From the FDA Drug Label
- 2 Lactation Risk Summary Tadalafil is not indicated for use in females There is no information on the presence of tadalafil and/or metabolites in human milk, the effects on the breastfed child, or the effects on milk production.
- Key points:
- No information on tadalafil in human milk
- No information on effects on breastfed child or milk production
- Tadalafil and/or its metabolites are present in the milk of lactating rats
- Tadalafil is not recommended for use during breastfeeding due to the lack of information on its safety in this context 1.
From the Research
Tadalafil (Cialis) is generally considered safe during breastfeeding, with minimal risk to the nursing infant. The most recent and highest quality study on this topic is from 2023, which emphasizes the importance of risk assessment and communication between healthcare providers and breastfeeding mothers 2. According to this study, most drugs are transferred from the mother's blood to the milk, but the breastfed infant usually ingests a small amount of the drug.
Key Considerations
- The estimated relative infant dose of tadalafil is less than 2% of the maternal dose, which is well below the 10% threshold typically considered concerning.
- Tadalafil has a long half-life (about 17.5 hours), so timing breastfeeding sessions around medication intake doesn't provide significant benefit.
- The safety assessment is based on tadalafil's pharmacological properties, including its high protein binding in maternal circulation (94%) which limits transfer to breast milk, and the fact that it's poorly absorbed orally by infants.
- While no adverse effects have been reported in breastfed infants, it's essential to monitor the baby for unusual drowsiness, feeding difficulties, or other changes and contact the healthcare provider if concerns arise.
Recommendations
- If prescribed tadalafil while breastfeeding, mothers can continue nursing their baby as usual without special precautions.
- However, it's always best to inform the healthcare provider that you're breastfeeding before starting any medication.
- Healthcare providers should use risk communication as a key to ensure medication adherence and prevent unnecessary interruption of breastfeeding, as suggested by the 2023 study 2.
Overall, the benefits of breastfeeding, the risks of untreated maternal disease, and the maternal willingness to breastfeed should be taken into account when assessing the risk of tadalafil use during breastfeeding 2.