Phenazopyridine Pregnancy and Breastfeeding Warnings
Brand names: Azo Urinary Pain Relief, Azo-Gesic, Azo-Septic, Azo-Standard, Baridium, Eridium, Phenazo, Preferred Maximum Strength Urinary Pain Relief, Preferred Urinary Pain Relief, Prodium, Pyridiate, Pyridium, Re-Azo, Uricalm, Urinary Analgesic, Uristat, Uristat Ultra, Urodol, Urogesic, Viridium
Medically reviewed by Drugs.com. Last updated on Aug 8, 2023.
Phenazopyridine Pregnancy Warnings
This drug should be used during pregnancy only if the benefit outweighs the risk.
US FDA pregnancy category: B
Animal studies have revealed no evidence of impaired fertility or harm to the fetus. There are no controlled data in human pregnancy.
US FDA pregnancy category B: Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women.
Phenazopyridine Breastfeeding Warnings
Use should be avoided.
Comments:
-The safety of this drug has not been established during breastfeeding.
-Because this drug can cause methemoglobinemia, sulfhemoglobinemia, and hemolytic anemia, it should be avoided while breastfeeding, especially with an infant under one month of age or with G-6-PD deficiency.
See also
References for pregnancy information
- Product Information. Phenazopyridine Hydrochloride (phenazopyridine). Amneal Pharmaceuticals. 2018.
- Product Information. AZO Urinary Pain Relief Max Strength (phenazopyridine). i-Health, Inc. 2018.
References for breastfeeding information
- Product Information. Phenazopyridine Hydrochloride (phenazopyridine). Amneal Pharmaceuticals. 2018.
- Product Information. AZO Urinary Pain Relief Max Strength (phenazopyridine). i-Health, Inc. 2018.
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.