pregabalin ๐Ÿถ Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definitionDrug idCAS RN
gabamimetic agents 2255 148553-50-8

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • pregabalin
  • (S)-Pregabalin
  • gabanext
  • maxgalin
  • lyrica
  • pregabalin hydrochloride
  • pregabalin HCl
A gamma-aminobutyric acid (GABA) derivative that functions as a CALCIUM CHANNEL BLOCKER and is used as an ANTICONVULSANT as well as an ANTI-ANXIETY AGENT. It is also used as an ANALGESIC in the treatment of NEUROPATHIC PAIN and FIBROMYALGIA.
  • Molecular weight: 159.23
  • Formula: C8H17NO2
  • CLOGP: -0.92
  • LIPINSKI: 0
  • HAC: 3
  • HDO: 2
  • TPSA: 63.32
  • ALOGS: -1.15
  • ROTB: 5

  • Status: OFP

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

Drug dosage:

DoseUnitRoute
0.30 g O

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 3 Benet LZ, Broccatelli F, Oprea TI
S (Water solubility) 33 mg/mL Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine) 90 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 53.83 ยตM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability) 90 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H

Approvals:

DateAgencyCompanyOrphan
July 6, 2004 EMA
Dec. 30, 2004 FDA PF PRISM CV

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
Withdrawal syndrome 1485.41 9.88 1002 263355 16588 50324179
Somnolence 1193.24 9.88 2552 261805 152433 50188334
Intentional product misuse 651.02 9.88 997 263360 45737 50295030
Feeling abnormal 590.04 9.88 1713 262644 123779 50216988
Pemphigus 504.16 9.88 31 264326 120135 50220632
Weight increased 454.88 9.88 2173 262184 199718 50141049
Pain 432.84 9.88 4768 259589 574135 49766632
Maternal exposure during pregnancy 412.89 9.88 159 264198 159619 50181148
Memory impairment 383.99 9.88 1095 263262 78265 50262502
Dizziness 376.76 9.88 3091 261266 343278 49997489
Glossodynia 370.75 9.88 76 264281 115493 50225274
Drug dependence 359.68 9.88 479 263878 19280 50321487
Systemic lupus erythematosus 350.14 9.88 148 264209 140474 50200293
Hand deformity 327.45 9.88 63 264294 100136 50240631
Drug hypersensitivity 322.71 9.88 2330 262027 248680 50092087
Vision blurred 310.01 9.88 1010 263347 77637 50263130
Therapeutic product effect incomplete 309.78 9.88 1117 263240 90398 50250369
Gait disturbance 307.20 9.88 1572 262785 148433 50192334
Insomnia 293.41 9.88 1736 262621 173129 50167638
Exposure during pregnancy 290.77 9.88 134 264223 120881 50219886
Anti-cyclic citrullinated peptide antibody positive 276.68 9.88 25 264332 70562 50270205
Alopecia 272.47 9.88 543 263814 244504 50096263
Drug withdrawal syndrome 268.02 9.88 475 263882 24606 50316161
Fall 252.41 9.88 2766 261591 332166 50008601
Prescribed overdose 252.11 9.88 345 264012 14255 50326512
Pericarditis 251.80 9.88 52 264305 78637 50262130
Tremor 245.57 9.88 1219 263138 113684 50227083
Abdominal discomfort 227.22 9.88 550 263807 231091 50109676
Sciatica 219.57 9.88 398 263959 20984 50319783
Disturbance in attention 219.35 9.88 496 263861 30690 50310077
Thinking abnormal 213.90 9.88 257 264100 9310 50331457
Infusion related reaction 211.32 9.88 350 264007 169207 50171560
Feeling drunk 207.90 9.88 164 264193 3489 50337278
Pain in extremity 207.45 9.88 2258 262099 270607 50070160
Speech disorder 203.42 9.88 522 263835 35026 50305741
Neuralgia 202.09 9.88 389 263968 21474 50319293
Suicidal ideation 201.08 9.88 692 263665 54693 50286074
Intentional product use issue 199.68 9.88 864 263493 76054 50264713
Hypoacusis 199.04 9.88 374 263983 20273 50320494
Impaired driving ability 194.16 9.88 163 264194 3798 50336969
Death 191.77 9.88 961 263396 324418 50016349
Drug abuse 186.13 9.88 711 263646 59135 50281632
Confusional state 182.88 9.88 1624 262733 184304 50156463
Sleep disorder 182.65 9.88 686 263671 56597 50284170
Euphoric mood 176.70 9.88 156 264201 3899 50336868
Burning sensation 175.72 9.88 580 263777 44866 50295901
Wound 174.40 9.88 177 264180 105617 50235150
Malaise 171.08 9.88 2579 261778 332953 50007814
Body height decreased 163.71 9.88 217 264140 8691 50332076
Pre-existing condition improved 159.24 9.88 191 264166 6906 50333861
Therapeutic response unexpected 154.29 9.88 289 264068 15626 50325141
Duodenal ulcer perforation 146.18 9.88 30 264327 45581 50295186
Folliculitis 143.20 9.88 18 264339 39207 50301560
Myoclonus 141.82 9.88 264 264093 14206 50326561
Coma 139.31 9.88 628 263729 56251 50284516
Sopor 135.16 9.88 312 264045 19567 50321200
Hepatic enzyme increased 132.35 9.88 329 264028 137051 50203716
Hypoaesthesia 128.35 9.88 1118 263239 126139 50214628
Synovitis 126.99 9.88 287 264070 123578 50217189
Product dispensing error 126.97 9.88 192 264165 8699 50332068
Fibromyalgia 126.62 9.88 518 263839 44460 50296307
Visual impairment 126.20 9.88 696 263661 67579 50273188
Febrile neutropenia 125.92 9.88 197 264160 97470 50243297
Muscle injury 121.89 9.88 23 264334 37088 50303679
Stomatitis 121.76 9.88 214 264143 101130 50239637
Muscle twitching 120.49 9.88 256 264101 15175 50325592
Impaired work ability 120.34 9.88 238 264119 13402 50327365
Balance disorder 120.21 9.88 704 263653 69886 50270881
Amnesia 119.99 9.88 488 263869 41772 50298995
Device expulsion 119.12 9.88 8 264349 28814 50311953
Impaired healing 116.99 9.88 115 264242 69671 50271096
Movement disorder 116.88 9.88 274 264083 17358 50323409
Arthropathy 113.75 9.88 432 263925 157474 50183293
Injection site pain 113.19 9.88 258 264099 110766 50230001
Rheumatoid factor positive 112.45 9.88 60 264297 49799 50290968
Illness 111.25 9.88 331 264026 24209 50316558
Disorientation 109.00 9.88 420 263937 35064 50305703
Contraindicated product administered 107.63 9.88 407 263950 148551 50192216
Sleep disorder due to general medical condition, insomnia type 106.52 9.88 18 264339 31429 50309338
Crying 102.83 9.88 286 264071 20130 50320637
Lower respiratory tract infection 98.03 9.88 220 264137 94981 50245786
Depression 97.45 9.88 1305 263052 164118 50176649
Diplopia 97.20 9.88 270 264087 18990 50321777
Dysstasia 97.14 9.88 257 264100 17562 50323205
Dyskinesia 96.66 9.88 343 264014 27518 50313249
Hypersensitivity 95.23 9.88 695 263662 214466 50126301
Expired product administered 92.63 9.88 127 264230 5255 50335512
Anxiety 91.74 9.88 1369 262988 176237 50164530
Dysarthria 91.59 9.88 413 263944 36990 50303777
Diarrhoea 89.63 9.88 2366 261991 586110 49754657
Ill-defined disorder 89.39 9.88 92 264265 54562 50286205
Hyperhidrosis 89.26 9.88 784 263573 88642 50252125
Discomfort 89.18 9.88 280 264077 108100 50232667
Hallucination 87.79 9.88 478 263879 46179 50294588
Mental impairment 87.40 9.88 194 264163 11850 50328917
Injection site erythema 86.63 9.88 162 264195 74774 50265993
Irritability 85.30 9.88 334 264023 28092 50312675
Macular degeneration 83.03 9.88 212 264145 14176 50326591
Depressed level of consciousness 82.60 9.88 509 263848 51444 50289323
Drug ineffective for unapproved indication 82.59 9.88 272 264085 21009 50319758
Product prescribing error 82.32 9.88 269 264088 20692 50320075
Loss of consciousness 82.03 9.88 870 263487 103483 50237284
Restlessness 81.48 9.88 303 264054 24870 50315897
Oedema peripheral 80.94 9.88 1216 263141 156745 50184022
Irritable bowel syndrome 80.34 9.88 90 264267 51351 50289416
Helicobacter infection 79.78 9.88 85 264272 49617 50291150
Respiratory depression 78.91 9.88 186 264171 11824 50328943
C-reactive protein abnormal 78.09 9.88 24 264333 27785 50312982
Cognitive disorder 77.67 9.88 444 263913 43679 50297088
Dry mouth 77.45 9.88 531 263826 55647 50285120
Haemoglobin decreased 76.88 9.88 372 263985 126844 50213923
Overdose 75.39 9.88 825 263532 98902 50241865
Drug effective for unapproved indication 75.24 9.88 71 264286 1938 50338829
Pyrexia 75.19 9.88 1467 262890 378736 49962031
Vertigo 75.10 9.88 496 263861 51336 50289431
Nervousness 75.10 9.88 315 264042 27336 50313431
Premature delivery 74.92 9.88 16 264341 23647 50317120
Muscle spasms 72.47 9.88 987 263370 124566 50216201
Injection site swelling 72.15 9.88 67 264290 41706 50299061
Neutropenia 71.83 9.88 465 263892 147500 50193267
Prescription drug used without a prescription 71.29 9.88 64 264293 1636 50339131
Gastrointestinal haemorrhage 70.25 9.88 176 264181 73145 50267622
Paraesthesia 69.29 9.88 945 263412 119298 50221469
Sedation 69.05 9.88 330 264027 30280 50310487
Back disorder 68.78 9.88 151 264206 9154 50331613
Therapeutic product effect decreased 67.86 9.88 424 263933 135626 50205141
Gait inability 66.75 9.88 375 263982 36652 50304115
Hospitalisation 66.71 9.88 161 264196 67776 50272991
Dysgraphia 63.37 9.88 74 264283 2599 50338168
Pneumonia aspiration 63.36 9.88 325 264032 30679 50310088
Pregnancy 63.23 9.88 38 264319 29539 50311228
Fatigue 62.91 9.88 3040 261317 704561 49636206
International normalised ratio fluctuation 62.87 9.88 67 264290 2123 50338644
Sensitivity to weather change 61.97 9.88 112 264245 5889 50334878
White blood cell count decreased 59.12 9.88 362 263995 116360 50224407
Altered state of consciousness 59.03 9.88 249 264108 21661 50319106
Increased appetite 58.79 9.88 133 264224 8228 50332539
Mucosal inflammation 58.66 9.88 74 264283 40068 50300699
Injection site reaction 57.08 9.88 109 264248 49923 50290844
Loss of personal independence in daily activities 56.90 9.88 588 263769 69462 50271305
Road traffic accident 56.72 9.88 265 264092 24087 50316680
Dysphemia 56.62 9.88 65 264292 2241 50338526
Platelet count decreased 54.95 9.88 305 264052 100421 50240346
Agitation 54.79 9.88 471 263886 52913 50287854
Foetal exposure during pregnancy 53.29 9.88 39 264318 27320 50313447
Hallucination, visual 53.16 9.88 199 264158 16383 50324384
Formication 52.44 9.88 79 264278 3567 50337200
Intervertebral disc protrusion 52.05 9.88 228 264129 20165 50320602
Premature baby 51.17 9.88 16 264341 18321 50322446
Sepsis 51.06 9.88 446 263911 132479 50208288
Pancytopenia 50.58 9.88 246 264111 83784 50256983
Multiple organ dysfunction syndrome 50.44 9.88 118 264239 50219 50290548
Hip arthroplasty 50.00 9.88 51 264306 30378 50310389
Accidental exposure to product 48.76 9.88 30 264327 23027 50317740
Nerve injury 48.14 9.88 123 264234 8227 50332540
Rheumatoid factor negative 47.82 9.88 33 264324 567 50340200
Injection site pruritus 47.01 9.88 87 264270 40324 50300443
Hepatotoxicity 46.62 9.88 44 264313 27182 50313585
Live birth 46.36 9.88 14 264343 16394 50324373
Hyperaesthesia 45.69 9.88 119 264238 8054 50332713
Oedema 45.63 9.88 564 263793 69617 50271150
Coronary artery disease 45.33 9.88 53 264304 29673 50311094
Coordination abnormal 45.27 9.88 148 264209 11386 50329381
Psoriatic arthropathy 45.18 9.88 409 263948 46623 50294144
Urinary retention 45.07 9.88 262 264095 25928 50314839
Anaemia 44.82 9.88 991 263366 251465 50089302
Condition aggravated 44.79 9.88 1938 262419 295120 50045647
Cardiac failure congestive 44.67 9.88 258 264099 84124 50256643
Knee arthroplasty 44.58 9.88 74 264283 35772 50304995
Wrong technique in product usage process 44.52 9.88 145 264212 55365 50285402
Acute myocardial infarction 43.78 9.88 53 264304 29220 50311547
Dyspnoea 43.67 9.88 2378 261979 545230 49795537
Intentional self-injury 43.61 9.88 237 264120 22875 50317892
Rash 43.47 9.88 1856 262501 435615 49905152
Multiple sclerosis 43.40 9.88 217 264140 20276 50320491
Bloody discharge 43.03 9.88 41 264316 1133 50339634
Aggression 42.90 9.88 221 264136 20895 50319872
Injection site warmth 42.64 9.88 10 264347 13856 50326911
Drug resistance 42.59 9.88 23 264334 18966 50321801
International normalised ratio increased 42.57 9.88 102 264255 43050 50297717
Pulmonary hypertension 42.48 9.88 68 264289 33349 50307418
Delirium 42.41 9.88 343 264014 37849 50302918
Gastrointestinal disorder 42.26 9.88 304 264053 94152 50246615
Breakthrough pain 42.17 9.88 40 264317 1099 50339668
Cough 41.14 9.88 953 263404 240311 50100456
Pleural effusion 41.03 9.88 253 264104 81201 50259566
Poor quality sleep 40.89 9.88 184 264173 16462 50324305
Blood iron abnormal 40.81 9.88 67 264290 3259 50337508
Neoplasm progression 40.30 9.88 56 264301 29101 50311666
Bedridden 40.24 9.88 124 264233 9243 50331524
Limb discomfort 40.20 9.88 241 264116 24116 50316651
Bradyphrenia 40.11 9.88 95 264262 6057 50334710
Cytomegalovirus infection 39.93 9.88 22 264335 17940 50322827
Lyme disease 39.31 9.88 57 264300 2486 50338281
Alanine aminotransferase increased 39.22 9.88 285 264072 88074 50252693
Muscular weakness 39.19 9.88 706 263651 94307 50246460
Intentional overdose 38.79 9.88 498 263859 62006 50278761
Blister 38.65 9.88 274 264083 85144 50255623
Panic attack 38.30 9.88 201 264156 19141 50321626
Thrombocytopenia 36.52 9.88 459 263898 127214 50213553
Drug use disorder 36.51 9.88 61 264296 3011 50337756
Joint swelling 36.39 9.88 989 263368 244297 50096470
Visual acuity reduced 36.32 9.88 204 264153 19935 50320832
Injection site bruising 36.19 9.88 87 264270 36681 50304086
Central obesity 36.15 9.88 35 264322 987 50339780
Hypotension 36.08 9.88 945 263412 234524 50106243
Trigeminal neuralgia 35.88 9.88 61 264296 3054 50337713
Restless legs syndrome 35.57 9.88 171 264186 15726 50325041
Multiple sclerosis relapse 35.53 9.88 362 263995 42602 50298165
Atrial fibrillation 35.35 9.88 350 264007 101395 50239372
Frustration tolerance decreased 35.25 9.88 86 264271 5588 50335179
Cataract 35.12 9.88 390 263967 46910 50293857
Haematocrit decreased 35.03 9.88 82 264275 34894 50305873
Diabetic neuropathy 34.54 9.88 65 264292 3526 50337241
Suicide attempt 33.73 9.88 416 263941 51316 50289451
Panic reaction 33.58 9.88 64 264293 3505 50337262
Ataxia 33.57 9.88 152 264205 13634 50327133
Septic shock 33.47 9.88 169 264188 57006 50283761
Dependence 33.41 9.88 45 264312 1830 50338937
Urticaria 33.35 9.88 476 263881 129085 50211682
Nightmare 33.13 9.88 169 264188 15917 50324850
Emotional disorder 33.04 9.88 136 264221 11700 50329067
Affective disorder 32.70 9.88 79 264278 5102 50335665
Intervertebral disc disorder 32.51 9.88 71 264286 4289 50336478
Chest pain 32.32 9.88 691 263666 176191 50164576
Depressed mood 32.23 9.88 295 264062 33728 50307039
Drug interaction 32.00 9.88 1311 263046 198310 50142457
Neutrophil count decreased 31.77 9.88 128 264229 45898 50294869
Tension 31.70 9.88 54 264303 2708 50338059
Abdominal pain 31.37 9.88 967 263390 235261 50105506
Hyperprolactinaemia 31.24 9.88 60 264297 3305 50337462
Bone erosion 31.21 9.88 11 264346 11676 50329091
Hypersomnia 30.92 9.88 160 264197 15154 50325613
Allodynia 30.91 9.88 27 264330 665 50340102
Hostility 30.59 9.88 42 264315 1740 50339027
Libido increased 30.46 9.88 35 264322 1208 50339559
Premature labour 30.30 9.88 11 264346 11465 50329302
Torsade de pointes 30.16 9.88 12 264345 11823 50328944
Middle insomnia 30.10 9.88 117 264240 9804 50330963
Epistaxis 29.99 9.88 203 264154 63751 50277016
Tenderness 29.56 9.88 182 264175 18383 50322384
Injection site haemorrhage 29.50 9.88 41 264316 21305 50319462
Foetal death 29.26 9.88 4 264353 8176 50332591
Therapy non-responder 29.19 9.88 152 264205 50870 50289897
Rheumatic fever 29.18 9.88 27 264330 16840 50323927
Feeling of body temperature change 29.09 9.88 68 264289 4299 50336468
Abnormal behaviour 29.00 9.88 189 264168 19469 50321298
Pruritus 28.95 9.88 1199 263158 282369 50058398
Full blood count decreased 28.85 9.88 45 264312 22301 50318466
Abnormal dreams 28.79 9.88 111 264246 9266 50331501
Swelling 28.72 9.88 814 263543 200058 50140709
Synovial fluid analysis 28.72 9.88 39 264318 1599 50339168
Red blood cell sedimentation rate abnormal 28.47 9.88 26 264331 16317 50324450
Mood altered 28.29 9.88 137 264220 12636 50328131
Dementia 28.16 9.88 161 264196 15836 50324931
Adverse drug reaction 28.08 9.88 171 264186 55051 50285716
Paralysis 27.79 9.88 104 264253 8560 50332207
Ventricular tachycardia 27.76 9.88 25 264332 15796 50324971
Renal failure 27.71 9.88 391 263966 106242 50234525
Hypomagnesaemia 27.69 9.88 49 264308 23107 50317660
Aspartate aminotransferase increased 27.64 9.88 267 264090 77731 50263036
Ankle fracture 27.52 9.88 158 264199 15564 50325203
Visual field defect 27.19 9.88 79 264278 5700 50335067
Product dose omission issue 27.04 9.88 742 263615 183096 50157671
Sinusitis 27.04 9.88 681 263676 169877 50170890
Dysuria 26.93 9.88 247 264110 28257 50312510
Blood creatinine increased 26.86 9.88 261 264096 75899 50264868
Multiple allergies 26.66 9.88 101 264256 8362 50332405
Pre-eclampsia 26.38 9.88 5 264352 8039 50332728
Tenosynovitis stenosans 26.21 9.88 44 264313 2180 50338587
Pneumonia 26.17 9.88 1665 262692 376736 49964031
Anger 26.15 9.88 123 264234 11210 50329557
Caesarean section 25.94 9.88 26 264331 15613 50325154
Ascites 25.85 9.88 98 264259 35763 50305004
Productive cough 25.85 9.88 165 264192 52529 50288238
Infective pulmonary exacerbation of cystic fibrosis 25.76 9.88 5 264352 7904 50332863
Leukopenia 25.72 9.88 227 264130 67301 50273466
Basal cell carcinoma 25.67 9.88 52 264305 23304 50317463
Spinal stenosis 25.60 9.88 139 264218 13411 50327356
Body tinea 25.43 9.88 33 264324 1294 50339473
Reading disorder 25.39 9.88 25 264332 720 50340047
Myelosuppression 25.39 9.88 20 264337 13497 50327270
Telangiectasia congenital 25.37 9.88 8 264349 16 50340751
Systemic infection 25.37 9.88 44 264313 2239 50338528
Dissociation 25.26 9.88 44 264313 2247 50338520
Body temperature increased 25.04 9.88 82 264275 31259 50309508
Hypokinesia 24.91 9.88 128 264229 12089 50328678
Colitis 24.83 9.88 110 264247 38419 50302348
Miosis 24.79 9.88 81 264276 6229 50334538
Spinal pain 24.75 9.88 117 264240 10686 50330081
Left ventricular dysfunction 24.64 9.88 12 264345 10494 50330273
Hypervolaemia 24.57 9.88 61 264296 25438 50315329
Eosinophilic colitis 24.30 9.88 13 264344 137 50340630
Skull fracture 24.26 9.88 27 264330 899 50339868
Ejection fraction decreased 24.19 9.88 37 264320 18483 50322284
Behaviour disorder 24.04 9.88 44 264313 2336 50338431
Monoplegia 23.87 9.88 48 264309 2735 50338032
Device dislocation 23.66 9.88 48 264309 21498 50319269
Device difficult to use 23.64 9.88 11 264346 9875 50330892
Nasopharyngitis 23.63 9.88 798 263559 192129 50148638
Dysaesthesia 23.62 9.88 57 264300 3678 50337089
Right ventricular failure 23.53 9.88 29 264328 15864 50324903
Fungal infection 23.52 9.88 79 264278 29886 50310881
Anorgasmia 23.48 9.88 21 264336 534 50340233
Product use in unapproved indication 23.48 9.88 781 263576 115038 50225729
Metastases to bone 23.46 9.88 36 264321 17959 50322808
Pulmonary arterial hypertension 23.41 9.88 44 264313 20275 50320492
Language disorder 23.28 9.88 37 264320 1751 50339016
Musculoskeletal pain 22.97 9.88 516 263841 71661 50269106
Therapy cessation 22.96 9.88 65 264292 25946 50314821
Cold sweat 22.74 9.88 113 264244 10531 50330236
Thirst decreased 22.71 9.88 15 264342 239 50340528
Pneumocystis jirovecii pneumonia 22.51 9.88 26 264331 14637 50326130
Neck pain 22.45 9.88 421 263936 56646 50284121
Carpal tunnel syndrome 22.28 9.88 158 264199 16735 50324032
Foaming at mouth 22.05 9.88 28 264329 1074 50339693
Body mass index increased 22.02 9.88 27 264330 999 50339768
Chest discomfort 22.01 9.88 346 264011 92376 50248391
Product use issue 21.98 9.88 973 263384 148502 50192265
Neuropathy peripheral 21.85 9.88 661 263696 96096 50244671
Acute myeloid leukaemia 21.80 9.88 28 264329 15046 50325721
Drug screen false positive 21.67 9.88 24 264333 795 50339972
Drug screen positive 21.60 9.88 52 264305 3350 50337417
Sensory disturbance 21.44 9.88 120 264237 11709 50329058
Flushing 21.44 9.88 235 264122 66780 50273987
Swollen joint count increased 21.12 9.88 28 264329 14845 50325922
Crepitations 21.08 9.88 76 264281 6143 50334624
Uterine perforation 21.01 9.88 4 264353 6411 50334356
Spinal disorder 20.75 9.88 92 264265 8178 50332589
Diverticulitis 20.62 9.88 96 264261 33086 50307681
Injection site rash 20.48 9.88 33 264324 16144 50324623
Parkinsonism 20.40 9.88 96 264261 8751 50332016
Complication associated with device 20.40 9.88 28 264329 14627 50326140
Oligohydramnios 20.13 9.88 3 264354 5747 50335020
Eyelid injury 20.11 9.88 6 264351 9 50340758
Cervix neoplasm 20.01 9.88 13 264344 201 50340566
Rash pruritic 19.96 9.88 157 264200 47689 50293078
Foetal growth restriction 19.95 9.88 5 264352 6622 50334145
Product quality issue 19.94 9.88 88 264269 30770 50309997
Electrocardiogram QT prolonged 19.94 9.88 174 264183 51712 50289055
Myoclonic epilepsy 19.87 9.88 25 264332 950 50339817
Rectal haemorrhage 19.81 9.88 119 264238 38439 50302328
Apathy 19.72 9.88 85 264272 7463 50333304
Pericardial effusion 19.72 9.88 68 264289 25521 50315246
Fracture 19.68 9.88 153 264204 16680 50324087
Coagulopathy 19.68 9.88 40 264317 17904 50322863
Tissue infiltration 19.68 9.88 19 264338 534 50340233
Amnestic disorder 19.63 9.88 15 264342 304 50340463
Eye disorder 19.57 9.88 166 264191 18573 50322194
Full blood count abnormal 19.52 9.88 60 264297 23328 50317439
Respiratory failure 19.44 9.88 347 264010 90834 50249933
Deep vein thrombosis 19.32 9.88 268 264089 73036 50267731
Sensorimotor disorder 19.18 9.88 17 264340 427 50340340
Peripheral coldness 19.10 9.88 105 264252 10178 50330589
Myelodysplastic syndrome 19.03 9.88 31 264326 15101 50325666
Orthostatic tremor 18.96 9.88 5 264352 3 50340764
Head injury 18.73 9.88 200 264157 23820 50316947
Unintentional medical device removal 18.65 9.88 3 264354 5432 50335335
Illusion 18.61 9.88 24 264333 935 50339832
Inhibitory drug interaction 18.54 9.88 38 264319 2195 50338572
Hypoxia 18.53 9.88 174 264183 50949 50289818
Blood parathyroid hormone decreased 18.48 9.88 7 264350 7107 50333660
Acute respiratory distress syndrome 18.42 9.88 53 264304 21046 50319721
Distractibility 18.42 9.88 16 264341 391 50340376
Normal newborn 18.38 9.88 6 264351 6685 50334082
Respiratory disorder 18.35 9.88 92 264265 31095 50309672
Device issue 18.31 9.88 49 264308 19923 50320844
Myocardial infarction 18.29 9.88 341 264016 88686 50252081
Somnambulism 18.27 9.88 62 264295 4862 50335905
Lung infiltration 18.23 9.88 26 264331 13367 50327400
Intentional dose omission 18.23 9.88 63 264294 4987 50335780
Ventricular fibrillation 18.15 9.88 17 264340 10542 50330225
Seizure 18.15 9.88 771 263586 117103 50223664
Device breakage 18.09 9.88 14 264343 9533 50331234
Aphasia 18.08 9.88 228 264129 28266 50312501
Reduced facial expression 18.08 9.88 31 264326 1563 50339204
Glaucoma 18.02 9.88 142 264215 15544 50325223
Nail growth abnormal 18.02 9.88 17 264340 464 50340303
Blood bilirubin increased 18.02 9.88 96 264261 31942 50308825
Limb injury 17.89 9.88 173 264184 20077 50320690
Rib fracture 17.87 9.88 166 264191 19055 50321712
Breast cancer 17.77 9.88 141 264216 42749 50298018
Vomiting 17.73 9.88 2122 262235 458636 49882131
Granulocytopenia 17.70 9.88 3 264354 5228 50335539
Crush syndrome 17.65 9.88 10 264347 119 50340648
Fear of injection 17.62 9.88 5 264352 6098 50334669
Small intestinal obstruction 17.47 9.88 36 264321 16032 50324735
Vascular access site infection 17.46 9.88 7 264350 35 50340732
Leukocytosis 17.40 9.88 60 264297 22519 50318248
Vascular access site thrombosis 17.30 9.88 7 264350 36 50340731
Aspergillus infection 17.24 9.88 7 264350 6814 50333953
Nerve compression 17.23 9.88 81 264276 7381 50333386
Metastases to liver 17.19 9.88 51 264306 20053 50320714
Urinary incontinence 17.18 9.88 224 264133 27984 50312783
Palmar-plantar erythrodysaesthesia syndrome 17.17 9.88 51 264306 20047 50320720
Anxiety disorder 17.08 9.88 50 264307 3623 50337144
Monocyte count abnormal 17.05 9.88 11 264346 168 50340599
Feeling jittery 16.89 9.88 108 264249 11052 50329715
Pituitary tumour benign 16.84 9.88 32 264325 1749 50339018
Dysphoria 16.75 9.88 59 264298 4715 50336052
Poor quality product administered 16.75 9.88 42 264315 2777 50337990
Panniculitis 16.72 9.88 12 264345 8491 50332276
Hypercalcaemia 16.71 9.88 64 264293 23288 50317479
Photophobia 16.68 9.88 134 264223 14753 50326014
Cardiac output decreased 16.65 9.88 22 264335 878 50339889
Abdominal pain lower 16.64 9.88 58 264299 21698 50319069
Social anxiety disorder 16.62 9.88 15 264342 386 50340381
Nervous system disorder 16.57 9.88 143 264214 16080 50324687
General physical health deterioration 16.52 9.88 906 263451 141528 50199239
Dyslexia 16.50 9.88 13 264344 276 50340491
Drug ineffective 16.49 9.88 4658 259699 814675 49526092
Pseudomonas infection 16.43 9.88 15 264342 9415 50331352
Injection site urticaria 16.35 9.88 24 264333 12193 50328574
Device malfunction 16.33 9.88 34 264323 15087 50325680
Negative symptoms in schizophrenia 16.26 9.88 9 264348 102 50340665
Eyelid skin dryness 16.23 9.88 8 264349 70 50340697
Hospice care 16.17 9.88 5 264352 5767 50335000
Oxygen saturation decreased 16.17 9.88 277 264080 72971 50267796
Inadequate analgesia 16.14 9.88 39 264318 2519 50338248
Epilepsy 16.08 9.88 178 264179 21389 50319378
Neurosis 16.05 9.88 12 264345 235 50340532
Scleritis 16.04 9.88 45 264312 3182 50337585
Blood calcium decreased 15.97 9.88 55 264302 20651 50320116
Peroneal nerve palsy 15.95 9.88 54 264303 4229 50336538
Melaena 15.95 9.88 79 264278 26785 50313982
Antinuclear antibody positive 15.91 9.88 70 264287 6202 50334565
Head titubation 15.90 9.88 19 264338 684 50340083
Pulmonary oedema 15.90 9.88 171 264186 48767 50292000
Feeling cold 15.87 9.88 164 264193 19367 50321400
Pulmonary haemorrhage 15.87 9.88 7 264350 6485 50334282
Sleep deficit 15.86 9.88 16 264341 475 50340292
Device use error 15.80 9.88 4 264353 5262 50335505
Negative thoughts 15.76 9.88 21 264336 845 50339922
Personality disorder 15.65 9.88 54 264303 4270 50336497
Mydriasis 15.57 9.88 102 264255 10525 50330242
Tunnel vision 15.56 9.88 19 264338 700 50340067
Treatment noncompliance 15.51 9.88 93 264264 30057 50310710
Eosinophil count increased 15.44 9.88 14 264343 8816 50331951
Gastrooesophageal reflux disease 15.38 9.88 515 263842 75913 50264854
Sternal fracture 15.38 9.88 33 264324 1969 50338798
Urticaria chronic 15.37 9.88 16 264341 493 50340274
Myocardial ischaemia 15.36 9.88 23 264334 11590 50329177
Cardiogenic shock 15.28 9.88 37 264320 15562 50325205
Cardiomyopathy 15.24 9.88 37 264320 15549 50325218
Cerebrospinal fluid retention 15.23 9.88 8 264349 81 50340686
Respiratory distress 15.19 9.88 95 264262 30394 50310373
Back pain 15.06 9.88 1340 263017 218690 50122077
Sinus tachycardia 14.98 9.88 59 264298 21295 50319472
Low birth weight baby 14.92 9.88 6 264351 5875 50334892
Tobacco abuse 14.88 9.88 17 264340 583 50340184
Infection susceptibility increased 14.83 9.88 38 264319 2546 50338221
Stress 14.81 9.88 377 263980 53416 50287351
Drug dose titration not performed 14.76 9.88 15 264342 449 50340318
White blood cell count abnormal 14.73 9.88 5 264352 5435 50335332
Neoplasm malignant 14.73 9.88 189 264168 23526 50317241
Temperature intolerance 14.69 9.88 78 264279 7461 50333306
Platelet count increased 14.63 9.88 34 264323 14506 50326261
Heart rate increased 14.61 9.88 300 264057 76950 50263817
Nasal congestion 14.52 9.88 184 264173 50936 50289831
Hyperglycaemia 14.47 9.88 121 264236 36284 50304483
Clostridium difficile colitis 14.46 9.88 46 264311 17696 50323071
Respiratory tract congestion 14.45 9.88 33 264324 14166 50326601
Mental status changes postoperative 14.43 9.88 10 264347 173 50340594
Pulmonary fibrosis 14.43 9.88 72 264285 24365 50316402
Haematotoxicity 14.43 9.88 12 264345 7883 50332884
Anal sphincter atony 14.35 9.88 11 264346 224 50340543
Apparent death 14.34 9.88 24 264333 1186 50339581
Drug tolerance decreased 14.33 9.88 16 264341 9144 50331623
Proteinuria 14.26 9.88 42 264315 16555 50324212
Motor dysfunction 14.25 9.88 81 264276 7950 50332817
Haemorrhage 14.21 9.88 195 264162 53246 50287521
Logorrhoea 14.20 9.88 35 264322 2289 50338478
Impaired quality of life 14.17 9.88 66 264291 5990 50334777
Face oedema 14.12 9.88 149 264208 17690 50323077
Incontinence 14.12 9.88 95 264262 9890 50330877
Erythema 14.09 9.88 623 263734 145791 50194976
Cytopenia 14.09 9.88 15 264342 8760 50332007
Arthralgia 14.02 9.88 2044 262313 436658 49904109
Rheumatoid arthritis 14.00 9.88 891 263466 201659 50139108
Granuloma 13.99 9.88 4 264353 4854 50335913
Contrast media allergy 13.98 9.88 32 264325 1995 50338772
Renal cell carcinoma stage I 13.98 9.88 5 264352 17 50340750
Hiatus hernia 13.97 9.88 49 264308 18295 50322472
Gangrene 13.97 9.88 55 264302 4637 50336130
Forceps delivery 13.95 9.88 10 264347 183 50340584
Intentional underdose 13.94 9.88 28 264329 1594 50339173
Obstructive airways disorder 13.90 9.88 39 264318 15613 50325154
Accommodation disorder 13.86 9.88 13 264344 352 50340415
Upper airway obstruction 13.81 9.88 16 264341 557 50340210
Orthostatic intolerance 13.79 9.88 21 264336 957 50339810
Adverse event 13.78 9.88 154 264203 43609 50297158
Laryngeal disorder 13.73 9.88 20 264337 876 50339891
Nephropathy toxic 13.72 9.88 13 264344 8016 50332751
Gastric bypass 13.67 9.88 26 264331 1422 50339345
Facial pain 13.67 9.88 77 264280 7532 50333235
Abnormal weight gain 13.62 9.88 26 264331 1426 50339341
Gingival bleeding 13.60 9.88 24 264333 11329 50329438
Confusion postoperative 13.50 9.88 10 264347 193 50340574
Candida infection 13.50 9.88 70 264287 23453 50317314
Bradypnoea 13.49 9.88 41 264316 3033 50337734
Swelling face 13.44 9.88 365 263992 52230 50288537
Mastocytosis 13.37 9.88 15 264342 504 50340263
Auditory disorder 13.36 9.88 14 264343 435 50340332
Decreased appetite 13.35 9.88 887 263470 200036 50140731
Bronchopulmonary aspergillosis 13.32 9.88 12 264345 7580 50333187
Dyspnoea exertional 13.25 9.88 188 264169 51045 50289722
Hypokalaemia 13.22 9.88 354 264003 87638 50253129
Hot flush 13.19 9.88 313 264044 43856 50296911
Throat irritation 13.19 9.88 98 264259 30141 50310626
Mental disorder 13.13 9.88 174 264183 21817 50318950
Peritonitis bacterial 13.13 9.88 4 264353 4657 50336110
Granuloma skin 13.12 9.88 7 264350 5811 50334956
Blindness 13.10 9.88 143 264214 17126 50323641
Graft versus host disease 13.07 9.88 8 264349 6158 50334609
Perfume sensitivity 13.05 9.88 16 264341 592 50340175
Sensory loss 13.05 9.88 77 264280 7661 50333106
Vertigo CNS origin 12.98 9.88 5 264352 22 50340745
Mood swings 12.98 9.88 134 264223 15820 50324947
Pneumonia viral 12.98 9.88 10 264347 6824 50333943
Cardiac arrest 12.97 9.88 335 264022 83316 50257451
Hepatic failure 12.97 9.88 107 264250 32176 50308591
Abortion induced 12.86 9.88 18 264339 9326 50331441
Neck injury 12.85 9.88 28 264329 1689 50339078
Colitis ulcerative 12.85 9.88 45 264312 16809 50323958
Disease progression 12.80 9.88 392 263965 95474 50245293
Laboratory test abnormal 12.79 9.88 70 264287 23138 50317629
Defaecation disorder 12.77 9.88 15 264342 530 50340237
Hippocampal sclerosis 12.75 9.88 7 264350 78 50340689
Erythema multiforme 12.74 9.88 86 264271 8964 50331803
Anti-actin antibody positive 12.69 9.88 4 264353 8 50340759
Basal ganglion degeneration 12.64 9.88 13 264344 395 50340372
Sickle cell anaemia with crisis 12.61 9.88 4 264353 4539 50336228
Lymphocyte count abnormal 12.59 9.88 16 264341 614 50340153
Naevus flammeus 12.58 9.88 8 264349 119 50340648
Complication of device insertion 12.58 9.88 8 264349 6033 50334734
Aplastic anaemia 12.55 9.88 13 264344 7690 50333077
Oropharyngeal pain 12.49 9.88 310 264047 77491 50263276
Hearing disability 12.47 9.88 5 264352 25 50340742
Hernia 12.44 9.88 89 264268 9454 50331313
Atonic urinary bladder 12.37 9.88 7 264350 83 50340684
Eye pain 12.29 9.88 213 264144 28236 50312531
Carcinoid tumour pulmonary 12.25 9.88 13 264344 410 50340357
Nephrolithiasis 12.18 9.88 119 264238 34574 50306193
Myalgia 12.17 9.88 779 263578 123540 50217227
Ear pain 12.17 9.88 92 264265 28191 50312576
Injury 12.14 9.88 181 264176 48744 50292023
Rash erythematous 12.05 9.88 120 264237 34732 50306035
Second primary malignancy 12.04 9.88 11 264346 6903 50333864
Atrial flutter 11.94 9.88 17 264340 8746 50332021
Feeling of despair 11.92 9.88 30 264327 1988 50338779
Heparin-induced thrombocytopenia 11.92 9.88 3 264354 3962 50336805
Hunger 11.91 9.88 49 264308 4214 50336553
Therapeutic product effect delayed 11.89 9.88 30 264327 1991 50338776
Cardiac murmur 11.86 9.88 24 264333 10760 50330007
Ligament pain 11.84 9.88 9 264348 181 50340586
Mite allergy 11.83 9.88 14 264343 499 50340268
Tongue necrosis 11.81 9.88 4 264353 11 50340756
Colitis microscopic 11.81 9.88 10 264347 6510 50334257
Holmes-Adie pupil 11.73 9.88 5 264352 30 50340737
Orthostatic hypotension 11.71 9.88 98 264259 29383 50311384
Electrocardiogram ST-T segment abnormal 11.66 9.88 10 264347 240 50340527
Cytomegalovirus viraemia 11.63 9.88 5 264352 4704 50336063
Burnout syndrome 11.55 9.88 9 264348 188 50340579
Neurotoxicity 11.47 9.88 39 264318 14701 50326066
Suspected counterfeit product 11.46 9.88 11 264346 307 50340460
Thought blocking 11.44 9.88 7 264350 97 50340670
Hepatic cirrhosis 11.43 9.88 50 264307 17527 50323240
Sudden onset of sleep 11.42 9.88 14 264343 518 50340249
Diarrhoea haemorrhagic 11.37 9.88 14 264343 7661 50333106
Bacteraemia 11.36 9.88 38 264319 14395 50326372
Corrective lens user 11.35 9.88 9 264348 193 50340574
Numb chin syndrome 11.32 9.88 4 264353 13 50340754
Daydreaming 11.31 9.88 11 264346 312 50340455
Spinal osteoarthritis 11.30 9.88 118 264239 13974 50326793
Supraventricular tachycardia 11.29 9.88 32 264325 12769 50327998
Accident 11.28 9.88 55 264302 5086 50335681
Cerebral ventricular rupture 11.27 9.88 9 264348 195 50340572
Herpes zoster oticus 11.26 9.88 10 264347 252 50340515
Skin cancer 11.12 9.88 20 264337 9374 50331393
Premature rupture of membranes 11.10 9.88 5 264352 4575 50336192
Cholecystitis chronic 11.08 9.88 21 264336 9648 50331119
Unintended pregnancy 11.08 9.88 6 264351 4940 50335827
Aura 11.07 9.88 19 264338 959 50339808
Dry eye 11.02 9.88 232 264125 31863 50308904
Oropharyngeal blistering 11.02 9.88 17 264340 784 50339983
White blood cell count increased 10.92 9.88 155 264202 42085 50298682
Lymphadenopathy 10.90 9.88 117 264240 33382 50307385
Stoma site inflammation 10.89 9.88 12 264345 395 50340372
Akathisia 10.87 9.88 77 264280 8152 50332615
Post-traumatic neck syndrome 10.87 9.88 28 264329 1882 50338885
Vitamin D deficiency 10.87 9.88 99 264258 11303 50329464
Change in seizure presentation 10.81 9.88 10 264347 266 50340501
Homicidal ideation 10.79 9.88 26 264331 1676 50339091
Urinary hesitation 10.79 9.88 29 264328 2000 50338767
Sleep apnoea syndrome 10.78 9.88 180 264177 23688 50317079
Enthesopathy 10.78 9.88 13 264344 7180 50333587
Limb fracture 10.72 9.88 3 264354 3 50340764
Venous valve ruptured 10.72 9.88 3 264354 3 50340764
Optic nerve cupping 10.72 9.88 3 264354 3 50340764
Burning feet syndrome 10.69 9.88 4 264353 16 50340751
Myoglobin urine 10.69 9.88 4 264353 16 50340751
Drug level decreased 10.67 9.88 11 264346 6522 50334245
Self esteem decreased 10.67 9.88 14 264343 555 50340212
Decreased interest 10.63 9.88 37 264320 2939 50337828
Congestive cardiomyopathy 10.57 9.88 8 264349 5510 50335257
Indifference 10.57 9.88 7 264350 112 50340655
Incoherent 10.57 9.88 47 264310 4183 50336584
Cholestasis 10.55 9.88 189 264168 25212 50315555
Sciatic nerve injury 10.54 9.88 12 264345 410 50340357
Eye injury 10.54 9.88 21 264336 1189 50339578
Inappropriate schedule of product administration 10.53 9.88 290 264067 71541 50269226
Psoriasis 10.52 9.88 277 264080 68723 50272044
Renal injury 10.50 9.88 18 264339 8593 50332174
Therapy interrupted 10.45 9.88 62 264295 20090 50320677
Concussion 10.45 9.88 72 264285 7556 50333211
Migraine without aura 10.42 9.88 10 264347 279 50340488
Gastritis 10.41 9.88 116 264241 32867 50307900
Histone antibody positive 10.40 9.88 6 264351 74 50340693
Rotator cuff syndrome 10.38 9.88 99 264258 11445 50329322
Back injury 10.38 9.88 68 264289 7017 50333750
Clostridium difficile infection 10.36 9.88 84 264273 25355 50315412
Encephalitis brain stem 10.36 9.88 7 264350 116 50340651
Pulmonary embolism 10.36 9.88 430 263927 101274 50239493
Snoring 10.34 9.88 40 264317 3344 50337423
Anaesthesia 10.31 9.88 11 264346 349 50340418
Myofascial pain syndrome 10.31 9.88 29 264328 2054 50338713
Upper-airway cough syndrome 10.31 9.88 18 264339 8532 50332235
Cholelithiasis 10.30 9.88 138 264219 37835 50302932
Hereditary angioedema 10.29 9.88 8 264349 5434 50335333
Dolichocolon 10.26 9.88 3 264354 4 50340763
Maternal drugs affecting foetus 10.20 9.88 7 264350 5070 50335697
Epstein-Barr virus infection 10.11 9.88 13 264344 6984 50333783
Asthenopia 10.08 9.88 28 264329 1969 50338798
Eating disorder 10.08 9.88 124 264233 15285 50325482
Infusion site pain 10.07 9.88 32 264325 12314 50328453
Drug tolerance 10.05 9.88 52 264305 4924 50335843
Mitral valve incompetence 10.02 9.88 52 264305 17419 50323348
Rhinovirus infection 10.01 9.88 3 264354 3531 50337236
Bradykinesia 10.00 9.88 44 264313 3899 50336868
Mandibular mass 9.99 9.88 8 264349 174 50340593
Cardiomegaly 9.99 9.88 46 264311 15899 50324868
Pathogen resistance 9.97 9.88 9 264348 5680 50335087
Illness anxiety disorder 9.96 9.88 7 264350 124 50340643
Sleep attacks 9.94 9.88 6 264351 81 50340686
Appendicitis 9.90 9.88 12 264345 6612 50334155

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 abuse 743.83 10.50 1298 130045 78585 29364599
Somnolence 679.46 10.50 1370 129973 92585 29350599
Withdrawal syndrome 619.07 10.50 459 130884 10533 29432651
Drug dependence 469.64 10.50 521 130822 20460 29422724
Intentional product misuse 362.79 10.50 594 130749 34067 29409117
Pain 335.26 10.50 1577 129766 169855 29273329
Drug use disorder 250.96 10.50 168 131175 3254 29439930
Coma 219.18 10.50 518 130825 38932 29404252
Miosis 207.51 10.50 215 131128 7794 29435390
Feeling abnormal 201.45 10.50 615 130728 53830 29389354
Prescribed overdose 198.31 10.50 218 131125 8465 29434719
Overdose 187.94 10.50 777 130566 79042 29364142
Burning sensation 182.93 10.50 285 131058 15653 29427531
Drug withdrawal syndrome 178.40 10.50 301 131042 17683 29425501
Drug hypersensitivity 157.14 10.50 661 130682 67745 29375439
Suicidal ideation 153.35 10.50 418 130925 34298 29408886
Memory impairment 148.20 10.50 426 130917 36044 29407140
Depressed level of consciousness 141.00 10.50 422 130921 36520 29406664
Gait disturbance 130.80 10.50 658 130685 72691 29370493
Insomnia 128.39 10.50 752 130591 88009 29355175
Prescription drug used without a prescription 128.05 10.50 77 131266 1227 29441957
Vision blurred 127.78 10.50 431 130912 39745 29403439
Therapeutic product effect incomplete 123.55 10.50 420 130923 38885 29404299
Altered state of consciousness 123.51 10.50 273 131070 19616 29423568
Disturbance in attention 122.95 10.50 285 131058 21139 29422045
Confusional state 116.73 10.50 968 130375 126909 29316275
Pain in extremity 113.40 10.50 859 130484 109574 29333610
Dysarthria 108.53 10.50 343 131000 30568 29412616
Myoclonus 107.90 10.50 204 131139 13105 29430079
Intentional overdose 107.60 10.50 396 130947 38132 29405052
Bradypnoea 107.27 10.50 87 131256 2284 29440900
Pre-existing condition improved 104.75 10.50 84 131259 2169 29441015
Neuralgia 103.87 10.50 179 131164 10695 29432489
Diarrhoea 102.46 10.50 965 130378 331733 29111451
Death 102.06 10.50 1000 130343 341084 29102100
Toxicity to various agents 101.55 10.50 1198 130145 172463 29270721
Weight increased 99.09 10.50 631 130712 76036 29367148
Dizziness 99.06 10.50 1281 130062 188403 29254781
Febrile neutropenia 98.01 10.50 221 131122 112019 29331165
Pyrexia 97.40 10.50 814 130529 286808 29156376
Euphoric mood 88.14 10.50 108 131235 4717 29438467
Hypoaesthesia 87.88 10.50 469 130874 52998 29390186
Fall 82.77 10.50 1173 130170 176005 29267179
Hypoacusis 80.70 10.50 190 131153 14233 29428951
Balance disorder 76.45 10.50 341 131002 35829 29407355
Poisoning 75.89 10.50 149 131194 9844 29433340
Anaemia 71.89 10.50 560 130783 200391 29242793
Middle insomnia 71.03 10.50 106 131237 5602 29437582
Impaired driving ability 70.36 10.50 68 131275 2263 29440921
Road traffic accident 70.31 10.50 189 131154 15372 29427812
Amnesia 70.28 10.50 241 131102 22402 29420782
Mydriasis 67.29 10.50 107 131236 5978 29437206
Neutropenia 65.15 10.50 332 131011 131379 29311805
Paraesthesia 64.55 10.50 435 130908 53410 29389774
Agitation 64.24 10.50 419 130924 50885 29392299
Feeling drunk 62.80 10.50 55 131288 1609 29441575
Respiratory depression 61.86 10.50 165 131178 13358 29429826
Ascites 61.16 10.50 44 131299 36575 29406609
Hyperaesthesia 60.71 10.50 76 131267 3393 29439791
C-reactive protein abnormal 60.34 10.50 106 131237 6430 29436754
Aggression 59.91 10.50 314 131029 35227 29407957
Therapeutic response unexpected 59.87 10.50 124 131219 8514 29434670
Intentional product use issue 58.12 10.50 355 130988 42143 29401041
Atrial fibrillation 57.66 10.50 257 131086 105389 29337795
Sedation 57.33 10.50 189 131154 17216 29425968
Cytomegalovirus infection 57.32 10.50 16 131327 23199 29419985
Hypotension 55.30 10.50 574 130769 193780 29249404
Multiple organ dysfunction syndrome 55.26 10.50 124 131219 62992 29380192
Visual impairment 54.64 10.50 269 131074 29439 29413745
Suicide attempt 54.52 10.50 297 131046 33813 29409371
Tremor 53.85 10.50 531 130812 73007 29370177
Cardiac failure congestive 53.73 10.50 168 131175 76413 29366771
Impaired work ability 52.76 10.50 92 131251 5548 29437636
Thinking abnormal 52.39 10.50 88 131255 5148 29438036
Restlessness 50.78 10.50 214 131129 21931 29421253
Cytology abnormal 48.25 10.50 27 131316 373 29442811
Prescription form tampering 47.80 10.50 28 131315 424 29442760
Victim of crime 47.25 10.50 26 131317 347 29442837
Limb discomfort 47.10 10.50 120 131223 9448 29433736
Fibromyalgia 46.65 10.50 58 131285 2571 29440613
Hospitalisation 46.56 10.50 83 131260 45905 29397279
Cough 45.78 10.50 352 130991 126375 29316809
Drug tolerance 45.63 10.50 52 131291 2101 29441083
Nerve injury 43.36 10.50 60 131283 2957 29440227
Therapy non-responder 43.25 10.50 44 131299 30867 29412317
Inadequate analgesia 43.06 10.50 56 131287 2598 29440586
Sopor 42.72 10.50 126 131217 10808 29432376
Dependence 42.70 10.50 36 131307 999 29442185
Speech disorder 42.58 10.50 212 131131 23304 29419880
Gastrointestinal haemorrhage 42.46 10.50 195 131148 79338 29363846
Bradyphrenia 42.39 10.50 71 131272 4143 29439041
Respiratory failure 41.91 10.50 256 131087 96875 29346309
Herpes zoster 41.69 10.50 252 131091 29800 29413384
Dry mouth 41.31 10.50 199 131144 21585 29421599
Pneumonia 41.26 10.50 1095 130248 319077 29124107
Nervousness 41.08 10.50 127 131216 11179 29432005
Disease progression 40.74 10.50 206 131137 81710 29361474
Trigeminal neuralgia 39.01 10.50 34 131309 988 29442196
Cardiac arrest 38.82 10.50 222 131121 85369 29357815
Interstitial lung disease 38.52 10.50 409 130934 57309 29385875
Sepsis 38.28 10.50 427 130916 142255 29300929
Dyskinesia 37.85 10.50 183 131160 19878 29423306
Infusion related reaction 37.77 10.50 87 131256 43799 29399385
Mucosal inflammation 36.73 10.50 52 131291 31543 29411641
Drug intolerance 36.20 10.50 351 130992 48028 29395156
Coronary artery disease 36.13 10.50 90 131253 44100 29399084
Anxiety 35.76 10.50 555 130788 84810 29358374
Congenital hiatus hernia 35.57 10.50 23 131320 419 29442765
Wrong patient 34.66 10.50 15 131328 113 29443071
Head discomfort 34.47 10.50 56 131287 3186 29439998
Dyspnoea 34.47 10.50 1148 130195 325584 29117600
Diplopia 34.45 10.50 135 131208 13383 29429801
Acute myocardial infarction 34.14 10.50 106 131237 48332 29394852
Allodynia 33.16 10.50 25 131318 588 29442596
Neck pain 32.43 10.50 184 131159 21263 29421921
Delirium 32.06 10.50 291 131052 39106 29404078
Arthropathy 31.99 10.50 184 131159 21370 29421814
Loss of consciousness 31.98 10.50 484 130859 73572 29369612
Movement disorder 31.79 10.50 109 131234 10128 29433056
Sleep disorder 31.63 10.50 201 131142 24185 29418999
Terminal state 31.39 10.50 56 131287 3438 29439746
Lymphadenopathy 31.39 10.50 39 131304 25010 29418174
Product prescribing error 31.10 10.50 160 131183 17816 29425368
Aspergillus infection 30.80 10.50 5 131338 10576 29432608
Sleep disorder due to general medical condition, insomnia type 30.77 10.50 33 131310 1245 29441939
Dysstasia 30.35 10.50 109 131234 10365 29432819
Colour blindness acquired 30.16 10.50 12 131331 71 29443113
Condition aggravated 29.91 10.50 856 130487 145439 29297745
Disorientation 29.88 10.50 229 131114 29286 29413898
Drug resistance 29.75 10.50 31 131312 21509 29421675
Erectile dysfunction 29.57 10.50 158 131185 17851 29425333
Cognitive disorder 29.44 10.50 192 131151 23307 29419877
Prerenal failure 29.44 10.50 38 131305 1750 29441434
Rash 29.40 10.50 631 130712 189188 29253996
Suicide threat 29.35 10.50 9 131334 20 29443164
Epistaxis 29.26 10.50 124 131219 51580 29391604
Anorgasmia 29.01 10.50 23 131320 584 29442600
Injection site pain 29.00 10.50 63 131280 32383 29410801
Intervertebral disc protrusion 28.41 10.50 94 131249 8576 29434608
Withdrawal arrhythmia 28.30 10.50 10 131333 40 29443144
Thrombocytopenia 28.20 10.50 425 130918 134398 29308786
Product dose omission issue 28.03 10.50 283 131060 96100 29347084
Pancytopenia 27.71 10.50 236 131107 82932 29360252
Muscle twitching 27.19 10.50 88 131255 7938 29435246
Graft versus host disease 27.03 10.50 5 131338 9623 29433561
Blood bilirubin increased 26.95 10.50 70 131273 33823 29409361
Infection 26.84 10.50 215 131128 76536 29366648
Mood altered 26.64 10.50 88 131255 8023 29435161
Housebound 26.20 10.50 15 131328 217 29442967
Platelet count decreased 26.20 10.50 318 131025 104354 29338830
Coordination abnormal 25.93 10.50 80 131263 7034 29436150
Oedematous pancreatitis 25.83 10.50 19 131324 430 29442754
Pleural effusion 25.81 10.50 200 131143 71708 29371476
Dysphemia 25.75 10.50 32 131311 1418 29441766
Myelosuppression 25.75 10.50 11 131332 12216 29430968
Depersonalisation/derealisation disorder 25.61 10.50 21 131322 560 29442624
Pathogen resistance 25.59 10.50 3 131340 8113 29435071
Pulmonary hypertension 25.45 10.50 27 131316 18581 29424603
Apparent death 25.10 10.50 51 131292 3453 29439731
Myoclonic epilepsy 24.94 10.50 26 131317 949 29442235
Clostridium difficile infection 24.91 10.50 21 131322 16120 29427064
Clumsiness 24.78 10.50 32 131311 1474 29441710
Ataxia 24.73 10.50 113 131230 11990 29431194
COVID-19 24.54 10.50 80 131263 35934 29407250
Bradykinesia 24.49 10.50 50 131293 3397 29439787
Ventricular tachycardia 24.45 10.50 39 131304 22535 29420649
Ejection fraction decreased 24.40 10.50 21 131322 15957 29427227
Haemodialysis 24.31 10.50 7 131336 9947 29433237
Illness 24.28 10.50 75 131268 6599 29436585
Formication 24.22 10.50 32 131311 1508 29441676
International normalised ratio increased 24.14 10.50 108 131235 44264 29398920
Nausea 24.10 10.50 1045 130298 288210 29154974
Foetal exposure during pregnancy 23.94 10.50 74 131269 33793 29409391
Blood creatinine increased 23.87 10.50 252 131091 84850 29358334
Urinary retention 23.65 10.50 231 131112 31667 29411517
Hyperpyrexia 23.34 10.50 39 131304 2271 29440913
Photosensitivity reaction 23.22 10.50 92 131251 9166 29434018
Intentional self-injury 23.02 10.50 113 131230 12348 29430836
Acute kidney injury 23.00 10.50 954 130389 264313 29178871
Septic shock 22.92 10.50 173 131170 62387 29380797
Oedema peripheral 22.85 10.50 612 130731 102945 29340239
Hallucination 22.82 10.50 301 131042 44411 29398773
Ventricular fibrillation 22.76 10.50 22 131321 15811 29427373
Hepatocellular injury 22.73 10.50 167 131176 21076 29422108
Phantom limb syndrome 22.70 10.50 14 131329 234 29442950
Wrong technique in product usage process 22.70 10.50 68 131275 31360 29411824
Drug ineffective 22.69 10.50 1889 129454 361281 29081903
Weight decreased 22.66 10.50 504 130839 150401 29292783
Depression 22.61 10.50 516 130827 84631 29358553
Myocardial infarction 22.60 10.50 349 130994 109947 29333237
Posterior reversible encephalopathy syndrome 22.51 10.50 6 131337 8970 29434214
Renal failure 22.40 10.50 381 130962 118218 29324966
Bone marrow failure 22.36 10.50 56 131287 27393 29415791
Mental impairment 22.26 10.50 90 131253 9051 29434133
Flushing 22.20 10.50 61 131282 28931 29414253
Hepatic failure 22.17 10.50 69 131274 31443 29411741
Hallucination, visual 22.16 10.50 128 131215 14887 29428297
White blood cell count decreased 22.12 10.50 250 131093 83112 29360072
Red blood cell sedimentation rate abnormal 22.11 10.50 38 131305 2265 29440919
Staphylococcal infection 22.04 10.50 62 131281 29178 29414006
Head circumference abnormal 21.89 10.50 8 131335 36 29443148
Clostridium difficile colitis 21.89 10.50 16 131327 13196 29429988
Thermophobia 21.85 10.50 9 131334 59 29443125
Haemoglobin decreased 21.84 10.50 344 130999 108031 29335153
White blood cell count increased 21.83 10.50 89 131254 37427 29405757
Post herpetic neuralgia 21.82 10.50 24 131319 932 29442252
Bronchopulmonary aspergillosis 21.72 10.50 14 131329 12330 29430854
Blepharospasm 21.55 10.50 25 131318 1030 29442154
Leukocytosis 21.53 10.50 38 131305 21104 29422080
Dysgraphia 21.39 10.50 35 131308 2003 29441181
Haematuria 21.36 10.50 112 131231 44027 29399157
Dysaesthesia 21.24 10.50 35 131308 2015 29441169
Limb injury 21.13 10.50 90 131253 9265 29433919
Sinusitis 20.93 10.50 80 131263 34270 29408914
Blood homocysteine increased 20.88 10.50 13 131330 221 29442963
Systemic infection 20.60 10.50 35 131308 2066 29441118
Persistent depressive disorder 20.43 10.50 14 131329 282 29442902
Leukopenia 20.06 10.50 153 131190 55050 29388134
Abdominal pain 20.05 10.50 453 130890 134904 29308280
Enterococcal infection 19.85 10.50 6 131337 8262 29434922
Drug ineffective for unapproved indication 19.58 10.50 119 131224 14095 29429089
Quality of life decreased 19.37 10.50 44 131299 3218 29439966
Hypervolaemia 19.29 10.50 30 131313 17515 29425669
Nephropathy toxic 19.20 10.50 12 131331 10744 29432440
Haemodynamic instability 19.13 10.50 6 131337 8067 29435117
Alanine aminotransferase increased 19.11 10.50 212 131131 70732 29372452
Gamma-glutamyltransferase increased 19.03 10.50 192 131151 26545 29416639
Neuropathy peripheral 19.02 10.50 431 130912 70596 29372588
Angioedema 19.02 10.50 75 131268 31840 29411344
Lymphoma 18.92 10.50 10 131333 9818 29433366
Multiple sclerosis 18.90 10.50 61 131282 5493 29437691
Back disorder 18.90 10.50 64 131279 5909 29437275
Petit mal epilepsy 18.77 10.50 39 131304 2683 29440501
Pulmonary thrombosis 18.75 10.50 68 131275 6497 29436687
Benzodiazepine drug level decreased 18.56 10.50 7 131336 35 29443149
Somatic symptom disorder 18.56 10.50 17 131326 528 29442656
Cytomegalovirus viraemia 18.36 10.50 3 131340 6317 29436867
Vestibular disorder 18.30 10.50 23 131320 1031 29442153
Transplant rejection 18.29 10.50 9 131334 9203 29433981
Chest pain 18.25 10.50 369 130974 111604 29331580
Psychotic behaviour 18.21 10.50 18 131325 616 29442568
Cardiogenic shock 18.21 10.50 36 131307 19154 29424030
Irritability 18.21 10.50 164 131179 21988 29421196
Pseudomonas infection 18.17 10.50 13 131330 10839 29432345
Unevaluable event 17.88 10.50 70 131273 29781 29413403
Gait inability 17.73 10.50 141 131202 18234 29424950
Tuberculosis 17.69 10.50 5 131338 7191 29435993
Accessory spleen 17.57 10.50 10 131333 143 29443041
Anger 17.51 10.50 95 131248 10795 29432389
Drug interaction 17.34 10.50 1056 130287 196329 29246855
Electrocardiogram QT prolonged 17.31 10.50 92 131251 36045 29407139
Upper respiratory tract infection 17.12 10.50 63 131280 27286 29415898
Sensory disturbance 17.03 10.50 59 131284 5510 29437674
Blood folate decreased 17.02 10.50 16 131327 514 29442670
Pneumonia aspiration 16.98 10.50 243 131100 36494 29406690
Colitis ulcerative 16.94 10.50 19 131324 12750 29430434
Rhabdomyolysis 16.92 10.50 371 130972 60437 29382747
Failure to anastomose 16.84 10.50 11 131332 204 29442980
Vomiting 16.79 10.50 771 130572 211489 29231695
Injection site reaction 16.73 10.50 15 131328 11173 29432011
Fatigue 16.69 10.50 1197 130146 315624 29127560
Substance abuse 16.67 10.50 67 131276 6720 29436464
Venoocclusive liver disease 16.64 10.50 5 131338 6912 29436272
Rectal haemorrhage 16.53 10.50 88 131255 34461 29408723
Brain injury 16.52 10.50 58 131285 5454 29437730
Sciatica 16.49 10.50 54 131289 4900 29438284
Panic attack 16.46 10.50 77 131266 8249 29434935
Aspartate aminotransferase increased 16.28 10.50 178 131165 59547 29383637
Drug diversion 16.12 10.50 19 131324 796 29442388
Jaundice 16.12 10.50 71 131272 29225 29413959
Renal injury 16.08 10.50 13 131330 10189 29432995
Off label use 16.08 10.50 1135 130208 299665 29143519
Failure to thrive 16.04 10.50 7 131336 7677 29435507
Asphyxia 15.99 10.50 56 131287 5259 29437925
Substance use 15.95 10.50 15 131328 482 29442702
Visual acuity reduced 15.94 10.50 117 131226 14759 29428425
Pancreatitis 15.91 10.50 89 131254 34425 29408759
Psychogenic seizure 15.91 10.50 13 131330 345 29442839
Spinal stenosis 15.84 10.50 49 131294 4314 29438870
Derealisation 15.82 10.50 16 131327 563 29442621
Panic reaction 15.76 10.50 24 131319 1291 29441893
Depressed mood 15.75 10.50 126 131217 16322 29426862
Deafness 15.69 10.50 87 131256 9968 29433216
Body height decreased 15.68 10.50 42 131301 3408 29439776
Product use issue 15.65 10.50 318 131025 51126 29392058
Haemoptysis 15.64 10.50 76 131267 30474 29412710
Hiccups 15.63 10.50 10 131333 8843 29434341
Nerve degeneration 15.62 10.50 10 131333 179 29443005
Gastrointestinal disorder 15.53 10.50 70 131273 28636 29414548
Abnormal behaviour 15.47 10.50 164 131179 22963 29420221
Testicular necrosis 15.46 10.50 4 131339 3 29443181
Haemorrhage 15.41 10.50 127 131216 44945 29398239
Upper gastrointestinal haemorrhage 15.40 10.50 48 131295 21866 29421318
Cellulitis 15.29 10.50 130 131213 45710 29397474
Kidney transplant rejection 15.24 10.50 6 131337 6999 29436185
Muscular weakness 15.22 10.50 372 130971 61680 29381504
Injection site erythema 15.22 10.50 24 131319 13932 29429252
Pseudolymphoma 15.21 10.50 15 131328 512 29442672
Feeling of body temperature change 15.19 10.50 23 131320 1231 29441953
Eosinophilic myocarditis 15.12 10.50 14 131329 441 29442743
Lung infiltration 15.11 10.50 18 131325 11761 29431423
Thrombotic microangiopathy 15.06 10.50 10 131333 8671 29434513
Reading disorder 15.04 10.50 14 131329 444 29442740
Product substitution 15.01 10.50 6 131337 36 29443148
Product prescribing issue 14.99 10.50 22 131321 1145 29442039
Candida infection 14.94 10.50 28 131315 15197 29427987
Motor dysfunction 14.93 10.50 59 131284 5871 29437313
Dialysis 14.89 10.50 14 131329 10194 29432990
Accident 14.89 10.50 43 131300 3645 29439539
Disseminated intravascular coagulation 14.59 10.50 43 131300 19937 29423247
Accidental poisoning 14.49 10.50 15 131328 543 29442641
Daydreaming 14.43 10.50 14 131329 468 29442716
Diabetic neuropathy 14.42 10.50 43 131300 3710 29439474
Nervous system disorder 14.35 10.50 101 131242 12573 29430611
Neutrophil count decreased 14.33 10.50 124 131219 43443 29399741
Bacteraemia 14.33 10.50 32 131311 16291 29426893
Substance use disorder 14.29 10.50 11 131332 267 29442917
Product dispensing error 14.18 10.50 55 131288 5425 29437759
Personality disorder 14.18 10.50 21 131322 1102 29442082
Stress at work 14.16 10.50 9 131334 159 29443025
Back pain 14.14 10.50 572 130771 101712 29341472
Cardio-respiratory arrest 14.11 10.50 150 131193 50451 29392733
Generalised anxiety disorder 14.07 10.50 16 131327 645 29442539
Melaena 14.04 10.50 81 131262 31095 29412089
Red blood cell sedimentation rate increased 14.03 10.50 68 131275 7393 29435791
Age-related macular degeneration 13.98 10.50 11 131332 276 29442908
Influenza virus test positive 13.98 10.50 7 131336 76 29443108
Sexual activity increased 13.96 10.50 5 131338 21 29443163
COVID-19 pneumonia 13.96 10.50 13 131330 9509 29433675
General physical health deterioration 13.95 10.50 574 130769 102283 29340901
Overweight 13.92 10.50 24 131319 1434 29441750
Application site hypersensitivity 13.90 10.50 8 131335 117 29443067
Generalised tonic-clonic seizure 13.89 10.50 138 131205 19001 29424183
Pericardial effusion 13.84 10.50 48 131295 21160 29422024
Visual field defect 13.82 10.50 45 131298 4071 29439113
Wrong drug 13.82 10.50 7 131336 78 29443106
Mucormycosis 13.81 10.50 3 131340 5155 29438029
Hepatic cirrhosis 13.79 10.50 27 131316 14417 29428767
Joint arthroplasty 13.78 10.50 16 131327 660 29442524
Abdominal discomfort 13.77 10.50 141 131202 47762 29395422
Venous oxygen saturation decreased 13.67 10.50 4 131339 7 29443177
Acute pulmonary oedema 13.63 10.50 63 131280 6716 29436468
Tinnitus 13.56 10.50 117 131226 15497 29427687
Nystagmus 13.48 10.50 46 131297 4263 29438921
Astigmatism 13.41 10.50 19 131324 957 29442227
Basal cell carcinoma 13.38 10.50 35 131308 16875 29426309
Hypopituitarism 13.38 10.50 26 131317 1704 29441480
Deep vein thrombosis 13.37 10.50 177 131166 57222 29385962
Amputee 13.26 10.50 3 131340 0 29443184
Diastolic hypotension 13.26 10.50 5 131338 25 29443159
Haemorrhage intracranial 13.19 10.50 28 131315 14514 29428670
Dysgeusia 13.06 10.50 54 131289 22620 29420564
Haemorrhage subcutaneous 13.00 10.50 29 131314 2096 29441088
Cardiomyopathy 12.97 10.50 29 131314 14758 29428426
Frustration tolerance decreased 12.96 10.50 30 131313 2222 29440962
Hypogammaglobulinaemia 12.95 10.50 5 131338 5902 29437282
Libido increased 12.94 10.50 16 131327 705 29442479
Epilepsy 12.94 10.50 132 131211 18300 29424884
Metabolic acidosis 12.93 10.50 106 131237 37556 29405628
Joint swelling 12.92 10.50 300 131043 49330 29393854
Oedema 12.90 10.50 252 131091 40231 29402953
Appendicitis 12.85 10.50 12 131331 8767 29434417
Atelectasis 12.85 10.50 31 131312 15361 29427823
Pseudoporphyria 12.84 10.50 11 131332 312 29442872
Vertigo 12.79 10.50 151 131192 21710 29421474
Premature baby 12.76 10.50 37 131306 17243 29425941
Seizure 12.70 10.50 520 130823 92603 29350581
Dementia 12.67 10.50 92 131251 11566 29431618
Drug effective for unapproved indication 12.66 10.50 23 131320 1432 29441752
Hypoxia 12.59 10.50 142 131201 47237 29395947
Hyperbilirubinaemia 12.53 10.50 30 131313 14904 29428280
Hypophagia 12.47 10.50 49 131294 20823 29422361
Preternatural anus 12.43 10.50 7 131336 98 29443086
Immunosuppression 12.40 10.50 4 131339 5282 29437902
Complex regional pain syndrome 12.39 10.50 13 131330 478 29442706
Alcohol interaction 12.38 10.50 33 131310 2670 29440514
Agitation neonatal 12.27 10.50 19 131324 1037 29442147
Haematocrit decreased 12.23 10.50 77 131266 28945 29414239
Nervous system neoplasm 12.22 10.50 8 131335 149 29443035
Acute respiratory failure 12.21 10.50 68 131275 26334 29416850
Therapy cessation 12.17 10.50 29 131314 14433 29428751
Sensory loss 12.14 10.50 43 131300 4061 29439123
Paresis 12.13 10.50 26 131317 1828 29441356
Genital swelling 12.13 10.50 8 131335 151 29443033
Poisoning deliberate 12.07 10.50 54 131289 5677 29437507
Panic disorder 11.90 10.50 20 131323 1170 29442014
Device related infection 11.90 10.50 33 131310 15603 29427581
Accidental overdose 11.88 10.50 125 131218 17468 29425716
Adrenocorticotropic hormone deficiency 11.85 10.50 14 131329 588 29442596
Nightmare 11.78 10.50 89 131254 11328 29431856
Homicidal ideation 11.75 10.50 31 131312 2493 29440691
Acute myeloid leukaemia 11.73 10.50 36 131307 16477 29426707
Rash scarlatiniform 11.67 10.50 7 131336 111 29443073
Behaviour disorder 11.67 10.50 39 131304 3577 29439607
Sleep deficit 11.64 10.50 12 131331 432 29442752
Polyneuropathy 11.59 10.50 93 131250 12059 29431125
Contraindication to medical treatment 11.51 10.50 12 131331 438 29442746
Aplasia pure red cell 11.47 10.50 5 131338 5486 29437698
Injection site swelling 11.44 10.50 15 131328 9402 29433782
Apathy 11.43 10.50 56 131287 6115 29437069
Phonophobia 11.39 10.50 8 131335 168 29443016
Neonatal hyponatraemia 11.39 10.50 6 131337 73 29443111
Ejaculation delayed 11.37 10.50 9 131334 228 29442956
Brain malformation 11.35 10.50 7 131336 117 29443067
Rhinalgia 11.31 10.50 11 131332 369 29442815
Sitting disability 11.25 10.50 7 131336 119 29443065
Post laminectomy syndrome 11.23 10.50 8 131335 172 29443012
Spinal pain 11.14 10.50 47 131296 4817 29438367
Shock 11.10 10.50 53 131290 21351 29421833
Libido decreased 11.01 10.50 43 131300 4255 29438929
Pneumothorax 10.92 10.50 35 131308 15807 29427377
Neoplasm progression 10.92 10.50 44 131299 18568 29424616
Dehydration 10.92 10.50 408 130935 114340 29328844
Mitral valve incompetence 10.92 10.50 27 131316 13266 29429918
Peripheral swelling 10.88 10.50 365 130978 63374 29379810
Activated partial thromboplastin time prolonged 10.85 10.50 11 131332 7731 29435453
Mood swings 10.82 10.50 62 131281 7189 29435995
Haemolysis 10.80 10.50 9 131334 6947 29436237
Tracheal pain 10.79 10.50 5 131338 45 29443139
Reactive psychosis 10.74 10.50 3 131340 4 29443180
Dysmetropsia 10.74 10.50 3 131340 4 29443180
Prostatic specific antigen increased 10.73 10.50 25 131318 12539 29430645
Anaphylactic reaction 10.69 10.50 75 131268 27498 29415686
Malaise 10.68 10.50 835 130508 158767 29284417
Undifferentiated connective tissue disease 10.61 10.50 4 131339 20 29443164
Injection site haemorrhage 10.56 10.50 13 131330 8373 29434811
Wrong product administered 10.55 10.50 44 131299 4487 29438697
Vertebral foraminal stenosis 10.55 10.50 12 131331 484 29442700
Multiple fractures 10.53 10.50 20 131323 1289 29441895
Increased appetite 10.50 10.50 54 131289 6010 29437174

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
Withdrawal syndrome 1978.02 9.81 1317 323300 22175 64151940
Somnolence 1456.12 9.81 3183 321434 200462 63973653
Intentional product misuse 921.78 9.81 1451 323166 70844 64103271
Pain 829.63 9.81 5183 319434 548328 63625787
Drug dependence 732.59 9.81 871 323746 32441 64141674
Feeling abnormal 673.67 9.81 1827 322790 131775 64042340
Drug abuse 622.69 9.81 1765 322852 130609 64043506
Memory impairment 512.59 9.81 1250 323367 84432 64089683
Therapeutic product effect incomplete 479.86 9.81 1373 323244 102109 64072006
Prescribed overdose 452.57 9.81 535 324082 19796 64154319
Gait disturbance 419.73 9.81 1848 322769 170307 64003808
Drug withdrawal syndrome 405.43 9.81 633 323984 30658 64143457
Drug hypersensitivity 402.39 9.81 2302 322315 235513 63938602
Insomnia 400.62 9.81 2012 322605 195824 63978291
Intentional product use issue 324.23 9.81 1137 323480 94227 64079888
Hypoacusis 323.64 9.81 515 324102 25352 64148763
Burning sensation 312.41 9.81 739 323878 48925 64125190
Fall 311.66 9.81 3336 321281 413490 63760625
Coma 300.77 9.81 1048 323569 86567 64087548
Dizziness 298.81 9.81 3393 321224 426770 63747345
Pain in extremity 295.11 9.81 2565 322052 300520 63873595
Pre-existing condition improved 274.16 9.81 212 324405 4550 64169565
Suicidal ideation 261.31 9.81 833 323784 65709 64108406
Weight increased 260.27 9.81 1902 322715 211446 63962669
Disturbance in attention 253.80 9.81 607 324010 40467 64133648
Confusional state 243.17 9.81 2189 322428 258955 63915160
Neuralgia 242.00 9.81 456 324161 25728 64148387
Drug use disorder 223.97 9.81 209 324408 5845 64168270
Tremor 213.60 9.81 1377 323240 146853 64027262
Therapeutic response unexpected 210.63 9.81 337 324280 16664 64157451
Body height decreased 209.58 9.81 223 324394 7331 64166784
Impaired driving ability 208.49 9.81 179 324438 4475 64169640
Febrile neutropenia 207.35 9.81 393 324224 187264 63986851
Pemphigus 203.69 9.81 31 324586 60670 64113445
Maternal exposure during pregnancy 201.42 9.81 116 324501 95768 64078347
Thinking abnormal 201.20 9.81 269 324348 11287 64162828
Death 195.56 9.81 1525 323092 481180 63692935
Sciatica 194.88 9.81 359 324258 19905 64154210
Myoclonus 194.25 9.81 406 324211 24712 64149403
Vision blurred 192.82 9.81 933 323684 89383 64084732
Depressed level of consciousness 189.77 9.81 863 323754 80573 64093542
Illness 184.33 9.81 367 324250 21571 64152544
Miosis 183.95 9.81 277 324340 12989 64161126
Speech disorder 183.44 9.81 599 324018 47842 64126273
Malaise 179.51 9.81 2895 321722 393352 63780763
Hypoaesthesia 178.06 9.81 1255 323362 137853 64036262
Euphoric mood 176.57 9.81 191 324426 6400 64167715
Overdose 172.34 9.81 1383 323234 158183 64015932
Anti-cyclic citrullinated peptide antibody positive 167.01 9.81 25 324592 49537 64124578
Feeling drunk 166.11 9.81 150 324467 4017 64170098
Sopor 164.89 9.81 421 324196 29240 64144875
Exposure during pregnancy 160.26 9.81 96 324521 77579 64096536
Glossodynia 154.38 9.81 66 324551 64630 64109485
Amnesia 153.29 9.81 563 324054 47706 64126409
Impaired work ability 153.17 9.81 275 324342 14944 64159171
Hand deformity 153.06 9.81 62 324555 62709 64111406
Altered state of consciousness 151.98 9.81 478 324139 37424 64136691
Visual impairment 142.40 9.81 743 323874 73334 64100781
Pyrexia 141.22 9.81 1972 322645 556672 63617443
Infusion related reaction 140.81 9.81 395 324222 164072 64010043
Balance disorder 140.67 9.81 811 323806 83115 64091000
Pericarditis 139.53 9.81 70 324547 62446 64111669
Product dispensing error 139.15 9.81 225 324392 11225 64162890
Movement disorder 137.91 9.81 327 324290 21673 64152442
Diarrhoea 132.30 9.81 2706 321911 719998 63454117
Prescription drug used without a prescription 128.84 9.81 106 324511 2494 64171621
Dysarthria 128.42 9.81 616 324001 58790 64115325
Neutropenia 117.06 9.81 716 323901 238908 63935207
Systemic lupus erythematosus 116.60 9.81 131 324486 77481 64096634
Respiratory depression 112.38 9.81 315 324302 23128 64150987
Synovitis 111.60 9.81 205 324412 98885 64075230
Loss of consciousness 110.66 9.81 1188 323429 147177 64026938
Nervousness 109.66 9.81 363 324254 29193 64144922
Multiple organ dysfunction syndrome 108.79 9.81 216 324401 101197 64072918
Gastrointestinal haemorrhage 108.68 9.81 324 324293 131988 64042127
Expired product administered 108.29 9.81 142 324475 5845 64168270
Injection site pain 108.12 9.81 251 324366 111157 64062958
Fibromyalgia 107.81 9.81 410 324207 35321 64138794
Restlessness 106.73 9.81 440 324177 39345 64134770
Alopecia 106.54 9.81 450 324167 165240 64008875
Abdominal discomfort 105.97 9.81 514 324103 181808 63992307
Product prescribing error 104.20 9.81 402 324215 34867 64139248
Dysstasia 103.59 9.81 304 324313 22911 64151204
Paraesthesia 103.05 9.81 1083 323534 133439 64040676
Cardiac failure congestive 102.11 9.81 327 324290 130253 64043862
Coronary artery disease 99.84 9.81 94 324523 60339 64113776
Mucosal inflammation 99.18 9.81 101 324516 62483 64111632
Anxiety 98.12 9.81 1498 323119 201151 63972964
Hypotension 96.01 9.81 1345 323272 379629 63794486
Irritability 95.91 9.81 403 324214 36343 64137772
Dyskinesia 93.65 9.81 420 324197 38968 64135147
Condition aggravated 93.28 9.81 2494 322123 369932 63804183
Disorientation 92.56 9.81 538 324079 55290 64118825
Crying 91.48 9.81 265 324352 19825 64154290
Cytomegalovirus infection 90.26 9.81 37 324580 37162 64136953
Bradypnoea 89.67 9.81 120 324497 5039 64169076
Rash 89.37 9.81 1698 322919 456851 63717264
Dysgraphia 88.48 9.81 98 324519 3373 64170742
Injection site erythema 87.50 9.81 138 324479 70662 64103453
Back disorder 87.40 9.81 170 324447 9820 64164295
Road traffic accident 87.22 9.81 346 324271 30399 64143716
Nerve injury 86.63 9.81 146 324471 7539 64166576
Drug ineffective for unapproved indication 86.43 9.81 348 324269 30785 64143330
Gait inability 86.31 9.81 432 324185 41936 64132179
Sedation 86.05 9.81 425 324192 41037 64133078
Hyperaesthesia 83.49 9.81 167 324450 9847 64164268
Agitation 83.19 9.81 743 323874 87624 64086491
Depression 83.05 9.81 1340 323277 181951 63992164
Ascites 82.31 9.81 115 324502 61886 64112229
Haemoglobin decreased 82.15 9.81 609 324008 194454 63979661
Muscle twitching 82.12 9.81 246 324371 18752 64155363
Stomatitis 81.88 9.81 280 324337 109325 64064790
Anaemia 81.73 9.81 1377 323240 377303 63796812
Aggression 80.23 9.81 451 324166 45781 64128334
Limb discomfort 79.66 9.81 309 324308 26866 64147249
Atrial fibrillation 79.50 9.81 519 324098 170570 64003545
Cognitive disorder 79.40 9.81 512 324105 54575 64119540
White blood cell count decreased 78.93 9.81 468 324149 157369 64016746
Intervertebral disc protrusion 78.52 9.81 252 324365 19939 64154176
Device expulsion 77.69 9.81 8 324609 21128 64152987
Diplopia 76.56 9.81 302 324315 26463 64147652
Folliculitis 76.15 9.81 28 324589 30049 64144066
Platelet count decreased 75.79 9.81 513 324104 167198 64006917
Sleep disorder 75.33 9.81 537 324080 59172 64114943
Wrong technique in product usage process 75.32 9.81 132 324485 64842 64109273
Sepsis 75.28 9.81 768 323849 229573 63944542
Acute myocardial infarction 75.19 9.81 148 324469 69570 64104545
Pleural effusion 75.14 9.81 354 324263 126205 64047910
Intentional overdose 75.02 9.81 737 323880 89207 64084908
Injection site swelling 74.79 9.81 59 324558 41294 64132821
Hyperhidrosis 73.94 9.81 957 323660 123963 64050152
Premature delivery 73.92 9.81 5 324612 18584 64155531
Dyspnoea 73.79 9.81 2915 321702 715759 63458356
Loss of personal independence in daily activities 73.30 9.81 619 323998 71835 64102280
Middle insomnia 72.83 9.81 184 324433 12693 64161422
Duodenal ulcer perforation 72.53 9.81 42 324575 34583 64139532
Hospitalisation 72.50 9.81 170 324447 75037 64099078
Impaired healing 71.80 9.81 121 324496 60352 64113763
Pulmonary hypertension 71.38 9.81 67 324550 43072 64131043
Mental impairment 71.00 9.81 212 324405 16131 64157984
Pancytopenia 70.56 9.81 427 324190 142882 64031233
Bradyphrenia 70.35 9.81 150 324467 9256 64164859
Drug effective for unapproved indication 70.27 9.81 90 324527 3618 64170497
Vertigo 69.45 9.81 522 324095 58489 64115626
Dry mouth 69.18 9.81 531 324086 59887 64114228
Alanine aminotransferase increased 68.58 9.81 414 324203 138617 64035498
International normalised ratio increased 68.55 9.81 189 324428 78978 64095137
Sleep disorder due to general medical condition, insomnia type 67.28 9.81 24 324593 26246 64147869
Lower respiratory tract infection 67.13 9.81 247 324370 94367 64079748
Hepatic enzyme increased 66.18 9.81 383 324234 129560 64044555
Drug resistance 64.85 9.81 49 324568 35053 64139062
Muscle injury 64.62 9.81 26 324591 26411 64147704
Hypersensitivity 64.18 9.81 655 323962 195797 63978318
Cough 64.08 9.81 1102 323515 301046 63873069
Mydriasis 64.05 9.81 196 324421 15116 64158999
Intentional self-injury 63.35 9.81 302 324315 28742 64145373
Pneumonia aspiration 62.96 9.81 512 324105 58759 64115356
Muscle spasms 62.73 9.81 1028 323589 139995 64034120
Suicide attempt 61.25 9.81 586 324031 70421 64103694
Dependence 60.46 9.81 64 324553 2091 64172024
Epistaxis 60.31 9.81 271 324346 97860 64076255
Thrombocytopenia 60.31 9.81 779 323838 223022 63951093
Hallucination 60.00 9.81 595 324022 72193 64101922
Blood creatinine increased 57.58 9.81 423 324194 135359 64038756
Sensitivity to weather change 57.21 9.81 113 324504 6601 64167514
Ventricular tachycardia 56.94 9.81 53 324564 34212 64139903
Allodynia 56.76 9.81 49 324568 1234 64172881
Respiratory failure 56.60 9.81 528 324089 160655 64013460
Disease progression 56.49 9.81 449 324168 141231 64032884
Chest pain 55.55 9.81 844 323773 235136 63938979
Hallucination, visual 55.42 9.81 282 324335 27552 64146563
Delirium 55.28 9.81 562 324055 68632 64105483
Drug ineffective 55.14 9.81 4925 319692 835322 63338793
Cardiac arrest 54.82 9.81 503 324114 153561 64020554
Infection 54.16 9.81 632 323985 184248 63989867
Septic shock 54.09 9.81 310 324307 105127 64068988
Panic attack 54.05 9.81 229 324388 20724 64153391
Transplant rejection 53.77 9.81 11 324606 17390 64156725
Multiple sclerosis 53.59 9.81 213 324404 18728 64155387
International normalised ratio fluctuation 53.20 9.81 70 324547 2891 64171224
Therapy non-responder 52.92 9.81 163 324454 65736 64108379
Rheumatoid factor positive 52.43 9.81 59 324558 34879 64139236
Apparent death 52.37 9.81 66 324551 2610 64171505
Aspartate aminotransferase increased 50.87 9.81 373 324244 119415 64054700
Blood iron abnormal 50.55 9.81 44 324573 1121 64172994
Pneumonia 49.51 9.81 2307 322310 557269 63616846
Aspergillus infection 49.29 9.81 11 324606 16368 64157747
Haematocrit decreased 49.19 9.81 128 324489 54527 64119588
Urinary retention 48.52 9.81 418 324199 48783 64125332
Hepatotoxicity 47.40 9.81 80 324537 39882 64134233
Dysphemia 47.39 9.81 68 324549 3051 64171064
Ill-defined disorder 47.08 9.81 94 324523 43958 64130157
Renal failure 46.89 9.81 638 323979 181050 63993065
Formication 46.77 9.81 81 324536 4276 64169839
Product use issue 46.27 9.81 1044 323573 150671 64023444
Frustration tolerance decreased 46.18 9.81 98 324519 6027 64168088
Accidental exposure to product 45.95 9.81 39 324578 26325 64147790
Coordination abnormal 45.37 9.81 172 324445 14792 64159323
Poisoning 45.20 9.81 224 324393 21655 64152460
Diabetic neuropathy 45.02 9.81 92 324525 5509 64168606
Systemic infection 44.66 9.81 79 324538 4242 64169873
Trigeminal neuralgia 44.65 9.81 66 324551 3043 64171072
Injection site pruritus 44.61 9.81 76 324541 37750 64136365
Graft versus host disease 44.23 9.81 8 324609 13805 64160310
Multiple sclerosis relapse 44.04 9.81 356 324261 40779 64133336
Depressed mood 43.94 9.81 355 324262 40657 64133458
Myocardial infarction 43.61 9.81 580 324037 165241 64008874
Bloody discharge 43.47 9.81 45 324572 1432 64172683
Neutrophil count decreased 43.45 9.81 220 324397 76976 64097139
Lyme disease 43.24 9.81 57 324560 2358 64171757
Cataract 43.20 9.81 421 324196 50841 64123274
General physical health deterioration 43.06 9.81 1340 323277 203085 63971030
Blood bilirubin increased 42.99 9.81 147 324470 57406 64116709
Sensory disturbance 42.71 9.81 155 324462 13053 64161062
Abdominal pain 42.71 9.81 1221 323396 311154 63862961
Multiple allergies 42.66 9.81 92 324525 5722 64168393
Irritable bowel syndrome 42.33 9.81 77 324540 37292 64136823
Infective pulmonary exacerbation of cystic fibrosis 42.00 9.81 5 324612 11791 64162324
Neck pain 41.85 9.81 484 324133 61049 64113066
Myelosuppression 41.84 9.81 35 324582 23795 64150320
Spinal stenosis 41.31 9.81 159 324458 13772 64160343
Psoriatic arthropathy 41.27 9.81 365 324252 42916 64131199
Dementia 41.07 9.81 210 324407 20556 64153559
Victim of crime 40.97 9.81 26 324591 401 64173714
Drug tolerance 40.93 9.81 93 324524 5992 64168123
Helicobacter infection 40.87 9.81 82 324535 38280 64135835
Injection site reaction 40.69 9.81 111 324506 46553 64127562
Hypervolaemia 40.65 9.81 82 324535 38203 64135912
Clostridium difficile infection 40.53 9.81 75 324542 36088 64138027
Wound 40.23 9.81 223 324394 76254 64097861
Nephropathy toxic 40.00 9.81 19 324598 17495 64156620
Neoplasm progression 39.95 9.81 92 324525 40872 64133243
Poor quality sleep 39.85 9.81 195 324422 18756 64155359
Panic reaction 39.54 9.81 72 324545 3955 64170160
Gastrointestinal disorder 39.22 9.81 277 324340 89432 64084683
Behaviour disorder 39.12 9.81 76 324541 4386 64169729
Muscular weakness 39.05 9.81 877 323740 126461 64047654
Spinal pain 39.04 9.81 146 324471 12475 64161640
Restless legs syndrome 38.81 9.81 180 324437 16936 64157179
Bronchopulmonary aspergillosis 38.78 9.81 24 324593 19061 64155054
Hypersomnia 38.72 9.81 199 324418 19518 64154597
Injection site warmth 38.63 9.81 10 324607 13452 64160663
Ventricular fibrillation 38.37 9.81 38 324579 23822 64150293
Ejection fraction decreased 38.34 9.81 53 324564 28654 64145461
Torsade de pointes 37.90 9.81 20 324597 17343 64156772
Therapy cessation 37.65 9.81 66 324551 32423 64141692
Injection site haemorrhage 37.53 9.81 40 324577 24238 64149877
Pregnancy 37.43 9.81 30 324587 20835 64153280
Breakthrough pain 37.41 9.81 38 324579 1182 64172933
Increased appetite 37.09 9.81 124 324493 10022 64164093
Acute kidney injury 36.37 9.81 1869 322748 447371 63726744
Feeling of body temperature change 36.27 9.81 77 324540 4737 64169378
Ankle fracture 35.82 9.81 158 324459 14552 64159563
Leukopenia 35.80 9.81 331 324286 100911 64073204
Lymphadenopathy 35.71 9.81 118 324499 46568 64127547
Cardiogenic shock 35.68 9.81 68 324549 32359 64141756
Cytology abnormal 35.60 9.81 22 324595 323 64173792
Electrocardiogram QT prolonged 35.37 9.81 244 324373 79204 64094911
Libido increased 34.79 9.81 44 324573 1746 64172369
Mood altered 34.74 9.81 166 324451 15813 64158302
Anger 34.56 9.81 164 324453 15577 64158538
Epstein-Barr virus infection 34.47 9.81 10 324607 12478 64161637
Neoplasm malignant 34.07 9.81 227 324390 24461 64149654
Prescription form tampering 33.97 9.81 22 324595 352 64173763
White blood cell count increased 33.90 9.81 194 324423 65820 64108295
Bedridden 33.85 9.81 120 324497 9989 64164126
Colitis 33.71 9.81 166 324451 58508 64115607
Anorgasmia 33.64 9.81 32 324585 917 64173198
Leukocytosis 33.49 9.81 89 324528 37651 64136464
Skull fracture 33.38 9.81 40 324577 1501 64172614
Bradykinesia 33.28 9.81 90 324527 6470 64167645
Hypomagnesaemia 33.27 9.81 88 324529 37288 64136827
Dysaesthesia 33.22 9.81 76 324541 4919 64169196
Angioedema 33.21 9.81 179 324438 61642 64112473
Interstitial lung disease 33.14 9.81 683 323934 97049 64077066
Cytomegalovirus viraemia 33.13 9.81 7 324610 10821 64163294
Hypoxia 33.01 9.81 284 324333 87865 64086250
Dyslexia 33.00 9.81 18 324599 206 64173909
Pseudomonas infection 32.99 9.81 25 324592 17858 64156257
Flushing 32.85 9.81 246 324371 78402 64095713
Lung infiltration 32.76 9.81 34 324583 20855 64153260
Clostridium difficile colitis 32.74 9.81 54 324563 27169 64146946
Nightmare 32.66 9.81 199 324418 20794 64153321
Haematotoxicity 32.65 9.81 12 324605 12884 64161231
Urticaria 32.58 9.81 533 324084 146784 64027331
Contraindicated product administered 32.57 9.81 366 324251 107463 64066652
Back pain 32.46 9.81 1555 323062 248616 63925499
Rectal haemorrhage 32.10 9.81 181 324436 61636 64112479
Reading disorder 31.88 9.81 29 324588 784 64173331
Deep vein thrombosis 31.78 9.81 357 324260 104825 64069290
Fungal infection 31.76 9.81 79 324538 34172 64139943
Enterococcal infection 31.73 9.81 15 324602 13851 64160264
Coagulopathy 31.69 9.81 71 324546 31849 64142266
Ataxia 31.65 9.81 205 324412 21879 64152236
Venoocclusive liver disease 31.64 9.81 6 324611 10009 64164106
Congenital hiatus hernia 31.56 9.81 22 324595 400 64173715
Pathogen resistance 31.21 9.81 12 324605 12531 64161584
Fatigue 31.13 9.81 3297 321320 745433 63428682
Melaena 31.05 9.81 151 324466 53397 64120718
Pericardial effusion 30.87 9.81 98 324519 39156 64134959
Hyperprolactinaemia 30.60 9.81 65 324552 4000 64170115
Limb injury 30.57 9.81 213 324404 23292 64150823
Haemorrhage 30.45 9.81 254 324363 79097 64095018
Hepatic failure 29.97 9.81 160 324457 55234 64118881
Acute myeloid leukaemia 29.86 9.81 58 324559 27405 64146710
Herpes zoster 29.74 9.81 562 324055 78625 64095490
Emotional disorder 29.63 9.81 134 324483 12473 64161642
Body mass index increased 29.41 9.81 38 324579 1541 64172574
Kidney transplant rejection 29.41 9.81 6 324611 9505 64164610
Inadequate analgesia 29.24 9.81 63 324554 3915 64170200
Body tinea 28.72 9.81 34 324583 1259 64172856
Tenosynovitis stenosans 28.71 9.81 42 324575 1918 64172197
Visual acuity reduced 28.57 9.81 234 324383 26907 64147208
Affective disorder 28.24 9.81 85 324532 6495 64167620
Synovial fluid analysis 28.04 9.81 37 324580 1532 64172583
Intervertebral disc disorder 27.66 9.81 66 324551 4391 64169724
Neuropathy peripheral 27.33 9.81 780 323837 116745 64057370
Poor quality product administered 27.26 9.81 54 324563 3161 64170954
Thirst decreased 27.08 9.81 17 324600 257 64173858
Central obesity 27.08 9.81 35 324582 1420 64172695
Withdrawal arrhythmia 27.08 9.81 10 324607 40 64174075
Nervous system disorder 27.06 9.81 204 324413 22874 64151241
Therapeutic product effect decreased 26.96 9.81 413 324204 114938 64059177
Chest discomfort 26.69 9.81 417 324200 115689 64058426
Device related infection 26.59 9.81 73 324544 30553 64143562
Pulmonary arterial hypertension 26.36 9.81 55 324562 25312 64148803
Personality disorder 26.31 9.81 67 324550 4644 64169471
Hepatocellular injury 26.09 9.81 345 324272 44890 64129225
Phantom limb syndrome 26.02 9.81 18 324599 323 64173792
Hip arthroplasty 26.01 9.81 42 324575 21309 64152806
Musculoskeletal pain 25.90 9.81 563 324054 80731 64093384
Injection site bruising 25.76 9.81 95 324522 36278 64137837
Atrial flutter 25.66 9.81 36 324581 19344 64154771
Colitis ulcerative 25.59 9.81 48 324569 22980 64151135
Apathy 25.37 9.81 118 324499 11114 64163001
Posterior reversible encephalopathy syndrome 25.35 9.81 48 324569 22898 64151217
Motor dysfunction 25.34 9.81 119 324498 11254 64162861
Housebound 25.25 9.81 20 324597 445 64173670
Vomiting 25.17 9.81 2410 322207 548707 63625408
Bone marrow failure 25.12 9.81 140 324477 47812 64126303
Fracture 25.01 9.81 171 324446 18584 64155531
Bacteraemia 25.00 9.81 62 324555 26849 64147266
Appendicitis 24.99 9.81 19 324598 13550 64160565
Post herpetic neuralgia 24.94 9.81 43 324574 2262 64171853
Sensorimotor disorder 24.86 9.81 25 324592 768 64173347
Glaucoma 24.82 9.81 154 324463 16194 64157921
Neurotoxicity 24.79 9.81 64 324553 27340 64146775
Orthostatic hypotension 24.73 9.81 136 324481 46602 64127513
Hypokalaemia 24.70 9.81 448 324169 121455 64052660
Peripheral coldness 24.55 9.81 134 324483 13450 64160665
Cardio-respiratory arrest 24.47 9.81 348 324269 98045 64076070
Accident 24.43 9.81 83 324534 6763 64167352
Daydreaming 24.42 9.81 25 324592 785 64173330
Haematuria 24.38 9.81 191 324426 60280 64113835
Blindness 24.35 9.81 192 324425 21827 64152288
Renal injury 24.32 9.81 25 324592 15404 64158711
Candida infection 24.32 9.81 79 324538 31340 64142775
Substance abuse 24.31 9.81 102 324515 9190 64164925
Parkinsonism 24.13 9.81 139 324478 14234 64159881
Mucormycosis 24.06 9.81 4 324613 7337 64166778
Left ventricular dysfunction 23.97 9.81 30 324587 16924 64157191
Cardiomyopathy 23.89 9.81 58 324559 25298 64148817
Foaming at mouth 23.82 9.81 36 324581 1693 64172422
Product prescribing issue 23.73 9.81 41 324576 2160 64171955
Adenovirus infection 23.67 9.81 4 324613 7251 64166864
Dissociation 23.66 9.81 49 324568 2962 64171153
Hostility 23.65 9.81 41 324576 2166 64171949
Proteinuria 23.39 9.81 67 324550 27656 64146459
Staphylococcal infection 23.38 9.81 154 324463 50524 64123591
Device difficult to use 23.36 9.81 10 324607 9788 64164327
Treatment noncompliance 23.29 9.81 126 324491 43356 64130759
Hepatic necrosis 23.00 9.81 7 324610 8466 64165649
Head discomfort 22.93 9.81 119 324498 11715 64162400
Tension 22.91 9.81 56 324561 3784 64170331
Live birth 22.89 9.81 14 324603 11190 64162925
Basal cell carcinoma 22.87 9.81 79 324538 30759 64143356
Feeling of despair 22.83 9.81 44 324573 2524 64171591
Granulocytopenia 22.83 9.81 12 324605 10428 64163687
Hiatus hernia 22.71 9.81 41 324576 19916 64154199
Abnormal behaviour 22.65 9.81 264 324353 33358 64140757
Full blood count decreased 22.60 9.81 50 324567 22532 64151583
Hepatic cirrhosis 22.60 9.81 63 324554 26235 64147880
Gastritis 22.55 9.81 124 324493 42494 64131621
Erythema 22.40 9.81 744 323873 186326 63987789
Rash erythematous 22.32 9.81 148 324469 48485 64125630
Myelodysplastic syndrome 22.29 9.81 68 324549 27511 64146604
Injection site rash 22.11 9.81 28 324589 15714 64158401
Hypokinesia 21.94 9.81 151 324466 16445 64157670
Cold sweat 21.92 9.81 150 324467 16305 64157810
Acute respiratory failure 21.91 9.81 154 324463 49780 64124335
Cervix neoplasm 21.88 9.81 13 324604 177 64173938
Tuberculosis 21.86 9.81 20 324597 13018 64161097
Dialysis 21.84 9.81 32 324585 16888 64157227
Upper gastrointestinal haemorrhage 21.79 9.81 97 324520 35123 64138992
Visual field defect 21.77 9.81 90 324527 8056 64166059
Pneumocystis jirovecii pneumonia 21.72 9.81 69 324548 27565 64146550
Eyelid injury 21.65 9.81 6 324611 6 64174109
Wrong patient 21.63 9.81 13 324604 181 64173934
Hypercalcaemia 21.63 9.81 83 324534 31333 64142782
Intentional dose omission 21.48 9.81 70 324547 5582 64168533
Myoclonic epilepsy 21.48 9.81 33 324584 1575 64172540
Haemodialysis 21.36 9.81 33 324584 17044 64157071
Suicide threat 21.29 9.81 9 324608 55 64174060
Eye disorder 21.12 9.81 165 324452 18704 64155411
Right ventricular failure 21.12 9.81 48 324569 21423 64152692
Thrombotic microangiopathy 21.01 9.81 32 324585 16623 64157492
Carpal tunnel syndrome 20.92 9.81 144 324473 15684 64158431
Dyspnoea exertional 20.81 9.81 254 324363 73476 64100639
Deafness 20.81 9.81 161 324456 18198 64155917
Psychomotor skills impaired 20.77 9.81 54 324563 3791 64170324
Thermophobia 20.77 9.81 9 324608 59 64174056
Mental disorder 20.74 9.81 214 324403 26231 64147884
Paralysis 20.70 9.81 114 324503 11481 64162634
Blood calcium decreased 20.66 9.81 63 324554 25491 64148624
Pruritus 20.65 9.81 1325 323292 311075 63863040
Small intestinal obstruction 20.61 9.81 56 324561 23517 64150598
Caesarean section 20.49 9.81 16 324601 11258 64162857
Intentional underdose 20.47 9.81 37 324580 2021 64172094
Nerve compression 20.39 9.81 83 324534 7378 64166737
Therapy interrupted 20.35 9.81 44 324573 19992 64154123
Sleep deficit 20.31 9.81 24 324593 887 64173228
Device use error 20.18 9.81 4 324613 6467 64167648
Oxygen saturation decreased 20.14 9.81 399 324218 106777 64067338
Unevaluable event 20.11 9.81 160 324457 50329 64123786
Drug level decreased 20.07 9.81 17 324600 11486 64162629
Abnormal dreams 19.97 9.81 104 324513 10252 64163863
Failure to thrive 19.90 9.81 14 324603 10390 64163725
Myocardial ischaemia 19.75 9.81 56 324561 23195 64150920
Substance use 19.74 9.81 20 324597 620 64173495
Cellulitis 19.35 9.81 343 324274 93314 64080801
Unintentional medical device removal 19.32 9.81 5 324612 6729 64167386
Oesophagitis 19.20 9.81 51 324566 21579 64152536
Mood swings 19.14 9.81 152 324465 17316 64156799
Drug diversion 19.10 9.81 26 324591 1110 64173005
Cardiac murmur 19.08 9.81 18 324599 11545 64162570
Cerebrospinal fluid retention 19.05 9.81 9 324608 74 64174041
Epilepsy 19.03 9.81 255 324362 33276 64140839
Complication associated with device 19 9.81 29 324588 15051 64159064
Blood urea increased 18.97 9.81 137 324480 44016 64130099
Activated partial thromboplastin time prolonged 18.89 9.81 22 324595 12809 64161306
Device dislocation 18.75 9.81 50 324567 21128 64152987
Metastases to liver 18.66 9.81 60 324557 23881 64150234
Atonic urinary bladder 18.65 9.81 9 324608 78 64174037
Reduced facial expression 18.53 9.81 36 324581 2077 64172038
Pancreatitis 18.52 9.81 201 324416 59406 64114709
Hyperpyrexia 18.51 9.81 62 324555 5015 64169100
Dysuria 18.46 9.81 306 324311 41751 64132364
Head titubation 18.41 9.81 22 324595 823 64173292
Blood parathyroid hormone decreased 18.41 9.81 7 324610 7359 64166756
Metabolic acidosis 18.35 9.81 249 324368 70709 64103406
Hepatitis B 18.31 9.81 8 324609 7737 64166378
Heparin-induced thrombocytopenia 18.17 9.81 10 324607 8469 64165646
Photophobia 18.15 9.81 149 324468 17144 64156971
Oedema 18.12 9.81 598 324019 91337 64082778
Rash pruritic 18.06 9.81 193 324424 57211 64116904
Bone erosion 18.04 9.81 19 324598 11576 64162539
Pseudolymphoma 17.98 9.81 24 324593 1005 64173110
Logorrhoea 17.96 9.81 53 324564 4006 64170109
Pulmonary tuberculosis 17.91 9.81 7 324610 7237 64166878
Mitral valve incompetence 17.89 9.81 67 324550 25471 64148644
Feeling cold 17.81 9.81 190 324427 23488 64150627
Foetal death 17.81 9.81 4 324613 5926 64168189
Spinal disorder 17.80 9.81 89 324528 8633 64165482
Benzodiazepine drug level decreased 17.71 9.81 7 324610 35 64174080
Language disorder 17.70 9.81 41 324576 2676 64171439
Impaired quality of life 17.69 9.81 72 324545 6399 64167716
Vascular access site thrombosis 17.55 9.81 7 324610 36 64174079
Sensory loss 17.50 9.81 99 324518 10070 64164045
Productive cough 17.47 9.81 261 324356 72942 64101173
Carcinoid tumour pulmonary 17.39 9.81 14 324603 319 64173796
Uterine perforation 17.33 9.81 4 324613 5816 64168299
Coronary artery bypass 17.31 9.81 4 324613 5811 64168304
Blood folate decreased 17.30 9.81 24 324593 1043 64173072
Neuroleptic malignant syndrome 17.23 9.81 66 324551 24930 64149185
Monoplegia 17.23 9.81 47 324570 3396 64170719
Blister 17.22 9.81 295 324322 80672 64093443
Pre-eclampsia 17.18 9.81 5 324612 6226 64167889
Therapeutic product effect delayed 17.09 9.81 39 324578 2520 64171595
Malnutrition 17.04 9.81 45 324572 19080 64155035
Sternal fracture 17.00 9.81 36 324581 2211 64171904
Cardiotoxicity 16.94 9.81 16 324601 10258 64163857
Psychogenic seizure 16.93 9.81 32 324585 1809 64172306
Rhinovirus infection 16.86 9.81 5 324612 6151 64167964
Sinus tachycardia 16.84 9.81 94 324523 32094 64142021
Lung consolidation 16.84 9.81 9 324608 7749 64166366
Crush syndrome 16.83 9.81 11 324606 179 64173936
Serum ferritin increased 16.72 9.81 11 324606 8457 64165658
Product quality issue 16.72 9.81 85 324532 29714 64144401
Cholestasis 16.68 9.81 318 324299 44554 64129561
Cardiomegaly 16.68 9.81 62 324555 23622 64150493
Sexual activity increased 16.65 9.81 6 324611 22 64174093
Body temperature increased 16.62 9.81 112 324505 36554 64137561
Blood lactate dehydrogenase increased 16.56 9.81 98 324519 32980 64141135
Persistent depressive disorder 16.52 9.81 23 324594 1003 64173112
Normal newborn 16.45 9.81 4 324613 5613 64168502
Orthostatic tremor 16.44 9.81 6 324611 23 64174092
Respiratory rate increased 16.44 9.81 43 324574 18288 64155827
Facial pain 16.43 9.81 81 324536 7814 64166301
Amnestic disorder 16.39 9.81 17 324600 542 64173573
Aplastic anaemia 16.38 9.81 28 324589 13892 64160223
Scleritis 16.38 9.81 42 324575 2924 64171191
Adverse drug reaction 16.34 9.81 148 324469 45316 64128799
Throat irritation 16.33 9.81 97 324520 32614 64141501
Hospice care 16.33 9.81 9 324608 7616 64166499
Premature labour 16.31 9.81 9 324608 7611 64166504
Adverse event 16.26 9.81 124 324493 39365 64134750
Abnormal weight gain 16.21 9.81 35 324582 2178 64171937
Substance use disorder 16.20 9.81 14 324603 353 64173762
Overweight 16.07 9.81 45 324572 3301 64170814
Eosinophil count increased 16.05 9.81 29 324588 14083 64160032
Snoring 16.04 9.81 56 324561 4626 64169489
Respiratory disorder 16.02 9.81 111 324506 36000 64138115
Terminal state 15.97 9.81 54 324563 4390 64169725
Negative symptoms in schizophrenia 15.92 9.81 9 324608 111 64174004
Arteriosclerosis coronary artery 15.86 9.81 34 324583 15495 64158620
Fear of injection 15.84 9.81 5 324612 5907 64168208
Shock 15.78 9.81 120 324497 38120 64135995
Tooth extraction 15.78 9.81 15 324602 9586 64164529
Jaundice 15.71 9.81 162 324455 48350 64125765
Cytopenia 15.70 9.81 34 324583 15437 64158678
Migraine 15.69 9.81 420 324197 62257 64111858
Laboratory test abnormal 15.66 9.81 65 324552 23998 64150117
Pneumothorax 15.59 9.81 66 324551 24232 64149883
Aphasia 15.59 9.81 291 324326 40615 64133500
Tissue infiltration 15.56 9.81 17 324600 576 64173539
Upper limb fracture 15.55 9.81 128 324489 14738 64159377
Device issue 15.49 9.81 60 324557 22588 64151527
Dysphoria 15.48 9.81 53 324564 4335 64169780
Decreased appetite 15.48 9.81 1212 323405 280077 63894038
Lower limb fracture 15.47 9.81 119 324498 13426 64160689
Ventricular hypokinesia 15.47 9.81 10 324607 7759 64166356
Nerve degeneration 15.46 9.81 12 324605 259 64173856
Brain malformation 15.42 9.81 7 324610 52 64174063
Cytomegalovirus chorioretinitis 15.40 9.81 3 324614 4909 64169206
Endophthalmitis 15.36 9.81 4 324613 5361 64168754
Nausea 15.31 9.81 3614 321003 782186 63391929
Completed suicide 15.30 9.81 949 323668 223465 63950650
Hepatitis B reactivation 15.29 9.81 3 324614 4886 64169229
Haemophagocytic lymphohistiocytosis 15.27 9.81 42 324575 17567 64156548
Eyelid skin dryness 15.26 9.81 8 324609 84 64174031
Poisoning deliberate 15.24 9.81 118 324499 13340 64160775
Auditory disorder 15.22 9.81 14 324603 384 64173731
Sickle cell anaemia with crisis 15.22 9.81 4 324613 5328 64168787
Electric shock sensation 15.21 9.81 13 324604 323 64173792
Device breakage 15.20 9.81 13 324604 8742 64165373
Palmar-plantar erythrodysaesthesia syndrome 15.17 9.81 84 324533 28735 64145380
Knee arthroplasty 15.15 9.81 77 324540 26922 64147193
Gamma-glutamyltransferase increased 15.14 9.81 335 324282 48175 64125940
Disseminated intravascular coagulation 15.07 9.81 98 324519 32250 64141865
Chronic kidney disease 15.06 9.81 203 324414 57716 64116399
Respiratory syncytial virus infection 14.96 9.81 9 324608 7259 64166856
Age-related macular degeneration 14.96 9.81 20 324597 839 64173276
Acute hepatic failure 14.92 9.81 74 324543 26038 64148077
Coronary arterial stent insertion 14.92 9.81 5 324612 5687 64168428
Cardiac output decreased 14.91 9.81 29 324588 1675 64172440
Dysgeusia 14.87 9.81 158 324459 46889 64127226
Feeling jittery 14.80 9.81 98 324519 10537 64163578
Nocardiosis 14.76 9.81 3 324614 4764 64169351
Pulmonary oedema 14.74 9.81 293 324324 78381 64095734
Somnambulism 14.69 9.81 58 324559 5083 64169032
Device leakage 14.69 9.81 12 324605 8254 64165861
Product dose omission issue 14.63 9.81 816 323801 193931 63980184
Injection site urticaria 14.58 9.81 21 324596 11160 64162955
Lipoma 14.55 9.81 37 324580 2562 64171553
Radicular pain 14.52 9.81 13 324604 344 64173771
Libido decreased 14.51 9.81 55 324562 4729 64169386
Blood culture positive 14.51 9.81 11 324606 7857 64166258
Nasal congestion 14.48 9.81 212 324405 59446 64114669
Panniculitis 14.44 9.81 14 324603 8865 64165250
Macular degeneration 14.41 9.81 62 324555 5648 64168467
Stress 14.41 9.81 403 324214 60131 64113984
Sinusitis 14.41 9.81 594 324023 145334 64028781
Distractibility 14.37 9.81 17 324600 629 64173486
Cytokine release syndrome 14.36 9.81 55 324562 20774 64153341
Back injury 14.34 9.81 77 324540 7680 64166435
Blood homocysteine increased 14.28 9.81 13 324604 352 64173763
Upper respiratory tract infection 14.27 9.81 269 324348 72516 64101599
Toxicity to various agents 14.26 9.81 2062 322555 361451 63812664
Post laminectomy syndrome 14.21 9.81 12 324605 293 64173822
Heart rate increased 14.14 9.81 383 324234 98292 64075823
Haemolytic anaemia 14.13 9.81 38 324579 16015 64158100
Perfume sensitivity 14.10 9.81 17 324600 642 64173473
Head injury 14.07 9.81 238 324379 32604 64141511
Prothrombin time prolonged 14.06 9.81 37 324580 15704 64158411
Cerebral haemorrhage 14.04 9.81 177 324440 50913 64123202
Discomfort 14.04 9.81 305 324312 80573 64093542
Ischaemic stroke 14.02 9.81 87 324530 28948 64145167
Anaphylactic reaction 14.01 9.81 252 324365 68412 64105703
Rheumatoid factor negative 14.00 9.81 22 324595 1071 64173044
Hypoalbuminaemia 13.98 9.81 44 324573 17630 64156485
Soft tissue injury 13.97 9.81 27 324590 1552 64172563
Homicidal ideation 13.91 9.81 42 324575 3215 64170900
Skin lesion 13.89 9.81 117 324500 36365 64137750
Intestinal ischaemia 13.80 9.81 23 324594 11526 64162589
Oropharyngeal pain 13.78 9.81 341 324276 88526 64085589
Social anxiety disorder 13.77 9.81 14 324603 436 64173679
Clumsiness 13.73 9.81 37 324580 2654 64171461
Sudden onset of sleep 13.63 9.81 16 324601 587 64173528
Contrast media allergy 13.61 9.81 32 324585 2109 64172006
Anal sphincter atony 13.55 9.81 12 324605 313 64173802
Hyperammonaemia 13.51 9.81 18 324599 9886 64164229
Neurosis 13.48 9.81 13 324604 379 64173736
Acute respiratory distress syndrome 13.45 9.81 128 324489 38807 64135308
Paradoxical drug reaction 13.43 9.81 7 324610 6113 64168002
Food craving 13.40 9.81 25 324592 1399 64172716
Urinary incontinence 13.37 9.81 256 324361 35895 64138220
End stage renal disease 13.34 9.81 20 324597 10455 64163660
Neutropenic sepsis 13.27 9.81 66 324551 23206 64150909
Brain contusion 13.26 9.81 23 324594 1216 64172899
Injury 13.24 9.81 200 324417 55792 64118323
Mental status changes postoperative 13.23 9.81 9 324608 157 64173958
Pituitary tumour benign 13.21 9.81 33 324584 2260 64171855
Red blood cell count decreased 13.16 9.81 168 324449 48218 64125897
Platelet count increased 13.13 9.81 49 324568 18647 64155468
Paraplegia 13.11 9.81 51 324566 4439 64169676
Streptococcal infection 13.11 9.81 11 324606 7468 64166647
Hearing disability 13.06 9.81 6 324611 46 64174069
Near death experience 13.04 9.81 13 324604 395 64173720
Respiratory distress 13.04 9.81 185 324432 52146 64121969
Tunnel vision 13.04 9.81 21 324596 1044 64173071
Hypernatraemia 13.03 9.81 26 324591 12163 64161952
Pulmonary alveolar haemorrhage 12.98 9.81 18 324599 9720 64164395
Inhibitory drug interaction 12.97 9.81 44 324573 3583 64170532
Graft versus host disease in gastrointestinal tract 12.95 9.81 6 324611 5606 64168509
Congestive cardiomyopathy 12.93 9.81 20 324597 10324 64163791
Methaemoglobinaemia 12.92 9.81 3 324614 4345 64169770
Blood arsenic increased 12.89 9.81 3 324614 0 64174115
Amputee 12.89 9.81 3 324614 0 64174115
Illusion 12.87 9.81 26 324591 1544 64172571
Cerebral disorder 12.87 9.81 51 324566 4478 64169637
Squamous cell carcinoma 12.85 9.81 32 324585 13837 64160278
Drug interaction 12.81 9.81 2042 322575 360041 63814074
Toxic encephalopathy 12.80 9.81 89 324528 9726 64164389
Peritonitis bacterial 12.79 9.81 16 324601 9027 64165088
Liver function test abnormal 12.76 9.81 216 324401 59185 64114930
Product substitution 12.69 9.81 7 324610 82 64174033
Burning feet syndrome 12.68 9.81 8 324609 122 64173993
Spinal osteoarthritis 12.68 9.81 119 324498 14222 64159893
Enthesopathy 12.67 9.81 18 324599 9620 64164495
Granuloma 12.62 9.81 9 324608 6632 64167483
Subdural haematoma 12.56 9.81 86 324531 27968 64146147
Prostate cancer 12.56 9.81 54 324563 19741 64154374
Cholecystitis chronic 12.55 9.81 17 324600 9270 64164845
Self-injurious ideation 12.52 9.81 40 324577 3157 64170958
Lymphoproliferative disorder 12.50 9.81 5 324612 5098 64169017
Migraine without aura 12.49 9.81 10 324607 226 64173889
Failure to anastomose 12.49 9.81 10 324607 226 64173889
Holmes-Adie pupil 12.49 9.81 5 324612 26 64174089
Skin toxicity 12.47 9.81 9 324608 6593 64167522
Renal tubular necrosis 12.44 9.81 63 324554 22047 64152068
Catatonia 12.41 9.81 12 324605 7608 64166507
Haemorrhage intracranial 12.36 9.81 70 324547 23814 64150301
Tumour lysis syndrome 12.35 9.81 53 324564 19387 64154728
Supraventricular tachycardia 12.35 9.81 51 324566 18856 64155259
Accessory spleen 12.35 9.81 9 324608 176 64173939
Pulmonary haemorrhage 12.34 9.81 30 324587 13079 64161036
Prerenal failure 12.33 9.81 40 324577 3182 64170933
Haemorrhage subcutaneous 12.30 9.81 49 324568 4312 64169803
Complications of transplanted kidney 12.25 9.81 6 324611 5429 64168686
Renal impairment 12.20 9.81 555 324062 134462 64039653
Accommodation disorder 12.18 9.81 14 324603 502 64173613
Hyperbilirubinaemia 12.17 9.81 60 324557 21145 64152970
Exposure to toxic agent 12.16 9.81 8 324609 6151 64167964
Cerebral infarction 12.12 9.81 140 324477 40904 64133211
Depersonalisation/derealisation disorder 12.09 9.81 26 324591 1614 64172501
Vertigo CNS origin 12.05 9.81 5 324612 29 64174086
International normalised ratio abnormal 12.04 9.81 5 324612 4983 64169132
Mastocytosis 12.03 9.81 13 324604 435 64173680
Hepatomegaly 12.01 9.81 44 324573 16838 64157277
Vascular access site infection 12.00 9.81 7 324610 92 64174023
Somatic symptom disorder 11.96 9.81 28 324589 1840 64172275
Angina unstable 11.89 9.81 39 324578 15428 64158687
Haemodynamic instability 11.89 9.81 37 324580 14875 64159240
Hernia 11.87 9.81 112 324505 13406 64160709
Hypogammaglobulinaemia 11.86 9.81 21 324596 10278 64163837
Neutrophil count increased 11.86 9.81 76 324541 25098 64149017
Granuloma skin 11.85 9.81 8 324609 6066 64168049
Systemic candida 11.84 9.81 6 324611 5323 64168792
Skin necrosis 11.82 9.81 35 324582 14294 64159821
Thought blocking 11.80 9.81 9 324608 189 64173926
Diverticulum 11.80 9.81 31 324586 13167 64160948
COVID-19 11.79 9.81 244 324373 64896 64109219
Inappropriate schedule of product administration 11.76 9.81 364 324253 91922 64082193
Nephrolithiasis 11.76 9.81 152 324465 43531 64130584
Oliguria 11.74 9.81 36 324581 14540 64159575
Defaecation disorder 11.68 9.81 13 324604 450 64173665
Anhedonia 11.65 9.81 33 324584 13673 64160442
Deafness neurosensory 11.64 9.81 9 324608 6365 64167750
Brain injury 11.63 9.81 88 324529 9877 64164238
Preternatural anus 11.61 9.81 7 324610 98 64174017
Disinhibition 11.61 9.81 31 324586 2212 64171903
Ligament pain 11.60 9.81 9 324608 194 64173921
Oedematous pancreatitis 11.55 9.81 18 324599 870 64173245
Haemorrhoids 11.54 9.81 72 324545 23929 64150186
Anal fistula 11.54 9.81 6 324611 5247 64168868
Acute lymphocytic leukaemia recurrent 11.53 9.81 3 324614 4023 64170092
Quality of life decreased 11.52 9.81 73 324544 7733 64166382
Neuropathic arthropathy 11.51 9.81 11 324606 317 64173798
Generalised anxiety disorder 11.50 9.81 28 324589 1887 64172228
Therapeutic response changed 11.50 9.81 19 324598 965 64173150
Confusion postoperative 11.49 9.81 9 324608 197 64173918
Product preparation error 11.44 9.81 3 324614 4002 64170113
Eosinophilic colitis 11.36 9.81 12 324605 391 64173724
Eating disorder 11.34 9.81 132 324485 16673 64157442
Pulseless electrical activity 11.33 9.81 30 324587 12709 64161406
Venous oxygen saturation decreased 11.24 9.81 4 324613 14 64174101
Procedural complication 11.20 9.81 12 324605 7253 64166862
Urinary hesitation 11.19 9.81 41 324576 3469 64170646
Coronary artery stenosis 11.18 9.81 25 324592 11223 64162892
Drug specific antibody present 11.16 9.81 6 324611 5148 64168967
Aspiration 11.11 9.81 132 324485 16753 64157362
Foot fracture 11.11 9.81 140 324477 18017 64156098
Neuritis 11.07 9.81 21 324596 1190 64172925
Gangrene 11.06 9.81 69 324548 7269 64166846
Crepitations 11.05 9.81 73 324544 7842 64166273
Tricuspid valve incompetence 11.02 9.81 46 324571 16957 64157158
Clostridial infection 11.02 9.81 6 324611 5113 64169002
Brain herniation 10.98 9.81 10 324607 6523 64167592
Surgery 10.96 9.81 90 324527 28123 64145992
Radiculopathy 10.93 9.81 57 324560 5621 64168494
Anxiety disorder 10.93 9.81 43 324574 3762 64170353
Ventricular hypertrophy 10.92 9.81 10 324607 6506 64167609
Juvenile idiopathic arthritis 10.90 9.81 3 324614 3876 64170239
Accidental overdose 10.87 9.81 233 324384 33324 64140791
Thrombosis in device 10.84 9.81 6 324611 5065 64169050
Syringe issue 10.83 9.81 4 324613 4282 64169833
Dolichocolon 10.83 9.81 3 324614 3 64174112
Arthropathy 10.78 9.81 498 324119 120469 64053646
Blood immunoglobulin E increased 10.76 9.81 3 324614 3841 64170274
Petit mal epilepsy 10.74 9.81 52 324565 4980 64169135
Accidental poisoning 10.67 9.81 23 324594 1430 64172685
Troponin I increased 10.66 9.81 3 324614 3818 64170297
Haemoptysis 10.65 9.81 178 324439 48870 64125245
Depression suicidal 10.65 9.81 32 324585 2443 64171672
Heart rate decreased 10.64 9.81 204 324413 54863 64119252
Blood pressure inadequately controlled 10.62 9.81 7 324610 5377 64168738
Glucose tolerance impaired 10.61 9.81 62 324555 6381 64167734
Complication of device insertion 10.61 9.81 6 324611 5006 64169109
Hydronephrosis 10.60 9.81 36 324581 14089 64160026
Renal cell carcinoma stage I 10.59 9.81 5 324612 41 64174074
Asterixis 10.59 9.81 31 324586 2332 64171783
Adrenocorticotropic hormone deficiency 10.59 9.81 17 324600 843 64173272
Infection susceptibility increased 10.58 9.81 34 324583 2692 64171423
Pyometra 10.54 9.81 6 324611 75 64174040
Fear of falling 10.54 9.81 13 324604 503 64173612
Hyponatraemia 10.51 9.81 625 323992 147714 64026401
Pleural rub 10.49 9.81 5 324612 42 64174073
COVID-19 pneumonia 10.48 9.81 45 324572 16459 64157656
Tenosynovitis 10.43 9.81 28 324589 11805 64162310
Fractured coccyx 10.42 9.81 18 324599 948 64173167
Oxygen consumption increased 10.41 9.81 5 324612 4576 64169539
Complex regional pain syndrome 10.40 9.81 25 324592 1671 64172444
Frequent bowel movements 10.39 9.81 52 324565 18253 64155862
Contraindicated product prescribed 10.38 9.81 20 324597 1147 64172968
Concussion 10.36 9.81 72 324545 7866 64166249
Infected neoplasm 10.33 9.81 10 324607 293 64173822
C-reactive protein increased 10.31 9.81 382 324235 94527 64079588
Oropharyngeal blistering 10.29 9.81 15 324602 683 64173432
Tenderness 10.28 9.81 147 324470 19455 64154660
Dehydration 10.26 9.81 945 323672 215818 63958297
Nail growth abnormal 10.23 9.81 12 324605 440 64173675
Rib fracture 10.22 9.81 174 324443 23864 64150251
Change in seizure presentation 10.22 9.81 10 324607 297 64173818
Hypophagia 10.20 9.81 139 324478 39448 64134667
Ventricular dysfunction 10.20 9.81 7 324610 5263 64168852
Tracheal pain 10.20 9.81 5 324612 45 64174070
Intestinal perforation 10.20 9.81 41 324576 15272 64158843
Myopathy 10.16 9.81 50 324567 17630 64156485
Aplasia 10.15 9.81 12 324605 6941 64167174
Lymphoma 10.14 9.81 36 324581 13905 64160210
Atelectasis 10.13 9.81 88 324529 27178 64146937
Peritonitis 10.10 9.81 79 324538 24944 64149171
Skin cancer 10.05 9.81 29 324588 11945 64162170
Illness anxiety disorder 10.03 9.81 9 324608 239 64173876
Coronary artery occlusion 10.02 9.81 36 324581 13855 64160260
Wrong dosage formulation 9.97 9.81 3 324614 5 64174110
Polyneuropathy 9.97 9.81 148 324469 19746 64154369
Prostatic specific antigen increased 9.97 9.81 18 324599 8742 64165373
Bacterial infection 9.96 9.81 79 324538 24871 64149244
Peroneal nerve palsy 9.96 9.81 53 324564 5268 64168847
Reflexes abnormal 9.95 9.81 16 324601 794 64173321
Periarthritis 9.94 9.81 32 324585 2535 64171580
Pneumonitis 9.91 9.81 186 324431 50179 64123936
Disseminated tuberculosis 9.91 9.81 3 324614 3642 64170473
Anal abscess 9.89 9.81 14 324603 7494 64166621
Pleural fibrosis 9.87 9.81 4 324613 4046 64170069
Intellectual disability 9.84 9.81 18 324599 992 64173123
Haemolysis 9.82 9.81 26 324591 11013 64163102
Asphyxia 9.81 9.81 82 324535 9484 64164631

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
Telangiectasia congenital 33.93 29.81 9 237 18 84414

Pharmacologic Action:

SourceCodeDescription
ATC N03AX16 NERVOUS SYSTEM
ANTIEPILEPTICS
ANTIEPILEPTICS
Other antiepileptics
MeSH PA D000700 Analgesics
MeSH PA D014151 Anti-Anxiety Agents
MeSH PA D000927 Anticonvulsants
MeSH PA D002121 Calcium Channel Blockers
MeSH PA D000077264 Calcium-Regulating Hormones and Agents
MeSH PA D002317 Cardiovascular Agents
MeSH PA D002491 Central Nervous System Agents
MeSH PA D002492 Central Nervous System Depressants
MeSH PA D049990 Membrane Transport Modulators
MeSH PA D018373 Peripheral Nervous System Agents
MeSH PA D011619 Psychotropic Drugs
MeSH PA D018689 Sensory System Agents
MeSH PA D014149 Tranquilizing Agents
CHEBI has role CHEBI:35623 anticonvulsants
CHEBI has role CHEBI:38215 calcium channel blockers

Drug Use (View source of the data)

DiseaseRelationSNOMED_IDDOID
Postherpetic neuralgia indication 2177002
Generalized anxiety disorder indication 21897009 DOID:14320
Fibromyalgia indication 203082005 DOID:631
Diabetic peripheral neuropathy indication 424736006
Partial Epilepsy Treatment Adjunct indication
Suicidal thoughts contraindication 6471006
Weight gain finding contraindication 8943002
Reduced visual acuity contraindication 13164000
Depressive disorder contraindication 35489007
Angioedema contraindication 41291007 DOID:1558
Chronic heart failure contraindication 48447003
Disorder of muscle contraindication 129565002 DOID:423
Decompensated cardiac failure contraindication 195111005
Impaired renal function disorder contraindication 197663003
Atrioventricular block contraindication 233917008 DOID:0050820
Rhabdomyolysis contraindication 240131006
Drowsy contraindication 271782001
Peripheral edema contraindication 271809000
Thrombocytopenic disorder contraindication 302215000 DOID:1588
Dizziness contraindication 404640003




๐Ÿถ Veterinary Drug Use

None

๐Ÿถ Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 3.97 acidic
pKa2 10.4 Basic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
165MG LYRICA CR UPJOHN N209501 Oct. 11, 2017 RX TABLET, EXTENDED RELEASE ORAL 10022447 Nov. 2, 2026 TREATMENT OF NEUROPATHIC PAIN ASSOCIATED WITH DIABETIC PERIPHERAL NEUROPATHY
165MG LYRICA CR UPJOHN N209501 Oct. 11, 2017 RX TABLET, EXTENDED RELEASE ORAL 10022447 Nov. 2, 2026 TREATMENT OF POSTHERPETIC NEURALGIA
165MG LYRICA CR UPJOHN N209501 Oct. 11, 2017 RX TABLET, EXTENDED RELEASE ORAL 8945620 Nov. 2, 2026 TREATMENT OF NEUROPATHIC PAIN ASSOCIATED WITH DIABETIC PERIPHERAL NEUROPATHY
165MG LYRICA CR UPJOHN N209501 Oct. 11, 2017 RX TABLET, EXTENDED RELEASE ORAL 8945620 Nov. 2, 2026 TREATMENT OF POSTHERPETIC NEURALGIA
330MG LYRICA CR UPJOHN N209501 Oct. 11, 2017 RX TABLET, EXTENDED RELEASE ORAL 10022447 Nov. 2, 2026 TREATMENT OF NEUROPATHIC PAIN ASSOCIATED WITH DIABETIC PERIPHERAL NEUROPATHY
330MG LYRICA CR UPJOHN N209501 Oct. 11, 2017 RX TABLET, EXTENDED RELEASE ORAL 10022447 Nov. 2, 2026 TREATMENT OF POSTHERPETIC NEURALGIA
330MG LYRICA CR UPJOHN N209501 Oct. 11, 2017 RX TABLET, EXTENDED RELEASE ORAL 8945620 Nov. 2, 2026 TREATMENT OF NEUROPATHIC PAIN ASSOCIATED WITH DIABETIC PERIPHERAL NEUROPATHY
330MG LYRICA CR UPJOHN N209501 Oct. 11, 2017 RX TABLET, EXTENDED RELEASE ORAL 8945620 Nov. 2, 2026 TREATMENT OF POSTHERPETIC NEURALGIA
82.5MG LYRICA CR UPJOHN N209501 Oct. 11, 2017 RX TABLET, EXTENDED RELEASE ORAL 10022447 Nov. 2, 2026 TREATMENT OF NEUROPATHIC PAIN ASSOCIATED WITH DIABETIC PERIPHERAL NEUROPATHY
82.5MG LYRICA CR UPJOHN N209501 Oct. 11, 2017 RX TABLET, EXTENDED RELEASE ORAL 10022447 Nov. 2, 2026 TREATMENT OF POSTHERPETIC NEURALGIA
82.5MG LYRICA CR UPJOHN N209501 Oct. 11, 2017 RX TABLET, EXTENDED RELEASE ORAL 8945620 Nov. 2, 2026 TREATMENT OF NEUROPATHIC PAIN ASSOCIATED WITH DIABETIC PERIPHERAL NEUROPATHY
82.5MG LYRICA CR UPJOHN N209501 Oct. 11, 2017 RX TABLET, EXTENDED RELEASE ORAL 8945620 Nov. 2, 2026 TREATMENT OF POSTHERPETIC NEURALGIA

Orange Book exclusivity data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
100MG LYRICA UPJOHN N021446 Dec. 30, 2004 RX CAPSULE ORAL May 23, 2022 NEW PATIENT POPULATION
150MG LYRICA UPJOHN N021446 Dec. 30, 2004 RX CAPSULE ORAL May 23, 2022 NEW PATIENT POPULATION
200MG LYRICA UPJOHN N021446 Dec. 30, 2004 RX CAPSULE ORAL May 23, 2022 NEW PATIENT POPULATION
225MG LYRICA UPJOHN N021446 Dec. 30, 2004 RX CAPSULE ORAL May 23, 2022 NEW PATIENT POPULATION
25MG LYRICA UPJOHN N021446 Dec. 30, 2004 RX CAPSULE ORAL May 23, 2022 NEW PATIENT POPULATION
300MG LYRICA UPJOHN N021446 Dec. 30, 2004 RX CAPSULE ORAL May 23, 2022 NEW PATIENT POPULATION
50MG LYRICA UPJOHN N021446 Dec. 30, 2004 RX CAPSULE ORAL May 23, 2022 NEW PATIENT POPULATION
75MG LYRICA UPJOHN N021446 Dec. 30, 2004 RX CAPSULE ORAL May 23, 2022 NEW PATIENT POPULATION
20MG/ML LYRICA UPJOHN N022488 Jan. 4, 2010 RX SOLUTION ORAL May 23, 2022 NEW PATIENT POPULATION
100MG LYRICA UPJOHN N021446 Dec. 30, 2004 RX CAPSULE ORAL Nov. 23, 2022 PEDIATRIC EXCLUSIVITY
150MG LYRICA UPJOHN N021446 Dec. 30, 2004 RX CAPSULE ORAL Nov. 23, 2022 PEDIATRIC EXCLUSIVITY
200MG LYRICA UPJOHN N021446 Dec. 30, 2004 RX CAPSULE ORAL Nov. 23, 2022 PEDIATRIC EXCLUSIVITY
225MG LYRICA UPJOHN N021446 Dec. 30, 2004 RX CAPSULE ORAL Nov. 23, 2022 PEDIATRIC EXCLUSIVITY
25MG LYRICA UPJOHN N021446 Dec. 30, 2004 RX CAPSULE ORAL Nov. 23, 2022 PEDIATRIC EXCLUSIVITY
300MG LYRICA UPJOHN N021446 Dec. 30, 2004 RX CAPSULE ORAL Nov. 23, 2022 PEDIATRIC EXCLUSIVITY
50MG LYRICA UPJOHN N021446 Dec. 30, 2004 RX CAPSULE ORAL Nov. 23, 2022 PEDIATRIC EXCLUSIVITY
75MG LYRICA UPJOHN N021446 Dec. 30, 2004 RX CAPSULE ORAL Nov. 23, 2022 PEDIATRIC EXCLUSIVITY
20MG/ML LYRICA UPJOHN N022488 Jan. 4, 2010 RX SOLUTION ORAL Nov. 23, 2022 PEDIATRIC EXCLUSIVITY

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
Voltage-dependent calcium channel subunit alpha-2/delta-1 Ion channel MODULATOR IC50 7.10 WOMBAT-PK CHEMBL
Voltage-dependent calcium channel subunit alpha-2/delta-2 Ion channel MODULATOR IC50 7.26 SCIENTIFIC LITERATURE SCIENTIFIC LITERATURE
Large neutral amino acids transporter small subunit 1 Transporter IC50 3.80 WOMBAT-PK
Uncharacterized protein; Voltage-dependent calcium channel alpha-2 delta subunit Ion channel IC50 7.14 CHEMBL

External reference:

IDSource
4024924 VUID
N0000171595 NUI
D02716 KEGG_DRUG
4024924 VANDF
C0657912 UMLSCUI
CHEBI:64356 CHEBI
CHEMBL1059 ChEMBL_ID
DB00230 DRUGBANK_ID
D000069583 MESH_DESCRIPTOR_UI
5486971 PUBCHEM_CID
7643 INN_ID
5484 IUPHAR_LIGAND_ID
530085-00-8 SECONDARY_CAS_RN
55JG375S6M UNII
187832 RXNORM
19649 MMSL
67412 MMSL
79550 MMSL
d05508 MMSL
010083 NDDF
415159003 SNOMEDCT_US
415160008 SNOMEDCT_US

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Lyrica HUMAN PRESCRIPTION DRUG LABEL 1 0071-1012 CAPSULE 25 mg ORAL NDA 33 sections
Lyrica HUMAN PRESCRIPTION DRUG LABEL 1 0071-1013 CAPSULE 50 mg ORAL NDA 33 sections
Lyrica HUMAN PRESCRIPTION DRUG LABEL 1 0071-1014 CAPSULE 75 mg ORAL NDA 33 sections
Lyrica HUMAN PRESCRIPTION DRUG LABEL 1 0071-1015 CAPSULE 100 mg ORAL NDA 33 sections
Lyrica HUMAN PRESCRIPTION DRUG LABEL 1 0071-1016 CAPSULE 150 mg ORAL NDA 33 sections
Lyrica HUMAN PRESCRIPTION DRUG LABEL 1 0071-1017 CAPSULE 200 mg ORAL NDA 33 sections
Lyrica HUMAN PRESCRIPTION DRUG LABEL 1 0071-1018 CAPSULE 300 mg ORAL NDA 33 sections
Lyrica HUMAN PRESCRIPTION DRUG LABEL 1 0071-1019 CAPSULE 225 mg ORAL NDA 33 sections
Lyrica HUMAN PRESCRIPTION DRUG LABEL 1 0071-1020 SOLUTION 20 mg ORAL NDA 33 sections
Lyrica CR HUMAN PRESCRIPTION DRUG LABEL 1 0071-1026 TABLET, FILM COATED, EXTENDED RELEASE 82.50 mg ORAL NDA 33 sections
Lyrica CR HUMAN PRESCRIPTION DRUG LABEL 1 0071-1027 TABLET, FILM COATED, EXTENDED RELEASE 165 mg ORAL NDA 33 sections
Lyrica CR HUMAN PRESCRIPTION DRUG LABEL 1 0071-1029 TABLET, FILM COATED, EXTENDED RELEASE 330 mg ORAL NDA 33 sections
Pregabalin HUMAN PRESCRIPTION DRUG LABEL 1 0228-2856 CAPSULE 25 mg ORAL ANDA 28 sections
Pregabalin HUMAN PRESCRIPTION DRUG LABEL 1 0228-2857 CAPSULE 50 mg ORAL ANDA 28 sections
Pregabalin HUMAN PRESCRIPTION DRUG LABEL 1 0228-2858 CAPSULE 75 mg ORAL ANDA 28 sections
Pregabalin HUMAN PRESCRIPTION DRUG LABEL 1 0228-2859 CAPSULE 100 mg ORAL ANDA 28 sections
Pregabalin HUMAN PRESCRIPTION DRUG LABEL 1 0228-2860 CAPSULE 150 mg ORAL ANDA 28 sections
Pregabalin HUMAN PRESCRIPTION DRUG LABEL 1 0228-2861 CAPSULE 200 mg ORAL ANDA 28 sections
Pregabalin HUMAN PRESCRIPTION DRUG LABEL 1 0228-2862 CAPSULE 225 mg ORAL ANDA 28 sections
Pregabalin HUMAN PRESCRIPTION DRUG LABEL 1 0228-2863 CAPSULE 300 mg ORAL ANDA 28 sections
PREGABALIN HUMAN PRESCRIPTION DRUG LABEL 1 0904-6991 CAPSULE 25 mg ORAL ANDA 19 sections
PREGABALIN HUMAN PRESCRIPTION DRUG LABEL 1 0904-6992 CAPSULE 50 mg ORAL ANDA 19 sections
PREGABALIN HUMAN PRESCRIPTION DRUG LABEL 1 0904-7000 CAPSULE 75 mg ORAL ANDA 19 sections
PREGABALIN HUMAN PRESCRIPTION DRUG LABEL 1 0904-7001 CAPSULE 100 mg ORAL ANDA 19 sections
PREGABALIN HUMAN PRESCRIPTION DRUG LABEL 1 0904-7002 CAPSULE 150 mg ORAL ANDA 19 sections
PREGABALIN HUMAN PRESCRIPTION DRUG LABEL 1 0904-7003 CAPSULE 200 mg ORAL ANDA 19 sections
PREGABALIN HUMAN PRESCRIPTION DRUG LABEL 1 0904-7004 CAPSULE 225 mg ORAL ANDA 19 sections
PREGABALIN HUMAN PRESCRIPTION DRUG LABEL 1 0904-7005 CAPSULE 300 mg ORAL ANDA 19 sections
LYRICA HUMAN PRESCRIPTION DRUG LABEL 1 16590-503 CAPSULE 50 mg ORAL NDA 34 sections
Lyrica HUMAN PRESCRIPTION DRUG LABEL 1 21695-276 CAPSULE 25 mg ORAL NDA 33 sections