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Nisoldipine Pregnancy and Breastfeeding Warnings

Nisoldipine is also known as: Sular

Medically reviewed on April 3, 2017.

Nisoldipine Pregnancy Warnings

Animal studies have failed to reveal evidence of teratogenicity or fetotoxicity. Increased fetal resorptions/postimplantation losses, decreased fetal weights, decreased placental weights, abortions, mortalities, and forelimb/vertebral abnormalities were observed in several different animal models given maternally toxic doses. There are no controlled data in human pregnancy.

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.

This drug should be used during pregnancy only if the benefit outweighs the risk to the fetus.

US FDA pregnancy category: Not assigned.

Risk summary: Malformative risks with the use of this drug in pregnant women at recommended doses are unlikely.

See references

Nisoldipine 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: Unknown
Excreted into animal milk: Data not available

Comments:
-The effects in the nursing infant are unknown.
-Some experts state that use of an alternative drug may be preferred (e.g., nifedipine, nitrendipine) during lactation.
-Other calcium channel blockers (e.g., nifedipine, diltiazem, verapamil) are considered compatible with breastfeeding by the American Academy of Pediatrics.

See references

References for pregnancy information

  1. Briggs GG, Freeman RK. "Drugs in Pregnancy and Lactation. 10th ed." Philadelphia, PA: Wolters Kluwer Health (2015):
  2. "Product Information. Sular (nisoldipine)." Zeneca Pharmaceuticals, Wilmington, DE.

References for breastfeeding information

  1. Briggs GG, Freeman RK. "Drugs in Pregnancy and Lactation. 10th ed." Philadelphia, PA: Wolters Kluwer Health (2015):
  2. "Product Information. Sular (nisoldipine)." Zeneca Pharmaceuticals, Wilmington, DE.
  3. United States National Library of Medicine "Toxnet. Toxicology Data Network. Available from: URL: http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT." ([cited 2013 -]):

Further information

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

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