardiovascular

Common (1% to 10%): Hypotension
Uncommon (0.1% to 1%): Tachycardia or tachyarrhythmia, angina pectoris, palpitations, Raynaud's syndrome, flushing, pallor, myocardial infarction, congestive heart failure
Very rare (less than 0.01%): Cardiac arrest, cardiogenic shock
Frequency not reported: Rhythm disturbances, orthostatic hypotension[Ref]

Genitourinary

Common (1% to 10%): Proteinuria
Uncommon (0.1% to 1%): Polyuria, oliguria, urinary frequency
Rare (less than 0.1%): Impotence[Ref]

Psychiatric

Common (1% to 10%): Sleep disorder
Rare (0.01% to 0.1%): Loss of libido
Very rare (less than 0.01%): Confusion, depression
Frequency not reported: Nervousness[Ref]

Other

Uncommon (0.1% to 1%): Chest pain, fatigue, malaise
Very rare (less than 0.01%): Gynecomastia, fever
Frequency not reported: Asthenia, alkaline phosphatase elevated[Ref]

Renal

Uncommon (0.1% to 1%): Renal insufficiency, acute renal failure, nephrotic syndrome
Very rare (less than 0.01%): BUN elevated, serum creatinine elevated
Frequency not reported: Glomerulopathy[Ref]

Metabolic

Rare (0.01% to 0.1%): Anorexia, weight loss, loss of appetite
Very rare (less than 0.01%): Hyperkalemia, hypoglycemia, serum potassium increased, serum sodium decreased
Frequency not reported: Hyponatremia[Ref]

Ocular

Rare (0.01% to 0.1%): Disturbed vision, dry eye, itchy eye
Very rare (less than 0.01%): Blurred vision[Ref]

Hematologic

Very rare (less than 0.01%): Neutropenia/agranulocytosis, pancytopenia, anemia, thrombocytopenia, lymphadenopathy, eosinophilia, hemoglobin decreased, hematocrit decreased, leukocytes decreased, thrombocytes decreased, erythrocyte sedimentation rate elevated[Ref]

Hepatic

Very rare (less than 0.01%): Liver enzymes elevated, bilirubin elevated, impaired hepatic function, cholestasis, hepatitis
Frequency not reported: Jaundice[Ref]

Immunologic

Very rare (less than 0.01%): Autoimmune disease, positive antinuclear antibody titer
Frequency not reported: Serum sickness-like syndrome, anaphylactoid reactions[Ref]

Musculoskeletal

Very rare (less than 0.01%): Myalgia, arthralgia
Frequency not reported: Myasthenia[Ref]

Some side effects of captopril may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Initial dose: 25 mg orally 2 to 3 times a day one hour before meals

Maintenance dose: May increase every 1 to 2 weeks up to 50 mg orally three times a day. If blood pressure remains uncontrolled after 1 to 2 weeks at this dose, add a thiazide diuretic (loop diuretic if severe renal impairment exists) and titrate to its highest usual antihypertensive dose before further increases of captopril.

Maximum dose: 450 mg/day

US BOXED WARNING:
-FETAL TOXICITY: If pregnancy is detected, discontinue this drug as soon as possible. Drugs that act directly on the renin-angiotensin system (RAS) can cause injury and death to the developing fetus.

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.