Safety of Amlodipine During Breastfeeding
Amlodipine is safe to use during breastfeeding, with minimal transfer into breast milk and no reported adverse effects in breastfed infants. 1, 2
Evidence on Amlodipine Safety in Breastfeeding
FDA and Guideline Recommendations
- The FDA drug label states that amlodipine is present in human milk at an estimated median relative infant dose of 4.2%, with no adverse effects observed in breastfed infants 1
- The 2025 Hypertension in Pregnancy and Postpartum guidelines specifically list amlodipine as safe during breastfeeding, noting a relative infant dose (RID) of 1.7%-4.3% 2
Clinical Research Findings
- Multiple studies confirm that amlodipine transfers into breast milk at low levels:
- A 2015 study found a median RID of 4.2% (interquartile range 3.1%-7.3%), well below the 10% threshold considered safe for breastfeeding 3
- A 2018 study calculated an RID of 3.4% of the maternal weight-adjusted dose, with all infant plasma concentrations below the quantitation limit (0.4 ng/mL) 4
- A 2018 pharmacokinetic study found amlodipine concentrations in both breast milk and infant plasma were undetectable at the lower limit of assay detection (<0.1 ng/mL) 5
Clinical Application
Safety Threshold
- The generally accepted safety threshold for medications during breastfeeding is a relative infant dose (RID) of <10% 2
- All studies consistently show amlodipine's RID is well below this threshold (typically 3-5%)
Monitoring Recommendations
- No specific monitoring of infants is required when mothers take amlodipine while breastfeeding
- The medication has been shown to have minimal to no detectable levels in infant plasma 4, 5
Alternative Options
- If there are concerns about using amlodipine, other calcium channel blockers like nifedipine XL are also considered safe during breastfeeding 2
- For patients requiring antihypertensive treatment during breastfeeding, enalapril is another safe option with minimal excretion in breast milk 6
Conclusion
Based on the most current evidence, amlodipine can be safely used by breastfeeding mothers with hypertension, with no significant risk to the nursing infant due to its minimal transfer into breast milk and absence of reported adverse effects in breastfed infants.