Overview
Phenazopyridine, also known as Pyridium, is a urinary tract analgesic used for the short-term management of urinary tract irritation and its associated unpleasant symptoms such as burning and pain during urination. In the USA, this drug was previously marked by Roche but has been discontinued by the FDA. It is still used in various parts of the world. Ingestion of phenazopyridine is found to change the appearance of the urine by imparting an orange or red color, as it is considered an azo dye.
Indication
Phenazopyridine hydrochloride is indicated to relieve uncomfortable symptoms that occur as a consequence of mucosal irritation of the lower urinary tract in adults. The irritation may be a result of trauma, surgery, endoscopic procedures, infection, or the insertion of instruments or urinary catheters. Phenazopyridine may be used in combination with antimicrobial therapy but is not used as an antimicrobial agent. It contributes to the relief of discomfort and pain before antimicrobial therapy begins to take effect. It is important to note that the duration of treatment with this drug should last a maximum of 2 days. Phenazopyridine is available in many countries as an over the counter drug.
Associated Conditions
- Lower Urinary Tract Infection
- Signs or symptoms of urinary tract irritation
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2024/08/29 | Phase 4 | Recruiting | |||
2024/07/23 | Phase 4 | Withdrawn | |||
2018/11/27 | Phase 4 | UNKNOWN | Women and Infants Hospital of Rhode Island | ||
2018/02/14 | Early Phase 1 | Completed | |||
2017/10/05 | Phase 4 | Completed | |||
2017/02/27 | Phase 3 | Completed | University of Massachusetts, Worcester | ||
2016/06/21 | Phase 3 | Completed | University of Massachusetts, Worcester | ||
2016/05/02 | Not Applicable | Withdrawn | |||
2016/03/22 | Not Applicable | UNKNOWN | Boston Urogynecology Associates | ||
2016/03/09 | Not Applicable | Withdrawn |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| REMEDYREPACK INC. | 70518-0218 | ORAL | 100 mg in 1 1 | 1/19/2024 | |
| Rebel Distributors Corp | 21695-301 | ORAL | 200 mg in 1 1 | 1/31/2011 | |
| RPK Pharmaceuticals, Inc. | 53002-3153 | ORAL | 200 mg in 1 1 | 10/31/2023 | |
| PD-Rx Pharmaceuticals, Inc. | 72789-362 | ORAL | 100 mg in 1 1 | 2/20/2024 | |
| RPK Pharmaceuticals, Inc. | 53002-3152 | ORAL | 200 mg in 1 1 | 12/16/2020 | |
| NuCare Pharmaceuticals,Inc. | 68071-5274 | ORAL | 100 mg in 1 1 | 2/7/2022 | |
| Direct_Rx | 61919-098 | ORAL | 200 mg in 1 1 | 1/21/2020 | |
| Preferred Pharmaceuticals Inc. | 68788-7981 | ORAL | 100 mg in 1 1 | 8/25/2023 | |
| Redpharm Drug, Inc. | 67296-1447 | ORAL | 200 mg in 1 1 | 2/6/2023 | |
| RedPharm Drug, Inc. | 67296-1350 | ORAL | 100 mg in 1 1 | 1/21/2022 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| UROSINA CAP | N/A | N/A | N/A | 12/28/2002 |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| No TGA approvals found for this drug. | |||||
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| PYRIDIUM | searchlight pharma inc | 00476722 | Tablet - Oral | 200 MG | 12/31/1981 |
| PHENAZOPYRIDINE TAB 100MG | 00385441 | Tablet - Oral | 100 MG / TAB | 12/31/1978 | |
| PYRONIUM 0.1GM | PRO DOC LIMITEE | 00156914 | Tablet - Oral | 100 MG | 12/31/1960 |
| PYRONIUM TAB 200MG | PRO DOC LIMITEE | 00386499 | Tablet - Oral | 200 MG | 12/31/1976 |
| VITO REINS TAB 100MG | 00385441 | Tablet - Oral | 100 MG / TAB | 12/31/1977 | |
| PYRIDIUM | searchlight pharma inc | 00476714 | Tablet - Oral | 100 MG | 12/31/1981 |
| PHENAZO | bausch health, canada inc. | 00271489 | Tablet - Oral | 100 MG | 12/31/1973 |
| PHENAZO | bausch health, canada inc. | 00454583 | Tablet - Oral | 200 MG | 12/31/1979 |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| No CIMA AEMPS (Spain) approvals found for this drug. | |||||
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Malaysia NPRA approvals found for this drug. | |||||
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
|---|---|---|---|---|---|
| No UK EMC drug information found for this drug. | |||||
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