Evista (Raloxifene) Drug Information: Description, User Reviews, Drug Side Effects, Interactions

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May 21, 2012

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Menopause »

What is menopause?

Menopause is defined as the state of an absence of menstrual periods for 12 months. The menopausal transition starts with varying menstrual cycle length and ends with the final menstrual period. Perimenopause means "the time around menopause" and is often used to refer to the menopausal transitional period. It is not officially a medical term, but is sometimes used to explain certain aspects of the menopause transition in lay terms. Postmenopause is the entire period of time that comes after the last menstrual period.

Menopause is the time in a woman's life when the function of the ovaries ceases. The ovary (female gonad), is one of a pair of reproductive glands in women. They are located in the pelvis, one on each side of the uterus. Each ovary is about the size and shape of an almond. The ovaries produce eggs (ova) and female hormones such as estrogen. During each monthly menstrual cycle, an egg is released f...

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EVISTA
(raloxifene hydrochloride) Tablet for Oral Use

WARNING: INCREASED RISK OF VENOUS THROMBOEMBOLISM AND DEATH FROM STROKE

Increased risk of deep vein thrombosis and pulmonary embolism have been reported with EVISTA (see PRECAUTIONS). Women with active or past history of venous thromboembolism should not take EVISTA (see CONTRAINDICATIONS).
Increased risk of death due to stroke occurred in a trial in postmenopausal women with documented coronary heart disease or at increased risk for major coronary events. Consider risk-benefit balance in women at risk for stroke (see PRECAUTIONS, Clinical Studies).

DRUG DESCRIPTION

EVISTA (raloxifene hydrochloride) is an estrogen agonist/antagonist, commonly referred to as a selective estrogen receptor modulator (SERM) that belongs to the benzothiophene class of compounds. The chemical structure is:

EVISTA (raloxifene hydrochloride) structural formula illustration

The chemical designation is methanone, [6-hydroxy-2-(4-hydroxyphenyl)benzo[b]thien-3-yl]-[4-[2-(1-piperidinyl)ethoxy]phenyl]-, hydrochloride. Raloxifene hydrochloride (HCl) has the empirical formula C₂₈H₂₇NO₄S•HCl, which corresponds to a molecular weight of 510.05. Raloxifene HCl is an off-white to pale-yellow solid that is very slightly soluble in water.

EVISTA (raloxifene) is supplied in a tablet dosage form for oral administration. Each EVISTA tablet contains 60 mg of raloxifene HCl, which is the molar equivalent of 55.71 mg of free base. Inactive ingredients include anhydrous lactose, carnauba wax, crospovidone, FD&C Blue No. 2 aluminum lake, hypromellose, lactose monohydrate, magnesium stearate, modified pharmaceutical glaze, polyethylene glycol, polysorbate 80, povidone, propylene glycol, and titanium dioxide.

What are the possible side effects of raloxifene (Evista)?

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.

Call your doctor at once if you have a serious side effect such as: