Ortho Dienestrol Side Effects

Generic name: dienestrol topical

Note: This document contains side effect information about dienestrol topical. Some dosage forms listed on this page may not apply to the brand name Ortho Dienestrol.

Applies to dienestrol topical: vaginal cream.

General

The systemic absorption of dienestrol cream has not been determined. The side effects noted for dienestrol have occurred during estrogen therapy.^[Ref]

Gastrointestinal

Gastrointestinal effects have occurred frequently with oral therapy and most often have included nausea and vomiting. Some studies have demonstrated a 2 to 4 fold increase in gallbladder disease in postmenopausal women taking oral estrogen therapy.^[Ref]

Cases of oral pigmentation and ischemic colitis have been reported rarely.^[Ref]

Oncologic

A number of studies have suggested that the risk of endometrial carcinoma is removed (or delayed) by the administration of progestins in combination with estrogen therapy.

The increased risk of breast cancer due to use of estrogens is controversial. Several studies have suggested that long-term estrogen therapy may be associated with a slightly increased risk of breast cancer. Meta analysis of 51 studies (epidemiological data) supports a modest risk increase associated with long-term hormone replacement therapy (HRT).

One study of Swedish women has reported that a 10% increase in the relative risk of breast cancer may occur and that the risk is related to increasing duration of estrogen therapy. In that study, women with more than nine years of estrogen use had a 70% greater relative risk of breast cancer than controls. That study, however, examined use of a variety of estrogen preparations of which estradiol was the most frequently prescribed. In addition, women who took progestins did not demonstrate a decreased risk of breast cancer and may even have been at higher risk.

The Toronto Breast Cancer Study has reported that women who receive unopposed conjugated estrogens for less than 15 years are not at increased risk of breast cancer. In that study, an increase in the risk of breast cancer for women who used conjugated estrogens for more than 15 years was not ruled out.

The Case-Control Surveillance Study has reported that there is "no evidence that the use of unopposed conjugated estrogens increases the risk of breast cancer, even after long duration of use or long latent intervals, but the possibility of a modest increase (less than a doubling) could not be excluded."

Follow-up to the Nurses' Health Study of 1992 concluded, however, that there is an increased risk of breast cancer in women taking estrogen replacement therapy and that the risk is not reduced by concurrent use of progestins. (In that study, greater risk was associated with advanced age and prolonged duration of hormonal therapy.)

A study of middle-aged women in the Puget Sound area concluded that "on the whole, the use of estrogen with progestin HRT [hormone replacement therapy] does not appear to be associated with an increased risk of breast cancer in middle-aged women."

A prospective cohort study (11 years) of 37105 women by Gapstur et al evaluated the histology of the breast cancer in women who ever used HRT. No association was found between duration of ever HRT use and the incidence of ductal carcinoma in situ or invasive ductal/lobular carcinoma. The duration of ever HRT use was associated with risk of invasive carcinoma with a favorable prognosis (relative risk (RR) = 1.81, 95% confidence interval (CI), 1.07 to 3.07 for HRT use less than or equal to 5yrs and RR = 2.65, CI, 1.32 to 5.23 for HRT use > 5yrs, p = 0.005). The relative risks of invasive carcinoma with a favorable prognosis for current users (adjusted for age and other risk factors) was 4.42, CI, 2.00 to 9.76 for less than or equal to 5yrs and 2.63, CI, 1.18 to 5.89 for > 5yrs). Risk of invasive ductal or lobular carcinoma for current users less than or equal to 5yrs was RR = 1.38, CI, 1.03 to 1.85.^[Ref]

Oncologic side effects associated with unopposed estrogen therapy have included an increased risk of endometrial carcinoma in patients with an intact uterus and less persuasively, an increased risk of breast cancer.^[Ref]

Cardiovascular

The effects of estrogen therapy in reducing cardiovascular risk are thought to be related to beneficial alterations in lipid profiles in treated women.

The reported effects of estrogens on cardiovascular activity are variable. Alterations in lipid profiles in treated women are thought to be responsible for reducing cardiovascular risks. Data suggest estrogen use may increase blood pressure, particularly in patients receiving high doses, decrease blood pressure, or result in no change. In addition, noncontraceptive use of estrogens in young women (particularly smokers) may substantially increases the risk of nonfatal myocardial infarction. Other studies have concluded that no increased risk of myocardial infarction exists.^[Ref]

Cardiovascular risks are thought to be reduced with estrogen therapy. Studies suggest that unopposed estrogen therapy may decrease the risk of coronary heart disease by as much as 35%. Combination therapy with a progestin may also decrease coronary risk. However, the extent of risk reduction with combination therapy has not been determined. Data are available that suggest combination therapy does not reduce the overall rate of coronary heart disease in postmenopausal women with established coronary disease.^[Ref]

Metabolic

While HDL, LDL and total cholesterol levels generally have been "improved" during estrogen therapy, triglyceride levels may be significantly increased. Some dramatic elevations in triglyceride levels and to a lesser extent, cholesterol levels, have been reported.^[Ref]

Metabolic side effects have included generally favorable alterations in plasma lipid profiles. Specifically, increased HDL and decreased cholesterol and LDL levels have occurred. Estrogen therapy may lead to an increase in serum triglyceride levels resulting in pancreatitis in patients with familial lipoprotein metabolic defects.

Hypercalcemia has occurred in patients with breast cancer and bone metastases. Aggravation of porphyria has been reported.^[Ref]

Hepatic

Hepatic side effects have included rare cases of focal nodular hyperplasia, liver cell adenomas, hepatic hemangiomas and well-differentiated hepatocellular carcinomas.^[Ref]

Many of the reports of hepatic tumors have occurred in women taking long-term oral contraceptives. However, some tumors have been reported in women taking isolated estrogen therapy.^[Ref]

Hematologic

Hematologic side effects of hypercoagulability have been reported, although the clinical significance of such hypercoagulability in postmenopausal women taking estrogens has not been determined.^[Ref]

Hypersensitivity

Hypersensitivity reactions including anaphylaxis have been reported in association with estrogens and the dyes contained in some conjugated estrogen formulations.^[Ref]

Other

Some investigators have suggested that estrogen therapy may increase the risk of "fibrocystic breast disease" by as much as two-fold. Estrogens may cause some degree of fluid retention and mastodynia.^[Ref]

Psychiatric

Psychiatric effects of estrogen use have included case reports of rapid mood cycling in patients with severe depression.^[Ref]

Nervous system

Nervous system side effects associated with estrogen therapy have included migraine, dizziness, and mental depression. A case of chorea has been reported in association with conjugated estrogen therapy. Alterations in libido have occurred.^[Ref]

Genitourinary

Genitourinary side effects may include abnormal uterine bleeding which must be carefully distinguished from bleeding related to endometrial carcinoma. In addition, estrogens may increase the size of preexisting uterine leiomyomata.

Several cases of pseudoincontinence (excessive vaginal discharge perceived by patients as urinary incontinence) have been reported in premenopausal who have undergone hysterectomy-oophorectomy and received post-operative estrogens.^[Ref]

Dermatologic

Dermatologic side effects have included chloasma or melasma, which may not resolve following discontinuation of estrogen therapy. Scalp hair loss, hirsutism, erythema nodosum, and hemorrhagic eruptions have occurred.^[Ref]

Endocrine

Endocrine effects have included decreased fasting plasma glucose. Estrogen use may result in increased levels of thyroxin-binding globulin leading to an increase in total thyroid serum levels and a decrease in resin uptake of T3. Free thyroid hormone levels remain unchanged.^[Ref]

Ocular

Ocular side effects of estrogen therapy including alterations in corneal curvature and contact lens discomfort have occurred.^[Ref]

Further information

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Some side effects may not be reported. You may report them to the FDA.

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