Estragyn

Side Effects
Interactions

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 Estragyn (estrone usp, 0.1% w/w vaginal cream) Side Effects Center for a complete guide to possible side effects

DRUG INTERACTIONS

Overview

Estrogens may diminish the effectiveness of anticoagulant, antidiabetic and antihypertensive agents.

Preparations inducing liver enzymes (e.g. barbiturates, hydantoins, carbamazepine, meprobamates, phenylbutazone or rifampicin) may interfere with the activity of orally administered estrogens.

Drug-Drug Interactions

Potential Drug-Drug Interactions Summary as Associated With Estrogen Therapy

Proper Name or Drug Classes: Ref: Effect: Clinical Comment:
Oral antidiabetic drugs The Essential Guide to Prescription Drugs 2002
Author: James J. Rybacki, Pharm. D.
May cause loss of glucose control and high blood sugars. Caution is warranted and therapeutic concentration monitoring is recommended
Warfarin May cause alterations of prothrombin activity.
Rifampin May decrease the effects of estrogens
Anticonvulsants: Barbiturates (Phenobarbital) The Essential Guide to Prescription Drugs 2002
Author: James J. Rybacki, Pharm. D.
May decrease the effects of estrogens Caution is warranted and therapeutic concentration monitoring is recommended
Phenytoin
Carbamazepine
Primidone
Corticosteroids Fiche professionnelle Santexpert May increase the effects of Corticosteroids Caution is warranted and therapeutic concentration monitoring is recommended
Ascorbic acid Health Canada Branch May increase AUC and /or plasma concentrations of ethinyl estradiol
Acetaminophen May increase AUC and /or plasma concentrations of ethinyl estradiol
Atorvastatin (Lipitor) The Essential Guide to Prescription Drugs 2002
Author: James J. Rybacki, Pharm. D.
May increase AUC for ethinyl estradiol by as much as 20%
Cyclosporine Health Canada Branch Ethinyl estradiol may cause increased plasma concentration of cyclosporine
Prednisolone Ethinyl estradiol may cause increased plasma concentrations of prednisolone.
Theophylline Ethinyl estradiol may cause increased plasma concentrations of theophylline.
Troglitazone Co-administrated with certain ethinyl estradiol drug (e.g. oral contraceptives) may reduce plasma concentrations of estradiol by as much as 30%
Salicylic acid May increase clearance of salicylic acid.
Temazapam May increase clearance of temazapam
Morphine Health Canada Branch May increase clearance of morphine
Clofibric acid May increase clearance of Clofibric acid

Drug-Food Interactions

As other inhibitors of CYP3A4, grapefruit juice may increase plasma concentrations of estrogens, possibly resulting in side effects.

Drug-Herb Interactions

It was found that some herbal products (e.g. St. John's wort) which are available as overthe- counter (OTC) products might interfere with steroid metabolism and therefore alter the efficacy and safety of estrogen /progestin products.

Physicians and other health care providers should be aware of other non-prescription products concomitantly used by the patient, including herbal and natural products, obtained from the widely spread Health Stores.

Drug-Laboratory Test Interactions

The results of certain endocrine and liver function test may be affected by estrogencontaining products:

  • increased prothrombin time and partial thromboplastin time; increased levels of fibrinogen and fibrinogen activity; increased coagulation factors VII, VIII, IX, X; increased norepinephrine-induced platelet aggregability; decreased antithrombin III;
  • increased thyroxine-binding globulin (TBG), leading to increased circulating total thyroid hormone (T4) as measured by column or radioimmunoassay; T3 resin uptake is decreased, reflecting the elevated TBG; free T4 concentration is unaltered;
  • other binding proteins may be elevated in serum i.e., corticosteroid binding globulin (CBG), sex-hormone binding globulin (SHBG), leading to increased circulating corticosteroids and sex steroids respectively; free or biologically active hormone concentrations are unchanged;
  • impaired glucose tolerance;
  • increased serum triglycerides and phospholipids concentration.

The results of the above laboratory tests should not be considered reliable unless therapy has been discontinued for two to four weeks.

The pathologist should be informed that the patient is receiving hormone replacement therapy (HRT) when relevant specimens are submitted.

Drug-Lifestyle Interactions

Acute alcohol ingestion during HRT may lead to elevations in circulating estradiol levels.

Last reviewed on RxList: 3/31/2014
This monograph has been modified to include the generic and brand name in many instances.

Side Effects
Interactions
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