Candesartan / hydrochlorothiazide Side Effects

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

For the Consumer

Applies to candesartan / hydrochlorothiazide: oral tablet

Get emergency medical help if you have any of these signs of an allergic reaction while taking candesartan / hydrochlorothiazide: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

In rare cases, hydrochlorothiazide and candesartan can cause a condition that results in the breakdown of skeletal muscle tissue, leading to kidney failure. Call your doctor right away if you have unexplained muscle pain, tenderness, or weakness especially if you also have fever, unusual tiredness, and dark colored urine.

Call your doctor at once if you have any other serious side effect, such as:

• eye pain, vision problems;

• feeling like you might pass out;

• chest pain, feeling short of breath, even with mild exertion;

• fever;

• swelling, rapid weight gain;

• urinating less than usual or not at all;

• jaundice (yellowing of the skin or eyes); or

• dry mouth, increased thirst, drowsiness, restless feeling, confusion, increased urination, fast heart rate, feeling light-headed, fainting, or seizure (convulsions).

Less serious side effects of candesartan / hydrochlorothiazide may include:

• stomach pain;

• back pain;

• dizziness, drowsiness;

• headache;

• runny or stuffy nose, sore throat; or

• dry cough.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

Applies to candesartan / hydrochlorothiazide: oral tablet

Respiratory

Respiratory side effects associated with candesartan-hydrochlorothiazide have included upper respiratory tract infection (3.6%), bronchitis, sinusitis, pharyngitis, coughing, rhinitis, and dyspnea. Respiratory distress, pneumonitis, and pulmonary edema have been reported with the use of HCTZ.

Nervous system

Nervous system side effects associated with candesartan-hydrochlorothiazide have included dizziness (2.9%), vertigo, paresthesia, and hypesthesia. Restlessness has been reported with the use of HCTZ.

Musculoskeletal

Musculoskeletal side effects associated with candesartan-hydrochlorothiazide have included arthralgia, myalgia, arthrosis, arthritis, leg cramps, and sciatica. Muscle spasm has been reported with the use HCTZ.

Musculoskeletal side effects associated with angiotensin II receptor blockers including rare reports of rhabdomyolysis have been reported during postmarketing experience.

Gastrointestinal

Gastrointestinal side effects associated with candesartan-hydrochlorothiazide have included nausea, abdominal pain, diarrhea, dyspepsia, gastritis, gastroenteritis, and vomiting. Pancreatitis, jaundice (intrahepatic cholestatic jaundice), sialadenitis, cramping, constipation, gastric irritation, and anorexia have been reported with the use of HCTZ.

Metabolic

Metabolic side effects associated with candesartan-hydrochlorothiazide have included hyperuricemia, hyperglycemia, hypokalemia, increased BUN, and increased creatine phosphokinase. Electrolyte imbalance and glycosuria have been reported with the use of HCTZ.

Metabolic side effects associated with candesartan have included hypertriglyceridemia.

Hepatic

Hepatic side effects associated with candesartan-hydrochlorothiazide have included abnormal hepatic function, increased transaminase levels, and hepatitis.

Cardiovascular

Cardiovascular side effects associated with candesartan-hydrochlorothiazide have included tachycardia, palpitation, extrasystoles, bradycardia, and ECG abnormalities. Angina pectoris, myocardial infarction, and angioedema have been reported in less than 0.5% of patients. Hypotension, orthostatic hypotension, and necrotizing angiitis (vasculitis and cutaneous vasculitis) have been reported with the use of HCTZ.

Psychiatric

Psychiatric side effects associated with candesartan-hydrochlorothiazide have included depression, insomnia, and anxiety. Somnolence has been reported with the use of candesartan.

Dermatologic

Dermatologic side effects associated with candesartan-hydrochlorothiazide have included eczema, increased sweating, pruritus, and dermatitis. Photosensitivity, urticaria, purpura, exfoliative dermatitis, toxic epidermal necrolysis, and alopecia have been reported with the use of HCTZ.

Hematologic

Hematologic side effects associated with candesartan-hydrochlorothiazide have included epistaxis. Aplastic anemia, agranulocytosis, leukopenia, hemolytic anemia, and thrombocytopenia have been reported with the use of HCTZ.

Immunologic

Immunologic side effects associated with candesartan-hydrochlorothiazide have included infection and viral infection.

Ocular

Ocular side effects associated with candesartan-hydrochlorothiazide have included conjunctivitis. Transient blurred vision and xanthopsia have been reported with the use of hydrochlorothiazide. FDA has received reports of idiosyncratic reactions to the hydrochlorothiazide component resulting in acute transient myopia and acute angle-closure glaucoma.

Other

Other side effects associated with candesartan-hydrochlorothiazide have included back pain (3.3%), influenza-like symptoms fatigue, pain, peripheral edema, asthenia fever, and tinnitus. Weakness has been reported with the use of HCTZ.

Renal

Renal side effects associated with candesartan-hydrochlorothiazide have included urinary tract infection, hematuria, and cystitis. Renal failure, renal dysfunction, and interstitial nephritis have been reported with the use of HCTZ.

Renal side effects associated with candesartan have included albuminuria.

Genitourinary

Genitourinary side effects associated with HCTZ have included impotence.

Hypersensitivity

Hypersensitivity side effects associated with HCTZ have included erythema multiforme and Stevens-Johnson syndrome.

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