phenazopyridine 🐶 Veterinary Use | 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:

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Property	Value	Reference
MRTD (Maximum Recommended Therapeutic Daily Dose)	45.76 µM/kg/day	Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
EoM (Fraction excreted unchanged in urine)	41 %	Hosey CM, Chan R, Benet LZ
BDDCS (Biopharmaceutical Drug Disposition Classification System)	2	Hosey CM, Chan R, Benet LZ
S (Water solubility)	0.03 mg/mL	Bocci G, Oprea TI, Benet LZ

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Approvals:

Date	Agency	Company	Orphan
June 26, 2001	FDA	ABLE

FDA Adverse Event Reporting System (Female)

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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	105.58	17.21	26	4370	2377	63482249
Urinary tract infection	77.02	17.21	93	4303	264591	63220035
Sulphaemoglobinaemia	61.30	17.21	8	4388	12	63484614
Drug hypersensitivity	56.57	17.21	87	4309	310600	63174026
Anaemia Heinz body	51.47	17.21	6	4390	0	63484626
Cystitis	35.81	17.21	30	4366	54961	63429665
Nephrolithiasis	29.62	17.21	24	4372	41960	63442666
Dysuria	27.49	17.21	21	4375	33717	63450909
Haemolytic anaemia	25.68	17.21	13	4383	10112	63474514
Emotional distress	23.79	17.21	19	4377	32530	63452096

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FDA Adverse Event Reporting System (Male)

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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	57.44	26.77	12	1011	1257	34954651
Urinary tract infection	42.87	26.77	28	995	84053	34871855
Nephrolithiasis	37.20	26.77	18	1005	30315	34925593
Methaemoglobinaemia	26.82	26.77	8	1015	3573	34952335

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FDA Adverse Event Reporting System (Geriatric)

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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	125.24	17.82	34	4536	5523	79734295
Urinary tract infection	83.31	17.82	90	4480	274422	79465396
Sulphaemoglobinaemia	53.90	17.82	8	4562	53	79739765
Anaemia Heinz body	52.61	17.82	6	4564	0	79739818
Nephrolithiasis	43.98	17.82	31	4539	53260	79686558
Anticholinergic syndrome	36.95	17.82	12	4558	3599	79736219
Drug hypersensitivity	36.41	17.82	63	4507	298853	79440965
Cystitis	35.21	17.82	27	4543	52705	79687113
Haemolytic anaemia	29.07	17.82	16	4554	17804	79722014
Emotional distress	23.52	17.82	19	4551	39950	79699868

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FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

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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	carcinogen
CHEBI has role	CHEBI:149553	anticoronaviral drug

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Drug Use | Suggest Off label Use Form| |View source of the data|

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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

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🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

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:

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Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Bioact source	MoA source
Sodium channel alpha subunit	Ion channel	P35498 P35499 Q01118 Q14524 Q15858 Q99250 Q9NY46 Q9UI33 Q9UQD0 Q9Y5Y9	SCN1A_HUMAN SCN4A_HUMAN SCN7A_HUMAN SCN5A_HUMAN SCN9A_HUMAN SCN2A_HUMAN SCN3A_HUMAN SCNBA_HUMAN SCN8A_HUMAN SCNAA_HUMAN	BLOCKER			CHEMBL	CHEMBL
Sterile alpha and TIR motif-containing protein 1	Unclassified	Q6SZW1	SARM1_HUMAN		Ki	4.16	CHEMBL
Snake venom metalloproteinase Bap1	Enzyme		VM1B1_BOTAS		IC50	4.27	CHEMBL

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External reference:

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ID	Source
002866	NDDF
004869	NDDF
136-40-3	SECONDARY_CAS_RN
15785009	SNOMEDCT_US
203197	RXNORM
2316	MMSL
357	INN_ID
370310006	SNOMEDCT_US
387119006	SNOMEDCT_US
4017768	VANDF

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Pharmaceutical products:

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Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
CVS Health Maximum Strength Urinary Pain Relief	HUMAN OTC DRUG LABEL	1	10956-523	TABLET	97.50 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
CVS Health Urinary Pain Relief	HUMAN OTC DRUG LABEL	1	10956-001	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
Maximum Strength Urinary Pain Relief	HUMAN OTC DRUG LABEL	1	11673-270	TABLET	99.50 mg	ORAL	unapproved drug other	11 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	0440-2070	TABLET	100 mg	ORAL	UNAPPROVED DRUG OTHER	11 sections
Phenazopyridine Hydrochloride	HUMAN PRESCRIPTION DRUG LABEL	1	10135-620	TABLET, FILM COATED	100 mg	ORAL	unapproved drug other	16 sections

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