carbamazepine ๐Ÿถ Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | 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) 0.26 mg/mL Benet LZ, Broccatelli F, Oprea TI
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

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 1234.67 10.11 1179 75239 116695 50412011
Drug reaction with eosinophilia and systemic symptoms 752.27 10.11 492 75926 27932 50500774
Abortion spontaneous 550.21 10.11 476 75942 41296 50487410
Toxicity to various agents 540.78 10.11 1068 75350 211431 50317275
Sedation 465.38 10.11 379 76039 30231 50498475
Cognitive disorder 458.10 10.11 440 75978 43683 50485023
Sedation complication 437.35 10.11 229 76189 8537 50520169
Epilepsy 435.18 10.11 316 76102 21251 50507455
Generalised tonic-clonic seizure 434.55 10.11 342 76076 25968 50502738
Drug interaction 428.61 10.11 936 75482 198685 50330021
Balance disorder 410.21 10.11 519 75899 70071 50458635
Creatinine renal clearance decreased 387.78 10.11 235 76183 11646 50517060
Depressed level of consciousness 374.01 10.11 426 75992 51527 50477179
Anticonvulsant drug level increased 364.18 10.11 119 76299 1265 50527441
Orthostatic hypotension 342.43 10.11 313 76105 29168 50499538
Stevens-Johnson syndrome 340.45 10.11 274 76144 21478 50507228
Hyponatraemia 332.85 10.11 553 75865 95586 50433120
Status epilepticus 315.86 10.11 216 76202 13190 50515516
Blood calcium decreased 309.66 10.11 254 76164 20452 50508254
Ataxia 257.80 10.11 193 76225 13593 50515113
Diarrhoea 225.92 10.11 338 76080 588138 49940568
Overdose 218.48 10.11 472 75946 99255 50429451
Psychotic disorder 208.46 10.11 208 76210 21604 50507102
Drug level increased 207.15 10.11 196 76222 19072 50509634
Rheumatoid arthritis 204.40 10.11 31 76387 202519 50326187
Dyspnoea 203.87 10.11 321 76097 547287 49981419
Joint swelling 203.65 10.11 59 76359 245227 50283479
Somnolence 202.63 10.11 603 75815 154382 50374324
Exposure during pregnancy 202.05 10.11 515 75903 120500 50408206
Diplopia 193.98 10.11 189 76229 19071 50509635
Petit mal epilepsy 193.33 10.11 96 76322 3193 50525513
Coma 191.09 10.11 323 76095 56556 50472150
Maternal exposure during pregnancy 187.80 10.11 599 75819 159179 50369527
Arthralgia 186.17 10.11 234 76184 438468 50090238
Nystagmus 184.02 10.11 111 76307 5450 50523256
Suicide attempt 178.07 10.11 297 76121 51435 50477271
Infusion related reaction 173.23 10.11 25 76393 169532 50359174
Stillbirth 172.06 10.11 109 76309 5843 50522863
Synovitis 171.87 10.11 3 76415 123862 50404844
Peripheral swelling 164.64 10.11 53 76365 205883 50322823
Contraindicated product administered 164.32 10.11 17 76401 148941 50379765
Partial seizures 160.71 10.11 97 76321 4768 50523938
Pemphigus 151.87 10.11 7 76411 120159 50408547
Focal dyscognitive seizures 149.59 10.11 76 76342 2656 50526050
Gamma-glutamyltransferase increased 147.42 10.11 202 76216 29421 50499285
Schizophrenia 143.75 10.11 106 76312 7291 50521415
Swelling 143.28 10.11 62 76356 200810 50327896
Fatigue 142.63 10.11 569 75849 707032 49821674
Drug eruption 140.82 10.11 176 76242 23430 50505276
Intentional overdose 140.42 10.11 299 76119 62205 50466501
Alopecia 139.68 10.11 100 76318 244947 50283759
Abdominal discomfort 138.06 10.11 90 76328 231551 50297155
Drug level decreased 136.92 10.11 98 76320 6435 50522271
Hand deformity 136.69 10.11 3 76415 100196 50428510
Arthropathy 134.66 10.11 36 76382 157870 50370836
Sinusitis 127.53 10.11 49 76369 170509 50358197
Inappropriate antidiuretic hormone secretion 126.80 10.11 126 76292 13017 50515689
Electroencephalogram abnormal 124.00 10.11 73 76345 3426 50525280
Aggression 122.08 10.11 155 76263 20961 50507745
Jaundice cholestatic 119.53 10.11 82 76336 5029 50523677
Dysarthria 118.48 10.11 207 76211 37196 50491510
Rash maculo-papular 116.79 10.11 171 76247 26470 50502236
Toxic epidermal necrolysis 113.39 10.11 149 76269 20843 50507863
Wound 111.81 10.11 14 76404 105780 50422926
Anticonvulsant drug level above therapeutic 110.71 10.11 38 76380 475 50528231
Glossodynia 109.21 10.11 21 76397 115548 50413158
Systemic lupus erythematosus 109.17 10.11 38 76380 140584 50388122
Drug intolerance 108.01 10.11 103 76315 219001 50309705
Trigeminal neuralgia 107.80 10.11 64 76354 3051 50525655
Altered state of consciousness 106.89 10.11 148 76270 21762 50506944
Fall 106.36 10.11 866 75552 334066 50194640
Loss of consciousness 101.14 10.11 367 76051 103986 50424720
Abortion induced 96.52 10.11 93 76325 9251 50519455
Pericarditis 95.00 10.11 6 76412 78683 50450023
Lymphocyte stimulation test positive 92.03 10.11 33 76385 473 50528233
Febrile neutropenia 91.74 10.11 18 76400 97649 50431057
Completed suicide 90.62 10.11 417 76001 131472 50397234
Death 90.30 10.11 226 76192 325153 50203553
Myoclonic epilepsy 90.27 10.11 39 76379 936 50527770
Erythema multiforme 87.74 10.11 87 76331 8963 50519743
Abnormal behaviour 84.45 10.11 125 76293 19533 50509173
Product complaint 84.08 10.11 95 76323 11371 50517335
Drug abuse 82.98 10.11 238 76180 59608 50469098
Treatment failure 79.88 10.11 55 76363 137582 50391124
Anticonvulsant drug level below therapeutic 79.47 10.11 31 76387 568 50528138
Discomfort 77.93 10.11 33 76385 108347 50420359
Product use issue 77.51 10.11 67 76351 149408 50379298
Mobility decreased 77.29 10.11 281 76137 79667 50449039
Aura 77.27 10.11 35 76383 943 50527763
Therapeutic product effect decreased 75.51 10.11 57 76361 135993 50392713
Infection 75.48 10.11 90 76328 172864 50355842
Nasopharyngitis 75.39 10.11 109 76309 192818 50335888
Product substitution issue 74.71 10.11 99 76319 13958 50514748
Back pain 74.14 10.11 137 76281 219893 50308813
Eosinophilia 73.60 10.11 114 76304 18538 50510168
Hypersensitivity 72.47 10.11 134 76284 215027 50313679
Human herpes virus 6 serology positive 72.10 10.11 19 76399 86 50528620
Intellectual disability 71.03 10.11 31 76387 763 50527943
Hepatic function abnormal 70.67 10.11 154 76264 32527 50496179
Hypotension 70.41 10.11 601 75817 234868 50293838
Multiple-drug resistance 70.10 10.11 50 76368 3264 50525442
Acute kidney injury 69.97 10.11 150 76268 227908 50300798
Anaemia 69.47 10.11 176 76242 252280 50276426
Lymphocyte morphology abnormal 67.49 10.11 25 76393 395 50528311
Bradyphrenia 66.90 10.11 63 76355 6089 50522617
Hyperammonaemia 66.54 10.11 56 76362 4668 50524038
Cerebellar syndrome 65.58 10.11 48 76370 3263 50525443
Anticonvulsant drug level decreased 65.35 10.11 33 76385 1138 50527568
Lower respiratory tract infection 65.29 10.11 31 76387 95170 50433536
Speech disorder 65.24 10.11 157 76261 35391 50493315
Pain in extremity 63.52 10.11 206 76212 272659 50256047
Rheumatoid factor positive 62.66 10.11 3 76415 49856 50478850
Oral mucosa erosion 62.62 10.11 31 76387 1024 50527682
Drug resistance 62.61 10.11 107 76311 18882 50509824
Myoclonus 60.70 10.11 91 76327 14379 50514327
Sopor 60.33 10.11 108 76310 19771 50508935
Impaired healing 59.28 10.11 16 76402 69770 50458936
Hyperammonaemic encephalopathy 58.75 10.11 37 76381 1962 50526744
Psychogenic seizure 58.62 10.11 34 76384 1551 50527155
Dysmorphism 58.46 10.11 38 76380 2129 50526577
Lip erosion 57.34 10.11 27 76391 797 50527909
Cross sensitivity reaction 56.76 10.11 36 76382 1933 50526773
Dermatitis exfoliative 56.58 10.11 53 76365 5089 50523617
Temporal lobe epilepsy 55.72 10.11 21 76397 349 50528357
Neuroleptic malignant syndrome 55.51 10.11 76 76342 11054 50517652
Product dose omission issue 55.46 10.11 122 76296 183716 50344990
Cough 54.85 10.11 184 76234 241080 50287626
Gastric lavage 54.01 10.11 13 76405 37 50528669
Neuropathy peripheral 53.08 10.11 41 76377 96716 50431990
Injection site pain 52.56 10.11 54 76364 110970 50417736
Pregnancy 52.53 10.11 129 76289 29448 50499258
Hypotonia 52.30 10.11 63 76355 8071 50520635
Musculoskeletal stiffness 51.74 10.11 71 76347 128410 50400296
Nausea 51.67 10.11 753 75665 704645 49824061
Helicobacter infection 51.48 10.11 7 76411 49695 50479011
Oculomucocutaneous syndrome 51.06 10.11 15 76403 108 50528598
Multiple sclerosis relapse 50.27 10.11 161 76257 42803 50485903
Arthritis 49.83 10.11 35 76383 86686 50442020
Intentional product use issue 49.81 10.11 27 76391 76891 50451815
Sudden unexplained death in epilepsy 49.15 10.11 18 76400 275 50528431
Tonic convulsion 49.07 10.11 27 76391 1112 50527594
Pain 47.73 10.11 603 75815 578300 49950406
Pyrexia 47.17 10.11 821 75597 379382 50149324
Histiocytosis 47.11 10.11 10 76408 12 50528694
Foetal anticonvulsant syndrome 46.88 10.11 21 76397 551 50528155
Face oedema 46.74 10.11 91 76327 17748 50510958
Nikolsky's sign 45.46 10.11 13 76405 84 50528622
Irritable bowel syndrome 45.21 10.11 11 76407 51430 50477276
Muscle injury 44.28 10.11 3 76415 37108 50491598
Behaviour disorder 43.77 10.11 33 76385 2347 50526359
Extrapyramidal disorder 43.75 10.11 70 76348 11700 50517006
Meningomyelocele 43.74 10.11 20 76398 551 50528155
Intentional self-injury 43.40 10.11 103 76315 23009 50505697
Mucosal erosion 43.38 10.11 26 76392 1261 50527445
Vertigo 43.34 10.11 174 76244 51658 50477048
Human herpesvirus 6 infection 43.26 10.11 34 76384 2572 50526134
Off label use 42.96 10.11 484 75934 473942 50054764
Chest pain 42.90 10.11 131 76287 176751 50351955
Ovarian granulosa-theca cell tumour 42.77 10.11 10 76408 24 50528682
Hepatotoxicity 42.40 10.11 113 76305 27113 50501593
Lymphadenopathy 42.39 10.11 129 76289 33370 50495336
Irritability 42.28 10.11 116 76302 28310 50500396
Coordination abnormal 42.05 10.11 68 76350 11466 50517240
Simple partial seizures 41.40 10.11 19 76399 528 50528178
Developmental glaucoma 41.35 10.11 11 76407 52 50528654
Gastrointestinal disorder 41.34 10.11 49 76369 94407 50434299
Agitation 41.32 10.11 175 76243 53209 50475497
Cardiac failure congestive 41.13 10.11 40 76378 84342 50444364
Injection site erythema 40.79 10.11 32 76386 74904 50453802
Teratogenicity 40.42 10.11 12 76406 90 50528616
General physical health deterioration 40.14 10.11 98 76320 142336 50386370
Normal newborn 40.07 10.11 50 76368 6641 50522065
Blood lactate dehydrogenase increased 39.83 10.11 90 76328 19472 50509234
Obsessive-compulsive disorder 39.80 10.11 36 76382 3304 50525402
Malignant neoplasm progression 39.79 10.11 27 76391 68097 50460609
Pneumonia 39.58 10.11 373 76045 378028 50150678
Psoriatic arthropathy 39.53 10.11 11 76407 47021 50481685
Change in seizure presentation 39.17 10.11 15 76403 261 50528445
Angiofibroma 38.40 10.11 12 76406 109 50528597
Abdominal pain 38.32 10.11 205 76213 236023 50292683
Hippocampal sclerosis 38.09 10.11 11 76407 74 50528632
Mania 37.97 10.11 63 76355 10853 50517853
Terminal insomnia 37.76 10.11 19 76399 650 50528056
Maternal drugs affecting foetus 37.11 10.11 42 76376 5035 50523671
Spina bifida 37.03 10.11 19 76399 678 50528028
Partial seizures with secondary generalisation 36.75 10.11 15 76403 311 50528395
Restlessness 36.72 10.11 102 76316 25071 50503635
Bronchitis 36.71 10.11 63 76355 104096 50424610
Constipation 36.56 10.11 435 75983 185273 50343433
Atonic seizures 36.37 10.11 18 76400 594 50528112
Atrial fibrillation 36.35 10.11 61 76357 101684 50427022
Hallucination, auditory 36.09 10.11 61 76357 10667 50518039
Toxic skin eruption 35.26 10.11 62 76356 11189 50517517
Angiomyolipoma 34.95 10.11 13 76405 208 50528498
Hip arthroplasty 34.78 10.11 3 76415 30426 50498280
Influenza 34.53 10.11 51 76367 89487 50439219
Poisoning 34.53 10.11 65 76353 12364 50516342
Headache 34.47 10.11 548 75870 505987 50022719
Aphasia 34.45 10.11 108 76310 28386 50500320
Psychomotor skills impaired 34.41 10.11 27 76391 2037 50526669
Dizziness 34.37 10.11 723 75695 345646 50183060
Febrile convulsion 34.15 10.11 15 76403 375 50528331
Osteoarthritis 34.04 10.11 32 76386 68574 50460132
Facial pain 33.57 10.11 49 76369 7560 50521146
Suicidal ideation 33.56 10.11 169 76249 55216 50473490
Abdominal pain upper 33.17 10.11 126 76292 159183 50369523
Gastrooesophageal reflux disease 33.07 10.11 40 76378 76388 50452318
Injection site pruritus 32.95 10.11 10 76408 40401 50488305
Injection site swelling 32.89 10.11 11 76407 41762 50486944
Blood creatine phosphokinase increased 32.86 10.11 101 76317 26266 50502440
Oscillopsia 32.76 10.11 11 76407 128 50528578
Coma scale abnormal 32.40 10.11 38 76380 4733 50523973
Blood alkaline phosphatase increased 32.19 10.11 127 76291 37399 50491307
Tremor 32.04 10.11 289 76129 114614 50414092
Dyspnoea exertional 31.71 10.11 19 76399 51214 50477492
Self esteem decreased 31.65 10.11 16 76402 553 50528153
Stomatitis 31.58 10.11 66 76352 101278 50427428
Unintended pregnancy 31.30 10.11 38 76380 4908 50523798
Myocardial infarction 31.23 10.11 54 76364 88973 50439733
Gastrointestinal haemorrhage 31.06 10.11 39 76379 73282 50455424
Mental impairment 31.02 10.11 61 76357 11983 50516723
Central nervous system lesion 30.66 10.11 53 76365 9436 50519270
Pregnancy with implant contraceptive 30.61 10.11 25 76393 1998 50526708
Asthma 30.60 10.11 55 76363 89282 50439424
Weight decreased 30.57 10.11 202 76216 221043 50307663
Urinary incontinence 30.57 10.11 103 76315 28105 50500601
Nephrogenic diabetes insipidus 30.22 10.11 18 76400 863 50527843
Cerebral atrophy 30.18 10.11 36 76382 4565 50524141
Hepatocellular injury 30.13 10.11 97 76321 25850 50502856
Hypogammaglobulinaemia 30.07 10.11 40 76378 5659 50523047
Fulminant type 1 diabetes mellitus 29.79 10.11 13 76405 320 50528386
Wheezing 29.56 10.11 30 76388 62017 50466689
Hyporeflexia 29.53 10.11 23 76395 1717 50526989
Convulsive threshold lowered 29.34 10.11 13 76405 332 50528374
Neurotoxicity 29.10 10.11 67 76351 14673 50514033
Ill-defined disorder 28.91 10.11 24 76394 54630 50474076
Disease progression 28.57 10.11 64 76354 95802 50432904
Bone pain 28.56 10.11 18 76400 47211 50481495
Osteonecrosis of jaw 28.49 10.11 7 76411 32519 50496187
Shock 28.48 10.11 82 76336 20568 50508138
Polydipsia 28.39 10.11 29 76389 3095 50525611
Cholelithiasis 28.24 10.11 123 76295 37850 50490856
Productive cough 28.05 10.11 23 76395 52671 50476035
COVID-19 27.92 10.11 18 76400 46644 50482062
Hypervolaemia 27.86 10.11 3 76415 25496 50503210
Urinary tract infection 27.32 10.11 212 76206 223808 50304898
Blood sodium decreased 27.28 10.11 82 76336 21065 50507641
Diabetes insipidus 27.23 10.11 25 76393 2339 50526367
Memory impairment 27.13 10.11 209 76209 79151 50449555
Blood bilirubin increased 27.13 10.11 108 76310 31930 50496776
Hypertension 27.12 10.11 197 76221 211006 50317700
Lymphangioleiomyomatosis 27.11 10.11 10 76408 156 50528550
Multiple sclerosis 26.94 10.11 80 76338 20413 50508293
Conversion disorder 26.87 10.11 21 76397 1575 50527131
Stupor 26.80 10.11 30 76388 3553 50525153
Injection site bruising 26.73 10.11 11 76407 36757 50491949
Hepatitis 26.61 10.11 106 76312 31347 50497359
Injection site reaction 26.43 10.11 22 76396 50010 50478696
Mental disorder 26.26 10.11 83 76335 21908 50506798
Epileptic psychosis 25.99 10.11 7 76411 35 50528671
Chest discomfort 25.95 10.11 64 76354 92658 50436048
Loss of personal independence in daily activities 25.95 10.11 41 76377 70009 50458697
Hospitalisation 25.90 10.11 39 76379 67898 50460808
Catatonia 25.78 10.11 30 76388 3706 50525000
Eye movement disorder 25.69 10.11 33 76385 4512 50524194
Gaze palsy 25.67 10.11 19 76399 1314 50527392
Diverticulitis 25.67 10.11 9 76409 33173 50495533
Disturbance in attention 25.51 10.11 104 76314 31082 50497624
Caesarean section 25.46 10.11 66 76352 15573 50513133
Foetal exposure during pregnancy 25.44 10.11 95 76323 27264 50501442
Delusion 25.39 10.11 52 76366 10517 50518189
Thinking abnormal 25.30 10.11 49 76369 9518 50519188
SUNCT syndrome 25.14 10.11 5 76413 3 50528703
Persecutory delusion 25.11 10.11 24 76394 2363 50526343
Epistaxis 25.08 10.11 36 76382 63918 50464788
Psychomotor hyperactivity 25.04 10.11 48 76370 9253 50519453
Stereotypy 25.00 10.11 12 76406 370 50528336
Adverse drug reaction 24.85 10.11 28 76390 55194 50473512
Fibromyalgia 24.73 10.11 19 76399 44959 50483747
Adverse event 24.69 10.11 18 76400 43745 50484961
Fluid retention 24.69 10.11 24 76394 50625 50478081
Paradoxical drug reaction 24.69 10.11 29 76389 3618 50525088
Gait disturbance 24.68 10.11 340 76078 149665 50379041
Antipsychotic drug level decreased 24.65 10.11 10 76408 204 50528502
Genital erosion 24.31 10.11 9 76409 142 50528564
Anaemia megaloblastic 23.99 10.11 11 76407 305 50528401
Blood hyposmosis 23.99 10.11 6 76412 21 50528685
Conjunctival hyperaemia 23.95 10.11 22 76396 2060 50526646
Illusion 23.89 10.11 16 76402 943 50527763
Confusional state 23.88 10.11 404 76014 185524 50343182
Areflexia 23.81 10.11 25 76393 2755 50525951
Device expulsion 23.74 10.11 7 76411 28815 50499891
Dyskinesia 23.66 10.11 94 76324 27767 50500939
Amnesia 23.56 10.11 126 76292 42134 50486572
Neuromyelitis optica spectrum disorder 23.55 10.11 15 76403 811 50527895
Disorganised speech 23.41 10.11 16 76402 975 50527731
Musculoskeletal pain 23.34 10.11 46 76372 72131 50456575
Contusion 23.16 10.11 89 76329 112094 50416612
Eosinophil count increased 23.08 10.11 45 76373 8785 50519921
Pleural effusion 22.97 10.11 56 76362 81398 50447308
Polydipsia psychogenic 22.86 10.11 7 76411 59 50528647
Gingival hypertrophy 22.83 10.11 18 76400 1368 50527338
Pseudolymphoma 22.74 10.11 13 76405 577 50528129
Psychiatric symptom 22.48 10.11 31 76387 4539 50524167
Epileptic aura 22.36 10.11 7 76411 64 50528642
Mitochondrial enzyme deficiency 22.28 10.11 6 76412 30 50528676
Epidermolysis bullosa 22.23 10.11 8 76410 116 50528590
Upper respiratory tract infection 22.18 10.11 41 76377 65857 50462849
Learning disorder 22.18 10.11 13 76405 605 50528101
Erythema 22.15 10.11 327 76091 146087 50382619
Dexamethasone suppression test positive 21.99 10.11 4 76414 0 50528706
Mood altered 21.93 10.11 55 76363 12718 50515988
Slow speech 21.87 10.11 17 76401 1265 50527441
Ear malformation 21.77 10.11 9 76409 193 50528513
Abortion 21.67 10.11 21 76397 2103 50526603
Apathy 21.62 10.11 40 76378 7508 50521198
Colitis 21.54 10.11 16 76402 38513 50490193
Psoriasis 21.44 10.11 45 76373 68955 50459751
Clostridium difficile infection 21.28 10.11 6 76412 25433 50503273
Ammonia increased 21.21 10.11 29 76389 4212 50524494
Ophthalmoplegia 21.21 10.11 17 76401 1323 50527383
Conjunctivitis 21.20 10.11 63 76355 16082 50512624
Blood pressure fluctuation 21.18 10.11 14 76404 35809 50492897
Deafness congenital 21.10 10.11 5 76413 13 50528693
Bradycardia 21.10 10.11 168 76250 64258 50464448
Hyperthermia 21.07 10.11 40 76378 7656 50521050
Intra-abdominal pressure increased 21.07 10.11 9 76409 210 50528496
Lymphocytosis 21.03 10.11 21 76397 2181 50526525
Bursitis 20.94 10.11 4 76414 22131 50506575
Dyspepsia 20.85 10.11 51 76367 74046 50454660
Septic shock 20.67 10.11 34 76384 57141 50471565
Alanine aminotransferase increased 20.57 10.11 214 76204 88145 50440561
Chronic kidney disease 20.38 10.11 18 76400 39753 50488953
Encapsulating peritoneal sclerosis 20.26 10.11 10 76408 328 50528378
Sepsis 20.08 10.11 118 76300 132807 50395899
Single umbilical artery 20.06 10.11 9 76409 237 50528469
Norovirus infection 19.99 10.11 9 76409 239 50528467
Disorientation 19.91 10.11 106 76312 35378 50493328
Pyuria 19.78 10.11 18 76400 1665 50527041
Herpes zoster 19.69 10.11 49 76369 70737 50457969
Peripheral nerve decompression 19.67 10.11 5 76413 19 50528687
Congenital spinal fusion 19.22 10.11 4 76414 4 50528702
Haemoglobin decreased 19.18 10.11 113 76305 127103 50401603
Cleft lip 19.17 10.11 7 76411 106 50528600
Benzodiazepine drug level increased 19.03 10.11 8 76410 179 50528527
Therapeutic response unexpected 18.94 10.11 60 76358 15855 50512851
Labelled drug-drug interaction medication error 18.92 10.11 46 76372 10431 50518275
Respiratory depression 18.85 10.11 50 76368 11960 50516746
Oxygen saturation decreased 18.64 10.11 53 76365 73195 50455511
Knee arthroplasty 18.64 10.11 16 76402 35830 50492876
Skin exfoliation 18.59 10.11 100 76318 33512 50495194
Encephalocele 18.48 10.11 7 76411 118 50528588
Myalgia 18.44 10.11 111 76307 124208 50404498
Developmental regression 18.40 10.11 5 76413 26 50528680
Hypomagnesaemia 18.40 10.11 6 76412 23150 50505556
Abortion threatened 18.38 10.11 11 76407 532 50528174
Bipolar disorder 18.35 10.11 35 76383 6722 50521984
Skin erosion 18.27 10.11 20 76398 2311 50526395
Acinetobacter test positive 18.26 10.11 6 76412 65 50528641
Product dispensing error 18.20 10.11 41 76377 8850 50519856
Cellulitis 18.18 10.11 51 76367 70747 50457959
Autism spectrum disorder 18.16 10.11 12 76406 691 50528015
Toxic encephalopathy 18.08 10.11 31 76387 5484 50523222
Rectal haemorrhage 17.96 10.11 19 76399 38539 50490167
Hyperkalaemia 17.95 10.11 28 76390 48061 50480645
Nasal congestion 17.93 10.11 31 76387 51089 50477617
Injection site haemorrhage 17.92 10.11 5 76413 21341 50507365
Dementia 17.85 10.11 59 76359 15938 50512768
Interstitial granulomatous dermatitis 17.80 10.11 5 76413 30 50528676
Respiratory arrest 17.78 10.11 91 76327 29918 50498788
Sinus arrest 17.72 10.11 17 76401 1681 50527025
Wrong drug 17.71 10.11 7 76411 133 50528573
Joint stiffness 17.71 10.11 12 76406 30296 50498410
Sensorimotor disorder 17.70 10.11 10 76408 434 50528272
Medulloblastoma 17.66 10.11 5 76413 31 50528675
Palpitations 17.62 10.11 78 76340 94428 50434278
Urticaria vesiculosa 17.61 10.11 4 76414 8 50528698
Developmental delay 17.53 10.11 15 76403 1279 50527427
Mydriasis 17.45 10.11 45 76373 10582 50518124
Mucosal inflammation 17.37 10.11 21 76397 40121 50488585
Lethargy 17.35 10.11 131 76287 49301 50479405
Cardiac arrest 17.34 10.11 198 76220 83453 50445253
Chronic obstructive pulmonary disease 17.32 10.11 34 76384 53401 50475305
Hepatic cytolysis 17.30 10.11 38 76380 8065 50520641
Pulmonary hypertension 17.27 10.11 15 76403 33402 50495304
Pulmonary valve stenosis congenital 17.11 10.11 7 76411 146 50528560
Drug withdrawal convulsions 16.95 10.11 15 76403 1338 50527368
Acid base balance abnormal 16.90 10.11 8 76410 239 50528467
Pneumonitis 16.83 10.11 12 76406 29498 50499208
Oedema peripheral 16.76 10.11 155 76263 157806 50370900
Dysphagia 16.76 10.11 185 76233 77333 50451373
Hypoproteinaemia 16.64 10.11 17 76401 1814 50526892
Rhesus incompatibility 16.61 10.11 6 76412 88 50528618
Therapeutic product effective for unapproved indication 16.61 10.11 6 76412 88 50528618
Petechiae 16.60 10.11 49 76369 12463 50516243
Microcephaly 16.55 10.11 12 76406 804 50527902
Asterixis 16.53 10.11 14 76404 1177 50527529
Eyelid oedema 16.50 10.11 41 76377 9425 50519281
Lymphocyte transformation test positive 16.49 10.11 3 76415 0 50528706
Tensilon test abnormal 16.49 10.11 3 76415 0 50528706
Lactate pyruvate ratio increased 16.48 10.11 6 76412 90 50528616
Ultrasound ovary abnormal 16.48 10.11 6 76412 90 50528616
Cholestasis 16.45 10.11 79 76339 25322 50503384
Euphoric mood 16.30 10.11 25 76393 4030 50524676
Osteomalacia 16.23 10.11 11 76407 661 50528045
Juvenile myoclonic epilepsy 16.22 10.11 4 76414 13 50528693
Hot flush 16.22 10.11 26 76392 44143 50484563
Blood osmolarity decreased 16.21 10.11 12 76406 830 50527876
Brain injury 16.14 10.11 31 76387 5983 50522723
Dystonia 16.10 10.11 47 76371 11879 50516827
Epileptic encephalopathy 16.05 10.11 8 76410 268 50528438
Lennox-Gastaut syndrome 16.03 10.11 8 76410 269 50528437
Skin ulcer 15.79 10.11 18 76400 35300 50493406
Full blood count decreased 15.74 10.11 7 76411 22339 50506367
Ideas of reference 15.69 10.11 6 76412 104 50528602
Immune thrombocytopenia 15.66 10.11 39 76379 8978 50519728
Hepatitis A 15.59 10.11 9 76409 407 50528299
Periodic limb movement disorder 15.54 10.11 7 76411 186 50528520
Drug level above therapeutic 15.52 10.11 24 76394 3896 50524810
Renal failure 15.40 10.11 96 76322 106537 50422169
Derailment 15.31 10.11 5 76413 53 50528653
Pneumatosis 15.29 10.11 9 76409 422 50528284
Thrombosis 15.26 10.11 39 76379 55794 50472912
Tearfulness 15.20 10.11 23 76395 3664 50525042
Trigeminal nerve disorder 15.18 10.11 6 76412 114 50528592
Neoplasm progression 15.18 10.11 13 76405 29144 50499562
Accidental overdose 15.08 10.11 64 76354 19469 50509237
Psychomotor retardation 15.06 10.11 22 76396 3396 50525310
Rash morbilliform 15.05 10.11 20 76398 2826 50525880
Aspartate aminotransferase increased 15.01 10.11 182 76236 77816 50450890
Papule 15.01 10.11 25 76393 4320 50524386
Renal impairment 14.99 10.11 61 76357 75600 50453106
Photophobia 14.94 10.11 53 76365 14834 50513872
Therapeutic product ineffective for unapproved indication 14.92 10.11 7 76411 205 50528501
Pulmonary arterial hypertension 14.90 10.11 6 76412 20313 50508393
Pigmentation disorder 14.84 10.11 23 76395 3741 50524965
Blood citric acid increased 14.83 10.11 5 76413 59 50528647
Nervous system disorder 14.80 10.11 56 76362 16167 50512539
Seizure cluster 14.61 10.11 7 76411 215 50528491
Sciatica 14.59 10.11 7 76411 21375 50507331
Anaphylactic reaction 14.59 10.11 38 76380 54017 50474689
Near drowning 14.54 10.11 4 76414 22 50528684
Fabry's disease 14.42 10.11 3 76415 3 50528703
Urinary tract malformation 14.42 10.11 3 76415 3 50528703
Vanishing bile duct syndrome 14.38 10.11 10 76408 627 50528079
Purpura 14.29 10.11 40 76378 9871 50518835
Metapneumovirus infection 14.24 10.11 11 76407 811 50527895
Oral mucosal eruption 14.24 10.11 10 76408 637 50528069
Arnold-Chiari malformation 14.21 10.11 9 76409 482 50528224
Paranoia 14.18 10.11 41 76377 10307 50518399
Skin test positive 14.13 10.11 10 76408 645 50528061
Congenital cystic kidney disease 14.06 10.11 8 76410 352 50528354
Hypothermia 14.02 10.11 45 76373 11971 50516735
Blood immunoglobulin A decreased 13.97 10.11 8 76410 356 50528350
Anal erosion 13.97 10.11 4 76414 26 50528680
Blood pressure increased 13.96 10.11 131 76287 133001 50395705
Cerebellar atrophy 13.96 10.11 10 76408 657 50528049
Dehydration 13.94 10.11 155 76263 152294 50376412
Neurosis 13.90 10.11 7 76411 240 50528466
Vaginal ulceration 13.85 10.11 8 76410 362 50528344
Genital burning sensation 13.79 10.11 7 76411 244 50528462
Congenital megaureter 13.74 10.11 5 76413 75 50528631
Vaginal erosion 13.71 10.11 4 76414 28 50528678
Enanthema 13.67 10.11 8 76410 371 50528335
Developmental hip dysplasia 13.62 10.11 13 76405 1278 50527428
Pseudophaeochromocytoma 13.62 10.11 5 76413 77 50528629
Neonatal seizure 13.61 10.11 8 76410 374 50528332
Vitamin D deficiency 13.58 10.11 43 76375 11359 50517347
Pharyngeal erythema 13.52 10.11 14 76404 1518 50527188
Bacteriuria 13.52 10.11 10 76408 691 50528015
Lymphopenia 13.50 10.11 53 76365 15568 50513138
Persistent depressive disorder 13.46 10.11 11 76407 880 50527826
Cardiac failure 13.43 10.11 64 76354 75976 50452730
Medication error 13.42 10.11 97 76321 36007 50492699
Thyroid adenoma 13.41 10.11 6 76412 157 50528549
Disease recurrence 13.40 10.11 63 76355 20018 50508688
Rhinorrhoea 13.36 10.11 37 76381 51546 50477160
Hyperacusis 13.31 10.11 15 76403 1789 50526917
Hypoglycaemia neonatal 13.28 10.11 11 76407 897 50527809
Infrapatellar fat pad inflammation 13.27 10.11 6 76412 161 50528545
Hypometabolism 13.25 10.11 4 76414 32 50528674
Odynophagia 13.24 10.11 30 76388 6502 50522204
Enlarged foetal cisterna magna 13.21 10.11 3 76415 6 50528700
Skin lesion 13.11 10.11 77 76341 26650 50502056
Acquired diaphragmatic eventration 13.07 10.11 8 76410 403 50528303
Affective disorder 13.05 10.11 26 76392 5155 50523551
Pulmonary mass 12.95 10.11 6 76412 18699 50510007
Tooth development disorder 12.93 10.11 4 76414 35 50528671
Trance 12.93 10.11 4 76414 35 50528671
Hyperglycinaemia 12.89 10.11 3 76415 7 50528699
Aortic bypass 12.89 10.11 3 76415 7 50528699
Joint range of motion decreased 12.73 10.11 6 76412 18506 50510200
Hyperlactacidaemia 12.72 10.11 17 76401 2416 50526290
Agranulocytosis 12.72 10.11 65 76353 21356 50507350
Full blood count abnormal 12.70 10.11 10 76408 23378 50505328
Musculoskeletal chest pain 12.69 10.11 6 76412 18480 50510226
Basal cell carcinoma 12.67 10.11 10 76408 23346 50505360
Hypercalcaemia 12.67 10.11 10 76408 23342 50505364
Mouth ulceration 12.64 10.11 79 76339 27945 50500761
Selective IgG subclass deficiency 12.61 10.11 3 76415 8 50528698
Carnitine decreased 12.61 10.11 3 76415 8 50528698
Skin oedema 12.56 10.11 10 76408 771 50527935
Muscle spasms 12.55 10.11 125 76293 125428 50403278
Throat tightness 12.53 10.11 8 76410 20839 50507867
Speech disorder developmental 12.50 10.11 9 76409 596 50528110
Nodule 12.50 10.11 5 76413 16998 50511708
Poisoning deliberate 12.48 10.11 33 76385 7879 50520827
Hepatitis fulminant 12.45 10.11 19 76399 3049 50525657
Hypotonia neonatal 12.38 10.11 11 76407 986 50527720
Necrosis ischaemic 12.36 10.11 10 76408 789 50527917
Hepatitis acute 12.35 10.11 33 76385 7928 50520778
Angiosclerosis 12.35 10.11 3 76415 9 50528697
Hirsutism 12.33 10.11 11 76407 992 50527714
Basilar migraine 12.28 10.11 4 76414 42 50528664
Altered visual depth perception 12.28 10.11 7 76411 309 50528397
Sinus congestion 12.25 10.11 3 76415 13968 50514738
Drug level below therapeutic 12.23 10.11 21 76397 3719 50524987
Quadriparesis 12.21 10.11 14 76404 1702 50527004
Syncope 12.20 10.11 221 76197 102781 50425925
Poverty of speech 12.18 10.11 7 76411 314 50528392
Flatulence 12.13 10.11 16 76402 29442 50499264
Thrombocytopenic purpura 12.12 10.11 12 76406 1234 50527472
Decreased appetite 12.10 10.11 222 76196 200701 50328005
Facial spasm 12.06 10.11 9 76409 630 50528076
Hemiparesis 12.02 10.11 61 76357 19987 50508719
Brugada syndrome 12.00 10.11 7 76411 323 50528383
Papillary thyroid cancer 11.97 10.11 15 76403 2000 50526706
Haemorrhage 11.95 10.11 41 76377 53400 50475306
Acantholysis 11.89 10.11 3 76415 11 50528695
Echopraxia 11.89 10.11 3 76415 11 50528695
Pregnancy on contraceptive 11.88 10.11 11 76407 1041 50527665
Throat irritation 11.87 10.11 17 76401 30222 50498484
Acanthosis 11.85 10.11 5 76413 113 50528593
Congenital anomaly 11.83 10.11 13 76405 1508 50527198
Drug dependence 11.76 10.11 60 76358 19699 50509007
Congenital foot malformation 11.72 10.11 6 76412 213 50528493
Gastric ulcer 11.71 10.11 9 76409 21296 50507410
Neonatal hypotension 11.69 10.11 5 76413 117 50528589
Tooth malformation 11.68 10.11 3 76415 12 50528694
Pulmonary venous thrombosis 11.68 10.11 3 76415 12 50528694
Kidney duplex 11.65 10.11 4 76414 50 50528656
Negative thoughts 11.65 10.11 10 76408 856 50527850
Candida infection 11.63 10.11 11 76407 23512 50505194
Fungal infection 11.61 10.11 17 76401 29948 50498758
Respiratory tract infection 11.61 10.11 19 76399 31998 50496708
Disseminated intravascular coagulation 11.61 10.11 54 76364 17081 50511625
Incoherent 11.60 10.11 22 76396 4208 50524498
Intervertebral disc degeneration 11.59 10.11 3 76415 13458 50515248
Gastroenteritis viral 11.58 10.11 7 76411 18779 50509927
Autoimmune hypothyroidism 11.53 10.11 5 76413 121 50528585
CSF oligoclonal band present 11.53 10.11 5 76413 121 50528585
Cerebellar ataxia 11.53 10.11 10 76408 868 50527838
Human herpesvirus 6 infection reactivation 11.50 10.11 5 76413 122 50528584
Urine calcium decreased 11.49 10.11 3 76415 13 50528693
Neurological examination abnormal 11.42 10.11 6 76412 225 50528481
Sinus node dysfunction 11.38 10.11 21 76397 3934 50524772
Hyperphosphatasaemia 11.31 10.11 3 76415 14 50528692
Blood cholesterol increased 11.26 10.11 44 76374 55171 50473535
Sinus disorder 11.20 10.11 7 76411 18451 50510255
Enlarged cerebral perivascular spaces 11.14 10.11 3 76415 15 50528691
Educational problem 11.10 10.11 7 76411 372 50528334
Blood immunoglobulin M decreased 11.08 10.11 9 76409 714 50527992
Joint injury 11.00 10.11 10 76408 21779 50506927
Hypochloraemia 10.99 10.11 13 76405 1634 50527072
Haemangioma 10.98 10.11 16 76402 2464 50526242
Congenital hydrocephalus 10.96 10.11 5 76413 137 50528569
Macular degeneration 10.96 10.11 4 76414 14384 50514322
Eye discharge 10.91 10.11 24 76394 5099 50523607
Anal atresia 10.90 10.11 7 76411 384 50528322
Transfusion 10.88 10.11 3 76415 12902 50515804
Postictal state 10.85 10.11 10 76408 940 50527766
Haematochezia 10.79 10.11 28 76390 39854 50488852
Cataract 10.77 10.11 36 76382 47264 50481442
Inhibitory drug interaction 10.76 10.11 15 76403 2218 50526488
Depressed mood 10.74 10.11 88 76330 33935 50494771
Respiratory tract congestion 10.73 10.11 4 76414 14195 50514511
Muscle twitching 10.73 10.11 49 76369 15382 50513324
Pulmonary embolism 10.69 10.11 100 76318 101604 50427102
Dry mouth 10.69 10.11 46 76372 56132 50472574
Cytomegalovirus mucocutaneous ulcer 10.68 10.11 3 76415 18 50528688
Wrong patient received product 10.66 10.11 13 76405 1687 50527019
Drug ineffective 10.61 10.11 1080 75338 818253 49710453
Granulocytopenia 10.57 10.11 24 76394 5207 50523499
Muscular dystrophy 10.54 10.11 3 76415 19 50528687
Haemorrhoids 10.54 10.11 8 76410 19045 50509661
Unevaluable event 10.53 10.11 35 76383 46031 50482675
Coronary artery disease 10.45 10.11 18 76400 29708 50498998
Metabolic disorder 10.40 10.11 24 76394 5262 50523444
Rash erythematous 10.40 10.11 89 76329 34763 50493943
Dermatitis bullous 10.39 10.11 29 76389 7144 50521562
Blood osmolarity increased 10.39 10.11 5 76413 155 50528551
Neurological symptom 10.37 10.11 22 76396 4560 50524146
Abdominal distension 10.33 10.11 66 76352 72837 50455869
Measles 10.30 10.11 5 76413 158 50528548
Logorrhoea 10.30 10.11 15 76403 2309 50526397
Blood pressure systolic increased 10.28 10.11 24 76394 35425 50493281
Procedural pain 10.28 10.11 4 76414 13828 50514878
Hepatic adenoma 10.26 10.11 6 76412 278 50528428
Myelodysplastic syndrome 10.26 10.11 5 76413 15127 50513579
Device malfunction 10.24 10.11 5 76413 15116 50513590
Anger 10.24 10.11 39 76379 11294 50517412
Atrioventricular block 10.20 10.11 27 76391 6451 50522255
Laboratory test abnormal 10.19 10.11 12 76406 23196 50505510
Lymphadenitis 10.13 10.11 16 76402 2644 50526062
Impaired driving ability 10.12 10.11 20 76398 3941 50524765

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 1023.88 11.30 1071 56230 92052 29425174
Drug reaction with eosinophilia and systemic symptoms 702.54 11.30 516 56785 27476 29489750
Generalised tonic-clonic seizure 354.45 11.30 295 57006 18844 29498382
Anticonvulsant drug level increased 339.69 11.30 122 57179 1344 29515882
Epilepsy 298.29 11.30 263 57038 18169 29499057
Status epilepticus 293.33 11.30 209 57092 10585 29506641
Stevens-Johnson syndrome 240.54 11.30 222 57079 16275 29500951
Aggression 227.27 11.30 311 56990 35230 29481996
Drug interaction 214.85 11.30 852 56449 196533 29320693
Ataxia 208.48 11.30 179 57122 11924 29505302
Death 193.15 11.30 228 57073 341856 29175370
Drug eruption 185.65 11.30 194 57107 16547 29500679
Somnolence 164.33 11.30 476 56825 93479 29423747
Gamma-glutamyltransferase increased 161.95 11.30 228 57073 26509 29490717
Toxicity to various agents 144.57 11.30 692 56609 172969 29344257
Nystagmus 144.43 11.30 95 57206 4214 29513012
Diarrhoea 140.88 11.30 270 57031 332428 29184798
Coordination abnormal 138.61 11.30 113 57188 7001 29510225
Febrile neutropenia 134.46 11.30 27 57274 112213 29405013
Dyspnoea 129.05 11.30 276 57025 326456 29190770
Acute kidney injury 124.17 11.30 202 57099 265065 29252161
Partial seizures 113.96 11.30 79 57222 3824 29513402
Petit mal epilepsy 113.73 11.30 69 57232 2653 29514573
Electroencephalogram abnormal 112.78 11.30 65 57236 2270 29514956
Pneumonia 108.50 11.30 293 57008 319879 29197347
Eosinophilia 108.39 11.30 171 57130 21990 29495236
Hyponatraemia 107.10 11.30 331 56970 67302 29449924
Lymphocyte stimulation test positive 106.94 11.30 43 57258 658 29516568
Anticonvulsant drug level above therapeutic 104.43 11.30 40 57261 534 29516692
Rash maculo-papular 103.36 11.30 176 57125 24113 29493113
Sudden unexplained death in epilepsy 102.08 11.30 37 57264 419 29516807
Overdose 100.90 11.30 362 56939 79457 29437769
Psychogenic seizure 99.04 11.30 34 57267 324 29516902
Anaemia 98.70 11.30 148 57153 200803 29316423
Sopor 97.43 11.30 113 57188 10821 29506405
Drug level increased 96.10 11.30 148 57153 18639 29498587
Human herpes virus 6 serology positive 93.47 11.30 26 57275 111 29517115
Focal dyscognitive seizures 92.01 11.30 46 57255 1200 29516026
Drug level decreased 87.03 11.30 82 57219 6165 29511061
Abnormal behaviour 84.77 11.30 157 57144 22970 29494256
Irritability 83.24 11.30 152 57149 22000 29495226
Dysarthria 82.55 11.30 184 57117 30727 29486499
Trigeminal neuralgia 82.22 11.30 40 57261 982 29516244
Lymphadenopathy 81.91 11.30 162 57139 24887 29492339
Diplopia 81.40 11.30 115 57186 13403 29503823
Cardiac failure congestive 80.79 11.30 24 57277 76557 29440669
Agitation 79.25 11.30 249 57052 51055 29466171
Anticonvulsant drug level decreased 76.37 11.30 38 57263 981 29516245
Atrial fibrillation 75.01 11.30 57 57244 105589 29411637
Toxic epidermal necrolysis 73.89 11.30 129 57172 18024 29499202
Gastric lavage 73.48 11.30 14 57287 0 29517226
Myocardial infarction 72.73 11.30 64 57237 110232 29406994
Multiple-drug resistance 71.90 11.30 60 57241 3840 29513386
Sepsis 69.09 11.30 106 57195 142576 29374650
Autism spectrum disorder 68.58 11.30 45 57256 1987 29515239
Hyperammonaemia 67.04 11.30 68 57233 5595 29511631
Arthralgia 66.38 11.30 105 57196 139512 29377714
Cross sensitivity reaction 65.98 11.30 37 57264 1225 29516001
Dermatitis exfoliative 65.10 11.30 71 57230 6354 29510872
Rash 64.92 11.30 606 56695 189213 29328013
Lymphocyte morphology abnormal 64.83 11.30 27 57274 454 29516772
Dysmorphism 63.86 11.30 50 57251 2921 29514305
Loss of consciousness 63.49 11.30 298 57003 73758 29443468
Fatigue 61.77 11.30 361 56940 316460 29200766
Toxic skin eruption 61.72 11.30 85 57216 9672 29507554
Decreased eye contact 61.27 11.30 26 57275 459 29516767
Altered state of consciousness 60.69 11.30 125 57176 19764 29497462
Drug resistance 59.51 11.30 130 57171 21410 29495816
Dyskinesia 58.78 11.30 124 57177 19937 29497289
Bruxism 58.13 11.30 37 57264 1550 29515676
Intentional self-injury 57.96 11.30 94 57207 12367 29504859
Gait disturbance 56.31 11.30 286 57015 73063 29444163
Oppositional defiant disorder 55.80 11.30 25 57276 506 29516720
Product dose omission issue 55.42 11.30 63 57238 96320 29420906
Hypospadias 54.96 11.30 46 57255 2956 29514270
Malignant neoplasm progression 54.81 11.30 38 57263 73821 29443405
Coma 54.18 11.30 184 57117 39266 29477960
Aura 53.34 11.30 21 57280 303 29516923
Psychomotor retardation 53.24 11.30 45 57256 2931 29514295
Hypotension 52.21 11.30 197 57104 194157 29323069
Suicide attempt 51.23 11.30 164 57137 33946 29483280
Gastrointestinal haemorrhage 49.05 11.30 49 57252 79484 29437742
Paraplegia 48.83 11.30 40 57261 2494 29514732
Back pain 48.51 11.30 77 57224 102207 29415019
Joint swelling 48.05 11.30 18 57283 49612 29467614
Cerebellar syndrome 47.90 11.30 36 57265 1978 29515248
Skin test positive 47.00 11.30 19 57282 295 29516931
Sedation 46.89 11.30 104 57197 17301 29499925
Gaze palsy 46.87 11.30 30 57271 1269 29515957
Hepatic adenoma 46.17 11.30 12 57289 37 29517189
Renal failure 45.91 11.30 101 57200 118498 29398728
Erythema multiforme 45.50 11.30 65 57236 7652 29509574
Mania 45.35 11.30 69 57232 8594 29508632
Weight decreased 45.18 11.30 146 57155 150759 29366467
Rheumatoid arthritis 44.71 11.30 5 57296 32147 29485079
Exposure during pregnancy 44.59 11.30 68 57233 8486 29508740
Depressed level of consciousness 44.46 11.30 165 57136 36777 29480449
Psychomotor hyperactivity 43.82 11.30 66 57235 8147 29509079
Plasmapheresis 43.69 11.30 18 57283 294 29516932
Human herpesvirus 6 infection 43.64 11.30 33 57268 1830 29515396
Inappropriate antidiuretic hormone secretion 43.59 11.30 77 57224 10855 29506371
Choreoathetosis 42.98 11.30 26 57275 994 29516232
Homicidal ideation 42.78 11.30 37 57264 2487 29514739
Head circumference abnormal 42.55 11.30 11 57290 33 29517193
Psychotic disorder 42.32 11.30 110 57191 20244 29496982
Balance disorder 42.24 11.30 160 57141 36010 29481216
Peripheral swelling 41.97 11.30 37 57264 63702 29453524
Cognitive disorder 41.87 11.30 120 57181 23379 29493847
Product complaint 41.82 11.30 52 57249 5353 29511873
Conjunctival hyperaemia 41.63 11.30 34 57267 2111 29515115
Congenital nail disorder 41.60 11.30 11 57290 37 29517189
Foetal exposure during pregnancy 41.37 11.30 152 57149 33715 29483511
Mucosal erosion 40.96 11.30 22 57279 668 29516558
Speech disorder 40.85 11.30 119 57182 23397 29493829
Skin exfoliation 40.70 11.30 116 57185 22529 29494697
Face oedema 40.45 11.30 72 57229 10211 29507015
Neuropathy peripheral 40.20 11.30 47 57254 70980 29446246
Nausea 40.12 11.30 363 56938 288892 29228334
Coronary artery disease 39.59 11.30 18 57283 44172 29473054
Hyperammonaemic encephalopathy 39.58 11.30 32 57269 1958 29515268
Oral mucosa erosion 39.52 11.30 23 57278 818 29516408
Dehydration 39.43 11.30 104 57197 114644 29402582
Off label use 39.37 11.30 383 56918 300417 29216809
Aspartate aminotransferase increased 39.11 11.30 223 57078 59502 29457724
Hypotonia 39.03 11.30 57 57244 6845 29510381
Intentional overdose 39.01 11.30 163 57138 38365 29478861
Alanine aminotransferase increased 38.93 11.30 253 57048 70691 29446535
Hepatic function abnormal 38.90 11.30 165 57136 39094 29478132
Postictal psychosis 38.43 11.30 14 57287 161 29517065
Neonatal pneumonia 38.04 11.30 13 57288 122 29517104
Middle insomnia 38.03 11.30 51 57250 5657 29511569
Excessive eye blinking 37.37 11.30 18 57283 432 29516794
Chest pain 37.34 11.30 103 57198 111870 29405356
Anticonvulsant drug level below therapeutic 37.21 11.30 20 57281 608 29516618
Abdominal pain 37.09 11.30 136 57165 135221 29382005
Vertigo 36.43 11.30 109 57192 21752 29495474
Neuroleptic malignant syndrome 36.41 11.30 90 57211 16058 29501168
Neonatal hypotension 36.20 11.30 13 57288 143 29517083
Disturbance in attention 35.87 11.30 107 57194 21317 29495909
Roseolovirus test positive 35.77 11.30 11 57290 71 29517155
Simple partial seizures 35.76 11.30 15 57286 257 29516969
Lip erosion 35.17 11.30 18 57283 494 29516732
Agnosia 35.00 11.30 10 57291 48 29517178
Hospitalisation 34.99 11.30 23 57278 45965 29471261
Bradyphrenia 34.96 11.30 42 57259 4172 29513054
Apathy 34.95 11.30 51 57250 6120 29511106
Blood lactate dehydrogenase increased 34.13 11.30 98 57203 19111 29498115
Delusion 33.63 11.30 70 57231 11146 29506080
Eosinophil count increased 33.47 11.30 55 57246 7314 29509912
Disease progression 33.15 11.30 68 57233 81848 29435378
Dysmetria 33.14 11.30 16 57285 386 29516840
Prostate cancer 33.02 11.30 5 57296 25522 29491704
Intentional product use issue 32.68 11.30 21 57280 42477 29474749
Drug ineffective 32.64 11.30 927 56374 362243 29154983
Neutropenia 32.48 11.30 138 57163 131573 29385653
Cellulitis 32.16 11.30 25 57276 45815 29471411
Product substitution issue 32.02 11.30 61 57240 9111 29508115
Oedema peripheral 31.80 11.30 99 57202 103458 29413768
Crying 31.44 11.30 45 57256 5306 29511920
Mucosal inflammation 31.36 11.30 11 57290 31584 29485642
Drug level below therapeutic 31.31 11.30 40 57261 4231 29512995
Cardiac failure 31.09 11.30 67 57234 79220 29438006
Pain 30.85 11.30 200 57101 171232 29345994
Intellectual disability 30.83 11.30 22 57279 1115 29516111
Septic shock 30.69 11.30 46 57255 62514 29454712
Postictal paralysis 30.61 11.30 13 57288 230 29516996
Myalgia 30.33 11.30 61 57240 73958 29443268
Hyperkinesia 30.31 11.30 25 57276 1574 29515652
Posture abnormal 29.92 11.30 27 57274 1920 29515306
Altered pitch perception 29.77 11.30 7 57294 12 29517214
Ascites 29.69 11.30 17 57284 36602 29480624
Acute myocardial infarction 29.67 11.30 30 57271 48408 29468818
Facial pain 29.66 11.30 26 57275 1779 29515447
Bradykinesia 29.66 11.30 35 57266 3412 29513814
Lymphocytic infiltration 29.64 11.30 17 57284 588 29516638
Pain in extremity 29.56 11.30 112 57189 110321 29406905
Epistaxis 29.48 11.30 34 57267 51670 29465556
Myoclonus 28.77 11.30 73 57228 13236 29503990
Microcephaly 28.76 11.30 18 57283 732 29516494
Psychiatric symptom 28.52 11.30 33 57268 3151 29514075
Low birth weight baby 28.25 11.30 48 57253 6560 29510666
Foetal anticonvulsant syndrome 28.12 11.30 21 57280 1143 29516083
Plasma cell myeloma 27.65 11.30 19 57282 37096 29480130
Hyperdynamic left ventricle 27.61 11.30 10 57291 113 29517113
Tonic convulsion 27.45 11.30 19 57282 917 29516309
Temporal lobe epilepsy 27.43 11.30 11 57290 167 29517059
COVID-19 27.41 11.30 18 57283 35996 29481230
Clumsiness 27.41 11.30 23 57278 1483 29515743
Mood altered 27.16 11.30 53 57248 8058 29509168
Thrombosis 27.13 11.30 26 57275 43019 29474207
Infusion related reaction 27.09 11.30 27 57274 43859 29473367
Non-24-hour sleep-wake disorder 27.08 11.30 7 57294 21 29517205
Blood alkaline phosphatase increased 27.07 11.30 118 57183 28288 29488938
Erythema 27.07 11.30 244 57057 75362 29441864
Liver disorder 27 11.30 116 57185 27633 29489593
Asterixis 27.00 11.30 20 57281 1075 29516151
Skin erosion 26.53 11.30 24 57277 1712 29515514
Thinking abnormal 25.03 11.30 40 57261 5196 29512030
Hyperexplexia 24.96 11.30 7 57294 31 29517195
Meningocele 24.78 11.30 7 57294 32 29517194
Epileptic aura 24.60 11.30 6 57295 13 29517213
Decreased appetite 24.42 11.30 173 57128 145169 29372057
Dyspraxia 24.40 11.30 13 57288 388 29516838
Chest discomfort 24.36 11.30 32 57269 45951 29471275
Frontotemporal dementia 24.05 11.30 11 57290 234 29516992
Infection 23.82 11.30 73 57228 76678 29440548
Epileptic psychosis 23.73 11.30 6 57295 16 29517210
Trismus 23.65 11.30 26 57275 2347 29514879
Pleural effusion 23.32 11.30 67 57234 71841 29445385
Accidental overdose 23.22 11.30 81 57220 17512 29499714
Constipation 22.71 11.30 129 57172 114031 29403195
Diabetic neuropathy 22.69 11.30 32 57269 3721 29513505
Completed suicide 22.68 11.30 271 57030 89975 29427251
Gingival atrophy 22.66 11.30 7 57294 46 29517180
Rash morbilliform 22.60 11.30 26 57275 2467 29514759
Medication error 22.46 11.30 91 57210 21120 29496106
Sinus arrest 22.10 11.30 20 57281 1427 29515799
Pneumonia aspiration 21.99 11.30 134 57167 36603 29480623
Guillain-Barre syndrome 21.96 11.30 37 57264 5021 29512205
Genital erosion 21.94 11.30 10 57291 211 29517015
Bone marrow failure 21.88 11.30 13 57288 27436 29489790
Apgar score low 21.88 11.30 16 57285 843 29516383
Blood pressure increased 21.64 11.30 72 57229 73731 29443495
Loose associations 21.58 11.30 7 57294 55 29517171
Congenital cystic lung 21.56 11.30 10 57291 220 29517006
Hepatosplenomegaly 21.46 11.30 31 57270 3686 29513540
Water intoxication 21.40 11.30 12 57289 397 29516829
Drowning 21.21 11.30 12 57289 404 29516822
Arthritis 21.17 11.30 11 57290 25008 29492218
Full blood count decreased 20.99 11.30 3 57298 15989 29501237
Developmental delay 20.73 11.30 25 57276 2493 29514733
Condition aggravated 20.65 11.30 398 56903 145897 29371329
Neurodevelopmental disorder 20.63 11.30 11 57290 329 29516897
Partial seizures with secondary generalisation 20.57 11.30 10 57291 245 29516981
Affect lability 20.56 11.30 29 57272 3373 29513853
Pyrexia 20.44 11.30 714 56587 286908 29230318
Suicidal ideation 20.38 11.30 126 57175 34590 29482636
Haemorrhage 20.35 11.30 35 57266 45037 29472189
Personality change 20.24 11.30 34 57267 4604 29512622
Atonic seizures 20.23 11.30 9 57292 179 29517047
Epidermal necrosis 20.17 11.30 12 57289 445 29516781
Personality disorder 20.13 11.30 17 57284 1106 29516120
Hangover 20.05 11.30 16 57285 961 29516265
Pneumonitis 20.04 11.30 15 57286 28029 29489197
Emotional disorder 20.00 11.30 35 57266 4896 29512330
Angina pectoris 19.77 11.30 15 57286 27835 29489391
Haemoglobin decreased 19.69 11.30 126 57175 108249 29408977
Psoriasis 19.69 11.30 20 57281 32207 29485019
Osteonecrosis of jaw 19.68 11.30 4 57297 16506 29500720
Chronic kidney disease 19.64 11.30 25 57276 36391 29480835
General physical health deterioration 19.51 11.30 118 57183 102739 29414487
Acute generalised exanthematous pustulosis 19.33 11.30 37 57264 5546 29511680
Sinusitis 19.13 11.30 23 57278 34327 29482899
Abdominal pain upper 18.93 11.30 58 57243 60935 29456291
Unevaluable event 18.84 11.30 18 57283 29833 29487393
Micrognathia 18.79 11.30 10 57291 298 29516928
Renal phospholipidosis 18.76 11.30 4 57297 3 29517223
Contraindicated product administered 18.75 11.30 6 57295 18260 29498966
Papule 18.74 11.30 27 57274 3202 29514024
Communication disorder 18.69 11.30 23 57278 2342 29514884
Rash papular 18.54 11.30 45 57256 7936 29509290
Respiratory disorder neonatal 18.51 11.30 18 57283 1407 29515819
Gout 18.37 11.30 5 57296 16906 29500320
Melaena 18.31 11.30 20 57281 31156 29486070
Cerebellar ataxia 18.31 11.30 15 57286 935 29516291
Tracheo-oesophageal fistula 18.22 11.30 11 57290 419 29516807
Tremor 18.11 11.30 220 57081 73318 29443908
Psychomotor skills impaired 18.07 11.30 24 57277 2637 29514589
Hyporeflexia 17.99 11.30 20 57281 1828 29515398
Bone metabolism disorder 17.89 11.30 9 57292 238 29516988
Injection site pain 17.78 11.30 22 57279 32424 29484802
Wrong patient received product 17.73 11.30 22 57279 2260 29514966
Oculomucocutaneous syndrome 17.72 11.30 8 57293 165 29517061
Blister 17.69 11.30 81 57220 19825 29497401
Congenital anomaly 17.67 11.30 17 57284 1311 29515915
Contraindicated product prescribed 17.64 11.30 10 57291 338 29516888
Perseveration 17.41 11.30 7 57294 107 29517119
Localised infection 17.21 11.30 3 57298 13813 29503413
Lymphocytosis 17.19 11.30 20 57281 1920 29515306
Memory impairment 16.99 11.30 125 57176 36345 29480881
Depressed mood 16.96 11.30 70 57231 16378 29500848
Anger 16.92 11.30 53 57248 10837 29506389
Brain malformation 16.85 11.30 7 57294 117 29517109
Osteoarthritis 16.80 11.30 7 57294 18096 29499130
Strabismus 16.75 11.30 17 57284 1399 29515827
Sitting disability 16.74 11.30 7 57294 119 29517107
Mental disorder 16.67 11.30 59 57242 12846 29504380
Mouth ulceration 16.65 11.30 51 57250 10304 29506922
Stomatitis 16.59 11.30 29 57272 37084 29480142
Ultrasound liver abnormal 16.58 11.30 7 57294 122 29517104
Rebound effect 16.45 11.30 20 57281 2011 29515215
Haemoptysis 16.44 11.30 21 57280 30529 29486697
Salivary hypersecretion 16.39 11.30 41 57260 7368 29509858
Skin ulcer 16.37 11.30 8 57293 18832 29498394
Arachnoid cyst 16.35 11.30 8 57293 199 29517027
Fluid retention 16.33 11.30 13 57288 23547 29493679
Distractibility 16.18 11.30 9 57292 293 29516933
Diverticulitis 16.18 11.30 7 57294 17697 29499529
Clostridium difficile colitis 16.17 11.30 3 57298 13209 29504017
Motor developmental delay 16.15 11.30 12 57289 648 29516578
Blood sodium decreased 16.15 11.30 64 57237 14703 29502523
Potentiating drug interaction 16.09 11.30 30 57271 4408 29512818
Suspiciousness 16.05 11.30 9 57292 298 29516928
Bone density decreased 16.04 11.30 18 57283 1662 29515564
Change in seizure presentation 16.02 11.30 6 57295 75 29517151
Hypertrophic scar 16.00 11.30 4 57297 10 29517216
Antisocial behaviour 15.99 11.30 9 57292 300 29516926
Myoclonic epilepsy 15.93 11.30 14 57287 961 29516265
Open angle glaucoma 15.88 11.30 7 57294 136 29517090
Hypertension 15.81 11.30 147 57154 116467 29400759
Learning disability 15.75 11.30 9 57292 309 29516917
Atypical benign partial epilepsy 15.75 11.30 3 57298 0 29517226
Dysphagia 15.62 11.30 169 57132 54757 29462469
Pericardial effusion 15.60 11.30 11 57290 21197 29496029
Haematochezia 15.55 11.30 30 57271 36953 29480273
Abdominal distension 15.45 11.30 42 57259 45869 29471357
Rectal haemorrhage 15.44 11.30 27 57274 34522 29482704
Language disorder 15.40 11.30 19 57282 1940 29515286
Restlessness 15.35 11.30 84 57217 22061 29495165
Hyperkalaemia 15.31 11.30 64 57237 61328 29455898
Body height below normal 15.29 11.30 8 57293 230 29516996
Extrapyramidal disorder 15.28 11.30 51 57250 10780 29506446
Therapeutic response unexpected 15.27 11.30 44 57257 8594 29508632
Abdominal discomfort 15.26 11.30 45 57256 47858 29469368
Labelled drug-food interaction medication error 15.23 11.30 5 57296 41 29517185
Poriomania 15.21 11.30 6 57295 87 29517139
Osteomalacia 15.17 11.30 13 57288 863 29516363
Nephrolithiasis 15.16 11.30 16 57285 25318 29491908
Dysgeusia 15.11 11.30 13 57288 22661 29494565
Pressure of speech 15.11 11.30 10 57291 448 29516778
Influenza 15.11 11.30 37 57264 41844 29475382
Congenital arterial malformation 15.09 11.30 6 57295 89 29517137
Rash erythematous 15.09 11.30 82 57219 21480 29495746
Lactic acidosis 15.06 11.30 22 57279 30225 29487001
Chills 15.03 11.30 79 57222 71221 29446005
Histiocytic necrotising lymphadenitis 15.00 11.30 4 57297 14 29517212
Ventricular tachycardia 14.97 11.30 13 57288 22561 29494665
Xanthoma 14.91 11.30 6 57295 92 29517134
Nervousness 14.87 11.30 52 57249 11254 29505972
Withdrawal syndrome 14.84 11.30 51 57250 10941 29506285
Parkinsonism 14.78 11.30 39 57262 7239 29509987
Xanthelasma 14.73 11.30 6 57295 95 29517131
Rickets 14.72 11.30 5 57296 46 29517180
Enanthema 14.69 11.30 9 57292 352 29516874
Paradoxical drug reaction 14.58 11.30 22 57279 2719 29514507
Cholinergic syndrome 14.57 11.30 10 57291 476 29516750
Stupor 14.56 11.30 22 57279 2722 29514504
Torticollis 14.54 11.30 14 57287 1081 29516145
Prominent epicanthal folds 14.53 11.30 7 57294 168 29517058
Cerebral palsy 14.45 11.30 6 57295 100 29517126
Tonic clonic movements 14.43 11.30 13 57288 922 29516304
Hypervolaemia 14.43 11.30 8 57293 17537 29499689
Haematuria 14.40 11.30 41 57260 44098 29473128
Premature baby 14.39 11.30 69 57232 17211 29500015
Patient uncooperative 14.36 11.30 9 57292 367 29516859
Muscle spasms 14.34 11.30 71 57230 65011 29452215
Hypomagnesaemia 14.31 11.30 8 57293 17460 29499766
Brain oedema 14.21 11.30 54 57247 12166 29505060
Cardiac disorder 14.17 11.30 32 57269 37231 29479995
Abulia 14.12 11.30 10 57291 501 29516725
Bacteraemia 14.08 11.30 7 57294 16316 29500910
Death of relative 13.87 11.30 4 57297 20 29517206
Carnitine deficiency 13.84 11.30 5 57296 56 29517170
Salivary gland calculus 13.84 11.30 5 57296 56 29517170
Measles 13.81 11.30 7 57294 188 29517038
Rash pustular 13.74 11.30 29 57272 4662 29512564
Maternal drugs affecting foetus 13.72 11.30 26 57275 3867 29513359
Drug withdrawal syndrome 13.69 11.30 70 57231 17914 29499312
Kluver-Bucy syndrome 13.67 11.30 3 57298 3 29517223
Biopsy lymph gland abnormal 13.67 11.30 3 57298 3 29517223
Multiple sclerosis 13.64 11.30 32 57269 5522 29511704
Hypochloraemia 13.57 11.30 10 57291 533 29516693
Seizure cluster 13.55 11.30 6 57295 118 29517108
Gastric hypomotility 13.53 11.30 5 57296 60 29517166
Basal cell carcinoma 13.49 11.30 8 57293 16902 29500324
Mycoplasma infection 13.36 11.30 8 57293 300 29516926
Coma scale abnormal 13.27 11.30 24 57277 3445 29513781
Onychophagia 13.24 11.30 5 57296 64 29517162
Low set ears 13.12 11.30 9 57292 428 29516798
Ammonia increased 13.08 11.30 26 57275 4005 29513221
Renal impairment 13.07 11.30 98 57203 81235 29435991
Oxygen saturation decreased 13.05 11.30 44 57257 44893 29472333
Mucosal ulceration 13.03 11.30 12 57289 876 29516350
Bronchitis 12.96 11.30 33 57268 36835 29480391
Dystonia 12.96 11.30 45 57256 9704 29507522
Leukoplakia oral 12.90 11.30 5 57296 69 29517157
Glomerular filtration rate decreased 12.88 11.30 3 57298 11263 29505963
Trigeminal nerve disorder 12.86 11.30 4 57297 27 29517199
Blood cholesterol increased 12.79 11.30 62 57239 15533 29501693
Therapy cessation 12.78 11.30 6 57295 14456 29502770
Chapped lips 12.72 11.30 9 57292 450 29516776
Conjunctival disorder 12.71 11.30 5 57296 72 29517154
Blood urea decreased 12.66 11.30 12 57289 909 29516317
Feeling of despair 12.64 11.30 12 57289 910 29516316
Maternal exposure during breast feeding 12.64 11.30 15 57286 1471 29515755
Asthenia 12.64 11.30 319 56982 214931 29302295
Human herpesvirus 7 infection 12.46 11.30 3 57298 6 29517220
Cataract 12.44 11.30 15 57286 22363 29494863
Muscle twitching 12.42 11.30 39 57262 7987 29509239
Cryptorchism 12.40 11.30 17 57284 1925 29515301
Acute respiratory failure 12.38 11.30 20 57281 26382 29490844
Clostridium difficile infection 12.37 11.30 8 57293 16133 29501093
Hypogammaglobulinaemia 12.35 11.30 32 57269 5875 29511351
Wrong schedule 12.34 11.30 6 57295 147 29517079
Poisoning 12.32 11.30 45 57256 9948 29507278
Cerebellar atrophy 12.23 11.30 9 57292 479 29516747
Multiple organ dysfunction syndrome 12.17 11.30 72 57229 63044 29454182
Attention deficit hyperactivity disorder 12.09 11.30 18 57283 2199 29515027
Blood creatinine increased 12.08 11.30 106 57195 84996 29432230
Hypoxia 12.05 11.30 49 57252 47330 29469896
Septic encephalopathy 12.01 11.30 5 57296 84 29517142
Flatulence 11.99 11.30 10 57291 17699 29499527
Metastases to liver 11.98 11.30 4 57297 11852 29505374
Eyelid erosion 11.86 11.30 3 57298 8 29517218
Ischaemic gastritis 11.86 11.30 3 57298 8 29517218
Blood lactate dehydrogenase 11.86 11.30 3 57298 8 29517218
Upper gastrointestinal haemorrhage 11.86 11.30 15 57286 21899 29495327
Treatment noncompliance 11.84 11.30 84 57217 24143 29493083
Head injury 11.83 11.30 62 57239 16019 29501207
Anaplastic large cell lymphoma T- and null-cell types 11.80 11.30 5 57296 88 29517138
Bone pain 11.79 11.30 11 57290 18441 29498785
Pigmentation disorder 11.76 11.30 17 57284 2022 29515204
Feelings of worthlessness 11.75 11.30 7 57294 260 29516966
Palmar-plantar erythrodysaesthesia syndrome 11.75 11.30 7 57294 14752 29502474
Urinary tract infection 11.71 11.30 87 57214 72267 29444959
Haemorrhoids 11.67 11.30 4 57297 11653 29505573
Regressive behaviour 11.66 11.30 4 57297 38 29517188
Multiple congenital abnormalities 11.66 11.30 9 57292 515 29516711
Blood immunoglobulin M decreased 11.65 11.30 8 57293 381 29516845
Hypercapnic coma 11.64 11.30 6 57295 167 29517059
Cardiogenic shock 11.62 11.30 12 57289 19178 29498048
Staphylococcal impetigo 11.60 11.30 3 57298 9 29517217
Drug half-life reduced 11.60 11.30 3 57298 9 29517217
Drug level above therapeutic 11.53 11.30 22 57279 3288 29513938
Hyperpyrexia 11.53 11.30 18 57283 2292 29514934
Blood glucose increased 11.53 11.30 67 57234 58917 29458309
Shock 11.52 11.30 76 57225 21328 29495898
Lennox-Gastaut syndrome 11.48 11.30 4 57297 40 29517186
Trigemino-cardiac reflex 11.45 11.30 6 57295 173 29517053
Subacute cutaneous lupus erythematosus 11.44 11.30 11 57290 848 29516378
Arthropathy 11.41 11.30 15 57286 21539 29495687
Cervicobrachial syndrome 11.33 11.30 7 57294 278 29516948
Brugada syndrome 11.32 11.30 10 57291 691 29516535
Asthenospermia 11.31 11.30 4 57297 42 29517184

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
Seizure 1362.01 10.38 1540 107586 165352 64224254
Drug reaction with eosinophilia and systemic symptoms 1305.23 10.38 924 108202 53293 64336313
Toxicity to various agents 670.58 10.38 1721 107405 361792 64027814
Generalised tonic-clonic seizure 649.80 10.38 539 108587 39318 64350288
Anticonvulsant drug level increased 558.29 10.38 193 108933 2184 64387422
Drug interaction 556.07 10.38 1603 107523 360480 64029126
Epilepsy 533.14 10.38 447 108679 33084 64356522
Status epilepticus 511.08 10.38 365 108761 21298 64368308
Stevens-Johnson syndrome 474.43 10.38 422 108704 33827 64355779
Cognitive disorder 450.82 10.38 510 108616 54577 64335029
Balance disorder 426.57 10.38 613 108513 83313 64306293
Sedation complication 416.43 10.38 244 108882 10110 64379496
Sedation 414.96 10.38 427 108699 41035 64348571
Ataxia 404.97 10.38 320 108806 21764 64367842
Depressed level of consciousness 403.93 10.38 588 108538 80848 64308758
Creatinine renal clearance decreased 354.04 10.38 249 108877 14172 64375434
Hyponatraemia 323.16 10.38 750 108376 147589 64242017
Aggression 305.64 10.38 384 108742 45848 64343758
Somnolence 301.47 10.38 891 108235 202754 64186852
Dyspnoea 296.05 10.38 476 108650 718198 63671408
Overdose 290.43 10.38 753 108373 158813 64230793
Diarrhoea 289.00 10.38 488 108638 722216 63667390
Blood calcium decreased 271.72 10.38 272 108854 25282 64364324
Nystagmus 266.44 10.38 175 108951 8893 64380713
Drug eruption 243.39 10.38 303 108823 35833 64353773
Orthostatic hypotension 241.16 10.38 344 108782 46394 64343212
Diplopia 238.16 10.38 259 108867 26506 64363100
Petit mal epilepsy 235.67 10.38 131 108995 4901 64384705
Drug level increased 233.95 10.38 289 108837 33907 64355699
Partial seizures 217.08 10.38 142 108984 7165 64382441
Rash maculo-papular 213.61 10.38 326 108800 46700 64342906
Arthralgia 210.31 10.38 264 108862 441996 63947610
Electroencephalogram abnormal 210.23 10.38 123 109003 5080 64384526
Gamma-glutamyltransferase increased 205.99 10.38 326 108800 48184 64341422
Focal dyscognitive seizures 203.16 10.38 103 109023 3187 64386419
Psychotic disorder 195.54 10.38 266 108860 34312 64355294
Rheumatoid arthritis 195.48 10.38 24 109102 164270 64225336
Joint swelling 194.80 10.38 61 109065 215321 64174285
Febrile neutropenia 192.93 10.38 41 109085 187616 64201990
Coma 189.52 10.38 442 108684 87173 64302433
Drug level decreased 182.03 10.38 153 108973 11350 64378256
Eosinophilia 181.52 10.38 270 108856 37806 64351800
Dysarthria 180.04 10.38 344 108782 59062 64330544
Anticonvulsant drug level above therapeutic 175.62 10.38 66 109060 964 64388642
Toxic epidermal necrolysis 169.28 10.38 258 108868 36908 64352698
Acute kidney injury 161.54 10.38 323 108803 448917 63940689
Coordination abnormal 160.39 10.38 160 108966 14804 64374802
Peripheral swelling 159.79 10.38 77 109049 209076 64180530
Suicide attempt 158.80 10.38 363 108763 70644 64318962
Death 158.68 10.38 365 108761 482340 63907266
Synovitis 152.71 10.38 3 109123 99087 64290519
Anaemia 148.69 10.38 258 108868 378422 64011184
Loss of consciousness 143.23 10.38 563 108563 147802 64241804
Infusion related reaction 142.68 10.38 50 109076 164417 64225189
Psychogenic seizure 141.73 10.38 67 109059 1774 64387832
Altered state of consciousness 139.70 10.38 239 108887 37663 64351943
Fatigue 137.98 10.38 726 108400 748004 63641602
Irritability 137.13 10.38 233 108893 36513 64353093
Intentional overdose 137.10 10.38 398 108728 89546 64300060
Sudden unexplained death in epilepsy 136.20 10.38 48 109078 577 64389029
Sopor 133.79 10.38 205 108921 29456 64360150
Abnormal behaviour 130.54 10.38 217 108909 33405 64356201
Completed suicide 128.77 10.38 732 108394 223682 64165924
Inappropriate antidiuretic hormone secretion 128.33 10.38 173 108953 22116 64367490
Schizophrenia 128.24 10.38 124 109002 11044 64378562
Human herpes virus 6 serology positive 124.88 10.38 35 109091 182 64389424
Lymphocyte stimulation test positive 122.76 10.38 52 109074 1054 64388552
Sinusitis 118.84 10.38 49 109077 145879 64243727
Contraindicated product administered 116.16 10.38 21 109105 107808 64281798
Hyperammonaemia 115.67 10.38 111 109015 9793 64379813
Lymphadenopathy 111.44 10.38 245 108881 46441 64343165
Cross sensitivity reaction 111.32 10.38 70 109056 3297 64386309
Trigeminal neuralgia 111.31 10.38 68 109058 3041 64386565
Pneumonia 109.49 10.38 531 108595 559045 63830561
Erythema multiforme 109.46 10.38 134 108992 15567 64374039
Multiple-drug resistance 108.10 10.38 89 109037 6413 64383193
Anticonvulsant drug level decreased 106.35 10.38 55 109071 1775 64387831
Arthropathy 106.23 10.38 36 109090 120931 64268675
Back pain 104.08 10.38 164 108962 250007 64139599
Dermatitis exfoliative 100.60 10.38 105 109021 10247 64379359
Agitation 99.11 10.38 352 108774 88015 64301591
Swelling 96.08 10.38 78 109048 160140 64229466
Myocardial infarction 95.43 10.38 84 109042 165737 64223869
Cardiac failure congestive 95.30 10.38 51 109075 130529 64259077
Abdominal discomfort 94.90 10.38 101 109025 182221 64207385
Hyperammonaemic encephalopathy 94.80 10.38 68 109058 3990 64385616
Drug resistance 92.76 10.38 192 108934 34910 64354696
Hand deformity 92.55 10.38 3 109123 62768 64326838
Intentional self-injury 91.44 10.38 171 108955 28873 64360733
Mobility decreased 91.23 10.38 336 108790 85504 64304102
Anticonvulsant drug level below therapeutic 90.46 10.38 41 109085 983 64388623
Lymphocyte morphology abnormal 86.93 10.38 38 109088 834 64388772
Myoclonus 84.27 10.38 152 108974 24966 64364640
Bradyphrenia 83.61 10.38 91 109035 9315 64380291
Fall 83.60 10.38 1074 108052 415752 63973854
Gastric lavage 83.57 10.38 20 109106 47 64389559
Pain in extremity 82.79 10.38 251 108875 302834 64086772
Cerebellar syndrome 82.01 10.38 68 109058 4948 64384658
Hepatic function abnormal 81.59 10.38 267 108859 64046 64325560
Oral mucosa erosion 81.47 10.38 45 109081 1662 64387944
Atrial fibrillation 81.24 10.38 102 109024 170987 64218619
Aura 80.97 10.38 36 109090 824 64388782
Product dose omission issue 80.65 10.38 128 108998 194619 64194987
Mucosal erosion 78.87 10.38 46 109080 1888 64387718
Neuroleptic malignant syndrome 78.48 10.38 147 108979 24849 64364757
Alopecia 78.44 10.38 99 109027 165591 64224015
Jaundice cholestatic 77.28 10.38 84 109042 8586 64381020
Gastrointestinal haemorrhage 74.95 10.38 68 109058 132244 64257362
Pericarditis 74.64 10.38 9 109117 62507 64327099
Nausea 74.56 10.38 912 108214 784888 63604718
Face oedema 74.50 10.38 143 108983 24618 64364988
Speech disorder 74.39 10.38 215 108911 48226 64341380
Toxic skin eruption 74.22 10.38 124 109002 19160 64370446
Human herpesvirus 6 infection 73.83 10.38 62 109064 4592 64385014
Drug intolerance 72.81 10.38 129 108997 187863 64201743
Pemphigus 71.83 10.38 9 109117 60692 64328914
Vertigo 71.31 10.38 241 108885 58770 64330836
Gait disturbance 71.15 10.38 517 108609 171638 64217968
Neuropathy peripheral 70.72 10.38 57 109069 117468 64272138
Hypotonia 70.68 10.38 91 109035 11121 64378485
Chest pain 70.63 10.38 187 108939 235793 64153813
Myoclonic epilepsy 70.25 10.38 40 109086 1568 64388038
Arthritis 70.08 10.38 27 109099 83787 64305819
Drug abuse 69.49 10.38 422 108704 131952 64257654
Nasopharyngitis 69.41 10.38 142 108984 195931 64193675
Infection 68.81 10.38 130 108996 184750 64204856
Malignant neoplasm progression 67.59 10.38 55 109071 112816 64276790
Intentional product use issue 67.04 10.38 39 109087 95325 64294281
Wound 65.01 10.38 24 109102 76453 64313153
Tonic convulsion 64.44 10.38 40 109086 1841 64387765
Intellectual disability 63.47 10.38 32 109094 978 64388628
Sepsis 62.69 10.38 191 108935 230150 64159456
Decreased eye contact 62.47 10.38 29 109097 736 64388870
Abdominal pain 62.34 10.38 294 108832 312081 64077525
Lip erosion 61.82 10.38 34 109092 1245 64388361
Pyrexia 61.75 10.38 1305 107821 557339 63832267
Oppositional defiant disorder 61.19 10.38 25 109101 461 64389145
Weight decreased 61.17 10.38 262 108864 285477 64104129
Dyskinesia 60.65 10.38 175 108951 39213 64350393
Lower respiratory tract infection 60.62 10.38 43 109083 94571 64295035
Mania 60.39 10.38 103 109023 16183 64373423
Simple partial seizures 59.70 10.38 27 109099 644 64388962
General physical health deterioration 58.90 10.38 165 108961 204260 64185346
Psychomotor hyperactivity 58.41 10.38 95 109031 14356 64375250
Gaze palsy 57.90 10.38 42 109084 2508 64387098
Delusion 57.88 10.38 107 109019 17907 64371699
Glossodynia 57.23 10.38 19 109107 64677 64324929
Off label use 55.25 10.38 747 108379 632059 63757547
Skin test positive 53.69 10.38 29 109097 1024 64388582
Suicidal ideation 53.57 10.38 239 108887 66303 64323303
Temporal lobe epilepsy 53.29 10.38 21 109105 351 64389255
Disease progression 53.25 10.38 99 109027 141581 64248025
Impaired healing 53.07 10.38 18 109108 60455 64329151
Systemic lupus erythematosus 52.78 10.38 33 109093 77579 64312027
Injection site pain 52.26 10.38 67 109059 111341 64278265
Rash 51.19 10.38 1073 108053 457476 63932130
Extrapyramidal disorder 50.54 10.38 106 109020 19446 64370160
Conjunctival hyperaemia 49.94 10.38 46 109080 3853 64385753
Injection site erythema 49.69 10.38 29 109097 70771 64318835
Abdominal pain upper 48.42 10.38 144 108982 174886 64214720
Partial seizures with secondary generalisation 47.62 10.38 21 109105 471 64389135
Atonic seizures 47.53 10.38 23 109103 642 64388964
Hepatic adenoma 47.52 10.38 18 109108 269 64389337
Rheumatoid factor positive 47.18 10.38 3 109123 34935 64354671
Epistaxis 47.08 10.38 58 109068 98073 64291533
Apathy 46.98 10.38 75 109051 11157 64378449
Exposure during pregnancy 46.86 10.38 257 108869 77418 64312188
Therapeutic product effect decreased 46.62 10.38 77 109049 115274 64274332
Blood lactate dehydrogenase increased 46.22 10.38 142 108984 32936 64356670
Postictal psychosis 45.87 10.38 15 109111 141 64389465
Septic shock 45.84 10.38 67 109059 105370 64284236
Alanine aminotransferase increased 45.61 10.38 396 108730 138635 64250971
Oculomucocutaneous syndrome 45.56 10.38 18 109108 303 64389303
Chest discomfort 45.54 10.38 79 109047 116027 64273579
Bronchitis 45.44 10.38 71 109055 108672 64280934
Skin exfoliation 45.42 10.38 173 108953 44712 64344894
Obsessive-compulsive disorder 45.26 10.38 48 109078 4770 64384836
Product substitution issue 45.20 10.38 96 109030 17765 64371841
Bruxism 44.96 10.38 42 109084 3582 64386024
Mucosal inflammation 44.83 10.38 25 109101 62559 64327047
Neutropenia 44.62 10.38 231 108895 239393 64150213
Skin erosion 44.43 10.38 43 109083 3833 64385773
Osteoarthritis 44.37 10.38 26 109100 63310 64326296
Hyporeflexia 44.31 10.38 40 109086 3264 64386342
Thinking abnormal 44.06 10.38 74 109052 11482 64378124
Fluid retention 43.88 10.38 23 109103 59583 64330023
Oedema peripheral 43.67 10.38 195 108931 210122 64179484
Facial pain 43.50 10.38 60 109066 7835 64381771
Nikolsky's sign 43.39 10.38 16 109110 221 64389385
Psoriatic arthropathy 43.34 10.38 10 109116 43271 64346335
Pain 43.14 10.38 668 108458 552843 63836763
Renal failure 43.02 10.38 160 108966 181528 64208078
Stupor 42.87 10.38 52 109074 5983 64383623
Change in seizure presentation 42.82 10.38 17 109109 290 64389316
Choreoathetosis 42.68 10.38 28 109098 1419 64388187
Psychomotor retardation 42.68 10.38 48 109078 5095 64384511
Ovarian granulosa-theca cell tumour 42.56 10.38 10 109116 21 64389585
Cough 42.42 10.38 318 108808 301830 64087776
Cellulitis 42.21 10.38 58 109068 93599 64296007
Discomfort 41.83 10.38 45 109081 80833 64308773
Headache 41.25 10.38 639 108487 528828 63860778
COVID-19 41.20 10.38 30 109096 65110 64324496
Shock 40.87 10.38 150 108976 38090 64351516
Hypomagnesaemia 40.84 10.38 7 109119 37369 64352237
Paradoxical drug reaction 40.68 10.38 51 109075 6069 64383537
Hypogammaglobulinaemia 40.67 10.38 67 109059 10232 64379374
Altered pitch perception 40.43 10.38 9 109117 13 64389593
Influenza 40.42 10.38 74 109052 106457 64283149
Blood alkaline phosphatase increased 40.05 10.38 195 108931 56084 64333522
Myalgia 40.01 10.38 136 108990 158481 64231125
Psychiatric symptom 39.68 10.38 51 109075 6222 64383384
Dysmorphism 39.58 10.38 19 109107 521 64389085
Middle insomnia 39.51 10.38 75 109051 12802 64376804
Poisoning 39.44 10.38 103 109023 21776 64367830
Injection site pruritus 39.38 10.38 8 109118 37818 64351788
Paraplegia 39.14 10.38 43 109083 4447 64385159
Medication error 39.11 10.38 178 108948 49788 64339818
Lymphocytosis 39.11 10.38 39 109087 3605 64386001
Disturbance in attention 38.87 10.38 155 108971 40919 64348687
Irritable bowel syndrome 38.70 10.38 8 109118 37361 64352245
Asterixis 38.56 10.38 32 109094 2331 64387275
Restlessness 38.34 10.38 151 108975 39634 64349972
Osteonecrosis of jaw 38.32 10.38 10 109116 39815 64349791
Histiocytosis 38.21 10.38 10 109116 38 64389568
Aspartate aminotransferase increased 38.14 10.38 339 108787 119449 64270157
Helicobacter infection 38.14 10.38 9 109117 38353 64351253
Roseolovirus test positive 38.12 10.38 14 109112 191 64389415
Gastrointestinal disorder 38.03 10.38 58 109068 89651 64299955
Accidental overdose 37.87 10.38 134 108992 33423 64356183
Hypertension 37.75 10.38 270 108856 258991 64130615
Product use issue 37.64 10.38 131 108995 151584 64238022
Hospitalisation 37.63 10.38 43 109083 75164 64314442
Stomatitis 37.40 10.38 81 109045 109524 64280082
Psychomotor skills impaired 37.36 10.38 39 109087 3806 64385800
Hallucination, auditory 37.18 10.38 86 109040 16853 64372753
Rectal haemorrhage 37.15 10.38 30 109096 61787 64327819
Dehydration 37.03 10.38 215 108911 216548 64173058
Coma scale abnormal 36.85 10.38 55 109071 7719 64381887
Hypersensitivity 36.78 10.38 189 108937 196263 64193343
Oxygen saturation decreased 36.74 10.38 79 109047 107097 64282509
Diverticulitis 36.58 10.38 10 109116 38608 64350998
Multiple sclerosis relapse 36.37 10.38 152 108974 40983 64348623
Hypervolaemia 36.11 10.38 10 109116 38275 64351331
Mood altered 36.04 10.38 82 109044 15897 64373709
Angiofibroma 35.94 10.38 12 109114 121 64389485
Eosinophil count increased 35.89 10.38 76 109050 14036 64375570
Conjunctivitis 35.85 10.38 95 109031 20259 64369347
Epileptic psychosis 35.52 10.38 10 109116 53 64389553
Coronary artery disease 35.49 10.38 30 109096 60403 64329203
Urinary tract infection 35.29 10.38 238 108888 231358 64158248
Homicidal ideation 35.22 10.38 35 109091 3222 64386384
Pleural effusion 35.08 10.38 104 109022 126455 64263151
Plasmapheresis 34.77 10.38 18 109108 582 64389024
Autism spectrum disorder 34.76 10.38 21 109105 920 64388686
Angiomyolipoma 34.64 10.38 13 109113 189 64389417
Contusion 34.29 10.38 90 109036 113875 64275731
Postictal paralysis 34.20 10.38 15 109111 332 64389274
Skin ulcer 33.83 10.38 16 109110 43958 64345648
Ascites 33.76 10.38 33 109093 61968 64327638
Cardiac failure 33.72 10.38 113 109013 132260 64257346
Blood pressure increased 33.44 10.38 164 108962 172388 64217218
Dysmetria 33.11 10.38 20 109106 876 64388730
Multiple sclerosis 32.95 10.38 88 109038 18853 64370753
Injection site reaction 32.90 10.38 19 109107 46645 64342961
Abortion induced 32.90 10.38 47 109079 6341 64383265
Mental impairment 32.65 10.38 80 109046 16263 64373343
Unintended pregnancy 32.64 10.38 33 109093 3101 64386505
Decreased appetite 32.30 10.38 312 108814 280977 64108629
Gastrooesophageal reflux disease 32.21 10.38 57 109069 83086 64306520
Folliculitis 32.07 10.38 6 109120 30071 64359535
Haemoglobin decreased 31.98 10.38 196 108930 194867 64194739
Injection site swelling 31.88 10.38 15 109111 41338 64348268
Nephrogenic diabetes insipidus 31.72 10.38 26 109100 1861 64387745
Lymphocytic infiltration 31.60 10.38 23 109103 1381 64388225
Bone pain 31.29 10.38 21 109105 47551 64342055
Rash morbilliform 31.27 10.38 41 109085 5100 64384506
Sinus arrest 31.21 10.38 32 109094 3058 64386548
Mouth ulceration 31.15 10.38 123 109003 32321 64357285
Agnosia 30.93 10.38 12 109114 192 64389414
Pneumonitis 30.82 10.38 24 109102 50341 64339265
Dizziness 30.34 10.38 947 108179 429216 63960390
Epidermolysis bullosa 30.05 10.38 12 109114 208 64389398
Tremor 30.04 10.38 383 108743 147847 64241759
Slow speech 29.99 10.38 26 109100 2011 64387595
Nasal congestion 29.96 10.38 34 109092 59624 64329982
Lennox-Gastaut syndrome 29.95 10.38 12 109114 210 64389396
Injection site bruising 29.93 10.38 12 109114 36361 64353245
Psoriasis 29.77 10.38 47 109079 71656 64317950
Erythema 29.72 10.38 463 108663 186607 64202999
Thrombosis 29.62 10.38 46 109080 70596 64319010
Osteomalacia 29.53 10.38 22 109104 1369 64388237
Epileptic aura 29.36 10.38 9 109117 67 64389539
Wrong patient received product 29.34 10.38 34 109092 3728 64385878
Terminal insomnia 29.28 10.38 19 109107 945 64388661
Chronic kidney disease 29.10 10.38 33 109093 57886 64331720
Bradykinesia 29.10 10.38 45 109081 6515 64383091
Acute myocardial infarction 28.66 10.38 46 109080 69672 64319934
Microcephaly 28.64 10.38 11 109115 171 64389435
Pregnancy with implant contraceptive 28.53 10.38 22 109104 1442 64388164
Oscillopsia 28.53 10.38 11 109115 173 64389433
Affect lability 28.38 10.38 53 109073 8937 64380669
Cerebral atrophy 28.24 10.38 47 109079 7238 64382368
Treatment failure 28.21 10.38 102 109024 116714 64272892
Hepatocellular injury 28.17 10.38 151 108975 45084 64344522
Trismus 28.14 10.38 38 109088 4863 64384743
Palpitations 28.14 10.38 87 109039 104401 64285205
Clostridium difficile infection 28.06 10.38 13 109113 36150 64353456
Pneumonia aspiration 27.99 10.38 184 108942 59087 64330519
Behaviour disorder 27.79 10.38 36 109090 4426 64385180
Self esteem decreased 27.67 10.38 18 109108 899 64388707
Memory impairment 27.54 10.38 243 108883 85439 64304167
Cerebellar atrophy 27.51 10.38 19 109107 1049 64388557
Papule 27.39 10.38 43 109083 6307 64383299
Dystonia 27.30 10.38 82 109044 18783 64370823
Lymphangioleiomyomatosis 27.06 10.38 10 109116 139 64389467
Normal newborn 27.00 10.38 40 109086 5577 64384029
Prominent epicanthal folds 26.92 10.38 5 109121 0 64389606
Peripheral nerve decompression 26.91 10.38 8 109118 53 64389553
Hyperkinesia 26.87 10.38 27 109099 2519 64387087
Trigeminal nerve disorder 26.80 10.38 10 109116 143 64389463
Persecutory delusion 26.60 10.38 34 109092 4124 64385482
Blood creatine phosphokinase increased 26.58 10.38 180 108946 58378 64331228
Dyspnoea exertional 26.40 10.38 53 109073 73677 64315929
Mental disorder 25.99 10.38 101 109025 26344 64363262
Fibromyalgia 25.98 10.38 14 109112 35717 64353889
Hyperkalaemia 25.97 10.38 86 109040 101043 64288563
Neonatal hypotension 25.90 10.38 7 109119 31 64389575
Neonatal pneumonia 25.90 10.38 7 109119 31 64389575
Ammonia increased 25.70 10.38 44 109082 6933 64382673
Hip arthroplasty 25.66 10.38 3 109123 21348 64368258
Blood pressure fluctuation 25.57 10.38 30 109096 51841 64337765
Melaena 25.31 10.38 32 109094 53516 64336090
Hyperexplexia 25.20 10.38 7 109119 35 64389571
Aphasia 25.10 10.38 136 108990 40770 64348836
Musculoskeletal stiffness 25.09 10.38 115 109011 123091 64266515
Therapeutic product ineffective for unapproved indication 24.76 10.38 9 109117 119 64389487
Cerebellar ataxia 24.73 10.38 22 109104 1761 64387845
Non-24-hour sleep-wake disorder 24.42 10.38 7 109119 40 64389566
Seizure cluster 24.25 10.38 12 109114 352 64389254
Rash erythematous 24.21 10.38 153 108973 48480 64341126
Hepatosplenomegaly 24.19 10.38 37 109089 5306 64384300
Genital erosion 23.94 10.38 12 109114 362 64389244
Colitis 23.85 10.38 39 109087 58635 64330971
Haemorrhage 23.61 10.38 63 109063 79288 64310318
Depressed mood 23.60 10.38 134 108992 40878 64348728
Pseudolymphoma 23.48 10.38 17 109109 1012 64388594
Gout 23.42 10.38 4 109122 21409 64368197
Prostate cancer 23.26 10.38 3 109123 19792 64369814
Pulmonary arterial hypertension 23.23 10.38 7 109119 25360 64364246
Confusional state 23.14 10.38 592 108534 260552 64129054
Musculoskeletal pain 23.10 10.38 66 109060 81228 64308378
Full blood count decreased 23.04 10.38 5 109121 22577 64367029
Illusion 23.03 10.38 20 109106 1550 64388056
Renal impairment 23.00 10.38 134 108992 134883 64254723
Palmar-plantar erythrodysaesthesia syndrome 22.92 10.38 10 109116 28809 64360797
Brain malformation 22.85 10.38 7 109119 52 64389554
Brugada syndrome 22.77 10.38 17 109109 1061 64388545
Pulmonary hypertension 22.31 10.38 24 109102 43115 64346491
Mitochondrial enzyme deficiency 22.30 10.38 6 109120 26 64389580
Euphoric mood 22.25 10.38 40 109086 6551 64383055
Ill-defined disorder 22.23 10.38 25 109101 44027 64345579
Condition aggravated 22.19 10.38 804 108322 371622 64017984
Loose associations 22.18 10.38 7 109119 58 64389548
Febrile convulsion 22.18 10.38 15 109111 800 64388806
Acute generalised exanthematous pustulosis 22.16 10.38 63 109063 13995 64375611
Clumsiness 22.13 10.38 25 109101 2666 64386940
Herpes zoster 21.99 10.38 65 109061 79122 64310484
Respiratory disorder neonatal 21.98 10.38 7 109119 60 64389546
Drug withdrawal syndrome 21.95 10.38 108 109018 31183 64358423
Blood immunoglobulin M decreased 21.87 10.38 16 109110 968 64388638
Haematochezia 21.86 10.38 50 109076 66323 64323283
Hypercalcaemia 21.85 10.38 13 109113 31403 64358203
Salivary hypersecretion 21.81 10.38 57 109069 12056 64377550
Communication disorder 21.69 10.38 29 109097 3677 64385929
Anaphylactic reaction 21.60 10.38 53 109073 68611 64320995
Opticokinetic nystagmus tests abnormal 21.53 10.38 4 109122 0 64389606
Dexamethasone suppression test positive 21.53 10.38 4 109122 0 64389606
Dyspepsia 21.53 10.38 67 109059 80245 64309361
Abortion spontaneous 21.52 10.38 92 109034 25051 64364555
Neuromyelitis optica spectrum disorder 21.50 10.38 15 109111 842 64388764
Conversion disorder 21.47 10.38 20 109106 1699 64387907
Hot flush 21.47 10.38 28 109098 46207 64343399
Anger 21.45 10.38 67 109059 15674 64373932
Congenital inguinal hernia 21.44 10.38 5 109121 10 64389596
Drug level below therapeutic 21.42 10.38 42 109084 7342 64382264
Mucosal ulceration 21.39 10.38 20 109106 1707 64387899
Dysgeusia 21.33 10.38 29 109097 47018 64342588
Purpura 21.32 10.38 71 109055 17175 64372431
Eyelid oedema 21.31 10.38 57 109069 12222 64377384
Plasma cell myeloma 21.30 10.38 28 109098 46047 64343559
Angina pectoris 21.25 10.38 27 109099 45054 64344552
Basal cell carcinoma 21.12 10.38 13 109113 30825 64358781
Blood osmolarity decreased 20.93 10.38 17 109109 1201 64388405
Water intoxication 20.88 10.38 14 109112 736 64388870
Gingival atrophy 20.76 10.38 7 109119 73 64389533
Liver disorder 20.74 10.38 158 108968 53193 64336413
Retinal deposits 20.62 10.38 8 109118 128 64389478
Hyperdynamic left ventricle 20.60 10.38 10 109116 281 64389325
Fulminant type 1 diabetes mellitus 20.55 10.38 16 109110 1064 64388542
Selective IgG subclass deficiency 20.54 10.38 5 109121 13 64389593
Anaemia megaloblastic 20.52 10.38 12 109114 495 64389111
Catatonia 20.50 10.38 42 109084 7578 64382028
Muscle spasms 20.44 10.38 147 108979 140876 64248730
Joint range of motion decreased 20.32 10.38 4 109122 19339 64370267
Product complaint 20.25 10.38 55 109071 11899 64377707
Eye movement disorder 20.22 10.38 40 109086 7039 64382567
Tracheo-oesophageal fistula 20.22 10.38 12 109114 509 64389097
Developmental regression 20.15 10.38 6 109120 40 64389566
Unevaluable event 20.11 10.38 34 109092 50455 64339151
Cardiac disorder 20.09 10.38 40 109086 55776 64333830
Measles 20.00 10.38 10 109116 300 64389306
Ejection fraction decreased 19.80 10.38 12 109114 28695 64360911
Rhesus incompatibility 19.77 10.38 5 109121 16 64389590
Learning disorder 19.70 10.38 12 109114 534 64389072
Drug withdrawal convulsions 19.64 10.38 21 109105 2107 64387499
Potentiating drug interaction 19.63 10.38 42 109084 7810 64381796
Haemorrhoids 19.62 10.38 8 109118 23993 64365613
Toxic encephalopathy 19.56 10.38 48 109078 9767 64379839
Bursitis 19.55 10.38 6 109120 21479 64368127
Metastases to liver 19.54 10.38 8 109118 23933 64365673
Right ventricular failure 19.53 10.38 6 109120 21465 64368141
B-lymphocyte count decreased 19.52 10.38 16 109110 1145 64388461
Photophobia 19.46 10.38 69 109057 17224 64372382
Hepatotoxicity 19.44 10.38 125 109001 39837 64349769
Clostridium difficile colitis 19.31 10.38 11 109115 27212 64362394
Abdominal distension 19.31 10.38 90 109036 95904 64293702
Joint stiffness 19.23 10.38 14 109112 30390 64359216
Rhinorrhoea 19.09 10.38 46 109080 59923 64329683
Intra-abdominal pressure increased 19.05 10.38 9 109117 238 64389368
Poverty of speech 19.05 10.38 12 109114 567 64389039
Encephalocele 18.91 10.38 5 109121 20 64389586
Hepatitis 18.86 10.38 137 108989 45445 64344161
Enanthema 18.66 10.38 13 109113 728 64388878
Acute respiratory failure 18.65 10.38 35 109091 49899 64339707
Convulsive threshold lowered 18.60 10.38 14 109112 885 64388721
Affective disorder 18.57 10.38 37 109089 6543 64383063
Excessive eye blinking 18.38 10.38 16 109110 1244 64388362
Blood hyposmosis 18.34 10.38 5 109121 23 64389583
Transfusion 18.33 10.38 4 109122 17990 64371616
Hyperthermia 18.33 10.38 63 109063 15487 64374119
Adverse event 18.25 10.38 24 109102 39465 64350141
Cataract 18.22 10.38 37 109089 51225 64338381
Personality change 18.17 10.38 43 109083 8550 64381056
Fabry's disease 18.17 10.38 5 109121 24 64389582
Sputum discoloured 18.13 10.38 4 109122 17852 64371754
Blood sodium decreased 18.07 10.38 98 109028 29384 64360222
Pulmonary mass 18.07 10.38 9 109117 24007 64365599
Metastases to bone 18.07 10.38 6 109120 20429 64369177
Constipation 18.05 10.38 512 108614 228825 64160781
Perseveration 18.04 10.38 10 109116 372 64389234
Mydriasis 18.02 10.38 62 109064 15250 64374356
Pericardial effusion 17.99 10.38 24 109102 39230 64350376
Nephrolithiasis 17.79 10.38 29 109097 43654 64345952
Fungal infection 17.77 10.38 19 109107 34232 64355374
Blood immunoglobulin A decreased 17.72 10.38 11 109115 506 64389100
Leukocytosis 17.72 10.38 117 109009 37623 64351983
Diabetic neuropathy 17.65 10.38 33 109093 5568 64384038
Thrombocytopenic purpura 17.64 10.38 20 109106 2142 64387464
Central nervous system lesion 17.62 10.38 52 109074 11797 64377809
Dysphagia 17.58 10.38 266 108860 106546 64283060
Brain oedema 17.54 10.38 79 109047 21996 64367610
Lethargy 17.53 10.38 194 108932 72400 64317206
Transplant rejection 17.46 10.38 4 109122 17397 64372209
Device expulsion 17.35 10.38 7 109119 21129 64368477
Polydipsia psychogenic 17.34 10.38 8 109118 200 64389406
Epidermal necrosis 17.33 10.38 16 109110 1344 64388262
Blood pressure systolic increased 17.32 10.38 36 109090 49417 64340189
Abortion threatened 17.31 10.38 10 109116 403 64389203
Rickets 17.19 10.38 6 109120 70 64389536
Derailment 17.19 10.38 6 109120 70 64389536
Stereotypy 17.17 10.38 13 109113 829 64388777
Mitral valve incompetence 17.16 10.38 11 109115 25527 64364079
Urticaria vesiculosa 17.15 10.38 4 109122 8 64389598
Fanconi syndrome 16.87 10.38 21 109105 2480 64387126
Immune thrombocytopenia 16.86 10.38 60 109066 15006 64374600
Gingival hypertrophy 16.85 10.38 22 109104 2725 64386881
Logorrhoea 16.83 10.38 27 109099 4032 64385574
Labelled drug-drug interaction medication error 16.82 10.38 78 109048 21984 64367622
Benzodiazepine drug level increased 16.81 10.38 8 109118 215 64389391
Hepatic cirrhosis 16.77 10.38 12 109114 26286 64363320
Disorientation 16.74 10.38 156 108970 55672 64333934
Procedural pain 16.74 10.38 3 109123 15505 64374101
Drug dependence 16.70 10.38 105 109021 33207 64356399
Chills 16.70 10.38 150 108976 137114 64252492
Muscle twitching 16.63 10.38 70 109056 18928 64370678
Incoherent 16.58 10.38 37 109089 7081 64382525
Emotional disorder 16.57 10.38 53 109073 12554 64377052
Lactate pyruvate ratio increased 16.53 10.38 6 109120 79 64389527
Conjunctival oedema 16.52 10.38 14 109112 1050 64388556
Disorganised speech 16.50 10.38 17 109109 1633 64387973
Suspiciousness 16.38 10.38 11 109115 580 64389026
Vaginal ulceration 16.25 10.38 8 109118 232 64389374
Drowning 16.25 10.38 12 109114 737 64388869
Sitting disability 16.21 10.38 7 109119 149 64389457
Cytomegalovirus mucocutaneous ulcer 16.20 10.38 6 109120 84 64389522
Wrong technique in product usage process 16.17 10.38 56 109070 64918 64324688
COVID-19 pneumonia 16.15 10.38 4 109122 16500 64373106
Flatulence 16.15 10.38 22 109104 35644 64353962
Tensilon test abnormal 16.15 10.38 3 109123 0 64389606
SUNCT syndrome 16.15 10.38 3 109123 0 64389606
Brain lobectomy 16.15 10.38 3 109123 0 64389606
Vitamin D deficiency 16.15 10.38 50 109076 11642 64377964
Dermatitis bullous 16.14 10.38 51 109075 12003 64377603
Upper respiratory tract infection 16.00 10.38 66 109060 72719 64316887
Hypoglycaemia 15.96 10.38 88 109038 89804 64299802
Pneumocystis jirovecii pneumonia 15.88 10.38 14 109112 27620 64361986
Cholestasis 15.86 10.38 130 108996 44742 64344864
Ultrasound ovary abnormal 15.82 10.38 6 109120 90 64389516
Scab 15.78 10.38 42 109084 8980 64380626
Vaginal erosion 15.77 10.38 4 109122 13 64389593
Urinary incontinence 15.74 10.38 110 109016 36041 64353565
Hypothermia 15.73 10.38 71 109055 19785 64369821
Unresponsive to stimuli 15.71 10.38 142 108984 50251 64339355
Blood immunoglobulin G decreased 15.71 10.38 21 109105 2662 64386944
Paranoia 15.70 10.38 62 109064 16290 64373316
Upper gastrointestinal haemorrhage 15.67 10.38 22 109104 35198 64354408
Candida infection 15.67 10.38 18 109108 31401 64358205
Oral mucosal eruption 15.60 10.38 11 109115 628 64388978
Human herpesvirus 7 infection 15.58 10.38 6 109120 94 64389512
Polydipsia 15.56 10.38 32 109094 5789 64383817
Distractibility 15.49 10.38 11 109115 635 64388971
Gastroenteritis viral 15.45 10.38 7 109119 19722 64369884
Cheilitis 15.39 10.38 28 109098 4628 64384978
Antipsychotic drug level below therapeutic 15.37 10.38 13 109113 972 64388634
Respiratory arrest 15.36 10.38 147 108979 52838 64336768
Posterior reversible encephalopathy syndrome 15.26 10.38 10 109116 22936 64366670
Low set ears 15.24 10.38 6 109120 100 64389506
Subacute cutaneous lupus erythematosus 15.20 10.38 22 109104 3003 64386603
Tooth development disorder 15.20 10.38 5 109121 48 64389558
Areflexia 15.16 10.38 29 109097 4978 64384628
Frontotemporal dementia 15.12 10.38 10 109116 514 64389092
Cholelithiasis 15.10 10.38 130 108996 45376 64344230
Drug level above therapeutic 15.10 10.38 35 109091 6866 64382740
Therapeutic product effective for unapproved indication 14.92 10.38 6 109120 106 64389500
Feeling of despair 14.88 10.38 20 109106 2548 64387058
Inhibitory drug interaction 14.87 10.38 24 109102 3603 64386003
Idiopathic generalised epilepsy 14.84 10.38 5 109121 52 64389554
Ultrasound liver abnormal 14.82 10.38 7 109119 185 64389421
Extensor plantar response 14.81 10.38 16 109110 1624 64387982
Epileptic encephalopathy 14.76 10.38 9 109117 401 64389205
Human herpesvirus 6 infection reactivation 14.64 10.38 8 109118 289 64389317
Nodule 14.64 10.38 6 109120 17941 64371665
Posture abnormal 14.60 10.38 23 109103 3383 64386223
Priapism 14.58 10.38 25 109101 3945 64385661
Thrombotic microangiopathy 14.54 10.38 5 109121 16650 64372956
Hangover 14.52 10.38 17 109109 1884 64387722
Respiratory depression 14.42 10.38 78 109048 23365 64366241
Bone metabolism disorder 14.35 10.38 9 109117 422 64389184
Bone marrow failure 14.32 10.38 38 109088 47914 64341692
Learning disability 14.32 10.38 7 109119 200 64389406
Blood citric acid increased 14.27 10.38 5 109121 59 64389547
Cardiac arrest 14.14 10.38 351 108775 153713 64235893
Throat irritation 14.00 10.38 21 109105 32690 64356916
Screaming 13.99 10.38 23 109103 3506 64386100
Pancytopenia 13.98 10.38 165 108961 143144 64246462
Juvenile myoclonic epilepsy 13.97 10.38 5 109121 63 64389543
Cytomegalovirus infection 13.96 10.38 26 109100 37173 64352433
Inappropriate schedule of product administration 13.95 10.38 95 109031 92191 64297415
Negative thoughts 13.95 10.38 14 109112 1304 64388302
Bacteraemia 13.88 10.38 15 109111 26896 64362710
Lip ulceration 13.82 10.38 17 109109 1984 64387622
Guillain-Barre syndrome 13.82 10.38 36 109090 7599 64382007
Therapy cessation 13.77 10.38 21 109105 32468 64357138
Labelled drug-food interaction medication error 13.76 10.38 5 109121 66 64389540
Drug-induced liver injury 13.72 10.38 132 108994 47511 64342095
Hyperpyrexia 13.68 10.38 28 109098 5049 64384557
Congenital arterial malformation 13.65 10.38 4 109122 25 64389581
Eye discharge 13.65 10.38 28 109098 5056 64384550
Hypospadias 13.63 10.38 6 109120 134 64389472
Selective IgA immunodeficiency 13.62 10.38 3 109123 4 64389602
Pyuria 13.60 10.38 17 109109 2016 64387590
Skin lesion 13.60 10.38 107 109019 36375 64353231
Tumour lysis syndrome 13.58 10.38 8 109118 19432 64370174
Atrioventricular block 13.57 10.38 48 109078 11967 64377639
Hallucination, visual 13.50 10.38 87 109039 27747 64361859
Muscle rigidity 13.49 10.38 62 109064 17411 64372195
Haematemesis 13.47 10.38 38 109088 46961 64342645
Malaise 13.46 10.38 541 108585 395706 63993900
Norovirus infection 13.45 10.38 7 109119 229 64389377
Hypochloraemia 13.42 10.38 17 109109 2044 64387562
Rash papular 13.41 10.38 61 109065 17052 64372554
Bipolar disorder 13.40 10.38 33 109093 6728 64382878
Wrong drug 13.39 10.38 7 109119 231 64389375
Illiteracy 13.39 10.38 4 109122 27 64389579
Bundle branch block right 13.34 10.38 43 109083 10226 64379380
Visual field defect 13.32 10.38 37 109089 8109 64381497
Diverticulum 13.31 10.38 3 109123 13195 64376411
Localised infection 13.26 10.38 19 109107 30142 64359464
Cardiomyopathy 13.23 10.38 14 109112 25342 64364264
Pyroglutamate increased 13.20 10.38 10 109116 638 64388968
Intervertebral disc degeneration 13.20 10.38 3 109123 13117 64376489
Dry mouth 13.14 10.38 55 109071 60363 64329243
Injection site haemorrhage 13.12 10.38 13 109113 24265 64365341
Pigmentation disorder 13.10 10.38 26 109100 4586 64385020
Thyroid adenoma 13.01 10.38 6 109120 150 64389456
Pulmonary embolism 12.97 10.38 172 108954 146184 64243422
Therapy interrupted 12.97 10.38 9 109117 20027 64369579
Acute hepatic failure 12.90 10.38 82 109044 26030 64363576
Poisoning deliberate 12.90 10.38 51 109075 13407 64376199
Apgar score low 12.87 10.38 3 109123 6 64389600
Drug half-life reduced 12.87 10.38 3 109123 6 64389600
Skin oedema 12.85 10.38 14 109112 1434 64388172
Abortion 12.85 10.38 13 109113 1223 64388383
Open angle glaucoma 12.83 10.38 8 109118 371 64389235
Medulloblastoma 12.83 10.38 5 109121 81 64389525
Cerebrovascular accident 12.82 10.38 160 108966 137423 64252183
Staring 12.81 10.38 18 109108 2392 64387214
Near drowning 12.80 10.38 4 109122 32 64389574
Device related infection 12.78 10.38 20 109106 30606 64359000
Tetany 12.72 10.38 17 109109 2155 64387451
Hypoosmolar state 12.71 10.38 7 109119 257 64389349
Caesarean section 12.70 10.38 45 109081 11229 64378377
Foot deformity 12.70 10.38 6 109120 16498 64373108
Coagulation time shortened 12.70 10.38 8 109118 378 64389228
Sluggishness 12.68 10.38 29 109097 5641 64383965
Xanthelasma 12.65 10.38 6 109120 160 64389446
Vision blurred 12.65 10.38 219 108907 90097 64299509
Disease recurrence 12.63 10.38 94 109032 31416 64358190
Infrapatellar fat pad inflammation 12.62 10.38 6 109120 161 64389445
Blood creatinine increased 12.61 10.38 158 108968 135624 64253982
Hypersexuality 12.61 10.38 14 109112 1465 64388141
Neurosis 12.58 10.38 8 109118 384 64389222
Amnesia 12.58 10.38 131 108995 48138 64341468
Nephropathy toxic 12.53 10.38 7 109119 17507 64372099
Onychophagia 12.50 10.38 5 109121 87 64389519
Myelodysplastic syndrome 12.50 10.38 17 109109 27562 64362044
Lower gastrointestinal haemorrhage 12.49 10.38 4 109122 13935 64375671
Squamous cell carcinoma 12.39 10.38 4 109122 13865 64375741
Encephalopathy 12.34 10.38 153 108973 58666 64330940
Acanthosis 12.33 10.38 8 109118 398 64389208
Tonic clonic movements 12.31 10.38 16 109110 1973 64387633
Treatment noncompliance 12.29 10.38 120 109006 43362 64346244
Oedema 12.29 10.38 98 109028 91837 64297769
Genital burning sensation 12.28 10.38 7 109119 275 64389331
Diabetes insipidus 12.26 10.38 25 109101 4496 64385110
Respiratory tract congestion 12.25 10.38 6 109120 16159 64373447
Pseudophaeochromocytoma 12.25 10.38 5 109121 92 64389514
Low birth weight baby 12.24 10.38 9 109117 549 64389057
Conjunctival disorder 12.23 10.38 7 109119 277 64389329
Hypoxia 12.23 10.38 93 109033 88056 64301550
Liver function test increased 12.20 10.38 21 109105 30949 64358657
Atelectasis 12.17 10.38 17 109109 27249 64362357
Bipolar I disorder 12.16 10.38 15 109111 1756 64387850
Patient uncooperative 12.11 10.38 9 109117 558 64389048
Acute coronary syndrome 12.07 10.38 9 109117 19301 64370305
Second primary malignancy 12.06 10.38 3 109123 12334 64377272
Neurological symptom 12.05 10.38 32 109094 6832 64382774
Granulocytopenia 12.05 10.38 42 109084 10398 64379208
Weight increased 12.03 10.38 272 108854 213076 64176530
Red cell distribution width increased 12.01 10.38 3 109123 12306 64377300
Niemann-Pick disease 12.01 10.38 4 109122 40 64389566
Migraine 11.88 10.38 60 109066 62617 64326989
Injection site warmth 11.82 10.38 4 109122 13458 64376148
Disability 11.82 10.38 3 109123 12169 64377437
Left ventricular dysfunction 11.81 10.38 7 109119 16947 64372659
Biopsy skin abnormal 11.79 10.38 6 109120 187 64389419
Crying 11.79 10.38 66 109060 20024 64369582
Glycosuria 11.79 10.38 16 109110 2058 64387548
Peritonitis 11.78 10.38 15 109111 25008 64364598
Conjunctival erosion 11.77 10.38 5 109121 102 64389504
Angiosclerosis 11.77 10.38 3 109123 10 64389596
Hyperglycinaemia 11.77 10.38 3 109123 10 64389596
Sinus disorder 11.76 10.38 7 109119 16901 64372705
Tri-iodothyronine decreased 11.73 10.38 6 109120 189 64389417
Neurotoxicity 11.70 10.38 83 109043 27321 64362285
Injection site rash 11.69 10.38 6 109120 15736 64373870
Tic 11.66 10.38 18 109108 2601 64387005
Bradycardia 11.65 10.38 272 108854 117947 64271659
Hepatomegaly 11.65 10.38 58 109068 16824 64372782
Ileus paralytic 11.64 10.38 36 109090 8379 64381227
Maternal drugs affecting foetus 11.57 10.38 14 109112 1606 64388000
Illness 11.57 10.38 12 109114 21926 64367680
Agranulocytosis 11.55 10.38 107 109019 38122 64351484
Hirsutism 11.54 10.38 11 109115 962 64388644
Acid base balance abnormal 11.52 10.38 7 109119 310 64389296
Product dispensing error 11.47 10.38 44 109082 11406 64378200
Adverse drug reaction 11.44 10.38 39 109087 45425 64344181
Sensorimotor disorder 11.43 10.38 10 109116 783 64388823
Biopsy lymph gland abnormal 11.34 10.38 3 109123 12 64389594
Dissociative amnesia 11.30 10.38 5 109121 113 64389493
Sinus congestion 11.30 10.38 6 109120 15433 64374173
Renal injury 11.28 10.38 6 109120 15423 64374183
Oral disorder 11.27 10.38 37 109089 8884 64380722
Device issue 11.27 10.38 13 109113 22635 64366971
Macule 11.26 10.38 17 109109 2409 64387197
Tuberculosis 11.23 10.38 4 109122 13034 64376572
Autoscopy 11.21 10.38 4 109122 50 64389556
Anaplastic large cell lymphoma T- and null-cell types 11.18 10.38 5 109121 116 64389490
Sinus node dysfunction 11.15 10.38 31 109095 6797 64382809
Ischaemic gastritis 11.15 10.38 3 109123 13 64389593
Glomerular filtration rate decreased 11.14 10.38 10 109116 19562 64370044
Obsessive thoughts 11.13 10.38 11 109115 1006 64388600
Neoplasm progression 11.10 10.38 34 109092 40930 64348676
Blood test abnormal 11.10 10.38 4 109122 12939 64376667
Parkinsonism 11.09 10.38 51 109075 14322 64375284
Encapsulating peritoneal sclerosis 11.09 10.38 10 109116 815 64388791
Deep vein thrombosis 11.09 10.38 119 109007 105063 64284543
Neuropsychiatric syndrome 11.07 10.38 5 109121 119 64389487
Sensory disturbance 11.05 10.38 48 109078 13160 64376446
Acinetobacter test positive 10.98 10.38 6 109120 217 64389389
Carnitine decreased 10.97 10.38 3 109123 14 64389592
Developmental delay 10.95 10.38 11 109115 1026 64388580
Knee arthroplasty 10.92 10.38 18 109108 26981 64362625
Pain in jaw 10.92 10.38 34 109092 40721 64348885
Erythema of eyelid 10.91 10.38 15 109111 1953 64387653
Cholinergic syndrome 10.90 10.38 10 109116 833 64388773
Neutropenic sepsis 10.90 10.38 14 109112 23258 64366348
Maculopathy 10.90 10.38 17 109109 2479 64387127
Stab wound 10.88 10.38 6 109120 221 64389385
Mucosal disorder 10.87 10.38 19 109107 3043 64386563
Diabetes mellitus inadequate control 10.87 10.38 12 109114 21309 64368297
Rebound effect 10.83 10.38 25 109101 4892 64384714
Pupillary reflex impaired 10.82 10.38 19 109107 3054 64386552
Tendonitis 10.80 10.38 11 109115 20271 64369335
Enlarged cerebral perivascular spaces 10.80 10.38 3 109123 15 64389591
Blood lactate dehydrogenase 10.80 10.38 3 109123 15 64389591
Mycoplasma infection 10.78 10.38 9 109117 661 64388945
Hepatitis fulminant 10.76 10.38 29 109097 6245 64383361
Hypoproteinaemia 10.75 10.38 20 109106 3362 64386244
Hyperbilirubinaemia 10.74 10.38 12 109114 21193 64368413
Enterococcal infection 10.73 10.38 5 109121 13861 64375745
Device dislocation 10.71 10.38 12 109114 21166 64368440
Rheumatoid nodule 10.70 10.38 4 109122 12647 64376959
Allodynia 10.69 10.38 12 109114 1271 64388335
Hypotension 10.68 10.38 765 108361 380209 64009397
Histiocytic necrotising lymphadenitis 10.67 10.38 4 109122 58 64389548
Tardive dyskinesia 10.66 10.38 37 109089 9141 64380465
Pharyngeal erythema 10.66 10.38 14 109112 1745 64387861
Wrong product administered 10.65 10.38 33 109093 7687 64381919
Impaired driving ability 10.62 10.38 24 109102 4630 64384976
Pregnancy 10.60 10.38 66 109060 20799 64368807
Gastric ulcer 10.59 10.38 22 109104 30212 64359394
Ulcer 10.59 10.38 14 109112 22976 64366630
Tonsillar hypertrophy 10.55 10.38 12 109114 1289 64388317
Vestibular disorder 10.55 10.38 16 109110 2277 64387329
Pathogen resistance 10.55 10.38 4 109122 12539 64377067
Basilar migraine 10.55 10.38 4 109122 60 64389546
Tricuspid valve incompetence 10.53 10.38 8 109118 16995 64372611
Lip swelling 10.51 10.38 91 109035 31816 64357790
Cell death 10.50 10.38 22 109104 4032 64385574
Febrile bone marrow aplasia 10.50 10.38 3 109123 11252 64378354
Trigemino-cardiac reflex 10.47 10.38 6 109120 238 64389368
Altered visual depth perception 10.46 10.38 7 109119 367 64389239
Odynophagia 10.45 10.38 38 109088 9603 64380003
Gastric disorder 10.44 10.38 21 109105 29176 64360430
Night sweats 10.43 10.38 29 109097 36017 64353589
Flushing 10.43 10.38 84 109042 78564 64311042
Abulia 10.43 10.38 10 109116 881 64388725
Breast cancer 10.39 10.38 21 109105 29127 64360479

FDA Adverse Event Reporting System (Pediatric)

None

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:35477 antimanic drugs
CHEBI has role CHEBI:35623 anticonvulsants
CHEBI has role CHEBI:35703 Xenobiotic
CHEBI has role CHEBI:38633 sodium channel blockers
CHEBI has role CHEBI:52290 mitogens
CHEBI has role CHEBI:61115 histone deacetylase inhibitors
CHEBI has role CHEBI:64370 glutamate transporter activators
CHEBI has role CHEBI:78298 environmental contaminants
CHEBI has role CHEBI:88188 allergenic drug
MeSH PA D000700 Analgesics
MeSH PA D018712 Analgesics, Non-Narcotic
MeSH PA D000927 Anticonvulsants
MeSH PA D018692 Antimanic Agents
MeSH PA D002317 Cardiovascular Agents
MeSH PA D002491 Central Nervous System Agents
MeSH PA D002492 Central Nervous System Depressants
MeSH PA D065701 Cytochrome P-450 CYP3A Inducers
MeSH PA D049990 Membrane Transport Modulators
MeSH PA D065606 Metabolic Side Effects of Drugs and Substances
MeSH PA D018373 Peripheral Nervous System Agents
MeSH PA D011619 Psychotropic Drugs
MeSH PA D018689 Sensory System Agents
MeSH PA D026941 Sodium Channel Blockers
MeSH PA D014149 Tranquilizing Agents
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

Drug Use (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
100MG EQUETRO VALIDUS PHARMS N021710 Dec. 10, 2004 RX CAPSULE, EXTENDED RELEASE ORAL 6977253 May 19, 2024 THE RECOMMENDED INITIAL DOSE OF EQUETRO IS 400MG/DAY GIVEN IN DIVIDED DOSES, TWICE DAILY. THE DOSE SHOULD BE ADJUSTED IN 200MG DAILY INCREMENTS TO ACHIEVE OPTIMAL CLINICAL RESPONSE.
200MG EQUETRO VALIDUS PHARMS N021710 Dec. 10, 2004 RX CAPSULE, EXTENDED RELEASE ORAL 6977253 May 19, 2024 THE RECOMMENDED INITIAL DOSE OF EQUETRO IS 400MG/DAY GIVEN IN DIVIDED DOSES, TWICE DAILY. THE DOSE SHOULD BE ADJUSTED IN 200MG DAILY INCREMENTS TO ACHIEVE OPTIMAL CLINICAL RESPONSE.
300MG EQUETRO VALIDUS PHARMS N021710 Dec. 10, 2004 RX CAPSULE, EXTENDED RELEASE ORAL 6977253 May 19, 2024 THE RECOMMENDED INITIAL DOSE OF EQUETRO IS 400MG/DAY GIVEN IN DIVIDED DOSES, TWICE DAILY. THE DOSE SHOULD BE ADJUSTED IN 200MG DAILY INCREMENTS TO ACHIEVE OPTIMAL CLINICAL RESPONSE.
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)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
200MG/20ML (10MG/ML) CARNEXIV LUNDBECK PHARMS LLC N206030 Oct. 7, 2016 DISCN SOLUTION INTRAVENOUS Oct. 7, 2023 REPLACEMENT THERAPY FOR ORAL CARBAMAZEPINE FORMULATIONS, WHEN ORAL ADMINISTRATION IS TEMPORARILY NOT FEASIBLE, IN ADULTS WITH THE FOLLOWING SEIZURE TYPES: PARTIAL WITH COMPLEX SYMPTOMOLOGY, GENERALIZED CLONIC-TONIC, AND MIXED

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 WOMBAT-PK 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
1836 INN_ID
5339 IUPHAR_LIGAND_ID
85756-57-6 SECONDARY_CAS_RN
33CM23913M UNII
4350 MMSL
513 MMSL
d00058 MMSL
001634 NDDF
387222003 SNOMEDCT_US
40820003 SNOMEDCT_US
4017873 VANDF

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
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 0121-0862 SUSPENSION 100 mg ORAL ANDA 28 sections
Carbamazepine HUMAN PRESCRIPTION DRUG LABEL 1 0121-0947 SUSPENSION 100 mg ORAL ANDA 29 sections
Carbamazepine HUMAN PRESCRIPTION DRUG LABEL 1 0121-1724 SUSPENSION 200 mg ORAL ANDA 28 sections
Carbamazepine HUMAN PRESCRIPTION DRUG LABEL 1 0121-1894 SUSPENSION 200 mg ORAL ANDA 29 sections
Carbamazepine HUMAN PRESCRIPTION DRUG LABEL 1 0615-3505 TABLET 200 mg ORAL ANDA 21 sections
CARBAMAZEPINE HUMAN PRESCRIPTION DRUG LABEL 1 0615-4515 TABLET 100 mg ORAL ANDA 25 sections
Carbamazepine HUMAN PRESCRIPTION DRUG LABEL 1 0615-8125 TABLET, CHEWABLE 100 mg ORAL ANDA 29 sections
CarbamazepineER HUMAN PRESCRIPTION DRUG LABEL 1 0781-5987 TABLET, EXTENDED RELEASE 200 mg ORAL NDA authorized generic 27 sections
CarbamazepineER HUMAN PRESCRIPTION DRUG LABEL 1 0781-5988 TABLET, EXTENDED RELEASE 400 mg ORAL NDA authorized generic 27 sections
CarbamazepineER HUMAN PRESCRIPTION DRUG LABEL 1 0781-8016 TABLET, EXTENDED RELEASE 100 mg ORAL NDA authorized generic 27 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