Hydralazine injection

FDA label, Navinta LLC, intravenous, effective 2026-04-21. Full label on DailyMed

Other products: Hydralazine

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From MedlinePlus, U.S. National Library of Medicine

Quoted from the FDA label. Product labels differ by manufacturer and change over time; confirm against the label for the product you are using.

Dosing in kidney impairment

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Preparation and administration

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Most patients can be transferred to oral hydralazine hydrochloride within 24 to 48 hours. The product should be used immediately after the vial is opened. It should not be added to infusion solutions. Hydralazine hydrochloride injection may discolor upon contact with metal; discolored solutions should be discarded. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

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  • Hydralazine injection
Label text (1 paragraph)

Drug Interactions: MAO inhibitors should be used with caution in patients receiving hydralazine. When other potent parenteral antihypertensive drugs, such as diazoxide, are used in combination with hydralazine, patients should be continuously observed for several hours for any excessive fall in blood pressure. Profound hypotensive episodes may occur when diazoxide injection and hydralazine injection are used concomitantly.

Contraindications

Hypersensitivity to hydralazine; coronary artery disease; mitral valvular rheumatic heart disease.

Safety data

Reported adverse events (FAERS)

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Source: FDA Adverse Event Reporting System via openFDA

Liver injury (LiverTox)

A

Likelihood score A: Well established cause of clinically apparent liver injury.

Hydralazine is a commonly used oral antihypertensive agent that acts by inducing peripheral vasodilation. Hydralazine has been linked to several forms of acute liver injury as well as a lupus-like syndrome.

ABCDEA: well known cause; E: unlikely cause. [HD]: high doses only.

Source: LiverTox: Hydralazine (NIDDK, public domain)Chapter updated Mar 24, 2018

Pregnancy and lactation

Pregnancy

Pregnancy: Teratogenic effects. Animal studies indicate that hydralazine is teratogenic in mice at 20 to 30 times the maximum daily human dose of 200 to 300 mg and possibly in rabbits at 10 to 15 times the maximum daily human dose, but that it is nonteratogenic in rats. Teratogenic effects observed were cleft palate and malformations of facial and cranial bones. There are no adequate and well-controlled studies in pregnant women. Although clinical experience does not include any positive evidence of adverse effects on the human fetus, hydralazine should be used during pregnancy only if the expected benefit justifies the potential risk to the fetus.

Lactation

Nursing Mothers: Hydralazine has been shown to be excreted in breast milk.

Breastfeeding (LactMed)

Limited milk level and infant serum level data and a long history of use in postpartum mothers indicate that hydralazine is an acceptable antihypertensive in nursing mothers, even those nursing newborns.

Alternatives LactMed suggests considering:
Source: LactMed: Hydralazine (NICHD, public domain)Revised Nov 15, 2024

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