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Vagifem (Estradiol Vaginal) - Side Effects and Adverse Reactions

 
 



ADVERSE REACTIONS

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

  • Cardiovascular Disorders [see Boxed Warning, Warnings and Precautions]
  • Endometrial Cancer [see Boxed Warning, Warnings and Precautions]

Clinical Study Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trial 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 12-month randomized, double-blind, parallel group, placebo-controlled study, a total of 309 postmenopausal women were randomized to receive either placebo or Vagifem 10 mcg tablets. Adverse events with an incidence of ≥5% in the Vagifem 10 mcg group and greater than those reported in the placebo group are listed in Table 1.

Table 1: Treatment-Emergent Adverse Events Reported at a Frequency of ≥5% and More Frequent in Women Receiving Vagifem 10 mcg

Body System

Adverse Event

Treatment

Number (%) of Women

Placebo

N = 103

n (%)

Vagifem

N = 205

n (%)

Body As A Whole
Back Pain 2 (2) 14(7)
Digestive System
Diarrhea 0 11 (5)
Urogenital System
Vulvovaginal Mycotic Infection 3 (3) 17 (8)
Vulvovaginal Pruritis 2 (2) 16 (8)
N = Total number of women in study.

n = Number of women who experienced adverse event.

In a 12-week, randomized, double-blind, placebo-controlled study, 138 postmenopausal women were randomized to receive either placebo or Vagifem 25 mcg tablets. Adverse events with an incidence of ≥5% in the Vagifem 25 mcg group and greater than those reported in the placebo group are listed in Table 2.

Table 2: Treatment-Emergent Adverse Events Reported at a Frequency of ≥5% and More Frequent in Women Receiving Vagifem 25 mcg

Body System

Adverse Event

Treatment

Number (%) of Women

Placebo

N = 47

n (%)

Vagifem

N = 91

n (%)

Body As A Whole
Headache 3 (6) 8 (9)
Abdominal Pain 2 (4) 6 (7)
Back Pain 3 (6) 6 (7)
Respiratory System

Upper Respiratory Tract

Infection

2 (4) 5 (5)
Urogenital System
Moniliasis Genital 1 (2) 5 (5)
N = Total number of women in study.

n = Number of women who experienced adverse event.

Postmarketing Experience

The following adverse reactions have been reported during post approval use of Vagifem 25 mcg. 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

Endometrial cancer, endometrial hyperplasia, vaginal irritation, vaginal pain, vaginismus, vaginal ulceration

Breast

Breast cancer

Cardiovascular

Deep vein thrombosis

Gastrointestinal

Diarrhea

Skin

Urticaria, erythematous/pruritic rash, genital pruritus

Central Nervous System

Aggravated migraine, depression, insomnia

Miscellaneous

Fluid retention, weight increase, drug ineffectiveness, hypersensitivity, blood estrogen increase

Additional postmarketing adverse reactions have been reported in patients receiving other forms of hormone therapy.



REPORTS OF SUSPECTED VAGIFEM SIDE EFFECTS / ADVERSE REACTIONS

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

Possible Vagifem side effects / adverse reactions in 67 year old female

Reported by a physician from United States on 2011-10-31

Patient: 67 year old female

Reactions: Breast Cancer, Hypergammaglobulinaemia Benign Monoclonal, Breast Cancer in Situ

Adverse event resulted in: hospitalization

Suspect drug(s):
Vagifem
    Dosage: 25 ug, qd, vaginal
    Indication: Atrophic Vulvovaginitis

Vagifem

Vagifem

Vagifem
    Dosage: 25 ug, unk, vaginal
    Indication: Atrophic Vulvovaginitis

Other drugs received by patient: Multivite /00067501/(ascorbic Acid, Ergocalciferol, Nicotinamide, Reti; Vitamin C /00008001/ (Ascorbic Acid); Vytorin; Lipitor; Crestor; Calcium Carbonate; Actonel; Vitamin A /00056001/ (Retinol)



Possible Vagifem side effects / adverse reactions in 72 year old female

Reported by a consumer/non-health professional from United States on 2012-01-18

Patient: 72 year old female weighing 59.0 kg (129.7 pounds)

Reactions: Breast Cancer Recurrent

Suspect drug(s):
Vagifem

Other drugs received by patient: Mobic



Possible Vagifem side effects / adverse reactions in 58 year old female

Reported by a consumer/non-health professional from United States on 2012-02-29

Patient: 58 year old female weighing 83.0 kg (182.6 pounds)

Reactions: Vomiting, Chest Discomfort, Dyspnoea, Nausea, Loss of Consciousness, Abdominal Discomfort, Diarrhoea, Chest Pain

Suspect drug(s):
Vagifem

Other drugs received by patient: Prilosec



See index of all Vagifem side effect reports >>

Drug label data at the top of this Page last updated: 2012-03-15

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