aminosalicylic acid 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definition	Drug id	CAS RN
	2050	65-49-6

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: aminosalicylic acid resin complex potassium aminosalicylate p-aminosalicylic acid aminosalicylic acid 4-Aminosalicylic acid 4-Carboxy-3-hydroxyaniline apacil calcium aminosalicylate sodium aminosalicylate para-aminosalicylic acid aminosalicylate potassium aminosalicylate sodium teebacin	An antitubercular agent often administered in association with ISONIAZID. The sodium salt of the drug is better tolerated than the free acid. Molecular weight: 153.14 Formula: C7H7NO3 CLOGP: 1.06 LIPINSKI: 0 HAC: 4 HDO: 3 TPSA: 83.55 ALOGS: -1.11 ROTB: 1 Status: OFP Legend: OFP - off patent OFM - off market ONP - on patent

Molecule

Description

Molfile Inchi Smiles

Synonyms:

aminosalicylic acid resin complex
potassium aminosalicylate
p-aminosalicylic acid
aminosalicylic acid
4-Aminosalicylic acid
4-Carboxy-3-hydroxyaniline
apacil
calcium aminosalicylate
sodium aminosalicylate
para-aminosalicylic acid
aminosalicylate potassium
aminosalicylate sodium
teebacin

An antitubercular agent often administered in association with ISONIAZID. The sodium salt of the drug is better tolerated than the free acid.

Molecular weight: 153.14
Formula: C7H7NO3
CLOGP: 1.06
LIPINSKI: 0
HAC: 4
HDO: 3
TPSA: 83.55
ALOGS: -1.11
ROTB: 1

Status: OFP

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

Drug dosage:

Dose	Unit	Route
12	g	O
14	g	O
14	g	P
15	g	O

ADMET properties:

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Property	Value	Reference
EoM (Fraction excreted unchanged in urine)	2 %	Benet LZ, Broccatelli F, Oprea TI
BDDCS (Biopharmaceutical Drug Disposition Classification System)	2	Bocci G, Oprea TI, Benet LZ
MRTD (Maximum Recommended Therapeutic Daily Dose)	1306.01 µM/kg/day	Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
S (Water solubility)	1.69 mg/mL	Bocci G, Oprea TI, Benet LZ

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Approvals:

Date	Agency	Company	Orphan
March 8, 1950	FDA	CONSOLIDATED MIDLAND

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
Colitis ulcerative	366.42	20.24	113	3952	25978	63458979
Frequent bowel movements	156.87	20.24	58	4007	22964	63461993
Off label use	103.98	20.24	167	3898	674295	62810662
Lipase increased	102.17	20.24	34	4031	9866	63475091
Pancreatitis	97.39	20.24	52	4013	49003	63435954
Drug resistance	97.17	20.24	41	4024	22892	63462065
Electrocardiogram QT prolonged	93.28	20.24	54	4011	59476	63425481
Rectal haemorrhage	75.52	20.24	44	4021	48986	63435971
Diarrhoea haemorrhagic	58.66	20.24	22	4043	9020	63475937
Mucous stools	57.77	20.24	18	4047	4230	63480727

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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
Electrocardiogram QT prolonged	270.89	31.27	112	3182	40840	34912797
Colitis ulcerative	245.61	31.27	82	3212	16438	34937199
Off label use	174.53	31.27	204	3090	419320	34534317
Hepatotoxicity	132.39	31.27	56	3238	21429	34932208
Frequent bowel movements	123.05	31.27	46	3248	12741	34940896
Intentional product use issue	107.57	31.27	68	3226	59748	34893889
Drug resistance	97.70	31.27	48	3246	25879	34927758
Tuberculosis	68.65	31.27	27	3267	8550	34945087
Haematochezia	66.77	31.27	46	3248	46488	34907149
Steroid dependence	64.42	31.27	17	3277	1500	34952137

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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
Colitis ulcerative	487.46	21.08	160	6454	34582	79703192
Electrocardiogram QT prolonged	351.37	21.08	164	6450	90222	79647552
Off label use	288.29	21.08	362	6252	906853	78830921
Drug resistance	177.41	21.08	81	6533	42132	79695642
Frequent bowel movements	174.22	21.08	72	6542	29467	79708307
Intentional product use issue	130.76	21.08	105	6509	152007	79585767
Hepatotoxicity	130.55	21.08	70	6544	51282	79686492
Haematochezia	93.84	21.08	69	6545	87576	79650198
Polyneuropathy	87.93	21.08	42	6572	24109	79713665
Neuropathy peripheral	83.81	21.08	79	6535	141226	79596548

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FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

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Source	Code	Description
ATC	J04AA01	ANTIINFECTIVES FOR SYSTEMIC USE ANTIMYCOBACTERIALS DRUGS FOR TREATMENT OF TUBERCULOSIS Aminosalicylic acid and derivatives
ATC	J04AA02	ANTIINFECTIVES FOR SYSTEMIC USE ANTIMYCOBACTERIALS DRUGS FOR TREATMENT OF TUBERCULOSIS Aminosalicylic acid and derivatives
ATC	J04AA03	ANTIINFECTIVES FOR SYSTEMIC USE ANTIMYCOBACTERIALS DRUGS FOR TREATMENT OF TUBERCULOSIS Aminosalicylic acid and derivatives
CHEBI has role	CHEBI:33231	antitubercular agents
MeSH PA	D000900	Anti-Bacterial Agents
MeSH PA	D000890	Anti-Infective Agents
MeSH PA	D000995	Antitubercular Agents

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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
Acute tuberculosis	indication	25629007
Pulmonary tuberculosis	indication	154283005	DOID:2957
Crohn's disease	off-label use	34000006
Ulcerative colitis	off-label use	64766004	DOID:8577
Goiter	contraindication	3716002	DOID:12176
Peptic ulcer	contraindication	13200003	DOID:750
Hypokalemia	contraindication	43339004
Crystalluria	contraindication	46784006
Chronic heart failure	contraindication	48447003
Acidosis	contraindication	51387008

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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	3.71	acidic
pKa2	12.94	acidic
pKa3	2.33	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
Cyclooxygenase	Enzyme	P23219 P35354	PGH1_HUMAN PGH2_HUMAN	INHIBITOR			CHEMBL	CHEMBL
Tyrosine-protein phosphatase non-receptor type 1	Enzyme	P18031	PTN1_HUMAN		Kd	2.92	CHEMBL
2-amino-4-hydroxy-6-hydroxymethyldihydropteridine pyrophosphokinase	Kinase		HPPK_MYCTO				WOMBAT-PK

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External reference:

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ID	Source
002845	NDDF
002846	NDDF
002847	NDDF
10002	MMSL
133-09-5	SECONDARY_CAS_RN
20231007	SNOMEDCT_US
255666002	SNOMEDCT_US
4018852	VUID
4018852	VANDF
4018919	VANDF

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Pharmaceutical products:

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Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Paser	HUMAN PRESCRIPTION DRUG LABEL	1	49938-107	GRANULE, DELAYED RELEASE	4 g	ORAL	ANDA	21 sections

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