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

Stem definition	Drug id	CAS RN
	2713	1197-18-8

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: tranexamic acid amchafibrin amikapron cyclocapron tranol transamin zataranax	Antifibrinolytic hemostatic used in severe hemorrhage. Molecular weight: 157.21 Formula: C8H15NO2 CLOGP: -1.80 LIPINSKI: 0 HAC: 3 HDO: 2 TPSA: 63.32 ALOGS: -0.94 ROTB: 2 Status: OFP Legend: OFP - off patent OFM - off market ONP - on patent

Molecule

Description

Molfile Inchi Smiles

Synonyms:

tranexamic acid
amchafibrin
amikapron
cyclocapron
tranol
transamin
zataranax

Antifibrinolytic hemostatic used in severe hemorrhage.

Molecular weight: 157.21
Formula: C8H15NO2
CLOGP: -1.80
LIPINSKI: 0
HAC: 3
HDO: 2
TPSA: 63.32
ALOGS: -0.94
ROTB: 2

Status: OFP

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

Drug dosage:

Dose	Unit	Route
2	g	O
2	g	P

ADMET properties:

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Property	Value	Reference
BA (Bioavailability)	34 %	Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
S (Water solubility)	31 mg/mL	Bocci G, Oprea TI, Benet LZ
BDDCS (Biopharmaceutical Drug Disposition Classification System)	3	Hosey CM, Chan R, Benet LZ
CL (Clearance)	2.40 mL/min/kg	Lombardo F, Berellini G, Obach RS
t_half (Half-life)	2.30 hours	Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma)	0.97 %	Lombardo F, Berellini G, Obach RS
Vd (Volume of distribution)	0.38 L/kg	Lombardo F, Berellini G, Obach RS

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Approvals:

Date	Agency	Company	Orphan
Dec. 30, 1986	FDA	PHARMACIA AND UPJOHN

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
Purpura	88.77	15.85	42	10884	11343	63466753
Wrong product administered	85.12	15.85	34	10892	6107	63471989
Melaena	82.16	15.85	56	10870	30309	63447787
Aplastic anaemia	73.68	15.85	35	10891	9534	63468562
Pulmonary embolism	72.98	15.85	95	10831	116589	63361507
Renal cortical necrosis	69.77	15.85	13	10913	117	63477979
Vaginal haemorrhage	68.04	15.85	48	10878	27439	63450657
Status epilepticus	63.62	15.85	37	10889	15196	63462900
Heavy menstrual bleeding	60.86	15.85	38	10888	17735	63460361
Hereditary angioedema	59.26	15.85	28	10898	7534	63470562

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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
Myoclonus	94.18	16.19	52	7888	14673	34934318
Factor VIII inhibition	80.98	16.19	18	7922	308	34948683
Febrile neutropenia	70.98	16.19	118	7822	136731	34812260
Anaphylactic reaction	61.26	16.19	54	7886	32247	34916744
Haemorrhage	58.49	16.19	65	7875	51305	34897686
Generalised tonic-clonic seizure	58.31	16.19	44	7896	21130	34927861
Vasodilatation	54.24	16.19	17	7923	1135	34947856
Post procedural hypotension	47.45	16.19	9	7931	66	34948925
Platelet count decreased	42.77	16.19	88	7852	119629	34829362
Haemophilia	39.26	16.19	6	7934	8	34948983

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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
Myoclonus	143.37	13.99	85	17914	27575	79698814
Wrong product administered	115.41	13.99	51	17948	8961	79717428
Generalised tonic-clonic seizure	114.25	13.99	88	17911	43822	79682567
Vasodilatation	101.68	13.99	35	17964	3156	79723233
Anaphylactic reaction	95.88	13.99	106	17893	83637	79642752
Haemorrhage	93.56	13.99	109	17890	91009	79635380
Aplastic anaemia	90.10	13.99	54	17945	17851	79708538
Platelet count decreased	77.20	13.99	149	17850	194515	79531874
Febrile neutropenia	73.00	13.99	161	17838	230838	79495551
Factor VIII inhibition	69.62	13.99	16	17983	322	79726067

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FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

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Source	Code	Description
ATC	B02AA02	BLOOD AND BLOOD FORMING ORGANS ANTIHEMORRHAGICS ANTIFIBRINOLYTICS Amino acids
CHEBI has role	CHEBI:48675	antifibrinolytic agent
CHEBI has role	CHEBI:50248	hematologic agents
FDA EPC	N0000175634	Antifibrinolytic Agent
FDA PE	N0000175632	Decreased Fibrinolysis
MeSH PA	D000933	Antifibrinolytic Agents
MeSH PA	D003029	Coagulants
MeSH PA	D006401	Hematologic Agents
MeSH PA	D006490	Hemostatics

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

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Disease	Relation	SNOMED_ID
Contraception	indication	13197004
Female hypogonadism syndrome	indication	16041008
Endometriosis	indication	129103003
Menorrhagia	indication	386692008
Hemorrhaging in Hemophilia	indication
Refractory melasma	off-label use	36209000
Epistaxis	off-label use	249366005
Hyperfibrinolysis Induced Hemorrhage	off-label use
Prevention of Hemorrhage with Cardiovascular Instability from Cardiopulmonary Bypass - CABG	off-label use
Postsurgical Hemorrhage	off-label use

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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	4.31	acidic
pKa2	10.7	Basic

Orange Book patent data (new drug applications)

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Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Patent number	Patent expiration date	Patent use
650MG	LYSTEDA	AMRING PHARMS	N022430	Nov. 13, 2009	RX	TABLET	ORAL	8022106	March 4, 2025	TREATMENT OF CYCLIC HEAVY MENSTRUAL BLEEDING
650MG	LYSTEDA	AMRING PHARMS	N022430	Nov. 13, 2009	RX	TABLET	ORAL	8273795	March 4, 2025	TREATMENT OF CYCLIC HEAVY MENSTRUAL BLEEDING
650MG	LYSTEDA	AMRING PHARMS	N022430	Nov. 13, 2009	RX	TABLET	ORAL	8487005	March 4, 2025	TREATMENT OF CYCLIC HEAVY MENSTRUAL BLEEDING
650MG	LYSTEDA	AMRING PHARMS	N022430	Nov. 13, 2009	RX	TABLET	ORAL	8791160	March 4, 2025	TREATMENT OF CYCLIC HEAVY MENSTRUAL BLEEDING
650MG	LYSTEDA	AMRING PHARMS	N022430	Nov. 13, 2009	RX	TABLET	ORAL	8809394	March 4, 2025	TREATMENT OF CYCLIC HEAVY MENSTRUAL BLEEDING
650MG	LYSTEDA	AMRING PHARMS	N022430	Nov. 13, 2009	RX	TABLET	ORAL	8957113	March 4, 2025	TREATMENT OF CYCLIC HEAVY MENSTRUAL BLEEDING

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Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

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Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Mechanism action	Bioact source	MoA source
Plasminogen	Enzyme	P00747	PLMN_HUMAN	INHIBITOR	Kd	5.96		CHEMBL	CHEMBL

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External reference:

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ID	Source
002073	NDDF
10691	RXNORM
109006003	SNOMEDCT_US
2060	INN_ID
386960009	SNOMEDCT_US
4020569	VUID
4020569	VANDF
5526	PUBCHEM_CID
5607	MMSL
6573	IUPHAR_LIGAND_ID

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Pharmaceutical products:

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Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Cyklokapron	HUMAN PRESCRIPTION DRUG LABEL	1	0013-1114	INJECTION, SOLUTION	100 mg	INTRAVENOUS	NDA	30 sections
Lysteda	HUMAN PRESCRIPTION DRUG LABEL	1	55566-2110	TABLET	650 mg	ORAL	NDA	28 sections
Tranexamic Acid	HUMAN PRESCRIPTION DRUG LABEL	1	0517-0960	INJECTION, SOLUTION	100 mg	INTRAVENOUS	ANDA	30 sections
Tranexamic Acid	HUMAN PRESCRIPTION DRUG LABEL	1	0591-3720	TABLET, FILM COATED	650 mg	ORAL	ANDA	25 sections
Tranexamic acid	HUMAN PRESCRIPTION DRUG LABEL	1	14789-500	INJECTION, SOLUTION	100 mg	INTRAVENOUS	ANDA	20 sections
Tranexamic Acid	HUMAN PRESCRIPTION DRUG LABEL	1	17478-017	INJECTION, SOLUTION	100 mg	INTRAVENOUS	ANDA	26 sections
Tranexamic Acid	HUMAN PRESCRIPTION DRUG LABEL	1	17478-018	INJECTION, SOLUTION	100 mg	INTRAVENOUS	ANDA	27 sections
Tranexamic Acid	HUMAN PRESCRIPTION DRUG LABEL	1	23155-166	INJECTION, SOLUTION	1 g	INTRAVENOUS	ANDA	24 sections
Tranexamic Acid	HUMAN PRESCRIPTION DRUG LABEL	1	23155-166	INJECTION, SOLUTION	1 g	INTRAVENOUS	ANDA	24 sections
Tranexamic Acid	HUMAN PRESCRIPTION DRUG LABEL	1	23155-524	INJECTION, SOLUTION	1 g	INTRAVENOUS	ANDA	24 sections

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