Prescription medicine
Tamoxifen Brand names: Soltamox; first approved as Nolvadex
Tamoxifen (Nolvadex) is a prescription medicine with an FDA approval on record since 1977. FDA's NDC Directory lists it from 10 generic labelers, and pharmacies paid $0.277 per tamoxifen 20 mg tablet in the October 7, 2026 NADAC survey.
- Generic listed
- Boxed warning
Check it at the source: the tamoxifen FDA label on DailyMed (effective December 18, 2025, Actavis Pharma, Inc.); the NDA 17970 record on Drugs@FDA; every tamoxifen label on DailyMed.
Highlights of the record
FDA label of December 18, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
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 ). Uterine malignancies consist of both endometrial adenocarcinoma (incidence rate per 1,000 women-years of 2.20 for tamoxifen vs. 0.71 for placebo) and uterine sarcoma (incidence rate per 1,000 women-years of 0.17 for tamoxifen vs. 0.4 for placebo)*. For stroke, the incidence rate per 1,000 women-years was 1.43 for tamoxifen vs. 1.00 for placebo**. For pulmonary embolism, the incidence rate per 1,000 women-years was 0.75 for tamoxifen versus 0.25 for placebo**. Some of the strokes, pulmonary emboli, and uterine malignancies were fatal. Health care providers should discuss the potential benefits versus the potential risks of these serious events with women at high risk of breast cancer and women with DCIS considering tamoxifen to reduce their risk of developing breast cancer. […]
Used for
From the label: indications and usageMetastatic Breast Cancer: Tamoxifen citrate tablets, USP are effective in the treatment of metastatic breast cancer in women and men.
Forms and strengths
- 10 mg
- 20 mg
- 20 mg/10ml
Tablet; film-coated tablet; liquid.
On the market
- Earliest approval on file
- December 30, 1977 Nolvadex, Astrazeneca; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 12 first February 20, 2003; 5 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 11 of which 10 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $0.277 per tablet Tamoxifen 20 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 5,727 through July 30, 2026
What is tamoxifen used for?
From the label: indications and usageMetastatic 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. Adjuvant Treatment of Breast Cancer: Tamoxifen citrate tablets, USP are indicated for the treatment of node-positive breast cancer in women following total mastectomy or segmental mastectomy, axillary dissection, and breast irradiation. […]
Conditions named in the indications of tamoxifen's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Estrogen Agonist/Antagonist.
Source: FDA drug label (Tamoxifen Citrate), Actavis Pharma, Inc., effective December 18, 2025 (SPL set 9b8a4211-120f-4981-ad69-928accb97637), via openFDA; the full label on DailyMed
What does the patient leaflet for tamoxifen say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about using tamoxifen to reduce the chance of getting breast cancer?Tamoxifen is a prescription medicine that is like estrogen (female hormone) in some ways and different in other ways. In the breast, tamoxifen can block estrogen’s effects. Because it does this, tamoxifen may block the growth of breast cancers that need estrogen to grow (cancers that are estrogen- or progesterone-receptor positive). Tamoxifen can lower the chance of getting breast cancer in women with a higher than normal chance of getting breast cancer in the next five years (high-risk women) and women with DCIS. Because high-risk women don’t have cancer yet, it is important to think carefully about whether the possible benefit of tamoxifen in lowering the chance of getting breast cancer is greater than its possible risks. This Medication Guide reviews the risks and benefits of using tamoxifen to reduce the chance of getting breast cancer in high-risk women and women with DCIS. This guide does not discuss the special benefits and decisions for people who already have breast cancer. Why do women and men use tamoxifen? Tamoxifen has more than one use. Tamoxifen is used: to lower the chance of getting breast cancer in women with a higher than normal chance of getting breast cancer in the next 5 years (high-risk women). to lower the chance of getting invasive (spreading) breast cancer in women who had surgery and radiation for ductal carcinoma in situ (DCIS). DCIS means the cancer is only inside the milk ducts. to treat breast cancer in women after they have finished early treatment. Early treatment can include surgery, radiation, and chemotherapy. Tamoxifen may keep the cancer from spreading to other parts of the body. […]
From the patient leaflet: What should I avoid while taking tamoxifen?Do not become pregnant while taking tamoxifen or for 2 months after you stop. Tamoxifen can stop hormonal birth control methods from working. Hormonal methods include birth control pills, patches, injections, rings and implants. Therefore, while taking tamoxifen, use birth control methods that don’t use hormones, such as condoms, diaphragms with spermicide, or plain IUD’s. If you get pregnant, stop taking tamoxifen right away and call your doctor. Do not breastfeed. We do not know if tamoxifen can pass through your milk and if it can harm the baby.
Source: FDA drug label (Tamoxifen Citrate), Actavis Pharma, Inc., effective December 18, 2025 (SPL set 9b8a4211-120f-4981-ad69-928accb97637), via openFDA; the full label on DailyMed
Is there a generic for tamoxifen (Nolvadex)?
The FDA approved the first generic tamoxifen on February 20, 2003. 12 generic applications are approved; 5 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists tamoxifen from 10 labelers under a generic (ANDA) application and from 1 brand labeler. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 1977 earliest approval on file
- 2003 first generic approved
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for tamoxifen (Nolvadex)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.277 per Tamoxifen 20 mg tablet, down 2% from $0.284 on October 8, 2025. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Tamoxifen 20 mg tablet (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Tamoxifen 10 mg tablet | Generic | $0.126 per tablet | $3.77 | -22% |
| Tamoxifen 20 mg tablet | Generic | $0.277 per tablet | $8.30 | -2% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
What does the tamoxifen label say about other medicines?
The tamoxifen label names 10 other medicines in its interaction, contraindication or warning sections. The labels of 15 other medicines name tamoxifen. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Anastrozole | drug interactions | Based on clinical and pharmacokinetic results from the anastrozole adjuvant trial, tamoxifen citrate should not be administered with anastrozole (see CLINICAL PHARMACOLOGY, Drug-Drug Interactions ). |
| Bromocriptine | drug interactions | Concomitant bromocriptine therapy has been shown to elevate serum tamoxifen and N-desmethyl tamoxifen. |
| Cyclophosphamide | drug interactions | The effect of tamoxifen on metabolism and excretion of other antineoplastic drugs, such as cyclophosphamide and other drugs that require mixed function oxidases for activation, is not known. |
| Estradiol | warnings | In rodent models of fetal reproductive tract development, tamoxifen (at doses 0.002 to 2.4-fold the daily maximum recommended human dose on a mg/m 2 basis) caused changes in both sexes that are similar to those caused by estradiol, ethynylestradiol and diethylstilbestrol. |
| Letrozole | drug interactions | Tamoxifen reduced letrozole plasma concentrations by 37%. |
| Medroxyprogesterone | drug interactions | Medroxyprogesterone reduces plasma concentrations of N-desmethyl, but not tamoxifen. |
| Paroxetine | drug interactions | Inhibitors of CYP2D6 The impact on the efficacy of tamoxifen with co-administration of strong CYP2D6 inhibitors (e.g., paroxetine) is not well established. |
| Phenobarbital | drug interactions | One patient receiving tamoxifen with concomitant phenobarbital exhibited a steady-state serum level of tamoxifen lower than that observed for other patients (i.e., 26 ng/mL vs. mean value of 122 ng/mL). |
| Rifampin | drug interactions | Tamoxifen and N-desmethyl tamoxifen plasma concentrations have been shown to be reduced when coadministered with rifampin or aminoglutethimide. |
| Warfarin | contraindications | SOLTAMOX is contraindicated in patients who require concomitant warfarin therapy or have a history of deep vein thrombosis or pulmonary embolus if the indication for treatment is either reduction of breast cancer incidence in high-risk patients or risk reduction of invasive breast cancer after treatment of DCIS [see … |
Other labels that name tamoxifen
Source: FDA drug label (Tamoxifen Citrate), Actavis Pharma, Inc., effective December 18, 2025 (SPL set 9b8a4211-120f-4981-ad69-928accb97637), via openFDA; the full label on DailyMed
What do FAERS reports show for tamoxifen?
The FDA Adverse Event Reporting System holds 5,727 reports that list tamoxifen among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 478 are coded as a death and 1,586 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as tamoxifen?
18 other medicines are given the same way (oral) and in the same FDA class as tamoxifen or labeled mainly for the same use (breast cancer), the same class first. Breast cancer lists all 44 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Raloxifene | Breast cancer | 17 labelers | $0.223 per tablet 60 mg tablet | No current entry |
| Toremifene | Breast cancer | 2 labelers | $19.60 per tablet 60 mg tablet | No current entry |
| Everolimus | Breast cancer | 14 labelers | $26.32 per tablet 10 mg tablet | A presentation being discontinued |
| Anastrozole | Breast cancer | 24 labelers | $0.142 per tablet 1 mg tablet | No current entry |
| Letrozole | Breast cancer | 19 labelers | $0.145 per tablet 2.5 mg tablet | No current entry |
| Exemestane | Breast cancer | 10 labelers | $0.748 per tablet 25 mg tablet | No current entry |
| Talazoparib | Breast cancer | none listed | n/a | No current entry |
| Palbociclib | Breast cancer | none listed | n/a | A presentation being discontinued |
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does tamoxifen compare with medicines for the same use?
4 side-by-side pages set tamoxifen beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to tamoxifen
- 18 medicines for the same use
- Other estrogen agonist/antagonists
- the pharmacologic class, with prices and generics
- Tamoxifen side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other