Amlodipine Pregnancy and Breastfeeding Warnings

Brand names: Katerzia, Norliqva, Norvasc, Sdamlo

Medically reviewed by Drugs.com. Last updated on May 1, 2025.

Amlodipine Pregnancy Warnings

This drug should be used during pregnancy only if the benefit outweighs the risk to the fetus.
-According to some authorities: Use is contraindicated.

AU TGA pregnancy category: C
US FDA pregnancy category: Not assigned

Risk summary: Based on animal data, this drug may cause fetal harm. Inadequate data available on the use of this drug in pregnant women to inform a drug-related risk.

Comments:
-Use of adequate methods of contraception should be encouraged.
-If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential harm to the fetus.

Animal studies have shown significantly decreased litter size, increased intrauterine deaths and prolongation of gestation and duration of labor when this drug was given before mating, throughout mating, and during gestation. There are no controlled data in human pregnancy.

Reversible biochemical changes in the head of spermatozoa occurred in some patients treated with calcium channel blockers. There are no controlled data for this drug, but animal models have shown adverse effects on male fertility.

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 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.

See references

Amlodipine Breastfeeding Warnings

Use is not recommended and a decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother (AU, US)
Use is contraindicated (UK)

Excreted into human milk: Yes

Comments:
-The effects in the nursing infant are unknown.
-Infants exposed to this drug should be closely monitored.

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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