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.
The use of AZO (phenazopyridine) during pregnancy is categorized as Pregnancy Category B. This means that while animal studies have shown no evidence of harm to the fetus, there are no adequate and well-controlled studies in pregnant women. Therefore, AZO should be used during pregnancy only if clearly needed. As a precaution, it is recommended to exercise caution and consult a healthcare provider before taking AZO during pregnancy 1.
From the Research
Phenazopyridine (AZO) should be used with caution during pregnancy and only under a healthcare provider's supervision. The medication is classified as FDA Pregnancy Category B, meaning animal studies haven't shown risk to the fetus, but there aren't adequate well-controlled studies in pregnant women 2. If prescribed, it's typically recommended for short-term use (2-3 days) at the lowest effective dose to relieve urinary pain and discomfort. The standard adult dosage is 100-200 mg three times daily. Importantly, phenazopyridine only treats urinary symptoms and doesn't treat the underlying infection, so it should be used alongside appropriate antibiotics if a urinary tract infection is present.
Some key points to consider:
- Phenazopyridine turns urine orange-red, which is normal, but can stain clothing.
- Existing data indicate that exposure to phenazopyridine during pregnancy is not associated with increased risk of fetal malformations 2.
- Pregnant women should consult their healthcare provider before taking any medication, as they can recommend the safest treatment option based on their specific situation and stage of pregnancy.
- It's essential to weigh the benefits and risks of using phenazopyridine during pregnancy, considering the potential effects on the fetus and the mother's health 3, 4.
In general, the use of medications during pregnancy should be approached with caution, and healthcare providers should carefully evaluate the potential risks and benefits before making a recommendation 5, 6.