baclofen 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 ┬ÁM/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
Muscle spasticity 2011.71 10.21 866 96467 16972 53234761
Hypertonia 1567.34 10.21 507 96826 4230 53247503
Multiple sclerosis relapse 1487.11 10.21 959 96374 43894 53207839
Drug withdrawal syndrome 1200.83 10.21 706 96627 27316 53224417
Multiple sclerosis 885.63 10.21 575 96758 26578 53225155
Implant site infection 549.31 10.21 158 97175 839 53250894
Implant site extravasation 527.62 10.21 134 97199 397 53251336
Hypotonia 416.49 10.21 238 97095 8703 53243030
Coma 382.50 10.21 516 96817 61267 53190466
Somnolence 338.30 10.21 862 96471 166872 53084861
Muscle spasms 323.49 10.21 741 96592 134054 53117679
Overdose 317.85 10.21 644 96689 107092 53144641
Urinary tract infection 303.14 10.21 1044 96289 238859 53012874
Gait disturbance 270.49 10.21 767 96566 158075 53093658
Cerebrospinal fluid leakage 262.20 10.21 90 97243 916 53250817
Seizure 247.98 10.21 653 96680 128856 53122877
Muscular weakness 233.14 10.21 547 96786 100445 53151288
Pneumonia aspiration 228.37 10.21 297 97036 34004 53217729
Complication associated with device 212.48 10.21 200 97133 15965 53235768
Withdrawal syndrome 203.95 10.21 212 97121 19089 53232644
Fall 202.06 10.21 1229 96104 357211 52894522
Device failure 185.48 10.21 124 97209 6011 53245722
Mental status changes 181.52 10.21 287 97046 39284 53212449
Implant site erosion 179.55 10.21 40 97293 51 53251682
Device infusion issue 175.81 10.21 71 97262 1172 53250561
Unresponsive to stimuli 170.99 10.21 255 97078 33171 53218562
Muscle tightness 165.62 10.21 147 97186 10874 53240859
Completed suicide 155.86 10.21 580 96753 137621 53114112
Diarrhoea 148.72 10.21 613 96720 624933 52626800
Intracranial hypotension 147.19 10.21 44 97289 273 53251460
Glossodynia 141.20 10.21 11 97322 100280 53151453
Device power source issue 138.02 10.21 47 97286 466 53251267
Implant site discharge 137.72 10.21 35 97298 104 53251629
Rheumatoid arthritis 134.17 10.21 230 97103 314301 52937432
Underdose 133.44 10.21 180 97153 21342 53230391
Joint swelling 132.04 10.21 140 97193 234498 53017235
Rash 130.00 10.21 401 96932 445790 52805943
Anaemia 128.71 10.21 191 97142 276527 52975206
Febrile neutropenia 128.71 10.21 19 97314 104917 53146816
Device malfunction 118.96 10.21 146 97187 15762 53235971
Therapy non-responder 118.67 10.21 271 97062 48849 53202884
Systemic lupus erythematosus 117.50 10.21 41 97292 125373 53126360
Secondary progressive multiple sclerosis 115.90 10.21 54 97279 1278 53250455
Implant site swelling 115.31 10.21 41 97292 467 53251266
Medical device site pain 113.59 10.21 34 97299 212 53251521
Medical device site infection 110.82 10.21 31 97302 146 53251587
Device physical property issue 109.73 10.21 57 97276 1718 53250015
Decubitus ulcer 108.59 10.21 114 97219 10379 53241354
Hypoaesthesia 106.68 10.21 503 96830 132492 53119241
White blood cell count abnormal 106.48 10.21 84 97249 5274 53246459
Abdominal discomfort 106.28 10.21 149 97184 220913 53030820
Device connection issue 105.96 10.21 43 97290 719 53251014
Contraindicated product administered 105.49 10.21 58 97275 135571 53116162
Pericarditis 103.57 10.21 3 97330 64403 53187330
Infusion related reaction 103.25 10.21 80 97253 155877 53095856
Implant site pain 103.17 10.21 60 97273 2267 53249466
Balance disorder 98.65 10.21 326 97007 72881 53178852
Hand deformity 98.17 10.21 18 97315 84831 53166902
Device dislocation 97.14 10.21 163 97170 23434 53228299
Progressive multiple sclerosis 96.29 10.21 41 97292 778 53250955
Neutropenia 94.03 10.21 91 97242 159094 53092639
Central nervous system lesion 92.20 10.21 103 97230 10059 53241674
Post lumbar puncture syndrome 91.00 10.21 37 97296 622 53251111
Memory impairment 90.73 10.21 350 96983 84407 53167326
Dyspnoea 90.35 10.21 663 96670 585569 52666164
Influenza like illness 90.17 10.21 280 97053 60579 53191154
Maternal exposure during pregnancy 89.59 10.21 91 97242 155548 53096185
Therapeutic response decreased 87.99 10.21 237 97096 47332 53204401
Device inversion 87.49 10.21 17 97316 3 53251730
Exposure during pregnancy 83.97 10.21 63 97270 124797 53126936
Acute kidney injury 83.49 10.21 215 97118 253653 52998080
Arthropathy 83.37 10.21 81 97252 141372 53110361
Lymphocyte count decreased 82.94 10.21 168 97165 27884 53223849
Synovitis 82.65 10.21 47 97286 107846 53143887
Device kink 80.27 10.21 49 97284 2026 53249707
Wound dehiscence 80.01 10.21 67 97266 4579 53247154
Malignant neoplasm progression 78.94 10.21 17 97316 71524 53180209
Urine analysis abnormal 77.71 10.21 65 97268 4435 53247298
Progressive multifocal leukoencephalopathy 77.56 10.21 103 97230 12026 53239707
Pseudomeningocele 74.59 10.21 15 97318 6 53251727
Musculoskeletal stiffness 72.35 10.21 428 96905 122940 53128793
Tremor 71.69 10.21 433 96900 125303 53126430
Toxic encephalopathy 71.57 10.21 70 97263 5857 53245876
Thrombocytopenia 71.22 10.21 89 97244 138638 53113095
Pancytopenia 70.51 10.21 39 97294 90889 53160844
Dystonia 68.96 10.21 101 97232 12920 53238813
Respiratory depression 68.79 10.21 100 97233 12706 53239027
Interstitial lung disease 68.75 10.21 12 97321 58610 53193123
Cough 68.33 10.21 240 97093 256653 52995080
Drug intolerance 68.32 10.21 173 97160 205320 53046413
Medical device site swelling 67.38 10.21 14 97319 9 53251724
Product use issue 67.11 10.21 94 97239 139490 53112243
Paraesthesia 66.98 10.21 430 96903 127085 53124648
Pain 66.39 10.21 1470 95863 586928 52664805
Muscle rigidity 66.17 10.21 90 97243 10751 53240982
Medical device site discharge 66.14 10.21 16 97317 36 53251697
Lower respiratory tract infection 64.99 10.21 43 97290 90938 53160795
Swelling 64.22 10.21 160 97173 190945 53060788
Clonus 64 10.21 57 97276 4234 53247499
Arthralgia 62.16 10.21 509 96824 439274 52812459
Peripheral swelling 61.43 10.21 183 97150 205925 53045808
Seroma 61.24 10.21 42 97291 2123 53249610
Asphyxia 60.86 10.21 64 97269 5837 53245896
Alopecia 59.17 10.21 224 97109 234359 53017374
Off label use 58.62 10.21 565 96768 471647 52780086
Toxicity to various agents 58.38 10.21 635 96698 218963 53032770
Immune reconstitution inflammatory syndrome 57.02 10.21 64 97269 6282 53245451
Infusion site mass 56.70 10.21 31 97302 1038 53250695
Pocket erosion 55.75 10.21 11 97322 3 53251730
Lethargy 55.07 10.21 219 97114 53541 53198192
Medical device site erythema 54.77 10.21 13 97320 26 53251707
Cardiac failure 53.11 10.21 47 97286 85797 53165936
Neurogenic bladder 52.48 10.21 44 97289 3012 53248721
Trigeminal neuralgia 52.01 10.21 45 97288 3216 53248517
Pleural effusion 51.85 10.21 51 97282 88528 53163205
Diplopia 51.73 10.21 116 97217 20649 53231084
Peroneal nerve palsy 51.11 10.21 51 97282 4372 53247361
Device alarm issue 50.95 10.21 33 97300 1515 53250218
Gastrointestinal haemorrhage 50.89 10.21 43 97290 80287 53171446
Device leakage 50.71 10.21 59 97274 6021 53245712
Mucosal inflammation 49.64 10.21 9 97324 42775 53208958
Agitation 49.35 10.21 225 97108 58401 53193332
Sedation 49.10 10.21 142 97191 29533 53222200
Implant site haematoma 49.03 10.21 14 97319 72 53251661
Generalised tonic-clonic seizure 47.96 10.21 138 97195 28620 53223113
Urinary incontinence 47.68 10.21 144 97189 30677 53221056
Escherichia urinary tract infection 47.07 10.21 78 97255 11095 53240638
Areflexia 46.62 10.21 41 97292 2995 53248738
Gastrooesophageal reflux disease 46.02 10.21 283 97050 82380 53169353
Gait inability 45.81 10.21 164 97169 38147 53213586
Paralysis 45.71 10.21 70 97263 9314 53242419
Wound 45.67 10.21 60 97273 91497 53160236
JC polyomavirus test positive 44.90 10.21 27 97306 1086 53250647
Motor dysfunction 44.74 10.21 65 97268 8253 53243480
Magnetic resonance imaging abnormal 44.57 10.21 39 97294 2830 53248903
Drug delivery device placement 44.55 10.21 14 97319 105 53251628
Implant site reaction 44.38 10.21 15 97318 145 53251588
Insomnia 44.30 10.21 529 96804 186543 53065190
Neuralgia 44.30 10.21 118 97215 23403 53228330
Hyporeflexia 43.59 10.21 33 97300 1949 53249784
Incision site oedema 43.56 10.21 10 97323 16 53251717
Device computer issue 43.19 10.21 9 97324 6 53251727
Folliculitis 43.18 10.21 4 97329 31705 53220028
Lymphopenia 42.97 10.21 95 97238 16748 53234985
Urosepsis 42.73 10.21 94 97239 16516 53235217
Status epilepticus 42.60 10.21 89 97244 15095 53236638
Meningitis 42.25 10.21 56 97277 6525 53245208
Renal impairment 42.17 10.21 54 97279 83264 53168469
Focal dyscognitive seizures 42.03 10.21 38 97295 2879 53248854
Implant site erythema 41.99 10.21 20 97313 498 53251235
Optic neuritis 41.93 10.21 59 97274 7276 53244457
Burning sensation 41.70 10.21 186 97147 47827 53203906
Osteonecrosis of jaw 41.09 10.21 8 97325 36138 53215595
Device occlusion 41.04 10.21 56 97277 6709 53245024
Ascites 40.77 10.21 11 97322 39724 53212009
Medical device site fibrosis 39.93 10.21 8 97325 3 53251730
Speech disorder 39.63 10.21 159 97174 39022 53212711
Atrial fibrillation 39.44 10.21 91 97242 111561 53140172
Nasopharyngitis 38.55 10.21 200 97133 192095 53059638
Therapeutic product effect decreased 38.55 10.21 110 97223 125545 53126188
Hallucination 38.38 10.21 197 97136 53641 53198092
Bone marrow failure 37.97 10.21 5 97328 30110 53221623
Metabolic encephalopathy 37.82 10.21 50 97283 5811 53245922
Encephalopathy 37.74 10.21 150 97183 36658 53215075
Concussion 37.71 10.21 58 97275 7746 53243987
Renal failure 37.59 10.21 102 97231 118350 53133383
Muscle injury 37.39 10.21 5 97328 29761 53221972
Scoliosis 37.34 10.21 54 97279 6828 53244905
Hypokinesia 37.30 10.21 77 97256 12950 53238783
Haemoglobin decreased 36.64 10.21 128 97205 137179 53114554
Decreased appetite 36.46 10.21 236 97097 214738 53036995
Hepatic function abnormal 36.41 10.21 11 97322 36888 53214845
Paraparesis 36.27 10.21 31 97302 2179 53249554
Platelet count decreased 35.89 10.21 91 97242 108008 53143725
Laboratory test abnormal 35.85 10.21 112 97221 24297 53227436
Cardiac failure congestive 35.75 10.21 72 97261 92685 53159048
Muscle twitching 35.71 10.21 87 97246 16339 53235394
Blood creatinine increased 35.55 10.21 60 97273 82602 53169131
Device extrusion 34.41 10.21 9 97324 31 53251702
Urine leukocyte esterase positive 34.19 10.21 34 97299 2902 53248831
Depression 33.89 10.21 495 96838 182557 53069176
Gait spastic 33.35 10.21 14 97319 256 53251477
Sleep disorder due to general medical condition, insomnia type 33.35 10.21 3 97330 24346 53227387
Device expulsion 33.05 10.21 7 97326 29806 53221927
Red blood cells urine positive 32.47 10.21 33 97300 2891 53248842
Toxic epidermal necrolysis 31.99 10.21 3 97330 23547 53228186
Abdominal pain 31.73 10.21 306 97027 255597 52996136
Electroencephalogram abnormal 31.73 10.21 37 97296 3784 53247949
Treatment failure 31.44 10.21 124 97209 128279 53123454
Neoplasm progression 31.23 10.21 8 97325 29911 53221822
Hyponatraemia 31.20 10.21 98 97235 108509 53143224
Medical device site reaction 30.97 10.21 7 97326 10 53251723
Implant site scar 30.96 10.21 13 97320 238 53251495
Muscle contracture 30.88 10.21 23 97310 1325 53250408
Disease progression 30.69 10.21 90 97243 101830 53149903
Multiple organ dysfunction syndrome 30.39 10.21 34 97299 55643 53196090
Erythema 29.93 10.21 166 97167 156803 53094930
Hypersensitivity 29.58 10.21 244 97089 210421 53041312
Asthma 29.46 10.21 101 97232 108871 53142862
Medical device change 28.80 10.21 14 97319 365 53251368
Blister 28.77 10.21 63 97270 78690 53173043
Hyperkalaemia 28.68 10.21 34 97299 54222 53197511
Dyspnoea exertional 28.50 10.21 35 97298 54965 53196768
White blood cells urine positive 28.14 10.21 38 97295 4507 53247226
General physical health deterioration 27.69 10.21 156 97177 146786 53104947
Ankle fracture 27.29 10.21 79 97254 16436 53235297
Premature delivery 27.21 10.21 7 97326 26097 53225636
Sinusitis 27.09 10.21 188 97145 168376 53083357
Loss of consciousness 27.02 10.21 323 97010 113889 53137844
Therapy cessation 26.97 10.21 112 97221 27913 53223820
Respiratory arrest 26.95 10.21 127 97206 33413 53218320
Irritability 26.94 10.21 120 97213 30833 53220900
Drug interaction 26.87 10.21 263 97070 219066 53032667
Urinary retention 26.80 10.21 113 97220 28353 53223380
Medical device site discomfort 26.71 10.21 13 97320 340 53251393
Arteriosclerosis coronary artery 26.63 10.21 52 97281 8402 53243331
CSF pressure decreased 26.54 10.21 5 97328 0 53251733
Device breakage 26.28 10.21 59 97274 10508 53241225
Palmar-plantar erythrodysaesthesia syndrome 26.27 10.21 4 97329 21602 53230131
Device issue 26.13 10.21 93 97240 21565 53230168
Dehydration 26.00 10.21 190 97143 168220 53083513
Monocyte percentage increased 25.92 10.21 19 97314 1068 53250665
Hemiparesis 25.73 10.21 92 97241 21383 53230350
Wheezing 25.72 10.21 50 97283 65225 53186508
Myoclonus 25.66 10.21 75 97258 15689 53236044
Confusional state 25.59 10.21 497 96836 193724 53058009
Temperature intolerance 25.50 10.21 50 97283 8103 53243630
Psoriasis 25.43 10.21 78 97255 87011 53164722
Medical device discomfort 25.43 10.21 25 97308 2105 53249628
Plasma cell myeloma 25.30 10.21 30 97303 47844 53203889
Hypoglycaemia 25.22 10.21 43 97290 58970 53192763
Consciousness fluctuating 25.19 10.21 16 97317 710 53251023
Hypothermia 25.09 10.21 66 97267 12990 53238743
Ataxia 24.84 10.21 71 97262 14666 53237067
Melaena 24.83 10.21 11 97322 29118 53222615
Cognitive disorder 24.72 10.21 153 97180 44625 53207108
Device programming error 24.58 10.21 8 97325 68 53251665
Soft tissue injury 24.50 10.21 20 97313 1319 53250414
Epistaxis 24.26 10.21 56 97277 68654 53183079
Enthesopathy 24.20 10.21 43 97290 6468 53245265
Pulmonary fibrosis 24.17 10.21 7 97326 24128 53227605
Depressed level of consciousness 24.06 10.21 176 97157 54252 53197481
Flushing 24.00 10.21 215 97118 70385 53181348
Productive cough 23.64 10.21 42 97291 56687 53195046
Cerebral palsy 23.63 10.21 9 97324 126 53251607
Drug resistance 23.59 10.21 4 97329 19958 53231775
Hyperhidrosis 23.45 10.21 275 97058 96518 53155215
Band neutrophil count increased 23.33 10.21 12 97321 354 53251379
Therapeutic response unexpected 23.32 10.21 77 97256 17193 53234540
Movement disorder 23.21 10.21 81 97252 18600 53233133
Dysstasia 23.03 10.21 82 97251 19017 53232716
Skin reaction 23.01 10.21 61 97272 12062 53239671
Disorientation 22.69 10.21 136 97197 39223 53212510
Basal ganglion degeneration 22.55 10.21 13 97320 483 53251250
Urinary sediment present 22.48 10.21 23 97310 2031 53249702
Dysphagia 22.35 10.21 244 97089 84153 53167580
Monoplegia 22.34 10.21 28 97305 3087 53248646
Incision site complication 22.31 10.21 14 97319 608 53251125
Muscle atrophy 22.30 10.21 41 97292 6333 53245400
Nausea 22.02 10.21 1142 96191 754949 52496784
Tissue infiltration 21.99 10.21 14 97319 624 53251109
Primary progressive multiple sclerosis 21.97 10.21 8 97325 98 53251635
Nitrite urine present 21.88 10.21 16 97317 896 53250837
Metabolic acidosis 21.76 10.21 27 97306 42215 53209518
Colitis microscopic 21.58 10.21 43 97290 7051 53244682
Coordination abnormal 21.54 10.21 59 97274 11892 53239841
Loss of control of legs 21.51 10.21 19 97314 1396 53250337
Amnesia 21.50 10.21 149 97184 45139 53206594
Dysarthria 21.39 10.21 137 97196 40431 53211302
Prescribed underdose 21.29 10.21 70 97263 15597 53236136
Cholestasis 21.25 10.21 13 97320 28682 53223051
Implant site ulcer 21.23 10.21 4 97329 0 53251733
Upper airway obstruction 21.19 10.21 14 97319 665 53251068
Lactic acidosis 21.16 10.21 22 97311 37231 53214502
Anaesthesia 21.13 10.21 12 97321 433 53251300
Postoperative wound infection 21.13 10.21 50 97283 9216 53242517
Discomfort 21.02 10.21 96 97237 95376 53156357
Hostility 21.02 10.21 20 97313 1617 53250116
Neutrophil percentage increased 20.93 10.21 26 97307 2840 53248893
Stiff person syndrome 20.92 10.21 10 97323 251 53251482
Relapsing-remitting multiple sclerosis 20.90 10.21 13 97320 556 53251177
Mobility decreased 20.89 10.21 222 97111 76049 53175684
Apnoea 20.83 10.21 45 97288 7808 53243925
Cytomegalovirus infection 20.83 10.21 5 97328 19534 53232199
Dysaesthesia 20.82 10.21 31 97302 4024 53247709
Culture urine positive 20.79 10.21 29 97304 3546 53248187
Neutrophil count decreased 20.78 10.21 36 97297 49062 53202671
Bladder disorder 20.70 10.21 45 97288 7843 53243890
Neurogenic bowel 20.69 10.21 8 97325 117 53251616
Sensory disturbance 20.68 10.21 61 97272 12825 53238908
Injection site scar 20.67 10.21 15 97318 830 53250903
Migraine 20.61 10.21 231 97102 80186 53171547
Tonic clonic movements 20.59 10.21 18 97315 1304 53250429
Proteinuria 20.53 10.21 4 97329 18064 53233669
Abdominal pain upper 20.53 10.21 199 97134 166092 53085641
Medical device site erosion 20.38 10.21 6 97327 35 53251698
Neurotoxicity 20.34 10.21 68 97265 15281 53236452
Device related infection 20.33 10.21 89 97244 22697 53229036
Dyskinesia 20.31 10.21 113 97220 31720 53220013
Drug reaction with eosinophilia and systemic symptoms 20.23 10.21 18 97315 32782 53218951
Incorrect route of product administration 20.19 10.21 79 97254 19165 53232568
C-reactive protein abnormal 20.18 10.21 11 97322 25859 53225874
Hepatic enzyme increased 20.14 10.21 141 97192 126054 53125679
Hepatotoxicity 20.14 10.21 13 97320 27867 53223866
Bladder spasm 20.14 10.21 19 97314 1520 53250213
Nystagmus 20.08 10.21 38 97295 5998 53245735
Fluid overload 20.07 10.21 13 97320 27818 53223915
Rash maculo-papular 19.99 10.21 15 97318 29734 53221999
Rash pruritic 19.97 10.21 38 97295 49972 53201761
Thyroid disorder 19.95 10.21 62 97271 13411 53238322
Haematochezia 19.87 10.21 29 97304 42329 53209404
Stevens-Johnson syndrome 19.85 10.21 10 97323 24572 53227161
Urticaria 19.70 10.21 156 97177 135729 53116004
Post procedural complication 19.63 10.21 71 97262 16595 53235138
Hypercalcaemia 19.52 10.21 10 97323 24338 53227395
Intentional self-injury 19.37 10.21 11 97322 25273 53226460
Band neutrophil percentage increased 19.16 10.21 9 97324 217 53251516
Product use in unapproved indication 19.15 10.21 123 97210 112166 53139567
Road traffic accident 19.11 10.21 95 97238 25536 53226197
Posturing 19.11 10.21 12 97321 522 53251211
Incision site vesicles 19 10.21 4 97329 3 53251730
Medical device site cellulitis 19 10.21 4 97329 3 53251730
Libido increased 18.96 10.21 16 97317 1105 53250628
Knee arthroplasty 18.87 10.21 20 97313 33549 53218184
Pulmonary oedema 18.79 10.21 44 97289 53679 53198054
Feeling abnormal 18.76 10.21 349 96984 134952 53116781
Agranulocytosis 18.67 10.21 10 97323 23739 53227994
Metastases to liver 18.51 10.21 8 97325 21488 53230245
International normalised ratio increased 18.46 10.21 37 97296 47724 53204009
Delirium 18.33 10.21 134 97199 41295 53210438
CSF test abnormal 18.20 10.21 10 97323 338 53251395
Myelocyte percentage increased 18.18 10.21 8 97325 165 53251568
Bradypnoea 18.08 10.21 26 97307 3271 53248462
Psoriatic arthropathy 18.06 10.21 38 97295 48152 53203581
Lower limb fracture 18.00 10.21 62 97271 14143 53237590
Pulmonary hypertension 17.99 10.21 25 97308 37245 53214488
Cataract 17.87 10.21 40 97293 49580 53202153
Incision site swelling 17.85 10.21 6 97327 57 53251676
Pneumocystis jirovecii pneumonia 17.84 10.21 4 97329 16374 53235359
Lymphocyte percentage decreased 17.82 10.21 24 97309 2839 53248894
Incoherent 17.55 10.21 31 97302 4641 53247092
Hypomagnesaemia 17.34 10.21 12 97321 24799 53226934
Hypersomnia 17.04 10.21 67 97266 16288 53235445
Rectal haemorrhage 17.02 10.21 31 97302 41450 53210283
Urinary tract infection bacterial 16.92 10.21 30 97303 4504 53247229
Incision site erythema 16.92 10.21 9 97324 285 53251448
Poisoning deliberate 16.70 10.21 44 97289 8669 53243064
Acute hepatic failure 16.47 10.21 5 97328 16715 53235018
Drug eruption 16.42 10.21 13 97320 25081 53226652
Blood potassium increased 16.41 10.21 6 97327 17835 53233898
Alcohol withdrawal syndrome 16.37 10.21 13 97320 824 53250909
Urine oxalate increased 16.31 10.21 8 97325 213 53251520
Conversion disorder 16.25 10.21 18 97315 1741 53249992
Neuropathy peripheral 16.12 10.21 116 97217 103071 53148662
Thyroxine decreased 16.06 10.21 11 97322 555 53251178
Injection site necrosis 16.05 10.21 16 97317 1370 53250363
CSF protein abnormal 15.93 10.21 3 97330 0 53251733
Medical device site bruise 15.93 10.21 3 97330 0 53251733
Obstructive defaecation 15.93 10.21 3 97330 0 53251733
Neuromuscular toxicity 15.70 10.21 7 97326 149 53251584
Suture rupture 15.68 10.21 8 97325 232 53251501
Pneumonitis 15.64 10.21 20 97313 30868 53220865
Coronary artery disease 15.58 10.21 23 97310 33414 53218319
Abnormal behaviour 15.57 10.21 80 97253 21786 53229947
Staphylococcal infection 15.55 10.21 122 97211 38426 53213307
Stomatitis 15.50 10.21 110 97223 98048 53153685
Bacterial test 15.45 10.21 15 97318 1244 53250489
Pulmonary arterial hypertension 15.42 10.21 16 97317 27106 53224627
Eosinophilia 15.34 10.21 10 97323 21325 53230408
B-lymphocyte count decreased 15.33 10.21 13 97320 904 53250829
Urinary tract infection enterococcal 15.06 10.21 21 97312 2568 53249165
Micturition urgency 15.04 10.21 42 97291 8560 53243173
Right ventricular failure 14.93 10.21 6 97327 16837 53234896
Injection site infection 14.92 10.21 17 97316 1696 53250037
Pollakiuria 14.71 10.21 89 97244 25750 53225983
Paraplegia 14.70 10.21 21 97312 2626 53249107
Psychogenic seizure 14.66 10.21 17 97316 1728 53250005
Decreased vibratory sense 14.66 10.21 8 97325 267 53251466
Poisoning 14.64 10.21 57 97276 13793 53237940
Incorrect drug administration rate 14.53 10.21 20 97313 2416 53249317
Aphasia 14.45 10.21 101 97232 30677 53221056
Retinal depigmentation 14.41 10.21 8 97325 276 53251457
Blood bilirubin increased 14.40 10.21 27 97306 35703 53216030
Haemoptysis 14.36 10.21 18 97315 28021 53223712
Asthenia 14.31 10.21 765 96568 342825 52908908
Urobilinogen urine increased 14.25 10.21 7 97326 187 53251546
Myelosuppression 14.24 10.21 3 97330 12825 53238908
Major depression 14.24 10.21 38 97295 7544 53244189
Anxiety 14.14 10.21 464 96869 196240 53055493
Angina pectoris 14.14 10.21 19 97314 28706 53223027
Implant site oedema 13.94 10.21 4 97329 21 53251712
Ill-defined disorder 13.92 10.21 45 97288 49399 53202334
Neuropsychiatric syndrome 13.90 10.21 5 97328 59 53251674
Medical device site scar 13.85 10.21 3 97330 3 53251730
Uterine enlargement 13.84 10.21 14 97319 1220 53250513
Hyperaesthesia 13.82 10.21 41 97292 8648 53243085
Liver injury 13.79 10.21 12 97321 22091 53229642
Persistent depressive disorder 13.74 10.21 13 97320 1044 53250689
Vision blurred 13.72 10.21 226 97107 85378 53166355
Urine osmolarity increased 13.71 10.21 6 97327 122 53251611
Colitis ulcerative 13.67 10.21 11 97322 21050 53230683
Sternal fracture 13.65 10.21 17 97316 1862 53249871
Irritable bowel syndrome 13.51 10.21 38 97295 43594 53208139
Wrong patient received product 13.49 10.21 18 97315 2110 53249623
Injection site abscess 13.49 10.21 13 97320 1068 53250665
Intervertebral disc disorder 13.48 10.21 28 97305 4729 53247004
Injection site ulcer 13.43 10.21 10 97323 576 53251157
Respiratory rate decreased 13.42 10.21 23 97310 3361 53248372
Limb discomfort 13.34 10.21 86 97247 25436 53226297
Anal incontinence 13.33 10.21 52 97281 12595 53239138
Narcotic bowel syndrome 13.32 10.21 6 97327 131 53251602
Hepatitis 13.32 10.21 26 97307 33868 53217865
Spinal cord disorder 13.32 10.21 14 97319 1276 53250457
Tibia fracture 13.28 10.21 28 97305 4779 53246954
Anaphylactic reaction 13.23 10.21 58 97275 58268 53193465
Sleep apnoea syndrome 13.21 10.21 87 97246 25915 53225818
Post-traumatic neck syndrome 13.18 10.21 16 97317 1707 53250026
Liver disorder 13.17 10.21 34 97299 40121 53211612
Bursitis 13.14 10.21 78 97255 22414 53229319
Myelodysplastic syndrome 13.12 10.21 7 97326 16653 53235080
Weight increased 13.09 10.21 279 97054 204288 53047445
Blood cholesterol increased 13.07 10.21 51 97282 52938 53198795
Cerebral vasoconstriction 13.07 10.21 13 97320 1110 53250623
Medical device site extravasation 12.99 10.21 3 97330 5 53251728
Chronic fatigue syndrome 12.82 10.21 13 97320 1136 53250597
Spinal operation 12.80 10.21 33 97300 6418 53245315
Obstructive airways disorder 12.76 10.21 8 97325 17421 53234312
Injection site mass 12.73 10.21 61 97272 16153 53235580
Athetosis 12.73 10.21 4 97329 30 53251703
Sports injury 12.73 10.21 4 97329 30 53251703
Metastases to bone 12.66 10.21 10 97323 19318 53232415
Invasive lobular breast carcinoma 12.64 10.21 11 97322 792 53250941
Congenital megacolon 12.64 10.21 3 97330 6 53251727
Visual impairment 12.63 10.21 195 97138 72717 53179016
Vitamin D deficiency 12.62 10.21 50 97283 12198 53239535
Foetal exposure during pregnancy 12.49 10.21 28 97305 34687 53217046
Bacterial test positive 12.48 10.21 28 97305 4985 53246748
Procedural headache 12.47 10.21 5 97328 81 53251652
Postoperative delirium 12.35 10.21 5 97328 83 53251650
Haemorrhage 12.35 10.21 59 97274 57928 53193805
Reflexes abnormal 12.32 10.21 10 97323 654 53251079
Foot fracture 12.32 10.21 73 97260 20966 53230767
Gastrointestinal disorder 12.27 10.21 105 97228 89899 53161834
Patient-device incompatibility 12.19 10.21 6 97327 161 53251572
CSF protein increased 12.18 10.21 9 97324 512 53251221
Pancreatitis acute 12.12 10.21 18 97315 26091 53225642
Klebsiella test positive 12.10 10.21 12 97321 1021 53250712
Quadriplegia 12.09 10.21 16 97317 1862 53249871
Nephrolithiasis 12.02 10.21 111 97222 36636 53215097
Myelocyte count increased 12.01 10.21 8 97325 385 53251348
Implant site abscess 11.99 10.21 4 97329 37 53251696
Invasive ductal breast carcinoma 11.98 10.21 33 97300 6674 53245059
Hypocalcaemia 11.97 10.21 22 97311 29315 53222418
Autonomic nervous system imbalance 11.93 10.21 19 97314 2615 53249118
Pulmonary renal syndrome 11.85 10.21 8 97325 394 53251339
Lymphocyte count abnormal 11.83 10.21 10 97323 692 53251041
Disturbance in attention 11.83 10.21 105 97228 34278 53217455
Urinary tract infection pseudomonal 11.82 10.21 11 97322 865 53250868
Quadriparesis 11.74 10.21 16 97317 1915 53249818
Glycosylated haemoglobin decreased 11.73 10.21 9 97324 542 53251191
Shock 11.70 10.21 15 97318 23124 53228609
Migraine without aura 11.70 10.21 7 97326 279 53251454
Varicella virus test positive 11.69 10.21 5 97328 96 53251637
Intestinal polyp 11.69 10.21 13 97320 1263 53250470
Pancreatitis chronic 11.66 10.21 18 97315 2412 53249321
Premature labour 11.64 10.21 4 97329 12358 53239375
Infective pulmonary exacerbation of cystic fibrosis 11.61 10.21 3 97330 11153 53240580
Incision site pain 11.60 10.21 12 97321 1074 53250659
Injection site atrophy 11.59 10.21 9 97324 552 53251181
Drug abuse 11.57 10.21 71 97262 65455 53186278
Tuberculosis 11.48 10.21 3 97330 11068 53240665
Occupational dermatitis 11.46 10.21 4 97329 43 53251690
Basophil count decreased 11.46 10.21 5 97328 101 53251632
Implant site warmth 11.46 10.21 4 97329 43 53251690
Upper gastrointestinal haemorrhage 11.44 10.21 9 97324 17421 53234312
Device ineffective 11.37 10.21 6 97327 187 53251546
Intentional overdose 11.36 10.21 179 97154 67026 53184707
Neurological decompensation 11.32 10.21 18 97315 2474 53249259
Hyperlipasaemia 11.30 10.21 9 97324 573 53251160
CD8 lymphocytes decreased 11.25 10.21 6 97327 191 53251542
Self-medication 11.23 10.21 18 97315 2490 53249243
Tremor neonatal 11.19 10.21 5 97328 107 53251626
Metastases to central nervous system 11.18 10.21 4 97329 12053 53239680
Procedural pneumothorax 11.12 10.21 3 97330 12 53251721
CSF culture positive 11.12 10.21 3 97330 12 53251721
Neurosis 11.09 10.21 7 97326 307 53251426
Implant site fibrosis 11.05 10.21 6 97327 198 53251535
Peritonitis 11.03 10.21 14 97319 21673 53230060
Expanded disability status scale score increased 11.01 10.21 7 97326 311 53251422
Intraductal proliferative breast lesion 11.00 10.21 19 97314 2795 53248938
Accidental overdose 10.99 10.21 72 97261 21407 53230326
Neck pain 10.97 10.21 162 97171 59854 53191879
Euphoric mood 10.94 10.21 25 97308 4504 53247229
Hepatocellular injury 10.94 10.21 24 97309 29962 53221771
Infected skin ulcer 10.93 10.21 17 97316 2292 53249441
Hyperglycaemia 10.93 10.21 37 97296 40047 53211686
Oedema 10.93 10.21 85 97248 74261 53177472
Product quality issue 10.92 10.21 33 97300 36990 53214743
Stitch abscess 10.91 10.21 4 97329 50 53251683
Aspiration 10.78 10.21 42 97291 10168 53241565
Neutralising antibodies 10.77 10.21 4 97329 52 53251681
Rash erythematous 10.76 10.21 34 97299 37589 53214144
Hemiplegia 10.73 10.21 35 97298 7765 53243968
Specific gravity urine decreased 10.70 10.21 9 97324 619 53251114
Oxygen saturation decreased 10.69 10.21 89 97244 76636 53175097
Eyelid oedema 10.68 10.21 3 97330 10551 53241182
Affective disorder 10.64 10.21 28 97305 5511 53246222
Inadequate analgesia 10.61 10.21 19 97314 2876 53248857
Glaucoma 10.61 10.21 60 97273 16943 53234790
Upper motor neurone lesion 10.59 10.21 5 97328 122 53251611
Infusion site macule 10.58 10.21 3 97330 15 53251718
Culture wound positive 10.53 10.21 6 97327 218 53251515
Hypoventilation 10.50 10.21 24 97309 4325 53247408
Dysuria 10.48 10.21 93 97240 30360 53221373
Enlarged uvula 10.45 10.21 6 97327 221 53251512
Implant site dehiscence 10.42 10.21 3 97330 16 53251717
Optic atrophy 10.38 10.21 12 97321 1216 53250517
Magnetic resonance imaging head abnormal 10.33 10.21 15 97318 1903 53249830
Crystal urine present 10.27 10.21 13 97320 1447 53250286
Cerebral infarction 10.27 10.21 18 97315 24426 53227307
Citrobacter test positive 10.27 10.21 3 97330 17 53251716
Bladder dysfunction 10.25 10.21 10 97323 834 53250899
Death 10.25 10.21 540 96793 356692 52895041
Sudden death 10.21 10.21 3 97330 10245 53241488

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
Muscle spasticity 3997.12 11.29 1108 61982 4697 32445739
Hypertonia 2262.13 11.29 683 62407 4126 32446310
Drug withdrawal syndrome 1967.35 11.29 901 62189 19330 32431106
Implant site infection 1059.77 11.29 278 62812 899 32449537
Implant site extravasation 721.22 11.29 169 62921 283 32450153
Complication associated with device 556.73 11.29 260 62830 5812 32444624
Hypotonia 521.56 11.29 268 62822 7419 32443017
Muscle spasms 504.06 11.29 651 62439 69767 32380669
Device failure 497.70 11.29 181 62909 2070 32448366
Overdose 463.32 11.29 698 62392 86379 32364057
Multiple sclerosis relapse 419.98 11.29 270 62820 11511 32438925
Withdrawal syndrome 362.45 11.29 249 62841 11873 32438563
Multiple sclerosis 338.01 11.29 201 62889 7443 32442993
Implant site swelling 288.21 11.29 61 63029 42 32450394
Coma 286.00 11.29 382 62708 42230 32408206
Therapy non-responder 276.85 11.29 329 62761 32325 32418111
Therapeutic response decreased 274.10 11.29 293 62797 25627 32424809
Implant site erosion 272.25 11.29 58 63032 43 32450393
Mental status changes 259.28 11.29 345 62745 37992 32412444
Intracranial hypotension 252.54 11.29 66 63024 209 32450227
Urinary tract infection 241.89 11.29 501 62589 79570 32370866
Cerebrospinal fluid leakage 240.04 11.29 71 63019 393 32450043
Muscle tightness 227.56 11.29 132 62958 4662 32445774
Implant site discharge 217.47 11.29 43 63047 9 32450427
Wound dehiscence 217.37 11.29 115 62975 3381 32447055
Somnolence 217.15 11.29 562 62528 103235 32347201
Device physical property issue 214.01 11.29 74 63016 721 32449715
Device infusion issue 211.50 11.29 70 63020 589 32449847
Device power source issue 205.18 11.29 60 63030 317 32450119
Pocket erosion 201.78 11.29 40 63050 9 32450427
Implant site erythema 199.00 11.29 43 63047 37 32450399
Medical device site infection 195.05 11.29 55 63035 249 32450187
Pain 181.46 11.29 782 62308 186774 32263662
Implant site pain 179.21 11.29 44 63046 99 32450337
Clonus 171.10 11.29 89 63001 2525 32447911
Underdose 167.65 11.29 164 62926 12905 32437531
Device kink 164.90 11.29 58 63032 597 32449839
Device malfunction 164.32 11.29 138 62952 8901 32441535
Device dislocation 163.61 11.29 117 62973 5946 32444490
Respiratory depression 160.61 11.29 161 62929 13050 32437386
Device breakage 156.83 11.29 77 63013 1927 32448509
Device connection issue 150.07 11.29 52 63038 510 32449926
Anaemia 145.56 11.29 132 62958 223492 32226944
Seizure 143.12 11.29 485 62605 103369 32347067
Diarrhoea 136.62 11.29 318 62772 364484 32085952
Febrile neutropenia 131.12 11.29 35 63055 119531 32330905
Medical device site swelling 124.02 11.29 27 63063 25 32450411
Medical device site discharge 124.02 11.29 27 63063 25 32450411
Infusion site mass 117.39 11.29 35 63055 200 32450236
Sedation 114.97 11.29 160 62930 18366 32432070
Medical device site erythema 111.42 11.29 24 63066 20 32450416
Toxicity to various agents 108.97 11.29 653 62437 177388 32273048
Unresponsive to stimuli 106.80 11.29 192 62898 27417 32423019
Implant site scar 104.94 11.29 20 63070 0 32450436
Acute kidney injury 103.25 11.29 264 62826 293204 32157232
Meningitis 102.87 11.29 81 63009 4765 32445671
Dyspnoea 101.43 11.29 362 62728 361683 32088753
Decubitus ulcer 100.59 11.29 102 62988 8379 32442057
Neutropenia 98.40 11.29 79 63011 142096 32308340
Device issue 98.15 11.29 103 62987 8809 32441627
Gait disturbance 94.01 11.29 356 62734 80052 32370384
Medical device site pain 91.82 11.29 24 63066 76 32450360
Device alarm issue 90.11 11.29 40 63050 790 32449646
Medical device site erosion 90.03 11.29 21 63069 34 32450402
Device computer issue 87.84 11.29 18 63072 8 32450428
Cardiac failure 87.79 11.29 34 63056 91639 32358797
Toxic encephalopathy 84.35 11.29 73 63017 4904 32445532
Seroma 83.32 11.29 35 63055 601 32449835
Autonomic dysreflexia 81.70 11.29 21 63069 61 32450375
Thrombocytopenia 80.25 11.29 102 62988 148197 32302239
Medical device site reaction 78.87 11.29 16 63074 6 32450430
Malignant neoplasm progression 77.01 11.29 28 63062 78468 32371968
Implant site haematoma 75.67 11.29 20 63070 67 32450369
Agitation 74.97 11.29 263 62827 56973 32393463
Pancytopenia 74.76 11.29 42 63048 91193 32359243
Device occlusion 73.28 11.29 78 63012 6780 32443656
Interstitial lung disease 73.18 11.29 18 63072 64983 32385453
Autonomic nervous system imbalance 72.76 11.29 51 63039 2509 32447927
Dystonia 70.81 11.29 95 62995 10528 32439908
Cardiac failure congestive 69.60 11.29 39 63051 84813 32365623
Atrial fibrillation 68.76 11.29 75 63015 116629 32333807
Incision site erythema 65.03 11.29 18 63072 75 32450361
Encephalopathy 64.89 11.29 179 62911 34078 32416358
Bradypnoea 64.84 11.29 47 63043 2439 32447997
Completed suicide 64.77 11.29 352 62738 92165 32358271
Renal impairment 63.71 11.29 51 63039 91921 32358515
Muscular weakness 63.70 11.29 281 62809 67648 32382788
CSF culture positive 63.29 11.29 14 63076 15 32450421
Secondary progressive multiple sclerosis 63.20 11.29 25 63065 365 32450071
Gait spastic 62.81 11.29 27 63063 492 32449944
Death 62.31 11.29 461 62629 382056 32068380
Rash 62.02 11.29 204 62886 209129 32241307
Lethargy 60.64 11.29 197 62893 41031 32409405
Renal failure 60.55 11.29 105 62985 134373 32316063
Intentional overdose 59.59 11.29 197 62893 41404 32409032
Foetal exposure during pregnancy 58.63 11.29 6 63084 41295 32409141
Medical device site fibrosis 57.72 11.29 11 63079 0 32450436
Blood creatinine increased 57.48 11.29 61 63029 96071 32354365
Depressed level of consciousness 57.24 11.29 192 62898 40655 32409781
Rheumatoid arthritis 57.12 11.29 9 63081 44535 32405901
Drug interaction 56.45 11.29 225 62865 217960 32232476
Confusional state 56.37 11.29 472 62618 142643 32307793
Hyperkalaemia 55.85 11.29 33 63057 69717 32380719
Platelet count decreased 55.77 11.29 85 63005 114506 32335930
Musculoskeletal stiffness 55.40 11.29 185 62905 39079 32411357
Post lumbar puncture syndrome 54.68 11.29 19 63071 188 32450248
Respiratory rate decreased 54.31 11.29 38 63052 1864 32448572
Arachnoiditis 53.79 11.29 22 63068 352 32450084
Device related infection 53.77 11.29 112 62978 17821 32432615
Gastrointestinal haemorrhage 53.22 11.29 54 63036 86828 32363608
Neurogenic bladder 53.12 11.29 36 63054 1676 32448760
Implant site cellulitis 52.41 11.29 12 63078 17 32450419
Device extrusion 52.31 11.29 11 63079 7 32450429
Relapsing-remitting multiple sclerosis 51.98 11.29 25 63065 597 32449839
Status epilepticus 50.96 11.29 87 63003 11919 32438517
Infection 50.57 11.29 309 62781 84406 32366030
Implant site vesicles 49.85 11.29 10 63080 3 32450433
Central nervous system lesion 49.76 11.29 59 63031 5773 32444663
Victim of child abuse 49.36 11.29 26 63064 757 32449679
Trigeminal neuralgia 47.77 11.29 28 63062 1008 32449428
Purulent discharge 47.12 11.29 42 63048 2934 32447502
Drug ineffective 47.04 11.29 1022 62068 382455 32067981
Device leakage 46.50 11.29 51 63039 4585 32445851
Implant site reaction 46.15 11.29 12 63078 37 32450399
Staphylococcus test positive 44.90 11.29 42 63048 3123 32447313
Cough 44.81 11.29 130 62960 138687 32311749
Urinary incontinence 44.74 11.29 105 62985 18102 32432334
Needle fatigue 44.28 11.29 20 63070 412 32450024
Myocardial infarction 44.08 11.29 113 62977 125563 32324873
Urosepsis 43.82 11.29 81 63009 11809 32438627
Pneumonia aspiration 43.81 11.29 177 62913 40979 32409457
Hyperhidrosis 43.36 11.29 261 62829 70907 32379529
Leukopenia 43.33 11.29 32 63058 60090 32390346
Tremor 43.28 11.29 288 62802 80989 32369447
Movement disorder 43.21 11.29 77 63013 10914 32439522
Fall 42.69 11.29 574 62516 195627 32254809
Medical device site inflammation 42.64 11.29 9 63081 6 32450430
Progressive multiple sclerosis 42.48 11.29 16 63074 203 32450233
Implant site abscess 42.21 11.29 10 63080 18 32450418
Medical device site cellulitis 41.98 11.29 8 63082 0 32450436
Muscle twitching 41.78 11.29 67 63023 8717 32441719
Hypoaesthesia 41.47 11.29 223 62867 58130 32392306
Pneumonia 40.88 11.29 467 62623 354785 32095651
Decreased appetite 40.19 11.29 168 62922 160645 32289791
Pleural effusion 39.97 11.29 57 63033 78935 32371501
Medical device site bruise 38.74 11.29 8 63082 4 32450432
Incision site complication 38.52 11.29 17 63073 331 32450105
Central nervous system infection 38.26 11.29 20 63070 573 32449863
Dyspnoea exertional 38.02 11.29 14 63076 38947 32411489
Medical device site discomfort 37.71 11.29 9 63081 17 32450419
Weight decreased 37.68 11.29 178 62912 164640 32285796
Ataxia 37.52 11.29 79 63011 12662 32437774
Infusion related reaction 37.31 11.29 21 63069 45578 32404858
Medical device discomfort 37.23 11.29 12 63078 92 32450344
General physical health deterioration 37.14 11.29 108 62982 115151 32335285
Stomatitis 36.73 11.29 16 63074 40213 32410223
Incision site vesicles 36.73 11.29 7 63083 0 32450436
Hepatic function abnormal 36.19 11.29 21 63069 44819 32405617
Epistaxis 36.19 11.29 33 63057 55822 32394614
Medical device change 35.78 11.29 13 63077 148 32450288
Cytomegalovirus infection 35.37 11.29 4 63086 25460 32424976
Fatigue 35.07 11.29 475 62615 350226 32100210
Abdominal pain 35.05 11.29 160 62930 149369 32301067
Electroencephalogram abnormal 34.29 11.29 33 63057 2543 32447893
Apnoea 34.24 11.29 53 63037 6690 32443746
Chest pain 33.99 11.29 125 62965 124012 32326424
Implant site oedema 33.57 11.29 7 63083 4 32450432
Weight increased 33.53 11.29 70 63020 83593 32366843
Lipoma 33.42 11.29 26 63064 1502 32448934
Hypertonic bladder 33.03 11.29 25 63065 1386 32449050
Lymphocyte percentage decreased 32.92 11.29 30 63060 2157 32448279
Mucosal inflammation 32.65 11.29 12 63078 33422 32417014
Coronary artery disease 32.64 11.29 29 63061 49677 32400759
Implant site dehiscence 32.58 11.29 8 63082 18 32450418
Asthma 32.34 11.29 23 63067 44042 32406394
Medical device site haematoma 32.23 11.29 9 63081 39 32450397
Implant site mass 31.89 11.29 7 63083 7 32450429
Hyperreflexia 31.80 11.29 34 63056 2970 32447466
Implant site ulcer 31.48 11.29 6 63084 0 32450436
Catheter site erosion 31.48 11.29 6 63084 0 32450436
Patient-device incompatibility 31.41 11.29 7 63083 8 32450428
Dyskinesia 31.34 11.29 109 62981 23494 32426942
Irritability 31.15 11.29 112 62978 24542 32425894
Incorrect drug administration rate 31.05 11.29 23 63067 1234 32449202
Staphylococcal infection 30.99 11.29 135 62955 32304 32418132
Alcohol poisoning 30.95 11.29 35 63055 3254 32447182
Granuloma 30.81 11.29 32 63058 2703 32447733
Wound infection staphylococcal 30.66 11.29 24 63066 1399 32449037
Pseudomeningocele 30.54 11.29 7 63083 10 32450426
White blood cell count decreased 30.44 11.29 84 63006 91114 32359322
Macrophages increased 30.35 11.29 12 63078 175 32450261
Drug delivery device placement 30.30 11.29 11 63079 125 32450311
Muscle rigidity 30.24 11.29 67 63023 11119 32439317
Balance disorder 30.23 11.29 154 62936 39305 32411131
Oedema peripheral 29.86 11.29 117 62973 113974 32336462
Bone marrow failure 29.54 11.29 11 63079 30393 32420043
Plasma cell myeloma 28.72 11.29 42 63048 57572 32392864
Rectal haemorrhage 28.17 11.29 19 63071 37404 32413032
Poisoning deliberate 28.12 11.29 47 63043 6328 32444108
Haemoglobin decreased 28.06 11.29 128 62962 119543 32330893
Cognitive disorder 28.05 11.29 112 62978 25782 32424654
Chronic kidney disease 27.87 11.29 22 63068 39953 32410483
Skin erosion 27.84 11.29 26 63064 1929 32448507
Areflexia 27.74 11.29 31 63059 2845 32447591
Hypoglycaemia 27.74 11.29 39 63051 54343 32396093
Jaundice 27.56 11.29 16 63074 34142 32416294
Disease progression 27.53 11.29 82 63008 86780 32363656
Device material issue 27.32 11.29 7 63083 20 32450416
Monoparesis 26.99 11.29 25 63065 1836 32448600
Miosis 26.84 11.29 55 63035 8649 32441787
Neurotoxicity 26.81 11.29 77 63013 14993 32435443
Dehydration 26.75 11.29 144 62946 128814 32321622
White blood cells urine positive 26.58 11.29 21 63069 1241 32449195
Delirium 26.47 11.29 161 62929 43885 32406551
Urinary retention 26.43 11.29 138 62952 35559 32414877
Seronegative arthritis 26.34 11.29 19 63071 978 32449458
Myalgia 26.24 11.29 76 63014 81154 32369282
Infusion site fibrosis 26.23 11.29 5 63085 0 32450436
Device inversion 26.23 11.29 5 63085 0 32450436
Implant site fibrosis 26.23 11.29 5 63085 0 32450436
Pneumocystis jirovecii pneumonia 26.12 11.29 3 63087 18867 32431569
Sleep apnoea syndrome 25.95 11.29 88 63002 18726 32431710
Bacterial test positive 25.88 11.29 31 63059 3065 32447371
Asphyxia 25.66 11.29 42 63048 5558 32444878
Pre-existing disease 25.30 11.29 9 63081 96 32450340
Lactic acidosis 25.27 11.29 17 63073 33519 32416917
Product use in unapproved indication 25.06 11.29 86 63004 87118 32363318
Angina pectoris 24.96 11.29 15 63075 31411 32419025
Monocyte percentage increased 24.81 11.29 18 63072 935 32449501
Metabolic encephalopathy 24.71 11.29 35 63055 4080 32446356
Pneumonitis 24.48 11.29 14 63076 30120 32420316
Discomfort 24.42 11.29 77 63013 15778 32434658
Device ineffective 24.25 11.29 7 63083 35 32450401
Micturition urgency 24.15 11.29 40 63050 5346 32445090
Anal incontinence 23.75 11.29 47 63043 7207 32443229
Haemorrhage 23.72 11.29 37 63053 49411 32401025
Motor dysfunction 23.62 11.29 44 63046 6452 32443984
Multiple organ dysfunction syndrome 23.56 11.29 64 63026 69790 32380646
Hypothermia 23.45 11.29 57 63033 10046 32440390
Infusion site granuloma 23.30 11.29 5 63085 4 32450432
Epidural lipomatosis 23.26 11.29 15 63075 642 32449794
Hallucination 23.08 11.29 178 62912 52441 32397995
Delirium tremens 23.03 11.29 14 63076 539 32449897
Hypocalcaemia 22.98 11.29 8 63082 23046 32427390
Chronic obstructive pulmonary disease 22.89 11.29 37 63053 48716 32401720
Neutrophil count decreased 22.87 11.29 35 63055 47104 32403332
Angioedema 22.84 11.29 22 63068 36267 32414169
Scar 22.80 11.29 41 63049 5852 32444584
Pulmonary fibrosis 22.76 11.29 3 63087 16971 32433465
Neuropathy peripheral 22.75 11.29 75 63015 76907 32373529
Muscle contractions involuntary 22.51 11.29 23 63067 1905 32448531
Myoclonus 22.49 11.29 71 63019 14558 32435878
Ascites 22.37 11.29 27 63063 40164 32410272
Drug eruption 22.17 11.29 5 63085 19161 32431275
Muscle contracture 22.16 11.29 19 63071 1260 32449176
Gait inability 21.95 11.29 87 63003 19960 32430476
Insomnia 21.93 11.29 294 62796 100054 32350382
Performance status decreased 21.92 11.29 33 63057 4065 32446371
Magnetic resonance imaging abnormal 21.69 11.29 21 63069 1630 32448806
Scoliosis 21.67 11.29 24 63066 2181 32448255
Paralysis 21.48 11.29 41 63049 6122 32444314
Cystitis 21.31 11.29 52 63038 9187 32441249
Drug reaction with eosinophilia and systemic symptoms 21.26 11.29 19 63071 32466 32417970
Intestinal pseudo-obstruction 21.14 11.29 19 63071 1342 32449094
CSF pressure decreased 20.99 11.29 4 63086 0 32450436
Tubulointerstitial nephritis 20.92 11.29 6 63084 19571 32430865
Posturing 20.92 11.29 13 63077 521 32449915
Toxic epidermal necrolysis 20.77 11.29 7 63083 20586 32429850
Pulmonary hypertension 20.62 11.29 7 63083 20487 32429949
Bradycardia 20.61 11.29 221 62869 71341 32379095
Coma scale abnormal 20.54 11.29 30 63060 3597 32446839
Dysgeusia 20.54 11.29 12 63078 25519 32424917
Neutrophil percentage increased 20.43 11.29 22 63068 1937 32448499
Culture wound positive 20.40 11.29 8 63082 114 32450322
Tachycardia 20.40 11.29 239 62851 78849 32371587
Arthralgia 20.34 11.29 187 62903 148261 32302175
Chest discomfort 20.13 11.29 42 63048 50188 32400248
Contraindicated product administered 20.11 11.29 6 63084 19070 32431366
Child abuse 20.05 11.29 11 63079 348 32450088
Lymphadenopathy 20.04 11.29 14 63076 27068 32423368
Generalised tonic-clonic seizure 19.79 11.29 86 63004 20553 32429883
Purulence 19.74 11.29 16 63074 981 32449455
Drug resistance 19.63 11.29 10 63080 22955 32427481
Gout 19.54 11.29 6 63084 18722 32431714
Wound decomposition 19.32 11.29 7 63083 79 32450357
Haemoptysis 19.22 11.29 22 63068 33503 32416933
General symptom 19.12 11.29 15 63075 877 32449559
Stiff person syndrome 19.12 11.29 8 63082 136 32450300
Liver disorder 19.00 11.29 20 63070 31634 32418802
Abdominal pain upper 18.95 11.29 67 63023 67271 32383165
Spinal cord injury 18.94 11.29 11 63079 389 32450047
Agranulocytosis 18.93 11.29 11 63079 23466 32426970
Incision site oedema 18.86 11.29 5 63085 17 32450419
Hepatotoxicity 18.78 11.29 7 63083 19330 32431106
Device deposit issue 18.76 11.29 4 63086 3 32450433
Colitis 18.69 11.29 23 63067 33928 32416508
Implant site inflammation 18.57 11.29 7 63083 89 32450347
Melaena 18.55 11.29 24 63066 34641 32415795
Acute myeloid leukaemia 18.52 11.29 7 63083 19167 32431269
Urine leukocyte esterase positive 18.47 11.29 11 63079 408 32450028
Posture abnormal 18.40 11.29 22 63068 2171 32448265
Postoperative wound infection 18.24 11.29 33 63057 4731 32445705
Haematochezia 18.18 11.29 30 63060 39178 32411258
Accidental overdose 18.10 11.29 80 63010 19259 32431177
Haematuria 18.10 11.29 42 63048 48319 32402117
Diabetes mellitus 17.91 11.29 38 63052 45135 32405301
Radicular pain 17.90 11.29 7 63083 99 32450337
Alcohol withdrawal syndrome 17.80 11.29 18 63072 1473 32448963
Suicide attempt 17.68 11.29 131 62959 38113 32412323
Altered state of consciousness 17.65 11.29 87 63003 21910 32428526
Premature baby 17.49 11.29 7 63083 18511 32431925
Respiratory acidosis 17.37 11.29 31 63059 4397 32446039
Proteinuria 17.33 11.29 6 63084 17349 32433087
International normalised ratio increased 17.23 11.29 44 63046 48991 32401445
Therapeutic response unexpected 16.99 11.29 49 63041 9563 32440873
Dysstasia 16.98 11.29 55 63035 11431 32439005
Blood bilirubin increased 16.78 11.29 31 63059 38753 32411683
Decreased vibratory sense 16.74 11.29 10 63080 373 32450063
Rash pruritic 16.59 11.29 14 63076 24597 32425839
Tumour lysis syndrome 16.42 11.29 4 63086 14543 32435893
Hypomagnesaemia 16.36 11.29 8 63082 18797 32431639
Syncope 16.35 11.29 105 62985 90019 32360417
Urticaria 16.31 11.29 60 63030 59554 32390882
Central pain syndrome 16.16 11.29 7 63083 130 32450306
Renal disorder 16.16 11.29 15 63075 25168 32425268
Euphoric mood 16.08 11.29 33 63057 5194 32445242
Pancreatitis 16.06 11.29 31 63059 38120 32412316
Septic shock 16.03 11.29 74 63016 68915 32381521
Blood ethanol increased 15.98 11.29 10 63080 406 32450030
Wound 15.94 11.29 59 63031 13108 32437328
Peritonitis 15.93 11.29 12 63078 22318 32428118
Brief psychotic disorder with marked stressors 15.87 11.29 8 63082 212 32450224
Implant site calcification 15.74 11.29 3 63087 0 32450436
Fluctuance 15.74 11.29 3 63087 0 32450436
Neuromuscular blocking therapy 15.74 11.29 3 63087 0 32450436
Device allergy 15.74 11.29 3 63087 0 32450436
Medical device site extravasation 15.74 11.29 3 63087 0 32450436
Medical device site oedema 15.74 11.29 3 63087 0 32450436
Medical device site ulcer 15.72 11.29 4 63086 11 32450425
Blood ketone body increased 15.65 11.29 10 63080 421 32450015
Arrhythmia 15.47 11.29 28 63062 35275 32415161
Axillary pain 15.45 11.29 9 63081 320 32450116
Electric shock 15.38 11.29 7 63083 147 32450289
Palpitations 15.34 11.29 29 63061 35940 32414496
Hallucination, visual 15.32 11.29 70 63020 17089 32433347
Brain stem syndrome 15.30 11.29 10 63080 438 32449998
Colitis ulcerative 15.22 11.29 7 63083 17044 32433392
Syringomyelia 15.22 11.29 5 63085 41 32450395
Tachyphrenia 15.06 11.29 15 63075 1205 32449231
Condition aggravated 15.05 11.29 402 62688 155259 32295177
Influenza B virus test positive 15.02 11.29 6 63084 90 32450346
Loss of control of legs 14.98 11.29 11 63079 582 32449854
Athetosis 14.91 11.29 5 63085 44 32450392
Scratch 14.89 11.29 23 63067 2897 32447539
Mobility decreased 14.70 11.29 100 62990 28309 32422127
Treatment failure 14.66 11.29 34 63056 39129 32411307
Streptococcus test positive 14.66 11.29 13 63077 902 32449534
Primary progressive multiple sclerosis 14.43 11.29 5 63085 49 32450387
Spinal cord infection 14.41 11.29 7 63083 171 32450265
Device programming error 14.39 11.29 4 63086 17 32450419
Rash maculo-papular 14.38 11.29 20 63070 28002 32422434
Respiratory disorder 14.32 11.29 75 63015 19342 32431094
Visual acuity reduced 14.30 11.29 7 63083 16438 32433998
Psoriasis 14.27 11.29 44 63046 46079 32404357
Brain injury 14.27 11.29 34 63056 5916 32444520
Medical device removal 14.26 11.29 7 63083 175 32450261
Polyneuropathy 14.22 11.29 4 63086 13211 32437225
Drug dependence 14.20 11.29 86 63004 23398 32427038
Quadriplegia 14.20 11.29 17 63073 1680 32448756
JC polyomavirus test positive 14.19 11.29 11 63079 632 32449804
Hepatitis 14.18 11.29 15 63075 23678 32426758
Cerebral palsy 14.18 11.29 6 63084 105 32450331
Memory impairment 14.07 11.29 130 62960 40349 32410087
Narcissistic personality disorder 14.03 11.29 4 63086 19 32450417
Band neutrophil percentage increased 14.02 11.29 6 63084 108 32450328
Bladder dysfunction 13.93 11.29 8 63082 277 32450159
Respiratory arrest 13.92 11.29 100 62990 28808 32421628
Hyperglycaemia 13.84 11.29 34 63056 38357 32412079
Glossopharyngeal nerve disorder 13.70 11.29 4 63086 21 32450415
Anaphylactic shock 13.69 11.29 6 63084 15028 32435408
Procedural complication 13.67 11.29 29 63061 4671 32445765
Ceruloplasmin decreased 13.67 11.29 3 63087 3 32450433
Lumbar puncture abnormal 13.67 11.29 3 63087 3 32450433
Grimacing 13.65 11.29 8 63082 288 32450148
Hallucination, olfactory 13.57 11.29 7 63083 195 32450241
Glomerular filtration rate decreased 13.56 11.29 4 63086 12807 32437629
Gram stain positive 13.53 11.29 5 63085 60 32450376
Mydriasis 13.53 11.29 35 63055 6411 32444025
Blood sodium increased 13.52 11.29 22 63068 2897 32447539
Acute myocardial infarction 13.51 11.29 58 63032 55091 32395345
Red blood cells urine positive 13.50 11.29 17 63073 1769 32448667
Excessive granulation tissue 13.46 11.29 10 63080 539 32449897
Haemorrhage intracranial 13.46 11.29 7 63083 15880 32434556
Mitral valve incompetence 13.44 11.29 6 63084 14865 32435571
Fluid overload 13.42 11.29 11 63079 19610 32430826
Hiccups 13.40 11.29 46 63044 9849 32440587
Myocardial ischaemia 13.38 11.29 9 63081 17750 32432686
Systolic hypertension 13.38 11.29 8 63082 299 32450137
Ventricular tachycardia 13.36 11.29 18 63072 25538 32424898
Pericardial effusion 13.28 11.29 15 63075 22987 32427449
Productive cough 13.28 11.29 29 63061 34087 32416349
Palmar-plantar erythrodysaesthesia syndrome 13.25 11.29 7 63083 15742 32434694
Hallucinations, mixed 13.24 11.29 21 63069 2706 32447730
CSF white blood cell count increased 13.24 11.29 5 63085 64 32450372
Off label use 13.23 11.29 474 62616 305846 32144590
Musculoskeletal discomfort 13.20 11.29 36 63054 6804 32443632
Bone pain 13.19 11.29 12 63078 20332 32430104
Influenza like illness 13.14 11.29 94 62996 27046 32423390
Myopathy 13.03 11.29 3 63087 11338 32439098
Post laminectomy syndrome 12.95 11.29 7 63083 215 32450221
Incorrect route of product administration 12.92 11.29 51 63039 11675 32438761
Urine abnormality 12.92 11.29 17 63073 1848 32448588
Apparent life threatening event 12.80 11.29 7 63083 220 32450216
Myelodysplastic syndrome 12.78 11.29 12 63078 20026 32430410
Epilepsy 12.76 11.29 80 63010 22029 32428407
Dysarthria 12.76 11.29 109 62981 33092 32417344
Mental disorder 12.73 11.29 59 63031 14489 32435947
Road traffic accident 12.73 11.29 67 63023 17314 32433122
Neuralgia 12.66 11.29 51 63039 11784 32438652
Eosinophilia 12.62 11.29 18 63072 24940 32425496
Meningitis staphylococcal 12.58 11.29 5 63085 74 32450362
Cerebrovascular accident 12.58 11.29 107 62983 86213 32364223
Drug-induced liver injury 12.52 11.29 17 63073 24046 32426390
Urine cannabinoids increased 12.46 11.29 3 63087 6 32450430
Ulcerative duodenitis 12.46 11.29 3 63087 6 32450430
Pituitary cyst 12.46 11.29 3 63087 6 32450430
Implant site rash 12.46 11.29 3 63087 6 32450430
Neuromyelitis optica spectrum disorder 12.45 11.29 6 63084 144 32450292
Spinal cord injury cauda equina 12.37 11.29 6 63084 146 32450290
Gun shot wound 12.37 11.29 13 63077 1113 32449323
Neurodegenerative disorder 12.36 11.29 7 63083 236 32450200
Wound secretion 12.33 11.29 20 63070 2627 32447809
Urinary tract infection pseudomonal 12.30 11.29 11 63079 772 32449664
Cholestasis 12.24 11.29 21 63069 27012 32423424
Adrenal insufficiency 12.19 11.29 4 63086 11964 32438472
Somatosensory evoked potentials abnormal 12.15 11.29 6 63084 152 32450284
Graft versus host disease 12.14 11.29 3 63087 10803 32439633
Wound infection 12.11 11.29 34 63056 6534 32443902
Feeling of body temperature change 12.09 11.29 14 63076 1335 32449101
Hyperbilirubinaemia 12.05 11.29 10 63080 17720 32432716
Metastases to liver 12.03 11.29 5 63085 12927 32437509
Product use issue 12.03 11.29 57 63033 52720 32397716
Candida infection 12.02 11.29 9 63081 16794 32433642
Acute coronary syndrome 12.02 11.29 6 63084 13935 32436501
Medical device site haemorrhage 12.01 11.29 6 63084 156 32450280
Cerebral infarction 12.01 11.29 22 63068 27592 32422844
Depression 11.89 11.29 259 62831 96801 32353635
Analgesic drug level above therapeutic 11.79 11.29 7 63083 258 32450178
Product prescribing error 11.79 11.29 72 63018 19645 32430791
Unevaluable event 11.74 11.29 108 62982 33478 32416958
Therapeutic product effect incomplete 11.71 11.29 41 63049 41300 32409136
Paraplegia 11.68 11.29 20 63070 2746 32447690
Tethered cord syndrome 11.60 11.29 3 63087 9 32450427
Myocarditis 11.59 11.29 4 63086 11586 32438850
Nausea 11.57 11.29 507 62583 320342 32130094
Alanine aminotransferase increased 11.56 11.29 97 62993 78382 32372054
C-reactive protein increased 11.53 11.29 51 63039 48051 32402385
Intensive care 11.48 11.29 8 63082 390 32450046
B-lymphocyte count decreased 11.45 11.29 9 63081 528 32449908
Disseminated intravascular coagulation 11.44 11.29 17 63073 23159 32427277
Priapism 11.41 11.29 28 63062 4963 32445473
CD8 lymphocytes increased 11.39 11.29 4 63086 41 32450395
CSF shunt operation 11.36 11.29 3 63087 10 32450426
Uhthoff's phenomenon 11.36 11.29 3 63087 10 32450426
Proteus test positive 11.35 11.29 5 63085 97 32450339

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 CNS depressants
CHEBI has role CHEBI:51371 muscle relaxants
CHEBI has role CHEBI:51373 gamma-aminobutyric acid receptor agonists
MeSH PA D002491 Central Nervous System Agents
MeSH PA D018682 GABA Agents
MeSH PA D018755 GABA Agonists
MeSH PA D058786 GABA-B Receptor Agonists
MeSH PA D009125 Muscle Relaxants, Central
MeSH PA D009465 Neuromuscular Agents
MeSH PA D018377 Neurotransmitter Agents
MeSH PA D018373 Peripheral Nervous System Agents
FDA EPC N0000175759 gamma-Aminobutyric Acid-ergic Agonist

Drug Use (View source of the data)

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

Acid dissociation constants calculated using MoKa v3.0.0

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

Orange Book patent data (new drug applications)

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

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

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

External reference:

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

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Baclofen HUMAN PRESCRIPTION DRUG LABEL 1 0115-1010 TABLET 10 mg ORAL ANDA 11 sections
Baclofen HUMAN PRESCRIPTION DRUG LABEL 1 0115-1011 TABLET 5 mg ORAL ANDA 11 sections
Baclofen HUMAN PRESCRIPTION DRUG LABEL 1 0115-1012 TABLET 20 mg ORAL ANDA 11 sections
Baclofen HUMAN PRESCRIPTION DRUG LABEL 1 0172-4096 TABLET 10 mg ORAL ANDA 12 sections
Baclofen HUMAN PRESCRIPTION DRUG LABEL 1 0172-4097 TABLET 20 mg ORAL ANDA 12 sections
Baclofen HUMAN PRESCRIPTION DRUG LABEL 1 0527-1330 TABLET 10 mg ORAL ANDA 12 sections
Baclofen HUMAN PRESCRIPTION DRUG LABEL 1 0527-1333 TABLET 5 mg ORAL ANDA 12 sections
Baclofen HUMAN PRESCRIPTION DRUG LABEL 1 0527-1337 TABLET 20 mg ORAL ANDA 12 sections
Baclofen HUMAN PRESCRIPTION DRUG LABEL 1 0603-2406 TABLET 10 mg ORAL ANDA 12 sections
Baclofen HUMAN PRESCRIPTION DRUG LABEL 1 0603-2407 TABLET 20 mg ORAL ANDA 12 sections
Baclofen HUMAN PRESCRIPTION DRUG LABEL 1 0615-3541 TABLET 10 mg ORAL ANDA 12 sections
Baclofen HUMAN PRESCRIPTION DRUG LABEL 1 0615-3542 TABLET 20 mg ORAL ANDA 12 sections
Baclofen HUMAN PRESCRIPTION DRUG LABEL 1 0615-8411 TABLET 10 mg ORAL ANDA 11 sections
Baclofen HUMAN PRESCRIPTION DRUG LABEL 1 0615-8412 TABLET 20 mg ORAL ANDA 11 sections
Baclofen HUMAN PRESCRIPTION DRUG LABEL 1 0832-1054 TABLET 10 mg ORAL ANDA 13 sections
Baclofen HUMAN PRESCRIPTION DRUG LABEL 1 0832-1055 TABLET 20 mg ORAL ANDA 13 sections
Baclofen HUMAN PRESCRIPTION DRUG LABEL 1 0904-6475 TABLET 10 mg ORAL ANDA 12 sections
Baclofen HUMAN PRESCRIPTION DRUG LABEL 1 0904-6476 TABLET 20 mg ORAL ANDA 12 sections
Baclofen HUMAN PRESCRIPTION DRUG LABEL 1 10135-532 TABLET 10 mg ORAL ANDA 13 sections
Baclofen HUMAN PRESCRIPTION DRUG LABEL 1 10135-533 TABLET 20 mg ORAL ANDA 13 sections
Baclofen HUMAN PRESCRIPTION DRUG LABEL 1 10544-172 TABLET 10 mg ORAL ANDA 12 sections
BACLOFEN HUMAN PRESCRIPTION DRUG LABEL 1 16590-026 TABLET 10 mg ORAL ANDA 11 sections
BACLOFEN HUMAN PRESCRIPTION DRUG LABEL 1 16590-027 TABLET 20 mg ORAL ANDA 11 sections
Baclofen Human Prescription Drug Label 1 16714-071 TABLET 10 mg ORAL ANDA 12 sections
Baclofen Human Prescription Drug Label 1 16714-072 TABLET 20 mg ORAL ANDA 12 sections
BACLOFEN HUMAN PRESCRIPTION DRUG LABEL 1 17856-0319 TABLET 5 mg ORAL ANDA 11 sections
Baclofen HUMAN PRESCRIPTION DRUG LABEL 1 17856-1024 TABLET 10 mg ORAL ANDA 12 sections
Baclofen HUMAN PRESCRIPTION DRUG LABEL 1 21695-014 TABLET 10 mg ORAL ANDA 13 sections
Baclofen HUMAN PRESCRIPTION DRUG LABEL 1 21695-015 TABLET 20 mg ORAL ANDA 13 sections
Baclofen HUMAN PRESCRIPTION DRUG LABEL 1 25021-678 INJECTION, SOLUTION 500 ug INTRATHECAL ANDA 22 sections