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

Stem definitionDrug idCAS RN
282 1134-47-0

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

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

Drug dosage:

DoseUnitRoute
50 mg O
0.55 mg P

ADMET properties:

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

Approvals:

DateAgencyCompanyOrphan
Nov. 22, 1977 FDA

FDA Adverse Event Reporting System (Female)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Multiple sclerosis relapse 1684.50 10.28 1021 101424 47457 63339120
Multiple sclerosis 1067.70 10.28 597 101848 23775 63362802
Drug withdrawal syndrome 983.35 10.28 588 101857 26606 63359971
Muscle spasticity 613.24 10.28 402 102043 21392 63365185
Coma 451.71 10.28 538 101907 63826 63322751
Implant site extravasation 446.55 10.28 113 102332 386 63386191
Implant site infection 440.49 10.28 130 102315 884 63385693
Urinary tract infection 358.63 10.28 1088 101357 263596 63122981
Somnolence 333.12 10.28 826 101619 177859 63208718
Gait disturbance 328.12 10.28 834 101611 182344 63204233
Seizure 290.40 10.28 653 101792 131981 63254596
Completed suicide 285.87 10.28 687 101758 144986 63241591
Fall 277.23 10.28 1309 101136 391025 62995552
Pneumonia aspiration 276.29 10.28 309 102136 34231 63352346
Cerebrospinal fluid leakage 262.08 10.28 91 102354 1099 63385478
Glossodynia 245.39 10.28 10 102435 178866 63207711
Muscular weakness 244.27 10.28 581 101864 121772 63264805
Hypotonia 241.15 10.28 163 102282 9122 63377455
Muscle spasms 238.08 10.28 670 101775 155480 63231097
Overdose 211.09 10.28 529 101916 114549 63272028
Systemic lupus erythematosus 199.90 10.28 46 102399 208872 63177705
Pericarditis 196.75 10.28 3 102442 131576 63255001
Unresponsive to stimuli 189.86 10.28 253 102192 33563 63353014
Mental status changes 189.02 10.28 274 102171 39325 63347252
Hypertonia 182.53 10.28 106 102339 4531 63382046
Hand deformity 179.03 10.28 23 102422 159434 63227143
Device failure 174.21 10.28 113 102332 5898 63380679
Joint swelling 171.06 10.28 166 102279 327500 63059077
Contraindicated product administered 168.68 10.28 70 102375 217578 63168999
Arthropathy 162.81 10.28 88 102357 234704 63151873
Synovitis 156.75 10.28 53 102392 186865 63199712
Device infusion issue 156.62 10.28 73 102372 1965 63384612
Infusion related reaction 149.51 10.28 107 102338 245414 63141163
Abdominal discomfort 148.15 10.28 180 102265 320705 63065872
Implant site erosion 146.58 10.28 33 102412 56 63386521
White blood cell count abnormal 144.27 10.28 102 102343 6140 63380437
Helicobacter infection 135.09 10.28 3 102442 92782 63293795
Rash 130.65 10.28 466 101979 560405 62826172
Maternal exposure during pregnancy 129.96 10.28 99 102346 219963 63166614
Febrile neutropenia 128.41 10.28 19 102426 118430 63268147
Balance disorder 127.30 10.28 361 102084 84061 63302516
Wound 127.28 10.28 52 102393 163211 63223366
Medical device site pain 126.23 10.28 34 102411 157 63386420
Central nervous system lesion 124.80 10.28 117 102328 10518 63376059
Drug intolerance 123.49 10.28 192 102253 308469 63078108
Muscle tightness 122.83 10.28 122 102323 11778 63374799
Lymphocyte count decreased 119.83 10.28 192 102253 30065 63356512
Hypoaesthesia 119.29 10.28 563 101882 167830 63218747
Secondary progressive multiple sclerosis 118.68 10.28 54 102391 1373 63385204
Decubitus ulcer 110.71 10.28 109 102336 10411 63376166
Memory impairment 110.64 10.28 395 102050 103863 63282714
Anaemia 108.56 10.28 192 102253 293238 63093339
Swelling 108.51 10.28 173 102272 275205 63111372
Exposure during pregnancy 108.20 10.28 58 102387 155489 63231088
Influenza like illness 107.89 10.28 293 102152 66531 63320046
Complication associated with device 107.76 10.28 135 102310 16843 63369734
Device physical property issue 103.90 10.28 55 102390 1957 63384620
Toxicity to various agents 103.36 10.28 718 101727 246532 63140045
Product use issue 102.44 10.28 123 102322 220397 63166180
Withdrawal syndrome 102.23 10.28 143 102302 19854 63366723
Diarrhoea 99.74 10.28 711 101734 714655 62671922
Drug ineffective 99.72 10.28 1144 101301 1043621 62342956
Medical device site infection 99.05 10.28 31 102414 263 63386314
Progressive multiple sclerosis 96.15 10.28 44 102401 1134 63385443
Tremor 94.98 10.28 444 102001 131795 63254782
Therapeutic product effect decreased 92.68 10.28 105 102340 193082 63193495
Urine analysis abnormal 89.13 10.28 70 102375 4946 63381631
Device power source issue 88.81 10.28 34 102411 551 63386026
Folliculitis 87.02 10.28 7 102438 70310 63316267
Implant site discharge 85.63 10.28 24 102421 132 63386445
Muscle injury 85.25 10.28 5 102440 65340 63321237
Toxic encephalopathy 84.23 10.28 76 102369 6503 63380074
Post lumbar puncture syndrome 83.58 10.28 33 102412 583 63385994
Malignant neoplasm progression 82.75 10.28 16 102429 82105 63304472
Implant site swelling 82.32 10.28 31 102414 479 63386098
Alopecia 81.39 10.28 276 102169 337260 63049317
Device kink 80.96 10.28 47 102398 2007 63384570
Urinary incontinence 80.67 10.28 167 102278 31847 63354730
Progressive multifocal leukoencephalopathy 80.51 10.28 102 102343 12869 63373708
Discomfort 80.24 10.28 91 102354 167283 63219294
Gastrooesophageal reflux disease 76.82 10.28 332 102113 95307 63291270
Encephalopathy 74.38 10.28 181 102264 38439 63348138
Medical device site discharge 73.95 10.28 16 102429 20 63386557
Neutropenia 72.68 10.28 106 102339 174899 63211678
Sleep disorder due to general medical condition, insomnia type 71.28 10.28 3 102442 52214 63334363
Implant site pain 71.02 10.28 46 102399 2394 63384183
Depression 70.84 10.28 551 101894 195941 63190636
Device malfunction 70.27 10.28 113 102332 17744 63368833
Lethargy 69.79 10.28 224 102221 55783 63330794
Insomnia 69.17 10.28 588 101857 214664 63171913
Thrombocytopenia 67.34 10.28 87 102358 151070 63235507
Respiratory depression 67.03 10.28 96 102349 13619 63372958
Medical device site swelling 66.86 10.28 14 102431 13 63386564
Lower respiratory tract infection 66.66 10.28 69 102376 132238 63254339
Pancytopenia 66.14 10.28 37 102408 96896 63289681
Underdose 65.43 10.28 140 102305 27316 63359261
Off label use 65.43 10.28 735 101710 673727 62712850
Device inversion 65.17 10.28 12 102433 0 63386577
Muscle rigidity 64.46 10.28 86 102359 11414 63375163
Peroneal nerve palsy 64.17 10.28 57 102388 4778 63381799
Paraesthesia 63.27 10.28 452 101993 156514 63230063
Blister 62.84 10.28 70 102375 129744 63256833
Peripheral swelling 62.35 10.28 220 102225 265722 63120855
Immune reconstitution inflammatory syndrome 62.10 10.28 62 102383 6022 63380555
JC polyomavirus test positive 61.96 10.28 35 102410 1418 63385159
Neuralgia 61.55 10.28 132 102313 25794 63360783
Asphyxia 61.27 10.28 62 102383 6119 63380458
Arthralgia 61.24 10.28 606 101839 569104 62817473
Medical device site erythema 60.65 10.28 13 102432 15 63386562
Trigeminal neuralgia 60.15 10.28 48 102397 3471 63383106
Device dislocation 60.03 10.28 130 102315 25575 63361002
Therapy non-responder 59.81 10.28 262 102183 75639 63310938
Dyspnoea 59.36 10.28 733 101712 660580 62725997
Lymphopenia 58.92 10.28 106 102339 18221 63368356
Neurogenic bladder 58.71 10.28 46 102399 3239 63383338
Liver injury 58.48 10.28 13 102432 60507 63326070
Hepatic enzyme increased 58.42 10.28 152 102293 202176 63184401
Interstitial lung disease 58.42 10.28 14 102431 61894 63324683
Treatment failure 57.12 10.28 150 102295 198893 63187684
Optic neuritis 55.01 10.28 68 102377 8367 63378210
Paraparesis 54.90 10.28 38 102407 2210 63384367
Acute kidney injury 53.37 10.28 231 102214 263184 63123393
Concussion 53.16 10.28 70 102375 9174 63377403
Status epilepticus 52.72 10.28 91 102354 15142 63371435
Magnetic resonance imaging abnormal 52.56 10.28 42 102403 3043 63383534
Dystonia 52.41 10.28 86 102359 13733 63372844
Wound dehiscence 51.96 10.28 51 102394 4852 63381725
Urosepsis 51.89 10.28 101 102344 18423 63368154
Hallucination 50.87 10.28 199 102246 54618 63331959
General physical health deterioration 50.33 10.28 162 102283 201240 63185337
Agitation 49.94 10.28 210 102235 59547 63327030
Mucosal inflammation 49.76 10.28 8 102437 46920 63339657
Drug delivery device placement 49.72 10.28 15 102430 111 63386466
Generalised tonic-clonic seizure 49.61 10.28 130 102315 28886 63357691
Neurotoxicity 49.26 10.28 94 102351 16896 63369681
Flushing 48.75 10.28 245 102200 74842 63311735
Hyporeflexia 48.56 10.28 33 102412 1862 63384715
Speech disorder 48.36 10.28 160 102285 40469 63346108
Hypersensitivity 48.21 10.28 276 102169 292409 63094168
Sedation 48.14 10.28 155 102290 38654 63347923
Psoriatic arthropathy 48.07 10.28 46 102399 91474 63295103
Hypokinesia 47.90 10.28 83 102362 13853 63372724
Escherichia urinary tract infection 47.48 10.28 76 102369 11886 63374691
Diplopia 46.53 10.28 112 102333 23616 63362961
Metabolic encephalopathy 46.48 10.28 52 102393 5757 63380820
Focal dyscognitive seizures 46.03 10.28 38 102407 2883 63383694
Areflexia 45.91 10.28 39 102406 3079 63383498
Medical device site fibrosis 45.58 10.28 9 102436 4 63386573
Device connection issue 45.22 10.28 22 102423 653 63385924
Clonus 45.04 10.28 46 102399 4590 63381987
Respiratory arrest 44.76 10.28 135 102310 32510 63354067
Paralysis 43.62 10.28 66 102379 9834 63376743
Laboratory test abnormal 43.41 10.28 118 102327 26794 63359783
Pleural effusion 43.22 10.28 52 102393 93158 63293419
Scoliosis 42.70 10.28 58 102387 7830 63378747
Device alarm issue 42.47 10.28 28 102417 1502 63385075
Burning sensation 42.24 10.28 187 102258 54220 63332357
Ankle fracture 41.35 10.28 90 102355 17765 63368812
Gait spastic 41.31 10.28 16 102429 268 63386309
Muscle twitching 40.92 10.28 95 102350 19573 63367004
Pocket erosion 40.91 10.28 8 102437 3 63386574
Feeling abnormal 40.79 10.28 392 102053 148000 63238577
Loss of consciousness 40.74 10.28 328 102117 117793 63268784
Red blood cells urine positive 39.80 10.28 36 102409 3090 63383487
Pulmonary fibrosis 39.59 10.28 8 102437 39801 63346776
Motor dysfunction 39.50 10.28 66 102379 10695 63375882
Irritable bowel syndrome 39.26 10.28 45 102400 82367 63304210
Infusion site mass 39.23 10.28 30 102415 2038 63384539
C-reactive protein abnormal 38.72 10.28 13 102432 46083 63340494
Gait inability 38.11 10.28 178 102267 52781 63333796
Gastrointestinal haemorrhage 37.94 10.28 45 102400 81131 63305446
Implant site haematoma 37.76 10.28 11 102434 71 63386506
Wheezing 37.64 10.28 60 102385 95535 63291042
Urine leukocyte esterase positive 37.50 10.28 37 102408 3542 63383035
Depressed level of consciousness 37.14 10.28 198 102247 61880 63324697
Cardiac failure 36.97 10.28 54 102391 89088 63297489
Ataxia 36.80 10.28 78 102367 15117 63371460
Intracranial hypotension 36.80 10.28 15 102430 289 63386288
Device leakage 36.64 10.28 51 102394 7045 63379532
Soft tissue injury 35.89 10.28 26 102419 1626 63384951
Implant site erythema 35.49 10.28 18 102427 585 63385992
Cough 35.42 10.28 302 102143 292441 63094136
Blood cholesterol increased 35.19 10.28 61 102384 93971 63292606
Knee arthroplasty 35.12 10.28 22 102423 54184 63332393
Decreased appetite 35.03 10.28 249 102196 250803 63135774
Electroencephalogram abnormal 34.89 10.28 36 102409 3636 63382941
Myoclonus 34.51 10.28 78 102367 15790 63370787
COVID-19 34.21 10.28 305 102140 112798 63273779
Dysphagia 33.88 10.28 252 102193 88333 63298244
Nasopharyngitis 33.65 10.28 256 102189 254001 63132576
Bone marrow failure 33.39 10.28 4 102441 29286 63357291
Urinary sediment present 33.35 10.28 28 102417 2175 63384402
Osteonecrosis of jaw 33.02 10.28 8 102437 35115 63351462
Hostility 32.99 10.28 26 102419 1846 63384731
Stomatitis 32.98 10.28 114 102331 138611 63247966
Arteriosclerosis coronary artery 32.96 10.28 53 102392 8320 63378257
Temperature intolerance 32.93 10.28 55 102390 8909 63377668
Sensory disturbance 32.90 10.28 70 102375 13602 63372975
Device expulsion 32.74 10.28 8 102437 34914 63351663
Nystagmus 32.56 10.28 45 102400 6175 63380402
Renal impairment 32.44 10.28 58 102387 88297 63298280
Device occlusion 32.20 10.28 49 102396 7338 63379239
Hepatic function abnormal 32.04 10.28 10 102435 37132 63349445
Impaired healing 31.96 10.28 74 102371 102468 63284109
Ascites 31.67 10.28 13 102432 40715 63345862
Abdominal pain 31.48 10.28 312 102133 293144 63093433
Muscle atrophy 31.15 10.28 47 102398 6986 63379591
Libido increased 31.13 10.28 22 102423 1323 63385254
White blood cells urine positive 31.12 10.28 40 102405 5118 63381459
Musculoskeletal stiffness 30.79 10.28 443 102002 184175 63202402
Nitrite urine present 30.79 10.28 20 102425 1046 63385531
Hemiparesis 30.72 10.28 95 102350 23187 63363390
Medical device site discomfort 30.69 10.28 13 102432 277 63386300
Migraine 30.39 10.28 277 102168 103069 63283508
Blood creatinine increased 30.20 10.28 60 102385 87784 63298793
Micturition urgency 30.14 10.28 55 102390 9556 63377021
Toxic epidermal necrolysis 30.05 10.28 3 102442 25331 63361246
Expanded disability status scale score increased 29.95 10.28 16 102429 580 63385997
Vitamin D deficiency 29.89 10.28 68 102377 13824 63372753
Incision site oedema 29.72 10.28 7 102438 16 63386561
Monocyte percentage increased 29.44 10.28 20 102425 1128 63385449
Neoplasm progression 29.36 10.28 11 102434 36417 63350160
Disease progression 29.10 10.28 101 102344 122657 63263920
Skin reaction 29.02 10.28 70 102375 14779 63371798
Device computer issue 28.79 10.28 9 102436 76 63386501
Dysstasia 28.52 10.28 87 102358 21079 63365498
Hepatotoxicity 28.51 10.28 12 102433 37029 63349548
Gastrointestinal disorder 28.47 10.28 112 102333 131127 63255450
Basal ganglion degeneration 28.21 10.28 14 102431 434 63386143
Type 2 diabetes mellitus 28.18 10.28 37 102408 63831 63322746
Coordination abnormal 28.07 10.28 66 102379 13707 63372870
Platelet count decreased 27.89 10.28 95 102350 116027 63270550
Bladder disorder 27.81 10.28 51 102394 8895 63377682
Device issue 27.72 10.28 93 102352 23688 63362889
Atrial fibrillation 27.62 10.28 96 102349 116540 63270037
Myelosuppression 27.62 10.28 3 102442 23700 63362877
Dysarthria 27.46 10.28 139 102306 42572 63344005
Rheumatoid arthritis 27.16 10.28 270 102175 253549 63133028
Incoherent 27.13 10.28 35 102410 4495 63382082
Ill-defined disorder 27.12 10.28 57 102388 81698 63304879
Thyroid disorder 27.02 10.28 69 102376 15093 63371484
Sinusitis 26.87 10.28 235 102210 226418 63160159
Vision blurred 26.83 10.28 246 102199 91678 63294899
Haemoglobin decreased 26.81 10.28 132 102313 145353 63241224
Disorientation 26.50 10.28 130 102315 39322 63347255
Neutrophil percentage increased 26.43 10.28 28 102417 2915 63383662
Tissue infiltration 26.41 10.28 15 102430 614 63385963
Medical device discomfort 26.01 10.28 23 102422 1916 63384661
Anxiety 25.92 10.28 494 101951 217047 63169530
Dysaesthesia 25.89 10.28 34 102411 4444 63382133
Renal failure 25.78 10.28 100 102345 117552 63269025
Muscle contracture 25.74 10.28 20 102425 1391 63385186
Urinary retention 25.71 10.28 107 102338 30194 63356383
Intentional product use issue 25.35 10.28 113 102332 127779 63258798
Medical device site erosion 25.09 10.28 6 102439 15 63386562
Cognitive disorder 24.99 10.28 165 102280 55650 63330927
Pollakiuria 24.77 10.28 100 102345 27837 63358740
Post-traumatic neck syndrome 24.68 10.28 23 102422 2051 63384526
Aphasia 24.54 10.28 112 102333 32888 63353689
Monoplegia 24.50 10.28 28 102417 3173 63383404
Culture urine positive 24.49 10.28 30 102415 3657 63382920
Palmar-plantar erythrodysaesthesia syndrome 24.23 10.28 4 102441 23011 63363566
Dyskinesia 24.09 10.28 109 102336 31893 63354684
Neurogenic bowel 24.08 10.28 9 102436 136 63386441
Implant site reaction 23.90 10.28 9 102436 139 63386438
Band neutrophil count increased 23.86 10.28 12 102433 383 63386194
Asthenia 23.86 10.28 798 101647 382806 63003771
Loss of control of legs 23.77 10.28 19 102426 1377 63385200
Disturbance in attention 23.66 10.28 123 102322 38066 63348511
Dyspnoea exertional 23.59 10.28 38 102407 60264 63326313
Injury 23.52 10.28 52 102393 73195 63313382
Sternal fracture 23.06 10.28 23 102422 2231 63384346
Premature delivery 23.00 10.28 10 102435 30271 63356306
Implant site scar 22.94 10.28 11 102434 316 63386261
Lymphocyte percentage decreased 22.66 10.28 26 102419 2959 63383618
Cardiac failure congestive 22.62 10.28 75 102370 92358 63294219
Primary progressive multiple sclerosis 22.37 10.28 8 102437 106 63386471
Upper airway obstruction 22.32 10.28 14 102431 689 63385888
Pulmonary renal syndrome 22.29 10.28 12 102433 442 63386135
Hyperhidrosis 22.23 10.28 269 102176 107567 63279010
Limb discomfort 22.21 10.28 101 102344 29615 63356962
Hypercalcaemia 22.08 10.28 9 102436 28313 63358264
Poisoning 22.02 10.28 60 102385 13640 63372937
Drug resistance 22.00 10.28 5 102440 22928 63363649
Consciousness fluctuating 21.98 10.28 15 102430 852 63385725
Multiple organ dysfunction syndrome 21.98 10.28 36 102409 56716 63329861
Spinal operation 21.84 10.28 44 102401 8227 63378350
Haematochezia 21.65 10.28 33 102412 53511 63333066
Colitis microscopic 21.54 10.28 47 102398 9292 63377285
Bacterial test positive 21.45 10.28 34 102411 5273 63381304
Device programming error 21.34 10.28 8 102437 122 63386455
Quadriparesis 21.30 10.28 21 102424 2008 63384569
Inadequate analgesia 21.28 10.28 25 102420 2918 63383659
Amnesia 21.18 10.28 158 102287 55427 63331150
Metastases to liver 21.05 10.28 6 102439 23633 63362944
B-lymphocyte count decreased 21.04 10.28 16 102429 1078 63385499
Post procedural complication 21.00 10.28 68 102377 17006 63369571
Proteinuria 20.90 10.28 3 102442 19142 63367435
Invasive ductal breast carcinoma 20.79 10.28 39 102406 6919 63379658
Therapeutic response unexpected 20.67 10.28 72 102373 18687 63367890
Enthesopathy 20.61 10.28 44 102401 8570 63378007
Nephrolithiasis 20.57 10.28 127 102318 41857 63344720
Erythema 20.48 10.28 183 102262 175568 63211009
Seroma 20.44 10.28 21 102424 2110 63384467
Therapeutic response decreased 20.21 10.28 169 102276 61356 63325221
Melaena 20.12 10.28 12 102433 30353 63356224
Abnormal behaviour 20.05 10.28 78 102367 21348 63365229
Bacterial test 20.04 10.28 16 102429 1158 63385419
Anaesthesia 19.97 10.28 11 102434 424 63386153
Conversion disorder 19.92 10.28 19 102426 1745 63384832
Injection site scar 19.82 10.28 15 102430 1003 63385574
Back pain 19.73 10.28 562 101883 263583 63122994
Stress 19.72 10.28 180 102265 66987 63319590
Bladder spasm 19.70 10.28 19 102426 1769 63384808
Hypersomnia 19.64 10.28 69 102376 17986 63368591
Irritability 19.57 10.28 102 102343 31592 63354985
Medical device site cellulitis 19.49 10.28 4 102441 3 63386574
Anal incontinence 19.42 10.28 57 102388 13519 63373058
Band neutrophil percentage increased 19.42 10.28 9 102436 239 63386338
Hypothermia 19.41 10.28 57 102388 13524 63373053
Relapsing-remitting multiple sclerosis 19.36 10.28 12 102433 578 63385999
Tonic clonic movements 19.21 10.28 17 102428 1418 63385159
Epistaxis 19.21 10.28 57 102388 72668 63313909
Abdominal pain upper 19.11 10.28 227 102218 206217 63180360
Incorrect route of product administration 18.82 10.28 91 102354 27361 63359216
Bladder dysfunction 18.71 10.28 14 102431 920 63385657
Frontotemporal dementia 18.71 10.28 10 102435 363 63386214
Psychogenic seizure 18.68 10.28 18 102427 1674 63384903
Hyperkalaemia 18.64 10.28 37 102408 54166 63332411
Staphylococcal infection 18.49 10.28 122 102323 41134 63345443
Visual impairment 18.44 10.28 213 102232 84233 63302344
Neurological decompensation 18.40 10.28 22 102423 2616 63383961
Urinary tract infection bacterial 18.25 10.28 31 102414 5091 63381486
Thyroxine decreased 18.25 10.28 12 102433 641 63385936
Hypoglycaemia 18.19 10.28 44 102401 60021 63326556
Intervertebral disc disorder 18.17 10.28 30 102415 4813 63381764
Hypomagnesaemia 18.16 10.28 12 102433 28725 63357852
Drug eruption 18.10 10.28 12 102433 28682 63357895
Device extrusion 18.07 10.28 5 102440 26 63386551
Pseudomeningocele 18.07 10.28 4 102441 6 63386571
Metabolic acidosis 18.01 10.28 28 102417 45041 63341536
Movement disorder 17.99 10.28 76 102369 21585 63364992
Rash maculo-papular 17.98 10.28 15 102430 31881 63354696
Alcohol withdrawal syndrome 17.93 10.28 13 102432 814 63385763
Stevens-Johnson syndrome 17.78 10.28 9 102436 24941 63361636
Urobilinogen urine increased 17.73 10.28 9 102436 293 63386284
Bradypnoea 17.57 10.28 25 102420 3525 63383052
Myelocyte percentage increased 17.49 10.28 8 102437 206 63386371
Sleep apnoea syndrome 17.47 10.28 93 102352 29040 63357537
Back disorder 17.46 10.28 48 102397 10969 63375608
Cytomegalovirus infection 17.44 10.28 6 102439 20946 63365631
Rectal haemorrhage 17.27 10.28 33 102412 48997 63337580
Persistent depressive disorder 17.26 10.28 14 102431 1036 63385541
Adverse event 17.09 10.28 54 102391 67505 63319072
Intentional overdose 17.08 10.28 189 102256 73963 63312614
Major depression 16.97 10.28 39 102406 7979 63378598
Uterine enlargement 16.93 10.28 15 102430 1253 63385324
Poisoning deliberate 16.92 10.28 48 102397 11170 63375407
Hip arthroplasty 16.84 10.28 32 102413 47614 63338963
Therapy cessation 16.77 10.28 95 102350 30362 63356215
Neuromuscular toxicity 16.57 10.28 7 102438 148 63386429
Agranulocytosis 16.56 10.28 10 102435 25124 63361453
Neutrophil count decreased 16.55 10.28 42 102403 56364 63330213
Hypervolaemia 16.47 10.28 13 102432 28400 63358177
Rash pruritic 16.43 10.28 46 102399 59753 63326824
Cholestasis 16.40 10.28 14 102431 29420 63357157
Urinary tract infection enterococcal 16.31 10.28 21 102424 2692 63383885
Implant site ulcer 16.29 10.28 3 102442 0 63386577
Medical device site bruise 16.29 10.28 3 102442 0 63386577
Injection site necrosis 16.18 10.28 15 102430 1329 63385248
Neuropsychiatric syndrome 16.13 10.28 5 102440 41 63386536
Head injury 16.12 10.28 87 102358 27309 63359268
CD8 lymphocytes decreased 16.03 10.28 7 102438 161 63386416
Urine oxalate increased 15.95 10.28 8 102437 254 63386323
Posturing 15.94 10.28 10 102435 492 63386085
Poor quality sleep 15.83 10.28 69 102376 19866 63366711
Intervertebral disc protrusion 15.83 10.28 78 102367 23631 63362946
Neurosis 15.78 10.28 8 102437 260 63386317
Acute hepatic failure 15.69 10.28 5 102440 18322 63368255
Haemoglobin increased 15.63 10.28 24 102421 3622 63382955
Oedema 15.53 10.28 93 102352 97529 63289048
Foot fracture 15.49 10.28 78 102367 23836 63362741
Glaucoma 15.45 10.28 66 102379 18839 63367738
Reflexes abnormal 15.44 10.28 11 102434 670 63385907
CD4 lymphocytes decreased 15.41 10.28 15 102430 1412 63385165
Frequent bowel movements 15.39 10.28 9 102436 23013 63363564
Urinary tract infection pseudomonal 15.36 10.28 12 102433 841 63385736
Meningitis 15.29 10.28 35 102410 7142 63379435
Confusional state 15.25 10.28 494 101951 235886 63150691
Pulmonary oedema 15.23 10.28 42 102403 54831 63331746
Retinal depigmentation 15.10 10.28 8 102437 285 63386292
Eosinophilia 15.07 10.28 9 102436 22747 63363830
Colitis ulcerative 15.04 10.28 12 102433 26079 63360498
Lipoedema 14.97 10.28 8 102437 290 63386287
Liver disorder 14.97 10.28 41 102404 53646 63332931
Intraductal proliferative breast lesion 14.96 10.28 21 102424 2924 63383653
Lymphocyte count abnormal 14.96 10.28 11 102434 704 63385873
Pneumonitis 14.93 10.28 21 102424 35201 63351376
Abnormal dreams 14.90 10.28 44 102401 10472 63376105
Hypochromic anaemia 14.88 10.28 17 102428 1925 63384652
Injection site infection 14.88 10.28 17 102428 1926 63384651
Invasive lobular breast carcinoma 14.85 10.28 12 102433 883 63385694
Suicidal ideation 14.79 10.28 160 102285 62261 63324316
Pregnancy 14.61 10.28 23 102422 36813 63349764
Intentional self-injury 14.58 10.28 12 102433 25675 63360902
Bronchiectasis 14.56 10.28 4 102441 16138 63370439
T-lymphocyte count decreased 14.53 10.28 8 102437 308 63386269
Intestinal polyp 14.49 10.28 15 102430 1520 63385057
Noninfective encephalitis 14.49 10.28 9 102436 435 63386142
Chronic fatigue syndrome 14.48 10.28 13 102432 1105 63385472
Product dose omission issue 14.43 10.28 487 101958 233826 63152751
Needle fatigue 14.42 10.28 6 102439 122 63386455
Injection site mass 14.38 10.28 64 102381 18592 63367985
Metastases to bone 14.36 10.28 8 102437 21011 63365566
Injection site ulcer 14.35 10.28 10 102435 588 63385989
Nausea 14.34 10.28 1186 101259 853285 62533292
Macular degeneration 14.32 10.28 11 102434 24365 63362212
Productive cough 14.31 10.28 53 102392 63155 63323422
Medical device site scar 14.22 10.28 3 102442 3 63386574
Quadriplegia 14.21 10.28 16 102429 1784 63384793
Autonomic nervous system imbalance 14.17 10.28 20 102425 2798 63383779
Rotator cuff syndrome 14.17 10.28 51 102394 13451 63373126
Stiff person syndrome 14.17 10.28 8 102437 324 63386253
Pupil fixed 14.14 10.28 16 102429 1793 63384784
Euphoric mood 14.12 10.28 27 102418 4860 63381717
Urine osmolarity increased 14.07 10.28 6 102439 130 63386447
Decreased vibratory sense 14.01 10.28 8 102437 331 63386246
Infection 13.99 10.28 273 102172 228900 63157677
Cytokine release syndrome 13.98 10.28 3 102442 14311 63372266
Pneumocystis jirovecii pneumonia 13.81 10.28 5 102440 16909 63369668
Apnoea 13.77 10.28 36 102409 7986 63378591
Cerebral vasoconstriction 13.62 10.28 13 102432 1195 63385382
Lung disorder 13.58 10.28 53 102392 62208 63324369
Paraplegia 13.49 10.28 19 102426 2653 63383924
Neck pain 13.46 10.28 171 102274 69147 63317430
Narcotic bowel syndrome 13.39 10.28 6 102439 147 63386430
Myelocyte count increased 13.36 10.28 8 102437 362 63386215
Medical device site extravasation 13.36 10.28 3 102442 5 63386572
Road traffic accident 13.32 10.28 103 102342 36529 63350048
Feeling hot 13.32 10.28 132 102313 50222 63336355
International normalised ratio increased 13.29 10.28 35 102410 46390 63340187
Sports injury 13.21 10.28 4 102441 30 63386547
Cerebral palsy 13.21 10.28 6 102439 152 63386425
Pre-existing condition improved 13.15 10.28 36 102409 8208 63378369
Hallucinations, mixed 13.12 10.28 26 102419 4803 63381774
Incontinence 13.12 10.28 45 102400 11587 63374990
Hyperaesthesia 13.11 10.28 39 102406 9319 63377258
Pancreatitis chronic 13.05 10.28 18 102427 2466 63384111
Creatinine renal clearance decreased 13.01 10.28 5 102440 16303 63370274
Congenital megacolon 13.01 10.28 3 102442 6 63386571
Hepatitis 12.97 10.28 28 102417 39760 63346817
Weight increased 12.95 10.28 321 102124 260471 63126106
Product use in unapproved indication 12.94 10.28 207 102238 178873 63207704
Incorrect drug administration rate 12.84 10.28 23 102422 3939 63382638
Cataract 12.81 10.28 48 102397 57005 63329572
Inguinal hernia 12.80 10.28 16 102429 1991 63384586
Drug interaction 12.79 10.28 277 102168 228854 63157723
Nightmare 12.71 10.28 63 102382 19131 63367446
Red blood cell sedimentation rate increased 12.71 10.28 33 102412 43949 63342628
Medical device site reaction 12.69 10.28 3 102442 7 63386570
Angina pectoris 12.68 10.28 18 102427 30060 63356517
Craniocerebral injury 12.65 10.28 19 102426 2813 63383764
Middle insomnia 12.63 10.28 47 102398 12596 63373981
Right ventricular failure 12.55 10.28 6 102439 17182 63369395
Cardio-respiratory arrest 12.54 10.28 150 102295 59809 63326768
Glycosylated haemoglobin decreased 12.51 10.28 9 102436 557 63386020
Postoperative delirium 12.48 10.28 5 102440 92 63386485
Joint effusion 12.39 10.28 6 102439 17054 63369523
Hyponatraemia 12.39 10.28 118 102327 111782 63274795
Occupational dermatitis 12.29 10.28 4 102441 39 63386538
Aspiration 12.26 10.28 42 102403 10809 63375768
Pulmonary hypertension 12.21 10.28 26 102419 37097 63349480
Urticaria 12.20 10.28 191 102254 165611 63220966
Altered state of consciousness 12.16 10.28 76 102369 25154 63361423
Enlarged uvula 12.15 10.28 6 102439 184 63386393
Cystitis 12.14 10.28 139 102306 54852 63331725
Fibromyalgia 12.08 10.28 78 102367 80342 63306235
Tibia fracture 12.07 10.28 26 102419 5094 63381483
Increased tendency to bruise 12.06 10.28 41 102404 10511 63376066
Bladder catheterisation 11.99 10.28 7 102438 302 63386275
Clubbing 11.99 10.28 8 102437 438 63386139
Specific gravity urine decreased 11.96 10.28 10 102435 772 63385805
Automatic bladder 11.96 10.28 5 102440 103 63386474
Klebsiella test positive 11.94 10.28 12 102433 1175 63385402
Macular oedema 11.92 10.28 22 102423 3855 63382722
Acquired diaphragmatic eventration 11.89 10.28 8 102437 444 63386133
Crystal urine present 11.87 10.28 14 102431 1640 63384937
Demyelination 11.82 10.28 31 102414 6889 63379688
Dysuria 11.79 10.28 94 102351 33644 63352933
Therapeutic product effect incomplete 11.76 10.28 137 102308 124919 63261658
Botulism 11.75 10.28 6 102439 198 63386379
Vitamin B6 deficiency 11.74 10.28 5 102440 108 63386469
Eye movement disorder 11.70 10.28 26 102419 5202 63381375
Neutralising antibodies 11.70 10.28 4 102441 46 63386531
Crying 11.68 10.28 71 102374 23272 63363305
CSF test abnormal 11.64 10.28 7 102438 319 63386258
Hypoxic-ischaemic encephalopathy 11.55 10.28 23 102422 4264 63382313
Medical device change 11.55 10.28 7 102438 324 63386253
Mechanical urticaria 11.52 10.28 8 102437 468 63386109
Infusion site macule 11.48 10.28 3 102442 12 63386565
CSF culture positive 11.48 10.28 3 102442 12 63386565
Injection site atrophy 11.48 10.28 9 102436 634 63385943
Brain injury 11.48 10.28 31 102414 7012 63379565
Premature labour 11.46 10.28 3 102442 12501 63374076
Premature baby 11.38 10.28 10 102435 20725 63365852
Dehydration 11.35 10.28 204 102241 173150 63213427
Haemoptysis 11.33 10.28 18 102427 28708 63357869
Delirium 11.26 10.28 128 102317 50413 63336164
Optic atrophy 11.20 10.28 12 102433 1266 63385311
Spinal cord disorder 11.17 10.28 12 102433 1269 63385308
Prescribed overdose 11.16 10.28 24 102421 34129 63352448
Citrobacter test positive 11.11 10.28 3 102442 14 63386563
Blood potassium increased 11.09 10.28 8 102437 18301 63368276
Implant site fibrosis 11.07 10.28 6 102439 224 63386353
Intervertebral disc operation 11.07 10.28 10 102435 857 63385720
Tender joint count 11.05 10.28 6 102439 225 63386352
Incision site swelling 11.05 10.28 6 102439 225 63386352
Hypervigilance 11.04 10.28 7 102438 351 63386226
Affective disorder 10.98 10.28 28 102417 6118 63380459
Obstructive defaecation 10.94 10.28 3 102442 15 63386562
Personality disorder 10.93 10.28 27 102418 5784 63380793
CSF protein increased 10.87 10.28 8 102437 513 63386064
Catatonia 10.86 10.28 23 102422 4454 63382123
Hyporesponsive to stimuli 10.81 10.28 11 102434 1093 63385484
Respiratory rate decreased 10.80 10.28 20 102425 3515 63383062
Device breakage 10.78 10.28 42 102403 11500 63375077
Implant site dehiscence 10.78 10.28 3 102442 16 63386561
Rash erythematous 10.74 10.28 34 102411 42476 63344101
Blood pressure diastolic abnormal 10.74 10.28 5 102440 14537 63372040
Pancreatitis acute 10.74 10.28 17 102428 27149 63359428
Decreased interest 10.69 10.28 19 102426 3235 63383342
Hyperlipasaemia 10.66 10.28 9 102436 704 63385873
Meningioma 10.66 10.28 21 102424 3864 63382713
Miosis 10.64 10.28 31 102414 7322 63379255
Blood bilirubin increased 10.63 10.28 28 102417 37112 63349465
Spinal stenosis 10.61 10.28 50 102395 14875 63371702
Metastases to central nervous system 10.49 10.28 4 102441 13101 63373476
Viral titre decreased 10.48 10.28 3 102442 18 63386559
Tremor neonatal 10.45 10.28 5 102440 143 63386434
Migraine without aura 10.44 10.28 7 102438 386 63386191
Mean platelet volume increased 10.43 10.28 8 102437 546 63386031
Hyperpyrexia 10.41 10.28 20 102425 3612 63382965
Lip dry 10.41 10.28 6 102439 15464 63371113
Asthma 10.41 10.28 144 102301 127417 63259160
Neutrophil percentage abnormal 10.35 10.28 3 102442 19 63386558
Hepatic cytolysis 10.33 10.28 6 102439 15401 63371176
Abdominal symptom 10.33 10.28 7 102438 393 63386184
Psychotic disorder 10.31 10.28 74 102371 25638 63360939

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 1553.80 11.20 732 59115 19102 34877982
Muscle spasticity 1313.10 11.20 461 59386 5427 34891657
Implant site infection 784.11 11.20 210 59637 880 34896204
Implant site extravasation 635.23 11.20 146 59701 261 34896823
Multiple sclerosis relapse 500.42 11.20 300 59547 12833 34884251
Device failure 428.13 11.20 159 59688 2217 34894867
Multiple sclerosis 402.34 11.20 206 59641 6439 34890645
Muscle spasms 388.81 11.20 556 59291 74445 34822639
Coma 325.41 11.20 396 59451 45282 34851802
Overdose 305.69 11.20 554 59293 90505 34806579
Complication associated with device 292.38 11.20 161 59686 5845 34891239
Hypertonia 269.75 11.20 136 59711 4110 34892974
Urinary tract infection 266.34 11.20 499 59348 83582 34813502
Hypotonia 259.85 11.20 164 59683 7689 34889395
Mental status changes 254.82 11.20 320 59527 37763 34859321
Therapy non-responder 254.12 11.20 324 59523 38822 34858262
Cerebrospinal fluid leakage 234.37 11.20 70 59777 466 34896618
Device infusion issue 227.04 11.20 77 59770 808 34896276
Implant site erosion 224.71 11.20 47 59800 38 34897046
Implant site swelling 205.46 11.20 43 59804 35 34897049
Medical device site infection 202.59 11.20 55 59792 245 34896839
Withdrawal syndrome 198.22 11.20 167 59680 12288 34884796
Device kink 196.03 11.20 58 59789 372 34896712
Device physical property issue 191.15 11.20 67 59780 782 34896302
Respiratory depression 171.20 11.20 173 59674 16072 34881012
Toxicity to various agents 168.67 11.20 734 59113 199628 34697456
Device power source issue 163.69 11.20 49 59798 329 34896755
Somnolence 160.82 11.20 486 59361 110630 34786454
Medical device site swelling 160.23 11.20 31 59816 7 34897077
Implant site pain 159.04 11.20 38 59809 87 34896997
Muscle tightness 156.59 11.20 100 59747 4784 34892300
Pocket erosion 144.99 11.20 28 59819 6 34897078
Medical device site discharge 137.29 11.20 27 59820 9 34897075
Implant site discharge 134.28 11.20 26 59821 6 34897078
Therapeutic response decreased 132.48 11.20 204 59643 29109 34867975
Seizure 130.96 11.20 436 59411 104421 34792663
Wound dehiscence 126.99 11.20 76 59771 3235 34893849
Completed suicide 126.89 11.20 413 59434 97755 34799329
Febrile neutropenia 123.90 11.20 40 59807 136809 34760275
Implant site erythema 121.20 11.20 26 59821 27 34897057
Anaemia 119.70 11.20 134 59713 233201 34663883
Medical device site erythema 116.10 11.20 24 59823 17 34897067
Clonus 115.65 11.20 67 59780 2683 34894401
Device dislocation 114.56 11.20 91 59756 6158 34890926
Unresponsive to stimuli 112.34 11.20 183 59664 27386 34869698
Sedation 108.99 11.20 156 59691 20850 34876234
Diarrhoea 104.60 11.20 332 59515 389580 34507504
Gait disturbance 101.82 11.20 349 59498 84791 34812293
Toxic encephalopathy 101.75 11.20 79 59768 5170 34891914
Encephalopathy 101.08 11.20 201 59646 35118 34861966
Medical device site erosion 100.39 11.20 21 59826 17 34897067
Medical device site pain 100.13 11.20 24 59823 56 34897028
Gait spastic 99.87 11.20 45 59802 1051 34896033
Decubitus ulcer 99.50 11.20 98 59749 8823 34888261
Device issue 99.14 11.20 102 59745 9675 34887409
Relapsing-remitting multiple sclerosis 95.33 11.20 43 59804 1007 34896077
Fall 90.73 11.20 626 59221 202259 34694825
Device alarm issue 90.61 11.20 36 59811 608 34896476
Pain 87.12 11.20 624 59223 204051 34693033
Neutropenia 87.11 11.20 84 59763 156694 34740390
Neurotoxicity 86.54 11.20 129 59718 17881 34879203
Needle fatigue 86.13 11.20 38 59809 843 34896241
Device breakage 83.58 11.20 51 59796 2249 34894835
Device malfunction 81.77 11.20 95 59752 10326 34886758
Implant site scar 80.58 11.20 15 59832 0 34897084
Infusion site mass 80.56 11.20 28 59819 318 34896766
Central nervous system lesion 79.63 11.20 75 59772 6388 34890696
Intentional overdose 78.70 11.20 207 59640 43467 34853617
Underdose 78.43 11.20 107 59740 13673 34883411
Confusional state 77.39 11.20 466 59381 143694 34753390
Device connection issue 75.99 11.20 28 59819 381 34896703
Hypertonic bladder 74.65 11.20 44 59803 1820 34895264
Intracranial hypotension 73.65 11.20 24 59823 220 34896864
Cardiac failure 73.61 11.20 32 59815 91216 34805868
Movement disorder 72.59 11.20 97 59750 12151 34884933
Thrombocytopenia 71.33 11.20 98 59749 156149 34740935
Interstitial lung disease 70.88 11.20 13 59834 65269 34831815
Muscular weakness 70.45 11.20 279 59568 72618 34824466
Dyspnoea 70.04 11.20 370 59477 376412 34520672
Hypoaesthesia 69.20 11.20 247 59600 61197 34835887
Device computer issue 68.89 11.20 14 59833 8 34897076
Malignant neoplasm progression 66.22 11.20 34 59813 88012 34809072
Urinary incontinence 65.92 11.20 117 59730 18757 34878327
Victim of child abuse 65.72 11.20 32 59815 895 34896189
Neurogenic bladder 65.36 11.20 40 59807 1773 34895311
Monoparesis 65.36 11.20 44 59803 2302 34894782
Agitation 64.86 11.20 231 59616 57168 34839916
Status epilepticus 64.43 11.20 93 59754 12521 34884563
Balance disorder 62.65 11.20 182 59665 40472 34856612
Secondary progressive multiple sclerosis 62.46 11.20 24 59823 369 34896715
Bradypnoea 62.41 11.20 46 59801 2783 34894301
Acute kidney injury 60.88 11.20 292 59555 304696 34592388
Atrial fibrillation 60.78 11.20 72 59775 122321 34774763
Ataxia 59.21 11.20 94 59753 13759 34883325
Medical device site fibrosis 59.09 11.20 11 59836 0 34897084
Dystonia 58.40 11.20 82 59765 10763 34886321
Pancytopenia 57.60 11.20 47 59800 95110 34801974
Autonomic nervous system imbalance 57.45 11.20 42 59805 2509 34894575
Tremor 55.64 11.20 284 59563 82303 34814781
Death 55.41 11.20 427 59420 397622 34499462
Device occlusion 53.59 11.20 61 59786 6484 34890600
Epidural lipomatosis 53.34 11.20 29 59818 1025 34896059
Depressed level of consciousness 52.37 11.20 177 59670 42664 34854420
Renal impairment 52.03 11.20 51 59796 94462 34802622
Trigeminal neuralgia 51.83 11.20 30 59817 1199 34895885
Cardiac failure congestive 51.81 11.20 40 59807 83230 34813854
Autonomic dysreflexia 50.75 11.20 14 59833 67 34897017
Arachnoiditis 49.48 11.20 20 59827 354 34896730
Drug dependence 49.04 11.20 120 59727 24097 34872987
Platelet count decreased 48.89 11.20 81 59766 119636 34777448
Micturition urgency 48.72 11.20 58 59789 6467 34890617
Progressive multiple sclerosis 48.58 11.20 18 59829 249 34896835
Medical device site discomfort 48.35 11.20 9 59838 0 34897084
Medical device site inflammation 48.35 11.20 9 59838 0 34897084
Renal failure 48.24 11.20 94 59753 130463 34766621
Rash 47.52 11.20 208 59639 222544 34674540
Hyperkalaemia 46.21 11.20 31 59816 69358 34827726
Medical device discomfort 44.94 11.20 11 59836 29 34897055
Blood creatinine increased 44.90 11.20 58 59789 94918 34802166
Delirium 44.61 11.20 171 59676 43820 34853264
Post lumbar puncture syndrome 44.36 11.20 16 59831 204 34896880
General physical health deterioration 43.47 11.20 97 59750 128172 34768912
Implant site abscess 43.45 11.20 10 59837 18 34897066
Pneumonia aspiration 43.41 11.20 164 59683 41739 34855345
Medical device site cellulitis 42.98 11.20 8 59839 0 34897084
Urosepsis 42.97 11.20 78 59769 12721 34884363
Urinary retention 41.79 11.20 147 59700 36141 34860943
Dyskinesia 41.14 11.20 107 59740 22306 34874778
Hyperreflexia 41.02 11.20 38 59809 3168 34893916
Implant site vesicles 40.43 11.20 8 59839 3 34897081
Respiratory rate decreased 40.37 11.20 33 59814 2326 34894758
Medical device site bruise 39.74 11.20 8 59839 4 34897080
Implant site cellulitis 38.96 11.20 10 59837 34 34897050
Rheumatoid arthritis 38.63 11.20 9 59838 38229 34858855
Medical device site reaction 38.51 11.20 8 59839 6 34897078
Leukopenia 38.08 11.20 31 59816 62825 34834259
Implant site haematoma 37.25 11.20 11 59836 70 34897014
Abdominal pain 37.20 11.20 149 59698 163469 34733615
Lymphocyte percentage decreased 36.85 11.20 30 59817 2102 34894982
Medical device site haematoma 36.69 11.20 9 59838 24 34897060
Lethargy 36.22 11.20 153 59694 40969 34856115
Gastrointestinal haemorrhage 35.98 11.20 60 59787 88417 34808667
Altered state of consciousness 35.75 11.20 103 59744 22790 34874294
Brain stem syndrome 35.60 11.20 18 59829 547 34896537
Disease progression 35.58 11.20 83 59764 107994 34789090
Juvenile idiopathic arthritis 35.57 11.20 28 59819 1869 34895215
Incision site erythema 35.41 11.20 11 59836 85 34896999
Myoclonus 35.33 11.20 78 59769 14647 34882437
Insomnia 34.80 11.20 300 59547 103607 34793477
Stiff person syndrome 34.75 11.20 11 59836 91 34896993
Cough 34.59 11.20 136 59711 150004 34747080
Poisoning deliberate 34.59 11.20 54 59793 7790 34889294
Sleep apnoea syndrome 34.25 11.20 94 59753 20227 34876857
Drug interaction 33.90 11.20 237 59610 225709 34671375
Musculoskeletal stiffness 33.87 11.20 164 59683 46516 34850568
Mucosal inflammation 33.67 11.20 12 59835 38610 34858474
Infusion related reaction 33.62 11.20 25 59822 53032 34844052
Muscle twitching 33.61 11.20 62 59785 10236 34886848
Dyspnoea exertional 33.60 11.20 16 59831 43263 34853821
Dysarthria 33.47 11.20 133 59714 34649 34862435
Electroencephalogram abnormal 32.93 11.20 30 59817 2448 34894636
Sedation complication 32.83 11.20 26 59821 1751 34895333
Product prescribing error 32.80 11.20 100 59747 22827 34874257
Memory impairment 32.74 11.20 154 59693 43164 34853920
Epistaxis 32.55 11.20 31 59816 58220 34838864
Pleural effusion 32.51 11.20 56 59791 81490 34815594
Central nervous system infection 32.46 11.20 18 59829 662 34896422
Macrophages increased 32.25 11.20 12 59835 168 34896916
Alcohol poisoning 32.01 11.20 35 59812 3558 34893526
Drug delivery device placement 31.88 11.20 11 59836 122 34896962
Generalised tonic-clonic seizure 31.85 11.20 94 59753 21080 34876004
Accidental overdose 31.82 11.20 91 59756 20049 34877035
Foetal exposure during pregnancy 31.28 11.20 13 59834 38088 34858996
Purulent discharge 31.09 11.20 31 59816 2832 34894252
Apnoea 30.96 11.20 47 59800 6617 34890467
Anal incontinence 30.47 11.20 51 59796 7798 34889286
Myocardial infarction 30.29 11.20 106 59741 120979 34776105
Metabolic encephalopathy 30.17 11.20 37 59810 4255 34892829
Implant site reaction 29.96 11.20 8 59839 33 34897051
Pneumonia 29.62 11.20 440 59407 362187 34534897
CSF culture positive 29.61 11.20 7 59840 15 34897069
Decreased appetite 29.34 11.20 166 59681 166226 34730858
Pollakiuria 29.26 11.20 87 59760 19587 34877497
Depression 29.26 11.20 274 59573 96824 34800260
Lipoma 29.23 11.20 24 59823 1702 34895382
Device programming error 29.14 11.20 9 59838 68 34897016
Muscle rigidity 29.04 11.20 59 59788 10459 34886625
White blood cells urine positive 28.48 11.20 21 59826 1271 34895813
Stomatitis 28.29 11.20 19 59828 42495 34854589
Gait inability 28.27 11.20 89 59758 20669 34876415
Seroma 28.21 11.20 16 59831 615 34896469
Device extrusion 28.08 11.20 6 59841 6 34897078
Hepatic function abnormal 27.98 11.20 21 59826 44342 34852742
Seronegative arthritis 27.78 11.20 19 59828 1020 34896064
Implant site mass 27.60 11.20 6 59841 7 34897077
Multiple organ dysfunction syndrome 27.50 11.20 56 59791 76510 34820574
Device inversion 26.86 11.20 5 59842 0 34897084
Rectal haemorrhage 26.77 11.20 18 59829 40231 34856853
Meningitis 26.62 11.20 37 59810 4810 34892274
Monocyte percentage increased 26.58 11.20 18 59829 951 34896133
Ascites 25.76 11.20 25 59822 46546 34850538
Haemorrhage 25.71 11.20 30 59817 51340 34845744
White blood cell count decreased 25.62 11.20 81 59766 95364 34801720
Delirium tremens 25.57 11.20 15 59832 615 34896469
Epilepsy 25.54 11.20 88 59759 21407 34875677
Motor dysfunction 25.34 11.20 44 59803 6930 34890154
Child abuse 25.15 11.20 13 59834 414 34896670
Posturing 25.12 11.20 14 59833 520 34896564
Weight decreased 24.94 11.20 188 59659 176113 34720971
Performance status decreased 24.87 11.20 33 59814 4104 34892980
Suicide attempt 24.58 11.20 132 59715 38984 34858100
Hyperhidrosis 24.53 11.20 217 59630 75475 34821609
Pseudomeningocele 24.51 11.20 5 59842 3 34897081
Areflexia 24.39 11.20 28 59819 3003 34894081
Oedema peripheral 24.23 11.20 114 59733 119698 34777386
Patient-device incompatibility 24.20 11.20 6 59841 17 34897067
Neutrophil percentage increased 23.98 11.20 22 59825 1811 34895273
Anxiety 23.94 11.20 268 59579 99160 34797924
Implant site oedema 23.93 11.20 5 59842 4 34897080
Infusion site granuloma 23.93 11.20 5 59842 4 34897080
Hallucination 23.56 11.20 160 59687 51338 34845746
Weight increased 23.56 11.20 81 59766 92952 34804132
Miosis 23.43 11.20 51 59796 9484 34887600
Bradycardia 23.30 11.20 214 59633 75204 34821880
Device leakage 23.26 11.20 41 59806 6534 34890550
Staphylococcus test positive 23.26 11.20 28 59819 3158 34893926
Cytomegalovirus infection 22.98 11.20 8 59839 26127 34870957
Jaundice 22.95 11.20 13 59834 31869 34865215
Chronic kidney disease 22.94 11.20 22 59825 41188 34855896
Implant site dehiscence 22.93 11.20 8 59839 92 34896992
Paralysis 22.92 11.20 39 59808 6043 34891041
Myelosuppression 22.80 11.20 3 59844 19262 34877822
Electric shock 22.76 11.20 9 59838 150 34896934
Mobility decreased 22.68 11.20 107 59740 30021 34867063
Coma scale abnormal 22.62 11.20 31 59816 3977 34893107
Cystitis 22.61 11.20 51 59796 9714 34887370
Bone marrow failure 22.42 11.20 11 59836 29242 34867842
Haematochezia 22.41 11.20 28 59819 46506 34850578
Bacterial test positive 22.28 11.20 27 59820 3066 34894018
Hypoglycaemia 22.25 11.20 37 59810 54603 34842481
Device material issue 22.23 11.20 6 59841 26 34897058
Nocturia 22.18 11.20 52 59795 10158 34886926
Asphyxia 22.12 11.20 41 59806 6794 34890290
Toxic epidermal necrolysis 22.05 11.20 5 59842 21641 34875443
Magnetic resonance imaging abnormal 21.91 11.20 20 59827 1636 34895448
Muscle contractions involuntary 21.84 11.20 21 59826 1835 34895249
JC polyomavirus test positive 21.67 11.20 14 59833 683 34896401
Medical device site extravasation 21.49 11.20 4 59843 0 34897084
Catheter site erosion 21.49 11.20 4 59843 0 34897084
Infusion site fibrosis 21.49 11.20 4 59843 0 34897084
Influenza like illness 21.43 11.20 99 59748 27535 34869549
Incorrect drug administration rate 21.41 11.20 20 59827 1685 34895399
Pneumocystis jirovecii pneumonia 21.22 11.20 4 59843 19706 34877378
Chest pain 20.98 11.20 129 59718 126633 34770451
Erectile dysfunction 20.73 11.20 80 59767 20557 34876527
Neutrophil count decreased 20.45 11.20 35 59812 51069 34846015
Hypocalcaemia 20.41 11.20 8 59839 24281 34872803
Dysgeusia 20.25 11.20 10 59837 26487 34870597
Pneumonitis 20.15 11.20 17 59830 33861 34863223
Lymphadenopathy 19.92 11.20 12 59835 28451 34868633
Hepatotoxicity 19.91 11.20 6 59841 21479 34875605
Respiratory acidosis 19.85 11.20 33 59814 5017 34892067
Alcohol withdrawal syndrome 19.77 11.20 18 59829 1468 34895616
Angina pectoris 19.58 11.20 15 59832 31348 34865736
Hallucination, visual 19.56 11.20 71 59776 17720 34879364
Drug resistance 19.49 11.20 10 59837 25917 34871167
Drug eruption 19.48 11.20 5 59842 19893 34877191
Coronary artery disease 19.40 11.20 33 59814 48272 34848812
Medical device site ulcer 19.25 11.20 4 59843 3 34897081
Liver disorder 19.09 11.20 17 59830 32980 34864104
Intestinal pseudo-obstruction 19.04 11.20 19 59828 1737 34895347
Pre-existing disease 18.95 11.20 7 59840 96 34896988
Cognitive disorder 18.83 11.20 98 59749 28595 34868489
Brain injury 18.83 11.20 36 59811 6106 34890978
General symptom 18.66 11.20 14 59833 870 34896214
Chest discomfort 18.64 11.20 41 59806 54489 34842595
Posture abnormal 18.55 11.20 21 59826 2218 34894866
Urine leukocyte esterase positive 18.55 11.20 11 59836 460 34896624
Agranulocytosis 18.19 11.20 9 59838 23812 34873272
Irritability 18.09 11.20 87 59760 24603 34872481
Peroneal nerve palsy 18.07 11.20 24 59823 2987 34894097
Drug reaction with eosinophilia and systemic symptoms 17.94 11.20 18 59829 32994 34864090
Dehydration 17.70 11.20 140 59707 129829 34767255
Proteinuria 17.65 11.20 5 59842 18637 34878447
Decreased vibratory sense 17.62 11.20 10 59837 385 34896699
Therapeutic response unexpected 17.31 11.20 46 59801 9711 34887373
Tumour lysis syndrome 17.26 11.20 4 59843 17055 34880029
Euphoric mood 17.21 11.20 33 59814 5608 34891476
Hypoventilation 17.18 11.20 25 59822 3389 34893695
Hyporeflexia 17.09 11.20 19 59828 1968 34895116
Hypomagnesaemia 17.08 11.20 8 59839 21843 34875241
Road traffic accident 17.00 11.20 67 59780 17383 34879701
Wound infection staphylococcal 16.96 11.20 16 59831 1365 34895719
Haemoglobin decreased 16.96 11.20 129 59718 120643 34776441
Amnesia 16.93 11.20 90 59757 26473 34870611
Colitis 16.87 11.20 24 59823 37726 34859358
Gout 16.75 11.20 6 59841 19247 34877837
Blood ketone body increased 16.55 11.20 10 59837 433 34896651
Brief psychotic disorder with marked stressors 16.45 11.20 8 59839 223 34896861
Muscle contracture 16.41 11.20 15 59832 1229 34895855
Asthma 16.35 11.20 30 59817 42626 34854458
Neuralgia 16.35 11.20 60 59787 15053 34882031
Dysstasia 16.34 11.20 52 59795 12143 34884941
Discomfort 16.31 11.20 70 59777 18868 34878216
Glossopharyngeal nerve disorder 16.17 11.20 5 59842 38 34897046
Tachyphrenia 16.16 11.20 15 59832 1254 34895830
Implant site ulcer 16.12 11.20 3 59844 0 34897084
Medical device site oedema 16.12 11.20 3 59844 0 34897084
Neuromuscular blocking therapy 16.12 11.20 3 59844 0 34897084
Device deposit issue 16.12 11.20 3 59844 0 34897084
Incision site vesicles 16.12 11.20 3 59844 0 34897084
Unevaluable event 15.96 11.20 103 59744 32487 34864597
Haemoptysis 15.90 11.20 22 59825 34984 34862100
Bladder dysfunction 15.89 11.20 9 59838 345 34896739
Arrhythmia 15.77 11.20 23 59824 35785 34861299
Bronchopulmonary aspergillosis 15.73 11.20 3 59844 14656 34882428
Narcissistic personality disorder 15.72 11.20 4 59843 13 34897071
Anaphylactic shock 15.62 11.20 4 59843 15937 34881147
Hallucinations, mixed 15.48 11.20 21 59826 2668 34894416
Influenza B virus test positive 15.40 11.20 6 59841 96 34896988
Blood ethanol increased 15.38 11.20 10 59837 493 34896591
Neuropathy peripheral 15.24 11.20 82 59765 83181 34813903
Axillary pain 15.23 11.20 9 59838 374 34896710
International normalised ratio increased 15.04 11.20 37 59810 47290 34849794
Bladder disorder 14.92 11.20 23 59824 3281 34893803
Band neutrophil percentage increased 14.90 11.20 6 59841 105 34896979
Scar 14.84 11.20 32 59815 5912 34891172
Implant site inflammation 14.80 11.20 6 59841 107 34896977
Scratch 14.69 11.20 23 59824 3325 34893759
Postoperative delirium 14.64 11.20 7 59840 188 34896896
Blood sodium increased 14.54 11.20 21 59826 2827 34894257
Tethered cord syndrome 14.52 11.20 4 59843 19 34897065
Pulmonary hypertension 14.40 11.20 9 59838 20915 34876169
Melaena 14.36 11.20 24 59823 35356 34861728
Cholestasis 14.29 11.20 15 59832 26933 34870151
Hallucination, olfactory 14.27 11.20 7 59840 199 34896885
Drug-induced liver injury 14.25 11.20 17 59830 28815 34868269
Hepatitis 14.21 11.20 12 59835 23892 34873192
Exaggerated startle response 14.19 11.20 4 59843 21 34897063
Loss of control of legs 14.14 11.20 11 59836 722 34896362
Polyneuropathy 14.10 11.20 4 59843 14892 34882192
Medical device site warmth 14.04 11.20 3 59844 3 34897081
Product use in unapproved indication 14.02 11.20 131 59716 117368 34779716
Staphylococcal infection 13.93 11.20 100 59747 32660 34864424
Acute myeloid leukaemia 13.80 11.20 7 59840 18263 34878821
Contraindicated product administered 13.76 11.20 10 59837 21471 34875613
Blood bilirubin increased 13.75 11.20 28 59819 38268 34858816
C-reactive protein increased 13.75 11.20 47 59800 54051 34843033
Mental status changes postoperative 13.58 11.20 3 59844 4 34897080
Pancreatitis 13.49 11.20 29 59818 38862 34858222
Eosinophilia 13.46 11.20 15 59832 26207 34870877
Medical device site haemorrhage 13.44 11.20 6 59841 137 34896947
Red blood cells urine positive 13.37 11.20 16 59831 1793 34895291
Palmar-plantar erythrodysaesthesia syndrome 13.36 11.20 6 59841 16789 34880295
Loss of consciousness 13.27 11.20 207 59640 82460 34814624
CD8 lymphocytes increased 13.22 11.20 4 59843 28 34897056
Rash pruritic 13.19 11.20 16 59831 26925 34870159
Procedural complication 13.00 11.20 25 59822 4258 34892826
Mental disorder 12.93 11.20 56 59791 15153 34881931
Streptococcus test positive 12.93 11.20 12 59835 1003 34896081
Burning sensation 12.89 11.20 64 59783 18330 34878754
Adrenal insufficiency 12.88 11.20 4 59843 14043 34883041
Spinal cord injury cauda equina 12.87 11.20 6 59841 152 34896932
Erythema 12.85 11.20 94 59753 88686 34808398
Ulcerative duodenitis 12.83 11.20 3 59844 6 34897078
Implant site rash 12.83 11.20 3 59844 6 34897078
Pituitary cyst 12.83 11.20 3 59844 6 34897078
Urine cannabinoids increased 12.83 11.20 3 59844 6 34897078
Rash maculo-papular 12.80 11.20 18 59829 28433 34868651
Feeling of body temperature change 12.80 11.20 14 59833 1424 34895660
Ventricular tachycardia 12.79 11.20 16 59831 26563 34870521
Chronic obstructive pulmonary disease 12.78 11.20 42 59805 48876 34848208
Hypothermia 12.77 11.20 44 59803 10704 34886380
Poor quality sleep 12.74 11.20 37 59810 8219 34888865
Drug ineffective 12.73 11.20 646 59201 456105 34440979
Mydriasis 12.72 11.20 34 59813 7203 34889881
Hiccups 12.61 11.20 42 59805 10040 34887044
Logorrhoea 12.55 11.20 18 59829 2408 34894676
CSF shunt operation 12.52 11.20 3 59844 7 34897077
Uhthoff's phenomenon 12.52 11.20 3 59844 7 34897077
Stitch abscess 12.52 11.20 3 59844 7 34897077
Hyperglycaemia 12.44 11.20 31 59816 39449 34857635
Somatosensory evoked potentials abnormal 12.41 11.20 6 59841 165 34896919
Haematuria 12.39 11.20 44 59803 50022 34847062
Myocarditis 12.36 11.20 4 59843 13678 34883406
Systolic hypertension 12.34 11.20 7 59840 269 34896815
Treatment failure 12.26 11.20 40 59807 46657 34850427
Arthralgia 12.26 11.20 211 59636 169830 34727254
Appendicitis 12.24 11.20 5 59842 14802 34882282
Spinal cord infection 12.12 11.20 6 59841 174 34896910
Proteus test positive 12.09 11.20 5 59842 94 34896990
Wound 12.08 11.20 54 59793 14810 34882274
Postoperative wound infection 12.07 11.20 26 59821 4800 34892284
Spinal cord injury 12.06 11.20 9 59838 555 34896529
Scoliosis 12.00 11.20 19 59828 2774 34894310
Grimacing 11.95 11.20 7 59840 286 34896798
Septic shock 11.93 11.20 73 59774 71761 34825323
Upper respiratory tract irritation 11.88 11.20 4 59843 41 34897043
Post laminectomy syndrome 11.84 11.20 6 59841 183 34896901
Primary progressive multiple sclerosis 11.71 11.20 4 59843 43 34897041
Abdominal pain upper 11.69 11.20 73 59774 71417 34825667
Productive cough 11.67 11.20 30 59817 37783 34859301
Temperature intolerance 11.67 11.20 21 59826 3401 34893683
Quadriplegia 11.65 11.20 15 59832 1812 34895272
Obstructive airways disorder 11.61 11.20 6 59841 15488 34881596
Patella fracture 11.57 11.20 7 59840 304 34896780
Excessive granulation tissue 11.53 11.20 8 59839 440 34896644
Analgesic drug level above therapeutic 11.53 11.20 7 59840 306 34896778
Duodenitis haemorrhagic 11.45 11.20 5 59842 108 34896976
Intentional product use issue 11.45 11.20 58 59789 59758 34837326
Cardiotoxicity 11.44 11.20 28 59819 5620 34891464
Conduction disorder 11.43 11.20 16 59831 2094 34894990
Vitamin B6 deficiency 11.38 11.20 6 59841 199 34896885
Musculoskeletal discomfort 11.36 11.20 35 59812 8033 34889051
Glomerular filtration rate decreased 11.34 11.20 4 59843 12957 34884127
Blood pressure fluctuation 11.33 11.20 16 59831 25233 34871851
Myalgia 11.26 11.20 91 59756 84019 34813065
Therapeutic response changed 11.24 11.20 8 59839 458 34896626
Neoplasm progression 11.24 11.20 14 59833 23286 34873798
Incision site swelling 11.24 11.20 4 59843 49 34897035
Bladder cancer 11.20 11.20 7 59840 16271 34880813

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 2167.52 10.13 1088 131634 33630 79578036
Multiple sclerosis relapse 1628.57 10.13 996 131726 45537 79566129
Muscle spasticity 1351.59 10.13 677 132045 20798 79590868
Multiple sclerosis 1066.88 10.13 585 132137 21697 79589969
Implant site infection 846.14 10.13 249 132473 1616 79610050
Implant site extravasation 814.22 10.13 203 132519 616 79611050
Coma 707.98 10.13 855 131867 99794 79511872
Device failure 529.75 10.13 242 132480 6019 79605647
Urinary tract infection 488.80 10.13 1271 131451 273241 79338425
Overdose 441.70 10.13 958 131764 183248 79428418
Muscle spasms 437.67 10.13 925 131797 173805 79437861
Somnolence 437.14 10.13 1118 131604 237863 79373803
Hypotonia 430.79 10.13 268 132454 12602 79599064
Completed suicide 407.01 10.13 1108 131614 244659 79367007
Mental status changes 396.13 10.13 522 132200 66437 79545229
Cerebrospinal fluid leakage 366.71 10.13 129 132593 1570 79610096
Hypertonia 357.46 10.13 194 132528 7038 79604628
Device infusion issue 313.27 10.13 125 132597 2201 79609465
Seizure 306.09 10.13 845 131877 187989 79423677
Complication associated with device 301.86 10.13 243 132479 17253 79594413
Unresponsive to stimuli 275.94 10.13 399 132323 55389 79556277
Withdrawal syndrome 265.92 10.13 273 132449 26581 79585085
Toxicity to various agents 263.75 10.13 1390 131332 420150 79191516
Fall 250.43 10.13 1525 131197 486104 79125562
Pneumonia aspiration 241.07 10.13 414 132308 66553 79545113
Gait disturbance 240.51 10.13 826 131896 206680 79404986
Medical device site infection 236.24 10.13 71 132651 500 79611166
Febrile neutropenia 232.89 10.13 50 132672 230949 79380717
Respiratory depression 226.24 10.13 254 132468 27376 79584290
Muscular weakness 218.82 10.13 676 132046 160053 79451613
Muscle tightness 215.67 10.13 176 132546 12738 79598928
Device physical property issue 204.85 10.13 96 132626 2534 79609132
Implant site erosion 198.95 10.13 49 132673 139 79611527
Device kink 198.17 10.13 85 132637 1810 79609856
Anaemia 196.01 10.13 273 132449 444742 79166924
Medical device site discharge 191.94 10.13 39 132683 24 79611642
Medical device site pain 190.87 10.13 53 132669 270 79611396
Implant site swelling 188.85 10.13 57 132665 408 79611258
Device power source issue 188.47 10.13 68 132654 895 79610771
Toxic encephalopathy 182.86 10.13 152 132570 11288 79600378
Therapy non-responder 177.98 10.13 441 132281 91864 79519802
Encephalopathy 176.88 10.13 364 132358 67033 79544633
Implant site discharge 176.58 10.13 44 132678 133 79611533
Medical device site swelling 174.25 10.13 38 132684 48 79611618
Diarrhoea 163.99 10.13 832 131890 879657 78732009
Medical device site erythema 163.98 10.13 36 132686 48 79611618
Pocket erosion 163.37 10.13 32 132690 11 79611655
Central nervous system lesion 158.56 10.13 150 132572 13218 79598448
Neurotoxicity 155.57 10.13 229 132493 32289 79579377
Decubitus ulcer 154.43 10.13 159 132563 15528 79596138
Wound dehiscence 152.23 10.13 109 132613 6486 79605180
Neutropenia 148.28 10.13 156 132566 287554 79324112
Hypoaesthesia 146.30 10.13 639 132083 178713 79432953
Rash 135.89 10.13 500 132222 577858 79033808
Contraindicated product administered 134.58 10.13 47 132675 157491 79454175
Pericarditis 132.24 10.13 11 132711 104225 79507441
Infusion related reaction 131.26 10.13 114 132608 230123 79381543
Glossodynia 130.84 10.13 11 132711 103326 79508340
Implant site pain 128.59 10.13 65 132657 2032 79609634
Secondary progressive multiple sclerosis 127.70 10.13 57 132665 1340 79610326
Tremor 126.73 10.13 590 132132 169493 79442173
Gait spastic 126.19 10.13 54 132668 1143 79610523
Synovitis 123.65 10.13 48 132674 150686 79460980
Clonus 122.23 10.13 97 132625 6743 79604923
Sedation 121.96 10.13 268 132454 51627 79560039
Device malfunction 120.30 10.13 163 132559 21285 79590381
Status epilepticus 117.84 10.13 175 132547 24866 79586800
Memory impairment 116.63 10.13 430 132292 111304 79500362
Systemic lupus erythematosus 116.51 10.13 29 132693 121120 79490546
Urinary incontinence 115.74 10.13 228 132494 40681 79570985
Arthropathy 114.59 10.13 77 132645 177034 79434632
Balance disorder 113.92 10.13 393 132329 98464 79513202
Malignant neoplasm progression 110.40 10.13 44 132678 135946 79475720
Pancytopenia 110.02 10.13 70 132652 165675 79445991
Interstitial lung disease 108.19 10.13 27 132695 112573 79499093
Joint swelling 108.10 10.13 197 132525 288449 79323217
Underdose 107.70 10.13 196 132526 32955 79578711
Thrombocytopenia 107.62 10.13 172 132550 265087 79346579
Device alarm issue 105.91 10.13 57 132665 2032 79609634
Hand deformity 105.68 10.13 22 132700 103897 79507769
Acute kidney injury 105.01 10.13 476 132246 518928 79092738
Relapsing-remitting multiple sclerosis 104.76 10.13 51 132671 1468 79610198
Dyspnoea 104.36 10.13 919 131803 856106 78755560
Progressive multiple sclerosis 102.82 10.13 47 132675 1170 79610496
Post lumbar puncture syndrome 102.63 10.13 41 132681 724 79610942
Agitation 101.77 10.13 381 132341 99334 79512332
Device dislocation 100.65 10.13 166 132556 25804 79585862
Neurogenic bladder 100.41 10.13 71 132651 4141 79607525
Intracranial hypotension 99.09 10.13 34 132688 382 79611284
Helicobacter infection 98.59 10.13 4 132718 69700 79541966
Needle fatigue 96.11 10.13 41 132681 861 79610805
Lethargy 95.25 10.13 325 132397 80967 79530699
Trigeminal neuralgia 93.45 10.13 64 132658 3545 79608121
Cardiac failure 92.76 10.13 73 132649 154769 79456897
Duodenal ulcer perforation 89.78 10.13 5 132717 66206 79545460
Urine analysis abnormal 88.70 10.13 79 132643 6441 79605225
Abdominal discomfort 86.16 10.13 180 132542 250547 79361119
Intentional overdose 85.17 10.13 376 132346 105584 79506082
Device connection issue 83.93 10.13 39 132683 1009 79610657
Atrial fibrillation 83.41 10.13 125 132597 197761 79413905
Dystonia 83.22 10.13 137 132585 21262 79590404
Asphyxia 81.35 10.13 99 132623 11621 79600045
Medical device site fibrosis 81.32 10.13 16 132706 6 79611660
Ataxia 81.28 10.13 148 132574 24891 79586775
Lymphocyte count decreased 79.84 10.13 215 132507 47074 79564592
Drug intolerance 79.18 10.13 204 132518 263915 79347751
General physical health deterioration 79.17 10.13 217 132505 275021 79336645
Mucosal inflammation 78.94 10.13 15 132707 75565 79536101
Depressed level of consciousness 78.46 10.13 344 132378 96308 79515358
Device issue 77.78 10.13 152 132570 26956 79584710
Exposure during pregnancy 76.86 10.13 36 132686 101096 79510570
Progressive multifocal leukoencephalopathy 76.26 10.13 129 132593 20471 79591195
Implant site erythema 76.03 10.13 30 132692 512 79611154
Medical device site erosion 75.90 10.13 18 132704 41 79611625
Device inversion 75.60 10.13 14 132708 0 79611666
Urosepsis 75.34 10.13 148 132574 26347 79585319
Maternal exposure during pregnancy 74.91 10.13 70 132652 136468 79475198
Infusion site mass 73.94 10.13 41 132681 1552 79610114
Muscle rigidity 72.93 10.13 124 132598 19758 79591908
Renal impairment 72.14 10.13 94 132628 157689 79453977
Confusional state 70.37 10.13 824 131898 317173 79294493
Metabolic encephalopathy 69.64 10.13 81 132641 9066 79602600
Bradypnoea 68.15 10.13 66 132656 5986 79605680
Therapeutic response decreased 67.83 10.13 255 132467 66598 79545068
Laboratory test abnormal 67.20 10.13 146 132576 27902 79583764
Folliculitis 67.15 10.13 7 132715 55373 79556293
Platelet count decreased 66.65 10.13 140 132582 194524 79417142
Electroencephalogram abnormal 66.41 10.13 62 132660 5372 79606294
Rheumatoid arthritis 66.40 10.13 156 132566 208314 79403352
Neuralgia 65.89 10.13 161 132561 33223 79578443
Influenza like illness 65.82 10.13 265 132457 71442 79540224
Victim of child abuse 65.73 10.13 32 132690 921 79610745
Hallucination 65.70 10.13 300 132422 85445 79526221
Autonomic nervous system imbalance 64.78 10.13 57 132665 4573 79607093
Device occlusion 64.76 10.13 89 132633 11777 79599889
Device computer issue 64.45 10.13 18 132704 94 79611572
Abdominal pain 64.02 10.13 383 132339 389186 79222480
Magnetic resonance imaging abnormal 63.85 10.13 50 132672 3409 79608257
Generalised tonic-clonic seizure 63.72 10.13 189 132533 43721 79567945
Areflexia 63.54 10.13 61 132661 5473 79606193
Movement disorder 62.03 10.13 139 132583 27120 79584546
Muscle injury 61.93 10.13 5 132717 48556 79563110
Micturition urgency 61.87 10.13 90 132632 12551 79599115
Drug ineffective 61.28 10.13 1353 131369 1079560 78532106
Pleural effusion 60.96 10.13 92 132630 145170 79466496
Gastrointestinal haemorrhage 60.61 10.13 95 132627 147624 79464042
JC polyomavirus test positive 60.37 10.13 36 132686 1566 79610100
Hyporeflexia 60.35 10.13 49 132673 3519 79608147
Sleep disorder due to general medical condition, insomnia type 59.96 10.13 3 132719 43553 79568113
Paraparesis 59.68 10.13 50 132672 3753 79607913
Cough 59.53 10.13 362 132360 366427 79245239
Decreased appetite 59.27 10.13 331 132391 342087 79269579
Delirium 58.93 10.13 288 132434 84339 79527327
Swelling 58.53 10.13 176 132546 216535 79395131
Myoclonus 58.47 10.13 137 132585 27523 79584143
Blood creatinine increased 57.84 10.13 106 132616 154951 79456715
Arthralgia 57.72 10.13 641 132081 571162 79040504
Hypertonic bladder 57.34 10.13 51 132671 4150 79607516
Drug delivery device placement 57.09 10.13 19 132703 193 79611473
Disease progression 57.09 10.13 140 132582 184222 79427444
Implant site haematoma 56.93 10.13 18 132704 153 79611513
Hyperkalaemia 56.68 10.13 64 132658 114334 79497332
Depression 55.83 10.13 579 132143 216211 79395455
Escherichia urinary tract infection 55.78 10.13 90 132632 13735 79597931
White blood cells urine positive 55.19 10.13 59 132663 6016 79605650
Hepatic function abnormal 54.06 10.13 27 132695 73080 79538586
Muscle twitching 53.82 10.13 124 132598 24640 79587026
Cardiac failure congestive 53.42 10.13 97 132625 142305 79469361
Monocyte percentage increased 53.16 10.13 37 132685 2104 79609562
Insomnia 52.74 10.13 632 132090 244538 79367128
Monoparesis 52.71 10.13 45 132677 3466 79608200
Respiratory arrest 52.27 10.13 212 132510 57338 79554328
Medical device site discomfort 51.93 10.13 18 132704 209 79611457
Lymphocyte percentage decreased 51.82 10.13 52 132670 4924 79606742
Medical device site inflammation 51.38 10.13 10 132712 3 79611663
Optic neuritis 51.35 10.13 71 132651 9449 79602217
Off label use 51.21 10.13 1136 131586 906079 78705587
Toxic epidermal necrolysis 50.69 10.13 7 132715 44574 79567092
Peroneal nerve palsy 50.23 10.13 56 132666 5986 79605680
Ascites 50.00 10.13 32 132690 75530 79536136
Epidural lipomatosis 49.97 10.13 29 132693 1199 79610467
Multiple organ dysfunction syndrome 49.64 10.13 77 132645 120169 79491497
Renal failure 49.53 10.13 170 132552 200798 79410868
Urine leukocyte esterase positive 48.69 10.13 46 132676 4045 79607621
Drug dependence 48.62 10.13 164 132558 40605 79571061
Scoliosis 48.50 10.13 61 132661 7403 79604263
Red blood cells urine positive 48.30 10.13 50 132672 4913 79606753
Hepatic enzyme increased 48.09 10.13 150 132572 182460 79429206
Haematochezia 47.99 10.13 45 132677 87600 79524066
Device breakage 47.94 10.13 73 132649 10602 79601064
Bone marrow failure 47.66 10.13 13 132709 51094 79560572
Lower respiratory tract infection 47.60 10.13 89 132633 129131 79482535
Dyskinesia 47.26 10.13 173 132549 44600 79567066
Implant site scar 47.24 10.13 17 132705 222 79611444
Therapeutic product effect decreased 47.23 10.13 129 132593 163734 79447932
Arachnoiditis 47.22 10.13 24 132698 759 79610907
Bacterial test positive 47.02 10.13 60 132662 7389 79604277
Product use issue 46.78 10.13 185 132537 209637 79402029
Paralysis 46.77 10.13 81 132641 13096 79598570
Device programming error 46.61 10.13 16 132706 180 79611486
Myelosuppression 46.60 10.13 6 132716 40290 79571376
Osteonecrosis of jaw 46.39 10.13 8 132714 43218 79568448
Poisoning deliberate 46.24 10.13 99 132623 18729 79592937
Medical device site bruise 46.02 10.13 9 132713 3 79611663
Pulmonary fibrosis 45.54 10.13 9 132713 44103 79567563
Motor dysfunction 45.20 10.13 85 132637 14648 79597018
Neutrophil percentage increased 45.20 10.13 47 132675 4642 79607024
Dysarthria 44.86 10.13 227 132495 67395 79544271
Gastrooesophageal reflux disease 44.66 10.13 312 132410 103934 79507732
Wound 44.60 10.13 78 132644 116101 79495565
Urinary retention 44.01 10.13 199 132523 56431 79555235
Medical device site cellulitis 44.01 10.13 9 132713 6 79611660
Drug interaction 43.62 10.13 461 132261 414722 79196944
Pollakiuria 43.52 10.13 149 132573 37168 79574498
Miosis 43.45 10.13 87 132635 15702 79595964
Loss of consciousness 43.44 10.13 449 132273 167494 79444172
Peripheral swelling 43.24 10.13 267 132455 269350 79342316
Device leakage 42.88 10.13 70 132652 10786 79600880
Dyspnoea exertional 42.82 10.13 49 132673 87024 79524642
Hepatotoxicity 42.68 10.13 16 132706 51336 79560330
Apnoea 41.62 10.13 72 132650 11632 79600034
Gait inability 41.37 10.13 201 132521 58716 79552950
Stomatitis 41.20 10.13 117 132605 146640 79465026
Focal dyscognitive seizures 40.87 10.13 39 132683 3473 79608193
Implant site abscess 40.82 10.13 11 132711 49 79611617
Blister 40.81 10.13 86 132636 119390 79492276
Rectal haemorrhage 40.81 10.13 40 132682 76260 79535406
Pseudomeningocele 40.66 10.13 8 132714 3 79611663
Immune reconstitution inflammatory syndrome 40.18 10.13 78 132644 13763 79597903
Nitrite urine present 40.01 10.13 25 132697 1184 79610482
Drug eruption 39.45 10.13 12 132710 43923 79567743
Hypoglycaemia 39.18 10.13 68 132654 101526 79510140
Epistaxis 39.17 10.13 79 132643 111436 79500230
Urinary sediment present 39.10 10.13 33 132689 2502 79609164
Dysstasia 38.90 10.13 118 132604 27628 79584038
Hypersensitivity 38.85 10.13 266 132456 261973 79349693
Psoriatic arthropathy 38.24 10.13 44 132678 77955 79533711
Wheezing 38.18 10.13 86 132636 116578 79495088
Sleep apnoea syndrome 37.71 10.13 140 132582 36338 79575328
Irritability 37.71 10.13 152 132570 40992 79570674
Cytomegalovirus infection 37.66 10.13 12 132710 42632 79569034
Respiratory rate decreased 37.55 10.13 45 132677 5198 79606468
Muscle contracture 37.47 10.13 31 132691 2286 79609380
Erythema 37.44 10.13 218 132504 223072 79388594
Liver injury 37.42 10.13 24 132698 56590 79555076
Oedema peripheral 37.32 10.13 256 132466 252032 79359634
Paraesthesia 37.23 10.13 453 132269 175870 79435796
Device extrusion 37.22 10.13 9 132713 23 79611643
Drug resistance 37.06 10.13 12 132710 42201 79569465
Accidental overdose 36.89 10.13 147 132575 39434 79572232
Concussion 35.82 10.13 60 132662 9443 79602223
Altered state of consciousness 35.57 10.13 156 132566 43666 79568000
C-reactive protein abnormal 35.55 10.13 18 132704 48349 79563317
Stiff person syndrome 35.51 10.13 15 132707 307 79611359
Hyperhidrosis 35.44 10.13 397 132325 151095 79460571
Bradycardia 35.32 10.13 363 132359 135194 79476472
Hypomagnesaemia 35.17 10.13 17 132705 46894 79564772
Tubulointerstitial nephritis 35.14 10.13 10 132712 38225 79573441
Treatment failure 35.09 10.13 155 132567 170331 79441335
Speech disorder 34.88 10.13 181 132541 54264 79557402
Alcohol withdrawal syndrome 34.83 10.13 28 132694 1983 79609683
Alopecia 34.59 10.13 234 132488 231121 79380545
Delirium tremens 34.27 10.13 19 132703 719 79610947
Burning sensation 34.22 10.13 190 132532 58442 79553224
Medical device site haematoma 34.18 10.13 9 132713 36 79611630
Implant site cellulitis 34.14 10.13 11 132711 100 79611566
B-lymphocyte count decreased 34.09 10.13 24 132698 1390 79610276
Irritable bowel syndrome 34.02 10.13 32 132690 62209 79549457
Medical device site extravasation 33.48 10.13 7 132715 6 79611660
Medical device site reaction 33.48 10.13 7 132715 6 79611660
Soft tissue injury 33.43 10.13 26 132696 1755 79609911
Intentional product use issue 33.34 10.13 135 132587 151977 79459689
Pneumocystis jirovecii pneumonia 32.80 10.13 7 132715 32501 79579165
Agranulocytosis 32.74 10.13 17 132705 45013 79566653
Neoplasm progression 32.69 10.13 23 132699 51659 79560007
Neutrophil count decreased 32.62 10.13 67 132655 93892 79517774
Melaena 32.47 10.13 32 132690 60858 79550808
Alcohol poisoning 32.29 10.13 40 132682 4781 79606885
Liver disorder 32.21 10.13 44 132678 72373 79539293
Euphoric mood 32.13 10.13 51 132671 7675 79603991
Dysaesthesia 32.12 10.13 44 132678 5804 79605862
Hypercalcaemia 31.89 10.13 12 132710 38418 79573248
Palmar-plantar erythrodysaesthesia syndrome 31.71 10.13 8 132714 33126 79578540
Seroma 31.55 10.13 28 132694 2272 79609394
Incorrect drug administration rate 31.23 10.13 36 132686 3990 79607676
Loss of control of legs 31.18 10.13 26 132696 1939 79609727
Pulmonary renal syndrome 31.16 10.13 17 132705 623 79611043
Proteinuria 30.81 10.13 8 132714 32494 79579172
Lymphopenia 30.52 10.13 116 132606 30441 79581225
Nasopharyngitis 30.38 10.13 273 132449 253608 79358058
Implant site dehiscence 30.28 10.13 10 132712 99 79611567
Haemoglobin decreased 30.13 10.13 231 132491 221888 79389778
Gastrointestinal disorder 29.67 10.13 104 132618 122101 79489565
Weight increased 29.50 10.13 307 132415 277079 79334587
Medical device discomfort 29.48 10.13 24 132698 1730 79609936
Disorientation 29.34 10.13 192 132530 62584 79549082
Erectile dysfunction 29.23 10.13 71 132651 14593 79597073
Haemoptysis 29.21 10.13 30 132692 55969 79555697
Pneumonitis 29.12 10.13 35 132687 60825 79550841
Meningitis 29.04 10.13 55 132667 9527 79602139
Dysphagia 28.99 10.13 321 132401 121815 79489851
Anxiety 28.81 10.13 577 132145 247935 79363731
Culture urine positive 28.43 10.13 36 132686 4399 79607267
Band neutrophil percentage increased 28.38 10.13 14 132708 415 79611251
Medical device site ulcer 28.25 10.13 6 132716 6 79611660
Anal incontinence 28.08 10.13 80 132642 18088 79593578
Sensory disturbance 27.95 10.13 71 132651 15006 79596660
Expanded disability status scale score increased 27.94 10.13 16 132706 645 79611021
Autonomic dysreflexia 27.80 10.13 14 132708 434 79611232
Hypothermia 27.56 10.13 92 132630 22654 79589012
Macrophages increased 27.41 10.13 12 132710 269 79611397
Temperature intolerance 27.33 10.13 54 132668 9651 79602015
Incorrect route of product administration 27.33 10.13 123 132599 34806 79576860
Band neutrophil count increased 27.30 10.13 16 132706 674 79610992
International normalised ratio increased 27.27 10.13 63 132659 84658 79527008
Migraine 27.09 10.13 243 132479 87250 79524416
Cholestasis 27.08 10.13 28 132694 52081 79559585
Suicide attempt 27.06 10.13 233 132489 82699 79528967
Infusion site fibrosis 27 10.13 5 132717 0 79611666
Medical device site warmth 27 10.13 5 132717 0 79611666
Neutropenic sepsis 26.95 10.13 6 132716 27058 79584608
Incoherent 26.93 10.13 47 132675 7645 79604021
Bronchiectasis 26.71 10.13 3 132719 22383 79589283
Angina pectoris 26.66 10.13 28 132694 51704 79559962
Discomfort 26.58 10.13 113 132609 125504 79486162
Coma scale abnormal 26.54 10.13 50 132672 8628 79603038
Hyperreflexia 26.50 10.13 49 132673 8336 79603330
Road traffic accident 26.49 10.13 143 132579 43521 79568145
Hypoventilation 26.42 10.13 45 132677 7179 79604487
Knee arthroplasty 26.38 10.13 20 132702 43228 79568438
Eosinophilia 26.36 10.13 22 132700 45323 79566343
Implant site reaction 26.28 10.13 10 132712 154 79611512
Vitamin D deficiency 26.22 10.13 67 132655 14212 79597454
Feeling abnormal 26.17 10.13 391 132331 158808 79452858
Rash maculo-papular 26.04 10.13 33 132689 56045 79555621
Incision site oedema 25.83 10.13 6 132716 12 79611654
Post-traumatic neck syndrome 25.80 10.13 24 132698 2070 79609596
Hypervolaemia 25.71 10.13 20 132702 42670 79568996
Bladder dysfunction 25.63 10.13 19 132703 1193 79610473
Sternal fracture 25.54 10.13 26 132696 2504 79609162
Child abuse 25.44 10.13 13 132709 416 79611250
Hallucination, visual 25.42 10.13 115 132607 32614 79579052
Amnesia 25.42 10.13 186 132536 62871 79548795
Purulent discharge 25.30 10.13 40 132682 5999 79605667
Hallucinations, mixed 25.26 10.13 43 132679 6856 79604810
Device expulsion 25.22 10.13 6 132716 25855 79585811
Adrenal insufficiency 25.18 10.13 8 132714 28479 79583187
Hepatic cytolysis 25.14 10.13 7 132715 27144 79584522
Metastases to liver 24.94 10.13 8 132714 28306 79583360
Blood bilirubin increased 24.93 10.13 45 132677 66187 79545479
Urinary tract infection pseudomonal 24.88 10.13 22 132700 1776 79609890
Urobilinogen urine increased 24.84 10.13 15 132707 668 79610998
Hypokinesia 24.81 10.13 79 132643 18981 79592685
Libido increased 24.78 10.13 23 132699 1978 79609688
Flushing 24.74 10.13 240 132482 88028 79523638
Pain 24.74 10.13 1419 131303 702383 78909283
Medical device site scar 24.66 10.13 5 132717 3 79611663
Postoperative delirium 24.47 10.13 12 132710 351 79611315
Tumour lysis syndrome 24.47 10.13 5 132717 23934 79587732
Bronchopulmonary aspergillosis 24.20 10.13 4 132718 22290 79589376
Drug hypersensitivity 24.15 10.13 351 132371 298565 79313101
Disturbance in attention 24.12 10.13 156 132566 50645 79561021
Colitis ulcerative 23.97 10.13 14 132708 34728 79576938
Drug reaction with eosinophilia and systemic symptoms 23.87 10.13 44 132678 64200 79547466
Intervertebral disc protrusion 23.87 10.13 90 132632 23531 79588135
Hostility 23.80 10.13 24 132698 2286 79609380
Patient-device incompatibility 23.69 10.13 9 132713 138 79611528
Ankle fracture 23.63 10.13 72 132650 16897 79594769
Performance status decreased 23.58 10.13 39 132683 6074 79605592
Epilepsy 23.57 10.13 132 132590 40728 79570938
CSF culture positive 23.45 10.13 7 132715 48 79611618
Poor quality sleep 23.31 10.13 87 132635 22635 79589031
Bacterial test 23.27 10.13 18 132704 1205 79610461
Rash pruritic 23.27 10.13 53 132669 71576 79540090
Product use in unapproved indication 23.12 10.13 286 132436 250073 79361593
Nystagmus 23.09 10.13 51 132671 9853 79601813
Sinusitis 23.04 10.13 211 132511 195290 79416376
Staphylococcal infection 22.95 10.13 171 132551 58124 79553542
Pupil fixed 22.94 10.13 29 132693 3537 79608129
Incision site erythema 22.93 10.13 13 132709 514 79611152
CD4 lymphocytes decreased 22.91 10.13 25 132697 2609 79609057
Cytokine release syndrome 22.80 10.13 16 132706 35982 79575684
Inadequate analgesia 22.71 10.13 33 132689 4596 79607070
Oedema 22.66 10.13 112 132610 119468 79492198
Abnormal behaviour 22.58 10.13 120 132602 36301 79575365
Blood cholesterol increased 22.58 10.13 68 132654 83652 79528014
Hypocalcaemia 22.54 10.13 30 132692 49894 79561772
Nephrolithiasis 22.52 10.13 159 132563 53132 79558534
Decreased vibratory sense 22.48 10.13 14 132708 659 79611007
Primary progressive multiple sclerosis 22.19 10.13 8 132714 105 79611561
Basal ganglion degeneration 22.09 10.13 12 132710 436 79611230
Implant site oedema 22.04 10.13 6 132716 28 79611638
Urinary tract infection bacterial 22.02 10.13 39 132683 6417 79605249
Vitamin B6 deficiency 22.02 10.13 11 132711 335 79611331
Dehydration 21.99 10.13 286 132436 247901 79363765
Paraplegia 21.91 10.13 34 132688 5019 79606647
Infusion site granuloma 21.87 10.13 5 132717 9 79611657
Right ventricular failure 21.86 10.13 6 132716 23491 79588175
Therapeutic response unexpected 21.84 10.13 78 132644 19868 79591798
Haemorrhage 21.81 10.13 78 132644 91040 79520626
Hepatitis 21.76 10.13 37 132685 55690 79555976
Bladder spasm 21.72 10.13 23 132699 2320 79609346
Frequent bowel movements 21.70 10.13 11 132711 29528 79582138
Fluctuance 21.60 10.13 4 132718 0 79611666
Medical device site vesicles 21.60 10.13 4 132718 0 79611666
Implant site ulcer 21.60 10.13 4 132718 0 79611666
Pulmonary hypertension 21.60 10.13 29 132693 48051 79563615
Productive cough 21.56 10.13 75 132647 88256 79523410
Haemophagocytic lymphohistiocytosis 21.43 10.13 5 132717 21832 79589834
Poisoning 21.30 10.13 91 132631 25181 79586485
Implant site vesicles 21.22 10.13 6 132716 33 79611633
Nausea 21.16 10.13 1342 131380 955854 78655812
Posturing 21.14 10.13 16 132706 1037 79610629
Asthma 21.01 10.13 135 132587 134960 79476706
Chronic kidney disease 20.65 10.13 50 132672 66104 79545562
Brain stem syndrome 20.65 10.13 15 132707 913 79610753
Stevens-Johnson syndrome 20.41 10.13 21 132701 39145 79572521
Neurogenic bowel 20.30 10.13 9 132713 208 79611458
Spinal cord injury 20.27 10.13 17 132705 1278 79610388
Muscle contractions involuntary 20.19 10.13 28 132694 3737 79607929
Toxic skin eruption 20.18 10.13 6 132716 22287 79589379
Tethered cord syndrome 20.09 10.13 5 132717 15 79611651
Brain injury 20.08 10.13 53 132669 11464 79600202
Bladder disorder 20.03 10.13 46 132676 9119 79602547
Nocturia 19.95 10.13 59 132663 13622 79598044
Leukopenia 19.92 10.13 113 132609 116400 79495266
Aplastic anaemia 19.92 10.13 3 132719 17902 79593764
Thyroid disorder 19.85 10.13 60 132662 14019 79597647
Intestinal pseudo-obstruction 19.69 10.13 23 132699 2586 79609080
Tissue infiltration 19.68 10.13 13 132709 678 79610988
Urticaria 19.67 10.13 205 132517 184996 79426670
T-lymphocyte count decreased 19.46 10.13 12 132710 555 79611111
Central nervous system infection 19.36 10.13 17 132705 1360 79610306
Cytopenia 19.35 10.13 5 132717 20378 79591288
Pancreatitis acute 19.31 10.13 33 132689 49571 79562095
Coronary artery disease 19.26 10.13 51 132671 65423 79546243
COVID-19 19.24 10.13 369 132353 157305 79454361
Persistent depressive disorder 19.23 10.13 16 132706 1189 79610477
Presyncope 19.23 10.13 24 132698 41030 79570636
Anaphylactic shock 19.10 10.13 19 132703 35977 79575689
Lactic acidosis 19.08 10.13 57 132665 70302 79541364
Monoplegia 19.04 10.13 28 132694 3943 79607723
C-reactive protein increased 19.02 10.13 131 132591 128896 79482770
Intervertebral disc disorder 18.91 10.13 31 132691 4794 79606872
Muscle atrophy 18.88 10.13 51 132671 11181 79600485
Metabolic acidosis 18.87 10.13 72 132650 82457 79529209
Type 2 diabetes mellitus 18.77 10.13 42 132680 57080 79554586
Post procedural complication 18.71 10.13 84 132638 23745 79587921
Incision site complication 18.62 10.13 13 132709 743 79610923
Hypersomnia 18.59 10.13 82 132640 23004 79588662
Musculoskeletal stiffness 18.52 10.13 401 132321 174607 79437059
Hyporesponsive to stimuli 18.48 10.13 20 132702 2068 79609598
CD8 lymphocytes decreased 18.46 10.13 9 132713 260 79611406
Faeces discoloured 18.37 10.13 13 132709 29114 79582552
Abdominal pain upper 18.35 10.13 262 132460 223557 79388109
Lipoma 18.31 10.13 24 132698 3035 79608631
Neuropathy peripheral 18.20 10.13 149 132573 141156 79470510
Metastases to bone 18.09 10.13 9 132713 24418 79587248
Colitis 18.05 10.13 62 132660 73245 79538421
Crystal urine present 17.92 10.13 20 132702 2140 79609526
Diplopia 17.92 10.13 106 132616 33360 79578306
Wound infection staphylococcal 17.79 10.13 24 132698 3120 79608546
Polyneuropathy 17.73 10.13 9 132713 24142 79587524
Respiratory failure 17.72 10.13 410 132312 180501 79431165
Jaundice 17.71 10.13 39 132683 53310 79558356
Anaesthesia 17.70 10.13 11 132711 516 79611150
Blood pressure diastolic abnormal 17.69 10.13 5 132717 19197 79592469
Mydriasis 17.64 10.13 67 132655 17576 79594090
Cognitive disorder 17.61 10.13 186 132536 69740 79541926
Coordination abnormal 17.52 10.13 66 132656 17246 79594420
Intervertebral disc degeneration 17.51 10.13 62 132660 15723 79595943
Incision site swelling 17.41 10.13 9 132713 295 79611371
Brief psychotic disorder with marked stressors 17.27 10.13 9 132713 300 79611366
Impaired healing 17.24 10.13 81 132641 87574 79524092
Cerebral infarction 17.22 10.13 31 132691 45645 79566021
Hyperaesthesia 17.15 10.13 52 132670 12170 79599496
Pulmonary oedema 17.10 10.13 82 132640 88172 79523494
Pre-existing disease 17.04 10.13 8 132714 212 79611454
Vision blurred 16.97 10.13 259 132463 105639 79506027
Lipoedema 16.97 10.13 8 132714 214 79611452
Back disorder 16.95 10.13 50 132672 11528 79600138
Thyroxine decreased 16.94 10.13 13 132709 860 79610806
Narcissistic personality disorder 16.90 10.13 4 132718 9 79611657
Upper airway obstruction 16.89 10.13 16 132706 1412 79610254
Hemiparesis 16.89 10.13 105 132617 33628 79578038
Invasive ductal breast carcinoma 16.85 10.13 33 132689 5859 79605807
Acute generalised exanthematous pustulosis 16.83 10.13 4 132718 17250 79594416
Alanine aminotransferase increased 16.83 10.13 181 132541 162389 79449277
Back pain 16.83 10.13 642 132080 303538 79308128
Conversion disorder 16.78 10.13 18 132704 1843 79609823
Acute myeloid leukaemia 16.73 10.13 16 132706 30869 79580797
Cystitis 16.60 10.13 147 132575 52585 79559081
Quadriplegia 16.55 10.13 24 132698 3336 79608330
Juvenile idiopathic arthritis 16.54 10.13 29 132693 4734 79606932
Uterine enlargement 16.49 10.13 13 132709 895 79610771
Infected skin ulcer 16.33 10.13 24 132698 3377 79608289
Angioedema 16.33 10.13 68 132654 75967 79535699
Fibula fracture 16.32 10.13 25 132697 3649 79608017
Glossopharyngeal nerve disorder 16.30 10.13 5 132717 38 79611628
Obstructive airways disorder 16.24 10.13 17 132705 31442 79580224
Medical device site rash 16.20 10.13 3 132719 0 79611666
Medical device site oedema 16.20 10.13 3 132719 0 79611666
Medical device site mass 16.20 10.13 3 132719 0 79611666
Urine oxalate increased 16.10 10.13 8 132714 241 79611425
Mean platelet volume increased 16.09 10.13 14 132708 1106 79610560
Psychotic disorder 16.04 10.13 121 132601 41281 79570385
Protein total decreased 16.01 10.13 42 132680 9050 79602616
Myocardial infarction 16.00 10.13 213 132509 183916 79427750
Myelocyte percentage increased 15.95 10.13 8 132714 246 79611420
Excessive granulation tissue 15.95 10.13 13 132709 939 79610727
Intervertebral disc operation 15.90 10.13 13 132709 943 79610723
Quadriparesis 15.80 10.13 24 132698 3477 79608189
Haematuria 15.77 10.13 60 132662 68776 79542890
Blood pressure fluctuation 15.72 10.13 58 132664 67087 79544579
Gout 15.67 10.13 11 132711 24738 79586928
Graft versus host disease 15.65 10.13 3 132719 15023 79596643
Metastases to central nervous system 15.58 10.13 4 132718 16371 79595295
Pancreatitis 15.56 10.13 60 132662 68515 79543151
Urinary tract infection enterococcal 15.46 10.13 23 132699 3272 79608394
Shock haemorrhagic 15.45 10.13 7 132715 20053 79591613
Premature delivery 15.44 10.13 10 132712 23457 79588209
Spinal operation 15.43 10.13 38 132684 7879 79603787
Chest pain 15.40 10.13 355 132367 281949 79329717
Vertebral foraminal stenosis 15.37 10.13 14 132708 1175 79610491
Ventricular tachycardia 15.33 10.13 29 132693 41906 79569760
Tibia fracture 15.30 10.13 30 132692 5331 79606335
Skin reaction 15.23 10.13 60 132662 16008 79595658
Blood sodium increased 15.12 10.13 28 132694 4770 79606896
Drug screen positive 15.02 10.13 32 132690 6031 79605635
Injury 15.02 10.13 72 132650 77424 79534242
Stitch abscess 14.92 10.13 5 132717 52 79611614
Weight decreased 14.84 10.13 464 132258 354734 79256932
Staphylococcus test positive 14.69 10.13 33 132689 6448 79605218
Second primary malignancy 14.66 10.13 3 132719 14347 79597319
Peripheral nerve operation 14.64 10.13 4 132718 19 79611647
Ulcer 14.59 10.13 17 132705 29955 79581711
Injection site necrosis 14.58 10.13 15 132707 1463 79610203
Blood ketone body increased 14.56 10.13 11 132711 711 79610955
Urine abnormality 14.51 10.13 38 132684 8181 79603485
Pregnancy 14.44 10.13 14 132708 26837 79584829
Neurosis 14.37 10.13 9 132713 428 79611238
Arrhythmia 14.30 10.13 53 132669 61219 79550447
Eosinophil percentage increased 14.25 10.13 15 132707 1503 79610163
CSF shunt operation 14.13 10.13 3 132719 3 79611663
Incision site vesicles 14.13 10.13 3 132719 3 79611663
Retinal depigmentation 14.09 10.13 8 132714 317 79611349
Myocardial ischaemia 14.09 10.13 13 132709 25506 79586160
Streptococcus test positive 14.08 10.13 18 132704 2220 79609446
Creatinine renal clearance decreased 14.07 10.13 7 132715 18995 79592671
Post laminectomy syndrome 14.07 10.13 8 132714 318 79611348
Unevaluable event 14.07 10.13 148 132574 55437 79556229
Posture abnormal 14.03 10.13 24 132698 3842 79607824
Tonic clonic movements 13.92 10.13 18 132704 2246 79609420
Lung disorder 13.84 10.13 78 132644 80479 79531187
General symptom 13.82 10.13 19 132703 2515 79609151
Frontotemporal dementia 13.82 10.13 10 132712 605 79611061
Therapeutic product effect incomplete 13.76 10.13 160 132562 141485 79470181
Medical device site irritation 13.72 10.13 4 132718 25 79611641
Implant site mass 13.71 10.13 5 132717 68 79611598
Mouth ulceration 13.65 10.13 27 132695 38367 79573299
Implant site rash 13.56 10.13 6 132716 138 79611528
Orthostatic hypotension 13.49 10.13 48 132674 56116 79555550
Neck pain 13.48 10.13 188 132534 75229 79536437
Asthenia 13.47 10.13 1007 131715 510682 79100984
Major depression 13.35 10.13 39 132683 8941 79602725
Cervical spinal stenosis 13.34 10.13 18 132704 2341 79609325
Injection site abscess 13.29 10.13 15 132707 1625 79610041
Urinary sediment abnormal 13.29 10.13 6 132716 145 79611521
Purpura 13.29 10.13 8 132714 19519 79592147
Hypervigilance 13.28 10.13 9 132713 490 79611176
Death 13.21 10.13 790 131932 565724 79045942
Device material issue 13.18 10.13 7 132715 243 79611423
Upper gastrointestinal haemorrhage 13.13 10.13 31 132691 41349 79570317
Nervous system disorder 13.07 10.13 83 132639 26773 79584893
Spinal cord injury cauda equina 13.03 10.13 6 132716 152 79611514
Prescribed underdose 13.02 10.13 89 132633 29425 79582241
Hyponatraemia 12.94 10.13 213 132509 177635 79434031
Psychogenic seizure 12.90 10.13 16 132706 1915 79609751
Myelodysplastic syndrome 12.89 10.13 19 132703 30282 79581384
Cerebral vasoconstriction 12.87 10.13 14 132708 1456 79610210
Pericardial effusion 12.87 10.13 37 132685 46200 79565466
Rotator cuff syndrome 12.85 10.13 52 132670 14043 79597623
Adverse event 12.83 10.13 54 132668 60160 79551506
Hip arthroplasty 12.83 10.13 25 132697 35731 79575935
Cardiogenic shock 12.83 10.13 32 132690 41882 79569784
Postoperative wound infection 12.78 10.13 49 132673 12912 79598754
Blood ethanol increased 12.75 10.13 10 132712 683 79610983
Blood folate increased 12.70 10.13 9 132713 527 79611139
Klebsiella test positive 12.69 10.13 15 132707 1708 79609958
Specific gravity urine decreased 12.67 10.13 11 132711 867 79610799
Hypoxic-ischaemic encephalopathy 12.64 10.13 35 132687 7785 79603881
Glycosylated haemoglobin decreased 12.64 10.13 10 132712 692 79610974
Immature granulocyte percentage increased 12.64 10.13 5 132717 86 79611580
Intraductal proliferative breast lesion 12.58 10.13 18 132704 2473 79609193
Colitis microscopic 12.56 10.13 43 132679 10725 79600941
Rales 12.52 10.13 9 132713 19992 79591674
Personality disorder 12.51 10.13 30 132692 6116 79605550
Pneumonia 12.50 10.13 938 131784 659308 78952358
Plasma cell myeloma 12.47 10.13 46 132676 53213 79558453
Partial seizures 12.41 10.13 38 132684 8940 79602726
Renal tubular necrosis 12.41 10.13 14 132708 25025 79586641
Hepatic failure 12.37 10.13 56 132666 61156 79550510
Angina unstable 12.37 10.13 6 132716 16521 79595145
Implant site warmth 12.35 10.13 4 132718 37 79611629
Neuromuscular blocking therapy 12.32 10.13 3 132719 8 79611658
Coagulopathy 12.22 10.13 26 132696 35980 79575686
Procedural complication 12.19 10.13 35 132687 7948 79603718
Diplegia 12.14 10.13 15 132707 1788 79609878
Chronic fatigue syndrome 12.09 10.13 13 132709 1334 79610332
Myocarditis 12.08 10.13 11 132711 21722 79589944
Progressive relapsing multiple sclerosis 12.08 10.13 4 132718 40 79611626
Medical device site haemorrhage 12.07 10.13 6 132716 181 79611485
Visual impairment 12.06 10.13 218 132504 91913 79519753
Implant site necrosis 12.06 10.13 3 132719 9 79611657
Urine cannabinoids increased 12.06 10.13 3 132719 9 79611657
Urine osmolarity increased 12.00 10.13 7 132715 292 79611374
Malaise 11.98 10.13 680 132042 489189 79122477
Logorrhoea 11.95 10.13 24 132698 4341 79607325
Incontinence 11.93 10.13 51 132671 14113 79597553
Device deposit issue 11.90 10.13 4 132718 42 79611624
Calculus bladder 11.89 10.13 13 132709 1359 79610307
Lower gastrointestinal haemorrhage 11.85 10.13 6 132716 16119 79595547
Eyelid oedema 11.82 10.13 4 132718 13683 79597983
Medical device site scab 11.82 10.13 3 132719 10 79611656
Panniculitis 11.81 10.13 3 132719 12368 79599298
Eosinophil percentage decreased 11.73 10.13 7 132715 305 79611361
Somatosensory evoked potentials abnormal 11.68 10.13 6 132716 194 79611472
Head injury 11.67 10.13 104 132618 37265 79574401
Hypokalaemia 11.67 10.13 169 132553 143871 79467795
Cerebral palsy 11.66 10.13 6 132716 195 79611471
Limb discomfort 11.62 10.13 94 132628 32756 79578910
Pituitary cyst 11.60 10.13 3 132719 11 79611655
Hyperthermia 11.57 10.13 60 132662 17977 79593689
Peripheral venous disease 11.57 10.13 6 132716 15903 79595763
Allodynia 11.56 10.13 14 132708 1634 79610032
Noninfective encephalitis 11.51 10.13 9 132713 612 79611054
Aspergillus infection 11.51 10.13 9 132713 19152 79592514
Pyrexia 11.49 10.13 973 131749 677736 78933930
Aspartate aminotransferase increased 11.46 10.13 162 132560 138479 79473187
Acute psychosis 11.46 10.13 23 132699 4157 79607509
Tender joint count 11.43 10.13 6 132716 203 79611463
Vasculitis 11.42 10.13 15 132707 25087 79586579
Drug ineffective for unapproved indication 11.40 10.13 133 132589 51105 79560561
Infusion site macule 11.39 10.13 3 132719 12 79611654
Acute coronary syndrome 11.39 10.13 11 132711 21122 79590544
Sedation complication 11.39 10.13 54 132668 15615 79596051
Cataract 11.30 10.13 59 132663 62061 79549605
Arteriosclerosis coronary artery 11.25 10.13 59 132663 17757 79593909
Syringomyelia 11.25 10.13 6 132716 210 79611456
Nodule 11.24 10.13 13 132709 22981 79588685
Facial asymmetry 11.22 10.13 10 132712 816 79610850
Fibromyalgia 11.21 10.13 62 132660 64278 79547388
Ill-defined disorder 11.20 10.13 64 132658 65811 79545855
Neuropsychiatric syndrome 11.14 10.13 5 132717 119 79611547
Demyelination 11.13 10.13 34 132688 7989 79603677
Consciousness fluctuating 11.09 10.13 15 132707 1954 79609712
Mobility decreased 11.08 10.13 274 132448 121901 79489765
Acquired diaphragmatic eventration 11.05 10.13 9 132713 649 79611017
Acute respiratory distress syndrome 11.03 10.13 37 132685 44030 79567636
Hyperuricaemia 11.00 10.13 3 132719 11796 79599870
Tachycardia 10.99 10.13 380 132342 177388 79434278
CD4 lymphocytes abnormal 10.99 10.13 4 132718 54 79611612
Lip dry 10.94 10.13 6 132716 15412 79596254
Decreased interest 10.93 10.13 21 132701 3676 79607990
Lymphocyte count abnormal 10.93 10.13 13 132709 1490 79610176
CD8 lymphocytes increased 10.93 10.13 4 132718 55 79611611
Implant site pruritus 10.92 10.13 8 132714 493 79611173
Anti-thyroid antibody positive 10.92 10.13 8 132714 493 79611173
Anaphylactic reaction 10.92 10.13 88 132634 83655 79528011
Blood potassium increased 10.92 10.13 20 132702 29255 79582411
Urine uric acid decreased 10.92 10.13 5 132717 125 79611541
Nerve compression 10.87 10.13 37 132685 9202 79602464
Implant site pustules 10.85 10.13 3 132719 15 79611651
Glaucoma 10.84 10.13 63 132659 19698 79591968
Adrenal neoplasm 10.81 10.13 8 132714 501 79611165
Fistula 10.80 10.13 4 132718 12936 79598730
Hyperbilirubinaemia 10.80 10.13 15 132707 24503 79587163
Hiccups 10.79 10.13 39 132683 9992 79601674
Neuromuscular toxicity 10.77 10.13 6 132716 229 79611437
Neoplasm malignant 10.77 10.13 23 132699 31787 79579879
Mental disorder 10.76 10.13 89 132633 31213 79580453
Enthesopathy 10.73 10.13 43 132679 11565 79600101
SARS-CoV-2 antibody test negative 10.70 10.13 6 132716 232 79611434
Intestinal perforation 10.70 10.13 8 132714 17418 79594248
Septic shock 10.69 10.13 142 132580 122659 79489007
Tuberculosis 10.66 10.13 6 132716 15192 79596474
Fear of falling 10.62 10.13 9 132713 686 79610980
Oxygen saturation decreased 10.59 10.13 151 132571 128896 79482770
Red blood cell sedimentation rate increased 10.55 10.13 40 132682 45902 79565764
Syncope 10.54 10.13 223 132499 179226 79432440
Granulocytopenia 10.49 10.13 3 132719 11428 79600238
Torsade de pointes 10.47 10.13 10 132712 19302 79592364
Haemoglobin increased 10.47 10.13 28 132694 6104 79605562
Spinal stenosis 10.46 10.13 53 132669 15738 79595928
Rib fracture 10.45 10.13 81 132641 27866 79583800
Invasive lobular breast carcinoma 10.44 10.13 9 132713 702 79610964
Catheter site mass 10.43 10.13 4 132718 63 79611603
Influenza B virus test positive 10.43 10.13 7 132715 375 79611291
Lupus-like syndrome 10.42 10.13 5 132717 13852 79597814
Hepatitis cholestatic 10.41 10.13 5 132717 13847 79597819
Hepatic cirrhosis 10.41 10.13 27 132695 34879 79576787
Athetosis 10.40 10.13 5 132717 140 79611526
Osteoporosis postmenopausal 10.39 10.13 3 132719 18 79611648
Viral titre decreased 10.39 10.13 3 132719 18 79611648
Ischaemic stroke 10.37 10.13 25 132697 33106 79578560
Gram stain positive 10.33 10.13 5 132717 142 79611524
Intestinal polyp 10.32 10.13 15 132707 2089 79609577
Spinal cord infection 10.31 10.13 8 132714 538 79611128
Drug-induced liver injury 10.31 10.13 66 132656 66051 79545615
Tongue biting 10.23 10.13 15 132707 2106 79609560

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

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

Drug Use | 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 AMNEAL N215422 Nov. 22, 2021 RX GRANULES ORAL 10792262 July 29, 2039 METHOD FOR TREATING SPASTICITY
20MG/PACKET LYVISPAH AMNEAL N215422 Nov. 22, 2021 RX GRANULES ORAL 10792262 July 29, 2039 METHOD FOR TREATING SPASTICITY
5MG/PACKET LYVISPAH AMNEAL N215422 Nov. 22, 2021 RX GRANULES ORAL 10792262 July 29, 2039 METHOD FOR TREATING SPASTICITY
5MG/5ML OZOBAX METACEL PHARMS LLC N208193 Sept. 18, 2019 RX SOLUTION ORAL 10610502 Aug. 30, 2039 TREATMENT OF SPASTICITY
10MG/PACKET LYVISPAH AMNEAL N215422 Nov. 22, 2021 RX GRANULES 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 AMNEAL N215422 Nov. 22, 2021 RX GRANULES ORAL 11491125 Sept. 29, 2041 TREATMENT OF SPASTICITY RESULTING FROM SPINAL CORD INJURIES AND OTHER SPINAL CORD DISEASES
20MG/PACKET LYVISPAH AMNEAL N215422 Nov. 22, 2021 RX GRANULES 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 AMNEAL N215422 Nov. 22, 2021 RX GRANULES ORAL 11491125 Sept. 29, 2041 TREATMENT OF SPASTICITY RESULTING FROM SPINAL CORD INJURIES AND OTHER SPINAL CORD DISEASES
5MG/PACKET LYVISPAH AMNEAL N215422 Nov. 22, 2021 RX GRANULES 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 AMNEAL N215422 Nov. 22, 2021 RX GRANULES ORAL 11491125 Sept. 29, 2041 TREATMENT OF SPASTICITY RESULTING FROM SPINAL CORD INJURIES AND OTHER SPINAL CORD DISEASES

Orange Book exclusivity data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
25MG/5ML BACLOFEN SLAYBACK PHARMA LLC A217252 June 8, 2023 RX SUSPENSION ORAL Dec. 16, 2023 PATENT CHALLENGE

Bioactivity Summary:

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

External reference:

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

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Baclofen HUMAN PRESCRIPTION DRUG LABEL 1 0115-1010 TABLET 10 mg ORAL ANDA 11 sections
Baclofen HUMAN PRESCRIPTION DRUG LABEL 1 0115-1010 TABLET 10 mg ORAL ANDA 11 sections
Baclofen HUMAN PRESCRIPTION DRUG LABEL 1 0115-1011 TABLET 5 mg ORAL ANDA 11 sections
Baclofen HUMAN PRESCRIPTION DRUG LABEL 1 0115-1011 TABLET 5 mg ORAL ANDA 11 sections
Baclofen HUMAN PRESCRIPTION DRUG LABEL 1 0115-1012 TABLET 20 mg ORAL ANDA 11 sections
Baclofen HUMAN PRESCRIPTION DRUG LABEL 1 0115-1012 TABLET 20 mg ORAL ANDA 11 sections
Baclofen HUMAN PRESCRIPTION DRUG LABEL 1 0172-4096 TABLET 10 mg ORAL ANDA 12 sections
Baclofen HUMAN PRESCRIPTION DRUG LABEL 1 0172-4097 TABLET 20 mg ORAL ANDA 12 sections
Baclofen HUMAN PRESCRIPTION DRUG LABEL 1 0527-1330 TABLET 10 mg ORAL ANDA 12 sections
Baclofen HUMAN PRESCRIPTION DRUG LABEL 1 0527-1333 TABLET 5 mg ORAL ANDA 12 sections
Baclofen HUMAN PRESCRIPTION DRUG LABEL 1 0527-1337 TABLET 20 mg ORAL ANDA 12 sections
Baclofen HUMAN PRESCRIPTION DRUG LABEL 1 0603-2406 TABLET 10 mg ORAL ANDA 12 sections
Baclofen HUMAN PRESCRIPTION DRUG LABEL 1 0603-2406 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 0603-2407 TABLET 20 mg ORAL ANDA 12 sections
Baclofen HUMAN PRESCRIPTION DRUG LABEL 1 0615-3541 TABLET 10 mg ORAL ANDA 12 sections
Baclofen HUMAN PRESCRIPTION DRUG LABEL 1 0615-3542 TABLET 20 mg ORAL ANDA 12 sections
Baclofen HUMAN PRESCRIPTION DRUG LABEL 1 0615-8411 TABLET 10 mg ORAL ANDA 11 sections
Baclofen HUMAN PRESCRIPTION DRUG LABEL 1 0615-8411 TABLET 10 mg ORAL ANDA 11 sections
Baclofen HUMAN PRESCRIPTION DRUG LABEL 1 0615-8412 TABLET 20 mg ORAL ANDA 11 sections
Baclofen HUMAN PRESCRIPTION DRUG LABEL 1 0615-8412 TABLET 20 mg ORAL ANDA 11 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 0832-1054 TABLET 10 mg ORAL ANDA 13 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 0832-1055 TABLET 20 mg ORAL ANDA 13 sections
Baclofen HUMAN PRESCRIPTION DRUG LABEL 1 0904-6475 TABLET 10 mg ORAL ANDA 12 sections
Baclofen HUMAN PRESCRIPTION DRUG LABEL 1 0904-6475 TABLET 10 mg ORAL ANDA 12 sections
Baclofen HUMAN PRESCRIPTION DRUG LABEL 1 0904-6476 TABLET 20 mg ORAL ANDA 12 sections