pharmacopeia
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/api/v1/drug/phenazopyridine

Mechanism of action

Sourced from openFDA

Mechanism-of-action class: Unknown Cellular or Molecular Interaction.

Indications

Sourced from openFDA
  • Phenazopyridine HCl is indicated for the symptomatic relief of pain, burning, urgency, frequency, and other discomforts arising from irritation of the lower urinary tract mucosa caused by infection, trauma, surgery, endoscopic procedures, or the passage of sounds or catheters. The use of Phenazopyridine HCl for relief of symptoms should not delay definitive diagnosis and treatment of causative conditions.

Contraindications

Sourced from openFDA
  • Phenazopyridine HCl should not be used in patients who have previously exhibited hypersensitivity to it. The use of Phenazopyridine HCl is contraindicated in patients with renal insufficiency.contraindicated

Dosage & administration

Sourced from openFDA

100 mg Tablets: Average adult dosage is two tablets 3 times a day after meals. 200 mg Tablets: Average adult dosage is one tablet 3 times a day after meals. When used concomitantly with an antibacterial agent for the treatment of a urinary tract infection, the administration of Phenazopyridine HCl should not exceed 2 days.

Adverse reactions

Sourced from openFDA

Headache, rash, pruritus and occasional gastrointestinal disturbance. An anaphylactoid-like reaction has been described. Methemoglobinemia, hemolytic anemia, renal and hepatic toxicity have been reported, usually at overdosage levels (see OVERDOSAGE Section ).

Overdosage

Sourced from openFDA

Exceeding the recommended dose in patients with good renal function or administering the usual dose to patients with impaired renal function (common in elderly patients) may lead to increased serum levels and toxic reactions. Methemoglobinemia generally follows a massive, acute overdose. Methylene blue, 1 to 2 mg/kg/body weight intravenously or ascorbic acid 100 to 200 mg given orally should cause prompt reduction of the methemoglobinemia and disappearance of the cyanosis which is an aid in diagnosis. Oxidative Heinz body hemolytic anemia may also occur, and “bite cells” (degmacytes) may be present in a chronic overdosage situation. Red blood cell G-6-PD deficiency may predispose to hemolysis. Renal and hepatic impairment and occasional failure, usually due to hypersensitivity, may also occur.

FAERS reports

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Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
3,793 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Chronic Kidney Disease39410%
  2. 2Nausea3108.2%
  3. 3Pain3078.1%
  4. 4Urinary Tract Infection2947.8%
  5. 5Fatigue2727.2%
  6. 6Acute Kidney Injury2687.1%
  7. 7Renal Failure2536.7%
  8. 8Diarrhoea2346.2%
  9. 9Headache1975.2%
  10. 10Vomiting1915.0%
  11. 11Anxiety1854.9%
  12. 12Off Label Use1804.7%
  13. 13Dyspnoea1534.0%
  14. 14Dizziness1493.9%
  15. 15Drug Ineffective1453.8%

Literature

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Recent PubMed references pinned to Phenazopyridine as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

Clinical trials

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The 10 most recently updated of 24 ClinicalTrials.gov registrations naming Phenazopyridine as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Pharmacogenomics

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CPIC-curated drug–gene pairs for Phenazopyridine. Levels describe the strength of curated evidence and guideline status — never a recommendation to test or to adjust therapy.

  • G6PDCPIC CClinPGx 3
    G6PD

Frequently asked questions

How does Phenazopyridine work?
Mechanism-of-action class: Unknown Cellular or Molecular Interaction.
What is Phenazopyridine used for?
According to FDA labeling, Phenazopyridine carries indications including: Phenazopyridine HCl is indicated for the symptomatic relief of pain, burning, urgency, frequency, and other discomforts arising from irritation of the lower urinary tract mucosa caused by infection, trauma, surgery, endoscopic procedures, or the passage of sounds or catheters. The use of Phenazopyridine HCl for relief of symptoms should not delay definitive diagnosis and treatment of causative conditions.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Phenazopyridine?
Phenazopyridine is classified as Other urologicals, Unknown Cellular or Molecular Interaction, Analgesia, Renal/Urological Activity Alteration.
What are the brand names for Phenazopyridine?
Phenazopyridine is marketed under brand names including Azo Urinary Pain Relief, Baridium, Pyridium, Uricalm, Uristat.
What are the contraindications for Phenazopyridine?
Phenazopyridine labeling lists contraindications including: Phenazopyridine HCl should not be used in patients who have previously exhibited hypersensitivity to it. The use of Phenazopyridine HCl is contraindicated in patients with renal insufficiency.. Always consult the full prescribing information and a clinician.
Note. Data for phenazopyridine is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

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