Fareston Side Effects

Generic name: toremifene

Note: This document contains side effect information about toremifene. Some of the dosage forms listed on this page may not apply to the brand name Fareston.

Some side effects of Fareston may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to toremifene: oral tablet

Get emergency medical help if you have any of these signs of an allergic reaction while taking toremifene (the active ingredient contained in Fareston) 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 pinpoint spots under your skin;

• vaginal bleeding or discharge;

• chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling;

• sudden numbness or weakness, especially on one side of the body;

• chest pain, sudden cough, wheezing, rapid breathing, coughing up blood;

• pain, swelling, warmth, or redness in one or both legs;

• blurred vision, eye pain, or seeing halos around lights;

• jaundice (yellowing of the skin or eyes);

• tremor; or

• loss of movement in any part of your body.

Less serious side effects of toremifene may include:

• sweating, hot flashes;

• mild nausea, constipation;

• dizziness, spinning sensation;

• depressed mood;

• swelling in your hands or feet;

• itching, skin discoloration; or

• hair loss.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

Applies to toremifene: oral tablet

General

Hot flashes (35%), sweating (20%), and dizziness (9%) have been reported.

Gastrointestinal

Gastrointestinal effects including nausea (14%) and vomiting (4%) have been reported.

Genitourinary

Genitourinary effects including vaginal discharge (13%) and vaginal bleeding (2%) have been reported.

Ocular

Ocular effects including cataracts (up to 10%), dry eyes (up to 9%), abnormal visual fields (up to 4%), corneal keratopathy (up to 2%), glaucoma (<1% to 1.5%) and abnormal vision/diplopia (up to 1.5%) have been reported.

Cardiovascular

Cardiovascular effects including edema (5%), arrhythmia (up to 1.5%), cardiac failure (up to 1%), myocardial infarction (up to 1%), angina pectoris (<1%), and QT interval prolongation have been reported.

Hematologic

Hematologic effects including hypercalcemia (3%), pulmonary embolism (up to 2%), thrombophlebitis (up to 2%), CVA/TIA (up to 2%), and thrombosis (up to 1.5%) have been reported.

Hepatic

Hepatic effects including elevated test results in the following percent of patients have been reported, SGOT (5% to 19%), alkaline phosphatase (8% to 19%), and bilirubin (1% to 1.5%). Toxic hepatitis has also been reported.

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