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

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

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: BIBR 1048 BIBR-1048 dabigatran etexilate mesilate dabigatran etexilate pradaxa dabigatran etexilate mesylate dabigatran etexilate methanesulfonate	A THROMBIN inhibitor which acts by binding and blocking thrombogenic activity and the prevention of thrombus formation. It is used to reduce the risk of stroke and systemic EMBOLISM in patients with nonvalvular atrial fibrillation. Molecular weight: 627.75 Formula: C34H41N7O5 CLOGP: 4.71 LIPINSKI: 2 HAC: 12 HDO: 3 TPSA: 151.53 ALOGS: -4.68 ROTB: 17 Status: OFP Legend: OFP - off patent OFM - off market ONP - on patent

Molecule

Description

Molfile Inchi Smiles

Synonyms:

BIBR 1048
BIBR-1048
dabigatran etexilate mesilate
dabigatran etexilate
pradaxa
dabigatran etexilate mesylate
dabigatran etexilate methanesulfonate

A THROMBIN inhibitor which acts by binding and blocking thrombogenic activity and the prevention of thrombus formation. It is used to reduce the risk of stroke and systemic EMBOLISM in patients with nonvalvular atrial fibrillation.

Molecular weight: 627.75
Formula: C34H41N7O5
CLOGP: 4.71
LIPINSKI: 2
HAC: 12
HDO: 3
TPSA: 151.53
ALOGS: -4.68
ROTB: 17

Status: OFP

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

Drug dosage:

Dose	Unit	Route
0.30	g	O

ADMET properties:

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

Approvals:

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

FDA Adverse Event Reporting System (Female)

MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Gastrointestinal haemorrhage	4609.59	15.00	1831	42873	79345	63364973
Ischaemic stroke	2437.97	15.00	776	43928	17181	63427137
Cerebrovascular accident	1607.59	15.00	979	43725	107045	63337273
Haemorrhage	1323.77	15.00	708	43996	60314	63384004
Melaena	1115.85	15.00	505	44199	29860	63414458
Rectal haemorrhage	1035.16	15.00	559	44145	48471	63395847
Haemorrhage intracranial	957.67	15.00	359	44345	13060	63431258
Cerebral haemorrhage	787.14	15.00	399	44305	30330	63413988
Lower gastrointestinal haemorrhage	692.68	15.00	246	44458	7644	63436674
Activated partial thromboplastin time prolonged	682.22	15.00	235	44469	6658	63437660
Cardiac tamponade	552.16	15.00	183	44521	4592	63439726
Subdural haematoma	493.51	15.00	228	44476	14100	63430218
Cerebral infarction	483.11	15.00	265	44439	23628	63420690
International normalised ratio increased	423.17	15.00	311	44393	46114	63398204
Haematoma	415.00	15.00	275	44429	34545	63409773
Fall	403.65	15.00	866	43838	391468	63052850
Shock haemorrhagic	393.18	15.00	174	44530	9721	63434597
Embolic stroke	386.30	15.00	132	44572	3644	63440674
Blood loss anaemia	385.96	15.00	167	44537	8834	63435484
Upper gastrointestinal haemorrhage	364.34	15.00	203	44501	18649	63425669
Coagulopathy	364.04	15.00	209	44495	20335	63423983
Procoagulant therapy	363.08	15.00	58	44646	0	63444318
Haematuria	325.14	15.00	221	44483	28936	63415382
Haematochezia	319.79	15.00	280	44424	53264	63391054
Transient ischaemic attack	319.60	15.00	242	44462	37511	63406807
Anaemia	316.63	15.00	661	44043	292769	63151549
Haemorrhagic stroke	307.07	15.00	125	44579	5667	63438651
Pericardial haemorrhage	278.40	15.00	84	44620	1535	63442783
Haematemesis	259.72	15.00	196	44508	30216	63414102
Thrombin time prolonged	245.85	15.00	46	44658	69	63444249
Acute kidney injury	244.75	15.00	559	44145	262856	63181462
Subarachnoid haemorrhage	236.29	15.00	139	44565	14144	63430174
Atrial thrombosis	231.63	15.00	75	44629	1743	63442575
Pain	229.98	15.00	118	44586	740510	62703808
Deep vein thrombosis	221.84	15.00	284	44420	83516	63360802
Haemoglobin decreased	218.82	15.00	378	44326	145107	63299211
Renal failure	213.82	15.00	333	44371	117319	63326999
Intestinal haemorrhage	210.71	15.00	85	44619	3762	63440556
Pulmonary embolism	201.99	15.00	323	44381	116361	63327957
Epistaxis	183.90	15.00	241	44463	72484	63371834
Hemiparesis	183.31	15.00	143	44561	23139	63421179
Cardiac failure	179.91	15.00	265	44439	88877	63355441
Hypovolaemic shock	162.43	15.00	82	44622	6159	63438159
Subdural haemorrhage	160.86	15.00	66	44638	3052	63441266
Drug hypersensitivity	146.66	15.00	22	44682	310665	63133653
Fatigue	142.21	15.00	256	44448	887772	62556546
Aortic dissection	133.06	15.00	51	44653	1967	63442351
Maternal exposure during pregnancy	133.03	15.00	5	44699	220057	63224261
Prothrombin time prolonged	129.76	15.00	82	44622	9482	63434836
Haemothorax	129.12	15.00	51	44653	2134	63442184
Renal impairment	128.05	15.00	226	44478	88129	63356189
Rheumatoid arthritis	124.41	15.00	16	44688	253803	63190515
Infusion related reaction	123.97	15.00	14	44690	245507	63198811
Haemoptysis	123.01	15.00	125	44579	28601	63415717
Systemic lupus erythematosus	122.13	15.00	6	44698	208912	63235406
Drug intolerance	120.64	15.00	34	44670	308627	63135691
Cerebral haematoma	118.68	15.00	56	44648	3627	63440691
Arthropathy	117.02	15.00	14	44690	234778	63209540
Rash	116.86	15.00	134	44570	560737	62883581
Head injury	113.30	15.00	117	44587	27279	63417039
Wound secretion	112.45	15.00	58	44646	4556	63439762
Coagulation time prolonged	111.50	15.00	41	44663	1407	63442911
Hemiplegia	109.46	15.00	73	44631	9250	63435068
Peripheral embolism	108.41	15.00	39	44665	1256	63443062
Arthralgia	107.30	15.00	147	44557	569563	62874755
Procedural haemorrhage	105.89	15.00	47	44657	2641	63441677
Gastric haemorrhage	105.10	15.00	62	44642	6336	63437982
Joint swelling	104.63	15.00	50	44654	327616	63116702
Therapeutic product effect decreased	102.77	15.00	9	44695	193178	63251140
Glossodynia	101.85	15.00	6	44698	178870	63265448
Faeces discoloured	100.90	15.00	92	44612	18417	63425901
Pyrexia	100.55	15.00	110	44594	470368	62973950
Drug ineffective	100.15	15.00	389	44315	1044376	62399942
Contraindicated product administered	99.08	15.00	17	44687	217631	63226687
Large intestinal haemorrhage	95.69	15.00	36	44668	1318	63443000
Post procedural haemorrhage	95.04	15.00	63	44641	7901	63436417
Musculoskeletal stiffness	94.51	15.00	10	44694	184608	63259710
Nasopharyngitis	92.17	15.00	32	44672	254225	63190093
Treatment failure	91.81	15.00	15	44689	199028	63245290
Condition aggravated	91.61	15.00	89	44615	402128	63042190
Hypersensitivity	91.39	15.00	46	44658	292639	63151679
Haemorrhoidal haemorrhage	90.69	15.00	49	44655	4230	63440088
Drug interaction	89.92	15.00	359	44345	228772	63215546
Pericardial effusion	86.02	15.00	106	44598	29952	63414366
Aphasia	84.35	15.00	110	44594	32890	63411428
Haemorrhagic transformation stroke	84.26	15.00	32	44672	1203	63443115
Creatinine renal clearance decreased	82.97	15.00	78	44626	16230	63428088
Alopecia	82.42	15.00	70	44634	337466	63106852
Gingival bleeding	81.51	15.00	69	44635	12518	63431800
Sinusitis	79.64	15.00	30	44674	226623	63217695
International normalised ratio abnormal	78.98	15.00	41	44663	3263	63441055
Traumatic haemorrhage	78.53	15.00	25	44679	549	63443769
Weight increased	78.43	15.00	43	44661	260749	63183569
Cerebral artery occlusion	75.09	15.00	27	44677	868	63443450
Mouth haemorrhage	74.58	15.00	51	44653	6732	63437586
Embolism	74.29	15.00	54	44650	7852	63436466
Swelling	73.69	15.00	52	44652	275326	63168992
Thrombosis	73.15	15.00	149	44555	64606	63379712
Thrombin time abnormal	72.44	15.00	12	44692	3	63444315
Discomfort	72.05	15.00	15	44689	167359	63276959
Pulmonary haemorrhage	71.95	15.00	51	44653	7130	63437188
Peripheral swelling	71.44	15.00	50	44654	265892	63178426
Death	71.21	15.00	479	44225	373902	63070416
Traumatic intracranial haemorrhage	69.59	15.00	22	44682	472	63443846
Headache	68.93	15.00	223	44481	633018	62811300
Anticoagulation drug level increased	68.42	15.00	18	44686	194	63444124
Product use issue	68.29	15.00	35	44669	220485	63223833
Splenic rupture	67.92	15.00	28	44676	1310	63443008
Dyspepsia	67.57	15.00	191	44513	102005	63342313
Wound	67.52	15.00	16	44688	163247	63281071
Hip fracture	67.30	15.00	93	44611	29381	63414937
Craniocerebral injury	67.29	15.00	35	44669	2797	63441521
Anxiety	66.66	15.00	35	44669	217506	63226812
Injection site pain	66.49	15.00	7	44697	129793	63314525
Intestinal ischaemia	65.65	15.00	49	44655	7419	63436899
Cerebral ischaemia	65.61	15.00	47	44657	6681	63437637
International normalised ratio	64.35	15.00	15	44689	93	63444225
Product dose omission issue	64.33	15.00	43	44661	234270	63210048
Cardiac valve replacement complication	63.71	15.00	16	44688	141	63444177
Peripheral ischaemia	61.65	15.00	40	44664	4838	63439480
Activated partial thromboplastin time abnormal	61.58	15.00	15	44689	115	63444203
Strangulated hernia	60.99	15.00	12	44692	27	63444291
Lower respiratory tract infection	60.92	15.00	10	44694	132297	63312021
Intracardiac thrombus	60.77	15.00	31	44673	2379	63441939
Product use in unapproved indication	60.76	15.00	25	44679	179055	63265263
Intra-abdominal haemorrhage	60.06	15.00	31	44673	2438	63441880
Colon cancer	59.59	15.00	52	44652	9826	63434492
Retroperitoneal haemorrhage	59.20	15.00	32	44672	2765	63441553
Infection	59.05	15.00	45	44659	229128	63215190
Pericarditis	58.28	15.00	11	44693	131568	63312750
Blood urine present	58.09	15.00	62	44642	15007	63429311
Puncture site haemorrhage	57.64	15.00	17	44687	286	63444032
Acute abdomen	57.17	15.00	26	44678	1547	63442771
Acute myocardial infarction	56.96	15.00	90	44614	32034	63412284
Stomatitis	56.56	15.00	14	44690	138711	63305607
Iron deficiency anaemia	56.45	15.00	70	44634	19899	63424419
Intentional product use issue	55.99	15.00	11	44693	127881	63316437
Haemarthrosis	55.54	15.00	32	44672	3129	63441189
Shock	55.02	15.00	75	44629	23388	63420930
Cerebral artery embolism	54.95	15.00	22	44682	954	63443364
Multiple organ dysfunction syndrome	54.20	15.00	122	44582	56630	63387688
Atrial fibrillation	54.17	15.00	193	44511	116443	63327875
Nausea	52.37	15.00	370	44334	854101	62590217
Haemorrhage subcutaneous	51.88	15.00	30	44674	2953	63441365
Gastritis erosive	51.70	15.00	39	44665	6000	63438318
Vaginal haemorrhage	51.51	15.00	79	44625	27408	63416910
Depression	51.36	15.00	38	44666	196454	63247864
Hepatic enzyme increased	50.51	15.00	41	44663	202287	63242031
Helicobacter infection	50.20	15.00	4	44700	92781	63351537
Femoral neck fracture	49.68	15.00	44	44660	8479	63435839
Neutropenia	49.54	15.00	31	44673	174974	63269344
Cardiac perforation	49.02	15.00	11	44693	56	63444262
Peripheral artery thrombosis	48.97	15.00	25	44679	1921	63442397
Cardiac failure congestive	48.21	15.00	159	44545	92274	63352044
Embolic cerebral infarction	48.20	15.00	17	44687	516	63443802
Disease progression	47.01	15.00	14	44690	122744	63321574
Intraventricular haemorrhage	46.96	15.00	25	44679	2095	63442223
Colitis ischaemic	46.57	15.00	47	44657	10661	63433657
Haemoperitoneum	46.17	15.00	27	44677	2714	63441604
Cerebral mass effect	45.99	15.00	19	44685	894	63443424
Microcytic anaemia	45.51	15.00	29	44675	3400	63440918
Back pain	43.93	15.00	74	44630	264071	63180247
Duodenal ulcer perforation	43.90	15.00	5	44699	87204	63357114
Pruritus	43.74	15.00	121	44583	361332	63082986
Internal haemorrhage	43.43	15.00	33	44671	5132	63439186
Irritable bowel syndrome	43.36	15.00	4	44700	82408	63361910
Toxicity to various agents	42.29	15.00	68	44636	247182	63197136
Diverticulum	42.15	15.00	47	44657	11944	63432374
Coagulation test abnormal	41.53	15.00	17	44687	781	63443537
Haemorrhagic cerebral infarction	41.33	15.00	16	44688	634	63443684
Hypocoagulable state	40.89	15.00	19	44685	1188	63443130
Impaired healing	40.55	15.00	11	44693	102531	63341787
Subcutaneous haematoma	40.15	15.00	21	44683	1697	63442621
Neuropathy peripheral	39.97	15.00	15	44689	113652	63330666
Hypotension	39.90	15.00	328	44376	272276	63172042
Chills	39.80	15.00	15	44689	113363	63330955
Syncope	39.78	15.00	176	44528	117209	63327109
Prothrombin time abnormal	37.84	15.00	14	44690	489	63443829
Mobility decreased	37.83	15.00	19	44685	121140	63323178
Wound haemorrhage	37.74	15.00	23	44681	2493	63441825
Therapeutic product effect incomplete	37.00	15.00	21	44683	125035	63319283
Off label use	36.99	15.00	301	44403	674161	62770157
Ecchymosis	36.47	15.00	42	44662	11052	63433266
Skull fracture	36.36	15.00	17	44687	1078	63443240
Ischaemic cerebral infarction	35.94	15.00	18	44686	1328	63442990
Exsanguination	35.81	15.00	7	44697	15	63444303
Ischaemia	34.73	15.00	28	44676	4744	63439574
Haematocrit decreased	34.73	15.00	82	44622	39258	63405060
Prothrombin time shortened	34.53	15.00	20	44684	1975	63442343
Overdose	34.16	15.00	166	44538	114912	63329406
Dysphagia	34.02	15.00	138	44566	88447	63355871
Type 2 diabetes mellitus	33.87	15.00	3	44701	63865	63380453
Ill-defined disorder	33.81	15.00	8	44696	81747	63362571
Post procedural haematoma	33.77	15.00	17	44687	1268	63443050
Small intestinal haemorrhage	33.65	15.00	20	44684	2072	63442246
Diverticulum intestinal haemorrhagic	33.43	15.00	18	44686	1543	63442775
Pelvic fracture	33.33	15.00	44	44660	13304	63431014
Mesenteric artery embolism	32.48	15.00	6	44698	8	63444310
Brain contusion	32.29	15.00	13	44691	572	63443746
Incarcerated hernia	32.25	15.00	9	44695	123	63444195
Blood cholesterol increased	32.08	15.00	13	44691	94019	63350299
Anticoagulation drug level above therapeutic	32.00	15.00	17	44687	1418	63442900
Gastric ulcer haemorrhage	31.97	15.00	27	44677	4881	63439437
Disseminated intravascular coagulation	31.89	15.00	52	44652	18999	63425319
Pelvic haematoma	31.78	15.00	13	44691	596	63443722
Coagulation factor increased	31.68	15.00	6	44698	10	63444308
Activated partial thromboplastin time	31.68	15.00	6	44698	10	63444308
Asthma	31.63	15.00	26	44678	127535	63316783
Skin haemorrhage	31.16	15.00	37	44667	10057	63434261
Influenza	31.11	15.00	19	44685	108703	63335615
Stress	31.08	15.00	5	44699	67162	63377156
Paraesthesia	30.96	15.00	39	44665	156927	63287391
Sepsis	30.87	15.00	199	44505	152924	63291394
Oesophagitis	30.78	15.00	45	44659	14963	63429355
Atrial flutter	30.46	15.00	36	44668	9736	63434582
Drug abuse	30.17	15.00	7	44697	72511	63371807
Discoloured vomit	30.06	15.00	14	44690	880	63443438
Oesophageal ulcer	29.86	15.00	25	44679	4465	63439853
Prothrombin time ratio decreased	29.85	15.00	12	44692	526	63443792
Brain herniation	29.83	15.00	23	44681	3654	63440664
Hypochromic anaemia	29.77	15.00	18	44686	1924	63442394
Femoral artery embolism	29.68	15.00	7	44697	46	63444272
Intracranial haematoma	29.33	15.00	11	44693	399	63443919
Blister	29.16	15.00	29	44675	129785	63314533
White blood cell count decreased	29.09	15.00	33	44671	139071	63305247
Petechiae	28.98	15.00	42	44662	13855	63430463
Peritonitis	28.95	15.00	47	44657	17107	63427211
Cardiogenic shock	28.74	15.00	48	44656	17884	63426434
Therapy non-responder	28.43	15.00	9	44695	75892	63368426
Contusion	28.43	15.00	192	44512	149852	63294466
Phlebitis	28.30	15.00	29	44675	6695	63437623
Myocardial infarction	28.15	15.00	142	44562	99751	63344567
COVID-19	28.11	15.00	23	44681	113080	63331238
Gastritis haemorrhagic	28.10	15.00	16	44688	1529	63442789
Gastric ulcer	27.95	15.00	56	44648	23981	63420337
Rhinorrhoea	27.95	15.00	6	44698	65571	63378747
Occult blood positive	27.71	15.00	22	44682	3648	63440670
Abdominal discomfort	27.66	15.00	124	44580	320761	63123557
Therapeutic response decreased	27.54	15.00	5	44699	61520	63382798
Bradycardia	27.27	15.00	113	44591	73114	63371204
Pulmonary alveolar haemorrhage	27.01	15.00	24	44680	4644	63439674
Osteoarthritis	26.81	15.00	17	44687	95326	63348992
Haemorrhagic arteriovenous malformation	26.62	15.00	8	44696	144	63444174
Neutrophil count decreased	26.55	15.00	4	44700	56402	63387916
Arterial haemorrhage	26.54	15.00	16	44688	1701	63442617
Cough	26.52	15.00	111	44593	292632	63151686
Heart transplant	26.40	15.00	11	44693	529	63443789
Gastrointestinal necrosis	26.03	15.00	19	44685	2779	63441539
Constipation	25.93	15.00	77	44627	224866	63219452
Diarrhoea	25.82	15.00	352	44352	715014	62729304
Haemodynamic instability	25.63	15.00	32	44672	9158	63435160
Anticoagulant-related nephropathy	25.49	15.00	5	44699	11	63444307
Hypoaesthesia	25.45	15.00	50	44654	168343	63275975
Upper respiratory tract infection	25.40	15.00	13	44691	82034	63362284
Sleep disorder	25.14	15.00	13	44691	81553	63362765
Intestinal infarction	25.01	15.00	13	44691	1037	63443281
Haemorrhage urinary tract	24.77	15.00	12	44692	824	63443494
Acute coronary syndrome	24.70	15.00	33	44671	10093	63434225
Basal ganglia haemorrhage	24.37	15.00	11	44693	643	63443675
Wheezing	24.30	15.00	19	44685	95576	63348742
Haemorrhagic diathesis	24.16	15.00	22	44682	4393	63439925
Night sweats	24.07	15.00	3	44701	48811	63395507
Gastritis	23.93	15.00	69	44635	37234	63407084
Conjunctival haemorrhage	23.91	15.00	20	44684	3567	63440751
Loss of personal independence in daily activities	23.91	15.00	20	44684	97270	63347048
Insomnia	23.87	15.00	75	44629	215177	63229141
Haemorrhoids	23.86	15.00	50	44654	22100	63422218
Psoriasis	23.78	15.00	16	44688	86941	63357377
Urticaria	23.56	15.00	51	44653	165751	63278567
Blood creatinine increased	23.45	15.00	123	44581	87721	63356597
Oesophageal pain	23.37	15.00	20	44684	3681	63440637
Lacunar infarction	23.35	15.00	19	44685	3261	63441057
Haemoglobin abnormal	23.35	15.00	23	44681	5065	63439253
Thrombotic stroke	23.26	15.00	10	44694	520	63443798
Rib fracture	23.18	15.00	50	44654	22547	63421771
Prothrombin time	22.88	15.00	5	44699	22	63444296
Infarction	22.48	15.00	17	44687	2624	63441694
Occult blood	22.40	15.00	13	44691	1288	63443030
Abdominal wall haematoma	22.39	15.00	18	44686	3037	63441281
Prothrombin level decreased	21.83	15.00	10	44694	605	63443713
Aortic thrombosis	21.67	15.00	12	44692	1087	63443231
Arthritis	21.63	15.00	30	44674	115891	63328427
Cerebellar haemorrhage	21.57	15.00	13	44691	1381	63442937
Haemorrhagic disorder	21.55	15.00	11	44693	845	63443473
C-reactive protein increased	21.44	15.00	21	44683	94686	63349632
Renal infarct	21.12	15.00	13	44691	1434	63442884
Migraine	21.08	15.00	25	44679	103321	63340997
Red blood cell sedimentation rate increased	20.97	15.00	3	44701	43979	63400339
Dysarthria	20.95	15.00	72	44632	42639	63401679
Nasal congestion	20.94	15.00	10	44694	65650	63378668
Pain in extremity	20.93	15.00	142	44562	331344	63112974
Cardiac ablation	20.81	15.00	13	44691	1472	63442846
Ileus	20.45	15.00	37	44667	14688	63429630
Cardiac failure chronic	20.33	15.00	20	44684	4398	63439920
Musculoskeletal pain	20.28	15.00	21	44683	92256	63352062
Embolism arterial	20.21	15.00	11	44693	963	63443355
Cardioversion	20.14	15.00	12	44692	1248	63443070
Influenza like illness	20.08	15.00	11	44693	66813	63377505
Post procedural haematuria	19.92	15.00	5	44699	44	63444274
Splenic haematoma	19.86	15.00	6	44698	110	63444208
Weight decreased	19.84	15.00	114	44590	276684	63167634
Injection site bruising	19.66	15.00	3	44701	41907	63402411
Arteriovenous malformation	19.30	15.00	12	44692	1348	63442970
Suicidal ideation	19.16	15.00	10	44694	62411	63381907
Diverticulitis intestinal haemorrhagic	19.10	15.00	6	44698	126	63444192
Duodenal ulcer haemorrhage	19.08	15.00	15	44689	2452	63441866
Road traffic accident	19.07	15.00	63	44641	36569	63407749
Extradural haematoma	19.05	15.00	13	44691	1709	63442609
Erosive oesophagitis	18.86	15.00	13	44691	1737	63442581
Malignant neoplasm progression	18.84	15.00	18	44686	82103	63362215
Abdominal incarcerated hernia	18.78	15.00	3	44701	0	63444318
Thrombotic cerebral infarction	18.59	15.00	6	44698	138	63444180
Hypertension	18.46	15.00	118	44586	279185	63165133
Inappropriate schedule of product administration	18.32	15.00	28	44676	103937	63340381
Spontaneous haematoma	18.30	15.00	10	44694	883	63443435
Rectal perforation	18.23	15.00	8	44696	437	63443881
Hospitalisation	17.98	15.00	20	44684	85061	63359257
Bleeding time prolonged	17.93	15.00	9	44695	667	63443651
Abdominal wall haemorrhage	17.89	15.00	6	44698	156	63444162
Multiple sclerosis relapse	17.71	15.00	6	44698	48472	63395846
Rectal ulcer	17.70	15.00	11	44693	1234	63443084
Hyperkalaemia	17.39	15.00	80	44624	54123	63390195
Appendicitis	17.35	15.00	25	44679	8204	63436114
Spinal cord haematoma	17.11	15.00	6	44698	179	63444139
Hypertensive crisis	17.04	15.00	35	44669	15251	63429067
Muscle spasms	16.89	15.00	55	44649	156095	63288223
Brain stem haemorrhage	16.87	15.00	9	44695	757	63443561
Herpes zoster	16.76	15.00	20	44684	82442	63361876
Tachyarrhythmia	16.61	15.00	18	44686	4432	63439886
Vomiting	16.52	15.00	286	44418	559331	62884987
Glomerular filtration rate decreased	16.45	15.00	32	44672	13409	63430909
Facial paresis	16.40	15.00	16	44688	3482	63440836
Surgery	16.29	15.00	59	44645	35853	63408465
Uterine haemorrhage	16.24	15.00	17	44687	4024	63440294
Arterial thrombosis	16.22	15.00	11	44693	1432	63442886
Brain stem stroke	16.17	15.00	7	44697	370	63443948
Cerebral artery thrombosis	16.12	15.00	7	44697	373	63443945
Muscle haemorrhage	15.78	15.00	15	44689	3164	63441154
Thoracic haemorrhage	15.66	15.00	4	44700	38	63444280
Joint stiffness	15.62	15.00	5	44699	41864	63402454
Vascular pseudoaneurysm	15.61	15.00	11	44693	1523	63442795
Duodenal ulcer	15.54	15.00	23	44681	7733	63436585
Polyp	15.52	15.00	21	44683	6500	63437818
Adverse drug reaction	15.51	15.00	20	44684	79694	63364624
Sudden death	15.47	15.00	27	44677	10422	63433896
Tongue haemorrhage	15.30	15.00	7	44697	422	63443896
Mucosal inflammation	15.19	15.00	7	44697	46921	63397397
Venous thrombosis	15.18	15.00	18	44686	4884	63439434
Vessel puncture site haemorrhage	15.09	15.00	5	44699	125	63444193
Cerebellar infarction	15.02	15.00	12	44692	2007	63442311
Thrombolysis	15.02	15.00	5	44699	127	63444191

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	2880.71	14.41	1720	49522	86757	34818932
Ischaemic stroke	2412.08	14.41	932	50310	17318	34888371
Cerebrovascular accident	1774.18	14.41	1251	49991	83560	34822129
Haemorrhage	1147.24	14.41	790	50452	50580	34855109
Haemorrhage intracranial	903.11	14.41	449	50793	15497	34890192
Rectal haemorrhage	862.84	14.41	604	50638	39645	34866044
Cerebral infarction	855.67	14.41	521	50721	26934	34878755
Cerebral haemorrhage	806.93	14.41	549	50693	34388	34871301
Melaena	777.05	14.41	539	50703	34841	34870848
Subdural haematoma	657.88	14.41	396	50846	20025	34885664
Cardiac tamponade	645.19	14.41	255	50987	5011	34900678
Atrial thrombosis	631.97	14.41	201	51041	2013	34903676
Embolic stroke	606.96	14.41	233	51009	4221	34901468
Haematuria	464.70	14.41	463	50779	49603	34856086
Fall	435.10	14.41	933	50309	201952	34703737
Activated partial thromboplastin time prolonged	414.13	14.41	218	51024	8477	34897212
Transient ischaemic attack	389.10	14.41	323	50919	27290	34878399
Lower gastrointestinal haemorrhage	388.77	14.41	215	51027	9237	34896452
Procoagulant therapy	366.55	14.41	68	51174	10	34905679
Shock haemorrhagic	336.84	14.41	209	51033	11145	34894544
Hemiparesis	328.78	14.41	233	51009	15545	34890144
Upper gastrointestinal haemorrhage	270.40	14.41	254	50988	25264	34880425
Blood loss anaemia	245.98	14.41	152	51090	8042	34897647
Coagulopathy	237.02	14.41	211	51031	19578	34886111
Thrombin time prolonged	236.02	14.41	55	51187	135	34905554
Pericardial haemorrhage	224.38	14.41	104	51138	3054	34902635
Haematoma	221.23	14.41	228	51014	25377	34880312
Haemorrhagic stroke	210.88	14.41	127	51115	6412	34899277
Subarachnoid haemorrhage	208.05	14.41	162	51080	12473	34893216
Aphasia	188.87	14.41	193	51049	21261	34884428
Haemothorax	178.89	14.41	95	51147	3757	34901932
Pulmonary embolism	177.08	14.41	400	50842	89346	34816343
Haematemesis	175.90	14.41	210	51032	27501	34878188
Aortic dissection	174.66	14.41	84	51158	2684	34903005
Deep vein thrombosis	173.63	14.41	329	50913	64919	34840770
Hemiplegia	159.32	14.41	109	51133	6863	34898826
Head injury	157.36	14.41	162	51080	17998	34887691
Epistaxis	152.83	14.41	292	50950	57959	34847730
Febrile neutropenia	152.37	14.41	13	51229	136836	34768853
Procedural haemorrhage	150.31	14.41	73	51169	2384	34903305
Haemorrhagic transformation stroke	149.69	14.41	63	51179	1460	34904229
Toxicity to various agents	142.16	14.41	58	51184	200304	34705385
Neutropenia	139.12	14.41	30	51212	156748	34748941
Subdural haemorrhage	135.06	14.41	74	51168	3117	34902572
Anaemia	129.06	14.41	678	50564	232657	34673032
Completed suicide	125.76	14.41	4	51238	98164	34807525
Pyrexia	121.65	14.41	188	51054	332825	34572864
International normalised ratio increased	121.36	14.41	235	51007	47092	34858597
Haemoptysis	120.89	14.41	198	51044	34808	34870881
Intracardiac thrombus	117.15	14.41	62	51180	2434	34903255
Cerebral haematoma	117.08	14.41	77	51165	4538	34901151
Brain contusion	111.89	14.41	43	51199	780	34904909
Drug abuse	111.41	14.41	9	51233	99087	34806602
Intestinal haemorrhage	110.39	14.41	67	51175	3429	34902260
Haematochezia	109.60	14.41	223	51019	46311	34859378
Post procedural haemorrhage	106.46	14.41	92	51150	8197	34897492
Product dose omission issue	105.97	14.41	23	51219	119688	34786001
Cardiac failure	103.97	14.41	332	50910	90916	34814773
Off label use	102.79	14.41	297	50945	419227	34486462
Peripheral embolism	101.82	14.41	43	51199	1005	34904684
Pericardial effusion	99.72	14.41	150	51092	24512	34881177
Disease progression	97.22	14.41	20	51222	108057	34797632
Colon cancer	93.54	14.41	87	51155	8534	34897155
Fatigue	93.23	14.41	259	50983	370394	34535295
Product use in unapproved indication	88.27	14.41	31	51211	117468	34788221
Gastric haemorrhage	84.32	14.41	89	51153	10172	34895517
Oesophageal pain	83.04	14.41	35	51207	814	34904875
Intraventricular haemorrhage	82.56	14.41	56	51186	3475	34902214
Road traffic accident	82.02	14.41	114	51128	17336	34888353
Traumatic intracranial haemorrhage	78.33	14.41	32	51210	686	34905003
Large intestinal haemorrhage	77.62	14.41	41	51201	1603	34904086
Anticoagulation drug level increased	76.23	14.41	29	51213	511	34905178
Faeces discoloured	75.68	14.41	101	51141	14777	34890912
Extradural haematoma	74.76	14.41	36	51206	1153	34904536
Activated partial thromboplastin time abnormal	74.29	14.41	21	51221	134	34905555
Hypovolaemic shock	73.99	14.41	70	51172	7015	34898674
Pancytopenia	73.38	14.41	24	51218	95133	34810556
Renal impairment	71.36	14.41	301	50941	94212	34811477
Pain	70.38	14.41	120	51122	204555	34701134
Nausea	69.05	14.41	261	50981	339647	34566042
Haemorrhagic infarction	68.72	14.41	26	51216	451	34905238
Pulmonary haemorrhage	68.51	14.41	80	51162	10224	34895465
Drug hypersensitivity	68.20	14.41	17	51225	80512	34825177
Depression	67.32	14.41	29	51213	97069	34808620
Cerebral artery occlusion	66.64	14.41	29	51213	731	34904958
Coagulation test abnormal	66.17	14.41	27	51215	577	34905112
Condition aggravated	65.78	14.41	113	51129	192083	34713606
Rash	64.96	14.41	144	51098	222608	34683081
Leukopenia	64.66	14.41	8	51234	62848	34842841
Diarrhoea	63.68	14.41	325	50917	389587	34516102
Embolism	62.72	14.41	67	51175	7762	34897927
Blood urine present	62.06	14.41	78	51164	10756	34894933
Embolic cerebral infarction	61.81	14.41	27	51215	687	34905002
Urinary bladder haemorrhage	61.69	14.41	36	51206	1713	34903976
Aortic aneurysm rupture	60.92	14.41	30	51212	1010	34904679
White blood cell count decreased	60.82	14.41	32	51210	95413	34810276
Contusion	60.67	14.41	152	51090	36212	34869477
Gingival bleeding	59.81	14.41	62	51180	6938	34898751
Cerebral mass effect	59.51	14.41	29	51213	954	34904735
Skull fracture	58.26	14.41	28	51214	893	34904796
Splenic rupture	57.76	14.41	33	51209	1508	34904181
Coagulation time prolonged	57.33	14.41	31	51211	1271	34904418
Wound secretion	56.97	14.41	40	51202	2625	34903064
Intentional product use issue	56.03	14.41	10	51232	59806	34845883
Dyspepsia	54.57	14.41	147	51095	36585	34869104
Surgery	54.24	14.41	84	51158	14073	34891616
Infusion related reaction	53.97	14.41	7	51235	53050	34852639
Tremor	53.64	14.41	27	51215	82560	34823129
Traumatic haemorrhage	52.94	14.41	25	51217	766	34904923
Renal failure	52.91	14.41	350	50892	130207	34775482
Haemoglobin decreased	52.77	14.41	330	50912	120442	34785247
Arthralgia	51.97	14.41	107	51135	169934	34735755
International normalised ratio abnormal	51.09	14.41	41	51201	3294	34902395
Anorectal discomfort	50.38	14.41	33	51209	1931	34903758
Cerebral artery embolism	50.19	14.41	25	51217	863	34904826
Neuropathy peripheral	50.04	14.41	30	51212	83233	34822456
Traumatic haemothorax	49.14	14.41	18	51224	284	34905405
Creatinine renal clearance decreased	48.50	14.41	40	51202	3341	34902348
Cardiac ablation	48.18	14.41	26	51216	1062	34904627
Chills	47.59	14.41	30	51212	81013	34824676
Incarcerated hernia	47.43	14.41	15	51227	147	34905542
Product use issue	46.89	14.41	17	51225	63199	34842490
Anxiety	46.80	14.41	46	51196	99382	34806307
Insomnia	46.72	14.41	50	51192	103857	34801832
Weight increased	46.19	14.41	41	51201	92992	34812697
Heart transplant	45.89	14.41	24	51218	919	34904770
Thrombosis	45.53	14.41	170	51072	50288	34855401
Embolism arterial	44.69	14.41	21	51221	636	34905053
Thrombin time abnormal	44.22	14.41	8	51234	0	34905689
Acute kidney injury	43.43	14.41	657	50585	304331	34601358
Vomiting	42.26	14.41	203	51039	247418	34658271
Intra-abdominal haemorrhage	42.13	14.41	32	51210	2372	34903317
Mucosal inflammation	42.04	14.41	4	51238	38618	34867071
Multiple injuries	41.81	14.41	29	51213	1866	34903823
Cerebellar haemorrhage	41.77	14.41	27	51215	1544	34904145
Mouth haemorrhage	41.69	14.41	45	51197	5274	34900415
Craniocerebral injury	41.46	14.41	36	51206	3227	34902462
Haemorrhoidal haemorrhage	41.32	14.41	38	51204	3673	34902016
Retroperitoneal haemorrhage	41.08	14.41	34	51208	2854	34902835
Muscle spasms	41.04	14.41	30	51212	74971	34830718
Drug ineffective	40.01	14.41	453	50789	456298	34449391
Malignant neoplasm progression	39.99	14.41	42	51200	88004	34817685
Strangulated hernia	39.56	14.41	9	51233	19	34905670
Neutrophil count decreased	39.18	14.41	13	51229	51091	34854598
Rheumatoid arthritis	38.99	14.41	5	51237	38233	34867456
Acute abdomen	38.69	14.41	28	51214	1927	34903762
Agitation	38.42	14.41	18	51224	57381	34848308
Oesophageal ulcer	38.38	14.41	35	51207	3346	34902343
Basal ganglia haemorrhage	37.88	14.41	21	51221	905	34904784
Pulmonary alveolar haemorrhage	36.68	14.41	50	51192	7462	34898227
Subarachnoid haematoma	36.47	14.41	14	51228	253	34905436
Dysarthria	36.36	14.41	123	51119	34659	34871030
Ischaemia	36.34	14.41	39	51203	4541	34901148
Alanine aminotransferase increased	36.20	14.41	39	51203	80776	34824913
Cough	36.04	14.41	107	51135	150033	34755656
Femur fracture	35.11	14.41	51	51191	8073	34897616
Injury	35.05	14.41	87	51155	20600	34885089
Renal infarct	35	14.41	23	51219	1353	34904336
Coagulation time shortened	34.87	14.41	13	51229	216	34905473
Cardiac valve replacement complication	34.73	14.41	9	51233	39	34905650
Somnolence	34.70	14.41	69	51173	111047	34794642
Acute myocardial infarction	34.40	14.41	163	51079	53556	34852133
Haemorrhage subcutaneous	34.39	14.41	28	51214	2296	34903393
Erythema	34.33	14.41	48	51194	88732	34816957
Joint swelling	34.02	14.41	23	51219	59867	34845822
International normalised ratio	33.85	14.41	9	51233	44	34905645
Activated partial thromboplastin time	33.16	14.41	6	51236	0	34905689
Creatinine renal clearance	33.16	14.41	6	51236	0	34905689
Arterial thrombosis	32.99	14.41	23	51219	1492	34904197
Haemorrhage urinary tract	32.96	14.41	25	51217	1849	34903840
Seizure	32.84	14.41	65	51177	104792	34800897
Cardioversion	32.33	14.41	19	51223	916	34904773
Stomatitis	32.27	14.41	11	51231	42503	34863186
Intracranial haematoma	32.12	14.41	15	51227	448	34905241
Platelet count decreased	31.95	14.41	81	51161	119636	34786053
Hemianopia	31.89	14.41	17	51225	677	34905012
Injection site pain	31.56	14.41	9	51233	38996	34866693
Femoral neck fracture	31.38	14.41	31	51211	3276	34902413
Drug intolerance	31.09	14.41	25	51217	59545	34846144
Intestinal ischaemia	30.91	14.41	47	51195	7747	34897942
Stress	30.87	14.41	4	51238	30343	34875346
Cerebral ischaemia	30.75	14.41	42	51200	6280	34899409
Elderly	30.73	14.41	6	51236	3	34905686
Haemoglobin abnormal	30.72	14.41	33	51209	3847	34901842
Musculoskeletal stiffness	30.69	14.41	15	51227	46665	34859024
Wound haemorrhage	30.60	14.41	25	51217	2060	34903629
Gastrointestinal motility disorder	29.82	14.41	27	51215	2557	34903132
Infection	29.65	14.41	55	51187	90860	34814829
Psoriasis	29.53	14.41	10	51232	38802	34866887
Prothrombin time prolonged	29.51	14.41	51	51191	9355	34896334
Neurologic neglect syndrome	29.33	14.41	11	51231	186	34905503
Thrombotic stroke	29.04	14.41	12	51230	265	34905424
Large intestine polyp	28.98	14.41	46	51196	7868	34897821
Nasopharyngitis	28.92	14.41	36	51206	69932	34835757
Weight decreased	28.62	14.41	147	51095	176154	34729535
Blood creatine phosphokinase increased	28.61	14.41	15	51227	44842	34860847
Cardiac perforation	28.57	14.41	9	51233	87	34905602
Iron deficiency anaemia	28.56	14.41	53	51189	10276	34895413
Cerebellar infarction	28.15	14.41	23	51219	1896	34903793
Rib fracture	28.12	14.41	64	51178	14336	34891353
Aggression	28.02	14.41	11	51231	38953	34866736
Peripheral artery thrombosis	27.91	14.41	25	51217	2335	34903354
C-reactive protein increased	27.86	14.41	23	51219	54075	34851614
Sinusitis	27.68	14.41	13	51229	41389	34864300
Asthma	27.60	14.41	14	51228	42642	34863047
Lumbar puncture	27.44	14.41	9	51233	100	34905589
Hyperhidrosis	27.24	14.41	43	51199	75649	34830040
COVID-19	27.02	14.41	45	51197	77505	34828184
Ecchymosis	26.95	14.41	41	51201	6762	34898927
Blood glucose increased	26.87	14.41	35	51207	66683	34839006
Infarction	26.48	14.41	26	51216	2727	34902962
Exsanguination	26.30	14.41	8	51234	68	34905621
Mesenteric artery embolism	26.20	14.41	8	51234	69	34905620
Hospitalisation	25.99	14.41	27	51215	56875	34848814
White blood cell count increased	25.89	14.41	14	51228	41137	34864552
Inappropriate schedule of product administration	25.80	14.41	32	51210	62264	34843425
Prothrombin time abnormal	25.34	14.41	15	51227	733	34904956
Hemianopia homonymous	25.32	14.41	15	51227	734	34904955
Anaphylactic reaction	25.14	14.41	8	51234	32293	34873396
Aspartate aminotransferase increased	24.87	14.41	38	51204	67745	34837944
Brain herniation	24.80	14.41	30	51212	3978	34901711
Gastrointestinal carcinoma	24.72	14.41	21	51221	1827	34903862
Gastric ulcer haemorrhage	24.62	14.41	35	51207	5431	34900258
Loss of personal independence in daily activities	24.47	14.41	9	51233	33170	34872519
Diverticulum intestinal haemorrhagic	24.43	14.41	24	51218	2518	34903171
Cholecystitis acute	24.37	14.41	38	51204	6401	34899288
Arteriovenous malformation	24.30	14.41	15	51227	791	34904898
Herpes zoster	24.26	14.41	10	51232	34389	34871300
Gastric cancer	24.24	14.41	38	51204	6431	34899258
Therapy non-responder	23.65	14.41	14	51228	39132	34866557
Thalamus haemorrhage	23.64	14.41	16	51226	989	34904700
Feeling abnormal	23.64	14.41	35	51207	63200	34842489
Rectal cancer	23.41	14.41	22	51220	2185	34903504
Thrombocytopenia	23.30	14.41	134	51108	156113	34749576
Therapeutic response decreased	23.28	14.41	7	51235	29306	34876383
Catheter site haemorrhage	23.27	14.41	22	51220	2202	34903487
Oxygen saturation decreased	22.97	14.41	27	51215	53791	34851898
Aortic aneurysm	22.92	14.41	38	51204	6741	34898948
Electrocardiogram QT prolonged	22.89	14.41	16	51226	40936	34864753
Urticaria	22.86	14.41	35	51207	62342	34843347
Diabetes mellitus	22.84	14.41	21	51221	46852	34858837
Pruritus	22.68	14.41	119	51123	141862	34763827
Peripheral swelling	22.64	14.41	49	51193	76492	34829197
Renal haemorrhage	22.51	14.41	18	51224	1439	34904250
Post procedural stroke	22.45	14.41	6	51236	30	34905659
Rhabdomyolysis	22.43	14.41	41	51201	68122	34837567
Dry skin	22.22	14.41	9	51233	31278	34874411
Productive cough	22.18	14.41	14	51228	37799	34867890
Drug interaction	22.14	14.41	459	50783	225487	34680202
Aneurysm ruptured	22.04	14.41	12	51230	499	34905190
Pulmonary contusion	21.83	14.41	7	51235	72	34905617
Cardiac pacemaker insertion	21.81	14.41	24	51218	2874	34902815
Venous thrombosis	21.72	14.41	26	51216	3409	34902280
Haemodynamic instability	21.64	14.41	45	51197	9478	34896211
Gastric ulcer	21.61	14.41	61	51181	15589	34890100
Subcutaneous haematoma	21.37	14.41	15	51227	984	34904705
Irritability	21.31	14.41	5	51237	24685	34881004
Orthopaedic procedure	21.25	14.41	5	51237	13	34905676
Skin haemorrhage	21.14	14.41	30	51212	4648	34901041
Arterial injury	21.01	14.41	11	51231	422	34905267
Colon neoplasm	20.71	14.41	11	51231	435	34905254
Traumatic haematoma	20.63	14.41	13	51229	711	34904978
Pneumonitis	20.63	14.41	12	51230	33866	34871823
Back pain	20.63	14.41	100	51142	121689	34784000
Coronary artery embolism	20.57	14.41	8	51234	150	34905539
Hyponatraemia	20.50	14.41	58	51184	82633	34823056
Dyskinesia	20.44	14.41	4	51238	22409	34883280
Blood pressure increased	20.26	14.41	64	51178	88038	34817651
Blood cholesterol increased	20.20	14.41	3	51239	20540	34885149
Myalgia	20.12	14.41	60	51182	84050	34821639
Microcytic anaemia	20.04	14.41	21	51221	2379	34903310
Gastrointestinal angiodysplasia	20.00	14.41	12	51230	601	34905088
Abnormal behaviour	19.76	14.41	6	51236	24963	34880726
Incarcerated inguinal hernia	19.65	14.41	8	51234	170	34905519
Osteoma	19.50	14.41	7	51235	104	34905585
Polycystic liver disease	19.43	14.41	7	51235	105	34905584
Haemorrhoids	19.34	14.41	56	51186	14519	34891170
Intentional product misuse	19.34	14.41	23	51219	45588	34860101
Pain in extremity	19.12	14.41	108	51134	126405	34779284
Angioedema	19.11	14.41	16	51226	37358	34868331
Splenic necrosis	18.74	14.41	7	51235	117	34905572
Factor V deficiency	18.71	14.41	5	51237	25	34905664
Lymphocyte count decreased	18.71	14.41	5	51237	22617	34883072
Arthropathy	18.69	14.41	8	51234	26899	34878790
Vision blurred	18.62	14.41	24	51218	45939	34859750
Small intestinal haemorrhage	18.62	14.41	19	51223	2087	34903602
Eye haemorrhage	18.56	14.41	27	51215	4278	34901411
Intestinal infarction	18.46	14.41	11	51231	544	34905145
Puncture site haemorrhage	18.41	14.41	9	51233	298	34905391
Ischaemic cerebral infarction	18.40	14.41	15	51227	1232	34904457
Gastritis erosive	18.40	14.41	32	51210	5900	34899789
Occult blood positive	18.35	14.41	26	51216	4022	34901667
Drug reaction with eosinophilia and systemic symptoms	18.32	14.41	13	51229	32999	34872690
Prothrombin time shortened	18.29	14.41	16	51226	1448	34904241
Sleep disorder	18.22	14.41	12	51230	31676	34874013
Ascites	18.17	14.41	25	51217	46546	34859143
Haemoglobin urine present	18.11	14.41	7	51235	129	34905560
Mesenteric haemorrhage	18.07	14.41	4	51238	7	34905682
Splenic cyst	18.01	14.41	7	51235	131	34905558
Pneumonia	17.99	14.41	400	50842	362227	34543462
Influenza like illness	17.98	14.41	9	51233	27625	34878064
Splenic injury	17.95	14.41	5	51237	30	34905659
Urogenital haemorrhage	17.86	14.41	12	51230	733	34904956
Appendicitis	17.85	14.41	55	51187	14752	34890937
Cataract	17.85	14.41	8	51234	26178	34879511
Dysphagia	17.75	14.41	154	51088	62227	34843462
Diverticulum	17.66	14.41	35	51207	7124	34898565
Colitis ischaemic	17.62	14.41	33	51209	6442	34899247
Conjunctival haemorrhage	17.50	14.41	22	51220	3033	34902656
Syncope	17.48	14.41	208	51034	91243	34814446
Shock	17.43	14.41	76	51166	24103	34881586
Haemoperitoneum	17.22	14.41	17	51225	1795	34903894
Myocardial infarction	17.20	14.41	261	50981	120824	34784865
Influenza	17.13	14.41	29	51213	49637	34856052
Diverticulitis intestinal haemorrhagic	17.13	14.41	9	51233	348	34905341
Cerebral vascular occlusion	17.11	14.41	4	51238	10	34905679
Pneumocystis jirovecii pneumonia	16.99	14.41	4	51238	19706	34885983
Aortic intramural haematoma	16.82	14.41	5	51237	39	34905650
Gait disturbance	16.79	14.41	66	51176	85074	34820615
Cerebral thrombosis	16.78	14.41	13	51229	992	34904697
Peripheral ischaemia	16.76	14.41	30	51212	5657	34900032
Osteonecrosis of jaw	16.72	14.41	3	51239	17886	34887803
Internal haemorrhage	16.69	14.41	28	51214	5013	34900676
Thrombotic cerebral infarction	16.60	14.41	9	51233	371	34905318
Anti factor VIII antibody test	16.58	14.41	3	51239	0	34905689
Inguinal hernia strangulated	16.58	14.41	3	51239	0	34905689
Feeling hot	16.56	14.41	4	51238	19368	34886321
Drug ineffective for unapproved indication	16.55	14.41	7	51235	23708	34881981
Hypersensitivity	16.50	14.41	41	51201	60994	34844695
Wheezing	16.38	14.41	22	51220	41380	34864309
Neoplasm progression	16.07	14.41	7	51235	23293	34882396
Skull fractured base	15.92	14.41	7	51235	181	34905508
Upper respiratory tract infection	15.88	14.41	15	51227	33044	34872645
Urinary sediment present	15.88	14.41	8	51234	283	34905406
Muscle strain	15.80	14.41	24	51218	3952	34901737
Thoracic haemorrhage	15.71	14.41	7	51235	187	34905502
Blood lactate dehydrogenase increased	15.71	14.41	7	51235	22983	34882706
Suicidal ideation	15.44	14.41	22	51220	40366	34865323
Serotonin syndrome	15.40	14.41	5	51237	19928	34885761
Chest injury	15.25	14.41	15	51227	1576	34904113
Bacteraemia	15.14	14.41	5	51237	19712	34885977
Hip fracture	15.04	14.41	45	51197	11880	34893809
Abdominal strangulated hernia	14.97	14.41	4	51238	20	34905669
Ulcer haemorrhage	14.94	14.41	19	51223	2651	34903038
Haemarthrosis	14.87	14.41	21	51221	3238	34902451
Right hemisphere deficit syndrome	14.81	14.41	4	51238	21	34905668
Encephalopathy	14.77	14.41	18	51224	35301	34870388
Meningorrhagia	14.71	14.41	6	51236	128	34905561
Cerebellar haematoma	14.63	14.41	7	51235	221	34905468
Bone pain	14.61	14.41	6	51236	20680	34885009
Post procedural pulmonary embolism	14.50	14.41	4	51238	23	34905666
Candida infection	14.49	14.41	4	51238	17711	34887978

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	4776.07	13.53	2468	73564	145251	79523105
Ischaemic stroke	4124.15	13.53	1445	74587	31686	79636670
Cerebrovascular accident	2124.23	13.53	1496	74536	153796	79514560
Melaena	1547.58	13.53	870	75162	60020	79608336
Haemorrhage	1525.85	13.53	996	75036	90122	79578234
Rectal haemorrhage	1451.24	13.53	904	75128	75396	79592960
Haemorrhage intracranial	1434.20	13.53	631	75401	25562	79642794
Cerebral haemorrhage	1363.15	13.53	786	75246	56887	79611469
Cerebral infarction	1290.42	13.53	700	75332	44976	79623380
Cardiac tamponade	1100.29	13.53	391	75641	8885	79659471
Subdural haematoma	992.57	13.53	519	75513	30915	79637441
Embolic stroke	853.37	13.53	310	75722	7516	79660840
Lower gastrointestinal haemorrhage	800.87	13.53	363	75669	15762	79652594
Activated partial thromboplastin time prolonged	785.71	13.53	345	75687	13883	79654473
Atrial thrombosis	737.38	13.53	230	75802	3426	79664930
Shock haemorrhagic	675.63	13.53	346	75686	19714	79648642
Haematuria	673.64	13.53	544	75488	68292	79600064
Fall	633.08	13.53	1417	74615	486212	79182144
Upper gastrointestinal haemorrhage	525.48	13.53	382	75650	40998	79627358
Hemiparesis	496.92	13.53	341	75691	33392	79634964
Transient ischaemic attack	495.51	13.53	407	75625	52288	79616068
Coagulopathy	479.14	13.53	342	75690	35664	79632692
Haematoma	467.60	13.53	392	75640	51803	79616553
Blood loss anaemia	441.35	13.53	239	75793	15259	79653097
Haemorrhagic stroke	432.26	13.53	211	75821	10835	79657521
Subarachnoid haemorrhage	402.70	13.53	265	75767	24200	79644156
Pericardial haemorrhage	398.43	13.53	153	75879	4342	79664014
Thrombin time prolonged	382.69	13.53	84	75948	258	79668098
Haematemesis	382.68	13.53	350	75682	51914	79616442
Anaemia	339.35	13.53	1062	74970	443953	79224403
Haematochezia	327.98	13.53	411	75621	87234	79581122
International normalised ratio increased	302.29	13.53	388	75644	84333	79584023
Aortic dissection	272.50	13.53	114	75918	4061	79664295
Procoagulant therapy	269.93	13.53	48	75984	19	79668337
Pulmonary embolism	257.34	13.53	530	75502	171124	79497232
Haemothorax	252.07	13.53	117	75915	5361	79662995
Pain	251.84	13.53	183	75849	703619	78964737
Subdural haemorrhage	248.96	13.53	119	75913	5829	79662527
Aphasia	248.80	13.53	263	75769	46469	79621887
Hemiplegia	241.40	13.53	160	75872	14779	79653577
Deep vein thrombosis	237.59	13.53	419	75613	120500	79547856
Intestinal haemorrhage	237.25	13.53	118	75914	6308	79662048
Cerebral haematoma	233.14	13.53	125	75907	7817	79660539
Cardiac failure	227.25	13.53	474	75558	154368	79513988
Epistaxis	225.03	13.53	391	75641	111124	79557232
Completed suicide	214.39	13.53	4	76028	245763	79422593
Haemoptysis	213.24	13.53	265	75767	55734	79612622
Hypovolaemic shock	211.83	13.53	137	75895	12139	79656217
Procedural haemorrhage	205.68	13.53	97	75935	4609	79663747
Head injury	200.14	13.53	211	75821	37158	79631198
Acute kidney injury	195.42	13.53	994	75038	518410	79149946
Haemoglobin decreased	195.17	13.53	558	75474	221561	79446795
Drug hypersensitivity	192.47	13.53	28	76004	298888	79369468
Renal failure	191.47	13.53	520	75512	200448	79467908
Fatigue	189.71	13.53	376	75656	929351	78739005
Arthralgia	175.68	13.53	172	75860	571631	79096725
Peripheral embolism	174.52	13.53	67	75965	1899	79666457
Pyrexia	169.16	13.53	241	75791	678468	78989888
Febrile neutropenia	167.95	13.53	14	76018	230985	79437371
Post procedural haemorrhage	167.86	13.53	124	75908	13620	79654736
Faeces discoloured	158.70	13.53	166	75866	28961	79639395
Infusion related reaction	156.77	13.53	18	76014	230219	79438137
Rash	155.61	13.53	194	75838	578164	79090192
Renal impairment	154.98	13.53	413	75619	157370	79510986
Haemorrhagic transformation stroke	154.15	13.53	67	75965	2625	79665731
Toxicity to various agents	151.25	13.53	109	75923	421431	79246925
Pericardial effusion	148.20	13.53	201	75831	46036	79622320
Gastric haemorrhage	147.16	13.53	119	75913	14931	79653425
Joint swelling	145.49	13.53	47	75985	288599	79379757
Drug interaction	143.82	13.53	777	75255	414406	79253950
Rheumatoid arthritis	140.18	13.53	17	76015	208453	79459903
Cerebral artery occlusion	139.79	13.53	55	75977	1667	79666689
Brain contusion	137.11	13.53	51	75981	1322	79667034
Anticoagulation drug level increased	136.79	13.53	44	75988	727	79667629
Intraventricular haemorrhage	135.31	13.53	74	75958	4813	79663543
Drug intolerance	134.89	13.53	42	75990	264077	79404279
Neutropenia	132.87	13.53	54	75978	287656	79380700
Large intestinal haemorrhage	132.45	13.53	61	75971	2744	79665612
Condition aggravated	131.71	13.53	171	75861	500953	79167403
Nausea	128.07	13.53	476	75556	956720	78711636
Synovitis	125.52	13.53	4	76028	150730	79517626
Product dose omission issue	120.04	13.53	43	75989	247494	79420862
Product use in unapproved indication	118.87	13.53	45	75987	250314	79418042
Arthropathy	117.71	13.53	15	76017	177096	79491260
Traumatic haemorrhage	116.79	13.53	45	75987	1288	79667068
Traumatic intracranial haemorrhage	116.44	13.53	44	75988	1193	79667163
Craniocerebral injury	115.09	13.53	68	75964	5128	79663228
Coagulation time prolonged	113.89	13.53	53	75979	2442	79665914
Off label use	113.69	13.53	463	75569	906752	78761604
Nasopharyngitis	113.45	13.53	50	75982	253831	79414525
Weight increased	112.81	13.53	62	75970	277324	79391032
Embolic cerebral infarction	111.69	13.53	43	75989	1228	79667128
Intracardiac thrombus	110.62	13.53	62	75970	4231	79664125
Activated partial thromboplastin time abnormal	110.17	13.53	31	76001	315	79668041
Maternal exposure during pregnancy	108.99	13.53	5	76027	136533	79531823
Pulmonary haemorrhage	108.50	13.53	99	75933	14618	79653738
Hypersensitivity	103.21	13.53	61	75971	262178	79406178
Drug abuse	102.90	13.53	16	76016	162675	79505681
Alopecia	102.67	13.53	46	75986	231309	79437047
Musculoskeletal stiffness	102.48	13.53	21	76011	174987	79493369
Sinusitis	99.95	13.53	31	76001	195470	79472886
Gingival bleeding	98.17	13.53	98	75934	16178	79652178
Systemic lupus erythematosus	98.14	13.53	4	76028	121145	79547211
Mouth haemorrhage	97.81	13.53	82	75950	10817	79657539
Colon cancer	96.11	13.53	92	75940	14431	79653925
Therapeutic product effect decreased	95.24	13.53	20	76012	163843	79504513
Haemorrhoidal haemorrhage	93.70	13.53	66	75966	6729	79661627
Anxiety	93.37	13.53	61	75971	248451	79419905
Disease progression	92.88	13.53	30	76002	184332	79484024
Intentional product use issue	91.70	13.53	17	76015	152095	79516261
Embolism	91.45	13.53	88	75944	13894	79654462
Splenic rupture	90.84	13.53	45	75987	2384	79665972
Cerebral artery embolism	88.90	13.53	41	75991	1850	79666506
International normalised ratio abnormal	88.90	13.53	60	75972	5708	79662648
Depression	88.78	13.53	48	75984	216742	79451614
Cerebral mass effect	88.59	13.53	41	75991	1865	79666491
Product use issue	88.08	13.53	45	75987	209777	79458579
Extradural haematoma	86.47	13.53	46	75986	2830	79665526
Peripheral swelling	86.25	13.53	78	75954	269539	79398817
Prothrombin time prolonged	84.43	13.53	92	75940	16807	79651549
Contraindicated product administered	82.29	13.53	24	76008	157514	79510842
Stomatitis	81.11	13.53	20	76012	146737	79521619
Cardiac valve replacement complication	79.51	13.53	22	76010	209	79668147
Thrombosis	79.35	13.53	217	75815	83883	79584473
Acute myocardial infarction	78.98	13.53	205	75827	76831	79591525
Coagulation test abnormal	78.73	13.53	34	75998	1311	79667045
Thrombin time abnormal	77.72	13.53	14	76018	7	79668349
Strangulated hernia	77.50	13.53	17	76015	52	79668304
Injection site pain	77.21	13.53	15	76017	129823	79538533
Cerebral ischaemia	76.14	13.53	72	75960	11123	79657233
Skull fracture	75.67	13.53	36	75996	1744	79666612
Intestinal ischaemia	74.74	13.53	77	75955	13193	79655163
Aortic aneurysm rupture	73.40	13.53	32	76000	1263	79667093
Glossodynia	73.07	13.53	7	76025	103330	79565026
Intra-abdominal haemorrhage	71.83	13.53	48	75984	4492	79663864
Chills	70.85	13.53	32	76000	160202	79508154
Acute abdomen	69.34	13.53	41	75991	3096	79665260
Blood urine present	68.86	13.53	93	75939	21204	79647152
Diarrhoea	68.72	13.53	525	75507	879964	78788392
Incarcerated hernia	67.92	13.53	22	76010	372	79667984
Headache	67.83	13.53	357	75675	653415	79014941
Cardiac perforation	67.59	13.53	18	76014	146	79668210
Lower respiratory tract infection	66.91	13.53	20	76012	129200	79539156
Ischaemia	66.84	13.53	58	75974	8017	79660339
Puncture site haemorrhage	65.68	13.53	24	76008	591	79667765
Cough	65.63	13.53	159	75873	366630	79301726
Creatinine renal clearance decreased	64.54	13.53	85	75947	18917	79649439
Road traffic accident	64.33	13.53	134	75898	43530	79624826
Vomiting	63.40	13.53	374	75658	665454	79002902
White blood cell count decreased	63.20	13.53	52	75980	188236	79480120
Heart transplant	63.10	13.53	30	76002	1451	79666905
Iron deficiency anaemia	62.46	13.53	98	75934	25574	79642782
Dysarthria	62.31	13.53	173	75859	67449	79600907
Surgery	62.28	13.53	112	75920	32654	79635702
Infection	61.82	13.53	84	75948	241628	79426728
Neuropathy peripheral	61.26	13.53	29	76003	141276	79527080
Microcytic anaemia	60.86	13.53	46	75986	5228	79663128
Traumatic haemothorax	60.58	13.53	22	76010	532	79667824
Discomfort	60.55	13.53	22	76010	125595	79542761
Peripheral artery thrombosis	60.40	13.53	39	75993	3444	79664912
Peripheral ischaemia	58.99	13.53	58	75974	9399	79658957
Cerebellar haemorrhage	58.94	13.53	36	75996	2884	79665472
Treatment failure	58.57	13.53	46	75986	170440	79497916
Activated partial thromboplastin time	58.32	13.53	12	76020	24	79668332
Oesophageal pain	57.70	13.53	41	75991	4238	79664118
Haemoperitoneum	57.15	13.53	41	75991	4302	79664054
Basal ganglia haemorrhage	56.74	13.53	29	76003	1642	79666714
Pruritus	56.68	13.53	190	75842	394458	79273898
Pancytopenia	56.59	13.53	45	75987	165700	79502656
Pulmonary alveolar haemorrhage	56.59	13.53	62	75970	11395	79656961
Ecchymosis	56.31	13.53	71	75961	15135	79653221
Syncope	56.07	13.53	327	75705	179122	79489234
Hepatic enzyme increased	55.82	13.53	55	75977	182555	79485801
Haemorrhage subcutaneous	55.62	13.53	42	75990	4767	79663589
Insomnia	55.17	13.53	93	75939	245077	79423279
Asthma	55.16	13.53	30	76002	135065	79533291
Haemoglobin abnormal	55.05	13.53	49	75983	7005	79661351
Internal haemorrhage	54.78	13.53	54	75978	8779	79659577
Swelling	54.72	13.53	76	75956	216635	79451721
Stress	54.71	13.53	6	76026	79606	79588750
Shock	54.33	13.53	125	75907	43423	79624933
Leukopenia	53.52	13.53	22	76010	116491	79551865
Back pain	53.50	13.53	133	75899	304047	79364309
International normalised ratio	53.41	13.53	14	76018	106	79668250
Urinary bladder haemorrhage	53.07	13.53	32	76000	2504	79665852
Retroperitoneal haemorrhage	52.94	13.53	43	75989	5427	79662929
Femoral neck fracture	52.77	13.53	56	75976	9928	79658428
Intracranial haematoma	52.54	13.53	23	76009	917	79667439
Gastritis erosive	52.36	13.53	58	75974	10789	79657567
Prothrombin time abnormal	52.06	13.53	24	76008	1082	79667274
Dyspepsia	51.62	13.53	223	75809	108464	79559892
Haemorrhage urinary tract	51.37	13.53	31	76001	2430	79665926
Cardiac ablation	51.25	13.53	30	76002	2223	79666133
Helicobacter infection	51.24	13.53	4	76028	69700	79598656
Colitis ischaemic	51.08	13.53	68	75964	15291	79653065
Diverticulum intestinal haemorrhagic	50.81	13.53	37	75995	3974	79664382
Gastric ulcer haemorrhage	50.15	13.53	52	75980	8975	79659381
Mobility decreased	50.07	13.53	27	76005	122148	79546208
Blister	49.55	13.53	26	76006	119450	79548906
Drug ineffective	49.46	13.53	730	75302	1080183	78588173
Haemodynamic instability	48.89	13.53	71	75961	17311	79651045
Injection site erythema	48.73	13.53	8	76024	78189	79590167
Rib fracture	48.68	13.53	92	75940	27855	79640501
Wound haemorrhage	47.37	13.53	36	75996	4125	79664231
Anorectal discomfort	47.31	13.53	34	75998	3577	79664779
Hypocoagulable state	47.15	13.53	28	76004	2131	79666225
Brain herniation	46.98	13.53	46	75986	7417	79660939
Paraesthesia	46.37	13.53	60	75972	176263	79492093
Neutrophil count decreased	46.06	13.53	16	76016	93943	79574413
Exsanguination	44.98	13.53	12	76020	98	79668258
Embolism arterial	44.85	13.53	24	76008	1494	79666862
Cerebellar infarction	44.74	13.53	33	75999	3614	79664742
Urticaria	44.73	13.53	67	75965	185134	79483222
Irritable bowel syndrome	44.58	13.53	4	76028	62237	79606119
Muscle spasms	44.38	13.53	61	75971	174669	79493687
Pain in extremity	44.21	13.53	188	75844	364350	79304006
C-reactive protein increased	44.08	13.53	35	75997	128992	79539364
Multiple organ dysfunction syndrome	43.48	13.53	228	75804	120018	79548338
Blood cholesterol increased	43.26	13.53	13	76019	83707	79584649
Therapy non-responder	43.09	13.53	17	76015	92288	79576068
Myalgia	43.08	13.53	69	75963	185572	79482784
Ischaemic cerebral infarction	43.01	13.53	28	76004	2507	79665849
Small intestinal haemorrhage	43	13.53	34	75998	4129	79664227
Pericarditis	42.76	13.53	23	76009	104213	79564143
Haemorrhagic cerebral infarction	42.63	13.53	23	76009	1456	79666900
Contusion	42.56	13.53	265	75767	148511	79519845
Infarction	42.21	13.53	35	75997	4547	79663809
Renal infarct	41.49	13.53	28	76004	2663	79665693
Hip fracture	41.39	13.53	91	75941	30670	79637686
Atrial flutter	41.20	13.53	74	75958	21551	79646805
Psoriasis	41.00	13.53	17	76015	89570	79578786
Subarachnoid haematoma	40.99	13.53	14	76018	281	79668075
Influenza	40.81	13.53	38	75994	129568	79538788
Subcutaneous haematoma	40.69	13.53	28	76004	2749	79665607
Mucosal inflammation	40.41	13.53	11	76021	75569	79592787
Musculoskeletal pain	39.96	13.53	24	76008	102330	79566026
Malignant neoplasm progression	39.25	13.53	43	75989	135947	79532409
Peritonitis	38.93	13.53	84	75948	27952	79640404
Oesophageal ulcer	38.43	13.53	40	75992	6935	79661421
Arthritis	38.20	13.53	32	76000	114848	79553508
Cardioversion	37.64	13.53	24	76008	2074	79666282
Thrombotic stroke	37.56	13.53	17	76015	734	79667622
Loss of personal independence in daily activities	37.39	13.53	26	76006	102554	79565802
Multiple injuries	37.08	13.53	29	76003	3466	79664890
Occult blood positive	37.07	13.53	39	75993	6844	79661512
Wheezing	36.97	13.53	34	75998	116630	79551726
Appendicitis	36.89	13.53	69	75963	20725	79647631
Wound secretion	36.84	13.53	37	75995	6151	79662205
Diverticulum	36.42	13.53	57	75975	14839	79653517
Intestinal infarction	36.35	13.53	20	76012	1316	79667040
Anticoagulation drug level abnormal	36.10	13.53	8	76024	26	79668330
Wound	35.48	13.53	35	75997	116144	79552212
Skin haemorrhage	35.25	13.53	50	75982	11931	79656425
Therapeutic response decreased	35.24	13.53	10	76022	66843	79601513
Erythema	35.19	13.53	103	75929	223187	79445169
Upper respiratory tract infection	34.72	13.53	22	76010	91146	79577210
Herpes zoster	34.72	13.53	23	76009	93060	79575296
Blood glucose increased	34.70	13.53	35	75997	114940	79553416
Pelvic fracture	34.54	13.53	50	75982	12154	79656202
Anticoagulant-related nephropathy	34.35	13.53	9	76023	68	79668288
Agitation	34.12	13.53	27	76005	99688	79568668
Aortic aneurysm	33.79	13.53	41	75991	8405	79659951
Cholecystitis acute	33.63	13.53	52	75980	13399	79654957
Impaired healing	33.60	13.53	21	76011	87634	79580722
Anaphylactic reaction	33.59	13.53	19	76013	83724	79584632
Sleep disorder	33.57	13.53	20	76012	85657	79582699
Alanine aminotransferase increased	33.57	13.53	65	75967	162505	79505851
Hemianopia homonymous	33.56	13.53	19	76013	1322	79667034
Catheter site haemorrhage	33.07	13.53	32	76000	5085	79663271
Conjunctival haemorrhage	32.97	13.53	34	75998	5831	79662525
Blood pressure increased	32.94	13.53	98	75934	211262	79457094
Coagulation time shortened	32.89	13.53	13	76019	399	79667957
Nasal congestion	32.73	13.53	16	76016	76536	79591820
Inappropriate schedule of product administration	32.59	13.53	48	75984	133580	79534776
Prothrombin time shortened	32.56	13.53	26	76006	3202	79665154
Arterial thrombosis	32.36	13.53	24	76008	2650	79665706
Influenza like illness	32.19	13.53	14	76018	71693	79596663
Anticoagulation drug level above therapeutic	32.00	13.53	27	76005	3593	79664763
Weight decreased	31.89	13.53	203	75829	354995	79313361
COVID-19	31.73	13.53	64	75968	157610	79510746
Haematocrit decreased	31.60	13.53	129	75903	61183	79607173
Gastric ulcer	31.48	13.53	87	75945	33818	79634538
Cardiac failure congestive	31.43	13.53	238	75794	142164	79526192
Feeling hot	31.36	13.53	9	76023	59725	79608631
Ileus	31.34	13.53	74	75958	26137	79642219
Injection site swelling	31.27	13.53	4	76028	47128	79621228
Duodenal ulcer perforation	31.22	13.53	12	76020	66199	79602157
Thalamus haemorrhage	31.02	13.53	20	76012	1762	79666594
Facial paresis	31	13.53	32	76000	5494	79662862
Dysphagia	30.93	13.53	211	75821	121925	79546431
Atrial fibrillation	30.74	13.53	306	75726	197580	79470776
Gastric cancer	30.72	13.53	43	75989	10136	79658220
Somnolence	30.35	13.53	121	75911	238860	79429496
Drug ineffective for unapproved indication	30.28	13.53	6	76026	51232	79617124
Pulmonary contusion	30.26	13.53	9	76023	113	79668243
Myocardial infarction	30.20	13.53	288	75744	183841	79484515
Haemorrhagic diathesis	30.18	13.53	33	75999	6051	79662305
C-reactive protein abnormal	30.02	13.53	5	76027	48362	79619994
Lumbar puncture	29.99	13.53	10	76022	186	79668170
Cytomegalovirus infection	29.85	13.53	3	76029	42641	79625715
Haemarthrosis	29.66	13.53	32	76000	5780	79662576
Serotonin syndrome	29.45	13.53	4	76028	45023	79623333
Aortic thrombosis	29.44	13.53	19	76013	1676	79666680
Discoloured vomit	29.26	13.53	18	76014	1460	79666896
Hemianopia	29.11	13.53	19	76013	1709	79666647
Night sweats	28.97	13.53	7	76025	52088	79616268
Arterial haemorrhage	28.81	13.53	22	76010	2539	79665817
Hypoaesthesia	28.79	13.53	82	75950	179270	79489086
Thrombotic cerebral infarction	28.77	13.53	13	76019	559	79667797
Coronary artery embolism	28.67	13.53	11	76021	311	79668045
Oesophagitis	28.42	13.53	68	75964	24221	79644135
Prothrombin time ratio decreased	28.39	13.53	15	76017	910	79667446
Haemorrhoids	28.30	13.53	76	75956	29052	79639304
Mesenteric artery embolism	28.28	13.53	8	76024	83	79668273
Acute coronary syndrome	27.85	13.53	62	75970	21071	79647285
Disseminated intravascular coagulation	27.56	13.53	86	75946	35756	79632600
Diverticulitis intestinal haemorrhagic	27.47	13.53	12	76020	476	79667880
Gastrointestinal necrosis	27.28	13.53	30	76002	5535	79662821
Cardiogenic shock	27.25	13.53	95	75937	41819	79626537
NIH stroke scale abnormal	27.19	13.53	6	76026	19	79668337
Platelet count decreased	27.03	13.53	95	75937	194569	79473787
Lymphocyte count decreased	27.00	13.53	6	76026	47283	79621073
Oropharyngeal pain	26.94	13.53	39	75993	109314	79559042
Constipation	26.84	13.53	159	75873	282891	79385465
Femoral artery embolism	26.82	13.53	7	76025	52	79668304
Brain oedema	26.67	13.53	68	75964	25195	79643161
Colon neoplasm	26.67	13.53	14	76018	838	79667518
Rectal cancer	26.61	13.53	24	76008	3489	79664867
Post procedural stroke	26.50	13.53	8	76024	106	79668250
Mucosal haemorrhage	26.45	13.53	21	76011	2565	79665791
Arteriovenous malformation	26.38	13.53	18	76014	1743	79666613
Psychotic disorder	26.33	13.53	4	76028	41398	79626958
Bone marrow failure	26.28	13.53	8	76024	51099	79617257
Malaise	26.20	13.53	320	75712	489549	79178807
Incarcerated inguinal hernia	26.01	13.53	9	76023	188	79668168
Joint stiffness	25.84	13.53	4	76028	40826	79627530
Cerebral artery thrombosis	25.82	13.53	15	76017	1096	79667260
Drug dependence	25.78	13.53	4	76028	40765	79627591
Creatinine renal clearance	25.72	13.53	6	76026	26	79668330
Tremor	25.68	13.53	80	75952	170003	79498353
Lacunar infarction	25.61	13.53	30	76002	5927	79662429
Bronchitis	25.46	13.53	54	75978	130590	79537766
Aneurysm ruptured	25.18	13.53	14	76018	940	79667416
Sedation	25.15	13.53	9	76023	51886	79616470
Cardiac failure chronic	25.02	13.53	41	75991	11094	79657262
Anuria	24.86	13.53	59	75973	20904	79647452
Aspartate aminotransferase increased	24.83	13.53	60	75972	138581	79529775
Hydrocephalus	24.52	13.53	36	75996	8864	79659492
Neurologic neglect syndrome	24.30	13.53	21	76011	2886	79665470
Flushing	24.28	13.53	29	76003	88239	79580117
Duodenal ulcer haemorrhage	24.26	13.53	32	76000	7131	79661225
Coagulation factor increased	24.21	13.53	7	76025	79	79668277
Pneumonia aspiration	24.21	13.53	127	75905	66840	79601516
Gastritis haemorrhagic	23.86	13.53	20	76012	2637	79665719
Pelvic haematoma	23.83	13.53	13	76019	841	79667515
Inguinal hernia strangulated	23.83	13.53	4	76028	0	79668356
Injection site bruising	23.82	13.53	5	76027	40997	79627359
Hospitalisation	23.82	13.53	33	75999	94203	79574153
Migraine	23.80	13.53	29	76003	87464	79580892
Traumatic haematoma	23.72	13.53	18	76014	2058	79666298
Gastrointestinal angiodysplasia	23.70	13.53	14	76018	1055	79667301
Ill-defined disorder	23.61	13.53	17	76015	65858	79602498
Inflammation	23.53	13.53	33	75999	93720	79574636
Gastrointestinal motility disorder	23.33	13.53	29	76003	6093	79662263
Bone pain	23.30	13.53	12	76020	55730	79612626
Hypochromic anaemia	23.25	13.53	20	76012	2731	79665625
Vision blurred	23.04	13.53	41	75991	105857	79562499
Venous thrombosis	22.89	13.53	31	76001	7085	79661271
Monoparesis	22.77	13.53	22	76010	3489	79664867
Arterial injury	22.77	13.53	12	76020	724	79667632
Paresis	22.70	13.53	24	76008	4237	79664119
Multiple sclerosis relapse	22.67	13.53	8	76024	46525	79621831
Osteoarthritis	22.65	13.53	30	76002	87279	79581077
Feeling abnormal	22.57	13.53	77	75955	159122	79509234
Seizure	22.48	13.53	98	75934	188736	79479620
Spontaneous haematoma	22.41	13.53	15	76017	1407	79666949
Renal haemorrhage	22.39	13.53	18	76014	2238	79666118
Large intestine polyp	22.33	13.53	42	75990	12666	79655690
Hypothyroidism	22.32	13.53	11	76021	52381	79615975
Osteoma	22.15	13.53	7	76025	109	79668247
Femur fracture	22.07	13.53	84	75948	38568	79629788
Dry mouth	22.07	13.53	31	76001	87988	79580368
Gastrointestinal vascular malformation haemorrhagic	21.95	13.53	12	76020	780	79667576
Cytokine release syndrome	21.73	13.53	4	76028	35994	79632362
Spinal cord haematoma	21.63	13.53	9	76023	316	79668040
Gait disturbance	21.60	13.53	113	75919	207393	79460963
Hypotension	21.58	13.53	561	75471	439756	79228600
Skull fractured base	21.47	13.53	9	76023	322	79668034
Dyskinesia	21.30	13.53	8	76024	44765	79623591
Vaginal haemorrhage	21.27	13.53	57	75975	21760	79646596
Carotid artery occlusion	21.16	13.53	31	76001	7616	79660740
Thoracic haemorrhage	21.13	13.53	8	76024	218	79668138
Suicidal ideation	21.09	13.53	25	76007	76315	79592041
Hyperhidrosis	20.98	13.53	74	75958	151418	79516938
Vascular pseudoaneurysm	20.92	13.53	21	76011	3489	79664867
Angioedema	20.89	13.53	25	76007	76010	79592346
Pain in jaw	20.73	13.53	9	76023	46142	79622214
Oxygen saturation decreased	20.70	13.53	59	75973	128988	79539368
Haemochromatosis	20.70	13.53	14	76018	1336	79667020
Prothrombin time	20.68	13.53	5	76027	26	79668330
Blood pressure systolic increased	20.66	13.53	20	76012	66966	79601390
Red blood cell sedimentation rate increased	20.57	13.53	9	76023	45933	79622423
Hypertension	20.53	13.53	209	75823	330783	79337573
Facial paralysis	20.49	13.53	55	75977	21017	79647339
Ear infection	20.41	13.53	4	76028	34428	79633928
Neoplasm progression	20.34	13.53	12	76020	51670	79616686
Petechiae	20.32	13.53	54	75978	20511	79647845
Mesenteric haemorrhage	20.12	13.53	6	76026	76	79668280
Drug reaction with eosinophilia and systemic symptoms	20.02	13.53	19	76013	64225	79604131
Bacterial infection	19.94	13.53	3	76029	31277	79637079
Aortic intramural haematoma	19.89	13.53	7	76025	154	79668202
Occult blood	19.82	13.53	15	76017	1708	79666648
Osteonecrosis	19.78	13.53	3	76029	31092	79637264
Cardiac pacemaker insertion	19.70	13.53	26	76006	5796	79662560
Post procedural haematuria	19.69	13.53	8	76024	264	79668092
Intentional overdose	19.66	13.53	45	75987	105915	79562441
Full blood count abnormal	19.65	13.53	7	76025	40467	79627889
Candida infection	19.62	13.53	6	76026	38208	79630148
Urogenital haemorrhage	19.60	13.53	12	76020	965	79667391
Haemorrhagic infarction	19.46	13.53	11	76021	763	79667593
Polycystic liver disease	19.40	13.53	7	76025	166	79668190
Prescribed overdose	19.36	13.53	6	76026	37877	79630479
Splenic necrosis	19.17	13.53	7	76025	172	79668184
Liver function test increased	19.10	13.53	7	76025	39766	79628590
Renal embolism	19.09	13.53	7	76025	174	79668182
Respiratory tract haemorrhage	19.07	13.53	15	76017	1808	79666548
Pneumonitis	18.97	13.53	18	76014	60842	79607514
Blood creatine phosphokinase increased	18.95	13.53	21	76011	66069	79602287
Type 2 diabetes mellitus	18.87	13.53	16	76016	57106	79611250
Pneumocystis jirovecii pneumonia	18.81	13.53	4	76028	32504	79635852
Orthopaedic procedure	18.76	13.53	7	76025	183	79668173
Memory impairment	18.73	13.53	50	75982	111684	79556672
Coagulation factor V level decreased	18.71	13.53	10	76022	621	79667735
Pharyngeal haemorrhage	18.65	13.53	13	76019	1303	79667053
Prostatic specific antigen abnormal	18.61	13.53	9	76023	452	79667904
Mesenteric artery thrombosis	18.55	13.53	10	76022	632	79667724
Osteonecrosis of jaw	18.53	13.53	9	76023	43217	79625139
Productive cough	18.50	13.53	35	75997	88296	79580060
Retroperitoneal haematoma	18.46	13.53	24	76008	5273	79663083
Polyp	18.42	13.53	30	76002	8077	79660279
Splenic haematoma	18.37	13.53	8	76024	315	79668041
Haemoglobin	18.23	13.53	6	76026	107	79668249
Brain stem haemorrhage	18.18	13.53	14	76018	1636	79666720
Muscle haemorrhage	18.11	13.53	26	76006	6274	79662082
Dry skin	18.01	13.53	23	76009	67972	79600384
Splenic haemorrhage	17.66	13.53	10	76022	696	79667660
Encephalopathy	17.64	13.53	23	76009	67374	79600982
Putamen haemorrhage	17.64	13.53	9	76023	508	79667848
Drug eruption	17.57	13.53	10	76022	43925	79624431
Brain stem stroke	17.49	13.53	10	76022	709	79667647
Acute myeloid leukaemia	17.47	13.53	4	76028	30881	79637475
Adverse event	17.41	13.53	19	76013	60195	79608161
Heart rate decreased	17.39	13.53	25	76007	70291	79598065
Hot flush	17.37	13.53	16	76016	54861	79613495
Cardiac ventricular thrombosis	17.29	13.53	14	76018	1759	79666597
Ear pain	17.17	13.53	5	76027	32864	79635492
Cystitis	17.14	13.53	15	76017	52717	79615639
White blood cell count increased	17.06	13.53	28	76004	74605	79593751
Lacunar stroke	16.96	13.53	8	76024	380	79667976
Cardiac myxoma	16.93	13.53	6	76026	135	79668221
Ruptured cerebral aneurysm	16.91	13.53	9	76023	554	79667802
Dry eye	16.91	13.53	7	76025	36924	79631432
Circulatory collapse	16.89	13.53	76	75956	37592	79630764
Anticoagulation drug level below therapeutic	16.87	13.53	13	76019	1520	79666836
Bleeding time prolonged	16.64	13.53	12	76020	1269	79667087
Haemorrhagic disorder	16.54	13.53	13	76019	1565	79666791
Splenic cyst	16.53	13.53	7	76025	257	79668099
Aortic dissection rupture	16.51	13.53	5	76027	67	79668289
Blood pressure fluctuation	16.48	13.53	24	76008	67121	79601235
Cataract	16.46	13.53	21	76011	62099	79606257
Mouth ulceration	16.45	13.53	8	76024	38386	79629970
Diabetic ketoacidosis	16.40	13.53	6	76026	34116	79634240
Prescribed underdose	16.34	13.53	4	76028	29510	79638846
Electrocardiogram QT prolonged	16.27	13.53	39	75993	90347	79578009
Hepatotoxicity	16.22	13.53	15	76017	51337	79617019
Bursitis	16.08	13.53	7	76025	35837	79632519
Fungal infection	16.00	13.53	10	76022	41738	79626618
Gastritis	15.98	13.53	89	75943	47904	79620452
Aggression	15.96	13.53	15	76017	50943	79617413
Accidental exposure to product	15.93	13.53	5	76027	31317	79637039
Cerebellar haematoma	15.88	13.53	9	76023	627	79667729
Neuralgia	15.82	13.53	6	76026	33378	79634978
Brain stem infarction	15.81	13.53	14	76018	1987	79666369
Traumatic renal injury	15.79	13.53	3	76029	3	79668353
Knee arthroplasty	15.71	13.53	11	76021	43237	79625119
Thrombosis mesenteric vessel	15.70	13.53	6	76026	168	79668188
Intentional product misuse	15.64	13.53	43	75989	95122	79573234
Eye haemorrhage	15.62	13.53	31	76001	9726	79658630
High frequency ablation	15.60	13.53	7	76025	296	79668060
Irritability	15.57	13.53	10	76022	41134	79627222
Open globe injury	15.52	13.53	5	76027	83	79668273
Depressed mood	15.51	13.53	14	76018	48466	79619890
Eczema	15.34	13.53	10	76022	40808	79627548
Abdominal wall haematoma	15.33	13.53	21	76011	4852	79663504
Body temperature increased	15.23	13.53	12	76020	44408	79623948
Mechanical ileus	15.22	13.53	10	76022	909	79667447
Rhabdomyolysis	15.22	13.53	49	75983	103082	79565274
Rhinorrhoea	15.19	13.53	31	76001	76043	79592313
Abdominal wall haemorrhage	15.15	13.53	9	76023	685	79667671
Meningorrhagia	15.09	13.53	7	76025	320	79668036
Anti factor VIII antibody test	14.93	13.53	3	76029	5	79668351
Gastric occult blood positive	14.93	13.53	3	76029	5	79668351
Subdural hygroma	14.91	13.53	8	76024	501	79667855
Abdominal strangulated hernia	14.89	13.53	5	76027	95	79668261
Pharyngeal mass	14.87	13.53	7	76025	331	79668025
Abdominal discomfort	14.85	13.53	160	75872	250567	79417789
Facial nerve disorder	14.82	13.53	9	76023	713	79667643
Gastrointestinal disorder	14.80	13.53	63	75969	122142	79546214
Vessel puncture site haemorrhage	14.77	13.53	6	76026	198	79668158
Basilar artery occlusion	14.68	13.53	6	76026	201	79668155
Hallucination	14.65	13.53	38	75994	85707	79582649
Overdose	14.65	13.53	252	75780	183954	79484402
Death	14.60	13.53	670	75362	565844	79102512
Decreased appetite	14.60	13.53	234	75798	342184	79326172
Splenic embolism	14.55	13.53	6	76026	206	79668150
Gait inability	14.52	13.53	21	76011	58896	79609460
Quadrantanopia	14.49	13.53	6	76026	208	79668148
Muscle twitching	14.43	13.53	3	76029	24761	79643595
Intracranial mass	14.36	13.53	14	76018	2245	79666111
Hypertensive crisis	14.31	13.53	48	75984	20722	79647634
Contraindication to surgery	14.26	13.53	3	76029	7	79668349
Epidural haemorrhage	14.18	13.53	6	76026	220	79668136
Toxic epidermal necrolysis	14.11	13.53	13	76019	44568	79623788
Ascites	14.09	13.53	32	76000	75530	79592826
Oesophageal carcinoma	14.02	13.53	32	76000	11052	79657304
Basilar artery thrombosis	14.00	13.53	7	76025	378	79667978
Osteorrhagia	13.98	13.53	3	76029	8	79668348
Diabetes mellitus	13.97	13.53	34	75998	78356	79590000
Sinus tachycardia	13.92	13.53	9	76023	36899	79631457
Muscular weakness	13.82	13.53	93	75939	160636	79507720
Carotid arterial embolus	13.77	13.53	4	76028	46	79668310
Speech disorder	13.74	13.53	94	75938	54351	79614005
Vascular stent occlusion	13.73	13.53	6	76026	238	79668118
Venous thrombosis limb	13.71	13.53	19	76013	4438	79663918
Urethral haemorrhage	13.64	13.53	7	76025	400	79667956

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	anticoagulants
CHEBI has role	CHEBI:50266	Prodrugs
CHEBI has role	CHEBI:65232	thrombin inhibitors
CHEBI has role	CHEBI:77020	NAD(P)H:quinone oxidoreductase-2 inhibitors

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)

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

Bioactivity Summary:

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

External reference:

ID	Source
4030255	VUID
N0000181837	NUI
D07082	KEGG_DRUG
872728-81-9	SECONDARY_CAS_RN
1037041	RXNORM
4030254	VANDF
4030255	VANDF
C1571583	UMLSCUI
CHEBI:70746	CHEBI
CHEBI:70752	CHEBI
CHEMBL539697	ChEMBL_ID
CHEMBL1615369	ChEMBL_ID
CHEMBL48361	ChEMBL_ID
D000069604	MESH_DESCRIPTOR_UI
DB06695	DRUGBANK_ID
6379	IUPHAR_LIGAND_ID
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
8027	INN_ID
211914-51-1	SECONDARY_CAS_RN
216210	PUBCHEM_CID
6380	IUPHAR_LIGAND_ID
I0VM4M70GC	UNII

Pharmaceutical products:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Pradaxa	HUMAN PRESCRIPTION DRUG LABEL	1	0597-0108	CAPSULE	110 mg	ORAL	NDA	33 sections
Pradaxa	HUMAN PRESCRIPTION DRUG LABEL	1	0597-0108	CAPSULE	110 mg	ORAL	NDA	33 sections
Pradaxa	HUMAN PRESCRIPTION DRUG LABEL	1	0597-0355	CAPSULE	75 mg	ORAL	NDA	33 sections
Pradaxa	HUMAN PRESCRIPTION DRUG LABEL	1	0597-0355	CAPSULE	75 mg	ORAL	NDA	33 sections
Pradaxa	HUMAN PRESCRIPTION DRUG LABEL	1	0597-0360	CAPSULE	150 mg	ORAL	NDA	33 sections
Pradaxa	HUMAN PRESCRIPTION DRUG LABEL	1	0597-0360	CAPSULE	150 mg	ORAL	NDA	33 sections
Pradaxa	HUMAN PRESCRIPTION DRUG LABEL	1	0597-0425	PELLET	20 mg	ORAL	NDA	33 sections
Pradaxa	HUMAN PRESCRIPTION DRUG LABEL	1	0597-0425	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	0597-0430	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	0597-0435	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	0597-0440	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	0597-0445	PELLET	110 mg	ORAL	NDA	33 sections
Pradaxa	HUMAN PRESCRIPTION DRUG LABEL	1	0597-0450	PELLET	150 mg	ORAL	NDA	33 sections
Pradaxa	HUMAN PRESCRIPTION DRUG LABEL	1	0597-0450	PELLET	150 mg	ORAL	NDA	33 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	31722-621	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	31722-622	CAPSULE	150 mg	ORAL	ANDA	28 sections
Pradaxa	HUMAN PRESCRIPTION DRUG LABEL	1	50090-3617	CAPSULE	150 mg	ORAL	NDA	32 sections
Pradaxa	HUMAN PRESCRIPTION DRUG LABEL	1	50090-4480	CAPSULE	150 mg	ORAL	NDA	32 sections
Pradaxa	HUMAN PRESCRIPTION DRUG LABEL	1	50090-4480	CAPSULE	150 mg	ORAL	NDA	32 sections
Dabigatran Etexilate	HUMAN PRESCRIPTION DRUG LABEL	1	60687-744	CAPSULE	75 mg	ORAL	ANDA	28 sections
Dabigatran Etexilate	HUMAN PRESCRIPTION DRUG LABEL	1	60687-752	CAPSULE	150 mg	ORAL	ANDA	28 sections
Pradaxa	HUMAN PRESCRIPTION DRUG LABEL	1	63629-8242	CAPSULE	150 mg	ORAL	NDA	32 sections
Dabigatran Etexilate	Human Prescription Drug Label	1	67877-474	CAPSULE, COATED PELLETS	75 mg	ORAL	ANDA	28 sections