Two medicines, side by side
Raloxifene vs tamoxifen
Raloxifene and tamoxifen are both labeled for breast cancer. Drugs@FDA records approvals of raloxifene since 1997 and of tamoxifen since 1977. Pharmacies paid $0.223 per raloxifene HCl 60 mg tablet and $0.277 per tamoxifen 20 mg tablet (NADAC, October 7, 2026); the strengths differ, so the two prices are not like for like.
Check it at the source: the raloxifene FDA label on DailyMed (effective April 14, 2026); the tamoxifen FDA label on DailyMed (effective December 18, 2025).
Highlights of the raloxifene record
Raloxifene (Evista) · label of April 14, 2026
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: indicationsRaloxifene 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 tamoxifen record
Tamoxifen (Nolvadex) · label of December 18, 2025
For Women with Ductal Carcinoma in Situ (DCIS) and Women at High Risk for Breast Cancer Serious and life-threatening events associated with tamoxifen in the risk reduction setting (women at high risk for cancer and women with DCIS) include uterine malignancies, stroke and pulmonary embolism. Incidence rates for these events were estimated from the NSABP P-1 trial (see CLINICAL PHARMACOLOGY, Clinical Studies, Reduction in Breast Cancer Incidence in High Risk Women ).
Used for
From the label: indicationsMetastatic Breast Cancer: Tamoxifen citrate tablets, USP are effective in the treatment of metastatic breast cancer in women and men. In premenopausal women with metastatic breast cancer, tamoxifen is an alternative to oophorectomy or ovarian irradiation. Available evidence indicates that patients whose tumors are estrogen receptor positive are more likely to benefit from tamoxifen therapy. […]
On the market
- Earliest approval on file
- December 30, 1977
- Generic labelers
- 10 labelers
- Pharmacy cost
- $0.277 per tablet
Supply and safety
- Shortage
- No current entry
- Recalls
- 0
Source: FDA drug labels via openFDA (Raloxifene label of April 14, 2026, Tamoxifen label of December 18, 2025); NDC Directory, Drugs@FDA, NADAC, FDA shortages and recalls (October 8, 2026)
How do raloxifene and tamoxifen differ on the record?
Both are in FDA's class estrogen agonist/antagonists.
Half-life, in each label's words: Raloxifene, “Raloxifene and its glucuronide conjugates are interconverted by reversible systemic metabolism and enterohepatic …”; Tamoxifen, “The decline in plasma concentrations of tamoxifen is biphasic with a terminal elimination half-life of about 5 to 7 …”
Both labels carry a boxed warning; the records quote them.
Generics: raloxifene since 2014; tamoxifen since 2003 (Drugs@FDA).
| Raloxifene | Tamoxifen | |
|---|---|---|
| Labeled for | Osteoporosis, Breast cancer | Breast cancer |
| Pharmacologic class | Estrogen Agonist/Antagonist | Estrogen Agonist/Antagonist |
| 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. | n/a |
| 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. | The decline in plasma concentrations of tamoxifen is biphasic with a terminal elimination half-life of about 5 to 7 days. |
| Earliest approval on file (Drugs@FDA) | December 9, 1997 | December 30, 1977 |
| First generic approved | March 4, 2014 | February 20, 2003 |
| Generic labelers (NDC) | 17 labelers | 10 labelers |
| Pharmacy cost (NADAC, each one's most listed form; strengths differ) | $0.223 per tablet (Raloxifene HCl 60 mg tablet) | $0.277 per tablet (Tamoxifen 20 mg tablet) |
| 12-month price change | -11% | -2% |
| Boxed warning | Yes | Yes |
| Shortage now | No current entry | No current entry |
| Recalls recorded | 1 | 0 |
| FAERS reports (a report is not proof of cause; counts follow how widely a medicine is used) | 16,046 | 5,727 |
| DEA schedule | none | none |
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?
- Alternatives to raloxifene
- every medicine labeled for the same conditions