Low-Dose Paroxetine (Brisdelle) and Pregnancy

Medically reviewed byEditorial Medical Review, MD, NAMS-CMP

Last reviewed: 6/2/2026 · Verify credentials →

Paroxetine is associated with cardiac malformations (especially atrial and ventricular septal defects) when taken in the first trimester. Brisdelle's postmenopausal indication makes this rarely relevant.

Pregnancy safety

Low-Dose Paroxetine (Brisdelle) pregnancy safety summary
FDA category	X (Brisdelle specifically — though 7.5 mg dose in postmenopausal women is the indication, hence rare clinical relevance)
Breastfeeding	Not applicable to Brisdelle's indicated population. Paroxetine generally passes into breast milk; SSRIs are typically continued postpartum when weighed benefit-risk.

Sources(5)

FDA label — Brisdelle ↗
Simon JA et al., Menopause 2013 ↗
Portman DJ et al., Menopause 2014 ↗
Menopause Society — Non-hormonal therapies position statement (2023) ↗
Kelly CM et al., BMJ 2010 (tamoxifen-paroxetine mortality study) ↗