gabapentin 🐶 Veterinary Use | 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 µM/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 1542.16 9.81 4613 362821 306074 62815514
Completed suicide 1030.68 9.81 2469 364965 143204 62978384
Pemphigus 1003.52 9.81 11 367423 183715 62937873
Drug ineffective for unapproved indication 958.50 9.81 1082 366352 32981 63088607
Glossodynia 746.54 9.81 82 367352 178794 62942794
Hand deformity 733.98 9.81 48 367386 159409 62962179
Systemic lupus erythematosus 716.95 9.81 165 367269 208753 62912835
Anti-cyclic citrullinated peptide antibody positive 653.93 9.81 3 367431 116209 63005379
Synovitis 585.47 9.81 177 367257 186741 62934847
Pericarditis 584.29 9.81 47 367387 131532 62990056
Contraindicated product administered 582.87 9.81 265 367169 217383 62904205
Maternal exposure during pregnancy 552.83 9.81 292 367142 219770 62901818
Arthropathy 480.80 9.81 392 367042 234400 62887188
Duodenal ulcer perforation 476.98 9.81 5 367429 87204 63034384
Multiple sclerosis relapse 458.46 9.81 924 366510 47554 63074034
Helicobacter infection 435.66 9.81 25 367409 92760 63028828
Rheumatoid factor positive 432.32 9.81 12 367422 84394 63037194
Wound 412.30 9.81 215 367219 163048 62958540
Somnolence 382.16 9.81 2041 365393 176644 62944944
Infusion related reaction 365.39 9.81 534 366900 244987 62876601
Toxicity to various agents 364.13 9.81 2564 364870 244686 62876902
Fall 345.83 9.81 3629 363805 388705 62732883
Hepatic enzyme increased 342.12 9.81 400 367034 201928 62919660
Joint swelling 320.98 9.81 908 366526 326758 62794830
Discomfort 317.63 9.81 300 367134 167074 62954514
Muscle injury 314.95 9.81 15 367419 65330 63056258
Folliculitis 306.90 9.81 27 367407 70290 63051298
Drug abuse 302.44 9.81 1016 366418 71502 63050086
Abdominal discomfort 290.68 9.81 922 366512 319963 62801625
Multiple sclerosis 290.61 9.81 513 366921 23859 63097729
General physical health deterioration 284.21 9.81 454 366980 200948 62920640
Depression 279.99 9.81 2022 365412 194470 62927118
Myoclonus 265.96 9.81 390 367044 15478 63106110
Swelling 250.89 9.81 789 366645 274589 62846999
Feeling abnormal 241.53 9.81 1578 365856 146814 62974774
Alopecia 238.63 9.81 1073 366361 336463 62785125
Therapeutic product effect decreased 237.00 9.81 475 366959 192712 62928876
Sleep disorder due to general medical condition, insomnia type 233.54 9.81 18 367416 52199 63069389
Tremor 226.12 9.81 1424 366010 130815 62990773
Suicidal ideation 213.72 9.81 820 366614 61601 63059987
Hypersensitivity 202.87 9.81 937 366497 291748 62829840
Liver injury 201.11 9.81 51 367383 60469 63061119
Product dose omission issue 198.75 9.81 2152 365282 232161 62889427
Exposure during pregnancy 192.84 9.81 380 367054 155167 62966421
Swollen joint count increased 188.90 9.81 4 367430 36050 63085538
Lower respiratory tract infection 188.68 9.81 296 367138 132011 62989577
Rheumatic fever 181.65 9.81 19 367415 43092 63078496
Irritable bowel syndrome 179.43 9.81 129 367305 82283 63039305
Dizziness 177.36 9.81 3481 363953 426444 62695144
Treatment failure 175.09 9.81 579 366855 198464 62923124
Impaired healing 170.75 9.81 205 367229 102337 63019251
Hallucination 169.85 9.81 698 366736 54119 63067469
Accidental death 164.20 9.81 116 367318 1860 63119728
Memory impairment 161.89 9.81 1096 366338 103162 63018426
Neuropathy peripheral 160.16 9.81 1167 366267 112500 63009088
Drug intolerance 158.55 9.81 1090 366344 307571 62814017
Drug withdrawal syndrome 153.69 9.81 424 367010 26770 63094818
C-reactive protein increased 152.79 9.81 194 367240 94513 63027075
Anxiety 149.86 9.81 1920 365514 215621 62905967
Balance disorder 149.81 9.81 918 366516 83504 63038084
Blister 148.39 9.81 332 367102 129482 62992106
Respiratory arrest 145.56 9.81 468 366966 32177 63089411
Product use issue 144.51 9.81 720 366714 219800 62901788
Withdrawal syndrome 144.37 9.81 342 367092 19655 63101933
Neuralgia 142.35 9.81 400 367034 25526 63096062
Vision blurred 141.90 9.81 965 366469 90959 63030629
Muscle spasms 138.28 9.81 1447 365987 154703 62966885
C-reactive protein abnormal 133.12 9.81 50 367384 46046 63075542
Drug dependence 128.83 9.81 372 367062 24111 63097477
Mental status changes 127.25 9.81 510 366924 39089 63082499
Febrile neutropenia 124.20 9.81 317 367117 118132 63003456
Product complaint 120.86 9.81 244 367190 12565 63109023
Seizure 114.55 9.81 1223 366211 131411 62990177
Cardio-respiratory arrest 111.45 9.81 660 366774 59299 63062289
Rash 111.31 9.81 2437 364997 558434 62563154
Pyrexia 109.63 9.81 1990 365444 468488 62653100
Respiratory depression 108.30 9.81 243 367191 13472 63108116
Rheumatoid arthritis 107.91 9.81 944 366490 252875 62868713
Ill-defined disorder 105.40 9.81 195 367239 81560 63040028
Gait disturbance 102.71 9.81 1559 365875 181619 62939969
Device expulsion 100.64 9.81 38 367396 34884 63086704
Pain in extremity 100.48 9.81 2570 364864 328916 62792672
Migraine 96.35 9.81 968 366466 102378 63019210
Hypoaesthesia 94.72 9.81 1434 366000 166959 62954629
Unresponsive to stimuli 94.22 9.81 417 367017 33399 63088189
Sopor 93.64 9.81 312 367122 21852 63099736
Urinary tract infection 86.39 9.81 2073 365361 262611 62858977
Infection 85.58 9.81 880 366554 228293 62893295
Blood cholesterol increased 85.06 9.81 270 367164 93762 63027826
Dyskinesia 84.94 9.81 389 367045 31613 63089975
Live birth 84.37 9.81 22 367412 25608 63095980
Drug use disorder 81.36 9.81 121 367313 4863 63116725
Hip arthroplasty 80.63 9.81 94 367340 47552 63074036
Lethargy 79.39 9.81 576 366858 55431 63066157
Interstitial lung disease 78.61 9.81 149 367285 61759 63059829
Plasma cell myeloma 75.13 9.81 408 367026 35497 63086091
Type 2 diabetes mellitus 74.88 9.81 161 367273 63707 63057881
Intentional product misuse 74.36 9.81 605 366829 60312 63061276
Cardiac arrest 72.40 9.81 837 366597 91708 63029880
Speech disorder 72.16 9.81 442 366992 40187 63081401
Paraesthesia 71.72 9.81 1292 366142 155674 62965914
Stomatitis 71.54 9.81 489 366945 138236 62983352
Myelosuppression 71.36 9.81 24 367410 23679 63097909
Back pain 69.74 9.81 2012 365422 262133 62859455
Mental disorder 69.49 9.81 316 367118 25603 63095985
Intentional product use issue 69.38 9.81 444 366990 127448 62994140
Bone erosion 69.27 9.81 10 367424 17707 63103881
Inadequate analgesia 68.68 9.81 85 367349 2858 63118730
Head injury 68.30 9.81 327 367107 27069 63094519
Muscular weakness 66.48 9.81 1036 366398 121317 63000271
Knee arthroplasty 65.77 9.81 134 367300 54072 63067516
Cytomegalovirus infection 65.23 9.81 20 367414 20932 63100656
Amnesia 64.61 9.81 546 366888 55039 63066549
Hepatic function abnormal 64.23 9.81 72 367362 37070 63084518
Insomnia 63.70 9.81 1664 365770 213588 62908000
Burning sensation 62.48 9.81 533 366901 53874 63067714
Therapeutic response unexpected 61.38 9.81 243 367191 18516 63103072
Intervertebral disc protrusion 61.30 9.81 286 367148 23423 63098165
Premature baby 60.69 9.81 22 367412 20713 63100875
Muscle twitching 60.55 9.81 250 367184 19418 63102170
Overdose 60.10 9.81 968 366466 114110 63007478
Vertigo 59.73 9.81 569 366865 59318 63062270
Sleep apnoea syndrome 58.91 9.81 328 367106 28805 63092783
Sedation 58.42 9.81 405 367029 38404 63083184
Trigeminal neuralgia 58.25 9.81 86 367348 3433 63118155
Off label use 58.23 9.81 3252 364182 671210 62450378
Influenza like illness 58.03 9.81 617 366817 66207 63055381
Gastrointestinal disorder 57.54 9.81 484 366950 130755 62990833
Feeling drunk 57.06 9.81 93 367341 4049 63117539
Coordination abnormal 56.52 9.81 192 367242 13581 63108007
Crying 56.30 9.81 276 367158 23067 63098521
Urinary incontinence 56.05 9.81 347 367087 31667 63089921
Hypersomnia 55.98 9.81 230 367204 17825 63103763
Hyperhidrosis 55.91 9.81 906 366528 106930 63014658
Back disorder 55.66 9.81 165 367269 10852 63110736
Cardiac failure 55.52 9.81 296 367138 88846 63032742
Full blood count decreased 55.31 9.81 297 367137 25727 63095861
Mucosal inflammation 55.26 9.81 118 367316 46810 63074778
Spinal operation 54.94 9.81 137 367297 8134 63113454
Pancytopenia 54.90 9.81 332 367102 96601 63024987
Malignant neoplasm progression 54.37 9.81 267 367167 81854 63039734
Anaemia 53.77 9.81 1290 366144 292140 62829448
Psoriatic arthropathy 53.67 9.81 310 367124 91210 63030378
Neck pain 53.34 9.81 625 366809 68693 63052895
Macular degeneration 53.24 9.81 38 367396 24338 63097250
Arthralgia 53.24 9.81 2725 364709 566985 62554603
Surgery 52.43 9.81 372 367062 35540 63086048
Death 52.25 9.81 2658 364776 371723 62749865
Pulmonary fibrosis 52.15 9.81 94 367340 39715 63081873
Drug tolerance decreased 52.07 9.81 18 367416 17455 63104133
Anticipatory anxiety 51.94 9.81 49 367385 1202 63120386
Nervousness 51.88 9.81 332 367102 30647 63090941
Confusional state 51.66 9.81 1760 365674 234620 62886968
Foetal exposure during pregnancy 50.98 9.81 66 367368 31896 63089692
Drug-induced liver injury 50.89 9.81 97 367337 40125 63081463
Hallucination, visual 50.78 9.81 234 367200 19064 63102524
Pleural fibrosis 50.63 9.81 80 367354 3392 63118196
Rheumatoid nodule 50.55 9.81 18 367416 17137 63104451
Presbyacusis 50.31 9.81 72 367362 2793 63118795
Nasopharyngitis 49.02 9.81 1109 366325 253148 62868440
Hepatotoxicity 48.94 9.81 87 367347 36954 63084634
Euphoric mood 48.39 9.81 95 367339 4792 63116796
Pregnancy 48.23 9.81 87 367347 36749 63084839
Suspected suicide 48.13 9.81 113 367321 6455 63115133
Therapeutic response decreased 47.40 9.81 189 367245 61336 63060252
Blood magnesium increased 47.09 9.81 72 367362 2966 63118622
Pleural thickening 47.07 9.81 70 367364 2813 63118775
Sinusitis 47.04 9.81 977 366457 225676 62895912
Poisoning 46.88 9.81 180 367254 13520 63108068
Thrombocytopenia 46.80 9.81 605 366829 150552 62971036
Restless legs syndrome 46.06 9.81 221 367213 18310 63103278
Disturbance in attention 45.91 9.81 378 367056 37811 63083777
Diplopia 45.90 9.81 264 367170 23464 63098124
Red blood cell sedimentation rate abnormal 45.67 9.81 29 367405 19753 63101835
Hypercholesterolaemia 45.63 9.81 34 367400 21300 63100288
Breast cancer stage III 45.27 9.81 4 367430 10382 63111206
Ataxia 45.10 9.81 191 367243 15004 63106584
Drug resistance 44.76 9.81 40 367394 22893 63098695
Ankle fracture 44.42 9.81 213 367221 17642 63103946
Myocardial stunning 43.91 9.81 21 367413 152 63121436
Nightmare 43.51 9.81 223 367211 18971 63102617
Pleural effusion 43.02 9.81 339 367095 92871 63028717
Mood altered 42.74 9.81 184 367250 14559 63107029
Multiple organ dysfunction syndrome 42.67 9.81 176 367258 56576 63065012
Drug ineffective 42.17 9.81 5352 362082 1039413 62082175
Anger 40.47 9.81 161 367273 12295 63109293
Impaired driving ability 40.28 9.81 84 367350 4427 63117161
Concussion 39.82 9.81 131 367303 9113 63112475
Hyperaesthesia 39.76 9.81 132 367302 9226 63112362
Limb injury 39.60 9.81 268 367166 25209 63096379
Hypermobility syndrome 39.57 9.81 35 367399 788 63120800
Joint injury 39.55 9.81 300 367134 29272 63092316
Musculoskeletal stiffness 39.43 9.81 792 366642 183826 62937762
Pre-existing condition improved 39.32 9.81 121 367313 8123 63113465
Nausea 38.33 9.81 5569 361865 848902 62272686
Coma 37.65 9.81 552 366882 63812 63057776
Blood lactate dehydrogenase increased 37.63 9.81 47 367387 23069 63098519
Bone marrow failure 37.62 9.81 70 367364 29220 63092368
Agitation 37.56 9.81 519 366915 59238 63062350
Mental impairment 37.54 9.81 172 367262 13979 63107609
Therapy non-responder 37.42 9.81 271 367163 75630 63045958
Accidental poisoning 36.96 9.81 30 367404 598 63120990
Accidental overdose 36.72 9.81 246 367188 23063 63098525
Irritability 36.65 9.81 311 367123 31383 63090205
Depressed level of consciousness 36.16 9.81 532 366902 61546 63060042
Serotonin syndrome 36.16 9.81 287 367147 28395 63093193
Dislocation of vertebra 35.88 9.81 4 367430 8631 63112957
Neutropenia 35.52 9.81 757 366677 174248 62947340
Anaphylactic shock 35.47 9.81 51 367383 23582 63098006
Drug screen positive 35.28 9.81 70 367364 3559 63118029
Brain injury 35.12 9.81 105 367329 6938 63114650
Asthenia 35.10 9.81 2625 364809 380979 62740609
Adjustment disorder with depressed mood 35.07 9.81 8 367426 10196 63111392
Premature delivery 34.94 9.81 77 367357 30204 63091384
Epigastric discomfort 34.69 9.81 102 367332 6678 63114910
Lupus-like syndrome 34.53 9.81 23 367411 15272 63106316
Incoherent 34.36 9.81 79 367355 4451 63117137
Bradyphrenia 33.81 9.81 103 367331 6877 63114711
Premature labour 33.77 9.81 15 367419 12489 63109099
Eosinophilic colitis 33.69 9.81 18 367416 169 63121419
Stiff person syndrome 33.56 9.81 22 367412 310 63121278
Nerve injury 33.48 9.81 130 367304 9816 63111772
Congenital absence of vertebra 33.47 9.81 12 367422 36 63121552
Neovascularisation 33.26 9.81 37 367397 1108 63120480
Injury 33.06 9.81 268 367166 72979 63048609
Deafness neurosensory 32.86 9.81 81 367353 4774 63116814
Dysarthria 32.81 9.81 385 367049 42326 63079262
Cyst 32.79 9.81 165 367269 13934 63107654
Muscle tightness 32.58 9.81 146 367288 11754 63109834
Leukopenia 32.54 9.81 288 367146 77002 63044586
Atrial fibrillation 32.45 9.81 477 366957 116159 63005429
Granuloma skin 32.44 9.81 5 367429 8432 63113156
Pneumocystis jirovecii pneumonia 32.42 9.81 30 367404 16884 63104704
Prescription drug used without a prescription 32.10 9.81 53 367381 2333 63119255
Visual snow syndrome 31.66 9.81 12 367422 44 63121544
Loss of consciousness 31.46 9.81 901 366533 117220 63004368
Encephalopathy 31.40 9.81 352 367082 38268 63083320
Thrombotic microangiopathy 31.26 9.81 11 367423 10550 63111038
Complex regional pain syndrome 31.23 9.81 52 367382 2305 63119283
Limb discomfort 30.96 9.81 285 367149 29431 63092157
Rash maculo-papular 30.68 9.81 89 367345 31807 63089781
Wheezing 30.55 9.81 380 367054 95215 63026373
Thinking abnormal 30.22 9.81 132 367302 10511 63111077
Panniculitis 30.21 9.81 14 367420 11371 63110217
Somatic delusion 30.12 9.81 26 367408 566 63121022
Condition aggravated 30.04 9.81 1965 365469 400252 62721336
Nerve compression 29.96 9.81 118 367316 8969 63112619
Peroneal nerve palsy 29.95 9.81 78 367356 4757 63116831
Haemophagocytic lymphohistiocytosis 29.90 9.81 12 367422 10615 63110973
Visual impairment 29.83 9.81 669 366765 83777 63037811
Hypokalaemia 29.76 9.81 422 367012 103382 63018206
Headache 29.62 9.81 4138 363296 629103 62492485
Body height decreased 29.38 9.81 126 367308 9952 63111636
Intervertebral disc degeneration 29.11 9.81 173 367261 15559 63106029
Dysstasia 29.02 9.81 216 367218 20950 63100638
Diabetic neuropathy 28.83 9.81 68 367366 3896 63117692
X-ray abnormal 28.60 9.81 6 367428 8104 63113484
Tooth loss 28.50 9.81 96 367338 6760 63114828
Thrombosis 28.49 9.81 530 366904 64225 63057363
Hyperreflexia 28.22 9.81 87 367347 5847 63115741
Tinnitus 28.19 9.81 323 367111 35305 63086283
Paranoia 28.10 9.81 138 367296 11541 63110047
Lymphoedema 28.02 9.81 138 367296 11554 63110034
Central nervous system lesion 28.01 9.81 129 367305 10506 63111082
Focal dyscognitive seizures 27.98 9.81 56 367378 2865 63118723
Somatic symptom disorder 27.92 9.81 53 367381 2607 63118981
Paradoxical drug reaction 27.82 9.81 69 367365 4083 63117505
Breast cancer stage II 27.81 9.81 8 367426 8728 63112860
Pituitary tumour benign 27.76 9.81 45 367389 1950 63119638
Pulmonary toxicity 27.73 9.81 10 367424 9445 63112143
Tardive dyskinesia 27.70 9.81 110 367324 8392 63113196
Chorea 27.33 9.81 40 367394 1584 63120004
Foot fracture 27.30 9.81 234 367200 23680 63097908
Neutropenic sepsis 27.20 9.81 33 367401 16405 63105183
Abortion spontaneous 27.05 9.81 161 367273 47034 63074554
Osteonecrosis of jaw 26.98 9.81 108 367326 35015 63086573
Drug diversion 26.46 9.81 30 367404 918 63120670
Congenital thrombocytopenia 26.35 9.81 11 367423 55 63121533
Therapy cessation 26.33 9.81 281 367153 30176 63091412
Gestational diabetes 26.16 9.81 8 367426 8388 63113200
Human epidermal growth factor receptor decreased 26.00 9.81 8 367426 12 63121576
Herpes zoster 25.97 9.81 643 366791 81819 63039769
Asterixis 25.81 9.81 36 367398 1363 63120225
Myoclonic epilepsy 25.77 9.81 34 367400 1220 63120368
Cognitive disorder 25.31 9.81 459 366975 55356 63066232
Dysphemia 25.29 9.81 51 367383 2624 63118964
Mobility decreased 25.19 9.81 522 366912 120637 63000951
Bone cyst 25.02 9.81 46 367388 2208 63119380
Cerebrovascular accident 25.01 9.81 810 366624 107214 63014374
Melaena 24.86 9.81 91 367343 30274 63091314
Hepatic failure 24.72 9.81 114 367320 35542 63086046
Rib deformity 24.63 9.81 17 367417 262 63121326
Eosinophilia 24.54 9.81 60 367374 22696 63098892
Bone density decreased 24.53 9.81 29 367405 14583 63107005
Disorientation 24.53 9.81 342 367092 39110 63082478
Skin reaction 24.37 9.81 30 367404 14819 63106769
Bipolar disorder 24.36 9.81 101 367333 7859 63113729
Substance abuse 24.29 9.81 72 367362 4735 63116853
Injection site mass 24.24 9.81 188 367246 18468 63103120
Illness 24.24 9.81 409 367025 48650 63072938
Skin necrosis 24.16 9.81 27 367407 13923 63107665
Anorgasmia 23.86 9.81 23 367411 580 63121008
Secondary progressive multiple sclerosis 23.80 9.81 35 367399 1392 63120196
Panic attack 23.68 9.81 215 367219 22116 63099472
Drug reaction with eosinophilia and systemic symptoms 23.56 9.81 108 367326 33728 63087860
Agranulocytosis 23.55 9.81 71 367363 25063 63096525
Exposure via ingestion 23.48 9.81 52 367382 2857 63118731
Therapy interrupted 23.37 9.81 289 367145 32166 63089422
Pollakiuria 23.34 9.81 256 367178 27681 63093907
Dry mouth 23.30 9.81 603 366831 77260 63044328
Oesophageal spasm 23.18 9.81 54 367380 3069 63118519
Transaminases increased 23.13 9.81 98 367336 31269 63090319
Blood parathyroid hormone decreased 23.09 9.81 14 367420 9777 63111811
Depressed mood 22.84 9.81 343 367091 39848 63081740
Dysphagia 22.84 9.81 673 366761 87912 63033676
Burns second degree 22.76 9.81 41 367393 1937 63119651
Urticaria 22.65 9.81 759 366675 165043 62956545
Adverse event 22.55 9.81 266 367168 67293 63054295
Red blood cell sedimentation rate increased 22.18 9.81 156 367278 43826 63077762
Micturition urgency 22.02 9.81 112 367322 9499 63112089
Obstructive airways disorder 21.99 9.81 55 367379 20644 63100944
Cervical spinal stenosis 21.96 9.81 43 367391 2165 63119423
Device difficult to use 21.91 9.81 25 367409 12771 63108817
Ascites 21.76 9.81 142 367292 40586 63081002
Psychomotor hyperactivity 21.52 9.81 120 367314 10543 63111045
Chronic obstructive pulmonary disease 21.32 9.81 494 366940 62192 63059396
Diffuse axonal injury 21.27 9.81 11 367423 96 63121492
Foot deformity 21.17 9.81 86 367348 27767 63093821
Hypopnoea 21.16 9.81 59 367375 3747 63117841
Constipation 20.98 9.81 1542 365892 223401 62898187
Blood pressure systolic abnormal 20.98 9.81 28 367406 13358 63108230
Creatinine renal clearance decreased 20.92 9.81 39 367395 16269 63105319
Pneumonia 20.84 9.81 2981 364453 453786 62667802
Transplant rejection 20.80 9.81 19 367415 10761 63110827
Somnambulism 20.78 9.81 75 367359 5468 63116120
Sensory disturbance 20.76 9.81 143 367291 13529 63108059
Stress 20.63 9.81 522 366912 66645 63054943
Metastases to liver 20.59 9.81 69 367365 23570 63098018
Cytomegalovirus viraemia 20.29 9.81 4 367430 5645 63115943
Psychotic disorder due to a general medical condition 20.19 9.81 15 367419 261 63121327
Low birth weight baby 20.14 9.81 8 367426 7121 63114467
Hypokinesia 20.13 9.81 144 367290 13792 63107796
Autonomic nervous system imbalance 20.13 9.81 48 367386 2770 63118818
Haematotoxicity 19.98 9.81 15 367419 9361 63112227
Bronchitis 19.90 9.81 899 366535 124036 62997552
Device adhesion issue 19.87 9.81 3 367431 5138 63116450
Cystitis 19.84 9.81 437 366997 54554 63067034
Myelodysplastic syndrome 19.83 9.81 42 367392 16712 63104876
Pruritus 19.72 9.81 1812 365622 359641 62761947
Metabolic encephalopathy 19.61 9.81 76 367358 5733 63115855
Dental caries 19.60 9.81 118 367316 10661 63110927
Drug titration error 19.58 9.81 24 367410 799 63120789
Jaundice 19.41 9.81 95 367339 29156 63092432
Hypertension 19.41 9.81 1373 366061 277930 62843658
Joint destruction 19.40 9.81 6 367428 6246 63115342
Arteriovenous malformation 19.37 9.81 31 367403 1329 63120259
JC polyomavirus test positive 19.18 9.81 32 367402 1421 63120167
Fatigue 19.15 9.81 5586 361848 882442 62239146
Pulmonary aplasia 19.12 9.81 6 367428 10 63121578
Foetal growth restriction 18.96 9.81 10 367424 7543 63114045
Anal incontinence 18.87 9.81 139 367295 13437 63108151
Device use error 18.86 9.81 5 367429 5756 63115832
Urinary retention 18.56 9.81 262 367172 30039 63091549
Spinal disorder 18.39 9.81 109 367325 9793 63111795
Spinal osteoarthritis 18.28 9.81 158 367276 16028 63105560
Facial pain 18.19 9.81 114 367320 10447 63111141
Toxic skin eruption 18.18 9.81 29 367405 12856 63108732
Toxic epidermal necrolysis 18.16 9.81 80 367354 25254 63096334
Blood potassium decreased 18.15 9.81 343 367091 41683 63079905
Hepatocellular injury 18.13 9.81 89 367345 27292 63094296
Hip fracture 18.12 9.81 255 367179 29219 63092369
Chronic sinusitis 18.04 9.81 29 367405 12814 63108774
White blood cell count decreased 18.01 9.81 981 366453 138123 62983465
Jaundice cholestatic 17.95 9.81 10 367424 7314 63114274
Drug abuser 17.95 9.81 47 367387 2876 63118712
Persistent depressive disorder 17.87 9.81 26 367408 1024 63120564
Laboratory test abnormal 17.84 9.81 236 367198 26676 63094912
Economic problem 17.75 9.81 37 367397 1949 63119639
Glycosylated haemoglobin decreased 17.68 9.81 19 367415 547 63121041
Facial spasm 17.63 9.81 21 367413 678 63120910
Sacroiliitis 17.63 9.81 50 367384 3207 63118381
Lip dry 17.31 9.81 40 367394 15430 63106158
Atonic urinary bladder 17.17 9.81 9 367425 81 63121507
Acute myeloid leukaemia 17.11 9.81 47 367387 17100 63104488
Acute respiratory distress syndrome 17.06 9.81 74 367360 23460 63098128
Bronchiectasis 17.06 9.81 43 367391 16099 63105489
Influenza 17.02 9.81 781 366653 107941 63013647
Septic shock 16.99 9.81 277 367157 66352 63055236
Bladder disorder 16.95 9.81 99 367335 8847 63112741
Maternal exposure timing unspecified 16.90 9.81 10 367424 7077 63114511
Psoriasis 16.88 9.81 639 366795 86318 63035270
Grip strength decreased 16.82 9.81 69 367365 22218 63099370
Hot flush 16.73 9.81 401 367033 50758 63070830
Head banging 16.71 9.81 16 367418 400 63121188
Drug screen false positive 16.69 9.81 23 367411 861 63120727
Subdural hygroma 16.67 9.81 13 367421 244 63121344
Osteosclerosis 16.66 9.81 55 367379 3833 63117755
Pulmonary tuberculosis 16.65 9.81 3 367431 4514 63117074
Erythema 16.64 9.81 839 366595 174912 62946676
Generalised tonic-clonic seizure 16.63 9.81 248 367186 28768 63092820
Gastrointestinal motility disorder 16.50 9.81 66 367368 5053 63116535
Lung disorder 16.49 9.81 257 367177 62004 63059584
Abortion induced 16.49 9.81 21 367413 10221 63111367
Epistaxis 16.42 9.81 309 367125 72416 63049172
Maternal exposure before pregnancy 16.41 9.81 12 367422 7591 63113997
Alcoholism 16.40 9.81 34 367400 1784 63119804
Blood potassium increased 16.33 9.81 170 367264 18139 63103449
Ligament sprain 16.09 9.81 128 367306 12672 63108916
Breast cancer stage I 16.04 9.81 10 367424 6879 63114709
Accidental exposure to product 15.97 9.81 93 367341 27312 63094276
Breakthrough pain 15.86 9.81 27 367407 1219 63120369
Diarrhoea 15.81 9.81 4505 362929 710861 62410727
Hyponatraemia 15.81 9.81 510 366924 111390 63010198
Nerve block 15.76 9.81 21 367413 761 63120827
Hostility 15.72 9.81 34 367400 1838 63119750
Blood lactic acid 15.71 9.81 9 367425 98 63121490
Cerebral infarction 15.62 9.81 78 367356 23815 63097773
Progressive multiple sclerosis 15.62 9.81 26 367408 1152 63120436
Cellulitis 15.61 9.81 601 366833 81357 63040231
Product use in unapproved indication 15.59 9.81 1221 366213 177859 62943729
Disorganised speech 15.56 9.81 27 367407 1238 63120350
Oesophageal obstruction 15.54 9.81 18 367416 564 63121024
Dependence 15.51 9.81 36 367398 2041 63119547
Pregnancy with contraceptive device 15.50 9.81 4 367430 4690 63116898
Unintentional medical device removal 15.50 9.81 8 367426 6107 63115481
Pre-eclampsia 15.47 9.81 18 367416 9115 63112473
Hyperbilirubinaemia 15.47 9.81 26 367408 11288 63110300
Stillbirth 15.44 9.81 10 367424 6740 63114848
Osteoporosis 15.42 9.81 236 367198 57102 63064486
Caesarean section 15.33 9.81 49 367385 16983 63104605
Genital haemorrhage 15.28 9.81 12 367422 7320 63114268
Seasonal allergy 15.28 9.81 187 367247 20763 63100825
Fluid retention 15.26 9.81 453 366981 59233 63062355
Basal cell carcinoma 15.25 9.81 97 367337 27894 63093694
Deprescribing error 15.24 9.81 6 367428 25 63121563
Nervous system disorder 15.24 9.81 171 367263 18595 63102993
Ejection fraction decreased 15.13 9.81 72 367362 22260 63099328
Tuberculosis 15.11 9.81 26 367408 11185 63110403
Dry eye 15.05 9.81 325 367109 40436 63081152
Postmortem blood drug level increased 15.00 9.81 18 367416 586 63121002
Postmortem blood drug level abnormal 14.82 9.81 14 367420 344 63121244
Abnormal dreams 14.81 9.81 108 367326 10408 63111180
Bradycardia 14.77 9.81 317 367117 72910 63048678
Medication overuse headache 14.74 9.81 21 367413 811 63120777
Pineal gland cyst 14.74 9.81 5 367429 12 63121576
Paralysis 14.71 9.81 103 367331 9797 63111791
Inflammation 14.67 9.81 363 367071 81910 63039678
Oesophageal pain 14.67 9.81 51 367383 3650 63117938
Sleep talking 14.59 9.81 23 367411 973 63120615
Cholestasis 14.55 9.81 105 367329 29329 63092259
Gastrointestinal toxicity 14.52 9.81 14 367420 7727 63113861
Intentional self-injury 14.51 9.81 219 367215 25468 63096120
Rib fracture 14.50 9.81 197 367237 22400 63099188
Spinal stenosis 14.48 9.81 141 367293 14784 63106804
Myotonia 14.44 9.81 10 367424 155 63121433
Kidney infection 14.44 9.81 201 367233 22975 63098613
Liver function test increased 14.37 9.81 121 367313 32690 63088898
Injection site induration 14.31 9.81 97 367337 9129 63112459
Graft versus host disease 14.18 9.81 11 367423 6752 63114836
Polyarthritis 14.16 9.81 23 367411 10123 63111465
Post herpetic neuralgia 14.16 9.81 36 367398 2163 63119425
Aphasia 14.13 9.81 269 367165 32731 63088857
Wrong patient received product 14.08 9.81 36 367398 2171 63119417
Electroencephalogram abnormal 14.03 9.81 50 367384 3622 63117966
Febrile bone marrow aplasia 14.03 9.81 13 367421 7312 63114276
Disturbance in social behaviour 13.99 9.81 3 367431 3990 63117598
Product availability issue 13.98 9.81 54 367380 4067 63117521
Toxicologic test abnormal 13.98 9.81 19 367415 702 63120886
Ageusia 13.96 9.81 131 367303 13597 63107991
Septic encephalopathy 13.89 9.81 8 367426 88 63121500
Facet joint syndrome 13.89 9.81 31 367403 12107 63109481
Oligohydramnios 13.80 9.81 10 367424 6356 63115232
Skin toxicity 13.80 9.81 5 367429 4709 63116879
Cytokine release syndrome 13.72 9.81 40 367394 14274 63107314
Intervertebral disc disorder 13.70 9.81 60 367374 4783 63116805
Mucocutaneous haemorrhage 13.66 9.81 8 367426 91 63121497
Myocardial infarction 13.63 9.81 708 366726 99185 63022403
Hypoxic-ischaemic encephalopathy 13.60 9.81 55 367379 4232 63117356
Carpal tunnel syndrome 13.57 9.81 182 367252 20635 63100953
Allodynia 13.54 9.81 20 367414 799 63120789
Hepatitis 13.53 9.81 156 367278 39632 63081956
Femoral artery dissection 13.48 9.81 6 367428 36 63121552
Drug eruption 13.40 9.81 104 367330 28590 63092998
Blood iron abnormal 13.40 9.81 3 367431 3873 63117715
Impaired gastric emptying 13.36 9.81 104 367330 10228 63111360
Pancreatitis chronic 13.31 9.81 38 367396 2446 63119142
Colitis 13.30 9.81 199 367235 48329 63073259
Shock haemorrhagic 13.29 9.81 23 367411 9872 63111716
Central nervous system infection 13.28 9.81 19 367415 737 63120851
Lymphoma 13.24 9.81 32 367402 12155 63109433
Post procedural infection 13.19 9.81 96 367338 9246 63112342
Disseminated intravascular coagulation 13.15 9.81 61 367373 18990 63102598
Post procedural complication 13.15 9.81 154 367280 16920 63104668
Hyperprolactinaemia 13.15 9.81 51 367383 3849 63117739
Tonic clonic movements 13.14 9.81 27 367407 1408 63120180
Dysgraphia 13.10 9.81 45 367389 3201 63118387
Drug screen negative 13.07 9.81 12 367422 284 63121304
Phobia 13.07 9.81 13 367421 341 63121247
Decreased interest 13.03 9.81 45 367389 3209 63118379
Pharyngitis 13.03 9.81 66 367368 20077 63101511
Peritonitis 13.02 9.81 53 367381 17101 63104487
Malignant urinary tract neoplasm 13.00 9.81 4 367430 6 63121582
Hyperacusis 13.00 9.81 34 367400 2079 63119509
Flushing 12.99 9.81 545 366889 74542 63047046
Acute generalised exanthematous pustulosis 12.99 9.81 28 367406 11071 63110517
Haemolysis 12.97 9.81 12 367422 6756 63114832
Peripheral venous disease 12.92 9.81 46 367388 15431 63106157
Osteopenia 12.90 9.81 173 367261 19612 63101976
Urinary occult blood positive 12.90 9.81 7 367427 68 63121520
Hepatitis C virus test positive 12.89 9.81 8 367426 102 63121486
Neurogenic bladder 12.79 9.81 45 367389 3240 63118348
Formication 12.78 9.81 54 367380 4237 63117351
Eyelid myoclonus 12.75 9.81 8 367426 104 63121484
Lung adenocarcinoma stage I 12.67 9.81 5 367429 21 63121567
Hereditary angioedema 12.63 9.81 81 367353 7481 63114107
Heteroplasia 12.63 9.81 4 367430 7 63121581
Schizophrenia 12.59 9.81 24 367410 9928 63111660
Conversion disorder 12.55 9.81 30 367404 1734 63119854
Normal newborn 12.52 9.81 18 367416 8323 63113265
Pharyngeal neoplasm 12.47 9.81 3 367431 0 63121588
Glossopharyngeal neuralgia 12.47 9.81 3 367431 0 63121588
Ligamentum flavum hypertrophy 12.47 9.81 3 367431 0 63121588
Muscle relaxant drug level above therapeutic 12.47 9.81 3 367431 0 63121588
Turbinectomy 12.47 9.81 3 367431 0 63121588
CSF neutrophil count increased 12.47 9.81 3 367431 0 63121588
Epidermal naevus 12.47 9.81 3 367431 0 63121588
Epstein-Barr virus infection 12.45 9.81 17 367417 8033 63113555
Night sweats 12.42 9.81 203 367231 48611 63072977
Transient ischaemic attack 12.37 9.81 296 367138 37457 63084131
Stereotypy 12.36 9.81 14 367420 428 63121160
Breast swelling 12.34 9.81 26 367408 1380 63120208
Blood potassium abnormal 12.34 9.81 38 367396 2552 63119036
Vascular malformation 12.30 9.81 13 367421 367 63121221
Posterior reversible encephalopathy syndrome 12.29 9.81 55 367379 17290 63104298
Prophylaxis 12.28 9.81 4 367430 8 63121580
Hepatitis cholestatic 12.26 9.81 13 367421 6865 63114723
Spinal cord injury 12.23 9.81 20 367414 873 63120715
Gait inability 12.22 9.81 397 367037 52562 63069026
Drug effective for unapproved indication 12.17 9.81 45 367389 3319 63118269
Neuroma 12.15 9.81 14 367420 436 63121152
Urinary hesitation 12.15 9.81 35 367399 2265 63119323
Incorrect route of product administration 12.13 9.81 101 367333 27351 63094237
Blood bilirubin increased 12.10 9.81 147 367287 36993 63084595
Product physical issue 12.09 9.81 59 367375 4921 63116667
Parapsoriasis 12.07 9.81 8 367426 115 63121473
Neutrophil count decreased 12.02 9.81 242 367192 56164 63065424
Sciatic nerve injury 12.01 9.81 15 367419 509 63121079
Vertebral foraminal stenosis 12.01 9.81 21 367413 969 63120619
Slow speech 11.97 9.81 27 367407 1502 63120086
Metastases to lung 11.95 9.81 36 367398 12714 63108874
Substance use 11.94 9.81 15 367419 512 63121076
Cardiotoxicity 11.90 9.81 19 367415 8419 63113169
Tooth disorder 11.88 9.81 229 367205 27928 63093660
Unevaluable event 11.81 9.81 385 367049 51001 63070587
Nephrogenic systemic fibrosis 11.81 9.81 55 367379 4501 63117087
Feeling of despair 11.79 9.81 35 367399 2304 63119284
Metabolic surgery 11.78 9.81 24 367410 1244 63120344
Respiratory rate decreased 11.73 9.81 46 367388 3489 63118099
Upper airway resistance syndrome 11.68 9.81 4 367430 10 63121578
Proteinuria 11.68 9.81 64 367370 19081 63102507
Internal hernia 11.64 9.81 6 367428 52 63121536
Naevus haemorrhage 11.61 9.81 8 367426 123 63121465
Movement disorder 11.59 9.81 183 367251 21478 63100110
Pharyngeal swelling 11.58 9.81 70 367364 6334 63115254
Paranasal cyst 11.56 9.81 13 367421 394 63121194
Face oedema 11.56 9.81 69 367365 20143 63101445
Narcolepsy 11.54 9.81 25 367409 1353 63120235
Connective tissue inflammation 11.54 9.81 6 367428 53 63121535
Dysphoria 11.47 9.81 58 367376 4908 63116680
Abnormal behaviour 11.46 9.81 181 367253 21245 63100343
Gastrointestinal haemorrhage 11.46 9.81 370 367064 80806 63040782
Urine amphetamine positive 11.44 9.81 6 367428 54 63121534
Increased tendency to bruise 11.40 9.81 102 367332 10450 63111138
Hepatic cirrhosis 11.38 9.81 90 367344 24644 63096944
Abdominal pain 11.38 9.81 1506 365928 291950 62829638
Metastases to bone 11.37 9.81 73 367361 20946 63100642
Neuromyelitis optica spectrum disorder 11.35 9.81 21 367413 1013 63120575
Intentional underdose 11.29 9.81 30 367404 1852 63119736
Alanine aminotransferase abnormal 11.25 9.81 6 367428 4498 63117090
Disease progression 11.24 9.81 588 366846 122170 62999418
Vulvar basal cell carcinoma 11.23 9.81 5 367429 30 63121558
Band sensation 11.22 9.81 19 367415 854 63120734
Proctitis 11.22 9.81 9 367425 5432 63116156
Congenital neuropathy 11.16 9.81 4 367430 12 63121576
Gastroschisis 11.15 9.81 13 367421 410 63121178
Face injury 11.13 9.81 43 367391 3239 63118349
Wrist fracture 11.12 9.81 124 367310 13463 63108125
Tumour lysis syndrome 11.09 9.81 22 367412 8968 63112620
Snoring 11.09 9.81 51 367383 4151 63117437
Injection site atrophy 11.06 9.81 16 367418 627 63120961
Prescribed underdose 11.06 9.81 114 367320 29575 63092013
Decubitus ulcer 11.01 9.81 101 367333 10419 63111169
Malignant polyp 10.98 9.81 9 367425 182 63121406
Pericardial effusion 10.96 9.81 116 367318 29942 63091646
Application site vesicles 10.86 9.81 25 367409 1410 63120178
Blood glucose decreased 10.83 9.81 176 367258 20776 63100812
Product adhesion issue 10.82 9.81 55 367379 4664 63116924
Blood pressure systolic increased 10.81 9.81 201 367233 47196 63074392
Pallor 10.73 9.81 119 367315 30449 63091139
Device dislocation 10.72 9.81 96 367338 25609 63095979
Dyspnoea 10.71 9.81 3546 363888 657767 62463821
Hepatitis acute 10.68 9.81 23 367411 9097 63112491
Unintended pregnancy 10.66 9.81 12 367422 6167 63115421
Concomitant disease aggravated 10.65 9.81 23 367411 9089 63112499
Peripheral swelling 10.65 9.81 1362 366072 264580 62857008
Tendon injury 10.62 9.81 30 367404 1920 63119668
Hypertonic bladder 10.57 9.81 45 367389 3543 63118045
Breast pain 10.53 9.81 87 367347 8711 63112877
Application site burn 10.52 9.81 18 367416 816 63120772
Femur fracture 10.51 9.81 174 367260 41582 63080006
Neck surgery 10.51 9.81 29 367405 1831 63119757
Dysphonia 10.50 9.81 355 367079 47259 63074329
Enamel anomaly 10.49 9.81 4 367430 15 63121573
Feeling of body temperature change 10.48 9.81 56 367378 4841 63116747
Uterine perforation 10.48 9.81 15 367419 6948 63114640
Screaming 10.47 9.81 42 367392 3220 63118368
Premature ageing 10.41 9.81 3 367431 3 63121585
Diabetic gastropathy 10.41 9.81 3 367431 3 63121585
Nervous system cyst 10.41 9.81 3 367431 3 63121585
Symptom masked 10.40 9.81 17 367417 742 63120846
Cervicogenic headache 10.29 9.81 4 367430 16 63121572
Graft versus host disease in gastrointestinal tract 10.26 9.81 3 367431 3238 63118350
Empty sella syndrome 10.25 9.81 5 367429 38 63121550
Ulcer 10.24 9.81 99 367335 26008 63095580
Fear of injection 10.23 9.81 16 367418 7148 63114440
Bladder spasm 10.22 9.81 28 367406 1760 63119828
Neurosis 10.19 9.81 10 367424 258 63121330
Myocardial oedema 10.16 9.81 9 367425 203 63121385
Product administration interrupted 10.15 9.81 55 367379 4781 63116807
Nerve root injury 10.14 9.81 5 367429 39 63121549
Toe operation 10.12 9.81 17 367417 759 63120829
Prescribed overdose 10.08 9.81 138 367296 34015 63087573
Suicide attempt 10.06 9.81 440 366994 60478 63061110
CSF white blood cell count increased 10.04 9.81 5 367429 40 63121548
Uveitis 10.02 9.81 38 367396 12515 63109073
Emotional disorder 10.01 9.81 120 367314 13259 63108329
Retroplacental haematoma 10.00 9.81 8 367426 156 63121432
Radiation necrosis 9.97 9.81 12 367422 392 63121196
Subileus 9.96 9.81 3 367431 3176 63118412
Gastric bypass 9.94 9.81 28 367406 1789 63119799
Hypoventilation 9.93 9.81 54 367380 4700 63116888
Lid lag 9.92 9.81 4 367430 18 63121570
Gout 9.91 9.81 119 367315 13152 63108436
Paraplegia 9.89 9.81 36 367398 2636 63118952
Inability to afford medication 9.88 9.81 33 367401 2314 63119274
Sudden onset of sleep 9.86 9.81 14 367420 539 63121049
Cardiogenic shock 9.84 9.81 62 367372 17870 63103718
CD8 lymphocytes decreased 9.83 9.81 8 367426 160 63121428
Aspergillus infection 9.82 9.81 20 367414 8073 63113515

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 835.75 10.48 1581 197799 78948 34678603
Completed suicide 558.23 10.48 1518 197862 96650 34660901
Drug ineffective for unapproved indication 423.68 10.48 596 198784 23119 34734432
Myoclonus 296.15 10.48 392 198988 14333 34743218
Somnolence 242.00 10.48 1262 198118 109854 34647697
Toxicity to various agents 236.44 10.48 1950 197430 198412 34559139
Sedation 183.24 10.48 384 198996 20622 34736929
Drug withdrawal syndrome 179.38 10.48 368 199012 19466 34738085
Drug dependence 168.98 10.48 405 198975 23812 34733739
Drug abuse 159.34 10.48 1039 198341 98057 34659494
Interstitial lung disease 156.17 10.48 89 199291 65193 34692358
Fall 144.25 10.48 1779 197601 201106 34556445
Multiple sclerosis relapse 138.55 10.48 260 199120 12873 34744678
Euphoric mood 135.33 10.48 164 199216 5477 34752074
Confusional state 122.04 10.48 1308 198072 142852 34614699
Febrile neutropenia 112.82 10.48 401 198979 136448 34621103
Neuropathy peripheral 112.58 10.48 837 198543 82426 34675125
Depression 111.50 10.48 940 198440 96158 34661393
Therapeutic product effect variable 110.58 10.48 100 199280 2356 34755195
Obsessive-compulsive disorder 107.07 10.48 145 199235 5419 34752132
Memory impairment 106.86 10.48 510 198870 42808 34714743
Hypoaesthesia 105.96 10.48 656 198724 60788 34696763
Withdrawal syndrome 103.20 10.48 223 199157 12232 34745319
Mental status changes 101.77 10.48 459 198921 37624 34719927
Pyrexia 101.36 10.48 1316 198064 331697 34425854
Hepatic function abnormal 101.14 10.48 64 199316 44299 34713252
Insomnia 99.94 10.48 968 198412 102939 34654612
Antipsychotic drug level below therapeutic 99.82 10.48 96 199284 2451 34755100
Pain in extremity 98.39 10.48 1129 198251 125384 34632167
Tremor 98.26 10.48 806 198574 81781 34675770
Disinhibition 98.04 10.48 106 199274 3120 34754431
Pain 95.62 10.48 1669 197711 203006 34554545
Cytomegalovirus infection 95.20 10.48 17 199363 26118 34731433
Anaemia 89.87 10.48 874 198506 232461 34525090
Nightmare 87.07 10.48 228 199152 14163 34743388
Gait disturbance 85.73 10.48 801 198579 84339 34673212
Respiratory arrest 84.91 10.48 351 199029 27692 34729859
Cardiac failure 83.70 10.48 255 199125 90993 34666558
C-reactive protein increased 83.15 10.48 112 199268 53986 34703565
Thrombocytopenia 80.46 10.48 541 198839 155706 34601845
Renal impairment 79.15 10.48 275 199105 94238 34663313
Muscle spasticity 78.21 10.48 129 199251 5759 34751792
Balance disorder 77.08 10.48 445 198935 40209 34717342
Drug resistance 75.00 10.48 27 199353 25900 34731651
Dizziness 73.01 10.48 1695 197685 216826 34540725
Increased appetite 72.12 10.48 142 199238 7287 34750264
Plasma cell myeloma 71.94 10.48 448 198932 41589 34715962
Neuralgia 71.44 10.48 219 199161 14894 34742657
Intervertebral disc degeneration 70.13 10.48 129 199251 6288 34751263
Muscle spasms 69.28 10.48 693 198687 74308 34683243
Right atrial hypertrophy 69.25 10.48 48 199332 757 34756794
Neutropenia 69.16 10.48 567 198813 156211 34601340
Mucosal inflammation 67.83 10.48 72 199308 38550 34719001
Overdose 67.79 10.48 806 198574 90253 34667298
Multiple sclerosis 66.93 10.48 129 199251 6516 34751035
Alanine aminotransferase increased 66.41 10.48 237 199143 80578 34676973
Anxiety 64.59 10.48 858 198522 98570 34658981
Hallucination 61.96 10.48 504 198876 50994 34706557
Appendicolith 61.23 10.48 145 199235 8456 34749095
Septic shock 60.13 10.48 209 199171 71625 34685926
Accidental death 59.88 10.48 72 199308 2384 34755167
Respiratory depression 58.67 10.48 215 199165 16030 34741521
Dysarthria 58.46 10.48 369 199011 34413 34723138
Product complaint 57.68 10.48 113 199267 5777 34751774
Disseminated intravascular coagulation 56.20 10.48 27 199353 21789 34735762
Myelosuppression 55.83 10.48 20 199360 19245 34738306
Intentional product misuse 55.75 10.48 448 198932 45163 34712388
Suicidal ideation 55.66 10.48 408 198972 39980 34717571
Feeling abnormal 54.44 10.48 576 198804 62659 34694892
Bronchial secretion retention 52.98 10.48 54 199326 1482 34756069
Prescription drug used without a prescription 50.65 10.48 62 199318 2092 34755459
Bronchial wall thickening 48.84 10.48 49 199331 1319 34756232
Bone marrow failure 48.66 10.48 57 199323 29196 34728355
Haemophagocytic lymphohistiocytosis 48.21 10.48 8 199372 12965 34744586
Ataxia 47.24 10.48 180 199200 13673 34743878
Drug reaction with eosinophilia and systemic symptoms 47.11 10.48 72 199308 32940 34724611
Constipation 46.41 10.48 1065 198315 135917 34621634
Right ventricular hypertrophy 45.91 10.48 50 199330 1484 34756067
Burning sensation 45.65 10.48 217 199163 18177 34739374
Back disorder 45.06 10.48 110 199270 6541 34751010
Myokymia 42.65 10.48 17 199363 75 34757476
Depressed level of consciousness 42.55 10.48 402 198978 42439 34715112
Appendicitis 42.22 10.48 182 199198 14625 34742926
Relapsing-remitting multiple sclerosis 41.95 10.48 40 199340 1010 34756541
Needle fatigue 41.90 10.48 37 199343 844 34756707
Amnesia 41.08 10.48 276 199104 26287 34731264
Serotonin syndrome 40.96 10.48 223 199157 19710 34737841
Fatigue 40.93 10.48 2541 196839 368112 34389439
Sleep apnoea syndrome 40.85 10.48 226 199154 20095 34737456
Malignant neoplasm progression 40.83 10.48 314 199066 87732 34669819
Infusion related reaction 40.70 10.48 160 199220 52897 34704654
Neutrophil count decreased 39.27 10.48 154 199226 50950 34706601
Melaena 39.16 10.48 90 199290 35290 34722261
Hypokalaemia 38.88 10.48 185 199195 58029 34699522
Aspergillus infection 38.56 10.48 11 199369 12243 34745308
Obstruction 38.05 10.48 61 199319 2658 34754893
Bronchopulmonary aspergillosis 37.98 10.48 18 199362 14641 34742910
Aspartate aminotransferase increased 37.75 10.48 229 199151 67554 34689997
Disease progression 37.73 10.48 414 198966 107663 34649888
General physical health deterioration 37.70 10.48 510 198870 127759 34629792
Vision blurred 37.38 10.48 414 198966 45549 34712002
Gait spastic 36.84 10.48 38 199342 1058 34756493
Eosinophilia 36.64 10.48 58 199322 26164 34731387
Metabolic acidosis 35.93 10.48 128 199252 43552 34713999
Hyperreflexia 35.73 10.48 65 199315 3141 34754410
Hepatic failure 35.72 10.48 91 199289 34440 34723111
Colitis 35.66 10.48 104 199276 37646 34719905
Dyspnoea 35.55 10.48 1772 197608 375010 34382541
Inadequate analgesia 35.31 10.48 62 199318 2913 34754638
Toxic epidermal necrolysis 35.12 10.48 43 199337 21603 34735948
Acute kidney injury 34.95 10.48 1404 197976 303584 34453967
Paraesthesia 34.55 10.48 536 198844 63636 34693915
Antidepressant drug level above therapeutic 34.55 10.48 20 199360 226 34757325
Aortic valve stenosis 34.27 10.48 58 199322 2645 34754906
Sopor 33.71 10.48 148 199232 11988 34745563
Multiple organ dysfunction syndrome 33.67 10.48 277 199103 76289 34681262
Congenital multiplex arthrogryposis 33.42 10.48 13 199367 53 34757498
Accidental poisoning 33.30 10.48 31 199349 759 34756792
Cerebral haemorrhage 33.19 10.48 96 199284 34841 34722710
Pulmonary function test abnormal 33.09 10.48 56 199324 2554 34754997
Haematotoxicity 32.91 10.48 4 199376 8190 34749361
Gastrointestinal haemorrhage 32.87 10.48 334 199046 88143 34669408
Synovitis 32.45 10.48 20 199360 14046 34743505
Erectile dysfunction 32.26 10.48 215 199165 20422 34737129
Pneumonitis 32.24 10.48 93 199287 33785 34723766
Blood bilirubin increased 31.64 10.48 112 199268 38184 34719367
Nervousness 31.49 10.48 149 199231 12457 34745094
Jaundice 31.47 10.48 86 199294 31796 34725755
Asterixis 31.47 10.48 37 199343 1196 34756355
Proteinuria 31.35 10.48 36 199344 18606 34738945
Renal failure 31.23 10.48 540 198840 130017 34627534
Pleural effusion 31.05 10.48 306 199074 81240 34676311
Victim of child abuse 30.90 10.48 32 199348 895 34756656
Off label use 30.69 10.48 2022 197358 417502 34340049
Contraindicated product administered 30.50 10.48 47 199333 21434 34736117
Irritability 30.42 10.48 243 199137 24447 34733104
Sweat gland disorder 30.22 10.48 14 199366 95 34757456
Analgesic drug level above therapeutic 30.11 10.48 20 199360 293 34757258
Parasomnia 29.94 10.48 22 199358 382 34757169
Delirium 29.94 10.48 383 198997 43608 34713943
Lethargy 29.69 10.48 362 199018 40760 34716791
Hallucination, visual 29.42 10.48 188 199192 17603 34739948
Haematochezia 29.28 10.48 151 199229 46383 34711168
Transaminases increased 29.06 10.48 69 199311 26754 34730797
Graft versus host disease 28.92 10.48 12 199368 10557 34746994
Gait inability 28.76 10.48 210 199170 20548 34737003
Gamma-glutamyltransferase increased 28.74 10.48 79 199301 29152 34728399
Hyperaesthesia 28.66 10.48 74 199306 4556 34752995
Full blood count decreased 28.61 10.48 189 199191 17899 34739652
Akathisia 28.17 10.48 106 199274 8003 34749548
Pneumocystis jirovecii pneumonia 28.11 10.48 43 199337 19667 34737884
Product dose omission issue 27.99 10.48 887 198493 118824 34638727
Hypernatraemia 27.89 10.48 7 199373 8483 34749068
Back pain 27.85 10.48 900 198480 120889 34636662
Hypertonic bladder 27.72 10.48 43 199337 1821 34755730
Erythema 27.53 10.48 349 199031 88431 34669120
Adverse drug reaction 27.49 10.48 272 199108 29070 34728481
Muscle twitching 27.40 10.48 124 199256 10174 34747377
Pathogen resistance 27.21 10.48 10 199370 9472 34748079
Labelled drug-drug interaction medication error 27.19 10.48 27 199353 14912 34742639
Mood altered 27.05 10.48 112 199268 8840 34748711
Post transplant lymphoproliferative disorder 26.68 10.48 3 199377 6525 34751026
Blood lactate dehydrogenase increased 26.65 10.48 57 199323 22933 34734618
Disorientation 26.56 10.48 298 199082 32890 34724661
Suspected suicide 26.48 10.48 73 199307 4675 34752876
Acute myocardial infarction 26.12 10.48 189 199191 53530 34704021
Product used for unknown indication 25.93 10.48 30 199350 953 34756598
Diabetic neuropathy 25.90 10.48 67 199313 4130 34753421
Spinal operation 25.87 10.48 54 199326 2890 34754661
Nerve injury 25.83 10.48 60 199320 3455 34754096
Dyskinesia 25.68 10.48 217 199163 22196 34735355
Acute respiratory distress syndrome 25.67 10.48 70 199310 25899 34731652
Sciatica 25.54 10.48 84 199296 5930 34751621
Cardio-respiratory arrest 25.44 10.48 450 198930 54823 34702728
Circulatory collapse 25.37 10.48 51 199329 20987 34736564
Peripheral swelling 25.24 10.48 593 198787 75948 34681603
Delirium tremens 25.17 10.48 24 199356 606 34756945
Pulmonary alveolar haemorrhage 25.05 10.48 6 199374 7506 34750045
Epistaxis 25.03 10.48 212 199168 58039 34699512
Bradyphrenia 25.02 10.48 72 199308 4726 34752825
Coordination abnormal 24.98 10.48 98 199282 7546 34750005
Posterior reversible encephalopathy syndrome 24.62 10.48 13 199367 9941 34747610
Myocarditis 24.59 10.48 25 199355 13657 34743894
Stress 24.51 10.48 273 199107 30074 34727477
Urinary incontinence 24.49 10.48 188 199192 18686 34738865
Agranulocytosis 24.46 10.48 63 199317 23758 34733793
Atrial fibrillation 24.43 10.48 522 198858 121871 34635680
Drug tolerance 24.33 10.48 52 199328 2830 34754721
Hostility 24.27 10.48 27 199353 821 34756730
Monoparesis 24.19 10.48 46 199334 2300 34755251
Pancytopenia 23.91 10.48 390 198990 94767 34662784
Shock haemorrhagic 23.72 10.48 18 199362 11336 34746215
Cholangitis 23.56 10.48 10 199370 8679 34748872
Venoocclusive liver disease 23.54 10.48 8 199372 7958 34749593
Drug eruption 23.35 10.48 49 199331 19849 34737702
Tooth disorder 23.21 10.48 123 199257 10759 34746792
Anaphylactic reaction 23.15 10.48 100 199280 32201 34725350
Anger 23.11 10.48 131 199249 11753 34745798
Head titubation 23.10 10.48 19 199361 392 34757159
Prostate cancer 23.10 10.48 132 199248 39517 34718034
Rash maculo-papular 22.98 10.48 84 199296 28367 34729184
Phantom limb syndrome 22.89 10.48 16 199364 256 34757295
Blood creatine phosphokinase increased 22.70 10.48 156 199224 44701 34712850
Nephropathy toxic 22.62 10.48 23 199357 12565 34744986
Restless legs syndrome 22.54 10.48 101 199279 8253 34749298
Dry mouth 22.41 10.48 267 199113 29898 34727653
Sedation complication 22.36 10.48 38 199342 1739 34755812
Anorgasmia 22.34 10.48 26 199354 831 34756720
Acute myeloid leukaemia 22.28 10.48 44 199336 18226 34739325
Cerebral infarction 22.21 10.48 81 199299 27374 34730177
Agitation 22.20 10.48 455 198925 56944 34700607
Foetal exposure during pregnancy 22.12 10.48 127 199253 37974 34719577
Encephalopathy neonatal 22.01 10.48 9 199371 43 34757508
Angioedema 22.00 10.48 124 199256 37250 34720301
Epstein-Barr virus infection 21.96 10.48 8 199372 7620 34749931
Hepatic enzyme increased 21.76 10.48 132 199248 38948 34718603
Acute hepatic failure 21.75 10.48 29 199351 14045 34743506
Tumour lysis syndrome 21.75 10.48 40 199340 17019 34740532
Suicidal behaviour 21.52 10.48 34 199346 1463 34756088
Neonatal toxicity 21.51 10.48 8 199372 28 34757523
Hypoacusis 21.50 10.48 163 199217 16138 34741413
Inflammation 21.27 10.48 86 199294 28209 34729342
Prescribed overdose 21.12 10.48 118 199262 10529 34747022
Ventricular tachycardia 21.12 10.48 79 199301 26500 34731051
Alcoholism 21.12 10.48 50 199330 2915 34754636
Epidural lipomatosis 21.09 10.48 28 199352 1026 34756525
Drug screen negative 21.03 10.48 13 199367 167 34757384
Haemolysis 20.87 10.48 10 199370 8084 34749467
Intervertebral disc protrusion 20.87 10.48 112 199268 9844 34747707
Transplant rejection 20.72 10.48 17 199363 10294 34747257
Drug tolerance increased 20.68 10.48 19 199361 457 34757094
Ischaemic stroke 20.53 10.48 46 199334 18204 34739347
Thrombosis 20.52 10.48 403 198977 50055 34707496
Bradypnoea 20.47 10.48 48 199332 2781 34754770
Child abuse 20.44 10.48 18 199362 409 34757142
Pulmonary toxicity 20.32 10.48 5 199375 6142 34751409
Personality disorder 20.32 10.48 29 199351 1139 34756412
Personality change 20.25 10.48 70 199310 5069 34752482
Liver disorder 20.24 10.48 108 199272 32889 34724662
Nephrolithiasis 20.18 10.48 263 199117 30070 34727481
Chest X-ray abnormal 20.10 10.48 63 199317 4335 34753216
Obesity 20.02 10.48 134 199246 12744 34744807
Cough 19.40 10.48 681 198699 149459 34608092
Haemoglobin decreased 18.94 10.48 534 198846 120238 34637313
Mental impairment 18.91 10.48 112 199268 10210 34747341
Nephrotic syndrome 18.87 10.48 9 199371 7294 34750257
Conversion disorder 18.83 10.48 16 199364 346 34757205
Treatment failure 18.72 10.48 173 199207 46524 34711027
Tuberculosis 18.70 10.48 13 199367 8564 34748987
Lower respiratory tract infection 18.61 10.48 105 199275 31532 34726019
Hyperbilirubinaemia 18.51 10.48 43 199337 16800 34740751
Pneumothorax 18.47 10.48 52 199328 19040 34738511
Palmar-plantar erythrodysaesthesia syndrome 18.36 10.48 43 199337 16752 34740799
Impaired driving ability 18.32 10.48 44 199336 2589 34754962
Immune reconstitution inflammatory syndrome 18.15 10.48 14 199366 8745 34748806
Mucosal atrophy 18.08 10.48 9 199371 73 34757478
Brief psychotic disorder with marked stressors 18.08 10.48 13 199367 218 34757333
Allodynia 18.07 10.48 23 199357 808 34756743
Hypomagnesaemia 17.99 10.48 64 199316 21787 34735764
Cytomegalovirus viraemia 17.94 10.48 10 199370 7420 34750131
Lumbar radiculopathy 17.79 10.48 23 199357 821 34756730
Haematuria 17.77 10.48 191 199189 49875 34707676
Affective disorder 17.72 10.48 60 199320 4300 34753251
Dysphoria 17.69 10.48 40 199340 2262 34755289
Facial wasting 17.49 10.48 11 199369 146 34757405
Ear deformity acquired 17.43 10.48 5 199375 5 34757546
Neoplasm progression 17.40 10.48 71 199309 23229 34734322
Distributive shock 17.37 10.48 28 199352 1226 34756325
Osteomyelitis 17.32 10.48 154 199226 15982 34741569
Opisthotonus 17.17 10.48 17 199363 450 34757101
Aggression 17.14 10.48 315 199065 38649 34718902
Quality of life decreased 17.10 10.48 56 199324 3945 34753606
Blood pressure fluctuation 16.99 10.48 80 199300 25169 34732382
Hepatotoxicity 16.98 10.48 64 199316 21421 34736130
Violence-related symptom 16.97 10.48 18 199362 518 34757033
Localised infection 16.94 10.48 164 199216 17423 34740128
Cytokine release syndrome 16.90 10.48 70 199310 22807 34734744
Bladder cancer 16.75 10.48 43 199337 16235 34741316
Idiopathic neutropenia 16.69 10.48 4 199376 0 34757551
Precancerous skin lesion 16.63 10.48 19 199361 595 34756956
Rectal haemorrhage 16.61 10.48 148 199232 40101 34717450
Cerebral disorder 16.55 10.48 42 199338 2559 34754992
Hepatitis 16.52 10.48 75 199305 23829 34733722
Road traffic accident 16.46 10.48 162 199218 17288 34740263
Intentional product use issue 16.43 10.48 241 199139 59575 34697976
Panic attack 16.42 10.48 101 199279 9331 34748220
Sleep disorder 16.41 10.48 263 199117 31425 34726126
Cognitive disorder 16.34 10.48 242 199138 28451 34729100
Amphetamines positive 16.30 10.48 12 199368 209 34757342
Heat exhaustion 16.28 10.48 11 199369 166 34757385
Stiff person syndrome 16.23 10.48 9 199371 93 34757458
Autoimmune haemolytic anaemia 16.21 10.48 3 199377 4493 34753058
Acute coronary syndrome 16.19 10.48 33 199347 13512 34744039
Binocular eye movement disorder 16.17 10.48 8 199372 64 34757487
Left ventricular dysfunction 16.11 10.48 20 199360 9987 34747564
Hyperthyroidism 16.10 10.48 22 199358 10544 34747007
Therapeutic response unexpected 16.07 10.48 103 199277 9654 34747897
Hypoalbuminaemia 16.01 10.48 28 199352 12146 34745405
Encephalitis 15.90 10.48 11 199369 7266 34750285
Mucormycosis 15.85 10.48 7 199373 5935 34751616
Breakthrough pain 15.83 10.48 18 199362 561 34756990
Hypersomnia 15.77 10.48 123 199257 12284 34745267
Acute graft versus host disease in skin 15.76 10.48 5 199375 5196 34752355
Degenerative bone disease 15.76 10.48 8 199372 68 34757483
Metastases to liver 15.73 10.48 34 199346 13629 34743922
Muscular weakness 15.70 10.48 535 198845 72362 34685189
Hyperhidrosis 15.67 10.48 553 198827 75139 34682412
Thinking abnormal 15.66 10.48 73 199307 6064 34751487
Metabolic encephalopathy 15.66 10.48 57 199323 4235 34753316
Blood creatinine increased 15.64 10.48 417 198963 94559 34662992
Oesophageal carcinoma 15.61 10.48 18 199362 9286 34748265
Drug use disorder 15.58 10.48 56 199324 4135 34753416
Loss of proprioception 15.53 10.48 15 199365 385 34757166
Seizure 15.49 10.48 739 198641 104118 34653433
Lung disorder 15.48 10.48 125 199255 34571 34722980
Pulmonary tuberculosis 15.46 10.48 4 199376 4750 34752801
Migraine 15.40 10.48 160 199220 17318 34740233
Gingival atrophy 15.30 10.48 7 199373 46 34757505
Blood pressure systolic increased 15.28 10.48 73 199307 22879 34734672
Spinal stenosis 15.20 10.48 65 199315 5204 34752347
Myasthenia gravis 15.18 10.48 79 199301 6861 34750690
Stomatitis 15.16 10.48 162 199218 42352 34715199
Central nervous system lesion 15.14 10.48 75 199305 6388 34751163
Diastolic dysfunction 15.11 10.48 73 199307 6154 34751397
Foetal disorder 15.10 10.48 21 199359 805 34756746
Stevens-Johnson syndrome 15.07 10.48 55 199325 18584 34738967
Leukaemia 15.03 10.48 59 199321 4544 34753007
Back injury 15.03 10.48 54 199326 3987 34753564
Haemorrhage intracranial 15.01 10.48 44 199336 15902 34741649
Anaphylactic shock 14.99 10.48 44 199336 15897 34741654
Feeding intolerance 14.97 10.48 10 199370 148 34757403
Inflammatory marker increased 14.95 10.48 5 199375 5023 34752528
Dysphemia 14.90 10.48 30 199350 1565 34755986
Acute pulmonary oedema 14.88 10.48 12 199368 7331 34750220
Peritonitis 14.80 10.48 46 199334 16319 34741232
Radiculopathy 14.76 10.48 42 199338 2739 34754812
Oxygen saturation decreased 14.72 10.48 217 199163 53601 34703950
Muscle tightness 14.67 10.48 61 199319 4823 34752728
Oesophageal mucosa erythema 14.62 10.48 6 199374 29 34757522
Hepatocellular injury 14.58 10.48 71 199309 22140 34735411
Colitis ulcerative 14.54 10.48 47 199333 16473 34741078
Tubulointerstitial nephritis 14.51 10.48 66 199314 20958 34736593
Hypometabolism 14.34 10.48 9 199371 119 34757432
Feeling drunk 14.32 10.48 33 199347 1890 34755661
Schizophrenia 14.29 10.48 17 199363 8649 34748902
Tachycardia 14.27 10.48 371 199009 84401 34673150
Respiratory disorder 14.19 10.48 59 199321 19205 34738346
Cardiac failure acute 14.19 10.48 24 199356 10546 34747005
Artery dissection 14.15 10.48 9 199371 122 34757429
Ventricular hypokinesia 14.10 10.48 7 199373 5545 34752006
Rhabdomyolysis 14.09 10.48 289 199091 67874 34689677
Drug abuser 14.00 10.48 52 199328 3902 34753649
Fear of weight gain 13.94 10.48 4 199376 4 34757547
Alcohol withdrawal syndrome 13.94 10.48 28 199352 1458 34756093
Anal abscess 13.86 10.48 10 199370 6463 34751088
Candida infection 13.85 10.48 53 199327 17662 34739889
Musculoskeletal disorder 13.83 10.48 71 199309 6133 34751418
Fibromyalgia 13.80 10.48 44 199336 3056 34754495
Adrenal insufficiency 13.78 10.48 38 199342 14009 34743542
Intentional underdose 13.76 10.48 18 199362 650 34756901
Oropharyngeal oedema 13.70 10.48 8 199372 92 34757459
Large intestine perforation 13.68 10.48 17 199363 8486 34749065
Blood phosphorus increased 13.65 10.48 83 199297 7638 34749913
Cardiac arrest 13.63 10.48 675 198705 95484 34662067
Fungal infection 13.57 10.48 46 199334 15889 34741662
Enterococcal infection 13.56 10.48 20 199360 9286 34748265
Abnormal labour affecting foetus 13.55 10.48 5 199375 17 34757534
Second primary malignancy 13.51 10.48 15 199365 7871 34749680
Hypertriglyceridaemia 13.48 10.48 17 199363 8431 34749120
Nocturia 13.41 10.48 102 199278 10108 34747443
Haemorrhage 13.41 10.48 209 199171 51161 34706390
Micturition urgency 13.40 10.48 73 199307 6452 34751099
Toxic skin eruption 13.39 10.48 28 199352 11357 34746194
Neurogenic bladder 13.38 10.48 31 199349 1782 34755769
Graft versus host disease in skin 13.36 10.48 3 199377 3922 34753629
Gastrointestinal adenocarcinoma 13.35 10.48 7 199373 64 34757487
Tracheobronchitis bacterial 13.33 10.48 5 199375 18 34757533
Ejection fraction decreased 13.30 10.48 60 199320 19094 34738457
Product communication issue 13.28 10.48 14 199366 400 34757151
Uveitis 13.28 10.48 14 199366 7521 34750030
Body height decreased 13.16 10.48 50 199330 3793 34753758
Drug withdrawal syndrome neonatal 13.15 10.48 48 199332 3571 34753980
Polyneuropathy in malignant disease 13.09 10.48 11 199369 234 34757317
Abnormal sleep-related event 13.08 10.48 15 199365 472 34757079
Immature granulocyte percentage increased 13.06 10.48 4 199376 6 34757545
Enthesopathy 13.01 10.48 5 199375 4608 34752943
Hypotension 12.97 10.48 1088 198292 220561 34536990
Neutrophil count increased 12.96 10.48 52 199328 17094 34740457
Neutropenic sepsis 12.95 10.48 38 199342 13729 34743822
Free androgen index decreased 12.93 10.48 5 199375 20 34757531
Slow speech 12.93 10.48 24 199356 1178 34756373
Sleep attacks 12.93 10.48 9 199371 143 34757408
Bipolar I disorder 12.90 10.48 19 199361 768 34756783
Hypertransaminasaemia 12.89 10.48 8 199372 5598 34751953
Blood urea increased 12.82 10.48 111 199269 30253 34727298
Implant site inflammation 12.79 10.48 8 199372 105 34757446
Rales 12.75 10.48 23 199357 9860 34747691
Hepatitis fulminant 12.75 10.48 4 199376 4186 34753365
Rheumatoid arthritis 12.73 10.48 148 199232 38090 34719461
Blood alkaline phosphatase increased 12.71 10.48 115 199265 31060 34726491
Gastric cancer 12.59 10.48 11 199369 6458 34751093
Electric shock 12.56 10.48 9 199371 150 34757401
Pulmonary fibrosis 12.55 10.48 58 199322 18338 34739213
Cholestasis 12.53 10.48 96 199284 26852 34730699
Traumatic amputation 12.52 10.48 3 199377 0 34757551
Nasal odour 12.52 10.48 3 199377 0 34757551
Severe myoclonic epilepsy of infancy 12.52 10.48 3 199377 0 34757551
Benign neoplasm of spinal cord 12.52 10.48 3 199377 0 34757551
Pancreatic fibrosis 12.52 10.48 3 199377 0 34757551
Opiates positive 12.51 10.48 16 199364 565 34756986
Pneumonia bacterial 12.50 10.48 31 199349 11841 34745710
Abnormal behaviour 12.47 10.48 206 199174 24763 34732788
Dependence 12.42 10.48 23 199357 1127 34756424
Swelling 12.39 10.48 323 199057 42043 34715508
Systemic candida 12.38 10.48 3 199377 3723 34753828
Nerve compression 12.35 10.48 44 199336 3235 34754316
Foot fracture 12.35 10.48 59 199321 4952 34752599
Cardiogenic shock 12.34 10.48 217 199163 26401 34731150
Open angle glaucoma 12.31 10.48 9 199371 155 34757396
Rib fracture 12.30 10.48 131 199249 14269 34743282
Lymphocyte count decreased 12.29 10.48 77 199303 22545 34735006
Cellulitis 12.26 10.48 392 198988 52559 34704992
Major depression 12.13 10.48 55 199325 4517 34753034
Diarrhoea 12.12 10.48 1997 197383 387915 34369636
Herpes zoster 12.10 10.48 269 199111 34130 34723421
Retinal haemorrhage 12.07 10.48 7 199373 5082 34752469
Nephrogenic systemic fibrosis 12.01 10.48 50 199330 3955 34753596
Chronic graft versus host disease 11.91 10.48 5 199375 4368 34753183
Neck surgery 11.82 10.48 13 199367 390 34757161
Pseudomonas infection 11.77 10.48 34 199346 12348 34745203
Teeth brittle 11.72 10.48 6 199374 52 34757499
Asphyxia 11.71 10.48 13 199367 6822 34750729
Movement disorder 11.69 10.48 114 199266 12134 34745417
Application site hypersensitivity 11.61 10.48 8 199372 125 34757426
Electrocardiogram QT prolonged 11.59 10.48 164 199216 40788 34716763
Intervertebral disc injury 11.59 10.48 5 199375 28 34757523
Sensory loss 11.58 10.48 55 199325 4604 34752947
Infective pulmonary exacerbation of cystic fibrosis 11.58 10.48 13 199367 6788 34750763
Joint hyperextension 11.44 10.48 8 199372 128 34757423
Complications of transplanted kidney 11.43 10.48 6 199374 4603 34752948
Adenovirus infection 11.42 10.48 8 199372 5249 34752302
Neutropenia neonatal 11.40 10.48 17 199363 695 34756856
Arrhythmia 11.38 10.48 140 199240 35668 34721883
Multiple-drug resistance 11.34 10.48 8 199372 5231 34752320
Trigeminal neuralgia 11.34 10.48 23 199357 1206 34756345
Systemic infection 11.23 10.48 8 199372 5204 34752347
White blood cell count increased 11.23 10.48 166 199214 40985 34716566
Post laminectomy syndrome 11.18 10.48 9 199371 180 34757371
Polyarthritis 11.12 10.48 6 199374 4534 34753017
Mouth ulceration 11.11 10.48 33 199347 11877 34745674
Carcinogenicity 11.08 10.48 6 199374 59 34757492
Thoracic vertebral fracture 11.07 10.48 28 199352 1702 34755849
Malaise 11.04 10.48 911 198469 184914 34572637
Hyperuricaemia 11.04 10.48 18 199362 8025 34749526
Developmental hip dysplasia 11.03 10.48 11 199369 294 34757257
Mental disorder 11.02 10.48 134 199246 15075 34742476
Decreased interest 10.97 10.48 34 199346 2326 34755225
Immunosuppressant drug level increased 10.95 10.48 11 199369 6044 34751507
Hypogammaglobulinaemia 10.93 10.48 17 199363 7723 34749828
Intestinal perforation 10.89 10.48 22 199358 9038 34748513
Platelet count decreased 10.84 10.48 565 198815 119152 34638399
Surgery 10.82 10.48 126 199254 14031 34743520
Seborrhoeic keratosis 10.81 10.48 23 199357 1248 34756303
Peripheral vascular disorder 10.79 10.48 57 199323 4979 34752572
Blood pressure decreased 10.77 10.48 218 199162 51297 34706254
Cyanosis 10.76 10.48 37 199343 12727 34744824
Hypotony maculopathy 10.75 10.48 4 199376 14 34757537
Multiple cardiac defects 10.74 10.48 6 199374 63 34757488
Arteriospasm coronary 10.71 10.48 3 199377 3379 34754172
Incision site complication 10.70 10.48 11 199369 305 34757246
Postmortem blood drug level 10.69 10.48 9 199371 192 34757359
Colorectal cancer 10.67 10.48 7 199373 4754 34752797
Electrocardiogram abnormal 10.66 10.48 23 199357 9224 34748327
Hypocalcaemia 10.61 10.48 88 199292 24201 34733350
Lipodystrophy acquired 10.52 10.48 3 199377 3341 34754210
Hyperglycaemia 10.51 10.48 160 199220 39320 34718231
Narcolepsy 10.50 10.48 14 199366 515 34757036
Spinal fusion surgery 10.50 10.48 20 199360 1001 34756550
Myocardial infarction 10.49 10.48 574 198806 120511 34637040

FDA Adverse Event Reporting System (Geriatric)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Drug hypersensitivity 2540.28 9.73 5353 443473 293563 79001999
Completed suicide 1640.48 9.73 4002 444824 241765 79053797
Drug ineffective for unapproved indication 1265.07 9.73 1501 447325 49737 79245825
Toxicity to various agents 622.37 9.73 4281 444545 417259 78878303
Myoclonus 579.00 9.73 746 448080 26914 79268648
Somnolence 522.92 9.73 2692 446134 236289 79059273
Pemphigus 510.55 9.73 10 448816 99572 79195990
Multiple sclerosis relapse 465.94 9.73 894 447932 45639 79249923
Drug abuse 427.36 9.73 1932 446894 160759 79134803
Synovitis 410.47 9.73 167 448659 150567 79144995
Hand deformity 384.05 9.73 62 448764 103857 79191705
Fall 377.52 9.73 4299 444527 483330 78812232
Pericarditis 363.93 9.73 72 448754 104164 79191398
Glossodynia 335.35 9.73 84 448742 103253 79192309
Duodenal ulcer perforation 330.29 9.73 9 448817 66202 79229360
Systemic lupus erythematosus 318.96 9.73 141 448685 121008 79174554
Depression 315.72 9.73 2196 446630 214594 79080968
Contraindicated product administered 314.33 9.73 255 448571 157283 79138279
Maternal exposure during pregnancy 309.18 9.73 193 448633 136345 79159217
Rheumatoid factor positive 288.27 9.73 11 448815 59828 79235734
Helicobacter infection 282.78 9.73 31 448795 69673 79225889
Drug withdrawal syndrome 266.46 9.73 598 448228 34120 79261442
Hepatic enzyme increased 260.32 9.73 390 448436 182220 79113342
Drug dependence 258.55 9.73 652 448174 40117 79255445
Respiratory arrest 253.85 9.73 807 448019 56743 79238819
Tremor 251.14 9.73 1729 447097 168354 79127208
Infusion related reaction 243.77 9.73 588 448238 229649 79065913
Arthropathy 238.45 9.73 393 448433 176718 79118844
Multiple sclerosis 234.05 9.73 437 448389 21845 79273717
Mental status changes 228.32 9.73 862 447964 66097 79229465
Withdrawal syndrome 219.03 9.73 474 448352 26380 79269182
Accidental death 215.85 9.73 185 448641 4106 79291456
Interstitial lung disease 215.09 9.73 190 448636 112410 79183152
C-reactive protein increased 214.17 9.73 246 448580 128781 79166781
General physical health deterioration 211.29 9.73 815 448011 274423 79021139
Feeling abnormal 205.97 9.73 1568 447258 157631 79137931
Suicidal ideation 205.08 9.73 913 447913 75427 79220135
Febrile neutropenia 200.69 9.73 649 448177 230350 79065212
Dizziness 196.73 9.73 4102 444724 522339 78773223
Muscle injury 195.96 9.73 22 448804 48539 79247023
Memory impairment 195.00 9.73 1185 447641 110549 79185013
Hallucination 192.13 9.73 973 447853 84772 79210790
Sedation 191.14 9.73 685 448141 51210 79244352
Joint swelling 188.34 9.73 909 447917 287737 79007825
Pyrexia 183.81 9.73 2702 446124 676007 78619555
Sleep disorder due to general medical condition, insomnia type 182.84 9.73 17 448809 43539 79252023
Folliculitis 181.63 9.73 44 448782 55336 79240226
Confusional state 162.15 9.73 2602 446224 315395 78980167
Wound 160.83 9.73 253 448573 115926 79179636
Respiratory depression 159.89 9.73 427 448399 27203 79268359
Cardio-respiratory arrest 154.73 9.73 1094 447732 107416 79188146
Hepatic function abnormal 152.53 9.73 113 448713 72994 79222568
Muscle spasms 151.06 9.73 1576 447250 173154 79122408
Exposure during pregnancy 150.95 9.73 209 448617 100923 79194639
Cytomegalovirus infection 147.68 9.73 30 448796 42614 79252948
Discomfort 147.46 9.73 303 448523 125314 79170248
Balance disorder 147.03 9.73 1007 447819 97850 79197712
Anxiety 145.41 9.73 2082 446744 246430 79049132
Vision blurred 144.82 9.73 1057 447769 104841 79190721
Hypersensitivity 144.40 9.73 874 447952 261365 79034197
C-reactive protein abnormal 142.73 9.73 47 448779 48320 79247242
Pain in extremity 142.38 9.73 2860 445966 361678 78933884
Neuralgia 138.05 9.73 458 448368 32926 79262636
Therapeutic product effect decreased 137.02 9.73 468 448358 163395 79132167
Gait disturbance 135.47 9.73 1773 447053 205733 79089829
Lower respiratory tract infection 129.69 9.73 339 448487 128881 79166681
Product dose omission issue 129.32 9.73 2034 446792 245503 79050059
Sopor 128.68 9.73 444 448382 32566 79262996
Anaemia 125.36 9.73 1757 447069 443258 78852304
Myelosuppression 119.18 9.73 39 448787 40257 79255305
Overdose 116.93 9.73 1566 447260 182640 79112922
Intentional product misuse 116.73 9.73 926 447900 94239 79201323
Cardiac failure 113.95 9.73 466 448360 154376 79141186
Hypoaesthesia 111.89 9.73 1520 447306 177832 79117730
Swollen joint count increased 111.16 9.73 4 448822 22923 79272639
Irritable bowel syndrome 110.66 9.73 112 448714 62129 79233433
Thrombocytopenia 106.28 9.73 967 447859 264292 79031270
Neuropathy peripheral 106.26 9.73 1240 447586 140065 79155497
Mucosal inflammation 101.38 9.73 168 448658 75412 79220150
Impaired healing 100.70 9.73 214 448612 87441 79208121
Nightmare 99.20 9.73 346 448480 25515 79270047
Lethargy 99.14 9.73 790 448036 80502 79215060
Insomnia 97.10 9.73 1928 446898 243242 79052320
Rheumatic fever 96.85 9.73 21 448805 28504 79267058
Drug resistance 95.05 9.73 60 448766 42153 79253409
Cardiac arrest 92.06 9.73 1420 447406 170676 79124886
Neutropenia 90.04 9.73 1111 447715 286599 79008963
Drug use disorder 90.01 9.73 169 448657 8482 79287080
Sleep apnoea syndrome 88.13 9.73 423 448403 36055 79259507
Migraine 87.16 9.73 813 448013 86680 79208882
Inadequate analgesia 86.31 9.73 118 448708 4511 79291051
Bone marrow failure 85.25 9.73 97 448729 51010 79244552
Depressed level of consciousness 84.05 9.73 873 447953 95779 79199783
Liver injury 82.48 9.73 119 448707 56495 79239067
Plasma cell myeloma 82.44 9.73 548 448278 52711 79242851
Urinary tract infection 81.12 9.73 2071 446755 272441 79023121
Product complaint 81.00 9.73 210 448616 13139 79282423
Abdominal discomfort 78.89 9.73 967 447859 249760 79045802
Ataxia 77.72 9.73 313 448513 24726 79270836
Dysarthria 76.98 9.73 647 448179 66975 79228587
Serotonin syndrome 76.27 9.73 474 448352 44553 79251009
Dyskinesia 75.01 9.73 470 448356 44303 79251259
Mood altered 74.81 9.73 246 448580 17601 79277961
Burning sensation 74.35 9.73 575 448251 58057 79237505
Hallucination, visual 73.70 9.73 372 448454 32357 79263205
Intervertebral disc degeneration 72.94 9.73 225 448601 15560 79280002
Pancytopenia 72.69 9.73 590 448236 165155 79130407
Malignant neoplasm progression 72.31 9.73 458 448368 135532 79160030
Death 71.41 9.73 3884 444942 562630 78732932
Suspected suicide 71.11 9.73 173 448653 10403 79285159
Haemophagocytic lymphohistiocytosis 68.45 9.73 19 448807 21818 79273744
Euphoric mood 68.36 9.73 141 448685 7585 79287977
Ill-defined disorder 68.25 9.73 170 448656 65705 79229857
Intentional product use issue 67.85 9.73 539 448287 151573 79143989
Right atrial hypertrophy 66.94 9.73 46 448780 725 79294837
Crying 66.76 9.73 282 448544 22761 79272801
Muscle twitching 66.34 9.73 296 448530 24468 79271094
Unresponsive to stimuli 66.30 9.73 539 448287 55249 79240313
Seizure 65.93 9.73 1458 447368 187376 79108186
Alopecia 65.88 9.73 911 447915 230444 79065118
Mental disorder 65.10 9.73 348 448478 30954 79264608
Hyperaesthesia 64.86 9.73 183 448643 12039 79283523
Nervousness 64.47 9.73 364 448462 33051 79262511
Drug reaction with eosinophilia and systemic symptoms 63.33 9.73 170 448656 64074 79231488
Fatigue 62.37 9.73 6056 442770 923671 78371891
Hypokalaemia 62.13 9.73 515 448311 143525 79152037
Device expulsion 62.13 9.73 34 448792 25827 79269735
Back disorder 62.07 9.73 174 448652 11404 79284158
Appendicolith 61.96 9.73 144 448682 8407 79287155
Multiple organ dysfunction syndrome 61.88 9.73 409 448417 119837 79175725
Spinal operation 61.44 9.73 137 448689 7780 79287782
Bone erosion 60.88 9.73 13 448813 17834 79277728
Therapeutic response unexpected 60.85 9.73 248 448578 19698 79275864
Head injury 60.57 9.73 389 448437 36980 79258582
Infection 60.47 9.73 976 447850 240736 79054826
Treatment failure 60.47 9.73 640 448186 169846 79125716
Amnesia 59.85 9.73 580 448246 62477 79233085
Blister 59.67 9.73 410 448416 119066 79176496
Septic shock 59.08 9.73 426 448400 122375 79173187
Blood lactate dehydrogenase increased 58.38 9.73 81 448745 39089 79256473
Swelling 58.30 9.73 863 447963 215848 79079714
Irritability 58.13 9.73 414 448412 40730 79254832
Melaena 57.87 9.73 164 448662 60726 79234836
Intervertebral disc protrusion 57.85 9.73 275 448551 23346 79272216
Live birth 57.47 9.73 17 448809 18727 79276835
Coordination abnormal 57.44 9.73 221 448605 17091 79278471
Speech disorder 57.30 9.73 512 448314 53933 79241629
Pneumocystis jirovecii pneumonia 57.21 9.73 59 448767 32449 79263113
Urinary incontinence 56.85 9.73 410 448416 40499 79255063
Anticipatory anxiety 56.71 9.73 50 448776 1154 79294408
Back pain 56.66 9.73 2170 446656 302010 78993552
Paraesthesia 56.45 9.73 1345 447481 174978 79120584
Pleural effusion 55.79 9.73 535 448291 144727 79150835
Accidental poisoning 55.51 9.73 57 448769 1600 79293962
Rash 55.46 9.73 2675 446151 575683 78719879
Stomatitis 55.31 9.73 543 448283 146214 79149348
Hepatic failure 54.47 9.73 170 448656 61042 79234520
Atrial fibrillation 54.28 9.73 785 448041 197101 79098461
Muscular weakness 53.58 9.73 1233 447593 159496 79136066
Eosinophilia 53.51 9.73 109 448717 45236 79250326
Stiff person syndrome 53.22 9.73 29 448797 293 79295269
Bradyphrenia 52.30 9.73 155 448671 10485 79285077
Colitis 51.81 9.73 224 448602 73083 79222479
Agitation 51.47 9.73 818 448008 98897 79196665
Feeling drunk 51.37 9.73 94 448732 4625 79290937
Hepatotoxicity 51.28 9.73 135 448691 51217 79244345
Disseminated intravascular coagulation 50.59 9.73 77 448749 35765 79259797
Renal impairment 50.18 9.73 607 448219 157176 79138386
Drug intolerance 50.16 9.73 1118 447708 263001 79032561
Presbyacusis 49.88 9.73 68 448758 2592 79292970
Anger 49.69 9.73 210 448616 16952 79278610
Rash maculo-papular 49.02 9.73 157 448669 55921 79239641
Rheumatoid arthritis 48.16 9.73 854 447972 207616 79087946
Nasopharyngitis 47.83 9.73 1076 447750 252805 79042757
Restless legs syndrome 47.10 9.73 231 448595 19861 79275701
Hypersomnia 46.88 9.73 255 448571 22831 79272731
Post transplant lymphoproliferative disorder 46.74 9.73 5 448821 11459 79284103
Psoriatic arthropathy 46.61 9.73 253 448573 77746 79217816
Transaminases increased 46.54 9.73 143 448683 51600 79243962
Anaphylactic shock 46.44 9.73 82 448744 35914 79259648
Rheumatoid nodule 46.34 9.73 20 448806 17418 79278144
Asterixis 46.00 9.73 66 448760 2641 79292921
Poisoning 45.95 9.73 271 448555 25001 79270561
Toxic epidermal necrolysis 45.44 9.73 116 448710 44465 79251097
Acute graft versus host disease 45.38 9.73 3 448823 10164 79285398
Gait spastic 45.31 9.73 44 448782 1153 79294409
Constipation 45.29 9.73 1987 446839 281063 79014499
Aspergillus infection 44.86 9.73 26 448800 19135 79276427
Jaundice 44.81 9.73 152 448674 53197 79242365
Trigeminal neuralgia 44.60 9.73 76 448750 3533 79292029
Agranulocytosis 44.50 9.73 119 448707 44911 79250651
Osteonecrosis of jaw 44.42 9.73 112 448714 43114 79252448
Red blood cell sedimentation rate abnormal 44.24 9.73 32 448794 20931 79274631
Alanine aminotransferase increased 44.19 9.73 646 448180 161924 79133638
Myocardial stunning 44.01 9.73 22 448804 183 79295379
Right ventricular hypertrophy 43.78 9.73 50 448776 1587 79293975
Graft versus host disease 43.63 9.73 15 448811 15011 79280551
Off label use 43.60 9.73 4457 444369 902758 78392804
Anorgasmia 43.58 9.73 44 448782 1210 79294352
Therapeutic response decreased 43.25 9.73 211 448615 66642 79228920
Transplant rejection 43.25 9.73 28 448798 19409 79276153
Hyperhidrosis 42.68 9.73 1136 447690 150356 79145206
Hyperreflexia 42.03 9.73 123 448703 8262 79287300
Disorientation 42.00 9.73 539 448287 62237 79233325
Pulmonary fibrosis 41.78 9.73 119 448707 43993 79251569
Blood bilirubin increased 41.72 9.73 211 448615 66021 79229541
Accidental overdose 41.54 9.73 372 448454 39209 79256353
Impaired driving ability 41.23 9.73 93 448733 5322 79290240
Diplopia 41.21 9.73 326 448500 33140 79262422
Pleural thickening 41.16 9.73 66 448760 2916 79292646
Myokymia 41.06 9.73 18 448808 107 79295455
Leukopenia 41.05 9.73 438 448388 116075 79179487
Neutrophil count decreased 40.93 9.73 335 448491 93624 79201938
Haematotoxicity 40.92 9.73 18 448808 15501 79280061
Vertigo 40.81 9.73 580 448246 68502 79227060
Pleural fibrosis 40.40 9.73 79 448747 4088 79291474
Proteinuria 40.19 9.73 76 448750 32426 79263136
Relapsing-remitting multiple sclerosis 39.96 9.73 46 448780 1473 79294089
Premature delivery 39.72 9.73 44 448782 23423 79272139
Hip arthroplasty 39.65 9.73 89 448737 35667 79259895
Joint injury 39.55 9.73 307 448519 31028 79264534
Delirium 39.53 9.73 683 448143 83944 79211618
Venoocclusive liver disease 39.29 9.73 9 448817 11762 79283800
Erythema 39.09 9.73 957 447869 222333 79073229
Acute respiratory distress syndrome 38.78 9.73 123 448703 43944 79251618
Drug-induced liver injury 38.66 9.73 216 448610 65901 79229661
Cytomegalovirus viraemia 38.64 9.73 12 448814 12809 79282753
Bronchopulmonary aspergillosis 38.63 9.73 41 448785 22253 79273309
Surgery 38.62 9.73 316 448510 32450 79263112
Thrombotic microangiopathy 38.53 9.73 34 448792 20135 79275427
Nausea 37.70 9.73 6033 442793 951163 78344399
Cytomegalovirus infection reactivation 37.68 9.73 3 448823 8713 79286849
Needle fatigue 37.65 9.73 35 448791 867 79294695
Lymphoedema 37.59 9.73 154 448672 12259 79283303
Somatic symptom disorder 37.58 9.73 58 448768 2479 79293083
Sinusitis 37.54 9.73 826 448000 194675 79100887
Neck pain 37.54 9.73 615 448211 74802 79220760
Full blood count decreased 37.39 9.73 269 448557 26550 79269012
Gastrointestinal disorder 36.65 9.73 476 448350 121729 79173833
Acute myeloid leukaemia 36.64 9.73 74 448752 30811 79264751
Epistaxis 36.21 9.73 427 448399 111088 79184474
Ankle fracture 36.20 9.73 190 448636 16779 79278783
Influenza like illness 36.16 9.73 586 448240 71121 79224441
Mental impairment 35.82 9.73 206 448620 18830 79276732
Knee arthroplasty 35.79 9.73 124 448702 43124 79252438
Shock haemorrhagic 35.76 9.73 36 448790 20024 79275538
Therapeutic product effect variable 35.64 9.73 50 448776 1959 79293603
Pulmonary toxicity 35.63 9.73 14 448812 12900 79282662
Headache 35.48 9.73 4200 444626 649572 78645990
Chorea 35.44 9.73 55 448771 2362 79293200
Stress 35.22 9.73 637 448189 78975 79216587
Muscle tightness 35.07 9.73 155 448671 12759 79282803
Neovascularisation 34.96 9.73 39 448787 1206 79294356
Visual snow syndrome 34.80 9.73 13 448813 47 79295515
Pregnancy 34.79 9.73 61 448765 26790 79268772
Disturbance in attention 34.75 9.73 438 448388 50363 79245199
Injection site mass 34.50 9.73 213 448613 19971 79275591
Hostility 34.48 9.73 53 448773 2257 79293305
Prescription drug used without a prescription 34.33 9.73 73 448753 4012 79291550
Somatic delusion 34.18 9.73 30 448796 688 79294874
Diabetic neuropathy 33.90 9.73 94 448732 6122 79289440
Complex regional pain syndrome 33.44 9.73 49 448777 1999 79293563
Blood magnesium increased 33.42 9.73 66 448760 3440 79292122
Erectile dysfunction 33.24 9.73 167 448659 14497 79281065
Panniculitis 33.17 9.73 14 448812 12357 79283205
Epstein-Barr virus infection 33.13 9.73 20 448806 14396 79281166
Alcoholism 33.00 9.73 68 448758 3655 79291907
Hypermobility syndrome 32.76 9.73 26 448800 516 79295046
Cystitis haemorrhagic 32.71 9.73 6 448820 9166 79286396
Obsessive-compulsive disorder 32.69 9.73 90 448736 5837 79289725
Coma 32.57 9.73 769 448057 99880 79195682
Arthralgia 32.41 9.73 2774 446052 569029 78726533
Tumour lysis syndrome 32.29 9.73 53 448773 23886 79271676
Central nervous system lesion 32.27 9.73 155 448671 13213 79282349
Pain 32.26 9.73 4475 444351 699327 78596235
Encephalopathy 32.22 9.73 546 448280 66851 79228711
Dysstasia 31.85 9.73 266 448560 27480 79268082
Muscle spasticity 31.45 9.73 218 448608 21257 79274305
Toxic skin eruption 31.36 9.73 48 448778 22245 79273317
Posterior reversible encephalopathy syndrome 31.15 9.73 63 448763 26218 79269344
Neutropenic sepsis 31.13 9.73 66 448760 26998 79268564
Appendicitis 31.00 9.73 212 448614 20582 79274980
Paranoia 30.70 9.73 201 448625 19231 79276331
Disease progression 30.68 9.73 796 448030 183566 79111996
Blood cholesterol increased 30.60 9.73 312 448514 83408 79212154
Bronchial wall thickening 30.53 9.73 54 448772 2587 79292975
Victim of child abuse 30.52 9.73 32 448794 921 79294641
Incoherent 30.44 9.73 104 448722 7588 79287974
Panic attack 30.42 9.73 237 448589 23979 79271583
Cholangitis 30.39 9.73 17 448809 12759 79282803
Product use issue 30.31 9.73 924 447902 208898 79086664
Limb injury 30.21 9.73 276 448550 29252 79266310
Gastrointestinal haemorrhage 30.14 9.73 618 448208 147101 79148461
Pathogen resistance 30.13 9.73 22 448804 14320 79281242
Drug abuser 29.94 9.73 88 448738 5925 79289637
Cerebral infarction 29.64 9.73 144 448682 45532 79250030
Hypertonic bladder 29.62 9.73 70 448756 4131 79291431
Nerve injury 29.62 9.73 118 448708 9274 79286288
Drug screen positive 29.49 9.73 88 448738 5975 79289587
Myocarditis 29.43 9.73 48 448778 21685 79273877
Inflammation 29.29 9.73 362 448464 93391 79202171
Thinking abnormal 29.21 9.73 149 448677 13012 79282550
Lung disorder 29.12 9.73 301 448525 80256 79215306
Metastases to liver 28.60 9.73 74 448752 28240 79267322
Pulmonary tuberculosis 28.36 9.73 5 448821 7860 79287702
Dry mouth 28.32 9.73 672 448154 87347 79208215
Drug eruption 28.22 9.73 139 448687 43796 79251766
Dysphemia 27.84 9.73 61 448765 3423 79292139
Haemolysis 27.77 9.73 19 448807 12793 79282769
Cerebral haemorrhage 27.76 9.73 200 448626 57473 79238089
Allodynia 27.74 9.73 40 448786 1608 79293954
Pituitary tumour benign 27.65 9.73 51 448775 2525 79293037
Gamma-glutamyltransferase increased 27.61 9.73 187 448639 54493 79241069
Therapy non-responder 27.50 9.73 360 448466 91945 79203617
Therapy cessation 27.49 9.73 328 448498 37234 79258328
Labelled drug-drug interaction medication error 27.37 9.73 73 448753 27577 79267985
Cytokine release syndrome 27.31 9.73 107 448719 35891 79259671
Autonomic nervous system imbalance 27.24 9.73 72 448754 4558 79291004
Acute kidney injury 27.19 9.73 2535 446291 516869 78778693
Drug tolerance decreased 27.14 9.73 20 448806 12958 79282604
Cellulitis 27.13 9.73 805 448021 108255 79187307
Epidural lipomatosis 27.08 9.73 34 448792 1194 79294368
Hepatocellular injury 27.01 9.73 157 448669 47436 79248126
Pneumonitis 26.96 9.73 216 448610 60644 79234918
Lupus-like syndrome 26.91 9.73 23 448803 13834 79281728
Device adhesion issue 26.63 9.73 4 448822 7071 79288491
Gait inability 26.61 9.73 473 448353 58444 79237118
Micturition urgency 26.60 9.73 141 448685 12500 79283062
Blood parathyroid hormone decreased 26.57 9.73 13 448813 10523 79285039
Metabolic encephalopathy 26.54 9.73 112 448714 9035 79286527
Adjustment disorder with depressed mood 26.51 9.73 9 448817 9077 79286485
Skin necrosis 26.36 9.73 38 448788 18049 79277513
Pulmonary function test abnormal 25.98 9.73 66 448760 4078 79291484
Nerve compression 25.94 9.73 112 448714 9127 79286435
Bradypnoea 25.89 9.73 84 448742 5968 79289594
Tooth loss 25.71 9.73 93 448733 6982 79288580
Burns second degree 25.69 9.73 50 448776 2578 79292984
Hyperbilirubinaemia 25.60 9.73 63 448763 24455 79271107
Spinal osteoarthritis 25.48 9.73 173 448653 16754 79278808
Hip fracture 25.39 9.73 275 448551 30486 79265076
Graft versus host disease in gastrointestinal tract 25.34 9.73 3 448823 6353 79289209
Antipsychotic drug level below therapeutic 25.29 9.73 33 448793 1205 79294357
Focal dyscognitive seizures 25.29 9.73 59 448767 3453 79292109
Rib deformity 25.27 9.73 16 448810 218 79295344
Tuberculosis 25.17 9.73 29 448797 15169 79280393
Transplant dysfunction 25.17 9.73 5 448821 7216 79288346
Prostate cancer 25.16 9.73 99 448727 33169 79262393
Tardive dyskinesia 25.11 9.73 122 448704 10449 79285113
Device difficult to use 25.05 9.73 23 448803 13362 79282200
Haemoglobin decreased 24.98 9.73 1009 447817 221110 79074452
Bone density decreased 24.90 9.73 23 448803 13324 79282238
Dyspnoea 24.83 9.73 4345 444481 852680 78442882
Acute coronary syndrome 24.76 9.73 51 448775 21082 79274480
Type 2 diabetes mellitus 24.72 9.73 204 448622 56918 79238644
Cardiac failure acute 24.53 9.73 43 448783 18886 79276676
Pre-existing condition improved 24.51 9.73 78 448748 5485 79290077
Loss of consciousness 24.25 9.73 1167 447659 166776 79128786
Slow speech 24.05 9.73 47 448779 2431 79293131
Pollakiuria 23.95 9.73 318 448508 36999 79258563
Haematochezia 23.90 9.73 348 448478 87297 79208265
Parasomnia 23.87 9.73 22 448804 539 79295023
Breast cancer stage II 23.76 9.73 8 448818 8112 79287450
Bipolar disorder 23.64 9.73 96 448730 7611 79287951
Hypercholesterolaemia 23.61 9.73 60 448766 23035 79272527
Concussion 23.53 9.73 111 448715 9392 79286170
Acute graft versus host disease in skin 23.38 9.73 7 448819 7651 79287911
Foot fracture 23.27 9.73 207 448619 21774 79273788
Limb discomfort 23.23 9.73 285 448541 32565 79262997
Exposure via ingestion 23.21 9.73 73 448753 5101 79290461
Pseudomonas infection 23.20 9.73 52 448774 20851 79274711
Epigastric discomfort 23.16 9.73 97 448729 7799 79287763
Cognitive disorder 23.15 9.73 536 448290 69390 79226172
Quality of life decreased 23.15 9.73 118 448708 10302 79285260
Complications of transplanted kidney 23.06 9.73 4 448822 6362 79289200
Blood creatine phosphokinase increased 23.05 9.73 249 448577 65841 79229721
Chronic graft versus host disease 23.00 9.73 5 448821 6776 79288786
Tinnitus 22.99 9.73 364 448462 43969 79251593
Schizophrenia 22.94 9.73 32 448794 15408 79280154
Liver disorder 22.85 9.73 279 448547 72138 79223424
Rales 22.82 9.73 49 448777 19952 79275610
Peritonitis 22.79 9.73 81 448745 27955 79267607
Hepatitis 22.78 9.73 202 448624 55525 79240037
Conversion disorder 22.75 9.73 39 448787 1822 79293740
Acute myocardial infarction 22.75 9.73 301 448525 76735 79218827
Diffuse axonal injury 22.74 9.73 12 448814 113 79295449
Oesophageal spasm 22.67 9.73 56 448770 3400 79292162
Circulatory collapse 22.60 9.73 122 448704 37546 79258016
Device use error 22.59 9.73 6 448820 7095 79288467
Acute hepatic failure 22.53 9.73 90 448736 30023 79265539
Analgesic drug level above therapeutic 22.42 9.73 20 448806 469 79295093
Cyst 22.38 9.73 144 448682 13696 79281866
Dysphoria 22.36 9.73 68 448758 4666 79290896
Alanine aminotransferase abnormal 22.27 9.73 11 448815 8856 79286706
Decreased interest 22.27 9.73 58 448768 3639 79291923
Oesophageal carcinoma 22.01 9.73 18 448808 11066 79284496
Tubulointerstitial nephritis 21.76 9.73 126 448700 38109 79257453
Angioedema 21.76 9.73 299 448527 75736 79219826
Blood pressure systolic abnormal 21.61 9.73 40 448786 17207 79278355
Skin toxicity 21.36 9.73 10 448816 8304 79287258
Colorectal cancer 21.31 9.73 11 448815 8636 79286926
Cholestasis 21.25 9.73 189 448637 51920 79243642
Dependence 21.19 9.73 44 448782 2378 79293184
Ischaemic stroke 21.18 9.73 105 448721 33026 79262536
Product used for unknown indication 21.07 9.73 34 448792 1510 79294052
Hypomagnesaemia 21.00 9.73 166 448660 46745 79248817
Gastric cancer 20.88 9.73 16 448810 10163 79285399
Rib fracture 20.87 9.73 245 448581 27702 79267860
Phantom limb syndrome 20.86 9.73 17 448809 351 79295211
Red blood cell sedimentation rate increased 20.84 9.73 162 448664 45780 79249782
Blood pressure systolic increased 20.79 9.73 259 448567 66727 79228835
Congenital multiplex arthrogryposis 20.77 9.73 7 448819 17 79295545
Stevens-Johnson syndrome 20.76 9.73 132 448694 39034 79256528
Ejection fraction decreased 20.74 9.73 112 448714 34465 79261097
Spinal stenosis 20.65 9.73 156 448670 15635 79279927
Obstruction 20.64 9.73 65 448761 4545 79291017
Gestational diabetes 20.63 9.73 5 448821 6288 79289274
Palmar-plantar erythrodysaesthesia syndrome 20.61 9.73 106 448720 33028 79262534
Child abuse 20.57 9.73 18 448808 411 79295151
Condition aggravated 20.54 9.73 2488 446338 498636 78796926
Deafness neurosensory 20.43 9.73 85 448741 6813 79288749
Antidepressant drug level above therapeutic 20.41 9.73 22 448804 654 79294908
Skin reaction 20.37 9.73 37 448789 16031 79279531
Disorganised speech 20.36 9.73 40 448786 2077 79293485
Unintentional medical device removal 20.25 9.73 9 448817 7703 79287859
Uveitis 20.24 9.73 40 448786 16790 79278772
Premature labour 20.20 9.73 11 448815 8379 79287183
Breakthrough pain 20.03 9.73 31 448795 1328 79294234
Persistent depressive disorder 19.92 9.73 29 448797 1176 79294386
Aspartate aminotransferase increased 19.90 9.73 611 448215 138030 79157532
Abnormal dreams 19.87 9.73 121 448705 11291 79284271
Psychotic disorder due to a general medical condition 19.86 9.73 15 448811 276 79295286
Hepatitis fulminant 19.83 9.73 8 448818 7254 79288308
Sweat gland disorder 19.76 9.73 13 448813 190 79295372
Sensory disturbance 19.75 9.73 149 448677 14928 79280634
Depressed mood 19.74 9.73 383 448443 48097 79247465
Dermatitis exfoliative generalised 19.73 9.73 8 448818 7233 79288329
Sacroiliitis 19.71 9.73 56 448770 3698 79291864
Creatinine renal clearance decreased 19.71 9.73 49 448777 18953 79276609
Duodenal ulcer 19.61 9.73 39 448787 16330 79279232
Psychomotor hyperactivity 19.59 9.73 162 448664 16687 79278875
Subileus 19.53 9.73 4 448822 5650 79289912
Neurogenic bladder 19.42 9.73 60 448766 4152 79291410
Developmental hip dysplasia 19.41 9.73 13 448813 196 79295366
Granuloma skin 19.36 9.73 14 448812 9160 79286402
Disinhibition 19.10 9.73 44 448782 2554 79293008
Violence-related symptom 19.00 9.73 22 448804 709 79294853
Bladder cancer 18.99 9.73 52 448774 19474 79276088
Herpes zoster 18.98 9.73 671 448155 92412 79203150
Breast cancer stage I 18.92 9.73 7 448819 6693 79288869
Cough 18.90 9.73 1792 447034 364997 78930565
Abnormal behaviour 18.87 9.73 299 448527 36122 79259440
Nephrotic syndrome 18.86 9.73 21 448805 11153 79284409
Delirium tremens 18.83 9.73 22 448804 716 79294846
Autoimmune haemolytic anaemia 18.74 9.73 12 448814 8368 79287194
Asthenia 18.68 9.73 3213 445613 508476 78787086
Intentional self-injury 18.67 9.73 271 448555 32148 79263414
Nephropathy toxic 18.67 9.73 56 448770 20363 79275199
Abortion spontaneous 18.58 9.73 94 448732 29413 79266149
Pruritus 18.42 9.73 1942 446884 392706 78902856
X-ray abnormal 18.33 9.73 5 448821 5808 79289754
Lip dry 18.24 9.73 37 448789 15381 79280181
Somnambulism 18.14 9.73 72 448754 5649 79289913
Secondary progressive multiple sclerosis 18.04 9.73 30 448796 1367 79294195
Enterocolitis 17.88 9.73 34 448792 14478 79281084
Haematuria 17.84 9.73 276 448550 68560 79227002
Drug effective for unapproved indication 17.82 9.73 74 448752 5927 79289635
Osteosclerosis 17.79 9.73 56 448770 3915 79291647
Graft versus host disease in skin 17.74 9.73 6 448820 6067 79289495
Respiratory disorder 17.72 9.73 164 448662 44692 79250870
Vascular malformation 17.70 9.73 16 448810 382 79295180
Pneumonia bacterial 17.69 9.73 53 448773 19278 79276284
Endophthalmitis 17.68 9.73 7 448819 6421 79289141
Aggression 17.61 9.73 393 448433 50565 79244997
Anal abscess 17.60 9.73 16 448810 9339 79286223
Thrombosis 17.58 9.73 608 448218 83492 79212070
Body height decreased 17.57 9.73 95 448731 8485 79287077
Renal failure 17.55 9.73 938 447888 200030 79095532
Wheezing 17.52 9.73 511 448315 116153 79179409
Hyperthyroidism 17.50 9.73 65 448761 22144 79273418
Ear deformity acquired 17.49 9.73 5 448821 5 79295557
Blood pressure fluctuation 17.48 9.73 269 448557 66876 79228686
Haemorrhage 17.47 9.73 385 448441 90733 79204829
Polyarthritis 17.43 9.73 26 448800 12176 79283386
Micrognathia 17.41 9.73 6 448820 16 79295546
Visual impairment 17.29 9.73 658 448168 91473 79204089
Inflammatory marker increased 17.25 9.73 21 448805 10719 79284843
Hypertension 17.21 9.73 1616 447210 329376 78966186
Long QT syndrome 17.20 9.73 6 448820 5949 79289613
Jaundice cholestatic 17.15 9.73 23 448803 11261 79284301
Lumbar radiculopathy 17.12 9.73 36 448790 1963 79293599
Blood pressure increased 17.09 9.73 994 447832 210366 79085196
Injury 17.08 9.73 320 448506 77176 79218386
Hyperuricaemia 16.99 9.73 25 448801 11774 79283788
Product physical issue 16.93 9.73 57 448769 4128 79291434
Brain injury 16.92 9.73 117 448709 11400 79284162
Snoring 16.81 9.73 69 448757 5497 79290065
Nephrogenic systemic fibrosis 16.78 9.73 74 448752 6086 79289476
Idiopathic neutropenia 16.74 9.73 4 448822 0 79295562
Hyperacusis 16.73 9.73 38 448788 2185 79293377
Asphyxia 16.71 9.73 25 448801 11695 79283867
Chest X-ray abnormal 16.63 9.73 88 448738 7795 79287767
Metabolic acidosis 16.61 9.73 346 448480 82183 79213379
Arteriovenous malformation 16.61 9.73 33 448793 1728 79293834
Binocular eye movement disorder 16.60 9.73 10 448816 124 79295438
Eosinophilic colitis 16.56 9.73 17 448809 477 79295085
Chronic sinusitis 16.51 9.73 30 448796 12996 79282566
Ligament sprain 16.49 9.73 131 448695 13333 79282229
Fluid retention 16.48 9.73 512 448314 69297 79226265
Sports injury 16.47 9.73 11 448815 165 79295397
Hypothyroidism 16.47 9.73 202 448624 52190 79243372
Urticaria 16.44 9.73 863 447963 184338 79111224
Adenovirus infection 16.43 9.73 14 448812 8433 79287129
Injection site induration 16.40 9.73 103 448723 9716 79285846
Drug diversion 16.35 9.73 27 448799 1223 79294339
Autoimmune disorder 16.34 9.73 44 448782 16568 79278994
Immunosuppressant drug level increased 16.32 9.73 16 448810 9011 79286551
Colitis microscopic 16.31 9.73 22 448804 10746 79284816
Fear of injection 16.31 9.73 11 448815 7463 79288099
Cervical spinal stenosis 16.30 9.73 39 448787 2320 79293242
Affective disorder 16.29 9.73 91 448735 8228 79287334
Drug tolerance increased 16.27 9.73 19 448807 618 79294944
Facial spasm 16.24 9.73 21 448805 760 79294802
Facial pain 16.15 9.73 122 448704 12228 79283334
Neutropenic colitis 16.06 9.73 6 448820 5701 79289861
Increased appetite 16.04 9.73 119 448707 11859 79283703
Urinary retention 16.03 9.73 425 448401 56205 79239357
Aphasia 16.02 9.73 360 448466 46372 79249190
Cystitis 15.88 9.73 399 448427 52333 79243229
Pre-eclampsia 15.86 9.73 10 448816 7031 79288531
Respiratory rate decreased 15.84 9.73 65 448761 5178 79290384
Pericardial effusion 15.80 9.73 175 448651 46062 79249500
Deprescribing error 15.79 9.73 6 448820 23 79295539
Movement disorder 15.75 9.73 228 448598 27031 79268531
Pallor 15.75 9.73 193 448633 49869 79245693
Platelet count decreased 15.64 9.73 916 447910 193748 79101814
Hypoxic-ischaemic encephalopathy 15.62 9.73 86 448740 7734 79287828
Rectal haemorrhage 15.62 9.73 319 448507 75981 79219581
Myelodysplastic syndrome 15.61 9.73 103 448723 30198 79265364
Laboratory test abnormal 15.58 9.73 233 448593 27815 79267747
Hypokinesia 15.55 9.73 170 448656 18890 79276672
Tendonitis 15.53 9.73 75 448751 23755 79271807
Eyelid myoclonus 15.48 9.73 9 448817 104 79295458
Kidney transplant rejection 15.46 9.73 21 448805 10225 79285337
Tenosynovitis 15.44 9.73 41 448785 15513 79280049
Joint destruction 15.42 9.73 7 448819 5918 79289644
Mouth ulceration 15.33 9.73 140 448686 38254 79257308
Mucormycosis 15.33 9.73 15 448811 8454 79287108
Head banging 15.28 9.73 17 448809 524 79295038
Hypopnoea 15.27 9.73 65 448761 5264 79290298
Monoparesis 15.26 9.73 49 448777 3462 79292100
Product communication issue 15.22 9.73 24 448802 1045 79294517
Myoclonic epilepsy 15.19 9.73 34 448792 1936 79293626
Sensory loss 15.15 9.73 125 448701 12866 79282696
Arthrofibrosis 15.12 9.73 9 448817 109 79295453
Lactic acidosis 15.05 9.73 292 448534 70067 79225495
Tachyphrenia 15.04 9.73 35 448791 2045 79293517
Organising pneumonia 14.96 9.73 24 448802 10915 79284647
Spinal disorder 14.94 9.73 104 448722 10156 79285406
Brief psychotic disorder with marked stressors 14.89 9.73 13 448813 296 79295266
Congenital neuropathy 14.88 9.73 5 448821 12 79295550
Pulmonary alveolar haemorrhage 14.87 9.73 26 448800 11431 79284131
Atonic urinary bladder 14.84 9.73 8 448818 79 79295483
Cytomegalovirus colitis 14.83 9.73 4 448822 4681 79290881
Drug screen negative 14.78 9.73 13 448813 299 79295263
Alcohol withdrawal syndrome 14.72 9.73 34 448792 1977 79293585
Systemic infection 14.70 9.73 20 448806 9732 79285830
Teeth brittle 14.62 9.73 16 448810 484 79295078
Human herpesvirus 6 infection 14.52 9.73 6 448820 5364 79290198
Acute pulmonary oedema 14.52 9.73 37 448789 14193 79281369
Systemic candida 14.46 9.73 10 448816 6696 79288866
Hypernatraemia 14.42 9.73 38 448788 14413 79281149
Radiation necrosis 14.35 9.73 15 448811 430 79295132
Anal incontinence 14.34 9.73 161 448665 18007 79277555
Oropharyngeal oedema 14.33 9.73 15 448811 431 79295131
Post laminectomy syndrome 14.29 9.73 13 448813 313 79295249
Self-medication 14.24 9.73 62 448764 5070 79290492
Lip oedema 14.19 9.73 9 448817 6307 79289255
Postmortem blood drug level increased 14.15 9.73 20 448806 789 79294773
Decreased appetite 14.14 9.73 1699 447127 340719 78954843
Hypercalcaemia 14.13 9.73 143 448683 38287 79257275
Abnormal sleep-related event 14.13 9.73 21 448805 868 79294694
Paranasal cyst 14.08 9.73 15 448811 440 79295122
Rapid eye movements sleep abnormal 13.97 9.73 12 448814 267 79295295
Musculoskeletal stiffness 13.97 9.73 824 448002 174184 79121378
Febrile bone marrow aplasia 13.96 9.73 33 448793 12987 79282575
Gastrointestinal toxicity 13.95 9.73 15 448811 8094 79287468
Mobility decreased 13.94 9.73 554 448272 121621 79173941
Acute generalised exanthematous pustulosis 13.92 9.73 50 448776 17204 79278358
Stress cardiomyopathy 13.90 9.73 26 448800 11140 79284422
Hot flush 13.90 9.73 406 448420 54471 79241091
JC polyomavirus test positive 13.90 9.73 29 448797 1573 79293989
Blood pressure decreased 13.87 9.73 440 448386 99026 79196536
Product use in unapproved indication 13.87 9.73 1611 447215 248748 79046814
Encephalitis 13.84 9.73 40 448786 14720 79280842
Hypometabolism 13.83 9.73 9 448817 129 79295433
Face oedema 13.82 9.73 97 448729 28039 79267523
Cardiac failure chronic 13.80 9.73 26 448800 11109 79284453
Colitis ulcerative 13.73 9.73 127 448699 34615 79260947
Haemolytic uraemic syndrome 13.70 9.73 4 448822 4445 79291117
Acute graft versus host disease in intestine 13.67 9.73 3 448823 4038 79291524
Varicella zoster virus infection 13.67 9.73 4 448822 4437 79291125
Clonus 13.52 9.73 75 448751 6765 79288797
Gout 13.52 9.73 205 448621 24544 79271018
Urine amphetamine positive 13.51 9.73 8 448818 96 79295466
Atrioventricular block complete 13.49 9.73 48 448778 16562 79279000
Formication 13.42 9.73 60 448766 4963 79290599
Opisthotonus 13.37 9.73 18 448808 678 79294884
Myofascial pain syndrome 13.35 9.73 33 448793 2004 79293558
Substance use 13.34 9.73 21 448805 913 79294649
Hypoalbuminaemia 13.32 9.73 68 448758 21229 79274333
Tachycardia 13.31 9.73 842 447984 176926 79118636
Lumbar spinal stenosis 13.30 9.73 62 448764 5220 79290342
Bronchial secretion retention 13.30 9.73 52 448774 4052 79291510
Large intestine perforation 13.28 9.73 40 448786 14527 79281035
Osteopenia 13.28 9.73 160 448666 18204 79277358
Parosmia 13.26 9.73 76 448750 6938 79288624
Caesarean section 13.25 9.73 32 448794 12503 79283059
Stillbirth 13.25 9.73 3 448823 3952 79291610
Hypoacusis 13.24 9.73 241 448585 29909 79265653
Aortic valve stenosis 13.23 9.73 62 448764 5232 79290330
Bone cyst 13.22 9.73 46 448780 3387 79292175
Cerebral disorder 13.22 9.73 64 448762 5474 79290088
Osteomyelitis 13.16 9.73 259 448567 32606 79262956
Dry eye 13.14 9.73 286 448540 36645 79258917
Peroneal nerve palsy 13.13 9.73 68 448758 5974 79289588
Breath sounds abnormal 13.11 9.73 46 448780 15938 79279624
Spinal cord injury 13.10 9.73 25 448801 1270 79294292
Nocturia 13.05 9.73 126 448700 13555 79282007
Erythema multiforme 13.05 9.73 53 448773 17598 79277964
Accidental exposure to product 13.04 9.73 113 448713 31209 79264353
Eyelid oedema 12.90 9.73 37 448789 13650 79281912
Oesophageal pain 12.89 9.73 53 448773 4226 79291336
Generalised tonic-clonic seizure 12.85 9.73 331 448495 43579 79251983
Carpal tunnel syndrome 12.78 9.73 167 448659 19361 79276201
Liver function test abnormal 12.77 9.73 271 448555 64204 79231358
Disturbance in social behaviour 12.74 9.73 6 448820 4964 79290598
Myopathy 12.67 9.73 66 448760 20497 79275065
Cytomegalovirus test positive 12.65 9.73 9 448817 5938 79289624
Liver function test increased 12.64 9.73 153 448673 39620 79255942
Lymphoproliferative disorder 12.61 9.73 8 448818 5607 79289955
Diffuse large B-cell lymphoma recurrent 12.57 9.73 4 448822 4203 79291359
Basal cell carcinoma 12.56 9.73 142 448684 37233 79258329
CSF neutrophil count increased 12.56 9.73 3 448823 0 79295562
Blood potassium 12.56 9.73 3 448823 0 79295562
Turbinectomy 12.56 9.73 3 448823 0 79295562
Tinel's sign 12.56 9.73 3 448823 0 79295562
Ligamentum flavum hypertrophy 12.56 9.73 3 448823 0 79295562
Muscle relaxant drug level above therapeutic 12.56 9.73 3 448823 0 79295562
Ulcer 12.53 9.73 108 448718 29864 79265698
Femoral artery dissection 12.53 9.73 6 448820 45 79295517
Haemorrhage intracranial 12.52 9.73 91 448735 26102 79269460
Toe operation 12.52 9.73 16 448810 572 79294990
Abortion induced 12.40 9.73 13 448813 7096 79288466
Prophylaxis 12.39 9.73 4 448822 8 79295554
Gingival atrophy 12.34 9.73 7 448819 77 79295485
Anosognosia 12.32 9.73 3 448823 3761 79291801
Feeling of body temperature change 12.32 9.73 61 448765 5265 79290297
Haematoma 12.30 9.73 213 448613 51982 79243580
Toxicologic test abnormal 12.24 9.73 25 448801 1335 79294227
Bladder disorder 12.24 9.73 91 448735 9074 79286488
Cytopenia 12.24 9.73 66 448760 20317 79275245
Cerebrovascular accident 12.21 9.73 1024 447802 154268 79141294
Immune-mediated enterocolitis 12.12 9.73 6 448820 4824 79290738
Concomitant disease aggravated 12.12 9.73 36 448790 13131 79282431
Carotid artery disease 12.11 9.73 34 448792 2230 79293332
Metastases to bone 12.10 9.73 84 448742 24343 79271219
Cytomegalovirus chorioretinitis 12.09 9.73 8 448818 5482 79290080
Vertebral foraminal stenosis 12.09 9.73 23 448803 1166 79294396
Vascular stent thrombosis 12.06 9.73 3 448823 3707 79291855
Intercepted medication error 12.06 9.73 20 448806 909 79294653
Left ventricular dysfunction 12.01 9.73 62 448764 19299 79276263
Narcolepsy 12.01 9.73 24 448802 1262 79294300
Product adhesion issue 11.99 9.73 38 448788 2666 79292896
Pneumatosis intestinalis 11.96 9.73 11 448815 6386 79289176
Drug screen false positive 11.96 9.73 22 448804 1087 79294475
Drug level below therapeutic 11.94 9.73 23 448803 9747 79285815
Infective pulmonary exacerbation of cystic fibrosis 11.93 9.73 35 448791 12816 79282746
Gastrointestinal inflammation 11.85 9.73 15 448811 7529 79288033
Shock 11.84 9.73 173 448653 43375 79252187
Naevus haemorrhage 11.81 9.73 8 448818 123 79295439
Pregnancy with contraceptive device 11.79 9.73 3 448823 3651 79291911
Blood potassium decreased 11.75 9.73 344 448482 46168 79249394
Progressive multiple sclerosis 11.71 9.73 23 448803 1194 79294368
Subarachnoid haemorrhage 11.70 9.73 85 448741 24380 79271182
Polyneuropathy in malignant disease 11.69 9.73 11 448815 277 79295285
Dermatitis bullous 11.68 9.73 41 448785 14204 79281358
Disability 11.68 9.73 53 448773 17067 79278495
Band sensation 11.65 9.73 18 448808 770 79294792
Metastases to peritoneum 11.64 9.73 5 448821 4367 79291195
Musculoskeletal chest pain 11.61 9.73 200 448626 24564 79270998
Hypertensive urgency 11.60 9.73 15 448811 543 79295019
Bronchospasm 11.58 9.73 87 448739 24772 79270790
Scleritis 11.57 9.73 5 448821 4351 79291211
Nerve block 11.56 9.73 17 448809 696 79294866
Pharyngitis 11.56 9.73 76 448750 22299 79273263
Granuloma 11.54 9.73 18 448808 8279 79287283
Visual field tests abnormal 11.52 9.73 4 448822 11 79295551
Heteroplasia 11.52 9.73 4 448822 11 79295551
Blood potassium increased 11.49 9.73 230 448596 29045 79266517
Dissociation 11.48 9.73 49 448777 3972 79291590
Bone contusion 11.47 9.73 23 448803 1212 79294350
Oral herpes 11.45 9.73 99 448727 27355 79268207
Radiculopathy 11.44 9.73 87 448739 8737 79286825
Lipodystrophy acquired 11.43 9.73 5 448821 4320 79291242
Ejaculation delayed 11.41 9.73 9 448817 177 79295385
Respiratory tract infection 11.37 9.73 199 448627 48490 79247072
Vulvar basal cell carcinoma 11.37 9.73 5 448821 30 79295532
Lymphoma 11.35 9.73 55 448771 17405 79278157
Diffuse large B-cell lymphoma 11.34 9.73 33 448793 12116 79283446
Sciatic nerve injury 11.32 9.73 15 448811 556 79295006
Second primary malignancy 11.31 9.73 42 448784 14308 79281254
Radiation pneumonitis 11.29 9.73 4 448822 3929 79291633
Intentional underdose 11.29 9.73 34 448792 2320 79293242
Application site vesicles 11.27 9.73 25 448801 1415 79294147
Retinal haemorrhage 11.26 9.73 18 448808 8199 79287363
Myotonia 11.26 9.73 10 448816 233 79295329
Neuropathic arthropathy 11.23 9.73 12 448814 353 79295209
Atrioventricular block 11.12 9.73 41 448785 14000 79281562
Gait apraxia 11.10 9.73 5 448821 32 79295530
Substance abuse 11.08 9.73 99 448727 10427 79285135
Nasal polyps 11.07 9.73 15 448811 7312 79288250
Essential hypertension 11.06 9.73 65 448761 5988 79289574
Immune effector cell-associated neurotoxicity syndrome 11.00 9.73 10 448816 5838 79289724
Medication overuse headache 11.00 9.73 19 448807 893 79294669
Libido decreased 10.96 9.73 59 448767 5262 79290300
Skin plaque 10.92 9.73 28 448798 10717 79284845
Bacteraemia 10.92 9.73 125 448701 32699 79262863
Adrenal insufficiency 10.89 9.73 105 448721 28382 79267180
Breast disorder 10.89 9.73 31 448795 2050 79293512
Arrhythmia 10.87 9.73 262 448564 61010 79234552
Open angle glaucoma 10.87 9.73 13 448813 434 79295128
Nystagmus 10.86 9.73 94 448732 9810 79285752
Intra-abdominal haemorrhage 10.86 9.73 6 448820 4534 79291028
Tendon injury 10.85 9.73 31 448795 2054 79293508
Muscle contractions involuntary 10.85 9.73 46 448780 3719 79291843
Pneumonia fungal 10.79 9.73 30 448796 11180 79284382
Lymphadenopathy 10.78 9.73 223 448603 53024 79242538
Subdural haematoma 10.73 9.73 119 448707 31315 79264247
Protein C deficiency 10.73 9.73 5 448821 35 79295527
Leg amputation 10.72 9.73 45 448781 3621 79291941
Injection site reaction 10.69 9.73 393 448433 54392 79241170
Hepatitis acute 10.67 9.73 48 448778 15494 79280068
Mitral valve prolapse 10.65 9.73 31 448795 2076 79293486
Nitrite urine present 10.62 9.73 22 448804 1187 79294375
Lung adenocarcinoma stage I 10.61 9.73 5 448821 36 79295526
Free androgen index decreased 10.59 9.73 4 448822 15 79295547
Panic disorder 10.59 9.73 39 448787 2953 79292609
Pustular psoriasis 10.59 9.73 7 448819 4799 79290763
Blood potassium abnormal 10.56 9.73 40 448786 3070 79292492
Paradoxical drug reaction 10.56 9.73 73 448753 7112 79288450
Screaming 10.53 9.73 47 448779 3886 79291676
Retinal deposits 10.51 9.73 8 448818 149 79295413
Acute myeloid leukaemia recurrent 10.50 9.73 3 448823 3380 79292182
Peritoneal carcinoma metastatic 10.49 9.73 3 448823 3 79295559
Sleep disorder due to a general medical condition 10.47 9.73 43 448783 14234 79281328
Grip strength decreased 10.45 9.73 76 448750 21793 79273769
Neck surgery 10.41 9.73 28 448798 1791 79293771
Suicidal behaviour 10.41 9.73 41 448785 3206 79292356
Neuromyelitis optica spectrum disorder 10.40 9.73 20 448806 1022 79294540
CD8 lymphocytes decreased 10.39 9.73 10 448816 259 79295303
International normalised ratio increased 10.36 9.73 381 448445 84340 79211222
Ascites 10.35 9.73 335 448491 75227 79220335
Glycosylated haemoglobin decreased 10.33 9.73 16 448810 686 79294876
Hospice care 10.31 9.73 96 448730 10228 79285334
Genital haemorrhage 10.29 9.73 12 448814 6243 79289319
Intervertebral disc disorder 10.28 9.73 54 448772 4771 79290791
Crepitations 10.26 9.73 26 448800 9991 79285571
Application site burn 10.26 9.73 18 448808 857 79294705
Blood phosphorus increased 10.22 9.73 96 448730 10251 79285311
Pineal gland cyst 10.21 9.73 4 448822 17 79295545
Feeling of despair 10.18 9.73 37 448789 2784 79292778
Bradycardia 10.16 9.73 642 448184 134915 79160647
Infected skin ulcer 10.15 9.73 42 448784 3359 79292203
Upper respiratory tract inflammation 10.14 9.73 5 448821 4030 79291532
Hypocalcaemia 10.13 9.73 209 448617 49715 79245847
Implant site inflammation 10.11 9.73 10 448816 268 79295294
Amphetamines positive 10.10 9.73 11 448815 331 79295231
Renal tubular disorder 10.08 9.73 13 448813 6473 79289089
Camptodactyly congenital 10.04 9.73 3 448823 4 79295558
Benign neoplasm of spinal cord 10.04 9.73 3 448823 4 79295558
Sleep paralysis 10.04 9.73 15 448811 623 79294939
Alcohol interaction 10.01 9.73 54 448772 4820 79290742
Pulmonary renal syndrome 10 9.73 15 448811 625 79294937
Post herpetic neuralgia 9.99 9.73 35 448791 2586 79292976
Hepatitis cholestatic 9.99 9.73 42 448784 13810 79281752
Post procedural infection 9.97 9.73 103 448723 11281 79284281
Face injury 9.97 9.73 44 448782 3620 79291942
Cortisol abnormal 9.92 9.73 6 448820 75 79295487
Heat exhaustion 9.92 9.73 11 448815 338 79295224
Gastrointestinal necrosis 9.91 9.73 10 448816 5555 79290007
Transplant failure 9.90 9.73 7 448819 4634 79290928
Drug tolerance 9.87 9.73 83 448743 8592 79286970
Abnormal weight gain 9.82 9.73 35 448791 2609 79292953
Nail disorder 9.79 9.73 34 448792 11818 79283744
Blood thyroid stimulating hormone normal 9.79 9.73 7 448819 118 79295444
Accident 9.78 9.73 84 448742 8747 79286815
Thyroiditis 9.76 9.73 7 448819 4598 79290964
Medical induction of coma 9.74 9.73 7 448819 119 79295443

FDA Adverse Event Reporting System (Pediatric)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Trismus 42.20 24.61 17 323 129 89323

Pharmacologic Action:

SourceCodeDescription
ATC N02BF01 NERVOUS SYSTEM
ANALGESICS
OTHER ANALGESICS AND ANTIPYRETICS
Gabapentinoids
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 anticonvulsants
CHEBI has role CHEBI:35703 Xenobiotic
CHEBI has role CHEBI:38215 calcium channel blockers
CHEBI has role CHEBI:78298 environmental contaminants

Drug Use | Suggest Off label Use Form| |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




🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

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 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 0071-0401 TABLET, FILM COATED 800 mg ORAL NDA 31 sections
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 0071-0513 TABLET, FILM COATED 600 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 0071-0803 CAPSULE 100 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 0071-0805 CAPSULE 300 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 0071-0806 CAPSULE 400 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
Neurontin HUMAN PRESCRIPTION DRUG LABEL 1 0071-2012 SOLUTION 250 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 0228-2636 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 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 0615-8132 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