Description
Unigen Tamoxifen Citrate is a branded formulation of Tamoxifen Citrate. It is a selective estrogen receptor modulator (SERM). It blocks the effects of estrogen in breast tissue . Consequently, this may help prevent breast cancer cells from growing. This note provides an overview of its scientific background. It also covers clinical applications and important safety warnings.
Chemical Identity and Properties
Chemical Identity
Tamoxifen Citrate has several names. These include Nolvadex and Soltamox. Its CAS number is 54965-24-1. The molecular formula is C32H37NO8. The molecular weight is 563.65 g/mol . The FDA originally approved it in 1977 . It is available as a prescription drug.
Mechanism of Action
Tamoxifen acts as a selective estrogen receptor modulator. It competitively inhibits estradiol binding to estrogen receptors . This prevents the receptor from binding to DNA . Consequently, DNA synthesis reduces. Cellular response to estrogen also decreases. Additionally, tamoxifen up-regulates transforming growth factor B (TGFb) production . This factor inhibits tumor cell growth. It also down-regulates insulin-like growth factor 1 (IGF-1) . IGF-1 stimulates breast cancer cell growth.
Clinical Applications
Approved Therapeutic Uses
Tamoxifen has several approved indications. First, it treats breast cancer in women and men . Second, it prevents invasive breast cancer in women with DCIS . Third, it reduces breast cancer incidence in high-risk women . The standard daily dose is 20-40 mg . Dosages greater than 20 mg should be given in divided doses . Tamoxifen is also listed in China’s 2025 national drug catalog .
Investigational Research
Researchers have studied tamoxifen for other applications. It has shown benefits in multiple myeloma patients . It has also been investigated for chemoprevention . Some research explores its use for preventing osteoporosis in postmenopausal women . However, these applications remain investigational.
Pharmacokinetics
Tamoxifen has a terminal elimination half-life of 5 to 7 days . After a single oral dose of 20 mg, peak plasma concentration occurs at approximately 5 hours . The drug undergoes extensive metabolism. CYP2D6 is the key enzyme for forming endoxifen and 4-hydroxytamoxifen . About 65% of the dose excretes through feces over 2 weeks . Fecal excretion is the primary route of elimination . Excretion occurs mainly as polar conjugates .
Severe Safety Concerns
Uterine Effects
Tamoxifen poses risks to the uterus. Most uterine malignancies associated with tamoxifen are endometrial adenocarcinoma . Mean uterine volume doubled after one year of treatment . Vaginal bleeding or bloody discharge could indicate serious problems . Pain or pressure in the pelvis also requires attention .
Thrombotic Events
Blood clots are a significant concern. Deep vein thrombosis occurred in 0.8% of tamoxifen patients . Pulmonary embolism occurred in 0.5% . Two patients died from thrombotic events . Patients may develop clots up to 2-3 months after stopping treatment .
Other Adverse Effects
Hot flashes are the most common side effect. They occurred in 64% of patients in one study . Vaginal discharge occurred in 30% . Irregular menses occurred in 25% . Liver problems including jaundice have been reported . Cataracts are also a risk . Tamoxifen may cause cataracts or increase cataract surgery risk . Hypercalcemia has been reported in breast cancer patients with bone metastases . In severe cases, discontinue the drug.
Legal Status and Regulatory Actions
Controlled Substance Status
Tamoxifen is a prescription drug. It is not a controlled substance. It is FDA-approved for several indications. The manufacturer has discontinued some formulations. FDA-approved Soltamox remains available.
Regulatory Status in China
In China, Tamoxifen Citrate is a prescription drug. It is listed as a national essential drug . Several Chinese manufacturers produce it. These include Shanghai Fudan Forward Pharmaceutical . Yangtze River Pharmaceutical Group also produces it . It is classified as an antineoplastic agent. Import and export are regulated accordingly.
Manufacturing and Quality
General Pharmaceuticals Ltd. in Bangladesh manufactures one version . The Philippines FDA has registered this product . Quality control varies across manufacturers. Research-grade material is available from chemical suppliers. These products are for laboratory use only.
Internal and External Links
Internal Resources
Visit our Research Chemical Library for related compounds. Explore our Guide to SERMs. Review our Safety Protocols and Regulatory Compliance FAQ.
External Resources
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[NCATS Inxight]: View chemical data at NCATS Inxight.
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[DailyMed]: Access the FDA label at DailyMed.
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[NIH/NCI]: Read the cancer glossary entry at NIH.
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[DrugBank]: View pharmacological data at DrugBank.
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[Wiley]: Access research articles at Wiley Online Library.
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