Over-the-counter medication · Urinary Analgesic
phenazopyridine
Also sold as Pyridium, AZO. This medicine treats pain, burning, and the need to urinate often.
Data updated 2026-05-15
- 3,599
- FDA reportsLightly reported
- 1
- Recall record
What the data shows
phenazopyridine (Pyridium) is an over-the-counter Urinary Analgesic, among the least-reported drugs the FDA tracks (3,599 FDA reports).
Reporting volume reflects how widely a drug is used and studied, not how dangerous it is, a FAERS report documents a temporal association, never proof of cause.
phenazopyridine (Pyridium) is an over-the-counter Urinary Analgesic. This medicine treats pain, burning, and the need to urinate often.
Phenazopyridine is a medicine that can relieve urinary pain. It helps with discomfort caused by irritation or infection in your urinary tract.
Verify with FDA → · CMS NADAC pricing →
Drug Pricing (NADAC)
Generic Price
$0.14/unit
Generic Available
Yes (0 manufacturers)
Pricing data from NADAC (CMS), effective December 18, 2024. Compare all drug costs →
What it does
This medicine treats pain, burning, and the need to urinate often.
Common side effects
Headache, Rash, Itching
Key warnings
You should not take this medicine if you are allergic to it.
The sections below are summarized in plain English from phenazopyridine's FDA-approved prescribing information. They describe what the official label says, and are not personal medical advice.
How It Works
Phenazopyridine has a direct pain-relieving effect on the urinary tract. It works locally to quickly reduce burning and pain. It does not treat the cause of the infection or irritation.
Side Effects (from patient reports)
Based on 3,599 FDA adverse event reports.
Most-reported reactions
Adverse reactions in FAERS for phenazopyridine, by number of reports
- Chronic Kidney Disease
Chronic Kidney Disease
392 reports
- Nausea
Nausea
296 reports
- Pain
Pain
294 reports
- Urinary Tract Infection
Urinary Tract Infection
281 reports
- Acute Kidney Injury
Acute Kidney Injury
266 reports
- Fatigue
Fatigue
257 reports
- Renal Failure
Renal Failure
253 reports
- Diarrhoea
Diarrhoea
218 reports
- Anxiety
Anxiety
182 reports
- Headache
Headache
181 reports
What this shows Bars show how often each reaction was reported, not how likely it is to happen, a report records a temporal association, never proof that the drug caused it.
Reports over time
Adverse-event reports filed for phenazopyridine each year to the FDA Adverse Event Reporting System (FAERS).
Year-to-year volume tracks usage, prescribing, and scrutiny, not a change in per-patient risk. Source: FDA FAERS.
Where phenazopyridine sits
phenazopyridine has more FDA adverse-event reports than 21% of the drugs FAERS tracks. A high position reflects how widely a drug is used and watched, not how dangerous it is.
Percentile across all drugs PlainMeds tracks by FAERS report volume. The dot is phenazopyridine; the line is the median (50th percentile).
FDA Adverse Event Report Analysis
Detailed analysis of 3,599 reports from the FDA Adverse Event Reporting System (FAERS). Reports span 1992–2025.
Total Reports
3,599
Reports Mentioning Death
261
7.3% of reports — not proof of cause
Hospitalization Reports
1,205
Top Indication
Product Used For Unknown Indication
Gender Distribution
Age Distribution
Most Reported Adverse Reactions (FAERS)
| # | Reaction | Reports |
|---|---|---|
| 1 | CHRONIC KIDNEY DISEASE | 392 |
| 2 | NAUSEA | 296 |
| 3 | PAIN | 294 |
| 4 | URINARY TRACT INFECTION | 281 |
| 5 | ACUTE KIDNEY INJURY | 266 |
| 6 | FATIGUE | 257 |
| 7 | RENAL FAILURE | 253 |
| 8 | DIARRHOEA | 218 |
| 9 | ANXIETY | 182 |
| 10 | HEADACHE | 181 |
| 11 | VOMITING | 179 |
| 13 | DRUG HYPERSENSITIVITY | 142 |
| 14 | DIZZINESS | 138 |
| 15 | DEPRESSION | 136 |
| 17 | DYSPNOEA | 134 |
Reactions in Death Reports
Reactions in Hospitalization Reports
Source: FDA FAERS (Adverse Event Reporting System) Reports are voluntary and do not establish causation
Serious Warnings
You should not take this medicine if you are allergic to it. Also, you should not take it if you have kidney problems.
Common Questions
What if my urine turns orange?
Can I take this for a long time?
Will this medicine cure my urinary tract infection?
Can I take this with other pain relievers?
What should I do if I have an allergic reaction?
Can I drive while taking this medicine?
Does this medicine interact with other drugs?
Can children take this medicine?
What if I accidentally take too much?
Can this medicine affect my lab tests?
What are the common side effects of phenazopyridine?
What drug class is phenazopyridine?
What pregnancy or breastfeeding source fields are listed for phenazopyridine?
Has phenazopyridine been recalled?
Active Recalls
CGMP Deviations: product held outside appropriate storage temperature conditions.
Family Dollar Stores, Llc.
Related Medications in Urinary Analgesic
Other drugs grouped near phenazopyridine - same-class peers and common alternatives.
alfuzosin
Uroxatral
Alfuzosin is a medicine that helps men with enlarged prostate glands.
Compare with phenazopyridine →
bethanechol
Urecholine
Bethanechol helps you to urinate if you have trouble emptying your bladder.
Compare with phenazopyridine →
darifenacin
Enablex
Darifenacin (Enablex) is a medicine that helps control an overactive bladder.
Compare with phenazopyridine →
dutasteride
Avodart
Dutasteride and tamsulosin hydrochloride capsules contain two medicines to treat enlarged prostate in men.
Compare with phenazopyridine →
dutasteride/tamsulosin
Jalyn
This medicine combines two drugs to treat enlarged prostate in men.
Compare with phenazopyridine →
Compare beyond drug class
Nationwide peers by FAERS volume & death-report share
Two PlainMeds-derived comparison paths for phenazopyridine: nearest FDA FAERS report volume and nearest death-report share among drugs with at least 1,000 logged reports, excluding same-class neighbors listed above. Counts reflect reporting volume, not proven individual harm.
Similar FAERS report volume
Nearest drugs by total FAERS reports. This record: 3,599.
Similar death-report share
Nearest drugs by FAERS death-report share. This record: 7.25%.
- losartan Δ 0.02 pts · 165,585 reports · Angiotensin II Receptor Blocker (ARB) 7.27%death share
- brinzolamide Δ 0.02 pts · 8,461 reports · Carbonic Anhydrase Inhibitor (Ophthalmic) 7.23%death share
- fenofibrate Δ 0.03 pts · 48,091 reports · Fibrate 7.22%death share
- deutetrabenazine Δ 0.05 pts · 6,445 reports · VMAT2 Inhibitor 7.20%death share
Medication Guides
Understanding Drug Interactions
How CYP450 enzymes, inhibitors, and inducers affect your medications
Generic vs Brand Name Drugs
FDA requirements, cost savings, and when the difference matters
Pain Relievers Compared
NSAIDs vs acetaminophen, which OTC pain reliever to use
Narrow Therapeutic Index Drugs
FDA bioequivalence and label-record context for narrow therapeutic index medicines
Common Drug Interactions
Dangerous medication combinations and how to protect yourself
What the FDA Data Shows for phenazopyridine
The FDA label for phenazopyridine (sold under brand names such as Pyridium, AZO) classifies it as an over-the-counter product in the Urinary Analgesic class. This medicine treats pain, burning, and the need to urinate often. Official labeling lists 4 commonly reported side effects, including Headache, Rash, Itching.
Post-market surveillance from the FDA Adverse Event Reporting System (FAERS) captures real-world experience. For this drug, FAERS contains 3,599 voluntary reports. Interaction data is drawn directly from FDA-approved prescribing information. NADAC pricing from CMS shows a generic unit cost of $0.14.
Report counts do not establish causation, a FAERS entry documents a temporal association, not proof that the drug produced the outcome. Widely prescribed medications naturally accumulate more reports than niche therapies, so raw totals must be interpreted alongside total exposure. Shortage status, recall history (currently 1 recall record on file), and patent information are separate source-record fields. This page is a public FDA/CMS registry and does not provide medical, treatment, substitution, or medication-change directions.
Data Sources
Drug labeling: FDA Drug Labels (SPL/DailyMed). Adverse events: FDA Adverse Event Reporting System (FAERS). Pricing: CMS National Average Drug Acquisition Cost (NADAC).
FAERS reports are voluntary and do not establish causation. Drug interactions are derived from FDA labeling and clinical references. This registry does not provide medication decisions.
Last updated: September 23, 2024
PlainMeds is rendered directly from FDA openFDA/FAERS extracts, DailyMed labels, and CMS drug-pricing files, no number is typed in by an editor. FAERS counts, recalls, shortages, and price figures on this page are queried live from those federal extracts. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of 2026-05-15. Primary sources: openFDA / FAERS, DailyMed and CMS Part B ASP.
Read our methodology - how this data is sourced, computed, and verified.
Data currency: FDA FAERS adverse-event reports through 2025, CMS NADAC acquisition-cost pricing effective December 2024, compiled and last refreshed May 2026. See our methodology for per-source dates and refresh cadence. Spot a figure that looks wrong? Report a correction.
All federal data sources used on this page
- FDA Orange Book - approved drug products with therapeutic equivalence. accessdata.fda.gov/cder/ob
- FDA DailyMed - NIH-hosted drug labeling for FDA-approved meds. dailymed.nlm.nih.gov
- FDA Adverse Event Reporting System (FAERS) - post-marketing safety surveillance. fda.gov/drugs/faers
- NLM RxNorm - standardized clinical drug nomenclature. nlm.nih.gov/research/umls/rxnorm
- CMS Medicare Part B Drug Average Sales Price Files - federal drug pricing data. cms.gov/medicare/part-b-drugs/asp
- FDA Drug Shortages Database - current and resolved drug shortage tracking. accessdata.fda.gov/drugshortages