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Phenazopyridine Side Effects

The most commonly reported side effects of phenazopyridine include chronic kidney disease, acute kidney injury, and pain, based on 2,827 FDA adverse event reports from 2004 to 2025. 3.4% of reports found the drug to be ineffective.

Phenazopyridine side effects

Percentages show how often each reaction appears relative to total reports for phenazopyridine.

1
Chronic Kidney Disease12.4%351
2
Acute Kidney Injury7.9%223
3
Pain7.3%206
4
Renal Failure7.1%201
5
Urinary Tract Infection6.8%191
6
Fatigue6.6%186
7
Diarrhoea6.3%179
8
Nausea6.3%178
9
Off Label Use4.4%124
10
Anxiety4.2%120
11
Vomiting4.0%112
12
Headache3.9%110
13
Drug Ineffective3.4%96
14
End Stage Renal Disease3.2%90
15
Death3.0%86

These are voluntary reports and do not establish that phenazopyridine caused these reactions.

Report severity

71.3%Serious2,016 reports
34.0%Hospitalizations962 reports
7.6%Fatal215 reports

Seriousness is determined by the reporter, not by OpenClaim.

Phenazopyridine drug interactions

Other drugs that appear in adverse event reports alongside phenazopyridine. Drugs flagged as a suspected cause appear in the first column. Drugs taken at the same time but not suspected appear in the second.

Also suspected

1
Esomeprazole10.9%308
2
Omeprazole10.1%286
3
Pantoprazole-sodium7.3%207
4
Lansoprazole7.1%201
5
Sodium-oxybate4.6%130
6
Lenalidomide4.6%129
7
Dexlansoprazole2.7%77
8
Dupilumab2.3%64
9
Relugolix2.2%61
10
Etanercept2.1%58
11
Ethinyl-estradiol2.0%57
12
Drospirenone1.9%55
13
Pentosan-polysulfate-sodium1.9%54
14
Olanzapine1.6%44
15
Acetaminophen1.5%42

Taken alongside

1
Acetaminophen31.9%902
2
Ciprofloxacin23.9%676
3
Ondansetron21.8%617
4
Ergocalciferol21.6%611
5
Gabapentin21.3%601
6
Albuterol20.0%565
7
Oxycodone17.9%507
8
Ibuprofen17.5%496
9
Aspirin17.4%493
10
Levothyroxine-sodium16.7%472
11
Prednisone16.6%470
12
Tramadol-hydrochloride16.6%470
13
Omeprazole16.6%468
14
Nitrofurantoin16.4%464
15
Lisinopril16.0%453

Co-occurrence in adverse event reports does not establish a drug interaction. Patients often take multiple medications, and these lists reflect prescribing patterns rather than causal relationships. Consult a healthcare provider about potential drug interactions.

Who reports phenazopyridine side effects

68.7% of phenazopyridine adverse event reports involve female patients and 24.6% involve male patients. The largest age group is adult at 61%. These figures reflect who reports side effects, not underlying risk.

Sex

Female68.7%
Male24.6%
Unknown6.7%

Age group

< 2<0.1%
2–110.5%
12–171.4%
18–6460.5%
65+37.4%

What is phenazopyridine used for

Conditions and purposes for which patients were taking phenazopyridine when the adverse event was reported.

Abdominal PainAnalgesic EffectAnalgesic TherapyAntibiotic LevelAntibiotic TherapyAntioxidant TherapyAutomatic BladderAnalgesic TherapyAutoimmune Haemolytic AnaemiaBiopsy ProstateBk Virus InfectionBladder DiscomfortBladder DisorderBladder IrritationBladder Pain

Showing 15 of 96 indications

Phenazopyridine brand names and reporting trend

Phenazopyridine is sold under the brand name Sulfamethoxazole And Trimethoprim And Phenazopyridine Hydrochloride.

Brand names

Sulfamethoxazole And Trimethoprim And Phenazopyridine Hydrochloride2,930

Quarterly reports (20042025)

20052010201520202025

An upward trend reflects increased FAERS reporting overall, not necessarily increased risk.

Taking phenazopyridine with another medication?

Ask OpenClaim about your specific drug combination. Get a sourced report using FDA data, drug labels, and medical literature.