AZO Urinary Pain Relief

Phenazopyridine is a pain reliever that affects the lower part of your urinary tract (bladder and urethra).

Phenazopyridine is used to treat urinary symptoms such as pain or burning, increased urination, and increased urge to urinate. These symptoms can be caused by infection, injury, surgery, catheter, or other conditions that irritate the bladder.

Phenazopyridine will treat urinary symptoms, but this medication will not treat a urinary tract infection.. Take any antibiotic that your doctor prescribes to treat an infection.

Phenazopyridine may also be used for purposes not listed in this medication guide.

You should not use phenazopyridine if you have kidney disease.

You should not use phenazopyridine if you are allergic to it, or if you have kidney disease.

To make sure phenazopyridine is safe for you, tell your doctor if you have:

• liver disease;
• diabetes; or
• a genetic enzyme deficiency called glucose-6-phosphate dehydrogenase (G6PD) deficiency.

FDA pregnancy category B. Phenazopyridine is not expected to harm an unborn baby. Do not use this medicine without a doctor's advice if you are pregnant.

It is not known whether phenazopyridine passes into breast milk or if it could harm a nursing baby. Do not use this medicine without a doctor's advice if you are breast-feeding a baby.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using phenazopyridine and call your doctor at once if you have:

• little or no urinating;
• swelling, rapid weight gain;
• confusion, loss of appetite, pain in your side or lower back;
• fever, pale or yellowed skin, stomach pain, nausea and vomiting; or
• blue or purple appearance of your skin.

Common side effects may include:

• headache;
• dizziness; or
• upset stomach.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Do not use this medication while wearing soft contact lenses. Phenazopyridine can permanently discolor soft contact lenses.

Applies to phenazopyridine: compounding powder, oral tablet

Nervous system

Nervous system side effects have included headache.[Ref]

Dermatologic

Dermatologic side effects have included rash and pruritus.[Ref]

Gastrointestinal

Gastrointestinal side effects have included occasional upset.[Ref]

Genitourinary

Genitourinary side effects have included an orange to red discoloration of the urine.[Ref]

Some side effects of Azo Urinary Pain Relief may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

190 to 200 mg orally 3 times a day after meals. Do not administer for more than 2 days when used with a urinary antibacterial.

>= 6 years to 18 years:

12 mg/kg/day orally divided into 3 doses for two days. Maximum dose: 600 mg/day.

Data not available