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Femring

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Femring

Femring

Femring Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Femring (estradiol acetate) is used to treat symptoms of menopause such as hot flashes, and vaginal dryness, burning, and irritation. It is a form of estrogen, a female hormone. Common side effects include nausea/vomiting, bloating, breast tenderness, headache, or weight changes.

Two doses of Femring are available, 0.05 mg/day and 0.10 mg/day. Patients should use the lowest effective dose. Femring may interact with St. John's wort, carbamazepine, phenobarbital, blood thinners, ritonavir, rifampin, thyroid replacement medications, antibiotics, or antifungal medications. Tell your doctor all medications and supplements you use. Femring must not be used during pregnancy. If you become pregnant or think you may be pregnant, tell your doctor. This medication passes into breast milk. It may reduce the quality and amount of breast milk produced. Consult your doctor before breastfeeding.

Our Femring (estradiol acetate) 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.

Femring in Detail - Patient Information: Side Effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Remove the vaginal ring and seek emergency medical attention if you have fever with nausea, vomiting, diarrhea, muscle pain, dizziness, fainting, and/or sunburn-like skin rash. These may be signs of a life-threatening disease called toxic shock syndrome.

Call your doctor at once if you have any of these serious side effects:

  • chest pain or heavy feeling, pain spreading to the arm or shoulder, sweating, general ill feeling;
  • sudden numbness or weakness, especially on one side of the body;
  • sudden headache, confusion, problems with vision, speech, or balance;
  • pain or swelling in your lower leg (calf);
  • heavy or unusual vaginal bleeding;
  • severe constipation;
  • symptoms of depression (sleep problems, weakness, mood changes);
  • loss of appetite, increased thirst, muscle weakness, feeling tired or restless;
  • pain, swelling, or tenderness in your stomach, jaundice (yellowing of the skin or eyes); or
  • a lump in your breast.

Less serious side effects may include:

  • swollen breasts;
  • acne or skin color changes;
  • decreased sex drive, impotence, or difficulty having an orgasm;
  • migraine headache;
  • vaginal pain, itching, or discharge;
  • swelling of your ankles or feet; or
  • changes in your menstrual periods, break-through bleeding.

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.

Read the entire detailed patient monograph for Femring (Estradiol Acetate) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Femring Overview - Patient Information: Side Effects

SIDE EFFECTS: See also Warning section.

Nausea/vomiting, bloating, 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), increased or new 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 Femring (Estradiol Acetate)»

What is Prescribing information?

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

Femring FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

See Boxed Warnings, WARNINGS and PRECAUTIONS.

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 a 13-week clinical trial that included 225 postmenopausal women treated with Femring (estradiol acetate) and 108 women treated with placebo vaginal rings, adverse events that occurred at a rate of ≥ 2 percent are summarized in Table 6.

Table 6. Incidence of AEs Occurring in ≥ 2% of Subjects Presented in Descending Frequency of Preferred Term

Adverse Event Placebo
(n = 108)
Estradiol
0.05 mg/day
(n = 113)
Estradiol
0.10 mg/day
(n = 112)
  n (%) n (%) n (%)
Headache (NOS) 10 (9.3) 8 (7.1) 11 (9.8)
Intermenstrual Bleeding 2 (1.9) 9 (8.0) 11 (9.8)
Vaginal Candidiasis 3 (2.8) 7 (6.2) 12 (10.7)
Breast Tenderness 2 (1.9) 7 (6.2) 12 (10.7)
Back Pain 4 (3.7) 7 (6.2) 4 (3.6)
Genital Disorder Female (NOS) 9 (8.3) 3 (2.7) 3 (2.7)
Upper Respiratory Tract Infection (NOS) 6 (5.6) 5 (4.4) 4 (3.6)
Abdominal Distension 3 (2.8) 8 (7.1) 3 (2.7)
Vaginal discharge 9 (8.3) 2 (1.8) 3 (2.7)
Vulvovaginitis (NOS) 7 (6.5) 6 (5.3) 1 (0.9)
Nausea 5 (4.6) 3 (2.7) 2 (1.8)
Arthralgia 4 (3.7) 2 (1.8) 2 (1.8)
Sinusitis (NOS) 2 (1.9) 2 (1.8) 4 (3.6)
Uterine Pain 1 (0.9) 2 (1.8) 5 (4.5)
Nasopharyngitis 3 (2.8) 2 (1.8) 2 (1.8)
Pain in Limb 3 (2.8) 1 (0.9) 3 (2.7)
Urinary Tract Infection (NOS) 2 (1.9) 1 (0.9) 4 (3.6)
Vaginal Irritation 4 (3.7) 1 (0.9) 2 (1.8)
AE = adverse event; NOS = not otherwise specified

Postmarketing Experience

  1. 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.
  2. A few cases of ring adherence to the vaginal or bladder wall, making ring removal difficult, have been reported in women using vaginal rings. Patients should be carefully evaluated for vaginal or bladder wall ulceration or erosion. If an ulceration or erosion has occurred, consideration should be given to leaving the ring out and not replacing it until healing is complete to prevent the ring from adhering to the vaginal tissue.
  3. A few cases of bowel obstruction associated with vaginal ring use have been reported. Persistent abdominal complaints consistent with obstruction should be carefully evaluated.
  4. A few cases of inadvertent ring insertion into the urinary bladder, which may require surgical removal, have been reported for women using vaginal rings. Persistent unexplained urinary symptoms should be carefully evaluated.

The following additional adverse reactions have been identified during post-approval use of Femring (estradiol acetate) . Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Genitourinary system

Uterine cancer, vaginal hemorrhage, ovarian cyst, irregular menstruation, metrorrhagia, menorrhagia, dysmenorrhea, uterine enlargement.

Breasts

Breast cancer, fibrocystic breast disease, breast disorder, breast mass, breast enlargement, breast pain, nipple pain, breast discharge.

Cardiovascular

Chest pain, increased blood pressure, irregular heart rate, pulmonary embolism, cerebrovascular accident (stroke), hemiparesis, transient ischemic attack, thrombosis.

Gastrointestinal

Abdominal pain, pancreatitis, cholecystitis, cholelithiasis, vomiting.

Skin

Generalized erythema, erythema multiforme, erythema nodosum, rash, hirsutism, pruritis.

Eyes

Blindness, contact lens intolerance.

Central Nervous System

Dizziness, headache, depression, nervousness, mood disturbances, irritability.

Miscellaneous

Medical device complication, back pain, angioedema, weight increased/decreased, edema, libido increased/decreased, urticaria, hypersensitivity, anaphylaxis.

Read the entire FDA prescribing information for Femring (Estradiol Acetate) »

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Femring - User Reviews

Femring User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Femring sorted by most helpful. Patient Discussions FAQs

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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