baclofen 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | 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 µM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability) 77.50 % 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

Predicted pharmacokinetic/toxicological properties (PK-AZ):

PropertyDescriptionValueUnitConfidenceSimilarity
azlogd74 LogD at pH 7.4 -0.053 High 1
caco2-efflux Caco-2 efflux ratio (BA/AB) 0.845 High 1
caco2-intrinsic-papp Caco-2 intrinsic apparent permeability 2.449 10^-6 cm/s High 1
dh-clint Dog hepatocyte intrinsic clearance 1.169 uL/min/10^6 cells High 1
dppb Dog plasma protein binding (% unbound) 74.080 % High 1
fcs-ppb Fetal calf serum protein binding (% unbound) 60.660 % High 1
herg hERG pIC50 5.391 pIC50 High 1
hh-clint Human hepatocyte intrinsic clearance 1.589 uL/min/10^6 cells High 1
hlm-clint Human liver microsomal intrinsic clearance 3.673 uL/min/mg protein High 1
hppb Human plasma protein binding (% unbound) 78.950 % High 1
kinase-safety-class ACVR2A,ACVR2B,AXL,BRAF,BTK,CAMK2D,CDK4,CDK5,CDK9,DYRK1B,EGFR,EIF2AK3,ERBB2,GRK2,IKBKB,ITK,JAK3,MAP2K6,MAP3K7,MAPK14,MAPK7,MAPKAPK2,NTRK2,PDK1,PDK2,PDK4,PIK3CB,PIM2,PRKDC,SIK2,STK33,SYK,TEK,TGFBR1,ZAP70 35
kinase-selectivity-class AKT1,AKT2,AKT3,AXL,BRAF,EIF2AK3,GRK2,PDK4,PRKACA,PRKG1,STK33 11
mdck-mdr1-bcrp-efflux MDCK-MDR1-BCRP efflux ratio 1.439 High 1
mdck-mdr1-efflux MDCK-MDR1 efflux ratio 2.234 High 1
mh-clint Mouse hepatocyte intrinsic clearance 4.688 High 1
mppb Mouse plasma protein binding (% unbound) 80.760 High 1
nih-mdck-mdr1-efflux NIH MDCK-MDR1 efflux ratio 1.578 High 1
pfas-class PFAS structural alert (1 = True, 0 = False) 0
pppb Pig plasma protein binding (% unbound) 76.230 % High 1
rat-kpuu-brain Rat brain Kpuu 0.055 % High 1
rh-clint Rat hepatocyte intrinsic clearance 2.075 uL/min/10^6 cells High 1
rh-fuinc Rat hepatocyte fraction unbound in incubation 83.900 % High 1
rppb Rat plasma protein binding (% unbound) 77.170 % High 1
solubility-dd Solubility at pH 7.4 in DMSO 841.395 uM High 1

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 1936.89 10.37 1065 116804 51240 90459338
Multiple sclerosis 1215.86 10.37 633 117236 27207 90483371
Drug withdrawal syndrome 1168.96 10.37 623 117246 28100 90482478
Coma 676.38 10.37 638 117231 71994 90438584
Completed suicide 636.72 10.37 861 117008 144197 90366381
Muscle spasticity 616.66 10.37 447 117422 34875 90475703
Urinary tract infection 507.33 10.37 1183 116686 304449 90206129
Somnolence 504.74 10.37 944 116925 208140 90302438
Implant site extravasation 497.37 10.37 121 117748 444 90510134
Implant site infection 478.94 10.37 137 117732 1052 90509526
Seizure 397.04 10.37 712 117157 151917 90358661
Fall 389.28 10.37 1442 116427 480368 90030210
Glossodynia 368.18 10.37 11 117858 321768 90188810
Pneumonia aspiration 357.03 10.37 347 117522 40593 90469985
Toxicity to various agents 349.71 10.37 991 116878 286855 90223723
Gait disturbance 340.30 10.37 921 116948 259575 90251003
Pericarditis 334.58 10.37 3 117866 270148 90240430
Systemic lupus erythematosus 300.49 10.37 54 117815 361842 90148736
Hand deformity 298.17 10.37 23 117846 296339 90214239
Cerebrospinal fluid leakage 291.40 10.37 100 117769 1467 90509111
Mental status changes 286.03 10.37 321 117548 44358 90466220
Overdose 281.72 10.37 629 117240 157080 90353498
Helicobacter infection 278.63 10.37 3 117866 226847 90283731
Hypotonia 259.27 10.37 170 117699 11256 90499322
Synovitis 257.42 10.37 57 117812 329695 90180883
Infusion related reaction 241.87 10.37 120 117749 416660 90093918
Arthropathy 235.33 10.37 91 117778 366151 90144427
Unresponsive to stimuli 234.01 10.37 268 117601 37853 90472725
Folliculitis 233.60 10.37 7 117862 204346 90306232
Wound 221.60 10.37 60 117809 302920 90207658
Encephalopathy 219.33 10.37 286 117583 46158 90464420
Hypertonia 215.76 10.37 114 117755 5041 90505537
Joint swelling 212.44 10.37 205 117664 503095 90007483
Contraindicated product administered 206.54 10.37 79 117790 320060 90190518
Muscle injury 205.83 10.37 5 117864 176649 90333929
Device failure 195.08 10.37 118 117751 6779 90503799
Muscular weakness 193.39 10.37 650 117219 206016 90304562
Maternal exposure during pregnancy 192.34 10.37 115 117754 359948 90150630
Muscle spasms 189.69 10.37 738 117131 251145 90259433
Abdominal discomfort 188.29 10.37 206 117663 477122 90033456
Balance disorder 186.67 10.37 399 117470 96681 90413897
Withdrawal syndrome 167.18 10.37 175 117694 22349 90488229
Device infusion issue 165.33 10.37 77 117792 2585 90507993
Liver injury 163.95 10.37 16 117853 170551 90340027
Tremor 159.72 10.37 500 117369 152673 90357905
Swelling 155.33 10.37 190 117679 418868 90091710
Implant site erosion 153.30 10.37 33 117836 57 90510521
Sleep disorder due to general medical condition, insomnia type 152.43 10.37 3 117866 128691 90381887
Muscle tightness 150.40 10.37 131 117738 13308 90497270
Secondary progressive multiple sclerosis 147.94 10.37 61 117808 1518 90509060
Lymphocyte count decreased 147.39 10.37 204 117665 34846 90475732
Lower respiratory tract infection 147.06 10.37 71 117798 250588 90259990
White blood cell count abnormal 144.82 10.37 101 117768 7403 90503175
Toxic encephalopathy 140.29 10.37 105 117764 8594 90501984
Drug intolerance 140.01 10.37 229 117640 447362 90063216
Type 2 diabetes mellitus 139.86 10.37 45 117824 203199 90307379
Blister 139.58 10.37 79 117790 254919 90255659
Hepatic enzyme increased 136.37 10.37 161 117708 360575 90150003
Exposure during pregnancy 136.13 10.37 70 117799 238340 90272238
Central nervous system lesion 135.35 10.37 116 117753 11530 90499048
Complication associated with device 135.30 10.37 146 117723 19303 90491275
Rash 134.04 10.37 557 117312 795543 89715035
Decubitus ulcer 129.88 10.37 114 117755 11699 90498879
Product use issue 129.30 10.37 143 117726 329776 90180802
Psoriatic arthropathy 128.95 10.37 68 117801 228267 90282311
Influenza like illness 127.86 10.37 307 117562 80304 90430274
Medical device site pain 126.51 10.37 34 117835 201 90510377
Febrile neutropenia 126.28 10.37 26 117843 158323 90352255
Irritable bowel syndrome 125.95 10.37 56 117813 207392 90303186
General physical health deterioration 124.33 10.37 168 117701 354947 90155631
Discomfort 122.41 10.37 106 117763 274229 90236349
C-reactive protein abnormal 122.33 10.37 12 117857 127417 90383161
Respiratory depression 120.97 10.37 124 117745 15451 90495127
Impaired healing 119.20 10.37 79 117790 234120 90276458
Wheezing 117.58 10.37 83 117786 237997 90272581
Device kink 116.04 10.37 57 117812 2158 90508420
Alopecia 116.03 10.37 299 117570 494772 90015806
Therapeutic product effect decreased 115.86 10.37 114 117755 277457 90233121
Neurotoxicity 115.31 10.37 141 117728 21326 90489252
Facet joint syndrome 113.77 10.37 3 117866 98386 90412192
Blood cholesterol increased 113.02 10.37 65 117804 207947 90302631
Device physical property issue 112.26 10.37 60 117809 2716 90507862
Lip dry 110.03 10.37 5 117864 100950 90409628
Lethargy 109.45 10.37 249 117620 62890 90447688
Injury 108.18 10.37 61 117808 197288 90313290
Status epilepticus 106.33 10.37 127 117742 18747 90491831
Depressed level of consciousness 105.69 10.37 268 117601 72516 90438062
Progressive multiple sclerosis 104.57 10.37 45 117824 1249 90509329
Pulmonary fibrosis 103.51 10.37 10 117859 107493 90403085
Medical device site infection 101.90 10.37 33 117836 400 90510178
Urine analysis abnormal 100.12 10.37 70 117799 5151 90505427
Urinary incontinence 98.48 10.37 176 117693 37390 90473188
Agitation 98.40 10.37 248 117621 66850 90443728
Device malfunction 97.19 10.37 128 117741 20849 90489729
Joint range of motion decreased 95.15 10.37 29 117840 135614 90374964
Neuralgia 93.61 10.37 156 117713 31344 90479234
Implant site discharge 90.31 10.37 24 117845 135 90510443
Hypersensitivity 90.18 10.37 297 117572 454380 90056198
Stomatitis 90.12 10.37 136 117733 274562 90236016
Device power source issue 89.94 10.37 36 117833 828 90509750
Live birth 89.32 10.37 3 117866 79104 90431474
Progressive multifocal leukoencephalopathy 89.28 10.37 106 117763 15549 90495029
Implant site swelling 89.12 10.37 32 117837 540 90510038
Loss of consciousness 88.97 10.37 390 117479 139848 90370730
Device dislocation 88.37 10.37 152 117717 31330 90479248
Sedation 88 10.37 194 117675 47977 90462601
Ill-defined disorder 87.97 10.37 67 117802 184824 90325754
Lymphopenia 87.09 10.37 127 117742 22754 90487824
Peripheral swelling 86.72 10.37 263 117606 412843 90097735
Flushing 85.94 10.37 282 117587 88209 90422369
Implant site pain 85.18 10.37 49 117820 2563 90508015
Hypercholesterolaemia 83.74 10.37 15 117854 100877 90409701
Peroneal nerve palsy 83.07 10.37 65 117804 5683 90504895
Fibromyalgia 82.32 10.37 88 117781 206181 90304397
Malignant neoplasm progression 82.24 10.37 19 117850 106851 90403727
Respiratory arrest 82.16 10.37 152 117717 33159 90477419
Muscle rigidity 81.79 10.37 97 117772 14212 90496366
Feeling abnormal 81.46 10.37 431 117438 166804 90343774
Thrombocytopenia 80.05 10.37 92 117777 208633 90301945
Dystonia 80.05 10.37 104 117765 16715 90493863
Generalised tonic-clonic seizure 79.57 10.37 154 117715 34749 90475829
Neurogenic bladder 79.27 10.37 53 117816 3625 90506953
Medical device site discharge 78.74 10.37 17 117852 30 90510548
JC polyomavirus test positive 78.69 10.37 41 117828 1761 90508817
Diarrhoea 78.65 10.37 812 117057 938378 89572200
Post lumbar puncture syndrome 78.47 10.37 33 117836 864 90509714
Concussion 78.44 10.37 84 117785 11007 90499571
Peripheral venous disease 77.73 10.37 9 117860 83912 90426666
Anaemia 76.63 10.37 221 117648 352581 90157997
Medical device site swelling 76.46 10.37 15 117854 11 90510567
COVID-19 74.09 10.37 423 117446 168420 90342158
Urosepsis 73.87 10.37 113 117756 21119 90489459
Myoclonus 73.83 10.37 107 117762 19061 90491517
Trigeminal neuralgia 73.70 10.37 53 117816 4078 90506500
Device inversion 73.40 10.37 13 117856 0 90510578
Areflexia 72.44 10.37 50 117819 3603 90506975
Hallucination 72.11 10.37 219 117650 65740 90444838
Metabolic encephalopathy 71.91 10.37 64 117805 6688 90503890
Gastrointestinal disorder 70.61 10.37 142 117727 256545 90254033
Asphyxia 67.20 10.37 63 117806 7040 90503538
Treatment failure 66.27 10.37 190 117679 303738 90206840
Immune reconstitution inflammatory syndrome 65.91 10.37 62 117807 6957 90503621
Lung disorder 65.50 10.37 59 117810 149824 90360754
Speech disorder 65.28 10.37 167 117702 45418 90465160
Electroencephalogram abnormal 65.07 10.37 49 117820 4047 90506531
Medical device site erythema 64.92 10.37 13 117856 12 90510566
Neutropenia 64.82 10.37 121 117748 224783 90285795
Diplopia 64.61 10.37 126 117743 28588 90481990
Burning sensation 63.21 10.37 204 117665 63248 90447330
Nasopharyngitis 62.75 10.37 294 117575 406810 90103768
Soft tissue injury 62.30 10.37 37 117832 2055 90508523
Hyporeflexia 62.11 10.37 38 117831 2228 90508350
Interstitial lung disease 62.04 10.37 12 117857 76393 90434185
Escherichia urinary tract infection 62.00 10.37 83 117786 13732 90496846
Liver disorder 61.54 10.37 41 117828 121228 90389350
Adjustment disorder with depressed mood 61.22 10.37 3 117866 56750 90453828
Optic neuritis 61 10.37 69 117800 9609 90500969
Decreased appetite 60.37 10.37 268 117601 376272 90134306
Hypokinesia 59.55 10.37 87 117782 15610 90494968
Intentional product use issue 58.78 10.37 121 117748 216771 90293807
Muscle twitching 57.89 10.37 109 117760 24093 90486485
Off label use 57.88 10.37 1048 116821 1101204 89409374
Hypoaesthesia 57.80 10.37 644 117225 313566 90197012
Wound dehiscence 57.71 10.37 53 117816 5769 90504809
Myelosuppression 57.28 10.37 3 117866 53588 90456990
Hostility 56.95 10.37 36 117833 2237 90508341
Cognitive disorder 56.79 10.37 209 117660 69198 90441380
Pancytopenia 56.66 10.37 44 117825 120219 90390359
Memory impairment 56.25 10.37 444 117425 196800 90313778
Paraparesis 55.42 10.37 39 117830 2899 90507679
Focal dyscognitive seizures 55.32 10.37 40 117829 3104 90507474
Wound infection 55.32 10.37 35 117834 106367 90404211
Libido increased 54.97 10.37 32 117837 1712 90508866
Sinusitis 53.90 10.37 246 117623 342842 90167736
Pocket erosion 53.84 10.37 10 117859 3 90510575
Magnetic resonance imaging abnormal 53.82 10.37 41 117828 3445 90507133
Sensory disturbance 53.58 10.37 82 117787 15331 90495247
Ataxia 53.13 10.37 89 117780 17953 90492625
Paralysis 53.11 10.37 70 117799 11408 90499170
Nail disorder 53.07 10.37 7 117862 59060 90451518
Dysphagia 53.04 10.37 287 117582 111991 90398587
Drug delivery device placement 52.68 10.37 15 117854 113 90510465
Intentional overdose 52.11 10.37 251 117618 93583 90416995
Urinary retention 51.71 10.37 136 117733 37608 90472970
Device occlusion 51.53 10.37 62 117807 9220 90501358
Back pain 51.21 10.37 634 117235 316541 90194037
Knee arthroplasty 51.17 10.37 22 117847 83160 90427418
Depression 50.76 10.37 606 117263 299995 90210583
Grip strength decreased 50.16 10.37 29 117840 92547 90418031
Micturition urgency 49.66 10.37 67 117802 11166 90499412
Prescribed overdose 49.54 10.37 33 117836 97592 90412986
Ankle fracture 49.04 10.37 92 117777 20278 90490300
Clonus 48.73 10.37 48 117821 5702 90504876
Disorientation 48.71 10.37 147 117722 43967 90466611
Scoliosis 48.64 10.37 59 117810 8848 90501730
Disturbance in attention 48.33 10.37 153 117716 46956 90463622
Infusion site mass 48.27 10.37 32 117837 2157 90508421
Medical device site fibrosis 47.51 10.37 9 117860 4 90510574
Device connection issue 47.36 10.37 24 117845 972 90509606
Urine leukocyte esterase positive 47.18 10.37 37 117832 3245 90507333
X-ray abnormal 47.15 10.37 3 117866 45421 90465157
Gait spastic 47.01 10.37 17 117852 293 90510285
Arthralgia 46.72 10.37 722 117147 777800 89732778
Post-traumatic neck syndrome 46.56 10.37 33 117836 2481 90508097
Device issue 46.28 10.37 112 117757 29425 90481153
Temperature intolerance 46.11 10.37 67 117802 11963 90498615
Autoimmune disorder 46.10 10.37 21 117848 76723 90433855
Insomnia 46.09 10.37 648 117221 332826 90177752
Red blood cells urine positive 45.59 10.37 36 117833 3189 90507389
C-reactive protein increased 45.18 10.37 106 117763 181283 90329295
Device alarm issue 45.10 10.37 29 117840 1856 90508722
Onychomadesis 45.02 10.37 4 117865 45994 90464584
Gastrooesophageal reflux disease 45.01 10.37 370 117499 165967 90344611
Mucosal inflammation 44.82 10.37 10 117859 57615 90452963
Sternal fracture 44.67 10.37 34 117835 2853 90507725
Underdose 44.48 10.37 163 117706 53854 90456724
Vitamin D deficiency 44.41 10.37 81 117788 17475 90493103
Urticaria 44.05 10.37 233 117636 312501 90198077
Device leakage 43.27 10.37 59 117810 9932 90500646
Oedema 43.06 10.37 126 117743 200169 90310409
Nystagmus 42.98 10.37 50 117819 7177 90503401
Night sweats 42.92 10.37 63 117806 128703 90381875
Cardio-respiratory arrest 42.64 10.37 179 117690 62961 90447617
Frequent bowel movements 42.09 10.37 11 117858 56924 90453654
Colitis ulcerative 42.04 10.37 13 117856 60253 90450325
Paraesthesia 41.95 10.37 504 117365 249822 90260756
Lupus-like syndrome 41.10 10.37 7 117862 48839 90461739
Abdominal pain upper 40.89 10.37 259 117610 332415 90178163
Rheumatoid arthritis 39.76 10.37 292 117577 362322 90148256
Bradypnoea 39.69 10.37 39 117830 4619 90505959
Implant site haematoma 39.59 10.37 11 117858 75 90510503
Inflammation 39.37 10.37 111 117758 178481 90332097
Bradycardia 39.37 10.37 214 117655 83633 90426945
Vision blurred 39.33 10.37 262 117607 110031 90400547
Dysstasia 39.26 10.37 95 117774 24957 90485621
Device computer issue 39.09 10.37 11 117858 79 90510499
Urinary sediment present 39.03 10.37 28 117841 2146 90508432
Intracranial hypotension 38.01 10.37 15 117854 332 90510246
Nephrolithiasis 37.82 10.37 145 117724 48940 90461638
Skin reaction 37.66 10.37 78 117791 18475 90492103
Incoherent 37.52 10.37 39 117830 4938 90505640
Quadriparesis 37.21 10.37 29 117840 2520 90508058
Persistent depressive disorder 36.83 10.37 22 117847 1235 90509343
Irritability 36.74 10.37 116 117753 35546 90475032
Adverse event 36.70 10.37 60 117809 117358 90393220
Dysarthria 36.43 10.37 154 117715 54328 90456250
Pleural effusion 36.16 10.37 56 117813 111935 90398643
Arteriosclerosis coronary artery 36.10 10.37 53 117816 9550 90501028
Red blood cell sedimentation rate increased 35.50 10.37 33 117836 82562 90428016
Sciatica 35.38 10.37 48 117821 101334 90409244
Medical device site discomfort 35.34 10.37 14 117855 313 90510265
Blepharospasm 35.18 10.37 14 117855 55431 90455147
Hyperhidrosis 35.16 10.37 300 117569 136005 90374573
Acute kidney injury 35.12 10.37 258 117611 320129 90190449
Dyskinesia 35.07 10.37 116 117753 36418 90474160
Nitrite urine present 34.54 10.37 20 117849 1059 90509519
Stress 34.42 10.37 202 117667 81193 90429385
Bladder disorder 34.23 10.37 55 117814 10717 90499861
Drug ineffective 34.08 10.37 1464 116405 1382834 89127744
Dysaesthesia 34.03 10.37 38 117831 5217 90505361
Post procedural complication 33.99 10.37 76 117793 18966 90491612
Muscle atrophy 33.97 10.37 48 117821 8353 90502225
Muscle contracture 33.95 10.37 24 117845 1797 90508781
Implant site erythema 33.93 10.37 17 117852 672 90509906
Taste disorder 33.74 10.37 19 117850 61527 90449051
Product dose omission issue 33.40 10.37 549 117320 291138 90219440
Laboratory test abnormal 33.37 10.37 125 117744 41729 90468849
Hemiparesis 33.24 10.37 104 117765 31715 90478863
Bone erosion 32.65 10.37 14 117855 53007 90457571
Abdominal pain 32.61 10.37 343 117526 395378 90115200
Conversion disorder 32.61 10.37 25 117844 2121 90508457
Abnormal behaviour 32.50 10.37 83 117786 22545 90488033
Neuroleptic malignant syndrome 32.46 10.37 65 117804 15031 90495547
Monocyte percentage increased 32.45 10.37 20 117849 1188 90509390
Neurosis 32.45 10.37 14 117855 391 90510187
Therapy non-responder 32.23 10.37 295 117574 136409 90374169
Hypothermia 32.22 10.37 66 117803 15509 90495069
Hypersomnia 31.99 10.37 80 117789 21451 90489127
Finger deformity 31.82 10.37 3 117866 32894 90477684
Hyperaesthesia 31.79 10.37 53 117816 10649 90499929
Somatosensory evoked potentials abnormal 31.53 10.37 7 117862 15 90510563
Osteoarthritis 31.51 10.37 139 117730 195591 90314987
Hepatic cirrhosis 31.27 10.37 22 117847 63231 90447347
Dyspnoea 31.22 10.37 890 116979 880065 89630513
Incision site oedema 31.22 10.37 7 117862 16 90510562
Rectal haemorrhage 31.13 10.37 37 117832 82707 90427871
Neutrophil percentage increased 31.06 10.37 28 117841 2975 90507603
Drug tolerance decreased 30.89 10.37 3 117866 32127 90478451
T-lymphocyte count decreased 30.78 10.37 13 117856 344 90510234
Culture urine positive 30.70 10.37 31 117838 3794 90506784
White blood cells urine positive 30.64 10.37 40 117829 6458 90504120
Pollakiuria 30.09 10.37 103 117766 32902 90477676
Head injury 29.91 10.37 99 117770 31089 90479489
Hip arthroplasty 29.84 10.37 33 117836 76175 90434403
Abnormal dreams 29.83 10.37 53 117816 11204 90499374
Limb discomfort 29.79 10.37 113 117756 37947 90472631
Liver function test increased 29.79 10.37 40 117829 84815 90425763
Spinal operation 29.63 10.37 50 117819 10146 90500432
Thyroid disorder 29.55 10.37 69 117800 17716 90492862
Hepatitis 29.54 10.37 29 117840 70710 90439868
Suspected suicide 29.25 10.37 48 117821 9520 90501058
Motor dysfunction 29.15 10.37 72 117797 19158 90491420
Asthma 28.99 10.37 190 117679 241970 90268608
Hepatic function abnormal 28.86 10.37 12 117857 46276 90464302
Poisoning 28.60 10.37 62 117807 15155 90495423
Bone marrow failure 28.52 10.37 4 117865 32217 90478361
Vulvovaginal mycotic infection 28.43 10.37 38 117831 6276 90504302
Medical device discomfort 28.40 10.37 23 117846 2113 90508465
Medical device site erosion 28.39 10.37 6 117863 9 90510569
Expanded disability status scale score increased 28.35 10.37 16 117853 807 90509771
Device expulsion 28.20 10.37 9 117860 40877 90469701
Therapeutic response unexpected 28.11 10.37 77 117792 21803 90488775
Middle insomnia 27.85 10.37 65 117804 16686 90493892
Invasive ductal breast carcinoma 27.75 10.37 42 117827 7776 90502802
Movement disorder 27.73 10.37 92 117777 28927 90481651
Pregnancy 27.61 10.37 24 117845 62023 90448555
Major depression 27.57 10.37 48 117821 9987 90500591
Gastrointestinal haemorrhage 27.38 10.37 47 117822 90201 90420377
Ascites 27.25 10.37 14 117855 47726 90462852
Product quality issue 27.23 10.37 38 117831 79287 90431291
Staphylococcal infection 27.19 10.37 130 117739 48309 90462269
Enthesopathy 27.17 10.37 46 117823 9358 90501220
Aphasia 27.08 10.37 119 117750 42693 90467885
Poor quality sleep 26.99 10.37 82 117787 24611 90485967
Injection site scar 26.82 10.37 18 117851 1239 90509339
Loss of control of legs 26.78 10.37 19 117850 1431 90509147
Basal ganglion degeneration 26.71 10.37 12 117857 370 90510208
Acute psychosis 26.65 10.37 26 117843 3052 90507526
Nightmare 26.48 10.37 75 117794 21650 90488928
Lymphocyte percentage decreased 26.31 10.37 26 117843 3101 90507477
Monoplegia 26.29 10.37 28 117841 3646 90506932
Osteonecrosis of jaw 26.28 10.37 9 117860 39094 90471484
Implant site reaction 26.04 10.37 9 117860 135 90510443
Laryngitis 25.96 10.37 17 117852 50736 90459842
Band neutrophil count increased 25.93 10.37 12 117857 397 90510181
Frontotemporal dementia 25.87 10.37 12 117857 399 90510179
Intervertebral disc protrusion 25.79 10.37 86 117783 27110 90483468
Exostosis 25.58 10.37 19 117850 53115 90457463
Neoplasm progression 25.46 10.37 13 117856 44473 90466105
Cystitis noninfective 25.42 10.37 18 117851 1351 90509227
Therapy cessation 25.27 10.37 104 117765 36257 90474321
Bladder spasm 25.19 10.37 21 117848 2009 90508569
Renal impairment 25.14 10.37 63 117806 105358 90405220
Needle fatigue 25.00 10.37 9 117860 153 90510425
Anal incontinence 24.85 10.37 61 117808 16169 90494409
Therapeutic product effect incomplete 24.82 10.37 149 117720 193747 90316831
Intervertebral disc disorder 24.80 10.37 33 117836 5427 90505151
Infection 24.75 10.37 327 117542 361767 90148811
Sleep apnoea syndrome 24.63 10.37 94 117775 31653 90478925
Obesity 24.43 10.37 64 117805 105443 90405135
Bacterial test positive 24.43 10.37 33 117836 5506 90505072
Paraplegia 24.41 10.37 26 117843 3386 90507192
Hallucinations, mixed 24.34 10.37 34 117835 5855 90504723
B-lymphocyte count decreased 24.29 10.37 18 117851 1451 90509127
Foot fracture 24.23 10.37 83 117786 26523 90484055
Primary progressive multiple sclerosis 24.19 10.37 8 117861 104 90510474
Breast cancer stage II 23.98 10.37 8 117861 35326 90475252
Anxiety 23.86 10.37 549 117320 309223 90201355
Inadequate analgesia 23.83 10.37 25 117844 3199 90507379
Implant site scar 23.79 10.37 11 117858 363 90510215
Consciousness fluctuating 23.74 10.37 15 117854 931 90509647
Respiratory failure 23.72 10.37 247 117622 118171 90392407
Neurogenic bowel 23.70 10.37 9 117860 179 90510399
Bacterial test 23.63 10.37 16 117853 1117 90509461
Autonomic dysreflexia 23.46 10.37 11 117858 375 90510203
Macular degeneration 23.42 10.37 10 117859 37960 90472618
Altered state of consciousness 23.36 10.37 92 117777 31440 90479138
Crying 23.35 10.37 80 117789 25565 90485013
Apnoea 23.26 10.37 43 117826 9371 90501207
Weight increased 23.19 10.37 393 117476 417534 90093044
Spinal stenosis 23.07 10.37 62 117807 17362 90493216
Bursitis 22.73 10.37 91 117778 131563 90379015
Cardiac failure 22.72 10.37 70 117799 109426 90401152
CD8 lymphocytes decreased 22.56 10.37 9 117860 205 90510373
Suicidal ideation 22.56 10.37 169 117700 73686 90436892
Upper airway obstruction 22.55 10.37 15 117854 1017 90509561
Asthenia 22.34 10.37 877 116992 532874 89977704
Band neutrophil percentage increased 22.05 10.37 9 117860 218 90510360
Euphoric mood 22.01 10.37 31 117838 5378 90505200
Psoriasis 21.96 10.37 108 117761 147646 90362932
Sleep disorder 21.91 10.37 159 117710 197871 90312707
Pulmonary renal syndrome 21.86 10.37 12 117857 573 90510005
Disease progression 21.85 10.37 117 117752 156498 90354080
Tonic clonic movements 21.75 10.37 18 117851 1704 90508874
Colitis microscopic 21.58 10.37 46 117823 11113 90499465
Coordination abnormal 21.57 10.37 69 117800 21287 90489291
Anaesthesia 21.54 10.37 11 117858 453 90510125
Palmar-plantar erythrodysaesthesia syndrome 21.52 10.37 5 117864 28018 90482560
Quadriplegia 21.51 10.37 20 117849 2211 90508367
Bladder dysfunction 21.39 10.37 15 117854 1109 90509469
Reflexes abnormal 21.34 10.37 13 117856 756 90509822
Hepatotoxicity 21.30 10.37 17 117852 45825 90464753
CD4 lymphocytes decreased 21.29 10.37 17 117852 1530 90509048
Psychogenic seizure 21.25 10.37 19 117850 1997 90508581
Dry mouth 21.23 10.37 146 117723 183913 90326665
Stiff person syndrome 20.89 10.37 11 117858 483 90510095
Catatonia 20.74 10.37 32 117837 6024 90504554
Increased tendency to bruise 20.72 10.37 47 117822 11843 90498735
Metastases to liver 20.48 10.37 6 117863 28801 90481777
Genital herpes 20.45 10.37 19 117850 2099 90508479
Therapeutic response decreased 20.32 10.37 192 117677 89537 90421041
Blood creatinine increased 20.20 10.37 66 117803 101320 90409258
Coeliac disease 20.16 10.37 17 117852 44593 90465985
Thyroxine decreased 20.10 10.37 12 117857 673 90509905
Foot deformity 20.05 10.37 29 117840 59622 90450956
Meningitis 20.04 10.37 38 117831 8443 90502135
Glaucoma 20.01 10.37 66 117803 20689 90489889
Suicide attempt 19.99 10.37 167 117702 75232 90435346
Respiratory acidosis 19.96 10.37 37 117832 8082 90502496
Tissue infiltration 19.87 10.37 13 117856 857 90509721
Myelocyte percentage increased 19.87 10.37 8 117861 187 90510391
Urinary tract infection bacterial 19.85 10.37 32 117837 6253 90504325
Migraine 19.83 10.37 353 117516 190039 90320539
Onychomycosis 19.83 10.37 12 117857 37364 90473214
Urobilinogen urine increased 19.81 10.37 9 117860 285 90510293
Affective disorder 19.77 10.37 36 117833 7757 90502821
Liposarcoma 19.75 10.37 8 117861 190 90510388
Haematochezia 19.67 10.37 39 117830 70874 90439704
Injection site necrosis 19.61 10.37 16 117853 1485 90509093
Hypercalcaemia 19.60 10.37 10 117859 34230 90476348
Seroma 19.60 10.37 22 117847 3038 90507540
Dysuria 19.47 10.37 102 117767 39299 90471279
Palpitations 19.38 10.37 267 117602 136461 90374117
Surgery 19.36 10.37 112 117757 44775 90465803
Medical device site extravasation 19.35 10.37 4 117865 5 90510573
Rash maculo-papular 19.24 10.37 15 117854 40918 90469660
Red blood cell sedimentation rate abnormal 19.23 10.37 4 117865 24200 90486378
Poisoning deliberate 19.21 10.37 56 117813 16430 90494148
Alcohol withdrawal syndrome 19.16 10.37 13 117856 911 90509667
Breast cancer 18.73 10.37 127 117742 53634 90456944
Device extrusion 18.54 10.37 5 117864 30 90510548
Rotator cuff syndrome 18.48 10.37 54 117815 15865 90494713
Relapsing-remitting multiple sclerosis 18.40 10.37 12 117857 787 90509791
Haemoglobin increased 18.27 10.37 34 117835 7447 90503131
Craniocerebral injury 18.26 10.37 22 117847 3276 90507302
Coma scale abnormal 18.26 10.37 29 117840 5597 90504981
Miosis 18.23 10.37 39 117830 9445 90501133
Urine oxalate increased 18.20 10.37 8 117861 234 90510344
Urinary tract infection enterococcal 18.16 10.37 21 117848 2995 90507583
Respiratory distress 18.01 10.37 99 117770 38847 90471731
Incontinence 17.98 10.37 48 117821 13387 90497191
Pre-existing condition improved 17.97 10.37 38 117831 9131 90501447
Decreased vibratory sense 17.96 10.37 9 117860 356 90510222
Invasive lobular breast carcinoma 17.90 10.37 13 117856 1016 90509562
Hypoxic-ischaemic encephalopathy 17.89 10.37 26 117843 4642 90505936
Injection site ulcer 17.87 10.37 11 117858 652 90509926
Agranulocytosis 17.53 10.37 12 117857 34990 90475588
Eye movement disorder 17.49 10.37 30 117839 6168 90504410
Autonomic nervous system imbalance 17.47 10.37 22 117847 3428 90507150
Dyspepsia 17.44 10.37 169 117700 197991 90312587
Noninfective encephalitis 17.40 10.37 10 117859 522 90510056
Device programming error 17.39 10.37 8 117861 261 90510317
Sinus bradycardia 17.33 10.37 55 117814 16897 90493681
Lymphocyte count abnormal 17.28 10.37 12 117857 873 90509705
Cystitis 17.28 10.37 147 117722 66571 90444007
Drug resistance 17.27 10.37 9 117860 30440 90480138
Neurological decompensation 17.21 10.37 22 117847 3479 90507099
Platelet count decreased 17.13 10.37 106 117763 136863 90373715
Osteoporosis 17.12 10.37 66 117803 96465 90414113
Rib fracture 17.11 10.37 74 117795 26361 90484217
Spinal cord injury 17.03 10.37 13 117856 1096 90509482
Acquired diaphragmatic eventration 16.96 10.37 10 117859 548 90510030
Medical device site bruise 16.94 10.37 3 117866 0 90510578
CSF protein abnormal 16.94 10.37 3 117866 0 90510578
Implant site ulcer 16.94 10.37 3 117866 0 90510578
Musculoskeletal pain 16.84 10.37 142 117727 171109 90339469
Posturing 16.83 10.37 10 117859 556 90510022
Condition aggravated 16.66 10.37 620 117249 594925 89915653
Cardiac arrest 16.57 10.37 209 117660 104726 90405852
Lumbosacral radiculopathy 16.46 10.37 10 117859 579 90509999
Dizziness 16.45 10.37 930 116939 588354 89922224
Urinary tract infection pseudomonal 16.43 10.37 12 117857 946 90509632
Cytomegalovirus infection 16.42 10.37 7 117862 26595 90483983
Atrial fibrillation 16.40 10.37 104 117765 133507 90377071
Retinal depigmentation 16.33 10.37 8 117861 301 90510277
Meningitis staphylococcal 16.30 10.37 6 117863 109 90510469
Hepatic cytolysis 16.30 10.37 10 117859 30906 90479672
Mechanical urticaria 16.23 10.37 10 117859 594 90509984
Cholestasis 16.20 10.37 14 117855 36285 90474293
Cough 16.17 10.37 361 117508 368601 90141977
CSF protein increased 16.16 10.37 11 117858 775 90509803
Hallucination, visual 16.00 10.37 66 117803 23026 90487552
Injection site mass 16.00 10.37 64 117805 22026 90488552
Intraductal proliferative breast lesion 15.88 10.37 21 117848 3432 90507146
Urine osmolarity increased 15.81 10.37 6 117863 119 90510459
Pancreatitis chronic 15.80 10.37 19 117850 2824 90507754
Crystal urine present 15.62 10.37 14 117855 1476 90509102
Haemoglobin decreased 15.61 10.37 135 117734 161821 90348757
Acute hepatic failure 15.50 10.37 5 117864 22556 90488022
Pseudomeningocele 15.44 10.37 4 117865 20 90510558
Drug eruption 15.39 10.37 14 117855 35393 90475185
Muscle contractions involuntary 15.35 10.37 19 117850 2909 90507669
Infrapatellar fat pad inflammation 15.34 10.37 7 117862 224 90510354
Injection site infection 15.34 10.37 17 117852 2315 90508263
Hypervigilance 15.33 10.37 9 117860 489 90510089
Bronchiectasis 15.25 10.37 5 117864 22325 90488253
Hip fracture 15.24 10.37 84 117785 32993 90477585
Blood magnesium decreased 15.21 10.37 50 117819 15643 90494935
Intestinal polyp 15.16 10.37 14 117855 1535 90509043
Vertigo 15.12 10.37 148 117721 69663 90440915
Blood potassium decreased 15.02 10.37 110 117759 47617 90462961
Narcotic bowel syndrome 14.87 10.37 6 117863 141 90510437
Medical device site scar 14.86 10.37 3 117866 3 90510575
Neuropsychiatric syndrome 14.85 10.37 5 117864 69 90510509
Pupil fixed 14.84 10.37 16 117853 2112 90508466
Melaena 14.83 10.37 14 117855 34783 90475795
Cytokine release syndrome 14.81 10.37 9 117860 27964 90482614
Uterine enlargement 14.80 10.37 13 117856 1335 90509243
Device breakage 14.76 10.37 46 117823 13998 90496580
Product use in unapproved indication 14.73 10.37 329 117540 335907 90174671
Multiple organ dysfunction syndrome 14.67 10.37 43 117826 68293 90442285
Polyarthritis 14.65 10.37 3 117866 18347 90492231
Proteinuria 14.58 10.37 6 117863 23285 90487293
Hypochromic anaemia 14.58 10.37 16 117853 2155 90508423
Thoracic radiculopathy 14.56 10.37 4 117865 26 90510552
Drug dependence 14.54 10.37 76 117793 29251 90481327
Disability 14.51 10.37 19 117850 40726 90469852
Seizure like phenomena 14.46 10.37 13 117856 1377 90509201
Back injury 14.40 10.37 24 117845 46598 90463980
Neutropenic sepsis 14.40 10.37 3 117866 18127 90492451
Incorrect drug administration rate 14.37 10.37 25 117844 5198 90505380
Visual impairment 14.35 10.37 247 117622 132118 90378460
Device related infection 14.32 10.37 69 117800 25717 90484861
Intervertebral disc degeneration 14.11 10.37 52 117817 17222 90493356
Myelocyte count increased 14.09 10.37 8 117861 408 90510170
Gastrointestinal motility disorder 14.03 10.37 27 117842 6064 90504514
Eosinophilia 14 10.37 10 117859 28523 90482055
Epistaxis 13.97 10.37 60 117809 85065 90425513
Self-medication 13.92 10.37 19 117850 3201 90507377
Hyperkalaemia 13.85 10.37 41 117828 64923 90445655
Sports injury 13.84 10.37 4 117865 32 90510546
Adverse reaction 13.83 10.37 11 117858 29701 90480877
Metastases to bone 13.80 10.37 8 117861 25497 90485081
Cerebral vasoconstriction 13.75 10.37 12 117857 1222 90509356
Maternal exposure timing unspecified 13.74 10.37 6 117863 22477 90488101
Transient lingual papillitis 13.65 10.37 3 117866 6 90510572
Congenital megacolon 13.65 10.37 3 117866 6 90510572
Infected skin ulcer 13.62 10.37 17 117852 2625 90507953
Specific gravity urine decreased 13.61 10.37 10 117859 795 90509783
Neuromuscular toxicity 13.58 10.37 7 117862 294 90510284
Allodynia 13.56 10.37 11 117858 1013 90509565
Foetal death 13.53 10.37 5 117864 20718 90489860
Stupor 13.50 10.37 25 117844 5457 90505121
Basophil count decreased 13.43 10.37 7 117862 301 90510277
Myofascial pain syndrome 13.39 10.37 18 117851 2989 90507589
Botulism 13.38 10.37 7 117862 303 90510275
Dysgraphia 13.38 10.37 20 117849 3663 90506915
Neutrophil count decreased 13.28 10.37 48 117821 71484 90439094
Ulcer haemorrhage 13.21 10.37 9 117860 26312 90484266
Glycosylated haemoglobin decreased 13.15 10.37 9 117860 640 90509938
Chronic fatigue syndrome 13.04 10.37 13 117856 1566 90509012
Medical device change 12.93 10.37 7 117862 325 90510253
Demyelination 12.90 10.37 31 117838 8109 90502469
Nervous system disorder 12.89 10.37 59 117810 21534 90489044
Premature delivery 12.88 10.37 19 117850 38743 90471835
Occupational dermatitis 12.87 10.37 4 117865 42 90510536
Macular oedema 12.86 10.37 23 117846 4886 90505692
Hypoventilation 12.85 10.37 24 117845 5272 90505306
Pneumocystis jirovecii pneumonia 12.85 10.37 6 117863 21610 90488968
Tibia fracture 12.84 10.37 26 117843 6061 90504517
Urine abnormality 12.84 10.37 30 117839 7707 90502871
Brain injury 12.83 10.37 30 117839 7708 90502870
Toxic epidermal necrolysis 12.83 10.37 14 117855 32514 90478064
Clubbing 12.73 10.37 8 117861 492 90510086
Upper motor neurone lesion 12.68 10.37 6 117863 209 90510369
Enlarged uvula 12.60 10.37 6 117863 212 90510366
Postictal psychosis 12.57 10.37 5 117864 113 90510465
Pain in extremity 12.55 10.37 711 117158 449818 90060760
Pneumonitis 12.50 10.37 24 117845 44146 90466432
Rebound psychosis 12.47 10.37 6 117863 217 90510361
Food allergy 12.41 10.37 9 117860 25469 90485109
Implant site warmth 12.39 10.37 4 117865 48 90510530
Meningioma 12.33 10.37 23 117846 5048 90505530
Postoperative wound infection 12.33 10.37 42 117827 13384 90497194
Serotonin syndrome 12.31 10.37 88 117781 37799 90472779
Renal failure 12.27 10.37 110 117759 130897 90379681
Psychotic disorder 12.24 10.37 76 117793 31154 90479424
Inferior vena cava syndrome 12.24 10.37 4 117865 50 90510528
Unevaluable event 12.24 10.37 117 117752 54731 90455847
Female genital tract fistula 12.20 10.37 4 117865 17864 90492714
Respiratory rate decreased 12.20 10.37 20 117849 3963 90506615
CSF test abnormal 12.17 10.37 8 117861 532 90510046
Hyperactive pharyngeal reflex 12.13 10.37 3 117866 12 90510566
Infusion site macule 12.13 10.37 3 117866 12 90510566
Cervical spinal stenosis 12.08 10.37 16 117853 2619 90507959
Drug withdrawal syndrome neonatal 12.08 10.37 15 117854 2304 90508274
Bedridden 12.04 10.37 39 117830 12109 90498469
Decreased interest 12.00 10.37 21 117848 4386 90506192
Cerebral palsy 11.98 10.37 6 117863 237 90510341
Metabolic acidosis 11.97 10.37 35 117834 55641 90454937
Idiosyncratic drug reaction 11.96 10.37 10 117859 961 90509617
Medical device site reaction 11.93 10.37 3 117866 13 90510565
Lumbar spinal stenosis 11.91 10.37 24 117845 5573 90505005
Neutralising antibodies 11.89 10.37 4 117865 55 90510523
Iron metabolism disorder 11.89 10.37 4 117865 55 90510523
Rash erythematous 11.88 10.37 44 117825 65060 90445518
Injection site erythema 11.85 10.37 187 117682 98315 90412263
Accidental overdose 11.84 10.37 70 117799 28203 90482375
Bladder catheterisation 11.83 10.37 7 117862 386 90510192
Dyspnoea exertional 11.83 10.37 51 117818 72237 90438341
Sepsis 11.83 10.37 312 117557 179502 90331076
Incorrect route of product administration 11.80 10.37 109 117760 50517 90460061
Citrobacter test positive 11.75 10.37 3 117866 14 90510564
Implant site fibrosis 11.75 10.37 6 117863 247 90510331
Feeling hot 11.74 10.37 154 117715 77854 90432724
Klebsiella test positive 11.73 10.37 12 117857 1491 90509087
Adrenal insufficiency 11.66 10.37 13 117856 29908 90480670
Joint noise 11.64 10.37 23 117846 5267 90505311
Inguinal hernia 11.62 10.37 14 117855 2084 90508494
Creatinine renal clearance decreased 11.62 10.37 5 117864 18894 90491684
Cerebral thrombosis 11.61 10.37 13 117856 1790 90508788
CSF culture positive 11.58 10.37 3 117866 15 90510563
Arachnoiditis 11.57 10.37 8 117861 578 90510000
Nerve compression 11.47 10.37 35 117834 10531 90500047
Brachial plexopathy 11.42 10.37 6 117863 262 90510316
Optic atrophy 11.35 10.37 12 117857 1549 90509029
Neoplasm skin 11.32 10.37 17 117852 3125 90507453
Right ventricular hypertrophy 11.29 10.37 9 117860 808 90509770
Mydriasis 11.28 10.37 44 117825 14968 90495610
Osmotic demyelination syndrome 11.24 10.37 10 117859 1044 90509534
Drug-induced liver injury 11.24 10.37 70 117799 90248 90420330
Hyperlipasaemia 11.16 10.37 9 117860 822 90509756
Incision site swelling 11.10 10.37 6 117863 278 90510300
Adrenal neoplasm 11.06 10.37 7 117862 436 90510142
Joint stiffness 11.05 10.37 58 117811 77984 90432594
Blood chloride increased 11.05 10.37 17 117852 3193 90507385
Injection site atrophy 11.03 10.37 9 117860 835 90509743
Cardiac failure congestive 11.02 10.37 79 117790 98615 90411963
Psychomotor skills impaired 11.01 10.37 16 117853 2856 90507722
Hypoglycaemia 10.99 10.37 50 117819 69798 90440780
Aspiration 10.99 10.37 45 117824 15648 90494930
Oral herpes 10.97 10.37 78 117791 33446 90477132
Varicella virus test positive 10.96 10.37 5 117864 160 90510418
Pyrexia 10.95 10.37 726 117143 659759 89850819
Foaming at mouth 10.94 10.37 11 117858 1339 90509239
Hypervolaemia 10.94 10.37 16 117853 32741 90477837
Tremor neonatal 10.93 10.37 5 117864 161 90510417
Implant site mass 10.90 10.37 4 117865 72 90510506
Implant site dehiscence 10.85 10.37 3 117866 20 90510558
Feeling drunk 10.85 10.37 21 117848 4737 90505841
Premature baby 10.80 10.37 10 117859 25067 90485511
Post concussion syndrome 10.74 10.37 8 117861 650 90509928
Abdominal symptom 10.71 10.37 7 117862 461 90510117
Oral pruritus 10.68 10.37 16 117853 2935 90507643
Excessive granulation tissue 10.63 10.37 9 117860 879 90509699
Rash pruritic 10.61 10.37 63 117806 82151 90428427
Anticonvulsant drug level decreased 10.61 10.37 11 117858 1389 90509189
Injection site haematoma 10.58 10.37 26 117843 6896 90503682
Mean platelet volume increased 10.56 10.37 9 117860 888 90509690
Urinary tract disorder 10.52 10.37 18 117851 3693 90506885
Incision site complication 10.46 10.37 8 117861 676 90509902
Temperature regulation disorder 10.43 10.37 3 117866 14576 90496002
Haemoptysis 10.43 10.37 17 117852 33303 90477275
Pancreatitis acute 10.42 10.37 16 117853 32099 90478479
Hypomagnesaemia 10.37 10.37 19 117850 35569 90475009

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 1779.54 11.26 811 68214 20738 42531572
Muscle spasticity 1522.80 11.26 527 68498 6295 42546015
Implant site infection 853.80 11.26 225 68800 936 42551374
Implant site extravasation 682.96 11.26 157 68868 306 42552004
Multiple sclerosis relapse 529.11 11.26 314 68711 13950 42538360
Coma 463.87 11.26 500 68525 53054 42499256
Multiple sclerosis 429.91 11.26 221 68804 7377 42544933
Device failure 428.85 11.26 163 68862 2580 42549730
Muscle spasms 415.40 11.26 599 68426 85445 42466865
Overdose 369.46 11.26 633 68392 104631 42447679
Complication associated with device 345.58 11.26 183 68842 6498 42545812
Mental status changes 339.90 11.26 379 68646 41736 42510574
Withdrawal syndrome 305.70 11.26 226 68799 14549 42537761
Toxicity to various agents 305.26 11.26 938 68087 228198 42324112
Hypertonia 293.16 11.26 149 68876 4852 42547458
Respiratory depression 273.22 11.26 234 68791 18634 42533676
Urinary tract infection 267.56 11.26 533 68492 98751 42453559
Hypotonia 258.80 11.26 172 68853 9327 42542983
Cerebrospinal fluid leakage 242.88 11.26 76 68949 642 42551668
Implant site erosion 234.10 11.26 49 68976 45 42552265
Completed suicide 224.87 11.26 488 68537 95977 42456333
Device kink 224.00 11.26 66 68959 444 42551866
Therapy non-responder 220.90 11.26 346 68679 53013 42499297
Device infusion issue 218.06 11.26 78 68947 1030 42551280
Implant site swelling 217.85 11.26 45 68980 36 42552274
Medical device site infection 215.11 11.26 57 68968 243 42552067
Somnolence 189.64 11.26 580 68445 140525 42411785
Implant site pain 183.03 11.26 44 68981 113 42552197
Seizure 174.68 11.26 509 68516 120052 42432258
Device physical property issue 171.37 11.26 71 68954 1423 42550887
Medical device site swelling 162.79 11.26 32 68993 13 42552297
Febrile neutropenia 157.93 11.26 52 68973 185651 42366659
Muscle tightness 157.20 11.26 103 68922 5450 42546860
Device dislocation 153.51 11.26 116 68909 7715 42544595
Pocket erosion 149.57 11.26 29 68996 9 42552301
Device power source issue 146.90 11.26 50 68975 564 42551746
Implant site discharge 145.73 11.26 28 68997 7 42552303
Medical device site discharge 138.79 11.26 27 68998 9 42552301
Anaemia 137.38 11.26 151 68874 280127 42272183
Implant site erythema 136.36 11.26 29 68996 31 42552279
Unresponsive to stimuli 136.01 11.26 208 68817 31195 42521115
Wound dehiscence 133.96 11.26 81 68944 3719 42548591
Toxic encephalopathy 131.90 11.26 101 68924 6852 42545458
Intentional overdose 130.99 11.26 270 68755 51186 42501124
Clonus 129.19 11.26 77 68948 3443 42548867
Gait spastic 122.33 11.26 55 68970 1354 42550956
Relapsing-remitting multiple sclerosis 119.21 11.26 55 68970 1440 42550870
Device issue 118.32 11.26 127 68898 13382 42538928
Medical device site erythema 117.43 11.26 24 69001 17 42552293
Encephalopathy 114.89 11.26 225 68800 41108 42511202
Therapeutic response decreased 114.65 11.26 211 68814 36801 42515509
Diarrhoea 112.87 11.26 377 68648 460472 42091838
Needle fatigue 110.59 11.26 49 68976 1164 42551146
Gait disturbance 109.09 11.26 378 68647 97622 42454688
Decubitus ulcer 108.92 11.26 108 68917 10369 42541941
Neutropenia 108.47 11.26 98 68927 199333 42352977
Agitation 108.30 11.26 287 68738 64027 42488283
Device malfunction 106.40 11.26 115 68910 12212 42540098
Fall 106.10 11.26 696 68329 233824 42318486
Sedation 104.99 11.26 182 68843 30293 42522017
Drug dependence 99.24 11.26 173 68852 28921 42523389
Medical device site pain 98.91 11.26 24 69001 65 42552245
Confusional state 97.26 11.26 531 68494 167066 42385244
Medical device site erosion 96.23 11.26 21 69004 28 42552282
Hypertonic bladder 92.40 11.26 54 68971 2327 42549983
Device breakage 92.03 11.26 63 68962 3586 42548724
Balance disorder 88.86 11.26 221 68804 47424 42504886
Myoclonus 88.35 11.26 123 68902 16942 42535368
Thrombocytopenia 88.27 11.26 107 68918 190172 42362138
Hypoaesthesia 87.78 11.26 285 68740 71178 42481132
Central nervous system lesion 87.18 11.26 84 68941 7786 42544524
Delirium 85.01 11.26 231 68794 52288 42500022
Neurogenic bladder 84.40 11.26 50 68975 2210 42550100
Malignant neoplasm progression 84.26 11.26 35 68990 108365 42443945
Pain 83.87 11.26 680 68345 244168 42308142
Neurotoxicity 83.76 11.26 143 68882 23508 42528802
Urinary incontinence 83.41 11.26 136 68889 21532 42530778
Underdose 83.12 11.26 118 68907 16548 42535762
Device alarm issue 82.06 11.26 35 68990 756 42551554
Monoparesis 81.58 11.26 54 68971 2906 42549404
Implant site scar 81.41 11.26 15 69010 0 42552310
Epidural lipomatosis 81.08 11.26 45 68980 1755 42550555
Device connection issue 80.49 11.26 31 68994 509 42551801
Victim of child abuse 80.26 11.26 39 68986 1150 42551160
Muscular weakness 80.15 11.26 307 68718 83191 42469119
Infusion site mass 78.53 11.26 28 68997 366 42551944
Interstitial lung disease 78.00 11.26 16 69009 78446 42473864
Movement disorder 76.18 11.26 106 68919 14592 42537718
Device occlusion 74.98 11.26 80 68945 8370 42543940
Cardiac failure 74.59 11.26 40 68985 106816 42445494
Device computer issue 73.18 11.26 15 69010 11 42552299
Bradypnoea 72.94 11.26 59 68966 4334 42547976
Dyspnoea 71.87 11.26 422 68603 442199 42110111
Depressed level of consciousness 71.72 11.26 205 68820 47765 42504545
Status epilepticus 71.44 11.26 106 68919 15472 42536838
Pancytopenia 71.26 11.26 52 68973 117691 42434619
Autonomic nervous system imbalance 69.73 11.26 50 68975 3066 42549244
Secondary progressive multiple sclerosis 69.54 11.26 26 68999 392 42551918
Intracranial hypotension 67.61 11.26 26 68999 425 42551885
Acute kidney injury 66.29 11.26 338 68687 366999 42185311
Ataxia 63.13 11.26 102 68923 16023 42536287
Juvenile idiopathic arthritis 62.88 11.26 44 68981 2595 42549715
Renal impairment 60.06 11.26 54 68971 110174 42442136
Dystonia 60.04 11.26 88 68937 12702 42539608
Poisoning deliberate 60.02 11.26 78 68947 10056 42542254
Medical device site fibrosis 59.70 11.26 11 69014 0 42552310
Child abuse 59.44 11.26 29 68996 863 42551447
Rash 58.76 11.26 240 68785 276714 42275596
Tremor 58.10 11.26 310 68715 96619 42455691
Hyperkalaemia 54.86 11.26 31 68994 80427 42471883
Medical device site discomfort 54.27 11.26 10 69015 0 42552310
Atrial fibrillation 54.24 11.26 89 68936 139504 42412806
Platelet count decreased 54.18 11.26 88 68937 138493 42413817
Electroencephalogram abnormal 53.56 11.26 42 68983 2950 42549360
Product prescribing error 52.81 11.26 125 68900 25987 42526323
Disease progression 52.70 11.26 95 68930 143561 42408749
Autonomic dysreflexia 51.35 11.26 14 69011 68 42552242
Myelosuppression 50.37 11.26 4 69021 40457 42511853
Renal failure 50.12 11.26 98 68927 143628 42408682
Progressive multiple sclerosis 50.09 11.26 18 69007 241 42552069
Urinary retention 49.70 11.26 166 68859 42048 42510262
Dyskinesia 49.69 11.26 120 68905 25270 42527040
Medical device site reaction 49.58 11.26 10 69015 6 42552304
Arachnoiditis 49.54 11.26 20 69005 374 42551936
Blood creatinine increased 48.73 11.26 64 68961 109939 42442371
Seronegative arthritis 48.13 11.26 28 68997 1196 42551114
Anal incontinence 47.63 11.26 67 68958 9314 42542996
Areflexia 47.32 11.26 43 68982 3700 42548610
General physical health deterioration 47.02 11.26 110 68915 151136 42401174
Muscle twitching 46.77 11.26 75 68950 11705 42540605
Post lumbar puncture syndrome 46.48 11.26 17 69008 240 42552070
Medical device site inflammation 46.26 11.26 9 69016 3 42552307
Insomnia 45.69 11.26 338 68687 117915 42434395
Lipoma 44.87 11.26 33 68992 2105 42550205
Memory impairment 44.40 11.26 180 68845 50042 42502268
Implant site abscess 44.01 11.26 10 69015 18 42552292
Leukopenia 43.93 11.26 34 68991 74712 42477598
Dysarthria 43.76 11.26 153 68872 39654 42512656
Altered state of consciousness 43.68 11.26 125 68900 29134 42523176
Medical device site cellulitis 43.42 11.26 8 69017 0 42552310
Mucosal inflammation 43.38 11.26 13 69012 49361 42502949
Urosepsis 43.22 11.26 83 68942 14937 42537373
Cardiac failure congestive 43.06 11.26 45 68980 85557 42466753
Hyperreflexia 42.81 11.26 40 68985 3567 42548743
Abdominal pain 42.29 11.26 162 68863 190309 42362001
Trigeminal neuralgia 41.74 11.26 28 68997 1541 42550769
Pleural effusion 41.54 11.26 58 68967 97108 42455202
Implant site vesicles 40.88 11.26 8 69017 3 42552307
Implant site cellulitis 40.46 11.26 10 69015 30 42552280
Death 40.30 11.26 530 68495 470655 42081655
Medical device discomfort 40.25 11.26 11 69014 54 42552256
Pneumonia aspiration 39.99 11.26 174 68851 49904 42502406
Bradycardia 39.91 11.26 256 68769 85228 42467082
Generalised tonic-clonic seizure 39.67 11.26 113 68912 26266 42526044
Tubulointerstitial nephritis 39.60 11.26 3 69022 31545 42520765
Respiratory rate decreased 39.54 11.26 35 68990 2910 42549400
Medical device site bruise 38.40 11.26 8 69017 7 42552303
Micturition urgency 38.31 11.26 69 68956 11829 42540481
Lethargy 38.27 11.26 164 68861 46726 42505584
Gastrointestinal haemorrhage 38.23 11.26 62 68963 97664 42454646
Hyperhidrosis 38.01 11.26 264 68761 90248 42462062
Rheumatoid arthritis 37.60 11.26 11 69014 42429 42509881
Suicide attempt 37.44 11.26 161 68864 45939 42506371
Cough 37.30 11.26 155 68870 177948 42374362
Sleep apnoea syndrome 36.92 11.26 97 68928 21511 42530799
Lymphocyte percentage decreased 36.79 11.26 30 68995 2229 42550081
Multiple organ dysfunction syndrome 36.63 11.26 63 68962 96972 42455338
Brain stem syndrome 36.29 11.26 19 69006 658 42551652
Medical device site haematoma 36.17 11.26 9 69016 28 42552282
Decreased appetite 35.14 11.26 177 68848 192960 42359350
Epistaxis 34.90 11.26 34 68991 66792 42485518
Accidental overdose 34.77 11.26 113 68912 28217 42524093
Pollakiuria 34.42 11.26 97 68928 22408 42529902
Seroma 34.11 11.26 18 69007 634 42551676
Implant site haematoma 33.96 11.26 11 69014 105 42552205
Hallucination 33.80 11.26 183 68842 57324 42494986
Macrophages increased 33.78 11.26 12 69013 155 42552155
Nocturia 33.71 11.26 66 68959 12046 42540264
Device programming error 33.24 11.26 11 69014 113 42552197
Dyspnoea exertional 33.21 11.26 20 69005 50128 42502182
Ascites 33.03 11.26 26 68999 56652 42495658
Drug delivery device placement 32.73 11.26 11 69014 119 42552191
Device extrusion 32.67 11.26 7 69018 8 42552302
Device inversion 32.56 11.26 6 69019 0 42552310
Pulmonary fibrosis 32.22 11.26 3 69022 26678 42525632
Brain injury 32.14 11.26 50 68975 7605 42544705
Sedation complication 32.03 11.26 31 68994 2888 42549422
Metabolic encephalopathy 31.92 11.26 41 68984 5224 42547086
Respiratory acidosis 31.82 11.26 45 68980 6286 42546024
Implant site mass 31.80 11.26 7 69018 10 42552300
Pneumonia 31.76 11.26 487 68538 421662 42130648
Infusion related reaction 31.68 11.26 31 68994 60775 42491535
Muscle rigidity 31.51 11.26 64 68961 11995 42540315
Musculoskeletal stiffness 31.41 11.26 180 68845 57585 42494725
Implant site reaction 31.21 11.26 8 69017 29 42552281
Stiff person syndrome 31.21 11.26 12 69013 196 42552114
Paralysis 31.08 11.26 47 68978 6973 42545337
Hepatic function abnormal 30.88 11.26 23 69002 51544 42500766
Irritability 30.81 11.26 108 68917 28020 42524290
Incision site erythema 30.36 11.26 11 69014 151 42552159
Haematochezia 30.20 11.26 30 68995 58406 42493904
Rectal haemorrhage 29.87 11.26 22 69003 49584 42502726
Foetal exposure during pregnancy 29.78 11.26 20 69005 47291 42505019
Gait inability 29.77 11.26 93 68932 22740 42529570
White blood cells urine positive 29.70 11.26 22 69003 1419 42550891
Purulent discharge 29.41 11.26 31 68994 3198 42549112
Anxiety 29.18 11.26 307 68718 118253 42434057
Haemorrhage 29.17 11.26 33 68992 60530 42491780
Weight decreased 29.15 11.26 207 68818 207741 42344569
Central nervous system infection 28.82 11.26 18 69007 876 42551434
Hypothermia 28.73 11.26 63 68962 12452 42539858
Apnoea 28.71 11.26 48 68977 7755 42544555
Monocyte percentage increased 28.48 11.26 19 69006 1036 42551274
Stomatitis 28.19 11.26 24 69001 50305 42502005
Hallucination, visual 27.76 11.26 86 68939 20934 42531376
White blood cell count decreased 27.76 11.26 89 68936 110307 42442003
Depression 27.71 11.26 289 68736 111074 42441236
Cytomegalovirus infection 27.49 11.26 9 69016 32297 42520013
CSF culture positive 27.18 11.26 7 69018 26 42552284
Medical device site extravasation 27.14 11.26 5 69020 0 42552310
Pneumonitis 27.12 11.26 17 69008 41701 42510609
Chronic kidney disease 27.11 11.26 22 69003 47219 42505091
Coma scale abnormal 26.82 11.26 35 68990 4530 42547780
Sinus bradycardia 26.73 11.26 68 68957 14785 42537525
Drug resistance 26.68 11.26 11 69014 34237 42518073
Dysgeusia 26.61 11.26 11 69014 34178 42518132
Hypocalcaemia 26.40 11.26 8 69017 30165 42522145
Delirium tremens 26.30 11.26 15 69010 617 42551693
Drug reaction with eosinophilia and systemic symptoms 26.20 11.26 18 69007 42057 42510253
Liver disorder 25.99 11.26 16 69009 39628 42512682
Meningitis 25.87 11.26 39 68986 5770 42546540
Miosis 25.72 11.26 63 68962 13383 42538927
Neutrophil percentage increased 25.68 11.26 23 69002 1942 42550368
Posturing 25.63 11.26 14 69011 529 42551781
Toxic epidermal necrolysis 25.47 11.26 6 69019 26744 42525566
Gout 25.35 11.26 7 69018 28048 42524262
Pneumocystis jirovecii pneumonia 25.30 11.26 5 69020 25176 42527134
Myocardial infarction 25.28 11.26 109 68916 123900 42428410
Bone marrow failure 25.19 11.26 11 69014 33082 42519228
Weight increased 25.15 11.26 90 68935 107893 42444417
Neutrophil count decreased 25.01 11.26 40 68985 63375 42488935
Epilepsy 24.89 11.26 96 68929 26075 42526235
Oedema peripheral 24.56 11.26 125 68900 135951 42416359
Infusion site granuloma 24.20 11.26 5 69020 4 42552306
Implant site oedema 24.20 11.26 5 69020 4 42552306
JC polyomavirus test positive 24.12 11.26 17 69008 1014 42551296
Muscular dystrophy 24.11 11.26 9 69016 135 42552175
Lymphadenopathy 23.99 11.26 12 69013 33353 42518957
Implant site dehiscence 23.64 11.26 9 69016 143 42552167
Tachycardia 23.59 11.26 259 68766 100828 42451482
Agranulocytosis 23.58 11.26 10 69015 30602 42521708
Haemoptysis 23.51 11.26 24 69001 46143 42506167
Mydriasis 23.46 11.26 47 68978 8723 42543587
Tumour lysis syndrome 23.22 11.26 4 69021 22227 42530083
Muscle contractions involuntary 23.07 11.26 22 69003 2012 42550298
Performance status decreased 22.91 11.26 33 68992 4687 42547623
Cytokine release syndrome 22.85 11.26 23 69002 44504 42507806
Colitis 22.84 11.26 25 69000 46547 42505763
Spinal cord injury 22.78 11.26 15 69010 800 42551510
Staphylococcus test positive 22.77 11.26 29 68996 3663 42548647
Device leakage 22.74 11.26 51 68974 10234 42542076
Obstructive airways disorder 22.71 11.26 6 69019 24753 42527557
Jaundice 22.62 11.26 14 69011 34575 42517735
Mobility decreased 22.56 11.26 115 68910 35191 42517119
Urine leukocyte esterase positive 22.25 11.26 12 69013 442 42551868
Motor dysfunction 22.20 11.26 44 68981 8102 42544208
Asthma 22.12 11.26 42 68983 62272 42490038
Magnetic resonance imaging abnormal 21.84 11.26 20 69005 1738 42550572
Erectile dysfunction 21.77 11.26 89 68936 24824 42527486
Implant site ulcer 21.71 11.26 4 69021 0 42552310
Infusion site fibrosis 21.71 11.26 4 69021 0 42552310
Catheter site erosion 21.71 11.26 4 69021 0 42552310
Bacterial test positive 21.60 11.26 27 68998 3348 42548962
Road traffic accident 21.51 11.26 74 68951 19019 42533291
Hepatotoxicity 21.43 11.26 7 69018 25160 42527150
Chronic obstructive pulmonary disease 21.15 11.26 44 68981 63070 42489240
Coronary artery disease 21.08 11.26 34 68991 53686 42498624
Colitis ulcerative 21.06 11.26 8 69017 26167 42526143
Alcohol withdrawal syndrome 21 11.26 18 69007 1433 42550877
Posture abnormal 20.85 11.26 23 69002 2498 42549812
Hypoglycaemia 20.68 11.26 41 68984 59813 42492497
Amnesia 20.59 11.26 96 68929 28341 42523969
Influenza like illness 20.55 11.26 104 68921 31736 42520574
Neuropathy peripheral 20.47 11.26 90 68935 101763 42450547
Proteinuria 20.28 11.26 6 69019 22977 42529333
Patient-device incompatibility 20.03 11.26 6 69019 43 42552267
Serotonin syndrome 20.01 11.26 89 68936 25756 42526554
Pre-existing disease 19.81 11.26 7 69018 89 42552221
Septic shock 19.66 11.26 79 68946 91593 42460717
Medical device site ulcer 19.48 11.26 4 69021 3 42552307
Cystitis 19.46 11.26 52 68973 11646 42540664
Hypomagnesaemia 19.37 11.26 11 69014 28477 42523833
Anaphylactic shock 19.24 11.26 7 69018 23510 42528800
Bronchopulmonary aspergillosis 19.22 11.26 4 69021 19425 42532885
Asphyxia 19.21 11.26 42 68983 8284 42544026
Electric shock 19.19 11.26 8 69017 163 42552147
Hypoventilation 19.07 11.26 27 68998 3775 42548535
Chest pain 19.00 11.26 140 68885 139390 42412920
Cognitive disorder 18.91 11.26 107 68918 34065 42518245
Appendicitis 18.90 11.26 5 69020 20608 42531702
Corneal reflex decreased 18.66 11.26 8 69017 175 42552135
Drug eruption 18.65 11.26 7 69018 23068 42529242
Tenderness 18.48 11.26 43 68982 8840 42543470
Incorrect drug administration rate 18.37 11.26 20 69005 2140 42550170
Athetosis 18.27 11.26 6 69019 60 42552250
Polyneuropathy 18.14 11.26 4 69021 18657 42533653
Unevaluable event 18.08 11.26 106 68919 34182 42518128
Peroneal nerve palsy 17.76 11.26 25 69000 3477 42548833
Loss of consciousness 17.74 11.26 228 68797 92126 42460184
Musculoskeletal discomfort 17.70 11.26 44 68981 9432 42542878
Pseudomeningocele 17.60 11.26 5 69020 29 42552281
Dehydration 17.55 11.26 146 68879 141621 42410689
Haemoglobin decreased 17.52 11.26 134 68891 132337 42419973
Hyporeflexia 17.51 11.26 20 69005 2256 42550054
Brain death 17.42 11.26 23 69002 3011 42549299
Hepatic cytolysis 17.36 11.26 11 69014 26833 42525477
Paraparesis 17.31 11.26 19 69006 2052 42550258
Productive cough 17.24 11.26 36 68989 51531 42500779
Drug-induced liver injury 17.21 11.26 22 69003 38251 42514059
Decreased vibratory sense 17.13 11.26 10 69015 430 42551880
Eczema 17.04 11.26 18 69007 34068 42518242
Cardiac output decreased 17.04 11.26 14 69011 1051 42551259
Chest discomfort 16.90 11.26 50 68975 63566 42488744
Scoliosis 16.88 11.26 23 69002 3103 42549207
Angina pectoris 16.87 11.26 17 69008 32879 42519431
Wound infection staphylococcal 16.70 11.26 16 69009 1472 42550838
Myasthenia gravis 16.64 11.26 3 69022 16134 42536176
Myocarditis 16.61 11.26 5 69020 18933 42533377
Adrenal insufficiency 16.59 11.26 5 69020 18919 42533391
Blood ethanol increased 16.52 11.26 10 69015 460 42551850
Cytopenia 16.51 11.26 4 69021 17493 42534817
Off label use 16.48 11.26 856 68169 637479 41914831
Frequent bowel movements 16.48 11.26 7 69018 21400 42530910
Therapeutic response unexpected 16.38 11.26 48 68977 11333 42540977
Disorientation 16.37 11.26 108 68917 36281 42516029
Erythema 16.36 11.26 106 68919 108687 42443623
Medical device site oedema 16.28 11.26 3 69022 0 42552310
Implant site warmth 16.28 11.26 3 69022 0 42552310
Incision site vesicles 16.28 11.26 3 69022 0 42552310
Pulmonary hypertension 16.17 11.26 9 69016 23560 42528750
Glossopharyngeal nerve disorder 16.11 11.26 5 69020 41 42552269
Neoplasm progression 16.03 11.26 14 69011 28986 42523324
Thrombosis 16.01 11.26 57 68968 68454 42483856
Acute myeloid leukaemia 16.01 11.26 8 69017 22248 42530062
Burning sensation 16.00 11.26 72 68953 20941 42531369
Intestinal pseudo-obstruction 15.99 11.26 19 69006 2236 42550074
Hypothyroidism 15.98 11.26 17 69008 32067 42520243
Narcissistic personality disorder 15.94 11.26 4 69021 13 42552297
Therapeutic product effect incomplete 15.93 11.26 60 68965 70879 42481431
Eosinophilia 15.76 11.26 18 69007 32881 42519429
Logorrhoea 15.68 11.26 21 69004 2786 42549524
Haematuria 15.66 11.26 45 68980 57754 42494556
Dysaesthesia 15.64 11.26 20 69005 2537 42549773
Brief psychotic disorder with marked stressors 15.58 11.26 8 69017 266 42552044
C-reactive protein increased 15.45 11.26 52 68973 63508 42488802
Band neutrophil percentage increased 15.44 11.26 6 69019 101 42552209
Rash maculo-papular 15.41 11.26 23 69002 37480 42514830
Euphoric mood 15.40 11.26 33 68992 6420 42545890
Dysstasia 15.35 11.26 54 68971 14032 42538278
Hepatitis 15.31 11.26 13 69012 27287 42525023
Bladder disorder 15.30 11.26 24 69001 3675 42548635
Muscle contracture 15.30 11.26 15 69010 1420 42550890
Upper motor neurone lesion 15.29 11.26 7 69018 180 42552130
Implant site inflammation 15.28 11.26 6 69019 104 42552206
Hypoxic-ischaemic encephalopathy 15.28 11.26 29 68996 5173 42547137
Blood ketone body increased 15.28 11.26 10 69015 528 42551782
Tachyphrenia 15.26 11.26 15 69010 1424 42550886
Bladder dysfunction 15.23 11.26 9 69016 396 42551914
Influenza B virus test positive 15.23 11.26 6 69019 105 42552205
Respiratory arrest 15.07 11.26 88 68937 28336 42523974
Alcohol poisoning 15.03 11.26 36 68989 7538 42544772
Drug interaction 14.98 11.26 324 68701 266675 42285635
General symptom 14.92 11.26 13 69012 1058 42551252
Postoperative wound infection 14.81 11.26 30 68995 5612 42546698
Acute encephalitis with refractory, repetitive partial seizures 14.80 11.26 5 69020 55 42552255
Product use in unapproved indication 14.78 11.26 210 68815 184246 42368064
Lung disorder 14.75 11.26 35 68990 47888 42504422
Tethered cord syndrome 14.74 11.26 4 69021 19 42552291
Axillary pain 14.69 11.26 9 69016 423 42551887
Cholestasis 14.68 11.26 19 69006 32860 42519450
Scar 14.60 11.26 33 68992 6655 42545655
Complication of device insertion 14.58 11.26 6 69019 118 42552192
SARS-CoV-2 test false positive 14.58 11.26 4 69021 20 42552290
Arrhythmia 14.46 11.26 27 68998 40290 42512020
Rash pruritic 14.41 11.26 20 69005 33583 42518727
Dry skin 14.33 11.26 36 68989 48302 42504008
Abdominal pain upper 14.27 11.26 77 68948 82532 42469778
Procedural complication 14.26 11.26 25 69000 4194 42548116
Medical device site warmth 14.21 11.26 3 69022 3 42552307
Urine cannabinoids increased 14.21 11.26 3 69022 3 42552307
Incontinence 14.14 11.26 33 68992 6797 42545513
Staring 14.06 11.26 15 69010 1568 42550742
Diabetes mellitus 14.03 11.26 50 68975 60037 42492273
Anticholinergic syndrome 14.02 11.26 15 69010 1574 42550736
Exaggerated startle response 13.96 11.26 4 69021 24 42552286
Haemophagocytic lymphohistiocytosis 13.96 11.26 6 69019 18216 42534094
Palmar-plantar erythrodysaesthesia syndrome 13.92 11.26 8 69017 20574 42531736
Melaena 13.85 11.26 26 68999 38720 42513590
Medical device site haemorrhage 13.84 11.26 6 69019 135 42552175
Hallucinations, mixed 13.81 11.26 22 69003 3413 42548897
Pancreatitis 13.80 11.26 31 68994 43237 42509073
Drug ineffective 13.72 11.26 859 68166 629338 41922972
Blood bilirubin increased 13.70 11.26 30 68995 42222 42510088
Device material issue 13.64 11.26 6 69019 140 42552170
Neutrophil percentage decreased 13.49 11.26 8 69017 354 42551956
Blood sodium increased 13.48 11.26 21 69004 3197 42549113
CD8 lymphocytes increased 13.44 11.26 4 69021 28 42552282
End stage renal disease 13.42 11.26 5 69020 16553 42535757
Red blood cells urine positive 13.39 11.26 16 69009 1894 42550416
Pupil fixed 13.34 11.26 16 69009 1901 42550409
Device ineffective 13.32 11.26 4 69021 29 42552281
Inflammatory marker increased 13.29 11.26 32 68993 6724 42545586
Ulcer 13.27 11.26 5 69020 16436 42535874
Spinal cord injury cauda equina 13.26 11.26 6 69019 150 42552160
Loss of control of legs 13.25 11.26 11 69014 838 42551472
Mental disorder 13.15 11.26 61 68964 17968 42534342
Post procedural infection 13.14 11.26 29 68996 5756 42546554
Shock haemorrhagic 13.01 11.26 5 69020 16237 42536073
Implant site rash 13.00 11.26 3 69022 6 42552304
Pituitary cyst 13.00 11.26 3 69022 6 42552304
Urinary hesitation 12.99 11.26 20 69005 3015 42549295
Hypophosphataemia 12.98 11.26 9 69016 20936 42531374
Spinal operation 12.98 11.26 24 69001 4196 42548114
Hypokalaemia 12.86 11.26 66 68959 71655 42480655
Hallucination, olfactory 12.85 11.26 7 69018 263 42552047
Somatosensory evoked potentials abnormal 12.83 11.26 6 69019 162 42552148
Pulmonary alveolar haemorrhage 12.83 11.26 4 69021 14812 42537498
Hiccups 12.70 11.26 46 68979 12125 42540185
Stitch abscess 12.68 11.26 3 69022 7 42552303
Uhthoff's phenomenon 12.68 11.26 3 69022 7 42552303
Neuromuscular blocking therapy 12.68 11.26 3 69022 7 42552303
Wound 12.55 11.26 58 68967 17059 42535251
Staphylococcal infection 12.53 11.26 104 68921 37539 42514771
Drug ineffective for unapproved indication 12.52 11.26 122 68903 46041 42506269
Dysphagia 12.50 11.26 176 68849 72543 42479767
Nausea 12.42 11.26 521 68504 396278 42156032
Upper respiratory tract irritation 12.37 11.26 4 69021 38 42552272
Skin exfoliation 12.28 11.26 31 68994 41522 42510788
Urticaria 12.25 11.26 70 68955 73966 42478344
Obesity 12.23 11.26 56 68969 16403 42535907
Nephropathy toxic 12.19 11.26 6 69019 16832 42535478
Duodenitis haemorrhagic 12.12 11.26 5 69020 99 42552211
Blood uric acid increased 12.10 11.26 5 69020 15542 42536768
Procedural headache 12.09 11.26 4 69021 41 42552269
Discomfort 12.05 11.26 76 68949 25143 42527167
Palpitations 12.04 11.26 42 68983 50755 42501555
Feeling of body temperature change 11.96 11.26 14 69011 1622 42550688
Bladder spasm 11.90 11.26 12 69013 1175 42551135
CSF shunt operation 11.90 11.26 3 69022 10 42552300
Poor quality sleep 11.89 11.26 38 68987 9402 42542908
Abdominal distension 11.77 11.26 68 68957 71667 42480643
Rebound psychosis 11.75 11.26 6 69019 197 42552113
Paraplegia 11.75 11.26 20 69005 3277 42549033
Quadriplegia 11.67 11.26 16 69009 2171 42550139
Primary progressive multiple sclerosis 11.60 11.26 4 69021 47 42552263
Glomerular filtration rate decreased 11.58 11.26 6 69019 16345 42535965
Spinal fusion surgery 11.55 11.26 12 69013 1217 42551093
Metastases to liver 11.54 11.26 6 69019 16320 42535990
Analgesic drug level above therapeutic 11.52 11.26 7 69018 324 42551986
Selective IgG subclass deficiency 11.47 11.26 3 69022 12 42552298
Post laminectomy syndrome 11.43 11.26 6 69019 209 42552101
Myelodysplastic syndrome 11.38 11.26 12 69013 22733 42529577
Neoplasm malignant 11.38 11.26 12 69013 22731 42529579
Urine abnormality 11.38 11.26 16 69009 2223 42550087
Spinal cord infection 11.37 11.26 7 69018 332 42551978
Gun shot wound 11.35 11.26 11 69014 1026 42551284
Cardiac arrest 11.35 11.26 244 68781 109076 42443234
Mouth ulceration 11.34 11.26 5 69020 14958 42537352
Streptococcus test positive 11.34 11.26 12 69013 1243 42551067
Electric shock sensation 11.31 11.26 8 69017 480 42551830
Symptom recurrence 11.31 11.26 13 69012 1477 42550833
Intentional product use issue 11.31 11.26 69 68956 71764 42480546
Vasculitis 11.28 11.26 8 69017 18386 42533924

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 2536.95 10.39 1181 153499 36873 110397746
Multiple sclerosis relapse 1849.25 10.39 1045 153635 49195 110385424
Muscle spasticity 1351.06 10.39 758 153922 35157 110399462
Multiple sclerosis 1185.52 10.39 621 154059 25077 110409542
Coma 1061.41 10.39 1050 153630 116819 110317800
Implant site infection 926.38 10.39 264 154416 1839 110432780
Implant site extravasation 895.29 10.39 217 154463 711 110433908
Completed suicide 881.49 10.39 1367 153313 241014 110193605
Toxicity to various agents 710.98 10.39 1861 152819 478694 109955925
Urinary tract infection 612.85 10.39 1386 153294 324896 110109723
Somnolence 605.46 10.39 1305 153375 296144 110138475
Overdose 605.28 10.39 1134 153546 232660 110201959
Mental status changes 588.52 10.39 625 154055 75497 110359122
Device failure 566.20 10.39 251 154429 6956 110427663
Hypotonia 451.66 10.39 279 154401 15466 110419153
Withdrawal syndrome 441.80 10.39 360 154320 31020 110403599
Seizure 425.41 10.39 949 153731 220236 110214383
Hypertonia 415.91 10.39 213 154467 8193 110426426
Respiratory depression 400.54 10.39 343 154337 31658 110402961
Cerebrospinal fluid leakage 397.05 10.39 139 154541 2009 110432610
Complication associated with device 358.14 10.39 265 154415 19808 110414811
Muscle spasms 351.53 10.39 1018 153662 277139 110157480
Encephalopathy 348.42 10.39 495 154185 80560 110354059
Fall 345.21 10.39 1712 152968 601770 109832849
Unresponsive to stimuli 338.99 10.39 432 154248 63358 110371261
Device infusion issue 318.72 10.39 130 154550 2915 110431704
Pneumonia aspiration 298.66 10.39 461 154219 80772 110353847
Toxic encephalopathy 271.74 10.39 201 154479 15013 110419606
Gait disturbance 268.62 10.39 928 153752 277280 110157339
Glossodynia 256.55 10.39 13 154667 221991 110212628
Pericarditis 252.67 10.39 13 154667 219101 110215518
Febrile neutropenia 249.95 10.39 67 154613 316700 110117919
Systemic lupus erythematosus 247.01 10.39 32 154648 254306 110180313
Device kink 243.99 10.39 96 154584 1953 110432666
Muscle tightness 243.59 10.39 186 154494 14576 110420043
Medical device site infection 235.56 10.39 72 154608 657 110433962
Synovitis 231.88 10.39 50 154630 274042 110160577
Neurotoxicity 230.82 10.39 290 154390 41917 110392702
Helicobacter infection 229.94 10.39 5 154675 181872 110252747
Hand deformity 225.99 10.39 22 154658 218484 110216135
Duodenal ulcer perforation 224.21 10.39 5 154675 177695 110256924
Infusion related reaction 209.13 10.39 138 154542 381024 110053595
Implant site swelling 206.19 10.39 60 154620 454 110434165
Device physical property issue 201.90 10.39 101 154579 3693 110430926
Agitation 200.44 10.39 470 154210 112581 110322038
Medical device site discharge 198.71 10.39 39 154641 24 110434595
Implant site erosion 198.50 10.39 50 154630 200 110434419
Folliculitis 196.32 10.39 9 154671 167644 110266975
Arthropathy 191.70 10.39 81 154599 287441 110147178
Medical device site pain 189.43 10.39 53 154627 342 110434277
Muscular weakness 189.08 10.39 768 153912 247700 110186919
Medical device site swelling 188.85 10.39 40 154640 54 110434565
Device power source issue 188.07 10.39 71 154609 1286 110433333
Intentional overdose 186.89 10.39 505 154175 131996 110302623
Tremor 185.09 10.39 663 154017 201569 110233050
Implant site discharge 184.43 10.39 44 154636 132 110434487
Status epilepticus 184.01 10.39 224 154456 31347 110403272
Contraindicated product administered 183.94 10.39 59 154621 248208 110186411
Balance disorder 178.39 10.39 458 154222 116102 110318517
Pocket erosion 175.75 10.39 34 154646 17 110434602
Central nervous system lesion 175.12 10.39 157 154523 15396 110419223
Decubitus ulcer 174.26 10.39 168 154512 18068 110416551
Anaemia 173.96 10.39 312 154368 546774 109887845
Muscle injury 173.70 10.39 5 154675 140802 110293817
Sedation 172.56 10.39 332 154348 69351 110365268
Medical device site erythema 170.65 10.39 36 154644 47 110434572
Device malfunction 169.96 10.39 194 154486 25364 110409255
Depressed level of consciousness 168.56 10.39 438 154242 111840 110322779
Implant site pain 163.94 10.39 74 154606 2141 110432478
Wound dehiscence 160.01 10.39 113 154567 7849 110426770
Rash 158.50 10.39 602 154078 820362 109614257
Gait spastic 154.87 10.39 64 154616 1485 110433134
Myoclonus 154.42 10.39 210 154470 32788 110401831
Maternal exposure during pregnancy 152.77 10.39 83 154597 254800 110179819
Urinary incontinence 151.60 10.39 256 154424 48331 110386288
Secondary progressive multiple sclerosis 150.71 10.39 63 154617 1506 110433113
Joint swelling 150.43 10.39 242 154438 442603 109992016
Neutropenia 149.90 10.39 182 154498 374438 110060181
Diarrhoea 148.45 10.39 960 153720 1138545 109296074
Device dislocation 142.69 10.39 198 154482 31506 110403113
General physical health deterioration 142.02 10.39 235 154445 425060 110009559
Neurogenic bladder 140.59 10.39 88 154592 4991 110429628
Clonus 139.82 10.39 108 154572 8608 110426011
Abdominal discomfort 139.70 10.39 209 154471 393649 110040970
Needle fatigue 132.41 10.39 54 154626 1210 110433409
Lethargy 132.27 10.39 357 154323 93219 110341400
Relapsing-remitting multiple sclerosis 130.54 10.39 62 154618 2020 110432599
Sleep disorder due to general medical condition, insomnia type 129.39 10.39 4 154676 105639 110328980
Wound 128.34 10.39 85 154595 234352 110200267
Liver injury 128.06 10.39 27 154653 150386 110284233
C-reactive protein abnormal 124.24 10.39 17 154663 129678 110304941
Thrombocytopenia 123.84 10.39 185 154495 348700 110085919
Drug intolerance 121.93 10.39 240 154440 406272 110028347
Lower respiratory tract infection 121.55 10.39 97 154583 243009 110191610
Malignant neoplasm progression 121.51 10.39 46 154634 174521 110260098
Hepatic enzyme increased 120.99 10.39 163 154517 320729 110113890
Electroencephalogram abnormal 120.34 10.39 86 154594 6087 110428532
Lip dry 118.38 10.39 5 154675 100078 110334541
Psoriatic arthropathy 118.00 10.39 64 154616 196697 110237922
Swelling 117.14 10.39 194 154486 350847 110083772
Therapy non-responder 117.02 10.39 483 154197 156824 110277795
Type 2 diabetes mellitus 114.81 10.39 52 154628 177180 110257439
Areflexia 113.24 10.39 86 154594 6683 110427936
Interstitial lung disease 112.65 10.39 28 154652 139306 110295313
Exposure during pregnancy 111.81 10.39 47 154633 167377 110267242
Device issue 111.79 10.39 185 154495 34350 110400269
Irritable bowel syndrome 111.44 10.39 45 154635 164170 110270449
Wheezing 110.78 10.39 116 154564 255114 110179505
Progressive multiple sclerosis 110.10 10.39 48 154632 1276 110433343
Dystonia 109.95 10.39 157 154523 25648 110408971
Drug dependence 109.04 10.39 226 154454 49794 110384825
Blister 107.20 10.39 96 154584 227280 110207339
Pancytopenia 106.85 10.39 82 154598 209531 110225088
Device alarm issue 106.78 10.39 57 154623 2389 110432230
Ataxia 105.23 10.39 167 154513 29941 110404678
Myelosuppression 104.45 10.39 7 154673 94333 110340286
Bradypnoea 102.73 10.39 90 154590 8559 110426060
Stomatitis 102.14 10.39 137 154543 270105 110164514
Facet joint syndrome 102.08 10.39 9 154671 96819 110337800
Urosepsis 100.20 10.39 165 154515 30510 110404109
Urine analysis abnormal 98.90 10.39 80 154600 6817 110427802
Pulmonary fibrosis 98.63 10.39 13 154667 102029 110332590
Post lumbar puncture syndrome 98.54 10.39 42 154638 1055 110433564
Intracranial hypotension 98.00 10.39 36 154644 602 110434017
Device occlusion 97.15 10.39 113 154567 15072 110419547
Metabolic encephalopathy 96.57 10.39 97 154583 10963 110423656
Hallucination 95.69 10.39 336 154344 101096 110333523
Device connection issue 95.68 10.39 43 154637 1231 110433388
Respiratory arrest 95.36 10.39 235 154445 58064 110376555
Lymphocyte count decreased 94.96 10.39 232 154448 57011 110377608
Generalised tonic-clonic seizure 94.34 10.39 225 154455 54455 110380164
Muscle rigidity 93.40 10.39 140 154540 23891 110410728
Bradycardia 93.37 10.39 448 154232 155069 110279550
Liver disorder 93.28 10.39 41 154639 142202 110292417
Loss of consciousness 92.69 10.39 529 154151 195777 110238842
Rheumatoid arthritis 92.32 10.39 174 154506 299439 110135180
Blood cholesterol increased 92.02 10.39 74 154606 184711 110249908
Trigeminal neuralgia 90.33 10.39 63 154617 4289 110430330
Decreased appetite 89.02 10.39 353 154327 475493 109959126
Peripheral venous disease 88.19 10.39 8 154672 84109 110350510
Impaired healing 88.09 10.39 87 154593 196630 110237989
Hypoaesthesia 86.92 10.39 743 153937 313480 110121139
Implant site erythema 86.09 10.39 32 154648 554 110434065
Muscle twitching 85.89 10.39 152 154528 29783 110404836
Gastrointestinal disorder 85.14 10.39 129 154551 241823 110192796
Victim of child abuse 85.03 10.39 39 154641 1172 110433447
Medical device site fibrosis 84.09 10.39 16 154664 6 110434613
Live birth 83.78 10.39 3 154677 69481 110365138
Device inversion 83.61 10.39 15 154665 0 110434619
Asphyxia 81.44 10.39 100 154580 14115 110420504
Epidural lipomatosis 81.42 10.39 45 154635 2022 110432597
Hypersensitivity 81.20 10.39 291 154389 403707 110030912
Progressive multifocal leukoencephalopathy 81.19 10.39 134 154546 24822 110409797
Autonomic nervous system imbalance 80.68 10.39 66 154614 5714 110428905
Device computer issue 80.58 10.39 21 154659 99 110434520
Infusion site mass 80.34 10.39 42 154638 1686 110432933
Mucosal inflammation 80.32 10.39 18 154662 96123 110338496
Urinary retention 80.22 10.39 247 154433 69436 110365183
Joint range of motion decreased 80.07 10.39 35 154645 121797 110312822
Alopecia 79.95 10.39 253 154427 364500 110070119
Fibromyalgia 79.55 10.39 73 154607 170836 110263783
Therapeutic product effect decreased 78.73 10.39 138 154542 244178 110190441
Medical device site erosion 77.56 10.39 18 154662 46 110434573
Micturition urgency 77.15 10.39 114 154566 19206 110415413
Acute kidney injury 77.13 10.39 546 154134 634884 109799735
Hypertonic bladder 77.08 10.39 62 154618 5240 110429379
Movement disorder 76.45 10.39 162 154518 36242 110398377
Influenza like illness 75.04 10.39 283 154397 88129 110346490
Neuralgia 74.66 10.39 191 154489 48287 110386332
Hyporeflexia 74.37 10.39 55 154625 4105 110430514
Memory impairment 74.30 10.39 501 154179 196443 110238176
Injury 74.20 10.39 83 154597 177182 110257437
Hypercholesterolaemia 73.92 10.39 18 154662 90819 110343800
Lung disorder 73.52 10.39 86 154594 179961 110254658
Irritability 73.25 10.39 188 154492 47621 110386998
Underdose 72.90 10.39 225 154455 63329 110371290
Poisoning deliberate 72.09 10.39 131 154549 26200 110408419
Paraparesis 71.98 10.39 56 154624 4510 110430109
Cardiac failure 70.99 10.39 95 154585 187531 110247088
JC polyomavirus test positive 70.91 10.39 43 154637 2304 110432315
Abdominal pain 68.65 10.39 428 154252 512561 109922058
Dyspnoea 68.48 10.39 1113 153567 1105759 109328860
Dyskinesia 68.44 10.39 192 154488 51254 110383365
Escherichia urinary tract infection 68.37 10.39 98 154582 16064 110418555
Peripheral swelling 67.99 10.39 312 154368 403722 110030897
Monoparesis 67.81 10.39 54 154626 4499 110430120
Hyperhidrosis 67.41 10.39 471 154209 186827 110247792
Intentional product use issue 67.06 10.39 155 154525 247751 110186868
Peroneal nerve palsy 66.53 10.39 66 154614 7348 110427271
Magnetic resonance imaging abnormal 65.73 10.39 50 154630 3895 110430724
Renal impairment 64.83 10.39 102 154578 188343 110246276
Dysarthria 63.88 10.39 260 154420 83861 110350758
Colitis ulcerative 63.60 10.39 15 154665 77348 110357271
Child abuse 63.58 10.39 29 154651 860 110433759
Discomfort 63.25 10.39 128 154552 214579 110220040
Delirium 62.49 10.39 362 154318 134663 110299956
Disorientation 62.30 10.39 229 154451 70442 110364177
Device breakage 61.96 10.39 86 154594 13683 110420936
Urine leukocyte esterase positive 60.92 10.39 47 154633 3739 110430880
Ill-defined disorder 60.79 10.39 78 154602 156775 110277844
Drug delivery device placement 60.70 10.39 19 154661 189 110434430
Frequent bowel movements 60.37 10.39 13 154667 71377 110363242
Pleural effusion 59.42 10.39 98 154582 177611 110257008
Therapeutic response decreased 58.63 10.39 279 154401 96220 110338399
Nasopharyngitis 58.63 10.39 318 154362 394043 110040576
Suicide attempt 58.57 10.39 293 154387 103101 110331518
Rectal haemorrhage 58.39 10.39 49 154631 119784 110314835
Product use issue 58.38 10.39 231 154449 311464 110123155
Confusional state 58.28 10.39 950 153730 467730 109966889
Atrial fibrillation 57.85 10.39 149 154531 229493 110205126
C-reactive protein increased 57.54 10.39 138 154542 217781 110216838
Hypothermia 57.51 10.39 119 154561 26183 110408436
Disease progression 57.22 10.39 164 154516 243870 110190749
Drug hypersensitivity 57.11 10.39 386 154294 453704 109980915
Soft tissue injury 56.95 10.39 37 154643 2239 110432380
Nail disorder 56.91 10.39 7 154673 57928 110376691
Medical device site discomfort 56.75 10.39 19 154661 238 110434381
Lymphocyte percentage decreased 56.63 10.39 52 154628 5258 110429361
Monocyte percentage increased 56.55 10.39 37 154643 2266 110432353
Implant site haematoma 56.29 10.39 18 154662 193 110434426
Feeling abnormal 56.23 10.39 439 154241 180272 110254347
Altered state of consciousness 56.17 10.39 193 154487 57433 110377186
Platelet count decreased 56.16 10.39 152 154528 230291 110204328
Miosis 55.96 10.39 106 154574 21877 110412742
Pollakiuria 55.93 10.39 162 154518 44033 110390586
Apnoea 55.21 10.39 81 154599 13558 110421061
White blood cells urine positive 54.97 10.39 60 154620 7464 110427155
Scoliosis 54.22 10.39 64 154616 8669 110425950
Red blood cells urine positive 53.79 10.39 50 154630 5135 110429484
Paralysis 53.79 10.39 86 154594 15514 110419105
Optic neuritis 53.76 10.39 72 154608 11075 110423544
Off label use 53.60 10.39 1645 153035 1498540 108936079
Concussion 53.33 10.39 73 154607 11465 110423154
Hyperkalaemia 53.17 10.39 67 154613 135729 110298890
Inflammation 52.92 10.39 120 154560 193118 110241501
Night sweats 52.57 10.39 66 154614 133917 110300702
Neutrophil percentage increased 52.18 10.39 48 154632 4865 110429754
Hepatic function abnormal 52.14 10.39 30 154650 89265 110345354
Urticaria 51.98 10.39 249 154431 318608 110116011
Burning sensation 51.82 10.39 213 154467 68999 110365620
Haematochezia 51.81 10.39 51 154629 115473 110319146
Autonomic dysreflexia 51.19 10.39 21 154659 478 110434141
Sleep apnoea syndrome 50.93 10.39 148 154532 40299 110394320
Bacterial test positive 50.43 10.39 59 154621 7918 110426701
Ascites 50.29 10.39 34 154646 92774 110341845
Medical device site inflammation 49.87 10.39 10 154670 8 110434611
Disturbance in attention 49.78 10.39 195 154485 61800 110372819
Treatment failure 49.69 10.39 209 154471 277025 110157594
Grip strength decreased 49.64 10.39 25 154655 80149 110354470
Osteoarthritis 49.53 10.39 114 154566 182509 110252110
Gastrointestinal haemorrhage 49.32 10.39 98 154582 165420 110269199
Hallucination, visual 48.99 10.39 144 154536 39461 110395158
Onychomadesis 48.80 10.39 4 154676 45659 110388960
Arthralgia 48.42 10.39 783 153897 778849 109655770
Implant site scar 48.28 10.39 17 154663 250 110434369
Dysphagia 47.70 10.39 373 154307 153227 110281392
Sinusitis 47.60 10.39 233 154447 296455 110138164
Anal incontinence 47.58 10.39 99 154581 21865 110412754
Medical device site bruise 47.58 10.39 9 154671 3 110434616
Arachnoiditis 47.47 10.39 25 154655 1019 110433600
Flushing 46.65 10.39 278 154402 104458 110330161
Accidental overdose 46.56 10.39 169 154511 51665 110382954
Speech disorder 46.50 10.39 190 154490 61379 110373240
Adjustment disorder with depressed mood 46.47 10.39 4 154676 43879 110390740
Device programming error 45.98 10.39 18 154662 361 110434258
Dysstasia 45.74 10.39 125 154555 32861 110401758
Post-traumatic neck syndrome 45.70 10.39 34 154646 2561 110432058
Focal dyscognitive seizures 45.61 10.39 40 154640 3809 110430810
Stiff person syndrome 45.54 10.39 21 154659 639 110433980
Device leakage 45.41 10.39 81 154599 15967 110418652
Multiple organ dysfunction syndrome 45.05 10.39 90 154590 151620 110282999
Blood creatinine increased 45.03 10.39 120 154560 182769 110251850
Hostility 44.54 10.39 34 154646 2662 110431957
Sternal fracture 44.48 10.39 37 154643 3279 110431340
Oedema 44.33 10.39 148 154532 209828 110224791
Urinary sediment present 44.25 10.39 33 154647 2495 110432124
Bone marrow failure 44.16 10.39 13 154667 57835 110376784
Coma scale abnormal 44.14 10.39 61 154619 9665 110424954
Libido increased 44.12 10.39 33 154647 2506 110432113
Lymphopenia 44.03 10.39 140 154540 40030 110394589
Hyperaesthesia 43.83 10.39 76 154604 14651 110419968
Nitrite urine present 43.54 10.39 25 154655 1210 110433409
Asthma 43.44 10.39 191 154489 250100 110184519
Muscle contracture 43.31 10.39 34 154646 2774 110431845
Laboratory test abnormal 43.28 10.39 148 154532 43931 110390688
Weight increased 43.20 10.39 377 154303 419267 110015352
Sensory disturbance 43.08 10.39 83 154597 17346 110417273
Taste disorder 42.62 10.39 19 154661 65368 110369251
Abdominal pain upper 42.27 10.39 300 154380 348811 110085808
Cough 41.85 10.39 428 154252 461213 109973406
Tubulointerstitial nephritis 41.80 10.39 12 154668 54272 110380347
X-ray abnormal 41.69 10.39 3 154677 38114 110396505
Device extrusion 41.67 10.39 10 154670 31 110434588
Hepatitis 41.26 10.39 39 154641 90015 110344604
Immune reconstitution inflammatory syndrome 41.00 10.39 78 154602 16148 110418471
Dysaesthesia 40.57 10.39 49 154631 6798 110427821
Cytokine release syndrome 40.51 10.39 24 154656 70282 110364337
Implant site abscess 40.43 10.39 11 154669 63 110434556
Incoherent 40.33 10.39 54 154626 8304 110426315
Cardio-respiratory arrest 40.32 10.39 289 154391 115547 110319072
Back pain 40.30 10.39 736 153944 370260 110064359
Cytomegalovirus infection 40.18 10.39 13 154667 54431 110380188
Medical device site extravasation 40.12 10.39 8 154672 6 110434613
Osteonecrosis of jaw 40.08 10.39 9 154671 48008 110386611
Cognitive disorder 40.08 10.39 234 154446 87277 110347342
Insomnia 39.39 10.39 716 153964 359874 110074745
Respiratory rate decreased 39.08 10.39 46 154634 6212 110428407
Juvenile idiopathic arthritis 38.93 10.39 45 154635 5962 110428657
Medical device site reaction 38.57 10.39 8 154672 9 110434610
Nocturia 38.48 10.39 78 154602 16912 110417707
Euphoric mood 38.04 10.39 54 154626 8773 110425846
Alcohol withdrawal syndrome 37.72 10.39 28 154652 2102 110432517
Knee arthroplasty 37.66 10.39 22 154658 64926 110369693
Serotonin syndrome 37.37 10.39 173 154507 58980 110375639
Agranulocytosis 37.14 10.39 20 154660 61740 110372879
Delirium tremens 37.06 10.39 19 154661 732 110433887
Persistent depressive disorder 36.93 10.39 24 154656 1453 110433166
Bronchiectasis 36.86 10.39 4 154676 36489 110398130
Respiratory acidosis 36.85 10.39 68 154612 13758 110420861
Brain injury 36.83 10.39 67 154613 13409 110421210
COVID-19 36.72 10.39 513 154167 244547 110190072
Oedema peripheral 36.65 10.39 289 154391 328371 110106248
Temperature intolerance 36.42 10.39 68 154612 13882 110420737
Somatosensory evoked potentials abnormal 36.39 10.39 13 154667 200 110434419
Hepatotoxicity 36.02 10.39 22 154658 63378 110371241
Erectile dysfunction 36.02 10.39 80 154600 18476 110416143
Drug eruption 35.91 10.39 15 154665 53644 110380975
Drug resistance 35.78 10.39 17 154663 56357 110378262
Hallucinations, mixed 35.73 10.39 52 154628 8641 110425978
Implant site cellulitis 35.54 10.39 11 154669 105 110434514
Adverse event 35.45 10.39 61 154619 108748 110325871
Lupus-like syndrome 35.38 10.39 7 154673 40785 110393834
Medical device site haematoma 35.34 10.39 9 154671 38 110434581
Depression 35.31 10.39 632 154048 316703 110117916
Finger deformity 35.08 10.39 3 154677 33089 110401530
Haemoptysis 34.98 10.39 29 154651 71325 110363294
Culture urine positive 34.61 10.39 38 154642 4758 110429861
Intervertebral disc protrusion 34.53 10.39 101 154579 27597 110407022
Sinus bradycardia 34.39 10.39 105 154575 29378 110405241
Hypoventilation 34.18 10.39 49 154631 8032 110426587
Autoimmune disorder 34.14 10.39 25 154655 65458 110369161
Epistaxis 34.05 10.39 83 154597 130289 110304330
Therapeutic product effect incomplete 34.04 10.39 179 154501 223626 110210993
Diplopia 33.81 10.39 132 154548 41762 110392857
Pneumocystis jirovecii pneumonia 33.74 10.39 9 154671 42726 110391893
Poor quality sleep 33.69 10.39 101 154579 27976 110406643
Cardiac failure congestive 33.56 10.39 104 154576 150896 110283723
Suspected suicide 33.50 10.39 69 154611 15130 110419489
Adrenal insufficiency 33.33 10.39 9 154671 42381 110392238
Loss of control of legs 33.29 10.39 26 154654 2106 110432513
Lipoma 33.27 10.39 34 154646 3921 110430698
Neoplasm progression 33.24 10.39 25 154655 64570 110370049
Toxic epidermal necrolysis 33.20 10.39 19 154661 56708 110377911
Respiratory failure 33.16 10.39 453 154227 214879 110219740
Pregnancy 33.03 10.39 15 154665 51052 110383567
Meningitis 33.03 10.39 59 154621 11643 110422976
Renal failure 32.93 10.39 184 154496 226390 110208229
Seroma 32.65 10.39 31 154649 3270 110431349
Wound infection 32.42 10.39 53 154627 96412 110338207
Abnormal behaviour 32.32 10.39 124 154556 38915 110395704
Hyperreflexia 32.30 10.39 52 154628 9433 110425186
Anxiety 32.18 10.39 669 154011 344409 110090210
Cardiac arrest 31.99 10.39 418 154262 196335 110238284
Incorrect drug administration rate 31.96 10.39 39 154641 5469 110429150
B-lymphocyte count decreased 31.95 10.39 25 154655 2030 110432589
Band neutrophil percentage increased 31.50 10.39 14 154666 390 110434229
Motor dysfunction 31.40 10.39 90 154590 24316 110410303
T-lymphocyte count decreased 31.36 10.39 16 154664 610 110434009
Hepatic cirrhosis 31.32 10.39 29 154651 67597 110367022
Hypercalcaemia 31.29 10.39 13 154667 46644 110387975
Blepharospasm 31.21 10.39 19 154661 54832 110379787
Implant site dehiscence 31.17 10.39 11 154669 163 110434456
Post procedural complication 31.15 10.39 95 154585 26563 110408056
Bone erosion 30.97 10.39 13 154667 46358 110388261
Hypoxic-ischaemic encephalopathy 30.81 10.39 49 154631 8798 110425821
Expanded disability status scale score increased 30.81 10.39 18 154662 900 110433719
Neutrophil count decreased 30.80 10.39 78 154602 120863 110313756
Mydriasis 30.76 10.39 84 154596 22073 110412546
Coeliac disease 30.68 10.39 11 154669 43176 110391443
Hypokinesia 30.55 10.39 83 154597 21743 110412876
Acute psychosis 30.06 10.39 36 154644 4951 110429668
Macrophages increased 30.01 10.39 12 154668 255 110434364
Muscle contractions involuntary 29.99 10.39 34 154646 4410 110430209
Pseudomeningocele 29.99 10.39 8 154672 42 110434577
Palmar-plantar erythrodysaesthesia syndrome 29.92 10.39 10 154670 41015 110393604
Pneumonitis 29.70 10.39 38 154642 76493 110358126
Pulmonary renal syndrome 29.58 10.39 17 154663 824 110433795
Vulvovaginal mycotic infection 29.47 10.39 37 154643 5340 110429279
Band neutrophil count increased 29.36 10.39 16 154664 699 110433920
Neuroleptic malignant syndrome 28.87 10.39 109 154571 33950 110400669
Neurosis 28.86 10.39 15 154665 595 110434024
Staphylococcal infection 28.83 10.39 182 154498 69762 110364857
Therapeutic response unexpected 28.83 10.39 86 154594 23757 110410862
Product prescribing error 28.73 10.39 145 154535 51186 110383433
Pupil fixed 28.73 10.39 31 154649 3807 110430812
Hepatic cytolysis 28.73 10.39 21 154659 55032 110379587
Liver function test increased 28.52 10.39 50 154630 88498 110346121
Medical device discomfort 28.50 10.39 23 154657 1953 110432666
Vitamin D deficiency 28.46 10.39 73 154607 18479 110416140
Nystagmus 28.45 10.39 55 154625 11522 110423097
Bronchopulmonary aspergillosis 28.39 10.39 4 154676 29859 110404760
Drug ineffective 28.22 10.39 1792 152888 1518748 108915871
Dyspnoea exertional 28.17 10.39 65 154615 103995 110330624
Sciatica 28.13 10.39 54 154626 92345 110342274
Implant site reaction 28.10 10.39 10 154670 152 110434467
Medical device site ulcer 27.96 10.39 6 154674 9 110434610
Incision site oedema 27.96 10.39 6 154674 9 110434610
Urobilinogen urine increased 27.94 10.39 15 154665 636 110433983
Implant site ulcer 27.87 10.39 5 154675 0 110434619
Infusion site fibrosis 27.87 10.39 5 154675 0 110434619
Medical device site warmth 27.87 10.39 5 154675 0 110434619
Nephrolithiasis 27.74 10.39 173 154507 66039 110368580
Rash maculo-papular 27.64 10.39 38 154642 74184 110360435
Unevaluable event 27.53 10.39 159 154521 59068 110375551
Spinal cord injury 27.51 10.39 21 154659 1644 110432975
Tumour lysis syndrome 27.32 10.39 5 154675 30796 110403823
Hypoglycaemia 27.22 10.39 78 154602 116026 110318593
Proteinuria 27.08 10.39 11 154669 40007 110394612
Bladder dysfunction 27.05 10.39 20 154660 1492 110433127
Brain stem syndrome 26.90 10.39 19 154661 1320 110433299
Conversion disorder 26.83 10.39 24 154656 2346 110432273
Prescribed overdose 26.83 10.39 51 154629 87530 110347089
Paraplegia 26.82 10.39 38 154642 6162 110428457
Drug reaction with eosinophilia and systemic symptoms 26.76 10.39 46 154634 82049 110352570
Hypomagnesaemia 26.66 10.39 27 154653 60343 110374276
Dry mouth 26.60 10.39 167 154513 199781 110234838
Bacterial test 26.54 10.39 18 154662 1171 110433448
Decreased vibratory sense 26.52 10.39 15 154665 705 110433914
Cytopenia 26.47 10.39 5 154675 30111 110404508
Inadequate analgesia 26.35 10.39 34 154646 5043 110429576
Red blood cell sedimentation rate increased 26.33 10.39 43 154637 78259 110356360
Poisoning 26.22 10.39 95 154585 29010 110405609
Haemophagocytic lymphohistiocytosis 26.17 10.39 6 154674 31553 110403066
Urinary tract infection pseudomonal 26.15 10.39 23 154657 2199 110432420
Hypocalcaemia 25.84 10.39 32 154648 65334 110369285
CD4 lymphocytes decreased 25.81 10.39 26 154654 2948 110431671
Melaena 25.81 10.39 35 154645 68722 110365897
Bursitis 25.78 10.39 94 154586 129824 110304795
Tachycardia 25.77 10.39 453 154227 226192 110208427
Pain 25.73 10.39 1605 153075 953350 109481269
Intervertebral disc disorder 25.66 10.39 35 154645 5477 110429142
Erythema 25.65 10.39 272 154408 291175 110143444
Product use in unapproved indication 25.54 10.39 456 154224 446921 109987698
Medical device site scar 25.52 10.39 5 154675 3 110434616
Eosinophilia 25.49 10.39 26 154654 57910 110376709
Logorrhoea 25.42 10.39 33 154647 4924 110429695
Musculoskeletal pain 25.32 10.39 151 154529 182872 110251747
Metastases to liver 25.16 10.39 9 154671 35377 110399242
Cholestasis 25.08 10.39 32 154648 64486 110370133
Bladder disorder 25.07 10.39 51 154629 11086 110423533
Bladder spasm 25.02 10.39 25 154655 2807 110431812
Neuropsychiatric syndrome 24.99 10.39 10 154670 213 110434406
Performance status decreased 24.97 10.39 40 154640 7226 110427393
CD8 lymphocytes decreased 24.90 10.39 11 154669 302 110434317
Rebound psychosis 24.85 10.39 12 154668 406 110434213
Ankle fracture 24.45 10.39 72 154608 19747 110414872
Basal ganglion degeneration 24.36 10.39 12 154668 424 110434195
Purulent discharge 24.35 10.39 39 154641 7044 110427575
Meningitis staphylococcal 24.24 10.39 10 154670 231 110434388
Nervous system disorder 24.04 10.39 98 154582 31623 110402996
Hypersomnia 23.95 10.39 90 154590 27971 110406648
CSF culture positive 23.94 10.39 7 154673 54 110434565
Upper motor neurone lesion 23.91 10.39 11 154669 333 110434286
Rib fracture 23.77 10.39 102 154578 33668 110400951
Drug-induced liver injury 23.74 10.39 87 154593 119980 110314639
Aplastic anaemia 23.72 10.39 3 154677 24305 110410314
Quadriparesis 23.62 10.39 31 154649 4676 110429943
Vision blurred 23.49 10.39 280 154400 128742 110305877
Device expulsion 23.47 10.39 7 154673 30884 110403735
Primary progressive multiple sclerosis 23.35 10.39 8 154672 108 110434511
Neutropenic sepsis 23.30 10.39 7 154673 30739 110403880
Breast cancer stage II 23.11 10.39 5 154675 27370 110407249
Incision site erythema 23.05 10.39 13 154667 608 110434011
Infusion site granuloma 22.73 10.39 5 154675 9 110434610
Cystitis noninfective 22.69 10.39 19 154661 1699 110432920
Intervertebral disc degeneration 22.60 10.39 66 154614 18019 110416600
Posturing 22.59 10.39 16 154664 1116 110433503
Stupor 22.47 10.39 41 154639 8224 110426395
Implant site oedema 22.41 10.39 6 154674 32 110434587
Crystal urine present 22.37 10.39 20 154660 1954 110432665
Laryngitis 22.36 10.39 16 154664 42395 110392224
Medical device site vesicles 22.30 10.39 4 154676 0 110434619
Fluctuance 22.30 10.39 4 154676 0 110434619
Hyperthermia 22.28 10.39 73 154607 21199 110413420
Muscle atrophy 22.28 10.39 54 154626 13200 110421419
Invasive ductal breast carcinoma 22.04 10.39 36 154644 6610 110428009
Major depression 21.99 10.39 47 154633 10574 110424045
Urinary tract infection bacterial 21.91 10.39 40 154640 8027 110426592
Anaphylactic shock 21.71 10.39 24 154656 51522 110383097
Red blood cell sedimentation rate abnormal 21.69 10.39 4 154676 24505 110410114
Colitis 21.67 10.39 72 154608 102251 110332368
Drug screen positive 21.64 10.39 35 154645 6375 110428244
Implant site warmth 21.54 10.39 6 154674 38 110434581
Implant site vesicles 21.41 10.39 6 154674 39 110434580
Toxic skin eruption 21.34 10.39 6 154674 27509 110407110
Medical device site cellulitis 21.27 10.39 9 154671 222 110434397
Patient-device incompatibility 21.19 10.39 9 154671 224 110434395
Middle insomnia 21.15 10.39 70 154610 20432 110414187
Alcohol poisoning 21.13 10.39 42 154638 8978 110425641
Spinal operation 20.96 10.39 47 154633 10925 110423694
Anaesthesia 20.69 10.39 12 154668 592 110434027
Muscular dystrophy 20.65 10.39 9 154671 239 110434380
Musculoskeletal discomfort 20.51 10.39 76 154604 23462 110411157
Spinal stenosis 20.50 10.39 66 154614 18990 110415629
Pancreatitis 20.37 10.39 65 154615 93468 110341151
Head injury 20.33 10.39 116 154564 42901 110391718
Angina pectoris 20.22 10.39 35 154645 62260 110372359
Haemorrhage 20.00 10.39 79 154601 106613 110328006
Productive cough 19.96 10.39 87 154593 114218 110320401
Upper airway obstruction 19.91 10.39 18 154662 1784 110432835
Intestinal pseudo-obstruction 19.86 10.39 24 154656 3332 110431287
Demyelination 19.84 10.39 42 154638 9387 110425232
Sleep disorder 19.74 10.39 180 154500 198464 110236155
Infected skin ulcer 19.71 10.39 26 154654 3941 110430678
Mean platelet volume increased 19.67 10.39 17 154663 1587 110433032
Monoplegia 19.65 10.39 29 154651 4880 110429739
Myofascial pain syndrome 19.64 10.39 21 154659 2552 110432067
Wound infection staphylococcal 19.56 10.39 24 154656 3385 110431234
Incision site complication 19.51 10.39 13 154667 821 110433798
Rash pruritic 19.43 10.39 71 154609 97998 110336621
Dyspepsia 19.43 10.39 172 154508 190793 110243826
Hip arthroplasty 19.38 10.39 30 154650 55783 110378836
Hypertransaminasaemia 19.35 10.39 5 154675 24250 110410369
Frontotemporal dementia 19.32 10.39 12 154668 671 110433948
Postoperative wound infection 19.22 10.39 57 154623 15696 110418923
Gastrooesophageal reflux disease 19.15 10.39 356 154324 179620 110254999
Tethered cord syndrome 19.11 10.39 5 154675 24 110434595
Metastases to bone 19.10 10.39 10 154670 31362 110403257
Skin reaction 19.04 10.39 69 154611 21075 110413544
Cervical spinal stenosis 19.00 10.39 22 154658 2920 110431699
Haemoglobin decreased 18.83 10.39 240 154440 248487 110186132
Hypervolaemia 18.74 10.39 25 154655 49435 110385184
Malaise 18.71 10.39 759 153921 671060 109763559
Cystitis 18.67 10.39 157 154523 65879 110368740
Pre-existing disease 18.59 10.39 8 154672 206 110434413
Blood bilirubin increased 18.58 10.39 50 154630 75922 110358697
Central nervous system infection 18.55 10.39 17 154663 1715 110432904
Thyroid disorder 18.47 10.39 59 154621 16910 110417709
Brain death 18.37 10.39 33 154647 6540 110428079
Thyroxine decreased 18.35 10.39 13 154667 907 110433712
Procedural complication 18.34 10.39 38 154642 8367 110426252
Polyneuropathy 18.34 10.39 11 154669 32001 110402618
Chest pain 18.32 10.39 394 154286 375981 110058638
Incontinence 18.25 10.39 58 154622 16577 110418042
Presyncope 18.23 10.39 25 154655 48862 110385757
Vitamin B6 deficiency 18.21 10.39 11 154669 585 110434034
Implant site mass 18.15 10.39 6 154674 72 110434547
Urine oxalate increased 18.10 10.39 8 154672 220 110434399
Product quality issue 18.07 10.39 52 154628 77247 110357372
Blood uric acid increased 18.04 10.39 4 154676 21525 110413094
Urinary tract infection enterococcal 17.99 10.39 24 154656 3678 110430941
Neurogenic bowel 17.94 10.39 9 154671 331 110434288
Protein total decreased 17.91 10.39 44 154636 10846 110423773
Myelocyte percentage increased 17.80 10.39 8 154672 229 110434390
Right ventricular failure 17.78 10.39 7 154673 25947 110408672
Vertebral foraminal stenosis 17.75 10.39 15 154665 1358 110433261
Metastases to central nervous system 17.65 10.39 5 154675 22812 110411807
Exostosis 17.65 10.39 23 154657 45933 110388686
Incision site swelling 17.60 10.39 9 154671 345 110434274
Narcissistic personality disorder 17.59 10.39 4 154676 9 110434610
Uterine enlargement 17.56 10.39 13 154667 972 110433647
Psychogenic seizure 17.53 10.39 19 154661 2345 110432274
Brief psychotic disorder with marked stressors 17.45 10.39 9 154671 351 110434268
Posture abnormal 17.45 10.39 26 154654 4412 110430207
Leukopenia 17.44 10.39 129 154551 148662 110285957
Quadriplegia 17.42 10.39 25 154655 4102 110430517
Urine abnormality 17.41 10.39 39 154641 9057 110425562
Chronic kidney disease 17.34 10.39 52 154628 76239 110358380
Hypervigilance 17.23 10.39 11 154669 646 110433973
Adverse reaction 17.19 10.39 10 154670 29584 110405035
Gastrointestinal motility disorder 17.19 10.39 34 154646 7242 110427377
Blood sodium increased 17.09 10.39 29 154651 5494 110429125
Paraesthesia 17.05 10.39 507 154173 276014 110158605
Pulmonary hypertension 17.05 10.39 32 154648 55188 110379431
Tissue infiltration 16.89 10.39 13 154667 1030 110433589
Acute myeloid leukaemia 16.88 10.39 17 154663 38093 110396526
Glossopharyngeal nerve disorder 16.83 10.39 5 154675 41 110434578
Graft versus host disease 16.79 10.39 3 154677 18803 110415816
Hemiparesis 16.73 10.39 112 154568 43791 110390828
Medical device site rash 16.72 10.39 3 154677 0 110434619
Medical device site mass 16.72 10.39 3 154677 0 110434619
Lower limb fracture 16.66 10.39 52 154628 75296 110359323
Athetosis 16.60 10.39 7 154673 171 110434448
Psychotic disorder 16.53 10.39 125 154555 50812 110383807
Respiratory distress 16.52 10.39 158 154522 68716 110365903
Faeces discoloured 16.39 10.39 14 154666 33934 110400685
Corneal reflex decreased 16.37 10.39 10 154670 543 110434076
Injection site necrosis 16.36 10.39 16 154664 1750 110432869
Excessive granulation tissue 16.35 10.39 13 154667 1081 110433538
Nodule 16.32 10.39 13 154667 32618 110402001
Hyporesponsive to stimuli 16.19 10.39 20 154660 2840 110431779
Rotator cuff syndrome 16.15 10.39 56 154624 16738 110417881
Surgery 16.14 10.39 106 154574 41177 110393442
Postoperative delirium 16.14 10.39 12 154668 903 110433716
Abdominal distension 15.98 10.39 162 154518 174941 110259678
Eosinophil percentage increased 15.92 10.39 15 154665 1567 110433052
Vasculitis 15.89 10.39 16 154664 35857 110398762
Incorrect route of product administration 15.89 10.39 148 154532 63913 110370706
Mechanical urticaria 15.88 10.39 10 154670 573 110434046
Second primary malignancy 15.88 10.39 3 154677 18065 110416554
Tibia fracture 15.84 10.39 31 154649 6554 110428065
Staphylococcus test positive 15.71 10.39 33 154647 7337 110427282
Drug ineffective for unapproved indication 15.68 10.39 216 154464 102622 110331997
Sedation complication 15.57 10.39 62 154618 19793 110414826
Maternal exposure timing unspecified 15.54 10.39 5 154675 21008 110413611
Acquired diaphragmatic eventration 15.49 10.39 11 154669 771 110433848
Limb discomfort 15.43 10.39 104 154576 40750 110393869
Gout 15.42 10.39 17 154663 36549 110398070
Sleep disorder due to a general medical condition 15.39 10.39 31 154649 52081 110382538
Lactic acidosis 15.39 10.39 72 154608 92739 110341880
Fibula fracture 15.38 10.39 25 154655 4573 110430046
Arthritis 15.31 10.39 155 154525 167431 110267188
Ulcer 15.14 10.39 23 154657 43093 110391526
Breast cancer 15.09 10.39 99 154581 38443 110396176
Therapy cessation 15.08 10.39 111 154569 44746 110389873
Back injury 15.05 10.39 27 154653 47372 110387247
Blood ethanol increased 15.02 10.39 10 154670 631 110433988
Obstructive airways disorder 14.91 10.39 26 154654 46123 110388496
Infrapatellar fat pad inflammation 14.85 10.39 7 154673 224 110434395
Proteus infection 14.77 10.39 19 154661 2809 110431810
CSF protein increased 14.74 10.39 14 154666 1477 110433142
Genital herpes 14.72 10.39 18 154662 2529 110432090
Epstein-Barr virus infection 14.69 10.39 4 154676 18734 110415885
Incision site vesicles 14.65 10.39 3 154677 3 110434616
Stevens-Johnson syndrome 14.64 10.39 27 154653 46874 110387745
Suicidal ideation 14.60 10.39 198 154482 93739 110340880
International normalised ratio increased 14.57 10.39 67 154613 86705 110347914
Neuromyelitis optica spectrum disorder 14.55 10.39 14 154666 1501 110433118
Purpura 14.51 10.39 8 154672 24380 110410239
Retinal depigmentation 14.50 10.39 8 154672 358 110434261
Intervertebral disc operation 14.46 10.39 12 154668 1060 110433559
Pyrexia 14.36 10.39 1072 153608 897193 109537426
Streptococcus test positive 14.35 10.39 18 154662 2596 110432023
Thoracic radiculopathy 14.27 10.39 4 154676 26 110434593
Specific gravity urine decreased 14.26 10.39 11 154669 875 110433744
Blood ketone body increased 14.24 10.39 11 154669 877 110433742
Catheter site mass 14.23 10.39 5 154675 73 110434546
Urinary sediment abnormal 14.22 10.39 6 154674 147 110434472
Medical device site oedema 14.19 10.39 3 154677 4 110434615
SARS-CoV-2 test false positive 14.14 10.39 4 154676 27 110434592
Tonic clonic movements 14.13 10.39 19 154661 2933 110431686
Spinal cord injury cauda equina 14.10 10.39 6 154674 150 110434469
Crying 14.07 10.39 72 154608 25556 110409063
Noninfective encephalitis 14.01 10.39 10 154670 706 110433913
Haematuria 13.99 10.39 64 154616 82941 110351678
Female genital tract fistula 13.98 10.39 3 154677 16516 110418103
Medical device site irritation 13.89 10.39 4 154676 29 110434590
Dysuria 13.87 10.39 137 154543 60094 110374525
Device delivery system issue 13.86 10.39 16 154664 2117 110432502
Implant site pruritus 13.82 10.39 9 154671 547 110434072
Injection site scar 13.82 10.39 12 154668 1128 110433491
Myocarditis 13.78 10.39 13 154667 30042 110404577
Jaundice 13.73 10.39 40 154640 59196 110375423
Implant site rash 13.71 10.39 6 154674 161 110434458
Eye movement disorder 13.62 10.39 37 154643 9691 110424928
Mental disorder 13.62 10.39 97 154583 38694 110395925
Cerebral infarction 13.53 10.39 33 154647 51805 110382814
Rales 13.48 10.39 9 154671 24730 110409889
Shock haemorrhagic 13.44 10.39 11 154669 27236 110407383
Post laminectomy syndrome 13.44 10.39 8 154672 414 110434205
CSF shunt operation 13.43 10.39 3 154677 6 110434613
Urine cannabinoids increased 13.43 10.39 3 154677 6 110434613
Psoriasis 13.41 10.39 128 154552 139865 110294754
Infection 13.35 10.39 395 154285 361805 110072814
Chronic fatigue syndrome 13.34 10.39 13 154667 1416 110433203
Immediate post-injection reaction 13.29 10.39 8 154672 423 110434196
Coordination abnormal 13.24 10.39 70 154610 25158 110409461
Post procedural infection 13.24 10.39 46 154634 13763 110420856
Enthesopathy 13.23 10.39 43 154637 12435 110422184
Stitch abscess 13.22 10.39 5 154675 91 110434528
Blood folate increased 13.22 10.39 9 154671 589 110434030
Wrong patient received product 13.21 10.39 29 154651 6645 110427974
Polyarthritis 13.18 10.39 5 154675 18958 110415661
Myelodysplastic syndrome 13.16 10.39 20 154660 37464 110397155
Urine osmolarity increased 13.12 10.39 7 154673 293 110434326
Aspergillus infection 13.07 10.39 10 154670 25606 110409013
Renal tubular necrosis 13.04 10.39 14 154666 30461 110404158
Hip fracture 12.99 10.39 89 154591 35062 110399557
Injection site abscess 12.95 10.39 15 154665 1991 110432628
Peripheral nerve operation 12.94 10.39 4 154676 38 110434581
Decreased interest 12.91 10.39 24 154656 4884 110429735
Pulmonary alveolar haemorrhage 12.90 10.39 6 154674 20144 110414475
Apnoeic attack 12.89 10.39 10 154670 802 110433817
Coronary artery disease 12.86 10.39 54 154626 71636 110362983
Intraductal proliferative breast lesion 12.86 10.39 18 154662 2887 110431732
Panniculitis 12.85 10.39 3 154677 15579 110419040
Device related infection 12.83 10.39 97 154583 39422 110395197
Cerebral vasoconstriction 12.80 10.39 13 154667 1488 110433131
Spinal osteoarthritis 12.73 10.39 59 154621 20124 110414495
Invasive lobular breast carcinoma 12.65 10.39 10 154670 824 110433795
Foot deformity 12.55 10.39 31 154649 48449 110386170
Osteoporosis 12.53 10.39 71 154609 87081 110347538
Urinary hesitation 12.53 10.39 23 154657 4635 110429984
Medical device site haemorrhage 12.51 10.39 6 154674 200 110434419
Cerebral palsy 12.40 10.39 7 154673 328 110434291
Feeling of body temperature change 12.37 10.39 27 154653 6161 110428458
Myelomalacia 12.37 10.39 6 154674 205 110434414
Nerve injury 12.35 10.39 38 154642 10675 110423944
Nausea 12.34 10.39 1527 153153 1234163 109200456
Pupillary reflex impaired 12.31 10.39 21 154659 3994 110430625
Glycosylated haemoglobin decreased 12.26 10.39 10 154670 862 110433757
Glaucoma 12.18 10.39 63 154617 22454 110412165
Hyperbilirubinaemia 12.14 10.39 15 154665 30656 110403963
Acute encephalitis with refractory, repetitive partial seizures 12.10 10.39 4 154676 48 110434571
CD8 lymphocytes increased 12.10 10.39 4 154676 48 110434571
Cerebral thrombosis 12.09 10.39 16 154664 2432 110432187
Oral candidiasis 12.08 10.39 28 154652 44732 110389887
Aphasia 12.07 10.39 131 154549 58866 110375753
Catatonia 12.03 10.39 39 154641 11261 110423358
Progressive relapsing multiple sclerosis 11.95 10.39 4 154676 50 110434569
Partial seizures 11.93 10.39 39 154641 11310 110423309
Infusion site macule 11.91 10.39 3 154677 12 110434607
Consciousness fluctuating 11.86 10.39 15 154665 2181 110432438
Pneumonia fungal 11.85 10.39 3 154677 14751 110419868
Tenderness 11.76 10.39 76 154604 29361 110405258
Urine uric acid decreased 11.75 10.39 5 154675 125 110434494
Infusion site reaction 11.74 10.39 5 154675 17677 110416942
Medical device site scab 11.72 10.39 3 154677 13 110434606
Back disorder 11.64 10.39 59 154621 20863 110413756
Eosinophil percentage decreased 11.61 10.39 7 154673 371 110434248
Anaphylactic reaction 11.60 10.39 103 154577 114197 110320422
Hiccups 11.59 10.39 42 154638 12827 110421792
Rash erythematous 11.59 10.39 67 154613 81765 110352854
Dizziness 11.55 10.39 1130 153550 697063 109737556
Foetal death 11.55 10.39 4 154676 16041 110418578
Adrenal neoplasm 11.53 10.39 8 154672 540 110434079
Neurological decompensation 11.52 10.39 28 154652 6855 110427764
Neoplasm skin 11.51 10.39 18 154662 3186 110431433
Foot fracture 11.49 10.39 68 154612 25478 110409141
Inappropriate affect 11.47 10.39 13 154667 1686 110432933
Foaming at mouth 11.47 10.39 15 154665 2255 110432364
Nerve compression 11.47 10.39 38 154642 11099 110423520
Colitis microscopic 11.46 10.39 43 154637 13351 110421268
End stage renal disease 11.45 10.39 8 154672 21465 110413154
Lipoedema 11.43 10.39 6 154674 243 110434376
Diplegia 11.41 10.39 15 154665 2266 110432353
Nephropathy toxic 11.34 10.39 13 154667 27465 110407154
Facial asymmetry 11.33 10.39 10 154670 960 110433659
Tongue biting 11.25 10.39 17 154663 2922 110431697
Blood urine present 11.21 10.39 65 154615 24180 110410439
Procedural headache 11.18 10.39 6 154674 254 110434365
Scar 11.13 10.39 50 154630 16831 110417788
Anti-thyroid antibody positive 11.11 10.39 8 154672 573 110434046
Spinal cord infection 11.09 10.39 9 154671 770 110433849
Asthenia 11.08 10.39 1113 153567 687886 109746733
Skin haemorrhage 11.08 10.39 11 154669 24816 110409803
Hallucination, auditory 11.07 10.39 69 154611 26328 110408291
Calculus bladder 11.07 10.39 13 154667 1751 110432868
Visual impairment 11.04 10.39 256 154424 134172 110300447
Amnesia 11.03 10.39 208 154472 105200 110329419
Cardiac output decreased 10.97 10.39 14 154666 2055 110432564
Weight decreased 10.92 10.39 539 154141 467518 109967101
Abnormal dreams 10.91 10.39 41 154639 12739 110421880
Pituitary cyst 10.91 10.39 3 154677 18 110434601
Duodenitis haemorrhagic 10.91 10.39 5 154675 150 110434469
Allodynia 10.89 10.39 14 154666 2069 110432550
Blood pressure diastolic abnormal 10.89 10.39 12 154668 25803 110408816
Medical device removal 10.87 10.39 9 154671 792 110433827
Influenza B virus test positive 10.87 10.39 7 154673 417 110434202
Product administration error 10.79 10.39 89 154591 37128 110397491
Product dose omission issue 10.79 10.39 552 154128 321230 110113389
Condition aggravated 10.79 10.39 883 153797 733953 109700666
Implant site pustules 10.77 10.39 3 154677 19 110434600
Nephrotic syndrome 10.76 10.39 3 154677 13828 110420791
Snoring 10.73 10.39 27 154653 6757 110427862
Coagulopathy 10.72 10.39 26 154654 40885 110393734
Patella fracture 10.69 10.39 15 154665 2411 110432208
Reflexes abnormal 10.68 10.39 10 154670 1037 110433582
Eyelid oedema 10.65 10.39 4 154676 15258 110419361
Syringomyelia 10.65 10.39 6 154674 280 110434339
Seizure like phenomena 10.62 10.39 15 154665 2426 110432193
Myocardial ischaemia 10.61 10.39 13 154667 26671 110407948
Klebsiella test positive 10.59 10.39 15 154665 2431 110432188
Clumsiness 10.59 10.39 19 154661 3761 110430858
Bedridden 10.59 10.39 42 154638 13383 110421236
Metastases to lung 10.55 10.39 10 154670 23053 110411566
Creatinine renal clearance decreased 10.53 10.39 9 154671 21806 110412813
Mean cell haemoglobin concentration decreased 10.47 10.39 24 154656 5658 110428961
Mania 10.44 10.39 57 154623 20739 110413880
Basophil count decreased 10.41 10.39 7 154673 449 110434170

FDA Adverse Event Reporting System (Pediatric)

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
Sneezing 39.17 38.80 9 124 29 113791

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:35480 analgesic
CHEBI has role CHEBI:35488 central nervous system depressant
CHEBI has role CHEBI:35610 antineoplastic agent
CHEBI has role CHEBI:35705 immunosuppressive agent
CHEBI has role CHEBI:51371 muscle relaxant
CHEBI has role CHEBI:51373 GABA agonist
CHEBI has role CHEBI:63726 neuroprotective agent
CHEBI has role CHEBI:74518 anti-obesity agent
MeSH PA D009125 Muscle Relaxants, Central
MeSH PA D009465 Neuromuscular Agents
MeSH PA D018377 Neurotransmitter Agents
MeSH PA D018682 GABA Agents
MeSH PA D058786 GABA-B Receptor Agonists
FDA EPC N0000175759 gamma-Aminobutyric Acid-ergic Agonist

Related Drugs by ATC class:

M03BX Other centrally acting agents 9 drugs
cyclobenzaprineeperisonefenyramidolmephenesinpridinoltetrazepamthiocolchicosidetizanidinetolperisone

Drug Use | Suggest Off label Use Form| |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




🐶 Veterinary Drug Use

None

🐶 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
25MG/5ML FLEQSUVY AZURITY N215602 Feb. 4, 2022 RX SUSPENSION ORAL 11446246 Sept. 8, 2037 INDICATED FOR THE TREATMENT OF SPASTICITY RESULTING FROM MULTIPLE SCLEROSIS
10MG/PACKET LYVISPAH STRIDES PHARMA INTL N215422 Nov. 22, 2021 DISCN GRANULE ORAL 10792262 July 29, 2039 METHOD FOR TREATING SPASTICITY
20MG/PACKET LYVISPAH STRIDES PHARMA INTL N215422 Nov. 22, 2021 DISCN GRANULE ORAL 10792262 July 29, 2039 METHOD FOR TREATING SPASTICITY
5MG/PACKET LYVISPAH STRIDES PHARMA INTL N215422 Nov. 22, 2021 DISCN GRANULE ORAL 10792262 July 29, 2039 METHOD FOR TREATING SPASTICITY
5MG/5ML OZOBAX METACEL PHARMS LLC N208193 Sept. 18, 2019 DISCN SOLUTION ORAL 10610502 Aug. 30, 2039 TREATMENT OF SPASTICITY
10MG/PACKET LYVISPAH STRIDES PHARMA INTL N215422 Nov. 22, 2021 DISCN GRANULE ORAL 11491125 Sept. 29, 2041 TREATMENT OF SPASTICITY RESULTING FROM MULTIPLE SCLEROSIS, PARTICULARLY FOR THE RELIEF OF FLEXOR SPASMS AND CONCOMITANT PAIN, CLONUS, AND MUSCULAR RIGIDITY
10MG/PACKET LYVISPAH STRIDES PHARMA INTL N215422 Nov. 22, 2021 DISCN GRANULE ORAL 11491125 Sept. 29, 2041 TREATMENT OF SPASTICITY RESULTING FROM SPINAL CORD INJURIES AND OTHER SPINAL CORD DISEASES
10MG/PACKET LYVISPAH STRIDES PHARMA INTL N215422 Nov. 22, 2021 DISCN GRANULE ORAL 11850225 Sept. 29, 2041 TREATMENT OF SPASTICITY RESULTING FROM MULTIPLE SCLEROSIS, PARTICULARLY FOR THE RELIEF OF FLEXOR SPASMS AND CONCOMITANT PAIN, CLONUS, AND MUSCULAR RIGIDITY
10MG/PACKET LYVISPAH STRIDES PHARMA INTL N215422 Nov. 22, 2021 DISCN GRANULE ORAL 11850225 Sept. 29, 2041 TREATMENT OF SPASTICITY RESULTING FROM SPINAL CORD INJURIES AND OTHER SPINAL CORD DISEASES
20MG/PACKET LYVISPAH STRIDES PHARMA INTL N215422 Nov. 22, 2021 DISCN GRANULE ORAL 11491125 Sept. 29, 2041 TREATMENT OF SPASTICITY RESULTING FROM MULTIPLE SCLEROSIS, PARTICULARLY FOR THE RELIEF OF FLEXOR SPASMS AND CONCOMITANT PAIN, CLONUS, AND MUSCULAR RIGIDITY
20MG/PACKET LYVISPAH STRIDES PHARMA INTL N215422 Nov. 22, 2021 DISCN GRANULE ORAL 11491125 Sept. 29, 2041 TREATMENT OF SPASTICITY RESULTING FROM SPINAL CORD INJURIES AND OTHER SPINAL CORD DISEASES
20MG/PACKET LYVISPAH STRIDES PHARMA INTL N215422 Nov. 22, 2021 DISCN GRANULE ORAL 11850225 Sept. 29, 2041 TREATMENT OF SPASTICITY RESULTING FROM MULTIPLE SCLEROSIS, PARTICULARLY FOR THE RELIEF OF FLEXOR SPASMS AND CONCOMITANT PAIN, CLONUS, AND MUSCULAR RIGIDITY
20MG/PACKET LYVISPAH STRIDES PHARMA INTL N215422 Nov. 22, 2021 DISCN GRANULE ORAL 11850225 Sept. 29, 2041 TREATMENT OF SPASTICITY RESULTING FROM SPINAL CORD INJURIES AND OTHER SPINAL CORD DISEASES
5MG/PACKET LYVISPAH STRIDES PHARMA INTL N215422 Nov. 22, 2021 DISCN GRANULE ORAL 11491125 Sept. 29, 2041 TREATMENT OF SPASTICITY RESULTING FROM MULTIPLE SCLEROSIS, PARTICULARLY FOR THE RELIEF OF FLEXOR SPASMS AND CONCOMITANT PAIN, CLONUS, AND MUSCULAR RIGIDITY
5MG/PACKET LYVISPAH STRIDES PHARMA INTL N215422 Nov. 22, 2021 DISCN GRANULE ORAL 11491125 Sept. 29, 2041 TREATMENT OF SPASTICITY RESULTING FROM SPINAL CORD INJURIES AND OTHER SPINAL CORD DISEASES
5MG/PACKET LYVISPAH STRIDES PHARMA INTL N215422 Nov. 22, 2021 DISCN GRANULE ORAL 11850225 Sept. 29, 2041 TREATMENT OF SPASTICITY RESULTING FROM MULTIPLE SCLEROSIS, PARTICULARLY FOR THE RELIEF OF FLEXOR SPASMS AND CONCOMITANT PAIN, CLONUS, AND MUSCULAR RIGIDITY
5MG/PACKET LYVISPAH STRIDES PHARMA INTL N215422 Nov. 22, 2021 DISCN GRANULE ORAL 11850225 Sept. 29, 2041 TREATMENT OF SPASTICITY RESULTING FROM SPINAL CORD INJURIES AND OTHER SPINAL CORD DISEASES

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:2972 CHEBI
2C0 PDB_CHEM_ID
CHEMBL701 ChEMBL_ID
DB00181 DRUGBANK_ID
D001418 MESH_DESCRIPTOR_UI
2284 PUBCHEM_CID
1084 IUPHAR_LIGAND_ID
2956 INN_ID
H789N3FKE8 UNII
1959 MMSL
4243 MMSL
709 MMSL
d00967 MMSL
4018392 VANDF
001677 NDDF
387342009 SNOMEDCT_US
6102009 SNOMEDCT_US

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
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 0615-8466 TABLET 10 mg ORAL ANDA 11 sections
BACLOFEN HUMAN PRESCRIPTION DRUG LABEL 1 0615-8467 TABLET 20 mg ORAL ANDA 11 sections
Baclofen HUMAN PRESCRIPTION DRUG LABEL 1 0615-8518 TABLET 5 mg ORAL ANDA 12 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 0904-6476 TABLET 20 mg ORAL ANDA 12 sections
Baclofen HUMAN PRESCRIPTION DRUG LABEL 1 0904-7341 TABLET 5 mg ORAL ANDA 11 sections
BACLOFEN HUMAN PRESCRIPTION DRUG LABEL 1 0904-7552 TABLET 10 mg ORAL ANDA 12 sections
BACLOFEN HUMAN PRESCRIPTION DRUG LABEL 1 0904-7553 TABLET 20 mg ORAL ANDA 12 sections
BACLOFEN HUMAN PRESCRIPTION DRUG LABEL 1 0904-7558 TABLET 5 mg ORAL ANDA 11 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 10135-780 TABLET 5 mg ORAL ANDA 11 sections
Baclofen HUMAN PRESCRIPTION DRUG LABEL 1 10135-781 TABLET 10 mg ORAL ANDA 11 sections
Baclofen HUMAN PRESCRIPTION DRUG LABEL 1 10135-782 TABLET 20 mg ORAL ANDA 11 sections
Baclofen HUMAN PRESCRIPTION DRUG LABEL 1 10544-172 TABLET 10 mg ORAL ANDA 12 sections
BACLOFEN HUMAN PRESCRIPTION DRUG LABEL 1 14789-161 INJECTION 2000 ug INTRATHECAL ANDA 23 sections
BACLOFEN HUMAN PRESCRIPTION DRUG LABEL 1 16571-169 TABLET 5 mg ORAL ANDA 11 sections
BACLOFEN HUMAN PRESCRIPTION DRUG LABEL 1 16571-171 TABLET 10 mg ORAL ANDA 11 sections
BACLOFEN HUMAN PRESCRIPTION DRUG LABEL 1 16571-172 TABLET 20 mg ORAL ANDA 11 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