ArticleActa psychiatrica Scandinavica2022
Mirtazapine exposure in pregnancy and fetal safety: A nationwide cohort study.
Article in Acta psychiatrica Scandinavica, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers, 3 of them syntheses that pooled it.
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Who cites it
9 citing papers in PubMed, 3 syntheses or guidelines pooled it, 25 citations in OpenAlex.
- Depression and antidepressant use in pregnancy and adverse maternal and offspring outcomes: a systematic review and meta-analysis.Molecular psychiatry · 2025Pooled it
- Depression with risks for spontaneous abortion: a meta-analysis.BMC psychology · 2025Pooled it
- Association between antidepressant use during pregnancy and miscarriage: a systematic review and meta-analysis.BMJ open · 2024Pooled it
- A cautionary note regarding the use of the FDA adverse event reporting system.Archives of women's mental health · 2025Article
- Risk of congenital anomalies associated with psychotropic medications: a review of neonatal reports in the FDA adverse event reporting System (FAERS).Archives of women's mental health · 2025Article
- Depression Treatment in Pregnancy: Is It Safe, or Is It Not?International journal of environmental research and public health · 2024Review
- Drug Exposure During Pregnancy: A Case-Control Study from a Primary Care Database.Women's health reports (New Rochelle, N.Y.) · 2024Article
- Mirtazapine exposure in pregnancy and fetal safety: A nationwide cohort study.Acta psychiatrica Scandinavica · 2022Article
- Mirtazapine for Severe Nausea and Vomiting During Pregnancy: Case Presentations and Recommendations.Journal of clinical psychopharmacologyArticle
Corrections and comments
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Authors and funding
6 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveTo investigate the association between mirtazapine exposure in pregnancy and risk of specific adverse pregnancy outcomes.
methodsA register-based nationwide cohort study was conducted including all registered pregnancies in Denmark from 1997 to 2016. Mirtazapine-exposed pregnancies were compared with mirtazapine unexposed pregnancies in a 1:4 ratio matched according to propensity scores. Outcomes were major congenital malformations analyzed using log binomial models, and spontaneous abortion, stillbirth and neonatal death analyzed using Cox proportional hazard regression.
resultsFrom a source population of 1,650,649 pregnancies, the propensity score-matched cohort included 4475 pregnancies (895 mirtazapine exposed) in the analysis of major congenital malformations. The analyses of spontaneous abortion included 9 500 pregnancies (1900 mirtazapine exposed), and for the analyses of stillbirths and neonatal deaths 9725 (1 945 mirtazapine-exposed) and 4485 pregnancies (897 mirtazapine-exposed) were included, respectively. Thirty-one (3.5%) children were diagnosed with major congenital malformation among the mirtazapine exposed compared with 152 (4.3%) among the unexposed pregnancies (OR=0.81, 95% CI 0.55-1.20). Spontaneous abortion occurred in 237 (12.5%) of the mirtazapine exposed compared with 931 (12.3%) of the unexposed pregnancies (HR = 1.04%, 95% CI 0.91-1.20). The analyses revealed no increased risk of stillbirth (HR = 0.88%, 95% CI 0.34-2.29) or neonatal death (HR = 0.60%, 95% CI 0.18-2.02).
conclusionsIn this nationwide Danish register study, mirtazapine exposure in pregnancy was not associated with major congenital malformations, spontaneous abortion, stillbirth, or neonatal death. Clinicians and patients can be reassured that mirtazapine is safe in pregnancy.
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