In the U.S.—

In Canada—

• Analgesic, urinary

Phenazopyridine (fen-az-oh-PEER-i-deen) is used to relieve the pain, burning, and discomfort caused by infection or irritation of the urinary tract. It is not an antibiotic and will not cure the infection itself.

In the U.S., phenazopyridine is available only with your doctor's prescription. In Canada, it is available without a prescription. It is available in the following dosage form:

Oral
• Tablets (U.S. and Canada)

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For phenazopyridine, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to phenazopyridine. Also tell your health care professional if you are allergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy—Phenazopyridine has not been studied in pregnant women. However, phenazopyridine has not been shown to cause birth defects in animal studies.

Breast-feeding—It is not known whether phenazopyridine passes into the breast milk. However, phenazopyridine has not been reported to cause problems in nursing babies.

Children—Although there is no specific information comparing use of phenazopyridine in children with use in other age groups, it is not expected to cause different side effects or problems in children than it does in adults.

Older adults—Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults. Although there is no specific information comparing use of phenazopyridine in the elderly with use in other age groups, this medicine is not expected to cause different side effects or problems in older people than it does in younger adults.

Other medicines—Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your health care professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

• Glucose-6-phosphate dehydrogenase (G6PD) deficiency or
• Hepatitis or
• Kidney disease—The chance of side effects may be increased.

This medicine is best taken with food or after eating a meal or a snack to lessen stomach upset.

Do not use any leftover medicine for future urinary tract problems without first checking with your doctor. An infection may require additional medicine.

Dosing—

The dose of phenazopyridine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of phenazopyridine. If your dose is different, do not change it unless your doctor tells you to do so.

• For oral dosage form (tablets):
  • For relieving pain, burning, and discomfort in the urinary tract:
    • Adults and teenagers—200 milligrams (mg) three times a day.
    • Children—The dose is based on body weight and must be determined by your doctor. The usual dose is 4 mg per kilogram (kg) (about 1.8 mg per pound) of body weight three times a day.

Missed dose—

If you miss a dose of this medicine, take it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—

To store this medicine:

• Keep out of the reach of children.
• Store away from heat and direct light.
• Do not store this medicine in the bathroom, near the kitchen sink, or in other damp places. Heat or moisture may cause the medicine to break down.
• Do not keep outdated medicine or medicine no longer needed. Be sure that any discarded medicine is out of the reach of children.

Check with your doctor if symptoms such as bloody urine, difficult or painful urination, frequent urge to urinate, or sudden decrease in the amount of urine appear or become worse while you are taking this medicine .

Phenazopyridine causes the urine to turn reddish orange . This is to be expected while you are using it. This effect is harmless and will go away after you stop taking the medicine. Also, the medicine may stain clothing.

For patients who wear soft contact lenses:

• It is best not to wear soft contact lenses while being treated with this medicine. Phenazopyridine may cause discoloration or staining of contact lenses. It may not be possible to remove the stain.

For diabetic patients:

• This medicine may cause false test results with urine sugar tests and urine ketone tests. If you have any questions about this, check with your health care professional, especially if your diabetes is not well controlled.

Before you have any medical tests, tell the person in charge that you are taking this medicine. The results of some tests may be affected by this medicine.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

• Rare
  • Blue or blue-purple color of skin;  fever and confusion;  shortness of breath, tightness in chest, wheezing, or troubled breathing;  skin rash ;  sudden decrease in the amount of urine;  swelling of face, fingers, feet, and/or lower legs;  unusual tiredness or weakness;  weight gain;  yellow eyes or skin 
  
  

Other side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. However, check with your doctor if any of the following side effects continue or are bothersome:

• Less common or rare
  • Dizziness;  headache;  indigestion;  itching of the skin;  stomach cramps or pain 
  
  

Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your doctor.