Information last updated: July 2020
The baseline risk of major birth defects in Canada is 3-5%. This means that 3-5 out of 100 babies born in the general population in Canada will be born with a major birth defect. There are also baseline risks for miscarriages (15-25 out of 100 pregnancies), prematurity and other outcomes. The information provided will summarize if taking this drug is likely to change these risks.
Summary: Approximately 150 pregnancies with exposure to trazodone during the first trimester were included in published studies. The limited information on trazodone has not found an increase in the number of babies born with birth defects compared to the general population. More information is needed to determine the safety of trazodone use in pregnancy.
Please consult with your health care provider if you are considering stopping or making any changes to your regular medications.
This information about trazodone is of a general nature and about medical use and does not replace the medical care and advice of your healthcare provider. For questions on dose, timing, side effects, interactions, etc. please consult your healthcare provider. Additionally, please read the patient insert provided with your medication.
Although participants in the studies referenced below may have used trazodone in various combinations, the studies usually do not provide detailed information on drug combinations. This makes it challenging to comment on the safety of using this medication in combination with others during pregnancy or lactation.
Trazodone is an antidepressant. It is also used off-label to treat insomnia (problems with falling and/or staying asleep).
If the product you are using contains other active ingredients, please check our Exposures A to Z for available information on the ingredient(s).
For more information on treating mental health conditions while pregnant or while providing your breastmilk to an infant, please see Mental Health in Pregnancy and Lactation.
Pronunciation
Approximately 150 pregnancies with exposure to trazodone during the first trimester were included in published studies. The limited information on trazodone has not found an increase in the number of babies born with birth defects compared to the general population.
The limited available information does not suggest an increased risk of miscarriages, still birth (loss of a baby before or during delivery), prematurity (delivery before 37 weeks of pregnancy), or low birth weight with use of trazodone or nefazodone (a similar medication) in pregnancy.
One study found no increased risk of preeclampsia (a pregnancy-related high blood pressure condition) in 339 pregnancies exposed to trazodone during the second trimester and part of the third trimester.
Although the limited information has not found evidence of harm, more information is needed to determine the safety of trazodone use in pregnancy.
Medications, if not taken as prescribed, if taken beyond the prescribed amount, or if taken in combination with certain other drugs, may cause harm to you and/or your pregnancy or your nursing child.
If you are using drugs or medications for non-medical reasons or beyond what was recommended by a healthcare practitioner and you are pregnant, providing your breastmilk to an infant, or parenting please click here Harm Reduction for additional information. In case of emergency, please go to the emergency room or call 911.
Pregnancy:
Approximately 150 pregnancies with exposure to trazodone during the first trimester were included in published studies. The limited available information does not suggest an increased risk of major malformations, miscarriages, still birth, prematurity, or low birth weight with use of trazodone or nefazodone (a similar medication) in pregnancy.
A study reported no increased risk of preeclampsia in 339 pregnancies exposed to trazodone monotherapy during the second trimester and part of the third trimester.
A prospective controlled study reported no NICU admissions in 18 infants exposed to trazodone 50 mg/day during the 3rd trimester.
Although, the limited information does not suggest increased risks for adverse pregnancy outcomes, more information is needed to determine the safety of trazodone use in pregnancy.
Lactation:
Please check back. We are in the process of reviewing if there is available information on the effects of taking trazodone during lactation.
Harm Reduction:
If your patient may be using drugs or medications not as indicated during pregnancy, while providing breastmilk to an infant, or parenting please click here Harm Reduction for additional information. In case of emergency, please advise them to go to the emergency room or call 911.
For additional resources see Health Canada Drug and Natural Health Product Monographs, Making Sense of Risk and Statistics.
Briggs GG, Freeman RK, Towers CV. et al. Briggs Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk. 11th ed. Philadelphia: Lippincott Williams & Wilkins (LWW); 2017.
Einarson A, Bonari L, Voyer-Lavigne S, Addis A, Matsui D, Johnson Y, Koren G. A multicentre prospective controlled study to determine the safety of trazodone and nefazodone use during pregnancy. Can J Psychiatry. 2003 Mar;48(2):106-10. [PMID: 12655908].
Einarson A, Choi J, Einarson TR, Koren G. Incidence of major malformations in infants following antidepressant exposure in pregnancy: results of a large prospective cohort study. Can J Psychiatry. 2009 Apr;54(4):242-6. [PMID: 19321030].
Einarson TR, Einarson A. Newer antidepressants in pregnancy and rates of major malformations: a meta-analysis of prospective comparative studies. Pharmacoepidemiol Drug Saf. 2005 Dec;14(12):823-7. [PMID: 15742359].
Khazaie H, Ghadami MR, Knight DC, Emamian F, Tahmasian M. Insomnia treatment in the third trimester of pregnancy reduces postpartum depression symptoms: a randomized clinical trial. Psychiatry Res. 2013 Dec 30;210(3):901-5. Epub 2013 Aug 30. [PMID: 23993464].
Palmsten K, Huybrechts KF, Michels KB, Williams PL, Mogun H, Setoguchi S, Hernández-Díaz S. Antidepressant use and risk for preeclampsia. Epidemiology. 2013 Sep;24(5):682-91. [PMID: 23873072]. [PMC4159745].
Public Health Agency of Canada. Congenital Anomalies in Canada 2013: A Perinatal Health Surveillance Report. [Internet]. Ottawa: Public Health Agency of Canada; 2013 [updated 2013 September; cited 2023 September 8]. Available from: https://publications.gc.ca/collections/collection_2014/aspc-phac/HP35-40-2013-eng.pdf
Public Health Agency of Canada. Family-centred maternity and newborn care: National guidelines Chapter 7: Loss and grief. [Internet]. Ottawa: Public Health Agency of Canada; 2022 [updated 2022 Aug 10; cited 2023 September 9]. Available from: https://www.canada.ca/en/public-health/services/publications/healthy-living/maternity-newborn-care-guidelines-chapter-7.html
First Exposure does not offer health care treatment. If you have an urgent question about your pregnancy or your baby’s health, you should contact your health care provider directly. If you don’t have a health care provider and you live in Ontario, you have a variety of health care options. In the case of an emergency, visit a hospital emergency room or call 911.
