Clomipramine Pregnancy and Breastfeeding Warnings

Brand names: Anafranil

Medically reviewed by Drugs.com. Last updated on Jun 1, 2023.

Clomipramine Pregnancy Warnings

This drug should be used during pregnancy only if the benefit outweighs the risk to the fetus.
-Some experts recommend: Use is not recommended.

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

Comments:
-Patients should notify their healthcare provider(s) if they are pregnant or planning to become pregnant.
-Neonates whose mothers had taken this drug up until delivery have developed dyspnea, lethargy, colic, irritability, hypotension or hypertension, tremor or spasms, during the first few hours or days.
-If possible, this drug should be gradually withdrawn at least 7 weeks before the calculated date of confinement.
-A pregnancy exposure registry is available.

Animal studies have revealed evidence of embryotoxic and fetotoxic effects. There are no controlled data in human pregnancy.

To monitor the outcomes of pregnant women exposed to antidepressant, a National Pregnancy Registry for Antidepressants 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 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

Clomipramine Breastfeeding Warnings

A decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Excreted into human milk: Yes

Comments:
-The effects in the nursing infant are unknown.
-Patients should notify their healthcare provider(s) if they are breastfeeding.
-The American Academy of Pediatrics classifies this drug as an agent whose effect on the nursing infant is unknown but may be of concern.
-The WHO classifies this drug as compatible with breastfeeding.

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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