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Phenazopyridine Hydrochloride

Generic: PHENAZOPYRIDINE HYDROCHLORIDE

Verified·Apr 23, 2026
NDC
50090-6951
RxCUI
1094126
Route
ORAL
ICD-10 indication
N30.00, N30.01, N39.0, N34.1, R30.0, R30.9, R35.0, R39.15

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About Phenazopyridine Hydrochloride

What is this medication? Phenazopyridine Hydrochloride is a medication primarily used to relieve symptoms caused by irritation of the urinary tract. It is specifically designed to target the discomfort associated with urinary tract infections, surgery, or medical procedures involving the bladder or urethra. Common symptoms it addresses include burning sensations during urination, increased frequency, and a persistent urge to urinate. By acting directly as a local anesthetic on the lining of the urinary tract, it helps to provide rapid relief from these painful sensations.

It is important to understand that while this medication provides symptomatic relief, it is not an antibiotic and does not treat the underlying cause of an infection. If a bacterial infection is present, a separate course of antibiotics is required to clear it. Patients should also be aware that this drug typically changes the color of urine to a bright orange or reddish hue, which is a normal and harmless side effect. It is usually prescribed for short-term use, often for no more than two days, to ensure that the medication does not mask worsening symptoms that may need further medical assessment.

Copay & patient assistance

Detailed copay and financial assistance information is not publicly available for this medication at this time. Please consult your pharmacist or the manufacturer's official patient support program for more details.

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Prescribing information

From the FDA-approved label for Phenazopyridine Hydrochloride. Official source: DailyMed (NLM) · Label effective Dec 10, 2025

Indications and usage
INDICATIONS AND USAGE Phenazopyridine Hydrochloride 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 Hydrochloride 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 Hydrochloride 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 Hydrochloride should not exceed 2 days. There is no evidence that the combined administration of Phenazopyridine Hydrochloride and an antimicrobial provides greater benefit than administration of the antimicrobial alone after 2 days. (See Dosage and Administration .)
Dosage and administration
DOSAGE AND ADMINISTRATION 100 mg Tablets: Average adult dosage is two tablets 3 times a day after meals. 200 mg Tablets: Average adult dosage is one tablet 3 times a day after meals. When used concomitantly with an antibacterial agent for the treatment of a urinary tract infection, the administration of Phenazopyridine Hydrochloride should not exceed 2 days.
Contraindications
CONTRAINDICATIONS Phenazopyridine Hydrochloride should not be used in patients who are hypersensitive to the drug or its ingredients. Phenazopyridine Hydrochloride is contraindicated in patients with renal insufficiency, severe liver disease, severe hepatitis or pyelonephritis of pregnancy. It should be used cautiously in the presence of GI disturbances.
Warnings
WARNINGS 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 (TARC 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.
Drug interactions
Drug Interactions The interaction of Phenazopyridine Hydrochloride with other drugs has not been studied in a systematic manner. However, the medical literature to date suggests that no significant interactions have been reported.
Adverse reactions
ADVERSE REACTIONS The following adverse events have been reported: CNS: headache. Gastrointestinal: nausea, vomiting and diarrhea. Dermatologic and Hypersensitivity: rash, pruritus, discoloration, anaphylactoid-like reaction and hypersensitivity hepatitis. Hematologic: methemoglobinemia, hemolytic anemia, potential hemolytic agent in G-6-PD deficiency, sulfhemoglobinemia. Other: visual disturbances, renal and hepatic toxicity usually associated with overdose, renal calculi, jaundice, discoloration of body fluids and aseptic meningitis.
Use in pregnancy
Pregnancy Category B Reproductive studies with Phenazopyridine Hydrochloride (in combination with sulfacytine) in rats given up to 110 mg/kg/day and in rabbits given up to 39 mg/kg/day during organogenesis revealed no evidence of harm to offspring. One prospective study in humans demonstrated that Phenazopyridine Hydrochloride traverses the placenta into the fetal compartment. There are no adequate and well-controlled studies in pregnant women. Therefore, Phenazopyridine Hydrochloride should be used in pregnant women only if the benefit clearly outweighs the risk.

Label text is reproduced as-is from the FDA-approved label. We do not paraphrase, summarize, or omit. Content above is for informational purposes only and is not medical advice. Always consult your prescribing clinician or pharmacist before making decisions about your medication.

Conditions we've indexed resources for

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How this page is sourced

  • Drug identity verified against openFDA NDC Directory.
  • Label text (when shown) originates from NLM DailyMed.
  • Copay and assistance URLs verified periodically; if you hit a broken link, tell us.