Introduction

Raloxifene hydrochloride (HCl) is a selective estrogen receptor modulator with estrogen agonist effects on bone and lipid metabolism and estrogen antagonist effects on reproductive tissues. EVISTA (raloxifene hydrochloride) is commonly referred to as a selective estrogen receptor modulator (SERM) that belongs to the benzothiophene class of compounds.

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 slightly soluble in water. EVISTA is supplied in a tablet dosage form for oral administration. Each EVISTA tablet contains 60 mg of raloxifene HCl, the molar equivalent of 55.71 mg 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.

Side effects

This medicine can cause side effects like all medicines, although not everybody gets them. The majority of side effects seen with Raloxifene Hydrochloride have been mild.

Very common: may affect more than 1 in 10 people

? Hot flushes (vasodilatation)

? Flu syndrome

? Gastrointestinal symptoms such as nausea, vomiting, abdominal pain and stomach upset

? Increased blood pressure

Common: may affect up to 1 in 10 people

? Headache, including migraine

? Leg cramps

? Swelling of hands, feet and legs (peripheral oedema)

? Gallstones

? Rash

? Mild breast symptoms such as pain, enlargement and tenderness

Uncommon: may affect up to 1 in 100 people

? Increased risk of blood clots in the legs (deep vein thrombosis)

? Increased risk of blood clots in the lungs (pulmonary embolism)

? Increased risk of blood clots in the eyes (retinal vein thrombosis)

? Skin around the vein is red and painful (superficial vein thrombophlebitis)

? Blood clot in an artery (for example, stroke, including an increased risk of dying from stroke)

? Decrease in the number of platelets in the blood

In rare cases, blood levels of liver enzymes may increase during treatment with Raloxifene.

Hydrochloride.