On label and off label drug use in the treatment of endometriosis

The use of “off-label” medications in the treatment of endometriosis is widespread. After an overview of Food and Drug Administration–approved treatments, this article reviews the use of “off-label” medications for endometriosis.

Alexander M. Quaas, M.D., Ph.D., Elizabeth A. Weedin, D.O., Karl R. Hansen, M.D., Ph.D.

Volume 103, Issue 3, Pages 612-625


Endometriosis, characterized by the presence of endometrial glands and stroma in extrauterine locations, is a significant cause of pelvic pain and infertility, as well as a major health care burden. Although Food and Drug Administration (FDA)–approved treatments are available, the use of “off-label” medications for endometriosis is widespread. In this review, we provide an overview of the current FDA-approved treatments, followed by a detailed review of the major “off-label” treatments being used in the United States and worldwide, including efficacy, side effects, drug interactions, contraindications, and anomaly risks.

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