Estradiol tablets – label (Pediatric Use)

Government Record · DailyMed (U.S. National Library of Medicine)

Estradiol labeling: not indicated for pediatric patients; no pediatric clinical studies – confirming cross-sex hormone use in minors is off-label for both sexes.

Estradiol is not indicated for use in pediatric patients. Clinical studies have not been conducted in the pediatric population.

8.4 Pediatric Use

Estradiol labeling: not indicated for pediatric patients; no pediatric clinical studies – confirming cross-sex hormone use in minors is off-label for both sexes.

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