Torsemide Side Effects

Some side effects of torsemide 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 torsemide: oral tablet

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

Call your doctor at once if you have a serious side effect such as:

• vomiting, fast heartbeats, feeling restless;

• ringing in your ears, sudden hearing loss;

• feeling very thirsty or hot, being unable to urinate, heavy sweating, or hot and dry skin

• feeling like you might pass out;

• low potassium (confusion, uneven heart rate, extreme thirst, increased urination, leg discomfort, muscle weakness or limp feeling);

• headache, slurred speech, hallucinations, vomiting, severe weakness, muscle cramps, loss of coordination, feeling unsteady, seizure (convulsions), fainting, shallow breathing or breathing that stops;

• severe pain in your upper stomach spreading to your back, nausea and vomiting;

• sudden numbness or weakness, sudden severe headache, problems with speech or balance;

• swelling or warmth in one or both legs, chest pain, sudden cough, wheezing, rapid breathing, coughing up blood; or

• high blood sugar (increased thirst, increased urination, hunger, dry mouth, fruity breath odor, drowsiness, dry skin, blurred vision, weight loss).

Other common side effects may include:

• increased urination;

• mild nausea, upset stomach;

• mild headache, dizziness;

• diarrhea or constipation;

• joint pain;

• cough, runny nose; or

• decreased sex drive, impotence, or difficulty having an orgasm.

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 torsemide: injectable solution, oral tablet

General

The reported side effects associated with torsemide are generally transient, and without relationship to age, sex, race, or duration of therapy. Approximately 4% of patients discontinue torsemide therapy due to side effects. In a controlled study, the withdrawal rate associated with torsemide versus placebo was similar.

Nervous system

Nervous system side effects have been associated with the use of torsemide. As with other loop diuretics, torsemide can rarely cause ototoxicity, especially with higher doses. Asthenia, nervousness, and insomnia have been reported in 1% to 2% of patients, headache in up to 10% of patients, and dizziness in up to 8% of patients. Withdrawal rates due to dizziness, headache, or weakness range from 0.1% to 0.5%.

Metabolic

Metabolic abnormalities can result from the urinary loss of potassium, sodium, calcium, and magnesium. Like other loop diuretics, hyperglycemia, hyperuricemia, hypercholesterolemia, and hypochloremic alkalosis have been reported, particularly after chronic administration. While many of these increases are not clinically significant, it is recommended that the blood glucose, serum uric acid, and serum cholesterol levels of patients with a history of diabetes, gout, or hypercholesterolemia, respectively, be monitored initially and periodically during therapy.

One case each of hypocalcemia and hypomagnesemia has been reported from a series of 426 patients who were treated for 11 months. Data from patients who were known not to have received magnesium supplementation reveal rates of serum magnesium levels less than 1.7 mg per dl (0.7 mmol per liter) of 6% and 7% after a four-week trial of torsemide 5 mg and 10 mg once a day, respectively.

Renal

Renal side effects including new or worsened renal insufficiency, as indicated by an average rise in BUN of 1.8 mg/dl (0.6 mmol/L), serum creatinine of 0.05 mg/dl (4 mcmol/L), and serum uric acid of 1.2 mg/dl (70 mcmol/L), is common. These changes appear to be reversible upon discontinuation of therapy.

Cardiovascular

Cardiovascular side effects including the effects of diuresis may become problematic. Hypovolemia, excessive thirst, and excessive urination can predispose some patients to lightheadedness and syncope. Cardiac arrhythmias may occur due to the urinary loss of potassium, although reports are extremely rare.

Gastrointestinal

Gastrointestinal side effects are typically mild, and include nausea, vomiting, diarrhea, and dyspepsia. Constipation has been reported in up to 16% of patients. Postmarketing gastrointestinal side effects have included pancreatitis.

Hypersensitivity

Hypersensitivity side effects including hypersensitivity reactions (such as angioedema) have been reported in a patient who was known to have a sulfa allergy.

Musculoskeletal

Musculoskeletal cramping has occasionally been reported during torsemide-induced diuresis.

Muscle cramps associated with torsemide are usually of short duration and can be alleviated by walking or massage.

Hematologic

Hematologic side effects including significant increases in hematologic indices (including red blood cell count, hemoglobin concentration, and packed cell volume) have been reported after higher (20 mg or more) doses. These changes have been consistent with the loss of intravascular fluid volume secondary to torsemide-induced diuresis, and are not considered side effects of torsemide itself. Hematologic side effects reported postmarketing have included leukopenia and thrombocytopenia.

Dermatologic

A 64-year-old man with chronic renal failure came to the dermatology clinic in October 2006 for evaluation of blistering lesions on the backs of his hands and scalp since July 2006. He had no changes in his treatment in the preceding year except for starting treatment with torsemide in May 2006, which had been replaced with furosemide in September 2006. Within 1 month after furosemide treatment was stopped, the lesions cleared. It is thought that torsemide induced pseudoporphyria is caused by the drug adhering to unknown specific target structures. Subsequent exposure to light may cause an inflammatory reaction resulting in blisters.

Dermatological side effects have included pseudoporphyria (an infrequent blistering skin disease), Stevens-Johnson syndrome, and toxic epidermal necrolysis.

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