Premarin Vaginal Cream

Premarin Vaginal Cream Adverse Reactions

estrogens

Manufacturer:

Pfizer

Distributor:

Zuellig Pharma

Marketer:

DKSH
Full Prescribing Info
Adverse Reactions
Adverse reactions are listed in the Table in CIOMS frequency categories: Very Common: ≥10%; Common: ≥1% and <10%; Uncommon: ≥0.1% and <1%; Rare: ≥0.01% and <0.1%; Very rare: <0.01%; Unknown Cannot be estimated from the available data.
Systemic absorption may occur with the use of CE vaginal cream. Adverse reactions associated with oral CE treatment should be taken into account.
In a 12-week, randomized, double-blind, placebo-controlled trial of CE vaginal cream, 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 CE vaginal cream-21/7 treatment group (0.5 g CE vaginal cream daily for 21 days, then 7 days off), 72 women in the matching placebo treatment group; 140 women in the CE vaginal cream- 2x/wk treatment group (0.5 g CE vaginal cream 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 CE vaginal cream, including those subjects randomized at baseline to placebo. In this study there were no statistically significant differences between CE vaginal cream and placebo.
The following adverse reactions have either been reported with CE vaginal cream or are undesirable effects associated with estrogens. It is not possible to calculate frequencies for these events based on prescription data for patient exposure because the dose of CE vaginal cream varies from patient to patient and the product is available worldwide in various sized units. (See Table 7.)

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