Phenazopyridine
Other Urologicals
Sold as Pyridium
- Drug class
- Other Urologicals
- Availability
- Prescription only
- Routes
- Oral
- Markets covered
- 1
- Products on record
- 8
- FDA reports (12 mo)
- 252
Overview
Plain-language summary, compiled from the cited regulatory records
Phenazopyridine is a medication classified as an "Other Urological" agent [1]. It is approved for the symptomatic relief of pain, burning, urgency, frequency, and other discomforts associated with irritation of the lower urinary tract [1]. These symptoms may arise from causes such as infection, trauma, surgery, endoscopic procedures, or the passage of medical instruments like sounds or catheters [1].
It is important to note that while phenazopyridine can alleviate these symptoms, its use should not postpone the definitive diagnosis and treatment of the underlying conditions causing the irritation [1]. The medication is intended for symptom management and not as a substitute for addressing the root cause [1]. Phenazopyridine is available under various brand names, including Pyridium [1]. In the past 12 months, there have been 252 adverse event reports associated with this active ingredient [2].
This is not medical advice. Consult a qualified healthcare professional.
Regulatory status by market
| Market | Regulator | Products | Last revision |
|---|---|---|---|
| US United States | FDA | 8 | March 5, 2026 |
USUnited States· FDA
8 products
Uses
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. )
Drug interactions
Known interactions involving Phenazopyridine. Select one for details. This list is informational and not a complete interaction checker.
Interaction data compiled from DDInter (academic, CC-BY). Severity classification only - this is not a complete interaction checker and not medical advice.
Sources & citations
- [1]FDA DailyMed · 0e34badf-c886-08… · revised July 9, 2024 [PDF]
- [2]OpenFDA adverse-event reports (US), 12 months ending June 4, 2026.
Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.