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Estring (Estradiol Vaginal Ring) - Side Effects and Adverse Reactions

 
 



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 pivotal 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 EVENT ESTRING
(n = 257)
%
Conjugated Estrogens Vaginal Cream (n = 129)
%
Musculoskeletal
  Back Pain 6 8
  Arthritis 4 2
  Arthralgia 3 5
  Skeletal Pain 2 4
CNS/Peripheral Nervous System
  Headache 13 16
Psychiatric
  Insomnia 4 0
Gastrointestinal
  Abdominal Pain 4 2
  Nausea 3 2
Respiratory
  Upper Respiratory Tract Infection 5 6
  Sinusitis 4 3
  Pharyngitis 1 3
Urinary
  Urinary Tract Infection 2 7
Female Reproductive
  Leukorrhea 7 3
  Vaginitis 5 2
  Vaginal Discomfort/Pain 5 5
  Vaginal Hemorrhage 4 5
  Asymptomatic Genital Bacterial Growth 4 6
  Breast Pain 1 7
Resistance Mechanisms
  Genital Moniliasis 6 7
Body as a Whole
  Flu-Like Symptoms 3 2
  Hot Flushes 2 3
  Allergy 1 4
Miscellaneous
  Family Stress 2 3

Other adverse events (listed alphabetically) occurring at a frequency of 1 to 3 percent in the two pivotal controlled studies by patients receiving ESTRING include: anxiety, bronchitis, chest pain, cystitis, dermatitis, diarrhea, dyspepsia, dysuria, flatulence, gastritis, genital eruption, urogenital pruritus, hemorrhoids, leg edema, migraine, otitis media, skin hypertrophy, syncope, toothache, tooth disorder, urinary incontinence.

Post-Marketing 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 wall, making ring removal difficult, have been reported. 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.
  3. A few cases of bowel obstruction and vaginal ring use have been reported. Persistent abdominal complaints consistent with obstruction should be carefully evaluated.

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

The following additional adverse reactions have been reported with estrogens:

Genitourinary system: abnormal uterine bleeding/spotting; dysmenorrheal/pelvic pain; increase in size of uterine leiomyomata; vaginitis, including vaginal candidiasis; change in amount of cervical secretion; changes in cervical ectropion; ovarian cancer; endometrial hyperplasia; endometrial cancer

Breasts: tenderness, enlargement, pain, nipple discharge, galactorrhea; fibrocystic breast changes; breast cancer

Cardiovascular: deep and superficial venous thrombosis; pulmonary embolism; thrombophlebitis; myocardial infarction; stroke; increase in blood pressure

Gastrointestinal: nausea, vomiting; abdominal cramps, bloating; cholestatic jaundice; increased incidence of gallbladder disease; pancreatitis, enlargement of hepatic hemangiomas

Skin: chloasma or melasma that may persist when drug is discontinued; erythema multiforme; erythema nodosum; hemorrhagic eruption; loss of scalp hair; hirsutism, rash

Eyes: retinal vascular thrombosis; intolerance to contact lenses

Central Nervous System: headache; migraine; dizziness; mental depression; exacerbation of chorea; nervousness; mood disturbances; irritability; exacerbation of epilepsy, dementia

Miscellaneous: increase or decrease in weight; glucose intolerance; aggravation of porphyria; edema; arthralgias; leg cramps; changes in libido; angioedema; anaphylactoid/anaphylactic reactions; hypocalcemia (preexisting condition); exacerbation of asthma; increased triglycerides



REPORTS OF SUSPECTED ESTRING SIDE EFFECTS / ADVERSE REACTIONS

Below is a sample of reports where side effects / adverse reactions may be related to Estring. The information is not vetted and should not be considered as verified clinical evidence.

Possible Estring side effects / adverse reactions in 48 year old female

Reported by a consumer/non-health professional from United States on 2011-10-14

Patient: 48 year old female weighing 63.0 kg (138.7 pounds)

Reactions: Toxic Shock Syndrome

Adverse event resulted in: life threatening event

Suspect drug(s):
Estring

Other drugs received by patient: Progesterone



Possible Estring side effects / adverse reactions in 76 year old female

Reported by a consumer/non-health professional from United States on 2011-10-21

Patient: 76 year old female

Reactions: Vulvovaginal Discomfort, Vulvovaginal Pain

Suspect drug(s):
Estring



Possible Estring side effects / adverse reactions in 80 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2011-10-26

Patient: 80 year old female

Reactions: Infection

Suspect drug(s):
Estring



See index of all Estring side effect reports >>

Drug label data at the top of this Page last updated: 2009-10-01

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