dabigatran etexilate Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definition	Drug id	CAS RN
thrombin inhibitors, antithrombotic agents	776	211915-06-9

Description:

Molecule

Description

Molfile Inchi Smiles Synonyms: BIBR 1048 BIBR-1048 dabigatran etexilate mesilate dabigatran etexilate pradaxa dabigatran etexilate mesylate dabigatran etexilate methanesulfonate

A THROMBIN inhibitor which acts by binding and blocking thrombogenic activity and the prevention of thrombus formation. It is used to reduce the risk of stroke and systemic EMBOLISM in patients with nonvalvular atrial fibrillation. Molecular weight: 627.75 Formula: C34H41N7O5 CLOGP: 4.71 LIPINSKI: 2 HAC: 12 HDO: 3 TPSA: 151.53 ALOGS: -4.68 ROTB: 17 Status: OFP Legend: OFP - off patent OFM - off market ONP - on patent

Drug dosage:

Dose	Unit	Route
0.30	g	O

ADMET properties:

Property	Value	Reference
BDDCS (Biopharmaceutical Drug Disposition Classification System)	1	Benet LZ, Broccatelli F, Oprea TI
S (Water solubility)	1.80 mg/mL	Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine)	0 %	Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose)	6.83 µM/kg/day	Contrera JF, Matthews EJ, Kruhlak NL, Benz RD

Approvals:

Date	Agency	Company	Orphan
Oct. 19, 2010	FDA	BOEHRINGER INGELHEIM

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
Gastrointestinal haemorrhage	4291.33	14.69	1799	40976	78531	53227760
Ischaemic stroke	2230.07	14.69	749	42026	17244	53289047
Cerebrovascular accident	1465.85	14.69	959	41816	104215	53202076
Haemorrhage	1184.72	14.69	676	42099	57311	53248980
Melaena	999.86	14.69	481	42294	28648	53277643
Rectal haemorrhage	976.27	14.69	531	42244	40950	53265341
Haemorrhage intracranial	893.06	14.69	353	42422	12999	53293292
Cerebral haemorrhage	702.66	14.69	383	42392	29613	53276678
Lower gastrointestinal haemorrhage	653.08	14.69	241	42534	7325	53298966
Activated partial thromboplastin time prolonged	591.45	14.69	220	42555	6839	53299452
Cardiac tamponade	469.93	14.69	166	42609	4434	53301857
Subdural haematoma	440.19	14.69	217	42558	13596	53292695
Cerebral infarction	437.62	14.69	262	42513	24182	53282109
Embolic stroke	391.51	14.69	138	42637	3661	53302630
Blood loss anaemia	365.19	14.69	166	42609	8657	53297634
Shock haemorrhagic	365.09	14.69	168	42607	9015	53297276
Haematoma	362.14	14.69	263	42512	33581	53272710
International normalised ratio increased	354.58	14.69	299	42476	47462	53258829
Fall	336.86	14.69	826	41949	357614	52948677
Coagulopathy	334.14	14.69	204	42571	19494	53286797
Upper gastrointestinal haemorrhage	333.32	14.69	195	42580	17235	53289056
Haematochezia	322.29	14.69	269	42506	42089	53264202
Transient ischaemic attack	305.74	14.69	243	42532	35482	53270809
Haematuria	288.74	14.69	214	42561	28175	53278116
Haemorrhagic stroke	285.53	14.69	123	42652	5635	53300656
Pericardial haemorrhage	261.15	14.69	82	42693	1501	53304790
Procoagulant therapy	251.33	14.69	41	42734	0	53306291
Anaemia	249.21	14.69	628	42147	276090	53030201
Atrial thrombosis	243.58	14.69	77	42698	1442	53304849
Haematemesis	226.48	14.69	192	42583	30665	53275626
Thrombin time prolonged	223.25	14.69	43	42732	67	53306224
Subarachnoid haemorrhage	221.95	14.69	131	42644	11762	53294529
Deep vein thrombosis	213.16	14.69	296	42479	82617	53223674
Pain	201.70	14.69	111	42664	588287	52718004
Rheumatoid arthritis	198.38	14.69	14	42761	314517	52991774
Pulmonary embolism	197.81	14.69	340	42435	114102	53192189
Intestinal haemorrhage	195.60	14.69	81	42694	3359	53302932
Acute kidney injury	189.78	14.69	538	42237	253330	53052961
Haemoglobin decreased	186.96	14.69	368	42407	136939	53169352
Atrial fibrillation	179.05	14.69	321	42454	111331	53194960
Hemiparesis	168.69	14.69	139	42636	21336	53284955
Renal failure	167.95	14.69	323	42452	118129	53188162
Epistaxis	157.02	14.69	232	42543	68478	53237813
Hypovolaemic shock	155.01	14.69	80	42695	5517	53300774
Subdural haemorrhage	144.93	14.69	63	42712	2949	53303342
Drug hypersensitivity	143.48	14.69	21	42754	265221	53041070
Aortic dissection	134.54	14.69	51	42724	1669	53304622
Cardiac failure	131.45	14.69	242	42533	85602	53220689
Fatigue	128.55	14.69	245	42530	730261	52576030
Renal impairment	111.69	14.69	222	42553	83096	53223195
Wound secretion	109.93	14.69	58	42717	4185	53302106
Prothrombin time prolonged	108.79	14.69	78	42697	9744	53296547
Cerebral haematoma	108.32	14.69	54	42721	3460	53302831
Haemoptysis	106.94	14.69	122	42653	27917	53278374
Hemiplegia	105.37	14.69	70	42705	7730	53298561
Haemothorax	104.27	14.69	45	42730	2069	53304222
Maternal exposure during pregnancy	103.87	14.69	5	42770	155634	53150657
Peripheral embolism	103.76	14.69	39	42736	1246	53305045
Creatinine renal clearance decreased	103.13	14.69	78	42697	10573	53295718
Procedural haemorrhage	102.08	14.69	47	42728	2522	53303769
Pyrexia	101.90	14.69	104	42671	403089	52903202
Head injury	101.24	14.69	114	42661	25719	53280572
Coagulation time prolonged	99.04	14.69	38	42737	1286	53305005
Rash	98.81	14.69	128	42647	446063	52860228
Gastric haemorrhage	94.53	14.69	60	42715	6131	53300160
Infusion related reaction	89.94	14.69	10	42765	155947	53150344
Large intestinal haemorrhage	86.68	14.69	34	42741	1222	53305069
Arthralgia	85.70	14.69	138	42637	439645	52866646
Haemorrhoidal haemorrhage	85.36	14.69	48	42727	3930	53302361
Faeces discoloured	85.06	14.69	87	42688	17599	53288692
Drug ineffective	83.74	14.69	355	42420	816890	52489401
Dyspepsia	82.29	14.69	188	42587	77412	53228879
Post procedural haemorrhage	80.81	14.69	60	42715	7908	53298383
Systemic lupus erythematosus	80.66	14.69	5	42770	125409	53180882
Traumatic haemorrhage	78.93	14.69	25	42750	471	53305820
Drug intolerance	78.90	14.69	33	42742	205460	53100831
Aphasia	77.68	14.69	109	42666	30669	53275622
Haemorrhagic transformation stroke	77.67	14.69	31	42744	1167	53305124
Nasopharyngitis	75.25	14.69	30	42745	192265	53114026
Joint swelling	74.80	14.69	48	42727	234590	53071701
Anxiety	73.28	14.69	33	42742	196671	53109620
Therapeutic product effect decreased	72.59	14.69	8	42767	125647	53180644
Pericardial effusion	72.43	14.69	99	42676	27179	53279112
Arthropathy	72.38	14.69	13	42762	141440	53164851
Embolism	70.55	14.69	54	42721	7449	53298842
Sinusitis	69.82	14.69	24	42751	168540	53137751
Cerebral artery occlusion	69.08	14.69	27	42748	961	53305330
Injection site pain	68.69	14.69	6	42769	113385	53192906
Musculoskeletal stiffness	68.44	14.69	9	42766	123359	53182932
International normalised ratio abnormal	68.16	14.69	38	42737	3059	53303232
Condition aggravated	68.01	14.69	83	42692	297051	53009240
Pulmonary haemorrhage	67.62	14.69	51	42724	6882	53299409
Mouth haemorrhage	67.43	14.69	50	42725	6576	53299715
Hypersensitivity	67.27	14.69	43	42732	210622	53095669
Headache	66.73	14.69	215	42560	536606	52769685
Depression	66.18	14.69	32	42743	183020	53123271
Gingival bleeding	65.55	14.69	64	42711	12244	53294047
Splenic rupture	65.05	14.69	28	42747	1279	53305012
Weight increased	64.98	14.69	42	42733	204525	53101766
Thrombin time abnormal	64.78	14.69	11	42764	3	53306288
International normalised ratio	64.32	14.69	15	42760	80	53306211
Nausea	62.54	14.69	354	42421	755737	52550554
Contraindicated product administered	62.18	14.69	16	42759	135613	53170678
Neutropenia	62	14.69	25	42750	159160	53147131
Product dose omission issue	61.32	14.69	39	42736	191581	53114710
Drug interaction	60.99	14.69	341	42434	218988	53087303
Activated partial thromboplastin time abnormal	60.35	14.69	15	42760	109	53306182
Craniocerebral injury	59.92	14.69	32	42743	2366	53303925
Anticoagulation drug level increased	59.87	14.69	17	42758	216	53306075
Thrombosis	59.76	14.69	143	42632	60650	53245641
Hip fracture	59.64	14.69	92	42683	28165	53278126
Treatment failure	59.15	14.69	15	42760	128388	53177903
Glossodynia	58.91	14.69	6	42769	100285	53206006
Cardiac valve replacement complication	58.38	14.69	16	42759	177	53306114
Peripheral swelling	58.08	14.69	48	42727	206060	53100231
Intestinal ischaemia	57.73	14.69	48	42727	7454	53298837
Peripheral ischaemia	57.37	14.69	40	42735	4779	53301512
Intra-abdominal haemorrhage	56.71	14.69	31	42744	2401	53303890
Cerebral ischaemia	56.24	14.69	45	42730	6620	53299671
Intracardiac thrombus	56.04	14.69	31	42744	2458	53303833
Puncture site haemorrhage	55.91	14.69	17	42758	278	53306013
Product use issue	55.88	14.69	21	42754	139563	53166728
Strangulated hernia	54.89	14.69	12	42763	45	53306246
Cerebral artery embolism	54.75	14.69	22	42753	843	53305448
Colon cancer	54.04	14.69	52	42723	9773	53296518
Iron deficiency anaemia	53.25	14.69	70	42705	18510	53287781
Toxicity to various agents	52.73	14.69	59	42716	219539	53086752
Acute abdomen	52.65	14.69	26	42749	1632	53304659
Traumatic intracranial haemorrhage	52.58	14.69	17	42758	343	53305948
Retroperitoneal haemorrhage	51.69	14.69	31	42744	2863	53303428
Blood urine present	50.97	14.69	58	42717	13227	53293064
Gastritis erosive	49.77	14.69	39	42736	5567	53300724
Swelling	49.64	14.69	48	42727	191057	53115234
Alopecia	49.06	14.69	70	42705	234513	53071778
Cardiac perforation	46.96	14.69	11	42764	60	53306231
Embolic cerebral infarction	46.39	14.69	17	42758	505	53305786
Infection	46.20	14.69	42	42733	172163	53134128
Back pain	45.99	14.69	73	42702	234174	53072117
Haemarthrosis	45.75	14.69	30	42745	3240	53303051
Shock	45.59	14.69	73	42702	23066	53283225
Chills	45.03	14.69	14	42761	104834	53201457
Death	44.23	14.69	459	42316	356773	52949518
Neuropathy peripheral	43.92	14.69	14	42761	103173	53203118
Haemoperitoneum	43.89	14.69	27	42748	2610	53303681
Acute myocardial infarction	43.82	14.69	88	42687	33147	53273144
Multiple organ dysfunction syndrome	43.37	14.69	120	42655	55557	53250734
Lower respiratory tract infection	43.12	14.69	10	42765	90971	53215320
Peripheral artery thrombosis	43.12	14.69	24	42751	1926	53304365
Contusion	42.70	14.69	189	42586	110543	53195748
Microcytic anaemia	42.42	14.69	29	42746	3356	53302935
Haemorrhage subcutaneous	42.38	14.69	28	42747	3063	53303228
Stomatitis	42.34	14.69	13	42762	98145	53208146
Femoral neck fracture	41.70	14.69	42	42733	8341	53297950
Disease progression	41.34	14.69	15	42760	101905	53204386
Vaginal haemorrhage	40.19	14.69	75	42700	26766	53279525
Intraventricular haemorrhage	39.67	14.69	23	42752	1995	53304296
Colitis ischaemic	39.24	14.69	46	42729	10828	53295463
Pruritus	39.01	14.69	114	42661	293718	53012573
Discomfort	38.81	14.69	14	42761	95458	53210833
Haemorrhagic cerebral infarction	38.61	14.69	16	42759	664	53305627
Diverticulum	37.88	14.69	47	42728	11732	53294559
Wound haemorrhage	37.76	14.69	23	42752	2184	53304107
Hypocoagulable state	37.66	14.69	18	42757	1051	53305240
Cerebral mass effect	37.22	14.69	17	42758	895	53305396
Product use in unapproved indication	37.09	14.69	22	42753	112267	53194024
Asthma	36.49	14.69	21	42754	108951	53197340
Skull fracture	35.97	14.69	17	42758	968	53305323
Skin haemorrhage	35.68	14.69	35	42740	6732	53299559
Subcutaneous haematoma	35.55	14.69	20	42755	1638	53304653
Exsanguination	34.90	14.69	7	42768	15	53306276
Diverticulum intestinal haemorrhagic	34.38	14.69	18	42757	1278	53305013
Prothrombin time abnormal	34.33	14.69	13	42762	424	53305867
Ischaemic cerebral infarction	34.20	14.69	18	42757	1292	53304999
Influenza	33.95	14.69	17	42758	95362	53210929
Prothrombin time shortened	33.78	14.69	20	42755	1804	53304487
Coagulation test abnormal	33.70	14.69	15	42760	743	53305548
Drug abuse	33.55	14.69	6	42769	65520	53240771
Wound	33.07	14.69	16	42759	91541	53214750
White blood cell count decreased	32.61	14.69	31	42744	124444	53181847
Cardiac failure congestive	32.54	14.69	154	42621	92603	53213688
Intentional product use issue	32.37	14.69	9	42766	72485	53233806
Mesenteric artery embolism	32.14	14.69	6	42769	7	53306284
Stress	32.04	14.69	4	42771	57080	53249211
Upper respiratory tract infection	31.95	14.69	8	42767	69089	53237202
Anticoagulation drug level above therapeutic	31.63	14.69	17	42758	1273	53305018
Small intestinal haemorrhage	31.09	14.69	20	42755	2091	53304200
Pelvic haematoma	31.07	14.69	13	42762	553	53305738
Coagulation factor increased	30.90	14.69	6	42769	10	53306281
Incarcerated hernia	30.57	14.69	9	42766	131	53306160
Ecchymosis	30.54	14.69	41	42734	11058	53295233
Psoriasis	30.29	14.69	16	42759	87073	53219218
Post procedural haematoma	30.24	14.69	17	42758	1391	53304900
Prothrombin time ratio decreased	30.11	14.69	12	42763	450	53305841
Ischaemia	29.90	14.69	27	42748	4681	53301610
Constipation	29.31	14.69	73	42702	198339	53107952
Diarrhoea	29.29	14.69	341	42434	625205	52681086
Cough	29.01	14.69	107	42668	256786	53049505
Intracranial haematoma	28.78	14.69	11	42764	368	53305923
Gastric ulcer haemorrhage	28.14	14.69	27	42748	5055	53301236
Hypochromic anaemia	28.07	14.69	18	42757	1871	53304420
Oesophageal ulcer	28.05	14.69	25	42750	4261	53302030
Femoral artery embolism	27.91	14.69	7	42768	53	53306238
Haematocrit decreased	27.63	14.69	79	42696	37252	53269039
Therapeutic response decreased	27.53	14.69	3	42772	47566	53258725
Insomnia	27.49	14.69	69	42706	187003	53119288
Brain contusion	27.26	14.69	12	42763	579	53305712
Phlebitis	27.17	14.69	29	42746	6158	53300133
Road traffic accident	27.03	14.69	62	42713	25569	53280722
Heart transplant	27	14.69	11	42764	437	53305854
Brain herniation	26.92	14.69	22	42753	3334	53302957
Gastritis haemorrhagic	26.77	14.69	16	42759	1468	53304823
Therapeutic product effect incomplete	26.29	14.69	21	42754	91763	53214528
Neutrophil count decreased	26.24	14.69	4	42771	49094	53257197
Atrial flutter	25.74	14.69	35	42740	9556	53296735
Paraesthesia	25.70	14.69	39	42736	127476	53178815
Occult blood positive	25.35	14.69	22	42753	3620	53302671
Pulmonary alveolar haemorrhage	25.32	14.69	24	42751	4426	53301865
Rhinorrhoea	25.16	14.69	6	42769	53572	53252719
Mobility decreased	25.10	14.69	15	42760	76256	53230035
Oesophageal pain	24.62	14.69	20	42755	3006	53303285
Dysphagia	24.59	14.69	133	42642	84264	53222027
Disseminated intravascular coagulation	24.55	14.69	51	42724	19668	53286623
Suicidal ideation	24.37	14.69	9	42766	60502	53245789
Pelvic fracture	24.34	14.69	39	42736	12325	53293966
Petechiae	24.21	14.69	41	42734	13564	53292727
Hepatic enzyme increased	24.10	14.69	40	42735	126155	53180136
Pericarditis	23.65	14.69	11	42764	64395	53241896
Hypotension	23.58	14.69	309	42466	253767	53052524
Impaired healing	23.52	14.69	11	42764	64194	53242097
Basal ganglia haemorrhage	23.41	14.69	11	42764	618	53305673
Conjunctival haemorrhage	23.40	14.69	20	42755	3224	53303067
Intestinal infarction	23.15	14.69	13	42762	1061	53305230
Gastrointestinal necrosis	22.79	14.69	19	42756	2961	53303330
Haemoglobin abnormal	22.73	14.69	23	42752	4591	53301700
Irritable bowel syndrome	22.32	14.69	4	42771	43628	53262663
Prothrombin time	22.23	14.69	5	42770	22	53306269
Gastric ulcer	21.91	14.69	54	42721	23315	53282976
Arterial haemorrhage	21.75	14.69	15	42760	1761	53304530
Weight decreased	21.51	14.69	106	42669	234842	53071449
Haemorrhagic diathesis	21.48	14.69	22	42753	4456	53301835
Influenza like illness	21.43	14.69	11	42764	60848	53245443
Haemorrhagic arteriovenous malformation	21.39	14.69	7	42768	147	53306144
Hypoaesthesia	21.17	14.69	47	42728	132948	53173343
Haemorrhoids	20.99	14.69	49	42726	20440	53285851
Abdominal wall haematoma	20.65	14.69	18	42757	2980	53303311
Haemorrhage urinary tract	20.60	14.69	11	42764	813	53305478
Pain in extremity	20.52	14.69	139	42636	284911	53021380
Sepsis	20.40	14.69	193	42582	146236	53160055
Cardiogenic shock	20.36	14.69	44	42731	17438	53288853
Osteoarthritis	20.34	14.69	16	42759	70470	53235821
Prothrombin level decreased	20.33	14.69	10	42765	622	53305669
Injection site bruising	20.27	14.69	3	42772	37643	53268648
Vomiting	20.24	14.69	279	42496	496860	52809431
Post procedural haematuria	20.04	14.69	5	42770	37	53306254
Syncope	20.01	14.69	156	42619	111837	53194454
Lacunar infarction	19.81	14.69	19	42756	3555	53302736
Myocardial infarction	19.79	14.69	142	42633	99212	53207079
Gastritis	19.76	14.69	69	42706	36165	53270126
Intentional overdose	19.72	14.69	15	42760	67190	53239101
Cardiac failure chronic	19.69	14.69	20	42755	4010	53302281
Activated partial thromboplastin time	19.52	14.69	4	42771	10	53306281
Neurologic neglect syndrome	19.48	14.69	12	42763	1163	53305128
Splenic haematoma	19.46	14.69	6	42769	103	53306188
Renal infarct	19.36	14.69	13	42762	1461	53304830
Acute coronary syndrome	19.33	14.69	32	42743	10392	53295899
Urticaria	19.28	14.69	51	42724	135834	53170457
Multiple sclerosis relapse	19.23	14.69	6	42769	44847	53261444
Rib fracture	19.16	14.69	47	42728	20231	53286060
Cardioversion	19.13	14.69	12	42763	1201	53305090
Occult blood	19.12	14.69	12	42763	1202	53305089
Helicobacter infection	19.10	14.69	4	42771	39065	53267226
Infarction	18.98	14.69	16	42759	2531	53303760
Ill-defined disorder	18.85	14.69	8	42767	49436	53256855
Thrombotic cerebral infarction	18.75	14.69	6	42769	117	53306174
Overdose	18.66	14.69	149	42626	107587	53198704
Thrombotic stroke	18.65	14.69	9	42766	537	53305754
Malignant neoplasm progression	18.52	14.69	18	42757	71523	53234768
Diverticulitis intestinal haemorrhagic	18.33	14.69	6	42769	126	53306165
Arteriovenous malformation	18.27	14.69	12	42763	1299	53304992
Nasal congestion	18.22	14.69	10	42765	53277	53253014
Cardiac ablation	18.17	14.69	12	42763	1312	53304979
Haemodynamic instability	18.15	14.69	28	42747	8566	53297725
Haemorrhagic disorder	17.86	14.69	10	42765	812	53305479
Spontaneous haematoma	17.80	14.69	10	42765	817	53305474
Migraine	17.79	14.69	23	42752	80394	53225897
Aortic thrombosis	17.70	14.69	11	42764	1083	53305208
Herpes zoster	17.61	14.69	20	42755	73999	53232292
Abdominal wall haemorrhage	17.54	14.69	6	42769	145	53306146
Sleep disorder	17.45	14.69	13	42762	58857	53247434
Arthritis	17.30	14.69	27	42748	87271	53219020
Gastric cancer	17.29	14.69	17	42758	3280	53303011
Brain stem stroke	17.28	14.69	7	42768	274	53306017
Internal haemorrhage	17.17	14.69	20	42755	4676	53301615
Musculoskeletal pain	17.16	14.69	21	42754	75179	53231112
Oesophagitis	17.16	14.69	37	42738	14640	53291651
Rectal perforation	17.15	14.69	8	42767	442	53305849
Cerebellar haemorrhage	17.14	14.69	12	42763	1443	53304848
Therapy non-responder	17.11	14.69	9	42766	49111	53257180
Blood creatinine increased	16.96	14.69	119	42656	82543	53223748
Somnolence	16.93	14.69	73	42702	167661	53138630
Embolism arterial	16.84	14.69	11	42764	1180	53305111
Muscle spasms	16.64	14.69	54	42721	134741	53171550
Loss of personal independence in daily activities	16.46	14.69	19	42756	69796	53236495
Spinal cord haematoma	16.41	14.69	6	42769	177	53306114
Leukopenia	16.26	14.69	21	42754	73442	53232849
Blood glucose increased	16.23	14.69	23	42752	77338	53228953
Rectal ulcer	16.20	14.69	11	42764	1259	53305032
Dysarthria	16.19	14.69	70	42705	40498	53265793
Mucosal inflammation	16.19	14.69	7	42768	42777	53263514
Blood pressure increased	16.18	14.69	58	42717	140421	53165870
Peritonitis	16.15	14.69	46	42729	21641	53284650
Off label use	16.14	14.69	274	42501	471938	52834353
Hospitalisation	16.03	14.69	20	42755	70992	53235299
Type 2 diabetes mellitus	15.99	14.69	3	42772	31667	53274624
Carotid artery occlusion	15.97	14.69	15	42760	2734	53303557
Inappropriate schedule of product administration	15.97	14.69	22	42753	74856	53231435
Hot flush	15.90	14.69	9	42766	47151	53259140
Bronchitis	15.87	14.69	42	42733	111857	53194434
Depressed mood	15.75	14.69	5	42770	36959	53269332
COVID-19	15.70	14.69	5	42770	36883	53269408
Brain stem haemorrhage	15.64	14.69	9	42766	770	53305521
Pancytopenia	15.42	14.69	31	42744	90897	53215394
Duodenal ulcer haemorrhage	15.41	14.69	14	42761	2446	53303845
Extradural haematoma	15.29	14.69	12	42763	1716	53304575
Lymphadenopathy	15.28	14.69	5	42770	36250	53270041
Hypertensive crisis	15.20	14.69	35	42740	14471	53291820
Venous thrombosis limb	15.10	14.69	15	42760	2928	53303363
Erosive oesophagitis	15.10	14.69	12	42763	1747	53304544
Phlebitis deep	15.10	14.69	3	42772	6	53306285
Polyp	15.00	14.69	21	42754	5893	53300398
Globulins decreased	14.86	14.69	6	42769	233	53306058
Myalgia	14.79	14.69	56	42719	133435	53172856
Facial paresis	14.74	14.69	16	42759	3464	53302827
Anaphylactic reaction	14.72	14.69	15	42760	58311	53247980
Tongue haemorrhage	14.71	14.69	7	42768	405	53305886

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
Gastrointestinal haemorrhage	2749.41	14.55	1672	47103	85210	32379541
Ischaemic stroke	2276.08	14.55	890	47885	16686	32448065
Cerebrovascular accident	1644.67	14.55	1214	47561	85106	32379645
Haemorrhage	1092.11	14.55	762	48013	48686	32416065
Haemorrhage intracranial	865.60	14.55	439	48336	15448	32449303
Cerebral infarction	821.62	14.55	513	48262	27101	32437650
Rectal haemorrhage	819.33	14.55	574	48201	36849	32427902
Cerebral haemorrhage	742.04	14.55	525	48250	34222	32430529
Melaena	726.96	14.55	518	48257	34147	32430604
Atrial thrombosis	632.00	14.55	197	48578	1790	32462961
Embolic stroke	628.19	14.55	230	48545	3544	32461207
Subdural haematoma	594.03	14.55	371	48404	19582	32445169
Cardiac tamponade	565.42	14.55	231	48544	4844	32459907
Haematuria	428.86	14.55	441	48334	47920	32416831
Fall	392.81	14.55	890	47885	195311	32269440
Transient ischaemic attack	378.70	14.55	312	48463	25482	32439269
Lower gastrointestinal haemorrhage	367.72	14.55	204	48571	8613	32456138
Activated partial thromboplastin time prolonged	367.41	14.55	201	48574	8254	32456497
Shock haemorrhagic	321.85	14.55	200	48575	10445	32454306
Hemiparesis	307.96	14.55	225	48550	15382	32449369
Upper gastrointestinal haemorrhage	264.53	14.55	246	48529	23603	32441148
Blood loss anaemia	239.17	14.55	149	48626	7813	32456938
Deep vein thrombosis	229.89	14.55	372	48403	63341	32401410
Procoagulant therapy	222.22	14.55	42	48733	10	32464741
Coagulopathy	221.08	14.55	204	48571	19373	32445378
Subarachnoid haemorrhage	211.96	14.55	153	48622	10258	32454493
Pulmonary embolism	210.10	14.55	417	48358	83242	32381509
Pericardial haemorrhage	208.93	14.55	99	48676	2987	32461764
Thrombin time prolonged	206.97	14.55	49	48726	128	32464623
Haemorrhagic stroke	206.71	14.55	126	48649	6352	32458399
Haematoma	202.15	14.55	220	48555	25464	32439287
Aphasia	179.08	14.55	187	48588	20641	32444110
Haemothorax	177.77	14.55	95	48680	3717	32461034
Aortic dissection	165.93	14.55	80	48695	2510	32462241
Hemiplegia	153.37	14.55	108	48667	6960	32457791
Haematemesis	150.18	14.55	196	48579	27439	32437312
Epistaxis	143.21	14.55	281	48494	55574	32409177
Head injury	141.93	14.55	153	48622	17510	32447241
Haemorrhagic transformation stroke	138.30	14.55	58	48717	1300	32463451
Procedural haemorrhage	133.01	14.55	68	48707	2425	32462326
Febrile neutropenia	132.53	14.55	13	48762	119553	32345198
Toxicity to various agents	130.47	14.55	52	48723	177989	32286762
Pyrexia	130.40	14.55	174	48601	319794	32144957
Neutropenia	124.79	14.55	30	48745	142145	32322606
Haematochezia	121.45	14.55	214	48561	38994	32425757
Completed suicide	120.79	14.55	4	48771	92513	32372238
Intracardiac thrombus	115.23	14.55	62	48713	2459	32462292
Subdural haemorrhage	115.11	14.55	66	48709	2967	32461784
Haemoptysis	114.37	14.55	191	48584	33334	32431417
Cerebral haematoma	112.55	14.55	77	48698	4734	32460017
Anaemia	112.45	14.55	644	48131	222980	32241771
Intestinal haemorrhage	105.94	14.55	65	48710	3314	32461437
Peripheral embolism	103.19	14.55	43	48732	948	32463803
Brain contusion	102.35	14.55	41	48734	814	32463937
International normalised ratio increased	99.23	14.55	224	48551	48811	32415940
Post procedural haemorrhage	94.64	14.55	87	48688	8213	32456538
Pericardial effusion	93.51	14.55	142	48633	22860	32441891
Product dose omission issue	93.25	14.55	20	48755	102555	32362196
Fatigue	89.39	14.55	252	48523	350449	32114302
Cardiac failure	87.27	14.55	319	48456	91354	32373397
Colon cancer	86.02	14.55	85	48690	8781	32455970
Oesophageal pain	84.10	14.55	35	48740	769	32463982
Gastric haemorrhage	80.11	14.55	86	48689	9790	32454961
Drug abuse	78.56	14.55	13	48762	80230	32384521
Large intestinal haemorrhage	77.56	14.55	41	48734	1568	32463183
Anticoagulation drug level increased	76.16	14.55	29	48746	500	32464251
Disease progression	74.85	14.55	19	48756	86843	32377908
Faeces discoloured	72.36	14.55	100	48675	14777	32449974
Pain	72.20	14.55	106	48669	187450	32277301
Depression	71.58	14.55	28	48747	97032	32367719
Renal impairment	71.26	14.55	300	48475	91672	32373079
Pancytopenia	71.21	14.55	24	48751	91211	32373540
Hypovolaemic shock	70.63	14.55	68	48707	6804	32457947
Road traffic accident	70.21	14.55	107	48668	17274	32447477
Pulmonary haemorrhage	68.21	14.55	79	48696	9778	32454973
Rash	67.97	14.55	132	48643	209201	32255550
Extradural haematoma	66.72	14.55	34	48741	1204	32463547
Traumatic intracranial haemorrhage	65.69	14.55	28	48747	654	32464097
Nausea	65.50	14.55	254	48521	320595	32144156
Drug hypersensitivity	65.30	14.55	15	48760	73385	32391366
Product use in unapproved indication	64.56	14.55	25	48750	87179	32377572
Blood urine present	64.27	14.55	79	48696	10406	32454345
Cerebral artery occlusion	64.26	14.55	29	48746	780	32463971
Diarrhoea	63.97	14.55	306	48469	364496	32100255
Intraventricular haemorrhage	63.16	14.55	46	48729	3124	32461627
Leukopenia	62.88	14.55	8	48767	60114	32404637
Haemorrhagic infarction	62.80	14.55	24	48751	418	32464333
Embolism	62.68	14.55	66	48709	7348	32457403
Coagulation test abnormal	62.51	14.55	25	48750	494	32464257
Dyspepsia	62.43	14.55	147	48628	32908	32431843
Contusion	61.22	14.55	147	48628	33321	32431430
Urinary bladder haemorrhage	60.29	14.55	36	48739	1746	32463005
White blood cell count decreased	59.90	14.55	31	48744	91167	32373584
Gingival bleeding	58.76	14.55	62	48713	6919	32457832
Tremor	57.41	14.55	25	48750	81252	32383499
Wound secretion	56.38	14.55	40	48735	2607	32462144
Embolic cerebral infarction	55.58	14.55	25	48750	667	32464084
Splenic rupture	55.50	14.55	33	48742	1588	32463163
Cerebral mass effect	55.47	14.55	27	48748	865	32463886
Coagulation time prolonged	54.81	14.55	31	48744	1357	32463394
Traumatic haemorrhage	54.40	14.55	25	48750	702	32464049
Skull fracture	54.02	14.55	27	48748	917	32463834
Anorectal discomfort	53.47	14.55	34	48741	1846	32462905
Insomnia	50.11	14.55	46	48729	100302	32364449
Thrombosis	49.34	14.55	166	48609	45588	32419163
Chills	49.15	14.55	28	48747	78056	32386695
Rheumatoid arthritis	48.90	14.55	5	48770	44539	32420212
Surgery	48.69	14.55	76	48699	12523	32452228
Cerebral artery embolism	47.97	14.55	25	48750	928	32463823
Anxiety	47.95	14.55	44	48731	95961	32368790
Infusion related reaction	47.84	14.55	6	48769	45593	32419158
Cardiac ablation	47.41	14.55	22	48753	632	32464119
Vomiting	47.01	14.55	188	48587	235369	32229382
Aortic aneurysm rupture	46.93	14.55	26	48749	1093	32463658
Activated partial thromboplastin time abnormal	46.66	14.55	13	48762	76	32464675
Neuropathy peripheral	46.49	14.55	29	48746	76953	32387798
Embolism arterial	46.46	14.55	21	48754	567	32464184
Condition aggravated	46.38	14.55	103	48672	155558	32309193
Creatinine renal clearance decreased	46.15	14.55	40	48735	3494	32461257
Intra-abdominal haemorrhage	43.20	14.55	32	48743	2231	32462520
Traumatic haemothorax	43.06	14.55	16	48759	257	32464494
Haemorrhoidal haemorrhage	42.83	14.55	37	48738	3217	32461534
Strangulated hernia	42.82	14.55	9	48766	10	32464741
Haemoglobin decreased	42.39	14.55	316	48459	119355	32345396
Atrial fibrillation	42.39	14.55	310	48465	116394	32348357
Weight increased	42.18	14.55	38	48737	83625	32381126
Renal failure	42.07	14.55	345	48430	134133	32330618
Arthralgia	40.42	14.55	103	48672	148345	32316406
Psoriasis	39.88	14.55	10	48765	46113	32418638
Agitation	39.79	14.55	18	48757	57218	32407533
Off label use	39.66	14.55	283	48492	306037	32158714
Neutrophil count decreased	39.28	14.55	11	48764	47128	32417623
Muscle spasms	39.21	14.55	29	48746	70389	32394362
Retroperitoneal haemorrhage	38.95	14.55	33	48742	2795	32461956
Intentional product use issue	38.80	14.55	8	48767	42203	32422548
Incarcerated hernia	38.68	14.55	14	48761	208	32464543
Basal ganglia haemorrhage	38.56	14.55	21	48754	853	32463898
Thrombin time abnormal	38.53	14.55	7	48768	0	32464751
Acute abdomen	37.70	14.55	28	48747	1960	32462791
Seizure	37.69	14.55	61	48714	103793	32360958
Mouth haemorrhage	37.67	14.55	43	48732	5238	32459513
Product use issue	37.63	14.55	16	48759	52761	32411990
Cerebellar haemorrhage	37.33	14.55	25	48750	1483	32463268
Renal infarct	36.84	14.55	23	48752	1209	32463542
Malignant neoplasm progression	36.84	14.55	38	48737	78458	32386293
Alanine aminotransferase increased	36.83	14.55	38	48737	78441	32386310
Oesophageal ulcer	36.76	14.55	35	48740	3453	32461298
International normalised ratio abnormal	36.57	14.55	34	48741	3255	32461496
Dysarthria	36.26	14.55	121	48654	33080	32431671
Mucosal inflammation	36.06	14.55	4	48771	33430	32431321
Somnolence	35.79	14.55	63	48712	103734	32361017
Acute kidney injury	34.97	14.55	626	48149	292842	32171909
Ischaemia	34.96	14.55	39	48736	4633	32460118
Haemorrhage urinary tract	34.64	14.55	25	48750	1674	32463077
Heart transplant	34.24	14.55	19	48756	801	32463950
Erythema	33.88	14.55	45	48730	83060	32381691
International normalised ratio	33.81	14.55	9	48766	43	32464708
Intracranial haematoma	33.81	14.55	15	48760	387	32464364
Blood creatine phosphokinase increased	33.70	14.55	13	48762	45463	32419288
Asthma	33.66	14.55	12	48763	44053	32420698
Cardiac valve replacement complication	33.64	14.55	9	48766	44	32464707
Pulmonary alveolar haemorrhage	33.29	14.55	47	48728	7082	32457669
Multiple injuries	33.23	14.55	26	48749	1967	32462784
Platelet count decreased	33.16	14.55	77	48698	114514	32350237
Drug intolerance	33.08	14.55	17	48758	50218	32414533
Coagulation time shortened	33.07	14.55	13	48762	245	32464506
Activated partial thromboplastin time	33.02	14.55	6	48769	0	32464751
Creatinine renal clearance	33.02	14.55	6	48769	0	32464751
Cardioversion	32.30	14.55	19	48756	896	32463855
C-reactive protein increased	32.09	14.55	16	48759	48086	32416665
Femoral neck fracture	31.99	14.55	31	48744	3125	32461626
Arterial thrombosis	31.96	14.55	23	48752	1533	32463218
Gastrointestinal carcinoma	31.81	14.55	21	48754	1216	32463535
Gastrointestinal motility disorder	31.53	14.55	27	48748	2320	32462431
Hemianopia	31.30	14.55	17	48758	687	32464064
Wound haemorrhage	31.14	14.55	25	48750	1963	32462788
Cough	30.77	14.55	106	48669	138711	32326040
Stomatitis	30.65	14.55	11	48764	40218	32424533
Neurologic neglect syndrome	29.87	14.55	11	48764	172	32464579
Aggression	29.62	14.55	11	48764	39378	32425373
Appendicitis	29.23	14.55	50	48725	8887	32455864
Craniocerebral injury	29.19	14.55	29	48746	3014	32461737
Blood glucose increased	29.04	14.55	33	48742	65208	32399543
Weight decreased	28.90	14.55	138	48637	164680	32300071
Elderly	28.87	14.55	6	48769	6	32464745
White blood cell count increased	28.80	14.55	13	48762	41389	32423362
Iron deficiency anaemia	28.79	14.55	52	48723	9649	32455102
Femur fracture	28.65	14.55	46	48729	7762	32456989
Gastric cancer	28.64	14.55	38	48737	5399	32459352
Large intestine polyp	28.59	14.55	44	48731	7162	32457589
Oesophageal carcinoma	28.43	14.55	33	48742	4093	32460658
Thrombotic stroke	28.32	14.55	12	48763	276	32464475
Cardiac perforation	28.18	14.55	9	48766	89	32464662
Plasma cell myeloma	28.05	14.55	27	48748	57587	32407164
Joint swelling	27.91	14.55	22	48753	51713	32413038
Acute myocardial infarction	27.67	14.55	159	48616	54990	32409761
Haemorrhage subcutaneous	27.11	14.55	25	48750	2368	32462383
Aspartate aminotransferase increased	27.04	14.55	36	48739	66393	32398358
Injection site pain	27.01	14.55	8	48767	33050	32431701
Infection	26.92	14.55	54	48721	84661	32380090
Lumbar puncture	26.76	14.55	9	48766	106	32464645
Nasopharyngitis	26.55	14.55	34	48741	63753	32400998
Prothrombin time prolonged	26.08	14.55	50	48725	9705	32455046
Mesenteric artery embolism	25.92	14.55	8	48767	70	32464681
Infarction	25.89	14.55	26	48749	2737	32462014
Ascites	25.87	14.55	14	48761	40177	32424574
Peripheral artery thrombosis	25.87	14.55	24	48751	2291	32462460
Intestinal ischaemia	25.46	14.55	42	48733	7249	32457502
Cerebral ischaemia	25.43	14.55	39	48736	6328	32458423
Rib fracture	25.38	14.55	61	48714	13828	32450923
Anaphylactic reaction	25.21	14.55	7	48768	30165	32434586
Hemianopia homonymous	25.02	14.55	15	48760	733	32464018
Diverticulum intestinal haemorrhagic	25.01	14.55	23	48752	2171	32462580
Ecchymosis	24.74	14.55	40	48735	6788	32457963
Hyperhidrosis	24.70	14.55	43	48732	71125	32393626
Cerebellar infarction	24.40	14.55	22	48753	2025	32462726
Abnormal behaviour	24.36	14.55	5	48770	26461	32438290
Rhabdomyolysis	23.93	14.55	40	48735	67225	32397526
Exsanguination	23.92	14.55	7	48768	50	32464701
Brain herniation	23.45	14.55	29	48746	3842	32460909
Musculoskeletal stiffness	23.40	14.55	15	48760	39249	32425502
Diabetes mellitus	23.38	14.55	20	48755	45153	32419598
Pulmonary contusion	23.34	14.55	7	48768	55	32464696
Feeling abnormal	23.34	14.55	34	48741	60389	32404362
Gastric ulcer haemorrhage	23.32	14.55	35	48740	5572	32459179
Arteriovenous malformation	23.26	14.55	14	48761	689	32464062
Sinusitis	23.15	14.55	13	48762	36547	32428204
Back pain	23.14	14.55	87	48688	110966	32353785
Cholecystitis acute	23.05	14.55	36	48739	5934	32458817
Stress	22.93	14.55	4	48771	23778	32440973
Post procedural stroke	22.84	14.55	6	48769	27	32464724
Herpes zoster	22.74	14.55	10	48765	32331	32432420
Thrombocytopenia	22.71	14.55	130	48645	148169	32316582
Dyskinesia	22.70	14.55	4	48771	23599	32441152
Skin haemorrhage	22.51	14.55	28	48747	3731	32461020
Electrocardiogram QT prolonged	22.48	14.55	16	48759	39625	32425126
Catheter site haemorrhage	22.41	14.55	22	48753	2253	32462498
Cerebral vascular occlusion	22.02	14.55	4	48771	0	32464751
Irritability	21.99	14.55	5	48770	24649	32440102
Colon neoplasm	21.78	14.55	11	48764	382	32464369
Urticaria	21.63	14.55	35	48740	59579	32405172
Hospitalisation	21.54	14.55	25	48750	48946	32415805
Aneurysm ruptured	21.54	14.55	12	48763	510	32464241
Drug ineffective	21.53	14.55	426	48349	383051	32081700
Subarachnoid haematoma	21.50	14.55	7	48768	74	32464677
Haemoglobin abnormal	21.42	14.55	26	48749	3379	32461372
Vision blurred	21.17	14.55	21	48754	44165	32420586
Subcutaneous haematoma	21.07	14.55	15	48760	983	32463768
Haemorrhoids	20.91	14.55	54	48721	12799	32451952
Thalamus haemorrhage	20.87	14.55	15	48760	998	32463753
Injury	20.77	14.55	77	48698	22168	32442583
Renal haemorrhage	20.60	14.55	17	48758	1388	32463363
Peripheral swelling	20.51	14.55	45	48730	68300	32396451
Pneumonia	20.43	14.55	393	48382	354859	32109892
Productive cough	20.38	14.55	13	48762	34103	32430648
Gastric ulcer	20.36	14.55	61	48714	15748	32449003
Pneumonitis	20.13	14.55	10	48765	30124	32434627
Ischaemic cerebral infarction	20.07	14.55	15	48760	1060	32463691
Coronary artery embolism	20.01	14.55	8	48767	158	32464593
Hallucination	19.94	14.55	30	48745	52589	32412162
Drug reaction with eosinophilia and systemic symptoms	19.93	14.55	12	48763	32473	32432278
Aortic aneurysm	19.92	14.55	36	48739	6683	32458068
Therapeutic response decreased	19.89	14.55	7	48768	25913	32438838
Influenza like illness	19.71	14.55	8	48767	27132	32437619
Oxygen saturation decreased	19.64	14.55	26	48749	48073	32416678
Cardiac pacemaker insertion	19.52	14.55	22	48753	2643	32462108
Venous thrombosis	19.46	14.55	25	48750	3442	32461309
Arterial injury	19.44	14.55	10	48765	361	32464390
Myalgia	19.39	14.55	60	48715	81170	32383581
Traumatic haematoma	19.20	14.55	13	48762	785	32463966
Gastrointestinal angiodysplasia	19.05	14.55	12	48763	641	32464110
Osteonecrosis of jaw	18.98	14.55	3	48772	19163	32445588
Angioedema	18.86	14.55	16	48759	36273	32428478
Urogenital haemorrhage	18.77	14.55	11	48764	515	32464236
Dry skin	18.74	14.55	7	48768	24971	32439780
Haemodynamic instability	18.64	14.55	41	48734	8770	32455981
Intestinal infarction	18.05	14.55	11	48764	554	32464197
Mesenteric haemorrhage	17.98	14.55	4	48771	7	32464744
Factor V deficiency	17.98	14.55	5	48770	29	32464722
Rectal cancer	17.92	14.55	20	48755	2377	32462374
Haemoperitoneum	17.91	14.55	17	48758	1670	32463081
Hypertension	17.83	14.55	120	48655	131630	32333121
Loss of personal independence in daily activities	17.78	14.55	9	48766	26824	32437927
Diverticulum	17.71	14.55	35	48740	6947	32457804
Colitis ischaemic	17.65	14.55	33	48742	6287	32458464
Splenic injury	17.56	14.55	5	48770	32	32464719
Hyperglycaemia	17.54	14.55	19	48756	38372	32426379
Pruritus	17.53	14.55	117	48658	128585	32336166
Abdominal discomfort	17.50	14.55	137	48638	52487	32412264
Therapy non-responder	17.46	14.55	14	48761	32640	32432111
Lymphocyte count decreased	17.46	14.55	5	48770	21114	32443637
Hypersensitivity	17.35	14.55	38	48737	57720	32407031
Orthopaedic procedure	17.31	14.55	4	48771	9	32464742
Puncture site haemorrhage	17.25	14.55	9	48766	335	32464416
Confusional state	17.13	14.55	135	48640	142980	32321771
Hyponatraemia	17.11	14.55	56	48719	74457	32390294
Blood cholesterol increased	17.09	14.55	3	48772	17754	32446997
Thrombotic cerebral infarction	17.03	14.55	9	48766	344	32464407
Prothrombin time shortened	16.79	14.55	16	48759	1580	32463171
Pain in extremity	16.74	14.55	107	48668	118794	32345957
Eye haemorrhage	16.69	14.55	25	48750	3972	32460779
Diverticulitis intestinal haemorrhagic	16.65	14.55	9	48766	360	32464391
Blood lactate dehydrogenase increased	16.54	14.55	6	48769	21799	32442952
Incarcerated inguinal hernia	16.52	14.55	6	48769	90	32464661
Inguinal hernia strangulated	16.51	14.55	3	48772	0	32464751
Pneumocystis jirovecii pneumonia	16.49	14.55	4	48771	18866	32445885
Small intestinal haemorrhage	16.44	14.55	18	48757	2094	32462657
Occult blood positive	16.36	14.55	25	48750	4044	32460707
Cataract	16.19	14.55	8	48767	24175	32440576
Gait disturbance	16.09	14.55	64	48711	80344	32384407
Aortic dissection rupture	16.02	14.55	4	48771	14	32464737
Internal haemorrhage	16.01	14.55	27	48748	4745	32460006
Muscle strain	15.99	14.55	24	48751	3821	32460930
Blood pressure increased	15.99	14.55	63	48712	79291	32385460
Shock	15.88	14.55	75	48700	24039	32440712
Peripheral ischaemia	15.80	14.55	30	48745	5781	32458970
Tachycardia	15.80	14.55	63	48712	79025	32385726
Influenza	15.78	14.55	28	48747	45986	32418765
Encephalopathy	15.60	14.55	17	48758	34240	32430511
Microvillous inclusion disease	15.52	14.55	5	48770	51	32464700
Intentional product misuse	15.22	14.55	19	48756	36032	32428719
Conjunctival haemorrhage	15.11	14.55	20	48755	2835	32461916
Toxic epidermal necrolysis	15.07	14.55	6	48769	20587	32444164
Post procedural pulmonary embolism	15.05	14.55	4	48771	19	32464732
Gastritis erosive	15.03	14.55	30	48745	5997	32458754
Serotonin syndrome	14.95	14.55	5	48770	19112	32445639
Sleep disorder	14.90	14.55	11	48764	26741	32438010
Cerebral thrombosis	14.86	14.55	12	48763	950	32463801
Ulcer haemorrhage	14.75	14.55	19	48756	2623	32462128
Monoparesis	14.73	14.55	16	48759	1845	32462906
Thoracic haemorrhage	14.71	14.55	7	48768	213	32464538

Pharmacologic Action:

Source	Code	Description
ATC	B01AE07	BLOOD AND BLOOD FORMING ORGANS ANTITHROMBOTIC AGENTS ANTITHROMBOTIC AGENTS Direct thrombin inhibitors
FDA MoA	N0000009963	Thrombin Inhibitors
FDA EPC	N0000175518	Direct Thrombin Inhibitor
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
CHEBI has role	CHEBI:50249	anticoagulante
CHEBI has role	CHEBI:50266	Prodrugs
CHEBI has role	CHEBI:65232	EC 3.4.21.5 inhibitor
CHEBI has role	CHEBI:77020	NRH:quinone oxidoreductase 2 inhibitors

Drug Use (View source of the data)

Disease	Relation	SNOMED_ID	DOID
Prevention of deep vein thrombosis	indication	439993001
Prevention of Thromboembolism with Chronic Atrial Fibrillation	indication
Acute hemorrhage	contraindication	8573003
Acute nephropathy	contraindication	58574008
Blood coagulation disorder	contraindication	64779008	DOID:1247
Anemia	contraindication	271737000	DOID:2355
Cerebral hemorrhage	contraindication	274100004

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation level	Dissociation constant	Type (acidic/basic)
pKa1	5.35	Basic
pKa2	2.31	Basic
pKa3	1.61	Basic
pKa4	0.55	Basic

Orange Book patent data (new drug applications)

Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Patent number	Patent expiration date	Patent use
EQ 110MG BASE	PRADAXA	BOEHRINGER INGELHEIM	N022512	Nov. 20, 2015	RX	CAPSULE	ORAL	9034822	Jan. 20, 2031	METHOD OF REVERSING THE ANTICOAGULANT EFFECT OF DABIGATRAN USING IDARUCIZUMAB
EQ 150MG BASE	PRADAXA	BOEHRINGER INGELHEIM	N022512	Oct. 19, 2010	RX	CAPSULE	ORAL	9034822	Jan. 20, 2031	METHOD OF REVERSING THE ANTICOAGULANT EFFECT OF DABIGATRAN USING IDARUCIZUMAB
EQ 75MG BASE	PRADAXA	BOEHRINGER INGELHEIM	N022512	Oct. 19, 2010	RX	CAPSULE	ORAL	9034822	Jan. 20, 2031	METHOD OF REVERSING THE ANTICOAGULANT EFFECT OF DABIGATRAN USING IDARUCIZUMAB

Orange Book exclusivity data (new drug applications)

Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Exclusivity date	Description
EQ 110MG BASE	PRADAXA	BOEHRINGER INGELHEIM	N022512	Nov. 20, 2015	RX	CAPSULE	ORAL	June 21, 2024	TREATMENT OF VENOUS THROMBOEMBOLIC EVENTS (VTE) IN PEDIATRIC PATIENTS 8 TO LESS THAN 18 YEARS OF AGE WHO HAVE BEEN TREATED WITH A PARENTERAL ANTICOAGULANT FOR AT LEAST 5 DAYS AND TO REDUCE THE RISK OF RECURRENCE OF VTE IN PEDIATRIC PATIENTS 8 TO LESS THAN 18 YEARS OF AGE WHO HAVE BEEN PREVIOUSLY TREATED
EQ 150MG BASE	PRADAXA	BOEHRINGER INGELHEIM	N022512	Oct. 19, 2010	RX	CAPSULE	ORAL	June 21, 2024	TREATMENT OF VENOUS THROMBOEMBOLIC EVENTS (VTE) IN PEDIATRIC PATIENTS 8 TO LESS THAN 18 YEARS OF AGE WHO HAVE BEEN TREATED WITH A PARENTERAL ANTICOAGULANT FOR AT LEAST 5 DAYS AND TO REDUCE THE RISK OF RECURRENCE OF VTE IN PEDIATRIC PATIENTS 8 TO LESS THAN 18 YEARS OF AGE WHO HAVE BEEN PREVIOUSLY TREATED
EQ 75MG BASE	PRADAXA	BOEHRINGER INGELHEIM	N022512	Oct. 19, 2010	RX	CAPSULE	ORAL	June 21, 2024	TREATMENT OF VENOUS THROMBOEMBOLIC EVENTS (VTE) IN PEDIATRIC PATIENTS 8 TO LESS THAN 18 YEARS OF AGE WHO HAVE BEEN TREATED WITH A PARENTERAL ANTICOAGULANT FOR AT LEAST 5 DAYS AND TO REDUCE THE RISK OF RECURRENCE OF VTE IN PEDIATRIC PATIENTS 8 TO LESS THAN 18 YEARS OF AGE WHO HAVE BEEN PREVIOUSLY TREATED
EQ 110MG BASE/PACKET	PRADAXA	BOEHRINGER INGELHEIM	N214358	June 21, 2021	RX	PELLETS	ORAL	June 21, 2024	NEW PRODUCT
EQ 150MG BASE/PACKET	PRADAXA	BOEHRINGER INGELHEIM	N214358	June 21, 2021	RX	PELLETS	ORAL	June 21, 2024	NEW PRODUCT
EQ 20MG BASE/PACKET	PRADAXA	BOEHRINGER INGELHEIM	N214358	June 21, 2021	RX	PELLETS	ORAL	June 21, 2024	NEW PRODUCT
EQ 30MG BASE/PACKET	PRADAXA	BOEHRINGER INGELHEIM	N214358	June 21, 2021	RX	PELLETS	ORAL	June 21, 2024	NEW PRODUCT
EQ 40MG BASE/PACKET	PRADAXA	BOEHRINGER INGELHEIM	N214358	June 21, 2021	RX	PELLETS	ORAL	June 21, 2024	NEW PRODUCT
EQ 50MG BASE/PACKET	PRADAXA	BOEHRINGER INGELHEIM	N214358	June 21, 2021	RX	PELLETS	ORAL	June 21, 2024	NEW PRODUCT
EQ 110MG BASE	PRADAXA	BOEHRINGER INGELHEIM	N022512	Nov. 20, 2015	RX	CAPSULE	ORAL	Dec. 21, 2024	PEDIATRIC EXCLUSIVITY
EQ 150MG BASE	PRADAXA	BOEHRINGER INGELHEIM	N022512	Oct. 19, 2010	RX	CAPSULE	ORAL	Dec. 21, 2024	PEDIATRIC EXCLUSIVITY
EQ 75MG BASE	PRADAXA	BOEHRINGER INGELHEIM	N022512	Oct. 19, 2010	RX	CAPSULE	ORAL	Dec. 21, 2024	PEDIATRIC EXCLUSIVITY
EQ 110MG BASE/PACKET	PRADAXA	BOEHRINGER INGELHEIM	N214358	June 21, 2021	RX	PELLETS	ORAL	Dec. 21, 2024	PEDIATRIC EXCLUSIVITY
EQ 150MG BASE/PACKET	PRADAXA	BOEHRINGER INGELHEIM	N214358	June 21, 2021	RX	PELLETS	ORAL	Dec. 21, 2024	PEDIATRIC EXCLUSIVITY
EQ 20MG BASE/PACKET	PRADAXA	BOEHRINGER INGELHEIM	N214358	June 21, 2021	RX	PELLETS	ORAL	Dec. 21, 2024	PEDIATRIC EXCLUSIVITY
EQ 30MG BASE/PACKET	PRADAXA	BOEHRINGER INGELHEIM	N214358	June 21, 2021	RX	PELLETS	ORAL	Dec. 21, 2024	PEDIATRIC EXCLUSIVITY
EQ 40MG BASE/PACKET	PRADAXA	BOEHRINGER INGELHEIM	N214358	June 21, 2021	RX	PELLETS	ORAL	Dec. 21, 2024	PEDIATRIC EXCLUSIVITY
EQ 50MG BASE/PACKET	PRADAXA	BOEHRINGER INGELHEIM	N214358	June 21, 2021	RX	PELLETS	ORAL	Dec. 21, 2024	PEDIATRIC EXCLUSIVITY

Bioactivity Summary:

Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Mechanism action	Bioact source	MoA source
Prothrombin	Enzyme	P00734	THRB_HUMAN	INHIBITOR	Ki	8.35		CHEMBL	CHEMBL
Plasminogen	Enzyme	P00747	PLMN_HUMAN		Ki	5.77		CHEMBL
Coagulation factor X	Enzyme	P00742	FA10_HUMAN		Ki	5.42		CHEMBL
Tissue-type plasminogen activator	Enzyme	P00750	TPA_HUMAN		Ki	4.34		CHEMBL
Vitamin K-dependent protein C	Enzyme	P04070	PROC_HUMAN		Ki	4.68		CHEMBL
Solute carrier family 22 member 2	Transporter	O15244	S22A2_HUMAN		IC50	5.33		CHEMBL
Multidrug and toxin extrusion protein 1	Transporter	Q96FL8	S47A1_HUMAN		IC50	5.09		CHEMBL
Multidrug and toxin extrusion protein 2	Transporter	Q86VL8	S47A2_HUMAN		IC50	4.60		CHEMBL
Trypsin	Enzyme	P07477 P07478 P35030	TRY1_HUMAN TRY2_HUMAN TRY3_HUMAN		Ki	7.30		CHEMBL
Serine protease hepsin	Enzyme	P05981	HEPS_HUMAN		Ki	6.08		CHEMBL
Ribosyldihydronicotinamide dehydrogenase [quinone]	Enzyme	P16083	NQO2_HUMAN		IC50	4.96		CHEMBL
Thrombin	Unclassified		Q28731_RABIT		IC50	6.26		CHEMBL

External reference:

ID	Source
4030255	VUID
N0000181837	NUI
D07082	KEGG_DRUG
872728-81-9	SECONDARY_CAS_RN
211914-51-1	SECONDARY_CAS_RN
C1571583	UMLSCUI
CHEBI:70746	CHEBI
CHEBI:70752	CHEBI
CHEMBL539697	ChEMBL_ID
CHEMBL1615369	ChEMBL_ID
CHEMBL48361	ChEMBL_ID
D000069604	MESH_DESCRIPTOR_UI
DB06695	DRUGBANK_ID
6379	IUPHAR_LIGAND_ID
6380	IUPHAR_LIGAND_ID
8028	INN_ID
8027	INN_ID
2E18WX195X	UNII
135565674	PUBCHEM_CID
216210	PUBCHEM_CID
DB14726	DRUGBANK_ID
I0VM4M70GC	UNII
1037041	RXNORM
136711	MMSL
25762	MMSL
d07137	MMSL
012668	NDDF
012669	NDDF
698871007	SNOMEDCT_US
700029008	SNOMEDCT_US
700039002	SNOMEDCT_US
714788005	SNOMEDCT_US
4030254	VANDF
4030255	VANDF
C2348066	UMLSCUI

Pharmaceutical products:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Pradaxa	HUMAN PRESCRIPTION DRUG LABEL	1	0597-0108	CAPSULE	110 mg	ORAL	NDA	33 sections
Pradaxa	HUMAN PRESCRIPTION DRUG LABEL	1	0597-0355	CAPSULE	75 mg	ORAL	NDA	33 sections
Pradaxa	HUMAN PRESCRIPTION DRUG LABEL	1	0597-0360	CAPSULE	150 mg	ORAL	NDA	33 sections
Pradaxa	HUMAN PRESCRIPTION DRUG LABEL	1	0597-0425	PELLET	20 mg	ORAL	NDA	33 sections
Pradaxa	HUMAN PRESCRIPTION DRUG LABEL	1	0597-0430	PELLET	30 mg	ORAL	NDA	33 sections
Pradaxa	HUMAN PRESCRIPTION DRUG LABEL	1	0597-0435	PELLET	40 mg	ORAL	NDA	33 sections
Pradaxa	HUMAN PRESCRIPTION DRUG LABEL	1	0597-0440	PELLET	50 mg	ORAL	NDA	33 sections
Pradaxa	HUMAN PRESCRIPTION DRUG LABEL	1	0597-0445	PELLET	110 mg	ORAL	NDA	33 sections
Pradaxa	HUMAN PRESCRIPTION DRUG LABEL	1	0597-0450	PELLET	150 mg	ORAL	NDA	33 sections
PRADAXA	HUMAN PRESCRIPTION DRUG LABEL	1	21695-899	CAPSULE	150 mg	ORAL	NDA	27 sections
Pradaxa	HUMAN PRESCRIPTION DRUG LABEL	1	50090-3617	CAPSULE	150 mg	ORAL	NDA	32 sections
Pradaxa	HUMAN PRESCRIPTION DRUG LABEL	1	50090-4480	CAPSULE	150 mg	ORAL	NDA	31 sections
Pradaxa	HUMAN PRESCRIPTION DRUG LABEL	1	63629-8242	CAPSULE	150 mg	ORAL	NDA	32 sections