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At this dose, fertility and reproductive indices were markedly reduced with total fetal mortality. Fetal mortality was also increased at doses of 0. Tamoxifen produced abortion, premature delivery and fetal death in rabbits administered doses equal to or greater than 0. There were no teratogenic changes in either rats or rabbits. Label: TAMOXIFEN CITRATE tablet. Boxed Warnings Report Adverse Events FDA Safety Recalls Presence in Breast Milk. Medline Plus Clinical Trials PubMed All Citations Adverse Effects Therapeutic Use Pharmacology Clinical Trials Biochemical Data Summary, anabolic supplements for sale. More Info For This Drug. View Labeling Archives RxNorm Get Label RSS Feed View NDC Code(s) NEW! NDC (National Drug Code) – Each drug product is assigned this unique number which can be found on the drug’s outer packaging. Category: HUMAN PRESCRIPTION DRUG LABEL DEA Schedule: None Marketing Status: Abbreviated New Drug Application. Updated April 30, 2015. If you are a consumer or patient please visit this version. Download DRUG LABEL INFO: PDFXML Medication Guide: HTML Official Label (Printer Friendly) Tamoxifen Citrate Tablets, USP. Revised: April 2015 196201- 2 Rx O nly. 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 1000 women-years of 2. For stroke, the incidence rate per 1000 women-years was 1. For pulmonary embolism, the incidence rate per 1000 women-years was 0. 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. The benefits of tamoxifen citrate outweigh its risks in women already diagnosed with breast cancer. See WARNINGS: Effects on the Uterus-Endometrial Cancer and Uterine Sarcoma.
During blinded follow-up, there were 36 cases of FIGO Stage I endometrial adenocarcinoma (22 were FIGO Stage IA, 13 IB, and 1 IC) in women receiving tamoxifen and 15 cases in women receiving placebo [14 were FIGO Stage I (9 IA and 5 IB), and 1 case was FIGO Stage IV], anabolic supplements for sale.
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