Classifications: hormone; selective estrogen receptor antagonist/agonist; Therapeutic: osteoporosis prophylactic
Pregnancy Category: X
60 mg tablets
Tamoxifen analog that exhibits selective estrogen receptor antagonist activity on uterus and breast tissue. Prevents tissue
proliferation in both sites. Decreases bone resorption and increases bone density.
Effectiveness indicated by increased bone mineral density.
Prevention and treatment of osteoporosis in postmenopausal women.
Active thromboembolic event; hypersensitivity to raloxifene; pregnancy (category X), lactation, children.
Concurrent use of raloxifene and estrogen hormone replacement therapy and lipid-lowering agents; hyperlipidemia; hepatic
Route & Dosage
|Prevention or Treatment of Osteoporosis
Adult: PO 60 mg q.d.
- Discontinue 72 h before and during prolonged immobilization.
- Store at 15°30° C (59°86° F) in a tightly closed container and protect from light.
Adverse Effects (≥1%)Body as a Whole: Infection
, flu-like syndrome
, leg cramps, fever, arthralgia
, myalgia, arthritis
Migraine headache, depression
. CV: Hot flashes,
chest pain, peripheral edema, decreased serum
Nausea, dyspepsia, vomiting, flatulence, GI disorder, gastroenteritis, weight gain. Respiratory: Sinusitis
, pharyngitis, cough, pneumonia
, laryngitis. Skin:
Rash, sweating. Urogenital: Vaginitis
, UTI, cystitis
, leukorrhea, endometrial disorder, breast pain, vaginal bleeding.
Use of estrogens
not recommended; absorption reduced by cholestyramine; use with warfarin or other coumarin derivatives may result in changes in prothrombin time (PT).
60% absorbed, absolute bioavailability 2%. Metabolism:
Extensive first-pass metabolism
in liver. Elimination:
Primarily in feces. Half-Life:
Assessment & Drug Effects
- Lab tests: Periodically monitor bone density, liver function, and plasma lipids; with concurrent oral anticoagulants, carefully
monitor PT and INR.
- Monitor carefully for and immediately report S&S of thromboembolic events.
- Do not give drug concurrently with cholestyramine; however, if unavoidable, space the two drugs as widely as possible.
Patient & Family Education
- Contact physician immediately if unexplained calf pain or tenderness occurs.
- Avoid prolonged restriction of movement during travel.
- Drug does not prevent and may induce hot flashes.
- Do not take drug with other estrogen-containing drugs.
- Tell prescriber if you are taking drugs to lower your cholesterol.