Skip to Content
Could you or a loved one be experiencing depression?

Clomipramine Pregnancy and Breastfeeding Warnings

Clomipramine is also known as: Anafranil

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 -If possible, this drug should be gradually withdrawn at least 7 weeks before the calculated date of confinement.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

References for pregnancy information

  1. "Product Information. Anafranil (clomipramine)." Basel Pharmaceuticals, Summit, NJ.
  2. Briggs GG, Freeman RK. "Drugs in Pregnancy and Lactation. 10th ed." Philadelphia, PA: Wolters Kluwer Health (2015):
  3. Cerner Multum, Inc. "Australian Product Information." O 0
  4. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

References for breastfeeding information

  1. United States National Library of Medicine "Toxnet. Toxicology Data Network. Available from: URL: http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT." ([cited 2013 -]):
  2. Briggs GG, Freeman RK. "Drugs in Pregnancy and Lactation. 10th ed." Philadelphia, PA: Wolters Kluwer Health (2015):
  3. Department of Adolescent and Child Health and Development. UNICEF. World Health Organization "Breastfeeding and maternal medication: recommendations for drugs in the eleventh Who model list of essential drugs. Available from: URL: http://whqlibdoc.who.int/hq/2002/55732.pdf?ua=1" ([2003]):
  4. "Product Information. Anafranil (clomipramine)." Basel Pharmaceuticals, Summit, NJ.
  5. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  6. Cerner Multum, Inc. "Australian Product Information." O 0

Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Wolters Kluwer Health and Drugs.com is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This drug information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective, or appropriate for any given patient. Multum Information Services, Inc. does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. Copyright 2000-2008 Multum Information Services, Inc. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse, or pharmacist.

Hide