Uricalm

Uricalm is part of the drug class:

• Other urologicals

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.

Use exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.

Take phenazopyridine after meals.

Drink plenty of liquids while you are taking phenazopyridine.

Phenazopyridine will most likely darken the color of your urine to an orange or red color. This is a normal effect and is not harmful. Darkened urine may also cause stains to your underwear that may be permanent.

Phenazopyridine can also permanently stain soft contact lenses, and you should not wear them while taking this medicine.

Do not use phenazopyridine for longer than 2 days unless your doctor has told you to.

This medication can cause unusual results with urine tests. Tell any doctor who treats you that you are using phenazopyridine.

Store at room temperature away from moisture and heat.

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

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.

Other drugs may interact with phenazopyridine, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

Applies to phenazopyridine: oral kit, oral tablet

Along with its needed effects, phenazopyridine (the active ingredient contained in Uricalm) 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 while taking phenazopyridine:

• 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

Some side effects of phenazopyridine may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Dizziness
• headache
• indigestion
• itching of the skin
• stomach cramps or pain

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 Uricalm may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.