FDA

FDA adds brain tumor warning to Depo‑Provera label

December 23, 2025

FDA has updated labeling for Depo‑Provera (medroxyprogesterone acetate, IM and SubQ) to include a warning about meningioma risk. The change, approved December 12, 2025, adds language to the “Warnings and Precautions” section and updates patient counseling information and the Medication Guide.

Clinicians are advised to inform patients about this potential risk and remain alert for symptoms such as persistent headache, vision changes, or other neurological signs that may indicate meningioma. While the overall risk remains low, early recognition is critical for patient safety.

Source:

U.S. Food and Drug Administration. (2025, December 12). “Depo‑Provera: NDA 020246/S‑074 & NDA 021583/S‑045 prior‑approval supplemental application approval letter.” Accessed December 22, 2025. https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/020246Orig1s074,021583Orig1s045ltr.pdf