Femring

Femring (estradiol acetate) is a form of estrogen a female hormone used to treat symptoms of menopause such as hot flashes and vaginal dryness burning and irritation. Common side effects of Femring include:

• nausea
vomiting bloating stomach cramps breast swelling and tenderness nipple discharge headache weight changes depression vaginal itching or discharge acne or skin color changes increased facial hair thinning scalp hair swelling of your ankles or feet changes in your menstrual periodsor break-through bleeding.

Tell your doctor if you have serious side effects of Femring including chest pain or heavy feeling pain spreading to the arm or shoulder nausea sweating general ill feeling; sudden numbness or weakness sudden severe headache sudden vision changes problems with speech or balance; sudden cough wheezing rapid breathing coughing up blood; pain swelling warmth or redness in one or both legs; swelling or tenderness in your stomach; yellowing of the skin or eyes (jaundice); unusual vaginal bleeding a lump in your breast; numbness or tingly feeling around your mouth fast or slow heart rate muscle tightness or contraction overactive reflexes; or dangerously high blood pressure (severe headache blurred vision buzzing in your ears anxiety confusion chest pain shortness of breath uneven heartbeats seizure).

Remove Femring 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

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.

 

Femring Consumer Information

Get emergency medical help if you have 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:

• heart attack symptoms--chest pain or pressure, pain spreading to your jaw or shoulder, nausea, sweating;
• signs of a stroke--sudden numbness or weakness (especially on one side of the body), sudden severe headache, slurred speech, problems with vision or balance;
• signs of a blood clot--sudden vision loss, stabbing chest pain, feeling short of breath, coughing up blood, pain or warmth in one or both legs;
• swelling or tenderness in your stomach;
• jaundice (yellowing of the skin or eyes);
• memory problems, confusion, unusual behavior;
• unusual vaginal bleeding, pelvic pain;
• a lump in your breast; or
• high levels of calcium in your blood--nausea, vomiting, constipation, increased thirst or urination, muscle weakness, bone pain, lack of energy.

Common side effects may include:

• nausea, vomiting, bloating, stomach cramps;
• headache;
• breast pain or tenderness;
• swelling in your hands or feet, weight gain;
• thinning scalp hair; or
• vaginal itching or discharge, changes in your menstrual periods, breakthrough 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)

 

Femring Professional Information

SIDE EFFECTS

The following serious adverse reactions are discussed elsewhere in the labeling:

• Cardiovascular Disorders [see BOX WARNING, WARNINGS AND PRECAUTIONS].
• Malignant Neoplasms [see BOX WARNING, WARNINGS AND PRECAUTIONS].

Clinical Trials Experience

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 and 108 women treated with placebo vaginal rings, adverse reactions that occurred at a rate of ≥ 2 percent are summarized in Table 1.

Table 1. Incidence of Adverse Reactions Occurring in ≥ 2 Percent 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 (percent)	n (percent)	n (percent)
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)
Abdominal Distension	3 (2.8)	8 (7.1)	3 (2.7)
Sinusitis (NOS)	2 (1.9)	2 (1.8)	4 (3.6)
Uterine Pain	1 (0.9)	2 (1.8)	5 (4.5)
Urinary Tract Infection (NOS)	2 (1.9)	1 (0.9)	4 (3.6)
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. Cases of ring adherence to the vaginal or bladder wall, making ring removal difficult, have been reported in women using vaginal rings and may require surgical removal of the device. Women should be carefully evaluated for vaginal or bladder wall ulceration or erosion. Cases of vaginal erosion and vaginal ulceration have been reported with other estradiol vaginal rings. 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. 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, pruritus.

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)

&Copy; Femring Patient Information is supplied by Cerner Multum, Inc. and Femring Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.