Demadex Side Effects

Generic Name: torsemide

Please note - some side effects for Demadex may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Demadex - for the Consumer

Demadex

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Demadex:

Constipation; dizziness or lightheadedness when sitting up or standing; excessive urination; headache; increased cough; nasal inflammation; nausea.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest pain; diarrhea; dry mouth or unusual thirst; hearing loss or ringing in the ears; loss of appetite; muscle pain or cramps; rapid or irregular heartbeat; rectal bleeding; restlessness; unusual tiredness or weakness; vomiting.

Demadex Solution

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Demadex Solution:

Constipation; dizziness or lightheadedness when sitting up or standing; excessive urination; headache; increased cough; nasal inflammation; nausea.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest pain; diarrhea; dry mouth or unusual thirst; hearing loss or ringing in the ears; loss of appetite; muscle pain or cramps; rapid or irregular heartbeat; rectal bleeding; restlessness; unusual tiredness or weakness; vomiting.

Demadex Side Effects - for the Professional

Demadex

To report SUSPECTED ADVERSE REACTIONS, contact Meda Pharmaceuticals Inc. at 1-800-526-3840 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

At the time of approval, Demadex had been evaluated for safety in approximately 4000 subjects: over 800 of these subjects received Demadex for at least 6 months, and over 380 were treated for more than 1 year. Among these subjects were 564 who received Demadex during United States-based trials in which 274 other subjects received placebo.

The reported side effects of Demadex were generally transient, and there was no relationship between side effects and age, sex, race, or duration of therapy. Discontinuation of therapy due to side effects occurred in 3.5% of United States patients treated with Demadex and in 4.4% of patients treated with placebo. In studies conducted in the United States and Europe, discontinuation rates due to side effects were 3.0% (38/1250) with Demadex and 3.4% (13/380) with furosemide in patients with congestive heart failure, 2.0% (8/409) with Demadex and 4.8% (11/230) with furosemide in patients with renal insufficiency, and 7.6% (13/170) with Demadex and 0% (0/33) with furosemide in patients with cirrhosis.

The most common reasons for discontinuation of therapy with Demadex were (in descending order of frequency) dizziness, headache, nausea, weakness, vomiting, hyperglycemia, excessive urination, hyperuricemia, hypokalemia, excessive thirst, hypovolemia, impotence, esophageal hemorrhage, and dyspepsia. Dropout rates for these adverse events ranged from 0.1% to 0.5%.

The side effects considered possibly or probably related to study drug that occurred in United States placebo-controlled trials in more than 1% of patients treated with Demadex are shown in Table 1.

The daily doses of Demadex used in these trials ranged from 1.25 mg to 20 mg, with most patients receiving 5 mg to 10 mg; the duration of treatment ranged from 1 to 52 days, with a median of 41 days. Of the side effects listed in the table, only “excessive urination” occurred significantly more frequently in patients treated with Demadex than in patients treated with placebo. In the placebo-controlled hypertension studies whose design allowed side-effect rates to be attributed to dose, excessive urination was reported by 1% of patients receiving placebo, 4% of those treated with 5 mg of daily Demadex, and 15% of those treated with 10 mg. The complaint of excessive urination was generally not reported as an adverse event among patients who received Demadex for cardiac, renal, or hepatic failure.

Serious adverse events reported in the clinical studies for which a drug relationship could not be excluded were atrial fibrillation, chest pain, diarrhea, digitalis intoxication, gastrointestinal hemorrhage, hyperglycemia, hyperuricemia, hypokalemia, hypotension, hypovolemia, shunt thrombosis, rash, rectal bleeding, syncope, and ventricular tachycardia.

Angioedema has been reported in a patient exposed to Demadex who was later found to be allergic to sulfa drugs.

Of the adverse reactions during placebo-controlled trials listed without taking into account assessment of relatedness to drug therapy, arthritis and various other nonspecific musculoskeletal problems were more frequently reported in association with Demadex than with placebo, even though gout was somewhat more frequently associated with placebo. These reactions did not increase in frequency or severity with the dose of Demadex. One patient in the group treated with Demadex withdrew due to myalgia, and one in the placebo group withdrew due to gout.

Hypokalemia: See WARNINGS

Side Effects by Body System

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.

Hypersensitivity

Hypersensitivity side effects including hypersensitivity reactions (including 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.

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