Estradiol (Page 4 of 10)

6 ADVERSE REACTIONS

The following serious adverse reactions are discussed elsewhere in labeling:

6.1 Clinical Trials Experience

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. There were no clinical trials conducted with estradiol transdermal system. Estradiol transdermal system is bioequivalent to the original formulation of estradiol transdermal system. The following adverse reactions have been reported with the original formulation of estradiol transdermal system therapy:

Table 1. Summary of Most Frequently Reported Adverse Reactions Regardless of Relationship Reported at a Frequency ≥5 Percent

Estradiol 0.025 mg/day (N=47) N (%)

Estradiol 0.0375 mg/day (N=130) N (%)

Estradiol 0.05 mg/day (N=103) N (%)

Estradiol 0.075 mg/day (N=46) N (%)

Estradiol 0.1 mg/day (N=132) N (%)

Placebo (N=157) N (%)

Gastrointestinal disorders

Constipation

2 (4.3)

5 (3.8)

4 (3.9)

3 (6.5)

2 (1.5)

4 (2.5)

Dyspepsia

4 (8.5)

12 (9.2)

3 (2.9)

2 (4.3)

0

10 (6.4)

Nausea

2 (4.3)

8 (6.2)

4 (3.9)

0

7 (5.3)

5 (3.2)

General disorders and administration site conditions***

Influenza-like illness

3 (6.4)

6 (4.6)

8 (7.8)

0

3 (2.3)

10 (6.4)

Pain NOS*

0

8 (6.2)

0

2 (4.3)

7 (5.3)

7 (4.5)

Infections and infestations

Influenza

4 (8.5)

4 (3.1)

6 (5.8)

0

10 (7.6)

14 (8.9)

Nasopharyngitis

3 (6.4)

16 (12.3)

10 (9.7)

9 (19.6)

11 (8.3)

24 (15.3)

Sinusitis NOS*

4 (8.5)

17 (13.1)

13 (12.6)

3 (6.5)

7 (5.3)

16 (10.2)

Upper respiratory tract infection NOS*

3 (6.4)

8 (6.2)

11 (10.7)

4 (8.7)

6 (4.5)

9 (5.7)

Investigations

Weight increased

4 (8.5)

5 (3.8)

2 (1.9)

2 (4.3)

0

3 (1.9)

Musculoskeletal and connective tissue disorders

Arthralgia

0

11 (8.5)

4 (3.9)

2 (4.3)

5 (3.8)

9 (5.7)

Back pain

4 (8.5)

10 (7.7)

9 (8.7)

4 (8.7)

14 (10.6)

10 (6.4)

Neck pain

3 (6.4)

4 (3.1)

4 (3.9)

0

6 (4.5)

2 (1.3)

Pain in limb

0

10 (7.7)

7 (6.8)

2 (4.3)

6 (4.5)

9 (5.7)

Nervous system disorders

Headache NOS*

7 (14.9)

35 (26.9)

32 (31.1)

23 (50.0)

34 (25.8)

37 (23.6)

Sinus headache

0

12 (9.2)

5 (4.9)

5 (10.9)

2 (1.5)

8 (5.1)

Psychiatric disorders

Anxiety NEC**

3 (6.4)

5 (3.8)

0

0

2 (1.5)

4 (2.5)

Depression

5 (10.6)

4 (3.1)

7 (6.8)

0

4 (3.0)

6 (3.8)

Insomnia

3 (6.4)

6 (4.6)

4 (3.9)

2 (4.3)

2 (1.5)

9 (5.7)

Reproductive system and breast disorders

Breast tenderness

8 (17.0)

10 (7.7)

8 (7.8)

3 (6.5)

17 (12.9)

0

Dysmenorrhea

0

0

0

3 (6.5)

0

0

Intermenstrual bleeding

3 (6.4)

9 (6.9)

6 (5.8)

0

14 (10.6)

7 (4.5)

Respiratory, thoracic and mediastinal disorders

Sinus congestion

0

4 (3.1)

3 (2.9)

3 (6.5)

6 (4.5)

7 (4.5)

Vascular disorders

Hot flushes NOS*

3 (6.4)

0

3 (2.9)

0

0

6 (3.8)

Hypertension NOS*

2 (4.3)

0

3 (2.9)

0

0

2 (1.3)

Represents milligrams of estradiol delivered daily by each system

* NOS represents not otherwise specified

** NEC represents not elsewhere classified

*** Application site erythema and application site irritation were observed in a small number of patients (3.2% or less of patients across treatment groups)

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