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

Stem definition	Drug id	CAS RN
	2120	94-78-0

Description:

Molecule	Description
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

Molecule

Description

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:

Dose	Unit	Route
0.60	g	O

ADMET properties:

Property	Value	Reference
MRTD (Maximum Recommended Therapeutic Daily Dose)	45.76 µM/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:

Date	Agency	Company	Orphan
June 26, 2001	FDA	ABLE

FDA Adverse Event Reporting System (Female)

MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients 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 term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients 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:

Source	Code	Description
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)

Disease	Relation	SNOMED_ID	DOID
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 level	Dissociation constant	Type (acidic/basic)
pKa1	7.39	Basic

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Mechanism action	Bioact source	MoA source
Sodium channel alpha subunit	Ion channel	P35498 P35499 Q01118 Q14524 Q15858 Q99250 Q9NY46 Q9UI33 Q9UQD0 Q9Y5Y9	SCN1A_HUMAN SCN2A_HUMAN SCN3A_HUMAN SCN4A_HUMAN SCN5A_HUMAN SCN7A_HUMAN SCN8A_HUMAN SCN9A_HUMAN SCNAA_HUMAN SCNBA_HUMAN	BLOCKER				CHEMBL	CHEMBL
Snake venom metalloproteinase Bap1	Unclassified		VM1B1_BOTAS		IC50	4.27		CHEMBL

External reference:

ID	Source
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:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
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