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, Uro-Pain, Urodol, Urogesic, Viridium

Medically reviewed by Drugs.com. Last updated on Jul 29, 2025.

Phenazopyridine Pregnancy Warnings

This drug should be used during pregnancy only if the benefit outweighs the risk.

US FDA pregnancy category: Not assigned

Risk summary: No data are available on the use of this drug in pregnant women to inform a drug-related risk.

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 Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D, and X are being phased out.

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

Further information

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

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