Drug Profile

Phenazopyridine is approved by the FDA to treat pain, burning and other symptoms when the lower part of the urinary tract (bladder and urethra) is irritated due to an infection or surgery. Much of its apparent effectiveness appears to derive from the fact that it turns the urine reddish-orange, making patients more likely to conclude that the drug is having an effect. Because older people’s kidneys eliminate drugs less effectively than younger people’s, this drug can stay in an older person’s system much longer than it should and can build up until it reaches dangerously high levels in the bloodstream. This can lead to harmful adverse effects such as anemia and liver damage. In addition, according to the World Health Organization’s International Agency for Research on Cancer, phenazopyridine can cause cancer.[1]

Despite the drug’s questionable effectiveness (the FDA recommends not using it for more than two days)[2] and its propensity to cause cancer, the drug is available over the counter (OTC). Misuse of the OTC versions (e.g., Azo-Standard, Prodium, Uristat) is rife: 51% of patients used the drug inappropriately, and 38% used it as a substitute for medical care.[3]

Phenazopyridine is also sometimes combined with antibiotics in prescription drugs, although the National Academy of Sciences has concluded that the evidence for the effectiveness of these combinations is lacking.[4]

Instead of prescribing this drug to relieve pain and irritation, a physician should find and treat the cause of the pain and irritation and use conventional painkillers if necessary.