Phenazopyridine

FDA label, Genus Lifesciences Inc., oral, effective 2026-07-14. 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 Phenazopyridine HCl should not be used in patients who have previously exhibited hypersensitivity to it. The use of Phenazopyridine HCl is contraindicated in patients with renal insufficiency.

Contraindications

Phenazopyridine HCl should not be used in patients who have previously exhibited hypersensitivity to it. The use of Phenazopyridine HCl is contraindicated in patients with renal insufficiency.

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 phenazopyridine. Check the label's hepatic warnings.

Pregnancy and lactation

Pregnancy

Pregnancy Reproduction studies have been performed in rats at doses up to 50 mg/kg/day and have revealed no evidence of impaired fertility or harm to the fetus due to Phenazopyridine HCl. There are, however, no adequate and well controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

Lactation

Nursing Mothers No information is available on the appearance of Phenazopyridine HCl, or its metabolites in human milk.

Breastfeeding (LactMed)

The safety of phenazopyridine is not established in infants or during breastfeeding. Because it can cause methemoglobinemia, sulfhemoglobinemia, and hemolytic anemia, it should be avoided while breastfeeding, especially with an infant under 1 month of age or with glucose-6-phosphate dehydrogenase (G6PD) deficiency.

Source: LactMed: Phenazopyridine (NICHD, public domain)Revised Oct 31, 2018

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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These are not what a patient pays at the pharmacy counter. They are what pharmacies, health plans, and government buyers pay, before manufacturer rebates. A patient's cost depends on their insurance (copay, coinsurance, or deductible) or the pharmacy's cash price.

Products and NDCs

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Recruiting clinical trials

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