From the FDA Drug Label
Pregnancy Category B Reproduction studies have been performed in rats at doses up to 50 mg/Kg/day and have revealed no evidence of impaired fertility or harm to the fetus due to Phenazopyridine HCl There are, however, no adequate and well controlled studies pregnant women. Because animal production studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.
Phenazopyridine is classified as Pregnancy Category B. Although animal studies have shown no evidence of harm to the fetus, there are no adequate and well-controlled studies in pregnant women. Therefore, phenazopyridine should be used during pregnancy only if clearly needed 1.
From the Research
Phenazopyridine can be used during pregnancy, but it should be taken with caution and under the supervision of a healthcare provider. According to the most recent and highest quality study available, which is from 2023 2, there is no clear evidence that phenazopyridine poses a significant risk to the fetus. However, it is essential to weigh the benefits and potential risks, especially since phenazopyridine is typically used for short-term relief of urinary pain and discomfort.
Key Considerations
- Phenazopyridine is generally considered a pregnancy Category B medication, meaning animal studies haven't shown risk to the fetus, but there aren't adequate well-controlled studies in pregnant women.
- The standard adult dose is 200 mg three times daily, and it's usually recommended for short durations when the benefit outweighs potential risks.
- Phenazopyridine works by providing a local anesthetic effect on the urinary tract lining rather than treating the infection itself.
- It's crucial to complete any prescribed antibiotic course alongside phenazopyridine if you have a urinary tract infection.
- Be aware that this medication turns urine orange-red, which is normal, but can stain clothing.
Important Precautions
- Always inform all healthcare providers about your pregnancy before taking any medication, including over-the-counter drugs like phenazopyridine.
- While studies like the one from 2008 3 suggest that exposure to phenazopyridine during pregnancy is not associated with increased risk of fetal malformations, it's still important to approach its use with caution and under medical supervision.
- Other studies, such as the one from 2022 4, focus on the treatment of urinary tract infections during pregnancy but do not directly address the safety of phenazopyridine, highlighting the need for careful consideration and consultation with healthcare providers.