phenazopyridine Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definitionDrug idCAS RN
2120 94-78-0

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • phenazopyridine
  • gastracid
  • phenazopyridine hydrochloride
  • phenazopyridine HCl
A local anesthetic that has been used in urinary tract disorders. Its use is limited by problems with toxicity (primarily blood disorders) and potential carcinogenicity.
  • Molecular weight: 213.24
  • Formula: C11H11N5
  • CLOGP: 2.32
  • LIPINSKI: 0
  • HAC: 5
  • HDO: 2
  • TPSA: 89.65
  • ALOGS: -3.02
  • ROTB: 2

  • Status: OFM

  • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

DoseUnitRoute
0.60 g O

ADMET properties:

PropertyValueReference
MRTD (Maximum Recommended Therapeutic Daily Dose) 45.76 ┬ÁM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BDDCS (Biopharmaceutical Drug Disposition Classification System) 2 Hosey CM, Chan R, Benet LZ
EoM (Fraction excreted unchanged in urine) 41 % Hosey CM, Chan R, Benet LZ

Approvals:

DateAgencyCompanyOrphan
June 26, 2001 FDA ABLE

FDA Adverse Event Reporting System (Female)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Methaemoglobinaemia 62.19 17.79 17 3507 2145 46680393
Drug hypersensitivity 58.00 17.79 81 3443 243744 46438794
Urinary tract infection 46.22 17.79 69 3455 220197 46462341
Injury 28.84 17.79 25 3499 44002 46638536
Cystitis 27.69 17.79 24 3500 42217 46640321
Dysuria 24.98 17.79 19 3505 27814 46654724
Micturition urgency 21.79 17.79 11 3513 7806 46674732
Emotional distress 21.25 17.79 18 3506 30689 46651849
Nephrolithiasis 18.15 17.79 17 3507 33034 46649504

FDA Adverse Event Reporting System (Male)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Anticholinergic syndrome 62.23 27.84 12 894 812 29950760
Urinary tract infection 37.96 27.84 25 881 73634 29877938
Nephrolithiasis 33.83 27.84 16 890 24794 29926778

Pharmacologic Action:

SourceCodeDescription
ATC G04BX06 GENITO URINARY SYSTEM AND SEX HORMONES
UROLOGICALS
UROLOGICALS
Other urologicals
CHEBI has role CHEBI:36333 local anesthetics
CHEBI has role CHEBI:50903 cancerogene
CHEBI has role CHEBI:149553 anti-coronaviral agents

Drug Use (View source of the data)

DiseaseRelationSNOMED_IDDOID
Dysuria indication 49650001
Urinary Tract Irritation indication
Suicidal thoughts contraindication 6471006
Alcoholism contraindication 7200002
Hyperammonemia contraindication 9360008
Chronic obstructive lung disease contraindication 13645005 DOID:3083
Hepatic encephalopathy contraindication 13920009 DOID:13413
Severe chronic ulcerative colitis contraindication 14311001
Disorder of autonomic nervous system contraindication 15241006
Glaucoma contraindication 23986001 DOID:1686
Toxic megacolon contraindication 28536002 DOID:1770
Atony of colon contraindication 29479008
Hyperthyroidism contraindication 34486009 DOID:7998
Depressive disorder contraindication 35489007
Glomerulonephritis contraindication 36171008 DOID:2921
Acute hepatitis contraindication 37871000
Hypertensive disorder contraindication 38341003 DOID:10763
Hypovolemic shock contraindication 39419009
Third trimester pregnancy contraindication 41587001
Hyperactive behavior contraindication 44548000
Uremia contraindication 44730006 DOID:4676
Conduction disorder of the heart contraindication 44808001
Achalasia of esophagus contraindication 45564002 DOID:9164
Chronic heart failure contraindication 48447003
Paralytic ileus contraindication 55525008 DOID:8442
Hepatic failure contraindication 59927004
Substance abuse contraindication 66214007
Hepatic coma contraindication 72836002 DOID:12550
Sleep apnea contraindication 73430006 DOID:0050847
Hiatal hernia contraindication 84089009 DOID:12642
Megaloblastic anemia due to folate deficiency contraindication 85649008 DOID:14026
Kidney disease contraindication 90708001 DOID:557
Myasthenia gravis contraindication 91637004 DOID:437
Anemia due to enzyme deficiency contraindication 111577008
Deficiency of glucose-6-phosphate dehydrogenase contraindication 124134002 DOID:2862
Liver function tests abnormal contraindication 166603001
Folic acid deficiency contraindication 190633005
Disease of blood AND/OR blood-forming organ contraindication 191124002 DOID:74
Gastroesophageal reflux disease contraindication 235595009 DOID:8534
Disease of liver contraindication 235856003 DOID:409
Bladder outflow obstruction contraindication 236645006
Pyloric obstruction contraindication 244815007
Sleep automatism contraindication 247962006
Benign prostatic hyperplasia contraindication 266569009
Anemia contraindication 271737000 DOID:2355
Pregnancy, function contraindication 289908002
Thrombocytopenic disorder contraindication 302215000 DOID:1588
Neutropenic disorder contraindication 303011007 DOID:1227
Pseudomembranous enterocolitis contraindication 397683000
Respiratory insufficiency contraindication 409623005
Breastfeeding (mother) contraindication 413712001
Disorder of coronary artery contraindication 414024009
Porphyria contraindication 418470004
Fever greater than 100.4 Fahrenheit contraindication 426000000
Severe dehydration contraindication 450316000
Acute exacerbation of asthma contraindication 708038006

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 7.39 Basic

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
Sodium channel alpha subunit Ion channel BLOCKER CHEMBL CHEMBL
Snake venom metalloproteinase Bap1 Unclassified IC50 4.27 CHEMBL

External reference:

IDSource
4019884 VUID
N0000147969 NUI
D05450 KEGG_DRUG
136-40-3 SECONDARY_CAS_RN
4017768 VANDF
4019884 VANDF
C0031379 UMLSCUI
CHEBI:71416 CHEBI
CHEMBL1242 ChEMBL_ID
CHEMBL1201022 ChEMBL_ID
D010621 MESH_DESCRIPTOR_UI
DB01438 DRUGBANK_ID
7616 IUPHAR_LIGAND_ID
357 INN_ID
K2J09EMJ52 UNII
4756 PUBCHEM_CID
203197 RXNORM
2316 MMSL
5266 MMSL
5267 MMSL
d00337 MMSL
002866 NDDF
004869 NDDF
15785009 SNOMEDCT_US
370310006 SNOMEDCT_US
387119006 SNOMEDCT_US

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Walgreens Urinary Pain Relief Maximum Strength HUMAN OTC DRUG LABEL 1 0363-0113 TABLET 97.50 mg ORAL unapproved drug other 11 sections
Walgreens Urinary Pain Relief HUMAN OTC DRUG LABEL 1 0363-0773 TABLET 95 mg ORAL unapproved drug other 11 sections
Walgreens Urinary Pain Relief HUMAN OTC DRUG LABEL 1 0363-7775 TABLET 95 mg ORAL unapproved drug other 11 sections
Walgreens Maximum Strength Urinary Pain Relief HUMAN OTC DRUG LABEL 1 0363-7776 TABLET 97.50 mg ORAL unapproved drug other 11 sections
Wallgreens Maximum Strength Urinary Pain Relief HUMAN OTC DRUG LABEL 1 0363-8455 TABLET 99.50 mg ORAL unapproved drug other 11 sections
Phenazopyridine Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0440-2070 TABLET 100 mg ORAL UNULLPPROVED DRUG OTHER 11 sections
UristatUTI Relief PakUTI Relief Pak HUMAN OTC DRUG LABEL 1 0440-8065 TABLET 95 mg ORAL UNULLPPROVED DRUG OTHER 14 sections
Phenazopyridine Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 10135-620 TABLET, FILM COATED 100 mg ORAL unapproved drug other 16 sections
Phenazopyridine Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 10135-621 TABLET, FILM COATED 200 mg ORAL unapproved drug other 16 sections
Phenazopyridine HCl HUMAN PRESCRIPTION DRUG LABEL 1 10544-055 TABLET 100 mg ORAL unapproved drug other 12 sections
Phenazopyridine HCl HUMAN PRESCRIPTION DRUG LABEL 1 10544-077 TABLET 200 mg ORAL unapproved drug other 12 sections
Phenazopyridine Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 10544-115 TABLET 100 mg ORAL unapproved drug other 11 sections
Phenazopyridine Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 10544-571 TABLET 200 mg ORAL unapproved drug other 11 sections
CVS Health Urinary Pain Relief HUMAN OTC DRUG LABEL 1 10956-001 TABLET 95 mg ORAL unapproved drug other 11 sections
Preferred Maximum Strength Urinary Pain Relief HUMAN OTC DRUG LABEL 1 10956-210 TABLET 99.50 mg ORAL unapproved drug other 11 sections
Preferred Maximum Strength Urinary Pain Relief HUMAN OTC DRUG LABEL 1 10956-333 TABLET 97.50 mg ORAL unapproved drug other 11 sections
CVS Health Maximum Strength Urinary Pain Relief HUMAN OTC DRUG LABEL 1 10956-523 TABLET 97.50 mg ORAL unapproved drug other 11 sections
Preferred Urinary Pain Relief HUMAN OTC DRUG LABEL 1 10956-551 TABLET 95 mg ORAL unapproved drug other 11 sections
Discount Drug Mart Maximum Strength Urinary Pain Relief HUMAN OTC DRUG LABEL 1 10956-552 TABLET 97.50 mg ORAL unapproved drug other 11 sections
Family Wellness Maximum Strength Urinary Pain Relief HUMAN OTC DRUG LABEL 1 10956-599 TABLET 97.50 mg ORAL unapproved drug other 11 sections
Rite Aid Maximum Strength Urinary Pain Relief HUMAN OTC DRUG LABEL 1 11822-3111 TABLET 99.50 mg ORAL unapproved drug other 11 sections
Rite Aid Urinary Pain Relief HUMAN OTC DRUG LABEL 1 11822-8855 TABLET 95 mg ORAL unapproved drug other 11 sections
Phenazopyridine Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 12634-189 TABLET 200 mg ORAL unapproved drug other 11 sections
Select Brand Maximum Strength Urinary Pain Relief HUMAN OTC DRUG LABEL 1 15127-138 TABLET 97.50 mg ORAL unapproved drug other 11 sections
Signature Care Maximum Strength Urinary Pain Relief HUMAN OTC DRUG LABEL 1 21130-523 TABLET 97.50 mg ORAL unapproved drug other 11 sections
Signature Care Maximum Strength Urinary Pain Relief HUMAN OTC DRUG LABEL 1 21130-792 TABLET 99.50 mg ORAL unapproved drug other 11 sections
Phenazopyridine Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 21695-301 TABLET 200 mg ORAL Unapproved drug other 11 sections
Phenazopyridine Hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 21695-638 TABLET 100 mg ORAL Unapproved drug other 11 sections
Kroger Maximum Strength Urinary Pain Relief HUMAN OTC DRUG LABEL 1 30142-221 TABLET 99.50 mg ORAL unapproved drug other 11 sections
Kroger Urinary Pain Relief HUMAN OTC DRUG LABEL 1 30142-564 TABLET 95 mg ORAL unapproved drug other 11 sections