Version May 2024
Diagnostic aid, dye test for identification of urogenital tract injury or fistula (off-label use):
Oral: 100 to 200 mg as a single dose for urine staining administered approximately 1 to 2 hours before examination (Abrams 2021; Garely 2022; Ghoniem 2014; Patel 2021).
Diagnostic aid, enhanced ureteral and bladder visualization during cystoscopic evaluation (off-label use):
Oral: 100 to 200 mg as a single dose administered approximately 1 hour prior to cystoscopy (Espaillat-Rijo 2016; Hui 2009; Propst 2016; Strom 2019). Note: Successful urine staining with phenazopyridine 200 mg (single dose) has been described up to 18 hours prior to cystoscopy (Rehfuss 2018).
Dysuria, symptomatic relief:
Note: For brief analgesic use, while addressing the underlying cause of dysuria (eg, treatment of a urinary tract infection) or self-limiting causes of dysuria without a urinary tract infection (eg, postcystoscopy discomfort, acute radiation therapy–induced cystitis).
Oral: 200 mg 3 times daily for up to 2 days. Note: For postcystoscopy dysuria without urinary tract infection, some experts use for up to 3 days if needed (Fok 2022). In patients with acute radiation therapy–induced cystitis without infection, may consider use in select patients for up to 2 to 3 weeks (Bradley 2022; Shore 2020).
OTC product labeling: 2 tablets (190 to 199 mg [amount varies based on product]) 3 times daily as needed for up to 2 days.
The renal dosing recommendations are based upon the best available evidence and clinical expertise. Senior Editorial Team: Bruce Mueller, PharmD, FCCP, FASN, FNKF; Jason Roberts, PhD, BPharm (Hons), B App Sc, FSHP, FISAC; Michael Heung, MD, MS.
Altered kidney function:
CrCl ≥50 mL/minute: No dosage adjustment necessary (Golightly 2013; expert opinion).
CrCl <50 mL/minute: Avoid use. Cases of acute kidney injury, hemolytic anemia, and methemoglobinemia have been reported in patients with reduced kidney function (Alano 1970; Chang 2014; Eisinger 1969; Fincher 1989; Gabor 1965; Golightly 2013; Greenberg 1964; Singh 2014; manufacturer's labeling).
Hemodialysis, intermittent (thrice weekly): Dialyzability unknown. Avoid use (expert opinion).
Peritoneal dialysis: Dialyzability unknown. Avoid use (expert opinion).
CRRT: Avoid use (expert opinion).
PIRRT (eg, sustained, low-efficiency diafiltration): Avoid use (expert opinion).
There are no dosage adjustments provided in the manufacturer’s labeling.
Refer to adult dosing.
(For additional information see "Phenazopyridine: Pediatric drug information")
Dysuria, symptomatic relief: Note: Generally, the use of phenazopyridine is not included by experts as a therapeutic consideration for management of urinary tract infection (UTI) in pediatric patients (AAP 2011; EAU/ESPU [Stein 2015]; Jerardi 2020).
Children and Adolescents: Limited data available in ages <12 years: Oral: 4 mg/kg/dose 3 times daily; maximum dose: 200 mg/dose (Finkelstein 2016; Gal 2007; Gearhart 2010; Leung 2019; Rudolph 1996); some experts suggest a minimum age of 6 years (Gearhart 2010). Limit therapy to 2 days if being used for UTI.
OTC Labeling: Children ≥12 years and Adolescents: Oral: 2 tablets (190 to 199 mg [dose varies by product]) 3 times daily as needed. Limit therapy to 2 days if being used for UTI.
Children ≥12 years and Adolescents: There are no pediatric-specific recommendations; in adults, use is contraindicated in any degree of renal insufficiency. In adults, cases of acute kidney injury, hemolytic anemia, and methemoglobinemia have been reported in patients with reduced kidney function (Alano 1970; Chang 2014; Eisinger 1969; Fincher 1989; Gabor 1964; Golightly 2013; Greenberg 1964; Singh 2014; manufacturer's labeling).
There are no dosage adjustments provided in the manufacturer’s labeling.
The following adverse drug reactions are derived from product labeling unless otherwise specified.
Frequency not defined:
Dermatologic: Pruritus, skin rash
Hypersensitivity: Nonimmune anaphylaxis
Nervous system: Headache
Postmarketing:
Dermatologic: Xanthoderma (Atreya 2017)
Gastrointestinal: Gastrointestinal distress (including nausea and vomiting) (Atreya 2017)
Genitourinary: Urine discoloration (Atreya 2017)
Hematologic & oncologic: Hemolytic anemia (Chang 2014), methemoglobinemia (Shahani 2012), pancytopenia (Haigh 2006), sulfhemoglobinemia (Gopalachar 2005)
Hepatic: Hepatitis (hypersensitivity-induced) (Badley 1976), hepatotoxicity
Hypersensitivity: Type IV hypersensitivity reaction (Yeung 2022)
Renal: Nephrotoxicity (including acute interstitial nephritis, acute kidney injury, and renal tubular necrosis) (Atreya 2017, Singh 2014)
Hypersensitivity to phenazopyridine or any component of the formulation; renal insufficiency.
Concerns related to adverse effects:
• Acute renal failure: Acute renal failure has been reported with larger than recommended doses, primarily in patients with preexisting kidney disease, although some reports have occurred in patients without preexisting kidney disease (Alano 1970; Holmes 2014; Onder 2006). Acute renal failure secondary to phenazopyridine toxicity is usually accompanied by hemolytic anemia, yellow discoloration of the skin, and methemoglobinemia, although acute renal failure can occur in isolation (Holmes 2014). Acute renal failure has also been reported following use of usual recommended doses in patients without preexisting kidney impairment (Shahani 2012; Singh 2014).
• Urine discoloration: A reddish-orange discoloration of the urine occurs.
• Yellow discoloration: Drug should be discontinued if skin or sclera develop a yellow color (may indicate drug accumulation due to impaired renal excretion).
Disease-related concerns:
• Renal impairment: Use is contraindicated in patients with kidney impairment (although a specific degree of impairment is not defined in the manufacturer's labeling). Use in patients with preexisting chronic kidney disease has been associated with acute kidney injury, hemolytic anemia, and methemoglobinemia (Chang 2014).
Special populations:
• Older adult: Use with caution in older adults due to potential for accumulation in patients with renal insufficiency.
• G6PD deficiency: Use caution in patients with G6PD deficiency; hemolytic anemia may occur in the setting of chronic overdose. OTC labeling recommends use only when directed by physician.
Other warnings/precautions:
• Contact lenses: Staining of contact lenses may occur if handled after touching tablets.
• Limitations of use: Does not treat urinary infection, acts only as an analgesic.
• Self-medication (OTC use): When used for self-medication, patients should be instructed to discontinue use if symptoms last for more than 2 days or if an adverse reaction occurs.
• Staining: May stain fabric or clothing.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product
Tablet, Oral:
AZO Urinary Pain Relief: 99.5 mg [DSC] [contains corn starch]
Tablet, Oral, as hydrochloride:
Pyridium: 100 mg, 200 mg
Urinary Pain Relief: 95 mg [DSC]
Generic: 100 mg, 200 mg
Yes
Tablets (Phenazopyridine HCl Oral)
100 mg (per each): $0.32 - $2.70
200 mg (per each): $0.44 - $4.00
Tablets (Pyridium Oral)
100 mg (per each): $5.32
200 mg (per each): $6.84
Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product
Tablet, Oral, as hydrochloride:
Phenazo: 100 mg [DSC], 200 mg [DSC]
Pyridium: 100 mg [contains corn starch]
Pyridium: 200 mg
Oral: Administer with or after meals.
Oral: Administer with a full glass of water; take with or after meals to reduce stomach upset.
Dysuria, symptomatic relief: Symptomatic relief of pain, burning, urgency, frequency, and other discomforts arising from irritation of the lower urinary tract mucosa caused by infection, trauma, surgery, endoscopic procedures, or the passage of sounds or catheters.
Diagnostic aid, dye test for identification of urogenital tract injury or fistula; Diagnostic aid, enhanced ureteral and bladder visualization during cystoscopic evaluation
Phenazopyridine may be confused with phenoxybenzamine
Pyridium may be confused with Dyrenium, Perdiem, pyridoxine, pyrithione
None known.
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.
Dapsone (Topical): May enhance the adverse/toxic effect of Methemoglobinemia Associated Agents. Risk C: Monitor therapy
Local Anesthetics: Methemoglobinemia Associated Agents may enhance the adverse/toxic effect of Local Anesthetics. Specifically, the risk for methemoglobinemia may be increased. Risk C: Monitor therapy
Nitric Oxide: May enhance the adverse/toxic effect of Methemoglobinemia Associated Agents. Combinations of these agents may increase the likelihood of significant methemoglobinemia. Risk C: Monitor therapy
Prilocaine: Methemoglobinemia Associated Agents may enhance the adverse/toxic effect of Prilocaine. Combinations of these agents may increase the likelihood of significant methemoglobinemia. Management: Monitor patients for signs of methemoglobinemia (e.g., hypoxia, cyanosis) when prilocaine is used in combination with other agents associated with development of methemoglobinemia. Avoid lidocaine/prilocaine in infants receiving such agents. Risk C: Monitor therapy
Sodium Nitrite: Methemoglobinemia Associated Agents may enhance the adverse/toxic effect of Sodium Nitrite. Combinations of these agents may increase the likelihood of significant methemoglobinemia. Risk C: Monitor therapy
Adverse events have not been observed in animal reproduction studies. Phenazopyridine crosses the placenta and can be detected in amniotic fluid (Meyer 1991).
It is not known if phenazopyridine is present in breast milk.
Take with or after meals.
An azo dye which exerts local anesthetic or analgesic action on urinary tract mucosa through an unknown mechanism
Metabolism: In the liver and other tissues
Excretion: Urine (66% as unchanged drug)
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