Trimipramine Pregnancy and Breastfeeding Warnings

Brand names: Surmontil

Medically reviewed by Drugs.com. Last updated on Jun 9, 2025.

Trimipramine Pregnancy Warnings

This drug should be used during pregnancy only if the benefit outweighs the risk to the fetus.
-Some experts recommend: This drug should not be used during the first and third trimesters of pregnancy unless the benefit outweighs the risk to the fetus.

AU TGA pregnancy category: C
US FDA pregnancy category: C

Risk summary: No data are available on the use of this drug in pregnant women to inform a drug-related risk.

Animal models have revealed evidence of embryotoxicity and an increased incidence of major anomalies. There are no controlled data in human pregnancy.

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 C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

See references

Trimipramine Breastfeeding Warnings

The manufacturer makes no recommendation regarding use during lactation.
-Some experts recommend: Use is contraindicated.

Excreted into human milk: Data not available
Excreted into animal milk: Data not available

Comments:
-The effects in the nursing infant are unknown.
-The American Academy of Pediatrics classifies other tricyclic antidepressants as drugs whose effects on the nursing infant are unknown but may be of concern.
-Alternative agents (e.g., nortriptyline, paroxetine, sertraline) may be preferred when breastfeeding newborn or preterm infants, or when large doses are necessary.

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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