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Questions & Answers
Side Effects & Adverse Reactions
Phenazopyridine hydrochloride is reasonably anticipated to be a human carcinogen based on sufficient evidence of carcinogenicity in experimental animals (IARC 1980, 1982, 1987, NCI 1978). When administered in the diet, phenazopyridine hydrochloride increased the incidences of hepatocellular adenomas and carcinomas in female mice and adenomas and adenocarcinomas of the colon and rectum in rats of both sexes.
There is inadequate evidence for the carcinogenicity of phenazopyridine hydrochloride in humans (IARC 1987). In one limited epidemiological study, no significant excess of any cancer was observed among 2,214 patients who received phenazopyridine hydrochloride and were followed for a minimum of 3 years.
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FDA Safety Alerts
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There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Phenazopyridine HCl is indicated for the symptomatic relief of pain, burning, urgency frequency, and other discomforts arising from irritation of the mucosa of the lower urinary tract caused by infection, trauma, surgery, endoscopic procedures, or the passage of sounds or catheters.
The use of phenazopyridine for relief of symptoms should not delay definitive diagnosis and treatment of causative conditions. The drug should be used for symptomatic relief of pain and not as a substitute for specific surgery or antimicrobial therapy.
Phenazopyridine is compatible with antimicrobial therapy and can help relieve pain and discomfort during the interval before antimicrobial therapy controls the infection.
Treatment of a urinary tract infection with phenazopyridine should not exceed 2 days. There is no evidence that the combined administration of phenazopyridine and an antimicrobial provides greater benefit than administration of the antimicrobial alone after 2 days. (See Dosage and Administration.)
There is currently no drug history available for this drug.
Phenazopyridine Hydrochloride is a reddish-brown, odorless, slightly bitter, crystalline powder. It has a specific local analgesic effect in the urinary tract, promptly relieving burning and pain.
Following is the structural formula:
Phenazopyridine HCl oral tablets contain the following inactive ingredients: Carnauba Wax, Croscarmellose Sodium, Hypromellose, Magnesium Stearate, Microcrystalline Cellulose, Polyethylene Glycol, Povidone, Pregelatinized Starch