Phenazopyridine Hcl

  • Urinary tract discomfort

Phenazopyridine Hcl Generic Name & Formulations

General Description

Phenazopyridine HCl 100mg, 200mg; tabs.

Pharmacological Class

Urinary tract analgesic.

How Supplied

Contact supplier.


Store at 20° C to 25° C (68° F to 77° F); excursions permitted to 15°–30° C (59°–86° F).

Mechanism of Action

Phenazopyridine HCl is excreted in the urine where it exerts a topical analgesic effect on the mucosa of the urinary tract. This action helps to relieve pain, burning, urgency and frequency. The precise mechanism of action is unknown.

Phenazopyridine Hcl Indications


Urinary tract discomfort.

Phenazopyridine Hcl Dosage and Administration


200mg 3 times a day after meals; max 2 day therapy when used with antibacterials.


Not recommended.

Phenazopyridine Hcl Contraindications


Renal insufficiency. Severe liver disease. Severe hepatitis. Pyelonephritis of pregnancy.

Phenazopyridine Hcl Boxed Warnings

Not Applicable

Phenazopyridine Hcl Warnings/Precautions


Yellow discoloration of skin or sclera may indicate poor renal excretion. Stains contact lenses. GI disturbances. G6PD deficiency. Discolors urine/feces and fabric (red-orange). Elderly. Pregnancy (Cat.B). Nursing mothers.



  • Phenazopyridine may cause discoloration of body fluids and staining of contact lenses.
  • Discontinue therapy if a yellowish color of the skin or sclera develops indicating phenazopyridine accumulation due to impaired renal function. 
  • Phenazopyridine may mask pathological conditions.
  • Caution in those with G6PD deficiency; may be susceptible to oxidative hemolysis and increased potential to develop hemolytic anemia.

Pregnancy Considerations

There are no adequate and well-controlled studies in pregnant women. Therefore, phenazopyridine should be used in pregnant women only if the benefit clearly outweighs the risk.

Nursing Mother Considerations

It is not known whether phenazopyridine or its metabolites are excreted in human milk. Because many drugs are excreted in human milk, a decision should be made to discontinue nursing or to discontinue the drug, taking into account the importance of drug therapy to the mother.

Pediatric Considerations

There are no adequate and well-controlled studies performed in the pediatric population. No pediatric-specific problems have been documented.

Phenazopyridine Hcl Pharmacokinetics





Phenazopyridine Hcl Interactions


Interferes with colorimetric, photometric, or fluorometric urine tests.

Phenazopyridine Hcl Adverse Reactions

Adverse Reactions

Headache, rash, pruritus, discoloration, GI upset, methemoglobinemia, hemolytic anemia, renal and hepatic toxicity.

Phenazopyridine Hcl Clinical Trials

See Literature

Phenazopyridine Hcl Note


Formerly known under the brand name Pyridium.

Phenazopyridine Hcl Patient Counseling

Patient Counseling

Advise patients to take phenazopyridine with or following food or after eating a snack to reduce stomach upset.

Advise patients that phenazopyridine causes a reddish orange discoloration of the urine and feces, and may stain clothing. Phenazopyridine may cause discoloration of body fluids and staining of contact lenses has been reported. There have been reports of teeth discoloration when the product has been broken or held in the mouth prior to swallowing.

Instruct patients to take phenazopyridine for only 2 days if an antibacterial agent is administered concurrently for the treatment of a urinary tract infection. If symptoms persist beyond those 2 days, the patient should contact his or her physician.