Doxepin Pregnancy and Breastfeeding Warnings

Brand names: Adapin, Silenor, Sinequan

Medically reviewed by Drugs.com. Last updated on Jun 2, 2025.

Doxepin Pregnancy Warnings

This drug should be used during pregnancy only if clearly needed and the benefit outweighs the risk to the fetus.

AU TGA pregnancy category: C
US FDA pregnancy category: Not assigned

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

Comments:
-A pregnancy exposure registry is available.
-Withdrawal symptoms in newborn infants have been reported following prolonged maternal use of tricyclic antidepressants.
-This drug may reduce fertility in females and males of reproductive potential.

Animal studies with the capsule and oral concentrate formulations have failed to reveal evidence of fetal harm; however, evidence exists regarding interference with central monoamine neurotransmission in rats. Animal studies with the tablet formulation have revealed evidence of developmental toxicity, including increased incidences of fetal structural abnormalities and decreased fetal body weights when this drug was administered at higher doses. Decreased pup survival and transient growth delay have also been reported at the highest dose. 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. For additional information: https://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/antidepressants

AU TGA pregnancy category C: Drugs which, owing to their pharmacological effects, have caused or may be suspected of causing, harmful effects on the human fetus or neonate without causing malformations. These effects may be reversible. Accompanying texts should be consulted for further details.

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

Doxepin Breastfeeding Warnings

Use is not recommended.
-According to some authorities: Use is contraindicated.

Excreted into human milk: Yes

Comments:
-Apnea and drowsiness have been reported in the nursing infant.
-If treatment is required in a mother of an older infant, the nursing infant should be monitored carefully for excessive sedation and adequate weight gain.

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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