How does phenazopyridine affect urinalysis results?

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Last updated: February 13, 2025View editorial policy

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From the FDA Drug Label

Laboratory Test Interaction Due to its properties as an azo dye, Phenazopyridine HCl may interfere with urinalysis based on spectrometry or color reactions. NOTE : Patients should be informed that Phenazopyridine HCl produces a reddish-orange discoloration of the urine Phenazopyridine affects urinalysis results by:

  • Producing a reddish-orange discoloration of the urine
  • Possibly interfering with urinalysis based on spectrometry or color reactions due to its properties as an azo dye 1

From the Research

Effects of Phenazopyridine on Urinalysis Results

  • Phenazopyridine can cause orange discoloration of urine 2
  • The drug has been associated with acute renal failure, which can lead to changes in urinalysis results, such as the presence of casts, proteinuria, and hematuria 3, 2, 4
  • Phenazopyridine-induced methemoglobinemia can also affect urinalysis results, as it can cause a false positive test for hematuria 2
  • Acute interstitial nephritis, a rare side effect of phenazopyridine, can also alter urinalysis results, including the presence of leukocyturia and hematuria 2

Mechanism of Action

  • Phenazopyridine acts as a local analgesic on the bladder mucosa, which can help reduce pain and discomfort during urination 5
  • The drug can also cause changes in urine color and composition, which can affect urinalysis results 2

Clinical Studies

  • A study published in 2020 found that phenazopyridine reduced pain intensity during and after cystoscopy, and alleviated pain during first urination 5
  • Another study published in 2021 found that the combination of phenazopyridine and fosfomycin was effective in treating acute uncomplicated cystitis, with a significant reduction in pain and symptoms 6
  • However, phenazopyridine has also been associated with adverse effects, such as nausea, and can cause changes in urinalysis results, which should be considered when interpreting test results 3, 2, 4, 6

Professional Medical Disclaimer

This information is intended for healthcare professionals. Any medical decision-making should rely on clinical judgment and independently verified information. The content provided herein does not replace professional discretion and should be considered supplementary to established clinical guidelines. Healthcare providers should verify all information against primary literature and current practice standards before application in patient care. Dr.Oracle assumes no liability for clinical decisions based on this content.

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