Side effects of phenazopyridine

Phenazopyridine

Medically reviewed by Drugs.com on Apr 15, 2019 – Written by Cerner Multum

  • Overview
  • Side Effects
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What is phenazopyridine?

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.

Important Information

You should not use phenazopyridine if you have kidney disease.

Before taking this medicine

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 phenazopyridine 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.

How should I take phenazopyridine?

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.

What happens if I miss a dose?

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.

What happens if I overdose?

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

What should I avoid while taking phenazopyridine?

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

Phenazopyridine side effects

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.

Phenazopyridine dosing information

Usual Adult Dose for Dysuria:

190 to 200 mg orally 3 times a day

-Take this drug after a meal.
-Take this drug with a full glass of water.
-This drug should not be used longer than 2 days concomitantly with an antibacterial, because of the lack of evidence that the combined administration of this drug and an antibacterial provides greater benefit than the antibacterial alone after 2 days.
Use: For the symptomatic relief of pain, burning, urgency, frequency, and other discomfort arising from irritation of the lower urinary tract mucosa caused by infection, trauma, surgery, endoscopic procedures, or the passage of sounds or catheters

Usual Pediatric Dose for Dysuria:

12 years and older:
190 to 195 mg orally 3 times a day

-Take this drug after a meal.
-Take this drug with a full glass of water.
-This drug should not be used longer than 2 days concomitantly with an antibacterial, because of the lack of evidence that the combined administration of this drug and an antibacterial provides greater benefit than the antibacterial alone after 2 days.
Use: For the symptomatic relief of pain, burning, urgency, frequency, and other discomfort arising from irritation of the lower urinary tract mucosa caused by infection, trauma, surgery, endoscopic procedures, or the passage of sounds or catheters

What other drugs will affect phenazopyridine?

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.

Further information

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Copyright 1996-2018 Cerner Multum, Inc. Version: 3.05.

Related questions

  • Why do you not take phenazopyridine for more than two days?

Medical Disclaimer

More about phenazopyridine

  • Side Effects
  • During Pregnancy or Breastfeeding
  • Dosage Information
  • Drug Images
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  • Support Group
  • Pricing & Coupons
  • En Español
  • 127 Reviews
  • Drug class: miscellaneous genitourinary tract agents

Consumer resources

  • Phenazopyridine
  • Phenazopyridine (Advanced Reading)

Other brands: Pyridium, Azo Urinary Pain Relief, Azo-Standard, Uristat, … +7 more

Professional resources

  • Phenazopyridine Hydrochloride (AHFS Monograph)
  • … +2 more

Related treatment guides

  • Interstitial Cystitis
  • Dysuria

Medically reviewed by Sanjai Sinha, MD Last updated on Apr 10, 2019.

  • Overview
  • Side Effects
  • Dosage
  • Professional
  • Interactions
  • More

What is Pyridium?

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

Pyridium 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.

Pyridium 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.

Do not take Pyridium if you are allergic to phenazopyridine, or if you have kidney disease. Pyridium will treat the symptoms of a urinary tract infection, but this medication does not treat the actual infection. Take any antibiotic that your doctor prescribes to treat your infection. To avoid stomach upset, take this medicine with food.

Pyridium will most likely darken the color of your urine to an orange or red color. This is a normal effect and is not cause for alarm unless you have other symptoms such as pale or yellowed skin, fever, stomach pain, nausea, and vomiting. Darkened urine may also cause stains to your underwear, which may or may not be removed by laundering.

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

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

Stop taking this medicine and call your doctor at once if you have pale skin, fever, confusion, yellowing of your skin or eyes, increased thirst, swelling, or if you urinate less than usual or not at all.

To make sure Pyridium is safe for you, tell your doctor if you have ever had:

  • liver disease;

  • diabetes; or

  • a genetic enzyme deficiency called glucose-6-phosphate dehydrogenase (G6PD) deficiency.

Pyridium 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.

How should I take Pyridium?

Use Pyridium 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 Pyridium after meals.

Drink plenty of liquids while you are taking Pyridium.

Pyridium 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 this medicine 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 this medicine.

Store at room temperature away from moisture and heat.

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

What should I avoid while taking Pyridium?

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

More about Pyridium (phenazopyridine)

  • Side Effects
  • During Pregnancy or Breastfeeding
  • Dosage Information
  • Drug Images
  • Drug Interactions
  • Compare Alternatives
  • Support Group
  • Pricing & Coupons
  • En Español
  • 26 Reviews
  • Drug class: miscellaneous genitourinary tract agents
  • Pyridium
  • Pyridium (Advanced Reading)

Other brands: Azo Urinary Pain Relief, Azo-Standard, Uristat, Baridium, … +5 more

  • Pyridium (FDA)
  • … +1 more
  • Interstitial Cystitis
  • Dysuria

Ms. Terrie is a clinical pharmacy writer based in Haymarket, Virginia.
Pharmacists are likely to encounter patients seeking assistance in the selection and proper use of the various OTC products available for providing relief from the pain associated with urinary tract infections (UTIs) and the athome testing kits to detect or confirm the presence of a UTI. OTC products marketed as urinary analgesics contain phenazopyridine hydrochloride, which is an azo dye that exerts a local anesthetic or analgesic effect on the mucosa of the urinary tract (Table).1,2 The precise mechanism of action of phenazopyridine is unknown.1,2

Phenazopyridine hydrochloride is indicated for the symptomatic relief of urinary burning, itching, frequency, and urgency with regard to the symptoms associated with UTIs.1,2 Patients should be reminded that phenazopyridine does not treat a UTI and acts only as an analgesic. Patients should be advised to consult their primary health care provider for further evaluation and treatment.
Common adverse effects associated with phenazopyridine include headache, dizziness, and abdominal cramps. Patients should be advised to take 2 tablets after meals 3 times a day as needed with a full glass of water for no more than 2 days without consulting a physician, and should be reminded to take no more than 12 tablets in a 48-hour period.1-3 These analgesics can be used in conjunction with antibiotics prescribed for the UTI. Patients should be advised to consult their primary care physician if they experience pain or discomfort lasting longer than 2 days.1,2 Phenazopyridine may cause discoloration of the urine to an orange or red color and may also cause staining of clothing.1,2 The use of products containing phenazopyridine should be avoided in those patients with renal disease or those with hypersensitivity to this agent.
Only one OTC product on the market contains the antibacterial agent methenamine and the analgesic sodium salicylate (Table).4 The recommended directions for use of the product are 2 tablets with a full glass of water 4 times a day. This product is not to be used as a replacement for antibiotic therapy.4 Patients with aspirin allergies, a history of gastric ulcers or bleeding disorders, diabetes, gout, or arthritis, or those on anticoagulation therapy, should always consult their primary care physician prior to using this product.4
In addition to analgesic products, nutritional supplement products are available that contain cranberry for preventive therapy. These products assist in maintaining a healthy urinary tract by preventing bacteria from attaching to the bladder wall.5 The exact mechanism of action is unknown, but research suggests that cranberry may inhibit bacteria, particularly Escherichia coli, from adhering to the bladder, kidneys, and urethra.6
OTC Tests for Detecting UTIs
at-home tests are available that detect nitrite; some detect both leukocytes and nitrites. The primary reasons for using UTI test kits are for early detection in individuals with a history of recurring UTIs and to confirm that a UTI has been cured after a complete course of antibiotic therapy.7 Vitamin C doses in excess of 250 mg may result in a false-negative result, because ascorbic acid inhibits the nitrite test reaction.4 Patients should be advised to wait at least 10 hours after ingesting vitamin C before testing.7 Patients should also be informed that if more than 500 mg of vitamin C are ingested within 24 hours of testing, they may obtain a false-negative result for those tests that detect leukocytes.7 Patients on strict vegetarian diets may also get inaccurate results, because the diet provides insufficient urinary nitrates—this, in turn, can cause false-negative nitrite results with UTI tests.7 Tetracycline may also produce a false-negative reading for nitrates.7 Women should be reminded not to use test strips during their menstrual cycle, because blood may cause a false-positive result.7

Conclusion
During counseling, pharmacists should ensure that patients clearly understand that OTC urinary tract analgesics are not intended to treat UTIs, and that they should always consult their primary health care provider for proper treatment. Patients who have never had a UTI or those experiencing severe symptoms also should be referred for further medical evaluation. Those patients susceptible to UTIs may also benefit from various nonpharmacologic measures that may prevent or reduce the incidence of infection. Key preventive measures for women include adequate daily hydration, always voiding when needed, always wiping from front to back after urination to prevent bacteria from entering the urethra, and taking showers instead of baths when possible.8,9
Patients electing to use the urinary tract analgesics should be reminded to adhere to the recommended dosage and duration of use and should be advised of the possible adverse effects that may occur. They should also be encouraged to complete the full course of prescribed therapy. Patients using test kits to detect UTIs should be reminded to immediately consult their primary care provider for medical evaluation and to prevent further complications if they get positive test results, or if they get a negative test result but still experience any urinary discomfort or UTI symptoms. For more in-depth information on UTIs, please visit the National Institutes of Health Web site at http://health.nih.gov/topic/ UrinaryTractInfections. â–
For pharmacist-recommended Urinary Tract Infection Products, visit: http://www.otcguide.net/woman_health.

1. Lacy CF, Armstrong LL, Goldman MP, Lance LL. Lexicomp’s Drug Information Handbook. 11th ed. Hudson, Ohio: Lexi comp, Inc; 2003:1093-1094.
2. Monograph – Phenazopyridine Hydrochloride. Medscape Web site. www.medscape.com/druginfo/monograph?cid=med&drugid=150712&drugname=AZO+Standard+Oral&monotype=monograph&secid=2. Accessed December 1, 2009.
3. Uristat Product Information Web site. www.uristat.com/documents/Uristatinsert.pdf. Accessed on December 8, 2009.
4. Cystex Product Information Web site. www.cystex.com/Pages/About%20Cystex. Accessed on December 7, 2009.
5. Azo Cranberry Supplement Product Information Web site. www.azoproducts.com/faq/azo_cranberry. Accessed December 2, 2009.
6. McQueen C, Orr K. Natural Products In: Berardi RR, Newton G, McDermott JH, et al, eds. Handbook of Nonprescription Drugs. 16th ed. Washington, DC: American Pharmacists Association; 2009:995.
7. Briggs G, Hurley H. Home Testing and Monitoring Devices. In: Berardi RR, Newton G, McDermott JH, et al, eds. Handbook of Nonprescription Drugs. 16th ed. Washington, DC: American Pharmacists Association; 2009:933-934.
8. Urinary Tract Infections in Adults. National Kidney and Urologic Diseases Information Clearinghouse Web site. http://kidney.niddk.nih.gov/kudiseases/pubs/utiadult/. Accessed November 30, 2009.
9. About Urinary Tract Infections. Azo Product Web site. www.azoproducts.com/uti/about. Accessed on December 4, 2009.

PRECAUTIONS: Before taking phenazopyridine/hyoscyamine/butabarbital, tell your doctor or pharmacist if you are allergic to any of these drugs; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: kidney disease, liver disease, blood disorders (e.g., G6PD deficiency, hemolytic anemia, porphyria), glaucoma, urinary blockage problems, enlarged prostate.Before using this medication, tell your doctor or pharmacist your medical history, especially of: stomach or intestinal disorders, overactive thyroid (hyperthyroidism), heart problems (e.g., coronary artery disease, congestive heart failure, arrhythmias), high blood pressure, mental/mood disorders, history of drug abuse, severe breathing problems, certain nervous system problems (autonomic neuropathy), myasthenia gravis.This drug may make you dizzy or drowsy or cause blurred vision. Do not drive, use machinery, or do any activity that requires alertness or clear vision until you are sure you can perform such activities safely.Avoid alcoholic beverages while using this medication, since alcohol may intensify the side effects.Before having surgery, tell your doctor or dentist that you are using this medication.Phenazopyridine can dye your urine and tears orange-red. This may stain clothing and contact lenses. Do not wear contact lenses while using this medication. Urine and tears will return to normal color after the medication is stopped.This drug may increase the risk for heatstroke because it decreases sweating. Avoid becoming overheated in hot weather, saunas, and during exercise or other strenuous activity.Older adults may be more sensitive to the side effects of this drug, especially drowsiness, confusion, constipation, difficulty urinating, change in amount of urine, or yellowing skin/eyes. Drowsiness and confusion can increase the risk of falling.This medication is not recommended for use during pregnancy. Consult your doctor for more details.This medication passes into breast milk. Consult your doctor before breast-feeding.

DRUG INTERACTIONS: Your healthcare professionals (e.g., doctor or pharmacist) may already be aware of any possible drug interactions and may be monitoring you for it. Do not start, stop or change the dosage of any medicine before checking with them first.This drug should not be used with the following medications because very serious interactions may occur: pramlintide, sodium oxybate.If you are currently using any of these medications listed above, tell your doctor or pharmacist before starting this drug.Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially: antidepressants (tricyclics such as amitriptyline, MAO inhibitors such as phenelzine), certain antibiotics (doxycycline, metronidazole), beta blockers (e.g., metoprolol, propranolol), “blood thinners” (e.g., warfarin), corticosteroids (e.g., prednisone), cyclosporine, estrogens, felodipine, potassium tablets/capsules, quinidine, theophyllines, valproic acid.Tell your doctor or pharmacist if you also take drugs that cause drowsiness such as: certain antihistamines (e.g., diphenhydramine), anti-seizure drugs (e.g., carbamazepine), medicines for sleep or anxiety (e.g., alprazolam, diazepam, zolpidem), muscle relaxants, narcotic pain relievers (e.g., codeine), psychiatric medicines (e.g., chlorpromazine, risperidone, trazodone).Check the labels on all your medicines (e.g., cough-and-cold products) because they may contain drowsiness-causing ingredients. Ask your pharmacist about the safe use of those products.This medication may decrease the effectiveness of hormonal birth control such as pills, patch, or ring. This could cause pregnancy. Discuss with your doctor or pharmacist if you should use additional reliable birth control methods while using this medication. Also tell your doctor if you have any new spotting or breakthrough bleeding, because these may be signs that your birth control is not working well.This product can interfere with certain laboratory tests (including urine tests for kidney function, bilirubin, and sugar levels), possibly causing false test results. Home urine tests (including diabetic tests) may be affected. Make sure laboratory personnel and all your doctors know you use this drug.This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

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