Estragyn

Estragyn Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Estragyn (estrone) USP, 0.1% W/W Vaginal Cream is a form of the female hormone estrogen used for short-term treatment of menopausal and postmenopausal symptoms. Common side effects include spotting, changes in vaginal discharge, abdominal pain, nausea or vomiting, breast tenderness, depression, or headaches.

The recommended dose of Estragyn is 2.0 to 4.0 g intravaginally per day, adjusted to the lowest amount that controls symptoms. Estragyn Vaginal Cream is intended for short-term use. Estragyn may interact with grapefruit juice, anticoagulants, insulin and oral diabetes drugs, blood pressure medications, barbiturates, hydantoins, carbamazepine, meprobamates, phenylbutazone, or rifampicin. Tell your doctor all medications and supplements you use. Estragyn is not recommended for use during pregnancy or while breastfeeding.

Our Estragyn (estrone) USP, 0.1% W/W Vaginal Cream Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Estragyn FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

Adverse Drug Reaction Overview

See WARNINGS AND PRECAUTIONS regarding potential induction of malignant neoplasms and adverse effects similar to those of oral contraceptives.

The following adverse reactions have been reported with estrogen/progestin combination in general:

Blood and lymphatic system disorders

Altered coagulation tests (see: WARNINGS AND PRECAUTIONS, Drug-Laboratory Tests Interactions).

Cardiac disorders

Palpitations; increase in blood pressure (see WARNINGS AND PRECAUTIONS); coronary thrombosis.

Endocrine disorders

Increased blood sugar levels; decreased glucose tolerance.

Eye disorders

Neuro-ocular lesions (e.g. retinal thrombosis, optic neuritis); visual disturbances; steepening of the corneal curvature; intolerance to contact lenses.

Gastrointestinal disorders

Nausea; vomiting abdominal discomfort (cramps, pressure, pain, bloating).

General disorders and administration site conditions

Fatigue; changes in appetite; changes in body weight; change in libido.

Hepatobiliary disorders

Gallbladder disorder; asymptomatic impaired liver function; cholestatic jaundice.

Musculoskeletal and connective tissue disorders

Musculoskeletal pain including leg pain not related to thromboembolic disease (usually transient, lasting 3-6 weeks) may occur.

Nervous system disorders

Aggravation of migraine episodes; headaches; dizziness; neuritis.

Psychiatric disorders

Mental depression; nervousness; irritability.

Renal and urinary disorders

Cystitis; dysuria; sodium retention; edema.

Reproductive system and breast disorders

Breakthrough bleeding; spotting; change in menstrual flow; dysmenorrhea; vaginal itching/discharge; dyspareunia; endometrial hyperplasia; pre-menstrual-like syndrome; reactivation of endometriosis; changes in cervical erosion and amount of cervical secretion; breast swelling and tenderness.

Skin and subcutaneous tissue disorders

Chloasma or melasma, which may persist when drug is discontinued; erythema multiforme; erythema nodosum; haemorrhagic eruption; loss of scalp hair; hirsutism and acne.

Vascular disorders

Isolated cases of: thrombophlebitis; thromboembolic disorders.

Clinical Trial Adverse Drug Reactions

Data are not available.

Less Common Clinical Trial Adverse Drug Reactions

Data are not available.

Post-Market Adverse Drug Reactions

Case #1- Complaint of a burning sensation.
Case# 2- Complaint of inflammation and vaginal discharge.

Read the entire FDA prescribing information for Estragyn (Estrone USP, 0.1% W/W Vaginal Cream) »

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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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