LOW-VOLUME · FEMALE-LED
phenazopyridine Side Effects
phenazopyridine (also sold as Pyridium, AZO) is a LOW-VOLUME FAERS extract #415 of 524 by FAERS report count. Still opens on FEMALE-LED: 76% of sex-coded reports are female (2,565 F / 811 M).
Data updated 2026-05-15
- 3,599
- FAERS reports
Thinner FAERS book - still a temporal association ledger, not proof of cause. Methodology.
phenazopyridine reporting skew - 76% of sex-coded reports are female (2,565 F / 811 M). Volume band LOW-VOLUME #415 of 524 by FAERS report count; caseload SIGNAL.
Thinner FAERS extract for phenazopyridine (Pyridium) (3,599 reports #415 of 524 by FAERS report count). 76% of sex-coded reports are female (2,565 F / 811 M). Sparse books still carry named reaction rows when present; not medical advice.
Counts from the openFDA FAERS extract (1992–2025). Stamps SIGNAL · DEATH-HEAVY · HOSP-HEAVY · FEMALE-LED.
CHRONIC KIDNEY DISEASE leads 392 of 3,599 reports
FEMALE-LED reporters · age peak 45-64
Female-led reporters (76% of sex-coded rows)
Age peak 45-64 (852 reports)
FAERS filings rising toward 2025
Reactions in Death Reports
Death-mentioned subset is HEAVY here (261 reports, 7.3%). Top co-reported reactions in that subset - voluntary, not causal.
| Reaction | Reports |
|---|---|
| DEATH | 98 |
| COMPLETED SUICIDE | 31 |
| ACUTE KIDNEY INJURY | 24 |
| NAUSEA | 24 |
| RENAL FAILURE | 24 |
| CHRONIC KIDNEY DISEASE | 23 |
| URINARY TRACT INFECTION | 18 |
| FATIGUE | 17 |
| VOMITING | 16 |
| PAIN | 14 |
| ASTHENIA | 13 |
| DIARRHOEA | 12 |
| DYSPNOEA | 12 |
| END STAGE RENAL DISEASE | 12 |
| MYOCARDIAL INFARCTION | 12 |
| PNEUMONIA | 12 |
| ABDOMINAL PAIN | 11 |
| ANAEMIA | 11 |
| ANXIETY | 11 |
Reactions in Hospitalization Reports
Hospitalization is HEAVY (1,205, 33.5% of the book). Top reactions in those rows:
| Reaction | Reports |
|---|---|
| URINARY TRACT INFECTION | 139 |
| PAIN | 127 |
| NAUSEA | 123 |
| ACUTE KIDNEY INJURY | 104 |
| VOMITING | 95 |
| FATIGUE | 89 |
| DIARRHOEA | 86 |
| CHRONIC KIDNEY DISEASE | 85 |
| RENAL FAILURE | 82 |
| FALL | 76 |
| DYSPNOEA | 75 |
| HEADACHE | 68 |
| ANXIETY | 67 |
| ABDOMINAL PAIN | 65 |
| DIZZINESS | 63 |
| ANAEMIA | 61 |
| DEHYDRATION | 61 |
| DEPRESSION | 61 |
| PNEUMONIA | 61 |
| ASTHENIA | 59 |
How to read phenazopyridine FAERS figures (SIGNAL · DEATH-HEAVY · HOSP-HEAVY)
FAERS holds 3,599 voluntary reports linked to phenazopyridine (Pyridium, AZO), 1992-2025. Death is listed on 261 (7.3%). Hospitalization appears on 1,205 (33.5%). Top co-reported indication: Product Used For Unknown Indication.
Sparse extract - named reactions and FEMALE-LED skew still differ by drug; not a complete safety profile.
Read with phenazopyridine
Peers ranked by ABS(total_reports), then an ABS(death_share) pole; guide hop follows DEATH-HEAVY · HOSP-HEAVY stamps.
ABS(total_reports) peer at 3,554 FAERS cases (Δ 45 lighter vs phenazopyridine); DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED vs this page's SIGNAL · DEATH-HEAVY · HOSP-HEAVY · FEMALE-LED.
ABS(total_reports) peer at 3,669 FAERS cases (Δ 70 heavier vs phenazopyridine); DEATH-HEAVY · HOSP-HEAVY · FEMALE-LED vs this page's SIGNAL · DEATH-HEAVY · HOSP-HEAVY · FEMALE-LED.
ABS(total_reports) peer at 3,682 FAERS cases (Δ 83 heavier vs phenazopyridine); DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED vs this page's SIGNAL · DEATH-HEAVY · HOSP-HEAVY · FEMALE-LED.
ABS(total_reports) peer at 3,736 FAERS cases (Δ 137 heavier vs phenazopyridine); DEATH-HEAVY · HOSP-HEAVY · SEX-BALANCED vs this page's SIGNAL · DEATH-HEAVY · HOSP-HEAVY · FEMALE-LED.
ABS(death_share) pole at 62.1% death-mentioned reports (Δ 54.9 pp vs phenazopyridine's DEATH-HEAVY): CASELOAD · HOSP-MID.
phenazopyridine stamps DEATH-HEAVY · HOSP-HEAVY; FAERS outcome shares are signal-detection rates, not incidence. Read them next to caseload SIGNAL and the label guide.