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

Stem definitionDrug idCAS RN
blood coagulation factor XA inhibitors, antithrombotics 4182 366789-02-8

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • xarelto
  • rivaroxaban
  • BAY 59-7939
A morpholine and thiophene derivative that functions as a FACTOR XA INHIBITOR and is used in the treatment and prevention of DEEP-VEIN THROMBOSIS and PULMONARY EMBOLISM. It is also used for the prevention of STROKE and systemic embolization in patients with non-valvular ATRIAL FIBRILLATION, and for the prevention of atherothrombotic events in patients after an ACUTE CORONARY SYNDROME.
  • Molecular weight: 435.88
  • Formula: C19H18ClN3O5S
  • CLOGP: 2.39
  • LIPINSKI: 0
  • HAC: 8
  • HDO: 1
  • TPSA: 88.18
  • ALOGS: -4.64
  • ROTB: 5
  • Status: ONP
    • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

DoseUnitRoute
20 mg O

ADMET properties:

PropertyValueReference
Vd (Volume of distribution) 0.70 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 2.40 mL/min/kg Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma) 0.06 % Lombardo F, Berellini G, Obach RS
t_half (Half-life) 7 hours Lombardo F, Berellini G, Obach RS

Approvals:

DateAgencyCompanyOrphan
Jan. 18, 2012 PMDA Bayer Yakuhin, Ltd.
July 1, 2011 FDA JANSSEN PHARMS
Sept. 30, 2008 EMA BAYER PHARMA AG

FDA Adverse Event Reporting System (Female)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Gastrointestinal haemorrhage 5871.39 10.72 2991 119375 72960 56096741
Pulmonary embolism 2544.45 10.72 1999 120367 105125 56064576
Deep vein thrombosis 2091.22 10.72 1557 120809 75420 56094281
Ischaemic stroke 1310.08 10.72 668 121698 16174 56153527
Haemorrhage 1245.74 10.72 1010 121356 55387 56114314
Cerebral haemorrhage 1134.44 10.72 731 121635 27875 56141826
Cerebrovascular accident 1122.05 10.72 1225 121141 98045 56071656
Epistaxis 1028.84 10.72 976 121390 66047 56103654
Thrombosis 863.89 10.72 840 121526 58587 56111114
Upper gastrointestinal haemorrhage 859.74 10.72 508 121858 16546 56153155
Haemorrhage intracranial 835.34 10.72 451 121915 12304 56157397
Haematuria 756.35 10.72 557 121809 26430 56143271
Heavy menstrual bleeding 744.97 10.72 455 121911 15754 56153947
Rectal haemorrhage 698.00 10.72 636 121730 40831 56128870
Haematoma 657.47 10.72 550 121816 31469 56138232
Vaginal haemorrhage 655.17 10.72 501 121865 25172 56144529
Haemoglobin decreased 648.12 10.72 1095 121271 133042 56036659
Cerebral infarction 604.83 10.72 453 121913 22052 56147649
Melaena 578.84 10.72 485 121881 27805 56141896
Rheumatoid arthritis 539.39 10.72 92 122274 382512 55787189
Lower gastrointestinal haemorrhage 535.36 10.72 277 122089 6910 56162791
Anaemia 523.68 10.72 1518 120848 265993 55903708
Embolic stroke 464.13 10.72 203 122163 3430 56166271
Haemorrhagic stroke 451.29 10.72 225 122141 5178 56164523
Atrial fibrillation 435.67 10.72 819 121547 108078 56061623
Internal haemorrhage 376.20 10.72 191 122175 4573 56165128
Haematochezia 372.11 10.72 467 121899 43251 56126450
Subdural haematoma 352.16 10.72 267 122099 13232 56156469
Synovitis 309.16 10.72 9 122357 161296 56008405
Blood loss anaemia 292.16 10.72 197 122169 8100 56161601
Infusion related reaction 283.71 10.72 55 122311 208876 55960825
Incorrect dose administered 277.56 10.72 447 121919 52100 56117601
Hand deformity 275.96 10.72 3 122363 134489 56035212
Atrial thrombosis 273.03 10.72 109 122257 1446 56168255
Systemic lupus erythematosus 272.46 10.72 35 122331 180043 55989658
Haemoptysis 272.39 10.72 312 122054 26248 56143453
Pain 271.65 10.72 656 121710 662528 55507173
Glossodynia 267.32 10.72 16 122350 152442 56017259
Therapeutic product effect decreased 258.63 10.72 32 122334 169420 56000281
Drug intolerance 254.53 10.72 129 122237 264689 55905012
Intraventricular haemorrhage 249.37 10.72 109 122257 1838 56167863
Pericardial haemorrhage 247.76 10.72 101 122265 1419 56168282
Haemarthrosis 240.23 10.72 122 122244 2922 56166779
International normalised ratio increased 239.93 10.72 380 121986 43661 56126040
Haematemesis 234.84 10.72 301 122065 28457 56141244
Faeces discoloured 222.21 10.72 227 122139 16769 56152932
Post procedural haemorrhage 220.49 10.72 159 122207 7290 56162411
Haemorrhoidal haemorrhage 209.66 10.72 122 122244 3854 56165847
Labelled drug-drug interaction medication error 205.22 10.72 183 122183 11403 56158298
Diverticulum intestinal haemorrhagic 201.01 10.72 83 122283 1207 56168494
Arthropathy 200.83 10.72 92 122274 200183 55969518
Maternal exposure during pregnancy 199.73 10.72 81 122285 189472 55980229
Shock haemorrhagic 199.58 10.72 162 122204 8871 56160830
Joint swelling 195.56 10.72 205 122161 289595 55880106
Fall 191.63 10.72 1381 120985 356129 55813572
Haemorrhagic arteriovenous malformation 186.65 10.72 47 122319 104 56169597
Transient ischaemic attack 186.03 10.72 292 122074 33285 56136416
Arthralgia 181.58 10.72 527 121839 501142 55668559
Gingival bleeding 177.00 10.72 169 122197 11497 56158204
Product prescribing issue 169.32 10.72 82 122284 1767 56167934
Cerebral haematoma 167.42 10.72 99 122267 3224 56166477
Subarachnoid haemorrhage 165.78 10.72 161 122205 11186 56158515
Hemiplegia 165.48 10.72 141 122225 8263 56161438
Discomfort 163.90 10.72 52 122314 141709 56027992
Basal ganglia haemorrhage 161.90 10.72 57 122309 519 56169182
Hypersensitivity 159.17 10.72 194 122172 256214 55913487
Uterine haemorrhage 159.08 10.72 98 122268 3442 56166259
Drug hypersensitivity 154.76 10.72 224 122142 274981 55894720
Alopecia 153.41 10.72 251 122115 293207 55876494
Wound 148.32 10.72 58 122308 138746 56030955
Blood urine present 147.07 10.72 164 122202 13391 56156310
Contraindicated product administered 146.79 10.72 114 122252 186172 55983529
Pericarditis 144.97 10.72 30 122336 108893 56060808
Dyspnoea exertional 144.88 10.72 348 122018 54341 56115360
Subcutaneous haematoma 141.72 10.72 69 122297 1505 56168196
Cerebellar haemorrhage 138.76 10.72 64 122302 1231 56168470
Treatment failure 138.45 10.72 101 122265 170291 55999410
Embolic cerebral infarction 133.71 10.72 48 122318 465 56169236
Abdominal wall haematoma 133.06 10.72 80 122286 2687 56167014
Rheumatoid factor positive 131.71 10.72 4 122362 69056 56100645
Drug interaction 131.03 10.72 842 121524 208913 55960788
Swelling 131.03 10.72 199 122167 239572 55930129
Iron deficiency anaemia 129.98 10.72 177 122189 17742 56151959
Cardiac failure 124.25 10.72 427 121939 81666 56088035
Muscle haemorrhage 122.71 10.72 78 122288 2897 56166804
Musculoskeletal stiffness 122.21 10.72 96 122270 155911 56013790
Hemiparesis 120.57 10.72 188 122178 21302 56148399
Mouth haemorrhage 117.13 10.72 103 122263 6298 56163403
Prothrombin time prolonged 116.60 10.72 120 122246 8940 56160761
Condition aggravated 115.51 10.72 375 121991 344523 55825178
Haemorrhagic transformation stroke 113.91 10.72 54 122312 1108 56168593
Pyrexia 113.84 10.72 496 121870 418277 55751424
Infection 113.42 10.72 162 122204 200044 55969657
Dyspnoea 112.82 10.72 1860 120506 590717 55578984
Toxicity to various agents 111.83 10.72 198 122168 224366 55945335
Thalamus haemorrhage 111.04 10.72 45 122321 622 56169079
Hepatic enzyme increased 109.12 10.72 127 122239 171257 55998444
Folliculitis 101.98 10.72 4 122362 54975 56114726
Creatinine renal clearance decreased 101.36 10.72 141 122225 14418 56155283
Subdural haemorrhage 100.82 10.72 68 122298 2796 56166905
Sinusitis 96.74 10.72 176 122190 197405 55972296
Product prescribing error 95.80 10.72 177 122189 23009 56146692
Gastrointestinal vascular malformation haemorrhagic 95.60 10.72 30 122336 183 56169518
Anxiety 94.65 10.72 172 122194 193000 55976701
Exposure during pregnancy 94.60 10.72 94 122272 136248 56033453
Embolism venous 94.04 10.72 65 122301 2783 56166918
Muscle injury 93.53 10.72 5 122361 52495 56117206
Haemorrhage urinary tract 92.50 10.72 42 122324 778 56168923
Gastric ulcer haemorrhage 91.47 10.72 78 122288 4575 56165126
Psoriatic arthropathy 91.29 10.72 24 122342 73984 56095717
Retroperitoneal haemorrhage 91.09 10.72 62 122304 2588 56167113
Duodenal ulcer haemorrhage 89.36 10.72 58 122308 2234 56167467
Abdominal discomfort 88.98 10.72 307 122059 276967 55892734
Depression 88.57 10.72 160 122206 179957 55989744
Cerebral artery embolism 87.75 10.72 40 122326 748 56168953
Eye haemorrhage 85.22 10.72 95 122271 7752 56161949
Irritable bowel syndrome 84.82 10.72 22 122344 68436 56101265
Hospitalisation 84.43 10.72 355 122011 74645 56095056
Post procedural haematoma 84.04 10.72 45 122321 1205 56168496
Drug ineffective 83.34 10.72 1453 120913 917536 55252165
Embolism 83.17 10.72 91 122275 7273 56162428
Splenic rupture 82.01 10.72 44 122322 1183 56168518
Extradural haematoma 81.47 10.72 48 122318 1552 56168149
Impaired healing 80.78 10.72 44 122322 86797 56082904
Acute kidney injury 80.73 10.72 839 121527 239924 55929777
Gastric haemorrhage 80.56 10.72 81 122285 5869 56163832
Postmenopausal haemorrhage 80.55 10.72 52 122314 1984 56167717
Injection site erythema 80.04 10.72 34 122332 77414 56092287
Mobility decreased 79.94 10.72 59 122307 98932 56070769
Stomatitis 79.62 10.72 87 122279 120723 56048978
Drug abuse 79.54 10.72 24 122342 67586 56102115
Renal impairment 79.45 10.72 367 121999 80346 56089355
Small intestinal haemorrhage 78.77 10.72 51 122315 1956 56167745
Activated partial thromboplastin time prolonged 78.69 10.72 84 122282 6528 56163173
Haemorrhage subcutaneous 78.67 10.72 58 122308 2752 56166949
Venous thrombosis 78.45 10.72 71 122295 4509 56165192
Pulmonary thrombosis 78.33 10.72 92 122274 7945 56161756
Cerebral artery occlusion 78.25 10.72 38 122328 824 56168877
Blister 77.93 10.72 73 122293 108814 56060887
Helicobacter infection 75.98 10.72 32 122334 73236 56096465
Peripheral embolism 75.63 10.72 41 122325 1126 56168575
Renal haemorrhage 75.21 10.72 37 122329 826 56168875
Injection site reaction 74.37 10.72 13 122353 53234 56116467
Wound haemorrhage 73.88 10.72 52 122314 2293 56167408
Blood cholesterol increased 73.20 10.72 33 122333 72546 56097155
Cerebral ischaemia 72.96 10.72 78 122288 6072 56163629
Nasopharyngitis 72.66 10.72 242 122124 220717 55948984
Coagulopathy 72.50 10.72 139 122227 18577 56151124
Weight increased 71.87 10.72 257 122109 229446 55940255
Pulmonary arterial hypertension 71.62 10.72 170 122196 26333 56143368
Abnormal uterine bleeding 70.86 10.72 41 122325 1281 56168420
Transfusion 67.26 10.72 112 122254 13408 56156293
Ill-defined disorder 66.31 10.72 33 122333 68510 56101191
Pulmonary hypertension 66.17 10.72 200 122166 35744 56133957
Anticoagulation drug level increased 65.99 10.72 22 122344 167 56169534
Treatment noncompliance 65.29 10.72 187 122179 32436 56137265
Injection site pain 65.06 10.72 96 122270 117022 56052679
Completed suicide 64.77 10.72 120 122246 133713 56035988
Cerebral ventricular rupture 64.34 10.72 22 122344 182 56169519
Therapeutic product effect incomplete 63.83 10.72 82 122284 105949 56063752
Loss of personal independence in daily activities 63.77 10.72 50 122316 81319 56088382
Gastric ulcer 63.44 10.72 147 122219 22416 56147285
Therapeutic response decreased 63.39 10.72 18 122348 52740 56116961
Febrile neutropenia 63.15 10.72 82 122284 105463 56064238
Haemothorax 61.68 10.72 44 122322 1982 56167719
Intracardiac thrombus 61.54 10.72 46 122320 2229 56167472
Venous thrombosis limb 61.25 10.72 50 122316 2759 56166942
Adrenal haemorrhage 60.88 10.72 26 122340 413 56169288
Underdose 60.56 10.72 149 122217 23608 56146093
Gastritis haemorrhagic 60.51 10.72 38 122328 1381 56168320
Spinal cord haematoma 59.74 10.72 20 122346 154 56169547
Haematoma muscle 59.66 10.72 33 122333 944 56168757
Incision site haemorrhage 58.98 10.72 27 122339 510 56169191
Intestinal haemorrhage 58.84 10.72 54 122312 3492 56166209
Dizziness 57.97 10.72 1143 121223 374997 55794704
Oedema peripheral 57.92 10.72 598 121768 170656 55999045
Occult blood positive 57.50 10.72 52 122314 3299 56166402
Sedation 57.19 10.72 5 122361 34849 56134852
Pericardial effusion 56.56 10.72 158 122208 27017 56142684
Retinal haemorrhage 56.54 10.72 60 122306 4631 56165070
Gastrointestinal disorder 56.37 10.72 99 122267 112603 56057098
Product use issue 56.29 10.72 211 122155 185830 55983871
Pregnancy 56.27 10.72 4 122362 33029 56136672
Brain stem haemorrhage 56.11 10.72 29 122337 721 56168980
Ecchymosis 55.87 10.72 89 122277 10267 56159434
Inflammation 54.69 10.72 42 122324 69029 56100672
Psoriasis 54.44 10.72 73 122293 92619 56077082
Rash 54.09 10.72 751 121615 492296 55677405
Intra-abdominal haemorrhage 53.99 10.72 43 122323 2290 56167411
Splenic haemorrhage 53.11 10.72 19 122347 182 56169519
Cerebral mass effect 52.86 10.72 29 122337 816 56168885
Salpingo-oophorectomy unilateral 52.47 10.72 27 122339 665 56169036
Traumatic intracranial haemorrhage 51.81 10.72 23 122343 403 56169298
Hypovolaemic shock 51.52 10.72 61 122305 5312 56164389
Cerebellar infarction 51.15 10.72 38 122328 1824 56167877
Type 2 diabetes mellitus 50.99 10.72 19 122347 46843 56122858
Pulmonary haemorrhage 50.70 10.72 68 122298 6715 56162986
Urinary bladder haemorrhage 50.45 10.72 30 122336 987 56168714
Fatigue 50.42 10.72 1318 121048 787234 55382467
Duodenal ulcer 49.36 10.72 69 122297 7086 56162615
Cardioversion 49.28 10.72 31 122335 1130 56168571
Pharyngeal haemorrhage 49.27 10.72 24 122342 524 56169177
Anaphylactic reaction 49.14 10.72 34 122332 58961 56110740
Lower respiratory tract infection 48.70 10.72 111 122255 114683 56055018
Head injury 48.53 10.72 142 122224 24924 56144777
Prothrombin time shortened 48.30 10.72 36 122330 1737 56167964
Large intestinal haemorrhage 47.62 10.72 31 122335 1200 56168501
Multiple sclerosis relapse 47.54 10.72 19 122347 44884 56124817
Product monitoring error 46.66 10.72 47 122319 3412 56166289
Microcytic anaemia 45.96 10.72 45 122321 3157 56166544
Glomerular filtration rate decreased 45.84 10.72 90 122276 12239 56157462
Vascular pseudoaneurysm 45.56 10.72 32 122334 1406 56168295
Cardiac failure chronic 45.48 10.72 50 122316 4017 56165684
Suicidal ideation 44.59 10.72 36 122330 57706 56111995
Sinusitis fungal 43.41 10.72 32 122334 1518 56168183
Neutropenia 43.04 10.72 187 122179 157980 56011721
Spontaneous haematoma 42.64 10.72 25 122341 801 56168900
Fibromyalgia 42.58 10.72 40 122326 59563 56110138
Hypertension 42.31 10.72 334 122032 243944 55925757
Device related thrombosis 42.27 10.72 32 122334 1581 56168120
Pallor 42.24 10.72 132 122234 24017 56145684
Retroperitoneal haematoma 42.23 10.72 40 122326 2693 56167008
Contusion 41.30 10.72 444 121922 127986 56041715
Anovulatory cycle 41.10 10.72 15 122351 153 56169548
Injection site pruritus 40.83 10.72 20 122346 41911 56127790
Injury 40.65 10.72 42 122324 59809 56109892
Syncope 40.52 10.72 386 121980 107813 56061888
Procedural haemorrhage 40.43 10.72 38 122328 2533 56167168
Haemorrhagic cerebral infarction 40.13 10.72 22 122344 618 56169083
Arterial haemorrhage 39.87 10.72 31 122335 1594 56168107
Intra-abdominal haematoma 39.05 10.72 31 122335 1643 56168058
Labelled drug-disease interaction medication error 38.96 10.72 14 122352 136 56169565
High frequency ablation 38.78 10.72 14 122352 138 56169563
Fluid retention 38.67 10.72 225 122141 53853 56115848
Sputum increased 38.51 10.72 34 122332 2090 56167611
Pelvic venous thrombosis 38.50 10.72 29 122337 1422 56168279
Peripheral ischaemia 38.46 10.72 48 122318 4415 56165286
Conjunctival haemorrhage 38.34 10.72 41 122325 3192 56166509
Foetal exposure during pregnancy 38.01 10.72 13 122353 33810 56135891
Traumatic haematoma 37.71 10.72 28 122338 1343 56168358
Peripheral artery thrombosis 37.43 10.72 31 122335 1746 56167955
Aphasia 37.40 10.72 148 122218 30267 56139434
Retinal artery occlusion 37.00 10.72 29 122337 1509 56168192
Pulmonary alveolar haemorrhage 36.97 10.72 46 122320 4218 56165483
Hypervolaemia 36.88 10.72 134 122232 26324 56143377
Hepatotoxicity 36.74 10.72 11 122355 31142 56138559
C-reactive protein abnormal 36.70 10.72 17 122349 36792 56132909
Injection site swelling 36.45 10.72 25 122341 43553 56126148
Subgaleal haematoma 35.94 10.72 11 122355 61 56169640
Coagulation factor X level increased 35.93 10.72 7 122359 0 56169701
Joint stiffness 35.88 10.72 16 122350 35409 56134292
Traumatic haemorrhage 35.75 10.72 19 122347 501 56169200
Death 35.66 10.72 983 121383 340443 55829258
Potentiating drug interaction 35.47 10.72 44 122322 4022 56165679
C-reactive protein increased 35.08 10.72 74 122292 78610 56091091
Herpes zoster 35.00 10.72 70 122296 75819 56093882
Gastritis erosive 34.40 10.72 51 122315 5526 56164175
Insomnia 34.30 10.72 260 122106 191600 55978101
Abdominal wall haemorrhage 34.27 10.72 13 122353 149 56169552
Respiratory symptom 34.19 10.72 36 122330 2754 56166947
Gastrointestinal angiodysplasia 33.78 10.72 17 122349 399 56169302
Spinal cord haemorrhage 33.51 10.72 14 122352 210 56169491
Seizure 33.38 10.72 149 122217 124970 56044731
Diverticulum 33.22 10.72 74 122292 10992 56158709
Rectal polyp 33.11 10.72 24 122342 1109 56168592
Nasal polyps 32.86 10.72 38 122328 3227 56166474
Bradycardia 32.70 10.72 255 122111 67249 56102452
Gastrointestinal ulcer haemorrhage 32.57 10.72 19 122347 603 56169098
Cardiac tamponade 32.52 10.72 44 122322 4382 56165319
Skin haemorrhage 31.99 10.72 62 122304 8351 56161350
Cerebral thrombosis 31.96 10.72 27 122339 1563 56168138
Right ventricular failure 31.91 10.72 93 122273 16286 56153415
Mesenteric artery embolism 31.61 10.72 7 122359 6 56169695
Sleep disorder 31.55 10.72 62 122304 67601 56102100
Ischaemic cerebral infarction 31.07 10.72 24 122342 1222 56168479
Asthenia 30.77 10.72 969 121397 342004 55827697
Polyp 30.60 10.72 50 122316 5892 56163809
Dry eye 30.53 10.72 20 122346 35696 56134005
Drug dependence 30.39 10.72 6 122360 22527 56147174
Ear haemorrhage 30.22 10.72 24 122342 1273 56168428
Oesophageal haemorrhage 29.88 10.72 17 122349 514 56169187
Cerebral artery thrombosis 29.65 10.72 15 122351 356 56169345
Atrial flutter 29.44 10.72 63 122303 9106 56160595
Hypersensitivity vasculitis 29.37 10.72 40 122326 4008 56165693
Prescribed underdose 29.23 10.72 105 122261 20512 56149189
Arrhythmia 29.12 10.72 152 122214 34931 56134770
Irritability 28.98 10.72 14 122352 29574 56140127
Creatinine renal clearance abnormal 28.95 10.72 15 122351 375 56169326
Menometrorrhagia 28.90 10.72 20 122346 858 56168843
Renal infarct 28.88 10.72 24 122342 1358 56168343
Foot deformity 28.86 10.72 8 122358 23817 56145884
Purpura 28.57 10.72 67 122299 10295 56159406
Chest wall haematoma 28.48 10.72 12 122354 184 56169517
Cardiac pacemaker insertion 28.34 10.72 38 122328 3752 56165949
Petechiae 28.31 10.72 77 122289 12962 56156739
Red blood cell sedimentation rate increased 28.07 10.72 23 122343 36600 56133101
Basal cell carcinoma 27.82 10.72 10 122356 25211 56144490
Alanine aminotransferase increased 27.80 10.72 107 122259 93555 56076146
Emotional distress 27.78 10.72 15 122351 29748 56139953
Haematoma infection 27.62 10.72 17 122349 596 56169105
Presyncope 27.16 10.72 119 122247 25463 56144238
International normalised ratio abnormal 27.14 10.72 33 122333 2955 56166746
Brain herniation 26.99 10.72 35 122331 3345 56166356
Therapeutic response increased 26.98 10.72 14 122352 351 56169350
Urticaria 26.83 10.72 194 122172 144482 56025219
Gastrointestinal polyp haemorrhage 26.64 10.72 11 122355 160 56169541
Injection site rash 26.34 10.72 3 122363 16955 56152746
Cytomegalovirus infection 26.32 10.72 5 122361 19291 56150410
Therapy non-responder 26.27 10.72 59 122307 61296 56108405
Premature delivery 26.21 10.72 13 122353 27047 56142654
Arterial thrombosis 25.83 10.72 22 122344 1288 56168413
Fibrin D dimer increased 25.81 10.72 40 122326 4507 56165194
Coagulation time prolonged 25.64 10.72 21 122345 1164 56168537
Toxic epidermal necrolysis 25.60 10.72 8 122358 22034 56147667
Agitation 25.57 10.72 52 122314 55984 56113717
Muscle spasticity 25.52 10.72 6 122360 19954 56149747
Haemoperitoneum 25.45 10.72 30 122336 2600 56167101
Cerebral vascular occlusion 25.32 10.72 6 122360 9 56169692
Intentional product use issue 25.27 10.72 121 122245 99612 56070089
Cardiac ablation 25.02 10.72 22 122344 1345 56168356
Bradyarrhythmia 24.89 10.72 26 122340 1970 56167731
Arthritis 24.80 10.72 122 122244 99730 56069971
Periorbital haematoma 24.57 10.72 17 122349 729 56168972
Chills 24.56 10.72 127 122239 102477 56067224
Hysterectomy 24.18 10.72 56 122310 8535 56161166
Ear pain 24.17 10.72 19 122347 30871 56138830
Premature baby 24.11 10.72 6 122360 19199 56150502
Migraine 23.97 10.72 102 122264 86695 56083006
Aggression 23.81 10.72 9 122357 21997 56147704
Brain stem infarction 23.75 10.72 17 122349 770 56168931
Oral herpes 23.72 10.72 10 122356 22880 56146821
Aortic valve calcification 23.70 10.72 14 122352 455 56169246
Arterial injury 23.64 10.72 11 122355 216 56169485
Mood swings 23.58 10.72 4 122362 16743 56152958
Female genital tract fistula 23.40 10.72 38 122328 4454 56165247
Pruritus 23.17 10.72 518 121848 316105 55853596
Haemorrhagic erosive gastritis 22.98 10.72 12 122354 305 56169396
Normochromic normocytic anaemia 22.94 10.72 37 122329 4312 56165389
Drug resistance 22.90 10.72 8 122358 20534 56149167
Crying 22.81 10.72 9 122357 21431 56148270
Inappropriate schedule of product administration 22.62 10.72 279 122087 83108 56086593
Stress 22.59 10.72 60 122306 58850 56110851
Peritoneal haematoma 22.52 10.72 8 122358 75 56169626
Diverticulitis intestinal haemorrhagic 22.50 10.72 9 122357 120 56169581
Ear infection 22.35 10.72 21 122345 31274 56138427
Orthopnoea 22.28 10.72 43 122323 5773 56163928
Catheter management 22.15 10.72 29 122337 2797 56166904
Osteopenia 22.14 10.72 6 122360 18135 56151566
Urethral haemorrhage 22.13 10.72 7 122359 44 56169657
Somnolence 21.97 10.72 238 122128 163175 56006526
Product administration error 21.95 10.72 97 122269 20832 56148869
Multiple sclerosis 21.88 10.72 17 122349 27785 56141916
Hypercoagulation 21.87 10.72 24 122342 1924 56167777
Peripheral artery occlusion 21.64 10.72 19 122347 1159 56168542
Prosthetic cardiac valve thrombosis 21.61 10.72 6 122360 22 56169679
Intracranial haematoma 21.51 10.72 12 122354 349 56169352
Haemoglobin abnormal 21.39 10.72 37 122329 4567 56165134
Pelvic haemorrhage 21.36 10.72 9 122357 138 56169563
Hypochromic anaemia 21.26 10.72 23 122343 1815 56167886
Heart rate irregular 21.05 10.72 95 122271 20584 56149117
Oropharyngeal pain 21.03 10.72 102 122264 83686 56086015
Thrombocytosis 20.98 10.72 40 122326 5322 56164379
Retinal vein thrombosis 20.89 10.72 13 122353 465 56169236
Arrhythmogenic right ventricular dysplasia 20.81 10.72 6 122360 26 56169675
Spontaneous haemorrhage 20.70 10.72 11 122355 290 56169411
Suicide attempt 20.62 10.72 61 122305 57775 56111926
Orthostatic heart rate response increased 20.53 10.72 4 122362 0 56169701
Aspartate aminotransferase increased 20.47 10.72 101 122265 82501 56087200
Protein S deficiency 20.45 10.72 6 122360 28 56169673
Cognitive disorder 20.43 10.72 48 122318 49085 56120616
Central nervous system haemorrhage 20.31 10.72 9 122357 157 56169544
Bursitis 20.31 10.72 18 122348 27564 56142137
Bone marrow failure 20.18 10.72 19 122347 28267 56141434
Abnormal withdrawal bleeding 20.12 10.72 6 122360 30 56169671
Drug withdrawal syndrome 20.11 10.72 16 122350 25841 56143860
Intentional overdose 20.09 10.72 78 122288 68039 56101662
Mucosal haemorrhage 20.02 10.72 17 122349 991 56168710
Antiphospholipid syndrome 20.01 10.72 21 122345 1600 56168101
Paraplegia 20.00 10.72 26 122340 2491 56167210
Rheumatoid nodule 19.94 10.72 4 122362 14853 56154848
Chest pain 19.92 10.72 547 121819 189250 55980451
Hypoaesthesia 19.86 10.72 204 122162 141287 56028414
Liver injury 19.81 10.72 38 122328 41810 56127891
Rhinorrhoea 19.74 10.72 61 122305 56976 56112725
Diastolic dysfunction 19.54 10.72 40 122326 5605 56164096
Urogenital haemorrhage 19.52 10.72 10 122356 244 56169457
Chronic gastritis 19.51 10.72 26 122340 2552 56167149
Erythema 19.43 10.72 231 122135 155708 56013993
Confusional state 19.34 10.72 327 122039 207828 55961873
Vascular stent thrombosis 19.21 10.72 16 122350 908 56168793
Peripheral coldness 19.08 10.72 60 122306 10951 56158750
Catheter site discharge 19.07 10.72 22 122344 1863 56167838
Body temperature increased 19.07 10.72 28 122338 34214 56135487
Putamen haemorrhage 19.06 10.72 9 122357 183 56169518
Anal haemorrhage 19.00 10.72 22 122344 1871 56167830
Post procedural pulmonary embolism 18.80 10.72 10 122356 264 56169437
Quadriplegia 18.80 10.72 21 122345 1717 56167984
Injection site warmth 18.78 10.72 4 122362 14239 56155462
Platelet aggregation inhibition 18.68 10.72 8 122358 128 56169573
Mesenteric haemorrhage 18.67 10.72 6 122360 40 56169661
Ulcer haemorrhage 18.61 10.72 30 122336 3495 56166206
Knee arthroplasty 18.59 10.72 43 122323 44216 56125485
Pulmonary endarterectomy 18.57 10.72 8 122358 130 56169571
Therapeutic procedure 18.54 10.72 15 122351 817 56168884
Tonic clonic movements 18.51 10.72 18 122348 1252 56168449
Lipase increased 18.48 10.72 52 122314 8927 56160774
Haemorrhagic infarction 18.37 10.72 10 122356 277 56169424
Prescribed overdose 18.37 10.72 13 122353 22283 56147418
Breast haematoma 18.33 10.72 9 122357 200 56169501
Gastric pH increased 18.29 10.72 6 122360 43 56169658
Coagulation test abnormal 18.21 10.72 14 122352 708 56168993
Subcapsular renal haematoma 18.17 10.72 10 122356 283 56169418
Overdose 18.15 10.72 145 122221 105685 56064016
Generalised tonic-clonic seizure 17.98 10.72 20 122346 27546 56142155
Protein C deficiency 17.87 10.72 5 122361 19 56169682
Thrombotic stroke 17.78 10.72 12 122354 494 56169207
Gait disturbance 17.74 10.72 249 122117 163072 56006629
Carotid artery occlusion 17.66 10.72 25 122341 2598 56167103
Cholestatic liver injury 17.48 10.72 23 122343 2229 56167472
Sinus tachycardia 17.32 10.72 14 122352 22430 56147271
Emergency care 17.28 10.72 15 122351 901 56168800
Hypotension 17.28 10.72 687 121679 249821 55919880
Change of bowel habit 17.26 10.72 22 122344 2067 56167634
Drug tolerance decreased 17.21 10.72 4 122362 13407 56156294
Contraindicated product prescribed 17.18 10.72 16 122350 1054 56168647
Mallory-Weiss syndrome 17.18 10.72 18 122348 1369 56168332
Grip strength decreased 17.01 10.72 7 122359 16249 56153452
Anastomotic ulcer haemorrhage 17.01 10.72 6 122360 55 56169646
Post procedural stroke 17.01 10.72 6 122360 55 56169646
Product dose omission issue 16.90 10.72 573 121793 204180 55965521
Neuralgia 16.81 10.72 16 122350 23679 56146022
Neutrophil count decreased 16.73 10.72 54 122312 49768 56119933
Antineutrophil cytoplasmic antibody positive 16.72 10.72 12 122354 546 56169155
Photophobia 16.65 10.72 7 122359 16043 56153658
Influenza like illness 16.64 10.72 72 122294 60916 56108785
Meningorrhagia 16.64 10.72 7 122359 107 56169594
Incorrect dosage administered 16.62 10.72 20 122346 1771 56167930
Osteomyelitis 16.62 10.72 17 122349 24329 56145372
Haemorrhagic diathesis 16.62 10.72 31 122335 4057 56165644
Full blood count decreased 16.59 10.72 97 122269 23252 56146449
Pain in jaw 16.58 10.72 146 122220 39890 56129811
Intentional self-injury 16.45 10.72 18 122348 24974 56144727
Abortion spontaneous 16.44 10.72 45 122321 43708 56125993
Arteriovenous malformation 16.20 10.72 17 122349 1295 56168406
Oesophagitis haemorrhagic 16.16 10.72 11 122355 459 56169242
Intervertebral disc protrusion 16.16 10.72 14 122352 21680 56148021
Myelosuppression 16.00 10.72 9 122357 17446 56152255
Cardiac failure acute 15.98 10.72 49 122317 8824 56160877
Duodenal polyp 15.96 10.72 7 122359 119 56169582
Traumatic fracture 15.94 10.72 12 122354 588 56169113
Cerebellar haematoma 15.89 10.72 10 122356 365 56169336
Intermenstrual bleeding 15.76 10.72 42 122324 6985 56162716
Anticoagulant therapy 15.73 10.72 5 122361 32 56169669
Ventricle rupture 15.73 10.72 5 122361 32 56169669
Spinal subdural haematoma 15.70 10.72 7 122359 124 56169577
Mania 15.68 10.72 3 122363 11517 56158184
Cerebral ventricle collapse 15.60 10.72 5 122361 33 56169668
Haemorrhagic hepatic cyst 15.60 10.72 5 122361 33 56169668
Intracranial aneurysm 15.57 10.72 27 122339 3340 56166361
Chronic gastrointestinal bleeding 15.55 10.72 7 122359 127 56169574
Catheter site erythema 15.48 10.72 30 122336 4040 56165661
Procedural pain 15.48 10.72 8 122358 16263 56153438
Malignant neoplasm progression 15.48 10.72 95 122271 73492 56096209
Monoparesis 15.48 10.72 18 122348 1538 56168163
Medical device site haemorrhage 15.47 10.72 5 122361 34 56169667
CHA2DS2-VASc annual stroke risk high 15.40 10.72 3 122363 0 56169701
Right hemisphere deficit syndrome 15.40 10.72 3 122363 0 56169701
Contraindication to surgery 15.40 10.72 3 122363 0 56169701
Dystonia 15.36 10.72 4 122362 12417 56157284
Toothache 15.30 10.72 10 122356 17870 56151831
Coagulation factor VIII level increased 15.27 10.72 4 122362 11 56169690
Breast cancer female 15.21 10.72 4 122362 12334 56157367
Osteoarthritis 15.20 10.72 107 122259 80189 56089512
Tricuspid valve incompetence 15.11 10.72 63 122303 13190 56156511
Hepatic steatosis 15.03 10.72 21 122345 26193 56143508
Tenderness 15.02 10.72 13 122353 20142 56149559
Injection site bruising 14.94 10.72 39 122327 38482 56131219
Pulmonary artery thrombosis 14.94 10.72 12 122354 647 56169054
Craniocerebral injury 14.91 10.72 23 122343 2581 56167120
Post procedural discharge 14.87 10.72 10 122356 409 56169292
Blood pressure increased 14.84 10.72 224 122142 144952 56024749
Sciatica 14.75 10.72 21 122345 25989 56143712
White blood cell count increased 14.69 10.72 49 122317 44710 56124991
Tumour haemorrhage 14.67 10.72 17 122349 1447 56168254
Mucosal inflammation 14.66 10.72 46 122320 42764 56126937
Lymphocyte count decreased 14.46 10.72 24 122342 27915 56141786
Incorrect route of product administration 14.44 10.72 15 122351 21314 56148387
Dyspnoea at rest 14.38 10.72 28 122338 3785 56165916
Post procedural haematuria 14.35 10.72 5 122361 44 56169657
Vena cava thrombosis 14.34 10.72 20 122346 2049 56167652
Glomerular filtration rate 14.33 10.72 4 122362 15 56169686
Night sweats 14.31 10.72 44 122322 41169 56128532
Respiratory tract haemorrhage 14.31 10.72 10 122356 436 56169265
Jaundice acholuric 14.30 10.72 6 122360 91 56169610
Swelling face 14.21 10.72 68 122298 56001 56113700
Leukopenia 14.19 10.72 93 122273 70847 56098854
Retinal ischaemia 14.19 10.72 9 122357 333 56169368
Metabolic acidosis 14.18 10.72 43 122323 40411 56129290
Vulval haemorrhage 14.13 10.72 4 122362 16 56169685
Thrombectomy 14.00 10.72 7 122359 162 56169539
Thrombophlebitis 14.00 10.72 29 122337 4098 56165603
Hypercholesterolaemia 13.94 10.72 7 122359 14466 56155235
Brain compression 13.90 10.72 9 122357 345 56169356
Autoimmune nephritis 13.90 10.72 9 122357 345 56169356
Pulmonary haematoma 13.88 10.72 5 122361 49 56169652
Bleeding varicose vein 13.85 10.72 8 122358 249 56169452
Throat tightness 13.82 10.72 17 122349 22390 56147311
Exsanguination 13.75 10.72 4 122362 18 56169683
Chondrocalcinosis 13.68 10.72 11 122355 594 56169107
Sensitisation 13.68 10.72 21 122345 2347 56167354
Tenosynovitis 13.64 10.72 5 122361 12456 56157245
Hip arthroplasty 13.58 10.72 41 122325 38582 56131119
Respiratory arrest 13.48 10.72 29 122337 30596 56139105
Respiratory disorder 13.46 10.72 34 122332 33923 56135778
Blood blister 13.45 10.72 18 122348 1774 56167927
Blood glucose increased 13.34 10.72 102 122264 75049 56094652
Mesenteric haematoma 13.33 10.72 3 122363 3 56169698
Manufacturing materials issue 13.33 10.72 3 122363 3 56169698
Cor pulmonale acute 13.32 10.72 9 122357 371 56169330
Splenic haematoma 13.32 10.72 6 122360 109 56169592
Catheter site pruritus 13.28 10.72 19 122347 1993 56167708
Degenerative mitral valve disease 13.25 10.72 4 122362 21 56169680
Thrombotic cerebral infarction 13.22 10.72 6 122360 111 56169590
Depressed mood 13.22 10.72 38 122328 36321 56133380
Lacunar stroke 13.07 10.72 6 122360 114 56169587
Affect lability 13.03 10.72 3 122363 10122 56159579
Tremor 13.01 10.72 185 122181 120904 56048797
Peripheral arterial occlusive disease 13.00 10.72 27 122339 3823 56165878
Retinal artery embolism 12.97 10.72 5 122361 60 56169641
Uveitis 12.93 10.72 4 122362 11091 56158610
Venous haemorrhage 12.91 10.72 8 122358 284 56169417
Abnormal behaviour 12.91 10.72 15 122351 20257 56149444
Post thrombotic syndrome 12.90 10.72 10 122356 512 56169189
Hypoglycaemia 12.84 10.72 70 122296 55745 56113956
Epidural haemorrhage 12.80 10.72 6 122360 120 56169581
Aortic intramural haematoma 12.75 10.72 5 122361 63 56169638
Intentional product misuse 12.74 10.72 63 122303 51441 56118260
Blood calcium decreased 12.69 10.72 20 122346 23749 56145952
Influenza 12.69 10.72 139 122227 95122 56074579
Vascular operation 12.62 10.72 6 122360 124 56169577
Pelvic haematoma 12.61 10.72 10 122356 529 56169172
Pharyngitis 12.59 10.72 13 122353 18525 56151176
Injection site urticaria 12.59 10.72 6 122360 12777 56156924
Serotonin syndrome 12.58 10.72 24 122342 26466 56143235
Extra dose administered 12.57 10.72 33 122333 5440 56164261
Intracranial mass 12.53 10.72 14 122352 1145 56168556
Withdrawal syndrome 12.48 10.72 13 122353 18449 56151252
Palpitations 12.43 10.72 294 122072 99378 56070323
Psychotic disorder 12.41 10.72 20 122346 23538 56146163
Vascular purpura 12.41 10.72 15 122351 1335 56168366
Myoclonus 12.34 10.72 9 122357 15194 56154507
White blood cell count decreased 12.33 10.72 196 122170 125794 56043907
Brain contusion 12.32 10.72 10 122356 547 56169154
Aortic thrombosis 12.24 10.72 13 122353 1004 56168697
Blindness unilateral 12.24 10.72 33 122333 5527 56164174
Investigation 12.23 10.72 16 122350 1542 56168159
Cardiac ventricular thrombosis 12.18 10.72 10 122356 556 56169145
Incision site haematoma 12.15 10.72 5 122361 72 56169629
Spinal cord compression 12.15 10.72 26 122340 3758 56165943
Colon cancer 12.14 10.72 47 122319 9514 56160187
Vascular device infection 12.12 10.72 33 122333 5557 56164144
Lymphostasis 12.12 10.72 3 122363 6 56169695
Osteorrhagia 12.12 10.72 3 122363 6 56169695
Panic attack 12.10 10.72 16 122350 20431 56149270
Muscle spasms 12.05 10.72 218 122148 137153 56032548
Blood pressure fluctuation 12.04 10.72 46 122320 40314 56129387
Infective pericardial effusion 12.04 10.72 4 122362 30 56169671
Basilar artery thrombosis 12.03 10.72 6 122360 138 56169563
Soft tissue haemorrhage 11.97 10.72 7 122359 223 56169478
Anaemia macrocytic 11.96 10.72 23 122343 3080 56166621
Catheter site bruise 11.92 10.72 8 122358 326 56169375
Neuroleptic malignant syndrome 11.92 10.72 5 122361 11473 56158228
Viral infection 11.90 10.72 33 122333 31913 56137788
Anaphylactic shock 11.89 10.72 18 122348 21722 56147979
Emphysema 11.83 10.72 48 122318 9928 56159773
Ovarian cyst 11.81 10.72 9 122357 14857 56154844
Laryngeal haemorrhage 11.80 10.72 3 122363 7 56169694
Colitis ischaemic 11.71 10.72 48 122318 9972 56159729
Hiatus hernia 11.69 10.72 78 122288 19574 56150127
Infarction 11.67 10.72 20 122346 2451 56167250
Therapeutic response shortened 11.65 10.72 3 122363 9383 56160318
Brain natriuretic peptide abnormal 11.63 10.72 8 122358 340 56169361
Nodule 11.61 10.72 14 122352 18605 56151096
Non-small cell lung cancer recurrent 11.56 10.72 5 122361 82 56169619
Bladder disorder 11.49 10.72 41 122325 7983 56161718
Muscle twitching 11.48 10.72 11 122355 16231 56153470
Postoperative thrombosis 11.47 10.72 6 122360 153 56169548
Degenerative aortic valve disease 11.45 10.72 5 122361 84 56169617
Cerebral amyloid angiopathy 11.44 10.72 6 122360 154 56169547
Tracheal haemorrhage 11.37 10.72 6 122360 156 56169545
Headache 11.31 10.72 1054 121312 557990 55611711
Osteonecrosis of jaw 11.31 10.72 36 122330 33322 56136379
Throat irritation 11.27 10.72 35 122331 32648 56137053
Lactic acidosis 11.25 10.72 122 122244 35224 56134477
Stevens-Johnson syndrome 11.24 10.72 20 122346 22643 56147058
Hypercalcaemia 11.24 10.72 24 122342 25387 56144314
Mydriasis 11.21 10.72 5 122361 11066 56158635
Acute respiratory distress syndrome 11.19 10.72 19 122347 21907 56147794
Catheter site haemorrhage 11.18 10.72 22 122344 2996 56166705
Accidental exposure to product 11.13 10.72 23 122343 24624 56145077
Lymphopenia 11.13 10.72 12 122354 16762 56152939
Mesenteric artery thrombosis 11.13 10.72 6 122360 163 56169538
Cerebellar ischaemia 11.12 10.72 4 122362 39 56169662
Sleep disorder due to a general medical condition 11.11 10.72 3 122363 9087 56160614
Bone density decreased 11.10 10.72 7 122359 12753 56156948
Pseudomonas infection 11.09 10.72 4 122362 10067 56159634
Shock 11.03 10.72 83 122283 21645 56148056
Status epilepticus 11.00 10.72 10 122356 15131 56154570
Carpal tunnel syndrome 10.94 10.72 14 122352 18130 56151571
Hepatic infarction 10.94 10.72 10 122356 643 56169058
Device expulsion 10.94 10.72 32 122334 30417 56139284
Stoma site haemorrhage 10.90 10.72 12 122354 966 56168735
Coordination abnormal 10.88 10.72 7 122359 12614 56157087
Contraindication to medical treatment 10.83 10.72 10 122356 652 56169049
Nerve injury 10.82 10.72 3 122363 8934 56160767
Breast cancer 10.82 10.72 62 122304 48771 56120930
Neurotoxicity 10.82 10.72 11 122355 15784 56153917
Computerised tomogram head abnormal 10.80 10.72 3 122363 11 56169690
Disability 10.79 10.72 11 122355 15769 56153932
Peptostreptococcus infection 10.77 10.72 4 122362 43 56169658
Anger 10.72 10.72 6 122360 11666 56158035

FDA Adverse Event Reporting System (Male)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Gastrointestinal haemorrhage 4726.41 11.53 3215 112809 79334 31501986
Deep vein thrombosis 1860.29 11.53 1636 114388 59100 31522220
Haemorrhage 1496.66 11.53 1299 114725 46035 31535285
Haematuria 1395.92 11.53 1237 114787 45077 31536243
Pulmonary embolism 1292.14 11.53 1541 114483 80105 31501215
Epistaxis 1137.33 11.53 1181 114843 52526 31528794
Cerebral haemorrhage 1100.60 11.53 932 115092 31880 31549440
Haemorrhage intracranial 977.35 11.53 637 115387 14451 31566869
Ischaemic stroke 913.96 11.53 639 115385 16332 31564988
Cerebrovascular accident 855.45 11.53 1242 114782 78242 31503078
Upper gastrointestinal haemorrhage 844.58 11.53 691 115333 22492 31558828
Cerebral infarction 746.46 11.53 676 115348 25301 31556019
Rectal haemorrhage 629.31 11.53 719 115305 35585 31545735
Thrombosis 605.04 11.53 785 115239 44366 31536954
Haematoma 604.53 11.53 582 115442 23557 31557763
Atrial thrombosis 567.60 11.53 231 115793 1826 31579494
Melaena 544.51 11.53 634 115390 32020 31549300
Lower gastrointestinal haemorrhage 504.91 11.53 343 115681 8346 31572974
Subdural haematoma 496.98 11.53 469 115555 18502 31562818
Haemorrhagic stroke 482.68 11.53 292 115732 5778 31575542
Embolic stroke 428.70 11.53 235 115789 3828 31577492
Gastric haemorrhage 405.44 11.53 315 115709 9490 31571830
Internal haemorrhage 392.47 11.53 231 115793 4337 31576983
Post procedural haemorrhage 373.50 11.53 273 115751 7485 31573835
Haemoptysis 348.43 11.53 505 115519 31684 31549636
Transient ischaemic attack 324.70 11.53 420 115604 23636 31557684
Blood loss anaemia 321.34 11.53 249 115775 7470 31573850
Anaemia 300.98 11.53 1558 114466 211964 31369356
Atrial fibrillation 256.93 11.53 957 115067 112826 31468494
Diverticulum intestinal haemorrhagic 251.59 11.53 134 115890 2054 31579266
Blood urine present 248.68 11.53 242 115782 9915 31571405
Drug abuse 243.34 11.53 21 116003 87737 31493583
Haemoglobin decreased 243.07 11.53 934 115090 111741 31469579
Haemarthrosis 243.00 11.53 145 115879 2794 31578526
Basal ganglia haemorrhage 239.93 11.53 96 115928 722 31580598
Gingival bleeding 232.32 11.53 193 115831 6408 31574912
Pericardial haemorrhage 231.79 11.53 142 115882 2875 31578445
Haemorrhagic arteriovenous malformation 217.53 11.53 73 115951 307 31581013
Toxicity to various agents 215.68 11.53 208 115816 181279 31400041
Haematochezia 210.97 11.53 461 115563 40003 31541317
Pyrexia 207.69 11.53 508 115516 303332 31277988
Labelled drug-drug interaction medication error 206.69 11.53 248 115776 12915 31568405
Fall 202.59 11.53 1268 114756 184821 31396499
Shock haemorrhagic 192.29 11.53 211 115813 9966 31571354
Cerebral haematoma 185.59 11.53 143 115881 4252 31577068
Incorrect dose administered 184.86 11.53 406 115618 35346 31545974
Febrile neutropenia 172.91 11.53 117 115907 121732 31459588
Cerebellar haemorrhage 172.70 11.53 91 115933 1363 31579957
Embolic cerebral infarction 170.06 11.53 70 115954 571 31580749
Thalamus haemorrhage 169.66 11.53 79 115945 891 31580429
Haemorrhoidal haemorrhage 160.32 11.53 115 115909 3058 31578262
Intraventricular haemorrhage 158.31 11.53 113 115911 2981 31578339
Haematemesis 148.41 11.53 305 115719 25348 31555972
Procedural haemorrhage 147.63 11.53 97 115927 2227 31579093
Subarachnoid haemorrhage 144.30 11.53 183 115841 10088 31571232
Contusion 144.24 11.53 351 115673 32677 31548643
Cerebral artery embolism 141.72 11.53 67 115957 784 31580536
Faeces discoloured 141.44 11.53 211 115813 13575 31567745
Product prescribing issue 132.84 11.53 79 115945 1512 31579808
International normalised ratio increased 132.23 11.53 415 115609 44808 31536512
Neutropenia 128.37 11.53 197 115827 140167 31441153
Gastrointestinal vascular malformation haemorrhagic 128.02 11.53 56 115968 539 31580781
Foetal exposure during pregnancy 127.72 11.53 5 116019 40871 31540449
Wound haemorrhage 126.41 11.53 81 115943 1779 31579541
Hemiplegia 124.61 11.53 138 115886 6584 31574736
Creatinine renal clearance decreased 122.22 11.53 98 115926 3091 31578229
Gastric ulcer haemorrhage 119.69 11.53 119 115905 5004 31576316
Cardioversion 112.34 11.53 58 115966 831 31580489
Hemiparesis 111.98 11.53 198 115826 14696 31566624
Mouth haemorrhage 109.00 11.53 112 115912 4900 31576420
Iron deficiency anaemia 108.79 11.53 152 115872 9207 31572113
Cardiac tamponade 107.87 11.53 110 115914 4769 31576551
Subcutaneous haematoma 106.30 11.53 57 115967 886 31580434
Sepsis 101.90 11.53 256 115768 151673 31429647
Disease progression 100.12 11.53 110 115914 90354 31490966
Condition aggravated 99.02 11.53 291 115733 163718 31417602
Retroperitoneal haemorrhage 97.10 11.53 81 115943 2704 31578616
Intracardiac thrombus 96.23 11.53 75 115949 2268 31579052
Haemorrhage urinary tract 94.54 11.53 66 115958 1679 31579641
Haemorrhagic transformation stroke 94.47 11.53 61 115963 1358 31579962
Depression 93.44 11.53 117 115907 90698 31490622
Muscle haemorrhage 91 11.53 86 115938 3394 31577926
Anticoagulation drug level increased 90.17 11.53 42 115982 474 31580846
Anxiety 88.83 11.53 122 115902 90911 31490409
Rheumatoid arthritis 87.03 11.53 33 115991 47776 31533544
Subdural haemorrhage 86.89 11.53 78 115946 2879 31578441
Cerebral ventricular rupture 84.57 11.53 30 115994 154 31581166
Splenic rupture 83.17 11.53 57 115967 1406 31579914
Completed suicide 83.06 11.53 129 115895 91385 31489935
Drug hypersensitivity 82.86 11.53 86 115938 72513 31508807
Haemothorax 78.84 11.53 81 115943 3543 31577777
Traumatic intracranial haemorrhage 78.64 11.53 41 115983 600 31580720
Prescribed underdose 78.27 11.53 122 115902 8156 31573164
Infusion related reaction 78.23 11.53 39 115985 48016 31533304
High frequency ablation 77.80 11.53 28 115996 151 31581169
Abdominal wall haematoma 75.87 11.53 57 115967 1630 31579690
Aphasia 75.73 11.53 201 115823 19730 31561590
Microcytic anaemia 75.26 11.53 62 115962 2033 31579287
Small intestinal haemorrhage 73.60 11.53 60 115964 1938 31579382
Occult blood positive 73.59 11.53 80 115944 3737 31577583
Pelvic venous thrombosis 73.31 11.53 37 115987 504 31580816
Renal haemorrhage 72.32 11.53 51 115973 1319 31580001
Agitation 71.56 11.53 56 115968 54113 31527207
Mucosal inflammation 71.12 11.53 19 116005 34408 31546912
Prothrombin time prolonged 70.91 11.53 123 115901 8989 31572331
Seizure 70.88 11.53 163 115861 99605 31481715
Haemorrhagic diathesis 70.06 11.53 66 115958 2594 31578726
Large intestinal haemorrhage 69.37 11.53 52 115972 1482 31579838
Brain stem haemorrhage 68.82 11.53 42 115982 844 31580476
Drug interaction 67.21 11.53 1104 114920 207439 31373881
Traumatic haemorrhage 65.56 11.53 37 115987 639 31580681
Nausea 65.47 11.53 767 115257 307180 31274140
Neutrophil count decreased 65.12 11.53 45 115979 46349 31534971
Haemorrhage subcutaneous 64.85 11.53 58 115966 2130 31579190
Drug dependence 63.65 11.53 5 116019 22574 31558746
Gastric ulcer 63.30 11.53 155 115869 14479 31566841
Post procedural haematoma 62.75 11.53 48 115976 1411 31579909
Head injury 62.28 11.53 167 115857 16491 31564829
Rhabdomyolysis 62.21 11.53 85 115939 63496 31517824
Spinal cord haemorrhage 61.55 11.53 28 115996 298 31581022
Aggression 59.60 11.53 31 115993 37260 31544060
Duodenal ulcer haemorrhage 59.56 11.53 80 115944 4666 31576654
Pulmonary alveolar haemorrhage 58.86 11.53 96 115928 6670 31574650
Coagulopathy 58.83 11.53 175 115849 18340 31562980
Pulmonary haemorrhage 58.77 11.53 117 115907 9498 31571822
Pancytopenia 58.57 11.53 147 115877 87169 31494151
Psoriasis 58.37 11.53 51 115973 46668 31534652
Therapeutic response decreased 57.93 11.53 13 116011 26496 31554824
Gastrointestinal ulcer haemorrhage 57.56 11.53 33 115991 588 31580732
Overdose 57.20 11.53 142 115882 84522 31496798
Bladder tamponade 56.65 11.53 30 115994 454 31580866
Tremor 55.77 11.53 123 115901 76297 31505023
Adrenal haemorrhage 55.62 11.53 23 116001 190 31581130
Haemorrhagic cerebral infarction 55.25 11.53 35 115989 753 31580567
Gastritis haemorrhagic 54.01 11.53 43 115981 1342 31579978
Insomnia 53.79 11.53 173 115851 94663 31486657
Inappropriate schedule of product administration 53.61 11.53 344 115680 50479 31530841
N-terminal prohormone brain natriuretic peptide abnormal 53.18 11.53 22 116002 182 31581138
Malignant neoplasm progression 52.97 11.53 133 115891 78865 31502455
Gastrointestinal polyp haemorrhage 52.69 11.53 25 115999 295 31581025
Eye haemorrhage 52.00 11.53 68 115956 3864 31577456
Gastritis erosive 51.77 11.53 82 115942 5557 31575763
Penile haemorrhage 51.64 11.53 31 115993 604 31580716
Bone marrow failure 51.52 11.53 19 116005 27989 31553331
Urogenital haemorrhage 51.15 11.53 30 115994 559 31580761
Drug withdrawal syndrome 50.55 11.53 5 116019 18745 31562575
Aspartate aminotransferase increased 49.95 11.53 96 115928 62623 31518697
Vomiting 49.80 11.53 552 115472 223421 31357899
Compartment syndrome 49.79 11.53 55 115969 2616 31578704
Hyponatraemia 49.67 11.53 124 115900 73675 31507645
Prostatic haemorrhage 49.47 11.53 22 116002 221 31581099
Peripheral embolism 49.35 11.53 36 115988 983 31580337
Cardiac failure 49.22 11.53 506 115518 85447 31495873
Product prescribing error 49.10 11.53 171 115853 19471 31561849
Urinary bladder haemorrhage 48.88 11.53 44 115980 1630 31579690
Multiple organ dysfunction syndrome 48.76 11.53 111 115913 68092 31513228
Cerebral ischaemia 48.46 11.53 82 115942 5873 31575447
Leukopenia 48.28 11.53 86 115938 57742 31523578
Arterial haemorrhage 48.26 11.53 33 115991 811 31580509
Dyspnoea exertional 48.03 11.53 274 115750 38563 31542757
Suicidal ideation 47.62 11.53 38 115986 36368 31544952
Cytomegalovirus infection 46.75 11.53 16 116008 24691 31556629
Psychotic disorder 46.62 11.53 12 116012 22281 31559039
Drug intolerance 46.56 11.53 74 115950 51959 31529361
Infection 46.07 11.53 150 115874 81781 31499539
Deep vein thrombosis postoperative 45.99 11.53 11 116013 6 31581314
Asthma 45.81 11.53 53 115971 42558 31538762
Chills 45.81 11.53 130 115894 74020 31507300
Treatment noncompliance 45.80 11.53 201 115823 25483 31555837
Cerebral ventricle collapse 45.69 11.53 15 116009 58 31581262
Somnolence 44.95 11.53 199 115825 99246 31482074
Pain 44.85 11.53 452 115572 186307 31395013
Embolism venous 44.64 11.53 39 115985 1388 31579932
Pneumonia 44.05 11.53 915 115109 334397 31246923
Alanine aminotransferase increased 43.86 11.53 134 115890 74522 31506798
Cerebellar infarction 43.48 11.53 43 115981 1796 31579524
White blood cell count decreased 43.16 11.53 169 115855 87229 31494091
Neutrophil count increased 42.93 11.53 4 116020 15727 31565593
Hypochromic anaemia 42.87 11.53 30 115994 766 31580554
Ecchymosis 42.48 11.53 81 115943 6369 31574951
Ischaemic cerebral infarction 42.37 11.53 35 115989 1152 31580168
Dizziness 42.28 11.53 990 115034 198157 31383163
Cardiac ablation 41.76 11.53 32 115992 943 31580377
Fractional exhaled nitric oxide increased 41.66 11.53 27 115997 605 31580715
Death 41.66 11.53 1004 115020 359565 31221755
White blood cell count increased 41.40 11.53 49 115975 38951 31542369
Vascular stent thrombosis 41.31 11.53 51 115973 2734 31578586
Haemorrhagic erosive gastritis 41.08 11.53 18 116006 174 31581146
Myoglobin blood increased 41.07 11.53 48 115976 2429 31578891
Duodenal ulcer 40.73 11.53 102 115922 9662 31571658
Retinal vascular thrombosis 40.61 11.53 14 116010 65 31581255
Retroperitoneal haematoma 40.14 11.53 48 115976 2489 31578831
Conjunctival haemorrhage 40.04 11.53 50 115974 2712 31578608
Haematoma muscle 39.80 11.53 34 115990 1173 31580147
Therapy non-responder 39.76 11.53 39 115985 33772 31547548
Lymphocyte count decreased 39.72 11.53 13 116011 20636 31560684
Irritability 39.69 11.53 17 116007 22872 31558448
Neurotoxicity 39.65 11.53 6 116018 16220 31565100
Wound haematoma 39.65 11.53 13 116011 50 31581270
Injection site pain 39.52 11.53 41 115983 34593 31546727
Vascular pseudoaneurysm 39.18 11.53 43 115981 2030 31579290
Hypovolaemic shock 38.74 11.53 78 115946 6384 31574936
Activated partial thromboplastin time prolonged 38.68 11.53 90 115934 8135 31573185
No adverse event 38.38 11.53 12 116012 19613 31561707
Anticoagulation drug level above therapeutic 38.36 11.53 41 115983 1878 31579442
Pericardial effusion 38.11 11.53 173 115851 22250 31559070
Splenic haemorrhage 38.08 11.53 22 116002 398 31580922
Venous thrombosis 38.03 11.53 53 115971 3202 31578118
Peptic ulcer haemorrhage 37.96 11.53 23 116001 456 31580864
Blood glucose increased 37.79 11.53 107 115917 60976 31520344
Ear haemorrhage 37.66 11.53 29 115995 861 31580459
Cerebral mass effect 37.26 11.53 29 115995 875 31580445
Spontaneous haematoma 37.17 11.53 23 116001 474 31580846
Vitreous haemorrhage 37.15 11.53 43 115981 2153 31579167
Brain natriuretic peptide increased 36.87 11.53 65 115959 4811 31576509
Peripheral swelling 36.71 11.53 395 115629 67470 31513850
Diabetes mellitus 36.69 11.53 62 115962 42494 31538826
Hypoxia 36.68 11.53 81 115943 50232 31531088
Skin haemorrhage 36.45 11.53 58 115966 3946 31577374
Loss of personal independence in daily activities 36.40 11.53 30 115994 28258 31553062
Cardiac ventricular thrombosis 36.25 11.53 30 115994 990 31580330
Pancreatitis 35.81 11.53 47 115977 35724 31545596
Blood creatine phosphokinase increased 35.41 11.53 62 115962 41912 31539408
Brain stem infarction 34.97 11.53 31 115993 1125 31580195
Venous thrombosis limb 34.97 11.53 38 115986 1774 31579546
Renal haematoma 34.78 11.53 22 116002 472 31580848
Therapeutic product effect incomplete 34.68 11.53 67 115957 43629 31537691
Puncture site haemorrhage 34.02 11.53 18 116006 272 31581048
Drug reaction with eosinophilia and systemic symptoms 33.73 11.53 36 115988 29982 31551338
Abnormal behaviour 33.58 11.53 23 116001 23805 31557515
Putamen haemorrhage 33.27 11.53 17 116007 238 31581082
Weight decreased 32.86 11.53 401 115623 159551 31421769
Anaphylactic reaction 32.59 11.53 36 115988 29517 31551803
Splenic haematoma 32.30 11.53 15 116009 168 31581152
Respiratory depression 31.94 11.53 7 116017 14503 31566817
Constipation 31.88 11.53 295 115729 123696 31457624
Blood blister 31.79 11.53 33 115991 1461 31579859
Haemophagocytic lymphohistiocytosis 31.78 11.53 3 116021 11675 31569645
Anticoagulation drug level decreased 31.58 11.53 13 116011 106 31581214
Incision site haemorrhage 31.07 11.53 21 116003 506 31580814
Ulcer haemorrhage 30.80 11.53 42 115982 2485 31578835
Arthralgia 30.58 11.53 381 115643 151043 31430277
Gastrointestinal angiectasia 30.57 11.53 17 116007 285 31581035
Cardiac arrest 30.35 11.53 196 115828 88866 31492454
Glomerular filtration rate decreased 30.26 11.53 104 115920 11761 31569559
Intentional self-injury 30.18 11.53 6 116018 13309 31568011
Syncope 30.00 11.53 458 115566 84724 31496596
Aneurysm ruptured 29.99 11.53 20 116004 471 31580849
Stomatitis 29.99 11.53 62 115962 39376 31541944
Osteonecrosis 29.95 11.53 7 116017 13877 31567443
Dehydration 29.93 11.53 285 115739 118826 31462494
Peripheral artery occlusion 29.79 11.53 32 115992 1474 31579846
Pruritus genital 29.75 11.53 21 116003 544 31580776
Thrombotic stroke 29.60 11.53 16 116008 253 31581067
Septic shock 29.51 11.53 133 115891 66025 31515295
Cerebral artery occlusion 29.41 11.53 23 116001 699 31580621
Haemorrhoids 29.40 11.53 106 115918 12276 31569044
Intestinal haemorrhage 29.25 11.53 47 115977 3224 31578096
Injection site reaction 29.19 11.53 4 116020 11647 31569673
Cerebral vascular occlusion 29.15 11.53 7 116017 4 31581316
Mesenteric haemorrhage 29.15 11.53 7 116017 4 31581316
Synovitis 28.99 11.53 5 116019 12278 31569042
Renal tubular necrosis 28.90 11.53 9 116015 14750 31566570
Hypophagia 28.83 11.53 23 116001 22019 31559301
Toxic epidermal necrolysis 28.66 11.53 18 116006 19506 31561814
Arteriovenous malformation 28.53 11.53 23 116001 731 31580589
Embolism 28.42 11.53 74 115950 7179 31574141
Polyp 28.36 11.53 47 115977 3309 31578011
Hypersensitivity 28.01 11.53 107 115917 55636 31525684
Extra dose administered 27.90 11.53 47 115977 3353 31577967
Respiratory arrest 27.85 11.53 33 115991 26224 31555096
Therapeutic procedure 27.78 11.53 14 116010 190 31581130
Dyspnoea 27.78 11.53 1529 114495 341950 31239370
Diarrhoea 27.77 11.53 1033 114991 351376 31229944
Emotional distress 27.68 11.53 9 116015 14347 31566973
Traumatic haematoma 27.62 11.53 22 116002 687 31580633
Fractured coccyx 27.58 11.53 13 116011 151 31581169
Abdominal pain 27.35 11.53 373 115651 145579 31435741
Therapeutic product effect decreased 27.32 11.53 46 115978 31576 31549744
Mesenteric artery thrombosis 27.29 11.53 18 116006 416 31580904
Sedation 27.13 11.53 18 116006 18947 31562373
Brain natriuretic peptide abnormal 26.87 11.53 16 116008 307 31581013
Colitis 26.86 11.53 52 115972 33835 31547485
Decreased appetite 26.79 11.53 397 115627 152820 31428500
Post thrombotic syndrome 26.77 11.53 12 116012 123 31581197
Mallory-Weiss syndrome 26.56 11.53 28 115996 1262 31580058
Coagulation test abnormal 26.36 11.53 19 116005 509 31580811
Cytokine release syndrome 26.34 11.53 14 116010 16628 31564692
Back pain 26.14 11.53 265 115759 109148 31472172
Neurologic neglect syndrome 26.09 11.53 13 116011 172 31581148
Sinusitis 25.99 11.53 60 115964 36636 31544684
Dental care 25.86 11.53 14 116010 222 31581098
Periorbital haemorrhage 25.60 11.53 11 116013 101 31581219
Paranoia 25.57 11.53 4 116020 10551 31570769
Prostate cancer 25.43 11.53 63 115961 37538 31543782
Aortic aneurysm rupture 25.21 11.53 24 116000 956 31580364
Bleeding varicose vein 25.13 11.53 15 116009 289 31581031
Cardiac failure chronic 25.10 11.53 71 115953 7232 31574088
Acute myeloid leukaemia 25.03 11.53 19 116005 18653 31562667
Anal haemorrhage 24.78 11.53 37 115987 2381 31578939
Penis injury 24.54 11.53 14 116010 247 31581073
Accidental exposure to product 24.40 11.53 6 116018 11489 31569831
Hyperglycaemia 23.98 11.53 62 115962 36414 31544906
Bronchopulmonary aspergillosis 23.84 11.53 10 116014 13624 31567696
Ascites 23.80 11.53 74 115950 40939 31540381
Hepatotoxicity 23.73 11.53 21 116003 19105 31562215
Herpes zoster 23.73 11.53 51 115973 31942 31549378
Stress 23.73 11.53 34 115990 24907 31556413
Myocardial infarction 23.44 11.53 284 115740 113170 31468150
C-reactive protein increased 23.42 11.53 95 115929 48555 31532765
Colitis ulcerative 23.41 11.53 20 116004 18509 31562811
Sensation of foreign body 23.37 11.53 34 115990 2137 31579183
Osteonecrosis of jaw 23.37 11.53 17 116007 17054 31564266
Brain compression 23.30 11.53 12 116012 171 31581149
Delirium 23.15 11.53 76 115948 41345 31539975
Retinal artery occlusion 23.06 11.53 30 115994 1696 31579624
Pharyngeal haemorrhage 23.00 11.53 20 116004 707 31580613
Respiratory failure 22.89 11.53 249 115775 101200 31480120
Diabetes mellitus inadequate control 22.84 11.53 9 116015 12732 31568588
Confusional state 22.78 11.53 347 115677 132987 31448333
Purpura 22.59 11.53 82 115942 9528 31571792
Multiple sclerosis relapse 22.45 11.53 8 116016 12039 31569281
Drug resistance 22.28 11.53 32 115992 23421 31557899
Psoriatic arthropathy 22.16 11.53 24 116000 19859 31561461
Intentional product use issue 22.13 11.53 99 115925 49248 31532072
Large intestine polyp 22.12 11.53 66 115958 6926 31574394
Hydrocephalus 22.03 11.53 51 115973 4594 31576726
Pulmonary arterial pressure abnormal 21.96 11.53 12 116012 194 31581126
Haemorrhagic infarction 21.93 11.53 16 116008 437 31580883
Neutropenic sepsis 21.77 11.53 9 116015 12370 31568950
Peripheral ischaemia 21.72 11.53 55 115969 5245 31576075
Neuroleptic malignant syndrome 21.57 11.53 18 116006 16851 31564469
Hypercoagulation 21.55 11.53 24 116000 1152 31580168
Labelled drug-disease interaction medication error 21.46 11.53 10 116014 113 31581207
Pancreatitis acute 21.42 11.53 38 115986 25562 31555758
Diverticulitis intestinal haemorrhagic 21.36 11.53 14 116010 320 31581000
Cardio-respiratory arrest 21.30 11.53 107 115917 51619 31529701
Candida infection 21.22 11.53 17 116007 16241 31565079
Progressive multifocal leukoencephalopathy 21.20 11.53 4 116020 9209 31572111
Haematospermia 21.17 11.53 14 116010 325 31580995
Aplastic anaemia 21.17 11.53 4 116020 9199 31572121
Dysphagia 21.17 11.53 124 115900 57552 31523768
Contraindicated product administered 20.93 11.53 134 115890 19638 31561682
Haemoperitoneum 20.84 11.53 28 115996 1633 31579687
Hospitalisation 20.80 11.53 276 115748 49531 31531789
Ill-defined disorder 20.77 11.53 10 116014 12567 31568753
Blood thyroid stimulating hormone abnormal 20.72 11.53 14 116010 337 31580983
Metastases to bone 20.56 11.53 7 116017 10841 31570479
Phlebitis deep 20.51 11.53 6 116018 14 31581306
Peripheral arterial occlusive disease 20.47 11.53 54 115970 5279 31576041
Product label issue 20.44 11.53 12 116012 224 31581096
Arterial thrombosis 20.42 11.53 26 115998 1438 31579882
Hypercalcaemia 20.42 11.53 13 116011 13987 31567333
Carotid artery occlusion 20.41 11.53 31 115993 2025 31579295
N-terminal prohormone brain natriuretic peptide increased 20.38 11.53 32 115992 2152 31579168
Pneumocystis jirovecii pneumonia 20.38 11.53 22 116002 18229 31563091
Renal infarct 20.32 11.53 24 116000 1228 31580092
Tumour lysis syndrome 20.19 11.53 16 116008 15369 31565951
Staphylococcal infection 20.19 11.53 52 115972 30580 31550740
Influenza like illness 20.18 11.53 39 115985 25398 31555922
Catheter site haemorrhage 20.10 11.53 31 115993 2053 31579267
Platelet dysfunction 19.98 11.53 12 116012 234 31581086
Plantar fasciitis 19.93 11.53 27 115997 1588 31579732
Respiratory distress 19.85 11.53 60 115964 33493 31547827
Neuropathy peripheral 19.85 11.53 179 115845 75470 31505850
Anger 19.79 11.53 8 116016 11145 31570175
Product administration error 19.79 11.53 109 115915 15138 31566182
Platelet count decreased 19.69 11.53 285 115739 110150 31471170
Intra-abdominal haematoma 19.64 11.53 24 116000 1273 31580047
Intentional product misuse 19.62 11.53 72 115952 37879 31543441
Hepatic function abnormal 19.52 11.53 81 115943 41141 31540179
Serotonin syndrome 19.48 11.53 24 116000 18749 31562571
Postoperative thrombosis 19.43 11.53 6 116018 18 31581302
Bleeding time prolonged 19.39 11.53 17 116007 608 31580712
Upper respiratory tract infection 19.35 11.53 50 115974 29372 31551948
Aspergillus infection 19.30 11.53 9 116015 11519 31569801
Angioedema 19.26 11.53 61 115963 33557 31547763
Electrocardiogram QRS complex abnormal 19.24 11.53 13 116011 313 31581007
Traumatic haemothorax 19.24 11.53 12 116012 251 31581069
Oesophageal haemorrhage 19.12 11.53 23 116001 1200 31580120
Hallucination 19.11 11.53 96 115928 46314 31535006
Ureteric haemorrhage 18.91 11.53 9 116015 107 31581213
Nephropathy toxic 18.79 11.53 9 116015 11344 31569976
Hypertriglyceridaemia 18.79 11.53 3 116021 7795 31573525
Blood triglycerides increased 18.78 11.53 13 116011 13384 31567936
Hyperhomocysteinaemia 18.75 11.53 11 116013 205 31581115
Peripheral artery thrombosis 18.72 11.53 31 115993 2181 31579139
Carotid artery aneurysm 18.69 11.53 7 116017 43 31581277
Encephalopathy 18.56 11.53 59 115965 32415 31548905
Haematotympanum 18.46 11.53 4 116020 0 31581320
Coagulation factor X level increased 18.46 11.53 4 116020 0 31581320
Plasma cell myeloma 18.45 11.53 126 115898 56405 31524915
Withdrawal syndrome 18.33 11.53 10 116014 11707 31569613
Injection site swelling 18.29 11.53 7 116017 10080 31571240
Vena cava thrombosis 18.14 11.53 21 116003 1052 31580268
Anastomotic ulcer haemorrhage 18.11 11.53 6 116018 24 31581296
Oxygen saturation increased 18.02 11.53 12 116012 282 31581038
Fear 17.95 11.53 7 116017 9967 31571353
Bladder neoplasm 17.89 11.53 23 116001 1285 31580035
Intra-abdominal haemorrhage 17.85 11.53 30 115994 2136 31579184
Gastrointestinal angiodysplasia 17.83 11.53 16 116008 590 31580730
Hypersensitivity vasculitis 17.83 11.53 38 115986 3237 31578083
Cytopenia 17.81 11.53 9 116015 11001 31570319
Electrocardiogram QT prolonged 17.77 11.53 75 115949 37912 31543408
Facial paresis 17.71 11.53 34 115990 2687 31578633
Malnutrition 17.71 11.53 10 116014 11483 31569837
Underdose 17.63 11.53 92 115932 12515 31568805
Lymphoma 17.62 11.53 9 116015 10934 31570386
Chronic gastrointestinal bleeding 17.58 11.53 12 116012 294 31581026
Poisoning 17.57 11.53 8 116016 10383 31570937
Hypertension 17.49 11.53 347 115677 127753 31453567
Lymphopenia 17.46 11.53 16 116008 14313 31567007
Vascular access site occlusion 17.45 11.53 7 116017 53 31581267
Pseudomonas infection 17.45 11.53 10 116014 11391 31569929
Multiple sclerosis 17.44 11.53 4 116020 8033 31573287
Duodenitis haemorrhagic 17.43 11.53 8 116016 87 31581233
Myocarditis 17.43 11.53 11 116013 11889 31569431
Brain herniation 17.40 11.53 41 115983 3736 31577584
Extradural haematoma 17.30 11.53 21 116003 1106 31580214
Tumour haemorrhage 17.30 11.53 33 115991 2595 31578725
Fatigue 17.26 11.53 1028 114996 334178 31247142
Blood lactate dehydrogenase increased 17.19 11.53 30 115994 20309 31561011
Splenomegaly 17.18 11.53 15 116009 13734 31567586
Hypocalcaemia 17.18 11.53 34 115990 21944 31559376
Diabetic ketoacidosis 17.14 11.53 22 116002 16883 31564437
Dystonia 17.09 11.53 8 116016 10217 31571103
Post-traumatic amnestic disorder 17.02 11.53 7 116017 57 31581263
Anaphylactic shock 16.99 11.53 16 116008 14129 31567191
Cyanosis 16.97 11.53 11 116013 11724 31569596
Cholestasis 16.96 11.53 42 115982 25033 31556287
Embolism arterial 16.93 11.53 15 116009 544 31580776
Supine hypertension 16.93 11.53 12 116012 313 31581007
Hypoglycaemia 16.90 11.53 113 115911 50833 31530487
International normalised ratio abnormal 16.90 11.53 36 115988 3066 31578254
Lung diffusion disorder 16.89 11.53 8 116016 94 31581226
Febrile bone marrow aplasia 16.84 11.53 4 116020 7842 31573478
Hepatitis C 16.74 11.53 9 116015 10621 31570699
Restlessness 16.70 11.53 38 115986 23323 31557997
Blood bilirubin increased 16.66 11.53 69 115955 35067 31546253
Intestinal perforation 16.63 11.53 5 116019 8384 31572936
Injection site erythema 16.63 11.53 17 116007 14445 31566875
Blood pressure increased 16.57 11.53 199 115825 79434 31501886
Oral candidiasis 16.55 11.53 10 116014 11067 31570253
Small intestinal obstruction 16.47 11.53 15 116009 13457 31567863
Stiff person syndrome 16.46 11.53 8 116016 100 31581220
Night sweats 16.44 11.53 20 116004 15712 31565608
Subclavian vein thrombosis 16.41 11.53 18 116006 849 31580471
Renal embolism 16.32 11.53 8 116016 102 31581218
Acidosis 16.29 11.53 8 116016 9938 31571382
Presyncope 16.28 11.53 114 115910 17214 31564106
Anal fissure haemorrhage 16.23 11.53 4 116020 3 31581317
Mental status changes 16.22 11.53 72 115952 35896 31545424
Mediastinal haematoma 16.18 11.53 8 116016 104 31581216
Vocal cord inflammation 16.13 11.53 7 116017 66 31581254
Spinal cord haematoma 16.11 11.53 8 116016 105 31581215
Pulmonary arterial hypertension 16.11 11.53 75 115949 9746 31571574
Skin ulcer haemorrhage 16.07 11.53 9 116015 153 31581167
COVID-19 16.05 11.53 126 115898 54695 31526625
Lymphadenopathy 15.97 11.53 46 115978 26075 31555245
Gastrointestinal arteriovenous malformation 15.92 11.53 12 116012 345 31580975
Haemodilution 15.87 11.53 6 116018 38 31581282
Vascular graft thrombosis 15.77 11.53 9 116015 159 31581161
Perforated ulcer 15.77 11.53 9 116015 159 31581161
Myelodysplastic syndrome 15.73 11.53 29 115995 19222 31562098
Metabolic acidosis 15.65 11.53 83 115941 39494 31541826
Surgery 15.64 11.53 89 115935 12510 31568810
Musculoskeletal stiffness 15.61 11.53 88 115936 41237 31540083
Conjunctivitis 15.61 11.53 6 116018 8617 31572703
Coagulation time prolonged 15.60 11.53 21 116003 1227 31580093
Hepatic steatosis 15.58 11.53 22 116002 16217 31565103
Visual acuity reduced 15.52 11.53 20 116004 15323 31565997
Implant site haematoma 15.51 11.53 7 116017 73 31581247
Biopsy prostate 15.51 11.53 5 116019 18 31581302
Subarachnoid haematoma 15.43 11.53 7 116017 74 31581246
Tongue haemorrhage 15.39 11.53 14 116010 526 31580794
Gravitational oedema 15.33 11.53 15 116009 618 31580702
Polyneuropathy 15.33 11.53 15 116009 13007 31568313
Cytomegalovirus viraemia 15.30 11.53 3 116021 6722 31574598
Neoplasm progression 15.30 11.53 32 115992 20240 31561080
Pulmonary endarterectomy 15.27 11.53 7 116017 76 31581244
Diffuse vasculitis 15.27 11.53 7 116017 76 31581244
Limb injury 15.25 11.53 75 115949 9966 31571354
Rhinorrhoea 15.21 11.53 39 115985 22973 31558347
Therapeutic product ineffective 15.20 11.53 15 116009 625 31580695
Stent placement 15.18 11.53 45 115979 4706 31576614
Weight increased 15.15 11.53 213 115811 82734 31498586
Cardiac valve replacement complication 15.12 11.53 6 116018 44 31581276
Hypertrophic osteoarthropathy 15.11 11.53 7 116017 78 31581242
Delusion 15.09 11.53 13 116011 11984 31569336
Post procedural haematuria 15.01 11.53 9 116015 175 31581145
Dyskinesia 14.96 11.53 34 115990 20876 31560444
Mobility decreased 14.94 11.53 51 115973 27418 31553902
Cerebral amyloid angiopathy 14.94 11.53 8 116016 124 31581196
Hemiataxia 14.90 11.53 6 116018 46 31581274
Tachycardia 14.89 11.53 193 115831 76014 31505306
Klebsiella infection 14.85 11.53 5 116019 7798 31573522
Therapy partial responder 14.78 11.53 3 116021 6559 31574761
Tuberculosis 14.77 11.53 6 116018 8335 31572985
Retinal artery thrombosis 14.72 11.53 5 116019 22 31581298
Sinus tachycardia 14.69 11.53 22 116002 15827 31565493
Fungal infection 14.68 11.53 19 116005 14532 31566788
Myopathy 14.60 11.53 11 116013 10841 31570479
Thrombotic microangiopathy 14.60 11.53 8 116016 9343 31571977
Lacunar stroke 14.57 11.53 9 116015 185 31581135
Erythema 14.50 11.53 207 115817 80198 31501122
Peritonitis 14.47 11.53 21 116003 15306 31566014
Lung infiltration 14.45 11.53 14 116010 12199 31569121
Soft tissue haemorrhage 14.44 11.53 8 116016 133 31581187
Uterine haemorrhage 14.44 11.53 4 116020 7 31581313
Cardiac assistance device user 14.44 11.53 4 116020 7 31581313
Post procedural oedema 14.44 11.53 4 116020 7 31581313
Subclavian artery thrombosis 14.44 11.53 4 116020 7 31581313
Hypernatraemia 14.43 11.53 5 116019 7658 31573662
Potentiating drug interaction 14.43 11.53 43 115981 4510 31576810
Urethral haemorrhage 14.30 11.53 12 116012 404 31580916
Disseminated intravascular coagulation 14.20 11.53 34 115990 20503 31560817
Cardiac vein perforation 14.20 11.53 5 116019 25 31581295
Viral infection 14.11 11.53 22 116002 15571 31565749
Renal injury 14.11 11.53 11 116013 10654 31570666
Myositis 13.98 11.53 12 116012 11082 31570238
Incorrect dosage administered 13.98 11.53 18 116006 1007 31580313
Blood glucose decreased 13.96 11.53 15 116009 12456 31568864
Skin exfoliation 13.90 11.53 43 115981 23831 31557489
Palmar-plantar erythrodysaesthesia syndrome 13.86 11.53 22 116002 15461 31565859
Severe invasive streptococcal infection 13.84 11.53 3 116021 0 31581320
Aortic surgery 13.84 11.53 3 116021 0 31581320
Phlebectomy 13.84 11.53 3 116021 0 31581320
Prostatic varices 13.84 11.53 3 116021 0 31581320
Tendonitis 13.84 11.53 7 116017 8551 31572769
Hemianaesthesia 13.83 11.53 7 116017 96 31581224
Transfusion 13.77 11.53 60 115964 7580 31573740
Thalamic infarction 13.76 11.53 15 116009 703 31580617
Hypophosphataemia 13.71 11.53 7 116017 8507 31572813
Renal vein thrombosis 13.60 11.53 8 116016 150 31581170
Blood calcium decreased 13.60 11.53 9 116015 9485 31571835
Atrial flutter 13.52 11.53 96 115928 14559 31566761
Obstructive airways disorder 13.51 11.53 86 115938 12578 31568742
Haemorrhagic disorder 13.50 11.53 14 116010 619 31580701
Hyperlipidaemia 13.47 11.53 17 116007 13143 31568177
Large intestinal polypectomy 13.43 11.53 6 116018 61 31581259
Gout 13.40 11.53 113 115911 18061 31563259
Vision blurred 13.39 11.53 94 115930 41821 31539499
Extrapyramidal disorder 13.37 11.53 14 116010 11764 31569556
Laryngeal haematoma 13.23 11.53 8 116016 158 31581162
Erectile dysfunction 13.18 11.53 32 115992 19203 31562117
Status epilepticus 13.07 11.53 15 116009 12091 31569229
Tonsillar ulcer 13.05 11.53 8 116016 162 31581158
Monoplegia 12.99 11.53 21 116003 1448 31579872
Sleep disorder 12.96 11.53 51 115973 26297 31555023
Spinal subdural haematoma 12.94 11.53 6 116018 67 31581253
Hyperkalaemia 12.93 11.53 162 115862 64189 31517131
Adverse event 12.93 11.53 105 115919 16600 31564720
Idiopathic interstitial pneumonia 12.92 11.53 8 116016 165 31581155
Oedema genital 12.87 11.53 11 116013 380 31580940
Vascular graft occlusion 12.85 11.53 13 116011 558 31580762
Colon cancer 12.85 11.53 64 115960 8549 31572771
Renal cancer 12.84 11.53 6 116018 7673 31573647
Disease recurrence 12.82 11.53 31 115993 18630 31562690
Creatinine renal clearance abnormal 12.82 11.53 9 116015 231 31581089
Macular ischaemia 12.78 11.53 6 116018 69 31581251
Mania 12.74 11.53 9 116015 9168 31572152
Dialysis 12.73 11.53 12 116012 10591 31570729
Subcapsular renal haematoma 12.72 11.53 11 116013 386 31580934
Paresis cranial nerve 12.71 11.53 6 116018 70 31581250
Product storage error 12.65 11.53 5 116019 7061 31574259
Depressed level of consciousness 12.61 11.53 86 115938 38515 31542805
Cerebral microhaemorrhage 12.56 11.53 6 116018 72 31581248
Intracranial haematoma 12.53 11.53 11 116013 394 31580926
Blood urea increased 12.53 11.53 59 115965 28953 31552367
Spontaneous haemorrhage 12.52 11.53 9 116015 240 31581080
Basilar artery thrombosis 12.52 11.53 9 116015 240 31581080
Eye pain 12.48 11.53 16 116008 12288 31569032
Varicose vein ruptured 12.45 11.53 5 116019 38 31581282
Glomerular filtration rate abnormal 12.45 11.53 15 116009 784 31580536
Photophobia 12.45 11.53 4 116020 6425 31574895
Thrombophlebitis 12.29 11.53 31 115993 2949 31578371
Catheter site cellulitis 12.25 11.53 7 116017 124 31581196
Atrial septal defect 12.24 11.53 5 116019 6922 31574398
Vascular pseudoaneurysm ruptured 12.13 11.53 6 116018 78 31581242
Spinal epidural haemorrhage 12.12 11.53 5 116019 41 31581279
Vascular rupture 12.12 11.53 8 116016 185 31581135
Fistula 12.11 11.53 3 116021 5718 31575602
Pollakiuria 12.10 11.53 30 115994 17872 31563448
Left ventricular dilatation 12.05 11.53 14 116010 704 31580616
Renal impairment 12.02 11.53 407 115617 85942 31495378
Oedema peripheral 12.00 11.53 504 115520 109335 31471985
Dose calculation error 11.92 11.53 5 116019 43 31581277
Drug ineffective for unapproved indication 11.87 11.53 30 115994 17760 31563560
Atelectasis 11.84 11.53 26 115998 16163 31565157
Lip discolouration 11.81 11.53 7 116017 133 31581187
Protein C deficiency 11.77 11.53 3 116021 3 31581317
Echocardiogram 11.77 11.53 3 116021 3 31581317
Hyperbilirubinaemia 11.77 11.53 25 115999 15725 31565595
Urinary incontinence 11.72 11.53 29 115995 17291 31564029
Hepatic encephalopathy 11.70 11.53 20 116004 13651 31567669
Ocular retrobulbar haemorrhage 11.70 11.53 4 116020 18 31581302
Salivary hypersecretion 11.69 11.53 7 116017 7785 31573535
Thinking abnormal 11.65 11.53 3 116021 5570 31575750
Intervertebral disc degeneration 11.64 11.53 3 116021 5568 31575752
Antiphospholipid syndrome 11.64 11.53 11 116013 434 31580886
Generalised oedema 11.62 11.53 15 116009 11486 31569834
Bacteraemia 11.57 11.53 30 115994 17604 31563716
Post procedural pulmonary embolism 11.53 11.53 4 116020 19 31581301

FDA Adverse Event Reporting System (Geriatric)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Gastrointestinal haemorrhage 8848.89 10.62 5243 195301 132165 70595735
Deep vein thrombosis 2445.36 10.62 2220 198324 108822 70619078
Pulmonary embolism 2392.48 10.62 2558 197986 153309 70574591
Cerebral haemorrhage 2030.79 10.62 1475 199069 52389 70675511
Ischaemic stroke 1899.20 10.62 1147 199397 29673 70698227
Haematuria 1894.34 10.62 1513 199031 62060 70665840
Haemorrhage 1801.69 10.62 1654 198890 82161 70645739
Epistaxis 1661.30 10.62 1734 198810 100893 70627007
Upper gastrointestinal haemorrhage 1653.16 10.62 1130 199414 36347 70691553
Haemorrhage intracranial 1370.71 10.62 861 199683 23916 70703984
Rectal haemorrhage 1256.94 10.62 1217 199327 64614 70663286
Cerebral infarction 1245.32 10.62 1007 199537 42002 70685898
Cerebrovascular accident 1161.64 10.62 1711 198833 141759 70586141
Melaena 1104.36 10.62 1057 199487 55298 70672602
Lower gastrointestinal haemorrhage 1024.76 10.62 593 199951 14127 70713773
Haematoma 957.82 10.62 913 199631 47505 70680395
Haemorrhagic stroke 874.86 10.62 472 200072 9770 70718130
Anaemia 853.00 10.62 2790 197754 400633 70327267
Subdural haematoma 795.49 10.62 661 199883 28637 70699263
Thrombosis 760.27 10.62 1000 199544 74405 70653495
Embolic stroke 748.42 10.62 380 200164 6909 70720991
Internal haemorrhage 738.13 10.62 390 200154 7726 70720174
Haemoglobin decreased 733.94 10.62 1721 198823 203438 70524462
Atrial thrombosis 617.03 10.62 259 200285 2966 70724934
Blood loss anaemia 616.52 10.62 427 200117 14014 70713886
Atrial fibrillation 599.65 10.62 1491 199053 182857 70545043
Haemoptysis 580.96 10.62 722 199822 50730 70677170
Haematochezia 505.45 10.62 811 199733 72270 70655630
Gastric haemorrhage 501.42 10.62 374 200170 13811 70714089
Rheumatoid arthritis 492.67 10.62 111 200433 291694 70436206
Diverticulum intestinal haemorrhagic 465.01 10.62 217 200327 3250 70724650
Heavy menstrual bleeding 463.55 10.62 341 200203 12324 70715576
Post procedural haemorrhage 438.71 10.62 332 200212 12534 70715366
Pericardial haemorrhage 433.77 10.62 221 200323 4047 70723853
Vaginal haemorrhage 414.13 10.62 390 200154 19962 70707938
Labelled drug-drug interaction medication error 397.42 10.62 412 200132 23715 70704185
Intraventricular haemorrhage 393.16 10.62 209 200335 4192 70723708
Haemorrhagic arteriovenous malformation 383.58 10.62 117 200427 465 70727435
Shock haemorrhagic 381.95 10.62 354 200190 17752 70710148
Haematemesis 368.55 10.62 564 199980 48233 70679667
Basal ganglia haemorrhage 357.80 10.62 141 200403 1354 70726546
Haemarthrosis 354.44 10.62 210 200334 5229 70722671
Transient ischaemic attack 351.18 10.62 534 200010 45410 70682490
Incorrect dose administered 345.78 10.62 652 199892 66067 70661833
Haemorrhoidal haemorrhage 334.80 10.62 210 200334 5809 70722091
Cerebral haematoma 333.45 10.62 226 200318 7152 70720748
Faeces discoloured 313.47 10.62 383 200161 26426 70701474
Infusion related reaction 312.17 10.62 86 200458 197448 70530452
Fall 311.74 10.62 2235 198309 441861 70286039
Synovitis 302.79 10.62 15 200529 129213 70598687
Cerebellar haemorrhage 300.63 10.62 149 200395 2566 70725334
Subarachnoid haemorrhage 297.99 10.62 320 200224 19184 70708716
Embolic cerebral infarction 292.69 10.62 114 200430 1058 70726842
Toxicity to various agents 279.26 10.62 405 200139 381767 70346133
Thalamus haemorrhage 276.43 10.62 122 200422 1592 70726308
Drug intolerance 275.91 10.62 147 200397 225540 70502360
Hemiplegia 274.54 10.62 262 200282 13633 70714267
Drug abuse 273.82 10.62 44 200500 147212 70580688
Product prescribing issue 269.45 10.62 144 200400 2920 70724980
Pain 267.82 10.62 899 199645 627917 70099983
Drug hypersensitivity 263.92 10.62 213 200331 262246 70465654
Gingival bleeding 257.87 10.62 264 200280 14968 70712932
Pyrexia 250.12 10.62 880 199664 606072 70121828
International normalised ratio increased 247.51 10.62 639 199905 80087 70647813
Therapeutic product effect decreased 241.96 10.62 54 200490 142964 70584936
Blood urine present 235.24 10.62 282 200262 19071 70708829
Hand deformity 228.46 10.62 3 200541 86479 70641421
Gastrointestinal vascular malformation haemorrhagic 225.67 10.62 84 200460 680 70727220
Hemiparesis 225.39 10.62 355 200189 31114 70696786
Subcutaneous haematoma 223.41 10.62 120 200424 2459 70725441
Iron deficiency anaemia 209.51 10.62 291 200253 22781 70705119
Gastric ulcer haemorrhage 206.20 10.62 180 200364 8338 70719562
Drug interaction 205.43 10.62 1807 198737 379634 70348266
Arthralgia 201.10 10.62 739 199805 502651 70225249
Cerebral artery embolism 197.91 10.62 96 200448 1574 70726326
Haemorrhagic transformation stroke 197.35 10.62 110 200434 2431 70725469
Hypersensitivity 189.82 10.62 222 200322 229590 70498310
Condition aggravated 187.51 10.62 603 199941 427032 70300868
Abdominal wall haematoma 186.73 10.62 130 200414 4300 70723600
Systemic lupus erythematosus 185.96 10.62 32 200512 101870 70626030
Muscle haemorrhage 181.30 10.62 143 200401 5741 70722159
Febrile neutropenia 181.28 10.62 186 200358 204132 70523768
Glossodynia 179.70 10.62 18 200526 86469 70641431
Maternal exposure during pregnancy 175.20 10.62 54 200490 115291 70612609
Subdural haemorrhage 174.93 10.62 136 200408 5345 70722555
Anxiety 172.30 10.62 222 200322 220108 70507792
Arthropathy 166.03 10.62 110 200434 149947 70577953
Cardiac failure 165.12 10.62 823 199721 142718 70585182
Retroperitoneal haemorrhage 163.53 10.62 128 200416 5081 70722819
Alopecia 162.54 10.62 193 200351 198297 70529603
Completed suicide 161.51 10.62 245 200299 226890 70501010
Joint swelling 153.69 10.62 302 200242 252909 70474991
Wound haemorrhage 153.63 10.62 108 200436 3629 70724271
Anticoagulation drug level increased 151.52 10.62 62 200482 662 70727238
Mouth haemorrhage 151.27 10.62 165 200379 10066 70717834
Prothrombin time prolonged 151.20 10.62 207 200337 15983 70711917
Neutropenia 149.86 10.62 314 200230 256842 70471058
Depression 146.94 10.62 209 200335 198765 70529135
Duodenal ulcer haemorrhage 146.82 10.62 134 200410 6584 70721316
Small intestinal haemorrhage 145.31 10.62 107 200437 3871 70724029
Discomfort 145.31 10.62 58 200486 105378 70622522
Infection 144.48 10.62 233 200311 210552 70517348
Splenic rupture 143.48 10.62 86 200458 2188 70725712
Uterine haemorrhage 142.67 10.62 91 200453 2593 70725307
Dyspnoea exertional 139.22 10.62 513 200031 77917 70649983
Haemothorax 136.60 10.62 114 200430 4963 70722937
Occult blood positive 136.42 10.62 126 200418 6287 70721613
Haemorrhage urinary tract 133.40 10.62 83 200461 2262 70725638
Coagulopathy 131.92 10.62 291 200253 32958 70694942
Procedural haemorrhage 127.92 10.62 104 200440 4363 70723537
Sinusitis 127.63 10.62 175 200369 169020 70558880
Cerebral ventricular rupture 125.89 10.62 47 200497 384 70727516
Renal haemorrhage 123.91 10.62 76 200468 2018 70725882
Haemorrhage subcutaneous 122.88 10.62 102 200442 4407 70723493
Duodenal ulcer perforation 122.74 10.62 5 200539 51107 70676793
Cardiac tamponade 122.54 10.62 136 200408 8459 70719441
Rheumatoid factor positive 122.43 10.62 3 200541 48397 70679503
Gastric ulcer 120.26 10.62 273 200271 31517 70696383
Dyspnoea 117.21 10.62 2925 197619 767135 69960765
Brain stem haemorrhage 115.70 10.62 66 200478 1527 70726373
Traumatic intracranial haemorrhage 115.06 10.62 58 200486 1037 70726863
Pulmonary haemorrhage 114.60 10.62 166 200378 13507 70714393
Stomatitis 113.92 10.62 117 200427 128394 70599506
Microcytic anaemia 113.51 10.62 100 200444 4689 70723211
Activated partial thromboplastin time prolonged 113.25 10.62 164 200380 13341 70714559
Pericarditis 112.84 10.62 49 200495 84656 70643244
Prescribed underdose 111.98 10.62 210 200334 21175 70706725
Musculoskeletal stiffness 110.26 10.62 154 200390 147606 70580294
Aphasia 110.22 10.62 320 200224 42929 70684971
Gastritis haemorrhagic 109.93 10.62 75 200469 2399 70725501
Nasopharyngitis 109.02 10.62 297 200247 221909 70505991
Post procedural haematoma 108.67 10.62 73 200471 2275 70725625
Peripheral embolism 106.43 10.62 66 200478 1788 70726112
Large intestinal haemorrhage 106.14 10.62 75 200469 2541 70725359
Exposure during pregnancy 104.38 10.62 59 200485 87658 70640242
Intracardiac thrombus 103.22 10.62 87 200457 3840 70724060
Cardioversion 100.77 10.62 65 200479 1889 70726011
Psoriatic arthropathy 100.75 10.62 29 200515 64742 70663158
Cerebral ischaemia 100.07 10.62 135 200409 10277 70717623
Acute kidney injury 98.22 10.62 1885 198659 472739 70255161
Pulmonary alveolar haemorrhage 97.46 10.62 133 200411 10236 70717664
Haemorrhagic cerebral infarction 96.67 10.62 56 200488 1335 70726565
Folliculitis 96.40 10.62 6 200538 42564 70685336
Product prescribing error 95.24 10.62 284 200260 38668 70689232
Mobility decreased 94.47 10.62 91 200453 102908 70624992
Therapeutic response decreased 93.10 10.62 25 200519 58428 70669472
Creatinine renal clearance decreased 92.68 10.62 171 200373 17029 70710871
Injection site reaction 92.39 10.62 15 200529 49837 70678063
Cerebellar infarction 92.01 10.62 77 200467 3365 70724535
Adrenal haemorrhage 91.62 10.62 41 200503 554 70727346
Ecchymosis 90.83 10.62 153 200391 14179 70713721
Weight increased 90.56 10.62 365 200179 241966 70485934
Hypovolaemic shock 89.99 10.62 131 200413 10706 70717194
Injection site erythema 89.75 10.62 47 200497 72877 70655023
Haematoma muscle 88.68 10.62 64 200480 2243 70725657
Duodenal ulcer 87.53 10.62 156 200388 15124 70712776
Psoriasis 86.80 10.62 90 200454 98343 70629557
Injection site pain 86.34 10.62 124 200420 117495 70610405
Dizziness 86.21 10.62 1814 198730 462327 70265573
Extradural haematoma 86.06 10.62 67 200477 2638 70725262
Eye haemorrhage 85.96 10.62 116 200428 8833 70719067
Head injury 84.49 10.62 250 200294 33891 70694009
Loss of personal independence in daily activities 83.88 10.62 70 200474 84840 70643060
Cerebral artery occlusion 83.39 10.62 54 200490 1580 70726320
Pericardial effusion 83.34 10.62 284 200260 41492 70686408
Traumatic haemorrhage 83.33 10.62 48 200496 1132 70726768
Anaphylactic reaction 82.84 10.62 55 200489 74919 70652981
Embolism venous 82.67 10.62 76 200468 3769 70724131
Therapeutic product effect incomplete 82.58 10.62 132 200412 119750 70608150
Gastritis erosive 82.34 10.62 121 200423 9974 70717926
Cerebral mass effect 82.13 10.62 55 200489 1705 70726195
Insomnia 80.78 10.62 329 200215 217477 70510423
Ill-defined disorder 80.67 10.62 27 200517 54714 70673186
Vascular pseudoaneurysm 80.39 10.62 70 200474 3231 70724669
Muscle injury 79.98 10.62 8 200536 38486 70689414
Hepatic enzyme increased 79.88 10.62 206 200338 156784 70571116
Swelling 78.23 10.62 272 200272 188267 70539633
Gastrointestinal ulcer haemorrhage 77.45 10.62 45 200499 1079 70726821
Retroperitoneal haematoma 76.50 10.62 82 200462 4903 70722997
Syncope 76.37 10.62 760 199784 164949 70562951
High frequency ablation 74.94 10.62 29 200515 264 70727636
Drug dependence 74.39 10.62 9 200535 37312 70690588
Arterial haemorrhage 73.00 10.62 58 200486 2353 70725547
Urinary bladder haemorrhage 72.94 10.62 58 200486 2356 70725544
Haemorrhagic diathesis 72.87 10.62 85 200459 5582 70722318
Treatment failure 71.91 10.62 191 200353 143951 70583949
Neutrophil count decreased 71.87 10.62 78 200466 83478 70644422
Underdose 71.61 10.62 214 200330 29169 70698731
Seizure 71.00 10.62 261 200283 177701 70550199
Sedation 70.72 10.62 22 200522 46709 70681191
Suicidal ideation 70.45 10.62 56 200488 69540 70658360
Pelvic venous thrombosis 70.33 10.62 51 200493 1801 70726099
Irritable bowel syndrome 70.00 10.62 28 200516 50822 70677078
Blister 69.88 10.62 110 200434 100416 70627484
Abnormal uterine bleeding 69.64 10.62 39 200505 870 70727030
Spinal cord haemorrhage 69.26 10.62 33 200511 519 70727381
Contusion 68.89 10.62 607 199937 127429 70600471
Intestinal haemorrhage 68.73 10.62 85 200459 5935 70721965
Rash 68.37 10.62 1024 199520 509538 70218362
Cardiac failure chronic 68.25 10.62 112 200432 10157 70717743
Venous thrombosis 68.19 10.62 89 200455 6560 70721340
Mucosal inflammation 68.17 10.62 55 200489 67795 70660105
Ischaemic cerebral infarction 67.75 10.62 55 200489 2302 70725598
Postmenopausal haemorrhage 66.66 10.62 45 200499 1414 70726486
Pulmonary arterial hypertension 66.10 10.62 224 200320 32631 70695269
Transfusion 66.02 10.62 157 200387 18679 70709221
Abdominal discomfort 64.43 10.62 350 200194 214308 70513592
Aspartate aminotransferase increased 64.29 10.62 167 200377 126811 70601089
Bone marrow failure 64.24 10.62 29 200515 48981 70678919
Conjunctival haemorrhage 64.14 10.62 77 200467 5213 70722687
Multiple sclerosis relapse 63.77 10.62 21 200523 42996 70684904
Agitation 63.19 10.62 104 200440 93271 70634629
Overdose 63.17 10.62 256 200288 169489 70558411
Helicobacter infection 62.61 10.62 40 200504 55616 70672284
Gastrointestinal polyp haemorrhage 62.39 10.62 29 200515 430 70727470
Fatigue 62.22 10.62 1816 198728 822503 69905397
Renal impairment 61.94 10.62 651 199893 143286 70584614
Nausea 61.88 10.62 1887 198657 850201 69877699
Alanine aminotransferase increased 61.68 10.62 212 200332 147268 70580632
Cytomegalovirus infection 61.46 10.62 18 200526 39740 70688160
Splenic haemorrhage 61.32 10.62 32 200512 617 70727283
Glomerular filtration rate decreased 61.21 10.62 162 200382 20594 70707306
Spontaneous haematoma 61.17 10.62 41 200503 1273 70726627
Hospitalisation 60.78 10.62 421 200123 82147 70645753
Cerebral ventricle collapse 60.76 10.62 20 200524 107 70727793
Treatment noncompliance 59.98 10.62 276 200268 46298 70681602
Incision site haemorrhage 59.90 10.62 37 200507 995 70726905
Blood cholesterol increased 59.32 10.62 57 200487 64547 70663353
Embolism 58.83 10.62 120 200424 12868 70715032
Hypochromic anaemia 58.36 10.62 52 200492 2475 70725425
Impaired healing 58.01 10.62 75 200469 74299 70653601
C-reactive protein increased 57.77 10.62 143 200401 110374 70617526
Compartment syndrome 57.20 10.62 67 200477 4419 70723481
Tremor 57.10 10.62 236 200308 155388 70572512
Aggression 57.04 10.62 33 200511 48413 70679487
N-terminal prohormone brain natriuretic peptide abnormal 56.93 10.62 23 200521 237 70727663
Herpes zoster 56.69 10.62 96 200448 85139 70642761
Inflammation 56.67 10.62 84 200460 78581 70649319
Spinal cord haematoma 56.32 10.62 24 200520 286 70727614
Oedema peripheral 56.30 10.62 932 199612 227159 70500741
Retinal artery occlusion 56.21 10.62 55 200489 2951 70724949
Wound 55.41 10.62 123 200421 98609 70629291
Penile haemorrhage 55.38 10.62 28 200516 504 70727396
Chills 55.37 10.62 216 200328 144570 70583330
Urogenital haemorrhage 55.27 10.62 32 200512 762 70727138
White blood cell count decreased 55.23 10.62 270 200274 169871 70558029
Pregnancy 54.92 10.62 3 200541 23778 70704122
Peptic ulcer haemorrhage 54.80 10.62 33 200511 847 70727053
Therapy non-responder 54.57 10.62 83 200461 76832 70651068
Traumatic haematoma 54.35 10.62 45 200499 1937 70725963
Haemorrhagic erosive gastritis 54.02 10.62 28 200516 532 70727368
Gastrointestinal disorder 53.87 10.62 138 200406 105289 70622611
Hypertension 53.77 10.62 556 199988 295477 70432423
Peripheral artery occlusion 53.32 10.62 47 200497 2205 70725695
Fibromyalgia 53.04 10.62 35 200509 47839 70680061
Potentiating drug interaction 52.86 10.62 88 200456 8076 70719824
Peripheral ischaemia 52.21 10.62 91 200453 8667 70719233
Leukopenia 51.78 10.62 143 200401 106417 70621483
Drug resistance 51.00 10.62 22 200522 38168 70689732
Toxic epidermal necrolysis 50.93 10.62 24 200520 39533 70688367
Vascular stent thrombosis 50.66 10.62 56 200488 3467 70724433
Pharyngeal haemorrhage 50.66 10.62 36 200508 1231 70726669
Somnolence 50.61 10.62 379 200165 215227 70512673
Venous thrombosis limb 50.53 10.62 60 200484 4015 70723885
Intra-abdominal haemorrhage 50.49 10.62 61 200483 4157 70723743
Hepatotoxicity 50.32 10.62 31 200513 43955 70683945
Injection site swelling 49.95 10.62 30 200514 43127 70684773
Peripheral artery thrombosis 49.65 10.62 53 200491 3154 70724746
Skin haemorrhage 49.64 10.62 97 200447 10083 70717817
Irritability 49.51 10.62 23 200521 38202 70689698
Lymphocyte count decreased 49.37 10.62 31 200513 43508 70684392
Emotional distress 48.75 10.62 22 200522 37166 70690734
Cerebral vascular occlusion 48.47 10.62 13 200531 28 70727872
Drug withdrawal syndrome 48.44 10.62 16 200528 32699 70695201
Pulmonary thrombosis 47.77 10.62 101 200443 11107 70716793
Atrial flutter 47.61 10.62 146 200398 20181 70707719
Polyp 47.38 10.62 78 200466 7092 70720808
Respiratory depression 47.08 10.62 7 200537 24824 70703076
Inappropriate schedule of product administration 46.51 10.62 487 200057 107068 70620832
Presyncope 46.10 10.62 219 200325 37219 70690681
Putamen haemorrhage 45.98 10.62 24 200520 463 70727437
Retinal haemorrhage 45.82 10.62 80 200464 7630 70720270
Product use issue 45.78 10.62 309 200235 179628 70548272
Diverticulum 45.70 10.62 112 200432 13581 70714319
Disease progression 45.60 10.62 258 200286 156414 70571486
Rhabdomyolysis 45.43 10.62 130 200414 95630 70632270
Purpura 44.83 10.62 132 200412 17843 70710057
Prothrombin time shortened 44.45 10.62 48 200496 2894 70725006
Myelosuppression 44.19 10.62 15 200529 30130 70697770
Intentional product use issue 44.18 10.62 182 200362 119960 70607940
Brain herniation 43.73 10.62 74 200470 6882 70721018
Ear haemorrhage 43.45 10.62 40 200504 1987 70725913
Bladder tamponade 43.36 10.62 24 200520 523 70727377
Cardiac ablation 43.27 10.62 40 200504 1998 70725902
Injection site pruritus 42.99 10.62 29 200515 39181 70688719
Pulmonary hypertension 42.72 10.62 251 200293 46285 70681615
Haemoperitoneum 42.54 10.62 55 200489 4016 70723884
Salpingo-oophorectomy unilateral 42.28 10.62 25 200519 620 70727280
Constipation 42.26 10.62 483 200061 251955 70475945
Stress 42.09 10.62 80 200464 67886 70660014
Prostatic haemorrhage 42 10.62 16 200528 139 70727761
Vitreous haemorrhage 41.92 10.62 50 200494 3362 70724538
Arteriovenous malformation 41.85 10.62 36 200508 1634 70726266
Product administration error 41.81 10.62 180 200364 29343 70698557
Neurotoxicity 41.75 10.62 16 200528 29810 70698090
Renal haematoma 41.45 10.62 26 200518 719 70727181
Migraine 41.35 10.62 89 200455 72149 70655751
Gastrointestinal angiodysplasia 41.31 10.62 29 200515 972 70726928
Rhinorrhoea 41.21 10.62 78 200466 66293 70661607
Bleeding varicose vein 41.03 10.62 23 200521 514 70727386
Hypersensitivity vasculitis 40.82 10.62 71 200473 6751 70721149
Labelled drug-disease interaction medication error 40.68 10.62 19 200525 285 70727615
Sepsis 40.51 10.62 469 200075 244076 70483824
Anal haemorrhage 40.36 10.62 52 200492 3784 70724116
Splenic haematoma 40.33 10.62 19 200525 291 70727609
Mesenteric haemorrhage 39.89 10.62 13 200531 67 70727833
Psychotic disorder 39.86 10.62 29 200515 37672 70690228
Mesenteric artery thrombosis 39.79 10.62 23 200521 546 70727354
Pancytopenia 39.69 10.62 257 200287 150850 70577050
Contraindicated product administered 39.53 10.62 221 200323 134391 70593509
Sleep disorder 39.24 10.62 87 200457 69785 70658115
Anticoagulation drug level decreased 39.09 10.62 16 200528 171 70727729
Subgaleal haematoma 38.97 10.62 13 200531 73 70727827
Coagulation factor X level increased 38.97 10.62 8 200536 0 70727900
Foot deformity 38.75 10.62 6 200538 20649 70707251
Brain stem infarction 38.59 10.62 36 200508 1819 70726081
Hydrocephalus 38.17 10.62 76 200468 8009 70719891
Red blood cell sedimentation rate increased 37.98 10.62 32 200512 38610 70689290
Lower respiratory tract infection 37.82 10.62 175 200369 111738 70616162
Multiple organ dysfunction syndrome 37.68 10.62 168 200376 108347 70619553
Ulcer haemorrhage 37.62 10.62 56 200488 4669 70723231
Pallor 37.61 10.62 221 200323 40753 70687147
Oral herpes 37.29 10.62 11 200533 24175 70703725
Peripheral arterial occlusive disease 37.16 10.62 72 200472 7437 70720463
White blood cell count increased 37.15 10.62 89 200455 69484 70658416
Malignant neoplasm progression 36.77 10.62 198 200346 121541 70606359
Anovulatory cycle 36.71 10.62 14 200530 122 70727778
Intentional self-injury 36.63 10.62 22 200522 31628 70696272
Haemorrhagic infarction 36.59 10.62 24 200520 718 70727182
Back pain 36.49 10.62 543 200001 270609 70457291
Puncture site haemorrhage 36.48 10.62 22 200522 566 70727334
Penis injury 36.42 10.62 14 200530 125 70727775
Coagulation test abnormal 36.41 10.62 29 200515 1181 70726719
Anticoagulation drug level above therapeutic 35.81 10.62 45 200499 3193 70724707
Aortic aneurysm rupture 35.80 10.62 29 200515 1210 70726690
Brain natriuretic peptide abnormal 35.61 10.62 23 200521 670 70727230
Diverticulitis intestinal haemorrhagic 35.60 10.62 20 200524 449 70727451
Bradycardia 35.60 10.62 522 200022 124093 70603807
Gastrointestinal angiectasia 35.43 10.62 19 200525 388 70727512
Blood glucose increased 35.42 10.62 160 200384 102822 70625078
Mesenteric artery embolism 35.31 10.62 12 200532 72 70727828
Hypoaesthesia 35.23 10.62 272 200272 153467 70574433
Dry eye 35.23 10.62 24 200520 32258 70695642
Coagulation time prolonged 35.14 10.62 37 200507 2167 70725733
Arthritis 35.05 10.62 150 200394 97830 70630070
COVID-19 34.78 10.62 167 200377 105590 70622310
Arterial thrombosis 34.73 10.62 39 200505 2457 70725443
Oropharyngeal pain 34.72 10.62 147 200397 96163 70631737
Renal infarct 34.21 10.62 39 200505 2498 70725402
Haematoma infection 34.08 10.62 30 200514 1405 70726495
Intra-abdominal haematoma 33.98 10.62 40 200504 2652 70725248
Urticaria 33.49 10.62 297 200247 162752 70565148
Neutrophil count increased 33.37 10.62 17 200527 26778 70701122
Osteopenia 33.34 10.62 4 200540 16693 70711207
Anastomotic ulcer haemorrhage 33.26 10.62 12 200532 88 70727812
Product monitoring error 32.36 10.62 64 200480 6712 70721188
Intentional product misuse 32.20 10.62 116 200428 79479 70648421
C-reactive protein abnormal 32.09 10.62 37 200507 38542 70689358
Bone erosion 31.92 10.62 3 200541 15170 70712730
Erythema 31.78 10.62 386 200158 199177 70528723
Rectal polyp 31.33 10.62 29 200515 1451 70726449
Chronic gastrointestinal bleeding 31.27 10.62 18 200526 424 70727476
Intracranial haematoma 31.26 10.62 23 200521 831 70727069
Joint stiffness 31.18 10.62 32 200512 35144 70692756
Device related thrombosis 30.98 10.62 36 200508 2354 70725546
Tumour haemorrhage 30.91 10.62 45 200499 3677 70724223
Vomiting 30.84 10.62 1367 199177 591744 70136156
Post thrombotic syndrome 30.71 10.62 20 200524 591 70727309
Brain compression 30.66 10.62 19 200525 514 70727386
Periorbital haemorrhage 30.65 10.62 14 200530 199 70727701
Lymphadenopathy 30.59 10.62 57 200487 48734 70679166
Wound haematoma 30.57 10.62 13 200531 154 70727746
Oesophageal haemorrhage 30.42 10.62 30 200514 1625 70726275
Respiratory arrest 30.41 10.62 67 200477 53866 70674034
Respiratory symptom 30.37 10.62 45 200499 3736 70724164
Weight decreased 30.30 10.62 658 199886 309830 70418070
Abnormal behaviour 30.29 10.62 32 200512 34677 70693223
Blood blister 30.28 10.62 38 200506 2693 70725207
Multiple sclerosis 30.08 10.62 17 200527 25268 70702632
Hypercoagulation 29.97 10.62 38 200506 2721 70725179
Blood pressure increased 29.88 10.62 365 200179 188152 70539748
Abdominal wall haemorrhage 29.78 10.62 20 200524 623 70727277
Hepatic steatosis 29.70 10.62 31 200513 33782 70694118
Hypercalcaemia 29.67 10.62 32 200512 34353 70693547
Pruritus 29.63 10.62 747 199797 344813 70383087
Blood creatine phosphokinase increased 29.17 10.62 83 200461 61180 70666720
Bradyarrhythmia 28.86 10.62 45 200499 3908 70723992
Osteonecrosis 28.84 10.62 24 200520 29136 70698764
Menometrorrhagia 28.82 10.62 20 200524 658 70727242
Arrhythmia 28.55 10.62 263 200281 55880 70672020
Dystonia 28.55 10.62 10 200534 19696 70708204
Injection site warmth 28.39 10.62 3 200541 13822 70714078
Pancreatitis 28.33 10.62 87 200457 62581 70665319
Body temperature increased 28.24 10.62 43 200501 39791 70688109
Bronchopulmonary aspergillosis 28.20 10.62 12 200532 20990 70706910
Asthma 28.01 10.62 213 200331 120580 70607320
Haematotoxicity 28.00 10.62 3 200541 13671 70714229
Withdrawal syndrome 27.87 10.62 18 200526 24886 70703014
Thrombotic stroke 27.81 10.62 20 200524 697 70727203
Lacunar stroke 27.64 10.62 15 200529 314 70727586
Influenza 27.55 10.62 198 200346 113502 70614398
Periorbital haematoma 27.49 10.62 22 200522 902 70726998
Serotonin syndrome 27.48 10.62 48 200496 42066 70685834
Subcapsular renal haematoma 27.41 10.62 20 200524 713 70727187
Premature delivery 27.31 10.62 13 200531 21291 70706609
Oesophagitis haemorrhagic 27.25 10.62 19 200525 630 70727270
Cardiac pacemaker insertion 27.19 10.62 52 200492 5320 70722580
Carotid artery occlusion 27.15 10.62 45 200499 4114 70723786
Confusional state 27.08 10.62 605 199939 283793 70444107
Blood calcium decreased 27.01 10.62 25 200519 28821 70699079
Pathogen resistance 26.97 10.62 3 200541 13276 70714624
Retinal vascular thrombosis 26.96 10.62 12 200532 160 70727740
Pseudomonas infection 26.90 10.62 10 200534 18984 70708916
Mallory-Weiss syndrome 26.85 10.62 35 200509 2576 70725324
Muscle spasticity 26.84 10.62 11 200533 19678 70708222
Haemophagocytic lymphohistiocytosis 26.66 10.62 11 200533 19601 70708299
Oral candidiasis 26.63 10.62 19 200525 24933 70702967
Osteonecrosis of jaw 26.51 10.62 47 200497 40955 70686945
Incorrect dosage administered 26.35 10.62 33 200511 2334 70725566
Neuroleptic malignant syndrome 26.22 10.62 21 200523 25986 70701914
Creatinine renal clearance abnormal 26.20 10.62 17 200527 499 70727401
Photophobia 26.11 10.62 10 200534 18640 70709260
Bleeding time prolonged 25.87 10.62 24 200520 1204 70726696
Aneurysm ruptured 25.74 10.62 21 200523 885 70727015
Night sweats 25.68 10.62 53 200491 43631 70684269
International normalised ratio abnormal 25.59 10.62 50 200494 5197 70722703
Urethral haemorrhage 25.44 10.62 15 200529 370 70727530
Osteomyelitis 25.30 10.62 29 200515 30289 70697611
Mood swings 25.28 10.62 10 200534 18276 70709624
Lymphopenia 25.27 10.62 24 200520 27335 70700565
Influenza like illness 25.26 10.62 97 200447 65234 70662666
Chest wall haematoma 25.15 10.62 15 200529 378 70727522
N-terminal prohormone brain natriuretic peptide increased 25.01 10.62 42 200502 3882 70724018
Prescribed overdose 24.93 10.62 24 200520 27157 70700743
Haemodialysis 24.84 10.62 9 200535 17357 70710543
Haematospermia 24.80 10.62 13 200531 253 70727647
Haemorrhoids 24.78 10.62 140 200404 25448 70702452
Sinusitis fungal 24.71 10.62 30 200514 2055 70725845
Sinus tachycardia 24.63 10.62 36 200508 33877 70694023
Asthenia 24.51 10.62 1553 198991 456113 70271787
Traumatic haemothorax 24.50 10.62 15 200529 397 70727503
Conjunctivitis 24.47 10.62 17 200527 22619 70705281
Grip strength decreased 24.43 10.62 7 200537 15678 70712222
Angioedema 24.42 10.62 101 200443 66509 70661391
Akathisia 24.41 10.62 3 200541 12290 70715610
Mania 24.39 10.62 9 200535 17165 70710735
Right ventricular failure 24.37 10.62 126 200418 22148 70705752
Antiphospholipid syndrome 24.34 10.62 27 200517 1678 70726222
Accidental exposure to product 24.32 10.62 26 200518 28025 70699875
Drug ineffective 24.31 10.62 2308 198236 937444 69790456
Basal cell carcinoma 24.25 10.62 36 200508 33662 70694238
Progressive multifocal leukoencephalopathy 24.21 10.62 12 200532 19202 70708698
Fluid retention 24.18 10.62 280 200264 63105 70664795
Crying 24.16 10.62 15 200529 21184 70706716
Anaphylactic shock 24.08 10.62 34 200510 32456 70695444
Craniocerebral injury 23.93 10.62 45 200499 4546 70723354
Spinal subdural haematoma 23.88 10.62 12 200532 213 70727687
Osteoarthritis 23.85 10.62 118 200426 74029 70653871
Extra dose administered 23.73 10.62 59 200485 7218 70720682
Anger 23.69 10.62 8 200536 16124 70711776
Female genital tract fistula 23.60 10.62 36 200508 3067 70724833
Mental disorder 23.58 10.62 27 200517 28213 70699687
Aplastic anaemia 23.34 10.62 9 200535 16707 70711193
Diabetes mellitus 23.27 10.62 114 200430 71710 70656190
Injury 23.26 10.62 100 200444 65145 70662755
Hypertriglyceridaemia 23.17 10.62 3 200541 11808 70716092
Poisoning 23.15 10.62 18 200526 22604 70705296
Duodenitis haemorrhagic 23.11 10.62 10 200534 124 70727776
Paranoia 23.02 10.62 10 200534 17278 70710622
Muscle spasms 23.01 10.62 302 200242 153744 70574156
Post-traumatic amnestic disorder 23.00 10.62 8 200536 52 70727848
Cytomegalovirus viraemia 22.84 10.62 3 200541 11682 70716218
Hypervolaemia 22.78 10.62 191 200353 39515 70688385
Thrombotic microangiopathy 22.71 10.62 11 200533 17837 70710063
Ear infection 22.69 10.62 28 200516 28308 70699592
Contraindicated product prescribed 22.61 10.62 24 200520 1419 70726481
Cardiac ventricular thrombosis 22.57 10.62 25 200519 1551 70726349
Drug reaction with eosinophilia and systemic symptoms 22.51 10.62 86 200458 57927 70669973
Hypogammaglobulinaemia 22.47 10.62 3 200541 11535 70716365
Cytokine release syndrome 22.43 10.62 25 200519 26442 70701458
Embolism arterial 22.43 10.62 23 200521 1306 70726594
Metabolic acidosis 22.40 10.62 121 200423 74225 70653675
Pruritus genital 22.35 10.62 21 200523 1071 70726829
Ventricle rupture 22.34 10.62 9 200535 92 70727808
Catheter site haemorrhage 22.31 10.62 45 200499 4786 70723114
Sciatica 22.29 10.62 22 200522 24605 70703295
Type 2 diabetes mellitus 22.28 10.62 58 200486 44022 70683878
Viral infection 22.22 10.62 47 200497 38344 70689556
Cerebral amyloid angiopathy 22.11 10.62 13 200531 319 70727581
Abdominal pain 21.98 10.62 769 199775 341358 70386542
Diabetes mellitus inadequate control 21.95 10.62 19 200525 22626 70705274
Throat tightness 21.91 10.62 23 200521 24999 70702901
Renal tubular necrosis 21.79 10.62 20 200524 23151 70704749
Upper respiratory tract infection 21.75 10.62 133 200411 79141 70648759
Bursitis 21.73 10.62 26 200518 26647 70701253
Nodule 21.58 10.62 15 200529 19954 70707946
Hypophagia 21.55 10.62 54 200490 41516 70686384
Cerebellar haematoma 21.46 10.62 16 200528 590 70727310
Intracranial mass 21.32 10.62 28 200516 2076 70725824
Vascular graft thrombosis 21.32 10.62 11 200533 207 70727693
Vision blurred 21.31 10.62 169 200375 94815 70633085
Mucosal haemorrhage 21.29 10.62 30 200514 2379 70725521
Aspergillus infection 21.27 10.62 12 200532 17856 70710044
Nephropathy toxic 21.24 10.62 13 200531 18501 70709399
Hypocalcaemia 21.19 10.62 61 200483 44798 70683102
Soft tissue haemorrhage 21.17 10.62 13 200531 346 70727554
Large intestine polyp 21.14 10.62 76 200468 11400 70716500
Hysterectomy 21.00 10.62 48 200496 5564 70722336
Status epilepticus 20.97 10.62 23 200521 24503 70703397
Phlebitis deep 20.96 10.62 6 200538 18 70727882
Facial paralysis 20.95 10.62 111 200433 19697 70708203
Facial paresis 20.92 10.62 45 200499 5008 70722892
Vena cava thrombosis 20.87 10.62 31 200513 2579 70725321
Quadriplegia 20.84 10.62 34 200510 3068 70724832
Injection site bruising 20.83 10.62 48 200496 37984 70689916
Pneumocystis jirovecii pneumonia 20.82 10.62 33 200511 30049 70697851
Catheter management 20.70 10.62 36 200508 3423 70724477
Cardiac failure acute 20.59 10.62 101 200443 17386 70710514
Mydriasis 20.49 10.62 10 200534 16143 70711757
Encephalopathy 20.49 10.62 97 200447 61564 70666336
Stent placement 20.46 10.62 50 200494 6051 70721849
Neutropenic sepsis 20.45 10.62 24 200520 24806 70703094
CHA2DS2-VASc annual stroke risk high 20.43 10.62 5 200539 6 70727894
Dysphagia 20.41 10.62 212 200332 112622 70615278
Tricuspid valve incompetence 20.34 10.62 102 200442 17715 70710185
Basilar artery thrombosis 20.33 10.62 13 200531 372 70727528
Lupus-like syndrome 20.17 10.62 4 200540 11511 70716389
Anti factor X activity increased 20.10 10.62 8 200536 79 70727821
Petechiae 19.98 10.62 107 200437 19065 70708835
Normochromic normocytic anaemia 19.88 10.62 54 200490 6969 70720931
Hemianopia 19.80 10.62 24 200520 1641 70726259
Panic attack 19.74 10.62 20 200524 22099 70705801
Haematotympanum 19.64 10.62 6 200538 24 70727876
Injection site rash 19.57 10.62 11 200533 16399 70711501
Blood pressure fluctuation 19.51 10.62 93 200451 58919 70668981
Tumour lysis syndrome 19.43 10.62 19 200525 21341 70706559
Thrombophlebitis 19.33 10.62 48 200496 5868 70722032
Gait disturbance 19.29 10.62 388 200156 184718 70543182
Tenderness 19.14 10.62 19 200525 21191 70706709
Acute myocardial infarction 19.13 10.62 301 200243 72586 70655314
Staphylococcal infection 18.94 10.62 82 200462 53322 70674578
Hyperhomocysteinaemia 18.94 10.62 13 200531 420 70727480
Memory impairment 18.90 10.62 169 200375 92472 70635428
Sputum increased 18.89 10.62 38 200506 4034 70723866
Adverse drug reaction 18.87 10.62 82 200462 53262 70674638
Oxygen saturation increased 18.81 10.62 14 200530 515 70727385
Orthopnoea 18.79 10.62 64 200480 9344 70718556
Protein C deficiency 18.73 10.62 6 200538 29 70727871
Abnormal withdrawal bleeding 18.73 10.62 6 200538 29 70727871
Therapy partial responder 18.64 10.62 6 200538 12468 70715432
Pharyngitis 18.63 10.62 18 200526 20333 70707567
Intentional overdose 18.61 10.62 183 200361 98252 70629648
Colon cancer 18.58 10.62 85 200459 14221 70713679
Monoparesis 18.57 10.62 33 200511 3191 70724709
Arrhythmogenic right ventricular dysplasia 18.56 10.62 6 200538 30 70727870
Pulmonary endarterectomy 18.44 10.62 10 200534 209 70727691
Fear 18.37 10.62 19 200525 20792 70707108
Subarachnoid haematoma 18.36 10.62 8 200536 101 70727799
Interstitial lung disease 18.33 10.62 406 200138 104279 70623621
Chronic gastritis 18.32 10.62 35 200509 3578 70724322
Meningorrhagia 18.31 10.62 11 200533 281 70727619
Neuralgia 18.30 10.62 33 200511 28570 70699330
Depressed mood 18.30 10.62 63 200481 43757 70684143
Retinal vein thrombosis 18.29 10.62 15 200529 637 70727263
Cardio-respiratory arrest 18.28 10.62 189 200355 100488 70627412
Monoplegia 18.20 10.62 35 200509 3596 70724304
Oral pain 18.18 10.62 34 200510 29032 70698868
Cerebral thrombosis 18.16 10.62 27 200517 2249 70725651
Supine hypertension 18.06 10.62 12 200532 367 70727533
Post procedural stroke 18.02 10.62 8 200536 106 70727794
Cognitive disorder 17.93 10.62 100 200444 60856 70667044
Therapeutic procedure 17.91 10.62 16 200528 764 70727136
Encephalitis 17.86 10.62 8 200536 13577 70714323
Laryngeal haematoma 17.85 10.62 9 200535 161 70727739
Proteinuria 17.81 10.62 35 200509 29339 70698561
Acute myeloid leukaemia 17.80 10.62 38 200506 30902 70696998
Hepatitis C 17.71 10.62 7 200537 12800 70715100
Breast cancer female 17.64 10.62 4 200540 10482 70717418
Uveitis 17.63 10.62 10 200534 14835 70713065
Pancreatitis acute 17.57 10.62 67 200477 45157 70682743
Platelet dysfunction 17.53 10.62 12 200532 386 70727514
Ear pain 17.51 10.62 32 200512 27567 70700333
Post procedural oedema 17.51 10.62 7 200537 70 70727830
Oesophageal ulcer haemorrhage 17.43 10.62 14 200530 577 70727323
Wheezing 17.42 10.62 176 200368 93994 70633906
Medical device site haemorrhage 17.36 10.62 9 200535 171 70727729
Generalised tonic-clonic seizure 17.33 10.62 60 200484 41601 70686299
Aortic intramural haematoma 17.31 10.62 8 200536 117 70727783
Peritoneal haematoma 17.27 10.62 9 200535 173 70727727
No adverse event 17.27 10.62 41 200503 32112 70695788
Parkinsonism 17.25 10.62 11 200533 15314 70712586
Aphthous ulcer 17.23 10.62 10 200534 14646 70713254
Tenosynovitis 17.20 10.62 9 200535 13967 70713933
Paraplegia 17.20 10.62 40 200504 4690 70723210
Hypoglycaemia 17.19 10.62 177 200367 94187 70633713
Feeling hot 17.10 10.62 75 200469 48595 70679305
Skin ulcer haemorrhage 17.10 10.62 13 200531 494 70727406
Thrombotic cerebral infarction 17.07 10.62 13 200531 495 70727405
Vascular access site occlusion 17.00 10.62 7 200537 76 70727824
Cholecystitis chronic 16.97 10.62 3 200541 9373 70718527
Cerebral artery thrombosis 16.88 10.62 18 200526 1070 70726830
Post procedural haematuria 16.87 10.62 10 200534 249 70727651
Anticoagulant-related nephropathy 16.87 10.62 6 200538 42 70727858
Spontaneous haemorrhage 16.83 10.62 13 200531 506 70727394
Coronary artery disease 16.82 10.62 106 200438 62630 70665270
Affect lability 16.81 10.62 4 200540 10142 70717758
Catheter site discharge 16.73 10.62 26 200518 2251 70725649
Venous haemorrhage 16.66 10.62 11 200533 333 70727567
Perforated ulcer 16.63 10.62 14 200530 617 70727283
Delirium 16.62 10.62 133 200411 74481 70653419
Hypotension 16.60 10.62 1343 199201 403038 70324862
Fractured coccyx 16.55 10.62 17 200527 967 70726933
Tendonitis 16.54 10.62 23 200521 22099 70705801
Hemianopia homonymous 16.50 10.62 19 200525 1230 70726670
Injection site induration 16.45 10.62 3 200541 9165 70718735
Septic shock 16.42 10.62 221 200323 112037 70615863
Neuropathy peripheral 16.40 10.62 256 200288 126640 70601260
Post procedural pulmonary embolism 16.35 10.62 10 200534 264 70727636
Myoclonus 16.33 10.62 31 200513 26324 70701576
Diverticulum intestinal 16.33 10.62 55 200489 7986 70719914
Traumatic fracture 16.30 10.62 16 200528 862 70727038
Tuberculosis 16.25 10.62 11 200533 14837 70713063
Nasal polyps 16.21 10.62 38 200506 4478 70723422
Extrapyramidal disorder 16.10 10.62 21 200523 20729 70707171
Haemoglobin abnormal 16.06 10.62 47 200497 6330 70721570
Facial bones fracture 16.06 10.62 38 200506 4506 70723394
Lung diffusion disorder 16.02 10.62 8 200536 140 70727760
Gastrointestinal erosion 16.00 10.62 17 200527 1006 70726894
Thinking abnormal 16.00 10.62 7 200537 12044 70715856
Spinal osteoarthritis 15.97 10.62 12 200532 15336 70712564
Throat irritation 15.96 10.62 49 200495 35255 70692645
Brain contusion 15.96 10.62 19 200525 1275 70726625
Product label issue 15.95 10.62 14 200530 653 70727247
Subclavian vein thrombosis 15.92 10.62 26 200518 2348 70725552
Exsanguination 15.88 10.62 7 200537 91 70727809
Platelet aggregation inhibition 15.87 10.62 8 200536 143 70727757
Gastric pH increased 15.86 10.62 6 200538 51 70727849
Febrile bone marrow aplasia 15.86 10.62 7 200537 11984 70715916
Contraindication to surgery 15.84 10.62 4 200540 6 70727894
Scar 15.79 10.62 10 200534 13971 70713929
Sleep disorder due to a general medical condition 15.73 10.62 5 200539 10471 70717429
Spinal epidural haemorrhage 15.72 10.62 8 200536 146 70727754
Vascular purpura 15.68 10.62 28 200516 2718 70725182
Nightmare 15.62 10.62 24 200520 22132 70705768
Hemianaesthesia 15.60 10.62 12 200532 464 70727436
Tongue haemorrhage 15.60 10.62 16 200528 909 70726991
Dental care 15.56 10.62 15 200529 790 70727110
Diabetic ketoacidosis 15.52 10.62 42 200502 31470 70696430
Colitis 15.52 10.62 111 200433 63703 70664197
Bladder neoplasm 15.51 10.62 21 200523 1604 70726296
Dry mouth 15.51 10.62 126 200418 70331 70657569
Electrocardiogram QRS complex abnormal 15.50 10.62 13 200531 570 70727330
Impaired work ability 15.49 10.62 14 200530 16326 70711574
Cardiac vein perforation 15.47 10.62 5 200539 25 70727875
Heart rate irregular 15.46 10.62 140 200404 29603 70698297
Osteorrhagia 15.46 10.62 4 200540 7 70727893
Pharyngeal oedema 15.42 10.62 13 200531 15683 70712217
Hot flush 15.32 10.62 80 200464 49504 70678396
Myopathy 15.32 10.62 18 200526 18594 70709306
Vascular pseudoaneurysm ruptured 15.29 10.62 8 200536 155 70727745
Disability 15.23 10.62 12 200532 14971 70712929
Cardiac valve replacement complication 15.19 10.62 9 200535 224 70727676
Haemorrhagic disorder 15.19 10.62 20 200524 1487 70726413
Peritonitis 15.16 10.62 32 200512 26127 70701773
Mesenteric haematoma 15.15 10.62 5 200539 27 70727873
Palmar-plantar erythrodysaesthesia syndrome 15.13 10.62 40 200504 30207 70697693
Emergency care 15.13 10.62 16 200528 942 70726958
Osteoporosis 15.06 10.62 79 200465 48828 70679072
Basal ganglia stroke 15.02 10.62 8 200536 161 70727739
Implant site haematoma 15.02 10.62 8 200536 161 70727739
Headache 15.01 10.62 1425 199119 578980 70148920
Acne 14.96 10.62 30 200514 24959 70702941
Brain natriuretic peptide increased 14.95 10.62 54 200490 8117 70719783
Coordination abnormal 14.95 10.62 14 200530 16052 70711848
Blood product transfusion dependent 14.94 10.62 11 200533 398 70727502
Breast cancer 14.86 10.62 47 200497 33502 70694398
Incorrect route of product administration 14.86 10.62 33 200511 26459 70701441
Hyperlipidaemia 14.85 10.62 28 200516 23835 70704065
Renal embolism 14.85 10.62 8 200536 165 70727735
Diffuse vasculitis 14.75 10.62 7 200537 109 70727791
Rhinitis allergic 14.75 10.62 4 200540 9291 70718609
Thrombocytosis 14.72 10.62 52 200492 7732 70720168
Miosis 14.71 10.62 11 200533 14090 70713810
Pulmonary artery thrombosis 14.69 10.62 18 200526 1245 70726655
Spinal subdural haemorrhage 14.61 10.62 3 200541 0 70727900
Atrio-oesophageal fistula 14.61 10.62 3 200541 0 70727900
Orthostatic heart rate response increased 14.61 10.62 3 200541 0 70727900
Pulmonary haematoma 14.58 10.62 7 200537 112 70727788
Anticoagulant therapy 14.57 10.62 5 200539 31 70727869
Fibrin D dimer increased 14.55 10.62 50 200494 7333 70720567
Monocyte count increased 14.55 10.62 4 200540 9205 70718695
Manufacturing materials issue 14.50 10.62 4 200540 10 70727890
Pulmonary microemboli 14.50 10.62 4 200540 10 70727890
Chondrocalcinosis 14.50 10.62 14 200530 739 70727161
Peritonitis bacterial 14.49 10.62 4 200540 9180 70718720
Muscle rigidity 14.34 10.62 19 200525 18631 70709269
Product storage error 14.34 10.62 12 200532 14529 70713371
Swollen tongue 14.32 10.62 55 200489 36991 70690909
Drug tolerance decreased 14.23 10.62 5 200539 9828 70718072
Tongue disorder 14.21 10.62 10 200534 13217 70714683
Emotional disorder 14.21 10.62 10 200534 13216 70714684
Subclavian artery thrombosis 14.18 10.62 5 200539 34 70727866
Coeliac disease 14.13 10.62 4 200540 9029 70718871
Pulmonary arterial pressure increased 14.12 10.62 35 200509 4274 70723626
Hypertrophic osteoarthropathy 14.10 10.62 7 200537 121 70727779
Hyperglycaemia 14.07 10.62 116 200428 64556 70663344
Application site haematoma 14.04 10.62 6 200538 72 70727828
Disorientation 13.96 10.62 101 200443 57822 70670078
Atelectasis 13.96 10.62 39 200505 28923 70698977
Hiatus hernia 13.95 10.62 105 200439 21029 70706871
Visual acuity reduced 13.92 10.62 37 200507 27893 70700007
Respiratory disorder 13.92 10.62 60 200484 39063 70688837
Prothrombin time ratio decreased 13.92 10.62 14 200530 777 70727123
Ovarian cyst 13.88 10.62 8 200536 11764 70716136
Pharyngeal haematoma 13.75 10.62 7 200537 128 70727772
Myelodysplastic syndrome 13.71 10.62 41 200503 29744 70698156
Alanine aminotransferase abnormal 13.70 10.62 3 200541 8056 70719844
Spinal epidural haematoma 13.70 10.62 18 200526 1335 70726565
Acidosis 13.64 10.62 19 200525 18244 70709656
Gastroenteritis 13.63 10.62 44 200500 31169 70696731
Diarrhoea 13.63 10.62 1975 198569 781366 69946534
Endocarditis noninfective 13.62 10.62 8 200536 196 70727704
Mucormycosis 13.59 10.62 3 200541 8011 70719889
Chronic kidney disease 13.52 10.62 109 200435 60948 70666952
Carpal tunnel syndrome 13.50 10.62 17 200527 17040 70710860
Reversible ischaemic neurological deficit 13.48 10.62 5 200539 40 70727860
Duodenitis 13.44 10.62 47 200497 6955 70720945
Infarction 13.42 10.62 34 200510 4208 70723692
Hepatic haematoma 13.38 10.62 14 200530 814 70727086
Paresis cranial nerve 13.38 10.62 5 200539 41 70727859
Oedema genital 13.38 10.62 11 200533 469 70727431
Mediastinal haematoma 13.37 10.62 8 200536 203 70727697
Colitis ulcerative 13.35 10.62 50 200494 33873 70694027
Immunosuppressant drug level increased 13.33 10.62 3 200541 7904 70719996
Ocular retrobulbar haemorrhage 13.32 10.62 7 200537 137 70727763
Myalgia 13.29 10.62 367 200177 167525 70560375
Bone density decreased 13.24 10.62 8 200536 11466 70716434
Enterococcal infection 13.23 10.62 13 200531 14569 70713331
Circulatory collapse 13.21 10.62 156 200388 35318 70692582
Blood triglycerides increased 13.21 10.62 22 200522 19642 70708258
Posterior reversible encephalopathy syndrome 13.20 10.62 31 200513 24371 70703529
Depressed level of consciousness 13.20 10.62 171 200373 87260 70640640
Incision site haematoma 13.18 10.62 7 200537 140 70727760
Hemiataxia 13.17 10.62 5 200539 43 70727857
Central nervous system haemorrhage 13.11 10.62 9 200535 291 70727609
Vulval haemorrhage 13.09 10.62 4 200540 16 70727884
Thoracic haemorrhage 13.09 10.62 8 200536 211 70727689
Aortic valve calcification 13.05 10.62 13 200531 713 70727187
Brain stem stroke 13.00 10.62 12 200532 598 70727302
Troponin increased 12.99 10.62 86 200458 16528 70711372
Idiopathic interstitial pneumonia 12.96 10.62 8 200536 215 70727685
Suicide attempt 12.95 10.62 153 200391 79357 70648543
Eye pain 12.94 10.62 51 200493 34051 70693849
Cerebral microhaemorrhage 12.92 10.62 8 200536 216 70727684
Lymphostasis 12.90 10.62 4 200540 17 70727883
Pneumonia fungal 12.87 10.62 6 200538 9947 70717953
Amaurosis fugax 12.85 10.62 14 200530 853 70727047
Blood thyroid stimulating hormone abnormal 12.85 10.62 14 200530 853 70727047
Dyskinesia 12.84 10.62 66 200478 41008 70686892
Vascular operation 12.84 10.62 7 200537 148 70727752
Duodenal polyp 12.81 10.62 9 200535 302 70727598
Prosthetic cardiac valve thrombosis 12.78 10.62 5 200539 47 70727853
Ventricular drainage 12.72 10.62 4 200540 18 70727882
Klebsiella infection 12.67 10.62 13 200531 14279 70713621
Dental caries 12.60 10.62 8 200536 11163 70716737
Diarrhoea haemorrhagic 12.59 10.62 66 200478 11664 70716236
Severe invasive streptococcal infection 12.54 10.62 3 200541 3 70727897
Transient epileptic amnesia 12.54 10.62 3 200541 3 70727897
Laryngitis 12.54 10.62 12 200532 13619 70714281
Bacterial infection 12.53 10.62 36 200508 26456 70701444
Pelvic haemorrhage 12.51 10.62 7 200537 156 70727744
Tooth socket haemorrhage 12.50 10.62 6 200538 96 70727804
Postoperative thrombosis 12.47 10.62 7 200537 157 70727743
Tracheal haemorrhage 12.45 10.62 12 200532 632 70727268
Spinal cord compression 12.44 10.62 41 200503 5887 70722013
Large intestinal ulcer haemorrhage 12.43 10.62 9 200535 317 70727583
Hypothyroidism 12.42 10.62 77 200467 45678 70682222
Immunodeficiency 12.39 10.62 19 200525 17536 70710364
Rales 12.38 10.62 87 200457 17048 70710852
Varicose vein ruptured 12.33 10.62 6 200538 99 70727801
Bacteraemia 12.33 10.62 42 200502 29267 70698633
Hypoalbuminaemia 12.29 10.62 22 200522 19100 70708800
Therapeutic product ineffective 12.29 10.62 19 200525 1638 70726262
Ankylosing spondylitis 12.26 10.62 9 200535 11637 70716263
Catheter site pruritus 12.22 10.62 22 200522 2149 70725751
Stevens-Johnson syndrome 12.21 10.62 56 200488 35851 70692049
Middle insomnia 12.21 10.62 13 200531 14040 70713860
Carotid artery aneurysm 12.21 10.62 8 200536 239 70727661
Glomerular filtration rate abnormal 12.21 10.62 18 200526 1488 70726412
Cor pulmonale acute 12.18 10.62 12 200532 649 70727251
Caesarean section 12.18 10.62 9 200535 11598 70716302
Nervousness 12.16 10.62 46 200498 31074 70696826
Hyponatraemia 12.15 10.62 352 200192 159735 70568165
Therapeutic response increased 12.09 10.62 11 200533 538 70727362
Musculoskeletal pain 12.09 10.62 181 200363 90146 70637754
Mental status changes 12.06 10.62 117 200427 62984 70664916
Cataract 12.02 10.62 100 200444 55545 70672355
Basal ganglia haematoma 12.01 10.62 5 200539 56 70727844
Movement disorder 12.00 10.62 32 200512 24097 70703803
Fistula 11.99 10.62 8 200536 10873 70717027
Retinal artery thrombosis 11.97 10.62 6 200538 106 70727794
Acute respiratory distress syndrome 11.96 10.62 68 200476 41186 70686714
Urinary tract infection 11.94 10.62 578 199966 248191 70479709
Gastrointestinal arteriovenous malformation 11.93 10.62 14 200530 925 70726975
Aortic aneurysm 11.92 10.62 49 200495 7824 70720076
Intervertebral disc protrusion 11.88 10.62 27 200517 21476 70706424
Pulmonary arterial pressure abnormal 11.87 10.62 12 200532 670 70727230
Hepatic function abnormal 11.79 10.62 129 200415 67867 70660033
Haemorrhagic hepatic cyst 11.78 10.62 5 200539 59 70727841
Cholestatic liver injury 11.75 10.62 32 200512 4136 70723764
Swelling face 11.70 10.62 118 200426 63046 70664854
Aortic thrombosis 11.70 10.62 18 200526 1545 70726355
Pain in extremity 11.63 10.62 785 199759 327297 70400603
Breast haematoma 11.61 10.62 7 200537 180 70727720
Hypoacusis 11.52 10.62 39 200505 27230 70700670
Gastrointestinal tract mucosal discolouration 11.50 10.62 4 200540 26 70727874
Coronary artery stenosis 11.47 10.62 64 200480 11580 70716320
Ammonia increased 11.46 10.62 3 200541 7135 70720765
Exercise tolerance decreased 11.46 10.62 50 200494 8198 70719702
Vascular graft occlusion 11.45 10.62 12 200532 699 70727201
Device expulsion 11.45 10.62 29 200515 22217 70705683
Jaundice acholuric 11.44 10.62 6 200538 117 70727783
Microvillous inclusion disease 11.41 10.62 5 200539 64 70727836
Melanaemia 11.41 10.62 5 200539 64 70727836
Shock 11.40 10.62 169 200375 40256 70687644
Sneezing 11.35 10.62 19 200525 16932 70710968
Myositis 11.35 10.62 20 200524 17469 70710431
Pancreatic neoplasm 11.34 10.62 17 200527 1426 70726474
Procedural pain 11.32 10.62 21 200523 17988 70709912
Aortic dissection 11.31 10.62 30 200514 3817 70724083
Fungal infection 11.27 10.62 61 200483 37406 70690494
Large intestine erosion 11.25 10.62 4 200540 28 70727872
Eosinophil count increased 11.21 10.62 16 200528 15206 70712694
Thirst 11.19 10.62 15 200529 14634 70713266
Salivary hypersecretion 11.18 10.62 12 200532 12913 70714987
Intracranial aneurysm 11.18 10.62 31 200513 4049 70723851
Toothache 11.14 10.62 22 200522 18408 70709492
Thrombectomy 11.12 10.62 8 200536 279 70727621
Brief psychotic disorder with marked stressors 11.09 10.62 8 200536 280 70727620
Gastroduodenal haemorrhage 11.09 10.62 8 200536 280 70727620
Gastroenteritis viral 11.02 10.62 28 200516 21427 70706473
Infective pericardial effusion 11.01 10.62 4 200540 30 70727870
Enteritis 11.00 10.62 12 200532 12819 70715081
Lacrimation increased 10.99 10.62 25 200519 19874 70708026
Product use in unapproved indication 10.98 10.62 477 200067 207001 70520899
Blood alkaline phosphatase increased 10.97 10.62 109 200435 58412 70669488
Prostate cancer 10.96 10.62 48 200496 31115 70696785
Photosensitivity reaction 10.92 10.62 24 200520 19316 70708584
Left ventricular dilatation 10.92 10.62 14 200530 1014 70726886
Drug ineffective for unapproved indication 10.91 10.62 64 200480 38474 70689426
Renal vascular thrombosis 10.89 10.62 5 200539 72 70727828
Muscle twitching 10.87 10.62 25 200519 19802 70708098
Hypoxia 10.85 10.62 192 200352 93152 70634748
Limb injury 10.84 10.62 116 200428 25636 70702264
Nipple exudate bloody 10.83 10.62 5 200539 73 70727827
Cardiovascular insufficiency 10.81 10.62 24 200520 2729 70725171
Nerve injury 10.79 10.62 5 200539 8319 70719581
Retinal artery embolism 10.79 10.62 6 200538 132 70727768
Bipolar disorder 10.78 10.62 4 200540 7604 70720296
Immunosuppression 10.71 10.62 10 200534 11482 70716418
Skull fractured base 10.71 10.62 8 200536 296 70727604
Blindness unilateral 10.67 10.62 45 200499 7268 70720632
Delusion 10.64 10.62 24 200520 19141 70708759
Cyanosis 10.64 10.62 32 200512 23174 70704726
Left ventricular dysfunction 10.63 10.62 87 200457 17870 70710030

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC B01AF01 BLOOD AND BLOOD FORMING ORGANS
ANTITHROMBOTIC AGENTS
ANTITHROMBOTIC AGENTS
Direct factor Xa inhibitors
MeSH PA D000925 Anticoagulants
MeSH PA D000991 Antithrombins
MeSH PA D004791 Enzyme Inhibitors
MeSH PA D065427 Factor Xa Inhibitors
MeSH PA D006401 Hematologic Agents
MeSH PA D011480 Protease Inhibitors
MeSH PA D015842 Serine Proteinase Inhibitors
FDA MoA N0000175635 Factor Xa Inhibitors
FDA EPC N0000175637 Factor Xa Inhibitor
CHEBI has role CHEBI:50249 anticoagulants
CHEBI has role CHEBI:68581 factor Xa inhibitors

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

DiseaseRelationSNOMED_IDDOID
Nonvalvular atrial fibrillation indication 49436004 DOID:0060224
Prevention of pulmonary embolism indication 59282003 DOID:9477
Pulmonary embolism indication 59282003 DOID:9477
Deep venous thrombosis indication 128053003
Prevention of stroke caused by a clot in a blood vessel in the brain indication 135875009
Prevention of systemic embolism caused by a clot in a blood vessel indication 414086009
Prevention of venous thromboembolism from re-occuring indication 429098002
Prevention of venous thromboembolism in undergoing surgery indication 429098002
Prevention of deep vein thrombosis indication 439993001
Peripheral arterial disease indication 840580004
Prevention of atherothrombotic events after an acute coronary syndrome indication
Prevention of atherothrombotic events at high risk of ischaemic events indication
Acute nephropathy contraindication 58574008
Hepatic failure contraindication 59927004
Blood coagulation disorder contraindication 64779008 DOID:1247
Kidney disease contraindication 90708001 DOID:557
Local anesthetic intrathecal block contraindication 231249005
Disease of liver contraindication 235856003 DOID:409
Procedure on spine contraindication 238181003
Lumbar puncture contraindication 277762005
Significant Bleeding contraindication
Placement of Epidural Catheter contraindication




🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 10.89 acidic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
10MG XARELTO JANSSEN PHARMS N022406 July 1, 2011 RX TABLET ORAL 7157456 Aug. 28, 2024 TREATMENT OF DEEP VEIN THROMBOSIS (DVT)
10MG XARELTO JANSSEN PHARMS N022406 July 1, 2011 RX TABLET ORAL 7157456 Aug. 28, 2024 TREATMENT OF PULMONARY EMBOLISM (PE)
15MG XARELTO JANSSEN PHARMS N022406 Nov. 4, 2011 RX TABLET ORAL 7157456 Aug. 28, 2024 TREATMENT OF DEEP VEIN THROMBOSIS (DVT)
15MG XARELTO JANSSEN PHARMS N022406 Nov. 4, 2011 RX TABLET ORAL 7157456 Aug. 28, 2024 TREATMENT OF PULMONARY EMBOLISM (PE)
20MG XARELTO JANSSEN PHARMS N022406 Nov. 4, 2011 RX TABLET ORAL 7157456 Aug. 28, 2024 TREATMENT OF DEEP VEIN THROMBOSIS (DVT)
20MG XARELTO JANSSEN PHARMS N022406 Nov. 4, 2011 RX TABLET ORAL 7157456 Aug. 28, 2024 TREATMENT OF PULMONARY EMBOLISM (PE)
10MG XARELTO JANSSEN PHARMS N022406 July 1, 2011 RX TABLET ORAL 9415053 Nov. 13, 2024 PROPHYLAXIS OF DEEP VEIN THROMBOSIS (DVT)
10MG XARELTO JANSSEN PHARMS N022406 July 1, 2011 RX TABLET ORAL 9415053 Nov. 13, 2024 PROPHYLAXIS OF THROMBOEMBOLIC DISEASES IN PEDIATRIC PATIENTS AGED 2 YEARS AND OLDER WITH CONGENITAL HEART DISEASE WHO HAVE UNDERGONE THE FONTAN PROCEDURE AND A BODY WEIGHT OF >=50 KG
10MG XARELTO JANSSEN PHARMS N022406 July 1, 2011 RX TABLET ORAL 9415053 Nov. 13, 2024 PROPHYLAXIS OF VENOUS THROMBOEMBOLISM IN ACUTELY ILL MEDICAL PATIENTS AT RISK FOR THROMBOEMBOLIC COMPLICATIONS NOT AT HIGH RISK OF BLEEDING
10MG XARELTO JANSSEN PHARMS N022406 July 1, 2011 RX TABLET ORAL 9415053 Nov. 13, 2024 REDUCTION IN THE RISK OF RECURRENCE OF DEEP VEIN THROMBOSIS (DVT) AND/OR PULMONARY EMBOLISM (PE) IN PATIENTS AT CONTINUED RISK FOR RECURRENT DVT AND/OR AFTER COMPLETION OF INITIAL TREATMENT LASTING AT LEAST 6 MONTHS
15MG XARELTO JANSSEN PHARMS N022406 Nov. 4, 2011 RX TABLET ORAL 9415053 Nov. 13, 2024 REDUCING THE RISK OF STROKE AND SYSTEMIC EMBOLISM
15MG XARELTO JANSSEN PHARMS N022406 Nov. 4, 2011 RX TABLET ORAL 9415053 Nov. 13, 2024 TREATMENT OF DEEP VEIN THROMBOSIS (DVT)
15MG XARELTO JANSSEN PHARMS N022406 Nov. 4, 2011 RX TABLET ORAL 9415053 Nov. 13, 2024 TREATMENT OF PULMONARY EMBOLISM (PE)
15MG XARELTO JANSSEN PHARMS N022406 Nov. 4, 2011 RX TABLET ORAL 9415053 Nov. 13, 2024 TREATMENT OF VENOUS THROMBOEMBOLISM (VTE) AND THE REDUCTION IN THE RISK OF RECURRENT VTE IN PEDIATRIC PATIENTS FROM BIRTH TO LESS THAN 18 YEARS WITH A BODY WEIGHT OF 30 KG TO 49.9 KG AFTER AT LEAST 5 DAYS OF INITIAL PARENTERAL ANTICOAGULANT TREATMENT
2.5MG XARELTO JANSSEN PHARMS N022406 Oct. 11, 2018 RX TABLET ORAL 9415053 Nov. 13, 2024 REDUCTION OF RISK OF MAJOR CARDIOVASCULAR EVENTS (CARDIOVASCULAR DEATH, MYOCARDIAL INFARCTION AND STROKE) IN PATIENTS WITH CAD
2.5MG XARELTO JANSSEN PHARMS N022406 Oct. 11, 2018 RX TABLET ORAL 9415053 Nov. 13, 2024 REDUCTION OF RISK OF MAJOR CARDIOVASCULAR EVENTS (CV DEATH, MI, AND STROKE) IN CHRONIC CAD OR PAD
2.5MG XARELTO JANSSEN PHARMS N022406 Oct. 11, 2018 RX TABLET ORAL 9415053 Nov. 13, 2024 REDUCTION OF RISK OF MAJOR THROMBOTIC VASCULAR EVENTS (MYOCARDIAL INFARCTION, ISCHEMIC STROKE, ACUTE LIMB ISCHEMIA, AND MAJOR AMPUTATION OF VASCULAR ETIOLOGY) IN PATIENTS WITH PAD
20MG XARELTO JANSSEN PHARMS N022406 Nov. 4, 2011 RX TABLET ORAL 9415053 Nov. 13, 2024 REDUCING THE RISK OF STROKE AND SYSTEMIC EMBOLISM
20MG XARELTO JANSSEN PHARMS N022406 Nov. 4, 2011 RX TABLET ORAL 9415053 Nov. 13, 2024 TREATMENT OF DEEP VEIN THROMBOSIS (DVT)
20MG XARELTO JANSSEN PHARMS N022406 Nov. 4, 2011 RX TABLET ORAL 9415053 Nov. 13, 2024 TREATMENT OF PULMONARY EMBOLISM (PE)
20MG XARELTO JANSSEN PHARMS N022406 Nov. 4, 2011 RX TABLET ORAL 9415053 Nov. 13, 2024 TREATMENT OF VENOUS THROMBOEMBOLISM (VTE) AND THE REDUCTION IN THE RISK OF RECURRENT VTE IN PEDIATRIC PATIENTS FROM BIRTH TO LESS THAN 18 YEARS WITH A BODY WEIGHT OF >=50 KG AFTER AT LEAST 5 DAYS OF INITIAL PARENTERAL ANTICOAGULANT TREATMENT
10MG XARELTO JANSSEN PHARMS N022406 July 1, 2011 RX TABLET ORAL 9539218 Feb. 17, 2034 AFTER COMPLETION OF INITIAL TREATMENT LASTING AT LEAST 6 MONTHS, TO REDUCE THE RISK OF RECURRENCE OF DEEP VEIN THROMBOSIS AND/OR PULMONARY EMBOLISM IN CERTAIN PATIENTS WITH ONCE DAILY, RAPID-RELEASE TABLET ADMINISTERED FOR AT LEAST 5 CONSECUTIVE DAYS
10MG XARELTO JANSSEN PHARMS N022406 July 1, 2011 RX TABLET ORAL 9539218 Feb. 17, 2034 PROPHYLAXIS OF DEEP VEIN THROMBOSIS, WHICH MAY LEAD TO PULMONARY EMBOLISM IN PATIENTS UNDERGOING KNEE OR HIP REPLACEMENT SURGERY, WITH ONCE DAILY, RAPID-RELEASE TABLET ADMINISTERED FOR AT LEAST FIVE CONSECUTIVE DAYS
10MG XARELTO JANSSEN PHARMS N022406 July 1, 2011 RX TABLET ORAL 9539218 Feb. 17, 2034 PROPHYLAXIS OF PE, DVT AND/OR STROKE IN PEDIATRIC PATIENTS (>=50 KG) AGED 2 YEARS AND OLDER WITH CONGENITAL HEART DISEASE AFTER FONTAN PROCEDURE WITH ONCE DAILY, RAPID-RELEASE TABLET ADMINISTERED FOR AT LEAST 5 CONSECUTIVE DAYS
10MG XARELTO JANSSEN PHARMS N022406 July 1, 2011 RX TABLET ORAL 9539218 Feb. 17, 2034 PROPHYLAXIS OF VENOUS THROMBOEMBOLISM IN ACUTELY ILL MEDICAL PATIENTS AT RISK FOR THROMBOEMBOLIC COMPLICATIONS NOT AT HIGH RISK OF BLEEDING WITH ONCE DAILY, RAPID-RELEASE TABLET ADMINISTERED FOR AT LEAST 5 CONSECUTIVE DAYS
15MG XARELTO JANSSEN PHARMS N022406 Nov. 4, 2011 RX TABLET ORAL 9539218 Feb. 17, 2034 REDUCE THE RISK OF STROKE IN PATIENTS WITH NONVALVULAR ATRIAL FIBRILLATION WITH ONCE DAILY, RAPID-RELEASE TABLET ADMINISTERED FOR AT LEAST FIVE CONSECUTIVE DAYS
15MG XARELTO JANSSEN PHARMS N022406 Nov. 4, 2011 RX TABLET ORAL 9539218 Feb. 17, 2034 TREATMENT OF DVT AND/OR PE AND REDUCTION IN RISK OF RECURRENT DVT AND/OR PE IN PEDIATRIC PATIENTS (30-49.9 KG) ONCE DAILY WITH RAPID-RELEASE TABLET ADMINISTERED FOR AT LEAST 5 CONSECUTIVE DAYS AFTER AT LEAST 5 DAYS PARENTERAL ANTICOAGULANT TREATMENT
20MG XARELTO JANSSEN PHARMS N022406 Nov. 4, 2011 RX TABLET ORAL 9539218 Feb. 17, 2034 REDUCE THE RISK OF STROKE IN PATIENTS WITH NONVALVULAR ATRIAL FIBRILLATION WITH ONCE DAILY, RAPID-RELEASE TABLET ADMINISTERED FOR AT LEAST FIVE CONSECUTIVE DAYS
20MG XARELTO JANSSEN PHARMS N022406 Nov. 4, 2011 RX TABLET ORAL 9539218 Feb. 17, 2034 TREATMENT OF DEEP VEIN THROMBOSIS WITH ONCE DAILY, RAPID-RELEASE TABLET ADMINISTERED FOR AT LEAST FIVE CONSECUTIVE DAYS
20MG XARELTO JANSSEN PHARMS N022406 Nov. 4, 2011 RX TABLET ORAL 9539218 Feb. 17, 2034 TREATMENT OF DVT AND/OR PE AND REDUCTION IN THE RISK OF RECURRENT DVT AND/OR PE IN PEDIATRIC PATIENTS (>=50 KG) ONCE DAILY WITH RAPID-RELEASE TABLET ADMINISTERED FOR AT LEAST 5 CONSECUTIVE DAYS AFTER AT LEAST 5 DAYS PARENTERAL ANTICOAGULANT TREATMENT
20MG XARELTO JANSSEN PHARMS N022406 Nov. 4, 2011 RX TABLET ORAL 9539218 Feb. 17, 2034 TREATMENT OF PULMONARY EMBOLISM WITH ONCE DAILY, RAPID-RELEASE TABLET ADMINISTERED FOR AT LEAST FIVE CONSECUTIVE DAYS
2.5MG XARELTO JANSSEN PHARMS N022406 Oct. 11, 2018 RX TABLET ORAL 10828310 Jan. 31, 2039 REDUCTION OF RISK OF CARDIOVASCULAR DEATH, MYOCARDIAL INFARCTION, AND STROKE IN PATIENTS WITH CAD BY ADMINISTERING CLINICALLY PROVEN EFFECTIVE AMOUNTS THAT ARE 2.5 MG RIVAROXABAN TWICE DAILY AND 75-100 MG ASPIRIN DAILY
2.5MG XARELTO JANSSEN PHARMS N022406 Oct. 11, 2018 RX TABLET ORAL 10828310 Jan. 31, 2039 REDUCTION OF RISK OF MYOCARDIAL INFARCTION AND ISCHEMIC STROKE IN PATIENTS WITH PAD BY ADMINISTERING CLINICALLY PROVEN EFFECTIVE AMOUNTS THAT ARE 2.5 MG RIVAROXABAN TWICE DAILY AND 75-100 MG ASPIRIN DAILY

Orange Book exclusivity data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
10MG XARELTO JANSSEN PHARMS N022406 July 1, 2011 RX TABLET ORAL Oct. 11, 2022 PROPHYLAXIS OF VENOUS THROMBOEMBOLISM IN ACUTELY ILL MEDICAL PATIENTS AT RISK FOR THROMBOEMBOLIC COMPLICATIONS NOT AT HIGH RISK OF BLEEDING
15MG XARELTO JANSSEN PHARMS N022406 Nov. 4, 2011 RX TABLET ORAL Oct. 11, 2022 PROPHYLAXIS OF VENOUS THROMBOEMBOLISM IN ACUTELY ILL MEDICAL PATIENTS AT RISK FOR THROMBOEMBOLIC COMPLICATIONS NOT AT HIGH RISK OF BLEEDING
2.5MG XARELTO JANSSEN PHARMS N022406 Oct. 11, 2018 RX TABLET ORAL Oct. 11, 2022 PROPHYLAXIS OF VENOUS THROMBOEMBOLISM IN ACUTELY ILL MEDICAL PATIENTS AT RISK FOR THROMBOEMBOLIC COMPLICATIONS NOT AT HIGH RISK OF BLEEDING
20MG XARELTO JANSSEN PHARMS N022406 Nov. 4, 2011 RX TABLET ORAL Oct. 11, 2022 PROPHYLAXIS OF VENOUS THROMBOEMBOLISM IN ACUTELY ILL MEDICAL PATIENTS AT RISK FOR THROMBOEMBOLIC COMPLICATIONS NOT AT HIGH RISK OF BLEEDING
10MG XARELTO JANSSEN PHARMS N022406 July 1, 2011 RX TABLET ORAL April 11, 2023 PEDIATRIC EXCLUSIVITY
15MG XARELTO JANSSEN PHARMS N022406 Nov. 4, 2011 RX TABLET ORAL April 11, 2023 PEDIATRIC EXCLUSIVITY
2.5MG XARELTO JANSSEN PHARMS N022406 Oct. 11, 2018 RX TABLET ORAL April 11, 2023 PEDIATRIC EXCLUSIVITY
20MG XARELTO JANSSEN PHARMS N022406 Nov. 4, 2011 RX TABLET ORAL April 11, 2023 PEDIATRIC EXCLUSIVITY
10MG XARELTO JANSSEN PHARMS N022406 July 1, 2011 RX TABLET ORAL Aug. 23, 2024 INDICATED TO REDUCE THE RISK OF MAJOR THROMBOTIC VASCULAR EVENTS (MYOCARDIAL INFARCTION, ISCHEMIC STROKE, ACUTE LIMB ISCHEMIA, AND MAJOR AMPUTATION OF VASCULAR ETIOLOGY) IN PATIENTS WITH PAD, INCLUDING PATIENTS WHO HAVE RECENTLY UNDERGONE A LOWER EXTREMITY REVASCULARIZATION PROCEDURE DUE TO SYMPTOMATIC PAD
15MG XARELTO JANSSEN PHARMS N022406 Nov. 4, 2011 RX TABLET ORAL Aug. 23, 2024 INDICATED TO REDUCE THE RISK OF MAJOR THROMBOTIC VASCULAR EVENTS (MYOCARDIAL INFARCTION, ISCHEMIC STROKE, ACUTE LIMB ISCHEMIA, AND MAJOR AMPUTATION OF VASCULAR ETIOLOGY) IN PATIENTS WITH PAD, INCLUDING PATIENTS WHO HAVE RECENTLY UNDERGONE A LOWER EXTREMITY REVASCULARIZATION PROCEDURE DUE TO SYMPTOMATIC PAD
2.5MG XARELTO JANSSEN PHARMS N022406 Oct. 11, 2018 RX TABLET ORAL Aug. 23, 2024 INDICATED TO REDUCE THE RISK OF MAJOR THROMBOTIC VASCULAR EVENTS (MYOCARDIAL INFARCTION, ISCHEMIC STROKE, ACUTE LIMB ISCHEMIA, AND MAJOR AMPUTATION OF VASCULAR ETIOLOGY) IN PATIENTS WITH PAD, INCLUDING PATIENTS WHO HAVE RECENTLY UNDERGONE A LOWER EXTREMITY REVASCULARIZATION PROCEDURE DUE TO SYMPTOMATIC PAD
20MG XARELTO JANSSEN PHARMS N022406 Nov. 4, 2011 RX TABLET ORAL Aug. 23, 2024 INDICATED TO REDUCE THE RISK OF MAJOR THROMBOTIC VASCULAR EVENTS (MYOCARDIAL INFARCTION, ISCHEMIC STROKE, ACUTE LIMB ISCHEMIA, AND MAJOR AMPUTATION OF VASCULAR ETIOLOGY) IN PATIENTS WITH PAD, INCLUDING PATIENTS WHO HAVE RECENTLY UNDERGONE A LOWER EXTREMITY REVASCULARIZATION PROCEDURE DUE TO SYMPTOMATIC PAD
1MG/ML XARELTO JANSSEN PHARMS N215859 Dec. 20, 2021 RX FOR SUSPENSION ORAL Dec. 20, 2024 NEW PRODUCT
10MG XARELTO JANSSEN PHARMS N022406 July 1, 2011 RX TABLET ORAL Feb. 23, 2025 PEDIATRIC EXCLUSIVITY
15MG XARELTO JANSSEN PHARMS N022406 Nov. 4, 2011 RX TABLET ORAL Feb. 23, 2025 PEDIATRIC EXCLUSIVITY
2.5MG XARELTO JANSSEN PHARMS N022406 Oct. 11, 2018 RX TABLET ORAL Feb. 23, 2025 PEDIATRIC EXCLUSIVITY
20MG XARELTO JANSSEN PHARMS N022406 Nov. 4, 2011 RX TABLET ORAL Feb. 23, 2025 PEDIATRIC EXCLUSIVITY
1MG/ML XARELTO JANSSEN PHARMS N215859 Dec. 20, 2021 RX FOR SUSPENSION ORAL June 20, 2025 PEDIATRIC EXCLUSIVITY

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])		Mechanism
action		Bioact sourceMoA source
Coagulation factor X Enzyme INHIBITOR Ki 9.40 CHEMBL CHEMBL
Suppressor of tumorigenicity 14 protein Enzyme Ki 5.47 CHEMBL
Coagulation factor X Enzyme IC50 6.29 CHEMBL

External reference:

IDSource
D07086 KEGG_DRUG
4030906 VANDF
CHEBI:68579 CHEBI
RIV PDB_CHEM_ID
CHEMBL198362 ChEMBL_ID
6388 IUPHAR_LIGAND_ID
8428 INN_ID
DB06228 DRUGBANK_ID
9NDF7JZ4M3 UNII
1114195 RXNORM
159029 MMSL
26019 MMSL
d07356 MMSL
012873 NDDF
442031002 SNOMEDCT_US
442539005 SNOMEDCT_US
C1739768 UMLSCUI
D000069552 MESH_DESCRIPTOR_UI
9875401 PUBCHEM_CID

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Xarelto HUMAN PRESCRIPTION DRUG LABEL 1 50090-3625 TABLET, FILM COATED 10 mg ORAL NDA 32 sections
Xarelto HUMAN PRESCRIPTION DRUG LABEL 1 50090-3639 TABLET, FILM COATED 20 mg ORAL NDA 31 sections
Xarelto HUMAN PRESCRIPTION DRUG LABEL 1 50090-4468 TABLET, FILM COATED 20 mg ORAL NDA 32 sections
Xarelto HUMAN PRESCRIPTION DRUG LABEL 1 50090-4469 TABLET, FILM COATED 10 mg ORAL NDA 32 sections
Xarelto HUMAN PRESCRIPTION DRUG LABEL 1 50458-575 GRANULE, FOR SUSPENSION 155 mg ORAL NDA 35 sections
Xarelto HUMAN PRESCRIPTION DRUG LABEL 1 50458-575 GRANULE, FOR SUSPENSION 155 mg ORAL NDA 35 sections
Xarelto HUMAN PRESCRIPTION DRUG LABEL 1 50458-575 GRANULE, FOR SUSPENSION 155 mg ORAL NDA 35 sections
XARELTO HUMAN PRESCRIPTION DRUG LABEL 1 50458-577 TABLET, FILM COATED 2.50 mg ORAL NDA 35 sections
XARELTO HUMAN PRESCRIPTION DRUG LABEL 1 50458-577 TABLET, FILM COATED 2.50 mg ORAL NDA 35 sections
XARELTO HUMAN PRESCRIPTION DRUG LABEL 1 50458-577 TABLET, FILM COATED 2.50 mg ORAL NDA 35 sections
Xarelto HUMAN PRESCRIPTION DRUG LABEL 1 50458-578 TABLET, FILM COATED 15 mg ORAL NDA 35 sections
Xarelto HUMAN PRESCRIPTION DRUG LABEL 1 50458-578 TABLET, FILM COATED 15 mg ORAL NDA 35 sections
Xarelto HUMAN PRESCRIPTION DRUG LABEL 1 50458-578 TABLET, FILM COATED 15 mg ORAL NDA 35 sections
Xarelto HUMAN PRESCRIPTION DRUG LABEL 1 50458-579 TABLET, FILM COATED 20 mg ORAL NDA 35 sections
Xarelto HUMAN PRESCRIPTION DRUG LABEL 1 50458-579 TABLET, FILM COATED 20 mg ORAL NDA 35 sections
Xarelto HUMAN PRESCRIPTION DRUG LABEL 1 50458-579 TABLET, FILM COATED 20 mg ORAL NDA 35 sections
Xarelto HUMAN PRESCRIPTION DRUG LABEL 1 50458-580 TABLET, FILM COATED 10 mg ORAL NDA 35 sections
Xarelto HUMAN PRESCRIPTION DRUG LABEL 1 50458-580 TABLET, FILM COATED 10 mg ORAL NDA 35 sections
Xarelto HUMAN PRESCRIPTION DRUG LABEL 1 50458-580 TABLET, FILM COATED 10 mg ORAL NDA 35 sections
Xarelto HUMAN PRESCRIPTION DRUG LABEL 1 55154-1422 TABLET, FILM COATED 10 mg ORAL NDA 32 sections
Xarelto HUMAN PRESCRIPTION DRUG LABEL 1 55154-1422 TABLET, FILM COATED 10 mg ORAL NDA 32 sections
Xarelto HUMAN PRESCRIPTION DRUG LABEL 1 55154-1423 TABLET, FILM COATED 20 mg ORAL NDA 32 sections
Xarelto HUMAN PRESCRIPTION DRUG LABEL 1 55154-1423 TABLET, FILM COATED 20 mg ORAL NDA 32 sections
Xarelto HUMAN PRESCRIPTION DRUG LABEL 1 55154-1424 TABLET, FILM COATED 15 mg ORAL NDA 32 sections
Xarelto HUMAN PRESCRIPTION DRUG LABEL 1 55154-1424 TABLET, FILM COATED 15 mg ORAL NDA 32 sections