Drug Information for TORSEMIDE TABLETSRx only (Par Pharmaceutical Inc): ADVERSE REACTIONS

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

    The reported side effects of torsemide 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 torsemide 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 torsemide and 3.4% (13/380) with furosemide in patients with congestive heart failure, 2.0% (8/409) with torsemide and 4.8% (11/230) with furosemide in patients with renal insufficiency, and 7.6% (13/170) with torsemide and 0% (0/33) with furosemide in patients with cirrhosis.

    The most common reasons for discontinuation of therapy with torsemide 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 torsemide are shown in Table 1.

    Table 1 - Reactions Possibly or Probably Drug-Related United States Placebo-Controlled Studies Incidence (Percentages of Patients)
    Torsemide Placebo
    (N=564) (N=274)
    Headache 7.3 9.1
    Excessive Urination 6.7 2.2
    Dizziness 3.2 4.0
    Rhinitis 2.8 2.2
    Asthenia 2.0 1.5
    Diarrhea 2.0 1.1
    ECG Abnormality 2.0 0.4
    Cough Increase 2.0 1.5
    Constipation 1.8 0.7
    Nausea 1.8 0.4
    Arthralgia 1.8 0.7
    Dyspepsia 1.6 0.7
    Sore Throat 1.6 0.7
    Myalgia 1.6 1.5
    Chest Pain 1.2 0.4
    Insomnia 1.2 1.8
    Edema 1.1 1.1
    Nervousness 1.1 0.4

    The daily doses of torsemide 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 torsemide 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 torsemide, 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 torsemide 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 torsemide 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 torsemide 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 torsemide. One patient in the group treated with torsemide withdrew due to myalgia, and one in the placebo group withdrew due to gout.

    Hypokalemia: See WARNINGS.

  • Drug Information Provided by National Library of Medicine (NLM).