Over-the-counter medication · Urinary Analgesic
phenazopyridine
Also sold as Pyridium, AZO. This medicine treats pain, burning, and the need to urinate often.
- 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.
How to Take It
Take this medicine after meals. If you are using the 100 mg tablet, take two tablets three times a day. If you are using the 200 mg tablet, take one tablet three times a day. Do not use it for more than 2 days when taking it with an antibiotic for a urinary tract infection.
This is a plain-language summary of phenazopyridine's FDA labeling, not individualized dosing advice. Ask a pharmacist or prescriber before changing how you take this medication.
Pregnancy & Breastfeeding
It is not known if this medicine will harm an unborn baby. Talk to your doctor if you are pregnant or plan to become pregnant. It is also not known if this medicine passes into breast milk, so talk to your doctor if you are breastfeeding.
This is a plain-language summary of phenazopyridine's FDA labeling, not individualized advice. Ask a pharmacist or prescriber about pregnancy or breastfeeding on this medication.
Missed Dose
If you miss a dose, take it as soon as you remember. If it is close to your next dose, skip the missed dose and continue with your regular schedule.
This is a plain-language summary of phenazopyridine's FDA labeling, not individualized advice. Ask a pharmacist or prescriber what to do about your specific missed dose.
Storage
Store at room temperature between 68° to 77°F.
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
- Long-term kidney disease
Long-term kidney disease
392 reports
- Feeling sick to your stomach
Feeling sick to your stomach
296 reports
- Aches or soreness
Aches or soreness
294 reports
- Bladder infection
Bladder infection
281 reports
- Sudden kidney damage
Sudden kidney damage
266 reports
- Feeling tired
Feeling tired
257 reports
- Kidney failure
Kidney failure
253 reports
- Loose stools
Loose stools
218 reports
- Feeling worried or nervous
Feeling worried or nervous
182 reports
- Head pain
Head pain
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) 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?
Is phenazopyridine safe during pregnancy?
Has phenazopyridine been recalled?
Active Recalls
CGMP Deviations: product held outside appropriate storage temperature conditions.
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Related Medications in Urinary Analgesic
Other drugs grouped near phenazopyridine - same-class peers and common alternatives.
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dutasteride
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dutasteride/tamsulosin
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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 further shape supply and switching decisions. This page summarizes public FDA data for educational purposes only and is not a substitute for professional medical advice, always consult a licensed healthcare provider before starting, stopping, or changing any medication.
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. Always consult a healthcare professional before making medication decisions.
Last updated: September 23, 2024
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