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Femring

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Femring

Femring

SIDE EFFECTS

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

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. 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. 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 Femring (estradiol acetate) Side Effects Center for a complete guide to possible side effects

DRUG INTERACTIONS

No drug interaction studies have been conducted for Femring.

Metabolic Interactions

In vitro and in vivo studies have shown that estrogens are metabolized partially by cytochrome P450 3A4 (CYP3A4). Therefore, inducers or inhibitors of CYP3A4 may affect estrogen drug metabolism. Inducers of CYP3A4 such as St. John's wort (Hypericum perforatum) preparations, phenobarbital, carbamazepine and rifampin may decrease the plasma concentration of estrogens, possibly resulting in a decrease in therapeutic effects and/or changes in the uterine bleeding profile. Inhibitors of CYP3A4 such as erythromycin, clarithromycin, ketoconazole, itraconazole, ritonavir and grapefruit juice may increase the plasma concentration of estrogens and may result in side effects.

Read the Femring Drug Interactions Center for a complete guide to possible interactions

Last reviewed on RxList: 6/12/2014
This monograph has been modified to include the generic and brand name in many instances.

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Femring - User Reviews

Femring User Reviews

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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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