Applies to captopril / hydrochlorothiazide: oral tablet.

Serious side effects

Along with its needed effects, captopril / hydrochlorothiazide 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 / hydrochlorothiazide:

More common

• Black, tarry stools
• chest pain
• chills
• cough
• fever
• painful or difficult urination
• sore throat
• sores, ulcers, or white spots on the lips or in the mouth
• swollen glands
• trouble breathing
• unusual bleeding or bruising
• unusual tiredness or weakness

Less common

• Blurred vision
• cloudy urine
• confusion
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• fast, pounding, or irregular heartbeat or pulse
• sweating

Rare

• Arm, back, or jaw pain or discomfort
• bloody urine
• chest discomfort, tightness, or heaviness
• decreased blood pressure
• decreased frequency or amount of urine
• dilated neck veins
• increased need to urinate
• increased thirst
• irregular breathing
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• loss of appetite
• lower back or side pain
• nausea
• paleness or cold feeling in fingertips and toes
• passing urine more often
• problems in urination or increase in amount of urine
• swelling of the face, fingers, feet, or lower legs
• tingling or pain in the fingers or toes when exposed to cold
• vomiting
• weight gain

incidence not known

• Persistent non-healing sore
• pink growth
• reddish patch or irritated area
• shiny bump
• white, yellow or waxy scar-like area

Other side effects

Some side effects of captopril / hydrochlorothiazide 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:

More common

• Difficulty in moving
• itching skin, rash
• muscle pain or stiffness
• pain in joints

Less common

• Change or loss of taste

For Healthcare Professionals

Applies to captopril / hydrochlorothiazide: oral tablet.

Gastrointestinal

Captopril:

Common (1% to 10%): Nausea, vomiting, gastric irritations, abdominal pain, diarrhea, constipation, dry mouth, peptic ulcer, aphthous ulcers

Rare (0.01% to 0.1%): Intestinal angioedema

Very rare (less than 0.01%): Glossitis, pancreatitis

Frequency not reported: Dyspepsia

Hydrochlorothiazide:

Frequency not reported: Sialadenitis, gastric irritation, diarrhea, constipation, pancreatitis, cramping, nausea, vomiting^[Ref]

Nervous system

Captopril:

Common (1% to 10%): Taste impairment, dizziness, headache, paresthesias

Rare (0.01% to 0.1%): Drowsiness

Very rare (less than 0.01%): Cerebrovascular incidents

Frequency not reported: Syncope, ataxia, somnolence

Hydrochlorothiazide:

Frequency not reported: Paresthesia, lightheadedness, vertigo, dizziness, headache^[Ref]

Dermatologic

Captopril:

Common (1% to 10%): Pruritus, rash, alopecia

Uncommon (0.1% to 1%): Angioedema

Very rare (less than 0.01%): Urticaria, Stevens-Johnson syndrome, erythema multiforme, photosensitivity, pemphigoid reactions, erythroderma, exfoliative dermatitis

Hydrochlorothiazide:

Frequency not reported: Cutaneous vasculitis, photosensitivity reactions, rash, cutaneous lupus erythematosus-like reactions, reactivation of cutaneous lupus erythematosus, urticaria, toxic epidermal necrolysis, purpura^[Ref]

Other

Captopril:

Common (1% to 10%): Chest pain, malaise, fatigue

Very rare (less than 0.01%): Gynecomastia, fever

Frequency not reported: Asthenia

Hydrochlorothiazide:

Frequency not reported: Fever, weakness^[Ref]

Cardiovascular

Captopril:

Common (1% to 10%): Tachycardia, palpitations

Uncommon (0.1% to 1%): Tachyarrhythmia, angina pectoris, hypotension, Raynaud's syndrome, flush, pallor, myocardial infarction, congestive heart failure

Very rare (less than 0.01%): Cardiac arrest, cardiogenic shock

Frequency not reported: Rhythm disturbances, orthostatic hypotension

Hydrochlorothiazide:

Frequency not reported: Postural hypotension, cardiac arrhythmias, vasculitis^[Ref]

Respiratory

Captopril:

Common (1% to 10%): Cough, dyspnea

Very rare (less than 0.01%): Bronchospasm, rhinitis, allergic alveolitis/eosinophilic pneumonia

Hydrochlorothiazide:

Frequency not reported: Respiratory distress, pneumonitis, pulmonary edema^[Ref]

Psychiatric

Captopril:

Common (1% to 10%): Sleep disorders, insomnia

Very rare (less than 0.01%): Confusion, depression

Frequency not reported: Nervousness

Hydrochlorothiazide:

Frequency not reported: Restlessness, depression, sleep disturbances^[Ref]

Genitourinary

Captopril:

Common (1% to 10%): Proteinuria

Uncommon (0.1% to 1%): Polyuria, oliguria, urinary frequency

Very rare (less than 0.01%): Impotence

Hydrochlorothiazide:

Frequency not reported: Glycosuria^[Ref]

Metabolic

Captopril:

Common (1% to 10%): Anorexia

Very rare (less than 0.01%): Hyperkalemia, hypoglycemia, serum potassium increased, serum sodium decreased

Frequency not reported: Symptomatic hyponatremia

Hydrochlorothiazide:

Frequency not reported: Anorexia, hyperglycemia, hyperuricemia, electrolyte imbalance, hyponatremia, hypokalemia, cholesterol increased, triglycerides increased, loss of appetite^[Ref]

Renal

Captopril:

Uncommon (0.1% to 1%): Renal insufficiency, renal failure, nephrotic syndrome

Very rare (less than 0.01%): BUN increased, serum creatinine increased

Hydrochlorothiazide:

Frequency not reported: Renal dysfunction, interstitial nephritis^[Ref]

Hematologic

Captopril:

Uncommon (0.1% to 1%): Eosinophilia

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

Hydrochlorothiazide:

Frequency not reported: Leukopenia, neutropenia/agranulocytosis, thrombocytopenia, aplastic anemia, hemolytic anemia, bone marrow depression^[Ref]

Immunologic

Captopril:

Uncommon (0.1% to 1%): Antinuclear antibody positive

Very rare (less than 0.01%): Autoimmune diseases

Frequency not reported: Anaphylactoid reactions

Hydrochlorothiazide:

Frequency not reported: Anaphylactic reactions^[Ref]

Hepatic

Captopril:

Very rare (less than 0.01%): Impaired hepatic function and cholestasis including jaundice, hepatitis including necrosis, elevated liver enzymes and bilirubin

Hydrochlorothiazide:

Frequency not reported: Intrahepatic cholestatic jaundice^[Ref]

Musculoskeletal

Captopril:

Very rare (less than 0.01%): Myalgia, arthralgia

Frequency not reported: Myasthenia

Hydrochlorothiazide:

Frequency not reported: Muscle spasm^[Ref]

Ocular

Captopril:

Very rare (less than 0.01%): Blurred vision

Hydrochlorothiazide:

Frequency not reported: Xanthopsia, transient blurred vision, acute myopia, secondary acute angle-closure glaucoma^[Ref]