"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.)
(See WARNINGS regarding induction of neoplasia, adverse effects on the fetus, increased incidence of gall bladder disease, and adverse effects similar to those of oral contraceptives, including thromboembolism.) The following additional adverse reactions have been reported with estrogenic therapy, including oral contraceptives:
1. Genitourinary system.
- Increase in size of uterine fibromyomata.
- Vaginal candidiasis.
- Breakthrough bleeding, spotting, change in menstrual flow.
- Dysmenorrhea. Premenstrual-like syndrome.
- Amenorrhea during and after treatment.
- Change in cervical eversion and in degree of cervical secretion.
- Cystitis-like syndrome.
Tenderness, enlargement, secretion.
- Cholestatic jaundice.
- Nausea, vomiting.
- Abdominal cramps, bloating.
- Erythema multiforme.
- Erythema nodosum.
- Hemorrhagic eruption.
- Loss of scalp hair.
- Chloasma or melasma which may persist when drug is discontinued.
- Steepening of corneal curvature.
- Intolerance to contact lenses.
- Reduced carbohydrate tolerance.
- Aggravation of porphyria.
- Changes in libido.
- Increase or decrease in weight.
Read the Dienestrol (dienestrol) Side Effects Center for a complete guide to possible side effects
Drug/ Laboratory Test Interactions
- Increased sulfobromophthalein retention.
- Increased prothrombin and factors VII, VIII, IX, and X; decreased antithrombin 3; increased norepinephrine-induced platelet aggregability.
- Increased thyroid-binding globulin (TBG) leading to in-creased circulating total thyroid hormone; as measured by PBI, T4 by column, or T4 by radioimmunoassay. Free T3 resin uptake is decreased, reflecting the elevated TBG; free T4 concentration is unaltered.
- Impaired glucose tolerance.
- Decreased pregnanediol excretion.
- Reduced response to metyrapone test.
- Reduced serum folate concentration.
- Increased serum triglyceride and phospholipid concentration.
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
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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