72/100 · Elevated
Manufactured by Amneal Pharmaceuticals LLC
Phenazopyridine Adverse Events Highlight Chronic Kidney Disease and Renal Issues
9,031 FDA adverse event reports analyzed
Last updated: 2026-05-12
PHENAZOPYRIDINE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Amneal Pharmaceuticals LLC. Based on analysis of 9,031 FDA adverse event reports, PHENAZOPYRIDINE has a safety score of 72 out of 100. This score indicates a relatively favorable safety profile, with fewer or less severe adverse events compared to many other tracked medications. The most commonly reported adverse reactions for PHENAZOPYRIDINE include CHRONIC KIDNEY DISEASE, NAUSEA, PAIN, URINARY TRACT INFECTION, ACUTE KIDNEY INJURY. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for PHENAZOPYRIDINE.
Phenazopyridine has a safety concern score of 72 out of 100, placing it in the elevated concern category based on analysis of FDA adverse event data. The FDA has received approximately 9,031 adverse event reports for this medication, which is primarily manufactured by Amneal Pharmaceuticals Llc.
The most commonly reported adverse events include Chronic Kidney Disease, Nausea, Pain. Of classified reports, 69.9% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Chronic kidney disease and acute kidney injury are among the most serious adverse reactions reported.
Renal failure and renal impairment are also frequently reported, indicating potential nephrotoxicity. The high volume of reports suggests a significant safety concern, especially for long-term use.
Patients taking Phenazopyridine should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Phenazopyridine should be used with caution in patients with pre-existing renal conditions, as it may exacerbate renal issues. Drug interactions, particularly with other nephrotoxic agents, should be monitored. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Phenazopyridine received a safety concern score of 72/100 (elevated concern). This is based on a 69.9% serious event ratio across 3,596 classified reports. The score accounts for 9,031 total adverse event reports and 100 distinct reaction types. This elevated score indicates a notable proportion of serious adverse events and warrants careful monitoring.
Adverse event reports by sex: Female: 2,564, Male: 811, Unknown: 5. The most frequently reported age groups are age 67 (65 reports), age 64 (63 reports), age 66 (63 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 3,596 classified reports for PHENAZOPYRIDINE:
The FDA classifies an adverse event as “serious” if it results in death, hospitalization, disability, congenital anomaly, or requires intervention to prevent permanent damage.
Demographics reflect voluntary FDA adverse event reporting patterns and may not represent the full patient population.
Phenazopyridine should be used with caution in patients with pre-existing renal conditions, as it may exacerbate renal issues. Drug interactions, particularly with other nephrotoxic agents, should be monitored.
If you are taking Phenazopyridine, here are important things to know. The most commonly reported side effects include chronic kidney disease, nausea, pain, urinary tract infection, acute kidney injury. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Patients should avoid long-term use of phenazopyridine and seek medical advice if they experience symptoms of kidney issues such as decreased urine output, swelling, or pain in the abdomen. Consumers should report any adverse reactions to the FDA's MedWatch program to help improve safety monitoring. If you experience a serious adverse reaction, seek emergency medical attention immediately or call 911. You can report side effects to the FDA's MedWatch program at 1-800-FDA-1088.
The FDA has issued warnings regarding the potential for renal toxicity with phenazopyridine. Healthcare providers should regularly monitor renal function in patients taking this medication, especially those with pre-existing renal conditions.
The FDA has received approximately 9,031 adverse event reports associated with Phenazopyridine. These reports come from healthcare professionals, consumers, and manufacturers through the FDA Adverse Event Reporting System (FAERS). Note that the number of reports does not directly indicate the frequency of side effects, as adverse events are voluntarily reported and may be underrepresented.
The most frequently reported adverse events for Phenazopyridine include Chronic Kidney Disease, Nausea, Pain, Urinary Tract Infection, Acute Kidney Injury. By volume, the top reported reactions are: Chronic Kidney Disease (392 reports), Nausea (296 reports), Pain (294 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Phenazopyridine.
Out of 3,596 classified reports, 2,513 (69.9%) were classified as serious and 1,083 as non-serious. The FDA classifies an event as "serious" if it results in death, hospitalization, disability, or other medically significant outcomes. A higher serious-event ratio warrants closer attention but does not necessarily mean the drug is unsafe.
Adverse event reports for Phenazopyridine break down by patient sex as follows: Female: 2,564, Male: 811, Unknown: 5. This distribution reflects reporting patterns rather than actual risk differences between groups. Reporting rates can be influenced by prescribing patterns, disease demographics, and reporting behavior.
The most frequently reported age groups for Phenazopyridine adverse events are: age 67: 65 reports, age 64: 63 reports, age 66: 63 reports, age 62: 61 reports, age 59: 58 reports. Age-related reporting patterns can reflect both the demographics of the patient population and potential age-related susceptibility to certain side effects.
The primary manufacturer associated with Phenazopyridine adverse event reports is Amneal Pharmaceuticals Llc. Multiple manufacturers may produce generic versions of this drug. The manufacturer listed reflects the most frequently reported brand in FDA adverse event data.
Beyond the most common reactions, other reported adverse events for Phenazopyridine include: Fatigue, Renal Failure, Diarrhoea, Anxiety, Headache. Less common side effects can still be clinically significant. Patients should report any unusual symptoms to their healthcare provider.
You can report adverse events from Phenazopyridine to the FDA through their MedWatch program at www.fda.gov/medwatch, by calling 1-800-FDA-1088, or by completing Form FDA 3500. Healthcare professionals, consumers, and manufacturers can all submit reports. Reporting helps the FDA monitor drug safety after approval.
Phenazopyridine has a safety concern score of 72 out of 100 (elevated concern). This score is calculated from the ratio of serious to non-serious adverse events, the diversity of reported reactions, and the overall volume of reports relative to usage. Chronic kidney disease and acute kidney injury are among the most serious adverse reactions reported.
Key safety signals identified in Phenazopyridine's adverse event data include: Chronic kidney disease and acute kidney injury. Renal failure and renal impairment. High volume of reports and diverse reactions. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Phenazopyridine should be used with caution in patients with pre-existing renal conditions, as it may exacerbate renal issues. Drug interactions, particularly with other nephrotoxic agents, should be monitored. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Phenazopyridine.
Patients should avoid long-term use of phenazopyridine and seek medical advice if they experience symptoms of kidney issues such as decreased urine output, swelling, or pain in the abdomen. Consumers should report any adverse reactions to the FDA's MedWatch program to help improve safety monitoring.
Phenazopyridine has 9,031 adverse event reports on file with the FDA. Renal failure and renal impairment are also frequently reported, indicating potential nephrotoxicity. The volume of reports for Phenazopyridine reflects both the drug's usage level and the vigilance of the reporting community.
The FDA has issued warnings regarding the potential for renal toxicity with phenazopyridine. Healthcare providers should regularly monitor renal function in patients taking this medication, especially those with pre-existing renal conditions. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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