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Felodipine Pregnancy and Breastfeeding Warnings

Brand names: Plendil

Medically reviewed by Drugs.com. Last updated on Jun 18, 2025.

Felodipine Pregnancy Warnings

Safety has not been established during pregnancy.
-According to some authorities: Use is contraindicated.

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

Risk summary: No data are available on the use of this drug in pregnant women to inform a drug-related risk.

Comments: 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 revealed evidence of fetolethality and fetotoxicity at doses greater than the maximum recommended human dose on a mg/m2 basis. There are no controlled data in human pregnancy.

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

Felodipine Breastfeeding Warnings

A decision should be made to discontinue breastfeeding or 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.

See references

Does Felodipine interact with my other drugs?

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See also

References for pregnancy information

  1. (2002) "Product Information. Plendil (felodipine)." Merck & Co., Inc
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics."
  3. Cerner Multum, Inc. "Australian Product Information."
  4. (2024) "Product Information. Felodipine ER (felodipine)." Par Pharmaceutical Inc (formerly Qualitest Pharmaceuticals Inc)

References for breastfeeding information

  1. (2002) "Product Information. Plendil (felodipine)." Merck & Co., Inc
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics."
  3. Cerner Multum, Inc. "Australian Product Information."

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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