All FDA-approved EMA-approved PMDA-approved
Target Card Uniprot Example: P23975

edoxaban 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |

Stem definition	Drug id	CAS RN
blood coagulation factor XA inhibitors, antithrombotics	4897	480449-70-5

Description:

Molecule

Description

Molfile Inchi Smiles Synonyms: edoxaban tosylate edoxaban edoxaban tosilate edoxaban tosilate hydrate lixiana DU-176b savaysa

An orally active inhibitor of coagulation factor Xa (activated factor X) with anticoagulant activity. Edoxaban is administered as edoxaban tosylate. This agent has an elimination half-life of 9-11 hours and undergoes renal excretion. Molecular weight: 548.06 Formula: C24H30ClN7O4S CLOGP: 1.86 LIPINSKI: 2 HAC: 11 HDO: 3 TPSA: 136.63 ALOGS: -4.68 ROTB: 6 Status: ONP Legend: OFP - off patent OFM - off market ONP - on patent

Drug dosage:

Dose	Unit	Route
60	mg	O

ADMET properties:

Property	Value	Reference
BDDCS (Biopharmaceutical Drug Disposition Classification System)	4	Hosey CM, Chan R, Benet LZ
Vd (Volume of distribution)	1.53 L/kg	Lombardo F, Berellini G, Obach RS
CL (Clearance)	5.19 mL/min/kg	Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma)	0.50 %	Lombardo F, Berellini G, Obach RS
t_half (Half-life)	6.70 hours	Lombardo F, Berellini G, Obach RS
S (Water solubility)	0.09 mg/mL	Bocci G, Oprea TI, Benet LZ
BA (Bioavailability)	62 %

Predicted pharmacokinetic/toxicological properties (PK-AZ):

Property	Description	Value	Unit	Confidence	Similarity
azlogd74	LogD at pH 7.4	1.489		High	1
caco2-efflux	Caco-2 efflux ratio (BA/AB)	7.925		High	1
caco2-intrinsic-papp	Caco-2 intrinsic apparent permeability	24.946	10^-6 cm/s	High	1
dh-clint	Dog hepatocyte intrinsic clearance	1.327	uL/min/10^6 cells	High	1
dppb	Dog plasma protein binding (% unbound)	66.720	%	High	1
fcs-ppb	Fetal calf serum protein binding (% unbound)	73.360	%	High	1
herg	hERG pIC50	4.593	pIC50	High	1
hh-clint	Human hepatocyte intrinsic clearance	1.503	uL/min/10^6 cells	High	1
hlm-clint	Human liver microsomal intrinsic clearance	6.166	uL/min/mg protein	High	1
hppb	Human plasma protein binding (% unbound)	56.470	%	High	1
kinase-safety-class	EIF2AK3,GRK2,PDK1,PDK2,PDK4	5
kinase-selectivity-class	PDK1	1
mdck-mdr1-efflux	MDCK-MDR1 efflux ratio	17.947		High	1
mh-clint	Mouse hepatocyte intrinsic clearance	3.972		High	1
mppb	Mouse plasma protein binding (% unbound)	47.810		High	1
nih-mdck-mdr1-efflux	NIH MDCK-MDR1 efflux ratio	43.451		High	1
pfas-class	PFAS structural alert (1 = True, 0 = False)	0
pppb	Pig plasma protein binding (% unbound)	65.430	%	High	1
rh-clint	Rat hepatocyte intrinsic clearance	3.141	uL/min/10^6 cells	High	1
rh-fuinc	Rat hepatocyte fraction unbound in incubation	87.920	%	High	1
rppb	Rat plasma protein binding (% unbound)	49.770	%	High	1
solubility-dd	Solubility at pH 7.4 in DMSO	578.096	uM	High	1

Approvals:

Date	Agency	Company	Orphan
June 19, 2015	EMA	Daiichi Sankyo Europe GmbH
Jan. 8, 2015	FDA	DAIICHI SANKYO
April 22, 2011	PMDA	DAIICHI SANKYO COMPANY, Limited

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
Anaemia	358.20	20.56	405	18726	352397	90256919
Cardiac failure	277.43	20.56	210	18921	109286	90500030
Cerebral infarction	262.66	20.56	123	19008	26473	90582843
Renal impairment	210.84	20.56	176	18955	105245	90504071
Atrial fibrillation	201.33	20.56	190	18941	133421	90475895
Gastrointestinal haemorrhage	185.27	20.56	153	18978	90095	90519221
Melaena	184.55	20.56	106	19025	34691	90574625
General physical health deterioration	184.01	20.56	294	18837	354821	90254495
Lymphatic fistula	135.70	20.56	36	19095	1425	90607891
Femoral hernia incarcerated	134.57	20.56	36	19095	1472	90607844
Arterial haemorrhage	133.33	20.56	40	19091	2483	90606833
Labelled drug-drug interaction medication error	130.36	20.56	63	19068	14519	90594797
Haematuria	130.32	20.56	85	19046	34852	90574464
Aortic valve stenosis	128.33	20.56	44	19087	4196	90605120
Pancreatic steatosis	126.90	20.56	35	19096	1607	90607709
Product monitoring error	125.35	20.56	44	19087	4500	90604816
Wound infection pseudomonas	124.10	20.56	36	19095	1987	90607329
Embolic stroke	118.36	20.56	41	19090	4031	90605285
Drug ineffective	112.41	20.56	78	19053	1384220	89225096
Haematochezia	110.83	20.56	103	19028	70810	90538506
Haemarthrosis	107.59	20.56	38	19093	3956	90605360
Seroma	105.41	20.56	35	19096	3025	90606291
Hyponatraemia	101.82	20.56	133	18998	133405	90475911
Tachyarrhythmia	99.91	20.56	39	19092	5367	90603949
Cerebral haemorrhage	95.76	20.56	70	19061	34452	90574864
Arrhythmia	95.74	20.56	76	19055	42256	90567060
Hyperkalaemia	93.20	20.56	90	19041	64874	90544442
Subarachnoid haemorrhage	90.80	20.56	53	19078	17851	90591465
Diverticulum intestinal	89.34	20.56	42	19089	9100	90600216
Hepatic cyst	89.23	20.56	38	19093	6530	90602786
Eructation	85.31	20.56	43	19088	10839	90598477
Streptococcal sepsis	84.88	20.56	31	19100	3553	90605763
Faecaloma	84.07	20.56	42	19089	10389	90598927
Anuria	83.54	20.56	47	19084	14771	90594545
Wound dehiscence	83.48	20.56	35	19096	5787	90603529
Mitral valve incompetence	79.61	20.56	53	19078	22471	90586845
Pseudomonal sepsis	79.37	20.56	31	19100	4271	90605045
Syncope	78.50	20.56	117	19014	132546	90476770
Aortic arteriosclerosis	77.25	20.56	36	19095	7648	90601668
Tachycardia	76.58	20.56	127	19004	157546	90451770
Nail bed inflammation	75.88	20.56	24	19107	1777	90607539
Tricuspid valve incompetence	75.65	20.56	46	19085	16685	90592631
Groin pain	72.29	20.56	40	19091	12173	90597143
Pallor	72.29	20.56	59	19072	34106	90575210
Nasal mucosal disorder	71.06	20.56	23	19108	1834	90607482
Inflammatory marker increased	71.03	20.56	36	19095	9178	90600138
Cardiovascular disorder	68.57	20.56	40	19091	13452	90595864
Cardiac failure chronic	67.99	20.56	30	19101	5616	90603700
Dyspnoea	67.95	20.56	365	18766	880590	89728726
Drug hypersensitivity	67.59	20.56	9	19122	463600	90145716
Acute kidney injury	67.14	20.56	183	18948	320204	90289112
Hypersensitivity	65.88	20.56	9	19122	454668	90154648
Escherichia infection	65.02	20.56	41	19090	15854	90593462
Maternal exposure during pregnancy	63.45	20.56	3	19128	360060	90249256
Left ventricular dysfunction	62.93	20.56	39	19092	14630	90594686
Arthropathy	61.61	20.56	4	19127	366238	90243078
Infusion related reaction	60.97	20.56	8	19123	416772	90192544
Postoperative wound infection	60.92	20.56	37	19094	13389	90595927
Atrial tachycardia	60.02	20.56	28	19103	5962	90603354
Oedema peripheral	59.79	20.56	153	18978	257762	90351554
Product prescribing error	59.49	20.56	50	19081	30095	90579221
Aplastic anaemia	58.76	20.56	36	19095	13233	90596083
Drug intolerance	57.90	20.56	12	19119	447579	90161737
Varicose vein	57.57	20.56	29	19102	7298	90602018
Heparin resistance	57.24	20.56	10	19121	47	90609269
Cardiospasm	57.18	20.56	23	19108	3423	90605893
Myelodysplastic syndrome	57.09	20.56	42	19089	20861	90588455
Palmoplantar keratoderma	56.79	20.56	23	19108	3484	90605832
Swelling	54.69	20.56	11	19120	419047	90190269
Pulmonary hypertension	53.73	20.56	55	19076	42468	90566848
Rheumatoid arthritis	52.93	20.56	7	19124	362607	90246709
Treatment failure	52.07	20.56	3	19128	303925	90305391
Sinusitis	51.59	20.56	6	19125	343082	90266234
Sleep terror	51.44	20.56	23	19108	4441	90604875
Bradycardia	51.08	20.56	75	19056	83772	90525544
Pruritus genital	50.98	20.56	23	19108	4535	90604781
Ischaemic stroke	50.54	20.56	40	19091	22126	90587190
Carotid artery occlusion	49.53	20.56	25	19106	6317	90602999
Nasopharyngitis	48.52	20.56	13	19118	407091	90202225
Pain	46.92	20.56	87	19044	996254	89613062
Systemic infection	46.85	20.56	22	19109	4753	90604563
Vascular device infection	46.82	20.56	30	19101	11922	90597394
Paronychia	46.77	20.56	26	19105	7980	90601336
Blindness	46.20	20.56	41	19090	26527	90582789
Shock haemorrhagic	46.15	20.56	30	19101	12215	90597101
Dehydration	45.71	20.56	116	19015	194331	90414985
Drug interaction	45.53	20.56	145	18986	276308	90333008
Osteopenia	45.07	20.56	38	19093	22964	90586352
Metastases to lymph nodes	44.95	20.56	29	19102	11660	90597656
Subdural haematoma	44.45	20.56	33	19098	16612	90592704
Upper gastrointestinal haemorrhage	43.06	20.56	37	19094	22939	90586377
Cardiogenic shock	43.03	20.56	38	19093	24430	90584886
Tension headache	42.82	20.56	24	19107	7485	90601831
Coronary artery disease	41.59	20.56	43	19088	33580	90575736
Internal haemorrhage	41.34	20.56	22	19109	6198	90603118
Thrombophlebitis migrans	41.30	20.56	10	19121	272	90609044
Urticaria	41.22	20.56	8	19123	312726	90296590
Joint swelling	41.07	20.56	28	19103	503272	90106044
Systemic lupus erythematosus	40.48	20.56	13	19118	361883	90247433
Haematoma	39.66	20.56	45	19086	39003	90570313
Aortic dissection	39.65	20.56	16	19115	2401	90606915
Cardiac failure acute	39.59	20.56	27	19104	11902	90597414
Urinary retention	39.19	20.56	44	19087	37700	90571616
Brain oedema	38.84	20.56	31	19100	17354	90591962
Mobility decreased	38.66	20.56	4	19127	250730	90358586
Hiatus hernia	37.99	20.56	36	19095	25325	90583991
Interstitial lung disease	37.67	20.56	62	19069	76343	90532973
Immunisation	37.51	20.56	15	19116	2198	90607118
Product dose omission issue	37.32	20.56	8	19123	291679	90317637
Therapeutic drug monitoring analysis not performed	37.15	20.56	13	19118	1316	90608000
Cerebrovascular accident	36.96	20.56	81	19050	123452	90485864
Anosmia	36.80	20.56	24	19107	9824	90599492
Exposure during pregnancy	36.25	20.56	4	19127	238406	90370910
Hepatic enzyme increased	35.28	20.56	16	19115	360720	90248596
Myocardial infarction	34.60	20.56	72	19059	105900	90503416
Metastases to central nervous system	34.41	20.56	29	19102	17513	90591803
Pleural effusion	34.15	20.56	74	19057	111917	90497399
Hepatic function abnormal	33.53	20.56	45	19086	46243	90563073
Depression	33.25	20.56	11	19120	300590	90308726
Ventricular tachycardia	33.12	20.56	33	19098	24675	90584641
Angina pectoris	32.95	20.56	41	19090	39119	90570197
Alopecia	32.46	20.56	34	19097	495037	90114279
Fall	31.92	20.56	192	18939	481618	90127698
Product used for unknown indication	31.40	20.56	10	19121	757	90608559
Chorea	31.31	20.56	13	19118	2097	90607219
Electrocardiogram abnormal	31.10	20.56	22	19109	10276	90599040
Blister	30.63	20.56	8	19123	254990	90354326
Facial pain	30.51	20.56	24	19107	13158	90596158
Sopor	29.55	20.56	31	19100	24613	90584703
Malignant neoplasm progression	28.54	20.56	67	19064	106803	90502513
Gastroenteritis clostridial	28.46	20.56	9	19122	666	90608650
Haemorrhage subcutaneous	28.33	20.56	14	19117	3382	90605934
Product use issue	27.36	20.56	18	19113	329901	90279415
Rhonchi	27.01	20.56	13	19118	2965	90606351
Electrolyte imbalance	26.93	20.56	29	19102	23716	90585600
Rash	26.69	20.56	83	19048	796017	89813299
Pain of skin	26.35	20.56	24	19107	16058	90593258
Vasculitis	26.24	20.56	28	19103	22665	90586651
Injection site pain	26.19	20.56	3	19128	173696	90435620
Candida infection	26.04	20.56	34	19097	34023	90575293
BRASH syndrome	25.95	20.56	11	19120	1868	90607448
Joint dislocation	25.88	20.56	39	19092	44543	90564773
Liver injury	25.58	20.56	3	19128	170564	90438752
Arthritis	24.95	20.56	3	19128	167312	90442004
Cerebral artery embolism	24.87	20.56	9	19122	1004	90608312
Haemorrhage	24.86	20.56	49	19082	69320	90539996
Asthma	24.85	20.56	10	19121	242150	90367166
Sinus node dysfunction	24.77	20.56	15	19116	5397	90603919
Lower gastrointestinal haemorrhage	24.58	20.56	18	19113	8874	90600442
Hypokalaemia	24.56	20.56	72	19059	131044	90478272
Femoral neck fracture	24.48	20.56	19	19112	10214	90599102
Sleep disorder	24.19	20.56	6	19125	198024	90411292
Atrial thrombosis	24.07	20.56	11	19120	2234	90607082
Injury	24.07	20.56	6	19125	197343	90411973
Pneumonia aspiration	24.03	20.56	36	19095	40904	90568412
Transient ischaemic attack	23.98	20.56	37	19094	43139	90566177
Contraindicated product administered	23.29	20.56	20	19111	320119	90289197
Restlessness	23.27	20.56	33	19098	35687	90573629
Oesophageal mucosal tear	23.23	20.56	4	19127	17	90609299
Hallucination	22.92	20.56	46	19085	65913	90543403
Marasmus	22.81	20.56	8	19123	815	90608501
Lip swelling	22.73	20.56	34	19097	38576	90570740
Palpitations	22.73	20.56	72	19059	136656	90472660
Gastrointestinal disorder	22.67	20.56	13	19118	256674	90352642
Faeces discoloured	22.38	20.56	25	19106	21295	90588021
Haemorrhage intracranial	21.71	20.56	21	19110	15141	90594175
Glomerular filtration rate decreased	21.56	20.56	22	19109	16910	90592406
Atrial conduction time prolongation	21.30	20.56	4	19127	30	90609286
Skin fissures	21.16	20.56	24	19107	20785	90588531
Gastrointestinal angiodysplasia	20.99	20.56	7	19124	613	90608703
Psychotic symptom	20.92	20.56	10	19121	2246	90607070
Cholangitis	20.90	20.56	15	19116	7167	90602149
Polyneuropathy	20.85	20.56	23	19108	19318	90589998
Haemorrhagic cerebral infarction	20.76	20.56	7	19124	634	90608682
Acute on chronic liver failure	20.63	20.56	6	19125	334	90608982

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
Cerebral infarction	247.67	15.69	153	16420	31016	42573746
Cardiac failure	202.76	15.69	228	16345	106628	42498134
Renal impairment	185.31	15.69	221	16352	110007	42494755
Haematuria	173.16	15.69	158	16415	57641	42547121
Melaena	142.33	15.69	119	16454	38627	42566135
Anaemia	133.93	15.69	319	16254	279959	42324803
Embolic stroke	130.44	15.69	55	16518	4985	42599777
Atrial fibrillation	123.73	15.69	206	16367	139387	42465375
General physical health deterioration	102.98	15.69	199	16374	151047	42453715
Interstitial lung disease	93.65	15.69	133	16440	78329	42526433
Pelvic mass	82.03	15.69	19	16554	222	42604540
Product monitoring error	78.30	15.69	37	16536	4386	42600376
Drug ineffective	74.09	15.69	82	16491	630115	41974647
Gastrointestinal haemorrhage	71.89	15.69	133	16440	97593	42507169
Cerebral haemorrhage	66.73	15.69	79	16494	38887	42565875
Prostate cancer recurrent	61.53	15.69	21	16552	1062	42603700
Cardiac failure acute	60.92	15.69	47	16526	13586	42591176
Cardiac amyloidosis	59.04	15.69	24	16549	1981	42602781
Epistaxis	56.91	15.69	97	16476	66729	42538033
Malignant transformation	55.71	15.69	19	16554	959	42603803
Blood electrolytes abnormal	54.67	15.69	19	16554	1015	42603747
Haematochezia	54.00	15.69	88	16485	58348	42546414
Blood urea abnormal	52.89	15.69	19	16554	1119	42603643
Upper gastrointestinal haemorrhage	51.16	15.69	61	16512	30238	42574524
Oedema peripheral	50.35	15.69	141	16432	135935	42468827
Systemic infection	50.25	15.69	29	16544	5176	42599586
Haemorrhage	47.77	15.69	85	16488	60478	42544284
Dehydration	44.90	15.69	139	16434	141628	42463134
Haematoma	43.38	15.69	54	16519	27969	42576793
Respiratory tract haemorrhage	41.95	15.69	17	16556	1392	42603370
Toxicity to various agents	40.89	15.69	19	16554	229117	42375645
Haemorrhage subcutaneous	40.39	15.69	20	16553	2626	42602136
Product dose omission issue	40.29	15.69	6	16567	154359	42450403
Drug interaction	38.60	15.69	205	16368	266794	42337968
Haematemesis	37.17	15.69	52	16521	30147	42574615
Urogenital haemorrhage	36.93	15.69	13	16560	721	42604041
Subdural haematoma	36.48	15.69	45	16528	23093	42581669
Cardiac failure chronic	36.27	15.69	30	16543	9571	42595191
Anticoagulant-related nephropathy	35.67	15.69	9	16564	154	42604608
Heparin resistance	35.51	15.69	9	16564	157	42604605
Shock haemorrhagic	34.76	15.69	37	16536	16205	42588557
Pneumonia aspiration	32.89	15.69	65	16508	50013	42554749
Hypovitaminosis	32.35	15.69	12	16561	774	42603988
Dysuria	31.70	15.69	49	16524	31047	42573715
Presyncope	31.27	15.69	41	16532	22346	42582416
Labelled drug-drug interaction medication error	30.73	15.69	34	16539	15548	42589214
Fluid intake reduced	29.98	15.69	19	16554	4013	42600749
Acute kidney injury	29.80	15.69	244	16329	367093	42237669
Ejection fraction	28.65	15.69	8	16565	205	42604557
Thalamus haemorrhage	28.24	15.69	12	16561	1107	42603655
Drug abuse	27.50	15.69	4	16569	104767	42499995
Electrocardiogram abnormal	26.99	15.69	26	16547	10119	42594643
Procedural failure	26.32	15.69	6	16567	65	42604697
Pseudarthrosis	25.17	15.69	6	16567	80	42604682
Anxiety	24.13	15.69	8	16565	118552	42486210
Dyspnoea	23.53	15.69	269	16304	442352	42162410
Faeces discoloured	23.51	15.69	31	16542	16983	42587779
Stress urinary incontinence	23.44	15.69	6	16567	109	42604653
Tracheal pain	23.18	15.69	5	16568	41	42604721
Varicella virus test positive	23.18	15.69	7	16566	238	42604524
Gastrointestinal stoma output decreased	22.85	15.69	6	16567	121	42604641
Peri-implantitis	22.67	15.69	6	16567	125	42604637
Atrioventricular block	22.54	15.69	23	16550	9592	42595170
Putamen haemorrhage	22.18	15.69	7	16566	276	42604486
Pallor	22.06	15.69	40	16533	28846	42575916
Cardiac tamponade	21.76	15.69	19	16554	6521	42598241
Loss of consciousness	21.68	15.69	82	16491	92272	42512490
Duodenal ulcer haemorrhage	21.63	15.69	18	16555	5790	42598972
Syncope	21.50	15.69	86	16487	99320	42505442
Monoplegia	21.43	15.69	12	16561	2022	42602740
Blood pressure decreased	21.09	15.69	60	16513	58272	42546490
Product prescribing error	21.02	15.69	37	16536	26075	42578687
Dizziness	20.94	15.69	167	16406	249087	42355675
Antithrombin III decreased	20.86	15.69	8	16565	566	42604196
Gastric haemorrhage	20.83	15.69	23	16550	10492	42594270
Hemiplegia	20.60	15.69	20	16553	7859	42596903
Aneurysm ruptured	20.36	15.69	8	16565	604	42604158
Sinus node dysfunction	20.21	15.69	16	16557	4796	42599966
Hydronephrosis	20.20	15.69	24	16549	11841	42592921
Ischaemic stroke	19.87	15.69	33	16540	22200	42582562
Haemothorax	19.03	15.69	16	16557	5220	42599542
Depression	18.68	15.69	10	16563	111353	42493409
Immobilisation syndrome	18.62	15.69	7	16566	469	42604293
Nasopharyngitis	18.30	15.69	5	16568	83991	42520771
Cholangitis acute	18.27	15.69	9	16564	1168	42603594
Medication error	18.21	15.69	40	16533	33114	42571648
Heart rate	17.75	15.69	4	16569	41	42604721
Eosinophil count decreased	17.45	15.69	13	16560	3563	42601199
Documented hypersensitivity to administered product	17.34	15.69	6	16567	316	42604446
Therapeutic drug monitoring analysis incorrectly performed	17.29	15.69	6	16567	319	42604443
Death	17.26	15.69	110	16463	471075	42133687
Drug intolerance	17.13	15.69	5	16568	80419	42524343
Endoscopy upper gastrointestinal tract	17.09	15.69	4	16569	49	42604713
Thrombophlebitis migrans	16.53	15.69	6	16567	364	42604398
Cerebral artery embolism	16.19	15.69	8	16565	1045	42603717
Helicobacter infection	16.15	15.69	11	16562	2621	42602141
Phrenic nerve paralysis	16.05	15.69	5	16568	189	42604573
Pulmonary alveolar haemorrhage	16.02	15.69	24	16549	14792	42589970
Therapeutic product effect incomplete	15.88	15.69	4	16569	70935	42533827

FDA Adverse Event Reporting System (Geriatric)

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
Cerebral infarction	531.03	15.85	279	34447	51559	110503014
Cardiac failure	475.65	15.85	425	34301	187201	110367372
Anaemia	474.92	15.85	711	34015	546375	110008198
Renal impairment	423.33	15.85	399	34327	188046	110366527
Haematuria	317.32	15.85	239	34487	82766	110471807
Atrial fibrillation	306.82	15.85	369	34357	229273	110325300
Melaena	305.90	15.85	217	34509	68540	110486033
General physical health deterioration	269.37	15.85	480	34246	424815	110129758
Gastrointestinal haemorrhage	242.57	15.85	279	34447	165239	110389334
Embolic stroke	226.95	15.85	90	34636	8653	110545920
Product monitoring error	194.35	15.85	81	34645	8846	110545727
Drug ineffective	161.27	15.85	145	34581	1520395	109034178
Cerebral haemorrhage	158.03	15.85	144	34582	64824	110489749
Haematochezia	154.64	15.85	186	34540	115338	110439235
Labelled drug-drug interaction medication error	140.79	15.85	97	34629	29205	110525368
Interstitial lung disease	122.90	15.85	183	34543	139151	110415422
Lymphatic fistula	120.72	15.85	36	34690	1459	110553114
Femoral hernia incarcerated	120.39	15.85	36	34690	1473	110553100
Arterial haemorrhage	115.74	15.85	44	34682	3775	110550798
Pancreatic steatosis	109.57	15.85	35	34691	1787	110552786
Cardiac failure acute	109.34	15.85	77	34649	24001	110530572
Wound infection pseudomonas	103.80	15.85	36	34690	2375	110552198
Aortic valve stenosis	103.54	15.85	47	34679	6303	110548270
Oedema peripheral	103.12	15.85	280	34446	328380	110226193
Acute kidney injury	98.92	15.85	428	34298	635002	109919571
Systemic infection	95.21	15.85	51	34675	9768	110544805
Dehydration	93.60	15.85	244	34482	279267	110275306
Upper gastrointestinal haemorrhage	93.46	15.85	96	34630	50000	110504573
Cardiac failure chronic	91.64	15.85	56	34670	13755	110540818
Drug intolerance	89.88	15.85	11	34715	406501	110148072
Drug hypersensitivity	89.66	15.85	17	34709	454073	110100500
Seroma	89.23	15.85	35	34691	3266	110551307
Syncope	86.21	15.85	194	34532	202342	110352231
Haemarthrosis	85.22	15.85	43	34683	7286	110547287
Pallor	83.97	15.85	96	34630	56371	110498202
Heparin resistance	83.85	15.85	19	34707	252	110554321
Tachyarrhythmia	83.18	15.85	44	34682	8217	110546356
Dyspnoea	79.99	15.85	607	34119	1106265	109448308
Hepatic cyst	79.92	15.85	42	34684	7741	110546832
Subdural haematoma	79.38	15.85	76	34650	36378	110518195
Shock haemorrhagic	77.44	15.85	66	34660	27181	110527392
Arrhythmia	75.57	15.85	101	34625	69474	110485099
Product prescribing error	74.19	15.85	86	34640	51245	110503328
Synovitis	73.10	15.85	3	34723	274089	110280484
Diverticulum intestinal	71.38	15.85	45	34681	11674	110542899
Nasopharyngitis	71.28	15.85	18	34708	394343	110160230
Sinusitis	70.82	15.85	6	34720	296682	110257891
Prostate cancer recurrent	68.38	15.85	21	34705	941	110553632
Haematoma	68.33	15.85	88	34638	58388	110496185
Arthropathy	68.12	15.85	6	34720	287516	110267057
Infusion related reaction	67.74	15.85	18	34708	381144	110173429
Nail bed inflammation	67.38	15.85	25	34701	2005	110552568
Maternal exposure during pregnancy	67.27	15.85	3	34723	254880	110299693
Hyperkalaemia	66.84	15.85	138	34588	135658	110418915
Rheumatoid arthritis	66.47	15.85	8	34718	299605	110254968
Haemorrhage subcutaneous	65.87	15.85	33	34693	5506	110549067
Product dose omission issue	65.77	15.85	11	34715	321771	110232802
Nasal mucosal disorder	65.48	15.85	24	34702	1859	110552714
Swelling	65.44	15.85	15	34711	351026	110203547
Hypersensitivity	64.74	15.85	23	34703	403975	110150598
Haemorrhage	64.18	15.85	118	34608	106574	110447999
Tricuspid valve incompetence	64.14	15.85	56	34670	23817	110530756
Streptococcal sepsis	62.63	15.85	31	34695	5041	110549532
Cardiac amyloidosis	62.62	15.85	26	34700	2811	110551762
Groin pain	62.41	15.85	46	34680	15382	110539191
Mitral valve incompetence	62.40	15.85	64	34662	33265	110521308
Drug interaction	62.34	15.85	316	34410	499867	110054706
Hyponatraemia	61.87	15.85	179	34547	217474	110337099
Pain	61.63	15.85	130	34596	954825	109599748
Pneumonia aspiration	60.84	15.85	99	34627	81134	110473439
Electrocardiogram abnormal	60.84	15.85	49	34677	18660	110535913
Lower respiratory tract infection	60.62	15.85	4	34722	243102	110311471
Wound dehiscence	59.88	15.85	35	34691	7927	110546646
Eructation	59.32	15.85	43	34683	14014	110540559
Aortic arteriosclerosis	59.21	15.85	39	34687	10899	110543674
Musculoskeletal stiffness	58.45	15.85	9	34717	279813	110274760
Tachycardia	58.36	15.85	180	34546	226465	110328108
Urinary retention	57.81	15.85	89	34637	69594	110484979
Presyncope	56.23	15.85	73	34653	48814	110505759
Ischaemic stroke	56.08	15.85	67	34659	41196	110513377
Subarachnoid haemorrhage	55.54	15.85	57	34669	29645	110524928
Discomfort	55.14	15.85	3	34723	214704	110339869
Varicose vein	53.50	15.85	31	34695	6909	110547664
Faecaloma	52.67	15.85	41	34685	14867	110539706
Pelvic mass	52.37	15.85	19	34707	1430	110553143
Dysuria	51.48	15.85	78	34648	60153	110494420
Malignant transformation	51.42	15.85	19	34707	1506	110553067
Thrombophlebitis migrans	51.24	15.85	16	34710	758	110553815
Epistaxis	50.08	15.85	120	34606	130252	110424321
Anuria	49.71	15.85	49	34677	24292	110530281
Bradycardia	49.19	15.85	133	34593	155384	110399189
Cardiovascular disorder	48.69	15.85	47	34679	22713	110531860
Alopecia	48.63	15.85	27	34699	364726	110189847
Pseudomonal sepsis	48.35	15.85	32	34694	9014	110545559
Angina pectoris	48.12	15.85	77	34649	62218	110492355
Left ventricular dysfunction	47.43	15.85	47	34679	23446	110531127
Blood urea abnormal	47.42	15.85	19	34707	1875	110552698
Inflammatory marker increased	47.27	15.85	38	34688	14431	110540142
Haematemesis	46.95	15.85	74	34652	59034	110495539
Toxicity to various agents	46.93	15.85	49	34677	480506	110074067
Mobility decreased	46.59	15.85	9	34717	237413	110317160
Postoperative wound infection	46.49	15.85	39	34687	15714	110538859
Urticaria	46.42	15.85	21	34705	318836	110235737
Depression	46.04	15.85	21	34705	317314	110237259
Joint swelling	45.72	15.85	43	34683	442802	110111771
Blood electrolytes abnormal	45.45	15.85	19	34707	2089	110552484
Anticoagulant-related nephropathy	45.30	15.85	11	34715	200	110554373
Faeces discoloured	44.30	15.85	54	34672	33894	110520679
Duodenal ulcer perforation	44.07	15.85	3	34723	177697	110376876
Systemic lupus erythematosus	43.33	15.85	13	34713	254325	110300248
Hepatic function abnormal	43.05	15.85	90	34636	89205	110465368
Treatment failure	42.36	15.85	17	34709	277217	110277356
Sinus node dysfunction	41.22	15.85	29	34697	9018	110545555
Anxiety	41.22	15.85	29	34697	345049	110209524
Type 2 diabetes mellitus	41.16	15.85	4	34722	177228	110377345
Exposure during pregnancy	41.02	15.85	3	34723	167421	110387152
Hepatic enzyme increased	41.00	15.85	25	34701	320867	110233706
Pulmonary hypertension	40.94	15.85	67	34659	55153	110499420
Asthma	40.50	15.85	14	34712	250277	110304296
Fall	40.08	15.85	325	34401	603157	109951416
Urogenital haemorrhage	39.98	15.85	14	34712	950	110553623
Escherichia infection	39.71	15.85	43	34683	23773	110530800
Respiratory tract haemorrhage	39.59	15.85	17	34709	1997	110552576
Putamen haemorrhage	39.18	15.85	12	34714	533	110554040
Internal haemorrhage	38.44	15.85	29	34697	10042	110544531
Gastrointestinal disorder	38.35	15.85	14	34712	241938	110312635
Gastric haemorrhage	38.14	15.85	35	34691	15880	110538693
Paronychia	38.12	15.85	30	34696	11051	110543522
Colon cancer	37.16	15.85	35	34691	16408	110538165
Therapeutic product effect incomplete	37.12	15.85	12	34714	223793	110330780
Thalamus haemorrhage	36.72	15.85	16	34710	1948	110552625
Injection site pain	36.52	15.85	6	34720	177916	110376657
Carotid artery occlusion	35.31	15.85	27	34699	9538	110545035
Aortic dissection	35.30	15.85	21	34705	4912	110549661
Hormone-dependent prostate cancer	35.14	15.85	9	34717	205	110554368
Blood pressure decreased	34.96	15.85	97	34629	114994	110439579
Blister	34.64	15.85	14	34712	227362	110327211
Atrioventricular block	34.51	15.85	34	34692	16843	110537730
Sleep disorder	34.11	15.85	10	34716	198634	110355939
Atrial tachycardia	34.08	15.85	26	34700	9152	110545421
Product used for unknown indication	33.50	15.85	15	34711	1948	110552625
Helicobacter infection	33.42	15.85	8	34718	181869	110372704
Osteopenia	33.41	15.85	38	34688	22171	110532402
Diverticulum intestinal haemorrhagic	33.36	15.85	20	34706	4743	110549830
Headache	32.84	15.85	154	34572	882223	109672350
Cerebral artery embolism	32.45	15.85	15	34711	2097	110552476
Wheezing	32.44	15.85	20	34706	255210	110299363
Aplastic anaemia	32.26	15.85	39	34687	24269	110530304
Injury	32.18	15.85	8	34718	177257	110377316
Metastases to lymph nodes	32.08	15.85	31	34695	15001	110539572
Metastases to nervous system	31.96	15.85	9	34717	297	110554276
Hypovitaminosis	30.94	15.85	13	34713	1447	110553126
Decreased appetite	30.88	15.85	255	34471	475591	110078982
Haemothorax	30.79	15.85	22	34704	7009	110547564
Intentional overdose	30.74	15.85	3	34723	132498	110422075
Therapeutic drug monitoring analysis not performed	30.56	15.85	14	34712	1917	110552656
Malignant neoplasm progression	30.49	15.85	122	34604	174445	110380128
Myelodysplastic syndrome	29.86	15.85	47	34679	37437	110517136
Arthralgia	29.63	15.85	135	34591	779497	109775076
Hypoaesthesia	29.59	15.85	33	34693	314190	110240383
Intentional product use issue	29.38	15.85	21	34705	247885	110306688
Rash	28.96	15.85	146	34580	820818	109733755
Electrolyte imbalance	28.91	15.85	46	34680	36982	110517591
Liver injury	28.88	15.85	6	34720	150407	110404166
Night sweats	28.68	15.85	4	34722	133979	110420594
Cholangitis	28.13	15.85	30	34696	16305	110538268
Procedural failure	27.57	15.85	7	34719	154	110554419
Endocarditis noninfective	27.50	15.85	8	34718	297	110554276
Joint dislocation	27.42	15.85	43	34683	34147	110520426
Hydronephrosis	27.17	15.85	33	34693	20632	110533941
Anticoagulation drug level abnormal	27.12	15.85	8	34718	312	110554261
Product use issue	26.94	15.85	35	34691	311660	110242913
Glomerular filtration rate decreased	26.89	15.85	39	34687	28917	110525656
Tachypnoea	26.80	15.85	46	34680	39349	110515224
Ill-defined disorder	26.74	15.85	8	34718	156845	110397728
Pleural effusion	26.23	15.85	118	34608	177591	110376982
Immobilisation syndrome	26.21	15.85	10	34716	866	110553707
Pulmonary alveolar haemorrhage	26.20	15.85	32	34694	20118	110534455
Vascular device infection	26.12	15.85	29	34697	16483	110538090
Arthritis	26.04	15.85	10	34716	167576	110386997
Duodenal ulcer haemorrhage	26.02	15.85	21	34705	8016	110546557
Hormone-refractory prostate cancer	25.84	15.85	10	34716	900	110553673
Brain natriuretic peptide increased	25.60	15.85	24	34702	11185	110543388
Cardiac tamponade	25.42	15.85	24	34702	11283	110543290
Cardiospasm	25.17	15.85	17	34709	4950	110549623
Haemorrhagic diathesis	25.12	15.85	20	34706	7488	110547085
Coagulation time prolonged	25.09	15.85	14	34712	2903	110551670
Metastases to central nervous system	24.58	15.85	33	34693	22784	110531789
BRASH syndrome	24.45	15.85	15	34711	3708	110550865
Thirst	24.31	15.85	32	34694	21675	110532898
Blood chromogranin A increased	24.23	15.85	9	34717	724	110553849
Sopor	23.98	15.85	42	34684	36504	110518069
Hiatus hernia	23.94	15.85	36	34690	27570	110527003
Palmoplantar keratoderma	23.92	15.85	17	34709	5370	110549203
Small intestinal haemorrhage	23.87	15.85	16	34710	4602	110549971
Chorea	23.75	15.85	14	34712	3221	110551352
Aneurysm ruptured	23.66	15.85	10	34716	1130	110553443
Brain oedema	23.41	15.85	38	34688	31060	110523513
Loss of personal independence in daily activities	23.23	15.85	9	34717	150011	110404562
Tracheal pain	23.09	15.85	5	34721	53	110554520
Endoscopy upper gastrointestinal tract	23.09	15.85	6	34720	145	110554428
Pulmonary toxicity	22.78	15.85	28	34698	17718	110536855
Haemorrhage intracranial	22.63	15.85	36	34690	28933	110525640
Psoriasis	22.35	15.85	8	34718	139985	110414588
Fluid intake reduced	22.08	15.85	18	34708	6968	110547605
Oesophageal mucosal tear	22.04	15.85	4	34722	15	110554558
Lung disorder	21.66	15.85	15	34711	180032	110374541
Anticoagulation drug level increased	21.65	15.85	9	34717	976	110553597
Loss of consciousness	21.63	15.85	120	34606	196186	110358387
Vertebrobasilar insufficiency	21.61	15.85	7	34719	374	110554199
Haemoptysis	21.53	15.85	60	34666	71294	110483279
Varicella virus test positive	21.24	15.85	7	34719	395	110554178
Cerebral artery occlusion	21.23	15.85	11	34715	1969	110552604
Road traffic accident	21.21	15.85	4	34722	107394	110447179
Pruritus genital	21.03	15.85	17	34709	6505	110548068
Pneumonia bacterial	21.02	15.85	33	34693	26228	110528345
Peri-implantitis	20.99	15.85	6	34720	209	110554364
Embolic cerebral infarction	20.99	15.85	10	34716	1496	110553077
Sleep terror	20.83	15.85	17	34709	6593	110547980
Obesity	20.79	15.85	5	34721	113346	110441227
Acute on chronic liver failure	20.68	15.85	7	34719	429	110554144
Renal infarct	20.58	15.85	13	34713	3382	110551191
Transient ischaemic attack	20.50	15.85	55	34671	63927	110490646
Influenza	20.46	15.85	14	34712	169087	110385486
Wound infection	20.37	15.85	3	34723	96462	110458111
Drug eruption	20.17	15.85	49	34677	53610	110500963
Oliguria	20.12	15.85	27	34699	18630	110535943
Coma	20.11	15.85	6	34720	117863	110436710
Palpitations	20.06	15.85	101	34625	159111	110395462
Atrial thrombosis	19.96	15.85	14	34712	4332	110550241
Marasmus	19.89	15.85	10	34716	1681	110552892
Gastrointestinal stoma output decreased	19.73	15.85	6	34720	260	110554313
Pulmonary fibrosis	19.73	15.85	4	34722	102038	110452535
Injection site erythema	19.72	15.85	3	34723	94173	110460400
Pain in extremity	19.29	15.85	83	34643	487035	110067538
Post procedural haemorrhage	19.15	15.85	24	34702	15488	110539085
Haemorrhagic infarction	19.12	15.85	8	34718	881	110553692
Product use in unapproved indication	19.11	15.85	74	34652	447303	110107270
Embolism arterial	18.99	15.85	10	34716	1849	110552724
Lower gastrointestinal haemorrhage	18.80	15.85	26	34700	18460	110536113
Hypercholesterolaemia	18.78	15.85	3	34723	90834	110463739
Balanoposthitis	18.76	15.85	9	34717	1367	110553206
Cholangitis acute	18.72	15.85	10	34716	1903	110552670
Off label use	18.53	15.85	346	34380	1499839	109054734
Pericarditis	18.52	15.85	25	34701	219089	110335484
Osteoarthritis	18.51	15.85	18	34708	182605	110371968
Hypotension	18.41	15.85	248	34478	523601	110030972
Contraindicated product administered	18.40	15.85	31	34695	248236	110306337
Anal haemorrhage	18.32	15.85	14	34712	4938	110549635
Injection site reaction	18.28	15.85	3	34723	89067	110465506
Ventricular arrhythmia	18.21	15.85	19	34707	10068	110544505
Disseminated intravascular coagulation	18.04	15.85	40	34686	41246	110513327
Rhinorrhoea	17.93	15.85	5	34721	102661	110451912
Altered state of consciousness	17.92	15.85	49	34677	57577	110496996
Haemobilia	17.92	15.85	7	34719	646	110553927
Soft tissue mass	17.84	15.85	9	34717	1524	110553049
Duodenal ulcer	17.71	15.85	26	34700	19488	110535085
Restlessness	17.66	15.85	48	34678	56211	110498362
Gastroenteritis clostridial	17.64	15.85	8	34718	1070	110553503
Coagulation test abnormal	17.55	15.85	9	34717	1577	110552996
Pruritus	17.45	15.85	109	34617	581451	109973122
Inflammation	17.42	15.85	21	34705	193217	110361356
Cardiomegaly	17.23	15.85	32	34694	29098	110525475
Rhonchi	17.22	15.85	13	34713	4505	110550068
Tension headache	17.16	15.85	18	34708	9600	110544973
Insomnia	17.15	15.85	57	34669	360533	110194040
Prothrombin time prolonged	17.14	15.85	24	34702	17237	110537336
Cerebrovascular accident	16.86	15.85	106	34620	181178	110373395
Blindness	16.77	15.85	36	34690	36323	110518250
Gastrointestinal angiodysplasia	16.58	15.85	8	34718	1230	110553343
Stomatitis	16.36	15.85	38	34688	270204	110284369
Monoplegia	16.26	15.85	13	34713	4896	110549677
Occult blood	16.22	15.85	9	34717	1847	110552726
Bleeding time prolonged	16.20	15.85	8	34718	1294	110553279
Muscle spasms	16.14	15.85	40	34686	278117	110276456
Cerebellar haemorrhage	16.11	15.85	11	34715	3260	110551313
Urosepsis	16.06	15.85	32	34694	30643	110523930
Hypokalaemia	15.94	15.85	105	34621	182343	110372230
Postrenal failure	15.93	15.85	7	34719	869	110553704
Eosinophil count decreased	15.93	15.85	14	34712	6004	110548569
Circulatory collapse	15.88	15.85	39	34687	42954	110511619

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

Source	Code	Description
ATC	B01AF03	BLOOD AND BLOOD FORMING ORGANS ANTITHROMBOTIC AGENTS ANTITHROMBOTIC AGENTS Direct factor Xa inhibitors
MeSH PA	D000925	Anticoagulants
MeSH PA	D000991	Antithrombins
MeSH PA	D004791	Enzyme Inhibitors
MeSH PA	D006401	Hematologic Agents
MeSH PA	D011480	Protease Inhibitors
MeSH PA	D015842	Serine Proteinase Inhibitors
MeSH PA	D065427	Factor Xa Inhibitors
FDA MoA	N0000175635	Factor Xa Inhibitors
FDA EPC	N0000175637	Factor Xa Inhibitor
CHEBI has role	CHEBI:22587	antiviral agent
CHEBI has role	CHEBI:35554	cardiovascular drug
CHEBI has role	CHEBI:38070	anti-arrhythmia drug
CHEBI has role	CHEBI:50249	anticoagulant
CHEBI has role	CHEBI:50427	platelet aggregation inhibitor
CHEBI has role	CHEBI:62868	hepatoprotective agent
CHEBI has role	CHEBI:68581	EC 3.4.21.6 (coagulation factor Xa) inhibitor

Related Drugs by ATC class:

B01AF Direct factor Xa inhibitors 4 drugs

acetylsalicylic acidapixabanbetrixabanrivaroxaban

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

Disease	Relation	SNOMED_ID	DOID
Pulmonary embolism	indication	59282003	DOID:9477
Embolism	indication	414086009
Ischemic stroke	indication	422504002
Prevention of deep vein thrombosis	indication	439993001

🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation level	Dissociation constant	Type (acidic/basic)
pKa1	11.7	acidic
pKa2	12.4	acidic
pKa3	6.8	Basic
pKa4	3.01	Basic
pKa5	2.14	Basic

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Exclusivity date	Description
EQ 15MG BASE	SAVAYSA	DAIICHI SANKYO INC	N206316	Jan. 8, 2015	RX	TABLET	ORAL	Oct. 18, 2026	ADDITIONAL CLINICAL TRIAL INFORMATION ADDED TO PEDIATRIC USE SUBSECTION
EQ 30MG BASE	SAVAYSA	DAIICHI SANKYO INC	N206316	Jan. 8, 2015	RX	TABLET	ORAL	Oct. 18, 2026	ADDITIONAL CLINICAL TRIAL INFORMATION ADDED TO PEDIATRIC USE SUBSECTION
EQ 60MG BASE	SAVAYSA	DAIICHI SANKYO INC	N206316	Jan. 8, 2015	RX	TABLET	ORAL	Oct. 18, 2026	ADDITIONAL CLINICAL TRIAL INFORMATION ADDED TO PEDIATRIC USE SUBSECTION

Bioactivity Summary:

Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Mechanism action	Bioact source	MoA source
Coagulation factor X	Enzyme	P00742	FA10_HUMAN	INHIBITOR	Ki	9.25		SCIENTIFIC LITERATURE	SCIENTIFIC LITERATURE
Prothrombin	Enzyme	P00734	THRB_HUMAN		Ki	5.22		CHEMBL

External reference:

ID	Source
D09546	KEGG_DRUG
480449-71-6	SECONDARY_CAS_RN
4034081	VANDF
CHEBI:85974	CHEBI
CHEMBL1269025	ChEMBL_ID
CHEMBL2105682	ChEMBL_ID
C552171	MESH_SUPPLEMENTAL_RECORD_UI
7575	IUPHAR_LIGAND_ID
DB09075	DRUGBANK_ID
1599538	RXNORM
232451	MMSL
30841	MMSL
30865	MMSL
d08338	MMSL
015852	NDDF
015853	NDDF
1162278009	SNOMEDCT_US
712778008	SNOMEDCT_US
714687009	SNOMEDCT_US
C2975435	UMLSCUI
8982	INN_ID
10280735	PUBCHEM_CID
NDU3J18APO	UNII
NDU3J18APO	INXIGHT DRUGS

Pharmaceutical products:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
SAVAYSA	HUMAN PRESCRIPTION DRUG LABEL	1	65597-201	TABLET, FILM COATED	15 mg	ORAL	NDA	33 sections
SAVAYSA	HUMAN PRESCRIPTION DRUG LABEL	1	65597-202	TABLET, FILM COATED	30 mg	ORAL	NDA	33 sections
SAVAYSA	HUMAN PRESCRIPTION DRUG LABEL	1	65597-203	TABLET, FILM COATED	60 mg	ORAL	NDA	33 sections