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

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

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

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

Drug dosage:

DoseUnitRoute
1.80 g O

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 3 Benet LZ, Broccatelli F, Oprea TI
S (Water solubility) 10 mg/mL Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine) 100 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 116.79 µM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability) 60 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
Vd (Volume of distribution) 0.71 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 1.70 mL/min/kg Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma) 0.97 % Lombardo F, Berellini G, Obach RS
t_half (Half-life) 5.30 hours Lombardo F, Berellini G, Obach RS

Approvals:

DateAgencyCompanyOrphan
Dec. 30, 1993 FDA PFIZER PHARMS

FDA Adverse Event Reporting System (Female)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Drug hypersensitivity 1687.75 9.78 4431 318963 246579 50035151
Drug ineffective for unapproved indication 1084.62 9.78 976 322418 20305 50261425
Completed suicide 795.36 9.78 2240 321154 129649 50152081
Pemphigus 719.80 9.78 9 323385 120157 50161573
Contraindicated product administered 522.05 9.78 152 323242 148806 50132924
Systemic lupus erythematosus 508.65 9.78 135 323259 140487 50141243
Glossodynia 490.41 9.78 76 323318 115493 50166237
Hand deformity 489.96 9.78 40 323354 100159 50181571
Synovitis 469.17 9.78 108 323286 123757 50157973
Anti-cyclic citrullinated peptide antibody positive 433.36 9.78 3 323391 70584 50211146
Maternal exposure during pregnancy 430.17 9.78 243 323151 159535 50122195
Pericarditis 406.21 9.78 24 323370 78665 50203065
Multiple sclerosis relapse 405.03 9.78 867 322527 42097 50239633
Somnolence 296.83 9.78 1849 321545 153136 50128594
Toxicity to various agents 294.44 9.78 2343 321051 210156 50071574
Arthropathy 282.85 9.78 356 323038 157550 50124180
Infusion related reaction 275.81 9.78 410 322984 169147 50112583
Rheumatoid factor positive 267.42 9.78 12 323382 49847 50231883
Duodenal ulcer perforation 266.28 9.78 5 323389 45606 50236124
Joint swelling 257.61 9.78 761 322633 244525 50037205
Fall 253.95 9.78 3260 320134 331672 49950058
Drug abuse 249.66 9.78 896 322498 58950 50222780
Myoclonus 245.41 9.78 377 323017 14093 50267637
Helicobacter infection 239.72 9.78 21 323373 49681 50232049
Multiple sclerosis 237.81 9.78 451 322943 20042 50261688
Wound 235.28 9.78 198 323196 105596 50176134
Hepatic enzyme increased 222.57 9.78 333 323061 137047 50144683
Depression 211.20 9.78 1791 321603 163632 50118098
Discomfort 207.19 9.78 232 323162 108148 50173582
Abdominal discomfort 194.95 9.78 790 322604 230851 50050879
Muscle injury 189.43 9.78 12 323382 37099 50244631
General physical health deterioration 188.41 9.78 392 323002 142042 50139688
Suicidal ideation 181.15 9.78 768 322626 54617 50227113
Alopecia 177.22 9.78 884 322510 244163 50037567
Feeling abnormal 176.44 9.78 1389 322005 124103 50157627
Memory impairment 175.05 9.78 983 322411 78377 50203353
Exposure during pregnancy 172.18 9.78 319 323075 120696 50161034
Tremor 169.42 9.78 1286 322108 113617 50168113
Folliculitis 165.83 9.78 26 323368 39199 50242531
Dizziness 163.68 9.78 3114 320280 343255 49938475
Treatment failure 155.45 9.78 412 322982 137225 50144505
Accidental death 153.00 9.78 110 323284 1634 50280096
Swelling 150.76 9.78 715 322679 200157 50081573
Febrile neutropenia 150.26 9.78 245 323149 97422 50184308
Therapeutic product effect decreased 148.58 9.78 414 322980 135636 50146094
Sleep disorder due to general medical condition, insomnia type 144.53 9.78 16 323378 31431 50250299
Hypersensitivity 143.87 9.78 797 322597 214364 50067366
Balance disorder 142.40 9.78 854 322540 69736 50211994
Product dose omission issue 139.18 9.78 1790 321604 182048 50099682
Neuropathy peripheral 133.78 9.78 1067 322327 95690 50186040
Hallucination 133.68 9.78 622 322772 46035 50235695
Respiratory arrest 127.41 9.78 452 322942 29557 50252173
Hypoaesthesia 126.27 9.78 1306 322088 125951 50155779
C-reactive protein abnormal 125.67 9.78 15 323379 27794 50253936
Muscle spasms 123.38 9.78 1286 322108 124267 50157463
Withdrawal syndrome 122.06 9.78 315 323079 17275 50264455
Lower respiratory tract infection 120.85 9.78 268 323126 94933 50186797
Product complaint 118.06 9.78 240 323154 11226 50270504
Vision blurred 117.99 9.78 884 322510 77763 50203967
Drug withdrawal syndrome 117.16 9.78 390 323004 24691 50257039
Mental status changes 114.75 9.78 498 322896 35774 50245956
Neuralgia 113.97 9.78 353 323041 21510 50260220
Pyrexia 113.90 9.78 1727 321667 378476 49903254
Rheumatoid arthritis 102.26 9.78 816 322578 201734 50079996
Anxiety 102.00 9.78 1648 321746 175958 50105772
Device expulsion 99.78 9.78 30 323364 28792 50252938
Drug intolerance 99.73 9.78 907 322487 218197 50063533
Impaired healing 96.54 9.78 187 323207 69599 50212131
C-reactive protein increased 96.49 9.78 173 323221 66301 50215429
Gait disturbance 96.11 9.78 1418 321976 148587 50133143
Rash 94.97 9.78 2102 321292 435369 49846361
Irritable bowel syndrome 93.02 9.78 115 323279 51326 50230404
Interstitial lung disease 84.98 9.78 130 323264 53046 50228684
Cardio-respiratory arrest 84.37 9.78 612 322782 53280 50228450
Pain in extremity 83.84 9.78 2310 321084 270555 50011175
Seizure 83.80 9.78 1135 322259 116739 50164991
Paraesthesia 83.12 9.78 1152 322242 119091 50162639
Migraine 81.58 9.78 787 322607 74493 50207237
Respiratory depression 81.20 9.78 213 323181 11797 50269933
Product use issue 80.67 9.78 591 322803 148884 50132846
Unresponsive to stimuli 78.97 9.78 396 322998 30213 50251517
Swollen joint count increased 78.39 9.78 4 323390 14869 50266861
Dyskinesia 78.01 9.78 369 323025 27492 50254238
Rheumatic fever 76.46 9.78 9 323385 16858 50264872
Sopor 76.44 9.78 290 323104 19589 50262141
Ill-defined disorder 75.12 9.78 147 323247 54507 50227223
Drug dependence 74.95 9.78 287 323107 19472 50262258
Thrombocytopenia 73.19 9.78 496 322898 127177 50154553
Amnesia 71.46 9.78 489 322905 41771 50239959
Live birth 71.37 9.78 10 323384 16398 50265332
Hepatic function abnormal 69.19 9.78 64 323330 32617 50249113
Red blood cell sedimentation rate abnormal 68.70 9.78 11 323383 16332 50265398
Lethargy 67.66 9.78 544 322850 48888 50232842
Anaemia 67.08 9.78 1172 322222 251284 50030446
Sedation 66.02 9.78 377 323017 30233 50251497
Confusional state 65.77 9.78 1604 321790 184324 50097406
Plasma cell myeloma 65.74 9.78 383 323011 30939 50250791
Blister 65.19 9.78 302 323092 85116 50196614
Speech disorder 64.12 9.78 418 322976 35130 50246600
Liver injury 63.46 9.78 40 323354 24766 50256964
Cytomegalovirus infection 63.45 9.78 18 323376 17944 50263786
Off label use 61.40 9.78 2445 320949 471981 49809749
Mental disorder 61.38 9.78 291 323103 21700 50260030
Pancytopenia 61.26 9.78 302 323092 83728 50198002
Muscular weakness 60.74 9.78 898 322496 94115 50187615
Coordination abnormal 59.90 9.78 186 323208 11348 50270382
Premature baby 58.40 9.78 22 323372 18315 50263415
Mucosal inflammation 57.77 9.78 105 323289 40037 50241693
Infection 57.12 9.78 770 322624 172184 50109546
Multiple organ dysfunction syndrome 56.53 9.78 151 323243 50186 50231544
Hypersomnia 56.10 9.78 220 323174 15094 50266636
Burning sensation 55.74 9.78 488 322906 44958 50236772
Insomnia 55.22 9.78 1486 321908 173379 50108351
Sleep apnoea syndrome 54.82 9.78 299 323095 23569 50258161
Intentional product misuse 54.33 9.78 496 322898 46238 50235492
Malignant neoplasm progression 53.69 9.78 238 323156 67886 50213844
Urinary tract infection 53.65 9.78 1840 321554 222180 50059550
Head injury 53.22 9.78 298 323096 23722 50258008
Cardiac failure 52.75 9.78 278 323116 75762 50205968
Full blood count decreased 52.04 9.78 281 323113 22065 50259665
Hepatotoxicity 51.20 9.78 59 323335 27167 50254563
Drug ineffective 49.94 9.78 4535 318859 814798 49466932
Influenza like illness 49.69 9.78 574 322820 56885 50224845
Foetal exposure during pregnancy 49.63 9.78 61 323333 27298 50254432
Feeling drunk 49.49 9.78 86 323308 3567 50278163
Arthralgia 49.40 9.78 2296 321098 436406 49845324
Therapeutic response decreased 48.40 9.78 148 323246 47083 50234647
Rheumatoid nodule 48.38 9.78 11 323383 12724 50269006
Inadequate analgesia 48.16 9.78 70 323324 2488 50279242
Neutropenia 48.04 9.78 661 322733 147304 50134426
Euphoric mood 47.97 9.78 90 323304 3965 50277765
Leukopenia 47.90 9.78 245 323149 67283 50214447
Cardiac arrest 47.87 9.78 776 322618 82875 50198855
Therapeutic response unexpected 47.67 9.78 215 323179 15700 50266030
Muscle twitching 47.37 9.78 210 323184 15221 50266509
Bone erosion 46.65 9.78 9 323385 11678 50270052
Crying 46.38 9.78 255 323139 20161 50261569
Bone marrow failure 45.62 9.78 66 323328 27558 50254172
Hallucination, visual 45.24 9.78 218 323176 16364 50265366
Pleural effusion 44.42 9.78 321 323073 81133 50200597
Overdose 44.30 9.78 889 322505 98838 50182892
Presbyacusis 43.83 9.78 70 323324 2706 50279024
Pleural fibrosis 43.69 9.78 78 323316 3306 50278424
Myocardial stunning 43.62 9.78 21 323373 138 50281592
Myelosuppression 43.41 9.78 16 323378 13501 50268229
Dry mouth 43.25 9.78 549 322845 55629 50226101
Trigeminal neuralgia 43.07 9.78 74 323320 3041 50278689
Pleural thickening 43.06 9.78 67 323327 2532 50279198
Drug resistance 42.85 9.78 35 323359 18954 50262776
Hypokalaemia 41.83 9.78 360 323034 87632 50194098
Sinusitis 41.74 9.78 803 322591 169755 50111975
Hyperaesthesia 41.70 9.78 131 323263 8042 50273688
Urinary incontinence 41.67 9.78 316 323078 27892 50253838
Premature delivery 41.63 9.78 54 323340 23609 50258121
Poisoning 41.11 9.78 173 323221 12256 50269474
Impaired driving ability 40.88 9.78 83 323311 3878 50277852
Diplopia 40.73 9.78 236 323158 19024 50262706
Blood magnesium increased 40.59 9.78 69 323325 2811 50278919
Spinal operation 40.27 9.78 109 323285 6151 50275579
Pregnancy 40.25 9.78 80 323314 29497 50252233
Intervertebral disc protrusion 40.00 9.78 245 323149 20148 50261582
Anaphylactic shock 39.75 9.78 42 323352 20113 50261617
Ataxia 39.62 9.78 184 323210 13602 50268128
Drug reaction with eosinophilia and systemic symptoms 39.44 9.78 76 323318 28348 50253382
Hip arthroplasty 39.13 9.78 85 323309 30344 50251386
Neck pain 39.09 9.78 546 322848 56521 50225209
Stomatitis 38.79 9.78 437 322957 100907 50180823
Vertigo 38.42 9.78 503 322891 51329 50230401
Back pain 38.30 9.78 1746 321648 218284 50063446
Knee arthroplasty 37.68 9.78 111 323283 35735 50245995
Nervousness 37.66 9.78 304 323090 27347 50254383
Mood altered 36.36 9.78 170 323224 12603 50269127
Premature labour 36.16 9.78 14 323380 11462 50270268
Atrial fibrillation 36.14 9.78 446 322948 101299 50180431
Back disorder 35.98 9.78 136 323258 9169 50272561
Hyperhidrosis 35.75 9.78 785 322609 88641 50193089
Eosinophilic colitis 35.75 9.78 18 323376 132 50281598
Accidental poisoning 35.46 9.78 30 323364 572 50281158
Anger 35.37 9.78 155 323239 11178 50270552
Hypermobility syndrome 35.20 9.78 33 323361 724 50281006
Restless legs syndrome 35.07 9.78 197 323197 15700 50266030
Osteonecrosis of jaw 34.71 9.78 100 323294 32426 50249304
Nasopharyngitis 34.10 9.78 955 322439 191972 50089758
Blood lactate dehydrogenase increased 34.04 9.78 45 323349 19517 50262213
Drug use disorder 33.66 9.78 66 323328 3006 50278724
Stiff person syndrome 33.60 9.78 20 323374 211 50281519
Drug-induced liver injury 33.29 9.78 82 323312 28013 50253717
Ankle fracture 32.83 9.78 192 323202 15530 50266200
Drug screen positive 32.43 9.78 69 323325 3333 50278397
Congenital absence of vertebra 32.31 9.78 12 323382 36 50281694
Pneumocystis jirovecii pneumonia 31.89 9.78 28 323366 14635 50267095
Septic shock 31.81 9.78 224 323170 56951 50224779
Limb injury 31.70 9.78 230 323164 20020 50261710
Gait inability 31.61 9.78 369 323025 36658 50245072
Abortion spontaneous 31.09 9.78 149 323245 41623 50240107
Pre-existing condition improved 31.07 9.78 108 323286 6989 50274741
Cyst 30.96 9.78 157 323237 12030 50269700
Epigastric discomfort 30.79 9.78 95 323299 5775 50275955
Incoherent 30.64 9.78 77 323317 4153 50277577
Erythema 30.35 9.78 708 322686 145706 50136024
Product use in unapproved indication 29.90 9.78 960 322434 114859 50166871
Therapy non-responder 29.82 9.78 197 323197 50825 50230905
Deafness neurosensory 29.58 9.78 79 323315 4422 50277308
Febrile bone marrow aplasia 29.54 9.78 3 323391 6308 50275422
Surgery 29.44 9.78 309 323085 29896 50251834
Suspected suicide 29.32 9.78 88 323306 5269 50276461
Somatic symptom disorder 29.30 9.78 48 323346 1896 50279834
Irritability 29.23 9.78 294 323100 28132 50253598
Panniculitis 29.16 9.78 9 323385 8494 50273236
Visual impairment 29.11 9.78 605 322789 67670 50214060
Melaena 29.10 9.78 82 323312 26782 50254948
Concussion 29.09 9.78 111 323283 7517 50274213
Thrombotic microangiopathy 28.92 9.78 10 323384 8781 50272949
Nightmare 28.91 9.78 189 323205 15897 50265833
Hyperreflexia 28.89 9.78 85 323309 5033 50276697
Intentional product use issue 28.52 9.78 334 323060 76584 50205146
Mental impairment 28.41 9.78 152 323242 11892 50269838
Dysarthria 28.14 9.78 364 323030 37039 50244691
Disturbance in attention 28.06 9.78 314 323080 30872 50250858
Intervertebral disc degeneration 27.85 9.78 164 323230 13297 50268433
Ascites 27.82 9.78 126 323268 35735 50245995
Hepatic failure 27.78 9.78 109 323285 32174 50249556
Serotonin syndrome 27.56 9.78 260 323134 24453 50257277
Depressed level of consciousness 27.52 9.78 476 322918 51477 50230253
Gestational diabetes 27.27 9.78 7 323387 7458 50274272
Congenital thrombocytopenia 27.23 9.78 11 323383 44 50281686
Neovascularisation 27.22 9.78 33 323361 980 50280750
Complex regional pain syndrome 27.11 9.78 47 323347 1946 50279784
Somatic delusion 26.95 9.78 25 323369 541 50281189
Hyponatraemia 26.87 9.78 442 322952 95697 50186033
Red blood cell sedimentation rate increased 26.82 9.78 97 323297 29319 50252411
Asthenia 26.79 9.78 2377 321017 316665 49965065
Paranoia 26.77 9.78 134 323260 10214 50271516
Focal dyscognitive seizures 26.73 9.78 56 323338 2676 50279054
Cognitive disorder 26.62 9.78 413 322981 43710 50238020
Haemophagocytic lymphohistiocytosis 26.44 9.78 11 323383 8622 50273108
Neutropenic sepsis 26.23 9.78 31 323363 14116 50267614
Rash maculo-papular 26.22 9.78 85 323309 26556 50255174
Gastrointestinal disorder 26.16 9.78 435 322959 94021 50187709
Agitation 26.12 9.78 483 322911 52901 50228829
Fibromyalgia 26.00 9.78 418 322976 44560 50237170
Drug tolerance decreased 25.98 9.78 13 323381 9147 50272583
Diabetic neuropathy 25.63 9.78 65 323329 3526 50278204
Pituitary tumour benign 25.54 9.78 43 323351 1738 50279992
Bradyphrenia 25.54 9.78 92 323302 6060 50275670
Pulmonary fibrosis 25.44 9.78 76 323318 24361 50257369
Human epidermal growth factor receptor decreased 25.22 9.78 8 323386 12 50281718
Peroneal nerve palsy 25.01 9.78 72 323322 4211 50277519
Nausea 24.97 9.78 4987 318407 700411 49581319
Pruritus 24.89 9.78 1521 321873 282047 49999683
Death 24.72 9.78 2407 320987 322972 49958758
Lupus-like syndrome 24.70 9.78 15 323379 9476 50272254
Central nervous system lesion 24.64 9.78 123 323271 9366 50272364
Asterixis 24.50 9.78 34 323360 1157 50280573
Body height decreased 24.22 9.78 117 323277 8791 50272939
Bradycardia 24.18 9.78 279 323115 64147 50217583
Macular degeneration 24.13 9.78 34 323360 14354 50267376
Bone cyst 24.04 9.78 45 323349 1979 50279751
Drug diversion 24.03 9.78 27 323367 738 50280992
Nerve injury 23.67 9.78 111 323283 8239 50273491
Limb discomfort 23.65 9.78 249 323145 24108 50257622
Anorgasmia 23.55 9.78 23 323371 532 50281198
Thinking abnormal 23.43 9.78 122 323272 9445 50272285
Nerve compression 23.25 9.78 102 323292 7360 50274370
Dysstasia 23.24 9.78 194 323200 17625 50264105
Jaundice 22.89 9.78 89 323305 26340 50255390
Epistaxis 22.83 9.78 280 323114 63674 50218056
Injection site mass 22.79 9.78 175 323219 15505 50266225
Agranulocytosis 22.75 9.78 66 323328 21355 50260375
Transaminases increased 22.65 9.78 96 323298 27728 50254002
Muscle tightness 22.42 9.78 127 323267 10153 50271577
Tardive dyskinesia 22.30 9.78 99 323295 7180 50274550
Dysphemia 22.25 9.78 47 323347 2259 50279471
Skin necrosis 22.16 9.78 22 323372 10845 50270885
Hepatocellular injury 22.07 9.78 88 323306 25859 50255871
Coma 22.00 9.78 497 322897 56382 50225348
Bronchiectasis 21.93 9.78 20 323374 10263 50271467
Blood parathyroid hormone decreased 21.89 9.78 9 323385 7105 50274625
Drug titration error 21.72 9.78 23 323371 587 50281143
Prescription drug used without a prescription 21.71 9.78 39 323355 1661 50280069
Brain injury 21.70 9.78 86 323308 5928 50275802
Thrombosis 21.64 9.78 488 322906 55345 50226385
Device difficult to use 21.35 9.78 19 323375 9867 50271863
Exposure via ingestion 21.33 9.78 52 323342 2751 50278979
Device use error 21.14 9.78 4 323390 5262 50276468
Psychotic disorder due to a general medical condition 21.08 9.78 15 323379 219 50281511
Progressive multiple sclerosis 20.95 9.78 25 323369 730 50281000
Lymphoedema 20.76 9.78 114 323280 9008 50272722
Myelodysplastic syndrome 20.53 9.78 41 323353 15091 50266639
Cerebral infarction 20.52 9.78 70 323324 21534 50260196
Cervical spinal stenosis 20.39 9.78 41 323353 1902 50279828
Acute respiratory distress syndrome 20.29 9.78 68 323326 21031 50260699
Encephalopathy 20.13 9.78 315 323079 33396 50248334
Transplant rejection 20.12 9.78 19 323375 9590 50272140
Secondary progressive multiple sclerosis 20.09 9.78 32 323362 1234 50280496
Unintentional medical device removal 20.04 9.78 5 323389 5430 50276300
Bipolar disorder 20.02 9.78 91 323303 6666 50275064
Therapy cessation 19.93 9.78 254 323140 25757 50255973
Bone density decreased 19.76 9.78 25 323369 11050 50270680
Sacroiliitis 19.58 9.78 48 323346 2549 50279181
Toxic skin eruption 19.46 9.78 26 323368 11225 50270505
Drug effective for unapproved indication 19.45 9.78 41 323353 1968 50279762
Toxic epidermal necrolysis 19.28 9.78 69 323325 20923 50260807
Hypokinesia 19.26 9.78 139 323255 12078 50269652
Metastases to liver 19.19 9.78 65 323329 20039 50261691
Pollakiuria 19.17 9.78 235 323159 23616 50258114
Substance abuse 19.14 9.78 64 323330 4060 50277670
Tooth loss 18.96 9.78 84 323310 6086 50275644
Autonomic nervous system imbalance 18.96 9.78 45 323349 2340 50279390
Eosinophilia 18.71 9.78 59 323335 18593 50263137
Glycosylated haemoglobin decreased 18.65 9.78 19 323375 463 50281267
Pulmonary aplasia 18.54 9.78 6 323388 10 50281720
Accidental exposure to product 18.49 9.78 80 323314 22977 50258753
Metabolic encephalopathy 18.30 9.78 73 323321 5048 50276682
Gastrointestinal haemorrhage 18.28 9.78 344 323050 72977 50208753
Chronic obstructive pulmonary disease 18.26 9.78 459 322935 52976 50228754
Somnambulism 18.25 9.78 71 323323 4853 50276877
Paradoxical drug reaction 18.19 9.78 58 323336 3589 50278141
Cytomegalovirus viraemia 18.02 9.78 4 323390 4705 50277025
Wrong patient received product 18.00 9.78 36 323358 1664 50280066
Pre-eclampsia 17.93 9.78 15 323379 8029 50273701
Foetal growth restriction 17.92 9.78 10 323384 6617 50275113
Skin reaction 17.79 9.78 29 323365 11539 50270191
Tuberculosis 17.74 9.78 23 323371 10060 50271670
Therapy interrupted 17.72 9.78 202 323192 19950 50261780
Disorientation 17.69 9.78 322 323072 35162 50246568
Joint injury 17.65 9.78 215 323179 21574 50260156
Obstructive airways disorder 17.53 9.78 47 323347 15605 50266125
Urticaria 17.47 9.78 664 322730 128897 50152833
Myoclonic epilepsy 17.38 9.78 26 323368 949 50280781
Posterior reversible encephalopathy syndrome 17.35 9.78 44 323350 14884 50266846
Haematotoxicity 17.26 9.78 15 323379 7880 50273850
Low birth weight baby 17.21 9.78 8 323386 5873 50275857
Creatinine renal clearance decreased 17.16 9.78 31 323363 11850 50269880
Acute myeloid leukaemia 17.08 9.78 45 323349 15029 50266701
Blood cholesterol increased 17.07 9.78 249 323145 54966 50226764
Disorganised speech 17.05 9.78 26 323368 965 50280765
Foot fracture 17.05 9.78 200 323194 19891 50261839
Neutrophil count decreased 17.00 9.78 200 323194 45826 50235904
Inflammation 16.79 9.78 259 323135 56653 50225077
Abortion induced 16.77 9.78 21 323373 9323 50272407
Caesarean section 16.74 9.78 48 323346 15591 50266139
Micturition urgency 16.66 9.78 100 323294 8164 50273566
Panic attack 16.61 9.78 193 323201 19149 50262581
Economic problem 16.61 9.78 37 323357 1845 50279885
Facial pain 16.59 9.78 94 323300 7515 50274215
Psychomotor hyperactivity 16.54 9.78 109 323285 9192 50272538
Pneumonia 16.39 9.78 2704 320690 375697 49906033
Atonic urinary bladder 16.33 9.78 9 323385 81 50281649
Bladder disorder 16.32 9.78 93 323301 7450 50274280
Road traffic accident 16.27 9.78 232 323162 24120 50257610
Peritonitis 16.24 9.78 48 323346 15438 50266292
Drug abuser 15.99 9.78 47 323347 2781 50278949
Subdural hygroma 15.94 9.78 13 323381 235 50281495
Cholestasis 15.91 9.78 96 323298 25305 50256425
Gastroschisis 15.90 9.78 13 323381 236 50281494
Cardiogenic shock 15.89 9.78 49 323345 15550 50266180
Facial spasm 15.86 9.78 20 323374 619 50281111
Shock haemorrhagic 15.78 9.78 18 323376 8326 50273404
Graft versus host disease 15.69 9.78 10 323384 6156 50275574
Dyspnoea 15.60 9.78 3176 320218 544432 49737298
Device adhesion issue 15.49 9.78 3 323391 3882 50277848
Deprescribing error 15.47 9.78 6 323388 21 50281709
Head banging 15.41 9.78 16 323378 399 50281331
Dental caries 15.40 9.78 112 323282 9755 50271975
Generalised tonic-clonic seizure 15.38 9.78 245 323149 26065 50255665
Osteosclerosis 15.38 9.78 53 323341 3414 50278316
Cough 15.33 9.78 1330 322064 239934 50041796
Basal cell carcinoma 15.30 9.78 87 323307 23269 50258461
Blood lactic acid 15.20 9.78 9 323385 94 50281636
Loss of consciousness 15.19 9.78 814 322580 103539 50178191
Pharyngitis 15.12 9.78 59 323335 17444 50264286
Herpes zoster 15.08 9.78 574 322820 70212 50211518
Ejection fraction decreased 15.01 9.78 64 323330 18456 50263274
Urinary retention 14.98 9.78 243 323151 25947 50255783
Arteriovenous malformation 14.98 9.78 28 323366 1230 50280500
Genital haemorrhage 14.98 9.78 12 323382 6562 50275168
JC polyomavirus test positive 14.88 9.78 26 323368 1083 50280647
Dry eye 14.87 9.78 288 323106 31807 50249923
Ventricular fibrillation 14.85 9.78 28 323366 10531 50271199
Hypercholesterolaemia 14.79 9.78 33 323361 11670 50270060
Colitis 14.79 9.78 166 323228 38363 50243367
Hyperbilirubinaemia 14.71 9.78 24 323370 9546 50272184
Stillbirth 14.68 9.78 10 323384 5942 50275788
Toxicologic test abnormal 14.68 9.78 19 323375 604 50281126
Disseminated intravascular coagulation 14.65 9.78 58 323336 17077 50264653
Diffuse axonal injury 14.61 9.78 8 323386 71 50281659
Myotonia 14.59 9.78 10 323384 137 50281593
Myocardial oedema 14.58 9.78 9 323385 102 50281628
Pineal gland cyst 14.55 9.78 5 323389 11 50281719
Spinal cord injury 14.52 9.78 20 323374 676 50281054
Sensory disturbance 14.49 9.78 127 323267 11702 50270028
Epstein-Barr virus infection 14.46 9.78 14 323380 6983 50274747
Anal incontinence 14.41 9.78 124 323270 11366 50270364
Accidental overdose 14.23 9.78 189 323205 19344 50262386
Pulmonary toxicity 14.18 9.78 9 323385 5553 50276177
Hepatitis cholestatic 14.14 9.78 11 323383 6106 50275624
Postmortem blood drug level increased 14.10 9.78 18 323376 564 50281166
Cervicogenic headache 14.02 9.78 4 323390 3 50281727
Depressed mood 14.01 9.78 300 323094 33723 50248007
Headache 13.99 9.78 3541 319853 502994 49778736
Mucocutaneous haemorrhage 13.97 9.78 8 323386 78 50281652
Substance use 13.91 9.78 14 323380 336 50281394
Fatigue 13.86 9.78 4878 318516 702723 49579007
Movement disorder 13.86 9.78 173 323221 17459 50264271
Oesophageal spasm 13.80 9.78 39 323355 2257 50279473
Dysgraphia 13.78 9.78 43 323351 2630 50279100
Oligohydramnios 13.73 9.78 10 323384 5740 50275990
Blood potassium decreased 13.72 9.78 321 323073 36624 50245106
Haemolysis 13.68 9.78 11 323383 6005 50275725
Proteinuria 13.67 9.78 57 323337 16540 50265190
Postmortem blood drug level abnormal 13.65 9.78 14 323380 344 50281386
Face oedema 13.64 9.78 63 323331 17776 50263954
Gastrointestinal motility disorder 13.57 9.78 61 323333 4448 50277282
Hip fracture 13.52 9.78 237 323157 25694 50256036
Radiculopathy 13.51 9.78 65 323329 4876 50276854
Hostility 13.50 9.78 33 323361 1749 50279981
Dysphagia 13.42 9.78 615 322779 76903 50204827
Jaundice cholestatic 13.41 9.78 8 323386 5103 50276627
Ankylosing spondylitis 13.37 9.78 85 323309 7080 50274650
Delirium 13.32 9.78 329 323065 37863 50243867
Tubulointerstitial nephritis 13.31 9.78 51 323343 15160 50266570
Constipation 13.23 9.78 1368 322026 184340 50097390
Alanine aminotransferase abnormal 13.21 9.78 5 323389 4151 50277579
Allodynia 13.12 9.78 19 323375 673 50281057
Hypoxic-ischaemic encephalopathy 13.12 9.78 54 323340 3788 50277942
Haemoglobin decreased 13.03 9.78 672 322722 126544 50155186
Maternal exposure before pregnancy 13.02 9.78 10 323384 5587 50276143
Femur fracture 13.00 9.78 165 323229 37299 50244431
Lung adenocarcinoma stage I 13.00 9.78 5 323389 17 50281713
Ageusia 12.98 9.78 122 323272 11461 50270269
Osteoporosis 12.98 9.78 205 323189 44674 50237056
Osteopenia 12.96 9.78 166 323228 16852 50264878
Haemorrhage 12.93 9.78 252 323142 53189 50228541
Condition aggravated 12.90 9.78 1682 321712 295376 49986354
Tonic clonic movements 12.86 9.78 26 323368 1211 50280519
Hyperprolactinaemia 12.86 9.78 49 323345 3316 50278414
Type 2 diabetes mellitus 12.84 9.78 149 323245 34226 50247504
Narcolepsy 12.80 9.78 25 323369 1135 50280595
Snoring 12.71 9.78 49 323345 3335 50278395
Phobia 12.69 9.78 13 323381 319 50281411
Hepatitis 12.68 9.78 134 323260 31319 50250411
Sleep talking 12.63 9.78 22 323372 914 50280816
Injection site atrophy 12.62 9.78 16 323378 498 50281232
Electroencephalogram abnormal 12.60 9.78 50 323344 3449 50278281
Alanine aminotransferase increased 12.54 9.78 450 322944 87909 50193821
Musculoskeletal stiffness 12.53 9.78 682 322712 127799 50153931
White blood cell count decreased 12.43 9.78 886 322508 115836 50165894
Laboratory test abnormal 12.42 9.78 213 323181 22995 50258735
Drug eruption 12.40 9.78 94 323300 23512 50258218
Blood iron abnormal 12.38 9.78 3 323391 3323 50278407
Liver function test abnormal 12.33 9.78 204 323190 44135 50237595
Blood bilirubin increased 12.31 9.78 138 323256 31900 50249830
Mouth ulceration 12.29 9.78 117 323277 27907 50253823
Alcoholism 12.27 9.78 30 323364 1590 50280140
Gastric bypass 12.26 9.78 28 323366 1420 50280310
Prophylaxis 12.24 9.78 4 323390 7 50281723
Heteroplasia 12.24 9.78 4 323390 7 50281723
Paralysis 12.20 9.78 96 323298 8568 50273162
Device dislocation 12.18 9.78 84 323310 21462 50260268
Abnormal dreams 12.18 9.78 102 323292 9275 50272455
CSF neutrophil count increased 12.18 9.78 3 323391 0 50281730
Turbinectomy 12.18 9.78 3 323391 0 50281730
Muscle relaxant drug level above therapeutic 12.18 9.78 3 323391 0 50281730
Ligamentum flavum hypertrophy 12.18 9.78 3 323391 0 50281730
Premature ageing 12.18 9.78 3 323391 0 50281730
Pharyngeal neoplasm 12.18 9.78 3 323391 0 50281730
Sensory loss 12.17 9.78 88 323306 7650 50274080
Blood pressure systolic abnormal 12.15 9.78 19 323375 7687 50274043
Persistent depressive disorder 12.10 9.78 21 323373 870 50280860
Blood potassium increased 12.09 9.78 159 323235 16239 50265491
Drug screen false positive 12.05 9.78 20 323374 799 50280931
Breast cancer stage III 12.00 9.78 3 323391 3253 50278477
Tumour lysis syndrome 11.99 9.78 18 323376 7403 50274327
Angioedema 11.96 9.78 169 323225 37507 50244223
Skin toxicity 11.96 9.78 5 323389 3908 50277822
Breakthrough pain 11.91 9.78 24 323370 1115 50280615
Tinnitus 11.89 9.78 249 323145 27883 50253847
Cerebral haemorrhage 11.84 9.78 113 323281 26939 50254791
Spinal osteoarthritis 11.83 9.78 140 323254 13952 50267778
Tachycardia 11.80 9.78 519 322875 99244 50182486
Septic encephalopathy 11.75 9.78 7 323387 74 50281656
Urinary hesitation 11.74 9.78 34 323360 1995 50279735
Carpal tunnel syndrome 11.71 9.78 162 323232 16731 50264999
Parapsoriasis 11.71 9.78 8 323386 109 50281621
Acute hepatic failure 11.61 9.78 56 323338 15621 50266109
Haemangioma of skin 11.60 9.78 12 323382 298 50281432
Enterocolitis 11.54 9.78 15 323379 6552 50275178
Vulvar basal cell carcinoma 11.50 9.78 5 323389 25 50281705
Liver disorder 11.45 9.78 168 323226 37054 50244676
Anticipatory anxiety 11.44 9.78 12 323382 303 50281427
Nervous system disorder 11.42 9.78 156 323238 16067 50265663
Lymphoma 11.39 9.78 28 323366 9573 50272157
Internal hernia 11.38 9.78 6 323388 49 50281681
Hypomagnesaemia 11.33 9.78 94 323300 23062 50258668
Spinal disorder 11.30 9.78 91 323303 8179 50273551
Ulcer 11.30 9.78 79 323315 20121 50261609
Upper airway resistance syndrome 11.29 9.78 4 323390 10 50281720
Burns second degree 11.29 9.78 18 323376 695 50281035
Urinary occult blood positive 11.27 9.78 6 323388 50 50281680
Injection site induration 11.26 9.78 92 323302 8305 50273425
Exostosis 11.25 9.78 119 323275 11534 50270196
Myocarditis 11.24 9.78 21 323373 7926 50273804
Cerebrovascular accident 11.20 9.78 725 322669 93955 50187775
Bronchitis 11.15 9.78 791 322603 103368 50178362
Drug screen negative 11.10 9.78 11 323383 259 50281471
Food allergy 11.08 9.78 22 323372 8115 50273615
Congenital neuropathy 11.02 9.78 4 323390 11 50281719
Withdrawal catatonia 10.98 9.78 6 323388 53 50281677
Connective tissue inflammation 10.98 9.78 6 323388 53 50281677
Urine amphetamine positive 10.98 9.78 6 323388 53 50281677
Rib deformity 10.98 9.78 9 323385 164 50281566
Neuroma 10.94 9.78 13 323381 378 50281352
Acute kidney injury 10.93 9.78 1283 322111 226775 50054955
Uterine perforation 10.92 9.78 15 323379 6400 50275330
Concomitant disease aggravated 10.91 9.78 22 323372 8069 50273661
Post herpetic neuralgia 10.88 9.78 32 323362 1894 50279836
Rib fracture 10.87 9.78 178 323216 19043 50262687
Tooth injury 10.81 9.78 21 323373 950 50280780
Pancreatitis chronic 10.79 9.78 35 323359 2185 50279545
Femoral artery dissection 10.76 9.78 5 323389 30 50281700
Formication 10.73 9.78 49 323345 3597 50278133
Confusional arousal 10.72 9.78 7 323387 88 50281642
Aphasia 10.71 9.78 248 323146 28246 50253484
Copper deficiency 10.70 9.78 6 323388 56 50281674
Toe operation 10.63 9.78 17 323377 658 50281072
Acute coronary syndrome 10.61 9.78 28 323366 9346 50272384
Pneumonitis 10.60 9.78 129 323265 29381 50252349
Palmar-plantar erythrodysaesthesia syndrome 10.57 9.78 80 323314 20018 50261712
Nephrogenic systemic fibrosis 10.51 9.78 55 323339 4267 50277463
Soft tissue disorder 10.50 9.78 7 323387 4207 50277523
Joint destruction 10.46 9.78 6 323388 3910 50277820
Lactic acidosis 10.45 9.78 150 323244 33205 50248525
Hypercalcaemia 10.45 9.78 97 323297 23255 50258475
Malignant polyp 10.41 9.78 9 323385 177 50281553
Complication of device insertion 10.41 9.78 14 323380 6027 50275703
Empty sella syndrome 10.37 9.78 5 323389 33 50281697
Impaired gastric emptying 10.37 9.78 93 323301 8625 50273105
Blood creatine phosphokinase increased 10.36 9.78 113 323281 26254 50255476
Haematoma 10.36 9.78 135 323259 30375 50251355
Liver function test increased 10.35 9.78 109 323285 25497 50256233
Foot deformity 10.32 9.78 76 323318 19134 50262596
Pericardial effusion 10.32 9.78 109 323285 25480 50256250
Polyarthritis 10.31 9.78 22 323372 7905 50273825
Seasonal allergy 10.28 9.78 141 323253 14535 50267195
Screaming 10.28 9.78 42 323352 2936 50278794
Metastases to lung 10.27 9.78 36 323358 10984 50270746
Uraemic encephalopathy 10.24 9.78 9 323385 181 50281549
Paranasal cyst 10.20 9.78 11 323383 287 50281443
Eyelid oedema 10.17 9.78 29 323365 9437 50272293
Application site vesicles 10.17 9.78 25 323369 1330 50280400
Application site burn 10.16 9.78 18 323376 758 50280972
Hypopnoea 10.13 9.78 35 323359 2258 50279472
Cystitis 10.13 9.78 364 323030 44200 50237530
Nervous system cyst 10.12 9.78 3 323391 3 50281727
Peripheral nerve operation 10.12 9.78 3 323391 3 50281727
Diabetic gastropathy 10.12 9.78 3 323391 3 50281727
Enamel anomaly 10.10 9.78 4 323390 15 50281715
Tooth disorder 10.10 9.78 214 323180 24014 50257716
Hepatitis C virus test positive 10.09 9.78 7 323387 98 50281632
Respiratory rate decreased 10.08 9.78 43 323351 3065 50278665
Cellulitis 10.05 9.78 551 322843 70247 50211483
Vascular malformation 10.05 9.78 11 323383 292 50281438
Disturbance in social behaviour 10.04 9.78 3 323391 2891 50278839
Forced expiratory volume decreased 10.04 9.78 8 323386 4386 50277344
Right ventricular failure 9.99 9.78 60 323334 15833 50265897
Muscle contractions involuntary 9.98 9.78 31 323363 1891 50279839
Labelled drug-drug interaction medication error 9.92 9.78 34 323360 10443 50271287
Naevus haemorrhage 9.91 9.78 7 323387 101 50281629
Urine protein/creatinine ratio abnormal 9.90 9.78 4 323390 16 50281714
Acute generalised exanthematous pustulosis 9.89 9.78 27 323367 8911 50272819
Anal abscess 9.85 9.78 6 323388 3785 50277945
Hot flush 9.85 9.78 360 323034 43809 50237921
Body temperature increased 9.80 9.78 141 323253 31200 50250530
Retroplacental haematoma 9.79 9.78 8 323386 145 50281585

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 884.75 10.33 1523 176429 66883 29329692
Completed suicide 473.87 10.33 1403 176549 88843 29307732
Drug ineffective for unapproved indication 472.44 10.33 502 177450 13712 29382863
Myoclonus 264.42 10.33 362 177590 12947 29383628
Somnolence 167.95 10.33 1053 176899 92902 29303673
Toxicity to various agents 161.42 10.33 1675 176277 171986 29224589
Interstitial lung disease 156.02 10.33 76 177876 57642 29338933
Drug withdrawal syndrome 149.67 10.33 333 177619 17651 29378924
Fall 137.30 10.33 1649 176303 175529 29221046
Drug abuse 136.96 10.33 886 177066 78997 29317578
Sedation 130.18 10.33 309 177643 17096 29379479
Drug dependence 126.21 10.33 343 177609 20638 29375937
Multiple sclerosis relapse 124 10.33 236 177716 11183 29385392
Neuropathy peripheral 120.03 10.33 785 177167 70242 29326333
Febrile neutropenia 115.95 10.33 321 177631 111919 29284656
Memory impairment 111.43 10.33 475 177477 35995 29360580
Euphoric mood 104.63 10.33 137 177815 4688 29391887
Confusional state 100.59 10.33 1194 176758 126683 29269892
Pain 99.13 10.33 1514 176438 169918 29226657
Mental status changes 96.17 10.33 441 177511 34486 29362089
Hypoaesthesia 95.89 10.33 600 177352 52867 29343708
Hepatic function abnormal 95.47 10.33 59 177893 39200 29357375
Cytomegalovirus infection 93.53 10.33 14 177938 23201 29373374
Depression 91.96 10.33 848 177104 84299 29312276
Insomnia 91.87 10.33 876 177076 87885 29308690
Tremor 89.03 10.33 751 177201 72787 29323788
Withdrawal syndrome 85.30 10.33 198 177754 10794 29385781
Anaemia 85.11 10.33 786 177166 200165 29196410
Obsessive-compulsive disorder 82.74 10.33 119 177833 4457 29392118
Cardiac failure 80.91 10.33 228 177724 79059 29317516
Therapeutic product effect variable 80.20 10.33 76 177876 1801 29394774
Pain in extremity 79.82 10.33 1015 176937 109418 29287157
Plasma cell myeloma 79.82 10.33 437 177515 36678 29359897
Pyrexia 77.93 10.33 1240 176712 286382 29110193
Respiratory arrest 76.24 10.33 333 177619 25500 29371075
Gait disturbance 74.44 10.33 721 177231 72628 29323947
Thrombocytopenia 72.49 10.33 494 177458 134329 29262246
Renal impairment 70.95 10.33 251 177701 81082 29315493
Neuralgia 69.66 10.33 182 177770 10692 29385883
C-reactive protein increased 69.44 10.33 99 177853 44164 29352411
Balance disorder 69.32 10.33 413 177539 35757 29360818
Multiple sclerosis 66.85 10.33 120 177832 5434 29391141
Muscle spasms 66.65 10.33 641 177311 64441 29332134
Antipsychotic drug level below therapeutic 66.06 10.33 70 177882 1904 29394671
Disinhibition 64.41 10.33 79 177873 2528 29394047
Anxiety 63.52 10.33 789 177163 84576 29311999
Drug resistance 63.50 10.33 25 177927 21515 29375060
Muscle spasticity 61.99 10.33 108 177844 4775 29391800
Dizziness 61.64 10.33 1535 176417 188149 29208426
Neutropenia 61.53 10.33 502 177450 131209 29265366
Suicidal ideation 61.23 10.33 388 177564 34328 29362247
Product complaint 60.28 10.33 113 177839 5292 29391283
Alanine aminotransferase increased 59.85 10.33 222 177730 70722 29325853
Accidental death 56.95 10.33 67 177885 2051 29394524
Feeling abnormal 56.11 10.33 537 177415 53908 29342667
Mucosal inflammation 55.40 10.33 65 177887 31530 29365045
Hallucination 55.34 10.33 459 177493 44253 29352322
Nightmare 54.59 10.33 172 177780 11245 29385330
Septic shock 53.26 10.33 195 177757 62365 29334210
Disseminated intravascular coagulation 52.92 10.33 27 177925 19953 29376622
Multiple organ dysfunction syndrome 51.61 10.33 200 177752 62916 29333659
Intervertebral disc degeneration 51.33 10.33 104 177848 5160 29391415
Increased appetite 51.24 10.33 113 177839 5951 29390624
Bone marrow failure 47.55 10.33 57 177895 27392 29369183
Overdose 47.19 10.33 708 177244 79111 29317464
Appendicolith 46.85 10.33 79 177873 3401 29393174
Intentional product misuse 46.80 10.33 363 177589 34298 29362277
Respiratory depression 46.72 10.33 183 177769 13340 29383235
Right atrial hypertrophy 46.64 10.33 33 177919 509 29396066
Dysarthria 46.42 10.33 332 177620 30579 29365996
Off label use 46.07 10.33 1419 176533 299381 29097194
Amnesia 45.61 10.33 262 177690 22381 29374194
Drug reaction with eosinophilia and systemic symptoms 45.51 10.33 61 177891 27931 29368644
Back disorder 44.60 10.33 106 177846 5867 29390708
Haemophagocytic lymphohistiocytosis 43.09 10.33 6 177946 10498 29386077
Myokymia 41.77 10.33 17 177935 75 29396500
Malignant neoplasm progression 40.45 10.33 269 177683 73590 29322985
General physical health deterioration 40.19 10.33 410 177542 102447 29294128
Vision blurred 39.78 10.33 393 177559 39783 29356792
Hepatic failure 39.75 10.33 81 177871 31431 29365144
Burning sensation 39.32 10.33 195 177757 15743 29380832
Paraesthesia 39.30 10.33 496 177456 53349 29343226
Fatigue 38.74 10.33 2301 175651 314520 29082055
Congenital multiplex arthrogryposis 38.18 10.33 13 177939 30 29396545
Dyspnoea 37.83 10.33 1595 176357 325137 29071438
Constipation 37.64 10.33 926 177026 113234 29283341
Infusion related reaction 37.21 10.33 137 177815 43749 29352826
Cerebral haemorrhage 36.96 10.33 84 177868 31342 29365233
Inadequate analgesia 36.73 10.33 61 177891 2593 29393982
Prescription drug used without a prescription 34.64 10.33 41 177911 1263 29395312
Product dose omission issue 34.26 10.33 790 177162 95593 29300982
Acute kidney injury 34.11 10.33 1279 176673 263988 29132587
Melaena 33.77 10.33 87 177865 31089 29365486
Sleep apnoea syndrome 33.73 10.33 201 177751 17398 29379177
Bronchial secretion retention 33.56 10.33 38 177914 1115 29395460
Asterixis 33.44 10.33 37 177915 1058 29395517
Ataxia 33.43 10.33 153 177799 11950 29384625
Aspergillus infection 33.36 10.33 11 177941 10570 29386005
Drug tolerance 33.23 10.33 52 177900 2101 29394474
Myelosuppression 33.17 10.33 16 177936 12211 29384364
Renal failure 33.09 10.33 508 177444 118091 29278484
Labelled drug-drug interaction medication error 32.85 10.33 16 177936 12143 29384432
Neutrophil count decreased 32.52 10.33 143 177809 43424 29353151
Aspartate aminotransferase increased 32.46 10.33 218 177734 59507 29337068
Jaundice 32.32 10.33 81 177871 29215 29367360
Bronchopulmonary aspergillosis 32.22 10.33 17 177935 12327 29384248
Hypokalaemia 32.14 10.33 174 177778 50029 29346546
Relapsing-remitting multiple sclerosis 31.96 10.33 30 177922 702 29395873
Muscle twitching 31.37 10.33 113 177839 7913 29388662
Bronchial wall thickening 31.18 10.33 35 177917 1017 29395558
Hyperreflexia 30.97 10.33 58 177894 2714 29393861
Needle fatigue 30.94 10.33 27 177925 573 29396002
Foetal exposure during pregnancy 30.53 10.33 103 177849 33764 29362811
Contraindicated product administered 30.52 10.33 39 177913 18227 29378348
Full blood count decreased 30.24 10.33 182 177770 15810 29380765
Back pain 30.01 10.33 817 177135 101467 29295108
Adverse drug reaction 29.93 10.33 247 177705 23773 29372802
Gait spastic 29.60 10.33 28 177924 662 29395913
Sweat gland disorder 29.51 10.33 14 177938 95 29396480
Metabolic acidosis 29.10 10.33 122 177830 37540 29359035
Toxic epidermal necrolysis 29.06 10.33 40 177912 18113 29378462
Colitis 28.88 10.33 94 177858 31154 29365421
Eosinophilia 28.78 10.33 56 177896 22105 29374470
Anorgasmia 28.69 10.33 26 177926 581 29395994
Graft versus host disease 28.66 10.33 11 177941 9617 29386958
Bradyphrenia 28.51 10.33 72 177880 4142 29392433
Parasomnia 28.41 10.33 21 177931 348 29396227
Right ventricular hypertrophy 28.39 10.33 35 177917 1126 29395449
Victim of child abuse 28.34 10.33 30 177922 815 29395760
Proteinuria 28.25 10.33 32 177920 15772 29380803
Mood altered 28.21 10.33 110 177842 8001 29388574
Depressed level of consciousness 28.11 10.33 343 177609 36599 29359976
Blood bilirubin increased 27.95 10.33 107 177845 33786 29362789
Sciatica 27.81 10.33 79 177873 4875 29391700
Lethargy 27.77 10.33 347 177605 37233 29359342
Peripheral swelling 27.68 10.33 538 177414 63201 29333374
Obstruction 27.64 10.33 45 177907 1881 29394694
Nerve injury 27.53 10.33 58 177894 2959 29393616
Pleural effusion 27.51 10.33 288 177664 71620 29324955
Gastrointestinal haemorrhage 27.48 10.33 326 177626 79207 29317368
Delirium tremens 27.40 10.33 24 177928 512 29396063
Gamma-glutamyltransferase increased 27.16 10.33 77 177875 26660 29369915
Haematotoxicity 27.07 10.33 4 177948 6695 29389880
Pneumonitis 26.87 10.33 83 177869 27961 29368614
Erectile dysfunction 26.79 10.33 193 177759 17816 29378759
Sopor 26.42 10.33 133 177819 10801 29385774
Diabetic neuropathy 26.31 10.33 65 177887 3688 29392887
Nervousness 26.25 10.33 136 177816 11170 29385405
Pancytopenia 26.08 10.33 348 177604 82820 29313755
Antidepressant drug level above therapeutic 25.43 10.33 15 177937 166 29396409
Dyskinesia 25.37 10.33 207 177745 19854 29376721
Erythema 25.32 10.33 312 177640 75294 29321281
Hyperaesthesia 25.30 10.33 61 177891 3408 29393167
Tooth disorder 25.24 10.33 119 177833 9410 29387165
Gait inability 25.10 10.33 193 177759 18182 29378393
Affective disorder 25.01 10.33 57 177895 3069 29393506
Hypernatraemia 24.51 10.33 7 177945 7379 29389196
Atrial fibrillation 24.45 10.33 468 177484 105178 29291397
Cholestasis 24.25 10.33 67 177885 23395 29373180
Venoocclusive liver disease 24.00 10.33 6 177946 6911 29389664
Posterior reversible encephalopathy syndrome 23.96 10.33 12 177940 8964 29387611
Pneumocystis jirovecii pneumonia 23.94 10.33 40 177912 16739 29379836
Anger 23.92 10.33 129 177823 10761 29385814
Spinal operation 23.90 10.33 48 177904 2366 29394209
Haematochezia 23.77 10.33 128 177824 36855 29359720
Hallucination, visual 23.55 10.33 163 177789 14852 29381723
Cholangitis 23.48 10.33 8 177944 7529 29389046
Acute myocardial infarction 23.32 10.33 183 177769 48255 29348320
Epistaxis 23.22 10.33 199 177753 51505 29345070
Transaminases increased 23.21 10.33 65 177887 22597 29373978
Synovitis 23.01 10.33 19 177933 10871 29385704
Pathogen resistance 22.98 10.33 10 177942 8106 29388469
Drug eruption 22.89 10.33 41 177911 16700 29379875
Localised infection 22.87 10.33 152 177800 13664 29382911
Post transplant lymphoproliferative disorder 22.86 10.33 3 177949 5490 29391085
Circulatory collapse 22.71 10.33 49 177903 18624 29377951
Acute respiratory distress syndrome 22.60 10.33 67 177885 22868 29373707
Haematuria 22.56 10.33 164 177788 43975 29352600
Encephalopathy neonatal 22.06 10.33 9 177943 40 29396535
Hepatic enzyme increased 21.71 10.33 117 177835 33682 29362893
Osteomyelitis 21.60 10.33 149 177803 13560 29383015
Urinary incontinence 21.35 10.33 171 177781 16310 29380265
Restless legs syndrome 21.34 10.33 91 177861 6893 29389682
Pulmonary alveolar haemorrhage 21.26 10.33 6 177946 6374 29390201
Serotonin syndrome 21.24 10.33 179 177773 17333 29379242
Coordination abnormal 21.20 10.33 92 177860 7022 29389553
Suicidal behaviour 21.11 10.33 33 177919 1332 29395243
Phantom limb syndrome 21.11 10.33 15 177937 233 29396342
Neonatal toxicity 21.09 10.33 8 177944 28 29396547
Aortic valve stenosis 20.79 10.33 43 177909 2165 29394410
Angioedema 20.76 10.33 110 177842 31805 29364770
Alcoholism 20.71 10.33 48 177904 2613 29393962
Analgesic drug level above therapeutic 20.58 10.33 15 177937 243 29396332
Acute myeloid leukaemia 20.35 10.33 43 177909 16470 29380105
Impaired driving ability 20.33 10.33 44 177908 2287 29394288
Rhabdomyolysis 20.33 10.33 251 177701 60557 29336018
Palmar-plantar erythrodysaesthesia syndrome 20.31 10.33 36 177916 14723 29381852
Blood creatine phosphokinase increased 20.30 10.33 152 177800 40492 29356083
Cerebral infarction 20.28 10.33 78 177874 24597 29371978
Drug tolerance increased 20.26 10.33 19 177933 444 29396131
Ischaemic stroke 20.20 10.33 41 177911 15936 29380639
Pulmonary function test abnormal 20.14 10.33 41 177911 2041 29394534
Prescribed overdose 19.85 10.33 104 177848 8579 29387996
Myocarditis 19.79 10.33 22 177930 10934 29385641
Blood lactate dehydrogenase increased 19.75 10.33 55 177897 19154 29377421
Delirium 19.71 10.33 340 177612 39057 29357518
Haemoglobin decreased 19.64 10.33 499 177453 107876 29288699
Personality change 19.59 10.33 67 177885 4571 29392004
Transplant rejection 19.55 10.33 16 177936 9196 29387379
Hypertonic bladder 19.53 10.33 33 177919 1423 29395152
Drug screen negative 19.31 10.33 12 177940 147 29396428
Appendicitis 19.28 10.33 104 177848 8675 29387900
Irritability 19.23 10.33 211 177741 21941 29374634
Inflammation 19.23 10.33 71 177881 22657 29373918
Facial pain 19.22 10.33 37 177915 1768 29394807
Mental impairment 19.21 10.33 107 177845 9034 29387541
Epstein-Barr virus infection 19.04 10.33 8 177944 6621 29389954
Liver disorder 18.98 10.33 94 177858 27655 29368920
Agranulocytosis 18.92 10.33 61 177891 20279 29376296
Cognitive disorder 18.67 10.33 220 177732 23279 29373296
Conversion disorder 18.59 10.33 16 177936 333 29396242
Shock haemorrhagic 18.58 10.33 18 177934 9533 29387042
Rash maculo-papular 18.56 10.33 79 177873 24210 29372365
Tubulointerstitial nephritis 18.52 10.33 50 177902 17593 29378982
Treatment failure 18.51 10.33 138 177814 36801 29359774
Acute hepatic failure 18.47 10.33 27 177925 11925 29384650
Cerebral disorder 18.37 10.33 42 177910 2266 29394309
Thrombosis 18.23 10.33 362 177590 42683 29353892
Lower respiratory tract infection 18.00 10.33 90 177862 26412 29370163
Nephropathy toxic 17.93 10.33 23 177929 10733 29385842
Rectal haemorrhage 17.83 10.33 128 177824 34421 29362154
Dysphoria 17.69 10.33 39 177913 2053 29394522
Mucosal atrophy 17.63 10.33 9 177943 73 29396502
Bradypnoea 17.62 10.33 42 177910 2329 29394246
Haemolysis 17.54 10.33 10 177942 6946 29389629
Agitation 17.43 10.33 418 177534 50886 29345689
Cardio-respiratory arrest 17.42 10.33 413 177539 50188 29346387
Hostility 17.41 10.33 23 177929 794 29395781
Anaphylactic reaction 17.40 10.33 96 177856 27477 29369098
Facial wasting 17.34 10.33 11 177941 140 29396435
Binocular eye movement disorder 17.28 10.33 8 177944 51 29396524
Hypometabolism 17.28 10.33 8 177944 51 29396524
Intervertebral disc protrusion 17.25 10.33 100 177852 8570 29388005
Tumour lysis syndrome 17.24 10.33 36 177916 13848 29382727
Ear deformity acquired 17.16 10.33 5 177947 5 29396570
Metastases to liver 17.16 10.33 28 177924 11828 29384747
Muscular weakness 17.16 10.33 492 177460 61560 29335015
Cough 17.13 10.33 607 177345 126120 29270455
Metabolic encephalopathy 17.12 10.33 55 177897 3632 29392943
Left ventricular dysfunction 17.06 10.33 17 177935 8885 29387690
Suspected suicide 16.92 10.33 58 177894 3962 29392613
Precancerous skin lesion 16.90 10.33 19 177933 553 29396022
Opisthotonus 16.81 10.33 17 177935 437 29396138
Disorientation 16.72 10.33 260 177692 29255 29367320
Idiopathic neutropenia 16.48 10.33 4 177948 0 29396575
Seizure 16.40 10.33 701 177251 92422 29304153
Disease progression 16.25 10.33 372 177580 81544 29315031
Heat exhaustion 16.19 10.33 10 177942 121 29396454
Therapeutic response unexpected 16.13 10.33 98 177854 8540 29388035
Migraine 16.12 10.33 129 177823 12301 29384274
Nephrotic syndrome 16.10 10.33 9 177943 6319 29390256
Hyperkalaemia 16.08 10.33 266 177686 61126 29335449
Immune reconstitution inflammatory syndrome 16.01 10.33 14 177938 7788 29388787
Hyperbilirubinaemia 15.92 10.33 42 177910 14892 29381683
Breakthrough pain 15.85 10.33 18 177934 530 29396045
Thinking abnormal 15.83 10.33 68 177884 5168 29391407
Sedation complication 15.81 10.33 28 177924 1254 29395321
Musculoskeletal disorder 15.80 10.33 68 177884 5172 29391403
Artery dissection 15.78 10.33 9 177943 93 29396482
Ventricular tachycardia 15.71 10.33 76 177876 22498 29374077
Loss of proprioception 15.71 10.33 15 177937 359 29396216
Hepatocellular injury 15.68 10.33 70 177882 21173 29375402
Pulmonary toxicity 15.56 10.33 5 177947 4885 29391690
Monoparesis 15.56 10.33 35 177917 1868 29394707
Obesity 15.42 10.33 107 177845 9756 29386819
Acute pulmonary oedema 15.38 10.33 11 177941 6768 29389807
Hypersomnia 15.28 10.33 114 177838 10640 29385935
Feeling drunk 15.20 10.33 32 177920 1632 29394943
Encephalitis 15.16 10.33 10 177942 6420 29390155
Colitis ulcerative 15.12 10.33 34 177918 12735 29383840
Blood creatinine increased 15.10 10.33 393 177559 84709 29311866
Foetal disorder 15.10 10.33 21 177931 762 29395813
Gingival atrophy 14.94 10.33 7 177945 46 29396529
Tachycardia 14.89 10.33 327 177625 72083 29324492
Stomatitis 14.86 10.33 147 177805 36966 29359609
Fibromyalgia 14.83 10.33 42 177910 2587 29393988
Aggression 14.75 10.33 298 177654 35243 29361332
Cytomegalovirus viraemia 14.67 10.33 10 177942 6310 29390265
Tuberculosis 14.66 10.33 13 177939 7183 29389392
Feeding intolerance 14.57 10.33 9 177943 109 29396466
Quality of life decreased 14.55 10.33 48 177904 3214 29393361
Pulmonary tuberculosis 14.48 10.33 4 177948 4311 29392264
Personality disorder 14.47 10.33 25 177927 1098 29395477
Acute coronary syndrome 14.44 10.33 33 177919 12292 29384283
Acute graft versus host disease in skin 14.44 10.33 5 177947 4659 29391916
Blood pressure fluctuation 14.42 10.33 66 177886 19828 29376747
Muscle tightness 14.41 10.33 58 177894 4280 29392295
Pneumothorax 14.40 10.33 48 177904 15794 29380781
Blood pressure decreased 14.35 10.33 190 177762 45287 29351288
Oesophageal mucosa erythema 14.31 10.33 6 177946 29 29396546
Spinal stenosis 14.23 10.33 58 177894 4305 29392270
Autoimmune haemolytic anaemia 14.02 10.33 3 177949 3845 29392730
Stiff person syndrome 14.00 10.33 8 177944 83 29396492
Intentional underdose 13.99 10.33 18 177934 605 29395970
Cardiac failure acute 13.98 10.33 21 177931 9171 29387404
Ventricular hypokinesia 13.95 10.33 5 177947 4560 29392015
Candida infection 13.93 10.33 46 177906 15179 29381396
Hypomagnesaemia 13.85 10.33 56 177896 17412 29379163
Body height decreased 13.85 10.33 49 177903 3401 29393174
Respiratory disorder 13.75 10.33 54 177898 16929 29379646
Foot fracture 13.75 10.33 54 177898 3941 29392634
Hypoacusis 13.74 10.33 140 177812 14283 29382292
Fear of weight gain 13.73 10.33 4 177948 4 29396571
Stevens-Johnson syndrome 13.65 10.33 52 177900 16445 29380130
Mucormycosis 13.61 10.33 7 177945 5151 29391424
Back injury 13.57 10.33 49 177903 3435 29393140
Lung disorder 13.57 10.33 117 177835 30245 29366330
Akathisia 13.56 10.33 78 177874 6664 29389911
Radiculopathy 13.43 10.33 39 177913 2437 29394138
Peritonitis 13.41 10.33 45 177907 14779 29381796
Hypoalbuminaemia 13.41 10.33 26 177926 10279 29386296
Dysphemia 13.38 10.33 28 177924 1422 29395153
Abnormal labour affecting foetus 13.29 10.33 5 177947 17 29396558
Dependence 13.28 10.33 23 177929 1012 29395563
Neutropenic sepsis 13.26 10.33 32 177920 11695 29384880
Haemorrhage intracranial 13.26 10.33 44 177908 14498 29382077
Diplopia 13.26 10.33 132 177820 13386 29383189
Shock 13.25 10.33 75 177877 21329 29375246
Alcohol withdrawal syndrome 13.24 10.33 27 177925 1346 29395229
Abnormal sleep-related event 13.23 10.33 15 177937 441 29396134
Seborrhoeic keratosis 13.19 10.33 21 177931 861 29395714
Herpes zoster 13.15 10.33 254 177698 29798 29366777
Hepatotoxicity 13.11 10.33 59 177893 17808 29378767
Lumbar radiculopathy 13.00 10.33 19 177933 722 29395853
Open angle glaucoma 12.99 10.33 9 177943 134 29396441
Hand deformity 12.98 10.33 35 177917 2095 29394480
Bipolar I disorder 12.92 10.33 19 177933 726 29395849
Thoracic vertebral fracture 12.90 10.33 27 177925 1371 29395204
Intentional product use issue 12.89 10.33 179 177773 42319 29354256
Joint hyperextension 12.87 10.33 8 177944 98 29396477
Head titubation 12.85 10.33 12 177940 279 29396296
Panic attack 12.83 10.33 90 177862 8236 29388339
Ejection fraction decreased 12.81 10.33 51 177901 15927 29380648
Fungal infection 12.76 10.33 41 177911 13644 29382931
Oxygen saturation decreased 12.67 10.33 192 177760 44745 29351830
Free androgen index decreased 12.67 10.33 5 177947 20 29396555
Hypoosmolar state 12.64 10.33 7 177945 68 29396507
Leukopenia 12.61 10.33 245 177707 54958 29341617
Anal abscess 12.61 10.33 8 177944 5243 29391332
Drug abuser 12.58 10.33 51 177901 3776 29392799
Haemorrhage 12.57 10.33 193 177759 44879 29351696
Road traffic accident 12.50 10.33 146 177806 15415 29381160
Implant site inflammation 12.47 10.33 8 177944 104 29396471
Enterocolitis 12.47 10.33 13 177939 6653 29389922
Enterococcal infection 12.46 10.33 19 177933 8249 29388326
Lactic acidosis 12.45 10.33 119 177833 30128 29366447
Hypertriglyceridaemia 12.44 10.33 16 177936 7459 29389116
Weight increased 12.36 10.33 572 177380 76095 29320480
Ventricular septal defect 12.36 10.33 3 177949 3526 29393049
Nasal odour 12.36 10.33 3 177949 0 29396575
Traumatic amputation 12.36 10.33 3 177949 0 29396575
Benign neoplasm of spinal cord 12.36 10.33 3 177949 0 29396575
Severe myoclonic epilepsy of infancy 12.36 10.33 3 177949 0 29396575
Pancreatic fibrosis 12.36 10.33 3 177949 0 29396575
Hepatitis 12.23 10.33 74 177878 20709 29375866
Amphetamines positive 12.23 10.33 9 177943 148 29396427
Hypotension 12.22 10.33 1005 176947 193349 29203226
Trigeminal neuralgia 12.19 10.33 22 177930 1000 29395575
Drug effective for unapproved indication 12.16 10.33 27 177925 1428 29395147
Hyperhidrosis 12.07 10.33 489 177463 64051 29332524
Large intestine perforation 11.98 10.33 16 177936 7340 29389235
Myocardial infarction 11.94 10.33 542 177410 109754 29286821
Violence-related symptom 11.94 10.33 15 177937 492 29396083
Nerve compression 11.87 10.33 40 177912 2708 29393867
Micturition urgency 11.85 10.33 62 177890 5111 29391464
Infective pulmonary exacerbation of cystic fibrosis 11.84 10.33 12 177940 6224 29390351
Hyperthyroidism 11.84 10.33 21 177931 8587 29387988
Blood urea increased 11.83 10.33 110 177842 28002 29368573
Immunosuppressant drug level increased 11.80 10.33 7 177945 4758 29391817
Rheumatoid arthritis 11.79 10.33 130 177822 32022 29364553
Neutropenia neonatal 11.75 10.33 17 177935 640 29395935
Major depression 11.74 10.33 50 177902 3785 29392790
Lymphocyte count decreased 11.67 10.33 68 177884 19203 29377372
Application site hypersensitivity 11.67 10.33 8 177944 117 29396458
Enthesopathy 11.61 10.33 4 177948 3739 29392836
Blood alkaline phosphatase increased 11.59 10.33 112 177840 28294 29368281
Injection site mass 11.56 10.33 64 177888 5391 29391184
Toxic skin eruption 11.54 10.33 26 177926 9731 29386844
Disturbance in attention 11.48 10.33 187 177765 21237 29375338
Teeth brittle 11.42 10.33 6 177946 52 29396523
Carpal tunnel syndrome 11.35 10.33 52 177900 4062 29392513
Chronic graft versus host disease 11.35 10.33 5 177947 4024 29392551
Sleep disorder 11.32 10.33 208 177744 24178 29372397
Slow speech 11.29 10.33 20 177932 896 29395679
Hyperuricaemia 11.21 10.33 15 177937 6874 29389701
Post laminectomy syndrome 11.14 10.33 9 177943 171 29396404
Child abuse 11.12 10.33 10 177942 221 29396354
Pulmonary fibrosis 11.11 10.33 52 177900 15530 29381045
White blood cell count increased 11.03 10.33 159 177793 37357 29359218
Nephrogenic systemic fibrosis 11.01 10.33 50 177902 3892 29392683
Premature baby 10.99 10.33 60 177892 17220 29379355
Drug withdrawal syndrome neonatal 10.97 10.33 45 177907 3350 29393225
Rib fracture 10.97 10.33 121 177831 12597 29383978
Nocturia 10.96 10.33 87 177865 8275 29388300
Polyarthritis 10.95 10.33 5 177947 3940 29392635
Abdominal discomfort 10.90 10.33 371 177581 47532 29349043
Neck surgery 10.90 10.33 12 177940 341 29396234
Antipsychotic drug level increased 10.90 10.33 3 177949 3240 29393335
Dysaesthesia 10.84 10.33 32 177920 2018 29394557
Carcinogenicity 10.77 10.33 6 177946 59 29396516
Exposure during pregnancy 10.77 10.33 22 177930 8532 29388043
Complex regional pain syndrome 10.74 10.33 14 177938 477 29396098
Epidural lipomatosis 10.73 10.33 17 177935 694 29395881
Joint injury 10.71 10.33 75 177877 6858 29389717
Electrocardiogram QT prolonged 10.67 10.33 153 177799 35984 29360591
Retinal haemorrhage 10.63 10.33 7 177945 4497 29392078
Dysstasia 10.62 10.33 103 177849 10371 29386204
Incision site complication 10.62 10.33 11 177941 291 29396284
Neoplasm progression 10.58 10.33 67 177885 18545 29378030
Hip fracture 10.56 10.33 103 177849 10389 29386186
Sleep attacks 10.55 10.33 8 177944 138 29396437
Hypotony maculopathy 10.55 10.33 4 177948 14 29396561
Pupillary reflex impaired 10.51 10.33 25 177927 1384 29395191
Second primary malignancy 10.51 10.33 15 177937 6690 29389885
Immunodeficiency common variable 10.50 10.33 8 177944 139 29396436
Central nervous system lesion 10.50 10.33 64 177888 5584 29390991
Pseudomonas infection 10.48 10.33 32 177920 10820 29385755
Drug interaction 10.47 10.33 1034 176918 196351 29200224
Multiple cardiac defects 10.44 10.33 6 177946 63 29396512
Anaphylactic shock 10.42 10.33 43 177909 13293 29383282
Light chain analysis decreased 10.41 10.33 5 177947 35 29396540
Creatinine urine decreased 10.41 10.33 5 177947 35 29396540
Mouth ulceration 10.38 10.33 30 177922 10325 29386250
Adenovirus infection 10.37 10.33 7 177945 4440 29392135
Genital burning sensation 10.33 10.33 4 177948 15 29396560
Cyanosis 10.33 10.33 34 177918 11233 29385342

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 2840.48 9.90 5152 388834 232663 63872083
Drug ineffective for unapproved indication 1421.47 9.90 1316 392670 29817 64074929
Completed suicide 1313.81 9.90 3662 390324 220752 63883994
Myoclonus 520.85 9.90 703 393283 24415 64080331
Toxicity to various agents 468.57 9.90 3806 390180 359707 63745039
Multiple sclerosis relapse 411.07 9.90 828 393158 40307 64064439
Somnolence 384.67 9.90 2341 391645 201304 63903442
Drug abuse 348.58 9.90 1667 392319 130707 63974039
Pemphigus 332.27 9.90 8 393978 60693 64044053
Synovitis 318.43 9.90 104 393882 98986 64005760
Fall 303.73 9.90 3882 390104 412944 63691802
Contraindicated product administered 296.06 9.90 144 393842 107685 63997061
Depression 253.55 9.90 1952 392034 181339 63923407
Febrile neutropenia 231.15 9.90 501 393485 187156 63917590
Pericarditis 228.34 9.90 51 393935 62465 64042281
Interstitial lung disease 226.56 9.90 160 393826 97572 64007174
Maternal exposure during pregnancy 224.88 9.90 155 393831 95729 64009017
Respiratory arrest 224.76 9.90 774 393212 52211 64052535
Hand deformity 221.77 9.90 55 393931 62716 64042030
Memory impairment 216.78 9.90 1067 392919 84615 64020131
Mental status changes 213.64 9.90 839 393147 60323 64044423
Multiple sclerosis 209.51 9.90 398 393588 18543 64086203
Systemic lupus erythematosus 207.98 9.90 107 393879 77505 64027241
Drug withdrawal syndrome 206.95 9.90 535 393451 30756 64073990
Accidental death 202.75 9.90 174 393812 3551 64101195
Tremor 198.48 9.90 1567 392419 146663 63958083
Suicidal ideation 192.74 9.90 862 393124 65680 64039066
Dizziness 187.91 9.90 3678 390308 426485 63678261
Glossodynia 187.53 9.90 80 393906 64616 64040130
Infusion related reaction 184.12 9.90 462 393524 164005 63940741
Hepatic enzyme increased 180.62 9.90 323 393663 129620 63975126
Withdrawal syndrome 178.96 9.90 424 393562 23068 64081678
Duodenal ulcer perforation 177.36 9.90 8 393978 34617 64070129
Drug dependence 172.44 9.90 521 393465 32791 64071955
Sedation 170.05 9.90 599 393387 40863 64063883
Rheumatoid factor positive 169.85 9.90 11 393975 34927 64069819
Feeling abnormal 168.87 9.90 1394 392592 132208 63972538
Pyrexia 164.13 9.90 2414 391572 556230 63548516
General physical health deterioration 162.01 9.90 670 393316 203755 63900991
Confusional state 159.89 9.90 2359 391627 258785 63845961
Hallucination 159.53 9.90 871 393115 71917 64032829
Hepatic function abnormal 153.42 9.90 102 393884 64211 64040535
C-reactive protein increased 149.67 9.90 217 393769 94692 64010054
Helicobacter infection 146.90 9.90 28 393958 38334 64066412
Joint swelling 146.24 9.90 747 393239 214635 63890111
Exposure during pregnancy 146.19 9.90 155 393831 77520 64027226
Cytomegalovirus infection 142.77 9.90 27 393959 37172 64067574
Balance disorder 140.37 9.90 936 393050 82990 64021756
Muscle spasms 139.75 9.90 1396 392590 139627 63965119
Hypoaesthesia 137.34 9.90 1376 392610 137732 63967014
Vision blurred 134.42 9.90 979 393007 89337 64015409
Anaemia 133.48 9.90 1575 392411 377105 63727641
C-reactive protein abnormal 127.91 9.90 14 393972 29033 64075713
Respiratory depression 126.40 9.90 372 393614 23071 64081675
Thrombocytopenia 125.79 9.90 825 393161 222976 63881770
Gait disturbance 122.65 9.90 1598 392388 170557 63934189
Arthropathy 122.40 9.90 357 393629 120610 63984136
Anxiety 117.88 9.90 1815 392171 200834 63903912
Pain in extremity 117.78 9.90 2548 391438 300537 63804209
Cardio-respiratory arrest 116.54 9.90 1012 392974 97381 64007365
Neuralgia 112.32 9.90 384 393602 25800 64078946
Sleep disorder due to general medical condition, insomnia type 109.95 9.90 15 393971 26255 64078491
Cardiac failure 107.86 9.90 429 393557 131944 63972802
Product dose omission issue 104.14 9.90 1720 392266 193027 63911719
Muscle injury 104.02 9.90 18 393968 26419 64078327
Sopor 103.64 9.90 407 393579 29254 64075492
Neutropenia 99.54 9.90 959 393027 238665 63866081
Hypersensitivity 98.71 9.90 748 393238 195704 63909042
Neuropathy peripheral 95.34 9.90 1118 392868 116407 63988339
Mucosal inflammation 93.91 9.90 148 393838 62436 64042310
Bone marrow failure 93.27 9.90 93 393893 47859 64056887
Multiple organ dysfunction syndrome 92.24 9.90 314 393672 101099 64003647
Intentional product misuse 91.10 9.90 754 393232 71541 64033205
Insomnia 89.97 9.90 1703 392283 196133 63908613
Lethargy 88.75 9.90 752 393234 71842 64032904
Drug resistance 85.99 9.90 54 393932 35048 64069698
Pancytopenia 82.64 9.90 524 393462 142785 63961961
Overdose 82.23 9.90 1401 392585 158165 63946581
Lower respiratory tract infection 81.99 9.90 299 393687 94315 64010431
Drug reaction with eosinophilia and systemic symptoms 81.55 9.90 128 393858 54089 64050657
Product complaint 80.69 9.90 206 393780 11748 64092998
Folliculitis 79.77 9.90 42 393944 30035 64074711
Sleep apnoea syndrome 79.35 9.90 377 393609 29455 64075291
Migraine 77.53 9.90 651 393335 62026 64042720
Discomfort 77.29 9.90 245 393741 80633 64024113
Paraesthesia 76.32 9.90 1200 392786 133322 63971424
Plasma cell myeloma 75.89 9.90 512 393474 45563 64059183
Therapeutic product effect decreased 73.80 9.90 408 393578 114943 63989803
Malignant neoplasm progression 72.89 9.90 398 393588 112473 63992273
Septic shock 72.45 9.90 364 393622 105073 63999673
Amnesia 72.23 9.90 524 393462 47745 64057001
Wound 72.14 9.90 233 393753 76244 64028502
Inadequate analgesia 71.52 9.90 104 393882 3874 64100872
Dyskinesia 69.92 9.90 446 393540 38942 64065804
Myelosuppression 69.80 9.90 29 393957 23801 64080945
Mood altered 69.11 9.90 235 393751 15744 64089002
Hypokalaemia 68.11 9.90 450 393536 121453 63983293
Ataxia 66.88 9.90 290 393696 21794 64082952
Burning sensation 65.27 9.90 523 393463 49141 64055605
Depressed level of consciousness 64.39 9.90 771 393215 80665 64024081
Hyperaesthesia 63.93 9.90 169 393817 9845 64094901
Cardiac arrest 63.22 9.90 1306 392680 152758 63951988
Hallucination, visual 62.25 9.90 335 393651 27499 64077247
Dysarthria 62.17 9.90 595 393391 58811 64045935
Hepatic failure 61.62 9.90 156 393830 55238 64049508
Intervertebral disc degeneration 61.24 9.90 198 393788 12922 64091824
Haemophagocytic lymphohistiocytosis 61.09 9.90 16 393970 17593 64087153
Off label use 60.50 9.90 3205 390781 629601 63475145
Muscle twitching 60.26 9.90 253 393733 18745 64086001
Crying 59.46 9.90 262 393724 19828 64084918
Melaena 59.42 9.90 151 393835 53397 64051349
Nightmare 59.29 9.90 270 393716 20723 64084023
Atrial fibrillation 58.07 9.90 717 393269 170372 63934374
Euphoric mood 58.02 9.90 126 393860 6465 64098281
Mental disorder 57.61 9.90 316 393670 26129 64078617
Coordination abnormal 56.94 9.90 211 393775 14753 64089993
Device expulsion 56.81 9.90 29 393957 21107 64083639
Leukopenia 56.41 9.90 374 393612 100868 64003878
Red blood cell sedimentation rate abnormal 56.22 9.90 15 393971 16291 64088455
Urinary tract infection 55.19 9.90 1827 392159 229769 63874977
Muscular weakness 54.40 9.90 1086 392900 126252 63978494
Unresponsive to stimuli 53.36 9.90 506 393480 49887 64054859
Pneumocystis jirovecii pneumonia 53.27 9.90 54 393932 27580 64077166
Premature delivery 52.26 9.90 24 393962 18565 64086181
Renal impairment 52.00 9.90 550 393436 134467 63970279
Pleural effusion 51.86 9.90 508 393478 126051 63978695
Gait inability 51.30 9.90 438 393548 41930 64062816
Anorgasmia 50.98 9.90 44 393942 905 64103841
Alanine aminotransferase increased 50.89 9.90 573 393413 138458 63966288
Blood lactate dehydrogenase increased 50.79 9.90 77 393909 33001 64071745
Seizure 50.72 9.90 1357 392629 165535 63939211
Hepatotoxicity 50.55 9.90 105 393881 39857 64064889
Erythema 50.39 9.90 821 393165 186249 63918497
Serotonin syndrome 50.17 9.90 411 393575 38871 64065875
Disseminated intravascular coagulation 49.96 9.90 75 393911 32273 64072473
Jaundice 49.90 9.90 142 393844 48370 64056376
Speech disorder 49.61 9.90 483 393503 47958 64056788
Osteonecrosis of jaw 49.24 9.90 106 393880 39719 64065027
Impaired healing 49.22 9.90 196 393790 60277 64044469
Feeling drunk 49.12 9.90 90 393896 4077 64100669
Back disorder 48.67 9.90 153 393833 9837 64094909
Spinal operation 48.13 9.90 112 393874 6021 64098725
Stiff person syndrome 48.09 9.90 26 393960 236 64104510
Anger 47.89 9.90 207 393779 15534 64089212
Live birth 47.84 9.90 6 393980 11198 64093548
Poisoning 47.36 9.90 261 393725 21618 64083128
Head injury 47.12 9.90 353 393633 32489 64072257
Treatment failure 46.98 9.90 471 393515 116345 63988401
Therapeutic response unexpected 46.79 9.90 217 393769 16784 64087962
Hypersomnia 46.63 9.90 241 393745 19476 64085270
Irritable bowel syndrome 46.58 9.90 99 393887 37270 64067476
Appendicolith 46.15 9.90 79 393907 3390 64101356
Right atrial hypertrophy 46.03 9.90 33 393953 512 64104234
Colitis 45.98 9.90 193 393793 58481 64046265
Bradyphrenia 45.77 9.90 144 393842 9262 64095484
Asterixis 45.75 9.90 64 393922 2299 64102447
Rash 45.72 9.90 2312 391674 456237 63648509
Fatigue 45.56 9.90 5230 388756 743500 63361246
Nervousness 45.45 9.90 323 393663 29233 64075513
Ill-defined disorder 45.27 9.90 129 393857 43923 64060823
Graft versus host disease 45.24 9.90 14 393972 13799 64090947
Urinary incontinence 44.97 9.90 376 393610 35775 64068971
Impaired driving ability 44.48 9.90 92 393894 4562 64100184
Presbyacusis 44.39 9.90 66 393920 2509 64102237
Myocardial stunning 44.11 9.90 22 393964 166 64104580
Anaphylactic shock 43.36 9.90 74 393912 30254 64074492
Eosinophilia 43.31 9.90 106 393880 37970 64066776
Diplopia 43.22 9.90 296 393690 26469 64078277
Toxic epidermal necrolysis 42.64 9.90 103 393883 37063 64067683
Suspected suicide 42.58 9.90 133 393853 8521 64096225
Neutrophil count decreased 42.58 9.90 286 393700 76910 64027836
Transplant rejection 42.30 9.90 27 393959 17374 64087372
Irritability 41.44 9.90 374 393612 36372 64068374
Epistaxis 41.42 9.90 391 393595 97740 64007006
Rheumatoid arthritis 41.33 9.90 730 393256 163564 63941182
Transaminases increased 41.26 9.90 137 393849 44457 64060289
Venoocclusive liver disease 41.25 9.90 6 393980 10009 64094737
Proteinuria 41.17 9.90 66 393920 27657 64077089
Post transplant lymphoproliferative disorder 41.02 9.90 5 393981 9539 64095207
Abdominal discomfort 40.66 9.90 827 393159 181495 63923251
Myokymia 40.64 9.90 18 393968 100 64104646
Intervertebral disc protrusion 40.50 9.90 236 393750 19955 64084791
Blood bilirubin increased 40.49 9.90 197 393789 57356 64047390
Rash maculo-papular 40.47 9.90 149 393837 46877 64057869
Acute respiratory distress syndrome 40.02 9.90 114 393872 38821 64065925
Rheumatoid nodule 39.37 9.90 14 393972 12637 64092109
Alopecia 39.23 9.90 744 393242 164946 63939800
Hyperreflexia 39.08 9.90 114 393872 7034 64097712
Aspergillus infection 39.02 9.90 26 393960 16353 64088393
Agranulocytosis 38.51 9.90 113 393873 38116 64066630
Somatic symptom disorder 38.28 9.90 52 393934 1816 64102930
Labelled drug-drug interaction medication error 38.27 9.90 47 393939 22015 64082731
Death 38.23 9.90 3434 390552 479271 63625475
Back pain 38.08 9.90 1881 392105 248290 63856456
Pleural thickening 37.76 9.90 63 393923 2647 64102099
Dry mouth 37.73 9.90 548 393438 59870 64044876
Cerebral haemorrhage 37.63 9.90 172 393814 50918 64053828
Posterior reversible encephalopathy syndrome 37.61 9.90 51 393935 22895 64081851
Restless legs syndrome 37.60 9.90 205 393781 16911 64087835
Acute kidney injury 36.04 9.90 2313 391673 446927 63657819
Therapeutic response decreased 35.93 9.90 180 393806 52008 64052738
Bone erosion 35.79 9.90 13 393973 11582 64093164
Delirium 35.77 9.90 608 393378 68586 64036160
Nasopharyngitis 35.65 9.90 918 393068 195155 63909591
Drug use disorder 35.47 9.90 99 393887 5955 64098791
Full blood count decreased 35.43 9.90 248 393738 22334 64082412
Infection 35.39 9.90 859 393127 184021 63920725
Drug-induced liver injury 35.33 9.90 160 393826 47483 64057263
Intentional product use issue 35.30 9.90 392 393594 94972 64009774
Pleural fibrosis 35.17 9.90 77 393909 3973 64100773
Agitation 34.89 9.90 745 393241 87622 64017124
Acute myeloid leukaemia 34.87 9.90 72 393914 27391 64077355
Injection site mass 34.73 9.90 202 393784 17068 64087678
Shock haemorrhagic 34.48 9.90 31 393955 16760 64087986
Haematotoxicity 34.21 9.90 18 393968 12878 64091868
Bronchopulmonary aspergillosis 33.80 9.90 40 393946 19045 64085701
Gait spastic 33.70 9.90 34 393952 858 64103888
Haemoglobin decreased 33.69 9.90 920 393066 194143 63910603
Cytomegalovirus viraemia 33.66 9.90 12 393974 10816 64093930
Influenza like illness 33.30 9.90 546 393440 61156 64043590
Gastrointestinal haemorrhage 33.23 9.90 588 393398 131724 63973022
Swollen joint count increased 33.12 9.90 4 393982 7685 64097061
Cerebral infarction 32.78 9.90 134 393852 40910 64063836
Trigeminal neuralgia 32.75 9.90 64 393922 3045 64101701
Pain 32.72 9.90 3860 390126 549651 63555095
Cholestasis 32.50 9.90 152 393834 44720 64060026
Epstein-Barr virus infection 32.29 9.90 18 393968 12470 64092276
Neutropenic sepsis 32.17 9.90 58 393928 23214 64081532
Accidental poisoning 32.16 9.90 42 393944 1411 64103335
Hepatocellular injury 31.73 9.90 155 393831 45080 64059666
Thrombotic microangiopathy 31.59 9.90 33 393953 16622 64088124
Neck pain 31.56 9.90 540 393446 60993 64043753
Complex regional pain syndrome 31.45 9.90 45 393941 1651 64103095
Gamma-glutamyltransferase increased 31.33 9.90 171 393815 48339 64056407
Somatic delusion 31.15 9.90 29 393957 661 64104085
Blood magnesium increased 31.03 9.90 64 393922 3167 64101579
Relapsing-remitting multiple sclerosis 30.94 9.90 36 393950 1072 64103674
Dyspnoea 30.80 9.90 3883 390103 714791 63389955
Constipation 30.58 9.90 1703 392283 227634 63877112
Stomatitis 30.50 9.90 478 393508 109127 63995619
Muscle spasticity 30.35 9.90 190 393796 16479 64088267
Diabetic neuropathy 30.30 9.90 89 393897 5512 64099234
Cholangitis 30.28 9.90 14 393972 10788 64093958
Liver disorder 30.26 9.90 196 393790 53155 64051591
Tumour lysis syndrome 30.09 9.90 45 393941 19395 64085351
Cystitis haemorrhagic 30.05 9.90 6 393980 7950 64096796
Pathogen resistance 29.76 9.90 20 393966 12523 64092223
Hypermobility syndrome 29.76 9.90 25 393961 495 64104251
Alcoholism 29.71 9.90 65 393921 3352 64101394
Mental impairment 29.58 9.90 186 393800 16157 64088589
Paranoia 29.54 9.90 186 393800 16166 64088580
Toxic skin eruption 29.50 9.90 45 393941 19239 64085507
Neovascularisation 29.41 9.90 35 393951 1068 64103678
Sinusitis 29.31 9.90 673 393313 145255 63959491
Tubulointerstitial nephritis 29.26 9.90 94 393892 30815 64073931
Lymphoedema 29.18 9.90 129 393857 9776 64094970
Disturbance in attention 29.08 9.90 381 393605 40693 64064053
Panniculitis 29.07 9.90 9 393977 8870 64095876
Disorientation 29.02 9.90 491 393495 55337 64049409
Lactic acidosis 28.86 9.90 238 393748 61172 64043574
Inflammation 28.50 9.90 258 393728 65042 64039704
Cognitive disorder 28.46 9.90 484 393502 54603 64050143
Pulmonary tuberculosis 28.35 9.90 5 393981 7239 64097507
Drug effective for unapproved indication 28.32 9.90 67 393919 3641 64101105
Dysstasia 28.10 9.90 240 393746 22975 64081771
Pneumonitis 28.07 9.90 186 393800 50179 64054567
Acute hepatic failure 27.92 9.90 75 393911 26037 64078709
Metastases to liver 27.74 9.90 66 393920 23875 64080871
Rheumatic fever 27.72 9.90 11 393975 9283 64095463
Incoherent 27.61 9.90 101 393885 7017 64097729
Hyperhidrosis 27.58 9.90 977 393009 123943 63980803
Obsessive-compulsive disorder 27.46 9.90 78 393908 4740 64100006
Right ventricular hypertrophy 27.44 9.90 37 393949 1283 64103463
Limb injury 27.41 9.90 241 393745 23264 64081482
Victim of child abuse 27.21 9.90 30 393956 841 64103905
Metabolic encephalopathy 27.13 9.90 109 393877 7916 64096830
Needle fatigue 27.10 9.90 25 393961 563 64104183
Aspartate aminotransferase increased 27.09 9.90 542 393444 119246 63985500
Muscle tightness 27.08 9.90 137 393849 10978 64093768
Myocarditis 26.82 9.90 39 393947 17004 64087742
Drug abuser 26.52 9.90 87 393899 5721 64099025
Drug intolerance 26.49 9.90 911 393075 187081 63917665
Hostility 26.44 9.90 48 393938 2159 64102587
Drug eruption 26.41 9.90 122 393864 36014 64068732
Pituitary tumour benign 26.37 9.90 49 393937 2244 64102502
Ankle fracture 26.37 9.90 167 393819 14543 64090203
Blood creatine phosphokinase increased 26.15 9.90 230 393756 58328 64046418
Haematuria 25.92 9.90 240 393746 60231 64044515
Acute coronary syndrome 25.92 9.90 49 393937 19261 64085485
Cough 25.87 9.90 1546 392440 300602 63804144
Thinking abnormal 25.78 9.90 139 393847 11417 64093329
Hypomagnesaemia 25.68 9.90 129 393857 37247 64067499
Haemolysis 25.66 9.90 18 393968 11021 64093725
Autonomic nervous system imbalance 25.63 9.90 69 393917 4063 64100683
Unintentional medical device removal 25.60 9.90 5 393981 6729 64098017
Swelling 25.54 9.90 764 393222 159454 63945292
Pulmonary fibrosis 25.49 9.90 95 393891 29783 64074963
Transplant dysfunction 25.46 9.90 5 393981 6703 64098043
Vertigo 25.42 9.90 504 393482 58507 64046239
Therapeutic product effect variable 25.33 9.90 40 393946 1604 64103142
Nausea 25.30 9.90 5298 388688 780502 63324244
Bradycardia 25.23 9.90 540 393446 117679 63987067
Therapy non-responder 25.13 9.90 269 393717 65630 64039116
Radiculopathy 24.99 9.90 84 393902 5594 64099152
Angioedema 24.95 9.90 249 393737 61572 64043174
Erectile dysfunction 24.94 9.90 147 393839 12480 64092266
Surgery 24.94 9.90 273 393713 27940 64076806
Acute myocardial infarction 24.85 9.90 289 393697 69429 64035317
Quality of life decreased 24.79 9.90 104 393882 7702 64097044
Fibromyalgia 24.70 9.90 330 393656 35401 64069345
Parasomnia 24.69 9.90 22 393964 473 64104273
Focal dyscognitive seizures 24.64 9.90 59 393927 3231 64101515
Pregnancy 24.59 9.90 57 393929 20808 64083938
Circulatory collapse 24.58 9.90 114 393872 33618 64071128
Drug screen positive 24.55 9.90 84 393902 5645 64099101
Tuberculosis 24.54 9.90 26 393960 13012 64091734
Peritonitis 24.46 9.90 75 393911 24948 64079798
Acute graft versus host disease in skin 24.22 9.90 6 393980 6849 64097897
Device use error 24.19 9.90 5 393981 6466 64098280
Facial pain 24.15 9.90 104 393882 7791 64096955
Central nervous system lesion 24.09 9.90 139 393847 11710 64093036
Ascites 24.09 9.90 252 393734 61749 64042997
Enterocolitis 23.72 9.90 23 393963 11995 64092751
Red blood cell sedimentation rate increased 23.70 9.90 104 393882 31131 64073615
Renal failure 23.65 9.90 889 393097 180799 63923947
Arthralgia 23.53 9.90 2354 391632 439906 63664840
Dysphemia 23.43 9.90 56 393930 3063 64101683
Skin necrosis 23.33 9.90 32 393954 14297 64090449
Nerve injury 23.33 9.90 101 393885 7584 64097162
Cardiac failure acute 23.26 9.90 40 393946 16304 64088442
Blood parathyroid hormone decreased 23.18 9.90 8 393978 7358 64097388
Chronic graft versus host disease 23.15 9.90 5 393981 6271 64098475
Liver injury 23.11 9.90 99 393887 29833 64074913
Palmar-plantar erythrodysaesthesia syndrome 23.07 9.90 94 393892 28725 64076021
Coma 22.88 9.90 699 393287 86916 64017830
Bone cyst 22.87 9.90 45 393941 2152 64102594
Therapy cessation 22.85 9.90 301 393685 32188 64072558
Visual impairment 22.67 9.90 603 393383 73474 64031272
Hyperbilirubinaemia 22.60 9.90 61 393925 21144 64083602
Hip fracture 22.49 9.90 259 393727 26840 64077906
Cyst 22.47 9.90 138 393848 11889 64092857
Metabolic acidosis 22.34 9.90 302 393684 70656 64034090
Blood pressure increased 22.31 9.90 845 393141 171707 63933039
Congenital multiplex arthrogryposis 22.19 9.90 7 393979 11 64104735
Hypertonic bladder 22.14 9.90 58 393928 3360 64101386
Joint injury 22.14 9.90 226 393760 22721 64082025
Haemorrhage 22.09 9.90 346 393640 79005 64025741
Exposure via ingestion 22 9.90 73 393913 4829 64099917
Panic attack 21.98 9.90 210 393776 20743 64084003
Exostosis 21.85 9.90 132 393854 11306 64093440
Febrile bone marrow aplasia 21.69 9.90 22 393964 11233 64093513
Gestational diabetes 21.57 9.90 4 393982 5586 64099160
Bradypnoea 21.55 9.90 75 393911 5084 64099662
Headache 21.44 9.90 3612 390374 525855 63578891
Bipolar disorder 21.41 9.90 90 393896 6671 64098075
Pulmonary toxicity 21.20 9.90 13 393973 8548 64096198
Hepatitis fulminant 21.20 9.90 6 393980 6268 64098478
Premature labour 21.17 9.90 10 393976 7610 64097136
Pruritus 21.14 9.90 1632 392354 310768 63793978
Spinal osteoarthritis 21.06 9.90 155 393831 14186 64090560
Bronchial wall thickening 21.00 9.90 40 393946 1867 64102879
Pseudomonas infection 20.96 9.90 49 393937 17834 64086912
Ejection fraction decreased 20.93 9.90 97 393889 28610 64076136
Delirium tremens 20.79 9.90 22 393964 588 64104158
Developmental hip dysplasia 20.75 9.90 13 393973 159 64104587
Complications of transplanted kidney 20.74 9.90 4 393982 5431 64099315
Ischaemic stroke 20.64 9.90 99 393887 28936 64075810
Nephropathy toxic 20.52 9.90 48 393938 17466 64087280
Limb discomfort 20.48 9.90 255 393731 26920 64077826
Haematochezia 20.35 9.90 284 393702 66089 64038657
Tachycardia 20.34 9.90 728 393258 148851 63955895
Slow speech 20.33 9.90 41 393945 1996 64102750
Epigastric discomfort 20.29 9.90 89 393897 6722 64098024
Device difficult to use 20.23 9.90 18 393968 9780 64094966
Micturition urgency 20.08 9.90 120 393866 10239 64094507
Rib fracture 20.06 9.90 230 393756 23808 64080938
Stevens-Johnson syndrome 19.84 9.90 125 393861 34124 64070622
Cellulitis 19.81 9.90 729 393257 92928 64011818
Pulmonary function test abnormal 19.79 9.90 53 393933 3111 64101635
Nerve compression 19.63 9.90 94 393892 7367 64097379
Affective disorder 19.61 9.90 86 393900 6494 64098252
Lupus-like syndrome 19.57 9.90 15 393971 8776 64095970
Shock 19.46 9.90 145 393841 38095 64066651
Device adhesion issue 19.40 9.90 4 393982 5182 64099564
Sacroiliitis 19.40 9.90 51 393935 2961 64101785
Skin toxicity 19.39 9.90 8 393978 6594 64098152
Dermatitis exfoliative generalised 19.37 9.90 6 393980 5910 64098836
Pollakiuria 19.30 9.90 285 393701 31245 64073501
Psychotic disorder due to a general medical condition 19.23 9.90 15 393971 266 64104480
Blood pressure decreased 19.19 9.90 391 393595 85808 64018938
Platelet count decreased 19.17 9.90 833 393153 166878 63937868
Long QT syndrome 19.15 9.90 4 393982 5135 64099611
Sweat gland disorder 19.14 9.90 13 393973 184 64104562
Hepatitis 19.06 9.90 182 393804 45400 64059346
Duodenal ulcer 19.05 9.90 37 393949 14398 64090348
Conversion disorder 18.86 9.90 36 393950 1683 64103063
Pre-existing condition improved 18.83 9.90 68 393918 4694 64100052
Deafness neurosensory 18.76 9.90 83 393903 6291 64098455
Decreased interest 18.76 9.90 54 393932 3306 64101440
Phantom limb syndrome 18.70 9.90 16 393970 325 64104421
Bone density decreased 18.56 9.90 20 393966 9932 64094814
Mouth ulceration 18.49 9.90 119 393867 32325 64072421
Eosinophilic colitis 18.31 9.90 17 393969 386 64104360
Subileus 18.29 9.90 4 393982 4973 64099773
Neutropenic colitis 18.29 9.90 3 393983 4578 64100168
Graft versus host disease in skin 18.28 9.90 5 393981 5342 64099404
Tardive dyskinesia 18.23 9.90 107 393879 9071 64095675
Allodynia 18.11 9.90 30 393956 1253 64103493
Nephrotic syndrome 18.09 9.90 19 393967 9548 64095198
Binocular eye movement disorder 17.85 9.90 10 393976 98 64104648
Micrognathia 17.79 9.90 6 393980 13 64104733
Anal abscess 17.78 9.90 12 393974 7496 64097250
Rales 17.63 9.90 42 393944 15187 64089559
Osteosclerosis 17.55 9.90 54 393932 3432 64101314
Candida infection 17.52 9.90 116 393870 31303 64073443
Concussion 17.38 9.90 95 393891 7843 64096903
Tooth loss 17.38 9.90 80 393906 6167 64098579
Hyperuricaemia 17.37 9.90 22 393964 10169 64094577
Chorea 17.34 9.90 38 393948 1962 64102784
Ear deformity acquired 17.09 9.90 5 393981 5 64104741
Product use in unapproved indication 17.06 9.90 1276 392710 175342 63929404
Accidental exposure to product 16.99 9.90 93 393893 26271 64078475
Sensory loss 16.74 9.90 113 393873 10056 64094690
Adenovirus infection 16.64 9.90 12 393974 7243 64097503
Blood pressure fluctuation 16.61 9.90 220 393766 51651 64053095
Endophthalmitis 16.59 9.90 6 393980 5359 64099387
Depressed mood 16.58 9.90 347 393639 40665 64064081
Atrioventricular block 16.56 9.90 30 393956 11985 64092761
Breakthrough pain 16.52 9.90 28 393958 1192 64103554
Dry eye 16.48 9.90 259 393727 28760 64075986
Idiopathic neutropenia 16.42 9.90 4 393982 0 64104746
Uveitis 16.40 9.90 33 393953 12675 64092071
Diffuse axonal injury 16.34 9.90 9 393977 85 64104661
Alanine aminotransferase abnormal 16.32 9.90 11 393975 6877 64097869
Gastrointestinal disorder 16.29 9.90 420 393566 89289 64015457
Drug tolerance 16.25 9.90 77 393909 6008 64098738
Disorganised speech 16.22 9.90 33 393953 1617 64103129
Pneumonia bacterial 16.21 9.90 43 393943 14992 64089754
Foot fracture 16.19 9.90 176 393810 17981 64086765
Sports injury 16.18 9.90 11 393975 156 64104590
Progressive multiple sclerosis 16.07 9.90 22 393964 774 64103972
Autoimmune haemolytic anaemia 15.85 9.90 12 393974 7064 64097682
Blister 15.81 9.90 375 393611 80592 64024154
Hypokinesia 15.79 9.90 163 393823 16433 64088313
Creatinine renal clearance decreased 15.74 9.90 41 393945 14380 64090366
Kidney transplant rejection 15.73 9.90 21 393965 9490 64095256
Disease progression 15.72 9.90 706 393280 140974 63963772
Body height decreased 15.61 9.90 89 393897 7465 64097281
Liver function test abnormal 15.54 9.90 262 393724 59139 64045607
Deprescribing error 15.52 9.90 6 393980 22 64104724
Abortion spontaneous 15.49 9.90 90 393896 25053 64079693
Dependence 15.45 9.90 38 393948 2117 64102629
Drug tolerance increased 15.41 9.90 19 393967 602 64104144
Blood pressure systolic abnormal 15.40 9.90 23 393963 9919 64094827
Granuloma skin 15.36 9.90 9 393977 6065 64098681
Nephrogenic systemic fibrosis 15.33 9.90 74 393912 5818 64098928
Spinal stenosis 15.30 9.90 141 393845 13790 64090956
Myelodysplastic syndrome 15.29 9.90 102 393884 27477 64077269
Anticipatory anxiety 15.28 9.90 13 393973 262 64104484
Hypoxic-ischaemic encephalopathy 15.27 9.90 85 393901 7067 64097679
Psychomotor hyperactivity 15.24 9.90 145 393841 14306 64090440
Myopathy 15.22 9.90 56 393930 17624 64087122
Skin reaction 15.16 9.90 33 393953 12319 64092427
Injection site induration 15.15 9.90 100 393886 8832 64095914
Asthenia 15.14 9.90 2900 391086 425144 63679602
Encephalitis 15.09 9.90 34 393952 12537 64092209
Acute pulmonary oedema 15.09 9.90 35 393951 12774 64091972
Blood pressure systolic increased 15.02 9.90 212 393774 49241 64055505
Osteopenia 14.96 9.90 153 393833 15387 64089359
Hypometabolism 14.95 9.90 8 393978 71 64104675
Intentional self-injury 14.93 9.90 255 393731 28789 64075957
Head banging 14.91 9.90 17 393969 495 64104251
Cerebral disorder 14.90 9.90 61 393925 4468 64100278
Secondary progressive multiple sclerosis 14.85 9.90 27 393959 1216 64103530
Lung disorder 14.84 9.90 271 393715 60429 64044317
Rectal haemorrhage 14.80 9.90 277 393709 61540 64043206
Cervical spinal stenosis 14.78 9.90 36 393950 1993 64102753
Congenital neuropathy 14.77 9.90 5 393981 11 64104735
Road traffic accident 14.76 9.90 267 393719 30478 64074268
Respiratory disorder 14.76 9.90 145 393841 35966 64068780
Encephalopathy 14.75 9.90 467 393519 58352 64046394
Pre-eclampsia 14.70 9.90 10 393976 6221 64098525
Sensory disturbance 14.67 9.90 134 393852 13074 64091672
Urine amphetamine positive 14.67 9.90 8 393978 74 64104672
Varicella zoster virus infection 14.54 9.90 3 393983 3885 64100861
Face oedema 14.53 9.90 90 393896 24671 64080075
Hypotension 14.50 9.90 2073 391913 378901 63725845
Persistent depressive disorder 14.49 9.90 24 393962 1002 64103744
Teeth brittle 14.47 9.90 16 393970 450 64104296
Arthrofibrosis 14.44 9.90 9 393977 109 64104637
Epidural lipomatosis 14.44 9.90 22 393964 855 64103891
Large intestine perforation 14.40 9.90 35 393951 12569 64092177
Food allergy 14.40 9.90 16 393970 7835 64096911
Respiratory rate decreased 14.39 9.90 60 393926 4431 64100315
Accident 14.37 9.90 81 393905 6765 64097981
Dysphoria 14.36 9.90 59 393927 4329 64100417
Movement disorder 14.31 9.90 201 393785 21799 64082947
Myofascial pain syndrome 14.29 9.90 33 393953 1765 64102981
Spinal cord injury 14.28 9.90 23 393963 938 64103808
Pneumonia fungal 14.28 9.90 20 393966 8857 64095889
Ventricular tachycardia 14.25 9.90 137 393849 34128 64070618
Abnormal sleep-related event 14.25 9.90 21 393965 792 64103954
Atonic urinary bladder 14.22 9.90 8 393978 79 64104667
Facial spasm 14.22 9.90 19 393967 653 64104093
Lip oedema 14.13 9.90 7 393979 5182 64099564
Post laminectomy syndrome 14.12 9.90 13 393973 292 64104454
Hyperthyroidism 14.11 9.90 60 393926 18119 64086627
Product use issue 14.10 9.90 770 393216 150945 63953801
Abnormal behaviour 14.09 9.90 286 393700 33336 64071410
Aphasia 13.99 9.90 338 393648 40568 64064178
Altered state of consciousness 13.94 9.90 156 393830 37746 64067000
Tendonitis 13.93 9.90 70 393916 20212 64084534
Hypoalbuminaemia 13.93 9.90 58 393928 17616 64087130
Antidepressant drug level above therapeutic 13.87 9.90 17 393969 535 64104211
Herpes zoster 13.87 9.90 604 393382 78583 64026163
Antipsychotic drug level below therapeutic 13.86 9.90 23 393963 962 64103784
Postmortem blood drug level increased 13.83 9.90 20 393966 741 64104005
Snoring 13.81 9.90 61 393925 4621 64100125
Self-medication 13.77 9.90 56 393930 4089 64100657
Hypocalcaemia 13.77 9.90 176 393810 41577 64063169
Hepatic encephalopathy 13.74 9.90 74 393912 20992 64083754
Violence-related symptom 13.72 9.90 19 393967 676 64104070
Lymphoproliferative disorder 13.72 9.90 7 393979 5096 64099650
Lumbar radiculopathy 13.69 9.90 32 393954 1725 64103021
Somnambulism 13.69 9.90 65 393921 5076 64099670
Analgesic drug level above therapeutic 13.65 9.90 15 393971 419 64104327
Polyarthritis 13.62 9.90 24 393962 9691 64095055
Schizophrenia 13.58 9.90 30 393956 11138 64093608
International normalised ratio increased 13.49 9.90 374 393612 78793 64025953
Aggression 13.48 9.90 374 393612 45858 64058888
Polyneuropathy 13.47 9.90 69 393917 19825 64084921
Knee arthroplasty 13.44 9.90 103 393883 26896 64077850
Product physical issue 13.43 9.90 49 393937 3400 64101346
Mucormycosis 13.42 9.90 15 393971 7326 64097420
Osteomyelitis 13.39 9.90 240 393746 27347 64077399
Obstruction 13.38 9.90 47 393939 3201 64101545
Myoclonic epilepsy 13.32 9.90 30 393956 1578 64103168
Haemolytic uraemic syndrome 13.30 9.90 4 393982 4017 64100729
Gastrointestinal inflammation 13.25 9.90 11 393975 6184 64098562
Concomitant disease aggravated 13.23 9.90 32 393954 11510 64093236
Heteroplasia 13.20 9.90 4 393982 5 64104741
Gastrointestinal necrosis 13.19 9.90 7 393979 4985 64099761
Stillbirth 13.19 9.90 3 393983 3630 64101116
Lymphadenopathy 13.19 9.90 203 393783 46483 64058263
Radiation necrosis 13.18 9.90 13 393973 319 64104427
Alcohol withdrawal syndrome 13.15 9.90 32 393954 1771 64102975
Caesarean section 13.13 9.90 31 393955 11243 64093503
Drug tolerance decreased 13.12 9.90 14 393972 6984 64097762
Pericardial effusion 13.11 9.90 165 393821 39089 64065657
Haematoma 13.10 9.90 201 393785 46049 64058697
Human herpesvirus 6 infection 13.10 9.90 6 393980 4648 64100098
Immunosuppressant drug level increased 13.08 9.90 15 393971 7244 64097502
Drug screen negative 13.02 9.90 12 393974 270 64104476
Carpal tunnel syndrome 13.01 9.90 151 393835 15677 64089069
Cytomegalovirus colitis 12.83 9.90 4 393982 3924 64100822
Cytomegalovirus chorioretinitis 12.82 9.90 7 393979 4905 64099841
Blood urea increased 12.81 9.90 191 393795 43962 64060784
Paranasal cyst 12.79 9.90 13 393973 331 64104415
Oral herpes 12.75 9.90 81 393905 22071 64082675
Opisthotonus 12.73 9.90 18 393968 653 64104093
Drug diversion 12.72 9.90 24 393962 1112 64103634
Inflammatory marker increased 12.66 9.90 20 393966 8431 64096315
Toxicologic test abnormal 12.64 9.90 25 393961 1200 64103546
Arteriovenous malformation 12.61 9.90 29 393957 1547 64103199
Oesophageal spasm 12.60 9.90 39 393947 2486 64102260
Eyelid oedema 12.58 9.90 36 393950 12243 64092503
Jaundice cholestatic 12.54 9.90 21 393965 8649 64096097
Lumbar spinal stenosis 12.53 9.90 59 393927 4591 64100155
Left ventricular dysfunction 12.53 9.90 57 393929 16897 64087849
Infective pulmonary exacerbation of cystic fibrosis 12.52 9.90 34 393952 11762 64092984
Hypercalcaemia 12.48 9.90 127 393859 31289 64073457
Cytomegalovirus test positive 12.48 9.90 8 393978 5136 64099610
Haemorrhage intracranial 12.42 9.90 90 393896 23794 64080952
Prophylaxis 12.41 9.90 4 393982 7 64104739
Pharyngitis 12.35 9.90 67 393919 18972 64085774
Tachyphrenia 12.32 9.90 32 393954 1844 64102902
Appendicitis 12.31 9.90 132 393854 13437 64091309
Tinel's sign 12.31 9.90 3 393983 0 64104746
Muscle relaxant drug level above therapeutic 12.31 9.90 3 393983 0 64104746
Ligamentum flavum hypertrophy 12.31 9.90 3 393983 0 64104746
CSF neutrophil count increased 12.31 9.90 3 393983 0 64104746
Turbinectomy 12.31 9.90 3 393983 0 64104746
Gastroenteritis 12.27 9.90 119 393867 29592 64075154
Respiratory tract infection 12.21 9.90 158 393828 37249 64067497
Asphyxia 12.21 9.90 25 393961 9541 64095205
Atrioventricular block complete 12.20 9.90 46 393940 14372 64090374
Thrombosis 12.19 9.90 538 393448 70104 64034642
Narcolepsy 12.16 9.90 23 393963 1068 64103678
Hyponatraemia 12.15 9.90 762 393224 147577 63957169
Organising pneumonia 12.13 9.90 23 393963 9032 64095714
Gingival atrophy 12.12 9.90 7 393979 73 64104673
Neurogenic bladder 12.11 9.90 49 393937 3570 64101176
Cytokine release syndrome 12.07 9.90 76 393910 20753 64083993
Fear of injection 12.04 9.90 11 393975 5901 64098845
Bladder disorder 12.01 9.90 85 393901 7682 64097064
Rapid eye movements sleep abnormal 11.99 9.90 11 393975 246 64104500
Burns second degree 11.97 9.90 21 393965 919 64103827
Pulmonary alveolar haemorrhage 11.97 9.90 26 393960 9712 64095034
Tinnitus 11.97 9.90 283 393703 33850 64070896
Sleep disorder 11.96 9.90 462 393524 59247 64045499
Muscle contractions involuntary 11.94 9.90 45 393941 3172 64101574
Loss of consciousness 11.92 9.90 1057 392929 147308 63957438
Substance use 11.90 9.90 17 393969 623 64104123
Dermatitis bullous 11.87 9.90 36 393950 12018 64092728
Colitis ulcerative 11.87 9.90 87 393899 22941 64081805
Arrhythmia 11.83 9.90 240 393746 52704 64052042
Toe operation 11.79 9.90 15 393971 491 64104255
Generalised tonic-clonic seizure 11.78 9.90 323 393663 39534 64065212
Nocturia 11.76 9.90 112 393874 11053 64093693
Open angle glaucoma 11.75 9.90 13 393973 366 64104380
Abortion induced 11.73 9.90 13 393973 6375 64098371
Vulvar basal cell carcinoma 11.72 9.90 5 393981 25 64104721
Colitis microscopic 11.70 9.90 17 393969 7415 64097331
Lipodystrophy acquired 11.63 9.90 5 393981 4022 64100724
Rash erythematous 11.61 9.90 218 393768 48415 64056331
Right ventricular failure 11.61 9.90 80 393906 21391 64083355
Hypernatraemia 11.58 9.90 37 393949 12152 64092594
Retinal haemorrhage 11.57 9.90 17 393969 7381 64097365
Formication 11.54 9.90 55 393931 4302 64100444
Gastric bypass 11.53 9.90 22 393964 1028 64103718
Neuropathic arthropathy 11.48 9.90 12 393974 316 64104430
Erythema multiforme 11.48 9.90 53 393933 15648 64089098
Laryngeal oedema 11.47 9.90 16 393970 7097 64097649
Child abuse 11.41 9.90 10 393976 210 64104536
Rib deformity 11.39 9.90 8 393978 120 64104626
Bone contusion 11.38 9.90 22 393964 1038 64103708
Product adhesion issue 11.38 9.90 37 393949 2422 64102324
Condition aggravated 11.36 9.90 2052 391934 370374 63734372
Subarachnoid haemorrhage 11.36 9.90 66 393920 18372 64086374
Application site vesicles 11.33 9.90 25 393961 1297 64103449
Torsade de pointes 11.32 9.90 61 393925 17302 64087444
Implant site inflammation 11.22 9.90 10 393976 215 64104531
Visual field tests abnormal 11.20 9.90 4 393982 11 64104735
Screaming 11.19 9.90 47 393939 3482 64101264
Myotonia 11.11 9.90 10 393976 218 64104528
Gastric cancer 11.08 9.90 14 393972 6479 64098267
Antipsychotic drug level increased 11.04 9.90 9 393977 5106 64099640
Prescription drug used without a prescription 11.03 9.90 38 393948 2562 64102184
JC polyomavirus test positive 10.97 9.90 24 393962 1238 64103508
Disturbance in social behaviour 10.96 9.90 5 393981 3882 64100864
Retinal deposits 10.95 9.90 8 393978 128 64104618
Retinal detachment 10.91 9.90 20 393966 7956 64096790
Subdural haematoma 10.90 9.90 114 393872 27940 64076806
Electrolyte imbalance 10.89 9.90 100 393886 25143 64079603
Hip arthroplasty 10.84 9.90 81 393905 21270 64083476
Urticaria 10.84 9.90 764 393222 146553 63958193
Increased appetite 10.80 9.90 102 393884 10044 64094702
Hypertransaminasaemia 10.79 9.90 17 393969 7174 64097572
Bronchial secretion retention 10.78 9.90 37 393949 2490 64102256
Anal incontinence 10.77 9.90 141 393845 15055 64089691
Systemic candida 10.75 9.90 10 393976 5319 64099427
Lung adenocarcinoma stage I 10.71 9.90 5 393981 32 64104714
Second primary malignancy 10.67 9.90 39 393947 12298 64092448
Hypertriglyceridaemia 10.66 9.90 34 393952 11171 64093575
Hypertension 10.64 9.90 1404 392582 257857 63846889
Bacteraemia 10.60 9.90 109 393877 26802 64077944
Vertebral foraminal stenosis 10.58 9.90 21 393965 1011 64103735
Blood potassium increased 10.56 9.90 220 393766 25760 64078986
Localised infection 10.55 9.90 250 393736 29911 64074835
Injection site reaction 10.55 9.90 366 393620 46298 64058448
Decreased appetite 10.52 9.90 1532 392454 279757 63824989
Laboratory test abnormal 10.52 9.90 206 393780 23857 64080889
Infected skin ulcer 10.50 9.90 41 393945 2939 64101807
Abnormal dreams 10.47 9.90 103 393883 10253 64094493
Blood potassium decreased 10.46 9.90 322 393664 40077 64064669
Upper respiratory tract inflammation 10.45 9.90 5 393981 3777 64100969
Medical induction of coma 10.43 9.90 7 393979 97 64104649
Application site burn 10.42 9.90 18 393968 778 64103968
Carotid artery disease 10.42 9.90 33 393953 2130 64102616
Cardiac failure chronic 10.41 9.90 25 393961 9016 64095730
Heat exhaustion 10.39 9.90 10 393976 238 64104508
Leg amputation 10.37 9.90 45 393941 3382 64101364
Stress cardiomyopathy 10.35 9.90 26 393960 9231 64095515
Pneumatosis intestinalis 10.33 9.90 10 393976 5219 64099527
Breast disorder 10.33 9.90 28 393958 1656 64103090
Eczema 10.28 9.90 124 393862 29596 64075150
Free androgen index decreased 10.28 9.90 4 393982 15 64104731
Drug withdrawal syndrome neonatal 10.25 9.90 10 393976 242 64104504
Nervous system cyst 10.25 9.90 3 393983 3 64104743
Peritoneal carcinoma metastatic 10.25 9.90 3 393983 3 64104743
Pulmonary renal syndrome 10.21 9.90 15 393971 564 64104182
Bronchospasm 10.20 9.90 84 393902 21598 64083148
Naevus haemorrhage 10.19 9.90 7 393979 101 64104645
Urinary retention 10.17 9.90 382 393604 48819 64055927
Diffuse large B-cell lymphoma 10.17 9.90 31 393955 10330 64094416
Intra-abdominal haemorrhage 10.15 9.90 6 393980 4025 64100721
Hepatitis cholestatic 10.14 9.90 39 393947 12116 64092630
Renal tubular disorder 10.13 9.90 13 393973 5974 64098772
Sciatica 10.09 9.90 177 393809 20087 64084659
Hypothyroidism 10.08 9.90 180 393806 40277 64064469
Pineal gland cyst 10.08 9.90 4 393982 16 64104730
Oophorectomy bilateral 10.08 9.90 4 393982 16 64104730
Nitrite urine present 10.02 9.90 21 393965 1051 64103695
Knee deformity 9.94 9.90 19 393967 889 64103857
Accidental overdose 9.93 9.90 272 393714 33285 64071461
CD8 lymphocytes decreased 9.92 9.90 10 393976 252 64104494
Peroneal nerve palsy 9.91 9.90 61 393925 5260 64099486

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 39.10 25.64 16 316 122 84224

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




🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

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

Orange Book patent data (new drug applications)

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

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

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

External reference:

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

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Neurontin HUMAN PRESCRIPTION DRUG LABEL 1 0071-0401 TABLET, FILM COATED 800 mg ORAL NDA 31 sections
Neurontin HUMAN PRESCRIPTION DRUG LABEL 1 0071-0513 TABLET, FILM COATED 600 mg ORAL NDA 31 sections
Neurontin HUMAN PRESCRIPTION DRUG LABEL 1 0071-0803 CAPSULE 100 mg ORAL NDA 31 sections
Neurontin HUMAN PRESCRIPTION DRUG LABEL 1 0071-0805 CAPSULE 300 mg ORAL NDA 31 sections
Neurontin HUMAN PRESCRIPTION DRUG LABEL 1 0071-0806 CAPSULE 400 mg ORAL NDA 31 sections
Neurontin HUMAN PRESCRIPTION DRUG LABEL 1 0071-2012 SOLUTION 250 mg ORAL NDA 31 sections
Gabapentin HUMAN PRESCRIPTION DRUG LABEL 1 0228-2636 TABLET, FILM COATED 600 mg ORAL ANDA 26 sections
Gabapentin HUMAN PRESCRIPTION DRUG LABEL 1 0228-2636 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 0615-8230 CAPSULE 100 mg ORAL ANDA 29 sections
Gabapentin HUMAN PRESCRIPTION DRUG LABEL 1 0615-8231 CAPSULE 300 mg ORAL ANDA 29 sections
Gabapentin HUMAN PRESCRIPTION DRUG LABEL 1 0615-8232 CAPSULE 400 mg ORAL ANDA 29 sections
Gabapentin HUMAN PRESCRIPTION DRUG LABEL 1 0615-8233 TABLET 600 mg ORAL ANDA 29 sections
Gabapentin HUMAN PRESCRIPTION DRUG LABEL 1 0615-8340 CAPSULE 100 mg ORAL ANDA 26 sections
Gabapentin HUMAN PRESCRIPTION DRUG LABEL 1 0615-8341 CAPSULE 300 mg ORAL ANDA 26 sections
Gabapentin HUMAN PRESCRIPTION DRUG LABEL 1 0615-8342 CAPSULE 400 mg ORAL ANDA 26 sections
Gabapentin HUMAN PRESCRIPTION DRUG LABEL 1 0904-6586 TABLET, FILM COATED 800 mg ORAL ANDA 25 sections
Gabapentin HUMAN PRESCRIPTION DRUG LABEL 1 0904-6665 CAPSULE 100 mg ORAL ANDA 30 sections
Gabapentin HUMAN PRESCRIPTION DRUG LABEL 1 0904-6665 CAPSULE 100 mg ORAL ANDA 30 sections
Gabapentin HUMAN PRESCRIPTION DRUG LABEL 1 0904-6666 CAPSULE 300 mg ORAL ANDA 30 sections
Gabapentin HUMAN PRESCRIPTION DRUG LABEL 1 0904-6666 CAPSULE 300 mg ORAL ANDA 30 sections
Gabapentin HUMAN PRESCRIPTION DRUG LABEL 1 0904-6667 CAPSULE 400 mg ORAL ANDA 30 sections
Gabapentin HUMAN PRESCRIPTION DRUG LABEL 1 0904-6667 CAPSULE 400 mg ORAL ANDA 30 sections
Gabapentin HUMAN PRESCRIPTION DRUG LABEL 1 0904-6823 TABLET, FILM COATED 600 mg ORAL ANDA 30 sections
Gabapentin HUMAN PRESCRIPTION DRUG LABEL 1 0904-6823 TABLET, FILM COATED 600 mg ORAL ANDA 30 sections