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Tox | Related Drugs | 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

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
BA (Bioavailability)	5 %

Predicted pharmacokinetic/toxicological properties (PK-AZ):

Property	Description	Value	Unit	Confidence	Similarity
azlogd74	LogD at pH 7.4	4.179		Moderate	0.79
caco2-efflux	Caco-2 efflux ratio (BA/AB)	6.427		Moderate	0.79
caco2-intrinsic-papp	Caco-2 intrinsic apparent permeability	12.445	10^-6 cm/s	Moderate	0.79
dh-clint	Dog hepatocyte intrinsic clearance	50.350	uL/min/10^6 cells	Moderate	0.79
dppb	Dog plasma protein binding (% unbound)	0.910	%	Moderate	0.79
fcs-ppb	Fetal calf serum protein binding (% unbound)	1.780	%	Moderate	0.79
herg	hERG pIC50	5.391	pIC50	Moderate	0.79
hh-clint	Human hepatocyte intrinsic clearance	289.068	uL/min/10^6 cells	Moderate	0.79
hlm-clint	Human liver microsomal intrinsic clearance	292.415	uL/min/mg protein	Moderate	0.79
hppb	Human plasma protein binding (% unbound)	0.710	%	Moderate	0.79
mdck-mdr1-efflux	MDCK-MDR1 efflux ratio	12.589		Moderate	0.79
mh-clint	Mouse hepatocyte intrinsic clearance	274.789		Moderate	0.79
mppb	Mouse plasma protein binding (% unbound)	0.750		Moderate	0.79
nih-mdck-mdr1-efflux	NIH MDCK-MDR1 efflux ratio	37.068		Moderate	0.79
pfas-class	PFAS structural alert (1 = True, 0 = False)	0
pppb	Pig plasma protein binding (% unbound)	1.510	%	Moderate	0.79
rh-clint	Rat hepatocyte intrinsic clearance	302.691	uL/min/10^6 cells	Moderate	0.79
rh-fuinc	Rat hepatocyte fraction unbound in incubation	7.390	%	Moderate	0.79
rppb	Rat plasma protein binding (% unbound)	0.840	%	Moderate	0.79
solubility-dd	Solubility at pH 7.4 in DMSO	1.107	uM	Moderate	0.79

Approvals:

Date	Agency	Company	Orphan
Oct. 19, 2010	FDA	BOEHRINGER INGELHEIM
March 18, 2008	EMA	BOEHRINGER INGELHEIM INTERNATIONAL GMBH

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	5262.96	16.19	1988	52419	88260	90485780
Ischaemic stroke	2562.02	16.19	816	53591	21350	90552690
Cerebrovascular accident	1775.89	16.19	1035	53372	122498	90451542
Haemorrhage	1525.74	16.19	771	53636	68598	90505442
Melaena	1371.56	16.19	580	53827	34217	90539823
Haemorrhage intracranial	1135.07	16.19	403	54004	14759	90559281
Rectal haemorrhage	969.92	16.19	609	53798	82135	90491905
Cerebral haemorrhage	871.98	16.19	422	53985	34100	90539940
Lower gastrointestinal haemorrhage	795.34	16.19	270	54137	8622	90565418
Activated partial thromboplastin time prolonged	780.81	16.19	258	54149	7567	90566473
Cardiac tamponade	619.76	16.19	200	54207	5432	90568608
Subdural haematoma	578.36	16.19	254	54153	16391	90557649
Fall	573.76	16.19	1031	53376	480779	90093261
International normalised ratio increased	568.43	16.19	354	54053	46962	90527078
Cerebral infarction	532.88	16.19	278	54129	26318	90547722
Coagulopathy	514.51	16.19	260	54147	23029	90551011
Haematoma	512.05	16.19	309	54098	38739	90535301
Upper gastrointestinal haemorrhage	471.29	16.19	244	54163	22732	90551308
Shock haemorrhagic	465.08	16.19	199	54208	12046	90561994
Embolic stroke	457.83	16.19	147	54260	3925	90570115
Anaemia	434.67	16.19	767	53640	352035	90222005
Blood loss anaemia	432.59	16.19	179	54228	9961	90564079
Haematuria	403.47	16.19	255	54152	34682	90539358
Procoagulant therapy	385.15	16.19	60	54347	0	90574040
Transient ischaemic attack	361.29	16.19	258	54149	42918	90531122
Acute kidney injury	353.11	16.19	664	53743	319723	90254317
Haemorrhagic stroke	347.55	16.19	135	54272	6361	90567679
Drug interaction	345.29	16.19	605	53802	275848	90298192
Haematochezia	338.79	16.19	305	54102	70608	90503432
Subarachnoid haemorrhage	329.85	16.19	177	54230	17727	90556313
Haemoglobin decreased	312.03	16.19	433	53974	161523	90412517
Deep vein thrombosis	302.69	16.19	322	54085	91298	90482742
Pericardial haemorrhage	301.11	16.19	89	54318	1787	90572253
Haematemesis	297.12	16.19	208	54199	33518	90540522
Thrombin time prolonged	291.22	16.19	52	54355	66	90573974
Renal failure	277.74	16.19	367	54040	130640	90443400
Pulmonary embolism	275.06	16.19	365	54042	130455	90443585
Cardiac failure	257.57	16.19	323	54084	109173	90464867
Atrial thrombosis	248.09	16.19	80	54327	2165	90571875
Pain	241.13	16.19	151	54256	996190	89577850
Epistaxis	241.06	16.19	276	54131	84849	90489191
Intestinal haemorrhage	236.41	16.19	92	54315	4355	90569685
Subdural haemorrhage	218.72	16.19	81	54326	3342	90570698
Hemiparesis	188.79	16.19	155	54252	31664	90542376
Infusion related reaction	187.99	16.19	17	54390	416763	90157277
Systemic lupus erythematosus	186.62	16.19	7	54400	361889	90212151
Maternal exposure during pregnancy	185.55	16.19	7	54400	360056	90213984
Drug hypersensitivity	175.51	16.19	33	54374	463576	90110464
Hypovolaemic shock	173.78	16.19	85	54322	7009	90567031
Prothrombin time prolonged	169.93	16.19	93	54314	9679	90564361
Arthropathy	167.70	16.19	14	54393	366228	90207812
Rash	167.09	16.19	140	54267	795960	89778080
Glossodynia	166.67	16.19	6	54401	321773	90252267
Coagulation time prolonged	165.65	16.19	55	54352	1635	90572405
Renal impairment	161.20	16.19	253	54154	105168	90468872
Rheumatoid arthritis	147.94	16.19	21	54386	362593	90211447
Drug intolerance	147.38	16.19	43	54364	447548	90126492
Hypotension	146.72	16.19	479	53928	324918	90249122
Haemothorax	146.39	16.19	55	54352	2363	90571677
Nasopharyngitis	143.74	16.19	34	54373	407070	90166970
Aortic dissection	142.78	16.19	54	54353	2363	90571677
Cerebral haematoma	141.04	16.19	63	54344	4226	90569814
Haemoptysis	140.99	16.19	134	54273	33186	90540854
Joint swelling	140.90	16.19	63	54344	503237	90070803
Head injury	140.75	16.19	130	54277	31058	90542982
Hypersensitivity	140.26	16.19	49	54358	454628	90119412
Faeces discoloured	139.51	16.19	110	54297	21210	90552830
Fatigue	138.96	16.19	305	54102	1153718	89420322
Wound secretion	128.89	16.19	62	54345	4928	90569112
Syncope	128.75	16.19	261	54146	132402	90441638
Therapeutic product effect decreased	128.73	16.19	10	54397	277561	90296479
Exposure during pregnancy	128.71	16.19	3	54404	238407	90335633
Atrial fibrillation	125.10	16.19	259	54148	133352	90440688
Procedural haemorrhage	122.66	16.19	52	54355	3072	90570968
Weight increased	122.24	16.19	49	54358	417878	90156162
Gastric haemorrhage	121.85	16.19	67	54340	7036	90567004
Treatment failure	120.72	16.19	19	54388	303909	90270131
Wound	117.98	16.19	20	54387	302960	90271080
Peripheral embolism	116.50	16.19	40	54367	1320	90572720
Contraindicated product administered	116.46	16.19	25	54382	320114	90253926
Stomatitis	114.16	16.19	15	54392	274683	90299357
Sinusitis	112.81	16.19	33	54374	343055	90230985
Musculoskeletal stiffness	112.36	16.19	21	54386	296511	90277529
Helicobacter infection	111.61	16.19	6	54401	226844	90347196
Duodenal ulcer perforation	111.60	16.19	5	54402	221283	90352757
Large intestinal haemorrhage	110.44	16.19	40	54367	1548	90572492
Alopecia	110.04	16.19	82	54325	494989	90079051
Swelling	108.82	16.19	58	54349	419000	90155040
Discomfort	107.04	16.19	18	54389	274317	90299723
Lower respiratory tract infection	105.82	16.19	13	54394	250646	90323394
Pericardial effusion	105.17	16.19	120	54287	36713	90537327
Irritable bowel syndrome	103.59	16.19	5	54402	207443	90366597
Post procedural haemorrhage	103.47	16.19	65	54342	8733	90565307
Impaired healing	101.72	16.19	11	54396	234188	90339852
Dementia	101.01	16.19	96	54311	23765	90550275
Traumatic intracranial haemorrhage	99.20	16.19	30	54377	653	90573387
Haemorrhoidal haemorrhage	99.07	16.19	53	54354	5270	90568770
Condition aggravated	98.53	16.19	128	54279	595417	89978623
Pyrexia	98.36	16.19	153	54254	660332	89913708
Infection	97.14	16.19	48	54359	362046	90211994
Anticoagulation drug level increased	96.99	16.19	25	54382	294	90573746
Product use in unapproved indication	95.74	16.19	41	54366	336195	90237845
Creatinine renal clearance decreased	95.56	16.19	84	54323	18815	90555225
Haemorrhagic transformation stroke	95.14	16.19	34	54373	1265	90572775
Thrombosis	94.66	16.19	163	54244	73088	90500952
Gastritis erosive	89.88	16.19	54	54353	6701	90567339
Hepatic enzyme increased	89.21	16.19	53	54354	360683	90213357
Aphasia	89.16	16.19	119	54288	42693	90531347
Pericarditis	88.76	16.19	26	54381	270125	90303915
Parkinsonism	88.66	16.19	71	54336	13994	90560046
Hemiplegia	88.13	16.19	75	54332	16085	90557955
Peripheral swelling	87.24	16.19	72	54335	413034	90161006
Gingival bleeding	87.13	16.19	72	54335	14831	90559209
Blood cholesterol decreased	85.44	16.19	35	54372	1896	90572144
Peripheral circulatory failure	84.60	16.19	33	54374	1571	90572469
Arthralgia	84.46	16.19	217	54190	778305	89795735
Blood cholesterol increased	82.58	16.19	13	54394	207999	90366041
Death	82.55	16.19	512	53895	456039	90118001
Cerebral artery occlusion	82.43	16.19	29	54378	1030	90573010
International normalised ratio abnormal	82.17	16.19	42	54365	3803	90570237
Ill-defined disorder	82.05	16.19	8	54399	184883	90389157
Wheezing	81.79	16.19	21	54386	238059	90335981
Traumatic haemorrhage	81.49	16.19	25	54382	572	90573468
Pulmonary haemorrhage	81.42	16.19	54	54353	7959	90566081
Thrombin time abnormal	80.75	16.19	13	54394	3	90574037
Mouth haemorrhage	78.52	16.19	54	54353	8447	90565593
Type 2 diabetes mellitus	77.81	16.19	14	54393	203230	90370810
Embolism	77.75	16.19	56	54351	9425	90564615
Drug ineffective	77	16.19	502	53905	1383796	89190244
Acute myocardial infarction	75.77	16.19	99	54308	34791	90539249
Splenic rupture	75.13	16.19	29	54378	1342	90572698
Sleep disorder	75.04	16.19	14	54393	198016	90376024
Intestinal ischaemia	74.06	16.19	53	54354	8830	90565210
Headache	73.94	16.19	268	54139	862478	89711562
Cardiac failure congestive	73.90	16.19	175	54232	98519	90475521
Asthma	73.05	16.19	27	54380	242133	90331907
Cardiac valve replacement complication	72.30	16.19	17	54390	132	90573908
Hip fracture	72.05	16.19	94	54313	32983	90541057
Cerebral ischaemia	71.92	16.19	48	54359	7148	90566892
Intra-abdominal haemorrhage	71.57	16.19	34	54373	2628	90571412
Intentional product use issue	71	16.19	21	54386	216871	90357169
Acute abdomen	69.71	16.19	29	54378	1634	90572406
Anxiety	69.15	16.19	51	54356	309721	90264319
Intracardiac thrombus	69	16.19	32	54375	2342	90571698
Off label use	68.91	16.19	385	54022	1101867	89472173
Injection site pain	68.62	16.19	11	54396	173688	90400352
Craniocerebral injury	67.52	16.19	35	54372	3263	90570777
International normalised ratio	67.29	16.19	15	54392	89	90573951
Cerebral mass effect	67.28	16.19	25	54382	1041	90572999
Hypoaesthesia	67.25	16.19	54	54353	314156	90259884
Activated partial thromboplastin time abnormal	66.97	16.19	16	54391	134	90573906
Product use issue	66.58	16.19	60	54347	329859	90244181
Blister	66.56	16.19	35	54372	254963	90319077
Gastric polyps	66.48	16.19	39	54368	4633	90569407
Product dose omission issue	66.44	16.19	47	54360	291640	90282400
Neuroglycopenia	66.18	16.19	25	54382	1090	90572950
Shock	66.16	16.19	84	54323	28694	90545346
Multiple drug therapy	65.86	16.19	45	54362	6964	90567076
Urticaria	65.38	16.19	55	54352	312679	90261361
Intraventricular haemorrhage	64.74	16.19	31	54376	2438	90571602
Peripheral ischaemia	64.47	16.19	41	54366	5626	90568414
Colon cancer	64.24	16.19	53	54354	10891	90563149
Retroperitoneal haemorrhage	63.96	16.19	33	54374	3047	90570993
Multiple organ dysfunction syndrome	63.36	16.19	132	54275	68204	90505836
Blood urine present	62.86	16.19	64	54343	17214	90556826
Strangulated hernia	62.59	16.19	12	54395	28	90574012
Diverticulum	61.56	16.19	54	54353	12059	90561981
Cerebral artery embolism	61.17	16.19	23	54384	990	90573050
Internal haemorrhage	60.99	16.19	41	54366	6179	90567861
Iron deficiency anaemia	60.73	16.19	73	54334	23589	90550451
Puncture site haemorrhage	60.04	16.19	18	54389	380	90573660
Microcytic anaemia	60.00	16.19	34	54373	3784	90570256
Vaginal haemorrhage	59.18	16.19	83	54324	31188	90542852
Night sweats	58.66	16.19	5	54402	128761	90445279
Hyperkalaemia	58.50	16.19	124	54283	64840	90509200
Completed suicide	57.71	16.19	9	54398	145049	90428991
Bursitis	57.62	16.19	6	54401	131648	90442392
Osteoarthritis	57.07	16.19	23	54384	195707	90378333
Femoral neck fracture	56.84	16.19	48	54359	10185	90563855
Liver injury	56.77	16.19	16	54391	170551	90403489
Haemarthrosis	55.93	16.19	33	54374	3961	90570079
Haemorrhage subcutaneous	55.42	16.19	31	54376	3365	90570675
Haematocrit decreased	55.23	16.19	94	54313	41738	90532302
Hyponatraemia	54.23	16.19	190	54217	133348	90440692
Neutropenia	54.22	16.19	34	54373	224870	90349170
Subcutaneous haematoma	53.54	16.19	25	54382	1858	90572182
Hypoglycaemia	53.53	16.19	125	54282	69723	90504317
Stupor	53.43	16.19	36	54371	5446	90568594
Anticoagulation drug level abnormal	53.00	16.19	13	54394	123	90573917
Colitis ischaemic	52.88	16.19	50	54357	12296	90561744
Peripheral artery thrombosis	52.69	16.19	26	54381	2184	90571856
Haemoperitoneum	51.65	16.19	30	54377	3498	90570542
Haemorrhagic cerebral infarction	51.60	16.19	18	54389	623	90573417
Atrioventricular block first degree	51.60	16.19	42	54365	8469	90565571
Coagulation test abnormal	51.30	16.19	20	54387	951	90573089
Cardiac perforation	50.77	16.19	11	54396	56	90573984
Paraesthesia	49.92	16.19	46	54361	250280	90323760
Sepsis	49.07	16.19	226	54181	179588	90394452
Therapy non-responder	49.01	16.19	11	54396	136693	90437347
Embolic cerebral infarction	48.69	16.19	17	54390	590	90573450
Hypercholesterolaemia	48.58	16.19	3	54404	100889	90473151
Myocardial infarction	48.52	16.19	157	54250	105815	90468225
Hypochromic anaemia	47.22	16.19	24	54383	2147	90571893
Blood creatinine increased	47.14	16.19	151	54256	101235	90472805
Anticoagulant-related nephropathy	46.95	16.19	9	54398	21	90574019
Ecchymosis	45.47	16.19	46	54361	12277	90561763
Musculoskeletal pain	45.43	16.19	23	54384	171228	90402812
Abdominal discomfort	45.05	16.19	142	54265	477186	90096854
Gait inability	44.71	16.19	16	54391	146440	90427600
Post procedural haematoma	44.62	16.19	20	54387	1352	90572688
Therapeutic product effect incomplete	44.45	16.19	31	54376	193865	90380175
Pulmonary fibrosis	44.32	16.19	6	54401	107497	90466543
Psoriasis	43.66	16.19	17	54390	147737	90426303
Gastric ulcer	43.48	16.19	67	54340	27381	90546659
Prothrombin time abnormal	43.06	16.19	15	54392	517	90573523
Bradycardia	42.79	16.19	129	54278	83718	90490322
Pelvic haematoma	41.96	16.19	16	54391	716	90573324
Disease progression	41.59	16.19	21	54386	156594	90417446
Sciatica	40.99	16.19	6	54401	101376	90472664
Wound haemorrhage	40.97	16.19	24	54383	2843	90571197
Conjunctival haemorrhage	40.84	16.19	27	54380	3957	90570083
Discoloured vomit	40.77	16.19	18	54389	1174	90572866
Overdose	40.66	16.19	195	54212	157514	90416526
Occult blood positive	40.60	16.19	27	54380	3996	90570044
Diabetes mellitus inadequate control	40.54	16.19	53	54354	18631	90555409
Inflammation	40.35	16.19	29	54378	178563	90395477
C-reactive protein increased	40.28	16.19	30	54377	181359	90392681
Dry mouth	40.15	16.19	31	54376	184028	90390012
Blood creatine increased	39.36	16.19	33	54374	6934	90567106
Skull fracture	39.21	16.19	18	54389	1287	90572753
Upper respiratory tract infection	39.20	16.19	14	54393	128304	90445736
Oesophagitis	39.10	16.19	50	54357	17199	90556841
Disseminated intravascular coagulation	39.03	16.19	56	54351	21482	90552558
Prescribed overdose	38.96	16.19	6	54401	97619	90476421
Bradyarrhythmia	38.90	16.19	22	54385	2439	90571601
Hypocoagulable state	38.68	16.19	19	54388	1580	90572460
Initial insomnia	38.53	16.19	37	54370	9273	90564767
Neuropathy peripheral	38.47	16.19	17	54390	136953	90437087
Blood urea increased	38.39	16.19	67	54340	30346	90543694
Ischaemia	38.30	16.19	29	54378	5266	90568774
Dysphagia	38.26	16.19	151	54256	112127	90461913
Gastric ulcer haemorrhage	38.22	16.19	29	54378	5282	90568758
Red blood cell sedimentation rate increased	38.19	16.19	3	54404	82592	90491448
Migraine	37.94	16.19	35	54372	190357	90383683
Petechiae	37.86	16.19	47	54360	15694	90558346
Small intestinal haemorrhage	37.79	16.19	21	54386	2250	90571790
Prothrombin time shortened	37.73	16.19	21	54386	2257	90571783
Atrial flutter	37.60	16.19	39	54368	10719	90563321
Pelvic fracture	37.50	16.19	46	54361	15173	90558867
Anticoagulation drug level above therapeutic	37.26	16.19	20	54387	2002	90572038
Pulmonary alveolar haemorrhage	37.21	16.19	30	54377	5968	90568072
Pruritus	37.12	16.19	183	54224	541342	90032698
Diverticulum intestinal haemorrhagic	36.95	16.19	19	54388	1742	90572298
Exsanguination	36.92	16.19	7	54400	15	90574025
Peritonitis	36.84	16.19	52	54355	19653	90554387
Liver function test increased	36.78	16.19	4	54403	84851	90489189
Ischaemic cerebral infarction	36.75	16.19	18	54389	1488	90572552
Incarcerated hernia	36.25	16.19	10	54397	155	90573885
Brain contusion	36.20	16.19	14	54393	651	90573389
Hiatus hernia	36.16	16.19	59	54348	25302	90548738
Bradykinesia	35.98	16.19	31	54376	6757	90567283
Muscle spasms	35.83	16.19	60	54347	251823	90322217
Wound infection	35.36	16.19	10	54397	106392	90467648
Hypertension	35.30	16.19	148	54259	457384	90116656
Obesity	34.91	16.19	10	54397	105497	90468543
Brain herniation	34.88	16.19	25	54382	4175	90569865
Gastritis	34.51	16.19	77	54330	41676	90532364
Vascular access site haemorrhage	34.25	16.19	10	54397	192	90573848
Arthritis	34.24	16.19	30	54377	167285	90406755
Activated partial thromboplastin time	33.88	16.19	6	54401	7	90574033
Gastritis haemorrhagic	33.72	16.19	18	54389	1782	90572258
Influenza	33.63	16.19	21	54386	139243	90434797
Chills	33.14	16.19	19	54388	131962	90442078
Renal infarct	32.66	16.19	17	54390	1598	90572442
Coagulation factor increased	32.63	16.19	6	54401	10	90574030
Oesophageal ulcer	32.60	16.19	26	54381	5093	90568947
Nausea	32.35	16.19	471	53936	1109845	89464195
Acute coronary syndrome	32.17	16.19	36	54371	10777	90563263
Rhinorrhoea	31.87	16.19	7	54400	88309	90485731
Prescribed underdose	31.37	16.19	4	54403	75015	90499025
Haemorrhoids	31.36	16.19	57	54350	26645	90547395
Femoral artery embolism	31.34	16.19	7	54400	42	90573998
Intracranial haematoma	31.31	16.19	11	54396	389	90573651
Basal ganglia haemorrhage	30.99	16.19	13	54394	748	90573292
Loss of personal independence in daily activities	30.87	16.19	22	54385	136083	90437957
Joint stiffness	30.68	16.19	5	54402	78037	90496003
Mesenteric artery embolism	30.21	16.19	6	54401	18	90574022
Heart transplant	30.18	16.19	12	54395	601	90573439
Intestinal infarction	29.83	16.19	14	54393	1053	90572987
Drug level increased	29.77	16.19	57	54350	27705	90546335
Phlebitis	29.76	16.19	29	54378	7401	90566639
Orthostatic intolerance	29.54	16.19	15	54392	1339	90572701
Urinary retention	29.41	16.19	68	54339	37676	90536364
Pain in extremity	29.30	16.19	155	54252	450374	90123666
Cardiac ablation	29.02	16.19	16	54391	1688	90572352
Drug abuse	28.77	16.19	7	54400	82340	90491700
Gastrointestinal necrosis	28.64	16.19	20	54387	3205	90570835
White blood cell count decreased	28.50	16.19	35	54372	167074	90406966
Cardiac failure chronic	28.35	16.19	25	54382	5621	90568419
Haemodynamic instability	28.15	16.19	35	54372	11704	90562336
Anticoagulation drug level below therapeutic	28.14	16.19	12	54395	719	90573321
Haemorrhagic arteriovenous malformation	28.09	16.19	8	54399	140	90573900
Normocytic anaemia	27.89	16.19	19	54388	2925	90571115
Peripheral venous disease	27.68	16.19	8	54399	83913	90490127
Infarction	27.50	16.19	19	54388	2994	90571046
Haemorrhagic disorder	27.43	16.19	13	54394	999	90573041
Hypotonia	27.29	16.19	34	54373	11392	90562648
Neutrophil count decreased	27.20	16.19	5	54402	71527	90502513
Memory impairment	27.12	16.19	48	54359	197196	90376844
Rib fracture	26.79	16.19	53	54354	26382	90547658
Femur fracture	26.49	16.19	74	54333	46008	90528032
Stress	26.40	16.19	8	54399	81387	90492653
Cardiogenic shock	25.95	16.19	50	54357	24418	90549622
Depression	25.88	16.19	93	54314	300508	90273532
Carotid artery occlusion	25.86	16.19	25	54382	6317	90567723
Cardiac arrest	25.78	16.19	128	54279	104807	90469233
Spontaneous haematoma	25.77	16.19	13	54394	1145	90572895
Abdominal wall haematoma	25.67	16.19	19	54388	3333	90570707
Haemorrhagic infarction	25.60	16.19	9	54398	319	90573721
Lacunar infarction	25.55	16.19	19	54388	3358	90570682
Oesophageal pain	25.29	16.19	21	54386	4353	90569687
Drug dependence	25.27	16.19	55	54352	29272	90544768
Dysarthria	25.18	16.19	81	54326	54401	90519639
Neck pain	25.10	16.19	19	54388	113944	90460096
Weight decreased	25.08	16.19	130	54277	379780	90194260
Cough	25.07	16.19	125	54282	368837	90205203
Diarrhoea	25.06	16.19	405	54002	938785	89635255
Prothrombin time	24.93	16.19	5	54402	16	90574024
Haemorrhagic diathesis	24.86	16.19	23	54384	5501	90568539
Rectal perforation	24.83	16.19	10	54397	518	90573522
Lower limb fracture	24.75	16.19	10	54397	85003	90489037
Mobility decreased	24.75	16.19	73	54334	250661	90323379
Prothrombin time ratio decreased	24.60	16.19	12	54395	983	90573057
Thrombotic stroke	24.44	16.19	10	54397	540	90573500
Diverticulitis intestinal haemorrhagic	24.29	16.19	7	54400	128	90573912
Ileus	24.28	16.19	39	54368	16507	90557533
Occult blood	24.25	16.19	13	54394	1298	90572742
Ear infection	24.24	16.19	6	54401	69769	90504271
Cerebellar haemorrhage	24.05	16.19	14	54393	1639	90572401
Knee arthroplasty	23.87	16.19	10	54397	83172	90490868
Hospitalisation	23.84	16.19	25	54382	128075	90445965
Adverse drug reaction	23.78	16.19	21	54386	116680	90457360
Appendicitis	23.73	16.19	30	54377	10201	90563839
Labelled drug-drug interaction medication error	23.67	16.19	36	54371	14546	90559494
Back pain	23.58	16.19	104	54303	317071	90256969
Haemoglobin abnormal	23.49	16.19	25	54382	7075	90566965
Illness	23.29	16.19	10	54397	81959	90492081
Haemorrhage urinary tract	23.29	16.19	12	54395	1105	90572935
Arterial haemorrhage	23.24	16.19	16	54391	2507	90571533
Duodenal ulcer haemorrhage	23.05	16.19	16	54391	2540	90571500
Gastrointestinal disorder	23.04	16.19	78	54329	256609	90317431
Inappropriate schedule of product administration	22.94	16.19	34	54373	149899	90424141
Pallor	22.82	16.19	58	54349	34107	90539933
Erosive oesophagitis	22.72	16.19	14	54393	1817	90572223
Rectal ulcer	22.63	16.19	13	54394	1485	90572555
Abdominal wall haemorrhage	22.58	16.19	7	54400	166	90573874
Nasal congestion	22.42	16.19	11	54396	83403	90490637
Therapeutic response decreased	22.40	16.19	13	54394	89716	90484324
Prothrombin level decreased	22.20	16.19	10	54397	684	90573356
Malignant neoplasm progression	22.06	16.19	19	54388	106851	90467189
Anuria	21.84	16.19	35	54372	14783	90559257
Uterine haemorrhage	21.80	16.19	20	54387	4732	90569308
Insomnia	21.51	16.19	115	54292	333359	90240681
Aortic thrombosis	21.47	16.19	12	54395	1300	90572740
Dyspepsia	21.39	16.19	197	54210	197963	90376077
Extradural haematoma	21.16	16.19	14	54393	2054	90571986
Lung disorder	21.03	16.19	36	54371	149847	90424193
Product administration error	21.02	16.19	48	54359	26375	90547665
Cardioversion	20.99	16.19	12	54395	1358	90572682
Glomerular filtration rate decreased	20.98	16.19	37	54370	16895	90557145
Vascular pseudoaneurysm	20.94	16.19	13	54394	1710	90572330
Post procedural haematuria	20.81	16.19	5	54402	43	90573997
COVID-19	20.67	16.19	44	54363	168799	90405241
Circulatory collapse	20.66	16.19	46	54361	24858	90549182
Injury	20.55	16.19	56	54351	197293	90376747
Brain stem haemorrhage	20.48	16.19	10	54397	821	90573219
Embolism arterial	20.41	16.19	11	54396	1110	90572930
Liver disorder	20.05	16.19	26	54381	121243	90452797
Cerebellar infarction	20.05	16.19	14	54393	2244	90571796
Splenic haematoma	20.04	16.19	6	54401	126	90573914
Muscle rigidity	20.01	16.19	33	54374	14276	90559764
Bleeding time prolonged	19.73	16.19	9	54398	634	90573406
Thoracic haemorrhage	19.70	16.19	5	54402	55	90573985
Arteriovenous malformation	19.58	16.19	12	54395	1543	90572497
Pharyngeal haemorrhage	19.56	16.19	9	54398	647	90573393
Lupus-like syndrome	19.49	16.19	3	54404	48843	90525197
Cerebral artery thrombosis	19.31	16.19	8	54399	446	90573594
Abdominal incarcerated hernia	19.26	16.19	3	54404	0	90574040
Thrombin time	19.26	16.19	3	54404	0	90574040
Sudden death	19.23	16.19	28	54379	10881	90563159
Anticoagulation drug level decreased	19.23	16.19	5	54402	61	90573979
Venous thrombosis	19.22	16.19	20	54387	5517	90568523
Retroperitoneal haematoma	19.12	16.19	16	54391	3352	90570688
Vomiting	19.03	16.19	346	54061	787947	89786093
Facial paresis	18.81	16.19	17	54390	3946	90570094
Product monitoring error	18.69	16.19	18	54389	4526	90569514
Acidosis	18.66	16.19	30	54377	12706	90561334
Micturition disorder	18.51	16.19	15	54392	3005	90571035
Feeling hot	18.50	16.19	12	54395	77996	90496044
Laryngitis	18.35	16.19	4	54403	50749	90523291
Influenza like illness	18.32	16.19	13	54394	80598	90493442
Back injury	18.30	16.19	3	54404	46619	90527421
Malaise	18.26	16.19	245	54162	585741	89988299
Chronic pigmented purpura	18.11	16.19	6	54401	177	90573863
Abortion spontaneous	18.11	16.19	5	54402	54051	90519989
Hepatitis acute	17.84	16.19	27	54380	10860	90563180
Tachyarrhythmia	17.83	16.19	19	54388	5387	90568653
Mucosal haemorrhage	17.75	16.19	11	54396	1442	90572598
Labelled drug-drug interaction issue	17.75	16.19	13	54394	2245	90571795
Colon neoplasm	17.67	16.19	9	54398	809	90573231
Hepatic failure	17.40	16.19	58	54349	39670	90534370
Stroke in evolution	17.32	16.19	5	54402	92	90573948
Hypertensive crisis	17.24	16.19	35	54372	17749	90556291
Injection site bruising	17.22	16.19	5	54402	52302	90521738
Muscle haemorrhage	17.17	16.19	15	54392	3331	90570709
Cardiac fibrillation	17.11	16.19	8	54399	596	90573444
Polyp	17.07	16.19	22	54385	7622	90566418
Blood potassium increased	16.85	16.19	38	54369	20711	90553329
Arterial thrombosis	16.78	16.19	11	54396	1589	90572451
Spinal cord haematoma	16.74	16.19	6	54401	225	90573815
Respiratory disorder	16.74	16.19	9	54398	64807	90509233
Venous thrombosis limb	16.73	16.19	15	54392	3447	90570593
Globulins decreased	16.68	16.19	7	54400	403	90573637
Adverse event	16.66	16.19	28	54379	117390	90456650
Brain stem stroke	16.55	16.19	7	54400	411	90573629
Ear pain	16.45	16.19	7	54400	57695	90516345
Duplicate therapy error	16.27	16.19	5	54402	115	90573925
Thrombotic cerebral infarction	16.26	16.19	6	54401	245	90573795
Atrial tachycardia	16.23	16.19	19	54388	5971	90568069
Lacunar stroke	16.21	16.19	6	54401	247	90573793

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	3275.25	14.23	1935	60415	95791	42463194
Ischaemic stroke	2521.03	14.23	1016	61334	21217	42537768
Cerebrovascular accident	1827.04	14.23	1343	61007	95817	42463168
Haemorrhage	1448.68	14.23	971	61379	59592	42499393
Melaena	1029.65	14.23	664	61686	38082	42520903
Rectal haemorrhage	985.17	14.23	710	61640	48896	42510089
Haemorrhage intracranial	965.26	14.23	481	61869	16711	42542274
Cerebral haemorrhage	874.04	14.23	601	61749	38365	42520620
Cerebral infarction	864.69	14.23	549	61801	30620	42528365
Cardiac tamponade	761.17	14.23	305	62045	6235	42552750
Subdural haematoma	739.20	14.23	446	61904	22692	42536293
Atrial thrombosis	682.02	14.23	218	62132	2226	42556759
Embolic stroke	614.16	14.23	243	62107	4797	42554188
Haematuria	586.98	14.23	561	61789	57238	42501747
Fall	453.69	14.23	1034	61316	233486	42325499
Lower gastrointestinal haemorrhage	439.93	14.23	244	62106	10564	42548421
Transient ischaemic attack	405.47	14.23	360	61990	33379	42525606
Gastric haemorrhage	397.07	14.23	226	62124	10289	42548696
Activated partial thromboplastin time prolonged	381.65	14.23	256	62094	15647	42543338
Procoagulant therapy	372.20	14.23	69	62281	10	42558975
Shock haemorrhagic	353.14	14.23	246	62104	15996	42542989
Hemiparesis	331.39	14.23	243	62107	17133	42541852
Coagulopathy	316.22	14.23	261	62089	21901	42537084
Pericardial haemorrhage	296.50	14.23	131	62219	3438	42555547
Upper gastrointestinal haemorrhage	292.03	14.23	286	62064	30013	42528972
Blood loss anaemia	270.94	14.23	172	62178	9564	42549421
Haematoma	254.29	14.23	256	62094	27767	42531218
Thrombin time prolonged	246.74	14.23	57	62293	133	42558852
Subarachnoid haemorrhage	241.77	14.23	187	62163	14285	42544700
Off label use	219.21	14.23	375	61975	637960	41921025
Epistaxis	215.51	14.23	366	61984	66460	42492525
Haemorrhagic stroke	211.54	14.23	133	62217	7269	42551716
Haematemesis	193.92	14.23	230	62120	29969	42529016
Aortic dissection	193.33	14.23	93	62257	2979	42556006
Haemothorax	190.84	14.23	110	62240	5126	42553859
Febrile neutropenia	189.92	14.23	24	62326	185679	42373306
Aphasia	187.97	14.23	203	62147	23880	42535105
Head injury	172.15	14.23	180	62170	20402	42538583
Neutropenia	170.80	14.23	41	62309	199390	42359595
Cardiac failure	168.18	14.23	436	61914	106420	42452565
Deep vein thrombosis	168.07	14.23	357	61993	76600	42482385
Procedural haemorrhage	166.74	14.23	82	62268	2759	42556226
International normalised ratio increased	164.83	14.23	271	62079	47897	42511088
Hemiplegia	161.15	14.23	115	62235	7764	42551221
Anaemia	161.13	14.23	822	61528	279456	42279529
Subdural haemorrhage	156.15	14.23	84	62266	3417	42555568
Intracardiac thrombus	154.18	14.23	74	62276	2358	42556627
Drug interaction	149.90	14.23	778	61572	266221	42292764
Haemorrhagic transformation stroke	149.60	14.23	66	62284	1725	42557260
Haematochezia	147.63	14.23	288	62062	58148	42500837
Pyrexia	139.82	14.23	226	62124	393816	42165169
Product dose omission issue	137.61	14.23	29	62321	154336	42404649
Pulmonary embolism	137.59	14.23	436	61914	119176	42439809
Post procedural haemorrhage	131.38	14.23	109	62241	9203	42549782
Disease progression	130.09	14.23	26	62324	143630	42415355
Product use in unapproved indication	126.15	14.23	56	62294	184400	42374585
Haemoptysis	124.54	14.23	234	62116	45933	42513052
Intestinal haemorrhage	123.05	14.23	75	62275	3876	42555109
Brain contusion	118.20	14.23	47	62303	939	42558046
Pericardial effusion	115.72	14.23	176	62174	29099	42529886
Cerebral haematoma	110.41	14.23	80	62270	5530	42553455
Drug abuse	108.35	14.23	13	62337	104758	42454227
Dyspepsia	108.32	14.23	207	62143	41145	42517840
Heart transplant	106.53	14.23	44	62306	973	42558012
Haemoglobin decreased	104.56	14.23	427	61923	132044	42426941
Peripheral embolism	101.79	14.23	43	62307	1008	42557977
Traumatic intracranial haemorrhage	101.37	14.23	39	62311	711	42558274
Anticoagulation drug level increased	94.78	14.23	35	62315	567	42558418
Toxicity to various agents	94.38	14.23	118	62232	229018	42329967
Faeces discoloured	93.73	14.23	120	62230	16894	42542091
Completed suicide	92.62	14.23	15	62335	96450	42462535
Colon cancer	92.50	14.23	91	62259	9590	42549395
Intraventricular haemorrhage	91.88	14.23	62	62288	3822	42555163
Fatigue	91.54	14.23	329	62021	435312	42123673
Pain	89.91	14.23	137	62213	244711	42314274
Rash	87.96	14.23	170	62180	276784	42282201
Large intestinal haemorrhage	84.22	14.23	44	62306	1685	42557300
Cerebral artery occlusion	83.46	14.23	35	62315	805	42558180
Activated partial thromboplastin time abnormal	83.19	14.23	23	62327	134	42558851
Road traffic accident	82.93	14.23	120	62230	18973	42540012
Extradural haematoma	82.29	14.23	40	62310	1311	42557674
Oesophageal pain	79.90	14.23	36	62314	990	42557995
International normalised ratio abnormal	79.44	14.23	54	62296	3369	42555616
Renal impairment	78.92	14.23	345	62005	109883	42449102
Leukopenia	77.95	14.23	9	62341	74737	42484248
Pancytopenia	76.96	14.23	38	62312	117705	42441280
Urinary bladder haemorrhage	73.22	14.23	41	62309	1806	42557179
Drug hypersensitivity	73.05	14.23	27	62323	99362	42459623
Pulmonary haemorrhage	71.80	14.23	86	62264	11311	42547674
White blood cell count decreased	70.10	14.23	37	62313	110359	42448626
Haemorrhagic infarction	69.84	14.23	27	62323	499	42558486
Depression	69.72	14.23	38	62312	111325	42447660
Hypovolaemic shock	69.31	14.23	74	62276	8585	42550400
Condition aggravated	68.88	14.23	177	62173	260577	42298408
Coagulation time prolonged	68.49	14.23	36	62314	1396	42557589
Blood urine present	68.19	14.23	85	62265	11648	42547337
Acute kidney injury	67.58	14.23	827	61523	366510	42192475
Drug ineffective	66.79	14.23	596	61754	629601	41929384
Arthralgia	65.08	14.23	126	62224	205112	42353873
Aortic aneurysm rupture	64.67	14.23	32	62318	1091	42557894
Coagulation test abnormal	63.75	14.23	27	62323	637	42558348
Gingival bleeding	63.52	14.23	70	62280	8415	42550570
Neuropathy peripheral	63.40	14.23	35	62315	101818	42457167
Creatinine renal clearance decreased	63.20	14.23	48	62302	3565	42555420
Intentional product use issue	62.93	14.23	14	62336	71819	42487166
Embolic cerebral infarction	62.34	14.23	29	62321	860	42558125
Contusion	61.55	14.23	167	62183	41818	42517167
Haemorrhoidal haemorrhage	61.11	14.23	50	62300	4138	42554847
Splenic rupture	61.08	14.23	35	62315	1612	42557373
Diarrhoea	60.83	14.23	410	61940	460439	42098546
Embolism	59.98	14.23	69	62281	8694	42550291
Cerebral mass effect	59.47	14.23	32	62318	1302	42557683
Wound secretion	59.40	14.23	42	62308	2793	42556192
Infusion related reaction	59.39	14.23	9	62341	60797	42498188
Skull fracture	58.33	14.23	29	62321	999	42557986
Neutrophil count decreased	54.27	14.23	13	62337	63402	42495583
Weight increased	54.09	14.23	47	62303	107936	42451049
Renal failure	53.62	14.23	377	61973	143349	42415636
Injection site pain	53.25	14.23	10	62340	57788	42501197
Prothrombin time prolonged	52.48	14.23	67	62283	9402	42549583
Cardiac ablation	52.13	14.23	29	62321	1261	42557724
Malignant neoplasm progression	52.13	14.23	49	62301	108351	42450634
Cerebral artery embolism	51.87	14.23	27	62323	1026	42557959
Anorectal discomfort	50.97	14.23	35	62315	2220	42556765
Coagulation time shortened	50.91	14.23	17	62333	201	42558784
Traumatic haemothorax	50.55	14.23	20	62330	394	42558591
Cytokine release syndrome	50.01	14.23	4	62346	44523	42514462
Product use issue	49.79	14.23	25	62325	76726	42482259
Thrombin time abnormal	49.76	14.23	9	62341	0	42558985
Stress	49.57	14.23	4	62346	44208	42514777
Chills	49.51	14.23	39	62311	94027	42464958
Mucosal inflammation	48.93	14.23	7	62343	49367	42509618
Muscle spasms	48.76	14.23	33	62317	86011	42472974
Basal ganglia haemorrhage	48.68	14.23	26	62324	1042	42557943
Embolism arterial	48.43	14.23	24	62326	821	42558164
Nausea	48.40	14.23	361	61989	396438	42162547
Craniocerebral injury	48.18	14.23	42	62308	3792	42555193
Cerebellar haemorrhage	47.20	14.23	30	62320	1670	42557315
Surgery	47.11	14.23	89	62261	17527	42541458
Incarcerated hernia	47.10	14.23	15	62335	151	42558834
Traumatic haemorrhage	46.99	14.23	27	62323	1250	42557735
Acute abdomen	46.95	14.23	32	62318	2005	42556980
Oesophageal ulcer	46.88	14.23	41	62309	3718	42555267
Retroperitoneal haemorrhage	46.74	14.23	38	62312	3117	42555868
Inappropriate schedule of product administration	46.52	14.23	43	62307	95859	42463126
Acute myocardial infarction	46.21	14.23	188	62162	57977	42501008
Anxiety	45.73	14.23	64	62286	118496	42440489
Somnolence	45.24	14.23	86	62264	141019	42417966
Rheumatoid arthritis	44.52	14.23	5	62345	42435	42516550
Tremor	44.09	14.23	46	62304	96883	42462102
COVID-19	43.33	14.23	64	62286	115884	42443101
Subarachnoid haematoma	43.22	14.23	16	62334	261	42558724
Intra-abdominal haemorrhage	42.81	14.23	35	62315	2893	42556092
Diverticulum	42.81	14.23	54	62296	7487	42551498
Insomnia	42.53	14.23	67	62283	118186	42440799
Asthma	42.41	14.23	19	62331	62295	42496690
Syncope	42.00	14.23	269	62081	99137	42459848
Multiple injuries	41.76	14.23	29	62321	1873	42557112
Drug intolerance	41.50	14.23	34	62316	80390	42478595
Hospitalisation	41.46	14.23	29	62321	74301	42484684
Large intestine polyp	41.35	14.23	59	62291	9206	42549779
Cardiac valve replacement complication	40.99	14.23	10	62340	32	42558953
Erythema	40.70	14.23	60	62290	108733	42450252
Mouth haemorrhage	40.68	14.23	48	62302	6213	42552772
Nasopharyngitis	40.34	14.23	38	62312	83958	42475027
Cough	40.30	14.23	130	62220	177973	42381012
Musculoskeletal stiffness	40.28	14.23	17	62333	57748	42501237
Gastric ulcer haemorrhage	39.86	14.23	47	62303	6080	42552905
Pruritus	39.85	14.23	142	62208	188629	42370356
Haemorrhage urinary tract	39.35	14.23	29	62321	2057	42556928
Dry skin	39.27	14.23	11	62339	48327	42510658
Agitation	38.72	14.23	23	62327	64291	42494694
Activated partial thromboplastin time	38.70	14.23	7	62343	0	42558985
Dysarthria	38.49	14.23	137	62213	39670	42519315
Ischaemia	38.41	14.23	42	62308	5005	42553980
International normalised ratio	38.13	14.23	10	62340	46	42558939
Intestinal ischaemia	37.87	14.23	57	62293	9331	42549654
Loss of personal independence in daily activities	37.49	14.23	13	62337	49803	42509182
Strangulated hernia	36.61	14.23	9	62341	30	42558955
Stomatitis	36.42	14.23	14	62336	50315	42508670
Joint swelling	36.04	14.23	28	62322	67994	42490991
Platelet count decreased	35.81	14.23	95	62255	138486	42420499
Haemorrhoids	35.75	14.23	78	62272	17019	42541966
Cerebral ischaemia	35.09	14.23	47	62303	6912	42552073
Iron deficiency anaemia	35.02	14.23	66	62284	12973	42546012
Intracranial haematoma	34.78	14.23	17	62333	564	42558421
Anticoagulation drug level abnormal	34.77	14.23	12	62338	158	42558827
Wound haemorrhage	34.58	14.23	28	62322	2283	42556702
Haemodynamic instability	34.27	14.23	64	62286	12493	42546492
Arterial thrombosis	34.21	14.23	25	62325	1751	42557234
Seizure	34.00	14.23	79	62271	120482	42438503
Injury	33.94	14.23	90	62260	22226	42536759
Urogenital haemorrhage	33.82	14.23	18	62332	716	42558269
Cardioversion	33.75	14.23	20	62330	981	42558004
Weight decreased	33.70	14.23	173	62177	207775	42351210
Infection	33.60	14.23	71	62279	111997	42446988
Cytomegalovirus infection	33.40	14.23	4	62346	32302	42526683
Prothrombin time abnormal	33.38	14.23	19	62331	864	42558121
Femur fracture	33.25	14.23	55	62295	9757	42549228
Renal infarct	32.90	14.23	25	62325	1858	42557127
Diabetes mellitus	32.78	14.23	24	62326	60063	42498922
Ecchymosis	32.61	14.23	48	62302	7704	42551281
Arrhythmia	32.56	14.23	131	62219	40186	42518799
Sleep disorder	32.20	14.23	15	62335	48080	42510905
Alanine aminotransferase increased	31.86	14.23	50	62300	88356	42470629
Facial asymmetry	31.83	14.23	14	62336	363	42558622
Exsanguination	31.78	14.23	9	62341	58	42558927
Cerebellar infarction	31.49	14.23	26	62324	2179	42556806
Arteriovenous malformation	31.49	14.23	18	62332	825	42558160
Psoriasis	31.26	14.23	16	62334	48588	42510397
Sedation	30.95	14.23	4	62346	30471	42528514
Vomiting	30.93	14.23	273	62077	289450	42269535
Therapeutic response decreased	30.86	14.23	8	62342	37004	42521981
Peripheral artery thrombosis	30.82	14.23	28	62322	2669	42556316
Gastrointestinal motility disorder	30.81	14.23	29	62321	2892	42556093
Mesenteric artery embolism	30.77	14.23	9	62341	66	42558919
Creatinine renal clearance	30.75	14.23	6	62344	3	42558982
Elderly	30.75	14.23	6	62344	3	42558982
Anastomotic infection	30.28	14.23	10	62340	114	42558871
C-reactive protein increased	30.23	14.23	29	62321	63531	42495454
Gastric ulcer	30.19	14.23	76	62274	18186	42540799
Occult blood positive	29.95	14.23	34	62316	4223	42554762
Cardiac perforation	29.77	14.23	9	62341	75	42558910
Rib fracture	29.56	14.23	71	62279	16500	42542485
Therapy non-responder	29.51	14.23	21	62329	53338	42505647
Bleeding time prolonged	29.49	14.23	16	62334	662	42558323
Gastrointestinal angiodysplasia	29.49	14.23	16	62334	662	42558323
Haemorrhage subcutaneous	29.32	14.23	27	62323	2619	42556366
Cardiac ventricular thrombosis	29.24	14.23	23	62327	1799	42557186
Thrombotic stroke	29.23	14.23	12	62338	261	42558724
Oxygen saturation decreased	29.07	14.23	31	62319	64656	42494329
Thrombocytopenia	28.77	14.23	162	62188	190117	42368868
Anticoagulation drug level decreased	28.72	14.23	11	62339	198	42558787
Haemorrhagic diathesis	28.66	14.23	29	62321	3160	42555825
Femoral neck fracture	28.57	14.23	33	62317	4176	42554809
Blood cholesterol increased	28.43	14.23	3	62347	26738	42532247
Neurologic neglect syndrome	28.42	14.23	11	62339	204	42558781
Sinusitis	28.34	14.23	17	62333	47275	42511710
Rectal cancer	28.14	14.23	25	62325	2315	42556670
Anticoagulant-related nephropathy	27.60	14.23	10	62340	153	42558832
Thrombosis	27.46	14.23	183	62167	68328	42490657
Mucosal haemorrhage	27.45	14.23	22	62328	1768	42557217
Haemoglobin abnormal	27.31	14.23	35	62315	4929	42554056
Hemianopia	27.26	14.23	17	62333	915	42558070
Drug ineffective for unapproved indication	27.10	14.23	17	62333	46146	42512839
Lumbar puncture	27.06	14.23	9	62341	105	42558880
Gastritis erosive	26.97	14.23	40	62310	6463	42552522
Influenza	26.62	14.23	31	62319	62144	42496841
Gastric cancer	26.56	14.23	41	62309	6862	42552123
Mucosal dryness	26.53	14.23	21	62329	1657	42557328
Productive cough	26.35	14.23	22	62328	51545	42507440
Diverticulum intestinal haemorrhagic	26.30	14.23	27	62323	2992	42555993
Infarction	26.19	14.23	27	62323	3008	42555977
Anaphylactic reaction	26.13	14.23	15	62335	42728	42516257
Gastrointestinal carcinoma	25.84	14.23	22	62328	1924	42557061
Aneurysm ruptured	25.39	14.23	14	62336	598	42558387
Blood glucose increased	25.32	14.23	43	62307	73656	42485329
Basilar artery occlusion	25.26	14.23	8	62342	79	42558906
Renal haemorrhage	25.04	14.23	20	62330	1599	42557386
Brain herniation	24.97	14.23	33	62317	4790	42554195
Wheezing	24.90	14.23	26	62324	54755	42504230
Peripheral swelling	24.76	14.23	60	62290	90210	42468775
Blood pressure increased	24.74	14.23	72	62278	101856	42457129
Urticaria	24.71	14.23	44	62306	73992	42484993
Feeling abnormal	24.64	14.23	40	62310	69746	42489239
White blood cell count increased	24.60	14.23	18	62332	45069	42513916
Thalamus haemorrhage	24.43	14.23	17	62333	1102	42557883
Myocardial infarction	24.34	14.23	283	62067	123726	42435259
Blood creatine phosphokinase increased	24.24	14.23	21	62329	48317	42510668
Hyperhidrosis	24.17	14.23	61	62289	90451	42468534
Arterial injury	24.07	14.23	12	62338	416	42558569
Pulmonary contusion	24.00	14.23	8	62342	94	42558891
Osteoma	24.00	14.23	8	62342	94	42558891
Pain in extremity	23.98	14.23	126	62224	150478	42408507
Pneumocystis jirovecii pneumonia	23.97	14.23	4	62346	25177	42533808
Myalgia	23.96	14.23	67	62283	96013	42462972
Full blood count abnormal	23.90	14.23	7	62343	29869	42529116
Aspartate aminotransferase increased	23.87	14.23	48	62302	77115	42481870
Hemianopia homonymous	23.81	14.23	15	62335	822	42558163
Eczema	23.81	14.23	10	62340	34076	42524909
Hyponatraemia	23.67	14.23	73	62277	101389	42457596
Polycystic liver disease	23.63	14.23	8	62342	99	42558886
Aggression	23.62	14.23	18	62332	44145	42514840
Irritability	23.61	14.23	6	62344	28122	42530863
Back pain	23.49	14.23	117	62233	141659	42417326
Ascites	23.47	14.23	29	62321	56649	42502336
Hypersensitivity	23.27	14.23	44	62306	72326	42486659
Lymphocyte count decreased	23.21	14.23	6	62344	27803	42531182
Splenic injury	23.17	14.23	6	62344	26	42558959
Aortic aneurysm	23.15	14.23	41	62309	7682	42551303
Venous thrombosis	23.07	14.23	29	62321	4006	42554979
Respiratory tract haemorrhage	23.07	14.23	18	62332	1391	42557594
Rhabdomyolysis	22.90	14.23	50	62300	77969	42481016
Neoplasm progression	22.82	14.23	7	62343	28993	42529992
Cardiac failure chronic	22.63	14.23	46	62304	9555	42549430
Catheter site haemorrhage	22.59	14.23	23	62327	2525	42556460
Small intestinal haemorrhage	22.45	14.23	22	62328	2306	42556679
Subcutaneous haematoma	22.43	14.23	16	62334	1079	42557906
Acute myeloid leukaemia	22.41	14.23	3	62347	22253	42536732
Splenic necrosis	22.41	14.23	8	62342	117	42558868
Pneumonitis	22.32	14.23	17	62333	41701	42517284
Dysphagia	22.16	14.23	182	62168	72537	42486448
Traumatic haematoma	22.14	14.23	14	62336	772	42558213
Suicidal ideation	21.72	14.23	23	62327	48138	42510847
Skull fractured base	21.50	14.23	9	62341	206	42558779
Splenic cyst	21.42	14.23	8	62342	134	42558851
Cataract	21.34	14.23	9	62341	30595	42528390
Post procedural stroke	21.27	14.23	6	62344	38	42558947
Cardiac pacemaker insertion	21.27	14.23	25	62325	3223	42555762
Atrial fibrillation	21.25	14.23	304	62046	139289	42419696
Cholecystitis acute	21.05	14.23	39	62311	7567	42551418
Haemoglobin urine present	20.99	14.23	8	62342	142	42558843
Constipation	20.99	14.23	145	62205	162146	42396839
Psychotic disorder due to a general medical condition	20.95	14.23	7	62343	83	42558902
Microcytic anaemia	20.94	14.23	24	62326	3011	42555974
Labelled drug-drug interaction medication error	20.88	14.23	60	62290	15522	42543463
Pneumonia	20.81	14.23	465	61885	421684	42137301
Pulmonary alveolar haemorrhage	20.78	14.23	58	62292	14758	42544227
Oesophagitis	20.71	14.23	59	62291	15188	42543797
Shock	20.69	14.23	91	62259	29030	42529955
Haematocrit increased	20.65	14.23	22	62328	2545	42556440
Herpes zoster	20.59	14.23	16	62334	38861	42520124
Neuralgia	20.53	14.23	6	62344	25641	42533344
Intentional product misuse	20.46	14.23	37	62313	61863	42497122
Coronary artery embolism	20.39	14.23	8	62342	154	42558831
Diabetic ketoacidosis	20.32	14.23	4	62346	22363	42536622
Puncture site haemorrhage	20.23	14.23	10	62340	340	42558645
Drug reaction with eosinophilia and systemic symptoms	20.23	14.23	19	62331	42056	42516929
Arthritis	20.22	14.23	19	62331	42046	42516939
Intestinal infarction	20.19	14.23	12	62338	592	42558393
Arthropathy	20.17	14.23	9	62341	29588	42529397
Left atrial dilatation	20.06	14.23	21	62329	2381	42556604
Feeling hot	19.72	14.23	5	62345	23477	42535508
Influenza like illness	19.71	14.23	11	62339	31829	42527156
Hypoxia	19.44	14.23	46	62304	69740	42489245
Non-compaction cardiomyopathy	19.44	14.23	6	62344	54	42558931
Colitis ulcerative	19.40	14.23	7	62343	26168	42532817
Candida infection	19.35	14.23	4	62346	21606	42537379
Prostate tenderness	19.34	14.23	6	62344	55	42558930
Factor V deficiency	19.24	14.23	5	62345	22	42558963
Neutrophil count increased	19.17	14.23	3	62347	19801	42539184
Urinary sediment present	19.13	14.23	9	62341	274	42558711
Eye haemorrhage	19.02	14.23	29	62321	4801	42554184
Cerebral thrombosis	18.99	14.23	14	62336	994	42557991
Haemoperitoneum	18.95	14.23	19	62331	2047	42556938
Peripheral ischaemia	18.89	14.23	34	62316	6451	42552534
Anticoagulation drug level below therapeutic	18.76	14.23	14	62336	1012	42557973
Haemarthrosis	18.64	14.23	26	62324	3972	42555013
Hepatic cytolysis	18.55	14.23	8	62342	26836	42532149
Dyskinesia	18.47	14.23	7	62343	25383	42533602
Toxic epidermal necrolysis	18.44	14.23	8	62342	26742	42532243
Colon neoplasm	18.32	14.23	11	62339	553	42558432
Blood pressure systolic increased	18.29	14.23	9	62341	27959	42531026
Bone pain	18.26	14.23	6	62344	23786	42535199
Lower respiratory tract infection	18.23	14.23	20	62330	41186	42517799
Cerebellar haematoma	18.17	14.23	8	62342	208	42558777
Abnormal behaviour	18.09	14.23	8	62342	26443	42532542
Colitis	18.08	14.23	25	62325	46547	42512438
Bacteraemia	18.05	14.23	7	62343	25033	42533952
Muscle haemorrhage	18.01	14.23	26	62324	4099	42554886
Respiratory depression	17.95	14.23	3	62347	18865	42540120
Anaphylactic shock	17.93	14.23	6	62344	23511	42535474
Gastritis	17.91	14.23	76	62274	23871	42535114
Prothrombin time ratio decreased	17.88	14.23	11	62339	578	42558407
Blood lactate dehydrogenase increased	17.66	14.23	8	62342	26073	42532912
Hallucination	17.59	14.23	36	62314	57471	42501514
Skin exfoliation	17.48	14.23	21	62329	41532	42517453
Colitis ischaemic	17.48	14.23	35	62315	7191	42551794
Encephalopathy	17.27	14.23	21	62329	41312	42517673
Prothrombin time shortened	17.19	14.23	16	62334	1573	42557412
Hypovolaemia	17.14	14.23	46	62304	11439	42547546
Intestinal mass	17.13	14.23	11	62339	623	42558362
Cerebral vascular occlusion	17.12	14.23	4	62346	10	42558975
Abdominal strangulated hernia	17.12	14.23	4	62346	10	42558975
Diverticulitis intestinal haemorrhagic	17.03	14.23	9	62341	353	42558632
Upper respiratory tract infection	17.02	14.23	22	62328	42151	42516834
Haematocrit decreased	16.97	14.23	98	62252	34810	42524175
Vision blurred	16.95	14.23	33	62317	53666	42505319
Bronchiectasis	16.84	14.23	3	62347	18016	42540969
Orthopaedic procedure	16.83	14.23	5	62345	39	42558946
Iliac artery embolism	16.59	14.23	3	62347	0	42558985
Anti factor VIII antibody test	16.59	14.23	3	62347	0	42558985
Inguinal hernia strangulated	16.59	14.23	3	62347	0	42558985
Gastrointestinal necrosis	16.56	14.23	25	62325	4103	42554882
Internal haemorrhage	16.54	14.23	29	62321	5392	42553593
Conjunctival haemorrhage	16.51	14.23	23	62327	3510	42555475
Gastritis haemorrhagic	16.48	14.23	16	62334	1658	42557327
Nightmare	16.43	14.23	8	62342	25004	42533981
Tumour lysis syndrome	16.39	14.23	6	62344	22225	42536760
Incarcerated inguinal hernia	16.38	14.23	8	62342	265	42558720
Pericardial fibrosis	16.26	14.23	7	62343	172	42558813
Cytopenia	16.17	14.23	3	62347	17494	42541491
Palmar-plantar erythrodysaesthesia syndrome	16.14	14.23	5	62345	20577	42538408
No adverse event	16.12	14.23	20	62330	39001	42519984
Putamen haemorrhage	16.11	14.23	8	62342	275	42558710
Disease recurrence	15.99	14.23	12	62338	29666	42529319
Myocarditis	15.97	14.23	4	62346	18934	42540051
Accidental exposure to product	15.91	14.23	5	62345	20388	42538597
Skin laceration	15.89	14.23	51	62299	14007	42544978
Mitral valve replacement	15.79	14.23	7	62343	185	42558800
Lacunar stroke	15.71	14.23	8	62342	290	42558695
Haemochromatosis	15.65	14.23	13	62337	1099	42557886
Brain oedema	15.61	14.23	56	62294	16271	42542714
Myoclonus	15.61	14.23	3	62347	17062	42541923
Gait disturbance	15.58	14.23	82	62268	97918	42461067
Aortic intramural haematoma	15.55	14.23	5	62345	52	42558933
Atrial flutter	15.51	14.23	58	62292	17193	42541792
Ulcer haemorrhage	15.46	14.23	21	62329	3129	42555856
Chest injury	15.34	14.23	16	62334	1806	42557179
Decreased appetite	15.29	14.23	195	62155	192942	42366043
Hypocalcaemia	15.26	14.23	13	62337	30160	42528825
Plasma cell myeloma	15.23	14.23	29	62321	47549	42511436
Carotid artery stenosis	15.20	14.23	28	62322	5408	42553577
Acute respiratory distress syndrome	15.19	14.23	13	62337	30095	42528890
Presyncope	15.18	14.23	69	62281	22318	42536667
Viral infection	15.07	14.23	7	62343	22476	42536509
Meningorrhagia	14.99	14.23	6	62344	122	42558863
Speech disorder	14.97	14.23	83	62267	29038	42529947
Haemorrhagic disorder	14.92	14.23	11	62339	781	42558204
Ischaemic cerebral infarction	14.87	14.23	15	62335	1628	42557357
Thrombotic cerebral infarction	14.85	14.23	9	62341	460	42558525
Right hemisphere deficit syndrome	14.82	14.23	4	62346	21	42558964
Duodenitis	14.77	14.23	28	62322	5528	42553457
Obstructive airways disorder	14.69	14.23	9	62341	24750	42534235
Muscle strain	14.63	14.23	25	62325	4552	42554433
Blood pressure systolic inspiratory decreased	14.51	14.23	3	62347	3	42558982
Mesenteric haemorrhage	14.51	14.23	4	62346	23	42558962
Lordosis	14.48	14.23	8	62342	343	42558642
Retroperitoneal haematoma	14.46	14.23	20	62330	3031	42555954
Coronary artery occlusion	14.40	14.23	42	62308	10955	42548030
Angioedema	14.39	14.23	25	62325	42452	42516533
Vascular stent occlusion	14.38	14.23	7	62343	230	42558755
Splenic lesion	14.38	14.23	8	62342	348	42558637
Paresis	14.37	14.23	18	62332	2478	42556507
Hypercoagulation	14.31	14.23	14	62336	1465	42557520
Osteonecrosis of jaw	14.28	14.23	5	62345	19044	42539941
Thoracic haemorrhage	14.27	14.23	7	62343	234	42558751

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
Gastrointestinal haemorrhage	5808.02	13.74	2840	93454	162678	110330327
Ischaemic stroke	4363.08	13.74	1558	94736	39705	110453300
Cerebrovascular accident	2356.48	13.74	1635	94659	179649	110313356
Melaena	2086.06	13.74	1072	95222	67685	110425320
Haemorrhage	2057.42	13.74	1234	95060	105458	110387547
Haemorrhage intracranial	1670.55	13.74	705	95589	28264	110464741
Cerebral haemorrhage	1543.12	13.74	861	95433	64107	110428898
Rectal haemorrhage	1497.24	13.74	1056	95238	118777	110374228
Cerebral infarction	1374.59	13.74	739	95555	51099	110441906
Cardiac tamponade	1280.86	13.74	450	95844	10857	110482148
Subdural haematoma	1161.78	13.74	588	95706	35866	110457139
Lower gastrointestinal haemorrhage	950.54	13.74	415	95879	18071	110474934
Embolic stroke	937.12	13.74	334	95960	8409	110484596
Haematuria	911.76	13.74	677	95617	82328	110410677
Activated partial thromboplastin time prolonged	835.19	13.74	402	95892	21966	110471039
Atrial thrombosis	801.76	13.74	250	96044	4096	110488909
Fall	799.18	13.74	1675	94619	601807	109891198
Shock haemorrhagic	771.46	13.74	406	95888	26841	110466164
Coagulopathy	697.51	13.74	438	95856	40473	110452532
Upper gastrointestinal haemorrhage	654.03	13.74	454	95840	49642	110443363
Drug interaction	595.62	13.74	1331	94963	498852	109994153
Haematoma	588.88	13.74	453	95841	58023	110434982
Transient ischaemic attack	563.42	13.74	458	95836	63524	110429481
Gastric haemorrhage	531.17	13.74	265	96029	15650	110477355
Subarachnoid haemorrhage	513.80	13.74	321	95973	29381	110463624
Blood loss anaemia	511.36	13.74	269	96025	17756	110475249
Pericardial haemorrhage	501.77	13.74	184	96110	5033	110487972
Anaemia	499.28	13.74	1314	94980	545772	109947233
Hemiparesis	492.83	13.74	363	95931	43540	110449465
Haemorrhagic stroke	449.57	13.74	226	96068	13563	110479442
International normalised ratio increased	445.44	13.74	459	95835	86313	110406692
Haematemesis	429.73	13.74	379	95915	58729	110434276
Thrombin time prolonged	427.97	13.74	91	96203	259	110492746
Haematochezia	406.41	13.74	502	95792	115022	110377983
Cardiac failure	395.70	13.74	638	95656	186988	110306017
Epistaxis	348.21	13.74	495	95799	129877	110363128
Haemoglobin decreased	344.90	13.74	705	95589	248022	110244983
Acute kidney injury	327.90	13.74	1254	95040	634176	109858829
Subdural haemorrhage	323.35	13.74	143	96151	6415	110486590
Deep vein thrombosis	304.86	13.74	483	95811	139404	110353601
Pain	301.41	13.74	235	96059	954720	109538285
Aortic dissection	300.72	13.74	125	96169	4808	110488197
Pulmonary embolism	290.28	13.74	602	95692	213872	110279133
Haemothorax	288.81	13.74	135	96159	6896	110486109
Procoagulant therapy	286.28	13.74	50	96244	19	110492986
Intestinal haemorrhage	274.14	13.74	132	96162	7209	110485796
Drug hypersensitivity	253.24	13.74	45	96249	454045	110038960
Cerebral haematoma	245.81	13.74	134	96160	9498	110483507
Infusion related reaction	245.34	13.74	24	96270	381138	110111867
Aphasia	244.75	13.74	279	96015	58718	110434287
Procedural haemorrhage	244.16	13.74	111	96183	5316	110487689
Haemoptysis	242.72	13.74	305	95989	71049	110421956
Renal failure	240.27	13.74	577	95717	225997	110267008
Head injury	237.90	13.74	237	96057	42780	110450225
Rash	229.85	13.74	226	96068	820738	109672267
Off label use	224.46	13.74	623	95671	1499562	108993443
Hypovolaemic shock	218.47	13.74	144	96150	14439	110478566
Faeces discoloured	215.93	13.74	202	96092	33746	110459259
Synovitis	214.62	13.74	5	96289	274087	110218918
Hemiplegia	210.87	13.74	168	96126	22614	110470391
Joint swelling	207.20	13.74	64	96230	442781	110050224
Post procedural haemorrhage	205.67	13.74	142	96152	15370	110477635
Renal impairment	204.16	13.74	484	95810	187961	110305044
Systemic lupus erythematosus	197.75	13.74	5	96289	254333	110238672
Maternal exposure during pregnancy	190.98	13.74	7	96287	254876	110238129
Arthropathy	190.64	13.74	16	96278	287506	110205499
Fatigue	190.63	13.74	493	95801	1215465	109277540
Febrile neutropenia	188.74	13.74	26	96268	316741	110176264
Nasopharyngitis	186.26	13.74	56	96238	394305	110098700
Drug intolerance	186.15	13.74	61	96233	406451	110086554
Pericardial effusion	185.77	13.74	239	96055	56978	110436027
Rheumatoid arthritis	184.77	13.74	22	96272	299591	110193414
Peripheral embolism	181.82	13.74	68	96226	1967	110491038
Anticoagulation drug level increased	178.89	13.74	56	96238	929	110492076
Pyrexia	176.38	13.74	321	95973	897944	109595061
Weight increased	175.28	13.74	73	96221	419571	110073434
Product use in unapproved indication	172.60	13.74	87	96207	447290	110045715
Hypersensitivity	172.44	13.74	68	96226	403930	110089075
Haemorrhagic transformation stroke	171.89	13.74	73	96221	2964	110490041
Coagulation time prolonged	171.37	13.74	72	96222	2845	110490160
Arthralgia	171.21	13.74	259	96035	779373	109713632
Cerebral artery occlusion	169.05	13.74	64	96230	1916	110491089
Traumatic intracranial haemorrhage	168.07	13.74	59	96235	1417	110491588
Syncope	166.53	13.74	469	95825	202067	110290938
Glossodynia	163.26	13.74	7	96287	221997	110271008
Intraventricular haemorrhage	161.34	13.74	84	96210	5423	110487582
Alopecia	157.96	13.74	60	96234	364693	110128312
Stomatitis	156.75	13.74	24	96270	270218	110222787
Intracardiac thrombus	154.10	13.74	75	96219	4193	110488812
Large intestinal haemorrhage	153.31	13.74	68	96226	3071	110489934
Neutropenia	151.92	13.74	68	96226	374552	110118453
Brain contusion	151.31	13.74	56	96238	1572	110491433
Atrial fibrillation	146.89	13.74	487	95807	229155	110263850
Sinusitis	145.85	13.74	39	96255	296649	110196356
Musculoskeletal stiffness	142.92	13.74	34	96260	279788	110213217
Completed suicide	139.49	13.74	22	96272	242359	110250646
Product dose omission issue	139.20	13.74	53	96241	321729	110171276
Prothrombin time prolonged	138.18	13.74	117	96177	17144	110475861
Hypotension	137.91	13.74	853	95441	522996	109970009
Therapeutic product effect decreased	136.55	13.74	24	96270	244292	110248713
Lower respiratory tract infection	135.62	13.74	24	96270	243082	110249923
Helicobacter infection	132.85	13.74	6	96288	181871	110311134
Condition aggravated	132.47	13.74	276	96018	734560	109758445
Folliculitis	131.43	13.74	3	96291	167650	110325355
Haemorrhoidal haemorrhage	126.32	13.74	82	96212	8011	110484994
Heart transplant	126.03	13.74	49	96245	1579	110491426
Pulmonary haemorrhage	124.52	13.74	108	96186	16348	110476657
Activated partial thromboplastin time abnormal	124.02	13.74	34	96260	344	110492661
International normalised ratio abnormal	123.44	13.74	74	96220	6283	110486722
Intentional product use issue	122.95	13.74	32	96262	247874	110245131
Craniocerebral injury	122.87	13.74	72	96222	5862	110487143
Irritable bowel syndrome	121.32	13.74	5	96289	164210	110328795
Asthma	119.10	13.74	35	96259	250256	110242749
Blood cholesterol increased	115.31	13.74	13	96281	184772	110308233
Peripheral swelling	114.23	13.74	110	96184	403924	110089081
Gingival bleeding	112.81	13.74	111	96183	19728	110473277
Wheezing	112.11	13.74	41	96253	255189	110237816
Embolic cerebral infarction	111.90	13.74	44	96250	1462	110491543
Acute myocardial infarction	111.83	13.74	234	96060	83543	110409462
Traumatic haemorrhage	109.95	13.74	46	96248	1798	110491207
Cerebral mass effect	107.32	13.74	49	96245	2370	110490635
Duodenal ulcer perforation	107.20	13.74	14	96280	177686	110315319
Swelling	107.10	13.74	89	96205	350952	110142053
Impaired healing	106.33	13.74	21	96273	196696	110296309
Discomfort	104.04	13.74	29	96265	214678	110278327
Contraindicated product administered	103.89	13.74	43	96251	248224	110244781
Sleep disorder	103.68	13.74	23	96271	198621	110294384
Hepatic enzyme increased	103.38	13.74	77	96217	320815	110172190
Colon cancer	102.94	13.74	97	96197	16346	110476659
Anticoagulation drug level abnormal	101.36	13.74	28	96266	292	110492713
Mouth haemorrhage	101.00	13.74	88	96206	13400	110479605
Disease progression	100.94	13.74	43	96251	243991	110249014
Splenic rupture	100.23	13.74	48	96246	2589	110490416
Infection	99.62	13.74	101	96193	362099	110130906
Blister	99.06	13.74	37	96257	227339	110265666
Anxiety	98.63	13.74	93	96201	344985	110148020
Urticaria	98.30	13.74	80	96214	318777	110174228
Injection site pain	98.27	13.74	18	96276	177904	110315101
Extradural haematoma	97.58	13.74	51	96243	3318	110489687
Cerebral artery embolism	97.55	13.74	44	96250	2068	110490937
Product use issue	95.10	13.74	79	96215	311616	110181389
Wound	94.29	13.74	43	96251	234394	110258611
Drug abuse	93.69	13.74	20	96274	177391	110315614
C-reactive protein abnormal	92.40	13.74	5	96289	129690	110363315
Embolism	92.36	13.74	91	96203	16198	110476807
Cardiac valve replacement complication	91.70	13.74	24	96270	200	110492805
Gastritis erosive	91.29	13.74	79	96215	11921	110481084
Thrombin time abnormal	90.95	13.74	16	96278	7	110492998
Nausea	89.45	13.74	670	95624	1235020	109257985
Intestinal ischaemia	87.34	13.74	88	96206	16091	110476914
Pericarditis	86.87	13.74	41	96253	219073	110273932
Muscle spasms	86.72	13.74	69	96225	278088	110214917
Coagulation test abnormal	86.05	13.74	37	96257	1549	110491456
Treatment failure	84.89	13.74	70	96224	277164	110215841
Night sweats	84.67	13.74	9	96285	133974	110359031
Aortic aneurysm rupture	83.73	13.74	35	96259	1365	110491640
Paraesthesia	83.22	13.74	71	96223	276450	110216555
Intra-abdominal haemorrhage	83.06	13.74	54	96240	5288	110487717
Musculoskeletal pain	82.76	13.74	28	96266	182995	110310010
Cerebral ischaemia	82.74	13.74	75	96219	12029	110480976
Creatinine renal clearance decreased	81.83	13.74	98	96196	21717	110471288
Bursitis	81.40	13.74	9	96285	129909	110363096
Acute abdomen	80.91	13.74	45	96249	3316	110489689
Blood urine present	79.81	13.74	102	96192	24143	110468862
Skull fracture	79.48	13.74	38	96256	2042	110490963
Diverticulum	79.36	13.74	82	96212	15444	110477561
Inflammation	78.40	13.74	35	96259	193203	110299802
Hypoaesthesia	78.28	13.74	95	96199	314128	110178877
Ill-defined disorder	78.23	13.74	20	96274	156833	110336172
Thrombosis	78.12	13.74	240	96054	108422	110384583
Gastric ulcer haemorrhage	77.90	13.74	67	96227	10027	110482978
Basal ganglia haemorrhage	76.76	13.74	36	96258	1852	110491153
Strangulated hernia	76.32	13.74	17	96277	64	110492941
Iron deficiency anaemia	75.71	13.74	114	96180	31445	110461560
Ischaemia	75.66	13.74	63	96231	9020	110483985
Microcytic anaemia	75.62	13.74	54	96240	6164	110486841
C-reactive protein increased	74.51	13.74	49	96245	217870	110275135
Headache	74.40	13.74	457	95837	881920	109611085
Urinary bladder haemorrhage	74.06	13.74	40	96254	2782	110490223
Type 2 diabetes mellitus	73.65	13.74	31	96263	177201	110315804
White blood cell count decreased	71.37	13.74	57	96237	229333	110263672
Therapy non-responder	71.24	13.74	24	96270	157283	110335722
Dysarthria	71.23	13.74	197	96097	83924	110409081
Puncture site haemorrhage	71.06	13.74	26	96268	706	110492299
Incarcerated hernia	70.47	13.74	23	96271	439	110492566
Cardiac perforation	70.10	13.74	18	96276	138	110492867
Internal haemorrhage	70.01	13.74	63	96231	10008	110482997
Dry mouth	69.67	13.74	44	96250	199904	110293101
Anticoagulant-related nephropathy	69.32	13.74	19	96275	192	110492813
Myelosuppression	69.25	13.74	3	96291	94337	110398668
Peripheral circulatory failure	68.80	13.74	33	96261	1786	110491219
Cerebellar haemorrhage	68.54	13.74	40	96254	3231	110489774
Ecchymosis	68.52	13.74	80	96214	17258	110475747
Haematocrit decreased	68.49	13.74	167	96127	65950	110427055
Shock	68.40	13.74	147	96147	53441	110439564
Peripheral artery thrombosis	68.33	13.74	43	96251	3981	110489024
Neuropathy peripheral	67.37	13.74	36	96258	179241	110313764
Haemodynamic instability	67.15	13.74	91	96203	22797	110470208
Peripheral ischaemia	66.87	13.74	64	96230	10994	110482011
Prothrombin time abnormal	66.58	13.74	29	96265	1253	110491752
Diarrhoea	66.20	13.74	654	95640	1138851	109354154
Pruritus	65.63	13.74	272	96022	581288	109911717
Surgery	65.53	13.74	124	96170	41159	110451846
Osteoarthritis	65.28	13.74	39	96255	182584	110310421
Vomiting	65.17	13.74	495	95799	910180	109582825
Cardiac ablation	64.82	13.74	36	96258	2646	110490359
Cough	64.69	13.74	197	96097	461444	110031561
Blood cholesterol decreased	64.39	13.74	36	96258	2680	110490325
Activated partial thromboplastin time	64.35	13.74	13	96281	26	110492979
Stress	64.25	13.74	8	96286	105340	110387665
Toxicity to various agents	63.89	13.74	210	96084	480345	110012660
Haemoperitoneum	63.71	13.74	46	96248	5342	110487663
Labelled drug-drug interaction medication error	63.51	13.74	101	96193	29201	110463804
Retroperitoneal haemorrhage	63.23	13.74	48	96246	6017	110486988
Lip dry	62.53	13.74	7	96287	100076	110392929
Traumatic haemothorax	62.48	13.74	24	96270	748	110492257
Arthritis	62.46	13.74	34	96260	167552	110325453
Depression	62.41	13.74	113	96181	317222	110175783
Chills	62.30	13.74	45	96249	190535	110302470
Leukopenia	61.86	13.74	26	96268	148765	110344240
Cardiac failure congestive	61.75	13.74	278	96016	150722	110342283
Gait inability	61.42	13.74	21	96273	136355	110356650
Pain in extremity	61.27	13.74	218	96076	486900	110006105
Multiple drug therapy	59.43	13.74	52	96242	7962	110485043
Dementia	59.02	13.74	102	96192	31571	110461434
Intracranial haematoma	59	13.74	25	96269	1009	110491996
Psoriasis	58.94	13.74	24	96270	139969	110353036
Oesophageal pain	58.89	13.74	43	96251	5082	110487923
Occult blood positive	58.64	13.74	50	96244	7395	110485610
Gastric polyps	58.22	13.74	44	96250	5479	110487526
Migraine	58.13	13.74	39	96255	171613	110321392
Neutrophil count decreased	57.35	13.74	17	96277	120924	110372081
Atrial flutter	57.29	13.74	87	96207	24175	110468830
Diverticulum intestinal haemorrhagic	57.09	13.74	41	96253	4722	110488283
Neuroglycopenia	56.95	13.74	25	96269	1101	110491904
Haemorrhage urinary tract	56.54	13.74	34	96260	2902	110490103
Myocardial infarction	56.30	13.74	322	95972	191761	110301244
Haemoglobin abnormal	55.97	13.74	53	96241	8985	110484020
Haemorrhage subcutaneous	55.91	13.74	43	96251	5496	110487509
Colitis ischaemic	55.81	13.74	73	96221	17677	110475328
Subcutaneous haematoma	55.49	13.74	34	96260	3002	110490003
Injection site erythema	55.41	13.74	8	96286	94168	110398837
Cardiac failure chronic	55.04	13.74	64	96230	13747	110479258
Femoral neck fracture	54.77	13.74	61	96233	12506	110480499
Cerebellar infarction	54.73	13.74	38	96256	4149	110488856
International normalised ratio	54.44	13.74	14	96280	108	110492897
Insomnia	54.06	13.74	149	96145	360441	110132564
Sciatica	54.02	13.74	8	96286	92391	110400614
Gastric ulcer	54.02	13.74	112	96182	39715	110453290
Haemorrhoids	53.98	13.74	105	96189	35567	110457438
Loss of personal independence in daily activities	53.67	13.74	32	96262	149988	110343017
Small intestinal haemorrhage	53.64	13.74	39	96255	4579	110488426
Subarachnoid haematoma	53.27	13.74	17	96277	301	110492704
Rib fracture	53.06	13.74	101	96193	33669	110459336
Brain herniation	53.03	13.74	51	96243	8812	110484193
Wound haemorrhage	52.74	13.74	39	96255	4699	110488306
Influenza	52.62	13.74	42	96252	169059	110323946
Liver injury	52.53	13.74	33	96261	150380	110342625
Renal infarct	52.01	13.74	34	96260	3361	110489644
Exsanguination	51.78	13.74	13	96281	90	110492915
Pulmonary alveolar haemorrhage	51.52	13.74	75	96219	20075	110472930
Inappropriate schedule of product administration	51.29	13.74	61	96233	203576	110289429
Anorectal discomfort	50.57	13.74	36	96258	4090	110488915
Hypercholesterolaemia	50.56	13.74	9	96285	90828	110402177
Anticoagulation drug level decreased	50.42	13.74	16	96278	278	110492727
Haemorrhagic diathesis	50.30	13.74	46	96248	7462	110485543
Haemorrhagic cerebral infarction	50.18	13.74	25	96269	1470	110491535
Mobility decreased	49.92	13.74	81	96213	237341	110255664
Drug ineffective	49.17	13.74	982	95312	1519558	108973447
Coagulation time shortened	49.07	13.74	17	96277	392	110492613
Liver function test increased	48.80	13.74	9	96285	88539	110404466
Feeling hot	48.64	13.74	10	96284	91096	110401909
Arrhythmia	48.45	13.74	152	96142	69423	110423582
Mucosal haemorrhage	48.12	13.74	31	96263	2989	110490016
Prescribed overdose	48.05	13.74	9	96285	87572	110405433
Oesophageal ulcer	47.98	13.74	46	96248	7918	110485087
Embolism arterial	47.81	13.74	26	96268	1833	110491172
Multiple organ dysfunction syndrome	47.56	13.74	259	96035	151451	110341554
Conjunctival haemorrhage	47.11	13.74	42	96252	6591	110486414
Peritonitis	46.95	13.74	94	96200	32513	110460492
Infarction	46.93	13.74	38	96256	5231	110487774
Pancytopenia	45.50	13.74	70	96224	209543	110283462
Malignant neoplasm progression	45.36	13.74	51	96243	174516	110318489
Wound infection	44.94	13.74	14	96280	96451	110396554
Hypocoagulable state	44.54	13.74	28	96266	2587	110490418
Cardiac ventricular thrombosis	44.54	13.74	30	96264	3117	110489888
Oesophagitis	44.03	13.74	85	96209	28630	110464375
Urinary retention	43.79	13.74	147	96147	69536	110423469
Pulmonary fibrosis	43.77	13.74	17	96277	102025	110390980
Wound secretion	43.75	13.74	41	96253	6860	110486145
Peripheral venous disease	43.35	13.74	10	96284	84107	110408898
Erythema	43.25	13.74	121	96173	291326	110201679
Upper respiratory tract infection	42.92	13.74	31	96263	131297	110361708
Drug level increased	42.64	13.74	114	96180	47605	110445400
Anticoagulation drug level above therapeutic	42.53	13.74	34	96260	4596	110488409
Intestinal infarction	42.43	13.74	22	96272	1408	110491597
Obesity	42.23	13.74	23	96271	113328	110379677
Hip fracture	42.10	13.74	94	96200	35057	110457948
Hypertension	41.95	13.74	266	96028	509818	109983187
Ischaemic cerebral infarction	41.50	13.74	28	96266	2917	110490088
Joint stiffness	41.26	13.74	5	96289	67238	110425767
Red blood cell sedimentation rate increased	40.97	13.74	9	96285	78293	110414712
Discoloured vomit	40.52	13.74	24	96270	1993	110491012
Malaise	40.40	13.74	382	95912	671437	109821568
Dysphagia	40.20	13.74	250	96044	153350	110339655
Ear infection	40.18	13.74	4	96290	62728	110430277
Cardioversion	39.89	13.74	25	96269	2298	110490707
Autoimmune disorder	39.86	13.74	5	96289	65478	110427527
Large intestine polyp	39.72	13.74	57	96237	15060	110477945
Aortic aneurysm	39.64	13.74	46	96248	9858	110483147
Gastritis haemorrhagic	39.61	13.74	28	96266	3145	110489860
Nasal congestion	39.54	13.74	18	96276	98264	110394741
Gastrointestinal angiodysplasia	39.49	13.74	20	96274	1218	110491787
Parkinsonism	39.45	13.74	70	96224	22117	110470888
Catheter site haemorrhage	39.34	13.74	36	96258	5844	110487161
Back pain	39.06	13.74	178	96116	370818	110122187
Weight decreased	39.04	13.74	243	96051	467814	110025191
Hospitalisation	38.83	13.74	40	96254	142453	110350552
Acute coronary syndrome	38.65	13.74	71	96223	23041	110469964
Multiple injuries	38.56	13.74	29	96265	3585	110489420
Thrombotic stroke	38.26	13.74	17	96277	771	110492234
Bradycardia	38.15	13.74	249	96045	155268	110337737
Mucosal inflammation	38.07	13.74	18	96276	96123	110396882
Urogenital haemorrhage	38.02	13.74	18	96276	946	110492059
Respiratory tract haemorrhage	37.95	13.74	23	96271	1991	110491014
Femur fracture	37.50	13.74	104	96190	44365	110448640
Gastrointestinal necrosis	37.47	13.74	37	96257	6603	110486402
Anaphylactic reaction	37.33	13.74	27	96267	114273	110378732
Cytokine release syndrome	36.95	13.74	8	96286	70298	110422707
COVID-19	36.90	13.74	101	96193	244959	110248046
Hiatus hernia	36.70	13.74	77	96217	27529	110465476
Adverse event	36.46	13.74	25	96269	108784	110384221
Facial paresis	36.25	13.74	35	96259	6078	110486927
Haemarthrosis	36.19	13.74	38	96256	7291	110485714
Gastritis	36.18	13.74	116	96178	53583	110439422
Arteriovenous malformation	36.05	13.74	22	96272	1929	110491076
Carotid artery occlusion	35.92	13.74	43	96251	9522	110483483
Anticoagulation drug level below therapeutic	35.80	13.74	21	96273	1713	110491292
Gastric cancer	35.74	13.74	46	96248	10962	110482043
Bleeding time prolonged	35.70	13.74	19	96275	1283	110491722
Dyspepsia	35.46	13.74	286	96008	190679	110302326
Arterial thrombosis	35.45	13.74	26	96268	3093	110489912
Memory impairment	35.34	13.74	74	96220	196870	110296135
Therapeutic response decreased	35.34	13.74	20	96274	96479	110396526
Disseminated intravascular coagulation	35.25	13.74	97	96197	41189	110451816
Pelvic fracture	35.20	13.74	52	96242	14102	110478903
Cardiogenic shock	35.19	13.74	120	96174	57218	110435787
Presyncope	35.14	13.74	108	96186	48779	110444226
Prescribed underdose	35.11	13.74	7	96287	65167	110427838
Hypochromic anaemia	34.85	13.74	26	96268	3175	110489830
Injection site swelling	34.65	13.74	6	96288	61784	110431221
Lung disorder	34.59	13.74	65	96229	179982	110313023
Stupor	34.11	13.74	39	96255	8226	110484779
Gastrointestinal disorder	34.03	13.74	103	96191	241849	110251156
Prothrombin time shortened	33.97	13.74	27	96267	3619	110489386
Anastomotic infection	33.78	13.74	10	96284	136	110492869
Lacunar stroke	33.71	13.74	14	96280	537	110492468
Blood pressure increased	33.54	13.74	114	96180	258259	110234746
Thalamus haemorrhage	33.38	13.74	21	96273	1943	110491062
Illness	33.13	13.74	15	96279	82156	110410849
Rectal cancer	33.06	13.74	27	96267	3762	110489243
Colitis ulcerative	32.99	13.74	13	96281	77350	110415655
Hypoglycaemia	32.94	13.74	193	96101	115911	110377094
Influenza like illness	32.84	13.74	18	96276	88394	110404611
Appendicitis	32.84	13.74	75	96219	28389	110464616
Hemianopia homonymous	32.77	13.74	19	96275	1516	110491489
Bradyarrhythmia	32.60	13.74	30	96264	4904	110488101
Abdominal discomfort	32.56	13.74	205	96089	393653	110099352
Myalgia	32.48	13.74	93	96201	222288	110270717
Coronary artery embolism	32.38	13.74	12	96282	338	110492667
Cholecystitis acute	32.29	13.74	53	96241	15729	110477276
Ileus	32.22	13.74	78	96216	30651	110462354
Colon neoplasm	32.04	13.74	16	96278	946	110492059
Circulatory collapse	31.86	13.74	96	96198	42897	110450108
Diabetes mellitus inadequate control	31.68	13.74	76	96218	29699	110463306
Brain oedema	31.61	13.74	78	96216	31020	110461985
Post procedural stroke	31.59	13.74	9	96285	106	110492899
Lower limb fracture	31.58	13.74	13	96281	75335	110417670
Diverticulitis intestinal haemorrhagic	31.34	13.74	13	96281	497	110492508
Anuria	31.32	13.74	67	96227	24274	110468731
Pulmonary contusion	31.29	13.74	10	96284	178	110492827
Cytomegalovirus infection	31.17	13.74	5	96289	54439	110438566
Renal haemorrhage	30.87	13.74	22	96272	2503	110490502
Pelvic haematoma	30.73	13.74	16	96278	1033	110491972
Agitation	30.50	13.74	32	96262	113019	110379986
Haemorrhagic infarction	30.24	13.74	15	96279	874	110492131
Ear pain	30.22	13.74	5	96289	53221	110439784
Overdose	30.22	13.74	324	95970	233470	110259535
Lumbar puncture	30.19	13.74	11	96283	295	110492710
Petechiae	29.79	13.74	64	96230	23253	110469752
Blood creatine increased	29.62	13.74	43	96251	11478	110481527
Prothrombin time ratio decreased	29.54	13.74	18	96276	1574	110491431
Oropharyngeal pain	29.52	13.74	45	96249	135231	110357774
Traumatic haematoma	29.38	13.74	21	96273	2400	110490605
Muscle haemorrhage	29.35	13.74	33	96261	6836	110486169
Exostosis	29.25	13.74	3	96291	45953	110447052
Drug ineffective for unapproved indication	29.01	13.74	28	96266	102810	110390195
Aortic thrombosis	28.97	13.74	20	96274	2163	110490842
Mesenteric artery embolism	28.83	13.74	8	96286	85	110492920
Psychotic disorder	28.45	13.74	5	96289	50932	110442073
Duodenal ulcer haemorrhage	28.34	13.74	35	96259	8002	110485003
Full blood count abnormal	28.22	13.74	7	96287	56045	110436960
Vascular access site haemorrhage	28.07	13.74	10	96284	251	110492754
Back injury	27.94	13.74	4	96290	47395	110445610
Eczema	27.92	13.74	14	96280	72279	110420726
Taste disorder	27.86	13.74	11	96283	65376	110427629
NIH stroke scale abnormal	27.74	13.74	6	96288	19	110492986
Accidental exposure to product	27.73	13.74	5	96289	50003	110443002
Knee arthroplasty	27.55	13.74	11	96283	64937	110428068
Skull fractured base	27.54	13.74	11	96283	381	110492624
Normocytic anaemia	27.51	13.74	31	96263	6436	110486569
Haemorrhagic disorder	27.39	13.74	18	96276	1795	110491210
Paresis	27.35	13.74	27	96267	4817	110488188
Bronchitis	27.34	13.74	60	96234	156972	110336033
Brain stem haemorrhage	27.27	13.74	18	96276	1808	110491197
Blood creatinine increased	27.25	13.74	261	96033	182628	110310377
Somnolence	27.13	13.74	150	96144	297299	110195706
Retroperitoneal haematoma	27.13	13.74	30	96264	6101	110486904
Initial insomnia	27.04	13.74	39	96255	10350	110482655
Osteoma	27.01	13.74	8	96286	109	110492896
Cardiac arrest	26.99	13.74	276	96018	196477	110296528
Venous thrombosis	26.77	13.74	35	96259	8470	110484535
Vascular pseudoaneurysm	26.77	13.74	25	96269	4165	110488840
Flushing	26.77	13.74	31	96263	104705	110388300
Arterial haemorrhage	26.76	13.74	24	96270	3795	110489210
Aneurysm ruptured	26.73	13.74	15	96279	1125	110491880
Basilar artery occlusion	26.71	13.74	10	96284	290	110492715
Lacunar infarction	26.52	13.74	30	96264	6256	110486749
Pharyngeal haemorrhage	26.34	13.74	16	96278	1391	110491614
Hemianopia	26.22	13.74	21	96273	2847	110490158
Prostate tenderness	26.17	13.74	7	96287	64	110492941
Femoral artery embolism	26.17	13.74	7	96287	64	110492941
Dry eye	26.16	13.74	8	96286	55785	110437220
Facial asymmetry	26.16	13.74	14	96280	956	110492049
Spontaneous haematoma	26.11	13.74	18	96276	1943	110491062
Hypovolaemia	26	13.74	58	96236	21616	110471389
Facial paralysis	25.97	13.74	62	96232	24152	110468853
Coagulation factor increased	25.88	13.74	7	96287	67	110492938
Bone marrow failure	25.88	13.74	9	96285	57839	110435166
Neck pain	25.88	13.74	42	96252	123088	110369917
Thrombotic cerebral infarction	25.84	13.74	13	96281	781	110492224
Neoplasm progression	25.72	13.74	12	96282	64583	110428422
Herpes zoster	25.68	13.74	34	96260	108345	110384660
Speech disorder	25.64	13.74	114	96180	61455	110431550
Hydrocephalus	25.63	13.74	38	96256	10337	110482668
Gait disturbance	25.54	13.74	140	96154	278068	110214937
Lymphocyte count decreased	25.45	13.74	9	96285	57234	110435771
Arterial injury	25.23	13.74	13	96281	821	110492184
Serotonin syndrome	25.12	13.74	10	96284	59143	110433862
Lupus-like syndrome	25.11	13.74	3	96291	40789	110452216
Decreased appetite	25.10	13.74	279	96015	475567	110017438
No adverse event	24.69	13.74	17	96277	73822	110419183
Bacterial infection	24.68	13.74	5	96289	46031	110446974
Injection site bruising	24.68	13.74	7	96287	51256	110441749
Duodenitis	24.64	13.74	35	96259	9161	110483844
Gastrointestinal motility disorder	24.56	13.74	31	96263	7245	110485760
Frequent bowel movements	24.46	13.74	16	96278	71374	110421631
Micturition disorder	24.35	13.74	25	96269	4673	110488332
Pneumocystis jirovecii pneumonia	24.30	13.74	4	96290	42731	110450274
Inguinal hernia strangulated	24.19	13.74	4	96290	0	110493005
Blood pressure systolic increased	24.11	13.74	22	96272	82969	110410036
Cerebral artery thrombosis	23.84	13.74	16	96278	1652	110491353
Abdominal wall haematoma	23.68	13.74	27	96267	5678	110487327
Immunodeficiency	23.56	13.74	3	96291	38835	110454170
Thoracic haemorrhage	23.54	13.74	9	96285	277	110492728
Polycystic liver disease	23.53	13.74	8	96286	174	110492831
Rhinorrhoea	23.53	13.74	33	96261	102633	110390372
Vaginal haemorrhage	23.52	13.74	61	96233	25013	110467992
Platelet count decreased	23.39	13.74	112	96182	230331	110262674
Aortic intramural haematoma	23.03	13.74	8	96286	186	110492819
Cardiac failure acute	23.02	13.74	59	96235	24019	110468986
Splenic necrosis	22.99	13.74	8	96286	187	110492818
Carotid artery stenosis	22.99	13.74	34	96260	9229	110483776
Atrioventricular block first degree	22.91	13.74	43	96251	14182	110478823
Spinal cord haematoma	22.72	13.74	9	96285	305	110492700
Alanine aminotransferase increased	22.56	13.74	83	96211	183690	110309315
Haemochromatosis	22.41	13.74	15	96279	1542	110491463
Prothrombin time	22.41	13.74	5	96289	19	110492986
Hyperkalaemia	22.35	13.74	198	96096	135598	110357407
Incarcerated inguinal hernia	22.34	13.74	9	96285	319	110492686
Confusional state	22.33	13.74	281	96013	468399	110024606
Creatinine renal clearance	22.32	13.74	6	96288	56	110492949
Left atrial dilatation	22.28	13.74	21	96273	3539	110489466
Multiple sclerosis relapse	22.16	13.74	8	96286	50232	110442773
Non-compaction cardiomyopathy	22.13	13.74	6	96288	58	110492947
Ventricular tachycardia	21.89	13.74	94	96200	49915	110443090
Postrenal failure	21.83	13.74	12	96282	864	110492141
Pneumonia aspiration	21.74	13.74	133	96161	81100	110411905
Red blood cell abnormality	21.68	13.74	12	96282	876	110492129
Stroke in evolution	21.53	13.74	7	96287	132	110492873
Ruptured cerebral aneurysm	21.52	13.74	11	96283	683	110492322
Cardiac pacemaker insertion	21.52	13.74	27	96267	6274	110486731
Monoparesis	21.40	13.74	23	96271	4530	110488475
Procedural pain	20.97	13.74	3	96291	35562	110457443
Putamen haemorrhage	20.96	13.74	10	96284	535	110492470
Neuralgia	20.91	13.74	8	96286	48470	110444535
Hepatic cytolysis	20.75	13.74	11	96283	55042	110437963
Candida infection	20.58	13.74	8	96286	48001	110445004
Gastrointestinal vascular malformation haemorrhagic	20.55	13.74	12	96282	970	110492035
Bone pain	20.48	13.74	16	96278	65117	110427888
Liver disorder	20.39	13.74	60	96234	142183	110350822
Product administration error	20.35	13.74	75	96219	37142	110455863
Skin exfoliation	20.26	13.74	28	96266	87623	110405382
Neutrophil count increased	20.25	13.74	3	96291	34649	110458356
Drug reaction with eosinophilia and systemic symptoms	20.23	13.74	25	96269	82070	110410935
Rash pruritic	20.10	13.74	34	96260	98035	110394970
Laryngitis	20.03	13.74	6	96288	42405	110450600
Therapy partial responder	19.92	13.74	4	96290	37057	110455948
Osteorrhagia	19.80	13.74	4	96290	8	110492997
Splenic haemorrhage	19.80	13.74	11	96283	809	110492196
Haematocrit increased	19.79	13.74	23	96271	4936	110488069
Mesenteric haemorrhage	19.79	13.74	6	96288	89	110492916
Suicidal ideation	19.78	13.74	32	96262	93905	110399100
Splenic cyst	19.77	13.74	8	96286	287	110492718
Polyp	19.73	13.74	33	96261	9947	110483058
Dry skin	19.69	13.74	40	96254	107613	110385392
Muscular weakness	19.67	13.74	131	96163	248337	110244668
Blood glucose increased	19.64	13.74	55	96239	132441	110360564
Cerebellar haematoma	19.52	13.74	10	96284	624	110492381
Psychotic disorder due to a general medical condition	19.48	13.74	8	96286	298	110492707
Anaemia megaloblastic	19.44	13.74	11	96283	838	110492167
Blood urea increased	19.40	13.74	97	96197	54860	110438145
Oxygen saturation decreased	19.21	13.74	71	96223	156911	110336094
Mucosal dryness	19.11	13.74	21	96273	4242	110488763
Thyroid haemorrhage	19.08	13.74	6	96288	101	110492904
Prostatic specific antigen abnormal	18.87	13.74	10	96284	669	110492336
Post procedural haematuria	18.83	13.74	8	96286	325	110492680
Coagulation factor V level decreased	18.82	13.74	10	96284	673	110492332
Splenic haematoma	18.74	13.74	8	96286	329	110492676
Acute myeloid leukaemia	18.73	13.74	5	96289	38105	110454900
Tachyarrhythmia	18.63	13.74	29	96265	8232	110484773
Renal embolism	18.51	13.74	7	96287	209	110492796
Blood pressure systolic inspiratory decreased	18.41	13.74	4	96290	13	110492992
Hepatic cirrhosis	18.40	13.74	19	96275	67607	110425398
Seizure	18.33	13.74	115	96179	221070	110271935
Brain stem infarction	18.19	13.74	15	96279	2119	110490886
Respiratory depression	18.18	13.74	3	96291	31998	110461007
Pain in jaw	18.18	13.74	11	96283	51166	110441839
Orthostatic intolerance	18.14	13.74	15	96279	2126	110490879
Thrombin time	18.14	13.74	3	96291	0	110493005
Diabetes mellitus	18.11	13.74	37	96257	99344	110393661
High frequency ablation	18.02	13.74	8	96286	362	110492643
Oedema	18.01	13.74	108	96186	209868	110283137
Atrioventricular block complete	17.96	13.74	48	96246	20034	110472971
Abdominal wall haemorrhage	17.90	13.74	10	96284	743	110492262
Pericardial fibrosis	17.85	13.74	7	96287	231	110492774
Occult blood	17.84	13.74	14	96280	1842	110491163
Orthopaedic procedure	17.82	13.74	7	96287	232	110492773
Abortion spontaneous	17.81	13.74	4	96290	34278	110458727
Cataract	17.77	13.74	26	96268	79459	110413546
Body temperature increased	17.76	13.74	13	96281	54700	110438305
Mechanical ileus	17.66	13.74	12	96282	1265	110491740
Gastroenteritis viral	17.58	13.74	3	96291	31223	110461782
Brain stem stroke	17.56	13.74	10	96284	771	110492234
Facial nerve disorder	17.55	13.74	10	96284	772	110492233
Quadrantanopia	17.54	13.74	7	96287	242	110492763
Myositis	17.50	13.74	3	96291	31113	110461892
Cystitis	17.47	13.74	19	96275	66017	110426988
Haemoglobin	17.46	13.74	6	96288	135	110492870
Thrombosis mesenteric vessel	17.41	13.74	7	96287	247	110492758
Post procedural haematoma	17.35	13.74	16	96278	2623	110490382
Aspartate aminotransferase increased	17.26	13.74	76	96218	159860	110333145
Swelling face	17.14	13.74	34	96260	92287	110400718
Pneumonitis	17.14	13.74	25	96269	76506	110416499
Erosive oesophagitis	17.13	13.74	17	96277	3052	110489953
Dyskinesia	17.00	13.74	12	96282	51434	110441571
Contraindication to medical treatment	16.95	13.74	12	96282	1351	110491654
Hepatitis acute	16.93	13.74	45	96249	18721	110474284
Aortic dissection rupture	16.89	13.74	5	96289	68	110492937
White blood cell count increased	16.86	13.74	37	96257	96805	110396200
Splenic injury	16.82	13.74	7	96287	270	110492735
Diarrhoea haemorrhagic	16.72	13.74	40	96254	15599	110477406
Encephalopathy	16.70	13.74	28	96266	81027	110411978
IgA nephropathy	16.65	13.74	17	96277	3156	110489849
Bradykinesia	16.62	13.74	32	96262	10756	110482249
Nodule	16.57	13.74	4	96290	32627	110460378
Productive cough	16.54	13.74	48	96246	114257	110378748
Vascular stent occlusion	16.51	13.74	7	96287	283	110492722
Cerebral thrombosis	16.40	13.74	15	96279	2433	110490572
Atrial tachycardia	16.37	13.74	29	96265	9149	110483856
Adverse drug reaction	16.26	13.74	43	96251	105516	110387489
Amnesia	16.19	13.74	43	96251	105365	110387640
Lordosis	16.14	13.74	8	96286	465	110492540
Hypothyroidism	16.14	13.74	24	96270	72875	110420130
Pericardial drainage	16.07	13.74	8	96286	470	110492535
Traumatic renal injury	16.06	13.74	3	96291	3	110493002
Intestinal mass	16.05	13.74	12	96282	1470	110491535
Vision blurred	16.01	13.74	58	96236	128964	110364041
Hypercoagulation	15.99	13.74	17	96277	3309	110489696
Diverticulum intestinal	15.94	13.74	33	96261	11686	110481319
Drug eruption	15.86	13.74	14	96280	53645	110439360
Hypertensive crisis	15.83	13.74	52	96242	24320	110468685
Anaphylactic shock	15.78	13.74	13	96281	51533	110441472
Bronchiectasis	15.78	13.74	6	96288	36487	110456518
Mesenteric artery thrombosis	15.72	13.74	10	96284	943	110492062
Contusion	15.69	13.74	288	96006	233073	110259932
Pelvic haemorrhage	15.68	13.74	6	96288	185	110492820
Periorbital haemorrhage	15.64	13.74	7	96287	323	110492682
Gastric occult blood positive	15.60	13.74	3	96291	4	110493001
Extravasation blood	15.53	13.74	8	96286	505	110492500
Osteonecrosis	15.53	13.74	5	96289	33736	110459269
Coagulation time abnormal	15.44	13.74	6	96288	193	110492812
Abdominal strangulated hernia	15.44	13.74	5	96289	93	110492912
Angina pectoris	15.42	13.74	100	96194	62195	110430810
Device related thrombosis	15.42	13.74	17	96277	3445	110489560
Toxic epidermal necrolysis	15.36	13.74	16	96278	56711	110436294
Hot flush	15.35	13.74	21	96273	66015	110426990
Hyperlipidaemia	15.32	13.74	6	96288	35842	110457163
Therapeutic product effect incomplete	15.30	13.74	123	96171	223682	110269323
Urethral haemorrhage	15.27	13.74	8	96286	523	110492482
Skin haemorrhage	15.26	13.74	52	96242	24775	110468230
Adrenal insufficiency	15.21	13.74	9	96285	42381	110450624
Anti factor VIII antibody test	15.20	13.74	3	96291	5	110493000
Haemoglobin increased	15.17	13.74	28	96266	9119	110483886
Vessel puncture site haemorrhage	15.16	13.74	6	96288	203	110492802
Oesophageal carcinoma	15.15	13.74	32	96262	11492	110481513
Burning sensation	15.12	13.74	23	96271	69189	110423816
Laparotomy	15.06	13.74	8	96286	538	110492467
Myoclonus	14.99	13.74	5	96289	32993	110460012
Pseudomonas infection	14.99	13.74	3	96291	27850	110465155
Rectal perforation	14.95	13.74	10	96284	1027	110491978
Sepsis	14.94	13.74	382	95912	326964	110166041
Ascites	14.92	13.74	37	96257	92771	110400234
Mallory-Weiss syndrome	14.92	13.74	16	96278	3145	110489860
Hepatotoxicity	14.91	13.74	20	96274	63380	110429625
Osteonecrosis of jaw	14.84	13.74	12	96282	48005	110445000
Colitis	14.78	13.74	43	96251	102280	110390725
Intracranial mass	14.78	13.74	14	96280	2374	110490631
Drug tolerance decreased	14.75	13.74	3	96291	27537	110465468
Thrombectomy	14.73	13.74	7	96287	371	110492634
Glomerular filtration rate decreased	14.71	13.74	57	96237	28899	110464106
Irritability	14.71	13.74	12	96282	47797	110445208
Splenic embolism	14.70	13.74	6	96288	220	110492785
Pharyngeal mass	14.69	13.74	7	96287	373	110492632
Eye haemorrhage	14.68	13.74	32	96262	11742	110481263
Cardiac myxoma	14.63	13.74	6	96288	223	110492782
Meningorrhagia	14.57	13.74	7	96287	380	110492625
Contraindication to surgery	14.54	13.74	3	96291	7	110492998
Body temperature decreased	14.49	13.74	7	96287	36928	110456077
Fracture	14.44	13.74	51	96243	24737	110468268
General physical health deterioration	14.44	13.74	272	96022	425023	110067982
Spinal epidural haematoma	14.44	13.74	12	96282	1713	110491292
Coronary artery occlusion	14.41	13.74	38	96256	15734	110477271
Haematocrit abnormal	14.39	13.74	12	96282	1721	110491284
Blood pressure fluctuation	14.38	13.74	27	96267	74797	110418208
Electrocardiogram T wave biphasic	14.33	13.74	6	96288	235	110492770
Adverse reaction	14.32	13.74	4	96290	29590	110463415
Subdural hygroma	14.28	13.74	8	96286	598	110492407
Epidural haemorrhage	14.14	13.74	7	96287	406	110492599
Antiphospholipid syndrome	14.13	13.74	14	96280	2509	110490496
Endocarditis	14.08	13.74	34	96260	13337	110479668
Neuroleptic malignant syndrome	14.07	13.74	6	96288	34053	110458952
Oral candidiasis	14.06	13.74	11	96283	44749	110448256
Basilar artery thrombosis	14.06	13.74	7	96287	411	110492594
Venous thrombosis limb	14.05	13.74	20	96274	5245	110487760
Gastrointestinal erosion	14.03	13.74	10	96284	1138	110491867
Splenic lesion	13.93	13.74	8	96286	627	110492378
Cerebral vascular occlusion	13.90	13.74	4	96290	49	110492956
Impaired work ability	13.90	13.74	3	96291	26416	110466589
Carotid arterial embolus	13.82	13.74	4	96290	50	110492955

FDA Adverse Event Reporting System (Pediatric)

None

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	anticoagulant
CHEBI has role	CHEBI:50266	prodrug
CHEBI has role	CHEBI:65232	EC 3.4.21.5 (thrombin) inhibitor
CHEBI has role	CHEBI:22587	antiviral agent
CHEBI has role	CHEBI:38070	anti-arrhythmia drug
CHEBI has role	CHEBI:73336	vulnerary
CHEBI has role	CHEBI:77020	EC 1.10.99.2 [ribosyldihydronicotinamide dehydrogenase (quinone)] inhibitor

Related Drugs by ATC class:

B01AE Direct thrombin inhibitors 5 drugs

argatroban bivalirudin desirudin lepirudin ximelagatran

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

Disease	Relation	SNOMED_ID	DOID
Pulmonary embolism	indication	59282003	DOID:9477
Deep vein thrombosis	indication	128053003
Prevention of systemic embolism	indication	414086009
Prevention of deep vein thrombosis	indication	439993001
Prevention of stroke	indication
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

🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

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)

None

Bioactivity Summary:

Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	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	Enzyme		Q28731_RABIT		IC50	6.26	CHEMBL

External reference:

ID	Source
4030255	VUID
N0000181837	NUI
D07082	KEGG_DRUG
872728-81-9	SECONDARY_CAS_RN
1037041	RXNORM
C1571583	UMLSCUI
CHEBI:70746	CHEBI
CHEMBL539697	ChEMBL_ID
CHEMBL1615369	ChEMBL_ID
D000069604	MESH_DESCRIPTOR_UI
DB06695	DRUGBANK_ID
6379	IUPHAR_LIGAND_ID
8028	INN_ID
2E18WX195X	UNII
135565674	PUBCHEM_CID
DB14726	DRUGBANK_ID
136711	MMSL
25762	MMSL
360089	MMSL
41106	MMSL
41303	MMSL
d07137	MMSL
012668	NDDF
012669	NDDF
698871007	SNOMEDCT_US
700029008	SNOMEDCT_US
700039002	SNOMEDCT_US
714788005	SNOMEDCT_US
C2348066	UMLSCUI
A1IO4	PDB_CHEM_ID
CHEMBL48361	ChEMBL_ID
211914-51-1	SECONDARY_CAS_RN
216210	PUBCHEM_CID
6380	IUPHAR_LIGAND_ID
8027	INN_ID
4030254	VANDF
4030255	VANDF
I0VM4M70GC	UNII
CHEBI:70752	CHEBI
2E18WX195X	INXIGHT DRUGS
I0VM4M70GC	INXIGHT DRUGS

Pharmaceutical products:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Dabigatran Etexilate	HUMAN PRESCRIPTION DRUG LABEL	1	0378-0265	CAPSULE	75 mg	ORAL	ANDA	29 sections
Dabigatran Etexilate	HUMAN PRESCRIPTION DRUG LABEL	1	0378-0266	CAPSULE	150 mg	ORAL	ANDA	29 sections
Pradaxa	HUMAN PRESCRIPTION DRUG LABEL	1	0597-0108	CAPSULE	110 mg	ORAL	NDA	32 sections
Pradaxa	HUMAN PRESCRIPTION DRUG LABEL	1	0597-0355	CAPSULE	75 mg	ORAL	NDA	32 sections
Pradaxa	HUMAN PRESCRIPTION DRUG LABEL	1	0597-0360	CAPSULE	150 mg	ORAL	NDA	32 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
Dabigatran Etexilate	Human Prescription Drug Label	1	0904-7253	CAPSULE, COATED PELLETS	75 mg	ORAL	ANDA	28 sections
Dabigatran Etexilate	Human Prescription Drug Label	1	0904-7254	CAPSULE, COATED PELLETS	110 mg	ORAL	ANDA	28 sections
Dabigatran Etexilate	Human Prescription Drug Label	1	0904-7255	CAPSULE, COATED PELLETS	150 mg	ORAL	ANDA	28 sections
PRADAXA	HUMAN PRESCRIPTION DRUG LABEL	1	21695-899	CAPSULE	150 mg	ORAL	NDA	27 sections
Dabigatran Etexilate	HUMAN PRESCRIPTION DRUG LABEL	1	31722-621	CAPSULE	75 mg	ORAL	ANDA	28 sections
Dabigatran Etexilate	HUMAN PRESCRIPTION DRUG LABEL	1	31722-622	CAPSULE	150 mg	ORAL	ANDA	28 sections
Dabigatran Etexilate	HUMAN PRESCRIPTION DRUG LABEL	1	31722-666	CAPSULE	110 mg	ORAL	ANDA	28 sections
DABIGATRAN	HUMAN PRESCRIPTION DRUG LABEL	1	42291-033	CAPSULE	75 mg	ORAL	ANDA	27 sections
DABIGATRAN	HUMAN PRESCRIPTION DRUG LABEL	1	42291-034	CAPSULE	150 mg	ORAL	ANDA	27 sections
Dabigatran etexilate	HUMAN PRESCRIPTION DRUG LABEL	1	43598-453	CAPSULE	110 mg	ORAL	ANDA	27 sections
Dabigatran etexilate	HUMAN PRESCRIPTION DRUG LABEL	1	43598-641	CAPSULE	150 mg	ORAL	ANDA	27 sections
Dabigatran etexilate	HUMAN PRESCRIPTION DRUG LABEL	1	43598-642	CAPSULE	75 mg	ORAL	ANDA	27 sections
Dabigatran Etexilate	Human Prescription Drug Label	1	46708-634	CAPSULE	75 mg	ORAL	ANDA	28 sections
Dabigatran Etexilate	Human Prescription Drug Label	1	46708-635	CAPSULE	110 mg	ORAL	ANDA	28 sections
Dabigatran Etexilate	Human Prescription Drug Label	1	46708-636	CAPSULE	150 mg	ORAL	ANDA	28 sections
Pradaxa	HUMAN PRESCRIPTION DRUG LABEL	1	50090-3617	CAPSULE	150 mg	ORAL	NDA	32 sections
DABIGATRAN	Human Prescription Drug Label	1	50090-7530	CAPSULE	150 mg	ORAL	ANDA	27 sections
DABIGATRAN	Human Prescription Drug Label	1	50090-7531	CAPSULE	75 mg	ORAL	ANDA	27 sections
Dabigatran Etexilate	Human Prescription Drug Label	1	50090-7656	CAPSULE, COATED PELLETS	75 mg	ORAL	ANDA	27 sections

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

Description:

Drug dosage:

ADMET properties:

Predicted pharmacokinetic/toxicological properties (PK-AZ):

Approvals:

FDA Adverse Event Reporting System (Female)

FDA Adverse Event Reporting System (Male)

FDA Adverse Event Reporting System (Geriatric)

FDA Adverse Event Reporting System (Pediatric)

Pharmacologic Action:

Related Drugs by ATC class:

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

🐶 Veterinary Drug Use

🐶 Veterinary products

Acid dissociation constants calculated using MoKa v3.0.0

Orange Book patent data (new drug applications)

Orange Book exclusivity data (new drug applications)

Bioactivity Summary:

External reference:

Pharmaceutical products: