Methenamine mandelate

FDA label, Oncora Pharma, LLC, oral, effective 2026-04-17. 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.

Dosing in kidney impairment

CONTRAINDICATIONS Contraindicated in renal insufficiency. Methenamine mandelate, USP should not be used in patients who have previously exhibited hypersensitivity to it.

Drug interactions

Check methenamine mandelate against a medication list
Label text (1 paragraph)

Formaldehyde and sulfamethizole form an insoluble precipitate in acid urine; therefore, methenamine mandelate, USP should not be administered concurrently with sulfamethizole.

Contraindications

Contraindicated in renal insufficiency. Methenamine mandelate, USP should not be used in patients who have previously exhibited hypersensitivity 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 methenamine mandelate. Check the label's hepatic warnings.

Pregnancy and lactation

Pregnancy

Pregnancy Category C: Animal reproduction studies have not been conducted with methenamine mandelate, USP. It is also not known whether methenamine mandelate, USP can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Methenamine mandelate, USP should be given to a pregnant woman only if clearly needed. Since introduction, published reports on the use of methenamine mandelate, USP in pregnant women have not shown an increased risk of fetal abnormalities from use during pregnancy.

Breastfeeding (LactMed)

Both methenamine and mandelic acid pass into milk in small quantities. Methenamine mandelate appears acceptable to use, even while nursing a newborn.

Alternatives LactMed suggests considering:
Source: LactMed: Methenamine Mandelate (NICHD, public domain)Revised Jan 18, 2021

Supply and cost

Drug shortage status

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Recalls (last 24 months)

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Therapeutic equivalence (Orange Book)

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Price ladder

Not the price at the counter
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Recruiting clinical trials

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