Nitroglycerin (topical)

FDA label, Encube Ethicals, Inc., topical, effective 2026-05-28. Full label on DailyMed

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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.

Nitrate Vasodilator

Dosing in kidney impairment

This label has no separate kidney-impairment dosing section. Check warnings and clinical pharmacology in the full label.

Drug interactions

Check nitroglycerin (topical) against a medication list
Label text (1 paragraph)

Drug Interactions The vasodilating effects of nitroglycerin may be additive with those of other vasodilators. Alcohol, in particular, has been found to exhibit additive effects of this variety. Marked symptomatic orthostatic hypotension has been reported when calcium channel blockers and organic nitrates were used in combination. Dose adjustments of either class of agents may be necessary.

Contraindications

Allergic reactions to organic nitrates are extremely rare, but they do occur. Nitroglycerin is contraindicated in patients who are allergic to it.

Safety data

Reported adverse events (FAERS)

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Source: FDA Adverse Event Reporting System via openFDA

Liver injury (LiverTox)

LiverTox has no chapter for nitroglycerin (topical). Check the label's hepatic warnings.

Pregnancy and lactation

Pregnancy

Pregnancy Animal reproduction studies have not been conducted with nitroglycerin. It is also not known whether nitroglycerin can cause fetal harm when administered to a pregnant woman or whether it can affect reproductive capacity. Nitroglycerin should be given to a pregnant woman only if clearly needed.

Lactation

Nursing Mothers It is not known whether nitroglycerin is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when nitroglycerin is administered to a nursing woman.

Breastfeeding (LactMed)

Topical use of nitroglycerin for anal fissures by nursing mothers appears to have no adverse effects on their breastfed infants. Topical use on the nipples has been used for alleviation of Raynaud phenomenon of the nipples, but only after cessation of breastfeeding. Nitroglycerin should not be used topically on the nipples during breastfeeding. Sublingual and intravenous nitroglycerin have not been studied during breastfeeding. Observe infants for flushing and discomfort after breastfeeding.

Source: LactMed: Nitroglycerin (NICHD, public domain)Revised Oct 15, 2024

Supply and cost

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Recalls (last 24 months)

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Therapeutic equivalence (Orange Book)

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