baclofen ๐Ÿถ Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definitionDrug idCAS RN
282 1134-47-0

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • baclofen
  • baclon
  • lioresal
  • DL-Baclofen
A GAMMA-AMINOBUTYRIC ACID derivative that is a specific agonist of GABA-B RECEPTORS. It is used in the treatment of MUSCLE SPASTICITY, especially that due to SPINAL CORD INJURIES. Its therapeutic effects result from actions at spinal and supraspinal sites, generally the reduction of excitatory transmission.
  • Molecular weight: 213.66
  • Formula: C10H12ClNO2
  • CLOGP: -0.62
  • LIPINSKI: 0
  • HAC: 3
  • HDO: 2
  • TPSA: 63.32
  • ALOGS: -2.48
  • ROTB: 4

  • Status: OFP

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

Drug dosage:

DoseUnitRoute
50 mg O
0.55 mg P

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 3 Benet LZ, Broccatelli F, Oprea TI
S (Water solubility) 2.10 mg/mL Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine) 69 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 6.22 ยตM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability) 90 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
Vd (Volume of distribution) 0.65 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 1.70 mL/min/kg Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma) 0.69 % Lombardo F, Berellini G, Obach RS
t_half (Half-life) 5.24 hours Lombardo F, Berellini G, Obach RS

Approvals:

DateAgencyCompanyOrphan
Nov. 22, 1977 FDA

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
Multiple sclerosis relapse 1536.56 10.29 961 90707 42003 50471453
Multiple sclerosis 941.60 10.29 539 91129 19954 50493502
Drug withdrawal syndrome 860.86 10.29 547 91121 24534 50488922
Muscle spasticity 610.11 10.29 383 91285 16801 50496655
Implant site extravasation 410.00 10.29 107 91561 368 50513088
Implant site infection 405.11 10.29 122 91546 786 50512670
Coma 404.81 10.29 507 91161 56372 50457084
Urinary tract infection 316.94 10.29 1008 90660 223012 50290444
Gait disturbance 296.78 10.29 762 90906 149243 50364213
Somnolence 280.87 10.29 762 90906 154223 50359233
Pneumonia aspiration 254.13 10.29 297 91371 30707 50482749
Cerebrospinal fluid leakage 245.92 10.29 84 91584 848 50512608
Fall 234.71 10.29 1211 90457 333721 50179735
Muscular weakness 234.43 10.29 526 91142 94487 50418969
Seizure 233.22 10.29 599 91069 117275 50396181
Hypotonia 224.60 10.29 155 91513 7979 50505477
Completed suicide 211.92 10.29 621 91047 131268 50382188
Muscle spasms 206.36 10.29 596 91072 124957 50388499
Overdose 183.13 10.29 493 91175 99234 50414222
Glossodynia 169.15 10.29 10 91658 115559 50397897
Hypertonia 165.15 10.29 98 91570 3875 50509581
Device infusion issue 159.77 10.29 68 91600 1299 50512157
Mental status changes 159.43 10.29 257 91411 36015 50477441
Unresponsive to stimuli 152.83 10.29 230 91438 30379 50483077
Device failure 144.80 10.29 102 91566 5426 50508030
Implant site erosion 139.69 10.29 32 91636 51 50513405
Systemic lupus erythematosus 139.09 10.29 41 91627 140581 50372875
Joint swelling 135.21 10.29 147 91521 245139 50268317
White blood cell count abnormal 134.72 10.29 97 91571 5343 50508113
Medical device site pain 124.15 10.29 34 91634 147 50513309
Rash 123.30 10.29 395 91273 437076 50076380
Hypoaesthesia 120.40 10.29 503 91165 126754 50386702
Muscle tightness 116.70 10.29 117 91551 10163 50503293
Infusion related reaction 115.81 10.29 83 91585 169474 50343982
Secondary progressive multiple sclerosis 115.74 10.29 53 91615 1213 50512243
Febrile neutropenia 115.66 10.29 19 91649 97648 50415808
Contraindicated product administered 113.97 10.29 64 91604 148894 50364562
Abdominal discomfort 113.65 10.29 152 91516 231489 50281967
Hand deformity 113.22 10.29 22 91646 100177 50413279
Diarrhoea 112.18 10.29 618 91050 587858 49925598
Anaemia 111.78 10.29 178 91490 252278 50261178
Balance disorder 110.01 10.29 329 91339 70261 50443195
Memory impairment 109.02 10.29 354 91314 79006 50434450
Synovitis 105.65 10.29 46 91622 123819 50389637
Medical device site infection 104.38 10.29 31 91637 189 50513267
Arthropathy 104.34 10.29 80 91588 157826 50355630
Decubitus ulcer 101.10 10.29 104 91564 9314 50504142
Progressive multiple sclerosis 99.80 10.29 41 91627 714 50512742
Device physical property issue 96.92 10.29 51 91617 1591 50511865
Exposure during pregnancy 92.55 10.29 52 91616 120963 50392493
Device power source issue 90.37 10.29 34 91634 463 50512993
Central nervous system lesion 89.81 10.29 98 91570 9391 50504065
Influenza like illness 88.76 10.29 267 91401 57192 50456264
Maternal exposure during pregnancy 87.69 10.29 96 91572 159682 50353774
Lymphocyte count decreased 87.66 10.29 165 91503 26142 50487314
Withdrawal syndrome 86.12 10.29 131 91537 17459 50495997
Therapy non-responder 83.49 10.29 242 91426 50780 50462676
Implant site discharge 82.44 10.29 23 91645 108 50513348
Neutropenia 82.20 10.29 88 91580 147877 50365579
Urine analysis abnormal 82.17 10.29 66 91602 4284 50509172
Implant site swelling 81.69 10.29 31 91637 433 50513023
Drug ineffective 81.67 10.29 1023 90645 818310 49695146
Drug intolerance 80.51 10.29 173 91495 218931 50294525
Malignant neoplasm progression 79.00 10.29 14 91654 68110 50445346
Post lumbar puncture syndrome 78.01 10.29 32 91636 555 50512901
Swelling 77.69 10.29 154 91514 200718 50312738
Wound 77.30 10.29 48 91620 105746 50407710
Progressive multifocal leukoencephalopathy 76.46 10.29 99 91569 11358 50502098
Complication associated with device 74.39 10.29 111 91557 14544 50498912
Toxic encephalopathy 74.35 10.29 69 91599 5446 50508010
Toxicity to various agents 73.24 10.29 645 91023 211854 50301602
Tremor 72.29 10.29 404 91264 114499 50398957
Medical device site discharge 72.11 10.29 16 91652 20 50513436
Implant site pain 71.11 10.29 46 91622 2123 50511333
Device kink 71.03 10.29 43 91625 1764 50511692
Product use issue 69.34 10.29 102 91566 149373 50364083
Underdose 68.57 10.29 128 91540 20150 50493306
Gastrooesophageal reflux disease 65.99 10.29 294 91374 76134 50437322
Lower respiratory tract infection 65.75 10.29 46 91622 95155 50418301
Dyspnoea 65.73 10.29 655 91013 546953 49966503
Thrombocytopenia 65.41 10.29 81 91587 127592 50385864
Medical device site swelling 65.25 10.29 14 91654 13 50513443
Device malfunction 64.87 10.29 106 91562 15015 50498441
Pancytopenia 64.39 10.29 36 91632 83994 50429462
Device inversion 63.79 10.29 12 91656 0 50513456
Alopecia 63.58 10.29 229 91439 244818 50268638
Paraesthesia 62.35 10.29 402 91266 119841 50393615
Asphyxia 62.03 10.29 62 91606 5365 50508091
Therapeutic product effect decreased 61.97 10.29 94 91574 135956 50377500
Acute kidney injury 61.25 10.29 210 91458 227848 50285608
Insomnia 60.34 10.29 531 91137 174334 50339122
Interstitial lung disease 59.37 10.29 12 91656 53164 50460292
Immune reconstitution inflammatory syndrome 59.36 10.29 61 91607 5455 50508001
Medical device site erythema 59.16 10.29 13 91655 15 50513441
Encephalopathy 58.16 10.29 163 91505 33548 50479908
Muscle rigidity 58.03 10.29 80 91588 9749 50503707
Neurogenic bladder 57.51 10.29 45 91623 2812 50510644
Urinary incontinence 57.38 10.29 145 91523 28063 50485393
Peroneal nerve palsy 56.61 10.29 53 91615 4230 50509226
Device dislocation 56.11 10.29 122 91546 21424 50492032
Folliculitis 55.57 10.29 4 91664 39221 50474235
Musculoskeletal stiffness 55.07 10.29 410 91258 128071 50385385
Peripheral swelling 54.36 10.29 191 91477 205745 50307711
Arthralgia 54.13 10.29 521 91147 438181 50075275
Off label use 53.77 10.29 575 91093 473851 50039605
Cough 52.80 10.29 241 91427 241023 50272433
Respiratory depression 52.61 10.29 85 91583 11925 50501531
Depression 51.82 10.29 492 91176 164931 50348525
Wound dehiscence 50.47 10.29 50 91618 4280 50509176
Urosepsis 50.28 10.29 96 91572 15369 50498087
Trigeminal neuralgia 49.98 10.29 43 91625 3072 50510384
Neuralgia 49.38 10.29 117 91551 21746 50491710
Mucosal inflammation 49.35 10.29 7 91661 40135 50473321
Muscle injury 49.25 10.29 5 91663 37106 50476350
Infusion site mass 48.49 10.29 29 91639 1163 50512293
Lymphopenia 48.38 10.29 95 91573 15526 50497930
Status epilepticus 48.33 10.29 87 91581 13319 50500137
JC polyomavirus test positive 47.78 10.29 28 91640 1081 50512375
Dystonia 47.67 10.29 81 91587 11845 50501611
Escherichia urinary tract infection 47.50 10.29 75 91593 10320 50503136
Lethargy 47.15 10.29 196 91472 49236 50464220
Diplopia 46.71 10.29 106 91562 19154 50494302
Magnetic resonance imaging abnormal 46.64 10.29 39 91629 2679 50510777
Device connection issue 46.44 10.29 22 91646 545 50512911
Gait inability 46.22 10.29 160 91508 36867 50476589
Drug delivery device placement 45.48 10.29 14 91654 98 50513358
Generalised tonic-clonic seizure 45.17 10.29 127 91541 26183 50487273
Sleep disorder due to general medical condition, insomnia type 45.15 10.29 3 91665 31444 50482012
Pleural effusion 44.59 10.29 49 91619 81405 50432051
Focal dyscognitive seizures 44.42 10.29 38 91630 2694 50510762
Areflexia 43.84 10.29 38 91630 2742 50510714
Concussion 43.41 10.29 61 91607 7567 50505889
Device computer issue 43.25 10.29 9 91659 6 50513450
Paralysis 43.08 10.29 65 91603 8599 50504857
Hyporeflexia 43.02 10.29 31 91637 1709 50511747
Paraparesis 42.61 10.29 33 91635 2031 50511425
Gastrointestinal haemorrhage 42.51 10.29 42 91626 73279 50440177
Hypokinesia 42.41 10.29 78 91590 12139 50501317
Device alarm issue 42.00 10.29 28 91640 1360 50512096
Metabolic encephalopathy 41.84 10.29 49 91619 5072 50508384
Laboratory test abnormal 41.79 10.29 114 91554 23094 50490362
Burning sensation 41.64 10.29 178 91490 45268 50468188
Sedation 41.50 10.29 136 91532 30474 50482982
Discomfort 41.08 10.29 84 91584 108296 50405160
Scoliosis 41.06 10.29 55 91613 6521 50506935
Motor dysfunction 41 10.29 61 91607 7970 50505486
Gait spastic 40.82 10.29 16 91652 245 50513211
Optic neuritis 40.56 10.29 56 91612 6834 50506622
Treatment failure 40.21 10.29 122 91546 137515 50375941
Medical device site fibrosis 39.98 10.29 8 91660 3 50513453
Pocket erosion 39.98 10.29 8 91660 3 50513453
Speech disorder 39.60 10.29 148 91520 35400 50478056
Cardiac failure 39.19 10.29 48 91620 75992 50437464
Muscle twitching 38.62 10.29 86 91582 15345 50498111
Agitation 37.82 10.29 194 91474 53190 50460266
Intracranial hypotension 37.17 10.29 15 91653 249 50513207
Osteonecrosis of jaw 37.02 10.29 7 91661 32519 50480937
Implant site haematoma 36.91 10.29 11 91657 68 50513388
Red blood cells urine positive 36.03 10.29 34 91634 2741 50510715
Respiratory arrest 36.01 10.29 128 91540 29881 50483575
Bone marrow failure 35.95 10.29 4 91664 27620 50485836
Nasopharyngitis 35.78 10.29 204 91464 192723 50320733
Neurotoxicity 35.61 10.29 81 91587 14659 50498797
Ankle fracture 35.35 10.29 84 91584 15638 50497818
Hepatic function abnormal 35.20 10.29 8 91660 32673 50480783
Blister 35.17 10.29 63 91605 85355 50428101
Urine leukocyte esterase positive 34.92 10.29 34 91634 2849 50510607
Hallucination 34.77 10.29 172 91496 46485 50466971
Renal impairment 34.70 10.29 52 91616 75609 50437847
Hypersensitivity 34.49 10.29 238 91430 214923 50298533
Clonus 34.19 10.29 40 91628 4135 50509321
Soft tissue injury 33.44 10.29 25 91643 1459 50511997
Ascites 32.71 10.29 12 91656 35849 50477607
Medical device site discomfort 32.59 10.29 13 91655 209 50513247
Arteriosclerosis coronary artery 32.04 10.29 53 91615 7583 50505873
Disease progression 31.70 10.29 80 91588 95786 50417670
Flushing 31.66 10.29 219 91449 66796 50446660
Migraine 31.53 10.29 239 91429 75041 50438415
Blood creatinine increased 31.51 10.29 56 91612 76104 50437352
Device expulsion 31.16 10.29 7 91661 28815 50484641
Device occlusion 31.11 10.29 46 91622 5977 50507479
Cardiac failure congestive 30.63 10.29 67 91601 84315 50429141
Muscle atrophy 30.54 10.29 46 91622 6075 50507381
Device leakage 30.51 10.29 45 91623 5833 50507623
Implant site erythema 30.38 10.29 16 91652 500 50512956
Haemoglobin decreased 30.29 10.29 123 91545 127093 50386363
Loss of consciousness 30.02 10.29 305 91363 104048 50409408
Neoplasm progression 29.73 10.29 8 91660 29149 50484307
White blood cells urine positive 29.68 10.29 39 91629 4539 50508917
Electroencephalogram abnormal 29.45 10.29 34 91634 3465 50509991
Hostility 29.41 10.29 25 91643 1757 50511699
Atrial fibrillation 29.13 10.29 91 91577 101654 50411802
Decreased appetite 28.96 10.29 229 91439 200694 50312762
Platelet count decreased 28.90 10.29 90 91578 100636 50412820
Renal failure 28.71 10.29 98 91570 106535 50406921
Temperature intolerance 28.55 10.29 50 91618 7489 50505967
Libido increased 28.14 10.29 21 91647 1222 50512234
Hemiparesis 28.01 10.29 90 91578 19958 50493498
Toxic epidermal necrolysis 27.41 10.29 3 91665 20989 50492467
Hepatic enzyme increased 27.25 10.29 142 91526 137238 50376218
Monocyte percentage increased 26.78 10.29 19 91649 1022 50512434
Medical device discomfort 26.60 10.29 23 91645 1654 50511802
Device issue 26.42 10.29 88 91580 19884 50493572
Skin reaction 26.22 10.29 62 91606 11506 50501950
Ataxia 26.11 10.29 69 91599 13717 50499739
Bladder disorder 25.98 10.29 48 91620 7495 50505961
Dysphagia 25.97 10.29 234 91434 77284 50436172
Dysstasia 25.82 10.29 81 91587 17738 50495718
Abdominal pain 25.59 10.29 289 91379 235939 50277517
Amnesia 25.49 10.29 147 91521 42113 50471343
Incorrect route of product administration 25.36 10.29 83 91585 18583 50494873
Sinusitis 25.22 10.29 193 91475 170365 50343091
Urinary sediment present 25.10 10.29 24 91644 1967 50511489
Basal ganglion degeneration 25.02 10.29 13 91655 395 50513061
General physical health deterioration 24.60 10.29 154 91514 142280 50371176
Dysaesthesia 24.49 10.29 32 91636 3703 50509753
Neurogenic bowel 24.44 10.29 9 91659 115 50513341
Medical device site erosion 24.40 10.29 6 91662 15 50513441
Pulmonary fibrosis 24.36 10.29 7 91661 24430 50489026
Implant site scar 24.34 10.29 11 91657 244 50513212
Feeling abnormal 24.27 10.29 340 91328 125152 50388304
C-reactive protein abnormal 24.21 10.29 10 91658 27799 50485657
Incision site oedema 24.13 10.29 6 91662 16 50513440
Nitrite urine present 24.03 10.29 17 91651 910 50512546
Myoclonus 24.01 10.29 69 91599 14401 50499055
Tissue infiltration 23.93 10.29 14 91654 539 50512917
Therapeutic response decreased 23.90 10.29 157 91511 47074 50466382
Band neutrophil count increased 23.89 10.29 12 91656 339 50513117
Nystagmus 23.87 10.29 39 91629 5522 50507934
Implant site reaction 23.70 10.29 9 91659 126 50513330
Dyspnoea exertional 23.69 10.29 35 91633 51198 50462258
Palmar-plantar erythrodysaesthesia syndrome 23.58 10.29 4 91664 20094 50493362
Road traffic accident 23.56 10.29 97 91571 24255 50489201
Upper airway obstruction 23.46 10.29 14 91654 559 50512897
Monoplegia 23.36 10.29 27 91641 2756 50510700
Sensory disturbance 23.22 10.29 60 91608 11769 50501687
Premature delivery 23.19 10.29 7 91661 23656 50489800
Poisoning deliberate 23.16 10.29 47 91621 7865 50505591
Dysarthria 23.15 10.29 131 91537 37272 50476184
Hyperkalaemia 23.08 10.29 32 91636 48057 50465399
Primary progressive multiple sclerosis 23.05 10.29 8 91660 85 50513371
Loss of control of legs 23.02 10.29 19 91649 1282 50512174
Erythema 22.93 10.29 163 91505 146251 50367205
Multiple organ dysfunction syndrome 22.69 10.29 35 91633 50302 50463154
Prescribed underdose 22.65 10.29 72 91596 15877 50497579
Thyroid disorder 22.55 10.29 62 91606 12615 50500841
Disorientation 22.44 10.29 125 91543 35359 50478097
Rheumatoid arthritis 22.24 10.29 247 91421 202303 50311153
Post-traumatic neck syndrome 22.16 10.29 22 91646 1888 50511568
Muscle contracture 22.13 10.29 18 91650 1189 50512267
Neutrophil percentage increased 22.12 10.29 26 91642 2701 50510755
Coordination abnormal 22.12 10.29 58 91610 11476 50501980
Urinary retention 22.02 10.29 100 91568 26090 50487366
Colitis microscopic 21.84 10.29 41 91627 6479 50506977
Hepatotoxicity 21.82 10.29 11 91657 27215 50486241
Anxiety 21.81 10.29 447 91221 177159 50336297
Drug resistance 21.80 10.29 4 91664 18985 50494471
Culture urine positive 21.76 10.29 29 91639 3422 50510034
Micturition urgency 21.75 10.29 47 91621 8217 50505239
Drug interaction 21.69 10.29 244 91424 199377 50314079
Hyponatraemia 21.61 10.29 95 91573 96044 50417412
Enthesopathy 21.38 10.29 43 91625 7150 50506306
Melaena 21.31 10.29 11 91657 26853 50486603
Sternal fracture 21.29 10.29 22 91646 1980 50511476
Consciousness fluctuating 21.28 10.29 14 91654 665 50512791
Vision blurred 21.25 10.29 227 91441 78420 50435036
Device programming error 21.20 10.29 7 91661 63 50513393
Seroma 20.98 10.29 21 91647 1820 50511636
Movement disorder 20.97 10.29 75 91593 17557 50495899
Dyskinesia 20.96 10.29 103 91565 27758 50485698
Pollakiuria 20.76 10.29 92 91576 23759 50489697
Injection site scar 20.70 10.29 15 91653 834 50512622
Mobility decreased 20.34 10.29 228 91440 79720 50433736
Relapsing-remitting multiple sclerosis 20.21 10.29 12 91656 475 50512981
Proteinuria 20.15 10.29 3 91665 16594 50496862
Asthenia 20.02 10.29 736 90932 318306 50195150
Incoherent 19.99 10.29 31 91637 4199 50509257
Epistaxis 19.90 10.29 55 91613 63899 50449557
Hypoglycaemia 19.89 10.29 42 91626 53539 50459917
Hypothermia 19.65 10.29 57 91611 11959 50501497
Metastases to liver 19.60 10.29 6 91662 20098 50493358
Bladder spasm 19.49 10.29 18 91650 1412 50512044
Band neutrophil percentage increased 19.42 10.29 9 91659 212 50513244
Hypercalcaemia 19.38 10.29 9 91659 23343 50490113
Therapeutic response unexpected 19.19 10.29 68 91600 15847 50497609
Knee arthroplasty 19.13 10.29 22 91646 35824 50477632
Medical device site cellulitis 19.03 10.29 4 91664 3 50513453
Wheezing 18.83 10.29 54 91614 61993 50451463
Hyperhidrosis 18.81 10.29 246 91422 89180 50424276
Confusional state 18.75 10.29 455 91213 185473 50327983
Lymphocyte percentage decreased 18.65 10.29 24 91644 2736 50510720
Irritable bowel syndrome 18.54 10.29 41 91627 51400 50462056
Poisoning 18.47 10.29 57 91611 12372 50501084
Incision site swelling 18.38 10.29 6 91662 52 50513404
Stomatitis 18.31 10.29 108 91560 101236 50412220
Productive cough 18.18 10.29 43 91625 52651 50460805
Bradypnoea 18.12 10.29 25 91643 3049 50510407
Depressed level of consciousness 18.00 10.29 158 91510 51795 50461661
Anaesthesia 17.95 10.29 10 91658 350 50513106
Alcohol withdrawal syndrome 17.83 10.29 13 91655 730 50512726
Conversion disorder 17.81 10.29 18 91650 1578 50511878
Tonic clonic movements 17.69 10.29 16 91652 1221 50512235
Urinary tract infection bacterial 17.63 10.29 29 91639 4130 50509326
B-lymphocyte count decreased 17.60 10.29 14 91654 896 50512560
Delirium 17.56 10.29 124 91544 38068 50475388
Device extrusion 17.50 10.29 5 91663 26 50513430
Metabolic acidosis 17.49 10.29 27 91641 38798 50474658
Cognitive disorder 17.31 10.29 138 91530 43985 50469471
Lower limb fracture 17.29 10.29 61 91607 14185 50499271
Neutrophil count decreased 17.15 10.29 36 91632 45990 50467466
Invasive ductal breast carcinoma 17.12 10.29 35 91633 5886 50507570
Stevens-Johnson syndrome 17.12 10.29 9 91659 21743 50491713
Liver injury 17.10 10.29 12 91656 24794 50488662
Post procedural complication 16.91 10.29 63 91605 15041 50498415
Gastrointestinal disorder 16.89 10.29 101 91567 94355 50419101
Pulmonary oedema 16.83 10.29 40 91628 48898 50464558
Major depression 16.82 10.29 38 91630 6846 50506610
Hypervolaemia 16.71 10.29 13 91655 25486 50487970
Agranulocytosis 16.66 10.29 9 91659 21412 50492044
Invasive lobular breast carcinoma 16.63 10.29 12 91656 663 50512793
Bacterial test 16.62 10.29 15 91653 1142 50512314
Myelocyte percentage increased 16.61 10.29 8 91660 206 50513250
Irritability 16.57 10.29 98 91570 28328 50485128
Acute hepatic failure 16.56 10.29 4 91664 15673 50497783
Psoriatic arthropathy 16.53 10.29 38 91630 46994 50466462
Abnormal behaviour 16.48 10.29 75 91593 19583 50493873
Aphasia 16.46 10.29 98 91570 28396 50485060
Hypersomnia 16.42 10.29 63 91605 15251 50498205
Cytomegalovirus infection 16.40 10.29 6 91662 17956 50495500
Nausea 16.38 10.29 1080 90588 704318 49809138
Impaired healing 16.27 10.29 68 91600 69718 50443738
Urinary tract infection enterococcal 16.19 10.29 21 91647 2413 50511043
Intentional self-injury 16.17 10.29 11 91657 23101 50490355
Neuromuscular toxicity 16.15 10.29 7 91661 140 50513316
Visual impairment 16.15 10.29 192 91476 68083 50445373
Psychogenic seizure 16.11 10.29 17 91651 1568 50511888
Bursitis 16.06 10.29 81 91587 22054 50491402
Abdominal pain upper 16.04 10.29 198 91470 159111 50354345
Implant site ulcer 15.95 10.29 3 91665 0 50513456
Obstructive defaecation 15.95 10.29 3 91665 0 50513456
Medical device site bruise 15.95 10.29 3 91665 0 50513456
Haematochezia 15.89 10.29 30 91638 39852 50473604
International normalised ratio increased 15.87 10.29 34 91634 43118 50470338
Urine oxalate increased 15.83 10.29 8 91660 229 50513227
Injection site necrosis 15.80 10.29 15 91653 1218 50512238
Urobilinogen urine increased 15.80 10.29 8 91660 230 50513226
Vitamin D deficiency 15.76 10.29 51 91617 11351 50502105
Neurological decompensation 15.75 10.29 20 91648 2250 50511206
Rash maculo-papular 15.74 10.29 15 91653 26626 50486830
Persistent depressive disorder 15.74 10.29 13 91655 878 50512578
Sleep apnoea syndrome 15.70 10.29 85 91583 23783 50489673
Uterine enlargement 15.67 10.29 14 91654 1052 50512404
Nephrolithiasis 15.58 10.29 112 91556 34581 50478875
Neuropsychiatric syndrome 15.56 10.29 5 91663 41 50513415
Drug eruption 15.52 10.29 12 91656 23594 50489862
Staphylococcal infection 15.43 10.29 114 91554 35502 50477954
Cholestasis 15.36 10.29 14 91654 25387 50488069
Intentional overdose 15.33 10.29 177 91491 62327 50451129
Injection site infection 15.32 10.29 17 91651 1659 50511797
Cataract 15.22 10.29 40 91628 47260 50466196
Myelosuppression 15.19 10.29 3 91665 13514 50499942
Expanded disability status scale score increased 15.05 10.29 9 91659 361 50513095
Rash pruritic 14.99 10.29 41 91627 47805 50465651
Pneumocystis jirovecii pneumonia 14.99 10.29 4 91664 14659 50498797
Haemoglobin increased 14.96 10.29 23 91645 3092 50510364
Bacterial test positive 14.96 10.29 29 91639 4694 50508762
Hypomagnesaemia 14.93 10.29 12 91656 23144 50490312
Ill-defined disorder 14.86 10.29 50 91618 54604 50458852
Pneumonitis 14.81 10.29 19 91649 29491 50483965
Dehydration 14.77 10.29 191 91477 152258 50361198
Blood cholesterol increased 14.68 10.29 51 91617 55164 50458292
Spinal operation 14.68 10.29 34 91634 6226 50507230
Anal incontinence 14.64 10.29 50 91618 11440 50502016
Pupil fixed 14.64 10.29 16 91652 1536 50511920
Retinal depigmentation 14.52 10.29 8 91660 274 50513182
Cerebral palsy 14.42 10.29 6 91662 108 50513348
Poor quality sleep 14.33 10.29 64 91604 16582 50496874
Middle insomnia 14.28 10.29 45 91623 9876 50503580
Eosinophilia 14.27 10.29 8 91660 18644 50494812
Injection site ulcer 14.16 10.29 10 91658 534 50512922
Head injury 14.12 10.29 83 91585 23937 50489519
Reflexes abnormal 14.11 10.29 10 91658 537 50512919
Therapy cessation 14.10 10.29 88 91580 25923 50487533
Intervertebral disc disorder 14.09 10.29 27 91641 4333 50509123
Meningitis 14.08 10.29 33 91635 6088 50507368
Chronic fatigue syndrome 14.05 10.29 13 91655 1022 50512434
Injection site mass 14.04 10.29 61 91607 15619 50497837
Medical device site scar 13.87 10.29 3 91665 3 50513453
Urine osmolarity increased 13.84 10.29 6 91662 120 50513336
Urticaria 13.81 10.29 159 91509 129402 50384054
Narcotic bowel syndrome 13.66 10.29 6 91662 124 50513332
Product use in unapproved indication 13.60 10.29 139 91529 115680 50397776
Hyperaesthesia 13.58 10.29 39 91629 8134 50505322
Limb discomfort 13.58 10.29 83 91585 24274 50489182
Pulmonary hypertension 13.43 10.29 25 91643 33392 50480064
Right ventricular failure 13.38 10.29 6 91662 15887 50497569
Metastases to bone 13.36 10.29 8 91660 17987 50495469
Apnoea 13.33 10.29 35 91633 6931 50506525
Quadriplegia 13.27 10.29 16 91652 1707 50511749
Klebsiella test positive 13.23 10.29 12 91656 919 50512537
Paraplegia 13.05 10.29 19 91649 2435 50511021
Disturbance in attention 13.04 10.29 99 91569 31087 50482369
Personality disorder 13.03 10.29 26 91642 4298 50509158
Medical device site extravasation 13.01 10.29 3 91665 5 50513451
Pancreatitis chronic 13 10.29 18 91650 2202 50511254
Angina pectoris 13.00 10.29 17 91651 26171 50487285
Euphoric mood 12.97 10.29 25 91643 4030 50509426
Rectal haemorrhage 12.88 10.29 32 91636 38526 50474930
Sports injury 12.87 10.29 4 91664 29 50513427
Glycosylated haemoglobin decreased 12.87 10.29 9 91659 473 50512983
Myelocyte count increased 12.85 10.29 8 91660 345 50513111
Foot fracture 12.85 10.29 71 91597 20020 50493436
Lymphocyte count abnormal 12.85 10.29 10 91658 620 50512836
Urinary tract infection pseudomonal 12.83 10.29 11 91657 782 50512674
Decreased vibratory sense 12.78 10.29 7 91661 237 50513219
Thyroxine decreased 12.77 10.29 9 91659 479 50512977
Neurosis 12.70 10.29 7 91661 240 50513216
Norovirus infection 12.67 10.29 7 91661 241 50513215
Pseudomeningocele 12.66 10.29 3 91665 6 50513450
Congenital megacolon 12.66 10.29 3 91665 6 50513450
Blood potassium increased 12.59 10.29 7 91661 16391 50497065
Cerebral vasoconstriction 12.58 10.29 12 91656 980 50512476
CD8 lymphocytes decreased 12.54 10.29 6 91662 152 50513304
Glaucoma 12.53 10.29 59 91609 15627 50497829
Intraductal proliferative breast lesion 12.49 10.29 19 91649 2531 50510925
Premature baby 12.47 10.29 9 91659 18328 50495128
Injection site atrophy 12.35 10.29 9 91659 505 50512951
Medical device site reaction 12.35 10.29 3 91665 7 50513449
Pancreatitis acute 12.29 10.29 15 91653 23797 50489659
Haemoptysis 12.29 10.29 17 91651 25556 50487900
Postoperative delirium 12.28 10.29 5 91663 85 50513371
Hyperlipasaemia 12.23 10.29 9 91659 513 50512943
Occupational dermatitis 12.22 10.29 4 91664 35 50513421
Incorrect drug administration rate 12.18 10.29 19 91649 2587 50510869
Eye movement disorder 12.13 10.29 26 91642 4519 50508937
Lipoedema 12.05 10.29 7 91661 266 50513190
Autonomic nervous system imbalance 12.01 10.29 18 91650 2367 50511089
Neck pain 12.00 10.29 157 91511 56910 50456546
Mechanical urticaria 11.99 10.29 8 91660 389 50513067
Pulmonary renal syndrome 11.94 10.29 8 91660 392 50513064
Pre-existing condition improved 11.93 10.29 34 91634 7063 50506393
Crystal urine present 11.87 10.29 14 91654 1460 50511996
Small fibre neuropathy 11.83 10.29 6 91662 173 50513283
Inguinal hernia 11.79 10.29 15 91653 1691 50511765
Nightmare 11.77 10.29 59 91609 16027 50497429
Back pain 11.76 10.29 499 91169 219531 50293925
Acquired diaphragmatic eventration 11.74 10.29 8 91660 403 50513053
Basophil count decreased 11.72 10.29 5 91663 96 50513360
Quadriparesis 11.72 10.29 15 91653 1701 50511755
Implant site fibrosis 11.71 10.29 6 91662 177 50513279
Intervertebral disc protrusion 11.69 10.29 70 91598 20323 50493133
Tremor neonatal 11.63 10.29 5 91663 98 50513358
Enlarged uvula 11.50 10.29 6 91662 184 50513272
Feeling hot 11.46 10.29 115 91553 39087 50474369
Neuropathy peripheral 11.41 10.29 116 91552 96641 50416815
Hepatitis 11.39 10.29 25 91643 31428 50482028
Neutralising antibodies 11.32 10.29 4 91664 45 50513411
Coronary artery disease 11.29 10.29 23 91645 29703 50483753
Tibia fracture 11.26 10.29 25 91643 4450 50509006
CD4 lymphocytes decreased 11.25 10.29 13 91655 1326 50512130
Altered state of consciousness 11.18 10.29 73 91595 21837 50491619
Blood bilirubin increased 11.16 10.29 26 91642 32012 50481444
Procedural pneumothorax 11.14 10.29 3 91665 12 50513444
Infusion site macule 11.14 10.29 3 91665 12 50513444
CSF culture positive 11.14 10.29 3 91665 12 50513444
Pregnancy 11.13 10.29 23 91645 29554 50483902
Self-medication 11.08 10.29 17 91651 2282 50511174
Macular oedema 11.04 10.29 22 91646 3632 50509824
Intestinal polyp 11.04 10.29 12 91656 1145 50512311
Medical device change 10.94 10.29 7 91661 317 50513139
Upper motor neurone lesion 10.94 10.29 5 91663 114 50513342
Myelodysplastic syndrome 10.86 10.29 7 91661 15125 50498331
Cystitis 10.84 10.29 126 91542 44438 50469018
Adrenal neoplasm 10.80 10.29 7 91661 324 50513132
Citrobacter test positive 10.77 10.29 3 91665 14 50513442
Coagulopathy 10.72 10.29 10 91658 17934 50495522
Weight increased 10.71 10.29 281 91387 201610 50311846
Meningioma 10.71 10.29 21 91647 3428 50510028
Aspiration 10.67 10.29 39 91629 9225 50504231
Suicidal ideation 10.67 10.29 150 91518 55235 50458221
Shock 10.67 10.29 13 91655 20637 50492819
CSF protein increased 10.64 10.29 8 91660 471 50512985
Spinal cord disorder 10.62 10.29 12 91656 1195 50512261
Posturing 10.61 10.29 8 91660 473 50512983
Injury 10.60 10.29 49 91619 48876 50464580
Abdominal symptom 10.57 10.29 7 91661 336 50513120
Accidental overdose 10.53 10.29 66 91602 19467 50493989
Varicella virus test positive 10.51 10.29 5 91663 125 50513331
Mean platelet volume increased 10.49 10.29 8 91660 481 50512975
Stress 10.49 10.29 146 91522 53647 50459809
Epilepsy 10.49 10.29 71 91597 21496 50491960
Relapsing multiple sclerosis 10.48 10.29 5 91663 126 50513330
Implant site dehiscence 10.44 10.29 3 91665 16 50513440
Abnormal dreams 10.41 10.29 39 91629 9338 50504118
Miosis 10.38 10.29 30 91638 6280 50507176
Hypochromic anaemia 10.31 10.29 14 91654 1682 50511774

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
Drug withdrawal syndrome 1388.41 11.01 672 53732 17312 29502811
Muscle spasticity 1190.04 11.01 416 53988 4467 29515656
Implant site infection 714.61 11.01 194 54210 792 29519331
Implant site extravasation 587.98 11.01 138 54266 254 29519869
Multiple sclerosis relapse 456.47 11.01 276 54128 11143 29508980
Multiple sclerosis 384.68 11.01 193 54211 5361 29514762
Muscle spasms 373.79 11.01 526 53878 64556 29455567
Device failure 361.35 11.01 137 54267 1879 29518244
Overdose 271.81 11.01 509 53895 79310 29440813
Hypertonia 264.97 11.01 133 54271 3696 29516427
Coma 262.98 11.01 343 54061 39107 29481016
Therapy non-responder 256.35 11.01 300 54104 30611 29489512
Urinary tract infection 245.79 11.01 461 53943 71893 29448230
Mental status changes 244.26 11.01 311 54093 34616 29485507
Hypotonia 243.21 11.01 154 54250 6748 29513375
Cerebrospinal fluid leakage 225.93 11.01 65 54339 342 29519781
Device infusion issue 212.04 11.01 68 54336 544 29519579
Medical device site infection 211.07 11.01 55 54349 184 29519939
Complication associated with device 206.16 11.01 125 54279 5066 29515057
Device physical property issue 196.44 11.01 65 54339 580 29519543
Implant site swelling 188.57 11.01 40 54364 32 29520091
Implant site erosion 185.89 11.01 40 54364 37 29520086
Device kink 170.26 11.01 51 54353 316 29519807
Withdrawal syndrome 168.96 11.01 149 54255 10843 29509280
Device power source issue 163.27 11.01 48 54356 276 29519847
Medical device site swelling 152.73 11.01 30 54374 7 29520116
Somnolence 152.23 11.01 448 53956 93507 29426616
Pocket erosion 142.98 11.01 28 54376 6 29520117
Muscle tightness 140.97 11.01 92 54312 4246 29515877
Implant site pain 138.64 11.01 34 54370 82 29520041
Respiratory depression 137.39 11.01 146 54258 13377 29506746
Therapeutic response decreased 136.09 11.01 196 54208 24515 29495608
Medical device site discharge 135.36 11.01 27 54377 9 29520114
Implant site discharge 132.42 11.01 26 54378 6 29520117
Toxicity to various agents 129.34 11.01 646 53758 173015 29347108
Implant site erythema 122.45 11.01 26 54378 21 29520102
Device dislocation 118.52 11.01 84 54320 4443 29515680
Medical device site erythema 114.39 11.01 24 54380 17 29520106
Wound dehiscence 113.02 11.01 70 54334 2947 29517176
Febrile neutropenia 111.42 11.01 34 54370 112206 29407917
Anaemia 108.60 11.01 126 54278 200825 29319298
Sedation 107.67 11.01 146 54258 17259 29502864
Seizure 101.78 11.01 389 54015 92734 29427389
Medical device site pain 100.28 11.01 24 54380 50 29520073
Medical device site erosion 98.88 11.01 21 54383 17 29520106
Gait disturbance 98.62 11.01 328 54076 73021 29447102
Toxic encephalopathy 96.97 11.01 75 54329 4537 29515586
Decubitus ulcer 96.49 11.01 91 54313 7220 29512903
Unresponsive to stimuli 95.17 11.01 168 54236 24958 29495165
Diarrhoea 94.08 11.01 307 54097 332391 29187732
Completed suicide 93.74 11.01 371 54033 89875 29430248
Clonus 91.18 11.01 56 54348 2322 29517801
Device alarm issue 88.13 11.01 35 54369 547 29519576
Device breakage 88.07 11.01 49 54355 1685 29518438
Encephalopathy 87.37 11.01 183 54221 30860 29489263
Infusion site mass 86.54 11.01 28 54376 231 29519892
Device issue 86.19 11.01 88 54316 7692 29512431
Pain 85.16 11.01 573 53831 170859 29349264
Underdose 81.80 11.01 105 54299 11764 29508359
Gait spastic 79.07 11.01 34 54370 656 29519467
Device connection issue 76.32 11.01 27 54377 300 29519823
Neutropenia 75.00 11.01 79 54325 131632 29388491
Intracranial hypotension 74.50 11.01 24 54380 195 29519928
Implant site scar 74.20 11.01 14 54390 0 29520123
Relapsing-remitting multiple sclerosis 73.92 11.01 33 54371 699 29519424
Cardiac failure 71.77 11.01 28 54376 79259 29440864
Fall 71.19 11.01 563 53841 176615 29343508
Device malfunction 71.17 11.01 83 54321 8424 29511699
Dyspnoea 70.29 11.01 336 54068 326396 29193727
Muscular weakness 69.20 11.01 261 54143 61791 29458332
Confusional state 68.64 11.01 436 53968 127441 29392682
Device computer issue 67.89 11.01 14 54390 8 29520115
Thrombocytopenia 67.01 11.01 90 54314 134733 29385390
Acute kidney injury 66.04 11.01 258 54146 265009 29255114
Interstitial lung disease 65.95 11.01 13 54391 57705 29462418
Agitation 65.02 11.01 225 54179 51079 29469044
Malignant neoplasm progression 63.75 11.01 28 54376 73831 29446292
Needle fatigue 63.65 11.01 28 54376 572 29519551
Intentional overdose 63.49 11.01 185 54219 38343 29481780
Central nervous system lesion 62.77 11.01 64 54340 5584 29514539
Victim of child abuse 60.37 11.01 30 54374 815 29519308
Secondary progressive multiple sclerosis 59.02 11.01 23 54381 341 29519782
Medical device site fibrosis 58.30 11.01 11 54393 0 29520123
Pancytopenia 58.12 11.01 41 54363 83127 29436996
Bradypnoea 57.50 11.01 42 54362 2329 29517794
Neurogenic bladder 57.30 11.01 36 54368 1554 29518569
Death 56.67 11.01 383 54021 341701 29178422
Movement disorder 56.04 11.01 81 54323 10156 29509967
Urinary incontinence 55.80 11.01 105 54299 16376 29503747
Status epilepticus 55.61 11.01 83 54321 10711 29509412
Hypoaesthesia 54.80 11.01 219 54185 53248 29466875
Device occlusion 54.22 11.01 59 54345 5549 29514574
Atrial fibrillation 53.01 11.01 70 54334 105576 29414547
Hypertonic bladder 52.56 11.01 33 54371 1423 29518700
Balance disorder 52.39 11.01 166 54238 36004 29484119
Cardiac failure congestive 51.88 11.01 39 54365 76542 29443581
Depressed level of consciousness 51.20 11.01 167 54237 36775 29483348
Autonomic dysreflexia 51.00 11.01 14 54390 60 29520063
Renal failure 47.75 11.01 91 54313 118508 29401615
Medical device site inflammation 47.70 11.01 9 54395 0 29520123
Medical device site discomfort 47.70 11.01 9 54395 0 29520123
Renal impairment 47.14 11.01 48 54356 81285 29438838
Trigeminal neuralgia 46.83 11.01 27 54377 995 29519128
Arachnoiditis 46.22 11.01 19 54385 326 29519797
Neurotoxicity 45.67 11.01 90 54314 14523 29505600
Post lumbar puncture syndrome 45.13 11.01 16 54388 179 29519944
Urosepsis 44.80 11.01 75 54329 10671 29509452
Foetal exposure during pregnancy 44.72 11.01 5 54399 33862 29486261
Ataxia 44.62 11.01 80 54324 12023 29508100
Hyperkalaemia 44.57 11.01 29 54375 61363 29458760
Monoparesis 44.55 11.01 33 54371 1870 29518253
Autonomic nervous system imbalance 44.29 11.01 36 54368 2340 29517783
Rash 43.79 11.01 190 54214 189629 29330494
Dystonia 43.29 11.01 70 54334 9679 29510444
Blood creatinine increased 43.07 11.01 56 54348 85046 29435077
Medical device site cellulitis 42.40 11.01 8 54396 0 29520123
Platelet count decreased 42.40 11.01 80 54324 104592 29415531
Medical device discomfort 42.39 11.01 10 54394 19 29520104
Implant site abscess 41.48 11.01 9 54395 9 29520114
Pneumonia aspiration 41.32 11.01 155 54249 36582 29483541
Tremor 40.17 11.01 252 54152 73286 29446837
Implant site vesicles 39.86 11.01 8 54396 3 29520120
Respiratory rate decreased 39.52 11.01 31 54373 1914 29518209
Implant site cellulitis 39.28 11.01 9 54395 14 29520109
Medical device site bruise 39.17 11.01 8 54396 4 29520119
Muscle twitching 38.91 11.01 60 54344 7966 29512157
Drug interaction 38.88 11.01 209 54195 197176 29322947
Musculoskeletal stiffness 38.82 11.01 154 54250 37304 29482819
Progressive multiple sclerosis 38.70 11.01 15 54389 219 29519904
Medical device site reaction 37.94 11.01 8 54396 6 29520117
Micturition urgency 37.60 11.01 47 54357 5126 29514997
Implant site haematoma 37.45 11.01 11 54393 63 29520060
Lethargy 36.95 11.01 152 54252 37428 29482695
Gastrointestinal haemorrhage 36.60 11.01 56 54348 79477 29440646
Lymphocyte percentage decreased 36.42 11.01 30 54374 1987 29518136
Incision site erythema 36.34 11.01 11 54393 71 29520052
Leukopenia 36.25 11.01 29 54375 55174 29464949
Delirium 36.13 11.01 156 54248 39241 29480882
Medical device site haematoma 36.05 11.01 9 54395 24 29520099
Dyskinesia 35.63 11.01 99 54305 19962 29500161
Sleep apnoea syndrome 35.45 11.01 91 54313 17508 29502615
General physical health deterioration 34.71 11.01 87 54317 102770 29417353
Alcohol poisoning 34.32 11.01 35 54369 3054 29517069
Implant site dehiscence 33.98 11.01 8 54396 15 29520108
Rheumatoid arthritis 33.22 11.01 9 54395 32143 29487980
Electroencephalogram abnormal 32.61 11.01 30 54374 2305 29517818
Metabolic encephalopathy 32.56 11.01 37 54367 3650 29516473
Poisoning deliberate 32.32 11.01 46 54358 5685 29514438
Myocardial infarction 32.24 11.01 100 54304 110196 29409927
Purulent discharge 32.24 11.01 31 54373 2519 29517604
Hyperreflexia 31.88 11.01 32 54372 2740 29517383
Insomnia 31.75 11.01 275 54129 88486 29431637
Macrophages increased 31.74 11.01 12 54392 163 29519960
Lipoma 31.68 11.01 24 54380 1407 29518716
Dyspnoea exertional 31.21 11.01 14 54390 36476 29483647
Drug delivery device placement 31.11 11.01 11 54393 122 29520001
Pleural effusion 30.86 11.01 53 54351 71855 29448268
Epidural lipomatosis 30.51 11.01 18 54386 693 29519430
Apnoea 30.12 11.01 46 54358 6056 29514067
Implant site reaction 29.99 11.01 8 54396 30 29520093
Central nervous system infection 29.41 11.01 16 54388 526 29519597
Epistaxis 29.40 11.01 31 54373 51673 29468450
Pneumonia 29.32 11.01 414 53990 319758 29200365
Cytomegalovirus infection 29.25 11.01 4 54400 23211 29496912
CSF culture positive 29.11 11.01 7 54397 15 29520108
Cough 29.09 11.01 127 54277 126600 29393523
Stomatitis 29.08 11.01 16 54388 37097 29483026
Abdominal pain 29.08 11.01 139 54265 135218 29384905
White blood cells urine positive 28.93 11.01 21 54383 1153 29518970
Seronegative arthritis 28.57 11.01 19 54385 905 29519218
Drug dependence 28.30 11.01 94 54310 20887 29499236
Infusion related reaction 27.65 11.01 24 54380 43862 29476261
Asphyxia 27.56 11.01 41 54363 5274 29514849
Accidental overdose 27.56 11.01 83 54321 17510 29502613
Anal incontinence 27.35 11.01 46 54358 6569 29513554
Mucosal inflammation 27.21 11.01 12 54392 31583 29488540
Implant site mass 27.17 11.01 6 54398 7 29520116
Stiff person syndrome 27.03 11.01 9 54395 82 29520041
Generalised tonic-clonic seizure 26.94 11.01 87 54317 19052 29501071
Delirium tremens 26.82 11.01 15 54389 521 29519602
Patient-device incompatibility 26.73 11.01 6 54398 8 29520115
Incorrect drug administration rate 26.65 11.01 20 54384 1156 29518967
Hepatic function abnormal 26.57 11.01 20 54384 39239 29480884
Device inversion 26.50 11.01 5 54399 0 29520123
Monocyte percentage increased 26.38 11.01 18 54386 895 29519228
Device material issue 26.32 11.01 6 54398 9 29520114
Hyperhidrosis 26.32 11.01 206 54198 64334 29455789
Meningitis 26.31 11.01 36 54368 4289 29515834
Myoclonus 25.97 11.01 68 54336 13241 29506882
Performance status decreased 25.72 11.01 33 54371 3694 29516429
Seroma 25.65 11.01 15 54389 568 29519555
Rectal haemorrhage 25.51 11.01 16 54388 34533 29485590
Staphylococcus test positive 25.12 11.01 28 54376 2705 29517418
Product prescribing error 24.66 11.01 81 54323 17895 29502228
Miosis 24.63 11.01 49 54355 7960 29512163
Urinary retention 24.56 11.01 120 54284 31778 29488345
Haemorrhage 24.54 11.01 28 54376 45044 29475079
Memory impairment 24.46 11.01 132 54272 36338 29483785
Decreased appetite 24.30 11.01 162 54242 145180 29374943
Hypoglycaemia 24.26 11.01 32 54372 48314 29471809
Motor dysfunction 24.20 11.01 41 54363 5889 29514234
Device extrusion 24.16 11.01 5 54399 3 29520120
Device leakage 23.78 11.01 35 54369 4460 29515663
Implant site oedema 23.57 11.01 5 54399 4 29520119
Infusion site granuloma 23.57 11.01 5 54399 4 29520119
Disease progression 23.41 11.01 75 54329 81841 29438282
Areflexia 23.25 11.01 27 54377 2727 29517396
Neutrophil percentage increased 23.18 11.01 22 54382 1759 29518364
Intestinal pseudo-obstruction 22.93 11.01 19 54385 1269 29518854
Coma scale abnormal 22.82 11.01 30 54374 3439 29516684
Bone marrow failure 22.75 11.01 11 54393 27438 29492685
Muscle rigidity 22.52 11.01 52 54352 9359 29510764
Anxiety 22.44 11.01 248 54156 85117 29435006
Jaundice 22.42 11.01 13 54391 29283 29490840
Weight decreased 22.42 11.01 174 54230 150731 29369392
Bacterial test positive 22.40 11.01 27 54377 2836 29517287
White blood cell count decreased 22.00 11.01 79 54325 83283 29436840
Oedema peripheral 21.84 11.01 107 54297 103450 29416673
Muscle contractions involuntary 21.84 11.01 21 54383 1706 29518417
Hallucination 21.82 11.01 149 54255 44563 29475560
Influenza like illness 21.75 11.01 96 54308 24374 29495749
Chronic kidney disease 21.65 11.01 21 54383 36395 29483728
Cognitive disorder 21.50 11.01 93 54311 23406 29496717
Coronary artery disease 21.41 11.01 30 54374 44160 29475963
Weight increased 21.35 11.01 71 54333 76596 29443527
Mobility decreased 21.31 11.01 99 54305 25681 29494442
Catheter site erosion 21.20 11.01 4 54400 0 29520123
Infusion site fibrosis 21.20 11.01 4 54400 0 29520123
Drug ineffective 20.89 11.01 509 53895 362661 29157462
Pneumocystis jirovecii pneumonia 20.88 11.01 3 54401 16776 29503347
Depression 20.86 11.01 244 54160 84903 29435220
Lymphadenopathy 20.81 11.01 10 54394 25039 29495084
Discomfort 20.68 11.01 67 54337 14696 29505427
Magnetic resonance imaging abnormal 20.09 11.01 19 54385 1512 29518611
Cystitis 20.04 11.01 46 54358 8246 29511877
Alcohol withdrawal syndrome 19.88 11.01 18 54386 1355 29518768
Paralysis 19.83 11.01 36 54368 5461 29514662
Bradycardia 19.76 11.01 196 54208 65433 29454690
Lactic acidosis 19.71 11.01 16 54388 30231 29489892
Ascites 19.67 11.01 23 54381 36596 29483527
Pollakiuria 19.53 11.01 72 54332 16844 29503279
Dysarthria 19.47 11.01 110 54294 30801 29489322
Gait inability 19.40 11.01 76 54328 18299 29501824
Urine leukocyte esterase positive 19.36 11.01 11 54393 394 29519729
Pneumonitis 19.34 11.01 14 54390 28030 29492093
Multiple organ dysfunction syndrome 19.31 11.01 56 54348 63060 29457063
Respiratory acidosis 19.11 11.01 31 54373 4297 29515826
Medical device site ulcer 18.97 11.01 4 54400 3 29520120
Pseudomeningocele 18.97 11.01 4 54400 3 29520120
Toxic epidermal necrolysis 18.91 11.01 5 54399 18148 29501975
Pre-existing disease 18.87 11.01 7 54397 90 29520033
Suicide attempt 18.67 11.01 117 54287 33993 29486130
Drug eruption 18.64 11.01 4 54400 16737 29503386
Chest pain 18.61 11.01 125 54279 111848 29408275
Epilepsy 18.46 11.01 75 54329 18357 29501766
Drug reaction with eosinophilia and systemic symptoms 18.00 11.01 15 54389 27977 29492146
Posture abnormal 17.98 11.01 20 54384 1927 29518196
Dysstasia 17.92 11.01 51 54353 10423 29509700
Euphoric mood 17.92 11.01 32 54372 4793 29515330
Angina pectoris 17.82 11.01 15 54389 27835 29492288
Juvenile idiopathic arthritis 17.72 11.01 17 54387 1377 29518746
Neuralgia 17.69 11.01 52 54352 10822 29509301
Liver disorder 17.69 11.01 15 54389 27734 29492389
Altered state of consciousness 17.65 11.01 78 54326 19811 29500312
Hypocalcaemia 17.56 11.01 8 54396 20657 29499466
Irritability 17.53 11.01 84 54320 22068 29498055
Decreased vibratory sense 17.50 11.01 10 54394 362 29519761
Dysgeusia 17.44 11.01 10 54394 22664 29497459
Drug resistance 17.29 11.01 9 54395 21531 29498592
Blood ketone body increased 17.26 11.01 10 54394 372 29519751
Proteinuria 17.14 11.01 4 54400 15800 29504323
Electric shock 17.14 11.01 7 54397 118 29520005
Brief psychotic disorder with marked stressors 17.12 11.01 8 54396 189 29519934
Scratch 17.10 11.01 23 54381 2695 29517428
Gout 16.98 11.01 5 54399 16906 29503217
Road traffic accident 16.94 11.01 65 54339 15496 29504627
Brain stem syndrome 16.67 11.01 10 54394 397 29519726
Hepatotoxicity 16.67 11.01 6 54398 17861 29502262
Hallucination, visual 16.58 11.01 63 54341 14952 29505171
Muscle contracture 16.47 11.01 15 54389 1138 29518985
General symptom 16.40 11.01 13 54391 815 29519308
Tachyphrenia 16.29 11.01 15 54389 1154 29518969
Dehydration 16.25 11.01 134 54270 114614 29405509
Neutrophil count decreased 16.17 11.01 35 54369 43532 29476591
Angioedema 16.13 11.01 21 54383 31894 29488229
Axillary pain 16.00 11.01 9 54395 316 29519807
Hallucinations, mixed 15.94 11.01 21 54383 2412 29517711
Medical device site oedema 15.90 11.01 3 54401 0 29520123
Implant site ulcer 15.90 11.01 3 54401 0 29520123
Medical device site extravasation 15.90 11.01 3 54401 0 29520123
Neuromuscular blocking therapy 15.90 11.01 3 54401 0 29520123
Device deposit issue 15.90 11.01 3 54401 0 29520123
Incision site vesicles 15.90 11.01 3 54401 0 29520123
Myalgia 15.88 11.01 76 54328 73943 29446180
Glossopharyngeal nerve disorder 15.81 11.01 5 54399 38 29520085
JC polyomavirus test positive 15.80 11.01 11 54393 565 29519558
Premature baby 15.79 11.01 6 54398 17274 29502849
Influenza B virus test positive 15.71 11.01 6 54398 84 29520039
Therapeutic response unexpected 15.70 11.01 43 54361 8595 29511528
Agranulocytosis 15.60 11.01 9 54395 20331 29499792
Nocturia 15.58 11.01 42 54362 8320 29511803
Product use in unapproved indication 15.44 11.01 95 54309 86780 29433343
Narcissistic personality disorder 15.44 11.01 4 54400 13 29520110
Arrhythmia 15.43 11.01 21 54383 31292 29488831
Asthma 15.40 11.01 24 54380 33825 29486298
International normalised ratio increased 15.37 11.01 37 54367 44335 29475788
Wound infection staphylococcal 15.19 11.01 15 54389 1259 29518864
Haematochezia 15.19 11.01 28 54376 36955 29483168
Incorrect route of product administration 15.11 11.01 49 54355 10752 29509371
Blood ethanol increased 14.95 11.01 10 54394 481 29519642
Blood sodium increased 14.77 11.01 21 54383 2593 29517530
Haemoglobin decreased 14.69 11.01 128 54276 108247 29411876
Chest discomfort 14.65 11.01 40 54364 45943 29474180
Neuropathy peripheral 14.62 11.01 74 54330 70953 29449170
Pulmonary hypertension 14.61 11.01 8 54396 18600 29501523
Band neutrophil percentage increased 14.49 11.01 6 54398 105 29520018
Implant site inflammation 14.44 11.01 6 54398 106 29520017
Hallucination, olfactory 14.30 11.01 7 54397 184 29519939
Melaena 14.28 11.01 22 54382 31154 29488969
Urinary tract infection pseudomonal 14.17 11.01 11 54393 669 29519454
Scar 14.14 11.01 31 54373 5388 29514735
Tumour lysis syndrome 14.13 11.01 4 54400 13880 29506243
Mental disorder 14.13 11.01 54 54350 12851 29507272
Contraindicated product administered 14.13 11.01 8 54396 18258 29501865
Loss of control of legs 14.05 11.01 10 54394 532 29519591
Musculoskeletal discomfort 14.04 11.01 34 54370 6307 29513816
Erectile dysfunction 14.04 11.01 68 54336 17941 29502182
Staphylococcal infection 14.00 11.01 97 54307 29143 29490980
Hypothermia 13.92 11.01 43 54361 9196 29510927
Lumbar puncture abnormal 13.83 11.01 3 54401 3 29520120
Medical device site warmth 13.83 11.01 3 54401 3 29520120
Brain injury 13.79 11.01 31 54373 5481 29514642
Scoliosis 13.77 11.01 19 54385 2281 29517842
Unevaluable event 13.69 11.01 98 54306 29753 29490370
Bronchopulmonary aspergillosis 13.64 11.01 3 54401 12341 29507782
Streptococcus test positive 13.59 11.01 12 54392 874 29519249
Haemoptysis 13.58 11.01 22 54382 30528 29489595
Feeling of body temperature change 13.55 11.01 14 54390 1240 29518883
Bladder dysfunction 13.46 11.01 8 54396 312 29519811
Red blood cells urine positive 13.45 11.01 16 54388 1657 29518466
Myelosuppression 13.45 11.01 3 54401 12224 29507899
Colitis 13.43 11.01 23 54381 31225 29488898
Polyneuropathy 13.33 11.01 3 54401 12149 29507974
Anaphylactic shock 13.28 11.01 4 54400 13332 29506791
Medical device site haemorrhage 13.27 11.01 6 54398 131 29519992
Postoperative wound infection 13.12 11.01 26 54378 4210 29515913
Acute myeloid leukaemia 13.11 11.01 7 54397 16506 29503617
Hypomagnesaemia 13.02 11.01 8 54396 17460 29502663
CD8 lymphocytes increased 12.93 11.01 4 54400 28 29520095
Wound 12.82 11.01 50 54354 12013 29508110
Spinal cord injury cauda equina 12.68 11.01 6 54398 146 29519977
Pituitary cyst 12.62 11.01 3 54401 6 29520117
CSF shunt operation 12.62 11.01 3 54401 6 29520117
Urine cannabinoids increased 12.62 11.01 3 54401 6 29520117
Implant site rash 12.62 11.01 3 54401 6 29520117
Ulcerative duodenitis 12.62 11.01 3 54401 6 29520117
Pancreatitis 12.58 11.01 28 54376 34486 29485637
Electrocardiogram QRS complex prolonged 12.46 11.01 25 54379 4085 29516038
Somatosensory evoked potentials abnormal 12.46 11.01 6 54398 152 29519971
Logorrhoea 12.37 11.01 18 54386 2270 29517853
Hepatitis 12.33 11.01 12 54392 20771 29499352
Cholestasis 12.31 11.01 15 54389 23447 29496676
Analgesic drug level above therapeutic 12.31 11.01 7 54397 251 29519872
Uhthoff's phenomenon 12.30 11.01 3 54401 7 29520116
Proteus test positive 12.26 11.01 5 54399 84 29520039
Patella fracture 12.24 11.01 7 54397 254 29519869
Haematuria 12.20 11.01 41 54363 44098 29476025
Hyporeflexia 12.18 11.01 16 54388 1832 29518291
Tachycardia 12.18 11.01 194 54210 72216 29447907
Palmar-plantar erythrodysaesthesia syndrome 12.10 11.01 6 54398 14753 29505370
Rash pruritic 12.06 11.01 14 54390 22349 29497774
B-lymphocyte count decreased 12.04 11.01 9 54395 517 29519606
Inflammatory marker increased 11.96 11.01 23 54381 3644 29516479
Systolic hypertension 11.95 11.01 7 54397 266 29519857
Blood bilirubin increased 11.94 11.01 28 54376 33865 29486258
Duodenitis haemorrhagic 11.94 11.01 5 54399 90 29520033
Septic shock 11.86 11.01 67 54337 62493 29457630
Fatigue 11.82 11.01 470 53934 316351 29203772
Peroneal nerve palsy 11.78 11.01 19 54385 2620 29517503
Excessive granulation tissue 11.77 11.01 8 54396 395 29519728
Pericardial effusion 11.73 11.01 13 54391 21195 29498928
Post laminectomy syndrome 11.71 11.01 6 54398 174 29519949
Urine abnormality 11.69 11.01 15 54389 1679 29518444
Grimacing 11.69 11.01 7 54397 277 29519846
Vitamin B6 deficiency 11.68 11.01 6 54398 175 29519948
Upper respiratory tract irritation 11.59 11.01 4 54400 41 29520082
Device programming error 11.52 11.01 3 54401 10 29520113
Procedural complication 11.49 11.01 24 54380 4036 29516087
Primary progressive multiple sclerosis 11.42 11.01 4 54400 43 29520080
Tongue biting 11.39 11.01 10 54394 723 29519400
Urinary sediment present 11.38 11.01 6 54398 185 29519938
Chronic obstructive pulmonary disease 11.34 11.01 38 54366 40917 29479206
Renal disorder 11.28 11.01 15 54389 22580 29497543
Rash maculo-papular 11.26 11.01 17 54387 24272 29495851
Ventricular tachycardia 11.26 11.01 15 54389 22559 29497564
Quadriplegia 11.23 11.01 14 54390 1522 29518601
Loss of consciousness 11.20 11.01 195 54209 73861 29446262
Dysdiadochokinesis 11.18 11.01 6 54398 192 29519931
Cardiotoxicity 11.11 11.01 26 54378 4718 29515405

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
Drug withdrawal syndrome 1918.11 10.21 1003 118486 30288 64348955
Multiple sclerosis relapse 1480.91 10.21 932 118557 40203 64339040
Muscle spasticity 1263.08 10.21 617 118872 16052 64363191
Multiple sclerosis 972.34 10.21 540 118949 18401 64360842
Implant site infection 777.39 10.21 233 119256 1436 64377807
Implant site extravasation 751.92 10.21 191 119298 555 64378688
Coma 606.76 10.21 779 118710 86836 64292407
Device failure 453.02 10.21 218 119271 5474 64373769
Urinary tract infection 447.26 10.21 1182 118307 230414 64148829
Hypotonia 405.46 10.21 255 119234 10957 64368286
Muscle spasms 404.87 10.21 841 118648 140182 64239061
Somnolence 379.52 10.21 1026 118463 202619 64176624
Overdose 369.38 10.21 873 118616 158693 64220550
Cerebrospinal fluid leakage 358.23 10.21 122 119367 1190 64378053
Mental status changes 348.77 10.21 495 118994 60667 64318576
Hypertonia 345.61 10.21 188 119301 6137 64373106
Device infusion issue 301.76 10.21 116 119373 1642 64377601
Completed suicide 294.86 10.21 1000 118489 223414 64155829
Medical device site infection 249.77 10.21 71 119418 352 64378891
Seizure 242.67 10.21 770 118719 166122 64213121
Withdrawal syndrome 230.76 10.21 250 119239 23242 64356001
Pneumonia aspiration 219.54 10.21 394 119095 58877 64320366
Gait disturbance 217.95 10.21 758 118731 171397 64207846
Muscular weakness 216.60 10.21 621 118868 126717 64252526
Complication associated with device 211.95 10.21 195 119294 14885 64364358
Febrile neutropenia 211.03 10.21 45 119444 187612 64191631
Unresponsive to stimuli 207.48 10.21 351 119138 50042 64329201
Therapy non-responder 206.70 10.21 408 119081 65491 64313752
Muscle tightness 203.23 10.21 167 119322 10948 64368295
Fall 202.06 10.21 1392 118097 415434 63963809
Device physical property issue 198.43 10.21 91 119398 2042 64377201
Medical device site pain 196.64 10.21 53 119436 207 64379036
Device power source issue 190.35 10.21 67 119422 727 64378516
Toxicity to various agents 189.32 10.21 1236 118253 362277 64016966
Anaemia 189.31 10.21 255 119234 378425 64000818
Medical device site discharge 187.78 10.21 39 119450 24 64379219
Implant site erosion 180.86 10.21 43 119446 85 64379158
Implant site swelling 175.37 10.21 54 119435 369 64378874
Respiratory depression 174.05 10.21 216 119273 23227 64356016
Implant site discharge 172.96 10.21 43 119446 111 64379132
Diarrhoea 172.60 10.21 722 118767 721982 63657261
Toxic encephalopathy 168.11 10.21 142 119347 9673 64369570
Device kink 166.24 10.21 75 119414 1618 64377625
Medical device site swelling 165.16 10.21 37 119452 48 64379195
Medical device site erythema 160.14 10.21 36 119453 48 64379195
Pocket erosion 159.95 10.21 32 119457 11 64379232
Encephalopathy 147.05 10.21 332 119157 58487 64320756
Neutropenia 146.25 10.21 137 119352 239487 64139756
Wound dehiscence 146.21 10.21 106 119383 5768 64373475
Decubitus ulcer 141.32 10.21 148 119341 13231 64366012
Hypoaesthesia 139.79 10.21 569 118920 138539 64240704
Rash 126.11 10.21 432 119057 458117 63921126
Acute kidney injury 125.05 10.21 421 119068 448819 63930424
Secondary progressive multiple sclerosis 125.03 10.21 56 119433 1187 64378056
Implant site pain 119.39 10.21 62 119427 1838 64377405
Dyspnoea 115.56 10.21 819 118670 717855 63661388
Sedation 113.79 10.21 243 119246 41219 64338024
Underdose 111.75 10.21 184 119305 25645 64353598
Malignant neoplasm progression 109.89 10.21 36 119453 112835 64266408
Device malfunction 109.85 10.21 149 119340 17484 64361759
Pancytopenia 109.19 10.21 65 119424 143244 64235999
Interstitial lung disease 108.66 10.21 24 119465 97708 64281535
Central nervous system lesion 107.54 10.21 121 119368 11728 64367515
Memory impairment 106.32 10.21 375 119114 85307 64293936
Infusion related reaction 103.91 10.21 91 119398 164376 64214867
Thrombocytopenia 103.49 10.21 159 119330 223642 64155601
Status epilepticus 102.86 10.21 161 119328 21502 64357741
Device alarm issue 102.76 10.21 56 119433 1834 64377409
Intracranial hypotension 100.71 10.21 34 119455 322 64378921
Progressive multiple sclerosis 100.15 10.21 42 119447 754 64378489
Gait spastic 98.79 10.21 43 119446 849 64378394
Tremor 98.71 10.21 538 118951 147692 64231551
Post lumbar puncture syndrome 98.52 10.21 40 119449 659 64378584
Cardiac failure 96.75 10.21 63 119426 132310 64246933
Neurotoxicity 94.89 10.21 177 119312 27227 64352016
Device dislocation 94.51 10.21 153 119336 21025 64358218
Contraindicated product administered 93.94 10.21 41 119448 107788 64271455
Balance disorder 93.74 10.21 355 119134 83571 64295672
Neurogenic bladder 91.65 10.21 66 119423 3553 64375690
Agitation 89.94 10.21 363 119126 88004 64291239
Urinary incontinence 89.16 10.21 203 119286 35948 64343295
Asphyxia 89.06 10.21 99 119390 9467 64369776
Infusion site mass 88.59 10.21 41 119448 940 64378303
Clonus 88.27 10.21 80 119409 5987 64373256
Device connection issue 86.50 10.21 39 119450 840 64378403
Urine analysis abnormal 83.94 10.21 76 119413 5680 64373563
Relapsing-remitting multiple sclerosis 83.83 10.21 41 119448 1067 64378176
Glossodynia 82.63 10.21 11 119478 64685 64314558
Trigeminal neuralgia 81.73 10.21 58 119431 3051 64376192
Atrial fibrillation 81.54 10.21 119 119370 170970 64208273
Device computer issue 81.40 10.21 18 119471 21 64379222
Synovitis 81.20 10.21 41 119448 99049 64280194
Pericarditis 78.97 10.21 11 119478 62505 64316738
Joint swelling 77.53 10.21 178 119311 215204 64164039
Therapeutic response decreased 76.81 10.21 242 119247 51946 64327297
Medical device site fibrosis 76.67 10.21 15 119474 3 64379240
Implant site erythema 76.21 10.21 30 119459 454 64378789
Systemic lupus erythematosus 75.11 10.21 25 119464 77587 64301656
Medical device site erosion 74.92 10.21 18 119471 38 64379205
Cough 74.18 10.21 298 119191 301850 64077393
Device inversion 74.10 10.21 14 119475 0 64379243
Lethargy 73.70 10.21 298 119191 72296 64306947
Progressive multifocal leukoencephalopathy 73.69 10.21 126 119363 18106 64361137
Urosepsis 73.14 10.21 140 119349 21954 64357289
Arthropathy 72.75 10.21 70 119419 120897 64258346
Mucosal inflammation 72.39 10.21 14 119475 62570 64316673
Intentional overdose 71.39 10.21 343 119146 89601 64289642
Confusional state 71.05 10.21 768 118721 260376 64118867
Renal impairment 70.31 10.21 88 119401 134929 64244314
Dystonia 69.29 10.21 125 119364 18740 64360503
Device issue 68.30 10.21 138 119351 22510 64356733
Device occlusion 68.27 10.21 88 119401 9825 64369418
Bradypnoea 67.27 10.21 64 119425 5095 64374148
Exposure during pregnancy 66.92 10.21 30 119459 77645 64301598
Metabolic encephalopathy 66.17 10.21 78 119411 7947 64371296
Laboratory test abnormal 65.98 10.21 141 119348 23922 64355321
Gastrointestinal haemorrhage 65.05 10.21 90 119399 132222 64247021
Cardiac failure congestive 64.01 10.21 89 119400 130491 64248752
Platelet count decreased 63.30 10.21 135 119354 167576 64211667
Abdominal discomfort 62.17 10.21 155 119334 182167 64197076
Drug interaction 61.74 10.21 405 119084 361678 64017565
Hyperkalaemia 61.41 10.21 58 119431 101071 64278172
Pleural effusion 61.30 10.21 87 119402 126472 64252771
Lymphocyte count decreased 61.06 10.21 190 119299 40509 64338734
Needle fatigue 60.77 10.21 27 119462 561 64378682
Muscle rigidity 60.67 10.21 113 119376 17360 64361883
Drug ineffective 60.08 10.21 1147 118342 839100 63540143
Areflexia 59.44 10.21 59 119430 4948 64374295
Delirium 59.40 10.21 270 119219 68924 64310319
Blood creatinine increased 59.40 10.21 100 119389 135682 64243561
Hand deformity 59.38 10.21 21 119468 62750 64316493
Electroencephalogram abnormal 59.36 10.21 60 119429 5143 64374100
Victim of child abuse 59.30 10.21 30 119459 841 64378402
Muscle twitching 58.77 10.21 117 119372 18881 64360362
Ataxia 57.80 10.21 127 119362 21957 64357286
Magnetic resonance imaging abnormal 57.25 10.21 47 119442 3076 64376167
Neuralgia 56.93 10.21 140 119349 26044 64353199
Generalised tonic-clonic seizure 56.08 10.21 182 119307 39675 64339568
Implant site haematoma 55.99 10.21 18 119471 144 64379099
Movement disorder 55.87 10.21 125 119364 21875 64357368
Hepatic function abnormal 55.15 10.21 25 119464 64288 64314955
Depressed level of consciousness 55.13 10.21 297 119192 81139 64298104
Escherichia urinary tract infection 55.12 10.21 88 119401 11949 64367294
Medical device site discomfort 54.73 10.21 18 119471 156 64379087
Influenza like illness 54.64 10.21 243 119246 61459 64317784
Rheumatoid arthritis 54.22 10.21 142 119347 164152 64215091
White blood cells urine positive 53.96 10.21 58 119431 5340 64373903
Renal failure 53.37 10.21 166 119323 181522 64197721
Drug delivery device placement 52.72 10.21 18 119471 177 64379066
Abdominal pain 51.92 10.21 352 119137 312023 64067220
Monocyte percentage increased 51.85 10.21 37 119452 1963 64377280
General physical health deterioration 51.16 10.21 200 119289 204225 64175018
Bone marrow failure 50.88 10.21 13 119476 47939 64331304
Poisoning deliberate 50.48 10.21 90 119399 13368 64365875
Medical device site inflammation 50.31 10.21 10 119479 3 64379240
Osteonecrosis of jaw 50.31 10.21 7 119482 39818 64339425
Decreased appetite 49.77 10.21 311 119178 280978 64098265
Autonomic nervous system imbalance 49.63 10.21 49 119440 4083 64375160
Hallucination 49.63 10.21 266 119223 72522 64306721
Drug intolerance 49.59 10.21 180 119309 187812 64191431
Disease progression 49.43 10.21 119 119370 141561 64237682
Insomnia 49.29 10.21 572 118917 197264 64181979
Arthralgia 49.23 10.21 553 118936 441707 63937536
Hyporeflexia 48.92 10.21 44 119445 3260 64375983
JC polyomavirus test positive 48.90 10.21 30 119459 1232 64378011
Scoliosis 48.31 10.21 58 119431 6024 64373219
Urine leukocyte esterase positive 47.80 10.21 44 119445 3359 64375884
Lymphocyte percentage decreased 46.56 10.21 50 119439 4599 64374644
Duodenal ulcer perforation 46.40 10.21 5 119484 34620 64344623
Ascites 45.98 10.21 29 119460 61972 64317271
Toxic epidermal necrolysis 45.87 10.21 7 119482 37159 64342084
Device breakage 45.70 10.21 68 119421 8687 64370556
Motor dysfunction 45.18 10.21 78 119411 11295 64367948
Medical device site bruise 45.05 10.21 9 119480 3 64379240
Paraparesis 44.82 10.21 43 119446 3459 64375784
Arachnoiditis 44.78 10.21 23 119466 666 64378577
Red blood cells urine positive 44.56 10.21 48 119441 4430 64374813
Maternal exposure during pregnancy 44.39 10.21 68 119421 95816 64283427
Implant site scar 44.39 10.21 16 119473 187 64379056
Paralysis 44.08 10.21 78 119411 11517 64367726
Miosis 43.83 10.21 84 119405 13182 64366061
Hypoglycaemia 43.32 10.21 62 119427 89830 64289413
Medical device site cellulitis 43.05 10.21 9 119480 6 64379237
Gait inability 43.05 10.21 174 119315 42194 64337049
Dyspnoea exertional 42.78 10.21 44 119445 73686 64305557
Respiratory arrest 42.71 10.21 203 119286 52782 64326461
Peroneal nerve palsy 42.69 10.21 51 119438 5270 64373973
Micturition urgency 42.40 10.21 72 119417 10287 64368956
Multiple organ dysfunction syndrome 42.25 10.21 77 119412 101336 64277907
Lower respiratory tract infection 42 10.21 69 119420 94545 64284698
Paraesthesia 41.95 10.21 407 119082 134115 64245128
Cytomegalovirus infection 41.61 10.21 9 119480 37190 64342053
Product use issue 41.51 10.21 143 119346 151572 64227671
Depression 41.31 10.21 520 118969 182771 64196472
Dyskinesia 41.01 10.21 163 119326 39225 64340018
Bacterial test positive 40.86 10.21 56 119433 6634 64372609
Hypertonic bladder 40.07 10.21 40 119449 3378 64375865
Off label use 39.71 10.21 882 118607 631924 63747319
Neutrophil percentage increased 39.66 10.21 45 119444 4400 64374843
Gastrooesophageal reflux disease 39.66 10.21 277 119212 82866 64296377
Implant site dehiscence 39.63 10.21 10 119479 28 64379215
Musculoskeletal stiffness 39.52 10.21 375 119114 122831 64256412
Focal dyscognitive seizures 39.49 10.21 39 119450 3251 64375992
Apnoea 39.48 10.21 70 119419 10352 64368891
Road traffic accident 39.35 10.21 136 119353 30609 64348634
Myoclonus 39.29 10.21 119 119370 24999 64354244
Incorrect route of product administration 38.94 10.21 113 119376 23185 64356058
Immune reconstitution inflammatory syndrome 38.81 10.21 77 119412 12393 64366850
Epistaxis 38.69 10.21 77 119412 98054 64281189
Sleep apnoea syndrome 38.22 10.21 132 119357 29700 64349543
Optic neuritis 38.08 10.21 60 119429 8056 64371187
Drug dependence 38.07 10.21 142 119347 33170 64346073
Swelling 38.03 10.21 160 119329 160058 64219185
Sleep disorder due to general medical condition, insomnia type 37.32 10.21 3 119486 26267 64352976
Implant site abscess 37.32 10.21 10 119479 38 64379205
Dysstasia 37.27 10.21 111 119378 23104 64356139
Erythema 37.26 10.21 199 119290 186871 64192372
Device extrusion 36.55 10.21 9 119480 22 64379221
Folliculitis 36.36 10.21 6 119483 30071 64349172
Drug eruption 36.09 10.21 11 119478 36125 64343118
Medical device site haematoma 35.99 10.21 9 119480 24 64379219
Incorrect drug administration rate 35.96 10.21 34 119455 2685 64376558
Device leakage 35.90 10.21 59 119430 8207 64371036
Delirium tremens 35.75 10.21 19 119470 591 64378652
Hyperhidrosis 35.60 10.21 371 119118 124549 64254694
Peripheral swelling 35.56 10.21 234 119255 208919 64170324
Hepatotoxicity 35.10 10.21 15 119474 39947 64339296
Burning sensation 34.88 10.21 183 119306 49481 64329762
Alcohol withdrawal syndrome 34.88 10.21 28 119461 1775 64377468
Rectal haemorrhage 34.63 10.21 38 119451 61779 64317464
Muscle contracture 34.62 10.21 30 119459 2115 64377128
Pneumocystis jirovecii pneumonia 34.57 10.21 5 119484 27629 64351614
Drug resistance 34.50 10.21 11 119478 35091 64344152
Oedema peripheral 34.41 10.21 238 119251 210079 64169164
Irritability 34.27 10.21 147 119342 36599 64342644
Accidental overdose 34.24 10.21 138 119351 33419 64345824
Pain 34.18 10.21 1300 118189 552211 63827032
Loss of consciousness 33.88 10.21 422 119067 147943 64231300
Monoparesis 33.78 10.21 34 119455 2900 64376343
Haematochezia 33.77 10.21 44 119445 66329 64312914
Melaena 33.34 10.21 30 119459 53518 64325725
Migraine 32.99 10.21 214 119275 62463 64316780
Nitrite urine present 32.90 10.21 22 119467 1050 64378193
Alcohol poisoning 32.86 10.21 40 119449 4215 64375028
Medical device site reaction 32.73 10.21 7 119482 6 64379237
Respiratory rate decreased 32.72 10.21 41 119448 4450 64374793
Implant site cellulitis 32.64 10.21 10 119479 67 64379176
Muscle injury 32.58 10.21 5 119484 26432 64352811
Dysaesthesia 32.31 10.21 43 119446 4952 64374291
Pulmonary fibrosis 31.89 10.21 8 119481 29870 64349373
Seroma 31.69 10.21 28 119461 2026 64377217
Urinary sediment present 31.60 10.21 29 119460 2205 64377038
Soft tissue injury 31.57 10.21 25 119464 1554 64377689
International normalised ratio increased 31.31 10.21 62 119427 79105 64300138
B-lymphocyte count decreased 31.31 10.21 22 119467 1139 64378104
Agranulocytosis 31.03 10.21 16 119473 38213 64341030
Pollakiuria 30.85 10.21 128 119361 31402 64347841
Neoplasm progression 30.59 10.21 19 119470 40945 64338298
Proteinuria 30.42 10.21 7 119482 27716 64351527
Haemoglobin decreased 30.32 10.21 224 119265 194839 64184404
Palmar-plantar erythrodysaesthesia syndrome 30.21 10.21 8 119481 28811 64350432
Dysarthria 30.16 10.21 201 119288 59205 64320038
Nasopharyngitis 30.08 10.21 226 119263 195847 64183396
Neutrophil count decreased 30.07 10.21 61 119428 77135 64302108
Loss of control of legs 29.96 10.21 25 119464 1674 64377569
Euphoric mood 29.92 10.21 48 119441 6543 64372700
Tubulointerstitial nephritis 29.82 10.21 10 119479 30899 64348344
Macrophages increased 29.82 10.21 12 119477 193 64379050
Urinary retention 29.68 10.21 174 119315 49027 64330216
Pseudomeningocele 29.33 10.21 6 119483 3 64379240
Pneumonitis 29.28 10.21 30 119459 50335 64328908
Hypothermia 29.13 10.21 92 119397 19764 64359479
Lactic acidosis 28.95 10.21 43 119446 61367 64317876
Haemoptysis 28.76 10.21 29 119460 49019 64330224
Therapeutic product effect decreased 28.74 10.21 113 119376 115238 64264005
Incision site erythema 28.58 10.21 13 119476 286 64378957
Concussion 28.39 10.21 52 119437 7886 64371357
Hypomagnesaemia 28.38 10.21 17 119472 37359 64341884
Meningitis 27.84 10.21 53 119436 8276 64370967
Band neutrophil percentage increased 27.82 10.21 14 119475 388 64378855
Medical device discomfort 27.74 10.21 23 119466 1526 64377717
Medical device site ulcer 27.61 10.21 6 119483 6 64379237
Medical device site extravasation 27.61 10.21 6 119483 6 64379237
Amnesia 27.39 10.21 168 119321 48101 64331142
Hypercalcaemia 27.26 10.21 12 119477 31404 64347839
Stiff person syndrome 26.98 10.21 12 119477 250 64378993
Epidural lipomatosis 26.92 10.21 18 119471 859 64378384
Liver disorder 26.50 10.21 36 119453 53315 64325928
Band neutrophil count increased 26.48 10.21 16 119473 639 64378604
Infusion site fibrosis 26.47 10.21 5 119484 0 64379243
Medical device site warmth 26.47 10.21 5 119484 0 64379243
Product use in unapproved indication 26.41 10.21 205 119284 176413 64202830
Device programming error 26.31 10.21 9 119480 89 64379154
Stomatitis 26.28 10.21 109 119380 109496 64269747
Myelosuppression 26.18 10.21 6 119483 23824 64355419
Angina pectoris 26.04 10.21 27 119462 45054 64334189
Implant site reaction 25.92 10.21 10 119479 143 64379100
Culture urine positive 25.73 10.21 35 119454 4116 64375127
Hypervolaemia 25.62 10.21 20 119469 38265 64340978
Drug reaction with eosinophilia and systemic symptoms 25.52 10.21 38 119451 54179 64325064
Neutropenic sepsis 25.29 10.21 6 119483 23266 64355977
Speech disorder 25.25 10.21 165 119324 48276 64330967
Anxiety 25.24 10.21 521 118968 202128 64177115
Purulent discharge 25.11 10.21 40 119449 5421 64373822
Haemorrhage 25.09 10.21 70 119419 79281 64299962
Urinary tract infection pseudomonal 25.08 10.21 21 119468 1413 64377830
Coronary artery disease 25.06 10.21 46 119443 60387 64318856
Lymphopenia 24.98 10.21 104 119385 25553 64353690
Hypersensitivity 24.93 10.21 238 119251 196214 64183029
Hepatic enzyme increased 24.89 10.21 140 119349 129803 64249440
Bradycardia 24.77 10.21 331 119158 117888 64261355
Cholestasis 24.67 10.21 28 119461 44844 64334399
Blood bilirubin increased 24.59 10.21 43 119446 57510 64321733
Autonomic dysreflexia 24.59 10.21 13 119476 400 64378843
Dehydration 24.46 10.21 270 119219 216493 64162750
Alopecia 24.46 10.21 193 119296 165497 64213746
Urobilinogen urine increased 24.43 10.21 15 119474 617 64378626
Weight increased 24.38 10.21 265 119224 213083 64166160
Productive cough 24.34 10.21 63 119426 73140 64306103
Performance status decreased 24.26 10.21 39 119450 5325 64373918
Prescribed underdose 24.20 10.21 81 119408 17934 64361309
Coma scale abnormal 24.19 10.21 48 119441 7726 64371517
Medical device site scar 24.12 10.21 5 119484 3 64379240
Eosinophilia 24.11 10.21 21 119468 38055 64341188
Sternal fracture 23.98 10.21 25 119464 2222 64377021
Patient-device incompatibility 23.97 10.21 9 119480 119 64379124
Device expulsion 23.87 10.21 5 119484 21131 64358112
Post-traumatic neck syndrome 23.67 10.21 23 119466 1879 64377364
Metabolic acidosis 23.64 10.21 61 119428 70897 64308346
Pulmonary hypertension 23.63 10.21 27 119462 43112 64336131
Dysphagia 23.60 10.21 302 119187 106510 64272733
Rash maculo-papular 23.08 10.21 32 119457 46994 64332249
Implant site oedema 23.00 10.21 6 119483 20 64379223
Libido increased 22.95 10.21 22 119467 1768 64377475
Urinary tract infection bacterial 22.85 10.21 37 119452 5084 64374159
CSF culture positive 22.71 10.21 7 119482 48 64379195
Primary progressive multiple sclerosis 22.71 10.21 8 119481 87 64379156
Metastases to liver 22.66 10.21 8 119481 23933 64355310
Bronchopulmonary aspergillosis 22.64 10.21 4 119485 19081 64360162
Mobility decreased 22.62 10.21 251 119238 85589 64293654
Right ventricular failure 22.43 10.21 6 119483 21465 64357778
Leukopenia 22.26 10.21 104 119385 101138 64278105
Temperature intolerance 22.20 10.21 48 119441 8207 64371036
Paraplegia 22.19 10.21 34 119455 4456 64374787
Disorientation 22.09 10.21 178 119311 55650 64323593
Hypocalcaemia 21.94 10.21 27 119462 41726 64337517
Myocardial infarction 21.84 10.21 199 119290 165622 64213621
Treatment failure 21.75 10.21 127 119362 116689 64262554
Wound 21.65 10.21 71 119418 76406 64302837
Neurogenic bowel 21.54 10.21 9 119480 160 64379083
Chronic kidney disease 21.52 10.21 47 119442 57872 64321371
Infusion site granuloma 21.33 10.21 5 119484 9 64379234
Wheezing 21.33 10.21 77 119412 80502 64298741
Muscle contractions involuntary 21.28 10.21 28 119461 3189 64376054
Neuropathy peripheral 21.24 10.21 129 119360 117396 64261847
Fluctuance 21.17 10.21 4 119485 0 64379243
Medical device site vesicles 21.17 10.21 4 119485 0 64379243
Implant site ulcer 21.17 10.21 4 119485 0 64379243
Bladder spasm 21.15 10.21 22 119467 1950 64377293
Epilepsy 21.15 10.21 120 119369 33411 64345832
Tumour lysis syndrome 21.15 10.21 5 119484 19435 64359808
Sensory disturbance 21.06 10.21 63 119426 13145 64366098
Anal incontinence 21.02 10.21 69 119420 15127 64364116
Incoherent 21.02 10.21 43 119446 7075 64372168
Rash pruritic 20.98 10.21 47 119442 57357 64321886
Intestinal pseudo-obstruction 20.90 10.21 22 119467 1978 64377265
Hypokinesia 20.88 10.21 73 119416 16523 64362720
Staphylococcal infection 20.83 10.21 163 119326 50515 64328728
Hostility 20.82 10.21 23 119466 2184 64377059
Bladder disorder 20.70 10.21 45 119444 7722 64371521
CD4 lymphocytes decreased 20.63 10.21 24 119465 2411 64376832
Implant site vesicles 20.59 10.21 6 119483 33 64379210
Intervertebral disc protrusion 20.57 10.21 83 119406 20108 64359135
Incision site swelling 20.51 10.21 8 119481 118 64379125
Pulmonary renal syndrome 20.51 10.21 13 119476 566 64378677
Adrenal insufficiency 20.46 10.21 8 119481 22479 64356764
Incision site oedema 20.37 10.21 5 119484 12 64379231
Blister 20.37 10.21 79 119410 80888 64298355
Haemophagocytic lymphohistiocytosis 20.23 10.21 4 119485 17605 64361638
Decreased vibratory sense 20.20 10.21 13 119476 581 64378662
Hyperaesthesia 20.15 10.21 52 119437 9962 64369281
Drug hypersensitivity 19.96 10.21 315 119174 237500 64141743
Erectile dysfunction 19.91 10.21 60 119429 12567 64366676
Therapeutic response unexpected 19.87 10.21 73 119416 16928 64362315
Diplopia 19.75 10.21 100 119389 26665 64352578
Vitamin B6 deficiency 19.74 10.21 10 119479 281 64378962
Hyperreflexia 19.73 10.21 42 119447 7106 64372137
Bacterial test 19.72 10.21 17 119472 1190 64378053
Altered state of consciousness 19.69 10.21 129 119360 37773 64341470
C-reactive protein abnormal 19.66 10.21 15 119474 29032 64350211
Pupil fixed 19.66 10.21 27 119462 3205 64376038
Hepatitis 19.52 10.21 34 119455 45548 64333695
Lipoma 19.37 10.21 24 119465 2575 64376668
Stevens-Johnson syndrome 19.24 10.21 21 119468 34228 64345015
Nausea 19.22 10.21 1227 118262 784573 63594670
Basal ganglion degeneration 19.21 10.21 11 119478 397 64378846
Jaundice 19.17 10.21 38 119451 48474 64330769
Adverse drug reaction 19.11 10.21 147 119342 45317 64333926
Cerebral infarction 19.09 10.21 29 119460 41015 64338228
Toxic skin eruption 19.02 10.21 6 119483 19278 64359965
Muscle atrophy 18.95 10.21 50 119439 9708 64369535
Urticaria 18.88 10.21 178 119311 147139 64232104
Gout 18.86 10.21 8 119481 21405 64357838
Ankle fracture 18.76 10.21 65 119424 14645 64364598
Spinal cord injury 18.75 10.21 15 119474 946 64378297
Poor quality sleep 18.59 10.21 77 119412 18874 64360369
Hallucination, visual 18.48 10.21 101 119388 27733 64351510
Pulmonary oedema 18.39 10.21 79 119410 78595 64300648
Monoplegia 18.34 10.21 27 119462 3416 64375827
Pancreatitis acute 18.32 10.21 32 119457 42823 64336420
Polyneuropathy 18.23 10.21 7 119482 19887 64359356
Oedema 18.18 10.21 98 119391 91837 64287406
Presyncope 18.12 10.21 23 119466 35066 64344177
Posturing 18.07 10.21 15 119474 997 64378246
Crystal urine present 18.02 10.21 20 119469 1909 64377334
Suicide attempt 17.96 10.21 206 119283 70801 64308442
Premature delivery 17.96 10.21 6 119483 18583 64360660
Incision site complication 17.93 10.21 13 119476 707 64378536
Persistent depressive disorder 17.89 10.21 15 119474 1011 64378232
Abnormal behaviour 17.81 10.21 115 119374 33507 64345736
Feeling abnormal 17.79 10.21 347 119142 133255 64245988
Tissue infiltration 17.79 10.21 12 119477 581 64378662
Faeces discoloured 17.78 10.21 13 119476 25716 64353527
Poisoning 17.75 10.21 84 119405 21795 64357448
Anaphylactic shock 17.70 10.21 18 119471 30310 64348933
Death 17.68 10.21 723 118766 481982 63897261
Nephrolithiasis 17.68 10.21 140 119349 43543 64335700
Sinusitis 17.58 10.21 179 119310 145749 64233494
Tethered cord syndrome 17.52 10.21 4 119485 6 64379237
Brief psychotic disorder with marked stressors 17.48 10.21 9 119480 262 64378981
Hyporesponsive to stimuli 17.42 10.21 19 119470 1778 64377465
Hallucinations, mixed 17.21 10.21 36 119453 6016 64373227
Upper airway obstruction 17.16 10.21 16 119473 1242 64378001
Nystagmus 17.14 10.21 46 119443 9022 64370221
Angioedema 17.08 10.21 58 119431 61763 64317480
Pre-existing disease 17.03 10.21 8 119481 190 64379053
Cytopenia 16.79 10.21 4 119485 15467 64363776
Bronchiectasis 16.70 10.21 3 119486 14137 64365106
Haematuria 16.53 10.21 57 119432 60414 64318829
Narcissistic personality disorder 16.47 10.21 4 119485 9 64379234
Gastrointestinal disorder 16.45 10.21 98 119391 89611 64289632
Coordination abnormal 16.44 10.21 63 119426 14901 64364342
Asthma 16.44 10.21 106 119383 95119 64284124
Pancreatitis 16.42 10.21 56 119433 59551 64319692
Acute myeloid leukaemia 16.37 10.21 16 119473 27447 64351796
Psychotic disorder 16.36 10.21 115 119374 34463 64344780
Aplastic anaemia 16.34 10.21 3 119486 13917 64365326
Pneumonia 16.31 10.21 859 118630 558717 63820526
Hyponatraemia 16.24 10.21 186 119303 148153 64231090
Peripheral nerve operation 16.18 10.21 4 119485 10 64379233
Psoriatic arthropathy 16.18 10.21 35 119454 43246 64335997
Graft versus host disease 16.16 10.21 3 119486 13810 64365433
Fibula fracture 16.14 10.21 24 119465 3064 64376179
Thyroid disorder 16.09 10.21 53 119436 11639 64367604
Metastases to bone 15.93 10.21 9 119480 20426 64358817
Central nervous system infection 15.93 10.21 15 119474 1179 64378064
Excessive granulation tissue 15.90 10.21 13 119476 846 64378397
Irritable bowel syndrome 15.89 10.21 28 119461 37341 64341902
Urine oxalate increased 15.89 10.21 8 119481 222 64379021
CSF shunt operation 15.88 10.21 3 119486 0 64379243
Medical device site mass 15.88 10.21 3 119486 0 64379243
Medical device site rash 15.88 10.21 3 119486 0 64379243
Medical device site oedema 15.88 10.21 3 119486 0 64379243
Wound infection staphylococcal 15.84 10.21 23 119466 2874 64376369
Glossopharyngeal nerve disorder 15.78 10.21 5 119484 38 64379205
Cystitis 15.78 10.21 134 119355 42541 64336702
Intervertebral disc disorder 15.69 10.21 29 119460 4428 64374815
Bursitis 15.66 10.21 80 119409 21405 64357838
Chest pain 15.57 10.21 326 119163 235654 64143589
Hypersomnia 15.49 10.21 75 119414 19642 64359601
Colitis ulcerative 15.45 10.21 12 119477 23016 64356227
Brain injury 15.39 10.21 47 119442 9918 64369325
Alanine aminotransferase increased 15.35 10.21 174 119315 138857 64240386
Infected skin ulcer 15.34 10.21 23 119466 2957 64376286
Pericardial effusion 15.30 10.21 31 119458 39223 64340020
Postoperative wound infection 15.26 10.21 48 119441 10288 64368955
Myelocyte percentage increased 15.23 10.21 8 119481 243 64379000
Post procedural complication 15.21 10.21 79 119410 21274 64357969
Expanded disability status scale score increased 15.20 10.21 10 119479 464 64378779
Disturbance in attention 15.20 10.21 129 119360 40945 64338298
Quadriplegia 15.15 10.21 23 119466 2990 64376253
Blood sodium increased 15.04 10.21 28 119461 4298 64374945
Vision blurred 15.02 10.21 243 119246 90073 64289170
Mouth ulceration 15.02 10.21 23 119466 32421 64346822
T-lymphocyte count decreased 14.96 10.21 10 119479 477 64378766
Cognitive disorder 14.93 10.21 162 119327 54925 64324318
Colitis 14.92 10.21 57 119432 58617 64320626
CD8 lymphocytes decreased 14.90 10.21 8 119481 254 64378989
Brain stem syndrome 14.85 10.21 12 119477 768 64378475
Uterine enlargement 14.83 10.21 12 119477 769 64378474
Blood ketone body increased 14.81 10.21 11 119478 621 64378622
Blood pressure fluctuation 14.79 10.21 48 119441 51823 64327420
Conversion disorder 14.66 10.21 17 119472 1702 64377541
Injection site necrosis 14.61 10.21 15 119474 1310 64377933
Hemiparesis 14.58 10.21 100 119389 29727 64349516
Personality disorder 14.55 10.21 29 119460 4682 64374561
Acute generalised exanthematous pustulosis 14.55 10.21 4 119485 14054 64365189
Hepatic cytolysis 14.54 10.21 4 119485 14045 64365198
Streptococcus test positive 14.54 10.21 18 119471 1930 64377313
Myocardial ischaemia 14.50 10.21 13 119476 23238 64356005
Mean platelet volume increased 14.43 10.21 13 119476 965 64378278
Tibia fracture 14.41 10.21 29 119460 4716 64374527
Arrhythmia 14.40 10.21 50 119439 52894 64326349
Lower gastrointestinal haemorrhage 14.37 10.21 4 119485 13935 64365308
Invasive ductal breast carcinoma 14.35 10.21 30 119459 5012 64374231
Purpura 14.32 10.21 7 119482 17239 64362004
Metastases to central nervous system 14.32 10.21 4 119485 13908 64365335
Myelodysplastic syndrome 14.32 10.21 18 119471 27561 64351682
Bladder dysfunction 14.29 10.21 13 119476 977 64378266
Abdominal pain upper 14.29 10.21 233 119256 174797 64204446
Urinary tract infection enterococcal 14.29 10.21 22 119467 2896 64376347
Staphylococcus test positive 14.25 10.21 32 119457 5613 64373630
Intervertebral disc degeneration 14.22 10.21 55 119434 13065 64366178
Klebsiella test positive 14.19 10.21 15 119474 1355 64377888
Mydriasis 14.08 10.21 61 119428 15251 64363992
Myocarditis 14.03 10.21 7 119482 17036 64362207
Lipoedema 14.01 10.21 7 119482 191 64379052
Hepatic failure 13.96 10.21 54 119435 55340 64323903
Nocturia 13.95 10.21 49 119440 11116 64368127
Injection site abscess 13.94 10.21 15 119474 1383 64377860
Anaesthesia 13.83 10.21 9 119480 410 64378833
Incision site vesicles 13.81 10.21 3 119486 3 64379240
Cytokine release syndrome 13.79 10.21 11 119478 20818 64358425
Post laminectomy syndrome 13.77 10.21 8 119481 297 64378946
Second primary malignancy 13.77 10.21 3 119486 12334 64366909
Eosinophil percentage increased 13.71 10.21 15 119474 1409 64377834
Shock haemorrhagic 13.67 10.21 7 119482 16784 64362459
Lymphocyte count abnormal 13.57 10.21 12 119477 869 64378374
Skin reaction 13.57 10.21 52 119437 12300 64366943
Vitamin D deficiency 13.49 10.21 50 119439 11642 64367601
Myopathy 13.48 10.21 8 119481 17672 64361571
Weight decreased 13.41 10.21 415 119074 285324 64093919
Implant site mass 13.39 10.21 5 119484 65 64379178
Retinal depigmentation 13.37 10.21 8 119481 314 64378929
Colitis microscopic 13.35 10.21 37 119452 7395 64371848
Intervertebral disc operation 13.30 10.21 11 119478 727 64378516
Medical device site irritation 13.29 10.21 4 119485 25 64379218
Angina unstable 13.28 10.21 6 119483 15461 64363782
Flushing 13.23 10.21 212 119277 78436 64300807
Allodynia 13.20 10.21 14 119475 1269 64377974
Neck pain 13.17 10.21 173 119316 61360 64317883
Cardiogenic shock 13.16 10.21 25 119464 32402 64346841
Major depression 13.15 10.21 38 119451 7778 64371465
Syncope 13.14 10.21 209 119280 157426 64221817
Posture abnormal 13.06 10.21 23 119466 3383 64375860
Renal tubular necrosis 13.04 10.21 13 119476 22097 64357146
Frequent bowel movements 12.98 10.21 9 119480 18296 64360947
Urinary sediment abnormal 12.91 10.21 6 119483 139 64379104
Stitch abscess 12.91 10.21 4 119485 28 64379215
Norovirus infection 12.85 10.21 7 119482 229 64379014
Glycosylated haemoglobin decreased 12.85 10.21 10 119479 606 64378637
Drug screen positive 12.84 10.21 31 119458 5698 64373545
Orthostatic hypotension 12.81 10.21 44 119445 46694 64332549
Tonic clonic movements 12.68 10.21 17 119472 1972 64377271
General symptom 12.64 10.21 18 119471 2210 64377033
Blood folate increased 12.64 10.21 9 119480 476 64378767
Spinal cord injury cauda equina 12.64 10.21 6 119483 146 64379097
Coagulopathy 12.62 10.21 25 119464 31895 64347348
Back disorder 12.62 10.21 44 119445 9946 64369297
Neuromuscular blocking therapy 12.59 10.21 3 119486 6 64379237
Anaphylactic reaction 12.59 10.21 75 119414 68589 64310654
Urine abnormality 12.58 10.21 36 119453 7326 64371917
Ventricular tachycardia 12.57 10.21 28 119461 34237 64345006
Thyroxine decreased 12.56 10.21 10 119479 626 64378617
Septic shock 12.42 10.21 130 119359 105307 64273936
Cervical spinal stenosis 12.41 10.21 17 119472 2012 64377231
Cataract 12.27 10.21 51 119438 51211 64328032
Blood ethanol increased 12.27 10.21 10 119479 648 64378595
Cerebral palsy 12.24 10.21 6 119483 157 64379086
Implant site warmth 12.23 10.21 4 119485 34 64379209
Liver injury 12.22 10.21 23 119466 29909 64349334
Plasma cell myeloma 12.21 10.21 44 119445 46031 64333212
Diplegia 12.20 10.21 15 119474 1596 64377647
Obstructive airways disorder 12.18 10.21 15 119474 23170 64356073
Fear of falling 12.14 10.21 9 119480 507 64378736
Progressive relapsing multiple sclerosis 12.03 10.21 4 119485 36 64379207
Calculus bladder 12.00 10.21 13 119476 1207 64378036
Implant site necrosis 12.00 10.21 3 119486 8 64379235
Cerebral vasoconstriction 11.99 10.21 13 119476 1209 64378034
Eosinophil percentage decreased 11.97 10.21 7 119482 263 64378980
Upper gastrointestinal haemorrhage 11.94 10.21 30 119459 35190 64344053
Ulcer 11.94 10.21 15 119474 22975 64356268
Protein total decreased 11.85 10.21 37 119452 7899 64371344
Medical device site haemorrhage 11.83 10.21 6 119483 169 64379074
Postoperative delirium 11.83 10.21 6 119483 169 64379074
Visual impairment 11.83 10.21 198 119291 73879 64305364
Implant site pruritus 11.83 10.21 8 119481 389 64378854
Acute respiratory distress syndrome 11.83 10.21 35 119454 38900 64340343
Urine osmolarity increased 11.81 10.21 7 119482 270 64378973
Acute coronary syndrome 11.80 10.21 11 119478 19299 64359944
Eyelid oedema 11.80 10.21 4 119485 12275 64366968
Partial seizures 11.79 10.21 35 119454 7272 64371971
Enthesopathy 11.78 10.21 42 119447 9596 64369647
Urine cannabinoids increased 11.74 10.21 3 119486 9 64379234
Medical device site scab 11.74 10.21 3 119486 9 64379234
Inadequate analgesia 11.71 10.21 24 119465 3954 64375289
Invasive lobular breast carcinoma 11.70 10.21 9 119480 536 64378707
Knee arthroplasty 11.69 10.21 20 119469 26979 64352264
Aspergillus infection 11.68 10.21 8 119481 16371 64362872
Intraductal proliferative breast lesion 11.65 10.21 17 119472 2134 64377109
Pregnancy 11.49 10.21 13 119476 20852 64358391
Blood potassium increased 11.47 10.21 19 119470 25961 64353282
Somatosensory evoked potentials abnormal 11.46 10.21 6 119483 181 64379062
Athetosis 11.43 10.21 5 119484 100 64379143
Logorrhoea 11.37 10.21 24 119465 4035 64375208
Device material issue 11.34 10.21 6 119483 185 64379058
Peritonitis 11.33 10.21 18 119471 25005 64354238
Aspartate aminotransferase increased 11.31 10.21 155 119334 119633 64259610
Acquired diaphragmatic eventration 11.30 10.21 9 119480 564 64378679
Pituitary cyst 11.28 10.21 3 119486 11 64379232
Ischaemic stroke 11.25 10.21 23 119466 29012 64350231
Blood pressure diastolic abnormal 11.25 10.21 4 119485 11913 64367330
Back pain 11.24 10.21 569 118920 249602 64129641
C-reactive protein increased 11.18 10.21 117 119372 94792 64284451
Tongue biting 11.15 10.21 15 119474 1745 64377498
Seronegative arthritis 11.14 10.21 19 119470 2724 64376519
Oxygen saturation decreased 11.11 10.21 136 119353 107040 64272203
Neuromuscular toxicity 11.08 10.21 6 119483 194 64379049
Infusion site macule 11.07 10.21 3 119486 12 64379231
Chest discomfort 11.05 10.21 150 119339 115956 64263287
Adrenal neoplasm 11.04 10.21 8 119481 435 64378808
Haemorrhage intracranial 10.99 10.21 17 119472 23867 64355376
Procedural complication 10.97 10.21 34 119455 7231 64372012
CD4 lymphocytes abnormal 10.93 10.21 4 119485 49 64379194
Hypoventilation 10.88 10.21 30 119459 5976 64373267
Drug abuse 10.87 10.21 176 119313 132198 64247045
Mean cell haemoglobin concentration abnormal 10.83 10.21 5 119484 114 64379129
CD8 lymphocytes increased 10.78 10.21 4 119485 51 64379192
Erythema multiforme 10.76 10.21 8 119481 15693 64363550
Musculoskeletal discomfort 10.76 10.21 59 119430 16218 64363025
Specific gravity urine decreased 10.76 10.21 10 119479 773 64378470
Granulocytopenia 10.75 10.21 3 119486 10437 64368806
Arteriosclerosis coronary artery 10.75 10.21 57 119432 15472 64363771
Consciousness fluctuating 10.67 10.21 14 119475 1591 64377652
Neuropsychiatric syndrome 10.63 10.21 5 119484 119 64379124
Psychogenic seizure 10.63 10.21 15 119474 1826 64377417
Urine uric acid decreased 10.59 10.21 5 119484 120 64379123
Child abuse 10.54 10.21 6 119483 214 64379029
Implant site pustules 10.53 10.21 3 119486 15 64379228
Immature granulocyte percentage increased 10.51 10.21 4 119485 55 64379188
Chronic fatigue syndrome 10.50 10.21 12 119477 1183 64378060
Torsade de pointes 10.49 10.21 10 119479 17353 64361890
Hypotension 10.48 10.21 588 118901 380386 63998857
Shock 10.48 10.21 36 119453 38204 64341039
Haemoglobin increased 10.46 10.21 27 119462 5174 64374069
Anti-thyroid antibody positive 10.44 10.21 8 119481 474 64378769
Unevaluable event 10.41 10.21 141 119348 50348 64328895
Proteus infection 10.41 10.21 14 119475 1629 64377614
Bone pain 10.37 10.21 49 119440 47523 64331720
Lumbar puncture abnormal 10.37 10.21 3 119486 16 64379227
Hypokalaemia 10.37 10.21 161 119328 121742 64257501
Creatinine renal clearance decreased 10.34 10.21 7 119482 14414 64364829
Duodenitis haemorrhagic 10.30 10.21 5 119484 128 64379115
Mental disorder 10.29 10.21 84 119405 26361 64352882
Sopor 10.27 10.21 25 119464 29636 64349607
Hypogonadism male 10.26 10.21 5 119484 129 64379114
Catheter site mass 10.25 10.21 4 119485 59 64379184
Intestinal perforation 10.24 10.21 8 119481 15305 64363938

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC M03BX01 MUSCULO-SKELETAL SYSTEM
MUSCLE RELAXANTS
MUSCLE RELAXANTS, CENTRALLY ACTING AGENTS
Other centrally acting agents
FDA MoA N0000000116 GABA B Agonists
FDA MoA N0000000196 GABA A Agonists
CHEBI has role CHEBI:35488 central nervous system depressants
CHEBI has role CHEBI:51371 muscle relaxants
CHEBI has role CHEBI:51373 gamma-aminobutyric acid receptor agonist
MeSH PA D002491 Central Nervous System Agents
MeSH PA D018682 GABA Agents
MeSH PA D018755 GABA Agonists
MeSH PA D058786 GABA-B Receptor Agonists
MeSH PA D009125 Muscle Relaxants, Central
MeSH PA D009465 Neuromuscular Agents
MeSH PA D018377 Neurotransmitter Agents
MeSH PA D018373 Peripheral Nervous System Agents
FDA EPC N0000175759 gamma-Aminobutyric Acid-ergic Agonist

Drug Use (View source of the data)

DiseaseRelationSNOMED_IDDOID
Muscle spasticity of spinal origin indication 416830008
Muscle Spasticity of Cerebral Origin indication
Trigeminal neuralgia off-label use 31681005 DOID:12098
Alcohol withdrawal syndrome off-label use 191480000
Gastroesophageal reflux disease off-label use 235595009 DOID:8534
Disorder of autonomic nervous system contraindication 15241006
Schizophrenia contraindication 58214004 DOID:5419
Psychotic disorder contraindication 69322001
Epilepsy contraindication 84757009 DOID:1826
Kidney disease contraindication 90708001 DOID:557
Autonomic dysreflexia contraindication 129618003
Cerebrovascular accident contraindication 230690007
Functional disorder of bladder neck and sphincter mechanism contraindication 236644005
Impaired cognition contraindication 386806002
Central nervous system depression contraindication 418072004




๐Ÿถ Veterinary Drug Use

None

๐Ÿถ Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 3.95 acidic
pKa2 9.54 Basic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
10MG/PACKET LYVISPAH AMNEAL N215422 Nov. 22, 2021 RX GRANULES ORAL 10792262 July 29, 2039 METHOD FOR TREATING SPASTICITY
20MG/PACKET LYVISPAH AMNEAL N215422 Nov. 22, 2021 RX GRANULES ORAL 10792262 July 29, 2039 METHOD FOR TREATING SPASTICITY
5MG/PACKET LYVISPAH AMNEAL N215422 Nov. 22, 2021 RX GRANULES ORAL 10792262 July 29, 2039 METHOD FOR TREATING SPASTICITY
5MG/5ML OZOBAX METACEL PHARMS LLC N208193 Sept. 18, 2019 RX SOLUTION ORAL 10610502 Aug. 30, 2039 TREATMENT OF SPASTICITY

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
GABA-B receptor GPCR AGONIST IC50 7.46 CHEMBL CHEMBL
Adenosine receptor A3 GPCR IC50 7.30 CHEMBL
GABA-A receptor; anion channel Ion channel IC50 7.52 CHEMBL
GABA B receptor GPCR IC50 7.52 CHEMBL

External reference:

IDSource
4018392 VUID
N0000146719 NUI
D00241 KEGG_DRUG
1292 RXNORM
C0004609 UMLSCUI
CHEBI:187893 CHEBI
2C0 PDB_CHEM_ID
CHEMBL701 ChEMBL_ID
DB00181 DRUGBANK_ID
D001418 MESH_DESCRIPTOR_UI
2284 PUBCHEM_CID
2956 INN_ID
1084 IUPHAR_LIGAND_ID
H789N3FKE8 UNII
1959 MMSL
4243 MMSL
709 MMSL
d00967 MMSL
001677 NDDF
4018392 VANDF
387342009 SNOMEDCT_US
6102009 SNOMEDCT_US

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Baclofen HUMAN PRESCRIPTION DRUG LABEL 1 0115-1010 TABLET 10 mg ORAL ANDA 11 sections
Baclofen HUMAN PRESCRIPTION DRUG LABEL 1 0115-1011 TABLET 5 mg ORAL ANDA 11 sections
Baclofen HUMAN PRESCRIPTION DRUG LABEL 1 0115-1012 TABLET 20 mg ORAL ANDA 11 sections
Baclofen HUMAN PRESCRIPTION DRUG LABEL 1 0172-4096 TABLET 10 mg ORAL ANDA 12 sections
Baclofen HUMAN PRESCRIPTION DRUG LABEL 1 0172-4097 TABLET 20 mg ORAL ANDA 12 sections
Baclofen HUMAN PRESCRIPTION DRUG LABEL 1 0527-1330 TABLET 10 mg ORAL ANDA 12 sections
Baclofen HUMAN PRESCRIPTION DRUG LABEL 1 0527-1333 TABLET 5 mg ORAL ANDA 12 sections
Baclofen HUMAN PRESCRIPTION DRUG LABEL 1 0527-1337 TABLET 20 mg ORAL ANDA 12 sections
Baclofen HUMAN PRESCRIPTION DRUG LABEL 1 0603-2406 TABLET 10 mg ORAL ANDA 12 sections
Baclofen HUMAN PRESCRIPTION DRUG LABEL 1 0603-2407 TABLET 20 mg ORAL ANDA 12 sections
Baclofen HUMAN PRESCRIPTION DRUG LABEL 1 0615-3541 TABLET 10 mg ORAL ANDA 12 sections
Baclofen HUMAN PRESCRIPTION DRUG LABEL 1 0615-3542 TABLET 20 mg ORAL ANDA 12 sections
Baclofen HUMAN PRESCRIPTION DRUG LABEL 1 0615-8411 TABLET 10 mg ORAL ANDA 11 sections
Baclofen HUMAN PRESCRIPTION DRUG LABEL 1 0615-8412 TABLET 20 mg ORAL ANDA 11 sections
Baclofen HUMAN PRESCRIPTION DRUG LABEL 1 0832-1054 TABLET 10 mg ORAL ANDA 13 sections
Baclofen HUMAN PRESCRIPTION DRUG LABEL 1 0832-1055 TABLET 20 mg ORAL ANDA 13 sections
Baclofen HUMAN PRESCRIPTION DRUG LABEL 1 0904-6475 TABLET 10 mg ORAL ANDA 12 sections
Baclofen HUMAN PRESCRIPTION DRUG LABEL 1 0904-6475 TABLET 10 mg ORAL ANDA 12 sections
Baclofen HUMAN PRESCRIPTION DRUG LABEL 1 0904-6476 TABLET 20 mg ORAL ANDA 12 sections
Baclofen HUMAN PRESCRIPTION DRUG LABEL 1 0904-6476 TABLET 20 mg ORAL ANDA 12 sections
Baclofen HUMAN PRESCRIPTION DRUG LABEL 1 10135-532 TABLET 10 mg ORAL ANDA 13 sections
Baclofen HUMAN PRESCRIPTION DRUG LABEL 1 10135-533 TABLET 20 mg ORAL ANDA 13 sections
Baclofen HUMAN PRESCRIPTION DRUG LABEL 1 10544-172 TABLET 10 mg ORAL ANDA 12 sections
BACLOFEN HUMAN PRESCRIPTION DRUG LABEL 1 16590-026 TABLET 10 mg ORAL ANDA 11 sections
BACLOFEN HUMAN PRESCRIPTION DRUG LABEL 1 16590-027 TABLET 20 mg ORAL ANDA 11 sections
Baclofen Human Prescription Drug Label 1 16714-071 TABLET 10 mg ORAL ANDA 12 sections
Baclofen Human Prescription Drug Label 1 16714-072 TABLET 20 mg ORAL ANDA 12 sections
BACLOFEN HUMAN PRESCRIPTION DRUG LABEL 1 17856-0319 TABLET 5 mg ORAL ANDA 11 sections
Baclofen HUMAN PRESCRIPTION DRUG LABEL 1 17856-1024 TABLET 10 mg ORAL ANDA 12 sections
Baclofen HUMAN PRESCRIPTION DRUG LABEL 1 21695-014 TABLET 10 mg ORAL ANDA 13 sections