"The U.S. Food and Drug Administration today notified Ranbaxy Laboratories, Ltd., that it is prohibited from manufacturing and distributing active pharmaceutical ingredients (APIs) from its facility in Toansa, India, for FDA-regulated drug product"...
(Generic versions may still be available.)
Numerous reports of ingestion of large doses of estrogen-containing oral contraceptives by young children indicate that serious ill effects do not occur. Overdosage of estrogen may cause nausea, and withdrawal bleeding may occur in females.
Estrogens may cause fetal harm when administered to a pregnant woman (see BOXED WARNING). Estrogens are contraindicated in women who are or may become pregnant. If this drug is used during pregnancy, or if the patient becomes pregnant while using this drug, the patient should be apprised of the potential hazard to the fetus.
Estrogens should also not be used in women with any of the following conditions:
- Known or suspected cancer of the breast.
- Known or suspected estrogen-dependent neoplasia.
- Undiagnosed abnormal genital bleeding.
- Active thrombophlebitis or thromboembolic disorders.
- A past history of thrombophlebitis, thrombosis, or thrombo-embolic disorders associated with previous estrogen use.
Last reviewed on RxList: 1/29/2005
This monograph has been modified to include the generic and brand name in many instances.
Additional Dienestrol Information
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