Generic Medicine Info
Indications and Dosage
Adult: Symptomatic relief of pain, burning, urgency, frequency, and other discomforts that arise from irritation of the lower urinary tract mucosa caused by infection, trauma, surgery, endoscopic procedures, or the passage of sounds or catheters: As phenazopyridine hydrochloride: 200 mg tid. Treatment duration should not exceed 2 days when given concurrently with an antibacterial agent for the treatment of UTI.
Renal Impairment
Should be taken with food.
Renal insufficiency or impairment; severe hepatitis.
Special Precautions
Patient with G6PD deficiency. Avoid prolonged use. Not used to treat UTI or as a substitute for antimicrobial therapy (acts only as an analgesic). Discontinue treatment if yellowish skin or sclerae discolouration occurs (may indicate accumulation due to impaired renal excretion). Pregnancy and lactation.
Adverse Reactions
Significant: Acute renal failure, hepatotoxicity, methaemoglobinaemia, and haemolytic anaemia (particularly with higher than recommended doses); urine discolouration (reddish-orange), skin or sclerae discolouration (yellow).
Gastrointestinal disorders: Stomach cramps, mild gastrointestinal disturbances.
Immune system disorders: Anaphylactoid-like reaction.
Nervous system disorders: Headache, dizziness.
Skin and subcutaneous tissue disorders: Rash, pruritus.
Patient Counseling Information
Staining of contact lenses may occur. May also stain fabric or clothing.
Symptoms: Methaemoglobinaemia, haemolytic anaemia, bite cells (degmacytes), renal and hepatic impairment or failure. Management: Symptomatic and supportive treatment. Administer 1-2 mg/kg IV methylthioninium chloride (methylene blue) or give 100-200 mg oral ascorbic acid for prompt reduction of methaemoglobinaemia and disappearance of cyanosis.
Lab Interference
May interfere with urine ketone tests and glucose oxidase reagents. May also interfere with urinalysis based on spectrometry or certain colour reactions.
Description: Phenazopyridine is an azo dye that exerts a local analgesic effect on the urinary tract mucosa. Its exact mechanism of action is unknown.
Absorption: Absorbed from the gastrointestinal tract.
Metabolism: May be metabolised in the liver and other tissues.
Excretion: Via urine (66% as unchanged drug).
Chemical Structure

Chemical Structure Image

Source: National Center for Biotechnology Information. PubChem Compound Summary for CID 4756, Phenazopyridine. Accessed May 26, 2021.

Store between 15-30°C.
MIMS Class
Drugs for Bladder & Prostate Disorders / Other Drugs Acting on the Genito-Urinary System / Urinary Antiseptics
ATC Classification
G04BX06 - phenazopyridine ; Belongs to the class of other urologicals.
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Anon. Phenazopyridine. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. Accessed 01/03/2021.

Buckingham R (ed). Phenazopyridine Hydrochloride. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. Accessed 01/03/2021.

Phenazopyridine Hydrochloride Tablet, Film Coated (Westminster Pharmaceuticals, LLC). DailyMed. Source: U.S. National Library of Medicine. Accessed 12/05/2021.

Phenazopyridine Tablet (Aidarex Pharmaceuticals LLC). DailyMed. Source: U.S. National Library of Medicine. Accessed 01/03/2021.

Phenazopyridine. Gold Standard Drug Database in ClinicalKey [online]. Elsevier Inc. Accessed 12/05/2021.

Pyridium Tablet, Film Coated (Amneal Pharmaceuticals LLC). DailyMed. Source: U.S. National Library of Medicine. Accessed 01/03/2021.

Disclaimer: This information is independently developed by MIMS based on Phenazopyridine from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to MIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, MIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2021 MIMS. All rights reserved. Powered by
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