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Hydralazine / isosorbide dinitrate Pregnancy and Breastfeeding Warnings

Hydralazine / isosorbide dinitrate is also known as: BiDil

Medically reviewed on Jul 2, 2018

Hydralazine / isosorbide dinitrate Pregnancy Warnings

Hydralazine animal studies have revealed evidence of teratogenicity. Isosorbide dinitrate animal studies have revealed evidence of embryotoxicity. A meta-analysis of randomized controlled trials comparing hydralazine to other antihypertensive agents for severe hypertension in pregnancy found that hydralazine was associated with significantly more maternal hypotension, placental abruption, caesarean sections, and oliguria, with more adverse effects on fetal heart rate and with lower Apgar scores. There are no controlled data for isosorbide dinitrate in human pregnancy.

US FDA pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

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

US FDA pregnancy category: C

See references

Hydralazine / isosorbide dinitrate Breastfeeding Warnings

The manufacturer makes no recommendation regarding use during lactation.

Excreted into human milk: Yes (hydralazine); Unknown (isosorbide dinitrate)
Excreted into animal milk: Data not available (isosorbide dinitrate)

Comments: The effects in the nursing infant are unknown.

See references

References for pregnancy information

  1. "Product Information. BiDil (hydralazine-isosorbide dinitrate)." NitroMed Inc, Lexington, MA.

References for breastfeeding information

  1. 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 -]):
  2. "Product Information. BiDil (hydralazine-isosorbide dinitrate)." NitroMed Inc, Lexington, MA.

Further information

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

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