Last update May 13, 2019

Phenazopyridine Hydrochloride

Low Risk

Possibly safe. Probably compatible. Mild risk possible. Follow up recommended. Read the Comment.

An azo dye with analgesic effects on the urinary tract mucosa.
One of its metabolites is paracetamol.
It may discolour body fluids orange.
Oral administration 3 times a day.

Since the last update we have not found any published data on its excretion in breast milk.

It may cause kidney damage (Singh 2014) and methemoglobinemia (Banimahd 2016, Gold 2003).

There are few studies on its pharmacokinetics and it has limited efficacy.

Until there is more published data on this drug in relation to breastfeeding, safer known alternatives may be preferable, especially during the neonatal period and in cases of prematurity or glucose-6PD deficiency.


  • Ibuprofen ( Safe. Compatible. Minimal risk for breastfeeding and infant.)
  • Paracetamol ( Safe. Compatible. Minimal risk for breastfeeding and infant.)

Suggestions made at e-lactancia are done by APILAM team of health professionals, and are based on updated scientific publications. It is not intended to replace the relationship you have with your doctor but to compound it. The pharmaceutical industry contraindicates breastfeeding, mistakenly and without scientific reasons, in most of the drug data sheets.

Jose Maria Paricio, Founder & President of APILAM/e-Lactancia

Your contribution is essential for this service to continue to exist. We need the generosity of people like you who believe in the benefits of breastfeeding.

Thank you for helping to protect and promote breastfeeding.

José María Paricio, founder of e-lactancia.

Other names

Phenazopyridine Hydrochloride is also known as

Phenazopyridine Hydrochloride in other languages or writings:


Phenazopyridine Hydrochloride belongs to this group or family:


Main tradenames from several countries containing Phenazopyridine Hydrochloride in its composition:


Variable Value Unit
Oral Bioavail. 100 %
Molecular weight 250 daltons
pKa 5.1 -
Tmax 2.48 ± 0.50 hours
9.41 ± 2.04 hours


  1. Banimahd F, Loo T, Amin M, Ahadiat OR, Chakravarthy B, Lotfipour S. A Rare but Important Clinical Presentation of Induced Methemoglobinemia. West J Emerg Med. 2016 Abstract
  2. Singh M, Shailesh F, Tiwari U, Sharma SG, Malik B. Phenazopyridine associated acute interstitial nephritis and review of literature. Ren Fail. 2014 Abstract
  3. Li KJ, Chen QH, Zhang Z, Zhou P, Li P, Liu J, Zhu J. Determination of phenazopyridine in human plasma by GC-MS and its pharmacokinetics. J Chromatogr Sci. 2008 Abstract Full text (link to original source) Full text (in our servers)
  4. Gold NA, Bithoney WG. Methemoglobinemia due to ingestion of at most three pills of pyridium in a 2-year-old: case report and review. J Emerg Med. 2003 Abstract

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