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Fareston

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Fareston

FARESTON®
(toremifene citrate)

WARNING: QT PROLONGATION

FARESTON has been shown to prolong the QTc interval in a dose- and concentration-related manner [see CLINICAL PHARMACOLOGY]. Prolongation of the QT interval can result in a type of ventricular tachycardia called Torsade de pointes, which may result in syncope, seizure, and/or death. Toremifene should not be prescribed to patients with congenital/acquired QT prolongation, uncorrected hypokalemia or uncorrected hypomagnesemia. Drugs known to prolong the QT interval and strong CYP3A4 inhibitors should be avoided [see WARNINGS AND PRECAUTIONS].

DRUG DESCRIPTION

FARESTON (toremifene citrate) Tablets for oral administration each contain 88.5 mg of toremifene citrate, which is equivalent to 60 mg toremifene.

FARESTON is an estrogen agonist/antagonist. The chemical name of toremifene is: 2-{p-[(Z)-4-chloro-1,2diphenyl-1-butenyl]phenoxy}-N,N-dimethylethylamine citrate (1:1). The structural formula is:

FARESTON® (toremifene citrate) Structural Formula Illustration

and the molecular formula is C26H28ClNO • C6H8O7. The molecular weight of toremifene citrate is 598.10. The pKa is 8.0. Water solubility at 37°C is 0.63 mg/mL and in 0.02N HCl at 37°C is 0.38 mg/mL.

FARESTON is available only as tablets for oral administration. Inactive ingredients: colloidal silicon dioxide, lactose, magnesium stearate, microcrystalline cellulose, povidone, sodium starch glycolate, and starch.

What are the possible side effects of toremifene (Fareston)?

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.

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

  • severe dizziness, fainting, fast or pounding heartbeats, seizure (convulsions);
  • nausea, vomiting, stomach pain, loss of appetite, constipation, increased thirst or urination, muscle pain or weakness, joint pain, confusion, and feeling tired or restless;
  • easy bruising, unusual bleeding, purple or red...

Read All Potential Side Effects and See Pictures of Fareston »

What are the precautions when taking toremifene (Fareston)?

See also Warning section.

Before taking toremifene, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: bone cancer (metastases), blood disorders (e.g., anemia, low platelets), diabetes, history of stroke or other blood clots (e.g., in the legs, lungs), heart disease (e.g., heart attack, irregular heartbeat), high blood pressure, liver disease, long periods of sitting or lying down (e.g., immobility such as being bedridden), uterus problems such as endometrial hyperplasia.

This drug may...

Read All Potential Precautions of Fareston »

Last reviewed on RxList: 6/3/2011
This monograph has been modified to include the generic and brand name in many instances.

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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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