gabapentin Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definitionDrug idCAS RN
gabamimetic agents 1264 60142-96-3

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • gabapentin
  • gabamox
  • gabapen
  • neurontin
  • gabapentine
The mechanism by which gabapentin exerts its analgesic action is unknown, but in animal models of analgesia, gabapentin prevents allodynia (pain-related behavior in response to a normally innocuous stimulus) and hyperalgesia (exaggerated response to painful stimuli). In particular, gabapentin prevents pain-related responses in several models of neuropathic pain in rats or mice (e.g., spinal nerve ligation models, streptozocin-induced diabetes model, spinal cord injury model, acute herpes zoster infection model). Gabapentin also decreases pain-related responses after peripheral inflammation (carrageenan footpad test, late phase of formalin test). Gabapentin did not alter immediate pain-related behaviors (rat tail flick test, formalin footpad acute phase, acetic acid abdominal constriction test, footpad heat irradiation test). The mechanism by which gabapentin exerts its anticonvulsant action is unknown, but in animal test systems designed to detect anticonvulsant activity, gabapentin prevents seizures as do other marketed anticonvulsants. Gabapentin exhibits antiseizure activity in mice and rats in both the maximal electroshock and pentylenetetrazole seizure models and other preclinical models (e.g., strains with genetic epilepsy, etc.). Gabapentin is structurally related to the neurotransmitter GABA (gamma-aminobutyric acid) but it does not modify GABAA or GABAB radioligand binding, it is not converted metabolically into GABA or a GABA agonist, and it is not an inhibitor of GABA uptake or degradation. Gabapentin was tested in radioligand binding assays at concentrations up to 100 uM and did not exhibit affinity for a number of other common receptor sites, including benzodiazepine, glutamate, N-methyl-D-aspartate (NMDA), quisqualate, kainate, strychnine-insensitive or strychnine-sensitive glycine, alpha 1, alpha 2, or beta adrenergic, adenosine A1 or A2, cholinergic muscarinic or nicotinic, dopamine D1 or D2, histamine H1, serotonin S1 or S2, opiate mu, delta or kappa, cannabinoid 1, voltage-sensitive calcium channel sites labeled with nitrendipine or diltiazem, or at voltage-sensitive sodium channel sites labeled with batrachotoxinin A 20-alpha-benzoate. Furthermore, gabapentin did not alter the cellular uptake of dopamine, noradrenaline, or serotonin. In vitro studies with radiolabeled gabapentin have revealed a gabapentin binding site in areas of rat brain including neocortex and hippocampus. A high-affinity binding protein in animal brain tissue has been identified as an auxiliary subunit of voltage-activated calcium channels.
  • Molecular weight: 171.24
  • Formula: C9H17NO2
  • CLOGP: -0.66
  • LIPINSKI: 0
  • HAC: 3
  • HDO: 2
  • TPSA: 63.32
  • ALOGS: -1.60
  • ROTB: 3

  • Status: OFP

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

Drug dosage:

DoseUnitRoute
1.80 g O

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 3 Benet LZ, Broccatelli F, Oprea TI
S (Water solubility) 10 mg/mL Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine) 100 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 116.79 ┬ÁM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability) 60 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
Vd (Volume of distribution) 0.71 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) 0.97 % Lombardo F, Berellini G, Obach RS
t_half (Half-life) 5.30 hours Lombardo F, Berellini G, Obach RS

Approvals:

DateAgencyCompanyOrphan
Dec. 30, 1993 FDA PFIZER PHARMS

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
Drug hypersensitivity 1717.29 9.79 4406 312043 260836 52771781
Drug ineffective for unapproved indication 1088.23 9.79 936 315513 19784 53012833
Completed suicide 718.69 9.79 2122 314327 136079 52896538
Pemphigus 574.90 9.79 8 316441 104023 52928594
Multiple sclerosis relapse 408.57 9.79 854 315595 43999 52988618
Contraindicated product administered 408.32 9.79 147 316302 135482 52897135
Systemic lupus erythematosus 386.00 9.79 131 316318 125283 52907334
Rheumatoid arthritis 379.96 9.79 812 315637 313719 52718898
Maternal exposure during pregnancy 363.32 9.79 238 316211 155401 52877216
Hand deformity 362.34 9.79 40 316409 84809 52947808
Glossodynia 354.80 9.79 80 316369 100211 52932406
Synovitis 349.29 9.79 103 316346 107790 52924827
Pericarditis 300.32 9.79 21 316428 64385 52968232
Toxicity to various agents 293.22 9.79 2267 314182 217331 52815286
Somnolence 278.17 9.79 1825 314624 165909 52866708
Myoclonus 238.08 9.79 374 316075 15390 53017227
Fall 233.80 9.79 3194 313255 355246 52677371
Neuropathy peripheral 219.14 9.79 1198 315251 101989 52930628
Drug abuse 210.44 9.79 858 315591 64668 52967949
Rheumatoid factor positive 196.29 9.79 12 316437 41186 52991431
Infusion related reaction 192.69 9.79 397 316052 155560 52877057
Neuralgia 192.53 9.79 429 316020 23092 53009525
Joint swelling 191.42 9.79 730 315719 233908 52798709
Duodenal ulcer perforation 188.94 9.79 4 316445 35179 52997438
Arthropathy 181.67 9.79 352 316097 141101 52891516
Depression 180.49 9.79 1768 314681 181284 52851333
General physical health deterioration 173.22 9.79 384 316065 146558 52886059
Memory impairment 169.92 9.79 969 315480 83788 52948829
Multiple sclerosis 167.42 9.79 444 316005 26709 53005908
Helicobacter infection 165.29 9.79 19 316430 39050 52993567
Suicidal ideation 164.84 9.79 754 315695 59757 52972860
Exposure during pregnancy 164.45 9.79 306 316143 124554 52908063
Feeling abnormal 159.30 9.79 1358 315091 133943 52898674
Accidental death 159.26 9.79 110 316339 1654 53030963
Tremor 156.02 9.79 1277 315172 124459 52908158
Hepatic enzyme increased 152.68 9.79 325 316124 125870 52906747
Wound 149.57 9.79 194 316255 91363 52941254
Febrile neutropenia 148.30 9.79 246 316203 104690 52927927
Balance disorder 147.42 9.79 838 315611 72369 52960248
Dizziness 144.40 9.79 3050 313399 369209 52663408
Muscle injury 137.90 9.79 10 316439 29756 53002861
Hypoaesthesia 137.65 9.79 1298 315151 131697 52900920
Discomfort 135.67 9.79 223 316226 95249 52937368
Abdominal discomfort 129.69 9.79 774 315675 220288 52812329
Product dose omission issue 125.56 9.79 1710 314739 189910 52842707
Product complaint 120.56 9.79 241 316208 12016 53020601
Muscle spasms 119.88 9.79 1275 315174 133520 52899097
Alopecia 117.14 9.79 862 315587 233721 52798896
Treatment failure 112.85 9.79 387 316062 128016 52904601
Pyrexia 112.78 9.79 1698 314751 401495 52631122
Hallucination 110.82 9.79 620 315829 53218 52979399
Folliculitis 110.68 9.79 26 316423 31683 53000934
Withdrawal syndrome 109.38 9.79 306 316143 18995 53013622
Respiratory arrest 108.28 9.79 440 316009 33100 52999517
Mental status changes 107.69 9.79 493 315956 39078 52993539
C-reactive protein abnormal 105.96 9.79 14 316435 25856 53006761
Vision blurred 105.90 9.79 869 315580 84735 52947882
Drug withdrawal syndrome 99.68 9.79 379 316070 27643 53004974
Hypersensitivity 99.53 9.79 786 315663 209879 52822738
Pain in extremity 99.42 9.79 2301 314148 282749 52749868
Swelling 98.38 9.79 696 315753 190409 52842208
Device expulsion 97.27 9.79 28 316421 29785 53002832
Sleep disorder due to general medical condition, insomnia type 95.49 9.79 15 316434 24334 53008283
Gait disturbance 92.62 9.79 1389 315060 157453 52875164
Therapeutic product effect decreased 92.28 9.79 407 316042 125248 52907369
Lower respiratory tract infection 91.39 9.79 258 316191 90723 52941894
Interstitial lung disease 89.90 9.79 130 316319 58492 52974125
Migraine 84.21 9.79 787 315662 79630 52952987
C-reactive protein increased 83.60 9.79 173 316276 67713 52964904
Anxiety 83.09 9.79 1633 314816 195071 52837546
Seizure 82.82 9.79 1151 315298 128358 52904259
Thrombocytopenia 80.08 9.79 488 315961 138239 52894378
Sedation 79.47 9.79 368 316081 29307 53003310
Paraesthesia 78.61 9.79 1126 315323 126389 52906228
Anaemia 78.40 9.79 1162 315287 275556 52757061
Unresponsive to stimuli 74.21 9.79 393 316056 33033 52999584
Rash 72.77 9.79 2053 314396 444138 52588479
Sopor 71.58 9.79 281 316168 20803 53011814
Respiratory depression 70.58 9.79 201 316248 12605 53020012
Drug dependence 70.35 9.79 283 316166 21189 53011428
Hepatic function abnormal 70.26 9.79 69 316380 36830 52995787
Amnesia 69.07 9.79 483 315966 44805 52987812
Cytomegalovirus infection 68.23 9.79 16 316433 19523 53013094
Trigeminal neuralgia 67.72 9.79 90 316359 3171 53029446
Cardiac failure 65.49 9.79 274 316175 85570 52947047
Burning sensation 65.16 9.79 498 315951 47515 52985102
Dyskinesia 64.44 9.79 365 316084 31468 53001149
Confusional state 64.31 9.79 1557 314892 192664 52839953
Impaired healing 63.78 9.79 183 316266 64022 52968595
Multiple organ dysfunction syndrome 63.52 9.79 148 316301 55529 52977088
Lethargy 63.40 9.79 540 315909 53220 52979397
Pancytopenia 62.88 9.79 301 316148 90627 52941990
Muscular weakness 61.91 9.79 891 315558 100101 52932516
Foetal exposure during pregnancy 61.51 9.79 69 316380 34646 52997971
Coordination abnormal 61.46 9.79 183 316266 11768 53020849
Cardio-respiratory arrest 60.98 9.79 574 315875 58184 52974433
Red blood cell sedimentation rate abnormal 60.77 9.79 10 316439 15679 53016938
Premature baby 58.62 9.79 22 316427 19779 53012838
Live birth 57.44 9.79 10 316439 15049 53017568
Hypersomnia 56.35 9.79 219 316230 16136 53016481
Speech disorder 56.34 9.79 412 316037 38769 52993848
Mental disorder 55.76 9.79 289 316160 24087 53008530
Irritable bowel syndrome 54.73 9.79 110 316339 43522 52989095
Mucosal inflammation 54.41 9.79 107 316342 42677 52989940
Swollen joint count increased 51.70 9.79 4 316445 11286 53021331
Full blood count decreased 50.95 9.79 279 316170 23750 53008867
Insomnia 50.46 9.79 1460 314989 185612 52847005
Intentional product misuse 50.00 9.79 480 315969 48912 52983705
Malignant neoplasm progression 49.94 9.79 236 316213 71305 52961312
Neutropenia 49.81 9.79 655 315794 158530 52874087
Influenza like illness 49.61 9.79 566 315883 60293 52972324
Fibromyalgia 49.51 9.79 438 316011 43637 52988980
Ill-defined disorder 49.06 9.79 141 316308 49303 52983314
Drug reaction with eosinophilia and systemic symptoms 49.05 9.79 74 316375 32726 52999891
Leukopenia 48.59 9.79 247 316202 73216 52959401
Drug intolerance 48.25 9.79 893 315556 204600 52828017
Pleural effusion 47.81 9.79 318 316131 88261 52944356
Feeling drunk 47.72 9.79 86 316363 3963 53028654
Hypokalaemia 47.45 9.79 356 316093 96161 52936456
Restless legs syndrome 47.16 9.79 215 316234 17008 53015609
Product use issue 46.78 9.79 566 315883 139018 52893599
Sleep apnoea syndrome 46.74 9.79 289 316160 25713 53006904
Rheumatic fever 46.72 9.79 9 316440 12595 53020022
Stiff person syndrome 46.09 9.79 25 316424 236 53032381
Bone marrow failure 45.95 9.79 67 316382 30048 53002569
Urinary tract infection 45.78 9.79 1798 314651 238105 52794512
Head injury 45.73 9.79 286 316163 25547 53007070
Inadequate analgesia 45.54 9.79 70 316379 2825 53029792
Pleural thickening 45.44 9.79 67 316382 2605 53030012
Muscle twitching 44.94 9.79 205 316244 16221 53016396
Atrial fibrillation 44.94 9.79 434 316015 111218 52921399
Crying 44.88 9.79 255 316194 22007 53010610
Hepatotoxicity 44.56 9.79 60 316389 27820 53004797
Euphoric mood 44.48 9.79 89 316360 4440 53028177
Pleural fibrosis 44.28 9.79 78 316371 3530 53029087
Off label use 44.26 9.79 2320 314129 469892 52562725
Premature delivery 43.97 9.79 54 316395 26050 53006567
Therapeutic response unexpected 43.92 9.79 211 316238 17059 53015558
Presbyacusis 43.81 9.79 70 316379 2922 53029695
Drug resistance 43.26 9.79 33 316416 19929 53012688
Myocardial stunning 43.19 9.79 21 316428 154 53032463
Liver injury 42.46 9.79 41 316408 22062 53010555
Overdose 42.31 9.79 885 315564 106851 52925766
Hyponatraemia 42.10 9.79 426 316023 108181 52924436
Therapeutic response decreased 42.01 9.79 143 316306 47426 52985191
Hyperaesthesia 41.82 9.79 130 316319 8559 53024058
Back pain 41.78 9.79 1743 314706 232504 52800113
Anaphylactic shock 41.61 9.79 41 316408 21852 53010765
Product use in unapproved indication 41.39 9.79 914 315535 111375 52921242
Blood magnesium increased 40.85 9.79 69 316380 3018 53029599
Infection 40.51 9.79 748 315701 171457 52861160
Intervertebral disc protrusion 39.50 9.79 244 316205 21701 53010916
Bone erosion 39.20 9.79 9 316440 11143 53021474
Dry mouth 39.15 9.79 532 315917 59018 52973599
Rheumatoid nodule 38.96 9.79 11 316438 11853 53020764
Osteonecrosis of jaw 38.93 9.79 99 316350 36047 52996570
Poisoning 38.75 9.79 174 316275 13676 53018941
Abortion spontaneous 38.64 9.79 144 316305 46491 52986126
Septic shock 38.50 9.79 214 316235 62015 52970602
Spinal operation 38.26 9.79 104 316345 6347 53026270
Hallucination, visual 38.16 9.79 216 316233 18616 53014001
Diplopia 38.08 9.79 232 316217 20533 53012084
Impaired driving ability 38.02 9.79 81 316368 4226 53028391
Pregnancy 37.96 9.79 81 316368 31360 53001257
Blood lactate dehydrogenase increased 37.81 9.79 44 316405 21737 53010880
Ataxia 37.44 9.79 180 316269 14557 53018060
Eosinophilic colitis 37.37 9.79 18 316431 129 53032488
Diabetic neuropathy 37.02 9.79 77 316372 3950 53028667
Blister 36.59 9.79 295 316154 78458 52954159
Neck pain 36.56 9.79 529 315920 59487 52973130
Premature labour 36.15 9.79 14 316435 12348 53020269
Sinusitis 35.76 9.79 745 315704 167819 52864798
Pneumocystis jirovecii pneumonia 35.59 9.79 27 316422 16351 53016266
Myelosuppression 35.15 9.79 16 316433 12812 53019805
Nervousness 34.98 9.79 302 316147 29876 53002741
Urinary incontinence 34.46 9.79 306 316143 30515 53002102
Accidental poisoning 34.35 9.79 30 316419 647 53031970
Back disorder 34.06 9.79 131 316318 9604 53023013
Anger 33.43 9.79 154 316295 12236 53020381
Peritonitis 33.33 9.79 48 316401 21639 53010978
Mood altered 32.62 9.79 166 316283 13735 53018882
Epigastric discomfort 32.19 9.79 95 316354 6078 53026539
Erythema 32.06 9.79 698 315751 156271 52876346
Nerve injury 31.98 9.79 120 316329 8695 53023922
Gait inability 31.98 9.79 358 316091 37953 52994664
Cognitive disorder 31.92 9.79 406 316043 44372 52988245
Cardiac arrest 31.89 9.79 754 315695 92913 52939704
Hypermobility syndrome 31.78 9.79 30 316419 718 53031899
Febrile bone marrow aplasia 31.68 9.79 3 316446 7186 53025431
Ascites 31.44 9.79 125 316324 39610 52993007
Hepatic failure 31.37 9.79 108 316341 35698 52996919
Complex regional pain syndrome 31.17 9.79 51 316398 2172 53030445
Drug screen positive 30.98 9.79 70 316379 3802 53028815
Rash maculo-papular 30.87 9.79 83 316366 29666 53002951
Concussion 30.65 9.79 109 316340 7695 53024922
Melaena 30.43 9.79 81 316368 29048 53003569
Bradycardia 30.39 9.79 272 316177 70784 52961833
Deafness neurosensory 30.33 9.79 79 316370 4699 53027918
Hepatocellular injury 30.12 9.79 85 316364 29901 53002716
Drug-induced liver injury 30.01 9.79 82 316367 29151 53003466
Ankle fracture 29.96 9.79 184 316265 16331 53016286
Cyst 29.48 9.79 153 316296 12758 53019859
Vertigo 29.44 9.79 482 315967 55599 52977018
Incoherent 29.40 9.79 77 316372 4595 53028022
Hyperhidrosis 28.75 9.79 765 315684 96028 52936589
Thrombotic microangiopathy 28.27 9.79 10 316439 9327 53023290
Hyperreflexia 28.26 9.79 84 316365 5396 53027221
Jaundice 28.23 9.79 89 316360 30224 53002393
Congenital thrombocytopenia 28.03 9.79 11 316438 44 53032573
Somatic symptom disorder 27.90 9.79 47 316402 2051 53030566
Intervertebral disc degeneration 27.66 9.79 162 316287 14136 53018481
Arthralgia 27.59 9.79 2240 314209 437543 52595074
Gestational diabetes 27.26 9.79 7 316442 8032 53024585
Serotonin syndrome 26.91 9.79 257 316192 26149 53006468
Somatic delusion 26.87 9.79 25 316424 587 53032030
Nightmare 26.87 9.79 189 316260 17562 53015055
Suspected suicide 26.49 9.79 71 316378 4297 53028320
Dysarthria 26.49 9.79 362 316087 40206 52992411
Obstructive airways disorder 26.37 9.79 39 316410 17390 53015227
Limb injury 26.26 9.79 217 316232 21193 53011424
Focal dyscognitive seizures 25.91 9.79 55 316394 2862 53029755
Mental impairment 25.88 9.79 151 316298 13158 53019459
Limb discomfort 25.81 9.79 248 316201 25274 53007343
Hip arthroplasty 25.81 9.79 82 316367 27780 53004837
Visual impairment 25.76 9.79 590 315859 72322 52960295
Knee arthroplasty 25.68 9.79 107 316342 33462 52999155
Haemophagocytic lymphohistiocytosis 25.66 9.79 11 316438 9126 53023491
Irritability 25.27 9.79 288 316161 30665 53001952
Pre-existing condition improved 25.22 9.79 105 316344 7984 53024633
Paranoia 25.13 9.79 134 316315 11290 53021327
Acute respiratory distress syndrome 25.05 9.79 64 316385 23268 53009349
Central nervous system lesion 25.01 9.79 123 316326 10039 53022578
Neutropenic sepsis 24.99 9.79 30 316419 14619 53017998
Agranulocytosis 24.84 9.79 66 316383 23683 53008934
Injection site mass 24.76 9.79 173 316276 16041 53016576
Bone cyst 24.44 9.79 45 316404 2109 53030508
Pituitary tumour benign 24.19 9.79 42 316407 1879 53030738
Epistaxis 24.01 9.79 276 316173 68434 52964183
Peroneal nerve palsy 23.96 9.79 69 316380 4354 53028263
Human epidermal growth factor receptor decreased 23.75 9.79 8 316441 18 53032599
Asterixis 23.68 9.79 34 316415 1290 53031327
Nerve compression 23.63 9.79 98 316351 7438 53025179
Eosinophilia 23.31 9.79 58 316391 21277 53011340
Anorgasmia 23.19 9.79 23 316426 586 53032031
Stomatitis 23.18 9.79 426 316023 97732 52934885
Accidental exposure to product 23.12 9.79 68 316381 23606 53009011
Dysstasia 23.12 9.79 193 316256 18906 53013711
Transaminases increased 23.08 9.79 96 316353 30036 53002581
Surgery 22.86 9.79 290 316159 31674 53000943
Toxic epidermal necrolysis 22.74 9.79 68 316381 23482 53009135
Drug diversion 22.62 9.79 27 316422 852 53031765
Panniculitis 22.60 9.79 9 316440 7805 53024812
Psychotic disorder due to a general medical condition 22.51 9.79 15 316434 212 53032405
Agitation 22.48 9.79 480 315969 58146 52974471
Depressed level of consciousness 22.30 9.79 450 315999 53978 52978639
Drug use disorder 22.28 9.79 55 316394 3164 53029453
Disturbance in attention 22.12 9.79 306 316143 34077 52998540
Sacroiliitis 22.05 9.79 47 316402 2453 53030164
Cerebral infarction 21.91 9.79 73 316376 24371 53008246
Body height decreased 21.82 9.79 116 316333 9763 53022854
Myelodysplastic syndrome 21.76 9.79 41 316408 16619 53015998
Transplant rejection 21.72 9.79 17 316432 10134 53022483
Pruritus 21.68 9.79 1476 314973 292356 52740261
Thinking abnormal 21.60 9.79 121 316328 10387 53022230
Drug titration error 21.56 9.79 23 316426 640 53031977
Bronchiectasis 21.44 9.79 19 316430 10653 53021964
Gastrointestinal haemorrhage 21.43 9.79 341 316108 79989 52952628
Muscle tightness 21.40 9.79 125 316324 10896 53021721
Device difficult to use 21.35 9.79 18 316431 10341 53022276
Nasopharyngitis 21.25 9.79 928 315521 191367 52841250
Progressive multiple sclerosis 20.82 9.79 25 316424 794 53031823
Dyspnoea 20.79 9.79 3106 313343 583126 52449491
Cough 20.73 9.79 1280 315169 255613 52777004
Brain injury 20.64 9.79 84 316365 6321 53026296
Drug ineffective 20.59 9.79 4411 312038 812834 52219783
Cholestasis 20.41 9.79 94 316355 28601 53004016
Device use error 20.23 9.79 4 316445 5495 53027122
Drug effective for unapproved indication 20.06 9.79 40 316409 1990 53030627
Joint injury 20.06 9.79 210 316239 21890 53010727
Asthenia 19.98 9.79 2329 314120 341261 52691356
Abortion induced 19.75 9.79 21 316428 10805 53021812
Therapy interrupted 19.72 9.79 189 316260 19247 53013370
Therapy non-responder 19.72 9.79 191 316258 48929 52983688
Bipolar disorder 19.61 9.79 94 316355 7592 53025025
Substance abuse 19.60 9.79 65 316384 4429 53028188
Tardive dyskinesia 19.38 9.79 97 316352 7973 53024644
Acute myeloid leukaemia 19.31 9.79 45 316404 16887 53015730
Herpes zoster 19.19 9.79 575 315874 73444 52959173
Pulmonary tuberculosis 19.15 9.79 3 316446 4878 53027739
Coma 19.12 9.79 491 315958 61292 52971325
Pulmonary fibrosis 19.04 9.79 76 316373 24059 53008558
Disseminated intravascular coagulation 19.00 9.79 57 316392 19662 53012955
Lupus-like syndrome 18.99 9.79 16 316433 9196 53023421
Pulmonary aplasia 18.98 9.79 6 316443 10 53032607
Exposure via ingestion 18.83 9.79 52 316397 3203 53029414
Metastases to liver 18.72 9.79 65 316384 21431 53011186
Tuberculosis 18.54 9.79 23 316426 11048 53021569
Neovascularisation 18.53 9.79 21 316428 626 53031991
Dysphemia 18.41 9.79 44 316405 2480 53030137
Autonomic nervous system imbalance 18.23 9.79 45 316404 2589 53030028
Caesarean section 18.22 9.79 48 316401 17272 53015345
Hypokinesia 18.16 9.79 136 316313 12891 53019726
Colitis ulcerative 18.13 9.79 64 316385 20997 53011620
Foetal growth restriction 18.07 9.79 10 316439 7164 53025453
Cervical spinal stenosis 17.93 9.79 39 316410 2064 53030553
Secondary progressive multiple sclerosis 17.93 9.79 30 316419 1302 53031315
Therapy cessation 17.85 9.79 249 316200 27776 53004841
Pre-eclampsia 17.85 9.79 15 316434 8632 53023985
Graft versus host disease 17.84 9.79 10 316439 7112 53025505
Lymphoedema 17.80 9.79 108 316341 9545 53023072
Acute kidney injury 17.77 9.79 1281 315168 252587 52780030
Unintentional medical device removal 17.68 9.79 5 316444 5381 53027236
Skin necrosis 17.67 9.79 22 316427 10550 53022067
Tooth loss 17.62 9.79 83 316366 6656 53025961
Red blood cell sedimentation rate increased 17.61 9.79 96 316353 27961 53004656
Post herpetic neuralgia 17.61 9.79 39 316410 2090 53030527
Cytomegalovirus viraemia 17.60 9.79 4 316445 4987 53027630
Posterior reversible encephalopathy syndrome 17.60 9.79 44 316405 16116 53016501
Bone density decreased 17.49 9.79 24 316425 11040 53021577
Blood bilirubin increased 17.45 9.79 132 316317 35598 52997019
Urticaria 17.32 9.79 645 315804 135240 52897377
Road traffic accident 17.26 9.79 230 316219 25401 53007216
Neutrophil count decreased 17.24 9.79 197 316252 48901 52983716
Cardiogenic shock 17.23 9.79 50 316399 17432 53015185
Low birth weight baby 17.21 9.79 8 316441 6329 53026288
Postmortem blood drug level abnormal 17.12 9.79 14 316435 275 53032342
Myoclonic epilepsy 17.03 9.79 26 316423 1043 53031574
Colitis 16.92 9.79 161 316288 41391 52991226
Pharyngitis 16.79 9.79 57 316392 18923 53013694
Ventricular fibrillation 16.79 9.79 28 316421 11897 53020720
Lactic acidosis 16.63 9.79 141 316308 37112 52995505
Atonic urinary bladder 16.59 9.79 9 316440 85 53032532
Fatigue 16.59 9.79 4715 311734 725791 52306826
Toxic skin eruption 16.58 9.79 33 316416 13106 53019511
Schizophrenia 16.55 9.79 22 316427 10257 53022360
Shock haemorrhagic 16.54 9.79 18 316431 9165 53023452
Hyperbilirubinaemia 16.52 9.79 25 316424 11044 53021573
Face oedema 16.44 9.79 63 316386 20177 53012440
Stillbirth 16.38 9.79 10 316439 6787 53025830
Facial pain 16.37 9.79 94 316355 8144 53024473
Thrombosis 16.23 9.79 474 315975 60319 52972298
Pollakiuria 16.23 9.79 229 316220 25610 53007007
Bradyphrenia 16.11 9.79 81 316368 6669 53025948
Tachycardia 16.03 9.79 504 315945 107708 52924909
Oligohydramnios 16 9.79 8 316441 6068 53026549
Glycosylated haemoglobin decreased 15.98 9.79 18 316431 533 53032084
Metabolic encephalopathy 15.92 9.79 73 316376 5788 53026829
Hostility 15.87 9.79 32 316417 1605 53031012
Economic problem 15.76 9.79 37 316412 2061 53030556
Skin reaction 15.69 9.79 30 316419 12093 53020524
Arteriovenous malformation 15.65 9.79 28 316421 1283 53031334
Blood parathyroid hormone decreased 15.64 9.79 9 316440 6309 53026308
Head banging 15.59 9.79 16 316433 425 53032192
Plasma cell myeloma 15.57 9.79 383 316066 47491 52985126
Cerebral haemorrhage 15.52 9.79 109 316340 29887 53002730
Foot fracture 15.52 9.79 192 316257 20847 53011770
Haemorrhage 15.52 9.79 246 316203 57741 52974876
Haemoglobin decreased 15.50 9.79 661 315788 136646 52895971
Angioedema 15.49 9.79 167 316282 41909 52990708
Mucocutaneous haemorrhage 15.36 9.79 8 316441 69 53032548
Forced expiratory volume decreased 15.25 9.79 7 316442 5578 53027039
Facial spasm 15.24 9.79 20 316429 696 53031921
Device dislocation 15.22 9.79 80 316369 23517 53009100
Circulatory collapse 15.22 9.79 76 316373 22638 53009979
Somnambulism 15.21 9.79 68 316381 5334 53027283
Epstein-Barr virus infection 15.15 9.79 13 316436 7405 53025212
Asthma 15.08 9.79 512 315937 108460 52924157
Alanine aminotransferase increased 15.05 9.79 439 316010 94656 52937961
Allodynia 15.04 9.79 20 316429 705 53031912
Disorientation 15.01 9.79 322 316127 39037 52993580
Tubulointerstitial nephritis 14.99 9.79 49 316400 16455 53016162
Drug tolerance decreased 14.90 9.79 13 316436 7345 53025272
Nausea 14.85 9.79 4852 311597 751239 52281378
Proteinuria 14.83 9.79 56 316393 18012 53014605
Genital haemorrhage 14.81 9.79 12 316437 7032 53025585
Myotonia 14.79 9.79 10 316439 145 53032472
Haematotoxicity 14.76 9.79 15 316434 7882 53024735
Ejection fraction decreased 14.73 9.79 64 316385 19784 53012833
Exostosis 14.67 9.79 117 316332 11307 53021310
Intentional product use issue 14.60 9.79 323 316126 72171 52960446
Hyperprolactinaemia 14.50 9.79 48 316401 3267 53029350
Disorganised speech 14.49 9.79 24 316425 1033 53031584
Blood lactic acid 14.48 9.79 9 316440 112 53032505
Deprescribing error 14.39 9.79 6 316443 29 53032588
Wrong patient received product 14.35 9.79 36 316413 2092 53030525
Osteosclerosis 14.34 9.79 52 316397 3706 53028911
Sensory loss 14.29 9.79 88 316361 7817 53024800
Drug abuser 14.10 9.79 46 316403 3107 53029510
Hypercholesterolaemia 14.05 9.79 34 316415 12592 53020025
Myocardial oedema 14.01 9.79 9 316440 119 53032498
Sensory disturbance 13.92 9.79 127 316322 12759 53019858
Carpal tunnel syndrome 13.92 9.79 164 316285 17603 53015014
Prescription drug used without a prescription 13.87 9.79 32 316417 1762 53030855
Food allergy 13.84 9.79 17 316432 8201 53024416
Hepatitis cholestatic 13.83 9.79 13 316436 7086 53025531
Congenital absence of vertebra 13.82 9.79 5 316444 15 53032602
Inflammation 13.79 9.79 247 316202 56889 52975728
Haemolysis 13.74 9.79 11 316438 6485 53026132
Abdominal pain 13.71 9.79 1319 315130 254584 52778033
Enterocolitis 13.64 9.79 13 316436 7039 53025578
JC polyomavirus test positive 13.58 9.79 24 316425 1089 53031528
Movement disorder 13.57 9.79 170 316279 18511 53014106
Jaundice cholestatic 13.53 9.79 8 316441 5526 53027091
Panic attack 13.52 9.79 190 316259 21228 53011389
Dry eye 13.40 9.79 277 316172 33367 52999250
Psychomotor hyperactivity 13.29 9.79 104 316345 9992 53022625
Macular degeneration 13.20 9.79 34 316415 12327 53020290
Radiculopathy 13.19 9.79 65 316384 5309 53027308
Liver function test abnormal 13.18 9.79 203 316246 47868 52984749
Bladder disorder 13.14 9.79 86 316363 7802 53024815
Unintended pregnancy 13.12 9.79 10 316439 6043 53026574
Injection site induration 13.00 9.79 92 316357 8566 53024051
Cervicogenic headache 12.90 9.79 4 316445 6 53032611
Uterine perforation 12.86 9.79 15 316434 7404 53025213
Phobia 12.86 9.79 13 316436 339 53032278
Device adhesion issue 12.82 9.79 3 316446 3667 53028950
Femur fracture 12.69 9.79 162 316287 39423 52993194
Hypoxic-ischaemic encephalopathy 12.63 9.79 54 316395 4154 53028463
Haematoma 12.59 9.79 134 316315 33710 52998907
Spinal cord injury 12.53 9.79 18 316431 683 53031934
Generalised tonic-clonic seizure 12.53 9.79 240 316209 28518 53004099
Prophylaxis 12.53 9.79 4 316445 7 53032610
Heteroplasia 12.53 9.79 4 316445 7 53032610
Tumour lysis syndrome 12.53 9.79 17 316432 7857 53024760
Injection site atrophy 12.45 9.79 16 316433 545 53032072
Ligamentum flavum hypertrophy 12.40 9.79 3 316446 0 53032617
Turbinectomy 12.40 9.79 3 316446 0 53032617
Muscle relaxant drug level above therapeutic 12.40 9.79 3 316446 0 53032617
CSF neutrophil count increased 12.40 9.79 3 316446 0 53032617
Premature ageing 12.40 9.79 3 316446 0 53032617
Hepatitis 12.29 9.79 135 316314 33759 52998858
Dental caries 12.27 9.79 106 316343 10486 53022131
Liver disorder 12.26 9.79 166 316283 39989 52992628
Electroencephalogram abnormal 12.23 9.79 50 316399 3771 53028846
Delirium 12.17 9.79 327 316122 41102 52991515
Accidental overdose 12.17 9.79 187 316262 21292 53011325
Encephalopathy 12.12 9.79 295 316154 36513 52996104
Internal hernia 12.12 9.79 6 316443 46 53032571
Gamma-glutamyltransferase increased 12.03 9.79 134 316315 33421 52999196
Lung adenocarcinoma stage I 12.02 9.79 5 316444 24 53032593
Shock 12.01 9.79 84 316365 23055 53009562
Narcolepsy 12.01 9.79 25 316424 1283 53031334
Toe operation 12.00 9.79 18 316431 711 53031906
Acute generalised exanthematous pustulosis 11.99 9.79 27 316422 10254 53022363
Ageusia 11.99 9.79 121 316328 12493 53020124
Blood potassium increased 11.97 9.79 160 316289 17681 53014936
Anal incontinence 11.87 9.79 121 316328 12526 53020091
Concomitant disease aggravated 11.86 9.79 21 316428 8717 53023900
Juvenile idiopathic arthritis 11.85 9.79 6 316443 4518 53028099
Paradoxical drug reaction 11.84 9.79 45 316404 3280 53029337
Lymphoma 11.84 9.79 28 316421 10454 53022163
Diffuse axonal injury 11.80 9.79 6 316443 49 53032568
Urinary occult blood positive 11.80 9.79 6 316443 49 53032568
Laboratory test abnormal 11.79 9.79 207 316242 24202 53008415
Toxicologic test abnormal 11.76 9.79 17 316432 649 53031968
Acute hepatic failure 11.75 9.79 55 316394 16665 53015952
Adverse drug reaction 11.67 9.79 408 316041 53217 52979400
Pseudomonas infection 11.67 9.79 28 316421 10400 53022217
Osteopenia 11.66 9.79 163 316286 18192 53014425
Haemangioma of skin 11.66 9.79 12 316437 320 53032297
Parapsoriasis 11.66 9.79 8 316441 119 53032498
Acute coronary syndrome 11.65 9.79 28 316421 10396 53022221
Snoring 11.65 9.79 49 316400 3743 53028874
Upper airway resistance syndrome 11.58 9.79 4 316445 10 53032607
Maternal exposure before pregnancy 11.57 9.79 10 316439 5676 53026941
Pulmonary toxicity 11.57 9.79 9 316440 5382 53027235
Headache 11.56 9.79 3458 312991 533363 52499254
Drug screen false positive 11.55 9.79 20 316429 893 53031724
Micturition urgency 11.54 9.79 89 316360 8513 53024104
Gastrointestinal disorder 11.51 9.79 427 316022 89577 52943040
Copper deficiency 11.50 9.79 6 316443 52 53032565
Septic encephalopathy 11.48 9.79 7 316442 84 53032533
Palmar-plantar erythrodysaesthesia syndrome 11.43 9.79 78 316371 21528 53011089
Pneumonia 11.43 9.79 2653 313796 404516 52628101
Withdrawal catatonia 11.40 9.79 6 316443 53 53032564
Skin toxicity 11.38 9.79 5 316444 4088 53028529
Basal cell carcinoma 11.32 9.79 87 316362 23382 53009235
Connective tissue inflammation 11.31 9.79 6 316443 54 53032563
Dysgraphia 11.30 9.79 40 316409 2817 53029800
Eyelid oedema 11.29 9.79 29 316420 10525 53022092
Confusional arousal 11.27 9.79 7 316442 87 53032530
Empty sella syndrome 11.25 9.79 5 316444 29 53032588
Neuromyelitis optica spectrum disorder 11.23 9.79 21 316428 996 53031621
Gastrointestinal motility disorder 11.16 9.79 58 316391 4838 53027779
Substance use 11.15 9.79 14 316435 466 53032151
White blood cell count decreased 11.12 9.79 870 315579 123605 52909012
Burns second degree 11.12 9.79 18 316431 760 53031857
Blood creatine phosphokinase increased 11.09 9.79 114 316335 28871 53003746
Altered state of consciousness 11.09 9.79 94 316355 24742 53007875
Blood iron abnormal 11.08 9.79 3 316446 3324 53029293
Oesophageal spasm 11.07 9.79 37 316412 2531 53030086
Hip fracture 11.04 9.79 232 316217 28025 53004592
Hypomagnesaemia 11.04 9.79 94 316355 24717 53007900
Acute myocardial infarction 11.03 9.79 135 316314 33100 52999517
Hypotension 11.01 9.79 1329 315120 252747 52779870
Femoral artery dissection 10.98 9.79 5 316444 31 53032586
Pericardial effusion 10.98 9.79 106 316343 27172 53005445
Gastroenteritis 10.97 9.79 98 316351 25518 53007099
Rash erythematous 10.96 9.79 157 316292 37466 52995151
Sleep talking 10.95 9.79 21 316428 1015 53031602
Blood potassium decreased 10.94 9.79 316 316133 40144 52992473
Normal newborn 10.92 9.79 16 316433 7163 53025454
Paralysis 10.92 9.79 94 316355 9290 53023327
Myocarditis 10.92 9.79 21 316428 8447 53024170
Postmortem blood drug level increased 10.89 9.79 15 316434 547 53032070
Atrioventricular block 10.78 9.79 16 316433 7124 53025493
Soft tissue disorder 10.78 9.79 6 316443 4284 53028333
Hepatitis fulminant 10.75 9.79 4 316445 3615 53029002
Impaired gastric emptying 10.74 9.79 91 316358 8952 53023665
Hepatitis acute 10.74 9.79 23 316426 8893 53023724
Lip oedema 10.69 9.79 4 316445 3603 53029014
Nervous system disorder 10.66 9.79 154 316295 17310 53015307
Persistent depressive disorder 10.66 9.79 21 316428 1036 53031581
Pathogen resistance 10.60 9.79 14 316435 6546 53026071
Dysphagia 10.60 9.79 607 315842 83790 52948827
Hypertension 10.56 9.79 1173 315276 224258 52808359
Mouth ulceration 10.55 9.79 117 316332 29209 53003408
Gastric bypass 10.55 9.79 26 316423 1494 53031123
Osteoporosis 10.54 9.79 203 316246 46257 52986360
Breakthrough pain 10.52 9.79 23 316426 1222 53031395
Naevus haemorrhage 10.50 9.79 7 316442 99 53032518
Vulvar basal cell carcinoma 10.48 9.79 5 316444 35 53032582
Pancreatitis chronic 10.47 9.79 35 316414 2395 53030222
Malignant polyp 10.46 9.79 9 316440 190 53032427
Metastases to lung 10.46 9.79 35 316414 11669 53020948
Depressed mood 10.36 9.79 290 316159 36674 52995943
Nervous system cyst 10.34 9.79 3 316446 3 53032614
Probiotic therapy 10.34 9.79 3 316446 3 53032614
Loss of consciousness 10.33 9.79 799 315650 113413 52919204
Laryngeal oedema 10.24 9.79 11 316438 5634 53026983
Abnormal dreams 10.22 9.79 102 316347 10499 53022118
Spinal osteoarthritis 10.20 9.79 136 316313 15021 53017596
Urine protein/creatinine ratio abnormal 10.19 9.79 4 316445 16 53032601
Formication 10.13 9.79 49 316400 3972 53028645
Creatinine renal clearance decreased 10.11 9.79 31 316418 10620 53021997
Exposure to SARS-CoV-2 10.09 9.79 11 316438 314 53032303
Hypercalcaemia 10.06 9.79 94 316355 24254 53008363
Uraemic encephalopathy 10.04 9.79 9 316440 201 53032416
No adverse event 10.03 9.79 168 316281 39097 52993520
Peripheral circulatory failure 9.97 9.79 12 316437 382 53032235
Neuroma 9.97 9.79 12 316437 382 53032235
Acne 9.95 9.79 81 316368 21505 53011112
Atrial septal defect 9.95 9.79 16 316433 6898 53025719
Drug eruption 9.89 9.79 98 316351 24996 53007621
Alanine aminotransferase abnormal 9.89 9.79 5 316444 3768 53028849
Tinnitus 9.87 9.79 244 316205 30275 53002342
Nephrogenic systemic fibrosis 9.87 9.79 55 316394 4712 53027905
Congenital neuropathy 9.82 9.79 4 316445 18 53032599
Enamel anomaly 9.82 9.79 4 316445 18 53032599
Hot flush 9.81 9.79 357 316092 46803 52985814
Screaming 9.80 9.79 42 316407 3235 53029382
Application site vesicles 9.79 9.79 25 316424 1469 53031148

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 hypersensitivity 929.98 10.26 1519 172776 71881 32267350
Drug ineffective for unapproved indication 498.13 10.26 485 173810 13427 32325804
Completed suicide 390.19 10.26 1236 173059 91281 32247950
Myoclonus 265.77 10.26 359 173936 14270 32324961
Neuropathy peripheral 184.72 10.26 860 173435 76122 32263109
Toxicity to various agents 183.83 10.26 1603 172692 176438 32162793
Somnolence 176.45 10.26 1054 173241 102743 32236488
Interstitial lung disease 148.02 10.26 82 174213 64919 32274312
Drug withdrawal syndrome 146.93 10.26 331 173964 19900 32319331
Fall 133.34 10.26 1622 172673 194579 32144652
Pain 128.50 10.26 1553 172742 186003 32153228
Sedation 127.78 10.26 297 173998 18229 32321002
Multiple sclerosis relapse 124.10 10.26 225 174070 11556 32327675
Drug abuse 118.33 10.26 786 173509 79457 32259774
Drug dependence 116.93 10.26 333 173962 23151 32316080
Neuralgia 113.37 10.26 217 174078 11618 32327613
Febrile neutropenia 112.02 10.26 302 173993 119264 32219967
Memory impairment 104.30 10.26 462 173833 40017 32299214
Mental status changes 99.87 10.26 439 173856 37898 32301333
Hypoaesthesia 99.32 10.26 593 173702 57760 32281471
Euphoric mood 99.09 10.26 131 174164 5096 32334135
Confusional state 92.70 10.26 1173 173122 141942 32197289
Hepatic function abnormal 91.77 10.26 64 174231 44776 32294455
Tremor 90.62 10.26 745 173550 80532 32258699
Withdrawal syndrome 89.88 10.26 200 174095 11922 32327309
Cytomegalovirus infection 86.25 10.26 16 174279 25448 32313783
Cardiac failure 86.24 10.26 231 174064 91442 32247789
Anaemia 85.81 10.26 776 173519 222848 32116383
Obsessive-compulsive disorder 84.94 10.26 118 174177 4816 32334415
Pain in extremity 83.23 10.26 989 173306 117912 32221319
Insomnia 81.74 10.26 860 173435 99488 32239743
Pyrexia 80.30 10.26 1220 173075 318748 32020483
Depression 77.73 10.26 829 173466 96231 32243000
Therapeutic product effect variable 76.73 10.26 74 174221 2022 32337209
Gait disturbance 75.10 10.26 709 173586 79699 32259532
Renal impairment 72.07 10.26 252 174043 91720 32247511
Muscle spasms 70.35 10.26 630 173665 69788 32269443
Thrombocytopenia 69.11 10.26 488 173807 147811 32191420
Balance disorder 69.05 10.26 404 173891 39055 32300176
Respiratory arrest 68.54 10.26 322 173973 28586 32310645
Suicidal ideation 67.99 10.26 392 173903 37691 32301540
Disinhibition 67.40 10.26 78 174217 2642 32336589
Antipsychotic drug level below therapeutic 65.54 10.26 66 174229 1903 32337328
Product complaint 63.89 10.26 113 174182 5690 32333541
Drug resistance 63.25 10.26 22 174273 22943 32316288
C-reactive protein increased 62.26 10.26 101 174194 48001 32291230
Accidental death 61.77 10.26 67 174228 2110 32337121
Multiple organ dysfunction syndrome 55.65 10.26 190 174105 69664 32269567
Alanine aminotransferase increased 55.63 10.26 224 174071 78255 32260976
Feeling abnormal 55.51 10.26 531 173764 59892 32279339
Neutropenia 55.47 10.26 491 173804 141684 32197547
Anxiety 55.07 10.26 770 173525 95235 32243996
Dizziness 54.49 10.26 1490 172805 208128 32131103
Disseminated intravascular coagulation 51.64 10.26 30 174265 23146 32316085
Septic shock 51.40 10.26 193 174102 68796 32270435
Overdose 50.99 10.26 701 173594 86376 32252855
Mucosal inflammation 50.40 10.26 63 174232 33371 32305860
Muscle spasticity 50.22 10.26 102 174193 5703 32333528
Increased appetite 49.30 10.26 108 174187 6368 32332863
Multiple sclerosis 48.86 10.26 119 174176 7525 32331706
Amnesia 48.19 10.26 263 174032 24773 32314458
Drug reaction with eosinophilia and systemic symptoms 48.15 10.26 62 174233 32423 32306808
General physical health deterioration 47.65 10.26 392 173903 114867 32224364
Back disorder 47.20 10.26 106 174189 6357 32332874
Bone marrow failure 46.13 10.26 57 174238 30347 32308884
Appendicolith 44.77 10.26 69 174226 3096 32336135
Vision blurred 44.45 10.26 396 173899 43790 32295441
Intentional product misuse 44.27 10.26 338 173957 35713 32303518
Nightmare 44.04 10.26 163 174132 13003 32326228
Burning sensation 43.88 10.26 198 174097 17280 32321951
Myokymia 43.68 10.26 17 174278 75 32339156
Dysarthria 42.87 10.26 315 173980 32886 32306345
Paraesthesia 42.37 10.26 493 173802 58451 32280780
Dyspnoea 42.28 10.26 1552 172743 360493 31978738
Respiratory depression 42.07 10.26 161 174134 13050 32326181
Hallucination 41.41 10.26 448 173847 52171 32287060
Haemophagocytic lymphohistiocytosis 40.88 10.26 6 174289 11329 32327902
Hepatic failure 40.71 10.26 81 174214 35599 32303632
Congenital multiplex arthrogryposis 38.25 10.26 13 174282 35 32339196
Prescription drug used without a prescription 38.24 10.26 41 174254 1274 32337957
Inadequate analgesia 37.16 10.26 60 174235 2803 32336428
Renal failure 36.28 10.26 505 173790 133973 32205258
Jaundice 36.07 10.26 81 174214 34077 32305154
Intervertebral disc degeneration 35.41 10.26 88 174207 5636 32333595
Cerebral haemorrhage 35.40 10.26 84 174211 34663 32304568
Acute kidney injury 34.21 10.26 1258 173037 292210 32047021
Back pain 33.96 10.26 807 173488 110246 32228985
Drug tolerance 33.39 10.26 51 174244 2270 32336961
Adverse drug reaction 33.18 10.26 245 174050 25616 32313615
Infusion related reaction 33.03 10.26 129 174166 45470 32293761
Bronchopulmonary aspergillosis 33.01 10.26 16 174279 13671 32325560
Full blood count decreased 32.94 10.26 179 174116 16831 32322400
Malignant neoplasm progression 32.86 10.26 266 174029 78230 32261001
Product dose omission issue 32.78 10.26 750 173545 101825 32237406
Off label use 32.66 10.26 1327 172968 304993 32034238
Ataxia 32.48 10.26 145 174150 12596 32326635
Hyperreflexia 32.43 10.26 58 174237 2946 32336285
Constipation 32.40 10.26 897 173398 125476 32213755
Diabetic neuropathy 32.38 10.26 70 174225 4090 32335141
Fatigue 32.30 10.26 2237 172058 348464 31990767
Hypokalaemia 32.05 10.26 169 174126 54925 32284306
Aspergillus infection 32.02 10.26 11 174284 11563 32327668
Asterixis 31.38 10.26 37 174258 1279 32337952
Melaena 31.34 10.26 89 174206 34576 32304655
Blood bilirubin increased 31.21 10.26 105 174190 38679 32300552
Aspartate aminotransferase increased 30.69 10.26 219 174076 66210 32273021
Restless legs syndrome 30.36 10.26 100 174195 7524 32331707
Anorgasmia 30.02 10.26 26 174269 616 32338615
Depressed level of consciousness 29.95 10.26 343 173952 40504 32298727
Toxic epidermal necrolysis 29.80 10.26 40 174255 20553 32318678
Peritonitis 29.73 10.26 46 174249 22284 32316947
Peripheral swelling 29.59 10.26 523 173772 67822 32271409
Muscle twitching 29.59 10.26 109 174186 8675 32330556
Mood altered 29.58 10.26 110 174185 8794 32330437
Atrial fibrillation 29.46 10.26 444 173851 116260 32222971
Sweat gland disorder 29.44 10.26 14 174281 109 32339122
Nerve injury 29.27 10.26 58 174237 3185 32336046
Lethargy 29.25 10.26 344 173951 40884 32298347
Delirium tremens 29.16 10.26 24 174271 529 32338702
Parasomnia 29.06 10.26 21 174274 379 32338852
Eosinophilia 29.04 10.26 56 174239 24902 32314329
Sciatica 29.04 10.26 80 174215 5454 32333777
Sopor 28.67 10.26 132 174163 11617 32327614
Graft versus host disease 28.66 10.26 11 174284 10795 32328436
Foetal exposure during pregnancy 28.55 10.26 119 174176 41182 32298049
Bradyphrenia 28.46 10.26 71 174224 4558 32334673
Neutrophil count decreased 28.32 10.26 143 174152 46996 32292235
Tooth disorder 28.04 10.26 118 174177 9989 32329242
Labelled drug-drug interaction medication error 27.75 10.26 16 174279 12397 32326834
Contraindicated product administered 27.66 10.26 37 174258 19039 32320192
Antidepressant drug level above therapeutic 26.97 10.26 15 174280 167 32339064
Colitis 26.58 10.26 93 174202 33858 32305373
Sleep apnoea syndrome 26.31 10.26 182 174113 18632 32320599
Cholestasis 26.25 10.26 67 174228 26966 32312265
Trigeminal neuralgia 26.16 10.26 30 174265 1006 32338225
Proteinuria 25.84 10.26 33 174262 17322 32321909
Colitis ulcerative 25.83 10.26 32 174263 17019 32322212
Gait inability 25.76 10.26 190 174105 19857 32319374
Rheumatoid arthritis 25.70 10.26 137 174158 44407 32294824
Gamma-glutamyltransferase increased 25.69 10.26 82 174213 30700 32308531
Victim of child abuse 25.61 10.26 26 174269 757 32338474
Metabolic acidosis 25.29 10.26 122 174173 40577 32298654
Acute myocardial infarction 24.90 10.26 183 174112 54966 32284265
Myelosuppression 24.77 10.26 16 174279 11660 32327571
Pathogen resistance 24.70 10.26 10 174285 9500 32329731
Nervousness 24.62 10.26 132 174163 12347 32326884
Erythema 24.62 10.26 306 173989 82799 32256432
Gastrointestinal haemorrhage 24.59 10.26 323 173972 86559 32252672
Pancytopenia 24.45 10.26 343 173952 90892 32248339
Venoocclusive liver disease 24.15 10.26 5 174290 7360 32331871
Pneumocystis jirovecii pneumonia 24.06 10.26 40 174255 18830 32320401
Erectile dysfunction 23.79 10.26 185 174110 19654 32319577
Anger 23.54 10.26 126 174169 11778 32327453
Asthma 23.54 10.26 139 174156 43926 32295305
Haematotoxicity 23.50 10.26 4 174291 6772 32332459
Hyperaesthesia 23.50 10.26 59 174236 3803 32335428
Pleural effusion 23.34 10.26 291 174004 78701 32260530
Needle fatigue 23.31 10.26 19 174276 413 32338818
Spinal operation 23.30 10.26 46 174249 2519 32336712
Circulatory collapse 23.21 10.26 49 174246 21076 32318155
Drug eruption 23.18 10.26 42 174253 19124 32320107
Myocarditis 23.10 10.26 17 174278 11573 32327658
Localised infection 23.09 10.26 150 174145 15037 32324194
Encephalopathy neonatal 23.07 10.26 9 174286 40 32339191
Cholangitis 23.03 10.26 8 174287 8350 32330881
Right atrial hypertrophy 22.87 10.26 17 174278 321 32338910
Relapsing-remitting multiple sclerosis 22.84 10.26 22 174273 600 32338631
Pneumonitis 22.63 10.26 84 174211 30050 32309181
Hypernatraemia 22.48 10.26 8 174287 8225 32331006
Angioedema 22.42 10.26 109 174186 36180 32303051
Acute myeloid leukaemia 22.32 10.26 43 174252 19131 32320100
Gait spastic 22.23 10.26 20 174275 499 32338732
Serotonin syndrome 22.22 10.26 177 174118 18940 32320291
Transplant rejection 22.19 10.26 13 174282 9986 32329245
Suicidal behaviour 22.13 10.26 33 174262 1438 32337793
Transaminases increased 22.08 10.26 65 174230 24963 32314268
Neonatal toxicity 21.99 10.26 8 174287 28 32339203
Acute respiratory distress syndrome 21.97 10.26 66 174229 25187 32314044
Thrombosis 21.94 10.26 356 173939 45398 32293833
Coordination abnormal 21.92 10.26 91 174204 7657 32331574
Posterior reversible encephalopathy syndrome 21.90 10.26 12 174283 9564 32329667
Plasma cell myeloma 21.86 10.26 432 173863 57182 32282049
Analgesic drug level above therapeutic 21.78 10.26 15 174280 250 32338981
Rash maculo-papular 21.78 10.26 77 174218 27945 32311286
Haematuria 21.58 10.26 161 174134 48200 32291031
Affective disorder 21.52 10.26 54 174241 3479 32335752
Impaired driving ability 21.48 10.26 44 174251 2475 32336756
Hepatic enzyme increased 21.32 10.26 114 174181 36923 32302308
Post transplant lymphoproliferative disorder 21.24 10.26 3 174292 5831 32333400
Drug tolerance increased 21.19 10.26 19 174276 472 32338759
Pulmonary alveolar haemorrhage 21.11 10.26 6 174289 7123 32332108
Metastases to liver 20.96 10.26 23 174272 12909 32326322
Dyskinesia 20.95 10.26 206 174089 23397 32315834
Personality change 20.72 10.26 67 174228 4992 32334239
Cerebral infarction 20.72 10.26 77 174218 27537 32311694
Fibromyalgia 20.71 10.26 46 174249 2738 32336493
Agranulocytosis 20.69 10.26 61 174234 23416 32315815
Phantom limb syndrome 20.51 10.26 15 174280 276 32338955
Delirium 20.49 10.26 341 173954 43705 32295526
Facial pain 20.46 10.26 37 174258 1896 32337335
Cough 20.44 10.26 577 173718 138240 32200991
Prescribed overdose 20.38 10.26 103 174192 9416 32329815
Urinary incontinence 20.31 10.26 167 174128 18040 32321191
Seizure 20.20 10.26 713 173582 103141 32236090
Hallucination, visual 20.02 10.26 159 174136 17000 32322231
Mental impairment 19.82 10.26 106 174189 9906 32329325
Hypometabolism 19.75 10.26 8 174287 40 32339191
Cerebral disorder 19.67 10.26 43 174252 2532 32336699
Hostility 19.61 10.26 24 174271 863 32338368
Liver disorder 19.60 10.26 95 174200 31559 32307672
Epistaxis 19.56 10.26 198 174097 55657 32283574
Bradypnoea 19.54 10.26 42 174253 2444 32336787
Irritability 19.43 10.26 210 174085 24444 32314787
Agitation 19.37 10.26 422 173873 56814 32282417
Muscular weakness 19.35 10.26 489 173806 67440 32271791
Blood creatinine increased 19.32 10.26 381 173914 95751 32243480
Feeding intolerance 19.15 10.26 9 174286 68 32339163
Conversion disorder 19.05 10.26 16 174279 363 32338868
Binocular eye movement disorder 18.99 10.26 8 174287 45 32339186
Blood lactate dehydrogenase increased 18.96 10.26 57 174238 21748 32317483
Hyperbilirubinaemia 18.75 10.26 42 174253 17688 32321543
Intervertebral disc protrusion 18.72 10.26 101 174194 9470 32329761
Haematochezia 18.72 10.26 128 174167 39080 32300151
Infective pulmonary exacerbation of cystic fibrosis 18.67 10.26 12 174283 8767 32330464
Blood creatine phosphokinase increased 18.61 10.26 155 174140 45321 32293910
Nephropathy toxic 18.54 10.26 22 174273 11924 32327307
Anaphylactic reaction 18.42 10.26 91 174204 30081 32309150
Hyperkalaemia 18.41 10.26 263 174032 69487 32269744
Osteomyelitis 18.31 10.26 145 174150 15488 32323743
Shock haemorrhagic 18.30 10.26 18 174277 10627 32328604
Ischaemic stroke 18.29 10.26 42 174253 17534 32321697
Schizophrenia 18.21 10.26 16 174279 9968 32329263
Opisthotonus 18.19 10.26 17 174278 446 32338785
Hepatocellular injury 18.09 10.26 72 174223 25246 32313985
Synovitis 18.01 10.26 19 174276 10859 32328372
Haemoglobin decreased 17.98 10.26 496 173799 119175 32220056
Rhabdomyolysis 17.97 10.26 253 174042 67012 32272219
Immune reconstitution inflammatory syndrome 17.82 10.26 15 174280 9544 32329687
Ear deformity acquired 17.73 10.26 5 174290 5 32339226
Treatment failure 17.65 10.26 130 174165 39033 32300198
Herpes zoster 17.56 10.26 257 174038 32084 32307147
Epstein-Barr virus infection 17.54 10.26 8 174287 7082 32332149
Cognitive disorder 17.46 10.26 214 174081 25680 32313551
Thinking abnormal 17.39 10.26 68 174227 5567 32333664
Precancerous skin lesion 17.37 10.26 19 174276 604 32338627
Inflammation 17.28 10.26 70 174225 24423 32314808
Appendicitis 17.27 10.26 94 174201 8843 32330388
Haemolysis 17.27 10.26 10 174285 7731 32331500
Tubulointerstitial nephritis 17.15 10.26 51 174244 19526 32319705
Tuberculosis 17.15 10.26 13 174282 8716 32330515
Breakthrough pain 17.00 10.26 19 174276 619 32338612
Acute hepatic failure 16.99 10.26 27 174268 12942 32326289
Dysphoria 16.98 10.26 38 174257 2273 32336958
Idiopathic neutropenia 16.94 10.26 4 174291 0 32339231
Hepatocellular carcinoma 16.94 10.26 18 174277 10252 32328979
Aggression 16.89 10.26 301 173994 39088 32300143
Musculoskeletal disorder 16.80 10.26 67 174228 5535 32333696
Disorientation 16.75 10.26 262 174033 33163 32306068
Tumour lysis syndrome 16.61 10.26 33 174262 14514 32324717
Obesity 16.37 10.26 102 174193 10080 32329151
Joint hyperextension 16.33 10.26 8 174287 67 32339164
Lower respiratory tract infection 16.28 10.26 91 174204 29152 32310079
Ventricular tachycardia 16.23 10.26 76 174219 25480 32313751
Migraine 15.99 10.26 129 174166 13856 32325375
Left ventricular dysfunction 15.98 10.26 17 174278 9678 32329553
Hand deformity 15.88 10.26 35 174260 2072 32337159
Spinal stenosis 15.75 10.26 57 174238 4497 32334734
Gingival atrophy 15.71 10.26 7 174288 46 32339185
Foetal disorder 15.69 10.26 20 174275 750 32338481
Nephrotic syndrome 15.61 10.26 10 174285 7319 32331912
Acute coronary syndrome 15.60 10.26 32 174263 13909 32325322
Rectal haemorrhage 15.57 10.26 127 174168 37296 32301935
Mucosal atrophy 15.56 10.26 8 174287 75 32339156
Metabolic encephalopathy 15.52 10.26 53 174242 4062 32335169
Quality of life decreased 15.40 10.26 47 174248 3395 32335836
Heat exhaustion 15.39 10.26 9 174286 111 32339120
Therapeutic response unexpected 15.27 10.26 96 174199 9516 32329715
Alcoholism 15.26 10.26 48 174247 3524 32335707
Stomatitis 15.19 10.26 140 174155 40089 32299142
Blood pressure decreased 15.15 10.26 188 174107 50892 32288339
Pulmonary tuberculosis 15.15 10.26 4 174291 4985 32334246
Suspected suicide 15.13 10.26 43 174252 2985 32336246
Diplopia 15.07 10.26 131 174164 14381 32324850
Personality disorder 14.99 10.26 25 174270 1200 32338031
Pulmonary toxicity 14.98 10.26 4 174291 4949 32334282
Muscle tightness 14.91 10.26 58 174237 4736 32334495
Feeling drunk 14.79 10.26 32 174263 1871 32337360
Myocardial infarction 14.75 10.26 538 173757 125138 32214093
Respiratory disorder 14.66 10.26 54 174241 19363 32319868
Acute pulmonary oedema 14.61 10.26 12 174283 7729 32331502
Candida infection 14.56 10.26 44 174251 16759 32322472
Drug effective for unapproved indication 14.54 10.26 27 174268 1412 32337819
Drug screen negative 14.48 10.26 12 174283 267 32338964
Encephalitis 14.48 10.26 10 174285 7034 32332197
Facial wasting 14.35 10.26 10 174285 170 32339061
Back injury 14.34 10.26 49 174246 3757 32335474
Akathisia 14.33 10.26 75 174220 6950 32332281
Autoimmune haemolytic anaemia 14.28 10.26 3 174292 4371 32334860
Body height decreased 14.27 10.26 49 174246 3766 32335465
Tachycardia 14.25 10.26 319 173976 78769 32260462
Blood urea increased 14.13 10.26 108 174187 32165 32307066
Artery dissection 14.05 10.26 9 174286 132 32339099
Hypersomnia 14.04 10.26 111 174184 11850 32327381
Abnormal labour affecting foetus 13.85 10.26 5 174290 17 32339214
Palmar-plantar erythrodysaesthesia syndrome 13.82 10.26 41 174254 15708 32323523
Weight increased 13.78 10.26 564 173731 83099 32256132
Thoracic vertebral fracture 13.76 10.26 27 174268 1472 32337759
Dysphemia 13.74 10.26 28 174267 1569 32337662
Cardio-respiratory arrest 13.65 10.26 395 173900 55594 32283637
Bronchial wall thickening 13.60 10.26 21 174274 944 32338287
Abnormal sleep-related event 13.59 10.26 15 174280 482 32338749
Injection site mass 13.57 10.26 62 174233 5439 32333792
Toxic skin eruption 13.56 10.26 26 174269 11588 32327643
Stevens-Johnson syndrome 13.50 10.26 53 174242 18656 32320575
Shock 13.45 10.26 75 174220 24039 32315192
Lactic acidosis 13.41 10.26 115 174180 33421 32305810
Lung disorder 13.38 10.26 116 174179 33638 32305593
Bronchial secretion retention 13.37 10.26 22 174273 1044 32338187
Hypoalbuminaemia 13.34 10.26 27 174268 11795 32327436
Radiculopathy 13.29 10.26 39 174256 2756 32336475
Cytomegalovirus viraemia 13.24 10.26 10 174285 6717 32332514
Free androgen index decreased 13.23 10.26 5 174290 20 32339211
Acute graft versus host disease in skin 13.22 10.26 5 174290 4952 32334279
Foot fracture 13.16 10.26 52 174243 4277 32334954
Neck pain 13.13 10.26 183 174112 22604 32316627
Mucormycosis 13.05 10.26 7 174288 5647 32333584
Hepatitis 13.04 10.26 74 174221 23619 32315612
Sedation complication 12.99 10.26 23 174272 1159 32338072
Ventricular hypokinesia 12.97 10.26 5 174290 4895 32334336
Nerve compression 12.88 10.26 41 174254 3029 32336202
Haemorrhage intracranial 12.78 10.26 43 174252 15844 32323387
Nasal odour 12.70 10.26 3 174292 0 32339231
Severe myoclonic epilepsy of infancy 12.70 10.26 3 174292 0 32339231
Benign neoplasm of spinal cord 12.70 10.26 3 174292 0 32339231
Pancreatic fibrosis 12.70 10.26 3 174292 0 32339231
Traumatic amputation 12.70 10.26 3 174292 0 32339231
Alcohol withdrawal syndrome 12.66 10.26 26 174269 1465 32337766
Hypoosmolar state 12.66 10.26 7 174288 77 32339154
Hyperuricaemia 12.62 10.26 15 174280 8126 32331105
Cardiac failure acute 12.60 10.26 22 174273 10162 32329069
Hypertriglyceridaemia 12.55 10.26 17 174278 8702 32330529
Laboratory test abnormal 12.55 10.26 157 174138 18930 32320301
Drug abuser 12.51 10.26 50 174245 4134 32335097
Hypomagnesaemia 12.49 10.26 55 174240 18750 32320481
Amphetamines positive 12.48 10.26 9 174286 162 32339069
Fungal infection 12.48 10.26 41 174254 15214 32324017
Seborrhoeic keratosis 12.46 10.26 21 174274 1017 32338214
Hypertonic bladder 12.45 10.26 25 174270 1386 32337845
Violence-related symptom 12.20 10.26 15 174280 542 32338689
Haemorrhage 12.16 10.26 189 174106 49259 32289972
Blood alkaline phosphatase increased 12.05 10.26 112 174183 32020 32307211
Hypotension 12.05 10.26 996 173299 215114 32124117
Enterococcal infection 12.02 10.26 19 174276 9128 32330103
Hepatotoxicity 11.99 10.26 58 174237 19279 32319952
Enterocolitis 11.95 10.26 13 174282 7327 32331904
Bipolar I disorder 11.93 10.26 19 174276 877 32338354
Neutropenic sepsis 11.92 10.26 32 174263 12667 32326564
Pneumothorax 11.91 10.26 51 174244 17519 32321712
Anaphylactic shock 11.89 10.26 41 174254 14993 32324238
Ascites 11.89 10.26 148 174147 40043 32299188
Road traffic accident 11.87 10.26 144 174151 17237 32321994
Disturbance in attention 11.83 10.26 186 174109 23567 32315664
Drug withdrawal syndrome neonatal 11.81 10.26 44 174251 3520 32335711
Hepatitis B 11.76 10.26 10 174285 6331 32332900
Neutropenia neonatal 11.61 10.26 16 174279 648 32338583
Dysstasia 11.57 10.26 103 174192 11383 32327848
Mental disorder 11.50 10.26 124 174171 14424 32324807
Hyperglycaemia 11.49 10.26 141 174154 38250 32300981
Oesophageal mucosa erythema 11.47 10.26 5 174290 31 32339200
Panic attack 11.46 10.26 87 174208 9174 32330057
Nephrogenic systemic fibrosis 11.45 10.26 50 174245 4302 32334929
Ventricular septal defect 11.43 10.26 3 174292 3754 32335477
Creatinine urine decreased 11.33 10.26 5 174290 32 32339199
Slow speech 11.33 10.26 20 174275 1005 32338226
Hyperfibrinogenaemia 11.22 10.26 4 174291 13 32339218
Right ventricular hypertrophy 11.20 10.26 19 174276 925 32338306
Abdominal discomfort 11.16 10.26 365 173930 52259 32286972
Hyperhidrosis 11.09 10.26 477 173818 70691 32268540
Lipodystrophy acquired 11.09 10.26 3 174292 3679 32335552
Dependence on respirator 11.08 10.26 5 174290 34 32339197
Lymphocyte count decreased 11.07 10.26 67 174228 21052 32318179
Intentional underdose 11.01 10.26 18 174277 850 32338381
Chronic graft versus host disease 11.00 10.26 5 174290 4435 32334796
Hypotony maculopathy 11.00 10.26 4 174291 14 32339217
Immunosuppressant drug level increased 10.98 10.26 7 174288 5138 32334093
Leukopenia 10.97 10.26 242 174053 59880 32279351
Neck surgery 10.96 10.26 12 174283 382 32338849
Teeth brittle 10.93 10.26 6 174289 65 32339166
Ejection fraction decreased 10.93 10.26 53 174242 17605 32321626
Drug interaction 10.92 10.26 1014 173281 217171 32122060
Axillary pain 10.90 10.26 11 174284 318 32338913
Hyperthyroidism 10.89 10.26 21 174274 9341 32329890
Disease progression 10.83 10.26 369 173926 86493 32252738
Dependence 10.82 10.26 22 174273 1231 32338000
Rib fracture 10.80 10.26 118 174177 13771 32325460
Brain stem auditory evoked response abnormal 10.78 10.26 4 174291 15 32339216
Fear of weight gain 10.78 10.26 4 174291 15 32339216
Dysaesthesia 10.78 10.26 32 174263 2276 32336955
Neutrophil count increased 10.78 10.26 47 174248 16067 32323164
Complex regional pain syndrome 10.74 10.26 14 174281 537 32338694
Pupillary reflex impaired 10.72 10.26 25 174270 1537 32337694
Aphasia 10.71 10.26 164 174131 20664 32318567
Carcinogenicity 10.70 10.26 6 174289 68 32339163
Multiple cardiac defects 10.70 10.26 6 174289 68 32339163
Post herpetic neuralgia 10.69 10.26 20 174275 1052 32338179
Dissociative disorder 10.69 10.26 9 174286 205 32339026
Immature granulocyte percentage increased 10.64 10.26 3 174292 3 32339228
Sleep disorder 10.62 10.26 202 174093 26550 32312681
White blood cell count increased 10.61 10.26 157 174138 41245 32297986
Intervertebral disc injury 10.58 10.26 4 174291 16 32339215
Large intestine perforation 10.58 10.26 17 174278 8113 32331118
Head titubation 10.56 10.26 10 174285 267 32338964
Light chain analysis decreased 10.51 10.26 5 174290 39 32339192
Retinal haemorrhage 10.49 10.26 7 174288 5014 32334217
Sensory disturbance 10.47 10.26 62 174233 6016 32333215
Pulmonary fibrosis 10.47 10.26 51 174244 16923 32322308
Antipsychotic drug level increased 10.47 10.26 3 174292 3543 32335688
Oxygen saturation decreased 10.47 10.26 188 174107 47911 32291320
Lumbar radiculopathy 10.42 10.26 18 174277 889 32338342
Post laminectomy syndrome 10.40 10.26 9 174286 213 32339018
Incision site complication 10.38 10.26 11 174284 337 32338894
Bipolar disorder 10.37 10.26 45 174250 3861 32335370
Bursa disorder 10.36 10.26 9 174286 214 32339017
Arthrofibrosis 10.33 10.26 6 174289 73 32339158

Pharmacologic Action:

SourceCodeDescription
ATC N03AX12 NERVOUS SYSTEM
ANTIEPILEPTICS
ANTIEPILEPTICS
Other antiepileptics
FDA PE N0000008486 Decreased Central Nervous System Disorganized Electrical Activity
MeSH PA D000700 Analgesics
MeSH PA D014151 Anti-Anxiety Agents
MeSH PA D000927 Anticonvulsants
MeSH PA D018692 Antimanic Agents
MeSH PA D002491 Central Nervous System Agents
MeSH PA D002492 Central Nervous System Depressants
MeSH PA D018691 Excitatory Amino Acid Antagonists
MeSH PA D018377 Neurotransmitter Agents
MeSH PA D018373 Peripheral Nervous System Agents
MeSH PA D011619 Psychotropic Drugs
MeSH PA D018689 Sensory System Agents
MeSH PA D014149 Tranquilizing Agents
FDA EPC N0000175753 Anti-epileptic Agent
CHEBI has role CHEBI:35623 antiepileptic
CHEBI has role CHEBI:35703 Xenobiotic
CHEBI has role CHEBI:38215 calcium channel blockers
CHEBI has role CHEBI:78298 environmental contaminants

Drug Use (View source of the data)

DiseaseRelationSNOMED_IDDOID
Postherpetic neuralgia indication 2177002
Restless legs indication 32914008 DOID:0050425
Partial Epilepsy Treatment Adjunct indication
Alcohol use disorder off-label use 7200002
Menopausal night sweats off-label use 42984000
Chronic cough off-label use 68154008
Chronic pain off-label use 82423001
Insomnia off-label use 193462001
Anxiety disorder off-label use 197480006 DOID:2030
Menopausal flushing off-label use 198436008
Fibromyalgia off-label use 203082005 DOID:631
Neuropathic pain off-label use 247398009
Chronic pruritus off-label use 418363000
Refractory pruritis off-label use 418363000
Post-stroke nausea off-label use 422587007
Essential tremor off-label use 609558009 DOID:4990
Intractable hiccups off-label use 716771000
Acute postoperative pain off-label use 107401000119105
Suicidal thoughts contraindication 6471006
Depressive disorder contraindication 35489007
Kidney disease contraindication 90708001 DOID:557

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 4.02 acidic
pKa2 10.31 Basic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
300MG GRALISE ALMATICA N022544 Jan. 28, 2011 RX TABLET ORAL 8192756 Oct. 25, 2022 TREATMENT WITH GABAPENTIN, INCLUDING TREATMENT OF NEUROPATHIC PAIN, INCLUDING NEUROPATHIC PAIN ASSOCIATED WITH POSTHERPETIC NEURALGIA
300MG GRALISE ALMATICA N022544 Jan. 28, 2011 RX TABLET ORAL 8252332 Oct. 25, 2022 TREATMENT WITH GABAPENTIN, INCLUDING TREATMENT OF NEUROPATHIC PAIN, INCLUDING NEUROPATHIC PAIN ASSOCIATED WITH POSTHERPETIC NEURALGIA
300MG GRALISE ALMATICA N022544 Jan. 28, 2011 RX TABLET ORAL 8333992 Oct. 25, 2022 TREATMENT WITH GABAPENTIN, INCLUDING TREATMENT OF NEUROPATHIC PAIN, INCLUDING NEUROPATHIC PAIN ASSOCIATED WITH POSTHERPETIC NEURALGIA
600MG GRALISE ALMATICA N022544 Jan. 28, 2011 RX TABLET ORAL 8192756 Oct. 25, 2022 TREATMENT WITH GABAPENTIN, INCLUDING TREATMENT OF NEUROPATHIC PAIN, INCLUDING NEUROPATHIC PAIN ASSOCIATED WITH POSTHERPETIC NEURALGIA
600MG GRALISE ALMATICA N022544 Jan. 28, 2011 RX TABLET ORAL 8252332 Oct. 25, 2022 TREATMENT WITH GABAPENTIN, INCLUDING TREATMENT OF NEUROPATHIC PAIN, INCLUDING NEUROPATHIC PAIN ASSOCIATED WITH POSTHERPETIC NEURALGIA
600MG GRALISE ALMATICA N022544 Jan. 28, 2011 RX TABLET ORAL 8333992 Oct. 25, 2022 TREATMENT WITH GABAPENTIN, INCLUDING TREATMENT OF NEUROPATHIC PAIN, INCLUDING NEUROPATHIC PAIN ASSOCIATED WITH POSTHERPETIC NEURALGIA
300MG GRALISE ALMATICA N022544 Jan. 28, 2011 RX TABLET ORAL 7438927 Feb. 26, 2024 TREATMENT WITH GABAPENTIN, INCLUDING TREATMENT OF NEUROPATHIC PAIN, INCLUDING NEUROPATHIC PAIN ASSOCIATED WITH POSTHERPETIC NEURALGIA
600MG GRALISE ALMATICA N022544 Jan. 28, 2011 RX TABLET ORAL 7438927 Feb. 26, 2024 TREATMENT WITH GABAPENTIN, INCLUDING TREATMENT OF NEUROPATHIC PAIN, INCLUDING NEUROPATHIC PAIN ASSOCIATED WITH POSTHERPETIC NEURALGIA

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
Voltage-dependent calcium channel subunit alpha-2/delta-2 Ion channel MODULATOR IC50 6.93 SCIENTIFIC LITERATURE SCIENTIFIC LITERATURE
Voltage-dependent calcium channel subunit alpha-2/delta-1 Ion channel MODULATOR IC50 7.26 WOMBAT-PK CHEMBL
Adenosine receptor A1 GPCR WOMBAT-PK
Gamma-aminobutyric acid type B receptor subunit 2 GPCR WOMBAT-PK
Glutamate receptor ionotropic, NMDA 3A Ion channel WOMBAT-PK
Large neutral amino acids transporter small subunit 1 Transporter IC50 4.52 WOMBAT-PK
Sodium channel protein type 5 subunit alpha Ion channel WOMBAT-PK
Potassium voltage-gated channel subfamily KQT member 3 Ion channel ACTIVATOR EC50 8.28 IUPHAR
Potassium voltage-gated channel subfamily KQT member 5 Ion channel ACTIVATOR EC50 8.72 IUPHAR
Alpha-2A adrenergic receptor GPCR WOMBAT-PK
Voltage-dependent calcium channel subunit alpha-2/delta-1 Ion channel Ki 6.92 CHEMBL
Uncharacterized protein; Voltage-dependent calcium channel alpha-2 delta subunit Ion channel IC50 7.15 CHEMBL

External reference:

IDSource
4020833 VUID
N0000148345 NUI
D00332 KEGG_DRUG
4020833 VANDF
C0060926 UMLSCUI
CHEBI:42797 CHEBI
GBN PDB_CHEM_ID
CHEMBL940 ChEMBL_ID
DB00996 DRUGBANK_ID
D000077206 MESH_DESCRIPTOR_UI
3446 PUBCHEM_CID
5094 INN_ID
C081867 MESH_SUPPLEMENTAL_RECORD_UI
5483 IUPHAR_LIGAND_ID
6CW7F3G59X UNII
196498 RXNORM
2269 MMSL
4770 MMSL
60712 MMSL
d03182 MMSL
004415 NDDF
108402001 SNOMEDCT_US
386845007 SNOMEDCT_US

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Neurontin HUMAN PRESCRIPTION DRUG LABEL 1 0071-0401 TABLET, FILM COATED 800 mg ORAL NDA 31 sections
Neurontin HUMAN PRESCRIPTION DRUG LABEL 1 0071-0513 TABLET, FILM COATED 600 mg ORAL NDA 31 sections
Neurontin HUMAN PRESCRIPTION DRUG LABEL 1 0071-0803 CAPSULE 100 mg ORAL NDA 31 sections
Neurontin HUMAN PRESCRIPTION DRUG LABEL 1 0071-0805 CAPSULE 300 mg ORAL NDA 31 sections
Neurontin HUMAN PRESCRIPTION DRUG LABEL 1 0071-0806 CAPSULE 400 mg ORAL NDA 31 sections
Neurontin HUMAN PRESCRIPTION DRUG LABEL 1 0071-2012 SOLUTION 250 mg ORAL NDA 31 sections
Gabapentin HUMAN PRESCRIPTION DRUG LABEL 1 0228-2636 TABLET, FILM COATED 600 mg ORAL ANDA 26 sections
Gabapentin HUMAN PRESCRIPTION DRUG LABEL 1 0228-2637 TABLET, FILM COATED 800 mg ORAL ANDA 26 sections
GABAPENTIN HUMAN PRESCRIPTION DRUG LABEL 1 0440-5562 TABLET, FILM COATED 600 mg ORAL ANDA 24 sections
GABAPENTIN HUMAN PRESCRIPTION DRUG LABEL 1 0440-5563 TABLET, FILM COATED 800 mg ORAL ANDA 24 sections
Gabapentin HUMAN PRESCRIPTION DRUG LABEL 1 0440-7559 CAPSULE 300 mg ORAL ANDA 14 sections
Gabapentin HUMAN PRESCRIPTION DRUG LABEL 1 0615-8132 TABLET 800 mg ORAL ANDA 29 sections
Gabapentin HUMAN PRESCRIPTION DRUG LABEL 1 0615-8230 CAPSULE 100 mg ORAL ANDA 29 sections
Gabapentin HUMAN PRESCRIPTION DRUG LABEL 1 0615-8231 CAPSULE 300 mg ORAL ANDA 29 sections
Gabapentin HUMAN PRESCRIPTION DRUG LABEL 1 0615-8232 CAPSULE 400 mg ORAL ANDA 29 sections
Gabapentin HUMAN PRESCRIPTION DRUG LABEL 1 0615-8233 TABLET 600 mg ORAL ANDA 29 sections
Gabapentin HUMAN PRESCRIPTION DRUG LABEL 1 0615-8340 CAPSULE 100 mg ORAL ANDA 26 sections
Gabapentin HUMAN PRESCRIPTION DRUG LABEL 1 0615-8341 CAPSULE 300 mg ORAL ANDA 26 sections
Gabapentin HUMAN PRESCRIPTION DRUG LABEL 1 0615-8342 CAPSULE 400 mg ORAL ANDA 26 sections
Gabapentin HUMAN PRESCRIPTION DRUG LABEL 1 0904-6586 TABLET, FILM COATED 800 mg ORAL ANDA 25 sections
Gabapentin HUMAN PRESCRIPTION DRUG LABEL 1 0904-6665 CAPSULE 100 mg ORAL ANDA 30 sections
Gabapentin HUMAN PRESCRIPTION DRUG LABEL 1 0904-6666 CAPSULE 300 mg ORAL ANDA 30 sections
Gabapentin HUMAN PRESCRIPTION DRUG LABEL 1 0904-6667 CAPSULE 400 mg ORAL ANDA 30 sections
Gabapentin HUMAN PRESCRIPTION DRUG LABEL 1 0904-6823 TABLET, FILM COATED 600 mg ORAL ANDA 30 sections
Gabapentin HUMAN PRESCRIPTION DRUG LABEL 1 0904-7108 TABLET, FILM COATED 800 mg ORAL ANDA 30 sections
Gabapentin HUMAN PRESCRIPTION DRUG LABEL 1 10135-644 CAPSULE 100 mg ORAL ANDA 30 sections
Gabapentin HUMAN PRESCRIPTION DRUG LABEL 1 10135-645 CAPSULE 300 mg ORAL ANDA 30 sections
Gabapentin HUMAN PRESCRIPTION DRUG LABEL 1 10135-646 CAPSULE 400 mg ORAL ANDA 30 sections
Gabapentin HUMAN PRESCRIPTION DRUG LABEL 1 10135-647 TABLET 600 mg ORAL ANDA 30 sections
Gabapentin HUMAN PRESCRIPTION DRUG LABEL 1 10135-648 TABLET 800 mg ORAL ANDA 30 sections