药物信息为Vagifem (estradiol vaginal tablets) Initial U.S. Approval: 1999 (Novo Nordisk): 6 ADVERSE REACTIONS

The following serious adverse reactions are discussed elsewhere in the labeling:
- Cardiovascular Disorders [see Boxed Warning, Warnings and Precautions (5.2)]
- Endometrial Cancer [see Boxed Warning, Warnings and Precautions (5.3)]
6.1 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.

6.2 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.

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

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药物信息为Vagifem (estradiol vaginal tablets) Initial U.S. Approval: 1999 (Novo Nordisk): 6 ADVERSE REACTIONS

6.1 Clinical Study Experience

6.2 Postmarketing Experience