International reference: 1 US FDA recall for this ingredient

CGMP Deviations: manufactured under practices which may result in assay or content uniformity failures. (phenazopyridine)

US-market enforcement records (OpenFDA), shown for reference - not specific to this product in Malawi.

Registered Malawi · PMRA

PYRIDIUM 100MG TABLET

PHENAZOPYRIDINE HYDROCHLORIDE

PMPB/PL48/30 TABLET INN generic

What it does

Phenazopyridine is a medicine used to relieve pain and discomfort in the urinary tract.

Commonly used for: pain during urination, bladder pain, urinary tract discomfort

Read more in plain English ↓

Plain-language summary for general understanding - not medical advice. Always follow your pharmacist/doctor.

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Answers come only from this medicine's registration record, BNF monograph and interaction data - not medical advice.

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Sourcing - Kenya only

Registration & product details

Registration no.
PMPB/PL48/30
Registration date
05/02/2001
Expiry date
30/03/1996
Status
Registered
Active ingredient
PHENAZOPYRIDINE HYDROCHLORIDE
Dosage form
TABLET
Strength
-
Pack size
-
Therapeutic class
-
Manufacturer / MAH
-
Applicant / LTR
-
Country of origin
-

Source: Pharmacy and Medicines Regulatory Authority · fetched 2026-04-21 17:37:44 · updated 2026-09-29 04:33:06

Disclaimer: This information is sourced from Pharmacy and Medicines Regulatory Authority (Malawi). Always consult a qualified healthcare professional before using any medication.

About this medicine

Phenazopyridine is a medicine used to relieve pain and discomfort in the urinary tract.

What it treats

  • pain during urination
  • bladder pain
  • urinary tract discomfort

How it works

It works by soothing the lining of the urinary tract, helping to relieve pain and irritation.

Who it's for

This medicine is for adults experiencing pain or discomfort related to urinary problems.

AI-assisted summary grounded in BNF data - general information only, not medical advice. Always confirm with your pharmacist or doctor.

Clinical monograph: phenazopyridine

BNF-referenced

Phenazopyridine is a synthetic compound used primarily as a urinary analgesic. It is known for its ability to relieve pain, burning, and discomfort associated with urinary tract infections (UTIs) and other urinary tract irritations. While phenazopyridine helps alleviate symptoms, it does not treat the underlying infection or condition.

Indications

  • Symptomatic relief of pain, burning, and discomfort in urinary tract infections
  • Irritation of the urinary tract
  • Post-operative urinary tract discomfort

Dosage

Children: Refer to the BNF for Children for appropriate dosing for paediatric patients.

Adults: The usual adult dose is 200 mg three times a day after meals for up to 2 days. It should not be used for more than 2 days unless directed by a healthcare provider.

Mechanism of action

Phenazopyridine exerts its effect primarily through local analgesic action on the urinary tract mucosa. It is believed to exert this effect by being absorbed in the urinary tract and providing relief from irritation and pain caused by inflammation. The exact biochemical pathways are not fully elucidated but are thought to involve the inhibition of the pain signaling pathways in the urinary system.

Pharmacodynamics

Phenazopyridine displays analgesic properties, providing symptomatic relief from pain and discomfort in the urinary tract. Its onset of action typically occurs within 30 minutes of administration, with a duration of effect that can last for several hours. The drug does not possess antibacterial activity, which is important for clinicians to remember when treating urinary infections.

Pharmacokinetics

Phenazopyridine is rapidly absorbed after oral administration, with peak plasma concentrations occurring approximately 2 hours post-dose. It is metabolized in the liver, and its metabolites are primarily excreted in the urine. The elimination half-life is approximately 2 hours. The drug's coloring effect on urine is due to its excretion in unchanged form, which can lead to bright orange or red urine.

Contra-indications

  • Hypersensitivity to phenazopyridine or any of its ingredients
  • Severe renal impairment
  • Glomerulonephritis

Adverse effects

  • Gastrointestinal disturbances
  • Headache
  • Dizziness
  • Skin discoloration (orange/red urine)
  • Allergic reactions (rare)

Interactions

  • May interfere with urine tests for glucose, ketones, and bilirubin
  • Potential interaction with other drugs that are metabolized by the liver

Precautions

  • Use with caution in patients with renal impairment
  • Not recommended for prolonged use
  • Should not be used as a substitute for proper treatment of urinary tract infections

Pregnancy

Safety in pregnancy has not been established. Use only if the benefits outweigh the risks.

Breast-feeding

Minimal amounts may be excreted in breast milk. Caution is advised.

Storage

Store at room temperature, away from light and moisture. Keep out of reach of children.

Formulations

  • Oral tablet
  • Liquid formulation
PubChem / pathway

AI-synthesized from BNF references - general information only, not a substitute for professional medical advice or the current BNF. Verify doses with a pharmacist.

Molecular reference: phenazopyridine

PubChem CID 4756

Molecular formula: C11H11N5

Source: PubChem (NCBI) · pathways from PathBank, Reactome, WikiPathways & PharmGKB.