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ESTRING®Adverse Reactions (estradiol)

ADVERSE REACTIONS

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 the two ESTRING controlled studies, discontinuation of treatment due to an adverse event was required by 5.4 percent of patients receiving ESTRING and 3.9 percent of patients receiving conjugated estrogens vaginal cream. The most common reasons for withdrawal from ESTRING 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 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 or Conjugated Estrogens Vaginal Cream in Two Pivotal Controlled Studies
ADVERSE EVENTESTRING
(n = 257)
%
Conjugated Estrogens Vaginal Cream
(n = 129)
%
Musculoskeletal
  Back Pain68
  Arthritis42
  Arthralgia35
  Skeletal Pain24
CNS/Peripheral Nervous System
  Headache1316
Psychiatric
  Insomnia40
Gastrointestinal
  Abdominal Pain42
  Nausea32
Respiratory
  Upper Respiratory Tract Infection56
  Sinusitis43
  Pharyngitis13
Urinary
  Urinary Tract Infection27
Female Reproductive
  Leukorrhea73
  Vaginitis52
  Vaginal Discomfort/Pain55
  Vaginal Hemorrhage45
  Asymptomatic Genital Bacterial Growth46
  Breast Pain17
Resistance Mechanisms
  Genital Moniliasis67
Body as a Whole
  Flu-Like Symptoms32
  Hot Flushes23
  Allergy14
Miscellaneous
  Family Stress23

Postmarketing Experience

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.

Vaginal erosion, vaginal ulceration, adherence of the vaginal ring to the vaginal wall:

  • Cases of ring adherence to the vaginal wall, making ring removal difficult, have occurred. Some cases have required surgical removal of vaginal rings.
  • Cases of vaginal erosion and vaginal ulceration that may manifest as vaginal irritation, erythema. abrasion or spotting have occurred.

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.

Cases of bowel obstruction and vaginal ring use have been reported. Persistent abdominal complaints consistent with obstruction should be carefully evaluated.

Cases of hypersensitivity have been reported.

The following additional adverse events were reported at least once by patients receiving ESTRING in the worldwide clinical program, which includes controlled and uncontrolled studies. A causal relationship with ESTRING 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

Vascular: thrombophlebitis

Vision: abnormal vision

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