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Two medicines, side by side

Raloxifene vs alendronate

Raloxifene and alendronate are both labeled for osteoporosis. Drugs@FDA records approvals of raloxifene since 1997 and of alendronate since 1995. Pharmacies paid $0.223 per raloxifene HCl 60 mg tablet and $0.256 per alendronate sodium 70 mg tablet (NADAC, October 7, 2026); the strengths differ, so the two prices are not like for like. In FDA's classes, raloxifene is an estrogen agonist/antagonist and alendronate a bisphosphonate.

Check it at the source: the raloxifene FDA label on DailyMed (effective April 14, 2026); the alendronate FDA label on DailyMed (effective March 12, 2026).

Highlights of the raloxifene record

Raloxifene (Evista) · label of April 14, 2026

Boxed warning

INCREASED RISK OF VENOUS THROMBOEMBOLISM AND DEATH FROM STROKE Increased risk of deep vein thrombosis and pulmonary embolism have been reported with raloxifene hydrochloride [see Warnings and Precautions (5.1) ]. Women with active or past history of venous thromboembolism should not take raloxifene hydrochloride [see Contraindications (4.1) ].

Used for

From the label: indications

Raloxifene hydrochloride tablets are an estrogen agonist/antagonist indicated for: Treatment and prevention of osteoporosis in postmenopausal women. (1.1) Reduction in risk of invasive breast cancer in postmenopausal women with osteoporosis. (1.2) Reduction in risk of invasive breast cancer in postmenopausal women at high risk for invasive breast cancer. […]

On the market

Earliest approval on file
December 9, 1997
Generic labelers
17 labelers
Pharmacy cost
$0.223 per tablet

Supply and safety

Shortage
No current entry
Recalls
1

Highlights of the alendronate record

Alendronate (Fosamax) · label of March 12, 2026

Used for

From the label: indications

FOSAMAX is a bisphosphonate indicated for: Treatment and prevention of osteoporosis in postmenopausal women ( 1.1 , 1.2 ) Treatment to increase bone mass in men with osteoporosis ( 1.3 ) Treatment of glucocorticoid-induced osteoporosis ( 1.4 ) Treatment of Paget's disease of bone ( 1.5 ) Limitations of use: Optimal duration of use has not been determined. […]

On the market

Earliest approval on file
September 29, 1995
Generic labelers
16 labelers
Pharmacy cost
$0.256 per tablet

Supply and safety

Shortage
No current entry
Recalls
2

Source: FDA drug labels via openFDA (Raloxifene label of April 14, 2026, Alendronate label of March 12, 2026); NDC Directory, Drugs@FDA, NADAC, FDA shortages and recalls (October 8, 2026)

How do raloxifene and alendronate differ on the record?

In FDA's classes, raloxifene is an estrogen agonist/antagonist and alendronate a bisphosphonate.

How each works, in its label's words: Raloxifene, “Raloxifene is an estrogen agonist/antagonist, commonly referred to as a selective estrogen receptor modulator (SERM).”; Alendronate, “Animal studies have indicated the following mode of action.”

Only the raloxifene label carries a boxed warning.

Generics: raloxifene since 2014; alendronate since 2008 (Drugs@FDA).

RaloxifeneAlendronate
Labeled forOsteoporosis, Breast cancerOsteoporosis
Pharmacologic classEstrogen Agonist/AntagonistBisphosphonate
How it works (label)Raloxifene is an estrogen agonist/antagonist, commonly referred to as a selective estrogen receptor modulator (SERM). The biological actions of raloxifene are largely mediated through binding to estrogen receptors.Animal studies have indicated the following mode of action. At the cellular level, alendronate shows preferential localization to sites of bone resorption, specifically under osteoclasts.
Half-life (label)Raloxifene and its glucuronide conjugates are interconverted by reversible systemic metabolism and enterohepatic cycling, thereby prolonging its plasma elimination half-life to 27.7 hours after oral dosing.n/a
Earliest approval on file (Drugs@FDA)December 9, 1997September 29, 1995
First generic approvedMarch 4, 2014February 6, 2008
Generic labelers (NDC)17 labelers16 labelers
Pharmacy cost (NADAC, each one's most listed form; strengths differ)$0.223 per tablet (Raloxifene HCl 60 mg tablet)$0.256 per tablet (Alendronate sodium 70 mg tablet)
12-month price change-11%-2%
Boxed warningYesNo
Shortage nowNo current entryNo current entry
Recalls recorded12
FAERS reports (a report is not proof of cause; counts follow how widely a medicine is used)16,046100,325
DEA schedulenonenone

Source: Drugs@FDA, FDA NDC Directory, CMS NADAC of October 7, 2026, FDA shortages and recalls, FAERS via openFDA (FDA files October 8, 2026)

What next?

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