Animal studies did not show teratogenicity or other embryofetal toxicity at doses 10 to 20 times the maximum recommended human dose (MRHD) administered during organogenesis; in rats litter size was decreased by about 50% and intrauterine deaths increased 5-fold when receiving a dose equivalent to 10 mg/kg/day amlodipine started 14 days before mating and continuing throughout gestation, as well as prolonged gestation and duration of labor. There are no controlled data in human pregnancy. The background birth defect and miscarriage risk for the indicated population is not known. In the US general population, the estimated major birth defect risk is 2 to 4% and the miscarriage risk is 15 to 20%.

US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D, and X are being phased out.

The manufacturer makes no recommendation regarding use during pregnancy.

US FDA pregnancy category: Not assigned

Comments:
-Limited post-marketing experience with amlodipine is insufficient to inform a drug-associated risk for major birth defects and miscarriage.
-Animal studies at 10 to 20 times the maximum recommended human dose (MRHD) showed no evidence of adverse developmental effects, however the rat model showed decreased litter size (by about 50%) and a 5-fold increase in intrauterine deaths, as well as prolonged gestation and duration of labor.
-Hypertension during pregnancy increases maternal risk of pre-eclampsia, gestational diabetes, premature delivery, and delivery complications (e.g. need for caesarian section or post-partum hemorrhage).
-Hypertension increases the fetal risk of intrauterine growth restriction and death.
-Carefully monitor and manage pregnant patients with hypertension.

See references

The manufacturer makes no recommendation regarding use during lactation.

Excreted into human milk: Yes

Comments:
-Amlodipine appears in human breast milk at an estimated median relative infant dose of 4.2%; no adverse effects have been observed in the infants.
-There is no information regarding this drugs effects on milk production.

See references