"The U.S. Food and Drug Administration today approved Osphena (ospemifene) to treat women experiencing moderate to severe dyspareunia (pain during sexual intercourse), a symptom of vulvar and vaginal atrophy due to menopause.
Estring Side Effects Center
Medical Editor: John P. Cunha, DO, FACOEP
Estring (estradiol vaginal ring) is used to treat certain symptoms of menopause such as dryness, burning, and itching of the vaginal area and urgency or irritation with urination. Estradiol (a form of estrogen) is a female sex hormone. Common side effects include nausea/vomiting, bloating, increased vaginal discharge, breast tenderness, headache, or weight changes.
The dose of Estring is one ring inserted into the upper one-third of the vagina. The ring remains in place continuously for three months, then it is removed and replaced by a new ring if needed. Estring may interact with anticoagulants (blood thinners), thyroid medications, insulin or an oral diabetes medicine, or tamoxifen. Tell your doctor all medications you are taking. Estring must not be used during pregnancy. This medication passes into breast milk. It may reduce the quality and amount of breast milk produced. Consult your doctor before breast-feeding.
Our Estring (estradiol vaginal ring) 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 Patient Information in Detail?
Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.
Estring in Detail - Patient Information: Side Effects
Estradiol increases the risk of developing a condition (endometrial hyperplasia) that may lead to cancer of the lining of the uterus. Taking progestins, another hormone drug, while using estradiol lowers the risk of developing this condition. Therefore, if your uterus has not been removed, your doctor may prescribe a progestin for you to take together while using estradiol. Visit your doctor regularly and report any unusual vaginal bleeding right away.
Treatment with estradiol long-term may increase the risk of stroke. Because of this risk, you should contact your doctor or healthcare provider to discuss your individual risks and benefits before taking estradiol long-term. You should also talk to your doctor or healthcare provider on a regular basis (for example, every 3-6 months) about whether you should continue this treatment.
If you experience any of the following serious side effects, stop using estradiol and seek emergency medical attention:
- an allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives);
- shortness or breath or pain in the chest;
- a painful, red, swollen leg;
- abnormal vaginal bleeding;
- pain, swelling, or tenderness in the abdomen;
- severe headache or vomiting, dizziness, faintness or changes in vision or speech;
- yellowing of the skin or eyes; or
- a lump in a breast.
Other, less serious side effects may be more likely to occur. Continue to use estradiol and talk to your doctor if you experience
- decreased appetite, nausea, or vomiting;
- swollen breasts;
- acne or skin color changes;
- decreased sex drive;
- migraine headaches or dizziness;
- vaginal pain, dryness, or discomfort;
- water retention (swollen hands, feet, or ankles);
- depression; or
- changes in your menstrual cycle or break-through bleeding.
Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.
Read the entire detailed patient monograph for Estring (Estradiol Vaginal Ring) »
What is Patient Information Overview?
A concise overview of the drug for the patient or caregiver from First DataBank.
Estring Overview - Patient Information: Side Effects
Nausea/vomiting, bloating, increased vaginal discharge, breast tenderness, headache, or weight changes may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Tell your doctor right away if you have any serious side effects, including: mental/mood changes (such as depression, memory loss), breast lumps, unusual vaginal bleeding (such as spotting, breakthrough bleeding, prolonged/recurrent bleeding), unusual vaginal irritation/itching/odor/discharge, severe stomach/abdominal pain, persistent nausea/vomiting, yellowing eyes/skin, dark urine, swelling hands/ankles/feet, increased thirst/urination.
This medication may rarely cause serious problems from blood clots (such as heart attacks, strokes, deep vein thrombosis, pulmonary embolism). Get medical help right away if you have any serious side effects, including: chest/jaw/left arm pain, unusual sweating, sudden/severe headache, weakness on one side of the body, confusion, slurred speech, sudden vision changes (such as partial/complete blindness), pain/redness/swelling of legs, tingling/weakness/numbness in the arms/legs, trouble breathing, coughing up blood, sudden dizziness/fainting.
Vaginal rings have rarely caused a very serious (possibly fatal) bacterial infection (toxic shock syndrome-TSS). Remove this product and get medical help right away if you have any symptoms of toxic shock syndrome, including: high fever, sudden dizziness/fainting, unusual muscle pain, sunburn-like rash, diarrhea.
A very serious allergic reaction to this product is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Read the entire patient information overview for Estring (Estradiol Vaginal Ring)»
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Estring FDA Prescribing Information: Side Effects
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
In the two pivotal controlled studies, discontinuation of treatment due to an adverse event was required by 5.4 percent of patients receiving ESTRING (estradiol vaginal ring) and 3.9 percent of patients receiving conjugated estrogens vaginal cream. The most common reasons for withdrawal from ESTRING (estradiol vaginal ring) treatment due to an adverse event were vaginal discomfort and gastrointestinal symptoms.
The adverse events reported with a frequency of 3 percent or greater in the two pivotal controlled studies by patients receiving ESTRING (estradiol vaginal ring) or conjugated estrogens vaginal cream are listed in Table 4.
Table 4: Adverse Events Reported by 3 Percent or More of
Patients Receiving Either ESTRING (estradiol vaginal ring) or Conjugated Estrogens Vaginal Cream in Two
Pivotal Controlled Studies
|ADVERSE EVENT||ESTRING (estradiol vaginal ring)
(n = 257)
|Conjugated Estrogens Vaginal Cream
(n = 129)
|CNS/Peripheral Nervous System|
|Upper Respiratory Tract Infection||5||6|
|Urinary Tract Infection||2||7|
|Asymptomatic Genital Bacterial Growth||4||6|
|Body as a Whole|
Other adverse events (listed alphabetically) occurring at a frequency of 1 to 3 percent in the two pivotal controlled studies by patients receiving ESTRING (estradiol vaginal ring) include: anxiety, bronchitis, chest pain, cystitis, dermatitis, diarrhea, dyspepsia, dysuria, flatulence, gastritis, genital eruption, urogenital pruritus, hemorrhoids, leg edema, migraine, otitis media, skin hypertrophy, syncope, toothache, tooth disorder, urinary incontinence.
- A few cases of toxic shock syndrome (TSS) have been reported in women using vaginal rings. TSS is a rare, but serious disease that may cause death. Warning signs of TSS include fever, nausea, vomiting, diarrhea, muscle pain, dizziness, faintness, or a sunburn-rash on face and body.
- A few cases of ring adherence to the vaginal wall, making ring removal difficult, have been reported. Vaginal wall ulceration or erosion should be carefully evaluated. If an ulceration or erosion has occurred, consideration should be given to leaving the ring out and not replacing it until healing is complete in order to prevent the ring from adhering to the healing tissue.
- A few cases of bowel obstruction and vaginal ring use have been reported. Persistent abdominal complaints consistent with obstruction should be carefully evaluated.
The following additional adverse events were reported at least once by patients receiving ESTRING (estradiol vaginal ring) in the worldwide clinical program, which includes controlled and uncontrolled studies. A causal relationship with ESTRING (estradiol vaginal ring) has not been established.
Body as a Whole:allergic reaction CNS/Peripheral Nervous System: dizziness Gastrointestinal: enlarged abdomen, vomiting
Metabolic/Nutritional Disorders: weight decrease or increase Musculoskeletal: arthropathy (including arthrosis) Psychiatric: depression, decreased libido, nervousness
Reproductive: breast engorgement, breast enlargement, intermenstrual bleeding, genital edema, vulval disorder
Skin/Appendages: pruritus, pruritus ani
Urinary: micturition frequency, urethral disorder
Vision: abnormal vision
The following additional adverse reactions have been reported with estrogens:
Genitourinary system: abnormal uterine bleeding/spotting; dysmenorrheal/pelvic pain; increase in size of uterine leiomyomata; vaginitis, including vaginal candidiasis; change in amount of cervical secretion; changes in cervical ectropion; ovarian cancer; endometrial hyperplasia; endometrial cancer
Eyes:retinal vascular thrombosis; intolerance to contact lenses
Miscellaneous: increase or decrease in weight; glucose intolerance; aggravation of porphyria; edema; arthralgias; leg cramps; changes in libido; angioedema; anaphylactoid/anaphylactic reactions; hypocalcemia (preexisting condition); exacerbation of asthma; increased triglycerides
Read the entire FDA prescribing information for Estring (Estradiol Vaginal Ring) »
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