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PREMARIN® VAGINAL CREAM (conjugated estrogens) Adverse Reactions

6 ADVERSE REACTIONS

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

6.1 Clinical Trials 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-week, randomized, double-blind, placebo-controlled trial of PREMARIN Vaginal Cream (PVC), a total of 423 postmenopausal women received at least 1 dose of study medication and were included in all safety analyses: 143 women in the PVC-21/7 treatment group (0.5 g PVC daily for 21 days, then 7 days off), 72 women in the matching placebo treatment group; 140 women in the PVC-2×/wk treatment group (0.5 g PVC twice weekly), 68 women in the matching placebo treatment group. A 40-week, open-label extension followed, in which a total of 394 women received treatment with PVC, including those subjects randomized at baseline to placebo. In this study, the most common adverse reactions ≥ 1 percent in the double blind phase are shown below (Table 1) [see Clinical Studies (14.1)].

Table 1: Number (%) of Patients Reporting Treatment Emergent Adverse Reactions ≥ 1 Percent Only
Treatment
Body System*/Adverse ReactionPVC 21/7

N=143
Placebo 21/7

N=72
PVC 2×/week

N=140
Placebo 2×/week
N=68
Number (%) of Patients with Adverse Reaction
*
Body system totals are not necessarily the sum of individual adverse events, since a patient may report two or more different adverse reactions in the same body system.
Body As A Whole
Abdominal Pain1 (0.7)1 (1.4)01 (1.5)
Headache5 (3.5)1 (1.4)3 (2.1)1 (1.5)
Moniliasis2 (1.4)1 (1.4)1 (0.7)0
Pain2 (1.4)01 (0.7)0
Pelvic Pain4 (2.8)2 (2.8)4 (2.9)0
Cardiovascular System
Migraine0001 (1.5)
Vasodilation3 (2.1)2 (2.8)2 (1.4)0
Musculoskeletal System
Muscle Cramp2 (1.4)000
Nervous System
Dizziness1 (0.7)001 (1.5)
Skin and Appendages
Acne002 (1.4)0
Erythema01 (1.4)00
Pruritus2 (1.4)1 (1.4)1 (0.7)0
Urogenital System
Breast Enlargement1 (0.7)1 (1.4)00
Breast Pain7 (4.9)03 (2.1)0
Dysuria2 (1.4)000
Leukorrhea3 (2.1)1 (1.4)4 (2.9)5 (7.4)
Metrorrhagia0002 (2.9)
Urinary Frequency01 (1.4)00
Urinary Tract Infection01 (1.4)00
Urinary Urgency1 (0.7)1 (1.4)00
Vaginal Hemorrhage2 (1.4)01 (0.7)1 (1.5)
Vaginal Moniliasis2 (1.4)000
Vaginitis2 (1.4)1 (1.4)3 (2.1)3 (4.4)
Vulvovaginal Disorder4 (2.8)03 (2.1)2 (2.9)

6.2 Postmarketing Experience

The following adverse reactions have been identified during post-approval use of PREMARIN Vaginal Cream. 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

Abnormal uterine bleeding or spotting, dysmenorrhea or pelvic pain, increase in size of uterine leiomyomata, vaginitis (including vaginal candidiasis), change in cervical secretion, cystitis-like syndrome, application site reactions of vulvovaginal discomfort, (including burning, irritation, and genital pruritus), endometrial hyperplasia, endometrial cancer, precocious puberty, leukorrhea.

Breasts

Tenderness, enlargement, pain, discharge, fibrocystic breast changes, breast cancer, gynecomastia in males.

Cardiovascular

Deep venous thrombosis, pulmonary embolism, myocardial infarction, stroke, increase in blood pressure.

Gastrointestinal

Nausea, vomiting, abdominal cramps, bloating, increased incidence of gallbladder disease.

Skin

Chloasma that may persist when drug is discontinued, loss of scalp hair, hirsutism, rash.

Eyes

Retinal vascular thrombosis, intolerance to contact lenses.

Central Nervous System

Headache, migraine, dizziness, mental depression, nervousness, mood disturbances, irritability, dementia.

Miscellaneous

Increase or decrease in weight, glucose intolerance, edema, arthralgias, leg cramps, changes in libido, urticaria, exacerbation of asthma, increased triglycerides, hypersensitivity.

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

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