Bendroflumethiazide / nadolol Side Effects

Some side effects of bendroflumethiazide / nadolol 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 bendroflumethiazide / nadolol: oral tablet

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

Stop using this medication and call your doctor at once if you have any of these serious side effects:

• swelling, rapid weight gain, feeling short of breath, even with mild exertion;

• fast, slow, or uneven heartbeat;

• easy bruising or bleeding;

• numbness or tingly feeling in your hands or feet;

• feeling weak, drowsy, restless, or light-headed;

• nausea, vomiting, dry mouth, extreme thirst, headache, confusion, hallucinations, seizure (convulsions);

• increased urination, leg discomfort, muscle pain or weakness or limp feeling;

• urinating less than usual or not at all;

• fever, sore throat, and headache with a severe blistering, peeling, and red skin rash; or

• upper stomach pain, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Less serious side effects of bendroflumethiazide / nadolol may include:

• diarrhea, constipation, upset stomach;

• dizziness, spinning sensation;

• blurred vision;

• depressed mood; or

• ringing in your ears.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect.

For Healthcare Professionals

Applies to bendroflumethiazide / nadolol: oral tablet

Cardiovascular

Cardiovascular complications of bendroflumethiazide therapy include orthostatic hypotension secondary to intravascular volume depletion. This has resulted in syncope and, in some patients with glaucoma, temporary loss of vision. Rare cases of cerebrovascular accident associated with thiazide-induced diuresis have been reported.

Cardiovascular side effects of nadolol are usually mild and transient and rarely require discontinuation of therapy. Bradycardia, hypotension, conduction disturbances, chest pain, and heart failure have each been reported in 1% to 3% of patients. Complaints of cold extremities have been reported in approximately 5% of patients. Edema has rarely been associated with the use of nadolol.

Rare cases of A-V heart block during nadolol therapy have been reported.

Dermatologic

Dermatologic reactions of bendroflumethiazide may indicate hypersensitivity to the drug. Erythema multiforme, Stevens-Johnson syndrome, exfoliative dermatitis (including toxic epidermal necrolysis), and alopecia have been reported in rare cases.

Endocrine

Endocrinologic changes associated with bendroflumethiazide, as with other thiazide diuretic agents, include decreased glucose tolerance and a potentially deleterious effect on the lipid profile. This may be important in some patients with or who are at risk for diabetes or coronary artery disease.

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

Gastrointestinal

Gastrointestinal problems associated with bendroflumethiazide use include anorexia, gastric irritation, nausea, vomiting, diarrhea, constipation, or abdominal pain in approximately 5% of patients. Thiazide diuretics have been associated with acute cholecystitis, intrahepatic cholestatic jaundice and rare cases of pancreatitis.

Gastrointestinal problems, such as nausea, diarrhea, constipation, anorexia, bloating, flatulence and general abdominal upset have each been reported in less than 1% of patients receiving nadolol.

A retrospective case-controlled drug surveillance study has revealed the relative risk of acute cholecystitis associated with the use of a thiazide diuretic is 2.0. The suspected explanation for this association is the potentially deleterious effect thiazides have on the serum lipid profile. Bendroflumethiazide-induced hypercholesterolemia or hypertriglyceridemia may enhance the formation of some types of gallstones.

Hematologic

Hematologic side effects associated with bendroflumethiazide use are rare. Rare cases of immune-complex hemolytic anemia, aplastic anemia, leukopenia, agranulocytosis, and thrombocytopenia have been associated with thiazide diuretics.

Nervous system

Side effects related to the nervous system during bendroflumethiazide administration include mild, transient dizziness, vertigo, xanthopsia, paresthesia, fatigue, or headache.

The most common nervous system side effect of nadolol appears to be fatigue (up to 10% of patients). Headache or dizziness have been reported in 5% and 8% of patients, respectively.

Nadolol is hydrophilic and is less likely to penetrate into the central nervous system compared to other beta-blockers. Depression and anxiety are reported in one patient while receiving nadolol. The symptoms started two days after an increase in his dosage and resolved within three days of discontinuing nadolol. Organic brain syndrome was diagnosed in two patients receiving nadolol should be considered as a possible cause of acute deterioration in mental or emotional status.

Hypersensitivity

Thiazides may induce allergic reactions in patients who are allergic to sulfonamides.

Hypersensitivity reactions with thiazide diuretics usually involve the skin (cutaneous vasculitis, urticaria, rash, purpura), but may involve the gastrointestinal system (nausea, vomiting, or diarrhea), the genitourinary system (interstitial nephritis), and the respiratory system (acute noncardiogenic pulmonary edema, pneumonitis). Thiazide diuretics may induce phototoxic dermatitis.

Metabolic

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 cases of hypercalcemia and milk-alkali syndrome (hypercalcemia, metabolic alkalosis, and renal insufficiency) have been associated with thiazide diuretics.

Metabolic changes associated with bendroflumethiazide, as with other thiazide diuretics, are relatively common, especially when daily doses greater than 100 mg are used. Mild hypokalemia (decrease of 0.5 mEq/L) occurs in up to 50%, and may predispose patients to cardiac arrhythmias. Metabolic alkalosis, hyponatremia, hypomagnesemia, hypophosphatemia, hypercalcemia, hyperglycemia, hypercholesterolemia, and hyperuricemia are also relatively common.
The electrolyte and intravascular fluid shifts that may occur during bendroflumethiazide diuresis can provoke hepatic encephalopathy in patients with hepatic cirrhosis.

Musculoskeletal

Musculoskeletal cramping or spasm are occasionally reported during bendroflumethiazide diuresis.

Psychiatric

Psychiatric side effects of nadolol have been limited to anxiety-depression in approximately 4% of patients.

Renal

New or worsened renal insufficiency associated with bendroflumethiazide therapy is a probable sign of intravascular volume depletion, and serves as a signal to reduce or withhold therapy. Rare cases of allergic interstitial nephritis have been associated with some thiazide diuretics.

Renal insufficiency has not associated with nadolol, but one study of 10 elderly hypertensive patients has shown that the antihypertensive effect of nadolol was associated with a decrease in effective renal blood flow. The glomerular filtration rate in affected patients remained stable, however.

Respiratory

Respiratory system side effects associated with nadolol therapy have been rare (1 in 1,000), but may be important in patients with reactive airways disease. The use of nadolol has been associated with precipitation of bronchospasm in patients with a history of asthma.

At least one case of severe bronchospasm associated with nadolol therapy is reported. This patient had a history of childhood asthma and exercise-induced bronchospasm requiring albuterol inhalations. After one dosage of nadolol the patient had a respiratory arrest and required mechanical ventilation for several days. If nadolol is necessary in a patient with a history of bronchospasm, it is recommended that therapy be initiated in a controlled environment with bronchodilators available.

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