carbamazepine ๐Ÿถ Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |

Stem definitionDrug idCAS RN
tricyclic compounds 489 298-46-4

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • carbamazepine
  • carbamazepen
  • carbamazepin
  • carbazepine
  • carbamazepine dihydrate
  • carbamazepine hydrate
  • carbamazepine hydrochloride
  • carbamazepine sulfate
  • carbamazepine anhydrous
  • carbamazepine phosphate
  • carbamazepine tartrate
A dibenzazepine that acts as a sodium channel blocker. It is used as an anticonvulsant for the treatment of grand mal and psychomotor or focal SEIZURES. It may also be used in the management of BIPOLAR DISORDER, and has analgesic properties.
  • Molecular weight: 236.27
  • Formula: C15H12N2O
  • CLOGP: 2.24
  • LIPINSKI: 0
  • HAC: 3
  • HDO: 1
  • TPSA: 46.33
  • ALOGS: -3.19
  • ROTB: 0

  • Status: OFP

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

Drug dosage:

DoseUnitRoute
1 g O
1 g R

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 2 Benet LZ, Broccatelli F, Oprea TI
S (Water solubility) 0.11 mg/mL Bocci G, Oprea TI, Benet LZ
EoM (Fraction excreted unchanged in urine) 0.50 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 113.00 ยตM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability) 70 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
fu (Fraction unbound in plasma) 0.29 % Kawashima H, Watanabe R, Esaki T, Kuroda M, Nagao C, Natsume-Kitatani Y, Ohashi R, Komura H, Mizuguchi K

Predicted pharmacokinetic/toxicological properties (PK-AZ):

PropertyDescriptionValueUnitConfidenceSimilarity
azlogd74 LogD at pH 7.4 1.865 High 1
caco2-efflux Caco-2 efflux ratio (BA/AB) 0.408 High 1
caco2-intrinsic-papp Caco-2 intrinsic apparent permeability 77.983 10^-6 cm/s High 1
dh-clint Dog hepatocyte intrinsic clearance 15.996 uL/min/10^6 cells High 1
dppb Dog plasma protein binding (% unbound) 23.570 % High 1
fcs-ppb Fetal calf serum protein binding (% unbound) 42.120 % High 1
herg hERG pIC50 4.147 pIC50 High 1
hh-clint Human hepatocyte intrinsic clearance 4.055 uL/min/10^6 cells High 1
hlm-clint Human liver microsomal intrinsic clearance 5.188 uL/min/mg protein High 1
hppb Human plasma protein binding (% unbound) 28.240 % High 1
kinase-safety-class ACVR2A,ACVR2B,AKT2,AKT3,ALK,AURKA,AXL,BRAF,BTK,CAMK2B,CAMK2D,CDK1,CDK5,CDK9,CHEK1,DDR1,DYRK1B,EIF2AK3,EPHB4,ERBB2,FLT3,GRK2,GSK3B,ITK,JAK1,JAK2,MAP3K1,MAP3K21,MAP3K7,MAP4K1,MAP4K3,MAPK10,MAPK12,MAPK7,MAPK9,MAPKAPK2,MAPKAPK5,MARK4,MET,MTOR,NTRK2,PDK2,PDK4,PDPK1,PIK3CB,PIK3CD,PIM2,PRKCD,PRKDC,SGK1,SIK2,SIK3,STK33,SYK,TEK,TTK,ULK1 57
kinase-selectivity-class ACVR2A,ACVR2B,AXL,DYRK1B,GRK2,MAP2K6,PDK4,STK33,TTK 9
mdck-mdr1-bcrp-efflux MDCK-MDR1-BCRP efflux ratio 0.753 High 1
mdck-mdr1-efflux MDCK-MDR1 efflux ratio 0.902 High 1
mh-clint Mouse hepatocyte intrinsic clearance 38.994 High 1
mppb Mouse plasma protein binding (% unbound) 24.830 High 1
nih-mdck-mdr1-efflux NIH MDCK-MDR1 efflux ratio 1.194 High 1
pfas-class PFAS structural alert (1 = True, 0 = False) 0
pld-class Phospholipidosis risk class (1 = positive, 0 = negative) 1 High 1
pppb Pig plasma protein binding (% unbound) 42.400 % High 1
rat-kpuu-brain Rat brain Kpuu 0.865 % High 1
rh-clint Rat hepatocyte intrinsic clearance 20.845 uL/min/10^6 cells High 1
rh-fuinc Rat hepatocyte fraction unbound in incubation 89.490 % High 1
rppb Rat plasma protein binding (% unbound) 28.380 % High 1
solubility-dd Solubility at pH 7.4 in DMSO 654.636 uM High 1

Approvals:

DateAgencyCompanyOrphan
March 11, 1968 FDA NOVARTIS

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
Seizure 1663.65 10.43 1356 97343 151273 90378475
Drug reaction with eosinophilia and systemic symptoms 1445.11 10.43 772 97927 41986 90487762
Toxicity to various agents 1057.09 10.43 1428 97271 286418 90243330
Drug interaction 943.34 10.43 1324 97375 275129 90254619
Sedation 805.57 10.43 554 98145 47617 90482131
Cognitive disorder 755.51 10.43 617 98082 68790 90460958
Sedation complication 743.47 10.43 365 98334 16579 90513169
Creatinine renal clearance decreased 737.57 10.43 376 98323 18523 90511225
Balance disorder 726.90 10.43 698 98001 96382 90433366
Orthostatic hypotension 652.44 10.43 461 98238 41366 90488382
Depressed level of consciousness 642.93 10.43 574 98125 72210 90457538
Blood calcium decreased 623.13 10.43 396 98303 29786 90499962
Abortion spontaneous 612.41 10.43 492 98207 53564 90476184
Generalised tonic-clonic seizure 535.78 10.43 381 98318 34522 90495226
Schizophrenia 508.30 10.43 271 98428 14643 90515105
Hyponatraemia 482.02 10.43 658 98041 132880 90396868
Stevens-Johnson syndrome 477.21 10.43 332 98367 29044 90500704
Status epilepticus 438.49 10.43 267 98432 18607 90511141
Psychotic disorder 411.68 10.43 311 98388 30919 90498829
Somnolence 410.87 10.43 781 97918 208303 90321445
Anticonvulsant drug level increased 388.35 10.43 122 98577 1614 90528134
Ataxia 373.03 10.43 237 98462 17805 90511943
Overdose 368.15 10.43 635 98064 157074 90372674
Joint swelling 350.03 10.43 63 98636 503237 90026511
Synovitis 342.41 10.43 3 98696 329749 90199999
Infusion related reaction 335.29 10.43 33 98666 416747 90113001
Pemphigus 318.22 10.43 8 98691 326856 90202892
Coma 315.01 10.43 392 98307 72240 90457508
Hand deformity 306.24 10.43 3 98696 296359 90233389
Suicide attempt 298.67 10.43 389 98310 75010 90454738
Jaundice cholestatic 293.83 10.43 165 98534 9878 90519870
Drug level increased 281.45 10.43 237 98462 27525 90502223
Drug eruption 278.84 10.43 262 98437 35145 90494603
Multiple-drug resistance 275.42 10.43 145 98554 7631 90522117
Rheumatoid arthritis 268.59 10.43 38 98661 362576 90167172
Glossodynia 268.08 10.43 22 98677 321757 90207991
Wound 266.04 10.43 16 98683 302964 90226784
Pericarditis 261.46 10.43 7 98692 270144 90259604
Contraindicated product administered 258.30 10.43 25 98674 320114 90209634
Drug abuse 257.35 10.43 379 98320 81968 90447780
Alopecia 253.66 10.43 111 98588 494960 90034788
Fall 253.45 10.43 1117 97582 480693 90049055
Arthralgia 251.57 10.43 287 98412 778235 89751513
Systemic lupus erythematosus 243.57 10.43 49 98650 361847 90167901
Diarrhoea 241.78 10.43 408 98291 938782 89590966
Epilepsy 240.69 10.43 367 98332 81839 90447909
Peripheral swelling 239.46 10.43 76 98623 413030 90116718
Petit mal epilepsy 236.10 10.43 113 98586 4845 90524903
Abdominal discomfort 233.70 10.43 114 98585 477214 90052534
Hypotension 228.50 10.43 826 97873 324571 90205177
Diplopia 223.27 10.43 211 98488 28503 90501245
Swelling 220.94 10.43 90 98609 418968 90110780
Nystagmus 220.33 10.43 122 98577 7105 90522643
Cholelithiasis 219.06 10.43 278 98421 52228 90477520
Intentional overdose 217.71 10.43 377 98322 93457 90436291
Partial seizures 217.07 10.43 121 98578 7139 90522609
Helicobacter infection 215.40 10.43 7 98692 226843 90302905
Sinusitis 211.87 10.43 56 98643 343032 90186716
Folliculitis 206.88 10.43 3 98696 204350 90325398
Psoriatic arthropathy 200.58 10.43 12 98687 228323 90301425
Arthropathy 199.06 10.43 75 98624 366167 90163581
Completed suicide 193.31 10.43 463 98236 144595 90385153
Stillbirth 190.26 10.43 112 98587 7331 90522417
Impaired healing 189.62 10.43 18 98681 234181 90295567
Altered state of consciousness 188.65 10.43 201 98498 31331 90498417
Aggression 188.57 10.43 186 98513 26482 90503266
Toxic epidermal necrolysis 185.22 10.43 202 98497 32326 90497422
Focal dyscognitive seizures 185.06 10.43 83 98616 3061 90526687
Gamma-glutamyltransferase increased 184.33 10.43 217 98482 37735 90492013
Drug intolerance 182.34 10.43 133 98566 447458 90082290
Muscle injury 177.08 10.43 3 98696 176651 90353097
Loss of consciousness 176.60 10.43 438 98261 139800 90389948
Rheumatoid factor positive 171.71 10.43 3 98696 171647 90358101
Dysarthria 166.22 10.43 248 98451 54234 90475514
Discomfort 165.16 10.43 47 98652 274288 90255460
Dyspnoea 164.02 10.43 458 98241 880497 89649251
Irritable bowel syndrome 162.60 10.43 18 98681 207430 90322318
Trigeminal neuralgia 160.57 10.43 82 98617 4049 90525699
Drug resistance 159.45 10.43 181 98518 30268 90499480
Rash maculo-papular 158.64 10.43 209 98490 40724 90489024
Asthma-chronic obstructive pulmonary disease overlap syndrome 158.45 10.43 86 98613 4813 90524935
Total lung capacity increased 156.47 10.43 86 98613 4935 90524813
Hypersensitivity 153.85 10.43 161 98538 454516 90075232
Inappropriate antidiuretic hormone secretion 152.91 10.43 144 98555 19361 90510387
Electroencephalogram abnormal 152.55 10.43 79 98620 4017 90525731
Hepatotoxicity 151.92 10.43 217 98482 45625 90484123
Drug level decreased 151.06 10.43 107 98592 9623 90520125
Myoclonic epilepsy 149.61 10.43 59 98640 1568 90528180
Fibromyalgia 147.17 10.43 24 98675 206245 90323503
Fatigue 145.19 10.43 706 97993 1153317 89376431
Infection 140.51 10.43 113 98586 361981 90167767
Exposure during pregnancy 136.77 10.43 568 98131 237842 90291906
Therapeutic product effect decreased 136.14 10.43 66 98633 277505 90252243
Product use issue 133.03 10.43 99 98600 329820 90199928
Constipation 131.43 10.43 629 98070 279766 90249982
Anticonvulsant drug level above therapeutic 127.33 10.43 40 98659 529 90529219
Intentional product use issue 127.16 10.43 39 98660 216853 90312895
Erythema multiforme 127.11 10.43 106 98593 12140 90517608
Nasopharyngitis 124.83 10.43 156 98543 406948 90122800
Sopor 124.82 10.43 144 98555 24500 90505248
Blood bilirubin increased 124.27 10.43 192 98507 43278 90486470
Abnormal behaviour 122.73 10.43 137 98562 22491 90507257
Joint range of motion decreased 122.60 10.43 6 98693 135637 90394111
Stomatitis 119.27 10.43 76 98623 274622 90255126
Sarcoidosis 118.35 10.43 96 98603 10577 90519171
Bursitis 115.34 10.43 7 98692 131647 90398101
Musculoskeletal stiffness 113.19 10.43 94 98605 296438 90233310
Osteoarthritis 111.53 10.43 37 98662 195693 90334055
Abortion induced 111.33 10.43 97 98602 11791 90517957
Gastrointestinal disorder 110.10 10.43 72 98627 256615 90273133
Type 2 diabetes mellitus 109.70 10.43 42 98657 203202 90326546
Eosinophilia 109.49 10.43 145 98554 28388 90501360
Febrile neutropenia 107.35 10.43 21 98678 158328 90371420
General physical health deterioration 106.84 10.43 138 98561 354977 90174771
Blood cholesterol increased 105.78 10.43 47 98652 207965 90321783
Speech disorder 105.48 10.43 183 98516 45402 90484346
Product substitution issue 104.55 10.43 113 98586 17895 90511853
Lymphocyte stimulation test positive 103.58 10.43 33 98666 458 90529290
Aura 101.04 10.43 41 98658 1176 90528572
Wound infection 98.48 10.43 4 98695 106398 90423350
Nasal polyps 98.33 10.43 87 98612 10793 90518955
Product complaint 96.99 10.43 95 98604 13405 90516343
Amyloid arthropathy 94.59 10.43 43 98656 1637 90528111
Asthma 93.35 10.43 76 98623 242084 90287664
Hyperammonaemia 93.18 10.43 68 98631 6407 90523341
Cerebellar syndrome 93.06 10.43 56 98643 3816 90525932
Treatment failure 92.56 10.43 117 98582 303811 90225937
Intellectual disability 92.15 10.43 39 98660 1247 90528501
Cardiac murmur 91.62 10.43 106 98593 18088 90511660
Hepatic function abnormal 90.81 10.43 173 98526 46115 90483633
Ill-defined disorder 90.56 10.43 44 98655 184847 90344901
Hypotonia 88.88 10.43 84 98615 11342 90518406
Dermatitis exfoliative 88.54 10.43 62 98637 5474 90524274
Anticonvulsant drug level below therapeutic 88.53 10.43 32 98667 664 90529084
Multiple sclerosis relapse 87.62 10.43 183 98516 52122 90477626
Hyperammonaemic encephalopathy 86.23 10.43 47 98652 2652 90527096
Myoclonus 83.92 10.43 104 98595 19064 90510684
Injury 83.74 10.43 56 98643 197293 90332455
Vertigo 82.55 10.43 213 98486 69598 90460150
Face oedema 81.13 10.43 113 98586 23205 90506543
Maternal exposure during pregnancy 80.90 10.43 669 98030 359394 90170354
Human herpes virus 6 serology positive 79.37 10.43 19 98680 80 90529668
Bradyphrenia 79.23 10.43 66 98633 7546 90522202
Sciatica 78.90 10.43 9 98690 101373 90428375
Peripheral venous disease 78.18 10.43 3 98696 83918 90445830
Psychomotor retardation 77.45 10.43 54 98645 4735 90525013
Oral mucosa erosion 77.23 10.43 36 98663 1453 90528295
Dyspepsia 76.60 10.43 62 98637 198098 90331650
Suicidal ideation 75.94 10.43 214 98485 73641 90456107
Arthritis 75.79 10.43 44 98655 167271 90362477
Agitation 73.52 10.43 199 98500 66899 90462849
Intentional self-injury 73.46 10.43 122 98577 29212 90500536
Anticonvulsant drug level decreased 73.09 10.43 34 98665 1366 90528382
Lower respiratory tract infection 72.71 10.43 100 98599 250559 90279189
Grip strength decreased 72.59 10.43 8 98691 92568 90437180
Behaviour disorder 72.02 10.43 51 98648 4584 90525164
Dry mouth 71.88 10.43 57 98642 184002 90345746
Rhinitis allergic 71.77 10.43 90 98609 16695 90513053
Liver injury 71.55 10.43 49 98650 170518 90359230
Lip dry 71.41 10.43 12 98687 100943 90428805
Death 70.90 10.43 257 98442 456294 90073454
Lymphocyte morphology abnormal 70.68 10.43 25 98674 486 90529262
Tremor 70.50 10.43 342 98357 152831 90376917
Abdominal pain upper 70.11 10.43 162 98537 332512 90197236
Psychogenic seizure 69.71 10.43 37 98662 1979 90527769
Contusion 69.14 10.43 104 98595 251112 90278636
Extrapyramidal disorder 69.04 10.43 87 98612 16216 90513532
Adverse event 69.00 10.43 21 98678 117397 90412351
Sudden unexplained death in epilepsy 68.22 10.43 23 98676 385 90529363
Cross sensitivity reaction 67.84 10.43 41 98658 2816 90526932
Creatinine renal clearance increased 67.55 10.43 43 98656 3238 90526510
Night sweats 67.19 10.43 28 98671 128738 90401010
Pain in extremity 67.09 10.43 258 98441 450271 90079477
Lung disorder 67.06 10.43 40 98659 149843 90379905
Hip arthroplasty 66.90 10.43 4 98695 76204 90453544
Dysmorphism 66.57 10.43 39 98660 2529 90527219
Lip erosion 64.42 10.43 30 98669 1208 90528540
Bradycardia 63.97 10.43 219 98480 83628 90446120
Temporal lobe epilepsy 63.42 10.43 22 98677 403 90529345
Tonic convulsion 63.23 10.43 33 98666 1705 90528043
Pulmonary pain 63.13 10.43 49 98650 5065 90524683
Lymphadenopathy 62.95 10.43 148 98551 45627 90484121
Poisoning 62.54 10.43 80 98619 15137 90514611
Hypertension 62.49 10.43 271 98428 457261 90072487
Renal function test abnormal 62.01 10.43 56 98643 7135 90522613
Inflammation 61.70 10.43 62 98637 178530 90351218
Chest pain 61.61 10.43 163 98536 319482 90210266
Neuroleptic malignant syndrome 61.47 10.43 79 98620 15017 90514731
Hypercholesterolaemia 61.20 10.43 17 98682 100875 90428873
Irritability 61.16 10.43 126 98573 35536 90494212
Psychomotor skills impaired 60.03 10.43 38 98661 2834 90526914
Musculoskeletal pain 58.54 10.43 60 98639 171191 90358557
Gastric lavage 58.24 10.43 13 98686 37 90529711
Lower limb fracture 58.19 10.43 11 98688 85002 90444746
Psoriasis 57.38 10.43 46 98653 147708 90382040
Mania 56.08 10.43 73 98626 14051 90515697
Mucosal erosion 55.84 10.43 31 98668 1814 90527934
Mental disorder 54.04 10.43 113 98586 32205 90497543
Multiple drug therapy 53.51 10.43 51 98648 6958 90522790
Partial seizures with secondary generalisation 53.05 10.43 20 98679 469 90529279
Toxic skin eruption 52.73 10.43 75 98624 15699 90514049
Autoimmune disorder 52.37 10.43 10 98689 76734 90453014
Pulmonary fibrosis 52.00 10.43 26 98673 107477 90422271
Taste disorder 51.77 10.43 4 98695 61542 90468206
Conversion disorder 51.48 10.43 31 98668 2115 90527633
Oculomucocutaneous syndrome 51.28 10.43 15 98684 153 90529595
Bronchiectasis 50.81 10.43 89 98610 22241 90507507
Headache 50.51 10.43 650 98049 862096 89667652
Foetal anticonvulsant syndrome 50.08 10.43 21 98678 656 90529092
Adjustment disorder with depressed mood 49.75 10.43 3 98696 56750 90472998
Nikolsky's sign 49.54 10.43 13 98686 85 90529663
Joint stiffness 49.53 10.43 12 98687 78030 90451718
Mental impairment 49.39 10.43 75 98624 16645 90513103
Change in seizure presentation 49.34 10.43 20 98679 572 90529176
Developmental glaucoma 49.31 10.43 12 98687 55 90529693
Hepatocellular injury 49.29 10.43 102 98597 28856 90500892
Nail disorder 49.24 10.43 4 98695 59063 90470685
Injection site pain 48.66 10.43 71 98628 173628 90356120
Restlessness 48.58 10.43 115 98584 35605 90494143
Pregnancy with implant contraceptive 48.54 10.43 37 98662 3724 90526024
Pyrexia 48.52 10.43 998 97701 659487 89870261
Maternal drugs affecting foetus 48.14 10.43 42 98657 5113 90524635
Unintended pregnancy 48.01 10.43 50 98649 7587 90522161
Disturbance in attention 47.93 10.43 136 98563 46973 90482775
Blood creatine phosphokinase increased 47.87 10.43 111 98588 33912 90495836
Meningomyelocele 47.77 10.43 20 98679 622 90529126
Coma scale abnormal 46.92 10.43 43 98656 5583 90524165
Mydriasis 46.72 10.43 69 98630 14943 90514805
Lung neoplasm malignant 46.72 10.43 90 98609 24183 90505565
Febrile convulsion 46.69 10.43 19 98680 549 90529199
Abdominal pain 46.65 10.43 247 98452 395474 90134274
Atonic seizures 46.30 10.43 21 98678 795 90528953
Hypothermia 46.20 10.43 70 98629 15505 90514243
Blood lactate dehydrogenase increased 46.10 10.43 93 98606 25839 90503909
Ovarian granulosa-theca cell tumour 46.02 10.43 10 98689 24 90529724
Central nervous system lesion 45.94 10.43 60 98639 11586 90518162
Hypogammaglobulinaemia 45.26 10.43 57 98642 10617 90519131
Blood alkaline phosphatase increased 45.26 10.43 135 98564 47944 90481804
Delusion 45.08 10.43 65 98634 13775 90515973
Human herpesvirus 6 infection 44.81 10.43 34 98665 3398 90526350
Urinary incontinence 44.80 10.43 115 98584 37451 90492297
Histiocytosis 44.66 10.43 10 98689 29 90529719
Neuropathy peripheral 44.57 10.43 50 98649 136920 90392828
Anaemia 44.54 10.43 215 98484 352587 90177161
Hippocampal sclerosis 43.96 10.43 12 98687 93 90529655
Aphasia 43.95 10.43 124 98575 42688 90487060
Cardiac arrest 43.14 10.43 227 98472 104708 90425040
Psychomotor hyperactivity 42.95 10.43 61 98638 12752 90516996
Nephrogenic diabetes insipidus 42.84 10.43 21 98678 949 90528799
Multiple sclerosis 42.70 10.43 94 98605 27746 90502002
Obsessive-compulsive disorder 42.67 10.43 37 98662 4467 90525281
Angiofibroma 42.27 10.43 12 98687 109 90529639
Blood sodium decreased 42.09 10.43 93 98606 27520 90502228
Simple partial seizures 41.98 10.43 19 98680 716 90529032
Back pain 41.97 10.43 190 98509 316985 90212763
Fulminant type 1 diabetes mellitus 41.77 10.43 20 98679 858 90528890
Spina bifida 41.73 10.43 20 98679 860 90528888
Hypoaesthesia 41.71 10.43 188 98511 314022 90215726
Dyskinesia 41.68 10.43 110 98589 36424 90493324
Disorientation 41.65 10.43 124 98575 43990 90485758
Muscle spasms 41.60 10.43 138 98561 251745 90278003
Slow speech 41.47 10.43 26 98673 1907 90527841
Prescribed underdose 41.30 10.43 15 98684 75004 90454744
Respiratory arrest 40.78 10.43 103 98596 33208 90496540
Hallucination, auditory 40.75 10.43 67 98632 15908 90513840
Shock 40.61 10.43 94 98605 28684 90501064
Malignant neoplasm progression 40.58 10.43 34 98665 106836 90422912
Dementia 40.56 10.43 84 98615 23777 90505971
Wheezing 40.31 10.43 129 98570 237951 90291797
Oscillopsia 40.13 10.43 12 98687 133 90529615
Dizziness 39.87 10.43 880 97819 588404 89941344
Coordination abnormal 39.66 10.43 78 98621 21278 90508470
Oedema 39.43 10.43 101 98598 200194 90329554
Respiratory depression 39.30 10.43 65 98634 15510 90514238
Erythema 39.27 10.43 402 98297 228844 90300904
Epileptic encephalopathy 38.93 10.43 15 98684 374 90529374
Liver function test increased 38.86 10.43 22 98677 84833 90444915
Red blood cell sedimentation rate increased 38.43 10.43 21 98678 82574 90447174
Prescribed overdose 38.39 10.43 30 98669 97595 90432153
Terminal insomnia 38.38 10.43 21 98678 1194 90528554
Dysphagia 38.28 10.43 231 98468 112047 90417701
Product administration error 38.05 10.43 87 98612 26336 90503412
Hyporeflexia 37.70 10.43 26 98673 2240 90527508
Frequent bowel movements 37.64 10.43 8 98691 56927 90472821
Papule 37.60 10.43 45 98654 7957 90521791
Adverse drug reaction 37.53 10.43 43 98656 116658 90413090
Cerebral atrophy 37.37 10.43 38 98661 5608 90524140
Drug dependence 37.29 10.43 92 98607 29235 90500513
Angiomyolipoma 37.23 10.43 13 98686 243 90529505
Colitis ulcerative 36.83 10.43 10 98689 60256 90469492
Right ventricular dilatation 36.82 10.43 23 98676 1676 90528072
Psychiatric symptom 36.73 10.43 42 98657 7076 90522672
Back injury 36.62 10.43 4 98695 46618 90483130
Thinking abnormal 36.62 10.43 54 98645 11678 90518070
Stereotypy 36.62 10.43 15 98684 441 90529307
Injection site reaction 36.59 10.43 28 98671 92052 90437696
Conjunctival hyperaemia 36.18 10.43 29 98670 3140 90526608
Mood altered 36.02 10.43 66 98633 17078 90512670
Onychomadesis 35.99 10.43 4 98695 45994 90483754
Hepatic cirrhosis 35.93 10.43 12 98687 63241 90466507
Hospitalisation 35.25 10.43 53 98646 128047 90401701
Acute kidney injury 35.00 10.43 205 98494 320182 90209566
Syncope 34.99 10.43 256 98443 132407 90397341
COVID-19 34.91 10.43 83 98616 168760 90360988
Neurosis 34.85 10.43 14 98685 391 90529357
Fluid retention 34.73 10.43 27 98672 88064 90441684
Pain 34.63 10.43 824 97875 995517 89534231
Neuromyelitis optica spectrum disorder 34.39 10.43 21 98678 1469 90528279
Drug withdrawal convulsions 34.26 10.43 21 98678 1479 90528269
Cough 34.26 10.43 248 98451 368714 90161034
Weight decreased 34.02 10.43 258 98441 379652 90150096
Depressed mood 33.87 10.43 126 98573 50096 90479652
Laryngitis 33.82 10.43 7 98692 50746 90479002
Diabetes insipidus 33.74 10.43 28 98671 3184 90526564
Petechiae 33.58 10.43 61 98638 15680 90514068
Caesarean section 33.47 10.43 67 98632 18510 90511238
Alanine aminotransferase increased 33.32 10.43 232 98467 118106 90411642
Apathy 33.29 10.43 50 98649 10990 90518758
Facial pain 33.24 10.43 55 98644 13127 90516621
Tearfulness 33.15 10.43 33 98666 4747 90525001
Mobility decreased 33.15 10.43 418 98281 250316 90279432
Pneumonia aspiration 33.05 10.43 109 98590 40831 90488917
Abortion 32.82 10.43 26 98673 2769 90526979
Eye movement disorder 32.71 10.43 37 98662 6161 90523587
Polydipsia 32.71 10.43 31 98668 4200 90525548
Colitis 32.22 10.43 18 98681 69924 90459824
Exostosis 32.13 10.43 9 98690 53125 90476623
Aspartate aminotransferase increased 32.10 10.43 207 98492 102730 90427018
Seizure cluster 31.93 10.43 13 98686 376 90529372
Teratogenicity 31.93 10.43 12 98687 279 90529469
Rectal haemorrhage 31.82 10.43 26 98673 82718 90447030
Bronchitis 31.75 10.43 75 98624 152852 90376896
Decreased appetite 31.72 10.43 260 98439 376280 90153468
Persecutory delusion 31.71 10.43 27 98672 3181 90526567
Catatonia 31.70 10.43 36 98663 6020 90523728
Live birth 31.50 10.43 24 98675 79083 90450665
Euphoric mood 31.50 10.43 34 98665 5375 90524373
Ophthalmoplegia 31.31 10.43 21 98678 1728 90528020
Neurotoxicity 31.26 10.43 71 98628 21396 90508352
Lethargy 31.23 10.43 144 98555 62995 90466753
Lymphocytosis 31.22 10.43 26 98673 2971 90526777
Self esteem decreased 31.14 10.43 16 98683 800 90528948
Areflexia 30.62 10.43 28 98671 3625 90526123
Loss of personal independence in daily activities 30.51 10.43 64 98635 136041 90393707
Bacteriuria 30.43 10.43 18 98681 1188 90528560
Cyclothymic disorder 30.13 10.43 11 98688 235 90529513
Road traffic accident 30.13 10.43 44 98655 107582 90422166
Persistent depressive disorder 29.74 10.43 18 98681 1239 90528509
Convulsive threshold lowered 29.67 10.43 13 98686 453 90529295
Illusion 29.65 10.43 18 98681 1246 90528502
Migraine 29.61 10.43 107 98592 190285 90339463
Vomiting 29.25 10.43 1091 97608 787202 89742546
Bipolar disorder 28.98 10.43 42 98657 8943 90520805
Nervous system disorder 28.80 10.43 69 98630 21524 90508224
Urticaria 28.64 10.43 211 98488 312523 90217225
Ammonia increased 28.44 10.43 31 98668 4955 90524793
Eosinophil count increased 28.30 10.43 51 98648 13030 90516718
Lymphopenia 28.27 10.43 71 98628 22810 90506938
Macular degeneration 28.02 10.43 4 98695 37966 90491782
Epidermolysis bullosa 28.01 10.43 10 98689 200 90529548
Joint dislocation 28.00 10.43 7 98692 44575 90485173
Foot deformity 27.99 10.43 15 98684 59636 90470112
Labelled drug-drug interaction medication error 27.98 10.43 54 98645 14528 90515220
Epileptic psychosis 27.78 10.43 7 98692 38 90529710
Unresponsive to stimuli 27.70 10.43 98 98601 38023 90491725
Gaze palsy 27.70 10.43 19 98680 1622 90528126
Immune thrombocytopenia 27.62 10.43 51 98648 13275 90516473
Gait inability 27.20 10.43 76 98623 146380 90383368
Accidental overdose 27.19 10.43 80 98619 28193 90501555
Product dose omission issue 27.09 10.43 196 98503 291491 90238257
Gingival hypertrophy 26.98 10.43 21 98678 2179 90527569
Blister 26.87 10.43 165 98534 254833 90274915
SUNCT syndrome 26.77 10.43 5 98694 3 90529745
Mouth ulceration 26.71 10.43 100 98599 39874 90489874
Diverticulitis 26.69 10.43 8 98691 45179 90484569
Upper respiratory tract infection 26.58 10.43 63 98636 128255 90401493
Rash morbilliform 26.45 10.43 27 98672 4002 90525746
Disability 26.38 10.43 6 98693 40739 90489009
Metapneumovirus infection 26.26 10.43 17 98682 1318 90528430
Cardio-respiratory arrest 26.22 10.43 137 98562 63003 90466745
Anaemia megaloblastic 26.15 10.43 12 98687 467 90529281
Injection site pruritus 26.06 10.43 13 98686 53821 90475927
Vaccination site reaction 26.04 10.43 10 98689 247 90529501
Wrong patient received product 25.97 10.43 25 98674 3452 90526296
Blepharospasm 25.93 10.43 14 98685 55431 90474317
Foetal exposure during pregnancy 25.86 10.43 104 98595 42871 90486877
Vanishing bile duct syndrome 25.83 10.43 17 98682 1355 90528393
Pseudolymphoma 25.74 10.43 13 98686 627 90529121
Poisoning deliberate 25.66 10.43 56 98643 16430 90513318
Finger deformity 25.39 10.43 3 98696 32894 90496854
Hypervolaemia 25.25 10.43 3 98696 32754 90496994
Lymphangioleiomyomatosis 25.07 10.43 10 98689 274 90529474
Injection site erythema 24.99 10.43 43 98656 98459 90431289
Asterixis 24.94 10.43 18 98681 1667 90528081
Dystonia 24.91 10.43 56 98643 16763 90512985
Intra-abdominal pressure increased 24.83 10.43 10 98689 281 90529467
Paradoxical drug reaction 24.78 10.43 31 98668 5735 90524013
Blood hyposmosis 24.74 10.43 6 98693 27 90529721
Antipsychotic drug level decreased 24.62 10.43 11 98688 402 90529346
Device expulsion 24.58 10.43 7 98692 40879 90488869
Hyperthermia 24.57 10.43 42 98657 10293 90519455
Stupor 24.41 10.43 30 98669 5452 90524296
Quadriparesis 24.27 10.43 21 98678 2528 90527220
Mitochondrial enzyme deficiency 24.22 10.43 6 98693 30 90529718
Vision blurred 24.20 10.43 204 98495 110089 90419659
Pleural neoplasm 24.17 10.43 11 98688 420 90529328
Chronic idiopathic pain syndrome 24.15 10.43 7 98692 69 90529679
Epileptic aura 23.97 10.43 7 98692 71 90529677
Hallucination 23.96 10.43 138 98561 65821 90463927
Therapeutic product effective for unapproved indication 23.95 10.43 8 98691 130 90529618
Eyelid oedema 23.72 10.43 44 98655 11490 90518258
Osteoporosis 23.71 10.43 43 98656 96488 90433260
Blood osmolarity decreased 23.38 10.43 14 98685 945 90528803
Cardiac failure congestive 23.32 10.43 45 98654 98649 90431099
Odynophagia 23.16 10.43 38 98661 9005 90520743
Sinus arrest 23.15 10.43 19 98680 2127 90527621
Toxic encephalopathy 22.89 10.43 37 98662 8662 90521086
Skin erosion 22.82 10.43 23 98676 3359 90526389
Cholestasis 22.77 10.43 89 98610 36210 90493538
Encapsulating peritoneal sclerosis 22.49 10.43 10 98689 361 90529387
Leukopenia 22.48 10.43 187 98512 100523 90429225
Ultrasound ovary abnormal 22.46 10.43 7 98692 90 90529658
Encephalopathy 22.29 10.43 105 98594 46339 90483409
Skin lesion 22.14 10.43 90 98609 37275 90492473
Pregnancy 22.01 10.43 129 98570 61918 90467830
Learning disorder 21.88 10.43 13 98686 865 90528883
Disease progression 21.80 10.43 92 98607 156523 90373225
Affective disorder 21.68 10.43 34 98665 7759 90521989
Injection site swelling 21.55 10.43 20 98679 59819 90469929
Macule 21.48 10.43 20 98679 2649 90527099
Ear malformation 21.32 10.43 9 98690 286 90529462
Pyuria 21.28 10.43 18 98681 2101 90527647
Coeliac disease 21.25 10.43 11 98688 44599 90485149
Osteonecrosis of jaw 21.22 10.43 8 98691 39095 90490653
Neuralgia 21.21 10.43 79 98620 31421 90498327
Atrioventricular block 21.19 10.43 36 98663 8779 90520969
Cervical dysplasia 21.15 10.43 24 98675 4010 90525738
Therapeutic product ineffective for unapproved indication 21.14 10.43 9 98690 292 90529456
Dexamethasone suppression test positive 21.06 10.43 4 98695 3 90529745
Lennox-Gastaut syndrome 21.03 10.43 9 98690 296 90529452
Mucosal ulceration 21.02 10.43 14 98685 1139 90528609
Disorganised speech 20.99 10.43 17 98682 1868 90527880
Benzodiazepine drug level increased 20.93 10.43 8 98691 195 90529553
Head injury 20.82 10.43 78 98621 31110 90498638
Respiratory disorder 20.71 10.43 24 98675 64792 90464956
Polydipsia psychogenic 20.66 10.43 7 98692 119 90529629
Abortion threatened 20.66 10.43 11 98688 592 90529156
Conjunctivitis 20.57 10.43 70 98629 26636 90503112
Purpura 20.55 10.43 48 98651 14730 90515018
Congenital spinal fusion 20.53 10.43 4 98695 4 90529744
Hypoproteinaemia 20.53 10.43 21 98678 3121 90526627
Gait disturbance 20.51 10.43 398 98301 260098 90269650
Developmental delay 20.36 10.43 16 98683 1684 90528064
Sensory disturbance 20.29 10.43 49 98650 15364 90514384
Single umbilical artery 20.22 10.43 9 98690 326 90529422
Pneumatosis 20.22 10.43 10 98689 461 90529287
Drug level above therapeutic 19.98 10.43 28 98671 5781 90523967
Drug level below therapeutic 19.96 10.43 28 98671 5786 90523962
Infrapatellar fat pad inflammation 19.93 10.43 8 98691 223 90529525
Breast discomfort 19.85 10.43 11 98688 641 90529107
Hypomagnesaemia 19.78 10.43 7 98692 35581 90494167
Gastrointestinal haemorrhage 19.75 10.43 43 98656 90205 90439543
Walking aid user 19.71 10.43 7 98692 35499 90494249
Effusion 19.66 10.43 17 98682 2045 90527703
Hypomania 19.64 10.43 35 98664 8862 90520886
Autism spectrum disorder 19.56 10.43 14 98685 1279 90528469
Developmental regression 19.42 10.43 5 98694 30 90529718
Circulating anticoagulant positive 19.42 10.43 5 98694 30 90529718
Sleep disorder 19.39 10.43 131 98568 197899 90331849
Therapeutic response unexpected 19.24 10.43 60 98639 21820 90507928
Paranoia 19.14 10.43 43 98656 12865 90516883
Weight increased 19.12 10.43 330 98369 417597 90112151
Lactate pyruvate ratio increased 19.12 10.43 6 98693 79 90529669
SJS-TEN overlap 19.11 10.43 13 98686 1095 90528653
Cranial nerve disorder 19.02 10.43 11 98688 696 90529052
Agranulocytosis 18.94 10.43 82 98617 34920 90494828
Ejection fraction decreased 18.83 10.43 3 98696 26250 90503498
Malaise 18.82 10.43 490 98209 585496 89944252
Postictal state 18.63 10.43 14 98685 1379 90528369
Lip ulceration 18.63 10.43 17 98682 2195 90527553
Acquired diaphragmatic eventration 18.62 10.43 10 98689 548 90529200
Drug tolerance decreased 18.42 10.43 6 98693 32124 90497624
Hyperprolactinaemia 18.41 10.43 26 98673 5407 90524341
Product dispensing error 18.33 10.43 41 98658 12232 90517516
Carcinoembryonic antigen 18.28 10.43 6 98693 92 90529656
Peripheral nerve decompression 18.18 10.43 5 98694 40 90529708
Hepatitis acute 18.12 10.43 38 98661 10849 90518899
Premature labour 18.12 10.43 43 98656 13333 90516415
Acinetobacter test positive 18.11 10.43 6 98693 95 90529653
Haematochezia 17.94 10.43 31 98668 70882 90458866
Carbohydrate antigen 15-3 17.93 10.43 6 98693 98 90529650
Pulmonary valve stenosis congenital 17.93 10.43 7 98692 181 90529567
Mental status changes 17.91 10.43 96 98603 44583 90485165
Sinus congestion 17.83 10.43 4 98695 27420 90502328
Obsessive thoughts 17.81 10.43 10 98689 598 90529150
Brain injury 17.81 10.43 31 98668 7707 90522041
Cleft lip 17.79 10.43 7 98692 185 90529563
Urticaria vesiculosa 17.76 10.43 4 98695 12 90529736
Drug withdrawal syndrome 17.67 10.43 70 98629 28653 90501095
Optic neuritis 17.55 10.43 35 98664 9643 90520105
Chronic obstructive pulmonary disease 17.51 10.43 139 98560 73690 90456058
Depressive symptom 17.48 10.43 25 98674 5260 90524488
Tensilon test abnormal 17.47 10.43 3 98696 0 90529748
Brain lobectomy 17.47 10.43 3 98696 0 90529748
Lymphocyte transformation test positive 17.47 10.43 3 98696 0 90529748
Genital erosion 17.44 10.43 9 98690 454 90529294
Enzyme level abnormal 17.44 10.43 8 98691 311 90529437
Abdominal distension 17.39 10.43 78 98621 130523 90399225
Pulse abnormal 17.31 10.43 19 98680 3060 90526688
Pregnancy on contraceptive 17.29 10.43 13 98686 1282 90528466
Rhesus incompatibility 17.19 10.43 6 98693 112 90529636
Encephalocele 17.18 10.43 7 98692 203 90529545
Paraesthesia 17.12 10.43 182 98517 250144 90279604
Oral mucosal eruption 17.11 10.43 11 98688 843 90528905
Ideas of reference 17.09 10.43 6 98693 114 90529634
Neoplasm progression 17.07 10.43 14 98685 44472 90485276
Pharyngeal erythema 17.05 10.43 15 98684 1847 90527901
Hyperacusis 16.95 10.43 18 98681 2793 90526955
Emotional disorder 16.94 10.43 45 98654 14952 90514796
Blood citric acid increased 16.92 10.43 5 98694 53 90529695
C-reactive protein increased 16.78 10.43 122 98577 181267 90348481
Systolic dysfunction 16.76 10.43 15 98684 1889 90527859
Mucosal inflammation 16.68 10.43 23 98676 57602 90472146
Shunt infection 16.67 10.43 6 98693 123 90529625
Osteomalacia 16.63 10.43 11 98688 884 90528864
Enanthema 16.62 10.43 9 98690 501 90529247
Torsade de pointes 16.59 10.43 45 98654 15137 90514611
Acid base balance abnormal 16.52 10.43 8 98691 352 90529396
Microcephaly 16.52 10.43 13 98686 1371 90528377
Atrial fibrillation 16.50 10.43 82 98617 133529 90396219
Hyperpyrexia 16.45 10.43 23 98676 4738 90525010
Personality change 16.42 10.43 29 98670 7292 90522456
Communication disorder 16.39 10.43 19 98680 3247 90526501
Feeling hot 16.39 10.43 38 98661 77970 90451778
Product quality issue 16.38 10.43 39 98660 79286 90450462
Anger 16.35 10.43 42 98657 13678 90516070
Juvenile myoclonic epilepsy 16.32 10.43 4 98695 19 90529729
Interstitial granulomatous dermatitis 16.28 10.43 5 98694 61 90529687
Anticoagulation drug level decreased 16.28 10.43 5 98694 61 90529687
Laboratory test abnormal 16.28 10.43 13 98686 41841 90487907
Disseminated intravascular coagulation 16.19 10.43 56 98643 21482 90508266
Derailment 16.14 10.43 5 98694 63 90529685
Infantile spasms 16.00 10.43 7 98692 243 90529505
Accidental poisoning 15.93 10.43 11 98688 949 90528799
Myelosuppression 15.91 10.43 21 98678 53570 90476178
Anaphylactic reaction 15.82 10.43 46 98653 87478 90442270
Hepatic enzyme increased 15.81 10.43 287 98412 360449 90169299
Sensorimotor disorder 15.81 10.43 10 98689 745 90529003
Influenza 15.78 10.43 88 98611 139176 90390572
Dermatitis allergic 15.69 10.43 48 98651 17279 90512469
Medulloblastoma 15.65 10.43 5 98694 70 90529678
Transaminases increased 15.65 10.43 81 98618 37111 90492637
Logorrhoea 15.63 10.43 17 98682 2710 90527038
Necrosis ischaemic 15.58 10.43 11 98688 984 90528764
Cheilitis 15.56 10.43 23 98676 4984 90524764
Knee arthroplasty 15.56 10.43 43 98656 83139 90446609
Epilepsy surgery 15.54 10.43 4 98695 24 90529724
Polyuria 15.51 10.43 34 98665 10006 90519742
Skin ulcer 15.51 10.43 19 98680 50056 90479692
Wrong product administered 15.46 10.43 29 98670 7636 90522112
Facial spasm 15.46 10.43 10 98689 774 90528974
Pupillary disorder 15.46 10.43 7 98692 264 90529484
Pleural effusion 15.45 10.43 66 98633 111925 90417823
Altered visual depth perception 15.42 10.43 8 98691 408 90529340
Prolonged expiration 15.42 10.43 12 98687 1245 90528503
Urinary tract malformation 15.39 10.43 3 98696 3 90529745
Fabry's disease 15.39 10.43 3 98696 3 90529745
Pigmentation disorder 15.24 10.43 25 98674 5924 90523824
Neurological symptom 15.20 10.43 27 98672 6820 90522928
Cerebellar atrophy 15.20 10.43 10 98689 797 90528951
Underdose 15.20 10.43 22 98677 53995 90475753
Disease recurrence 15.15 10.43 81 98618 37572 90492176
Hepatitis A 15.01 10.43 9 98690 609 90529139
Off label use 14.96 10.43 1017 97682 1101235 89428513
Vaginal erosion 14.89 10.43 4 98695 29 90529719
Photophobia 14.88 10.43 54 98645 21215 90508533
Wrong drug 14.82 10.43 7 98692 291 90529457
Vaginal ulceration 14.80 10.43 8 98691 444 90529304
Hallucination, visual 14.79 10.43 57 98642 23035 90506713
Potentiating drug interaction 14.78 10.43 24 98675 5638 90524110
Thyroid adenoma 14.69 10.43 6 98693 175 90529573
Palpitations 14.64 10.43 88 98611 136640 90393108
Negative thoughts 14.62 10.43 11 98688 1086 90528662
Mitral valve prolapse 14.59 10.43 16 98683 2575 90527173
Paralogism 14.54 10.43 4 98695 32 90529716
Blood immunoglobulin M decreased 14.46 10.43 12 98687 1365 90528383
Hypochloraemia 14.43 10.43 16 98683 2606 90527142
Brugada syndrome 14.43 10.43 8 98691 467 90529281
Papillary thyroid cancer 14.41 10.43 16 98683 2611 90527137
Vitamin D deficiency 14.40 10.43 47 98652 17509 90512239
Hypoglycaemia neonatal 14.40 10.43 11 98688 1111 90528637
Fear-related avoidance of activities 14.38 10.43 6 98693 185 90529563
Sinus disorder 14.30 10.43 10 98689 34437 90495311
Screaming 14.30 10.43 19 98680 3731 90526017
Incoherent 14.24 10.43 22 98677 4955 90524793
Sinus node dysfunction 14.21 10.43 23 98676 5389 90524359
Skin test positive 14.21 10.43 10 98689 890 90528858
Heart sounds 14.21 10.43 11 98688 1133 90528615
Poverty of speech 14.19 10.43 7 98692 321 90529427
Aortic bypass 14.18 10.43 3 98696 6 90529742
Enlarged foetal cisterna magna 14.18 10.43 3 98696 6 90529742
Anal erosion 14.12 10.43 4 98695 36 90529712
Hypometabolism 14.12 10.43 4 98695 36 90529712
Skin oedema 14.12 10.43 11 98688 1143 90528605
Hypotonia neonatal 14.06 10.43 12 98687 1418 90528330
Skin exfoliation 14.05 10.43 124 98575 67789 90461959
Dysmetria 14.04 10.43 9 98690 686 90529062
Dry skin 14.02 10.43 49 98650 88024 90441724
Feeling abnormal 14.01 10.43 258 98441 166977 90362771
Cerebellar ataxia 13.99 10.43 10 98689 912 90528836
Congenital cystic kidney disease 13.95 10.43 8 98691 498 90529250
Septic shock 13.95 10.43 46 98653 84114 90445634
Incorrect route of product administration 13.87 10.43 21 98678 50605 90479143
Conjunctival discolouration 13.87 10.43 5 98694 103 90529645
Hyperglycinaemia 13.87 10.43 3 98696 7 90529741
Pulmonary mass 13.85 10.43 7 98692 28765 90500983
Near drowning 13.84 10.43 4 98695 39 90529709
Sleep disorder due to a general medical condition 13.83 10.43 17 98682 44721 90485027
Dyspnoea exertional 13.80 10.43 37 98662 72251 90457497
Dermatitis bullous 13.80 10.43 33 98666 10283 90519465
Speech disorder developmental 13.79 10.43 10 98689 933 90528815
Arnold-Chiari malformation 13.77 10.43 9 98690 709 90529039
Trigeminal nerve disorder 13.75 10.43 6 98693 207 90529541
Pseudophaeochromocytoma 13.73 10.43 5 98694 106 90529642
Drug level changed 13.72 10.43 6 98693 208 90529540
Myocardial infarction 13.69 10.43 64 98635 105908 90423840
Nodule 13.60 10.43 6 98693 26680 90503068
Carnitine decreased 13.58 10.43 3 98696 8 90529740
Chronic kidney disease 13.58 10.43 21 98678 50170 90479578
Hepatitis fulminant 13.54 10.43 19 98680 3926 90525822
Lip swelling 13.51 10.43 80 98619 38530 90491218
Full blood count abnormal 13.46 10.43 12 98687 36585 90493163
Postictal psychosis 13.44 10.43 5 98694 113 90529635
Pneumonitis 13.43 10.43 17 98682 44153 90485595
Tooth development disorder 13.40 10.43 4 98695 44 90529704
Genital burning sensation 13.37 10.43 7 98692 364 90529384
Hyperkalaemia 13.37 10.43 32 98667 64932 90464816
Trismus 13.36 10.43 21 98678 4800 90524948
Adrenal insufficiency 13.35 10.43 8 98691 29913 90499835
Angiosclerosis 13.32 10.43 3 98696 9 90529739
Pulmonary hypertension 13.31 10.43 16 98683 42507 90487241
Norovirus infection 13.29 10.43 13 98686 1831 90527917
Congenital megaureter 13.27 10.43 5 98694 117 90529631
Thrombocytopenic purpura 13.19 10.43 13 98686 1848 90527900
Blood pressure fluctuation 13.18 10.43 23 98676 52390 90477358
Acute respiratory distress syndrome 13.15 10.43 64 98635 28622 90501126
Romberg test positive 13.09 10.43 6 98693 233 90529515
Deafness congenital 13.08 10.43 5 98694 122 90529626
Premature baby 13 10.43 58 98641 25019 90504729
Developmental hip dysplasia 13.00 10.43 12 98687 1573 90528175
Blood chloride decreased 12.86 10.43 24 98675 6295 90523453
Hypercalcaemia 12.86 10.43 11 98688 34229 90495519
Productive cough 12.86 10.43 42 98657 77021 90452727
Hyperlactacidaemia 12.85 10.43 19 98680 4117 90525631
Basilar migraine 12.80 10.43 4 98695 52 90529696
Chronic sinusitis 12.70 10.43 5 98694 23797 90505951
Oxygen saturation decreased 12.69 10.43 67 98632 107416 90422332
Lupus-like syndrome 12.68 10.43 21 98678 48825 90480923
Threatened uterine rupture 12.66 10.43 3 98696 12 90529736
Granulocytopenia 12.54 10.43 24 98675 6417 90523331
Haemangioma 12.51 10.43 16 98683 3026 90526722
Cellulitis 12.49 10.43 54 98645 91283 90438465
Neonatal seizure 12.49 10.43 8 98691 609 90529139
Withdrawal syndrome 12.37 10.43 53 98646 22471 90507277
Chest discomfort 12.34 10.43 94 98605 138271 90391477
Congenital foot malformation 12.33 10.43 6 98693 267 90529481
Fear 12.31 10.43 43 98656 16579 90513169
Clonic convulsion 12.30 10.43 9 98690 851 90528897
Dysstasia 12.28 10.43 57 98642 24995 90504753
Urine calcium decreased 12.28 10.43 3 98696 14 90529734
Impaired driving ability 12.27 10.43 21 98678 5152 90524596
Vulvovaginal candidiasis 12.24 10.43 18 98681 3882 90525866
Depression suicidal 12.14 10.43 13 98686 2036 90527712
Lymphocytic infiltration 12.14 10.43 10 98689 1126 90528622
Selective eating disorder 12.12 10.43 13 98686 2040 90527708
Tooth malformation 12.11 10.43 3 98696 15 90529733
Enlarged cerebral perivascular spaces 12.11 10.43 3 98696 15 90529733
Anal atresia 12.10 10.43 7 98692 443 90529305
Trance 12.09 10.43 4 98695 63 90529685
Extensor plantar response 12.08 10.43 11 98688 1416 90528332
Leukocytosis 12.02 10.43 66 98633 30924 90498824
Inhibitory drug interaction 12.02 10.43 16 98683 3147 90526601
Bipolar I disorder 11.97 10.43 13 98686 2069 90527679
Visual field defect 11.91 10.43 25 98674 7141 90522607
Hemiparesis 11.83 10.43 67 98632 31752 90497996
Muscle twitching 11.82 10.43 55 98644 24147 90505601
Lung neoplasm 11.79 10.43 24 98675 6711 90523037
Inadequate analgesia 11.78 10.43 16 98683 3208 90526540
Cytokine release syndrome 11.77 10.43 8 98691 27965 90501783
Neonatal hypotension 11.72 10.43 5 98694 163 90529585
Therapy interrupted 11.70 10.43 23 98676 50085 90479663
Pulmonary arterial hypertension 11.69 10.43 7 98692 26180 90503568
Nausea 11.68 10.43 1046 97653 1109270 89420478
Nodal rhythm 11.60 10.43 12 98687 1806 90527942
Rash erythematous 11.53 10.43 115 98584 64989 90464759
Respiratory tract infection 11.46 10.43 30 98669 59048 90470700
Product dose omission in error 11.45 10.43 4 98695 20499 90509249
Hypervigilance 11.45 10.43 7 98692 491 90529257
Narcolepsy 11.42 10.43 11 98688 1521 90528227
Precocious puberty 11.41 10.43 6 98693 315 90529433
Selective IgG subclass deficiency 11.38 10.43 3 98696 20 90529728
Injection site bruising 11.38 10.43 25 98674 52282 90477466
Conjunctival oedema 11.35 10.43 9 98690 960 90528788
Normal newborn 11.34 10.43 53 98646 23309 90506439
Antipsychotic drug level below therapeutic 11.25 10.43 6 98693 324 90529424
Congenital arterial malformation 11.23 10.43 6 98693 325 90529423
Culture stool positive 11.18 10.43 6 98693 328 90529420
Product administered to patient of inappropriate age 11.18 10.43 19 98680 4634 90525114
Hyperphosphatasaemia 11.13 10.43 3 98696 22 90529726
Aspiration 11.11 10.43 40 98659 15653 90514095
Gastrointestinal motility disorder 11.01 10.43 22 98677 6069 90523679
ECG signs of myocardial ischaemia 10.98 10.43 4 98695 85 90529663
Saccadic eye movement 10.98 10.43 4 98695 85 90529663
Bone pain 10.89 10.43 33 98666 61950 90467798
Meningorrhagia 10.89 10.43 5 98694 195 90529553
Illness 10.89 10.43 49 98650 81920 90447828
Troponin T increased 10.88 10.43 11 98688 1612 90528136
Automatism 10.85 10.43 4 98695 88 90529660
Acute psychosis 10.83 10.43 15 98684 3063 90526685
Pyroglutamate increased 10.81 10.43 6 98693 351 90529397
Cerebral ventricle dilatation 10.74 10.43 9 98690 1037 90528711
Ileus 10.73 10.43 41 98658 16505 90513243
Cytomegalovirus infection 10.68 10.43 8 98691 26594 90503154
Respiratory rate increased 10.67 10.43 40 98659 15961 90513787
Hepatic failure 10.66 10.43 77 98622 39651 90490097
Lymphocyte percentage decreased 10.65 10.43 15 98684 3112 90526636
Foaming at mouth 10.64 10.43 10 98689 1340 90528408
Facial paresis 10.62 10.43 17 98682 3946 90525802
Blood osmolarity increased 10.61 10.43 6 98693 364 90529384
Eye discharge 10.60 10.43 26 98673 8232 90521516
Illiteracy 10.59 10.43 3 98696 27 90529721
Intestinal infarction 10.59 10.43 9 98690 1058 90528690
Talipes 10.56 10.43 11 98688 1669 90528079
Educational problem 10.55 10.43 7 98692 566 90529182
Blood pressure systolic abnormal 10.54 10.43 4 98695 19474 90510274
Transfusion 10.50 10.43 3 98696 17485 90512263
Mucosal disorder 10.50 10.43 14 98685 2757 90526991
Carbon monoxide poisoning 10.50 10.43 5 98694 212 90529536
Congenital hydrocephalus 10.50 10.43 5 98694 212 90529536
Blood luteinising hormone decreased 10.50 10.43 3 98696 28 90529720
Dysentery 10.48 10.43 9 98690 1073 90528675
Candida infection 10.46 10.43 13 98686 34044 90495704
Ulcer haemorrhage 10.46 10.43 8 98691 26313 90503435

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
Seizure 1173.31 11.38 1209 69511 119352 42431263
Drug reaction with eosinophilia and systemic symptoms 876.93 11.38 652 70068 41423 42509192
Epilepsy 379.21 11.38 328 70392 25843 42524772
Generalised tonic-clonic seizure 368.91 11.38 324 70396 26055 42524560
Anticonvulsant drug level increased 367.53 11.38 128 70592 1515 42549100
Drug interaction 347.41 11.38 1101 69619 265898 42284717
Ataxia 333.55 11.38 249 70471 15876 42534739
Status epilepticus 318.76 11.38 239 70481 15339 42535276
Aggression 294.94 11.38 365 70355 43798 42506817
Stevens-Johnson syndrome 285.51 11.38 260 70460 21918 42528697
Drug eruption 265.24 11.38 254 70466 22821 42527794
Toxicity to various agents 243.90 11.38 884 69836 228252 42322363
Death 208.95 11.38 287 70433 470898 42079717
Somnolence 200.66 11.38 601 70119 140504 42410111
Multiple-drug resistance 195.14 11.38 132 70588 7190 42543425
Febrile neutropenia 184.94 11.38 41 70679 185662 42364953
Nystagmus 182.53 11.38 113 70607 5283 42545332
Gamma-glutamyltransferase increased 171.02 11.38 239 70481 32258 42518357
Diarrhoea 166.45 11.38 321 70399 460528 42090087
Coordination abnormal 159.09 11.38 121 70599 7929 42542686
Overdose 157.79 11.38 457 70263 104807 42445808
Anticonvulsant drug level above therapeutic 138.40 11.38 50 70670 663 42549952
Partial seizures 133.61 11.38 96 70624 5763 42544852
Dysarthria 130.78 11.38 236 70484 39571 42511044
Petit mal epilepsy 127.43 11.38 78 70642 3572 42547043
Acute kidney injury 126.31 11.38 263 70457 367074 42183541
Dyspnoea 122.38 11.38 355 70365 442266 42108349
Hyponatraemia 121.93 11.38 408 70312 101054 42449561
Electroencephalogram abnormal 117.59 11.38 69 70651 2923 42547692
Sudden unexplained death in epilepsy 117.49 11.38 41 70679 488 42550127
Lymphocyte stimulation test positive 117.22 11.38 43 70677 597 42550018
Sopor 116.42 11.38 126 70594 13076 42537539
Agitation 116.03 11.38 299 70421 64015 42486600
Trigeminal neuralgia 115.40 11.38 55 70665 1514 42549101
Drug level decreased 114.94 11.38 110 70610 9867 42540748
Pneumonia 114.19 11.38 342 70378 421807 42128808
Rash maculo-papular 112.72 11.38 214 70506 37289 42513326
Psychogenic seizure 110.07 11.38 38 70682 437 42550178
Irritability 109.77 11.38 180 70540 27948 42522667
Focal dyscognitive seizures 109.66 11.38 52 70668 1415 42549200
Anaemia 105.52 11.38 190 70530 280088 42270527
Toxic epidermal necrolysis 101.45 11.38 169 70551 26581 42524034
Toxic skin eruption 100.57 11.38 119 70601 13611 42537004
Diplopia 100.35 11.38 145 70575 20171 42530444
Abnormal behaviour 98.83 11.38 166 70554 26285 42524330
Drug resistance 98.72 11.38 192 70528 34056 42516559
Drug level increased 98.66 11.38 165 70555 26035 42524580
Suicide attempt 95.49 11.38 226 70494 45874 42504741
Sepsis 94.59 11.38 115 70605 199219 42351396
Arthralgia 93.65 11.38 122 70598 205116 42345499
Loss of consciousness 93.42 11.38 351 70369 92003 42458612
Eosinophilia 91.87 11.38 182 70538 32717 42517898
Human herpes virus 6 serology positive 90.15 11.38 26 70694 156 42550459
Dermatitis exfoliative 82.70 11.38 78 70642 6869 42543746
Anticonvulsant drug level decreased 78.26 11.38 39 70681 1186 42549429
Hyperammonaemia 78.13 11.38 80 70640 7786 42542829
Off label use 77.96 11.38 682 70038 637653 41912962
Dyskinesia 77.67 11.38 146 70574 25244 42525371
Lymphadenopathy 77.31 11.38 171 70549 33194 42517421
Dysmorphism 77.14 11.38 55 70665 3261 42547354
Gastric lavage 75.64 11.38 14 70706 0 42550615
Gait disturbance 74.36 11.38 341 70379 97659 42452956
Atrial fibrillation 73.36 11.38 74 70646 139519 42411096
Cross sensitivity reaction 72.14 11.38 41 70679 1634 42548981
Aura 72.13 11.38 27 70693 398 42550217
Coma 72.10 11.38 224 70496 53330 42497285
Autism spectrum disorder 70.52 11.38 50 70670 2938 42547677
Decreased eye contact 70.15 11.38 28 70692 495 42550120
Intentional overdose 68.14 11.38 214 70506 51242 42499373
Rash 67.92 11.38 730 69990 276224 42274391
Hypospadias 66.94 11.38 52 70668 3515 42547100
Altered state of consciousness 66.71 11.38 149 70571 29110 42521505
Fatigue 66.50 11.38 437 70283 435204 42115411
Malignant neoplasm progression 65.98 11.38 50 70670 108350 42442265
Cardiac failure congestive 65.48 11.38 30 70690 85572 42465043
Lymphocyte morphology abnormal 65.28 11.38 27 70693 525 42550090
Inappropriate antidiuretic hormone secretion 64.72 11.38 106 70614 16435 42534180
Oppositional defiant disorder 64.35 11.38 27 70693 545 42550070
Psychomotor hyperactivity 62.76 11.38 84 70636 10874 42539741
Disease progression 60.86 11.38 90 70630 143566 42407049
Neuropathy peripheral 60.69 11.38 48 70672 101805 42448810
Mania 59.11 11.38 80 70640 10467 42540148
Oral mucosa erosion 59.01 11.38 31 70689 1055 42549560
Intentional self-injury 58.91 11.38 97 70623 15105 42535510
Mucosal erosion 58.37 11.38 30 70690 975 42549640
Bruxism 57.54 11.38 39 70681 2130 42548485
Drug ineffective 57.51 11.38 1408 69312 628789 41921826
Neutropenia 57.07 11.38 157 70563 199274 42351341
COVID-19 56.97 11.38 65 70655 115883 42434732
Cerebellar syndrome 56.60 11.38 43 70677 2812 42547803
Myocardial infarction 56.21 11.38 74 70646 123935 42426680
Completed suicide 55.80 11.38 311 70409 96154 42454461
Temporal lobe epilepsy 55.39 11.38 19 70701 214 42550401
Depressed level of consciousness 55.00 11.38 190 70530 47780 42502835
Rheumatoid arthritis 54.98 11.38 4 70716 42436 42508179
Joint swelling 54.95 11.38 22 70698 68000 42482615
Erythema multiforme 54.89 11.38 75 70645 9902 42540713
Sedation 54.22 11.38 141 70579 30334 42520281
Product dose omission issue 53.31 11.38 110 70610 154255 42396360
Exposure during pregnancy 52.79 11.38 68 70652 8480 42542135
Gaze palsy 52.33 11.38 35 70685 1870 42548745
Intentional product use issue 52.16 11.38 27 70693 71806 42478809
Drug level below therapeutic 51.73 11.38 59 70661 6486 42544129
Altered pitch perception 51.34 11.38 11 70709 12 42550603
Hypotension 50.35 11.38 238 70482 257393 42293222
Vertigo 50.29 11.38 148 70572 34199 42516416
Gastrointestinal haemorrhage 49.97 11.38 53 70667 97673 42452942
Cognitive disorder 48.85 11.38 146 70574 34026 42516589
Homicidal ideation 48.70 11.38 39 70681 2755 42547860
Excessive eye blinking 48.70 11.38 23 70697 620 42549995
Back pain 48.13 11.38 102 70618 141674 42408941
Balance disorder 48.06 11.38 181 70539 47464 42503151
Psychomotor retardation 47.84 11.38 47 70673 4352 42546263
Neuroleptic malignant syndrome 47.44 11.38 108 70612 21364 42529251
Choreoathetosis 47.37 11.38 27 70693 1082 42549533
Intellectual disability 47.23 11.38 33 70687 1894 42548721
Skin exfoliation 47.12 11.38 164 70556 41389 42509226
Speech disorder 47.03 11.38 130 70590 28991 42521624
Ascites 46.32 11.38 18 70702 56660 42493955
Prostate cancer 46.13 11.38 9 70711 44634 42505981
Apathy 45.96 11.38 63 70657 8343 42542272
Posture abnormal 45.68 11.38 36 70684 2485 42548130
Septic shock 45.45 11.38 51 70669 91621 42458994
Paraplegia 45.06 11.38 40 70680 3257 42547358
Renal failure 45.05 11.38 108 70612 143618 42406997
Hospitalisation 44.30 11.38 35 70685 74295 42476320
Nausea 44.30 11.38 433 70287 396366 42154249
Product complaint 44.09 11.38 52 70668 5925 42544690
Hepatic adenoma 43.77 11.38 12 70708 58 42550557
Head circumference abnormal 43.52 11.38 11 70709 36 42550579
Plasmapheresis 43.45 11.38 19 70701 426 42550189
Radiation inflammation 43.38 11.38 25 70695 1023 42549592
Congenital nail disorder 43.29 11.38 11 70709 37 42550578
Weight decreased 43.06 11.38 188 70532 207760 42342855
Skin test positive 42.80 11.38 19 70701 442 42550173
Conjunctival hyperaemia 42.35 11.38 38 70682 3138 42547477
Pain 42.28 11.38 236 70484 244612 42306003
Alanine aminotransferase increased 42.14 11.38 271 70449 88135 42462480
Tonic convulsion 42.04 11.38 29 70691 1630 42548985
Postictal psychosis 41.04 11.38 15 70705 206 42550409
Coronary artery disease 40.80 11.38 19 70701 53701 42496914
Foetal exposure during pregnancy 40.69 11.38 171 70549 47140 42503475
Hepatic function abnormal 40.24 11.38 181 70539 51386 42499229
Dehydration 40.23 11.38 112 70608 141655 42408960
Neonatal pneumonia 40.02 11.38 13 70707 122 42550493
Product substitution issue 39.71 11.38 69 70651 11221 42539394
Cardiac failure 39.60 11.38 73 70647 106783 42443832
Asterixis 39.52 11.38 26 70694 1351 42549264
Human herpesvirus 6 infection 39.30 11.38 33 70687 2492 42548123
Psychotic disorder 39.13 11.38 122 70598 29086 42521529
Hyperammonaemic encephalopathy 38.77 11.38 34 70686 2724 42547891
Capillaritis 38.62 11.38 31 70689 2197 42548418
Face oedema 38.61 11.38 76 70644 13590 42537025
Anticonvulsant drug level below therapeutic 37.63 11.38 20 70700 697 42549918
Oedema peripheral 37.50 11.38 109 70611 135967 42414648
Middle insomnia 37.35 11.38 55 70665 7778 42542837
Hypotonia 37.33 11.38 61 70659 9438 42541177
Infection 36.89 11.38 82 70638 111986 42438629
Aspartate aminotransferase increased 36.44 11.38 236 70484 76927 42473688
Abdominal pain 35.99 11.38 178 70542 190293 42360322
Bradyphrenia 35.90 11.38 44 70676 5218 42545397
Roseolovirus test positive 35.52 11.38 11 70709 87 42550528
Crying 35.07 11.38 48 70672 6346 42544269
Facial pain 34.69 11.38 39 70681 4221 42546394
Partial seizures with secondary generalisation 34.66 11.38 16 70704 409 42550206
Neonatal hypotension 34.52 11.38 13 70707 195 42550420
Chest pain 34.08 11.38 118 70602 139412 42411203
Pulmonary pain 34.03 11.38 25 70695 1553 42549062
Disturbance in attention 33.96 11.38 118 70602 29748 42520867
Delusion 33.54 11.38 75 70645 14659 42535956
Infusion related reaction 33.35 11.38 31 70689 60775 42489840
Epistaxis 33.31 11.38 37 70683 66789 42483826
Dysmetria 33.05 11.38 19 70701 774 42549841
Plasma cell myeloma 32.91 11.38 19 70701 47559 42503056
Tuberous sclerosis complex 32.87 11.38 10 70710 74 42550541
Blood alkaline phosphatase increased 32.53 11.38 126 70594 33471 42517144
Blood lactate dehydrogenase increased 32.26 11.38 106 70614 25975 42524640
Clumsiness 32.01 11.38 26 70694 1874 42548741
Drug abuse 31.32 11.38 288 70432 104483 42446132
Pneumonitis 31.30 11.38 15 70705 41703 42508912
Simple partial seizures 31.07 11.38 15 70705 425 42550190
Growth hormone-producing pituitary tumour 31.00 11.38 11 70709 138 42550477
Lip erosion 30.96 11.38 17 70703 633 42549982
Decreased appetite 30.74 11.38 191 70529 192946 42357669
Agnosia 30.58 11.38 10 70710 96 42550519
Erythema 30.50 11.38 295 70425 108498 42442117
Gastric hypomotility 30.49 11.38 12 70708 204 42550411
Pleural effusion 30.44 11.38 73 70647 97093 42453522
Foetal anticonvulsant syndrome 30.43 11.38 21 70699 1181 42549434
Myoclonus 30.39 11.38 79 70641 16986 42533629
Loose associations 30.27 11.38 9 70711 61 42550554
Arthritis 30.25 11.38 16 70704 42049 42508566
Hepatosplenomegaly 30.24 11.38 38 70682 4622 42545993
Schizophrenia 30.21 11.38 59 70661 10491 42540124
Hyperkinesia 29.76 11.38 26 70694 2072 42548543
Peripheral swelling 29.74 11.38 66 70654 90204 42460411
Cellulitis 29.72 11.38 35 70685 61550 42489065
Phonophobia 29.58 11.38 13 70707 295 42550320
Mood altered 29.55 11.38 59 70661 10659 42539956
Withdrawal syndrome 29.03 11.38 71 70649 14704 42535911
Tremor 28.75 11.38 266 70454 96663 42453952
Gout 28.27 11.38 6 70714 28049 42522566
Myelosuppression 28.21 11.38 16 70704 40445 42510170
Eosinophil count increased 28.19 11.38 58 70662 10705 42539910
Hyperpyrexia 28.13 11.38 32 70688 3508 42547107
Accidental overdose 28.04 11.38 107 70613 28223 42522392
Trismus 28.04 11.38 29 70691 2855 42547760
Papule 27.91 11.38 41 70679 5785 42544830
Non-24-hour sleep-wake disorder 27.91 11.38 7 70713 22 42550593
Microcephaly 27.69 11.38 18 70702 916 42549699
Stupor 27.63 11.38 30 70690 3123 42547492
Neurodevelopmental disorder 27.55 11.38 14 70706 444 42550171
Lymphocytic infiltration 27.48 11.38 18 70702 928 42549687
Abdominal distension 27.47 11.38 48 70672 71687 42478928
Pneumonia aspiration 27.32 11.38 159 70561 49919 42500696
Mucosal inflammation 27.27 11.38 25 70695 49349 42501266
Dyspraxia 27.13 11.38 14 70706 459 42550156
Postictal paralysis 27.07 11.38 13 70707 364 42550251
Acute myocardial infarction 27.07 11.38 34 70686 58131 42492484
Porocarcinoma 26.94 11.38 6 70714 9 42550606
Chest discomfort 26.77 11.38 40 70680 63576 42487039
Psychiatric symptom 26.60 11.38 34 70686 4207 42546408
Multiple organ dysfunction syndrome 26.53 11.38 78 70642 96957 42453658
Acute myeloid leukaemia 26.41 11.38 3 70717 22253 42528362
Hyperexplexia 26.03 11.38 7 70713 31 42550584
Genital ulceration 26.00 11.38 17 70703 874 42549741
Meningocele 25.85 11.38 7 70713 32 42550583
Water intoxication 25.74 11.38 13 70707 407 42550208
Myalgia 25.71 11.38 78 70642 96002 42454613
Developmental delay 25.68 11.38 29 70691 3153 42547462
Constipation 25.56 11.38 161 70559 162130 42388485
Epileptic aura 25.52 11.38 6 70714 13 42550602
Cardiogenic shock 24.98 11.38 14 70706 35626 42514989
Bone marrow failure 24.67 11.38 12 70708 33081 42517534
Injection site pain 24.65 11.38 36 70684 57762 42492853
Brain oedema 24.51 11.38 71 70649 16256 42534359
Hangover 24.48 11.38 18 70702 1120 42549495
General physical health deterioration 24.35 11.38 149 70571 151097 42399518
Frontotemporal dementia 24.31 11.38 11 70709 268 42550347
Shunt malfunction 24.24 11.38 11 70709 270 42550345
Pancreatic steatosis 24.15 11.38 10 70710 195 42550420
Rectal haemorrhage 24.14 11.38 28 70692 49578 42501037
Personality disorder 24.13 11.38 18 70702 1145 42549470
Conduction disorder 23.91 11.38 25 70695 2493 42548122
Gingival atrophy 23.86 11.38 7 70713 45 42550570
Total lung capacity abnormal 23.84 11.38 33 70687 4410 42546205
Strabismus 23.53 11.38 24 70696 2324 42548291
Diabetic neuropathy 23.50 11.38 33 70687 4469 42546146
Hypomagnesaemia 23.35 11.38 9 70711 28479 42522136
Affect lability 23.16 11.38 31 70689 4013 42546602
Rash erythematous 23.08 11.38 110 70610 31981 42518634
Congenital cystic lung 23.00 11.38 10 70710 221 42550394
Bradykinesia 22.85 11.38 36 70684 5400 42545215
Skin erosion 22.74 11.38 26 70694 2865 42547750
Viral diarrhoea 22.68 11.38 11 70709 315 42550300
Chronic kidney disease 22.63 11.38 27 70693 47214 42503401
Astrocytoma, low grade 22.57 11.38 8 70712 100 42550515
Haematochezia 22.47 11.38 39 70681 58397 42492218
Apgar score low 22.43 11.38 16 70704 949 42549666
Epileptic psychosis 22.42 11.38 6 70714 26 42550589
Antisocial behaviour 22.35 11.38 12 70708 427 42550188
Salivary hypersecretion 21.94 11.38 53 70667 10890 42539725
Pain in extremity 21.90 11.38 153 70567 150451 42400164
Stomatitis 21.81 11.38 31 70689 50298 42500317
Dysgeusia 21.79 11.38 15 70705 34174 42516441
Dry skin 21.72 11.38 29 70691 48309 42502306
Congenital anomaly 21.67 11.38 19 70701 1522 42549093
Appendicitis 21.63 11.38 4 70716 20609 42530006
Spirometry abnormal 21.52 11.38 34 70686 5112 42545503
Inappropriate schedule of product administration 21.50 11.38 84 70636 95818 42454797
Wrong patient received product 21.34 11.38 28 70692 3555 42547060
Psychomotor skills impaired 21.24 11.38 34 70686 5170 42545445
Eye movement disorder 21.14 11.38 33 70687 4912 42545703
Hyperkalaemia 21.04 11.38 66 70654 80392 42470223
Hyperdynamic left ventricle 21.02 11.38 10 70710 274 42550341
Drowning 20.85 11.38 12 70708 490 42550125
Rebound effect 20.80 11.38 41 70679 7338 42543277
Sinusitis 20.62 11.38 29 70691 47263 42503352
Rash pustular 20.59 11.38 37 70683 6178 42544437
Flatulence 20.53 11.38 8 70712 25144 42525471
Lactic acidosis 20.50 11.38 27 70693 45234 42505381
Thinking abnormal 20.44 11.38 40 70680 7121 42543494
Bacteraemia 20.38 11.38 8 70712 25032 42525583
Blister 20.33 11.38 95 70625 27395 42523220
Condition aggravated 20.21 11.38 571 70149 260183 42290432
Personality change 20.18 11.38 35 70685 5684 42544931
Haemorrhage 20.17 11.38 44 70676 60519 42490096
Emotional disorder 20.17 11.38 37 70683 6277 42544338
Atonic seizures 20.15 11.38 11 70709 405 42550210
Micrognathia 20.07 11.38 10 70710 304 42550311
Therapy interrupted 20.02 11.38 6 70714 22244 42528371
Benign cardiac neoplasm 20.01 11.38 6 70714 42 42550573
Fluid retention 19.98 11.38 14 70706 31605 42519010
Dizziness 19.93 11.38 548 70172 248706 42301909
Drug withdrawal convulsions 19.83 11.38 17 70703 1321 42549294
Genital erosion 19.80 11.38 10 70710 313 42550302
Low birth weight baby 19.73 11.38 48 70672 9907 42540708
Electrocardiogram QRS complex prolonged 19.72 11.38 35 70685 5788 42544827
Renal impairment 19.67 11.38 105 70615 110123 42440492
Osteoarthritis 19.53 11.38 8 70712 24397 42526218
Pressure of speech 19.45 11.38 12 70708 557 42550058
Motor developmental delay 19.38 11.38 13 70707 698 42549917
Pyrexia 19.27 11.38 818 69902 393224 42157391
Localised infection 19.25 11.38 5 70715 20368 42530247
Haematuria 19.25 11.38 42 70678 57757 42492858
Anger 18.96 11.38 56 70664 12962 42537653
Oculomucocutaneous syndrome 18.86 11.38 8 70712 166 42550449
Acute generalised exanthematous pustulosis 18.72 11.38 43 70677 8552 42542063
Genital pain 18.69 11.38 14 70706 896 42549719
Memory impairment 18.68 11.38 145 70575 50077 42500538
Drug withdrawal syndrome 18.61 11.38 78 70642 21471 42529144
Hypoventilation 18.57 11.38 27 70693 3775 42546840
Haemoglobin decreased 18.56 11.38 136 70584 132335 42418280
Brain malformation 18.56 11.38 8 70712 173 42550442
Liver disorder 18.55 11.38 121 70599 39523 42511092
Perseveration 18.41 11.38 7 70713 108 42550507
Bone metabolism disorder 18.39 11.38 9 70711 263 42550352
Communication disorder 18.27 11.38 23 70697 2802 42547813
Chills 18.27 11.38 87 70633 93979 42456636
Enanthema 18.25 11.38 12 70708 623 42549992
Blood pressure increased 18.24 11.38 97 70623 101831 42448784
Rash morbilliform 18.15 11.38 28 70692 4125 42546490
Blood growth hormone increased 18.09 11.38 12 70708 632 42549983
Low set ears 18.08 11.38 11 70709 498 42550117
Conjunctivitis allergic 18.08 11.38 34 70686 5877 42544738
Ultrasound liver abnormal 18.06 11.38 7 70713 114 42550501
Restlessness 18.03 11.38 96 70624 29153 42521462
Skin ulcer 18.02 11.38 10 70710 25591 42525024
Fall 18.01 11.38 513 70207 234007 42316608
Sinus arrest 18.00 11.38 20 70700 2136 42548479
Pulmonary vasculitis 17.89 11.38 35 70685 6231 42544384
End stage renal disease 17.83 11.38 3 70717 16555 42534060
Hypervolaemia 17.83 11.38 8 70712 23117 42527498
Mouth ulceration 17.78 11.38 60 70660 14903 42535712
Parkinsonism 17.72 11.38 48 70672 10575 42540040
Full blood count decreased 17.69 11.38 6 70714 20554 42530061
Neurological symptom 17.53 11.38 46 70674 9945 42540670
Coma scale abnormal 17.51 11.38 29 70691 4536 42546079
Breath odour 17.48 11.38 14 70706 989 42549626
Seizure cluster 17.44 11.38 9 70711 295 42550320
COVID-19 pneumonia 17.43 11.38 7 70713 21606 42529009
Dysphagia 17.42 11.38 191 70529 72528 42478087
Osteonecrosis of jaw 17.39 11.38 5 70715 19044 42531571
Language disorder 17.38 11.38 21 70699 2454 42548161
Cerebellar ataxia 17.36 11.38 15 70705 1178 42549437
Suicidal ideation 17.33 11.38 138 70582 48023 42502592
Basal cell carcinoma 17.32 11.38 8 70712 22725 42527890
Tracheo-oesophageal fistula 17.19 11.38 11 70709 545 42550070
Suspiciousness 17.14 11.38 10 70710 419 42550196
Hyporeflexia 17.12 11.38 20 70700 2256 42548359
Photophobia 17.01 11.38 40 70680 8079 42542536
Lymphocytosis 17.00 11.38 23 70697 3008 42547607
Oxygen saturation decreased 16.96 11.38 53 70667 64634 42485981
Clostridium difficile colitis 16.95 11.38 7 70713 21245 42529370
Maternal drugs affecting foetus 16.94 11.38 26 70694 3813 42546802
Feelings of worthlessness 16.90 11.38 9 70711 315 42550300
Epidermal necrosis 16.85 11.38 12 70708 710 42549905
Osteomalacia 16.83 11.38 13 70707 871 42549744
Nervousness 16.74 11.38 55 70665 13477 42537138
Hypocalcaemic seizure 16.71 11.38 6 70714 78 42550537
Depressed mood 16.70 11.38 80 70640 23304 42527311
Tumour lysis syndrome 16.67 11.38 8 70712 22223 42528392
Guillain-Barre syndrome 16.56 11.38 37 70683 7226 42543389
Cheilitis 16.50 11.38 21 70699 2587 42548028
Bladder cancer 16.47 11.38 4 70716 17043 42533572
Body height below normal 16.34 11.38 8 70712 234 42550381
Cerebellar atrophy 16.33 11.38 12 70708 746 42549869
Influenza 16.25 11.38 51 70669 62124 42488491
Colitis 16.21 11.38 33 70687 46539 42504076
Atypical benign partial epilepsy 16.21 11.38 3 70717 0 42550615
Palmar-plantar erythrodysaesthesia syndrome 16.06 11.38 7 70713 20575 42530040
Anaphylactic reaction 16 11.38 29 70691 42714 42507901
Unevaluable event 15.99 11.38 20 70700 34268 42516347
Xanthelasma 15.99 11.38 6 70714 89 42550526
Respiratory disorder neonatal 15.98 11.38 18 70702 1952 42548663
Cardiac disorder 15.93 11.38 36 70684 48896 42501719
Therapy cessation 15.89 11.38 7 70713 20443 42530172
Muscle spasms 15.89 11.38 81 70639 85963 42464652
Blood sodium decreased 15.89 11.38 66 70654 18096 42532519
Labelled drug-food interaction medication error 15.88 11.38 5 70715 42 42550573
Hypertrophic scar 15.85 11.38 4 70716 13 42550602
Chapped lips 15.83 11.38 13 70707 952 42549663
Ventricular tachycardia 15.81 11.38 16 70704 30144 42520471
Ammonia increased 15.77 11.38 28 70692 4631 42545984
Clostridium difficile infection 15.74 11.38 9 70711 22650 42527965
Psoriasis 15.63 11.38 36 70684 48568 42502047
Histiocytic necrotising lymphadenitis 15.62 11.38 4 70716 14 42550601
Torticollis 15.58 11.38 15 70705 1355 42549260
Hypertension 15.56 11.38 190 70530 167014 42383601
Angina pectoris 15.54 11.38 19 70701 32877 42517738
Staring 15.54 11.38 16 70704 1567 42549048
Metastases to liver 15.44 11.38 4 70716 16322 42534293
Extrapyramidal disorder 15.44 11.38 61 70659 16351 42534264
Mental disorder 15.37 11.38 65 70655 17964 42532651
Prominent epicanthal folds 15.34 11.38 7 70713 174 42550441
Learning disability 15.32 11.38 9 70711 382 42550233
Arachnoid cyst 15.31 11.38 8 70712 269 42550346
Metastases to bone 15.27 11.38 3 70717 14806 42535809
Liver function test abnormal 15.24 11.38 99 70621 32292 42518323
Trigeminal nerve disorder 15.20 11.38 4 70716 16 42550599
Craniofacial fracture 15.19 11.38 9 70711 388 42550227
Myasthenia gravis 15.17 11.38 4 70716 16133 42534482
Poriomania 15.09 11.38 6 70714 105 42550510
Rhesus incompatibility 15.02 11.38 5 70715 51 42550564
Death of relative 15.01 11.38 4 70716 17 42550598
Dystonia 14.94 11.38 51 70669 12739 42537876
Potentiating drug interaction 14.80 11.38 33 70687 6435 42544180
Myoclonic epilepsy 14.80 11.38 16 70704 1658 42548957
Hallucinations, mixed 14.79 11.38 23 70697 3412 42547203
Dry age-related macular degeneration 14.78 11.38 6 70714 111 42550504
Colitis ulcerative 14.76 11.38 13 70707 26162 42524453
Haemorrhoids 14.69 11.38 5 70715 17092 42533523
Multiple congenital abnormalities 14.69 11.38 10 70710 550 42550065
Rickets 14.68 11.38 5 70715 55 42550560
Xanthoma 14.68 11.38 6 70714 113 42550502
Pancytopenia 14.58 11.38 125 70595 117618 42432997
Diverticulitis 14.50 11.38 10 70710 22763 42527852
Palpitations 14.49 11.38 40 70680 50757 42499858
Antineutrophil cytoplasmic antibody positive 14.48 11.38 26 70694 4339 42546276
Bone density decreased 14.33 11.38 18 70702 2188 42548427
Hypercalcaemia 14.32 11.38 6 70714 18052 42532563
Normochromic normocytic anaemia 14.26 11.38 40 70680 8991 42541624
Change in seizure presentation 14.21 11.38 8 70712 313 42550302
Biopsy lymph gland abnormal 14.14 11.38 3 70717 3 42550612
Kluver-Bucy syndrome 14.14 11.38 3 70717 3 42550612
Treatment noncompliance 14.13 11.38 109 70611 37563 42513052
Drug tolerance 14.12 11.38 22 70698 3268 42547347
Hypokalaemia 14.12 11.38 66 70654 71655 42478960
Troponin increased 14.08 11.38 7 70713 19055 42531560
Maternal exposure during breast feeding 13.98 11.38 15 70705 1540 42549075
Distractibility 13.93 11.38 9 70711 453 42550162
Cryptorchism 13.91 11.38 17 70703 2010 42548605
Priapism 13.90 11.38 32 70688 6375 42544240
Onychophagia 13.86 11.38 5 70715 66 42550549
Ulcer 13.80 11.38 5 70715 16436 42534179
Vision blurred 13.77 11.38 143 70577 53556 42497059
Tonic clonic movements 13.75 11.38 14 70706 1353 42549262
Infrequent bowel movements 13.74 11.38 13 70707 1149 42549466
Rash papular 13.72 11.38 47 70673 11764 42538851
Antemortem blood drug level abnormal 13.66 11.38 5 70715 69 42550546
Attention deficit hyperactivity disorder 13.65 11.38 21 70699 3087 42547528
Premature baby 13.60 11.38 75 70645 23078 42527537
Epidermolysis bullosa 13.58 11.38 6 70714 138 42550477
Sitting disability 13.58 11.38 7 70713 229 42550386
Blood creatinine increased 13.52 11.38 117 70603 109886 42440729
Thrombosis 13.51 11.38 63 70657 68448 42482167
Leukocytosis 13.49 11.38 90 70630 29618 42520997
Congenital arterial malformation 13.46 11.38 6 70714 141 42550474
Pigmentation disorder 13.44 11.38 21 70699 3127 42547488
Poverty of speech 13.44 11.38 7 70713 234 42550381
Mental impairment 13.43 11.38 48 70672 12269 42538346
Nikolsky's sign 13.42 11.38 6 70714 142 42550473
Device issue 13.38 11.38 3 70717 13506 42537109
Multiple sclerosis 13.35 11.38 35 70685 7563 42543052
Withdrawal catatonia 13.33 11.38 7 70713 238 42550377
Tardive dyskinesia 13.31 11.38 33 70687 6891 42543724
Liver injury 13.31 11.38 65 70655 19083 42531532
Facial bones fracture 13.28 11.38 18 70702 2358 42548257
Abdominal discomfort 13.25 11.38 72 70648 75183 42475432
Ileus paralytic 13.22 11.38 35 70685 7606 42543009
Hyperbilirubinaemia 13.22 11.38 9 70711 20626 42529989
Cough 13.15 11.38 212 70508 177891 42372724
Cataract 13.11 11.38 19 70701 30585 42520030
Cholinergic syndrome 13.07 11.38 10 70710 661 42549954
Patient uncooperative 13.07 11.38 10 70710 661 42549954
Cell death 13.00 11.38 20 70700 2939 42547676
Therapeutic response unexpected 12.96 11.38 45 70675 11336 42539279
Paradoxical drug reaction 12.96 11.38 26 70694 4712 42545903
Abdominal pain upper 12.96 11.38 82 70638 82527 42468088
Nasal congestion 12.95 11.38 18 70702 29483 42521132
Urinary tract infection 12.93 11.38 104 70616 99180 42451435
Injection site swelling 12.89 11.38 6 70714 16967 42533648
Extensor plantar response 12.88 11.38 10 70710 675 42549940
Bronchitis 12.85 11.38 38 70682 47163 42503452
Abulia 12.82 11.38 10 70710 680 42549935
Bronchiectasis 12.74 11.38 7 70713 18012 42532603
Contraindicated product prescribed 12.70 11.38 10 70710 689 42549926
Neutrophil count decreased 12.69 11.38 58 70662 63357 42487258
Sinus node dysfunction 12.68 11.38 26 70694 4786 42545829
Sluggishness 12.66 11.38 23 70697 3873 42546742
Open angle glaucoma 12.59 11.38 7 70713 267 42550348
Paresis 12.59 11.38 18 70702 2478 42548137
Talipes 12.59 11.38 17 70703 2219 42548396
Contraindicated product administered 12.58 11.38 14 70706 25258 42525357
Infantile spasms 12.50 11.38 7 70713 271 42550344
Feeling drunk 12.46 11.38 17 70703 2241 42548374
Impaired quality of life 12.44 11.38 4 70716 14173 42536442
Ischaemic gastritis 12.33 11.38 3 70717 8 42550607
Therapeutic product ineffective 12.20 11.38 12 70708 1113 42549502
Blood glucose increased 12.17 11.38 72 70648 73627 42476988
Hypochloraemia 12.12 11.38 11 70709 922 42549693
Hypercapnic coma 12.11 11.38 6 70714 180 42550435
Mucosal ulceration 12.07 11.38 13 70707 1341 42549274
Drug half-life reduced 12.07 11.38 3 70717 9 42550606
Nephrolithiasis 12.06 11.38 27 70693 36803 42513812
Bone pain 12.04 11.38 13 70707 23779 42526836
Pulmonary mass 11.97 11.38 6 70714 16259 42534356
Acute hepatic failure 11.90 11.38 58 70662 17015 42533600
Sedation complication 11.81 11.38 19 70701 2900 42547715
Pneumothorax 11.77 11.38 13 70707 23530 42527085
Conjunctival disorder 11.73 11.38 5 70715 105 42550510
Salivary gland calculus 11.69 11.38 5 70715 106 42550509
Ventricular fibrillation 11.67 11.38 20 70700 30103 42520512
Alcohol interaction 11.67 11.38 16 70704 2119 42548496
Head injury 11.64 11.38 66 70654 20516 42530099
Akathisia 11.63 11.38 41 70679 10410 42540205
Measles 11.60 11.38 7 70713 312 42550303
Overweight 11.59 11.38 17 70703 2395 42548220
Presyncope 11.59 11.38 12 70708 22375 42528240
Therapeutic response shortened 11.59 11.38 4 70716 13550 42537065
Impulsive behaviour 11.52 11.38 17 70703 2408 42548207
Feeling of despair 11.48 11.38 12 70708 1196 42549419
Pericarditis 11.44 11.38 4 70716 13440 42537175
Melaena 11.43 11.38 30 70690 38716 42511899
Swollen tongue 11.43 11.38 11 70709 21220 42529395
Cervicobrachial syndrome 11.41 11.38 7 70713 322 42550293
Asthenia 11.40 11.38 367 70353 280426 42270189
Blood lactate dehydrogenase 11.40 11.38 3 70717 12 42550603
Fabry's disease 11.40 11.38 3 70717 12 42550603
Medication error 11.38 11.38 94 70626 33060 42517555

FDA Adverse Event Reporting System (Geriatric)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Drug reaction with eosinophilia and systemic symptoms 2147.40 10.62 1330 141240 80765 110365964
Seizure 1785.76 10.62 1787 140783 219398 110227331
Toxicity to various agents 1288.64 10.62 2256 140314 478299 109968430
Drug interaction 1158.24 10.62 2204 140366 497979 109948750
Generalised tonic-clonic seizure 760.62 10.62 602 141968 54078 110392651
Sedation complication 692.85 10.62 388 142182 19467 110427262
Cognitive disorder 691.74 10.62 700 141870 86811 110359918
Balance disorder 684.48 10.62 797 141773 115763 110330966
Sedation 680.15 10.62 626 141944 69057 110377672
Status epilepticus 677.46 10.62 452 142118 31119 110415610
Creatinine renal clearance decreased 648.36 10.62 384 142186 21431 110425298
Ataxia 648.32 10.62 432 142138 29676 110417053
Stevens-Johnson syndrome 645.09 10.62 513 142057 46388 110400341
Depressed level of consciousness 636.46 10.62 754 141816 111524 110335205
Anticonvulsant drug level increased 610.66 10.62 202 142368 2656 110444073
Somnolence 547.94 10.62 1194 141376 296255 110150474
Blood calcium decreased 527.32 10.62 408 142162 35437 110411292
Overdose 512.09 10.62 1008 141562 232786 110213943
Schizophrenia 483.99 10.62 319 142251 21507 110425222
Aggression 461.16 10.62 470 142100 58740 110387989
Drug eruption 458.60 10.62 448 142122 53211 110393518
Orthostatic hypotension 457.26 10.62 493 142077 65756 110380973
Hyponatraemia 452.12 10.62 918 141652 216735 110229994
Multiple-drug resistance 411.74 10.62 240 142330 12995 110433734
Epilepsy 373.67 10.62 548 142022 99661 110347068
Joint swelling 356.99 10.62 69 142501 442776 110003953
Psychotic disorder 354.89 10.62 381 142189 50556 110396173
Nystagmus 344.53 10.62 204 142366 11373 110435356
Synovitis 336.48 10.62 3 142567 274089 110172640
Diarrhoea 330.85 10.62 604 141966 1138901 109307828
Arthralgia 318.21 10.62 322 142248 779310 109667419
Drug level increased 311.65 10.62 345 142225 47374 110399355
Infusion related reaction 303.77 10.62 61 142509 381101 110065628
Coma 302.29 10.62 544 142026 117325 110329404
Suicide attempt 300.11 10.62 504 142066 102890 110343839
Petit mal epilepsy 283.89 10.62 155 142415 7392 110439337
Rheumatoid arthritis 282.62 10.62 29 142541 299584 110147145
Completed suicide 282.57 10.62 818 141752 241563 110205166
Diplopia 280.71 10.62 307 142263 41587 110405142
Dysarthria 276.68 10.62 434 142136 83687 110363042
Partial seizures 269.06 10.62 173 142397 11176 110435553
Rash maculo-papular 268.17 10.62 400 142170 73822 110372907
Hand deformity 265.34 10.62 3 142567 218503 110228226
Focal dyscognitive seizures 264.11 10.62 119 142451 3730 110442999
Toxic epidermal necrolysis 257.40 10.62 341 142229 56386 110390343
Loss of consciousness 248.81 10.62 683 141887 195623 110251106
Drug abuse 247.86 10.62 640 141930 176771 110269958
Gamma-glutamyltransferase increased 242.68 10.62 345 142225 60964 110385765
Electroencephalogram abnormal 241.15 10.62 130 142440 6043 110440686
Dyspnoea 239.72 10.62 687 141883 1106185 109340544
Pericarditis 239.33 10.62 10 142560 219104 110227625
Febrile neutropenia 237.60 10.62 58 142512 316709 110130020
Pemphigus 233.67 10.62 10 142560 214560 110232169
Anticonvulsant drug level above therapeutic 225.51 10.62 78 142492 1184 110445545
Sopor 221.19 10.62 254 142316 36292 110410437
Jaundice cholestatic 220.75 10.62 169 142401 14439 110432290
Intentional overdose 217.97 10.62 509 142061 131992 110314737
Drug level decreased 217.51 10.62 185 142385 18363 110428366
Glossodynia 215.92 10.62 19 142551 221985 110224744
Wound 215.19 10.62 25 142545 234412 110212317
Peripheral swelling 215.18 10.62 127 142443 403907 110042822
Altered state of consciousness 213.10 10.62 314 142256 57312 110389417
Drug resistance 211.10 10.62 309 142261 56065 110390664
Eosinophilia 208.94 10.62 312 142258 57624 110389105
Psoriatic arthropathy 208.35 10.62 11 142559 196750 110249979
Sinusitis 208.03 10.62 62 142508 296626 110150103
Contraindicated product administered 207.89 10.62 35 142535 248232 110198497
Systemic lupus erythematosus 204.03 10.62 40 142530 254298 110192431
Alopecia 202.35 10.62 109 142461 364644 110082085
Fall 198.33 10.62 1394 141176 602088 109844641
Swelling 190.23 10.62 108 142462 350933 110095796
Folliculitis 188.79 10.62 6 142564 167647 110279082
Irritability 187.68 10.62 268 142302 47541 110399188
Trigeminal neuralgia 179.42 10.62 95 142475 4257 110442472
Agitation 178.02 10.62 427 142143 112624 110334105
Inappropriate antidiuretic hormone secretion 178.02 10.62 219 142351 33632 110413097
Impaired healing 178.01 10.62 22 142548 196695 110250034
Helicobacter infection 175.69 10.62 16 142554 181861 110264868
Abdominal discomfort 175.30 10.62 150 142420 393708 110053021
Sudden unexplained death in epilepsy 175.14 10.62 58 142512 765 110445964
Abnormal behaviour 171.45 10.62 231 142339 38808 110407921
Muscle injury 166.33 10.62 3 142567 140804 110305925
Psychogenic seizure 165.10 10.62 74 142496 2290 110444439
Intentional product use issue 161.15 10.62 59 142511 247847 110198882
Cholelithiasis 159.07 10.62 290 142280 63132 110383597
Fibromyalgia 157.39 10.62 18 142552 170891 110275838
Coordination abnormal 155.47 10.62 177 142393 25051 110421678
Rheumatoid factor positive 154.70 10.62 3 142567 131637 110315092
Erythema multiforme 154.34 10.62 162 142408 20935 110425794
Drug intolerance 153.20 10.62 179 142391 406333 110040396
Hyperammonaemia 152.96 10.62 133 142437 13599 110433130
Fatigue 152.42 10.62 932 141638 1215026 109231703
Total lung capacity increased 146.69 10.62 88 142482 5024 110441705
Arthropathy 146.60 10.62 95 142475 287427 110159302
Dermatitis exfoliative 145.11 10.62 119 142451 11228 110435501
Death 142.09 10.62 446 142124 698423 109748306
Infection 140.25 10.62 156 142414 362044 110084685
Osteoarthritis 139.72 10.62 32 142538 182591 110264138
Lymphocyte stimulation test positive 138.79 10.62 52 142518 1004 110445725
Joint range of motion decreased 138.47 10.62 4 142566 121828 110324901
Toxic skin eruption 133.51 10.62 171 142399 27344 110419385
Stomatitis 132.79 10.62 93 142477 270149 110176580
Bursitis 132.26 10.62 9 142561 129909 110316820
Lymphadenopathy 130.84 10.62 268 142302 63567 110383162
Asthma-chronic obstructive pulmonary disease overlap syndrome 129.27 10.62 88 142482 6256 110440473
Human herpes virus 6 serology positive 128.30 10.62 35 142535 223 110446506
Irritable bowel syndrome 127.18 10.62 28 142542 164187 110282542
Discomfort 123.70 10.62 61 142509 214646 110232083
Vertigo 122.89 10.62 315 142255 86555 110360174
Intentional self-injury 122.87 10.62 193 142377 37236 110409493
Hyperammonaemic encephalopathy 121.85 10.62 80 142490 5354 110441375
Anaemia 121.38 10.62 335 142235 546751 109899978
Nasopharyngitis 120.29 10.62 202 142368 394159 110052570
Anticonvulsant drug level decreased 118.48 10.62 57 142513 2079 110444650
Cerebellar syndrome 118.03 10.62 83 142487 6219 110440510
General physical health deterioration 115.39 10.62 234 142336 425061 110021668
Speech disorder 115.15 10.62 249 142321 61320 110385409
Oral mucosa erosion 114.01 10.62 58 142512 2390 110444339
Cross sensitivity reaction 112.91 10.62 77 142493 5490 110441239
Therapeutic product effect decreased 112.41 10.62 90 142480 244226 110202503
Arthritis 112.12 10.62 38 142532 167548 110279181
Gastrointestinal disorder 111.48 10.62 89 142481 241863 110204866
Aura 111.07 10.62 45 142525 1079 110445650
Mucosal erosion 108.99 10.62 59 142511 2765 110443964
Acute kidney injury 107.47 10.62 438 142132 634992 109811737
Myoclonus 106.72 10.62 169 142401 32829 110413900
Hypersensitivity 105.62 10.62 227 142343 403771 110042958
Hepatotoxicity 104.69 10.62 244 142326 63156 110383573
Type 2 diabetes mellitus 104.16 10.62 49 142521 177183 110269546
Dyskinesia 103.09 10.62 214 142356 51232 110395497
Hepatic function abnormal 102.59 10.62 300 142270 88995 110357734
Temporal lobe epilepsy 101.61 10.62 34 142536 464 110446265
Psychomotor retardation 100.23 10.62 82 142488 7710 110439019
Neuroleptic malignant syndrome 100.06 10.62 167 142403 33892 110412837
Anticonvulsant drug level below therapeutic 99.51 10.62 42 142528 1120 110445609
Bradyphrenia 98.44 10.62 97 142473 11631 110435098
Face oedema 98.18 10.62 164 142406 33305 110413424
Pulmonary pain 97.71 10.62 74 142496 6219 110440510
Myoclonic epilepsy 94.98 10.62 53 142517 2638 110444091
Peripheral venous disease 94.72 10.62 3 142567 84114 110362615
Mania 92.75 10.62 124 142446 20672 110426057
Sarcoidosis 92.74 10.62 97 142473 12482 110434247
Intellectual disability 92.50 10.62 47 142523 1932 110444797
Lymphocyte morphology abnormal 91.32 10.62 38 142532 977 110445752
Ill-defined disorder 91.20 10.62 44 142526 156809 110289920
Abdominal pain upper 89.71 10.62 198 142372 348913 110097816
Psychomotor hyperactivity 89.05 10.62 120 142450 20157 110426572
Gastric lavage 88.98 10.62 20 142550 47 110446682
Tonic convulsion 88.42 10.62 53 142517 3021 110443708
Hypotonia 87.88 10.62 105 142465 15640 110431089
Amyloid arthropathy 87.67 10.62 43 142527 1637 110445092
Night sweats 86.85 10.62 32 142538 133951 110312778
Wound infection 86.73 10.62 11 142559 96454 110350275
Dry mouth 85.46 10.62 79 142491 199869 110246860
Suicidal ideation 85.32 10.62 291 142279 93646 110353083
Partial seizures with secondary generalisation 83.54 10.62 34 142536 825 110445904
Chest pain 83.00 10.62 231 142339 376144 110070585
Neuropathy peripheral 82.50 10.62 66 142504 179211 110267518
Gait disturbance 81.58 10.62 626 141944 277582 110169147
Lip dry 79.67 10.62 16 142554 100067 110346662
Pain in extremity 79.66 10.62 340 142230 486778 109959951
Back pain 79.38 10.62 231 142339 370765 110075964
Musculoskeletal stiffness 78.39 10.62 151 142419 279671 110167058
Dyspepsia 76.36 10.62 80 142490 190885 110255844
Product use issue 75.85 10.62 182 142388 311513 110135216
Nasal polyps 75.28 10.62 89 142481 13111 110433618
Malignant neoplasm progression 74.56 10.62 69 142501 174498 110272231
Hypotension 73.88 10.62 1014 141556 522835 109923894
Oppositional defiant disorder 73.56 10.62 27 142543 491 110446238
Abdominal pain 72.74 10.62 377 142193 512612 109934117
Apathy 72.68 10.62 97 142473 16142 110430587
Tremor 72.64 10.62 478 142092 201754 110244975
Grip strength decreased 72.42 10.62 9 142561 80165 110366564
Injury 72.31 10.62 73 142497 177192 110269537
Decreased eye contact 71.52 10.62 31 142539 884 110445845
Gaze palsy 71.18 10.62 48 142522 3359 110443370
Extrapyramidal disorder 71.11 10.62 131 142439 28736 110417993
Papule 70.91 10.62 76 142494 10057 110436672
Musculoskeletal pain 70.60 10.62 79 142491 182944 110263785
Product substitution issue 70.33 10.62 115 142455 22946 110423783
Human herpesvirus 6 infection 69.81 10.62 62 142508 6519 110440210
Delusion 69.14 10.62 116 142454 23639 110423090
Sciatica 69.06 10.62 17 142553 92382 110354347
Pyrexia 68.95 10.62 1578 140992 896687 109550042
Pneumonia aspiration 68.88 10.62 246 142324 80987 110365742
Cytokine release syndrome 68.37 10.62 6 142564 70300 110376429
Hypertension 67.29 10.62 384 142186 509700 109937029
Behaviour disorder 66.88 10.62 72 142498 9575 110437154
Conjunctival hyperaemia 66.00 10.62 57 142513 5774 110440955
Taste disorder 65.19 10.62 5 142565 65382 110381347
COVID-19 64.57 10.62 137 142433 244923 110201806
Altered pitch perception 64.52 10.62 13 142557 13 110446716
Adverse event 64.05 10.62 30 142540 108779 110337950
Constipation 63.91 10.62 724 141846 357062 110089667
Lip erosion 63.82 10.62 36 142534 1830 110444899
Blood bilirubin increased 63.50 10.62 229 142341 75743 110370986
Pneumonia 62.88 10.62 776 141794 875938 109570791
Alanine aminotransferase increased 62.76 10.62 429 142141 183344 110263385
Contusion 62.71 10.62 129 142441 233232 110213497
Blood cholesterol increased 62.67 10.62 88 142482 184697 110262032
Muscle spasms 62.58 10.62 169 142401 277988 110168741
Disturbance in attention 62.51 10.62 199 142371 61796 110384933
Weight decreased 62.46 10.62 351 142219 467706 109979023
Rhinitis allergic 62.44 10.62 95 142475 17827 110428902
Lower limb fracture 62.20 10.62 11 142559 75337 110371392
Rectal haemorrhage 61.85 10.62 39 142531 119794 110326935
Hypercholesterolaemia 61.79 10.62 20 142550 90817 110355912
Cardiac failure congestive 61.79 10.62 62 142508 150938 110295791
Multiple sclerosis relapse 61.78 10.62 173 142397 50067 110396662
Creatinine renal clearance increased 61.60 10.62 45 142525 3580 110443149
Lower respiratory tract infection 61.50 10.62 139 142431 242967 110203762
Accidental overdose 61.31 10.62 176 142394 51658 110395071
Sepsis 60.16 10.62 218 142352 327128 110119601
Frequent bowel movements 59.86 10.62 10 142560 71380 110375349
Headache 59.21 10.62 792 141778 881585 109565144
Nail disorder 59.00 10.62 4 142566 57931 110388798
Choreoathetosis 58.72 10.62 33 142537 1665 110445064
Decreased appetite 58.64 10.62 366 142204 475480 109971249
Atonic seizures 58.62 10.62 29 142541 1125 110445604
Psychomotor skills impaired 58.54 10.62 58 142512 7000 110439729
Poisoning 58.22 10.62 121 142449 28984 110417745
Gastrointestinal haemorrhage 57.96 10.62 77 142493 165441 110281288
Change in seizure presentation 57.90 10.62 26 142544 808 110445921
Asterixis 57.77 10.62 41 142529 3117 110443612
Disease progression 57.39 10.62 145 142425 243889 110202840
Hepatocellular injury 57.06 10.62 169 142401 50473 110396256
Hip arthroplasty 56.41 10.62 4 142566 55809 110390920
Multiple drug therapy 55.89 10.62 60 142510 7954 110438775
Simple partial seizures 55.51 10.62 27 142543 1009 110445720
Blood lactate dehydrogenase increased 54.84 10.62 153 142417 44181 110402548
Skin exfoliation 54.60 10.62 241 142329 87410 110359319
Coma scale abnormal 54.51 10.62 65 142505 9661 110437068
Hospitalisation 54.41 10.62 62 142508 142431 110304298
Stupor 54.36 10.62 60 142510 8205 110438524
Psychiatric symptom 54.00 10.62 63 142507 9150 110437579
Fluid retention 53.98 10.62 27 142543 94280 110352449
Aspartate aminotransferase increased 53.81 10.62 372 142198 159564 110287165
Obsessive-compulsive disorder 53.67 10.62 56 142514 7185 110439544
Mental impairment 53.59 10.62 101 142469 22538 110424191
Atrial fibrillation 53.57 10.62 137 142433 229505 110217224
Dysmorphism 53.55 10.62 23 142547 641 110446088
Myocardial infarction 53.48 10.62 104 142466 191979 110254750
Postictal psychosis 52.92 10.62 18 142552 259 110446470
Mood altered 52.65 10.62 97 142473 21278 110425451
Restlessness 52.59 10.62 176 142394 56083 110390646
Skin test positive 52.40 10.62 29 142541 1420 110445309
Cardiac murmur 52.36 10.62 105 142465 24523 110422206
Psoriasis 52.28 10.62 62 142508 139931 110306798
Hyporeflexia 51.88 10.62 43 142527 4117 110442612
Injection site pain 51.59 10.62 94 142476 177828 110268901
Rash 51.27 10.62 1403 141167 819561 109627168
Bruxism 50.90 10.62 46 142524 4948 110441781
Erythema 50.78 10.62 587 141983 290860 110155869
Drug ineffective 50.67 10.62 2419 140151 1518121 108928608
Dysmetria 50.59 10.62 28 142542 1371 110445358
Nikolsky's sign 50.47 10.62 16 142554 182 110446547
Injection site reaction 50.24 10.62 26 142544 89044 110357685
Facial pain 50.21 10.62 79 142491 15260 110431469
Wrong patient received product 50.16 10.62 52 142518 6622 110440107
Lymphocytosis 49.64 10.62 47 142523 5364 110441365
Blood alkaline phosphatase increased 49.58 10.62 202 142368 70733 110375996
Shock 49.52 10.62 167 142403 53421 110393308
Hypomagnesaemia 49.43 10.62 9 142561 60361 110386368
Radiation inflammation 49.30 10.62 25 142545 1023 110445706
Colitis ulcerative 49.26 10.62 19 142551 77344 110369385
Autoimmune disorder 49.03 10.62 12 142558 65471 110381258
Off label use 48.96 10.62 1518 141052 1498667 108948062
Depressed mood 48.88 10.62 181 142389 60628 110386101
Pregnancy with implant contraceptive 48.56 10.62 33 142537 2339 110444390
Homicidal ideation 48.41 10.62 39 142531 3588 110443141
Skin erosion 48.36 10.62 48 142522 5806 110440923
Oculomucocutaneous syndrome 48.21 10.62 18 142552 344 110446385
Thinking abnormal 48.21 10.62 77 142493 15063 110431666
Slow speech 47.99 10.62 38 142532 3410 110443319
Inflammation 47.65 10.62 112 142458 193126 110253603
Unintended pregnancy 46.49 10.62 43 142527 4765 110441964
Mouth ulceration 46.25 10.62 152 142418 47986 110398743
Back injury 46.21 10.62 4 142566 47395 110399334
Oedema 46.16 10.62 129 142441 209847 110236882
Hepatic cirrhosis 45.80 10.62 15 142555 67611 110379118
Renal function test abnormal 45.62 10.62 57 142513 8889 110437840
Pain 45.54 10.62 913 141657 954042 109492687
Lung disorder 45.49 10.62 103 142467 179944 110266785
Liver function test increased 45.44 10.62 29 142541 88519 110358210
Joint stiffness 45.39 10.62 15 142555 67228 110379501
Capillaritis 45.39 10.62 32 142538 2407 110444322
Product dose omission issue 45.27 10.62 237 142333 321545 110125184
Ovarian granulosa-theca cell tumour 45.26 10.62 10 142560 21 110446708
Migraine 45.17 10.62 96 142474 171556 110275173
Septic shock 44.98 10.62 84 142486 157444 110289285
Adjustment disorder with depressed mood 44.77 10.62 3 142567 43880 110402849
Multiple sclerosis 44.73 10.62 101 142469 25597 110421132
Paraplegia 44.26 10.62 47 142523 6153 110440576
Neutropenia 44.16 10.62 292 142278 374328 110072401
Hepatic adenoma 43.76 10.62 18 142552 449 110446280
Cerebral atrophy 43.34 10.62 56 142514 9029 110437700
Mydriasis 43.02 10.62 91 142479 22066 110424663
Hypoaesthesia 42.78 10.62 234 142336 313989 110132740
Seizure cluster 42.51 10.62 21 142549 812 110445917
Colitis 41.87 10.62 42 142528 102281 110344448
Myelosuppression 41.82 10.62 36 142534 94304 110352425
Dizziness 41.81 10.62 1187 141383 697006 109749723
Bradycardia 41.74 10.62 343 142227 155174 110291555
Conversion disorder 41.59 10.62 30 142540 2340 110444389
Withdrawal syndrome 41.51 10.62 111 142459 31269 110415460
Paradoxical drug reaction 41.44 10.62 57 142513 9760 110436969
Bronchitis 41.17 10.62 88 142482 156944 110289785
Red blood cell sedimentation rate increased 41.07 10.62 25 142545 78277 110368452
Drug level below therapeutic 40.84 10.62 62 142508 11611 110435118
Abortion induced 40.74 10.62 51 142519 7968 110438761
Mental disorder 40.46 10.62 126 142444 38665 110408064
Ascites 40.43 10.62 36 142534 92772 110353957
Dystonia 40.09 10.62 97 142473 25708 110421021
Hypothermia 39.93 10.62 98 142472 26204 110420525
Blood creatine phosphokinase increased 39.66 10.62 193 142377 72884 110373845
Live birth 39.61 10.62 20 142550 69464 110377265
Rash morbilliform 39.49 10.62 50 142520 7901 110438828
Injection site erythema 39.29 10.62 38 142532 94138 110352591
Conjunctivitis 39.25 10.62 114 142456 33678 110413051
Lung neoplasm malignant 39.14 10.62 114 142456 33728 110413001
Clumsiness 38.88 10.62 35 142535 3745 110442984
Angiofibroma 38.80 10.62 12 142558 125 110446604
Disorientation 38.61 10.62 187 142383 70484 110376245
Nephrogenic diabetes insipidus 38.51 10.62 29 142541 2416 110444313
Abdominal distension 38.17 10.62 108 142462 174995 110271734
Eosinophil count increased 38.04 10.62 84 142486 20974 110425755
Posture abnormal 37.79 10.62 37 142533 4401 110442328
Mobility decreased 37.75 10.62 470 142100 236952 110209777
Acute myeloid leukaemia 37.75 10.62 3 142567 38107 110408622
Mucosal inflammation 37.61 10.62 41 142529 96100 110350629
Eye movement disorder 37.39 10.62 54 142516 9674 110437055
Fulminant type 1 diabetes mellitus 37.16 10.62 28 142542 2335 110444394
Dysphagia 37.13 10.62 331 142239 153269 110293460
Nausea 36.98 10.62 1264 141306 1234426 109212303
Onychomadesis 36.97 10.62 7 142563 45656 110401073
Treatment failure 36.89 10.62 208 142362 277026 110169703
Plasmapheresis 36.86 10.62 19 142551 805 110445924
Trismus 36.83 10.62 44 142526 6552 110440177
Hallucination, auditory 36.57 10.62 95 142475 26302 110420427
Roseolovirus test positive 36.50 10.62 14 142556 289 110446440
Epileptic psychosis 36.49 10.62 10 142560 65 110446664
Epidermolysis bullosa 36.40 10.62 15 142555 376 110446353
Histiocytosis 36.10 10.62 10 142560 68 110446661
Diverticulitis 36.02 10.62 12 142558 53510 110393219
Drug withdrawal syndrome 35.52 10.62 119 142451 37935 110408794
Macule 35.50 10.62 33 142537 3680 110443049
Rash erythematous 35.40 10.62 203 142367 81629 110365100
Injection site pruritus 35.37 10.62 11 142559 51247 110395482
Prescribed underdose 35.33 10.62 20 142550 65154 110381575
Respiratory arrest 35.32 10.62 159 142411 58140 110388589
Skin ulcer 35.27 10.62 19 142551 63626 110383103
Hypervolaemia 35.25 10.62 10 142560 49450 110397279
Hypogammaglobulinaemia 35.05 10.62 79 142491 19997 110426732
Middle insomnia 35.04 10.62 80 142490 20422 110426307
Dementia 35.02 10.62 105 142465 31568 110415161
Unresponsive to stimuli 34.99 10.62 169 142401 63621 110383108
Ammonia increased 34.98 10.62 48 142522 8202 110438527
Autism spectrum disorder 34.97 10.62 25 142545 1923 110444806
Mucosal ulceration 34.80 10.62 27 142543 2352 110444377
Aphasia 34.33 10.62 159 142411 58838 110387891
Hyperpyrexia 34.29 10.62 47 142523 8022 110438707
Pneumonitis 34.17 10.62 29 142541 76502 110370227
Epileptic encephalopathy 34.16 10.62 17 142553 668 110446061
Drug withdrawal convulsions 34.11 10.62 27 142543 2422 110444307
Cerebellar atrophy 34.07 10.62 22 142548 1431 110445298
Lethargy 34.07 10.62 222 142348 93354 110353375
Personality change 33.73 10.62 55 142515 10947 110435782
Sinus arrest 33.60 10.62 34 142536 4208 110442521
Cellulitis 33.55 10.62 70 142500 125946 110320783
Pleural effusion 33.52 10.62 117 142453 177592 110269137
Growth hormone-producing pituitary tumour 33.29 10.62 11 142559 144 110446585
Neurosis 32.99 10.62 16 142554 594 110446135
Weight increased 32.87 10.62 364 142206 419280 110027449
Vision blurred 32.73 10.62 281 142289 128741 110317988
Postictal paralysis 32.72 10.62 16 142554 605 110446124
Asthma 32.64 10.62 189 142381 250102 110196627
Lennox-Gastaut syndrome 32.63 10.62 13 142557 298 110446431
Haematochezia 32.62 10.62 62 142508 115462 110331267
Euphoric mood 32.47 10.62 48 142522 8779 110437950
Chest discomfort 32.43 10.62 115 142455 173733 110272996
Osteomalacia 32.30 10.62 22 142548 1565 110445164
Angiomyolipoma 32.19 10.62 13 142557 309 110446420
Illusion 32.05 10.62 24 142546 1983 110444746
Salivary hypersecretion 32.04 10.62 70 142500 17351 110429378
Cardiac arrest 31.92 10.62 391 142179 196362 110250367
Lymphocytic infiltration 31.86 10.62 24 142546 2001 110444728
Febrile convulsion 31.57 10.62 19 142551 1091 110445638
Exostosis 31.46 10.62 10 142560 45946 110400783
Palpitations 31.27 10.62 103 142467 159109 110287620
Epileptic aura 31.10 10.62 9 142561 73 110446656
Product administration error 30.94 10.62 112 142458 37105 110409624
Gout 30.93 10.62 5 142565 36561 110410168
Neuromyelitis optica spectrum disorder 30.83 10.62 21 142549 1494 110445235
Cardio-respiratory arrest 30.82 10.62 255 142315 115581 110331148
Retinitis 30.79 10.62 3 142567 32324 110414405
Cardiac failure 30.59 10.62 131 142439 187495 110259234
Malaise 30.57 10.62 647 141923 671172 109775557
Leukocytosis 30.54 10.62 144 142426 53684 110393045
Oxygen saturation decreased 30.53 10.62 102 142468 156880 110289849
Stereotypy 30.46 10.62 18 142552 999 110445730
Hepatosplenomegaly 30.46 10.62 41 142529 6878 110439851
Communication disorder 30.44 10.62 35 142535 5004 110441725
Labelled drug-drug interaction medication error 30.40 10.62 95 142475 29207 110417522
Pulmonary fibrosis 30.39 10.62 53 142517 101989 110344740
Microcephaly 30.23 10.62 11 142559 195 110446534
Osteonecrosis of jaw 30.22 10.62 12 142558 48005 110398724
Genital ulceration 30.17 10.62 23 142547 1952 110444777
Anger 30.12 10.62 72 142498 18935 110427794
Agnosia 30.08 10.62 12 142558 276 110446453
Cheilitis 30 10.62 39 142531 6326 110440403
Prostate cancer 29.99 10.62 6 142564 37635 110409094
Drug dependence 29.99 10.62 136 142434 49884 110396845
Cough 29.92 10.62 417 142153 461224 109985505
Loose associations 29.89 10.62 9 142561 85 110446644
Hyperkinesia 29.87 10.62 28 142542 3156 110443573
Total lung capacity abnormal 29.68 10.62 33 142537 4550 110442179
Hypospadias 29.52 10.62 10 142560 142 110446587
Self esteem decreased 29.51 10.62 18 142552 1059 110445670
Blepharospasm 29.49 10.62 17 142553 54834 110391895
Nervous system disorder 29.44 10.62 99 142471 31622 110415107
Gastric hypomotility 29.41 10.62 12 142558 293 110446436
Petechiae 29.36 10.62 81 142489 23236 110423493
Finger deformity 29.20 10.62 4 142566 33088 110413641
Anaphylactic reaction 29.18 10.62 65 142505 114235 110332494
Excessive eye blinking 29.06 10.62 22 142548 1848 110444881
Neurological symptom 29.03 10.62 63 142507 15545 110431184
Acute generalised exanthematous pustulosis 29.03 10.62 77 142493 21587 110425142
Quadriparesis 28.95 10.62 33 142537 4674 110442055
Brain oedema 28.81 10.62 97 142473 31001 110415728
Coeliac disease 28.51 10.62 10 142560 43177 110403552
Oscillopsia 28.51 10.62 13 142557 419 110446310
C-reactive protein 28.40 10.62 3 142567 30328 110416401
Brain malformation 28.32 10.62 8 142562 59 110446670
Blood sodium decreased 28.28 10.62 111 142459 38208 110408521
Injection site swelling 28.10 10.62 23 142547 61767 110384962
Neonatal pneumonia 27.78 10.62 7 142563 31 110446698
Eyelid oedema 27.70 10.62 61 142509 15201 110431528
Urticaria 27.65 10.62 270 142300 318587 110128142
Potentiating drug interaction 27.63 10.62 52 142518 11591 110435138
Sluggishness 27.63 10.62 41 142529 7526 110439203
Bipolar disorder 27.58 10.62 45 142525 8962 110437767
Foot deformity 27.56 10.62 14 142556 48466 110398263
Catatonia 27.48 10.62 51 142519 11249 110435480
Persecutory delusion 27.27 10.62 37 142533 6254 110440475
Pseudolymphoma 27.25 10.62 18 142552 1217 110445512
Hypercalcaemia 27.24 10.62 13 142557 46644 110400085
Respiratory depression 27.20 10.62 97 142473 31904 110414825
Purpura 27.10 10.62 81 142489 24307 110422422
Gait inability 26.94 10.62 88 142482 136288 110310441
Cerebellar ataxia 26.91 10.62 22 142548 2066 110444663
SJS-TEN overlap 26.83 10.62 21 142549 1853 110444876
Road traffic accident 26.66 10.62 62 142508 107336 110339393
Blood osmolarity decreased 26.60 10.62 19 142551 1459 110445270
Infantile spasms 26.54 10.62 12 142558 379 110446350
Coronary artery disease 26.49 10.62 32 142538 71658 110375071
Spirometry abnormal 26.41 10.62 34 142536 5463 110441266
Influenza 26.39 10.62 120 142450 168981 110277748
Right ventricular dilatation 26.34 10.62 23 142547 2364 110444365
Dehydration 26.25 10.62 232 142338 279279 110167450
Palmar-plantar erythrodysaesthesia syndrome 26.24 10.62 10 142560 41015 110405714
Terminal insomnia 26.21 10.62 21 142549 1917 110444812
Enanthema 26.17 10.62 17 142553 1117 110445612
Neonatal hypotension 26.02 10.62 7 142563 42 110446687
Non-24-hour sleep-wake disorder 26.02 10.62 7 142563 42 110446687
Tuberous sclerosis complex 26.00 10.62 9 142561 137 110446592
Maternal exposure during pregnancy 25.99 10.62 207 142363 254676 110192053
Prominent epicanthal folds 25.93 10.62 5 142565 3 110446726
Hyperkalaemia 25.88 10.62 89 142481 135707 110311022
Therapeutic product ineffective for unapproved indication 25.73 10.62 11 142559 303 110446426
Trigeminal nerve disorder 25.56 10.62 10 142560 218 110446511
Sensory disturbance 25.47 10.62 64 142506 17365 110429364
Emotional disorder 25.37 10.62 61 142509 16099 110430630
Adverse drug reaction 25.36 10.62 62 142508 105497 110341232
Neck pain 25.34 10.62 78 142492 123052 110323677
Onychomycosis 25.31 10.62 9 142561 38522 110408207
Lymphangioleiomyomatosis 25.27 10.62 10 142560 225 110446504
Lip ulceration 25.24 10.62 24 142546 2754 110443975
Chronic kidney disease 25.19 10.62 37 142533 76254 110370475
Affective disorder 25.19 10.62 49 142521 11192 110435537
Poisoning deliberate 25.16 10.62 83 142487 26248 110420481
Vomiting 25.12 10.62 1424 141146 909251 109537478
Renal failure 25.00 10.62 180 142390 226394 110220335
Underdose 24.97 10.62 27 142543 63527 110383202
Skin lesion 24.95 10.62 132 142438 51499 110395230
Myalgia 24.86 10.62 176 142394 222205 110224524
Vaccination site reaction 24.79 10.62 10 142560 237 110446492
Bacteriuria 24.77 10.62 18 142552 1420 110445309
Feeling hot 24.77 10.62 50 142520 91056 110355673
Central nervous system lesion 24.73 10.62 59 142511 15494 110431235
Developmental regression 24.73 10.62 7 142563 52 110446677
Peripheral nerve decompression 24.55 10.62 8 142562 100 110446629
Toxic encephalopathy 24.50 10.62 58 142512 15156 110431573
Laryngitis 24.48 10.62 12 142558 42399 110404330
Poverty of speech 24.44 10.62 13 142557 588 110446141
Photophobia 24.42 10.62 81 142489 25690 110421039
Product complaint 24.41 10.62 55 142515 13917 110432812
Hyperexplexia 24.39 10.62 7 142563 55 110446674
Infrequent bowel movements 24.09 10.62 21 142549 2154 110444575
Dysgeusia 24.04 10.62 33 142537 69952 110376777
Shunt malfunction 24.00 10.62 11 142559 359 110446370
Mitochondrial enzyme deficiency 23.92 10.62 6 142564 26 110446703
Liver injury 23.92 10.62 106 142464 150307 110296422
Crying 23.79 10.62 80 142490 25548 110421181
Respiratory disorder neonatal 23.75 10.62 7 142563 61 110446668
Dry skin 23.75 10.62 66 142504 107587 110339142
Disability 23.70 10.62 5 142565 30218 110416511
Water intoxication 23.68 10.62 15 142555 944 110445785
Breath odour 23.62 10.62 20 142550 1972 110444757
Sinus node dysfunction 23.48 10.62 42 142528 9005 110437724
Plasma cell myeloma 23.36 10.62 28 142542 62908 110383821
Urinary incontinence 23.33 10.62 124 142446 48463 110398266
Brugada syndrome 23.18 10.62 18 142552 1570 110445159
Pulmonary vasculitis 23.17 10.62 35 142535 6525 110440204
Astrocytoma, low grade 23.15 10.62 8 142562 121 110446608
Epistaxis 23.15 10.62 88 142482 130284 110316445
Hyperprolactinaemia 23.11 10.62 35 142535 6540 110440189
Bradykinesia 22.94 10.62 46 142524 10742 110435987
Porocarcinoma 22.90 10.62 6 142564 32 110446697
Pleural neoplasm 22.82 10.62 11 142559 403 110446326
Congenital inguinal hernia 22.80 10.62 5 142565 10 110446719
Anaemia megaloblastic 22.78 10.62 14 142556 835 110445894
Phonophobia 22.70 10.62 13 142557 680 110446049
Opticokinetic nystagmus tests abnormal 22.62 10.62 4 142566 0 110446729
Abortion 22.53 10.62 18 142552 1636 110445093
Acute hepatic failure 22.50 10.62 100 142470 36368 110410361
Immune thrombocytopenia 22.48 10.62 72 142498 22422 110424307
Pulmonary mass 22.39 10.62 10 142560 37291 110409438
Haemorrhoids 22.31 10.62 9 142561 35663 110411066
Prescribed overdose 22.19 10.62 50 142520 87531 110359198
Dermatitis allergic 22.14 10.62 70 142500 21654 110425075
Gingival atrophy 22.13 10.62 7 142563 79 110446650
Therapy interrupted 22.09 10.62 19 142551 49803 110396926
Metastases to liver 22.02 10.62 9 142561 35377 110411352
Postictal state 21.97 10.62 21 142549 2425 110444304
Incoherent 21.95 10.62 39 142531 8319 110438410
Retinal deposits 21.92 10.62 8 142562 143 110446586
Abortion spontaneous 21.90 10.62 95 142475 34187 110412542
Extensor plantar response 21.90 10.62 19 142551 1936 110444793
Encephalopathy 21.86 10.62 179 142391 80876 110365853
Blood test abnormal 21.83 10.62 5 142565 28549 110418180
Upper respiratory tract infection 21.83 10.62 91 142479 131237 110315492
Learning disorder 21.72 10.62 13 142557 739 110445990
Atrioventricular block 21.62 10.62 59 142511 16818 110429911
Benign cardiac neoplasm 21.51 10.62 6 142564 42 110446687
Suspiciousness 21.48 10.62 13 142557 754 110445975
Haemoglobin decreased 21.39 10.62 211 142359 248516 110198213
Product quality issue 21.38 10.62 42 142528 77257 110369472
Therapeutic product effective for unapproved indication 21.33 10.62 8 142562 155 110446574
Ultrasound ovary abnormal 21.30 10.62 7 142563 90 110446639
Logorrhoea 21.25 10.62 29 142541 4928 110441801
Dermatitis bullous 21.19 10.62 60 142510 17469 110429260
Hyperthermia 21.18 10.62 68 142502 21204 110425525
Ulcer 20.94 10.62 15 142555 43101 110403628
Pulmonary arterial hypertension 20.73 10.62 8 142562 32560 110414169
Device expulsion 20.66 10.62 7 142563 30884 110415845
Intra-abdominal pressure increased 20.60 10.62 10 142560 372 110446357
Inappropriate schedule of product administration 20.47 10.62 166 142404 203471 110243258
Rhesus incompatibility 20.46 10.62 5 142565 19 110446710
Body mass index decreased 20.45 10.62 13 142557 823 110445906
Dexamethasone suppression test positive 20.39 10.62 4 142566 3 110446726
Conjunctivitis allergic 20.37 10.62 34 142536 6897 110439832
Polydipsia 20.35 10.62 36 142534 7652 110439077
Ileus paralytic 20.28 10.62 46 142524 11691 110435038
Low set ears 20.25 10.62 7 142563 106 110446623
Diabetic neuropathy 20.13 10.62 34 142536 6965 110439764
Convulsive threshold lowered 20.11 10.62 14 142556 1032 110445697
Liver function test abnormal 20.09 10.62 155 142415 68795 110377934
Fabry's disease 20.06 10.62 5 142565 21 110446708
Persistent depressive disorder 19.96 10.62 16 142554 1461 110445268
Major depression 19.90 10.62 43 142527 10578 110436151
Thrombocytopenic purpura 19.88 10.62 22 142548 3017 110443712
Effusion 19.86 10.62 21 142549 2736 110443993
Brain lobectomy 19.85 10.62 4 142566 4 110446725
Tracheo-oesophageal fistula 19.81 10.62 12 142558 697 110446032
Romberg test positive 19.74 10.62 9 142561 290 110446439
Blood pressure systolic abnormal 19.72 10.62 4 142566 24846 110421883
Perseveration 19.55 10.62 10 142560 417 110446312
Bronchiectasis 19.52 10.62 96 142474 36397 110410332
Obsessive thoughts 19.48 10.62 15 142555 1292 110445437
Condition aggravated 19.46 10.62 1145 141425 733691 109713038
Sputum discoloured 19.27 10.62 6 142564 27939 110418790
Therapeutic response shortened 19.27 10.62 7 142563 29576 110417153
Joint dislocation 19.25 10.62 10 142560 34180 110412549
Antineutrophil cytoplasmic antibody positive 19.25 10.62 28 142542 5048 110441681
Blood immunoglobulin M decreased 19.25 10.62 18 142552 2023 110444706
Oedema peripheral 19.16 10.62 303 142267 328357 110118372
Blood pressure increased 19.08 10.62 227 142343 258146 110188583
Viral diarrhoea 19.08 10.62 11 142559 583 110446146
Feeling of despair 19.05 10.62 24 142546 3774 110442955
Treatment noncompliance 19.05 10.62 160 142410 72830 110373899
Blood hyposmosis 19.03 10.62 5 142565 27 110446702
Ejection fraction decreased 18.86 10.62 15 142555 40865 110405864
Cataract 18.85 10.62 47 142523 79438 110367291
Thrombotic microangiopathy 18.82 10.62 7 142563 29142 110417587
Paresis 18.78 10.62 27 142543 4817 110441912
Automatism 18.76 10.62 8 142562 219 110446510
Hypomania 18.75 10.62 41 142529 10169 110436560
Blood pressure fluctuation 18.73 10.62 43 142527 74781 110371948
Abortion threatened 18.70 10.62 10 142560 457 110446272
Lactate pyruvate ratio increased 18.63 10.62 6 142564 72 110446657
Infrapatellar fat pad inflammation 18.62 10.62 8 142562 223 110446506
Genital pain 18.57 10.62 15 142555 1385 110445344
Sinus congestion 18.54 10.62 8 142562 30451 110416278
Neurotoxicity 18.45 10.62 105 142465 42102 110404627
Circulating anticoagulant positive 18.45 10.62 5 142565 31 110446698
Transfusion 18.43 10.62 5 142565 25467 110421262
Cytomegalovirus infection 18.38 10.62 26 142544 54418 110392311
Drug-induced liver injury 18.35 10.62 236 142334 119831 110326898
Genital erosion 18.33 10.62 12 142558 799 110445930
Lip swelling 18.31 10.62 120 142450 50547 110396182
Areflexia 18.31 10.62 32 142538 6737 110439992
Hallucination, visual 18.29 10.62 100 142470 39505 110407224
Disseminated intravascular coagulation 18.23 10.62 103 142467 41183 110405546
Enzyme level abnormal 18.23 10.62 8 142562 235 110446494
Derailment 18.20 10.62 6 142564 78 110446651
Laboratory test abnormal 18.14 10.62 18 142552 44061 110402668
Benzodiazepine drug level increased 18.08 10.62 8 142562 240 110446489
Gingival hypertrophy 18.06 10.62 25 142545 4306 110442423
Basal cell carcinoma 18.05 10.62 19 142551 45251 110401478
Affect lability 18.04 10.62 59 142511 18578 110428151
Depressive symptom 18.04 10.62 36 142534 8378 110438351
Pulmonary hypertension 18.02 10.62 27 142543 55193 110391536
Respiratory disorder 17.89 10.62 41 142529 71341 110375388
Measles 17.84 10.62 11 142559 660 110446069
Conduction disorder 17.81 10.62 24 142546 4031 110442698
Selective IgG subclass deficiency 17.80 10.62 5 142565 36 110446693
Injection site bruising 17.78 10.62 24 142546 51239 110395490
Odynophagia 17.77 10.62 49 142521 14052 110432677
Rhabdomyolysis 17.71 10.62 235 142335 120166 110326563
Cholestasis 17.68 10.62 143 142427 64375 110382354
Priapism 17.56 10.62 29 142541 5832 110440897
Tearfulness 17.51 10.62 33 142537 7362 110439367
Flatulence 17.51 10.62 25 142545 52124 110394605
Clostridium difficile infection 17.49 10.62 25 142545 52104 110394625
Paranoia 17.48 10.62 66 142504 22308 110424421
Tic 17.40 10.62 22 142548 3471 110443258
Tumour lysis syndrome 17.35 10.62 9 142561 30792 110415937
Breast discomfort 17.34 10.62 10 142560 530 110446199
Staring 17.33 10.62 20 142550 2872 110443857
Rickets 17.29 10.62 6 142564 92 110446637
Carcinoembryonic antigen 17.29 10.62 6 142564 92 110446637
Fanconi syndrome 17.27 10.62 22 142548 3497 110443232
B-lymphocyte count decreased 17.25 10.62 17 142553 2038 110444691
Conjunctival oedema 17.19 10.62 15 142555 1541 110445188
Screaming 17.18 10.62 26 142544 4855 110441874
Candida infection 17.14 10.62 22 142548 47987 110398742
Drug tolerance decreased 17.14 10.62 7 142563 27533 110419196
Ophthalmoplegia 17.12 10.62 22 142548 3528 110443201
Ultrasound liver abnormal 17.12 10.62 7 142563 172 110446557
Urticaria vesiculosa 17.09 10.62 4 142566 12 110446717
Drowning 16.99 10.62 12 142558 905 110445824
Renal impairment 16.99 10.62 158 142412 188287 110258442
HLA-B*1502 assay positive 16.97 10.62 3 142567 0 110446729
Tensilon test abnormal 16.97 10.62 3 142567 0 110446729
SUNCT syndrome 16.97 10.62 3 142567 0 110446729
Pneumocystis jirovecii pneumonia 16.96 10.62 18 142552 42717 110404012
Head injury 16.86 10.62 104 142466 42913 110403816
Carbohydrate antigen 15-3 16.83 10.62 6 142564 100 110446629
Wrong product administered 16.81 10.62 41 142529 10919 110435810
Anticoagulation drug level decreased 16.78 10.62 8 142562 286 110446443
Obesity 16.77 10.62 82 142488 113269 110333460
Vaginal ulceration 16.75 10.62 8 142562 287 110446442
Bladder cancer 16.67 10.62 3 142567 20289 110426440
Vaginal erosion 16.62 10.62 4 142566 14 110446715
Rash pustular 16.58 10.62 45 142525 12784 110433945
Pigmentation disorder 16.54 10.62 32 142538 7279 110439450
Cervical dysplasia 16.50 10.62 19 142551 2721 110444008
Hyperdynamic left ventricle 16.49 10.62 10 142560 582 110446147
Negative thoughts 16.46 10.62 15 142555 1631 110445098
Muscle rigidity 16.44 10.62 68 142502 23963 110422766
Fungal infection 16.43 10.62 25 142545 50781 110395948
Inadequate analgesia 16.41 10.62 26 142544 5051 110441678
Gastroenteritis viral 16.33 10.62 10 142560 31216 110415513
Walking aid user 16.22 10.62 6 142564 25069 110421660
Hangover 16.17 10.62 18 142552 2484 110444245
Electrocardiogram QRS complex prolonged 16.16 10.62 45 142525 12976 110433753
Dyspnoea exertional 16.14 10.62 74 142496 103986 110342743
Learning disability 16.14 10.62 7 142563 200 110446529
Blood citric acid increased 16.09 10.62 5 142565 53 110446676
Normochromic normocytic anaemia 16.09 10.62 45 142525 13012 110433717
Drug level changed 16.07 10.62 10 142560 610 110446119
End stage renal disease 15.95 10.62 4 142566 21469 110425260
Developmental delay 15.93 10.62 14 142556 1451 110445278
Cardiac disorder 15.92 10.62 48 142522 76232 110370497
Bone pain 15.85 10.62 38 142532 65095 110381634
Encephalocele 15.84 10.62 5 142565 56 110446673
Strabismus 15.81 10.62 21 142549 3478 110443251
Full blood count decreased 15.81 10.62 11 142559 32088 110414641
Bundle branch block right 15.78 10.62 43 142527 12248 110434481
Hippocampal sclerosis 15.76 10.62 7 142563 212 110446517
Hot flush 15.70 10.62 39 142531 65997 110380732
Nervousness 15.66 10.62 91 142479 36760 110409969
Pyroglutamate increased 15.63 10.62 10 142560 640 110446089
Polydipsia psychogenic 15.63 10.62 8 142562 334 110446395
Adrenal insufficiency 15.58 10.62 19 142551 42371 110404358
Radiculopathy 15.58 10.62 3 142567 19333 110427396
Inhibitory drug interaction 15.53 10.62 25 142545 4922 110441807
Device issue 15.52 10.62 13 142557 34522 110412207
COVID-19 pneumonia 15.48 10.62 15 142555 37128 110409601
Blood pressure systolic increased 15.40 10.62 55 142515 82936 110363793
Fear-related avoidance of activities 15.37 10.62 6 142564 130 110446599
Chronic idiopathic pain syndrome 15.37 10.62 7 142563 225 110446504
Blood pressure diastolic abnormal 15.37 10.62 7 142563 25808 110420921
Subacute cutaneous lupus erythematosus 15.36 10.62 25 142545 4969 110441760
Drug level above therapeutic 15.34 10.62 41 142529 11547 110435182
Cranial nerve disorder 15.33 10.62 13 142557 1284 110445445
Hypochloraemia 15.26 10.62 21 142549 3597 110443132
Antisocial behaviour 15.26 10.62 11 142559 857 110445872
Hypocalcaemic seizure 15.25 10.62 6 142564 133 110446596
Idiopathic generalised epilepsy 15.23 10.62 5 142565 64 110446665
Acute myocardial infarction 15.23 10.62 56 142514 83721 110363008
Frontotemporal dementia 15.18 10.62 10 142560 673 110446056
Polyarthritis 15.16 10.62 3 142567 18960 110427769
Sinus disorder 15.11 10.62 12 142558 32716 110414013
Appendicitis 15.05 10.62 9 142561 28455 110418274
Pupillary reflex impaired 15.01 10.62 22 142548 3993 110442736
Distractibility 14.89 10.62 11 142559 890 110445839
Cold agglutinins 14.89 10.62 3 142567 3 110446726
Weight fluctuation 14.84 10.62 5 142565 22140 110424589
Metapneumovirus infection 14.81 10.62 17 142553 2427 110444302
Cytomegalovirus mucocutaneous ulcer 14.76 10.62 6 142564 145 110446584
Juvenile myoclonic epilepsy 14.76 10.62 5 142565 71 110446658
Haemorrhage 14.75 10.62 79 142491 106613 110340116
Maternal drugs affecting foetus 14.75 10.62 14 142556 1603 110445126
Scab 14.75 10.62 44 142526 13192 110433537
Visual field defect 14.73 10.62 37 142533 10035 110436694
Chronic sinusitis 14.63 10.62 7 142563 25077 110421652
Product dose omission in error 14.60 10.62 6 142564 23506 110423223
Nasal congestion 14.59 10.62 71 142499 98211 110348518
Urinary tract infection 14.58 10.62 315 142255 325967 110120762
Antemortem blood drug level abnormal 14.57 10.62 5 142565 74 110446655
Tooth development disorder 14.57 10.62 5 142565 74 110446655
Laryngeal pain 14.57 10.62 27 142543 5948 110440781
Bacteraemia 14.55 10.62 20 142550 42370 110404359
Caesarean section 14.52 10.62 45 142525 13772 110432957
Antipsychotic drug level decreased 14.38 10.62 13 142557 1399 110445330
Hypersexuality 14.37 10.62 15 142555 1925 110444804
Oral mucosal eruption 14.33 10.62 12 142558 1165 110445564
Incorrect route of product administration 14.33 10.62 39 142531 64022 110382707
Coagulation time shortened 14.28 10.62 8 142562 401 110446328
Second primary malignancy 14.15 10.62 3 142567 18065 110428664
Xanthelasma 14.11 10.62 6 142564 163 110446566
Transplant rejection 14.11 10.62 7 142563 24560 110422169
Throat irritation 14.04 10.62 30 142540 53522 110393207
Bipolar I disorder 14.03 10.62 16 142554 2267 110444462
Skin oedema 14.00 10.62 15 142555 1984 110444745
Feelings of worthlessness 14.00 10.62 9 142561 581 110446148
Bone metabolism disorder 14.00 10.62 9 142561 581 110446148
Congenital arterial malformation 13.98 10.62 4 142566 31 110446698
Acquired diaphragmatic eventration 13.95 10.62 10 142560 772 110445957
Diabetes insipidus 13.95 10.62 28 142542 6542 110440187
Neuritis 13.92 10.62 30 142540 7369 110439360
Antipsychotic drug level below therapeutic 13.91 10.62 14 142556 1721 110445008
Granulocytopenia 13.91 10.62 42 142528 12673 110434056
Vitamin D deficiency 13.90 10.62 54 142516 18498 110428231
Paralogism 13.87 10.62 4 142566 32 110446697
Mite allergy 13.87 10.62 26 142544 5777 110440952
Fear 13.86 10.62 63 142507 23130 110423599
Parkinsonism 13.81 10.62 61 142509 22126 110424603
Pulmonary toxicity 13.79 10.62 3 142567 17743 110428986
Tonic clonic movements 13.78 10.62 18 142552 2934 110443795
Dysstasia 13.72 10.62 81 142489 32905 110413824
Apgar score low 13.68 10.62 3 142567 6 110446723
Drug half-life reduced 13.68 10.62 3 142567 6 110446723
Illiteracy 13.66 10.62 4 142566 34 110446695
Red cell distribution width increased 13.62 10.62 3 142567 17599 110429130
Joint injury 13.60 10.62 19 142551 39975 110406754
Dry age-related macular degeneration 13.53 10.62 7 142563 299 110446430
Muscle twitching 13.43 10.62 75 142495 29860 110416869
Hypoproteinaemia 13.43 10.62 26 142544 5919 110440810
Mycotic allergy 13.40 10.62 26 142544 5928 110440801
Niemann-Pick disease 13.36 10.62 4 142566 37 110446692
Impaired driving ability 13.35 10.62 27 142543 6343 110440386
Unevaluable event 13.29 10.62 36 142534 59191 110387538
Lupus-like syndrome 13.26 10.62 20 142550 40772 110405957
Blood growth hormone increased 13.24 10.62 11 142559 1057 110445672
Guillain-Barre syndrome 13.21 10.62 37 142533 10707 110436022
Tardive dyskinesia 13.15 10.62 43 142527 13536 110433193
Syncope 13.11 10.62 348 142222 202188 110244541
Hepatitis fulminant 13.11 10.62 32 142538 8528 110438201
Incorrect product administration duration 13.10 10.62 5 142565 20493 110426236
Pulse abnormal 13.07 10.62 21 142549 4128 110442601
Porphyria acute 13.01 10.62 4 142566 18776 110427953
Thyroid adenoma 13.00 10.62 6 142564 199 110446530
Akathisia 12.97 10.62 50 142520 17063 110429666
Chapped lips 12.96 10.62 18 142552 3110 110443619
Skin haemorrhage 12.92 10.62 8 142562 24819 110421910
Rheumatoid nodule 12.89 10.62 5 142565 20291 110426438
Glomerular filtration rate decreased 12.89 10.62 11 142559 28945 110417784
Encapsulating peritoneal sclerosis 12.82 10.62 10 142560 878 110445851
Vanishing bile duct syndrome 12.78 10.62 18 142552 3150 110443579
Hallucinations, mixed 12.78 10.62 32 142538 8661 110438068
Confusional state 12.71 10.62 732 141838 467948 109978781
Human herpesvirus 7 infection 12.70 10.62 6 142564 210 110446519
Lower gastrointestinal haemorrhage 12.69 10.62 4 142566 18482 110428247
Rebound effect 12.68 10.62 45 142525 14761 110431968
Cell death 12.68 10.62 25 142545 5766 110440963
Pericardial effusion 12.68 10.62 35 142535 57182 110389547
Hepatomegaly 12.67 10.62 58 142512 21356 110425373
Asthenia 12.66 10.62 743 141827 688256 109758473
Accidental exposure to product by child 12.65 10.62 18 142552 3180 110443549
Mental status changes 12.65 10.62 152 142418 75970 110370759
Right ventricular failure 12.64 10.62 9 142561 25945 110420784
Pharyngeal erythema 12.63 10.62 15 142555 2220 110444509
Altered visual depth perception 12.62 10.62 8 142562 504 110446225
Electrocardiogram QT prolonged 12.60 10.62 204 142366 108756 110337973
Heart sounds 12.59 10.62 11 142559 1132 110445597
Erythema of eyelid 12.59 10.62 20 142550 3895 110442834
Hyperglycinaemia 12.58 10.62 3 142567 10 110446719
Myelodysplastic syndrome 12.55 10.62 18 142552 37466 110409263
Cytomegalovirus infection reactivation 12.53 10.62 4 142566 18329 110428400
Herpes zoster 12.49 10.62 85 142485 108294 110338435
Brain injury 12.45 10.62 42 142528 13434 110433295
Onychophagia 12.37 10.62 5 142565 119 110446610
Feeling drunk 12.36 10.62 24 142546 5476 110441253
Enzyme induction 12.34 10.62 5 142565 120 110446609
Localised infection 12.24 10.62 23 142547 43025 110403704
Dissociative amnesia 12.22 10.62 5 142565 123 110446606
Glycosuria 12.22 10.62 16 142554 2614 110444115
Vestibular disorder 12.21 10.62 16 142554 2616 110444113
Disorganised speech 12.21 10.62 18 142552 3285 110443444
Conjunctival discolouration 12.18 10.62 5 142565 124 110446605
Impulsive behaviour 12.16 10.62 18 142552 3297 110443432
Threatened uterine rupture 12.15 10.62 3 142567 12 110446717
Biopsy lymph gland abnormal 12.15 10.62 3 142567 12 110446717
Thrombosis 12.14 10.62 86 142484 108576 110338153
Patient uncooperative 12.13 10.62 10 142560 950 110445779
Exposure during pregnancy 12.11 10.62 292 142278 167132 110279597
Shunt occlusion 12.10 10.62 13 142557 1724 110445005
Mucosal disorder 12.10 10.62 21 142549 4396 110442333
Vaginal discharge 12.08 10.62 4 142566 17904 110428825
Dust allergy 12.06 10.62 25 142545 5976 110440753
Pyuria 12.06 10.62 16 142554 2647 110444082
Medulloblastoma 12.04 10.62 5 142565 128 110446601
Porphyria non-acute 11.97 10.62 9 142561 748 110445981
Pseudophaeochromocytoma 11.96 10.62 5 142565 130 110446599
Angiosclerosis 11.96 10.62 3 142567 13 110446716
Back disorder 11.96 10.62 6 142564 20916 110425813
Tuberculosis 11.93 10.62 4 142566 17770 110428959
Agranulocytosis 11.93 10.62 127 142443 61633 110385096
Cytomegalovirus viraemia 11.92 10.62 4 142566 17760 110428969
Maculopathy 11.92 10.62 17 142553 3010 110443719
Mitral valve prolapse 11.88 10.62 15 142555 2363 110444366
Device dislocation 11.88 10.62 14 142556 31690 110415039
Therapy cessation 11.87 10.62 25 142545 44832 110401897
Neoplasm progression 11.86 10.62 43 142527 64552 110382177
Blood 1,25-dihydroxycholecalciferol decreased 11.86 10.62 4 142566 56 110446673
Mitochondrial cytopathy 11.86 10.62 7 142563 388 110446341
Gastrooesophageal reflux disease 11.84 10.62 162 142408 179814 110266915
Pathogen resistance 11.83 10.62 4 142566 17668 110429061
Wheezing 11.81 10.62 245 142325 254985 110191744
Iliac artery occlusion 11.81 10.62 7 142563 391 110446338
Open angle glaucoma 11.79 10.62 8 142562 566 110446163
Pneumatosis 11.77 10.62 10 142560 991 110445738
Dependence 11.75 10.62 16 142554 2713 110444016
Medication error 11.72 10.62 196 142374 105170 110341559
Acanthosis 11.68 10.62 8 142562 574 110446155
Genital burning sensation 11.63 10.62 7 142563 402 110446327
Oral disorder 11.62 10.62 38 142532 11965 110434764
Enlarged cerebral perivascular spaces 11.61 10.62 3 142567 15 110446714
Respiratory symptom 11.60 10.62 44 142526 14901 110431828
Rash papular 11.58 10.62 68 142502 27571 110419158
Peritonitis 11.58 10.62 15 142555 32592 110414137
Nephropathy toxic 11.56 10.62 11 142559 27467 110419262
Lymphopenia 11.53 10.62 90 142480 40080 110406649
Withdrawal catatonia 11.50 10.62 7 142563 410 110446319
Tendonitis 11.50 10.62 10 142560 26073 110420656
Prolonged expiration 11.50 10.62 12 142558 1540 110445189
Hypoosmolar state 11.47 10.62 7 142563 412 110446317
Compulsions 11.46 10.62 7 142563 413 110446316
Eyelid erosion 11.43 10.62 4 142566 63 110446666
Biopsy skin abnormal 11.39 10.62 6 142564 266 110446463
Loss of personal independence in daily activities 11.38 10.62 131 142439 149889 110296840
Anticonvulsant drug level abnormal 11.37 10.62 4 142566 64 110446665
Device difficult to use 11.35 10.62 5 142565 18800 110427929
Device related infection 11.34 10.62 21 142549 39498 110407231
Chills 11.33 10.62 175 142395 190405 110256324
Squamous cell carcinoma of skin 11.33 10.62 4 142566 17199 110429530
Diverticulum 11.32 10.62 3 142567 15523 110431206
Basilar migraine 11.31 10.62 4 142566 65 110446664
Eosinophilic oesophagitis 11.29 10.62 11 142559 1301 110445428
Abulia 11.28 10.62 11 142559 1302 110445427
Conjunctival disorder 11.28 10.62 7 142563 425 110446304
Paraesthesia 11.21 10.62 271 142299 276250 110170479
Lip oedema 11.20 10.62 28 142542 7572 110439157
Mitral valve incompetence 11.16 10.62 16 142554 33313 110413416
Transaminases increased 11.16 10.62 128 142442 63262 110383467
Kluver-Bucy syndrome 11.15 10.62 3 142567 18 110446711
Carnitine decreased 11.15 10.62 3 142567 18 110446711
Pressure of speech 11.15 10.62 11 142559 1321 110445408
Near drowning 11.15 10.62 4 142566 68 110446661
Hypoventilation 11.11 10.62 29 142541 8052 110438677
Neutropenic sepsis 11.07 10.62 14 142556 30732 110415997
Respiratory tract infection 11.06 10.62 51 142519 71566 110375163
Hypoglycaemia 11.05 10.62 96 142474 116008 110330721
Proctitis 11.04 10.62 4 142566 16923 110429806
Hypothyroidism 11.01 10.62 143 142427 72756 110373973
Snake bite 11.01 10.62 3 142567 19 110446710
Low birth weight baby 11.00 10.62 9 142561 846 110445883
Wrong drug 11.00 10.62 7 142563 444 110446285
Product dispensing error 10.99 10.62 46 142524 16299 110430430
Venoocclusive liver disease 10.97 10.62 3 142567 15204 110431525
Acinetobacter test positive 10.97 10.62 6 142564 287 110446442
Necrosis ischaemic 10.96 10.62 11 142559 1348 110445381
Bone marrow failure 10.96 10.62 38 142532 57810 110388919
Histiocytic necrotising lymphadenitis 10.94 10.62 4 142566 72 110446657
Nephrolithiasis 10.93 10.62 46 142524 66166 110380563
Herpes virus infection 10.87 10.62 30 142540 8608 110438121
Dermatitis exfoliative generalised 10.86 10.62 35 142535 10937 110435792
Blood creatinine increased 10.85 10.62 168 142402 182721 110264008
Foaming at mouth 10.84 10.62 14 142556 2256 110444473
Immunodeficiency 10.83 10.62 21 142549 38817 110407912
Blood chloride decreased 10.82 10.62 31 142539 9084 110437645
Disease recurrence 10.82 10.62 123 142447 60661 110386068
Hypervigilance 10.81 10.62 8 142562 649 110446080
Erectile dysfunction 10.79 10.62 50 142520 18506 110428223
Hyperacusis 10.78 10.62 16 142554 2936 110443793
Facial spasm 10.76 10.62 9 142561 873 110445856
Splenomegaly 10.74 10.62 61 142509 24437 110422292
Illness 10.73 10.62 62 142508 82109 110364620
Human herpesvirus 6 infection reactivation 10.73 10.62 10 142560 1119 110445610
Osteoporosis 10.73 10.62 67 142503 87085 110359644
Insulin-like growth factor increased 10.72 10.62 14 142556 2282 110444447
Haematotoxicity 10.68 10.62 7 142563 21075 110425654
Salivary gland calculus 10.65 10.62 6 142564 304 110446425
Stab wound 10.65 10.62 6 142564 304 110446425
Rhinorrhoea 10.63 10.62 83 142487 102583 110344146

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
Epilepsy 23.26 20.73 9 269 98 113577
Magnetic resonance imaging head abnormal 22.95 20.73 8 270 63 113612

Pharmacologic Action:

SourceCodeDescription
ATC N03AF01 NERVOUS SYSTEM
ANTIEPILEPTICS
ANTIEPILEPTICS
Carboxamide derivatives
FDA PE N0000008486 Decreased Central Nervous System Disorganized Electrical Activity
CHEBI has role CHEBI:22587 antiviral agent
CHEBI has role CHEBI:35469 antidepressant
CHEBI has role CHEBI:35474 anxiolytic drug
CHEBI has role CHEBI:35476 antipsychotic agent
CHEBI has role CHEBI:35477 antimanic drug
CHEBI has role CHEBI:35480 analgesic
CHEBI has role CHEBI:35481 non-narcotic analgesic
CHEBI has role CHEBI:35623 anticonvulsant
CHEBI has role CHEBI:35703 xenobiotic
CHEBI has role CHEBI:38633 sodium channel blocker
CHEBI has role CHEBI:48407 antiparkinson drug
CHEBI has role CHEBI:50919 antiemetic
CHEBI has role CHEBI:52290 mitogen
CHEBI has role CHEBI:61115 EC 3.5.1.98 (histone deacetylase) inhibitor
CHEBI has role CHEBI:64370 glutamate transporter activator
CHEBI has role CHEBI:64946 anti-HIV agent
CHEBI has role CHEBI:64951 anti-HBV agent
CHEBI has role CHEBI:78298 environmental contaminant
CHEBI has role CHEBI:88188 drug allergen
MeSH PA D000700 Analgesics
MeSH PA D000927 Anticonvulsants
MeSH PA D002317 Cardiovascular Agents
MeSH PA D002492 Central Nervous System Depressants
MeSH PA D011619 Psychotropic Drugs
MeSH PA D018689 Sensory System Agents
MeSH PA D018692 Antimanic Agents
MeSH PA D018712 Analgesics, Non-Narcotic
MeSH PA D026941 Sodium Channel Blockers
MeSH PA D049990 Membrane Transport Modulators
MeSH PA D065701 Cytochrome P-450 CYP3A Inducers
FDA EPC N0000175751 Mood Stabilizer
FDA MoA N0000185506 Cytochrome P450 3A4 Inducers
FDA MoA N0000185507 Cytochrome P450 2C9 Inducers
FDA MoA N0000185607 Cytochrome P450 2C19 Inducers
FDA MoA N0000187064 Cytochrome P450 2B6 Inducers
FDA MoA N0000191266 Cytochrome P450 1A2 Inducers

Related Drugs by ATC class:

N03AF Carboxamide derivatives 3 drugs

Drug Use | Suggest Off label Use Form| |View source of the data|

DiseaseRelationSNOMED_IDDOID
Mixed bipolar I disorder indication 16506000 DOID:3312
Trigeminal neuralgia indication 31681005 DOID:12098
Glossopharyngeal neuralgia indication 43763009 DOID:14423
Tonic-clonic seizure indication 54200006
Epilepsy indication 84757009 DOID:1826
Bipolar disorder in remission indication 85248005
Bipolar affective disorder, current episode manic indication 191618007
Localization-related epilepsy indication 230381009 DOID:2234
Lennox-Gastaut syndrome indication 230418006
Tonic-clonic epilepsy indication 352818000 DOID:7725
Epilepsy characterized by intractable complex partial seizures indication 442481002
Simple partial seizure indication 117891000119100
Mixed Epilepsy indication
Neurohypophyseal diabetes insipidus off-label use 45369008 DOID:12388
Bipolar affective disorder, current episode depression off-label use 191627008 DOID:3312
Neuropathic pain off-label use 247398009
Attention deficit hyperactivity disorder off-label use 406506008
Prevention of Seizures following Cranial Trauma or Surgery off-label use
Rapid Cycling Bipolar Affective Disorder off-label use
Ocular hypertension contraindication 4210003 DOID:9282
Suicidal thoughts contraindication 6471006
Hypercholesterolemia contraindication 13644009
Agranulocytosis contraindication 17182001 DOID:12987
Mood swings contraindication 18963009
Glaucoma contraindication 23986001 DOID:1686
Complete atrioventricular block contraindication 27885002
Depressive disorder contraindication 35489007
Hypertensive disorder contraindication 38341003 DOID:10763
Conduction disorder of the heart contraindication 44808001
Chronic heart failure contraindication 48447003
Syndrome of inappropriate vasopressin secretion contraindication 55004003 DOID:3401
Acute nephropathy contraindication 58574008
Absence seizure contraindication 79631006
Hyponatremia contraindication 89627008
Kidney disease contraindication 90708001 DOID:557
Pancytopenia contraindication 127034005 DOID:12450
Impaired renal function disorder contraindication 197663003
Non-infective meningitis contraindication 230155003
Acute intermittent porphyria contraindication 234422006 DOID:3890
Disease of liver contraindication 235856003 DOID:409
Retention of urine contraindication 267064002
Anemia contraindication 271737000 DOID:2355
Pregnancy, function contraindication 289908002
Thrombocytopenic disorder contraindication 302215000 DOID:1588
Neutropenic disorder contraindication 303011007 DOID:1227
Aplastic anemia contraindication 306058006 DOID:12449
Bone marrow depression contraindication 307762000
Disorder of coronary artery contraindication 414024009
HLA-B 1502 Positive Status contraindication
Carbamazepine Toxicity contraindication




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 13.13 acidic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
200MG/20ML (10MG/ML) CARNEXIV LUNDBECK PHARMS LLC N206030 Oct. 7, 2016 DISCN SOLUTION INTRAVENOUS 9629797 Nov. 10, 2028 REPLACEMENT THERAPY FOR ORAL CARBAMAZEPINE IN ADULTS WITH GENERALIZED TONIC-CLONIC SEIZURES
200MG/20ML (10MG/ML) CARNEXIV LUNDBECK PHARMS LLC N206030 Oct. 7, 2016 DISCN SOLUTION INTRAVENOUS 9629797 Nov. 10, 2028 REPLACEMENT THERAPY FOR ORAL CARBAMAZEPINE IN ADULTS WITH MIXED SEIZURE PATTERNS THAT INCLUDE PARTIAL SEIZURES WITH COMPLEX SYMPTOMATOLOGY, GENERALIZED TONIC-CLONIC SEIZURES, OR OTHER PARTIAL OR GENERALIZED SEIZURES
200MG/20ML (10MG/ML) CARNEXIV LUNDBECK PHARMS LLC N206030 Oct. 7, 2016 DISCN SOLUTION INTRAVENOUS 9629797 Nov. 10, 2028 REPLACEMENT THERAPY FOR ORAL CARBAMAZEPINE IN ADULTS WITH PARTIAL SEIZURES WITH COMPLEX SYMPTOMATOLOGY

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
Sodium channel protein type 4 subunit alpha Ion channel BLOCKER Ki 4.28 CHEMBL CHEMBL
Sodium channel protein type 9 subunit alpha Ion channel BLOCKER IC50 4.66 CHEMBL CHEMBL
Sodium channel protein type 5 subunit alpha Ion channel BLOCKER IC50 4.33 CHEMBL CHEMBL
Nuclear receptor subfamily 1 group I member 2 Nuclear hormone receptor WOMBAT-PK
GABA-A receptor alpha-1/beta-2/gamma-2 Ion channel WOMBAT-PK
Neuronal acetylcholine receptor; alpha2/beta4 Ion channel IC50 4.31 WOMBAT-PK
Frizzled-8 GPCR ALLOSTERIC MODULATOR Kd 4.77 IUPHAR
Sodium-dependent serotonin transporter Transporter Kd 4.50 WOMBAT-PK
Histamine H1 receptor GPCR Ki 4.13 WOMBAT-PK
Frizzled-8 GPCR Kd 4.78 CHEMBL

External reference:

IDSource
4017873 VUID
N0000146226 NUI
D00252 KEGG_DRUG
2002 RXNORM
C0006949 UMLSCUI
CHEBI:3387 CHEBI
N6W PDB_CHEM_ID
CHEMBL108 ChEMBL_ID
DB00564 DRUGBANK_ID
D002220 MESH_DESCRIPTOR_UI
2554 PUBCHEM_CID
5339 IUPHAR_LIGAND_ID
1836 INN_ID
33CM23913M UNII
4350 MMSL
513 MMSL
d00058 MMSL
387222003 SNOMEDCT_US
40820003 SNOMEDCT_US
85756-57-6 SECONDARY_CAS_RN
4017873 VANDF
001634 NDDF
33CM23913M INXIGHT DRUGS

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Tegretol HUMAN PRESCRIPTION DRUG LABEL 1 0078-0508 SUSPENSION 100 mg ORAL NDA 27 sections
Tegretol HUMAN PRESCRIPTION DRUG LABEL 1 0078-0508 SUSPENSION 100 mg ORAL NDA 27 sections
Tegretol HUMAN PRESCRIPTION DRUG LABEL 1 0078-0509 TABLET 200 mg ORAL NDA 27 sections
Tegretol HUMAN PRESCRIPTION DRUG LABEL 1 0078-0509 TABLET 200 mg ORAL NDA 27 sections
TegretolXR HUMAN PRESCRIPTION DRUG LABEL 1 0078-0510 TABLET, EXTENDED RELEASE 100 mg ORAL NDA 27 sections
TegretolXR HUMAN PRESCRIPTION DRUG LABEL 1 0078-0510 TABLET, EXTENDED RELEASE 100 mg ORAL NDA 27 sections
TegretolXR HUMAN PRESCRIPTION DRUG LABEL 1 0078-0511 TABLET, EXTENDED RELEASE 200 mg ORAL NDA 27 sections
TegretolXR HUMAN PRESCRIPTION DRUG LABEL 1 0078-0511 TABLET, EXTENDED RELEASE 200 mg ORAL NDA 27 sections
TegretolXR HUMAN PRESCRIPTION DRUG LABEL 1 0078-0512 TABLET, EXTENDED RELEASE 400 mg ORAL NDA 27 sections
TegretolXR HUMAN PRESCRIPTION DRUG LABEL 1 0078-0512 TABLET, EXTENDED RELEASE 400 mg ORAL NDA 27 sections
Epitol HUMAN PRESCRIPTION DRUG LABEL 1 0093-0090 TABLET 200 mg ORAL ANDA 27 sections
Carbamazepine HUMAN PRESCRIPTION DRUG LABEL 1 0093-0109 TABLET 200 mg ORAL ANDA 27 sections
Carbamazepine HUMAN PRESCRIPTION DRUG LABEL 1 0093-0109 TABLET 200 mg ORAL ANDA 27 sections
Carbamazepine HUMAN PRESCRIPTION DRUG LABEL 1 0093-0778 TABLET, CHEWABLE 100 mg ORAL ANDA 27 sections
Carbamazepine HUMAN PRESCRIPTION DRUG LABEL 1 0093-0778 TABLET, CHEWABLE 100 mg ORAL ANDA 27 sections
Carbamazepine HUMAN PRESCRIPTION DRUG LABEL 1 0615-8125 TABLET, CHEWABLE 100 mg ORAL ANDA 29 sections
Carbamazepine HUMAN PRESCRIPTION DRUG LABEL 1 0615-8545 TABLET 200 mg ORAL ANDA 29 sections
Carbamazepine HUMAN PRESCRIPTION DRUG LABEL 1 0832-6022 TABLET, EXTENDED RELEASE 100 mg ORAL ANDA 27 sections
Carbamazepin HUMAN PRESCRIPTION DRUG LABEL 1 0832-6023 TABLET, EXTENDED RELEASE 200 mg ORAL ANDA 27 sections
Carbamazepine HUMAN PRESCRIPTION DRUG LABEL 1 0832-6024 TABLET, EXTENDED RELEASE 400 mg ORAL ANDA 27 sections
CARBAMAZEPINE HUMAN PRESCRIPTION DRUG LABEL 1 0904-3854 TABLET, CHEWABLE 100 mg ORAL ANDA 23 sections
CARBAMAZEPINE HUMAN PRESCRIPTION DRUG LABEL 1 0904-6172 TABLET 200 mg ORAL ANDA 23 sections
Carbamazepine HUMAN PRESCRIPTION DRUG LABEL 1 0904-6885 CAPSULE, EXTENDED RELEASE 200 mg ORAL ANDA 25 sections
CARBAMAZEPINE HUMAN PRESCRIPTION DRUG LABEL 1 13668-268 TABLET 200 mg ORAL ANDA 23 sections
CARBAMAZEPINE HUMAN PRESCRIPTION DRUG LABEL 1 13668-268 TABLET 200 mg ORAL ANDA 23 sections
CARBAMAZEPINE HUMAN PRESCRIPTION DRUG LABEL 1 13668-271 TABLET, CHEWABLE 100 mg ORAL ANDA 23 sections
CARBAMAZEPINE HUMAN PRESCRIPTION DRUG LABEL 1 13668-271 TABLET, CHEWABLE 100 mg ORAL ANDA 23 sections
Carbamazepine HUMAN PRESCRIPTION DRUG LABEL 1 13668-284 TABLET, EXTENDED RELEASE 100 mg ORAL ANDA 24 sections
Carbamazepine HUMAN PRESCRIPTION DRUG LABEL 1 13668-284 TABLET, EXTENDED RELEASE 100 mg ORAL ANDA 24 sections
Carbamazepine HUMAN PRESCRIPTION DRUG LABEL 1 13668-285 TABLET, EXTENDED RELEASE 200 mg ORAL ANDA 24 sections