gabapentin ๐Ÿถ 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 ยตM/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 1642.83 9.81 4502 337284 270703 55679578
Drug ineffective for unapproved indication 1048.60 9.81 1018 340768 24675 55925606
Pemphigus 904.87 9.81 9 341777 157203 55793078
Completed suicide 863.30 9.81 2256 339530 131577 55818704
Systemic lupus erythematosus 671.08 9.81 138 341648 179940 55770341
Hand deformity 647.88 9.81 43 341743 134449 55815832
Glossodynia 641.14 9.81 84 341702 152374 55797907
Anti-cyclic citrullinated peptide antibody positive 580.30 9.81 3 341783 98597 55851684
Rheumatoid arthritis 571.65 9.81 901 340885 381703 55568578
Contraindicated product administered 565.35 9.81 212 341574 186074 55764207
Pericarditis 542.25 9.81 29 341757 108894 55841387
Synovitis 521.50 9.81 165 341621 161140 55789141
Maternal exposure during pregnancy 512.78 9.81 255 341531 189298 55760983
Multiple sclerosis relapse 427.87 9.81 883 340903 44020 55906261
Arthropathy 408.01 9.81 369 341417 199906 55750375
Duodenal ulcer perforation 388.10 9.81 5 341781 68337 55881944
Rheumatoid factor positive 364.91 9.81 12 341774 69048 55881233
Infusion related reaction 352.13 9.81 451 341335 208480 55741801
Helicobacter infection 351.05 9.81 24 341762 73244 55877037
Wound 349.98 9.81 204 341582 138600 55811681
Somnolence 340.31 9.81 1919 339867 161494 55788787
Toxicity to various agents 316.99 9.81 2391 339395 222173 55728108
Fall 316.01 9.81 3438 338348 354072 55596209
Joint swelling 312.48 9.81 823 340963 288977 55661304
Hepatic enzyme increased 311.02 9.81 349 341437 171035 55779246
Drug abuse 309.45 9.81 1009 340777 66601 55883680
Discomfort 288.81 9.81 261 341525 141500 55808781
Neuropathy peripheral 267.83 9.81 1286 340500 101607 55848674
Abdominal discomfort 266.89 9.81 831 340955 276443 55673838
Muscle injury 261.14 9.81 14 341772 52486 55897795
Myoclonus 255.83 9.81 384 341402 14819 55935462
Depression 250.76 9.81 1912 339874 178205 55772076
Folliculitis 241.59 9.81 26 341760 54953 55895328
General physical health deterioration 234.21 9.81 421 341365 169589 55780692
Neuralgia 224.53 9.81 465 341321 23230 55927051
Alopecia 217.46 9.81 979 340807 292479 55657802
Feeling abnormal 211.61 9.81 1463 340323 132139 55818142
Tremor 210.45 9.81 1357 340429 119732 55830549
Therapeutic product effect decreased 206.39 9.81 451 341335 169001 55781280
Swelling 205.14 9.81 756 341030 239015 55711266
Sleep disorder due to general medical condition, insomnia type 202.42 9.81 16 341770 43322 55906959
Suicidal ideation 198.63 9.81 785 341001 56957 55893324
Treatment failure 197.38 9.81 466 341320 169926 55780355
Hypersensitivity 196.22 9.81 845 340941 255563 55694718
Dizziness 194.46 9.81 3285 338501 372855 55577426
Multiple sclerosis 193.72 9.81 483 341303 27319 55922962
Exposure during pregnancy 190.11 9.81 335 341451 136007 55814274
Memory impairment 186.29 9.81 1026 340760 85531 55864750
Product dose omission issue 178.10 9.81 1964 339822 202789 55747492
Lower respiratory tract infection 159.17 9.81 283 341503 114511 55835770
Hallucination 155.39 9.81 651 341135 48498 55901783
Accidental death 153.20 9.81 110 341676 1722 55948559
Muscle spasms 152.41 9.81 1386 340400 135985 55814296
Balance disorder 148.87 9.81 883 340903 75637 55874644
Irritable bowel syndrome 146.70 9.81 120 341666 68338 55881943
Febrile neutropenia 142.92 9.81 264 341522 105281 55845000
Anxiety 139.75 9.81 1789 339997 191383 55758898
Vision blurred 139.45 9.81 922 340864 82021 55868260
Impaired healing 138.46 9.81 195 341591 86646 55863635
Liver injury 138.37 9.81 41 341745 41807 55908474
Respiratory arrest 135.53 9.81 452 341334 30173 55920108
Product use issue 134.45 9.81 626 341160 185415 55764866
Drug intolerance 133.03 9.81 1001 340785 263817 55686464
Withdrawal syndrome 132.05 9.81 324 341462 18138 55932143
Swollen joint count increased 128.46 9.81 4 341782 24180 55926101
Drug withdrawal syndrome 127.46 9.81 396 341390 25461 55924820
Hypoaesthesia 127.44 9.81 1367 340419 140124 55810157
Mental status changes 126.67 9.81 507 341279 36994 55913287
Product complaint 124.83 9.81 242 341544 11518 55938763
Pyrexia 120.32 9.81 1804 339982 416969 55533312
C-reactive protein increased 120.23 9.81 182 341604 78502 55871779
Rheumatic fever 118.43 9.81 17 341769 28810 55921471
Blister 116.52 9.81 310 341476 108577 55841704
Migraine 115.39 9.81 912 340874 85885 55864396
C-reactive protein abnormal 114.72 9.81 40 341746 36769 55913512
Drug dependence 112.84 9.81 347 341439 22186 55928095
Seizure 110.88 9.81 1205 340581 123914 55826367
Rash 110.17 9.81 2222 339564 490825 55459456
Gait disturbance 106.66 9.81 1485 340301 161836 55788445
Pain in extremity 102.00 9.81 2444 339342 294987 55655294
Paraesthesia 99.56 9.81 1221 340565 129293 55820988
Device expulsion 95.05 9.81 33 341753 30416 55919865
Cardio-respiratory arrest 94.80 9.81 618 341168 54703 55895578
Respiratory depression 92.97 9.81 222 341564 12213 55938068
Ill-defined disorder 90.52 9.81 174 341612 68369 55881912
Dyskinesia 90.01 9.81 383 341403 28725 55921556
Unresponsive to stimuli 89.41 9.81 406 341380 31319 55918962
Interstitial lung disease 84.29 9.81 135 341651 56928 55893353
Live birth 84.28 9.81 10 341776 19595 55930686
Sopor 84.02 9.81 299 341487 20623 55929658
Infection 77.42 9.81 809 340977 199397 55750884
Amnesia 77.26 9.81 514 341272 45808 55904473
Lethargy 75.91 9.81 554 341232 50887 55899394
Trigeminal neuralgia 73.58 9.81 97 341689 3310 55946971
Urinary tract infection 71.40 9.81 1939 339847 238574 55711707
Mental disorder 70.99 9.81 308 341478 23296 55926985
Stiff person syndrome 70.84 9.81 37 341749 313 55949968
Speech disorder 70.55 9.81 429 341357 37064 55913217
Thrombocytopenia 69.21 9.81 513 341273 135711 55814570
Off label use 68.92 9.81 2721 339065 553459 55396822
Drug use disorder 68.87 9.81 111 341675 4558 55945723
Burning sensation 67.64 9.81 517 341269 48179 55902102
Muscular weakness 67.43 9.81 948 340838 103504 55846777
Head injury 64.92 9.81 313 341473 24753 55925528
Hepatic function abnormal 64.11 9.81 69 341717 34489 55915792
Cytomegalovirus infection 63.61 9.81 19 341767 19277 55931004
Back pain 61.54 9.81 1880 339906 235290 55714991
Sleep apnoea syndrome 60.15 9.81 315 341471 25746 55924535
Coordination abnormal 60.09 9.81 191 341595 12430 55937851
Therapeutic response unexpected 59.62 9.81 233 341553 16811 55933470
Sedation 59.48 9.81 389 341397 34465 55915816
Bone erosion 58.85 9.81 10 341776 14964 55935317
Insomnia 58.40 9.81 1552 340234 190308 55759973
Cardiac arrest 58.40 9.81 790 340996 85524 55864757
Hip arthroplasty 58.35 9.81 90 341696 38533 55911748
Stomatitis 58.05 9.81 462 341324 120348 55829933
Premature baby 57.93 9.81 22 341764 19183 55931098
Full blood count decreased 57.93 9.81 288 341498 23061 55927220
Hypersomnia 57.65 9.81 224 341562 16117 55934164
Muscle twitching 56.78 9.81 222 341564 16020 55934261
Influenza like illness 56.14 9.81 592 341194 60396 55889885
Myelosuppression 56.08 9.81 18 341768 17437 55932844
Inadequate analgesia 56.08 9.81 75 341711 2596 55947685
Crying 55.73 9.81 268 341518 21172 55929109
Intervertebral disc protrusion 55.54 9.81 270 341516 21424 55928857
Cardiac failure 54.76 9.81 284 341502 81809 55868472
Anaemia 54.76 9.81 1222 340564 266289 55683992
Intentional product misuse 54.20 9.81 514 341272 50990 55899291
Foetal exposure during pregnancy 53.84 9.81 76 341710 33747 55916534
Restless legs syndrome 53.17 9.81 224 341562 16723 55933558
Mucosal inflammation 52.83 9.81 113 341673 42697 55907584
Confusional state 52.65 9.81 1645 340141 206510 55743771
Rheumatoid nodule 52.03 9.81 13 341773 14844 55935437
Intentional product use issue 51.89 9.81 373 341413 99360 55850921
Malignant neoplasm progression 51.69 9.81 250 341536 73337 55876944
Feeling drunk 51.69 9.81 87 341699 3705 55946576
Multiple organ dysfunction syndrome 51.45 9.81 157 341629 52613 55897668
Neck pain 51.37 9.81 586 341200 60969 55889312
Sinusitis 51.26 9.81 867 340919 196714 55753567
Knee arthroplasty 51.21 9.81 121 341665 44138 55906143
Pancytopenia 51.04 9.81 322 341464 88393 55861888
Drug ineffective 49.75 9.81 4857 336929 914132 55036149
Overdose 49.68 9.81 911 340875 104919 55845362
Nervousness 49.61 9.81 324 341462 28691 55921590
Arthralgia 49.26 9.81 2517 339269 499152 55451129
Euphoric mood 49.11 9.81 92 341694 4266 55946015
Hallucination, visual 48.81 9.81 223 341563 17245 55933036
Spinal operation 48.32 9.81 125 341661 7231 55943050
Presbyacusis 48.19 9.81 72 341714 2766 55947515
Hyperhidrosis 48.11 9.81 821 340965 93267 55857014
Vertigo 48.03 9.81 525 341261 54047 55896234
Pleural fibrosis 48 9.81 80 341706 3379 55946902
Red blood cell sedimentation rate abnormal 47.65 9.81 27 341759 18646 55931635
Nasopharyngitis 47.32 9.81 1002 340784 219957 55730324
Urinary incontinence 46.77 9.81 324 341462 29261 55921020
Back disorder 46.29 9.81 151 341635 9962 55940319
Pleural thickening 46.12 9.81 69 341717 2654 55947627
Premature delivery 45.92 9.81 58 341728 27002 55923279
Anticipatory anxiety 45.74 9.81 43 341743 999 55949282
Poisoning 45.50 9.81 176 341610 12637 55937644
Blood magnesium increased 44.68 9.81 71 341715 2880 55947401
Myocardial stunning 44.64 9.81 21 341765 138 55950143
Blood cholesterol increased 44.60 9.81 258 341528 72321 55877960
Therapeutic response decreased 44.59 9.81 167 341619 52591 55897690
Gastrointestinal disorder 44.51 9.81 453 341333 112249 55838032
Pregnancy 44.35 9.81 83 341703 32950 55917331
Hepatotoxicity 42.97 9.81 77 341709 31076 55919205
Diplopia 42.81 9.81 240 341546 20129 55930152
Bone marrow failure 42.64 9.81 66 341720 28220 55922061
Asthenia 42.38 9.81 2515 339271 340458 55609823
Impaired driving ability 41.91 9.81 83 341703 4013 55946268
Drug-induced liver injury 41.67 9.81 92 341694 34370 55915911
Hyperaesthesia 41.20 9.81 131 341655 8526 55941755
Ataxia 41.08 9.81 185 341601 14218 55936063
Drug tolerance decreased 41.06 9.81 15 341771 13396 55936885
Pleural effusion 41 9.81 327 341459 85153 55865128
Drug resistance 40.40 9.81 39 341747 20503 55929778
Surgery 40.25 9.81 336 341450 32150 55918131
Mood altered 39.95 9.81 174 341612 13181 55937100
Psoriatic arthropathy 39.86 9.81 274 341512 73734 55876547
Death 39.82 9.81 2491 339295 338935 55611346
Ankle fracture 39.75 9.81 201 341585 16202 55934079
Diabetic neuropathy 39.62 9.81 77 341709 3671 55946610
Macular degeneration 39.44 9.81 34 341752 18874 55931407
Hypermobility syndrome 39.24 9.81 35 341751 758 55949523
Nausea 39.15 9.81 5251 336535 758927 55191354
Neutropenia 38.78 9.81 701 341085 157466 55792815
Anger 37.97 9.81 156 341630 11516 55938765
Hypokalaemia 37.94 9.81 378 341408 94059 55856222
Dry mouth 37.58 9.81 573 341213 63632 55886649
Pre-existing condition improved 37.10 9.81 114 341672 7284 55942997
Therapy non-responder 36.69 9.81 220 341566 61135 55889146
Anaphylactic shock 36.47 9.81 47 341739 21693 55928588
Lupus-like syndrome 36.23 9.81 15 341771 12412 55937869
Leukopenia 36.08 9.81 267 341519 70673 55879608
Limb injury 35.86 9.81 245 341541 22025 55928256
Eosinophilic colitis 35.31 9.81 18 341768 144 55950137
Mental impairment 35.24 9.81 162 341624 12560 55937721
Premature labour 35.19 9.81 14 341772 11868 55938413
Accidental poisoning 35.08 9.81 30 341756 613 55949668
Irritability 35.06 9.81 303 341483 29285 55920996
Concussion 34.97 9.81 120 341666 8126 55942155
Epigastric discomfort 34.87 9.81 100 341686 6148 55944133
Disturbance in attention 34.86 9.81 326 341460 32214 55918067
Type 2 diabetes mellitus 34.80 9.81 156 341630 46706 55903575
Blood lactate dehydrogenase increased 34.38 9.81 45 341741 20630 55929651
Drug screen positive 34.01 9.81 69 341717 3395 55946886
Atrial fibrillation 33.99 9.81 461 341325 108436 55841845
Somatic symptom disorder 33.94 9.81 52 341734 2043 55948238
Brain injury 33.82 9.81 100 341686 6255 55944026
Nerve injury 33.58 9.81 125 341661 8812 55941469
Complex regional pain syndrome 33.42 9.81 52 341734 2071 55948210
Cyst 33.40 9.81 160 341626 12618 55937663
Nightmare 33.23 9.81 195 341591 16631 55933650
Bradyphrenia 33.19 9.81 102 341684 6518 55943763
Agitation 33.15 9.81 501 341285 55535 55894746
Congenital absence of vertebra 32.91 9.81 12 341774 36 55950245
Serotonin syndrome 32.83 9.81 274 341512 26216 55924065
Incoherent 32.76 9.81 77 341709 4192 55946089
Breast cancer stage III 32.47 9.81 3 341783 7160 55943121
Joint injury 32.13 9.81 266 341520 25388 55924893
Deafness neurosensory 32.07 9.81 81 341705 4617 55945664
Pneumocystis jirovecii pneumonia 31.83 9.81 29 341757 15672 55934609
Nerve compression 31.52 9.81 115 341671 8029 55942252
Dysarthria 31.42 9.81 373 341413 39177 55911104
Hyperreflexia 31.23 9.81 86 341700 5164 55945117
Suspected suicide 31.01 9.81 88 341698 5378 55944903
Pulmonary fibrosis 30.85 9.81 86 341700 29672 55920609
Visual impairment 30.81 9.81 627 341159 73575 55876706
Panniculitis 30.14 9.81 11 341775 9831 55940450
Intervertebral disc degeneration 29.99 9.81 168 341618 14086 55936195
Osteonecrosis of jaw 29.90 9.81 103 341683 33255 55917026
Paranoia 29.90 9.81 137 341649 10607 55939674
Thrombotic microangiopathy 29.71 9.81 10 341776 9401 55940880
Limb discomfort 29.67 9.81 269 341517 26353 55923928
Drug reaction with eosinophilia and systemic symptoms 29.65 9.81 90 341696 30214 55920067
Gait inability 29.62 9.81 386 341400 41432 55908849
Depressed level of consciousness 29.41 9.81 494 341292 55939 55894342
Neovascularisation 29.32 9.81 34 341752 1015 55949266
Body height decreased 29.28 9.81 122 341664 9063 55941218
Melaena 29.15 9.81 82 341704 28208 55922073
Febrile bone marrow aplasia 29.14 9.81 3 341783 6569 55943712
Rash maculo-papular 28.90 9.81 85 341701 28822 55921459
Herpes zoster 28.52 9.81 632 341154 75257 55875024
Peroneal nerve palsy 28.48 9.81 75 341711 4386 55945895
Gestational diabetes 28.35 9.81 7 341779 8057 55942224
Musculoskeletal stiffness 28.19 9.81 726 341060 155281 55795000
Somatic delusion 27.82 9.81 25 341761 547 55949734
Congenital thrombocytopenia 27.78 9.81 11 341775 44 55950237
Focal dyscognitive seizures 27.42 9.81 56 341730 2769 55947512
Pituitary tumour benign 27.30 9.81 45 341741 1883 55948398
Septic shock 27.23 9.81 237 341549 60598 55889683
Haemophagocytic lymphohistiocytosis 27.19 9.81 12 341774 9560 55940721
Lymphoedema 26.91 9.81 131 341655 10399 55939882
Coma 26.76 9.81 510 341276 59145 55891136
Abortion spontaneous 26.63 9.81 156 341630 43597 55906684
Muscle tightness 26.41 9.81 133 341653 10703 55939578
Central nervous system lesion 26.39 9.81 125 341661 9813 55940468
Thinking abnormal 26.37 9.81 125 341661 9816 55940465
Neutropenic sepsis 26.34 9.81 32 341754 15153 55935128
Dysstasia 26.05 9.81 204 341582 19150 55931131
Asterixis 25.64 9.81 34 341752 1167 55949114
Human epidermal growth factor receptor decreased 25.62 9.81 8 341778 12 55950269
Bone cyst 25.62 9.81 46 341740 2064 55948217
Encephalopathy 25.41 9.81 327 341459 34998 55915283
Drug diversion 25.36 9.81 28 341758 791 55949490
Therapy cessation 25.24 9.81 265 341521 26999 55923282
Headache 25.20 9.81 3814 337972 555230 55395051
Thrombosis 24.95 9.81 503 341283 58924 55891357
Substance abuse 24.84 9.81 72 341714 4453 55945828
Loss of consciousness 24.48 9.81 852 340934 108497 55841784
Bipolar disorder 24.41 9.81 101 341685 7479 55942802
Anorgasmia 24.20 9.81 23 341763 542 55949739
Dysphemia 24.15 9.81 49 341737 2411 55947870
Ascites 23.85 9.81 132 341654 37412 55912869
Pulmonary toxicity 23.83 9.81 9 341777 7874 55942407
Skin necrosis 23.69 9.81 24 341762 12337 55937944
Erythema 23.52 9.81 744 341042 155195 55795086
Hepatic failure 23.37 9.81 114 341672 33372 55916909
Pollakiuria 23.35 9.81 245 341541 24957 55925324
Bronchiectasis 23.32 9.81 21 341765 11413 55938868
Injection site mass 23.15 9.81 178 341608 16615 55933666
Agranulocytosis 23.11 9.81 66 341720 22593 55927688
Disorientation 23.09 9.81 331 341455 36282 55913999
Exposure via ingestion 23.04 9.81 52 341734 2756 55947525
Blood parathyroid hormone decreased 22.96 9.81 11 341775 8353 55941928
Foot fracture 22.61 9.81 217 341569 21592 55928689
Hypercholesterolaemia 22.56 9.81 33 341753 14440 55935841
Tooth loss 22.46 9.81 87 341699 6250 55944031
Condition aggravated 22.43 9.81 1796 339990 343102 55607179
Cervical spinal stenosis 22.38 9.81 42 341744 1950 55948331
Pneumonia 22.19 9.81 2809 338977 404289 55545992
Hyponatraemia 22.18 9.81 462 341324 101677 55848604
Myoclonic epilepsy 22.13 9.81 31 341755 1122 55949159
Bone density decreased 22.02 9.81 27 341759 12733 55937548
Cognitive disorder 21.68 9.81 419 341367 48714 55901567
Product use in unapproved indication 21.60 9.81 1054 340732 139768 55810513
Somnambulism 21.50 9.81 74 341712 5018 55945263
Myelodysplastic syndrome 21.35 9.81 42 341744 16364 55933917
Pruritus 21.33 9.81 1644 340142 314979 55635302
Tardive dyskinesia 21.31 9.81 101 341685 7930 55942351
Progressive multiple sclerosis 21.30 9.81 25 341761 756 55949525
Psychotic disorder due to a general medical condition 21.26 9.81 15 341771 228 55950053
Skin reaction 21.14 9.81 29 341757 13034 55937247
Bradycardia 20.97 9.81 286 341500 67218 55883063
Oesophageal spasm 20.92 9.81 50 341736 2752 55947529
Acute myeloid leukaemia 20.77 9.81 45 341741 16927 55933354
Colitis ulcerative 20.74 9.81 77 341709 24314 55925967
Secondary progressive multiple sclerosis 20.71 9.81 33 341753 1342 55948939
Hypokinesia 20.70 9.81 141 341645 12662 55937619
Device use error 20.67 9.81 4 341782 5452 55944829
Transaminases increased 20.63 9.81 97 341689 28673 55921608
Drug titration error 20.52 9.81 23 341763 661 55949620
Panic attack 20.49 9.81 202 341584 20245 55930036
Dislocation of vertebra 20.45 9.81 4 341782 5411 55944870
Dysphagia 20.25 9.81 646 341140 81301 55868980
Sacroiliitis 20.20 9.81 49 341737 2723 55947558
Jaundice 20.18 9.81 91 341695 27203 55923078
Autonomic nervous system imbalance 20.15 9.81 47 341739 2546 55947735
Eosinophilia 20.09 9.81 59 341727 20018 55930263
Unintentional medical device removal 19.91 9.81 5 341781 5689 55944592
Therapy interrupted 19.62 9.81 240 341546 25385 55924896
Micturition urgency 19.48 9.81 105 341681 8676 55941605
Acute respiratory distress syndrome 19.45 9.81 68 341718 21858 55928423
Transplant rejection 19.37 9.81 19 341767 9915 55940366
Paradoxical drug reaction 19.28 9.81 59 341727 3761 55946520
Hepatocellular injury 19.24 9.81 89 341697 26425 55923856
Creatinine renal clearance decreased 19.18 9.81 37 341749 14522 55935759
Metabolic encephalopathy 19.13 9.81 73 341713 5207 55945074
Arteriovenous malformation 19.09 9.81 31 341755 1281 55949000
Chronic obstructive pulmonary disease 19.06 9.81 470 341316 56945 55893336
Prescription drug used without a prescription 18.92 9.81 39 341747 1941 55948340
Cytomegalovirus viraemia 18.89 9.81 4 341782 5116 55945165
Psychomotor hyperactivity 18.87 9.81 113 341673 9707 55940574
Pulmonary aplasia 18.84 9.81 6 341780 10 55950271
Foetal growth restriction 18.49 9.81 10 341776 7089 55943192
Toxic epidermal necrolysis 18.47 9.81 70 341716 21972 55928309
Metastases to liver 18.45 9.81 68 341718 21518 55928763
Sensory disturbance 18.45 9.81 135 341651 12408 55937873
Laboratory test abnormal 18.35 9.81 230 341556 24465 55925816
Schizophrenia 18.34 9.81 22 341764 10477 55939804
Fibromyalgia 18.34 9.81 483 341303 59120 55891161
Tuberculosis 18.34 9.81 24 341762 11005 55939276
Plasma cell myeloma 18.33 9.81 391 341395 46255 55904026
Device difficult to use 18.33 9.81 23 341763 10738 55939543
Cystitis 18.30 9.81 408 341378 48630 55901651
Glycosylated haemoglobin decreased 18.26 9.81 19 341767 501 55949780
Urticaria 18.20 9.81 706 341080 143970 55806311
Facial pain 18.14 9.81 95 341691 7763 55942518
Post herpetic neuralgia 18.03 9.81 39 341747 2008 55948273
Visual snow syndrome 17.87 9.81 7 341779 27 55950254
Rib deformity 17.86 9.81 13 341773 208 55950073
Depressed mood 17.76 9.81 315 341471 36044 55914237
Dental caries 17.66 9.81 114 341672 10054 55940227
Hypertension 17.61 9.81 1261 340525 243017 55707264
Spinal disorder 17.60 9.81 103 341683 8775 55941506
Haematotoxicity 17.57 9.81 15 341771 8368 55941913
Device adhesion issue 17.56 9.81 3 341783 4471 55945810
Low birth weight baby 17.53 9.81 8 341778 6250 55944031
Tinnitus 17.53 9.81 268 341518 29774 55920507
Economic problem 17.51 9.81 37 341749 1874 55948407
Disorganised speech 17.49 9.81 27 341759 1068 55949213
Epistaxis 17.38 9.81 294 341492 66729 55883552
Oesophageal obstruction 17.35 9.81 18 341768 473 55949808
Foot deformity 17.28 9.81 80 341706 23745 55926536
Maternal exposure before pregnancy 17.22 9.81 10 341776 6813 55943468
Hot flush 17.19 9.81 388 341398 46338 55903943
Drug abuser 17.17 9.81 47 341739 2812 55947469
Accidental exposure to product 17.15 9.81 84 341702 24563 55925718
Injury 17.04 9.81 258 341528 59593 55890688
Graft versus host disease 17.02 9.81 10 341776 6771 55943510
Constipation 16.92 9.81 1435 340351 200508 55749773
Pre-eclampsia 16.82 9.81 16 341770 8470 55941811
Atonic urinary bladder 16.76 9.81 9 341777 81 55950200
Fatigue 16.68 9.81 5190 336596 783362 55166919
JC polyomavirus test positive 16.67 9.81 28 341758 1190 55949091
Urinary retention 16.60 9.81 251 341535 27823 55922458
Blood pressure systolic abnormal 16.54 9.81 21 341765 9756 55940525
Bladder disorder 16.50 9.81 94 341692 7930 55942351
White blood cell count decreased 16.49 9.81 929 340857 125061 55825220
Diffuse axonal injury 16.48 9.81 9 341777 84 55950197
Facial spasm 16.43 9.81 20 341766 629 55949652
Obstructive airways disorder 16.43 9.81 52 341734 17230 55933051
Subdural hygroma 16.39 9.81 13 341773 238 55950043
Cerebrovascular accident 16.28 9.81 748 341038 98522 55851759
Hip fracture 16.27 9.81 242 341544 26731 55923550
Anal incontinence 16.20 9.81 129 341657 12169 55938112
Osteosclerosis 16.14 9.81 54 341732 3609 55946672
Blood potassium decreased 16.12 9.81 327 341459 38345 55911936
Generalised tonic-clonic seizure 16.12 9.81 246 341540 27320 55922961
Blood potassium increased 16.09 9.81 168 341618 17093 55933188
Cerebral infarction 16.06 9.81 76 341710 22429 55927852
Head banging 16.06 9.81 16 341770 400 55949881
Abortion induced 16.03 9.81 21 341765 9624 55940657
Drug effective for unapproved indication 16.02 9.81 43 341743 2543 55947738
Osteoporosis 16.00 9.81 221 341565 51831 55898450
Posterior reversible encephalopathy syndrome 15.90 9.81 47 341739 15913 55934368
Cholestasis 15.83 9.81 97 341689 26816 55923465
Deprescribing error 15.76 9.81 6 341780 21 55950260
Shock haemorrhagic 15.71 9.81 19 341767 9014 55941267
Blood lactic acid 15.63 9.81 9 341777 94 55950187
Cardiogenic shock 15.60 9.81 49 341737 16276 55934005
Gastrointestinal motility disorder 15.39 9.81 63 341723 4643 55945638
Red blood cell sedimentation rate increased 15.37 9.81 145 341641 36478 55913803
Gastroschisis 15.31 9.81 13 341773 263 55950018
Basal cell carcinoma 15.30 9.81 90 341696 25131 55925150
Bronchitis 15.26 9.81 831 340955 111480 55838801
Tubulointerstitial nephritis 15.25 9.81 51 341735 16614 55933667
Breast cancer stage II 15.16 9.81 8 341778 5750 55944531
Hostility 15.13 9.81 34 341752 1797 55948484
Road traffic accident 15.11 9.81 246 341540 27681 55922600
Spinal osteoarthritis 15.08 9.81 147 341639 14689 55935592
Myocardial oedema 15 9.81 9 341777 102 55950179
Accidental overdose 14.96 9.81 190 341596 20271 55930010
Joint destruction 14.90 9.81 6 341780 5049 55945232
Caesarean section 14.89 9.81 49 341737 16042 55934239
Dry eye 14.89 9.81 302 341484 35414 55914867
Epstein-Barr virus infection 14.87 9.81 14 341772 7449 55942832
Pineal gland cyst 14.80 9.81 5 341781 11 55950270
Carpal tunnel syndrome 14.80 9.81 172 341614 17972 55932309
Genital haemorrhage 14.73 9.81 12 341774 6850 55943431
Postmortem blood drug level increased 14.59 9.81 18 341768 574 55949707
Tonic clonic movements 14.55 9.81 27 341759 1243 55949038
Peritonitis 14.54 9.81 50 341736 16152 55934129
Colitis 14.53 9.81 173 341613 41638 55908643
Breast cancer stage I 14.52 9.81 10 341776 6220 55944061
Ageusia 14.48 9.81 127 341659 12324 55937957
Myotonia 14.46 9.81 10 341776 147 55950134
Stillbirth 14.45 9.81 10 341776 6204 55944077
Septic encephalopathy 14.44 9.81 8 341778 77 55950204
Ventricular fibrillation 14.28 9.81 28 341758 10924 55939357
Disseminated intravascular coagulation 14.22 9.81 58 341728 17827 55932454
Postmortem blood drug level abnormal 14.22 9.81 14 341772 345 55949936
Dysgraphia 14.19 9.81 43 341743 2727 55947554
Rib fracture 14.18 9.81 187 341599 20122 55930159
Spinal cord injury 14.17 9.81 20 341766 729 55949552
Ejection fraction decreased 14.16 9.81 67 341719 19774 55930507
Delirium 14.10 9.81 348 341438 42169 55908112
Pancreatitis chronic 14.07 9.81 38 341748 2256 55948025
Jaundice cholestatic 14.05 9.81 8 341778 5511 55944770
Osteopenia 13.93 9.81 170 341616 17971 55932310
Cellulitis 13.90 9.81 572 341214 74377 55875904
Hypoxic-ischaemic encephalopathy 13.85 9.81 54 341732 3891 55946390
Gastrointestinal haemorrhage 13.83 9.81 353 341433 75598 55874683
Nervous system disorder 13.73 9.81 160 341626 16729 55933552
Kidney infection 13.72 9.81 189 341597 20536 55929745
Electroencephalogram abnormal 13.72 9.81 50 341736 3489 55946792
Abnormal dreams 13.71 9.81 103 341683 9546 55940735
Diarrhoea 13.68 9.81 4205 337581 634302 55315979
Toxicologic test abnormal 13.62 9.81 19 341767 685 55949596
Pharyngitis 13.59 9.81 62 341724 18476 55931805
Adjustment disorder with depressed mood 13.57 9.81 7 341779 5096 55945185
Juvenile idiopathic arthritis 13.53 9.81 6 341780 4767 55945514
Hyperbilirubinaemia 13.49 9.81 26 341760 10209 55940072
Oligohydramnios 13.48 9.81 10 341776 5984 55944297
Illness 13.47 9.81 289 341497 34222 55916059
Mucocutaneous haemorrhage 13.46 9.81 8 341778 89 55950192
Sedation complication 13.43 9.81 32 341754 11640 55938641
Injection site induration 13.41 9.81 94 341692 8521 55941760
Snoring 13.38 9.81 50 341736 3531 55946750
Wrong patient received product 13.35 9.81 36 341750 2135 55948146
Hepatitis 13.35 9.81 144 341642 35297 55914984
Proteinuria 13.34 9.81 58 341728 17512 55932769
Wheezing 13.31 9.81 350 341436 74676 55875605
Sleep talking 13.27 9.81 22 341764 925 55949356
Phobia 13.25 9.81 13 341773 319 55949962
Breakthrough pain 13.17 9.81 25 341761 1171 55949110
Injection site atrophy 13.15 9.81 16 341770 503 55949778
Substance use 13.10 9.81 14 341772 381 55949900
Alanine aminotransferase abnormal 12.92 9.81 5 341781 4310 55945971
Toxic skin eruption 12.87 9.81 33 341753 11706 55938575
Hepatitis cholestatic 12.82 9.81 12 341774 6402 55943879
Persistent depressive disorder 12.81 9.81 21 341765 875 55949406
Drug screen false positive 12.79 9.81 20 341766 800 55949481
Influenza 12.77 9.81 704 341082 94557 55855724
Hyperprolactinaemia 12.76 9.81 50 341736 3611 55946670
Adverse event 12.76 9.81 248 341538 55128 55895153
Intentional self-injury 12.73 9.81 218 341568 24774 55925507
Urinary hesitation 12.70 9.81 34 341752 2008 55948273
Movement disorder 12.68 9.81 175 341611 19023 55931258
Drug eruption 12.60 9.81 98 341688 25665 55924616
Paralysis 12.60 9.81 96 341690 8936 55941345
Lymphoma 12.47 9.81 28 341758 10400 55939881
Oesophageal pain 12.47 9.81 46 341740 3229 55947052
Haemolysis 12.46 9.81 12 341774 6316 55943965
Neutrophil count decreased 12.45 9.81 220 341566 49602 55900679
Prophylaxis 12.44 9.81 4 341782 7 55950274
Cervicogenic headache 12.44 9.81 4 341782 7 55950274
Heteroplasia 12.44 9.81 4 341782 7 55950274
Stereotypy 12.34 9.81 14 341772 408 55949873
Epidermal naevus 12.33 9.81 3 341783 0 55950281
Glossopharyngeal neuralgia 12.33 9.81 3 341783 0 55950281
Ligamentum flavum hypertrophy 12.33 9.81 3 341783 0 55950281
Muscle relaxant drug level above therapeutic 12.33 9.81 3 341783 0 55950281
CSF neutrophil count increased 12.33 9.81 3 341783 0 55950281
Pharyngeal neoplasm 12.33 9.81 3 341783 0 55950281
Turbinectomy 12.33 9.81 3 341783 0 55950281
Aphasia 12.29 9.81 256 341530 30159 55920122
Face oedema 12.20 9.81 64 341722 18388 55931893
Skin toxicity 12.13 9.81 5 341781 4148 55946133
Dyspnoea 12.05 9.81 3309 338477 589268 55361013
Vascular malformation 12.04 9.81 13 341773 358 55949923
Angioedema 12.04 9.81 178 341608 41275 55909006
Paranasal cyst 12.01 9.81 13 341773 359 55949922
Allodynia 11.93 9.81 19 341767 772 55949509
Lung adenocarcinoma stage I 11.91 9.81 5 341781 24 55950257
Gastric bypass 11.89 9.81 28 341758 1526 55948755
Post procedural infection 11.87 9.81 89 341697 8243 55942038
Vulvar basal cell carcinoma 11.74 9.81 5 341781 25 55950256
Blood iron abnormal 11.74 9.81 3 341783 3374 55946907
Internal hernia 11.67 9.81 6 341780 49 55950232
Parapsoriasis 11.66 9.81 8 341778 116 55950165
Haemangioma of skin 11.64 9.81 12 341774 313 55949968
Hypopnoea 11.64 9.81 37 341749 2408 55947873
Blood potassium abnormal 11.63 9.81 36 341750 2309 55947972
Central nervous system infection 11.60 9.81 18 341768 715 55949566
Narcolepsy 11.60 9.81 25 341761 1284 55948997
Drug screen negative 11.58 9.81 11 341775 259 55950022
Upper airway resistance syndrome 11.49 9.81 4 341782 10 55950271
X-ray abnormal 11.48 9.81 6 341780 4335 55945946
Radiculopathy 11.41 9.81 66 341720 5599 55944682
Mobility decreased 11.39 9.81 488 341298 98503 55851778
Sensory loss 11.38 9.81 93 341693 8842 55941439
Naevus haemorrhage 11.37 9.81 8 341778 121 55950160
Neuroma 11.34 9.81 13 341773 383 55949898
Formication 11.33 9.81 51 341735 3919 55946362
Seasonal allergy 11.32 9.81 156 341630 16952 55933329
Femur fracture 11.32 9.81 169 341617 39126 55911155
Tooth disorder 11.30 9.81 218 341568 25335 55924946
Unevaluable event 11.28 9.81 374 341412 47313 55902968
Urine amphetamine positive 11.27 9.81 6 341780 53 55950228
Withdrawal catatonia 11.27 9.81 6 341780 53 55950228
Enterocolitis 11.27 9.81 16 341770 7088 55943193
Nerve block 11.26 9.81 17 341769 659 55949622
Congenital neuropathy 11.22 9.81 4 341782 11 55950270
Connective tissue inflammation 11.17 9.81 6 341780 54 55950227
Liver function test increased 11.13 9.81 113 341673 28020 55922261
Abnormal behaviour 11.13 9.81 179 341607 20093 55930188
Burns second degree 11.08 9.81 18 341768 744 55949537
Device dislocation 11.06 9.81 86 341700 22520 55927761
Spinal stenosis 11.05 9.81 132 341654 13882 55936399
Confusional arousal 11.05 9.81 7 341779 88 55950193
Impaired gastric emptying 11.05 9.81 95 341691 9168 55941113
Nephrogenic systemic fibrosis 11.02 9.81 55 341731 4410 55945871
Metabolic surgery 11.02 9.81 23 341763 1155 55949126
Maternal exposure timing unspecified 11.01 9.81 10 341776 5413 55944868
Femoral artery dissection 11.00 9.81 5 341781 30 55950251
Toe operation 10.95 9.81 17 341769 676 55949605
Diffuse large B-cell lymphoma 10.93 9.81 16 341770 7000 55943281
Conversion disorder 10.93 9.81 28 341758 1610 55948671
Application site vesicles 10.89 9.81 25 341761 1340 55948941
Screaming 10.88 9.81 42 341744 3012 55947269
Ligament sprain 10.84 9.81 112 341674 11363 55938918
Pericardial effusion 10.81 9.81 109 341677 27066 55923215
Pharyngeal swelling 10.81 9.81 62 341724 5244 55945037
Polyarthritis 10.80 9.81 23 341763 8705 55941576
Normal newborn 10.72 9.81 18 341768 7452 55942829
Wrist fracture 10.72 9.81 116 341670 11910 55938371
Acute hepatic failure 10.69 9.81 58 341728 16520 55933761
Complication of device insertion 10.66 9.81 14 341772 6410 55943871
Application site burn 10.65 9.81 18 341768 769 55949512
Intervertebral disc disorder 10.64 9.81 55 341731 4471 55945810
Malignant polyp 10.64 9.81 9 341777 181 55950100
Metastases to lung 10.63 9.81 36 341750 11682 55938599
Acute generalised exanthematous pustulosis 10.62 9.81 28 341758 9841 55940440
Metastases to bone 10.61 9.81 72 341714 19436 55930845
Vertebral foraminal stenosis 10.60 9.81 19 341767 851 55949430
Stress 10.56 9.81 448 341338 58462 55891819
Urinary occult blood positive 10.55 9.81 6 341780 61 55950220
Scratch 10.47 9.81 64 341722 5539 55944742
Cardiotoxicity 10.47 9.81 19 341767 7631 55942650
Post procedural complication 10.43 9.81 143 341643 15523 55934758
Hepatitis C virus test positive 10.41 9.81 7 341779 98 55950183
Flushing 10.39 9.81 523 341263 69577 55880704
Chorea 10.33 9.81 25 341761 1387 55948894
Ulcer 10.33 9.81 87 341699 22398 55927883
Enamel anomaly 10.30 9.81 4 341782 15 55950266
Inflammation 10.30 9.81 330 341456 68741 55881540
Acute coronary syndrome 10.29 9.81 28 341758 9740 55940541
Intentional underdose 10.29 9.81 28 341758 1670 55948611
Blood glucose decreased 10.28 9.81 168 341618 18919 55931362
Premature ageing 10.27 9.81 3 341783 3 55950278
Nervous system cyst 10.27 9.81 3 341783 3 55950278
Diabetic gastropathy 10.27 9.81 3 341783 3 55950278
Neurogenic bladder 10.26 9.81 41 341745 2988 55947293
Slow speech 10.25 9.81 24 341762 1303 55948978
Empty sella syndrome 10.25 9.81 5 341781 36 55950245
Eyelid myoclonus 10.23 9.81 7 341779 101 55950180
Dependence 10.23 9.81 31 341755 1966 55948315
Colorectal cancer 10.22 9.81 4 341782 3425 55946856
Product adhesion issue 10.21 9.81 54 341732 4429 55945852
Respiratory rate decreased 10.14 9.81 43 341743 3219 55947062
Decreased interest 10.14 9.81 41 341745 3005 55947276
Uveitis 10.12 9.81 34 341752 11061 55939220
Blood bilirubin increased 10.11 9.81 142 341644 33212 55917069
Hypercalcaemia 10.08 9.81 102 341684 25309 55924972
Retroplacental haematoma 10.06 9.81 8 341778 147 55950134
Face injury 10.06 9.81 40 341746 2909 55947372
Haemorrhage 10.03 9.81 263 341523 56134 55894147
Laryngeal dyspnoea 10.02 9.81 8 341778 148 55950133
Disturbance in social behaviour 10.01 9.81 3 341783 3038 55947243
Uterine perforation 9.98 9.81 15 341771 6490 55943791
Dysphonia 9.93 9.81 329 341457 41618 55908663
Copper deficiency 9.93 9.81 6 341780 69 55950212
Nerve root injury 9.91 9.81 5 341781 39 55950242
Sciatic nerve injury 9.90 9.81 13 341773 442 55949839
Neck surgery 9.88 9.81 28 341758 1710 55948571
Radiation necrosis 9.87 9.81 12 341774 377 55949904
Soft tissue disorder 9.81 9.81 7 341779 4275 55946006
Eyelid contusion 9.81 9.81 3 341783 4 55950277

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 869.65 10.58 1543 184888 71056 31439857
Completed suicide 488.16 10.58 1410 185021 90104 31420809
Drug ineffective for unapproved indication 462.89 10.58 547 185884 17243 31493670
Myoclonus 279.34 10.58 377 186054 13613 31497300
Somnolence 201.17 10.58 1132 185299 98313 31412600
Drug abuse 190.24 10.58 1018 185413 86740 31424173
Toxicity to various agents 188.83 10.58 1760 184671 179727 31331186
Neuropathy peripheral 180.93 10.58 902 185529 74747 31436166
Drug withdrawal syndrome 157.77 10.58 344 186087 18406 31492507
Sedation 150.62 10.58 340 186091 18625 31492288
Interstitial lung disease 150.52 10.58 87 186344 61316 31449597
Fall 145.83 10.58 1704 184727 184385 31326528
Drug dependence 144.13 10.58 372 186059 22207 31488706
Multiple sclerosis relapse 133.63 10.58 248 186183 11799 31499114
Pain 123.50 10.58 1657 184774 185102 31325811
Febrile neutropenia 118.36 10.58 347 186084 121502 31389411
Memory impairment 118.21 10.58 491 185940 37639 31473274
Neuralgia 109.41 10.58 226 186205 11640 31499273
Euphoric mood 108.11 10.58 139 186292 4781 31506132
Hypoaesthesia 105.49 10.58 626 185805 55396 31455517
Confusional state 105.21 10.58 1223 185208 132111 31378802
Mental status changes 101.36 10.58 450 185981 35518 31475395
Insomnia 97.00 10.58 917 185514 93919 31416994
Tremor 94.79 10.58 771 185660 75649 31435264
Hepatic function abnormal 94.64 10.58 63 186368 41159 31469754
Cytomegalovirus infection 94.06 10.58 16 186415 24691 31486222
Withdrawal syndrome 92.96 10.58 210 186221 11507 31499406
Depression 92.82 10.58 878 185553 89937 31420976
Cardiac failure 90.72 10.58 235 186196 85718 31425195
Pain in extremity 88.15 10.58 1058 185373 115145 31395768
Anaemia 87.26 10.58 819 185612 212703 31298210
Pyrexia 86.09 10.58 1264 185167 302576 31208337
Therapeutic product effect variable 83.42 10.58 78 186353 1860 31509053
Obsessive-compulsive disorder 82.18 10.58 122 186309 4815 31506098
Gait disturbance 81.06 10.58 753 185678 76742 31434171
Respiratory arrest 78.16 10.58 334 186097 25923 31484990
Renal impairment 78.05 10.58 254 186177 86095 31424818
C-reactive protein increased 77.99 10.58 103 186328 48547 31462366
Balance disorder 76.19 10.58 427 186004 36995 31473918
Thrombocytopenia 74.65 10.58 512 185919 142235 31368678
Dizziness 72.08 10.58 1604 184827 197543 31313370
Antipsychotic drug level below therapeutic 69.77 10.58 72 186359 1943 31508970
Disinhibition 68.68 10.58 82 186349 2611 31508302
Drug resistance 68.59 10.58 26 186405 23427 31487486
Muscle spasms 68.03 10.58 657 185774 67661 31443252
Anxiety 67.75 10.58 826 185605 90207 31420706
Nightmare 66.44 10.58 189 186242 11948 31498965
Suicidal ideation 64.81 10.58 401 186030 36005 31474908
Neutropenia 64.07 10.58 523 185908 139841 31371072
Mucosal inflammation 61.44 10.58 67 186364 34360 31476553
Muscle spasticity 61.23 10.58 115 186316 5520 31505393
Alanine aminotransferase increased 60.49 10.58 230 186201 74426 31436487
Product complaint 60.36 10.58 113 186318 5411 31505502
Feeling abnormal 60.14 10.58 555 185876 56447 31454466
Septic shock 57.44 10.58 198 186233 65960 31444953
Appendicolith 57.42 10.58 113 186318 5618 31505295
Hallucination 57.38 10.58 468 185963 45942 31464971
Intervertebral disc degeneration 57.22 10.58 111 186320 5460 31505453
Accidental death 55.71 10.58 67 186364 2150 31508763
Overdose 55.30 10.58 750 185681 83914 31426999
Respiratory depression 54.86 10.58 199 186232 14311 31496602
Dysarthria 54.71 10.58 349 186082 31668 31479245
Right atrial hypertrophy 54.33 10.58 38 186393 589 31510324
Disseminated intravascular coagulation 53.36 10.58 27 186404 20510 31490403
Increased appetite 52.90 10.58 116 186315 6228 31504685
Intentional product misuse 52.60 10.58 393 186038 37558 31473355
Burning sensation 49.04 10.58 212 186219 16535 31494378
Amnesia 48.93 10.58 269 186162 23133 31487780
Multiple sclerosis 47.80 10.58 129 186302 7908 31503005
Bone marrow failure 47.27 10.58 57 186374 27951 31482962
Drug reaction with eosinophilia and systemic symptoms 46.64 10.58 65 186366 29953 31480960
Back disorder 45.89 10.58 107 186324 5986 31504927
Fatigue 45.01 10.58 2405 184026 332801 31178112
Haemophagocytic lymphohistiocytosis 43.49 10.58 8 186423 11670 31499243
Paraesthesia 42.65 10.58 511 185920 55560 31455353
Myokymia 42.15 10.58 17 186414 75 31510838
Constipation 41.75 10.58 989 185442 123002 31387911
Malignant neoplasm progression 41.41 10.58 283 186148 78715 31432198
Vision blurred 41.16 10.58 402 186029 41513 31469400
Serotonin syndrome 40.74 10.58 218 186213 18555 31492358
Bronchial secretion retention 40.65 10.58 44 186387 1256 31509657
Prescription drug used without a prescription 40.63 10.58 46 186385 1382 31509531
Off label use 40.38 10.58 1652 184779 345622 31165291
Ataxia 40.12 10.58 166 186265 12697 31498216
Myelosuppression 39.69 10.58 19 186412 14901 31496012
Rheumatoid arthritis 39.55 10.58 146 186285 47663 31463250
Multiple organ dysfunction syndrome 39.49 10.58 237 186194 67966 31442947
Depressed level of consciousness 37.80 10.58 370 186061 38231 31472682
Needle fatigue 37.75 10.58 33 186398 719 31510194
Sleep apnoea syndrome 37.55 10.58 212 186219 18413 31492500
Inadequate analgesia 37.10 10.58 61 186370 2632 31508281
Relapsing-remitting multiple sclerosis 37.04 10.58 36 186395 902 31510011
Bronchial wall thickening 37.03 10.58 40 186391 1139 31509774
Bronchopulmonary aspergillosis 36.83 10.58 17 186414 13617 31497296
Aspergillus infection 36.81 10.58 11 186420 11517 31499396
Dyspnoea 36.78 10.58 1649 184782 341830 31169083
Hypokalaemia 36.07 10.58 177 186254 53397 31457516
Infusion related reaction 35.17 10.58 154 186277 47901 31463012
General physical health deterioration 35.14 10.58 463 185968 112972 31397941
Hepatic failure 34.78 10.58 89 186342 32613 31478300
Aspartate aminotransferase increased 34.72 10.58 221 186210 62498 31448415
Muscle twitching 34.68 10.58 117 186314 8113 31502800
Melaena 34.63 10.58 89 186342 32565 31478348
Right ventricular hypertrophy 34.57 10.58 40 186391 1231 31509682
Gait spastic 34.47 10.58 34 186397 868 31510045
Foetal exposure during pregnancy 34.35 10.58 124 186307 40752 31470161
Colitis ulcerative 34.24 10.58 35 186396 18494 31492419
Neutrophil count decreased 33.76 10.58 149 186282 46245 31464668
Appendicitis 33.46 10.58 145 186286 11320 31499593
Jaundice 33.33 10.58 81 186350 30206 31480707
Congenital multiplex arthrogryposis 33.23 10.58 13 186418 52 31510861
Sopor 32.88 10.58 145 186286 11407 31499506
Acute kidney injury 32.81 10.58 1329 185102 278385 31232528
Antidepressant drug level above therapeutic 32.79 10.58 19 186412 208 31510705
Renal failure 32.74 10.58 519 185912 122811 31388102
Diabetic neuropathy 32.69 10.58 72 186359 3877 31507036
Contraindicated product administered 32.56 10.58 41 186390 19731 31491182
Cerebral haemorrhage 32.12 10.58 93 186338 32719 31478194
Asterixis 32.07 10.58 37 186394 1135 31509778
Product dose omission issue 31.89 10.58 830 185601 104756 31406157
Back pain 31.87 10.58 856 185575 108557 31402356
Colitis 31.77 10.58 98 186333 33789 31477124
Labelled drug-drug interaction medication error 31.74 10.58 19 186412 13144 31497769
Obstruction 31.70 10.58 50 186381 2082 31508831
Prostate cancer 31.64 10.58 114 186317 37487 31473426
Restless legs syndrome 31.57 10.58 109 186322 7647 31503266
Graft versus host disease 31.53 10.58 11 186420 10436 31500477
Full blood count decreased 31.21 10.58 185 186246 16355 31494558
Lethargy 31.08 10.58 356 186075 38285 31472628
Eosinophilia 30.78 10.58 56 186375 23197 31487716
Metabolic acidosis 30.71 10.58 124 186307 39453 31471460
Toxic epidermal necrolysis 30.60 10.58 42 186389 19482 31491431
Victim of child abuse 30.52 10.58 32 186399 880 31510033
Adverse drug reaction 29.99 10.58 252 186179 24949 31485964
Sweat gland disorder 29.81 10.58 14 186417 95 31510818
Hyperreflexia 29.36 10.58 58 186373 2891 31508022
Blood bilirubin increased 29.25 10.58 107 186324 35029 31475884
Sciatica 29.06 10.58 83 186348 5258 31505655
Parasomnia 28.68 10.58 21 186410 351 31510562
Mood altered 28.67 10.58 111 186320 8235 31502678
Haematotoxicity 28.58 10.58 4 186427 7133 31503780
Pleural effusion 28.55 10.58 292 186139 74628 31436285
Gastrointestinal haemorrhage 28.55 10.58 329 186102 82220 31428693
Pneumonitis 28.48 10.58 89 186342 30563 31480350
Proteinuria 28.41 10.58 34 186397 16729 31494184
Atrial fibrillation 28.16 10.58 485 185946 113298 31397615
Analgesic drug level above therapeutic 28.04 10.58 19 186412 279 31510634
Drug tolerance 27.99 10.58 52 186379 2475 31508438
Synovitis 27.88 10.58 19 186412 12264 31498649
Gamma-glutamyltransferase increased 27.87 10.58 78 186353 27747 31483166
Nervousness 27.66 10.58 140 186291 11660 31499253
Bradyphrenia 27.52 10.58 72 186359 4332 31506581
Nerve injury 27.49 10.58 60 186371 3211 31507702
Erectile dysfunction 27.10 10.58 200 186231 19035 31491878
Pneumocystis jirovecii pneumonia 26.90 10.58 41 186390 18210 31492703
Transaminases increased 26.86 10.58 65 186366 24276 31486637
Haematochezia 26.48 10.58 135 186296 40329 31470584
Dyskinesia 26.45 10.58 212 186219 20698 31490215
Spinal operation 26.36 10.58 51 186380 2503 31508410
Peripheral swelling 26.18 10.58 552 185879 67313 31443600
Acute myocardial infarction 26.16 10.58 183 186248 50640 31460273
Erythema 26.07 10.58 325 186106 80080 31430833
Disorientation 25.98 10.58 286 186145 30458 31480455
Acute respiratory distress syndrome 25.93 10.58 67 186364 24473 31486440
Drug eruption 25.72 10.58 42 186389 18145 31492768
Tooth disorder 25.66 10.58 122 186309 9907 31501006
Schizophrenia 25.60 10.58 16 186415 10814 31500099
Acute myeloid leukaemia 25.59 10.58 44 186387 18628 31492285
Post transplant lymphoproliferative disorder 25.31 10.58 3 186428 6073 31504840
Anger 25.22 10.58 131 186300 11022 31499891
Hyperaesthesia 25.10 10.58 65 186366 3886 31507027
Hypernatraemia 25.04 10.58 7 186424 7656 31503257
Trigeminal neuralgia 25.01 10.58 32 186399 1095 31509818
Pulmonary function test abnormal 24.97 10.58 46 186385 2175 31508738
Delirium tremens 24.90 10.58 24 186407 595 31510318
Circulatory collapse 24.86 10.58 49 186382 19695 31491218
Pathogen resistance 24.85 10.58 10 186421 8691 31502222
Anorgasmia 24.83 10.58 26 186405 714 31510199
Cholangitis 24.81 10.58 8 186423 7978 31502935
Gait inability 24.71 10.58 195 186236 18949 31491964
Delirium 24.63 10.58 361 186070 41060 31469853
Hallucination, visual 24.45 10.58 168 186263 15626 31495287
Pancytopenia 24.33 10.58 364 186067 86952 31423961
Aortic valve stenosis 24.23 10.58 48 186383 2398 31508515
Venoocclusive liver disease 23.80 10.58 7 186424 7405 31503508
Hypertonic bladder 23.58 10.58 39 186392 1691 31509222
Hepatic enzyme increased 23.38 10.58 120 186311 35788 31475125
Posterior reversible encephalopathy syndrome 23.33 10.58 13 186418 9354 31501559
Epistaxis 23.16 10.58 203 186228 53504 31457409
Angioedema 22.66 10.58 111 186320 33507 31477406
Cholestasis 22.46 10.58 74 186357 25001 31485912
Pulmonary alveolar haemorrhage 22.45 10.58 6 186425 6760 31504153
Encephalopathy neonatal 22.26 10.58 9 186422 40 31510873
Coordination abnormal 22.16 10.58 93 186338 7158 31503755
Drug screen negative 21.93 10.58 13 186418 149 31510764
Suicidal behaviour 21.87 10.58 34 186397 1398 31509515
Cerebral infarction 21.69 10.58 79 186352 25898 31485015
Inflammation 21.59 10.58 76 186355 25165 31485748
Urinary incontinence 21.58 10.58 175 186256 17145 31493768
Monoparesis 21.33 10.58 42 186389 2089 31508824
Neonatal toxicity 21.27 10.58 8 186423 28 31510885
Irritability 21.24 10.58 217 186214 22672 31488241
Anaphylactic reaction 20.84 10.58 96 186335 29457 31481456
Acute hepatic failure 20.83 10.58 27 186404 12832 31498081
Palmar-plantar erythrodysaesthesia syndrome 20.75 10.58 37 186394 15446 31495467
Transplant rejection 20.75 10.58 16 186415 9692 31501221
Phantom limb syndrome 20.63 10.58 15 186416 248 31510665
Fibromyalgia 20.60 10.58 49 186382 2777 31508136
Drug tolerance increased 20.53 10.58 19 186412 447 31510466
Osteomyelitis 20.49 10.58 152 186279 14491 31496422
Blood lactate dehydrogenase increased 20.38 10.58 57 186374 20282 31490631
Rash maculo-papular 20.32 10.58 80 186351 25639 31485274
Myocarditis 20.31 10.58 24 186407 11876 31499037
Affective disorder 20.27 10.58 58 186373 3678 31507235
Shock haemorrhagic 20.23 10.58 18 186413 10159 31500754
Agranulocytosis 20.23 10.58 61 186370 21186 31489727
Blood creatine phosphokinase increased 20.22 10.58 154 186277 41820 31469093
Disease progression 20.06 10.58 393 186038 90071 31420842
Impaired driving ability 19.88 10.58 44 186387 2377 31508536
Accidental poisoning 19.87 10.58 23 186408 708 31510205
Epstein-Barr virus infection 19.85 10.58 8 186423 6945 31503968
Lower respiratory tract infection 19.75 10.58 92 186339 28145 31482768
Treatment failure 19.49 10.58 150 186281 40642 31470271
Nephropathy toxic 19.27 10.58 23 186408 11330 31499583
Personality change 19.18 10.58 67 186364 4728 31506185
Head titubation 19.15 10.58 16 186415 327 31510586
Ischaemic stroke 18.97 10.58 45 186386 16926 31493987
Localised infection 18.89 10.58 154 186277 15111 31495802
Mental impairment 18.88 10.58 108 186323 9424 31501489
Tuberculosis 18.80 10.58 13 186418 8328 31502585
Agitation 18.79 10.58 434 185997 53735 31457178
Cardio-respiratory arrest 18.75 10.58 417 186014 51309 31459604
Brief psychotic disorder with marked stressors 18.72 10.58 13 186418 199 31510714
Conversion disorder 18.71 10.58 16 186415 338 31510575
Facial pain 18.71 10.58 38 186393 1933 31508980
Tumour lysis syndrome 18.67 10.58 39 186392 15346 31495567
Intervertebral disc protrusion 18.62 10.58 104 186327 8996 31501917
Nephrotic syndrome 18.50 10.58 9 186422 6994 31503919
Muscular weakness 18.18 10.58 509 185922 64939 31445974
Lumbar radiculopathy 18.11 10.58 23 186408 781 31510132
Prescribed overdose 18.11 10.58 104 186327 9088 31501825
Rhabdomyolysis 18.07 10.58 264 186167 63317 31447596
Migraine 18.06 10.58 144 186287 14036 31496877
Cognitive disorder 18.01 10.58 225 186206 24698 31486215
Haemolysis 17.99 10.58 10 186421 7206 31503707
Thrombosis 17.97 10.58 369 186062 44782 31466131
Mucosal atrophy 17.82 10.58 9 186422 73 31510840
Hostility 17.82 10.58 23 186408 794 31510119
Tubulointerstitial nephritis 17.68 10.58 53 186378 18443 31492470
Rectal haemorrhage 17.58 10.58 133 186298 36171 31474742
Facial wasting 17.57 10.58 11 186420 140 31510773
Binocular eye movement disorder 17.45 10.58 8 186423 51 31510862
Hyperbilirubinaemia 17.42 10.58 42 186389 15708 31495205
Pulmonary toxicity 17.41 10.58 5 186426 5372 31505541
Sedation complication 17.40 10.58 31 186400 1428 31509485
Cerebral disorder 17.40 10.58 42 186389 2403 31508510
Dysphoria 17.30 10.58 39 186392 2133 31508780
Ear deformity acquired 17.27 10.58 5 186426 5 31510908
Breakthrough pain 17.23 10.58 19 186412 554 31510359
Therapeutic response unexpected 17.07 10.58 101 186330 8923 31501990
Suspected suicide 16.96 10.58 58 186373 4049 31506864
Cough 16.96 10.58 635 185796 134179 31376734
Violence-related symptom 16.91 10.58 18 186413 504 31510409
Opisthotonus 16.89 10.58 17 186414 445 31510468
Immune reconstitution inflammatory syndrome 16.82 10.58 14 186417 8164 31502749
Hypoacusis 16.80 10.58 148 186283 14851 31496062
Liver disorder 16.78 10.58 104 186327 29603 31481310
Ventricular tachycardia 16.71 10.58 77 186354 23624 31487289
Precancerous skin lesion 16.70 10.58 19 186412 574 31510339
Stress 16.69 10.58 222 186209 24719 31486194
Haemoglobin decreased 16.66 10.58 520 185911 112155 31398758
Idiopathic neutropenia 16.57 10.58 4 186427 0 31510913
Blood pressure fluctuation 16.55 10.58 73 186358 22663 31488250
Bradypnoea 16.28 10.58 42 186389 2505 31508408
Quality of life decreased 16.25 10.58 51 186380 3404 31507509
Haematuria 16.23 10.58 184 186247 46130 31464783
Encephalitis 16.20 10.58 10 186421 6805 31504108
Panic attack 16.20 10.58 97 186334 8606 31502307
Intentional product use issue 16.16 10.58 199 186232 49148 31461765
Metabolic encephalopathy 16.13 10.58 55 186376 3834 31507079
Plasma cell myeloma 16.08 10.58 441 185990 56090 31454823
Hyperhidrosis 15.98 10.58 514 185917 66879 31444034
Pulmonary tuberculosis 15.97 10.58 4 186427 4707 31506206
Loss of proprioception 15.96 10.58 15 186416 360 31510553
Feeding intolerance 15.92 10.58 10 186421 128 31510785
Hypertransaminasaemia 15.92 10.58 3 186428 4301 31506612
Thinking abnormal 15.89 10.58 70 186361 5503 31505410
Hypomagnesaemia 15.89 10.58 58 186373 19000 31491913
Cytomegalovirus viraemia 15.81 10.58 10 186421 6715 31504198
Heat exhaustion 15.79 10.58 10 186421 130 31510783
Pneumothorax 15.78 10.58 49 186382 16861 31494052
Artery dissection 15.73 10.58 9 186422 96 31510817
Bladder cancer 15.71 10.58 40 186391 14685 31496228
Aggression 15.59 10.58 307 186124 36984 31473929
Hypersomnia 15.32 10.58 115 186316 11004 31499909
Autoimmune haemolytic anaemia 15.23 10.58 3 186428 4169 31506744
Hypoalbuminaemia 15.10 10.58 26 186405 11002 31499911
Gingival atrophy 15.09 10.58 7 186424 46 31510867
Stevens-Johnson syndrome 15.06 10.58 52 186379 17320 31493593
Acute coronary syndrome 15.04 10.58 33 186398 12756 31498157
Foot fracture 14.98 10.58 57 186374 4194 31506719
Mucormycosis 14.96 10.58 7 186424 5563 31505350
Alcoholism 14.92 10.58 49 186382 3350 31507563
Foetal disorder 14.92 10.58 21 186410 789 31510124
Lung disorder 14.89 10.58 120 186311 32192 31478721
Dry mouth 14.86 10.58 214 186217 24244 31486669
Metastases to liver 14.83 10.58 33 186398 12694 31498219
Hyperthyroidism 14.81 10.58 21 186410 9610 31501303
Left ventricular dysfunction 14.79 10.58 20 186411 9337 31501576
Hepatotoxicity 14.79 10.58 60 186371 19066 31491847
Acute graft versus host disease in skin 14.73 10.58 5 186426 4827 31506086
Acute pulmonary oedema 14.70 10.58 12 186419 7064 31503849
Blood creatinine increased 14.69 10.58 405 186026 88673 31422240
Personality disorder 14.66 10.58 25 186406 1112 31509801
Hepatocellular injury 14.60 10.58 71 186360 21473 31489440
Nerve compression 14.59 10.58 44 186387 2874 31508039
Feeling drunk 14.58 10.58 32 186399 1719 31509194
Shock 14.56 10.58 76 186355 22569 31488344
Muscle tightness 14.56 10.58 59 186372 4470 31506443
Oesophageal mucosa erythema 14.44 10.58 6 186425 29 31510884
Fungal infection 14.42 10.58 41 186390 14510 31496403
Hypometabolism 14.34 10.58 8 186423 81 31510832
Enterocolitis 14.30 10.58 13 186418 7261 31503652
Akathisia 14.25 10.58 82 186349 7171 31503742
Central nervous system lesion 14.24 10.58 71 186360 5877 31505036
Hepatitis 14.22 10.58 74 186357 21992 31488921
Gastric cancer 14.19 10.58 9 186422 6036 31504877
Intentional underdose 14.18 10.58 18 186413 611 31510302
Stomatitis 14.09 10.58 156 186275 39282 31471631
Musculoskeletal disorder 14.06 10.58 69 186362 5675 31505238
Body height decreased 14.03 10.58 49 186382 3458 31507455
Micturition urgency 13.96 10.58 69 186362 5691 31505222
Back injury 13.95 10.58 51 186380 3681 31507232
Respiratory disorder 13.94 10.58 56 186375 17844 31493069
Seizure 13.93 10.58 719 185712 99049 31411864
Oesophageal carcinoma 13.93 10.58 16 186415 8017 31502896
Peritonitis 13.89 10.58 45 186386 15282 31495631
Haemorrhage intracranial 13.88 10.58 44 186387 15044 31495869
Gastrointestinal adenocarcinoma 13.84 10.58 7 186424 57 31510856
Radiculopathy 13.83 10.58 40 186391 2552 31508361
Fear of weight gain 13.82 10.58 4 186427 4 31510909
Psoriasis 13.62 10.58 193 186238 46526 31464387
Oxygen saturation decreased 13.58 10.58 205 186226 48910 31462003
Hepatocellular carcinoma 13.56 10.58 19 186412 8737 31502176
Diplopia 13.49 10.58 135 186296 14027 31496886
Abnormal labour affecting foetus 13.40 10.58 5 186426 17 31510896
Alcohol withdrawal syndrome 13.39 10.58 27 186404 1366 31509547
Cardiac failure acute 13.30 10.58 23 186408 9718 31501195
Seborrhoeic keratosis 13.30 10.58 21 186410 875 31510038
Dysphemia 13.24 10.58 28 186403 1466 31509447
Road traffic accident 13.20 10.58 151 186280 16230 31494683
Leukopenia 13.18 10.58 250 186181 57578 31453335
Nephrolithiasis 13.14 10.58 230 186201 27109 31483804
Colorectal cancer 13.08 10.58 6 186425 4823 31506090
Spinal stenosis 13.06 10.58 59 186372 4689 31506224
Abnormal sleep-related event 13.06 10.58 15 186416 458 31510455
Pulmonary fibrosis 13.05 10.58 52 186379 16608 31494305
Chest X-ray abnormal 13.04 10.58 53 186378 4020 31506893
Hypertriglyceridaemia 13.02 10.58 16 186415 7782 31503131
Ventricular hypokinesia 12.97 10.58 6 186425 4800 31506113
Immature granulocyte percentage increased 12.94 10.58 4 186427 6 31510907
Neutropenic sepsis 12.92 10.58 34 186397 12345 31498568
Herpes zoster 12.91 10.58 262 186169 31731 31479182
Stiff person syndrome 12.90 10.58 8 186423 100 31510813
Cardiac arrest 12.88 10.58 644 185787 88418 31422495
Drug abuser 12.84 10.58 51 186380 3829 31507084
Sleep disorder 12.78 10.58 222 186209 26126 31484787
Free androgen index decreased 12.78 10.58 5 186426 20 31510893
Dependence 12.73 10.58 23 186408 1071 31509842
Ventricular septal defect 12.70 10.58 3 186428 3674 31507239
Hyperuricaemia 12.69 10.58 15 186416 7423 31503490
Obesity 12.68 10.58 110 186321 10990 31499923
Implant site inflammation 12.63 10.58 8 186423 104 31510809
Chronic graft versus host disease 12.62 10.58 5 186426 4387 31506526
Haemorrhage 12.60 10.58 199 186232 47135 31463778
Epidural lipomatosis 12.52 10.58 19 186412 765 31510148
Neoplasm progression 12.50 10.58 69 186362 20203 31490710
Enterococcal infection 12.50 10.58 20 186411 8711 31502202
Joint hyperextension 12.44 10.58 8 186423 107 31510806
Tachycardia 12.43 10.58 347 186084 75860 31435053
Benign neoplasm of spinal cord 12.43 10.58 3 186428 0 31510913
Traumatic amputation 12.43 10.58 3 186428 0 31510913
Pancreatic fibrosis 12.43 10.58 3 186428 0 31510913
Nasal odour 12.43 10.58 3 186428 0 31510913
Severe myoclonic epilepsy of infancy 12.43 10.58 3 186428 0 31510913
Amphetamines positive 12.42 10.58 9 186422 148 31510765
Neck surgery 12.41 10.58 13 186418 357 31510556
Large intestine perforation 12.40 10.58 16 186415 7620 31503293
Blood urea increased 12.35 10.58 110 186321 28902 31482011
Disturbance in attention 12.31 10.58 193 186238 22257 31488656
Immunosuppressant drug level increased 12.23 10.58 8 186423 5277 31505636
Rales 12.17 10.58 20 186411 8619 31502294
Enthesopathy 12.13 10.58 5 186426 4282 31506631
Dysstasia 12.09 10.58 109 186322 11009 31499904
Ejection fraction decreased 12.08 10.58 57 186374 17377 31493536
Slow speech 12.07 10.58 22 186409 1032 31509881
Bipolar I disorder 11.98 10.58 19 186412 795 31510118
Candida infection 11.95 10.58 52 186379 16206 31494707
Hypoosmolar state 11.90 10.58 7 186424 79 31510834
Nocturia 11.88 10.58 94 186337 9141 31501772
Anal abscess 11.84 10.58 10 186421 5790 31505123
Hyperkalaemia 11.82 10.58 288 186143 64063 31446850
Anaphylactic shock 11.82 10.58 43 186388 14102 31496811
Rib fracture 11.77 10.58 125 186306 13191 31497722
Neutrophil count increased 11.76 10.58 50 186381 15681 31495232
Product communication issue 11.65 10.58 12 186419 323 31510590
Drug withdrawal syndrome neonatal 11.63 10.58 46 186385 3446 31507467
Inflammatory marker increased 11.61 10.58 5 186426 4173 31506740
Hyperglycaemia 11.60 10.58 148 186283 36328 31474585
Antipsychotic drug level increased 11.60 10.58 3 186428 3455 31507458
Adrenal insufficiency 11.59 10.58 37 186394 12622 31498291
Neutropenia neonatal 11.58 10.58 17 186414 664 31510249
Blood pressure decreased 11.56 10.58 206 186225 47885 31463028
Teeth brittle 11.55 10.58 6 186425 52 31510861
Blood alkaline phosphatase increased 11.54 10.58 114 186317 29339 31481574
Lactic acidosis 11.54 10.58 126 186305 31811 31479102
Nephrogenic systemic fibrosis 11.52 10.58 50 186381 3905 31507008
Multiple-drug resistance 11.47 10.58 6 186425 4474 31506439
Open angle glaucoma 11.45 10.58 9 186422 168 31510745
Therapy partial responder 11.45 10.58 13 186418 6549 31504364
Thoracic vertebral fracture 11.44 10.58 27 186404 1522 31509391
Asthma 11.39 10.58 179 186252 42432 31468481
Pseudomonas infection 11.39 10.58 32 186399 11369 31499544
Application site hypersensitivity 11.38 10.58 8 186423 125 31510788
Mental disorder 11.37 10.58 128 186303 13706 31497207
Uveitis 11.36 10.58 14 186417 6802 31504111
Arrhythmia 11.36 10.58 132 186299 32945 31477968
Myoclonic dystonia 11.35 10.58 4 186427 11 31510902
Injection site mass 11.33 10.58 66 186365 5798 31505115
Adenovirus infection 11.27 10.58 7 186424 4747 31506166
Mouth ulceration 11.17 10.58 30 186401 10818 31500095
Retinal haemorrhage 11.16 10.58 7 186424 4723 31506190
Second primary malignancy 11.15 10.58 15 186416 7017 31503896
Infective pulmonary exacerbation of cystic fibrosis 11.15 10.58 13 186418 6471 31504442
Carpal tunnel syndrome 11.12 10.58 53 186378 4308 31506605
Hip fracture 11.09 10.58 106 186325 10880 31500033
Irritable bowel syndrome 11.07 10.58 42 186389 3086 31507827
White blood cell count increased 11.05 10.58 162 186269 38838 31472075
Post herpetic neuralgia 11.04 10.58 21 186410 1018 31509895
Electric shock 11.01 10.58 8 186423 132 31510781
Pneumonia bacterial 10.96 10.58 28 186403 10268 31500645
Cyanosis 10.95 10.58 34 186397 11701 31499212
Diastolic dysfunction 10.93 10.58 61 186370 5274 31505639
Drug effective for unapproved indication 10.92 10.58 30 186401 1858 31509055
Carcinogenicity 10.90 10.58 6 186425 59 31510854
Lymphocyte count decreased 10.79 10.58 74 186357 20575 31490338
Post laminectomy syndrome 10.73 10.58 9 186422 185 31510728
Sleep attacks 10.71 10.58 8 186423 138 31510775
Intestinal obstruction 10.70 10.58 74 186357 20536 31490377
Complications of transplanted kidney 10.68 10.58 6 186425 4299 31506614
Dysaesthesia 10.64 10.58 32 186399 2087 31508826
Hypotony maculopathy 10.63 10.58 4 186427 14 31510899
Lipodystrophy acquired 10.63 10.58 3 186428 3261 31507652
Spinal fusion surgery 10.62 10.58 19 186412 878 31510035
Cytokine release syndrome 10.62 10.58 56 186375 16586 31494327
Toxic skin eruption 10.60 10.58 28 186403 10152 31500761
Hepatitis B 10.59 10.58 11 186420 5770 31505143

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 2722.73 9.84 5236 411555 257223 70254430
Completed suicide 1392.60 9.84 3679 413112 223456 70288197
Drug ineffective for unapproved indication 1365.70 9.84 1393 415398 37145 70474508
Myoclonus 549.37 9.84 725 416066 25630 70486023
Toxicity to various agents 517.86 9.84 3929 412862 378243 70133410
Drug abuse 468.11 9.84 1909 414882 145347 70366306
Somnolence 450.37 9.84 2474 414317 213132 70298521
Pemphigus 447.33 9.84 8 416783 83028 70428625
Multiple sclerosis relapse 434.02 9.84 850 415941 42167 70469486
Fall 357.37 9.84 4084 412707 440012 70071641
Synovitis 355.34 9.84 157 416634 129071 70382582
Hand deformity 324.55 9.84 58 416733 86424 70425229
Pericarditis 317.46 9.84 57 416734 84648 70427005
Contraindicated product administered 315.06 9.84 201 416590 134411 70377242
Systemic lupus erythematosus 304.40 9.84 109 416682 101793 70409860
Rheumatoid arthritis 300.49 9.84 807 415984 290998 70220655
Maternal exposure during pregnancy 285.69 9.84 161 416630 115184 70396469
Depression 285.48 9.84 2075 414716 196899 70314754
Glossodynia 267.88 9.84 87 416704 86400 70425253
Duodenal ulcer perforation 263.44 9.84 8 416783 51104 70460549
Hepatic enzyme increased 246.56 9.84 337 416454 156653 70355000
Rheumatoid factor positive 237.72 9.84 11 416780 48389 70463264
Tremor 234.79 9.84 1643 415148 153981 70357672
Respiratory arrest 234.29 9.84 774 416017 53159 70458494
Infusion related reaction 229.37 9.84 513 416278 197021 70314632
Mental status changes 227.88 9.84 852 415939 62249 70449404
Memory impairment 227.03 9.84 1112 415679 91529 70420124
Febrile neutropenia 226.48 9.84 544 416247 203774 70307879
Helicobacter infection 225.49 9.84 30 416761 55626 70456027
Neuralgia 225.42 9.84 511 416280 28092 70483561
Drug dependence 223.36 9.84 600 416191 36721 70474932
Interstitial lung disease 221.66 9.84 174 416617 104511 70407142
Drug withdrawal syndrome 220.54 9.84 550 416241 32165 70479488
Dizziness 217.37 9.84 3882 412909 460259 70051394
Suicidal ideation 205.88 9.84 883 415908 68713 70442940
Neuropathy peripheral 204.03 9.84 1361 415430 125535 70386118
Accidental death 201.36 9.84 174 416617 3734 70507919
Withdrawal syndrome 195.24 9.84 444 416347 24460 70487193
Feeling abnormal 193.65 9.84 1466 415325 140853 70370800
Arthropathy 191.64 9.84 369 416422 149688 70361965
Joint swelling 186.52 9.84 809 415982 252402 70259251
C-reactive protein increased 181.93 9.84 229 416562 110288 70401365
General physical health deterioration 181.33 9.84 742 416049 235289 70276364
Pyrexia 179.31 9.84 2501 414290 604451 69907202
Hallucination 176.66 9.84 901 415890 75359 70436294
Multiple sclerosis 171.39 9.84 426 416365 24859 70486794
Sedation 171.24 9.84 634 416157 46097 70465556
Exposure during pregnancy 162.64 9.84 165 416626 87552 70424101
Muscle spasms 159.19 9.84 1492 415299 152554 70359099
Sleep disorder due to general medical condition, insomnia type 155.43 9.84 15 416776 35717 70475936
Muscle injury 155.34 9.84 21 416770 38473 70473180
Vision blurred 150.99 9.84 1016 415775 93968 70417685
Hepatic function abnormal 149.07 9.84 109 416682 67887 70443766
Anxiety 148.81 9.84 1962 414829 218368 70293285
Confusional state 147.46 9.84 2419 414372 281979 70229674
Respiratory depression 146.36 9.84 397 416394 24434 70487219
Cytomegalovirus infection 146.28 9.84 28 416763 39730 70471923
Balance disorder 146.24 9.84 969 415822 89159 70422494
Pain in extremity 139.06 9.84 2703 414088 325379 70186274
Gait disturbance 136.71 9.84 1676 415115 183430 70328223
Hypoaesthesia 136.06 9.84 1442 415349 152297 70359356
Hypersensitivity 134.58 9.84 795 415996 229017 70282636
Folliculitis 133.26 9.84 42 416749 42528 70469125
Wound 127.58 9.84 241 416550 98491 70413162
Cardio-respiratory arrest 127.44 9.84 1020 415771 99657 70411996
Discomfort 126.28 9.84 269 416522 105167 70406486
Thrombocytopenia 124.72 9.84 857 415934 238253 70273400
Anaemia 124.05 9.84 1648 415143 401775 70109878
Product dose omission issue 119.13 9.84 1867 414924 215601 70296052
C-reactive protein abnormal 119.10 9.84 39 416752 38540 70473113
Cardiac failure 118.65 9.84 438 416353 143103 70368550
Sopor 117.74 9.84 428 416363 30839 70480814
Therapeutic product effect decreased 113.94 9.84 443 416348 142575 70369078
Migraine 113.77 9.84 771 416020 71467 70440186
Lower respiratory tract infection 112.39 9.84 313 416478 111600 70400053
Intentional product misuse 96.71 9.84 799 415992 78796 70432857
Lethargy 96.64 9.84 765 416026 74485 70437168
Mucosal inflammation 94.52 9.84 158 416633 67692 70443961
Overdose 93.57 9.84 1459 415332 168286 70343367
Neutropenia 91.68 9.84 1017 415774 256139 70255514
Insomnia 91.66 9.84 1793 414998 216013 70295640
Bone marrow failure 89.92 9.84 93 416698 48917 70462736
Myelosuppression 88.71 9.84 33 416758 30112 70481541
Sleep apnoea syndrome 88.35 9.84 404 416387 32309 70479344
Drug resistance 87.97 9.84 58 416733 38132 70473521
Paraesthesia 86.03 9.84 1266 415525 144271 70367382
Product complaint 84.93 9.84 208 416583 12023 70499630
Irritable bowel syndrome 84.04 9.84 105 416686 50745 70460908
Dyskinesia 80.04 9.84 463 416328 40611 70471042
Impaired healing 79.99 9.84 201 416590 74173 70437480
Cardiac arrest 79.95 9.84 1352 415439 158482 70353171
Burning sensation 79.52 9.84 558 416233 52312 70459341
Inadequate analgesia 77.68 9.84 108 416683 4014 70507639
Amnesia 77.59 9.84 549 416242 51606 70460047
Multiple organ dysfunction syndrome 76.01 9.84 353 416438 108162 70403491
Depressed level of consciousness 74.01 9.84 813 415978 86618 70425035
Mood altered 73.82 9.84 239 416552 16236 70495417
Nightmare 73.28 9.84 291 416500 21865 70489788
Malignant neoplasm progression 72.34 9.84 419 416372 121320 70390333
Serotonin syndrome 72.08 9.84 459 416332 41655 70469998
Ataxia 72.07 9.84 299 416492 22918 70488735
Pancytopenia 71.79 9.84 556 416235 150551 70361102
Dysarthria 71.71 9.84 618 416173 61695 70449958
Drug reaction with eosinophilia and systemic symptoms 71.14 9.84 146 416645 57867 70453786
Septic shock 70.71 9.84 379 416412 111879 70399774
Muscle twitching 70.13 9.84 266 416525 19561 70492092
Urinary tract infection 69.71 9.84 1935 414856 246834 70264819
Abdominal discomfort 68.76 9.84 869 415922 213789 70297864
Drug use disorder 68.01 9.84 149 416642 8002 70503651
Hypokalaemia 67.45 9.84 472 416319 130716 70380937
Intervertebral disc degeneration 67.19 9.84 207 416584 13693 70497960
Crying 66.58 9.84 274 416517 20925 70490728
Mental disorder 66.31 9.84 335 416456 27905 70483748
Treatment failure 65.86 9.84 536 416255 143606 70368047
Stiff person syndrome 65.61 9.84 35 416756 322 70511331
Hallucination, visual 64.71 9.84 342 416449 28995 70482658
Swollen joint count increased 64.50 9.84 4 416787 13696 70497957
Seizure 63.12 9.84 1429 415362 176533 70335120
Hyperaesthesia 62.54 9.84 173 416618 10769 70500884
Haemophagocytic lymphohistiocytosis 62.01 9.84 19 416772 19593 70492060
Restless legs syndrome 61.72 9.84 243 416548 18185 70493468
Atrial fibrillation 61.41 9.84 740 416051 183608 70328045
Euphoric mood 59.84 9.84 128 416663 6761 70504892
Off label use 59.68 9.84 3668 413123 739392 69772261
Live birth 59.36 9.84 6 416785 13773 70497880
Trigeminal neuralgia 59.11 9.84 86 416705 3335 70508318
Melaena 58.52 9.84 155 416636 56200 70455453
Premature delivery 58.33 9.84 26 416765 21278 70490375
Muscular weakness 58.21 9.84 1139 415652 137197 70374456
Unresponsive to stimuli 58.17 9.84 512 416279 51419 70460234
Fatigue 58.04 9.84 5608 411183 818711 69692942
Coordination abnormal 57.20 9.84 216 416575 15850 70495803
Head injury 57.13 9.84 370 416421 33771 70477882
Appendicolith 56.98 9.84 112 416679 5568 70506085
Nervousness 56.90 9.84 345 416446 30775 70480878
Therapeutic response unexpected 56.75 9.84 235 416556 17996 70493657
Device expulsion 56.58 9.84 30 416761 22216 70489437
Pneumocystis jirovecii pneumonia 56.42 9.84 56 416735 30026 70481627
Spinal operation 55.86 9.84 126 416665 6902 70504751
Ill-defined disorder 55.76 9.84 152 416639 54589 70457064
Intentional product use issue 55.69 9.84 445 416346 119697 70391956
Back disorder 55.48 9.84 162 416629 10402 70501251
Rash 55.24 9.84 2445 414346 508117 70003536
Alopecia 54.80 9.84 828 415963 197662 70313991
Intervertebral disc protrusion 54.71 9.84 261 416530 21242 70490411
Death 54.43 9.84 3584 413207 506477 70005176
Speech disorder 54.25 9.84 494 416297 50086 70461567
Right atrial hypertrophy 54.19 9.84 38 416753 592 70511061
Back pain 53.79 9.84 2024 414767 269128 70242525
Bradyphrenia 53.66 9.84 154 416637 9792 70501861
Liver injury 53.14 9.84 100 416691 40935 70470718
Hepatic failure 52.90 9.84 168 416623 57457 70454196
Rheumatic fever 52.53 9.84 19 416772 17641 70494012
Blood lactate dehydrogenase increased 51.56 9.84 79 416712 35048 70476605
Bone erosion 51.14 9.84 13 416778 15160 70496493
Pleural effusion 50.72 9.84 517 416274 132347 70379306
Anticipatory anxiety 50.54 9.84 44 416747 954 70510699
Infection 50.38 9.84 903 415888 209882 70301771
Anger 50.26 9.84 208 416583 15924 70495729
Poisoning 50.09 9.84 264 416527 22358 70489295
Disseminated intravascular coagulation 49.86 9.84 75 416716 33523 70478130
Renal impairment 49.77 9.84 573 416218 143364 70368289
Pain 49.00 9.84 4310 412481 624506 69887147
Feeling drunk 48.60 9.84 90 416701 4277 70507376
Graft versus host disease 48.51 9.84 14 416777 15009 70496644
Urinary incontinence 48.18 9.84 384 416407 37458 70474195
Nasopharyngitis 48.16 9.84 968 415823 221238 70290415
Presbyacusis 48.07 9.84 68 416723 2569 70509084
Leukopenia 47.87 9.84 398 416393 106162 70405491
Irritability 47.64 9.84 386 416405 37839 70473814
Jaundice 47.47 9.84 144 416647 49964 70461689
Colitis 47.44 9.84 203 416588 63611 70448042
Anorgasmia 47.37 9.84 44 416747 1041 70510612
Hypersomnia 47.13 9.84 244 416547 20520 70491133
Asterixis 45.90 9.84 64 416727 2385 70509268
Gait inability 45.74 9.84 451 416340 46724 70464929
Eosinophilia 45.69 9.84 106 416685 40213 70471440
Swelling 45.59 9.84 806 415985 187733 70323920
Osteonecrosis of jaw 45.50 9.84 109 416682 40893 70470760
Diabetic neuropathy 45.42 9.84 104 416687 5754 70505899
Diplopia 45.25 9.84 302 416489 27845 70483808
Rheumatoid nodule 45.17 9.84 16 416775 15051 70496602
Hepatotoxicity 44.90 9.84 122 416669 43864 70467789
Stomatitis 44.66 9.84 511 416280 128000 70383653
Rash maculo-papular 44.57 9.84 150 416641 50395 70461258
Post transplant lymphoproliferative disorder 44.38 9.84 5 416786 10540 70501113
Myocardial stunning 44.37 9.84 22 416769 171 70511482
Erythema 44.25 9.84 866 415925 198697 70312956
Impaired driving ability 44.23 9.84 92 416699 4765 70506888
Suspected suicide 44.05 9.84 133 416658 8701 70502952
Red blood cell sedimentation rate abnormal 43.54 9.84 30 416761 19273 70492380
Agitation 43.48 9.84 781 416010 92594 70419059
Toxic epidermal necrolysis 43.23 9.84 106 416685 39451 70472202
Anaphylactic shock 43.11 9.84 78 416713 32412 70479241
Transplant rejection 42.66 9.84 27 416764 18144 70493509
Somatic symptom disorder 42.53 9.84 56 416735 1974 70509679
Transaminases increased 42.51 9.84 138 416653 46880 70464773
Acute respiratory distress syndrome 42.43 9.84 114 416677 41140 70470513
Acute myeloid leukaemia 42.21 9.84 73 416718 30867 70480786
Delirium 42.09 9.84 644 416147 73970 70437683
Disorientation 42.07 9.84 523 416268 57400 70454253
Drug intolerance 42.05 9.84 1007 415784 224680 70286973
Aspergillus infection 41.34 9.84 27 416764 17841 70493812
Accidental poisoning 41.05 9.84 49 416742 1561 70510092
Gait spastic 41.04 9.84 40 416751 1007 70510646
Myokymia 40.88 9.84 18 416773 103 70511550
Alanine aminotransferase increased 40.77 9.84 615 416176 146865 70364788
Blister 40.52 9.84 386 416405 100140 70411513
Venoocclusive liver disease 40.40 9.84 7 416784 10671 70500982
Proteinuria 40.35 9.84 69 416722 29305 70482348
Agranulocytosis 40.22 9.84 113 416678 40185 70471468
Pleural thickening 40.21 9.84 65 416726 2767 70508886
Hyperreflexia 39.93 9.84 115 416676 7327 70504326
Nausea 39.88 9.84 5648 411143 846440 69665213
Sinusitis 39.42 9.84 728 416063 168467 70343186
Hyperhidrosis 38.94 9.84 1031 415760 130555 70381098
Full blood count decreased 38.67 9.84 257 416534 23661 70487992
Neutrophil count decreased 38.48 9.84 310 416481 83246 70428407
Drug-induced liver injury 38.42 9.84 184 416607 55929 70455724
Blood bilirubin increased 38.40 9.84 201 416590 59700 70451953
Pleural fibrosis 38.39 9.84 79 416712 4060 70507593
Bronchopulmonary aspergillosis 38.36 9.84 40 416751 20962 70490691
Lymphoedema 37.99 9.84 148 416643 11021 70500632
Neck pain 37.47 9.84 575 416216 66082 70445571
Influenza like illness 36.51 9.84 563 416228 64768 70446885
Epistaxis 36.47 9.84 406 416385 102221 70409432
Psoriatic arthropathy 36.32 9.84 227 416564 64544 70447109
Shock haemorrhagic 35.96 9.84 32 416759 18074 70493579
Therapeutic response decreased 35.89 9.84 199 416592 58254 70453399
Cytomegalovirus viraemia 35.74 9.84 12 416779 11673 70499980
Posterior reversible encephalopathy syndrome 35.70 9.84 55 416736 24347 70487306
Constipation 35.53 9.84 1819 414972 250619 70261034
Haematotoxicity 35.43 9.84 18 416773 13656 70497997
Relapsing-remitting multiple sclerosis 35.36 9.84 42 416749 1331 70510322
Mental impairment 35.25 9.84 197 416594 17058 70494595
Joint injury 35.22 9.84 275 416516 26657 70484996
Disturbance in attention 34.98 9.84 396 416395 42498 70469155
Dry mouth 34.83 9.84 595 416196 69862 70441791
Colitis ulcerative 33.95 9.84 95 416696 33828 70477825
Injection site mass 33.94 9.84 204 416587 18139 70493514
Blood magnesium increased 33.80 9.84 66 416725 3265 70508388
Right ventricular hypertrophy 33.75 9.84 42 416749 1398 70510255
Thrombotic microangiopathy 33.73 9.84 33 416758 17815 70493838
Complex regional pain syndrome 33.68 9.84 47 416744 1753 70509900
Prostate cancer 33.67 9.84 84 416707 31079 70480574
Needle fatigue 33.43 9.84 31 416760 732 70510921
Epstein-Barr virus infection 33.27 9.84 18 416773 13180 70498473
Headache 33.16 9.84 3895 412896 576510 69935143
Paranoia 33.10 9.84 194 416597 17094 70494559
Schizophrenia 32.86 9.84 30 416761 16738 70494915
Panniculitis 32.59 9.84 11 416780 10665 70500988
Ankle fracture 32.56 9.84 177 416614 15167 70496486
Hypermobility syndrome 32.20 9.84 26 416765 506 70511147
Cholangitis 31.77 9.84 14 416777 11535 70500118
Somatic delusion 31.75 9.84 29 416762 671 70510982
Neutropenic sepsis 31.72 9.84 61 416730 24769 70486884
Cystitis haemorrhagic 31.72 9.84 6 416785 8587 70503066
Vertigo 31.33 9.84 530 416261 62113 70449540
Dysstasia 31.24 9.84 254 416537 24925 70486728
Neovascularisation 31.11 9.84 36 416755 1109 70510544
Cholestasis 31.04 9.84 160 416631 47712 70463941
Muscle tightness 30.82 9.84 144 416647 11618 70500035
Surgery 30.70 9.84 290 416501 29699 70481954
Labelled drug-drug interaction medication error 30.19 9.84 60 416731 24067 70487586
Cerebral haemorrhage 30.08 9.84 189 416602 53675 70457978
Lupus-like syndrome 30.07 9.84 15 416776 11500 70500153
Cerebral infarction 30.05 9.84 140 416651 42869 70468784
Pulmonary tuberculosis 29.99 9.84 5 416786 7840 70503813
Tubulointerstitial nephritis 29.96 9.84 97 416694 32979 70478674
Gastrointestinal haemorrhage 29.93 9.84 598 416193 136810 70374843
Pregnancy 29.88 9.84 59 416732 23722 70487931
Pulmonary toxicity 29.85 9.84 13 416778 10785 70500868
Gamma-glutamyltransferase increased 29.80 9.84 175 416616 50510 70461143
Victim of child abuse 29.80 9.84 32 416759 906 70510747
Central nervous system lesion 29.43 9.84 148 416643 12305 70499348
Limb injury 29.41 9.84 255 416536 25497 70486156
Gastrointestinal disorder 29.35 9.84 439 416352 104988 70406665
Autonomic nervous system imbalance 29.29 9.84 73 416718 4266 70507387
Nerve injury 28.88 9.84 111 416680 8213 70503440
Therapy non-responder 28.64 9.84 301 416490 76614 70435039
Tuberculosis 28.59 9.84 27 416764 14821 70496832
Drug eruption 28.53 9.84 127 416664 39369 70472284
Product use issue 28.45 9.84 822 415969 179115 70332538
Quality of life decreased 28.43 9.84 112 416679 8383 70503270
Incoherent 28.34 9.84 101 416690 7205 70504448
Hostility 28.33 9.84 49 416742 2206 70509447
Nerve compression 28.33 9.84 109 416682 8069 70503584
Thinking abnormal 28.32 9.84 143 416648 11908 70499745
Hepatocellular injury 28.25 9.84 157 416634 45934 70465719
Acute kidney injury 28.22 9.84 2403 414388 472221 70039432
Pathogen resistance 28.18 9.84 22 416769 13257 70498396
Pulmonary fibrosis 28.12 9.84 105 416686 34205 70477448
Acute hepatic failure 28.06 9.84 77 416714 27595 70484058
Drug abuser 28.04 9.84 87 416704 5777 70505876
Therapy cessation 27.96 9.84 312 416479 33364 70478289
Tumour lysis syndrome 27.70 9.84 52 416739 21308 70490345
Pituitary tumour benign 27.48 9.84 51 416740 2428 70509225
Panic attack 27.37 9.84 223 416568 21896 70489757
Drug screen positive 27.33 9.84 86 416705 5754 70505899
Dyspnoea 27.26 9.84 4040 412751 766020 69745633
Metabolic encephalopathy 26.98 9.84 109 416682 8254 70503399
Haemoglobin decreased 26.98 9.84 960 415831 204199 70307454
Bronchial wall thickening 26.92 9.84 47 416744 2132 70509521
Coma 26.70 9.84 718 416073 91126 70420527
Skin necrosis 26.54 9.84 34 416757 16257 70495396
Erectile dysfunction 26.49 9.84 153 416638 13409 70498244
Blood parathyroid hormone decreased 26.35 9.84 10 416781 9014 70502639
Metastases to liver 26.24 9.84 72 416719 25806 70485847
Parasomnia 26.14 9.84 23 416768 506 70511147
Obsessive-compulsive disorder 25.98 9.84 80 416711 5290 70506363
Myocarditis 25.95 9.84 44 416747 18749 70492904
Acute coronary syndrome 25.94 9.84 49 416742 20030 70491623
Hypertonic bladder 25.91 9.84 64 416727 3719 70507934
Pneumonitis 25.86 9.84 201 416590 54396 70457257
Circulatory collapse 25.66 9.84 114 416677 35360 70476293
Asthenia 25.53 9.84 3067 413724 454599 70057054
Angioedema 25.48 9.84 259 416532 66351 70445302
Hip fracture 25.39 9.84 266 416525 27997 70483656
Dysphemia 25.38 9.84 58 416733 3205 70508448
Therapeutic product effect variable 25.31 9.84 40 416751 1670 70509983
Muscle spasticity 25.17 9.84 200 416591 19489 70492164
Transplant dysfunction 25.13 9.84 5 416786 6904 70504749
Hypomagnesaemia 24.90 9.84 139 416652 40625 70471028
Arthralgia 24.88 9.84 2584 414207 500806 70010847
Enterocolitis 24.87 9.84 24 416767 13042 70498611
Facial pain 24.73 9.84 105 416686 8131 70503522
Radiculopathy 24.69 9.84 85 416706 5960 70505693
Haemolysis 24.69 9.84 19 416772 11532 70500121
Focal dyscognitive seizures 24.68 9.84 59 416732 3358 70508295
Acute myocardial infarction 24.47 9.84 292 416499 72595 70439058
Chronic graft versus host disease 24.41 9.84 5 416786 6765 70504888
Acute graft versus host disease in skin 24.27 9.84 6 416785 7131 70504522
Drug effective for unapproved indication 24.27 9.84 71 416720 4564 70507089
Pollakiuria 24.24 9.84 302 416489 33159 70478494
Unintentional medical device removal 24.21 9.84 6 416785 7118 70504535
Device use error 24.03 9.84 5 416786 6691 70504962
Epigastric discomfort 23.92 9.84 95 416696 7138 70504515
Colorectal cancer 23.73 9.84 10 416781 8460 70503193
Spinal osteoarthritis 23.67 9.84 163 416628 15185 70496468
Micturition urgency 23.66 9.84 130 416661 11184 70500469
Bipolar disorder 23.63 9.84 98 416693 7510 70504143
Exposure via ingestion 23.57 9.84 73 416718 4842 70506811
Pulmonary function test abnormal 23.52 9.84 58 416733 3367 70508286
Peritonitis 23.49 9.84 77 416714 26082 70485571
Cellulitis 23.46 9.84 754 416037 98174 70413479
Bradypnoea 23.39 9.84 78 416713 5381 70506272
Cyst 23.25 9.84 141 416650 12578 70499075
Cardiac failure acute 23.18 9.84 42 416749 17445 70494208
Knee arthroplasty 23.18 9.84 113 416678 34188 70477465
Appendicitis 23.08 9.84 173 416618 16560 70495093
Intentional self-injury 23.07 9.84 286 416505 31364 70480289
Rib fracture 22.94 9.84 239 416552 25117 70486536
Device adhesion issue 22.88 9.84 4 416787 6059 70505594
Febrile bone marrow aplasia 22.86 9.84 22 416769 11969 70499684
Lactic acidosis 22.79 9.84 258 416533 64766 70446887
Limb discomfort 22.77 9.84 271 416520 29434 70482219
Encephalopathy 22.74 9.84 498 416293 61163 70450490
Hyperbilirubinaemia 22.73 9.84 63 416728 22505 70489148
Cognitive disorder 22.70 9.84 493 416298 60463 70451190
Gestational diabetes 22.56 9.84 4 416787 5997 70505656
Disorganised speech 22.45 9.84 39 416752 1762 70509891
Congenital multiplex arthrogryposis 22.45 9.84 7 416784 11 70511642
Blood creatine phosphokinase increased 22.30 9.84 241 416550 61022 70450631
Hip arthroplasty 22.22 9.84 87 416704 27953 70483700
Complications of transplanted kidney 22.21 9.84 4 416787 5930 70505723
Concussion 22.17 9.84 104 416687 8405 70503248
Toxic skin eruption 22.05 9.84 54 416737 20108 70491545
Palmar-plantar erythrodysaesthesia syndrome 22.00 9.84 97 416694 30150 70481503
Bone density decreased 21.93 9.84 21 416770 11453 70500200
Pre-existing condition improved 21.90 9.84 72 416719 4930 70506723
Herpes zoster 21.90 9.84 656 416135 84579 70427074
Visual impairment 21.81 9.84 622 416169 79628 70432025
Slow speech 21.72 9.84 43 416748 2149 70509504
Premature labour 21.53 9.84 10 416781 7990 70503663
Hepatitis fulminant 21.49 9.84 6 416785 6575 70505078
Pseudomonas infection 21.47 9.84 50 416741 18944 70492709
Foot fracture 21.30 9.84 192 416599 19408 70492245
Alcoholism 21.30 9.84 66 416725 4379 70507274
Rales 21.11 9.84 43 416748 17092 70494561
Blood pressure increased 21.09 9.84 899 415892 187618 70324035
Nephrotic syndrome 20.89 9.84 19 416772 10621 70501032
Visual snow syndrome 20.85 9.84 8 416783 30 70511623
Hypertension 20.81 9.84 1478 415313 294555 70217098
Inflammation 20.72 9.84 331 416460 78334 70433319
Conversion disorder 20.69 9.84 37 416754 1711 70509942
Dermatitis exfoliative generalised 20.67 9.84 6 416785 6408 70505245
Device difficult to use 20.57 9.84 20 416771 10829 70500824
Oesophageal carcinoma 20.54 9.84 15 416776 9351 70502302
Hepatitis 20.53 9.84 191 416600 49789 70461864
Stress 20.52 9.84 534 416257 67432 70444221
Alanine aminotransferase abnormal 20.30 9.84 11 416780 8048 70503605
Analgesic drug level above therapeutic 20.27 9.84 19 416772 455 70511198
Deafness neurosensory 20.26 9.84 85 416706 6547 70505106
Renal failure 20.25 9.84 906 415885 188164 70323489
Lung disorder 20.15 9.84 287 416504 69197 70442456
Neutropenic colitis 20.14 9.84 3 416788 5111 70506542
Gastric cancer 20.09 9.84 14 416777 8941 70502712
Stevens-Johnson syndrome 20.05 9.84 126 416665 35781 70475872
Shock 20.01 9.84 147 416644 40278 70471375
Drug tolerance decreased 19.98 9.84 17 416774 9816 70501837
Ischaemic stroke 19.98 9.84 103 416688 30717 70480936
Tooth loss 19.96 9.84 83 416708 6367 70505286
Sacroiliitis 19.96 9.84 53 416738 3220 70508433
Endophthalmitis 19.88 9.84 6 416785 6249 70505404
Aspartate aminotransferase increased 19.83 9.84 581 416210 126397 70385256
Blood cholesterol increased 19.75 9.84 264 416527 64340 70447313
Developmental hip dysplasia 19.60 9.84 13 416778 184 70511469
Sweat gland disorder 19.60 9.84 13 416778 184 70511469
Blood pressure fluctuation 19.58 9.84 237 416554 58775 70452878
Haematochezia 19.42 9.84 307 416484 72774 70438879
Oesophageal spasm 19.40 9.84 51 416740 3080 70508573
Haemorrhage 19.39 9.84 361 416430 83454 70428199
Uveitis 19.37 9.84 36 416755 14809 70496844
Skin toxicity 19.37 9.84 9 416782 7189 70504464
Psychotic disorder due to a general medical condition 19.33 9.84 15 416776 275 70511378
Decreased interest 19.27 9.84 54 416737 3387 70508266
Antidepressant drug level above therapeutic 19.23 9.84 21 416770 606 70511047
Cough 19.21 9.84 1648 415143 323729 70187924
Metabolic acidosis 19.19 9.84 314 416477 74032 70437621
Duodenal ulcer 19.12 9.84 38 416753 15242 70496411
Dysphoria 19.03 9.84 64 416727 4434 70507219
Haematuria 18.99 9.84 261 416530 63312 70448341
Breakthrough pain 18.85 9.84 30 416761 1260 70510393
Hyperuricaemia 18.80 9.84 22 416769 10944 70500709
Delirium tremens 18.75 9.84 22 416769 688 70510965
Ejection fraction decreased 18.73 9.84 105 416686 30657 70480996
Violence-related symptom 18.70 9.84 22 416769 690 70510963
Graft versus host disease in skin 18.64 9.84 5 416786 5625 70506028
Granuloma skin 18.61 9.84 11 416780 7671 70503982
Subileus 18.56 9.84 4 416787 5223 70506430
Loss of consciousness 18.53 9.84 1105 415686 154611 70357042
Chorea 18.50 9.84 39 416752 2039 70509614
Allodynia 18.47 9.84 31 416760 1362 70510291
Rib deformity 18.45 9.84 12 416779 164 70511489
Nephropathy toxic 18.41 9.84 52 416739 18462 70493191
Skin reaction 18.40 9.84 34 416757 14015 70497638
Phantom limb syndrome 18.30 9.84 16 416775 349 70511304
Psychomotor hyperactivity 18.24 9.84 154 416637 15279 70496374
Binocular eye movement disorder 18.21 9.84 10 416781 98 70511555
Diffuse axonal injury 18.21 9.84 10 416781 98 70511555
Depressed mood 18.15 9.84 360 416431 43460 70468193
Tardive dyskinesia 18.10 9.84 110 416681 9819 70501834
Creatinine renal clearance decreased 18.09 9.84 47 416744 17153 70494500
Tinnitus 18.06 9.84 306 416485 35870 70475783
Body height decreased 18.04 9.84 92 416699 7691 70503962
Blood pressure systolic abnormal 18.03 9.84 30 416761 12879 70498774
Epidural lipomatosis 17.92 9.84 25 416766 932 70510721
Eosinophilic colitis 17.90 9.84 17 416774 414 70511239
Disease progression 17.76 9.84 746 416045 155926 70355727
Osteosclerosis 17.74 9.84 55 416736 3650 70508003
Adenovirus infection 17.62 9.84 12 416779 7756 70503897
Diffuse large B-cell lymphoma 17.59 9.84 32 416759 13270 70498383
Autoimmune haemolytic anaemia 17.52 9.84 12 416779 7734 70503919
Pruritus 17.43 9.84 1771 415020 343789 70167864
Breast cancer stage I 17.42 9.84 7 416784 6095 70505558
Myelodysplastic syndrome 17.42 9.84 103 416688 29682 70481971
Cytokine release syndrome 17.42 9.84 88 416703 26379 70485274
Obstruction 17.39 9.84 54 416737 3587 70508066
Ear deformity acquired 17.28 9.84 5 416786 5 70511648
Atrioventricular block 17.25 9.84 30 416761 12658 70498995
Micrognathia 17.16 9.84 6 416785 16 70511637
Fibromyalgia 17.13 9.84 385 416406 47489 70464164
Bone cyst 16.98 9.84 46 416745 2828 70508825
Condition aggravated 16.89 9.84 2228 414563 425407 70086246
Sensory disturbance 16.87 9.84 139 416652 13693 70497960
Arteriovenous malformation 16.84 9.84 33 416758 1637 70510016
Bladder cancer 16.73 9.84 49 416742 17193 70494460
Idiopathic neutropenia 16.57 9.84 4 416787 0 70511653
Tachycardia 16.52 9.84 762 416029 157784 70353869
Sports injury 16.45 9.84 11 416780 158 70511495
Affective disorder 16.36 9.84 87 416704 7392 70504261
Pneumonia bacterial 16.36 9.84 47 416744 16594 70495059
Injection site induration 16.35 9.84 101 416690 9067 70502586
Bradycardia 16.17 9.84 584 416207 124031 70387622
Spinal stenosis 16.16 9.84 144 416647 14509 70497144
Hyperthyroidism 16.13 9.84 62 416729 20029 70491624
Progressive multiple sclerosis 16.10 9.84 22 416769 804 70510849
Blood pressure systolic increased 16.08 9.84 238 416553 57021 70454632
Cervical spinal stenosis 16.08 9.84 37 416754 2054 70509599
Mouth ulceration 16.01 9.84 127 416664 34222 70477431
Kidney transplant rejection 16.01 9.84 21 416770 9940 70501713
Hypoxic-ischaemic encephalopathy 15.98 9.84 85 416706 7223 70504430
Post herpetic neuralgia 15.94 9.84 41 416750 2443 70509210
Drug tolerance increased 15.90 9.84 19 416772 606 70511047
Respiratory disorder 15.86 9.84 150 416641 38973 70472680
Dependence 15.85 9.84 39 416752 2261 70509392
Lumbar radiculopathy 15.83 9.84 35 416756 1891 70509762
Nephrogenic systemic fibrosis 15.79 9.84 74 416717 5978 70505675
Deprescribing error 15.74 9.84 6 416785 22 70511631
Aggression 15.61 9.84 384 416407 48062 70463591
Ascites 15.60 9.84 291 416500 67256 70444397
Product communication issue 15.55 9.84 21 416770 759 70510894
Colitis microscopic 15.51 9.84 18 416773 8987 70502666
Myoclonic epilepsy 15.47 9.84 34 416757 1830 70509823
Tendonitis 15.46 9.84 72 416719 22050 70489603
Cystitis 15.41 9.84 373 416418 46568 70465085
Long QT syndrome 15.39 9.84 6 416785 5321 70506332
Urinary retention 15.38 9.84 411 416380 52109 70459544
Dry eye 15.37 9.84 271 416520 32011 70479642
Abnormal behaviour 15.34 9.84 288 416503 34421 70477232
Brief psychotic disorder with marked stressors 15.20 9.84 13 416778 275 70511378
Anal abscess 15.17 9.84 16 416775 8342 70503311
Encephalitis 15.16 9.84 36 416755 13549 70498104
Hypokinesia 15.16 9.84 163 416628 17269 70494384
Sensory loss 15.15 9.84 117 416674 11302 70500351
Snoring 15.10 9.84 63 416728 4841 70506812
Carpal tunnel syndrome 15.07 9.84 160 416631 16897 70494756
Platelet count decreased 15.05 9.84 875 415916 177347 70334306
Radiation necrosis 15.03 9.84 15 416776 389 70511264
Lip oedema 15.00 9.84 7 416784 5576 70506077
Congenital neuropathy 14.96 9.84 5 416786 11 70511642
Urine amphetamine positive 14.96 9.84 8 416783 74 70511579
Varicella zoster virus infection 14.95 9.84 3 416788 4117 70507536
Mucormycosis 14.93 9.84 15 416776 7999 70503654
Osteopenia 14.93 9.84 157 416634 16540 70495113
Persistent depressive disorder 14.93 9.84 24 416767 1017 70510636
Aphasia 14.91 9.84 346 416445 42903 70468750
Head banging 14.89 9.84 17 416774 516 70511137
Drug screen negative 14.89 9.84 13 416778 283 70511370
Arthrofibrosis 14.76 9.84 9 416782 109 70511544
Abortion spontaneous 14.74 9.84 93 416698 26386 70485267
Pre-eclampsia 14.73 9.84 10 416781 6475 70505178
Large intestine perforation 14.70 9.84 35 416756 13160 70498493
Alcohol withdrawal syndrome 14.62 9.84 33 416758 1808 70509845
Myofascial pain syndrome 14.61 9.84 33 416758 1809 70509844
Laboratory test abnormal 14.60 9.84 223 416568 25600 70486053
Paranasal cyst 14.60 9.84 15 416776 403 70511250
Teeth brittle 14.59 9.84 16 416775 464 70511189
Antipsychotic drug level below therapeutic 14.52 9.84 23 416768 962 70510691
Atonic urinary bladder 14.51 9.84 8 416783 79 70511574
Rectal haemorrhage 14.47 9.84 286 416505 65545 70446108
Red blood cell sedimentation rate increased 14.47 9.84 151 416640 38491 70473162
Blood pressure decreased 14.47 9.84 418 416373 91097 70420556
Self-medication 14.41 9.84 58 416733 4385 70507268
Respiratory rate decreased 14.38 9.84 61 416730 4721 70506932
Accidental exposure to product 14.37 9.84 101 416690 27950 70483703
Hypothyroidism 14.34 9.84 186 416605 45569 70466084
Liver disorder 14.30 9.84 265 416526 61303 70450350
Movement disorder 14.28 9.84 210 416581 23919 70487734
Somnambulism 14.23 9.84 65 416726 5195 70506458
Fear of injection 14.23 9.84 11 416780 6661 70504992
Hot flush 14.23 9.84 387 416404 49197 70462456
Facial spasm 14.21 9.84 19 416772 680 70510973
Neurogenic bladder 14.19 9.84 52 416739 3761 70507892
Pericardial effusion 14.16 9.84 167 416624 41609 70470044
Product physical issue 14.11 9.84 51 416740 3663 70507990
Polyarthritis 14.11 9.84 26 416765 10730 70500923
Post laminectomy syndrome 14.02 9.84 13 416778 307 70511346
Hepatocellular carcinoma 14.00 9.84 24 416767 10184 70501469
Postmortem blood drug level increased 13.99 9.84 20 416771 763 70510890
Asthma 13.93 9.84 574 416217 120219 70391434
Hypercalcaemia 13.86 9.84 132 416659 34253 70477400
Acute pulmonary oedema 13.84 9.84 37 416754 13375 70498278
Lymphoproliferative disorder 13.83 9.84 7 416784 5322 70506331
Abnormal sleep-related event 13.82 9.84 21 416770 847 70510806
Secondary progressive multiple sclerosis 13.77 9.84 27 416764 1340 70510313
Cerebral disorder 13.69 9.84 62 416729 4937 70506716
Cytomegalovirus chorioretinitis 13.69 9.84 7 416784 5291 70506362
Spinal cord injury 13.68 9.84 23 416768 1012 70510641
Product use in unapproved indication 13.68 9.84 1406 415385 206072 70305581
Drug diversion 13.60 9.84 25 416766 1181 70510472
Lumbar spinal stenosis 13.57 9.84 61 416730 4842 70506811
Asphyxia 13.57 9.84 25 416766 10317 70501336
Substance use 13.57 9.84 19 416772 711 70510942
Cytomegalovirus colitis 13.53 9.84 4 416787 4222 70507431
Inflammatory marker increased 13.47 9.84 21 416770 9253 70502400
Organising pneumonia 13.45 9.84 24 416767 10026 70501627
Accident 13.43 9.84 81 416710 7210 70504443
Immunosuppressant drug level increased 13.41 9.84 16 416775 7891 70503762
Road traffic accident 13.39 9.84 282 416509 34400 70477253
Heteroplasia 13.36 9.84 4 416787 5 70511648
Tachyphrenia 13.35 9.84 33 416758 1918 70509735
Tenosynovitis 13.35 9.84 40 416751 13936 70497717
Liver function test abnormal 13.34 9.84 266 416525 60880 70450773
Stillbirth 13.33 9.84 3 416788 3802 70507851
Face oedema 13.29 9.84 92 416699 25547 70486106
Hypercholesterolaemia 13.24 9.84 58 416733 18059 70493594
Human herpesvirus 6 infection 13.19 9.84 6 416785 4853 70506800
Cytomegalovirus test positive 13.19 9.84 8 416783 5500 70506153
Altered state of consciousness 13.18 9.84 161 416630 39861 70471792
Jaundice cholestatic 13.15 9.84 21 416770 9163 70502490
Brain injury 13.11 9.84 107 416684 10510 70501143
Hypocalcaemia 13.10 9.84 185 416606 44674 70466979
Thrombosis 13.09 9.84 555 416236 74850 70436803
Haemolytic uraemic syndrome 13.06 9.84 4 416787 4126 70507527
Opisthotonus 13.05 9.84 18 416773 664 70510989
Hypometabolism 13.05 9.84 8 416783 98 70511555
Prescription drug used without a prescription 13.00 9.84 43 416748 2954 70508699
Exostosis 12.88 9.84 135 416656 14210 70497443
Monoparesis 12.88 9.84 45 416746 3179 70508474
Gastrointestinal necrosis 12.87 9.84 7 416784 5111 70506542
Pulmonary alveolar haemorrhage 12.79 9.84 26 416765 10343 70501310
Myopathy 12.76 9.84 61 416730 18551 70493102
Accidental overdose 12.74 9.84 283 416508 34838 70476815
Atrioventricular block complete 12.69 9.84 46 416745 15117 70496536
Respiratory tract infection 12.69 9.84 174 416617 42224 70469429
Haematoma 12.66 9.84 204 416587 48214 70463439
Eyelid myoclonus 12.64 9.84 8 416783 104 70511549
Abnormal dreams 12.64 9.84 106 416685 10497 70501156
Product adhesion issue 12.58 9.84 38 416753 2486 70509167
Prophylaxis 12.57 9.84 4 416787 7 70511646
Nocturia 12.48 9.84 118 416673 12086 70499567
Breast cancer stage II 12.47 9.84 8 416783 5338 70506315
Eyelid oedema 12.47 9.84 36 416755 12691 70498962
Cardiac failure chronic 12.45 9.84 26 416765 10243 70501410
CSF neutrophil count increased 12.43 9.84 3 416788 0 70511653
Turbinectomy 12.43 9.84 3 416788 0 70511653
Tinel's sign 12.43 9.84 3 416788 0 70511653
Muscle relaxant drug level above therapeutic 12.43 9.84 3 416788 0 70511653
Ligamentum flavum hypertrophy 12.43 9.84 3 416788 0 70511653
Systemic candida 12.38 9.84 10 416781 5924 70505729
Gingival atrophy 12.38 9.84 7 416784 73 70511580
Hypoalbuminaemia 12.34 9.84 64 416727 19058 70492595
Hyperacusis 12.32 9.84 33 416758 2015 70509638
Arrhythmia 12.32 9.84 244 416547 55899 70455754
Hypertransaminasaemia 12.29 9.84 21 416770 8922 70502731
Rapid eye movements sleep abnormal 12.28 9.84 11 416780 248 70511405
Intercepted medication error 12.28 9.84 20 416771 857 70510796
Metastases to bone 12.24 9.84 79 416712 22297 70489356
Pneumonia fungal 12.24 9.84 25 416766 9928 70501725
JC polyomavirus test positive 12.23 9.84 25 416766 1279 70510374
Osteomyelitis 12.19 9.84 248 416543 30070 70481583
Formication 12.19 9.84 57 416734 4600 70507053
Generalised tonic-clonic seizure 12.19 9.84 326 416465 41335 70470318
Ventricular tachycardia 12.19 9.84 146 416645 36277 70475376
Pneumatosis intestinalis 12.18 9.84 10 416781 5877 70505776
Blood potassium increased 12.17 9.84 227 416564 27099 70484554
Erythema multiforme 12.12 9.84 53 416738 16511 70495142
Drug tolerance 12.12 9.84 80 416711 7348 70504305
Pharyngitis 12.10 9.84 70 416721 20281 70491372
Hypertensive urgency 12.08 9.84 13 416778 369 70511284
Ejaculation delayed 12.07 9.84 9 416782 155 70511498
Increased appetite 12.07 9.84 105 416686 10508 70501145
Gastrointestinal inflammation 12.06 9.84 13 416778 6710 70504943
Bronchial secretion retention 12.01 9.84 42 416749 2968 70508685
Candida infection 11.99 9.84 137 416654 34336 70477317
Caesarean section 11.99 9.84 32 416759 11575 70500078
Toxicologic test abnormal 11.92 9.84 25 416766 1302 70510351
Vulvar basal cell carcinoma 11.90 9.84 5 416786 25 70511628
Muscle contractions involuntary 11.88 9.84 45 416746 3306 70508347
Hypernatraemia 11.85 9.84 37 416754 12724 70498929
Eczema 11.85 9.84 134 416657 33647 70478006
Application site vesicles 11.85 9.84 25 416766 1308 70510345
Haemorrhage intracranial 11.83 9.84 91 416700 24686 70486967
Oesophageal pain 11.83 9.84 49 416742 3753 70507900
Toe operation 11.81 9.84 15 416776 510 70511143
Urticaria 11.78 9.84 812 415979 162237 70349416
Lipodystrophy acquired 11.77 9.84 5 416786 4211 70507442
Burns second degree 11.68 9.84 21 416770 975 70510678
Abortion induced 11.67 9.84 13 416778 6612 70505041
Neuropathic arthropathy 11.66 9.84 12 416779 323 70511330
Peroneal nerve palsy 11.65 9.84 64 416727 5506 70506147
Hepatic encephalopathy 11.64 9.84 79 416712 22039 70489614
Naevus haemorrhage 11.61 9.84 8 416783 121 70511532
Bladder disorder 11.60 9.84 86 416705 8203 70503450
Antipsychotic drug level increased 11.56 9.84 9 416782 5431 70506222
Substance abuse 11.54 9.84 98 416693 9739 70501914
Retinal detachment 11.53 9.84 20 416771 8447 70503206
Bone contusion 11.53 9.84 23 416768 1156 70510497
Infective pulmonary exacerbation of cystic fibrosis 11.47 9.84 35 416756 12123 70499530
Oral herpes 11.47 9.84 89 416702 24097 70487556
Spinal disorder 11.43 9.84 93 416698 9127 70502526
Ligament sprain 11.42 9.84 114 416677 11849 70499804
Implant site inflammation 11.40 9.84 10 416781 219 70511434
Visual field tests abnormal 11.35 9.84 4 416787 11 70511642
Concomitant disease aggravated 11.34 9.84 35 416756 12079 70499574
Breast disorder 11.32 9.84 31 416760 1918 70509735
Basal cell carcinoma 11.31 9.84 135 416656 33563 70478090
Blood potassium decreased 11.30 9.84 328 416463 42093 70469560
Hypoacusis 11.28 9.84 224 416567 27045 70484608
Liver function test increased 11.20 9.84 136 416655 33711 70477942
Cytopenia 11.17 9.84 58 416733 17265 70494388
Screaming 11.17 9.84 47 416744 3625 70508028
Stress cardiomyopathy 11.11 9.84 26 416765 9836 70501817
Chest X-ray abnormal 11.09 9.84 76 416715 7068 70504585
Disturbance in social behaviour 11.08 9.84 5 416786 4062 70507591
Narcolepsy 11.05 9.84 23 416768 1192 70510461
Retinal deposits 11.02 9.84 8 416783 132 70511521
Rash erythematous 10.98 9.84 226 416565 51492 70460161
Radiation pneumonitis 10.94 9.84 4 416787 3689 70507964
Myotonia 10.93 9.84 10 416781 232 70511421
Carotid artery disease 10.92 9.84 33 416758 2160 70509493
Joint destruction 10.91 9.84 7 416784 4671 70506982
Hypotension 10.89 9.84 2153 414638 402228 70109425
Disinhibition 10.87 9.84 34 416757 2267 70509386
Blood urea increased 10.85 9.84 197 416594 45712 70465941
Vertebral foraminal stenosis 10.84 9.84 21 416770 1033 70510620
Leg amputation 10.83 9.84 45 416746 3451 70508202
Acute generalised exanthematous pustulosis 10.83 9.84 50 416741 15347 70496306
Vascular malformation 10.81 9.84 12 416779 353 70511300
Suicidal behaviour 10.81 9.84 41 416750 3015 70508638
Pustular psoriasis 10.79 9.84 7 416784 4643 70507010
Ulcer 10.76 9.84 98 416693 25656 70485997
Anal incontinence 10.75 9.84 146 416645 16344 70495309
Lymphadenopathy 10.72 9.84 212 416579 48579 70463074
Retinal haemorrhage 10.69 9.84 18 416773 7692 70503961
Medical induction of coma 10.68 9.84 7 416784 97 70511556
Glycosylated haemoglobin decreased 10.66 9.84 16 416775 638 70511015
Granuloma 10.64 9.84 18 416773 7677 70503976
Application site burn 10.61 9.84 18 416773 798 70510855
Child abuse 10.59 9.84 12 416779 361 70511292
Infected skin ulcer 10.58 9.84 41 416750 3045 70508608
Oesophageal obstruction 10.56 9.84 19 416772 883 70510770
Left ventricular dysfunction 10.55 9.84 62 416729 17895 70493758
Right ventricular failure 10.55 9.84 82 416709 22192 70489461
Gastric bypass 10.54 9.84 22 416769 1142 70510511
Pulmonary renal syndrome 10.52 9.84 15 416776 571 70511082
Upper respiratory tract inflammation 10.50 9.84 5 416786 3937 70507716
Gastroenteritis 10.49 9.84 125 416666 31088 70480565
Open angle glaucoma 10.44 9.84 13 416778 433 70511220
Myoclonic dystonia 10.43 9.84 4 416787 15 70511638
Free androgen index decreased 10.43 9.84 4 416787 15 70511638
Lymphoma 10.41 9.84 51 416740 15411 70496242
Knee deformity 10.40 9.84 20 416771 978 70510675
Intentional underdose 10.38 9.84 32 416759 2117 70509536
Nervous system cyst 10.37 9.84 3 416788 3 70511650
Subdural haematoma 10.36 9.84 116 416675 29182 70482471
Multiple-drug resistance 10.36 9.84 17 416774 7338 70504315
Nystagmus 10.35 9.84 92 416699 9263 70502390
Disability 10.33 9.84 49 416742 14934 70496719
International normalised ratio increased 10.31 9.84 379 416412 80347 70431306
B-cell lymphoma 10.30 9.84 13 416778 6256 70505397
Intra-abdominal haemorrhage 10.28 9.84 6 416785 4212 70507441
Feeling of body temperature change 10.27 9.84 57 416734 4922 70506731
Decreased appetite 10.27 9.84 1603 415188 303177 70208476
CD8 lymphocytes decreased 10.25 9.84 10 416781 252 70511401
Pineal gland cyst 10.23 9.84 4 416787 16 70511637
Neck surgery 10.16 9.84 27 416764 1641 70510012
Dissociation 10.10 9.84 43 416748 3333 70508320
Subarachnoid haemorrhage 10.10 9.84 70 416721 19434 70492219
Skin plaque 10.08 9.84 27 416764 9756 70501897
Vasoplegia syndrome 10.08 9.84 3 416788 3153 70508500
Lung adenocarcinoma stage I 10.07 9.84 5 416786 39 70511614
Femoral artery dissection 10.07 9.84 5 416786 39 70511614
Injection site reaction 10.07 9.84 373 416418 49479 70462174
Second primary malignancy 10.02 9.84 41 416750 13010 70498643
Food allergy 9.99 9.84 22 416769 8502 70503151
Cortisol abnormal 9.96 9.84 6 416785 71 70511582
Libido decreased 9.96 9.84 56 416735 4860 70506793
Artery dissection 9.93 9.84 9 416782 206 70511447
Metastases to peritoneum 9.93 9.84 5 416786 3814 70507839
Abnormal weight gain 9.92 9.84 33 416758 2273 70509380
Drug screen false positive 9.92 9.84 20 416771 1013 70510640
Arachnoiditis 9.92 9.84 16 416775 680 70510973
Benign neoplasm of spinal cord 9.91 9.84 3 416788 4 70511649
Camptodactyly congenital 9.91 9.84 3 416788 4 70511649
Diffuse large B-cell lymphoma recurrent 9.90 9.84 4 416787 3472 70508181
Neutrophilia 9.88 9.84 17 416774 7204 70504449
Heat exhaustion 9.87 9.84 10 416781 264 70511389
Malabsorption from injection site 9.86 9.84 4 416787 18 70511635
Dermatitis bullous 9.84 9.84 40 416751 12717 70498936
Bronchospasm 9.84 9.84 86 416705 22706 70488947

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




๐Ÿถ Veterinary Drug Use

None

๐Ÿถ 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 8192756 Oct. 25, 2022 TREATMENT WITH GABAPENTIN, INCLUDING TREATMENT OF NEUROPATHIC PAIN, INCLUDING NEUROPATHIC PAIN ASSOCIATED WITH POSTHERPETIC NEURALGIA
300MG GRALISE ALMATICA N022544 Jan. 28, 2011 RX TABLET ORAL 8252332 Oct. 25, 2022 TREATMENT WITH GABAPENTIN, INCLUDING TREATMENT OF NEUROPATHIC PAIN, INCLUDING NEUROPATHIC PAIN ASSOCIATED WITH POSTHERPETIC NEURALGIA
300MG GRALISE ALMATICA N022544 Jan. 28, 2011 RX TABLET ORAL 8333992 Oct. 25, 2022 TREATMENT WITH GABAPENTIN, INCLUDING TREATMENT OF NEUROPATHIC PAIN, INCLUDING NEUROPATHIC PAIN ASSOCIATED WITH POSTHERPETIC NEURALGIA
600MG GRALISE ALMATICA N022544 Jan. 28, 2011 RX TABLET ORAL 8192756 Oct. 25, 2022 TREATMENT WITH GABAPENTIN, INCLUDING TREATMENT OF NEUROPATHIC PAIN, INCLUDING NEUROPATHIC PAIN ASSOCIATED WITH POSTHERPETIC NEURALGIA
600MG GRALISE ALMATICA N022544 Jan. 28, 2011 RX TABLET ORAL 8252332 Oct. 25, 2022 TREATMENT WITH GABAPENTIN, INCLUDING TREATMENT OF NEUROPATHIC PAIN, INCLUDING NEUROPATHIC PAIN ASSOCIATED WITH POSTHERPETIC NEURALGIA
600MG GRALISE ALMATICA N022544 Jan. 28, 2011 RX TABLET ORAL 8333992 Oct. 25, 2022 TREATMENT WITH GABAPENTIN, INCLUDING TREATMENT OF NEUROPATHIC PAIN, INCLUDING NEUROPATHIC PAIN ASSOCIATED WITH POSTHERPETIC NEURALGIA
300MG GRALISE ALMATICA N022544 Jan. 28, 2011 RX TABLET ORAL 7438927 Feb. 26, 2024 TREATMENT WITH GABAPENTIN, INCLUDING TREATMENT OF NEUROPATHIC PAIN, INCLUDING NEUROPATHIC PAIN ASSOCIATED WITH POSTHERPETIC NEURALGIA
600MG GRALISE ALMATICA N022544 Jan. 28, 2011 RX TABLET ORAL 7438927 Feb. 26, 2024 TREATMENT WITH GABAPENTIN, INCLUDING TREATMENT OF NEUROPATHIC PAIN, INCLUDING NEUROPATHIC PAIN ASSOCIATED WITH POSTHERPETIC NEURALGIA

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

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

External reference:

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

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Neurontin HUMAN PRESCRIPTION DRUG LABEL 1 0071-0401 TABLET, FILM COATED 800 mg ORAL NDA 31 sections
Neurontin HUMAN PRESCRIPTION DRUG LABEL 1 0071-0401 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 0071-0803 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 0071-0806 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
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
Gabapentin HUMAN PRESCRIPTION DRUG LABEL 1 0615-8233 TABLET 600 mg ORAL ANDA 29 sections
Gabapentin HUMAN PRESCRIPTION DRUG LABEL 1 0615-8233 TABLET 600 mg ORAL ANDA 29 sections
Gabapentin HUMAN PRESCRIPTION DRUG LABEL 1 0615-8340 CAPSULE 100 mg ORAL ANDA 26 sections
Gabapentin HUMAN PRESCRIPTION DRUG LABEL 1 0615-8340 CAPSULE 100 mg ORAL ANDA 26 sections
Gabapentin HUMAN PRESCRIPTION DRUG LABEL 1 0615-8341 CAPSULE 300 mg ORAL ANDA 26 sections
Gabapentin HUMAN PRESCRIPTION DRUG LABEL 1 0615-8341 CAPSULE 300 mg ORAL ANDA 26 sections