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Demadex

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Demadex

Demadex

Demadex Side Effects Center

Pharmacy Editor: Charles Patrick Davis, MD, PhD

Demadex (torsemide) is a diuretic drug used to reduce edema from multiple causes and also used to treat hypertension. Demadex is available as a generic termed torsemide. Common side effects include excessive urination, dizziness, headache and rhinitis.

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. Serious side effects include hypotension, hypokalemia, electrolyte disorders, syncopy, atrial fibrillation, ventricular fibrillation, hepatic disease and angioedema. 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.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Demadex in Detail - Patient Information: Side Effects

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

Stop using torsemide and call your doctor at once if you have a serious side effect such as:

  • dry mouth, thirst, nausea, vomiting;
  • feeling weak, drowsy, restless, or light-headed;
  • fast or uneven heartbeat;
  • muscle pain or weakness;
  • coughing up blood;
  • bloody or black, tarry stools; or
  • hearing loss.

Less serious side effects may include:

  • diarrhea or constipation;
  • headache;
  • dizziness; 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) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Demadex Overview - Patient Information: Side Effects

SIDE EFFECTS: Dizziness or headache may occur as your body adjusts to the medication. If either of these effects persist or worsen, tell your doctor or pharmacist promptly.

To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

This medication may cause a serious loss of body water (dehydration) and salt/minerals. Tell your doctor right away if you have any of these unlikely but serious side effects: muscle cramps, weakness, unusual tiredness, confusion, severe dizziness, fainting, drowsiness, unusual dry mouth/thirst, nausea, vomiting, fast/irregular heartbeat, unusual decrease in the amount of urine.

Tell your doctor right away if any of these rare but serious side effects occur: numbness/tingling/pain/redness/swelling of the arms/legs, hearing changes (such as ringing in the ears, temporary or permanent decreased hearing/deafness).

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Demadex (Torsemide)»

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Demadex FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

To report SUSPECTED ADVERSE REACTIONS, contact Meda PharmaceuticalsInc. 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.

Table 1 : Reactions Possibly or Probably Drug-Related
United States Placebo-Controlled Studies Incidence (Percentages of Patients)

  DEMADEX
(N=564)
Placebo
(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 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.

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 reliably estimate their frequency or establish a causal relationship to drug exposure. Adverse reactions reported include the following: leucopenia, thrombocytopenia.

Serious skin reactions (i.e., Stevens-Johnson syndrome, toxic epidermal necrolysis) have been reported in association with torsemide use.

Pancreatitis has been reported in association with torsemide use.

Read the entire FDA prescribing information for Demadex (Torsemide) »

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Demadex - User Reviews

Demadex User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Demadex sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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