药物信息为Femring (estradiol acetate vaginal ring) (Warner Chilcott (US), LLC): ADVERSE REACTIONS

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  • See BOXED WARNINGS, WARNINGSand 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 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
    AE = adverse event; NOS = not otherwise specified
    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 Bleeding2 (1.9)9 (8.0)11 (9.8)
    Vaginal Candidiasis3 (2.8)7 (6.2) 12 (10.7)
    Breast Tenderness2 (1.9)7 (6.2) 12 (10.7)
    Back Pain4 (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 Distension3 (2.8)8 (7.1)3 (2.7)
    Vaginal discharge9 (8.3)2 (1.8)3 (2.7)
    Vulvovaginitis (NOS)7 (6.5)6 (5.3)1 (0.9)
    Nausea5 (4.6)3 (2.7)2 (1.8)
    Arthralgia4 (3.7)2 (1.8)2 (1.8)
    Sinusitis (NOS)2 (1.9)2 (1.8)4 (3.6)
    Uterine Pain1 (0.9)2 (1.8)5 (4.5)
    Nasopharyngitis3 (2.8)2 (1.8)2 (1.8)
    Pain in Limb3 (2.8)1 (0.9)3 (2.7)
    Urinary Tract Infection (NOS)2 (1.9)1 (0.9)4 (3.6)
    Vaginal Irritation4 (3.7)1 (0.9)2 (1.8)
  • Postmarketing Experience

    • 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 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.
    • A few cases of bowel obstruction associated with vaginal ring use have been reported. Persistent abdominal complaints consistent with obstruction should be carefully evaluated.
    • 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.

    1. Genitourinary system

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

    2. Breasts

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

    3. Cardiovascular

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

    4. Gastrointestinal

    Abdominal pain, pancreatitis, cholecystitis, cholelithiasis, vomiting.

    5. Skin

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

    6. Eyes

    Blindness, contact lens intolerance.

    7. Central Nervous System

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

    8. Miscellaneous

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

  • Drug Information Provided by National Library of Medicine (NLM).
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