Trazodone Pregnancy and Breastfeeding Warnings

Brand names: Desyrel, Desyrel Dividose, Oleptro, Raldesy

Medically reviewed by Drugs.com. Last updated on Jul 31, 2025.

Trazodone Pregnancy Warnings

This drug should be used during pregnancy only if the benefit outweighs the risk to the fetus.
-According to some authorities: Caution is recommended; use should be avoided during the first trimester of pregnancy.

US FDA pregnancy category: Not assigned

Risk summary: Inconclusive data available on the use of this drug in pregnant women to inform a drug-related risk.

Comment:
-A pregnancy exposure registry is available.
-When this drug is used until delivery, newborns should be monitored for the occurrence of withdrawal symptoms.

Animal studies have revealed evidence of increased fetal resorption and congenital anomalies in adolescents. Other animal models have failed to reveal evidence of adverse effects on embryofetal development, parturition, or postnatal development when given at therapeutic doses. There are no controlled data in human pregnancy.

To monitor the outcomes of pregnant women exposed to this drug, a pregnancy registry has been established. Physicians are encouraged to register patients and pregnant women are encouraged to register themselves by calling 1-844-405-6185.
US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D, and X are being phased out.

See references

Trazodone Breastfeeding Warnings

A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother.
-Some experts recommend: Caution is recommended.

Excreted into human milk: Yes

Comments:
-The effects in the nursing infant are unknown.
-The American Academy of Pediatrics considers this agent a drug for which the effect on nursing infants is unknown but may be of concern.

See references

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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