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Phenazopyridine Pregnancy and Breastfeeding Warnings

Phenazopyridine is also known as: 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, Urodol, Urogesic, Viridium

Medically reviewed on Apr 24, 2018

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.

See references

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 references

References for pregnancy information

  1. "Product Information. Phenazopyridine Hydrochloride (phenazopyridine)." Amneal Pharmaceuticals, Glasgow, KY.
  2. "Product Information. AZO Urinary Pain Relief Max Strength (phenazopyridine)." i-Health, Inc, Cromwell, CT.

References for breastfeeding information

  1. "Product Information. Phenazopyridine Hydrochloride (phenazopyridine)." Amneal Pharmaceuticals, Glasgow, KY.
  2. "Product Information. AZO Urinary Pain Relief Max Strength (phenazopyridine)." i-Health, Inc, Cromwell, CT.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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