Hydrochlorothiazide / valsartan Side Effects

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

Applies to hydrochlorothiazide / valsartan: oral tablet

Nervous system

Common (1% to 10%): Headache, fatigue, dizziness
Rare (less than 0.1%): Vertigo, tinnitus

Hypersensitivity

Rare cases of interstitial nephritis have been associated with the use of HCTZ. Although HCTZ has been used to treat nephrogenic diabetes insipidus, a case report in which the drug was believed to have caused this condition has been reported.

Rare (less than 0.1%): Nausea, diarrhea, rash, acute pulmonary edema, interstitial nephritis or cystitis, anaphylaxis

Renal

Rare (less than 0.1%): Renal insufficiency, azotemia

In multiple-dose studies in hypertensive patients with stable renal insufficiency and renovascular hypertension, the use of valsartan alone had no clinically significant effects of glomerular filtrate rate, filtration fraction, creatinine clearance, or renal plasma flow. The use of HCTZ has been associated with the development of pre-renal azotemia. Pretreatment volume repletion is recommended prior to initiating therapy.

Cardiovascular

Chest pain was reported in more than 2% of patients who were taking this combination drug in controlled trials, but this incidence was not significantly different compared with the incidence of chest pain among placebo patients.

Rare (less than 0.1%): Palpitations, chest pain, angioedema
Frequency not reported: Cardiac arrhythmias (including ventricular ectopy and complete AV heart block)

Respiratory

Angiotensin II receptor blockade, unlike ACE inhibition, has no impact on the processing of peptides such as bradykinin and substance P, two peptides able to induce cough.

Bronchospasm, dyspnea, and epistaxis have rarely been associated with the use of this drug.

Common (1% to 10%): Cough (valsartan component)
Uncommon (0.1% to 1%): Dyspnea, acute pulmonary edema

Dermatologic

Frequency not reported: Erythema annular centrifugum, acute eczematous dermatitis, morbilliform, leukocytoclastic vasculitis, phototoxic dermatitis, subacute cutaneous lupus erythematosus-like condition, pruritus, rash

Metabolic

Since HCTZ may increase total serum cholesterol by 11%, LDL lipoprotein cholesterol by 12%, and VLDL lipoprotein cholesterol levels by 50%, and may reduce insulin secretion, it should be used with caution in diabetic patients and in those with hypercholesterolemia. True glucose intolerance may develop in approximately 3% of patients. It is typically reversible within six months after discontinuation of therapy.

Hyperuricemia may be an important consideration in patients with a history of gout. Hypophosphatemia and low serum magnesium concentrations may occur, but are usually clinically insignificant except in malnourished patients.

Rare (0.01% to 0.1%): Hypokalemia, hyperkalemia, metabolic alkalosis, hyponatremia, hypomagnesemia, hypercalcemia, hyperglycemia, elevated serum uric acid levels, elevated serum cholesterol

Gastrointestinal

Thiazide diuretics may increase serum cholesterol and triglycerides, resulting in an increased risk of cholesterol gallstone formation. Reports of bowel strictures associated with thiazide ingestion were reported in the 1960s (although patients in these reports were on a combination HCTZ-potassium product).

Uncommon (0.1% to 1%): Diarrhea, constipation, appetite changes, dry mouth, dyspepsia, nausea, vomiting, flatulence, pancreatitis, cholecystitis

Immunologic

Rare (0.01% to 0.1%): Allergic vasculitis, hemolytic anemia

Endocrine

Frequency not reported: Glucose intolerance, altered lipid profile

Use of valsartan alone has not been associated with significant changes in serum lipids or glucose concentrations. However, use of HCTZ may be associated with increases in total serum cholesterol by 11%, LDL lipoprotein cholesterol by 12%, and VLDL lipoprotein cholesterol levels by 50%. In addition, use of HCTZ may be associated with reduced insulin secretion. Therefore, caution is recommended when giving this combination drug to diabetic patients or those with hypercholesterolemia.

Hyperuricemia may be an important consideration in patients with a history of gout. Hypophosphatemia and low serum magnesium concentrations may occur, but are usually clinically insignificant except in malnourished patients.

A prospective study of 34 patients who received oral thiazide diuretics for 14 years without interruption revealed significantly increased average fasting blood glucose levels. Withdrawal of thiazide therapy for 7 months in 10 of the patients resulted in average reductions of 10% in fasting blood glucose and 25% in 2-hour glucose tolerance test values. A control group was not reported.

Musculoskeletal

Common (1% to 10%): Back pain, muscle cramps, myalgia

Hematologic

Common (1% to 10%): Neutropenia
Uncommon (0.1% to 1%): Hematocrit decreased, hemoglobin decreased
Rare (0.01% to 0.1%): Immune complex hemolytic anemia
Postmarketing reports: Thrombocytopenia

Psychiatric

Rare (less than 0.1%): Anxiety, depression, decreased libido, insomnia, paresthesias, somnolence

Genitourinary

Rare (less than 0.1%): Impotence, dysuria

Hepatic

Uncommon (0.1% to 1%): Increases in hepatic enzymes (usually reversible)

Ocular

Rare (less than 0.1%): Abnormal vision, idiosyncratic reactions to hydrochlorothiazide resulting in acute transient myopia and acute angle-closure glaucoma

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