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Demadex

Last reviewed on RxList: 3/17/2017
Demadex Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Last reviewed on RxList 11/07/2016

Demadex (torsemide) is a diuretic used to reduce edema (swelling) from multiple causes and also used to treat high blood pressure (hypertension). Demadex is available as a generic. Common side effects of Demadex include:

  • increased or excessive urination,
  • dizziness,
  • nausea,
  • stomach upset,
  • headache,
  • diarrhea,
  • constipation,
  • joint pain,
  • cough,
  • runny or stuffy nose,
  • decreased sex drive,
  • impotence, or
  • difficulty having an orgasm.

Serious side effects include:

Demadex (torsemide) is available in tablets in strengths of 5, 10, 20, or 100mg. Doseage usually starts at 5 - 20mg, depending on the cause of edema or hypertension. Demadex may interact with cholestyramine, ethacrynic acid, lithium, probenecid, antibiotics, salicylates such as aspirin, nonsteroidal anti-inflammatory drugs (NSAIDs), or steroids. Tell your doctor all medications and supplements you use. Tell your doctor if you are pregnant or plan to become pregnant during treatment with Demadex; it is not expected to harm a fetus. It is unknown if Demadex passes into breast milk or if it could harm a nursing baby. Consult your doctor before breastfeeding. Adequate studies of Demadex have not been done in pregnant or breast-feeding women. Safety and effectiveness in pediatric patients has not been established for Demadex.

Our Demadex Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Demadex Consumer Information

Get emergency medical help if you have any of these signs of an allergic reaction: 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. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Demadex (Torsemide)

Demadex Professional Information

SIDE EFFECTS

The following risks are discussed in more detail in others sections:

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

In pre-approval studies, DEMADEX has 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.

Discontinuation of therapy due to adverse reactions occurred in 3.5% of United States patients treated with DEMADEX and in 4.4% of patients treated with placebo.

In United States placebo-controlled trials excessive urination occurred in 6.7% of patients compared with 2.2% of patients receiving placebo. 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.

In the placebo-controlled hypertension studies excessive urination was dose related; 1% of patients receiving placebo, 4% of those treated with 5 mg of daily DEMADEX, and 15% of those treated with 10 mg. Excessive urination was generally not reported as an adverse event among patients who received DEMADEX for cardiac, renal, or hepatic failure.

There was no effect of age or sex on the incidence of adverse reactions.

Laboratory Parameters

Potassium

In controlled studies in the United States, DEMADEX was administered to hypertensive patients at doses of 5 mg or 10 mg daily. After 6 weeks at these doses, the mean decrease in serum potassium was approximately 0.1 mEq/L. The percentage of patients who had a serum potassium level below 3.5 mEq/L at any time during the studies was 1.5% on DEMADEX and 3% on placebo. In patients followed for 1 year, there was no progressive change in mean serum potassium levels. In patients with congestive heart failure, hepatic cirrhosis, or renal disease treated with DEMADEX at doses higher than those studied in United States antihypertensive trials, hypokalemia was observed with greater frequency, in a dose-related manner.

Blood Urea Nitrogen (BUN), Creatinine and Uric Acid

DEMADEX produces small dose-related increases in each of these laboratory values. In hypertensive patients who received 10 mg of DEMADEX daily for 6 weeks, the mean increase in blood urea nitrogen was 1.8 mg/dL (0.6 mmol/L), the mean increase in serum creatinine was 0.05 mg/dL (4 mmol/L), and the mean increase in serum uric acid was 1.2 mg/dL (70 mmol/L). Little further change occurred with long-term treatment, and all changes reversed when treatment was discontinued.

Glucose

Hypertensive patients who received 10 mg of daily DEMADEX experienced a mean increase in serum glucose concentration of 5.5 mg/dL (0.3 mmol/L) after 6 weeks of therapy, with a further increase of 1.8 mg/dL (0.1 mmol/L) during the subsequent year. In long-term studies in diabetics, mean fasting glucose values were not significantly changed from baseline.

Serum Lipids

DEMADEX 20 mg caused small increases in total cholesterol and triglycerides in short term hypertension studies. The changes subsided with chronic therapy.

Postmarketing Experience

The following adverse reactions have been identified during the post-approval use of DEMADEX. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to estimate their frequency reliably or establish a causal relationship to drug exposure.

Gastrointestinal system: Pancreatitis, abdominal pain

Nervous System: Paresthesia, confusion, visual impairment, loss of appetite

Hematologic: Leucopenia, thrombocytopenia, anemia

Hepatobiliary: Increase in liver transaminases, gamma-glutamyltransferase

Metabolism: Thiamine (vitamin B1) deficiency

Skin/hypersensitivity: Stevens-Johnson syndrome, toxic epidermal necrolysis, photosensitivity reaction, pruritus

Urogenital: Acute urinary retention

Read the entire FDA prescribing information for Demadex (Torsemide)

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