Tamoxifen is an estrogen agonist/antagonist indicated for treatment of adult patients with estrogen receptor-positive metastatic breast cancer, among other approved uses. It is available as tablets and oral liquid. MedsAcross supplies Tamoxifen for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
From the regulator-approved product information. Each section names its source.
SOLTAMOX is an estrogen agonist/antagonist indicated: For treatment of adult patients with estrogen receptor-positive metastatic breast cancer. For adjuvant treatment of adult patients with early stage estrogen receptor- positive breast cancer. To reduce risk of invasive breast cancer following breast surgery and radiation in adult women with ductal carcinoma in situ (DCIS). To reduce the incidence of breast cancer in adult women at high risk
Source: US FDA prescribing information
Tamoxifen is an estrogen agonist/antagonist. Tamoxifen competes with estrogen for binding to the estrogen receptor, which can result in a decrease in estrogen receptor signaling-dependent growth in breast tissue. Tamoxifen has demonstrated antitumor activity against human breast cancer cell lines xenografted in mice. The drug has been shown to inhibit the induction of rat mammary carcinoma induced by dimethylbenzanthracene (DMBA) and to cause the regression of already established DMBA-induced tumors.
Source: US FDA prescribing information
Metastatic breast cancer: 20-40 mg per day. For doses greater than 20 mg per day, administer in divided doses (morning and evening). Adjuvant treatment of breast cancer, DCIS, reduction of breast cancer incidence in women at high risk: 20 mg per day. Metastatic Breast Cancer For patients with breast cancer, the recommended daily dose of SOLTAMOX is 20 to 40 mg. Doses greater than 20 mg per day should be given in divided doses (morning and evening). Adjuvant Treatment of Breast Cancer For use in the adjuvant setting, the recommended dose of SOLTAMOX is 20 mg daily for 5-10 years. Doses greater than 20 mg daily yield no additional clinical benefit. Ductal Carcinoma in Situ For patients with DCIS, the recommended dose of SOLTAMOX is 20 mg daily for 5 years.
Source: US FDA prescribing information
SOLTAMOX is contraindicated in patients with known hypersensitivity (e.g., angioedema, serious skin reactions) to tamoxifen or any other SOLTAMOX ingredient. 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. Known hypersensitivity to tamoxifen or any other SOLTAMOX ingredient.
Source: US FDA prescribing information
Boxed warning (uterine malignancies and thromboembolic events): Serious and life-threatening events from the use of SOLTAMOX include uterine malignancies, stroke, and pulmonary embolism. Fatal cases of each type of event have occurred. Uterine malignancies: Promptly evaluate abnormal vaginal bleeding in a woman with current or past tamoxifen use. Thromboembolic events: Risk increases with coadministered chemotherapy. For treatment of breast cancer, consider risks and benefits in patients with a history of thromboembolic events. Embryo-fetal toxicity: Can cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus and to use effective contraception. Effects on the liver: Liver cancer and liver abnormalities, some fatal, have occurred. Perform periodic liver function testing.
Source: US FDA prescribing information
The following serious adverse reactions are discussed below and elsewhere in the labeling: Uterine malignancies Thromboembolic events Embryo-Fetal Toxicity Liver cancer Most common adverse reactions: hot flashes, mood disturbances, vaginal discharge, vaginal bleeding, nausea, and fluid retention.
Source: US FDA prescribing information
Anastrozole and letrozole: Should not be used in combination with tamoxifen. Warfarin: Do not use in patients taking tamoxifen for DCIS and for reduction in breast cancer incidence in women at high risk. Closely monitor coagulation indices for increased anticoagulant effect when used with tamoxifen for metastatic breast cancer or as adjuvant therapy.
Source: US FDA prescribing information
Store at room temperatures 20° to 25°C (68° - 77°F), excursions permitted between 15° to 30°C (59° - 86°F). DO NOT freeze or refrigerate. Store in original packaging in order to protect from light.
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
3 presentations of Tamoxifen, sorted by availability.
| Medicine | Manufacturer | Register | Availability |
|---|---|---|---|
| Tamoxifen 20 mg tabletOralGeneric name | — | US FDA | Available on request |
| Tamoxifen 10 mg tabletOralGeneric name | — | US FDA | Available on request |
| Soltamox 20 mg/10 mL oral liquidOral | Mayne Pharma | US FDA | Available on request |
1 brand names across 1 markets.
United States
Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.
| Register | Status | Source |
|---|---|---|
| US FDA | First approved 30 December 1977 | Drugs@FDA |
| EU (EMA) | Not recorded | — |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US FDA (NDC directory, openFDA)Checked 12 November 2026 |
Conditions linked to Tamoxifen in public data. This is not a list of approved uses, see the clinical information.
Yes, on request. MedsAcross lists 3 presentations of Tamoxifen and sources them for licensed hospitals, importers and physicians against valid import documents.
The catalogue lists 1 brand names for Tamoxifen, including Soltamox.
Yes. The US FDA first approved Tamoxifen on 30 December 1977, according to Drugs@FDA.
No listed presentation of Tamoxifen is recorded as needing a cold chain. Storage conditions are shown on each presentation page.
Tamoxifen is classified under ATC code L02BA01 (Tamoxifen).
Tell us the strength, quantity and destination country. Our team replies with availability, lead time and the import documents needed.