Hydralazine / isosorbide dinitrate Pregnancy and Breastfeeding Warnings

Brand names: BiDil

Medically reviewed by Drugs.com. Last updated on Jun 20, 2023.

Hydralazine / isosorbide dinitrate Pregnancy Warnings

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

US FDA pregnancy category: C

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.

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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

Further information

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