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

Stem definitionDrug idCAS RN
2706 97240-79-4

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • topiramate
  • beta-D-fructopyranose sulfamate
  • epitoma
  • epitomax
  • topamac
  • topamax
  • topimax
  • topomax
  • topina
The precise mechanisms by which topiramate exerts its anticonvulsant and migraine prophylaxis effects are unknown; however, preclinical studies have revealed four properties that may contribute to topiramate's efficacy for epilepsy and migraine prophylaxis. Electrophysiological and biochemical evidence suggests that topiramate, at pharmacologically relevant concentrations, blocks voltage-dependent sodium channels, augments the activity of the neurotransmitter gamma-aminobutyrate at some subtypes of the GABA-A receptor, antagonizes the AMPA/kainate subtype of the glutamate receptor, and inhibits the carbonic anhydrase enzyme, particularly isozymes II and IV.
  • Molecular weight: 339.36
  • Formula: C12H21NO8S
  • CLOGP: 0.04
  • LIPINSKI: 0
  • HAC: 9
  • HDO: 1
  • TPSA: 115.54
  • ALOGS: -1.70
  • ROTB: 3
  • Status: OFP
    • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

DoseUnitRoute
0.30 g O

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 3 Benet LZ, Broccatelli F, Oprea TI
S (Water solubility) 9.80 mg/mL Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine) 70 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 19.65 µM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability) 70 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
Vd (Volume of distribution) 0.80 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 0.27 mL/min/kg Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma) 0.72 % Lombardo F, Berellini G, Obach RS
t_half (Half-life) 34.80 hours Lombardo F, Berellini G, Obach RS

Approvals:

DateAgencyCompanyOrphan
Dec. 24, 1996 FDA JANSSEN PHARMS
July 1, 2007 PMDA

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
Angle closure glaucoma 1193.04 10.27 340 108134 1879 63378669
Seizure 1171.40 10.27 1282 107192 131352 63249196
Migraine 639.36 10.27 834 107640 102512 63278036
Product substitution issue 472.99 10.27 311 108163 15685 63364863
Myopia 452.58 10.27 151 108323 1504 63379044
Drug ineffective for unapproved indication 424 10.27 397 108077 33666 63346882
Completed suicide 420.12 10.27 830 107644 144843 63235705
Choroidal effusion 396.53 10.27 103 108371 373 63380175
Multiple-drug resistance 353.57 10.27 174 108300 4996 63375552
Intentional self-injury 326.63 10.27 303 108171 25384 63355164
Visual perseveration 321.42 10.27 62 108412 13 63380535
Renal tubular acidosis 311.54 10.27 115 108359 1577 63378971
Epilepsy 311.26 10.27 302 108172 26763 63353785
Status epilepticus 293.03 10.27 228 108246 15005 63365543
Suicidal ideation 290.74 10.27 440 108034 61981 63318567
Pemphigus 269.87 10.27 10 108464 183716 63196832
Joint swelling 268.54 10.27 112 108362 327554 63052994
Intentional overdose 252.64 10.27 454 108020 73698 63306850
Synovitis 236.26 10.27 23 108451 186895 63193653
Depression 222.73 10.27 790 107684 195702 63184846
Abortion spontaneous 220.19 10.27 333 108141 46862 63333686
Paraesthesia 217.00 10.27 675 107799 156291 63224257
Hand deformity 211.39 10.27 16 108458 159441 63221107
Nephrolithiasis 209.89 10.27 306 108168 41678 63338870
Somnolence 206.43 10.27 723 107751 177962 63202586
Generalised tonic-clonic seizure 201.02 10.27 248 108226 28768 63351780
Metabolic acidosis 200.40 10.27 311 108163 44758 63335790
Glossodynia 197.30 10.27 34 108440 178842 63201706
Arthropathy 192.65 10.27 80 108394 234712 63145836
Memory impairment 190.53 10.27 496 107978 103762 63276786
Toxicity to various agents 183.35 10.27 872 107602 246378 63134170
Wound 180.12 10.27 31 108443 163232 63217316
Infusion related reaction 176.57 10.27 100 108374 245421 63135127
Overdose 171.27 10.27 508 107966 114570 63265978
Choroidal detachment 164.00 10.27 44 108430 186 63380362
Petit mal epilepsy 163.90 10.27 94 108380 3700 63376848
Abdominal discomfort 160.71 10.27 187 108287 320698 63059850
Anti-cyclic citrullinated peptide antibody positive 158.83 10.27 10 108464 116202 63264346
Pericarditis 156.61 10.27 20 108454 131559 63248989
Drug ineffective 150.92 10.27 2560 105914 1042205 62338343
Contraindicated product administered 150.33 10.27 93 108381 217555 63162993
Blepharospasm 149.64 10.27 105 108369 5891 63374657
Hyperammonaemic encephalopathy 149.00 10.27 76 108398 2358 63378190
Rheumatoid arthritis 147.47 10.27 130 108344 253689 63126859
Irritability 146.92 10.27 223 108251 31471 63349077
Disturbance in attention 145.88 10.27 246 108228 37943 63342605
Acute myopia 136.57 10.27 33 108441 81 63380467
Swelling 134.09 10.27 164 108310 275214 63105334
Systemic lupus erythematosus 133.88 10.27 97 108377 208821 63171727
Exposure during pregnancy 133.43 10.27 573 107901 154974 63225574
Aggression 133.32 10.27 182 108292 23316 63357232
Psychotic disorder 130.81 10.27 189 108285 25523 63355025
Headache 130.21 10.27 1651 106823 631590 62748958
Rheumatoid factor positive 129.69 10.27 3 108471 84403 63296145
Anaemia 126.47 10.27 191 108283 293239 63087309
Cognitive disorder 124.75 10.27 287 108187 55528 63325020
Myokymia 123.60 10.27 23 108451 0 63380548
Febrile neutropenia 123.17 10.27 26 108448 118423 63262125
Myoclonic epilepsy 122.41 10.27 54 108420 1200 63379348
Acidosis hyperchloraemic 120.63 10.27 40 108434 390 63380158
Medication overuse headache 118.86 10.27 47 108427 785 63379763
Helicobacter infection 115.65 10.27 12 108462 92773 63287775
Arthralgia 114.90 10.27 542 107932 569168 62811380
Duodenal ulcer perforation 114.83 10.27 9 108465 87200 63293348
Tremor 114.82 10.27 489 107985 131750 63248798
Product use in unapproved indication 114.53 10.27 606 107868 178474 63202074
Flat anterior chamber of eye 112.52 10.27 25 108449 35 63380513
Lower respiratory tract infection 106.97 10.27 46 108428 132261 63248287
Suicide attempt 106.32 10.27 285 108189 60633 63319915
Peripheral swelling 105.29 10.27 183 108291 265759 63114789
Drug interaction 102.85 10.27 707 107767 228424 63152124
Ciliary body disorder 99.39 10.27 20 108454 10 63380538
Focal dyscognitive seizures 99.22 10.27 62 108412 2859 63377689
Drug resistance 98.78 10.27 156 108318 22777 63357771
Aphasia 98.51 10.27 191 108283 32809 63347739
Discomfort 96.82 10.27 86 108388 167288 63213260
Pneumonia 96.49 10.27 427 108047 456340 62924208
Intraocular pressure increased 95.79 10.27 81 108393 5997 63374551
Abnormal behaviour 95.42 10.27 148 108326 21278 63359270
Infection 95.05 10.27 153 108321 229020 63151528
Malignant neoplasm progression 94.11 10.27 14 108460 82107 63298441
Anxiety 91.04 10.27 660 107814 216881 63163667
Acute kidney injury 90.60 10.27 197 108277 263218 63117330
Rash 89.75 10.27 576 107898 560295 62820253
General physical health deterioration 89.74 10.27 128 108346 201274 63179274
Vision blurred 88.50 10.27 351 108123 91573 63288975
Partial seizures 88.28 10.27 76 108398 5766 63374782
Anorexia nervosa 87.43 10.27 28 108446 242 63380306
Blindness 87.17 10.27 143 108331 21556 63358992
Stomatitis 86.77 10.27 66 108408 138659 63241889
Paradoxical drug reaction 86.09 10.27 65 108409 4087 63376461
Impaired healing 85.55 10.27 34 108440 102508 63278040
Folliculitis 85.34 10.27 10 108464 70307 63310241
Muscle injury 85.31 10.27 7 108467 65338 63315210
Multiple sclerosis relapse 83.78 10.27 226 108248 48252 63332296
Pyrexia 83.21 10.27 468 108006 470010 62910538
Blister 80.89 10.27 62 108412 129752 63250796
Hepatic enzyme increased 80.25 10.27 139 108335 202189 63178359
Cerebral venous thrombosis 78.05 10.27 47 108427 2027 63378521
Nasopharyngitis 76.46 10.27 204 108270 254053 63126495
Sleep disorder due to general medical condition, insomnia type 76.07 10.27 3 108471 52214 63328334
Disease progression 74.75 10.27 60 108414 122698 63257850
Hypoaesthesia 74.55 10.27 518 107956 167875 63212673
Diplopia 74.09 10.27 140 108334 23588 63356960
Multiple sclerosis 73.89 10.27 142 108332 24230 63356318
Off label use 73.81 10.27 1586 106888 672876 62707672
Mitochondrial DNA mutation 71.54 10.27 27 108447 395 63380153
Neovascularisation 70.81 10.27 36 108438 1109 63379439
Weight decreased 70.53 10.27 753 107721 276045 63104503
Therapeutic response unexpected 69.19 10.27 119 108355 18640 63361908
Atrial fibrillation 68.56 10.27 59 108415 116577 63263971
Dyspnoea 67.55 10.27 764 107710 660549 62719999
Propofol infusion syndrome 66.96 10.27 33 108441 950 63379598
Photophobia 66.53 10.27 113 108361 17522 63363026
Bradyphrenia 65.83 10.27 70 108404 6910 63373638
Hyperammonaemia 65.10 10.27 61 108413 5171 63375377
Sluggishness 64.73 10.27 61 108413 5208 63375340
Corneal oedema 64.51 10.27 37 108437 1456 63379092
Maculopathy 64.47 10.27 43 108431 2219 63378329
Pleural effusion 64.06 10.27 40 108434 93170 63287378
Speech disorder 63.87 10.27 183 108291 40446 63340102
Withdrawal syndrome 63.70 10.27 119 108355 19878 63360670
Bipolar disorder 63.29 10.27 73 108401 7887 63372661
Diarrhoea 63.07 10.27 853 107621 714513 62666035
Crying 62.35 10.27 129 108345 23214 63357334
Pancytopenia 62.05 10.27 45 108429 96888 63283660
Coma blister 61.86 10.27 19 108455 141 63380407
Cardiac failure 61.61 10.27 38 108436 89104 63291444
Drug abuse 61.22 10.27 266 108208 72252 63308296
Neutropenia 60.86 10.27 130 108344 174875 63205673
Infantile spasms 60.31 10.27 20 108454 195 63380353
Musculoskeletal stiffness 60.24 10.27 142 108332 184476 63196072
Alopecia 59.46 10.27 336 108138 337200 63043348
Hypocitraturia 59.11 10.27 11 108463 0 63380548
Mucosal inflammation 58.65 10.27 6 108468 46922 63333626
Anhidrosis 58.59 10.27 17 108457 101 63380447
Aura 58.50 10.27 31 108443 1042 63379506
Agitation 58.16 10.27 229 108245 59528 63321020
Drug withdrawal convulsions 58.08 10.27 34 108440 1391 63379157
Hypersensitivity 57.90 10.27 280 108194 292405 63088143
Cardiac failure congestive 57.76 10.27 44 108430 92389 63288159
Haemoglobin decreased 57.62 10.27 100 108374 145385 63235163
Dysarthria 57.36 10.27 182 108292 42529 63338019
Amnesia 57.35 10.27 217 108257 55368 63325180
Hallucination, auditory 56.28 10.27 88 108386 12736 63367812
Dizziness 55.91 10.27 1038 107436 428887 62951661
Mania 55.87 10.27 86 108388 12281 63368267
Necrotising colitis 55.76 10.27 25 108449 578 63379970
Visual field defect 55.26 10.27 62 108412 6499 63374049
Amenorrhoea 55.04 10.27 76 108398 9838 63370710
Sedation 54.54 10.27 168 108306 38641 63341907
Blood prolactin increased 53.80 10.27 46 108428 3457 63377091
Alexia 51.12 10.27 10 108464 3 63380545
Fanconi syndrome 50.98 10.27 31 108443 1361 63379187
Visual snow syndrome 50.95 10.27 13 108461 43 63380505
Eye pain 50.82 10.27 150 108324 33704 63346844
Visual acuity reduced 50.71 10.27 114 108360 21712 63358836
Product physical issue 50.65 10.27 52 108422 4928 63375620
Heat stroke 50.52 10.27 26 108448 822 63379726
Hip arthroplasty 50.46 10.27 10 108464 47636 63332912
Hyponatraemia 49.92 10.27 71 108403 111829 63268719
Self-induced vomiting 49.79 10.27 12 108462 29 63380519
Ill-defined disorder 49.71 10.27 40 108434 81715 63298833
Taste disorder 49.51 10.27 86 108388 13576 63366972
Thrombocytopenia 49.51 10.27 116 108358 151041 63229507
Feeling abnormal 48.74 10.27 426 108048 147966 63232582
Knee arthroplasty 48.55 10.27 16 108458 54190 63326358
Benign familial pemphigus 48.37 10.27 9 108465 0 63380548
Slow speech 48.30 10.27 31 108443 1498 63379050
CSF oligoclonal band present 48.21 10.27 20 108454 380 63380168
Pruritus 48.08 10.27 391 108083 361062 63019486
Suicidal behaviour 47.51 10.27 38 108436 2601 63377947
Muscle twitching 47.12 10.27 104 108370 19564 63360984
Therapeutic product effect decreased 46.73 10.27 171 108303 193016 63187532
Blood creatinine increased 46.28 10.27 49 108425 87795 63292753
Mood altered 46.04 10.27 87 108387 14656 63365892
Mood swings 45.43 10.27 98 108376 18150 63362398
Interstitial lung disease 44.74 10.27 25 108449 61883 63318665
Cough 44.48 10.27 305 108169 292438 63088110
C-reactive protein abnormal 44.20 10.27 12 108462 46084 63334464
Mental disorder 43.94 10.27 120 108354 25799 63354749
Change in seizure presentation 43.84 10.27 19 108455 404 63380144
Salivary gland calculus 43.78 10.27 15 108459 163 63380385
Blindness transient 43.44 10.27 42 108432 3702 63376846
Vertigo 43.36 10.27 210 108264 59677 63320871
Respiratory arrest 42.82 10.27 138 108336 32507 63348041
Tonic convulsion 42.72 10.27 27 108447 1270 63379278
Ammonia increased 42.68 10.27 46 108428 4610 63375938
Somnambulism 42.67 10.27 50 108424 5493 63375055
Iridocyclitis 42.63 10.27 35 108439 2487 63378061
Sepsis 42.20 10.27 128 108346 152995 63227553
Migraine with aura 42.12 10.27 36 108438 2704 63377844
Oligomenorrhoea 41.96 10.27 23 108451 828 63379720
Coma 41.89 10.27 219 108255 64145 63316403
Bulimia nervosa 41.76 10.27 19 108455 455 63380093
Iris adhesions 41.42 10.27 17 108457 314 63380234
Bezoar 41.08 10.27 28 108446 1498 63379050
Major depression 40.86 10.27 59 108415 7959 63372589
Intentional product misuse 40.84 10.27 209 108265 60708 63319840
Pulmonary fibrosis 40.83 10.27 9 108465 39800 63340748
Renal impairment 40.47 10.27 55 108419 88300 63292248
Mental impairment 39.92 10.27 80 108394 14071 63366477
Blood bicarbonate decreased 39.92 10.27 36 108438 2905 63377643
Anger 39.52 10.27 74 108400 12382 63368166
Nephrocalcinosis 39.46 10.27 24 108450 1054 63379494
Libido increased 39.38 10.27 26 108448 1319 63379229
Red blood cell sedimentation rate increased 39.36 10.27 13 108461 43969 63336579
Atonic seizures 39.25 10.27 20 108454 619 63379929
Visual impairment 39.25 10.27 263 108211 84183 63296365
Paranoia 39.08 10.27 71 108403 11608 63368940
Gene mutation 38.88 10.27 28 108446 1637 63378911
Anticonvulsant drug level decreased 38.60 10.27 25 108449 1227 63379321
C-reactive protein increased 38.49 10.27 64 108410 94643 63285905
Gastrointestinal disorder 38.13 10.27 107 108367 131132 63249416
Blood gases abnormal 37.82 10.27 21 108453 776 63379772
Gastrointestinal haemorrhage 37.72 10.27 50 108424 81126 63299422
Blood pressure systolic increased 37.46 10.27 17 108457 47380 63333168
Mobility decreased 37.30 10.27 96 108378 121063 63259485
Ataxia 37.14 10.27 81 108393 15114 63365434
Angiofibroma 36.94 10.27 12 108462 109 63380439
Pleocytosis 36.67 10.27 21 108453 824 63379724
Drug withdrawal syndrome 36.62 10.27 116 108358 27078 63353470
Phonophobia 36.42 10.27 16 108458 352 63380196
Hostility 35.95 10.27 28 108446 1844 63378704
Alice in wonderland syndrome 35.93 10.27 9 108465 27 63380521
Tardive dyskinesia 35.46 10.27 57 108417 8445 63372103
Simple partial seizures 35.39 10.27 18 108456 555 63379993
Oedema 35.20 10.27 71 108403 97551 63282997
Sudden unexplained death in epilepsy 35.09 10.27 15 108459 308 63380240
Plasma cell myeloma 35.08 10.27 9 108465 35896 63344652
Electroencephalogram abnormal 34.94 10.27 37 108437 3635 63376913
Renal failure 34.86 10.27 95 108379 117557 63262991
Dysphemia 34.85 10.27 32 108442 2643 63377905
Central nervous system lesion 34.76 10.27 64 108410 10571 63369977
Partial seizures with secondary generalisation 34.65 10.27 16 108458 397 63380151
Galactorrhoea 34.54 10.27 39 108435 4116 63376432
Death 34.46 10.27 442 108032 373939 63006609
Pre-existing condition improved 34.01 10.27 55 108419 8189 63372359
Affective disorder 33.95 10.27 47 108427 6099 63374449
Osteonecrosis of jaw 33.95 10.27 9 108465 35114 63345434
Myoclonus 33.69 10.27 80 108394 15788 63364760
Hyperthermia 33.65 10.27 58 108416 9098 63371450
Cervix neoplasm 33.62 10.27 13 108461 204 63380344
Hypophosphataemic osteomalacia 33.44 10.27 13 108461 207 63380341
Serotonin syndrome 32.98 10.27 116 108358 28566 63351982
Hypomagnesaemia 32.69 10.27 5 108469 28732 63351816
Lichen planus 32.49 10.27 29 108445 2309 63378239
Brugada syndrome 32.45 10.27 15 108459 373 63380175
Hyperkalaemia 32.35 10.27 27 108447 54176 63326372
Ciliary muscle spasm 32.24 10.27 6 108468 0 63380548
Cholecystitis chronic 32.18 10.27 61 108413 10300 63370248
Nystagmus 32.03 10.27 46 108428 6174 63374374
Thalamic infarction 31.98 10.27 16 108458 476 63380072
Weight increased 31.88 10.27 624 107850 260168 63120380
Arthritis 31.86 10.27 97 108377 115824 63264724
Drug screen positive 31.78 10.27 35 108439 3594 63376954
Tearfulness 31.30 10.27 37 108437 4102 63376446
Psychomotor hyperactivity 30.94 10.27 61 108413 10602 63369946
Status migrainosus 30.90 10.27 11 108463 135 63380413
Respiratory alkalosis 30.78 10.27 30 108444 2671 63377877
Neoplasm progression 30.50 10.27 12 108462 36416 63344132
Skin ulcer 30.22 10.27 18 108456 43027 63337521
Apathy 30.11 10.27 54 108420 8740 63371808
Hypersomnia 30.01 10.27 83 108391 17972 63362576
Dysgeusia 29.75 10.27 158 108316 46552 63333996
Apnoea 29.73 10.27 51 108423 7971 63372577
Blood pressure measurement 29.50 10.27 13 108461 288 63380260
Concussion 29.43 10.27 55 108419 9189 63371359
Bone marrow failure 29.28 10.27 7 108467 29283 63351265
Wheezing 29.22 10.27 76 108398 95519 63285029
Migraine without aura 29.20 10.27 14 108460 379 63380169
Amino acid level increased 29.09 10.27 14 108460 382 63380166
Hypertension 28.64 10.27 322 108152 278981 63101567
Osteoarthritis 28.24 10.27 77 108397 95266 63285282
Septic shock 28.04 10.27 44 108430 66585 63313963
Emotional distress 27.92 10.27 120 108354 32429 63348119
Therapeutic response changed 27.72 10.27 19 108455 1026 63379522
Road traffic accident 27.63 10.27 130 108344 36502 63344046
Eye movement disorder 27.42 10.27 39 108435 5189 63375359
Post-traumatic neck syndrome 27.39 10.27 25 108449 2049 63378499
Lung disorder 27.27 10.27 40 108434 62221 63318327
Erythema 27.22 10.27 182 108292 175569 63204979
Intellectual disability 27.06 10.27 19 108455 1067 63379481
Pseudomyopia 26.96 10.27 8 108466 52 63380496
Disorientation 26.89 10.27 136 108338 39316 63341232
Hyposthenuria 26.87 10.27 5 108469 0 63380548
Cardiac malposition 26.70 10.27 8 108466 54 63380494
Intentional product use issue 26.63 10.27 120 108354 127772 63252776
Angiomyolipoma 26.42 10.27 11 108463 211 63380337
Panic attack 26.27 10.27 91 108383 22240 63358308
Granulomatous dermatitis 26.21 10.27 10 108464 151 63380397
Retinitis pigmentosa 26.17 10.27 9 108465 99 63380449
Granuloma annulare 26.11 10.27 15 108459 592 63379956
Extrapyramidal disorder 26.10 10.27 65 108409 13219 63367329
Soft tissue injury 26.00 10.27 22 108452 1630 63378918
Vestibular migraine 25.82 10.27 11 108463 224 63380324
Anoxia 25.77 10.27 11 108463 225 63380323
Retinogram abnormal 25.62 10.27 10 108464 161 63380387
Oedema peripheral 25.61 10.27 204 108270 189307 63191241
Psychogenic seizure 25.54 10.27 22 108452 1670 63378878
Melaena 25.43 10.27 10 108464 30355 63350193
Anticonvulsant drug level above therapeutic 25.19 10.27 14 108460 518 63380030
Persistent left superior vena cava 25.13 10.27 7 108467 35 63380513
Cardio-respiratory arrest 25.07 10.27 182 108292 59777 63320771
Nightmare 25.05 10.27 81 108393 19113 63361435
Heart rate 24.89 10.27 8 108466 70 63380478
Drug dependence 24.77 10.27 95 108379 24388 63356160
Borderline personality disorder 24.53 10.27 16 108458 795 63379753
Lymphangioleiomyomatosis 24.50 10.27 10 108464 182 63380366
Liver injury 24.49 10.27 41 108433 60479 63320069
Screaming 24.41 10.27 29 108445 3233 63377315
Depressed mood 24.27 10.27 134 108340 40057 63340491
Thyroxine free decreased 24.17 10.27 15 108459 683 63379865
Conjunctival oedema 24.09 10.27 15 108459 687 63379861
Lennox-Gastaut syndrome 24.08 10.27 11 108463 266 63380282
Rectal haemorrhage 24.02 10.27 29 108445 49001 63331547
Delusion 23.82 10.27 59 108415 11958 63368590
Sternal fracture 23.77 10.27 24 108450 2230 63378318
Dehydration 23.71 10.27 186 108288 173168 63207380
Iris disorder 23.68 10.27 8 108466 83 63380465
Myocardial oedema 23.54 10.27 10 108464 202 63380346
Narrow anterior chamber angle 23.53 10.27 7 108467 46 63380502
Necrotising enterocolitis neonatal 23.41 10.27 10 108464 205 63380343
Biliary dyskinesia 23.35 10.27 26 108448 2703 63377845
Product quality issue 23.31 10.27 122 108352 35743 63344805
Acquired haemophilia 23.30 10.27 17 108457 1014 63379534
Loss of consciousness 23.23 10.27 306 108168 117815 63262733
Acute myocardial infarction 23.17 10.27 13 108461 32111 63348437
Myelosuppression 23.05 10.27 6 108468 23697 63356851
Thinking abnormal 22.97 10.27 54 108420 10589 63369959
Papilloedema 22.95 10.27 31 108443 3929 63376619
Homicidal ideation 22.91 10.27 21 108453 1731 63378817
Decreased interest 22.83 10.27 28 108446 3226 63377322
Gastrooesophageal reflux disease 22.83 10.27 257 108217 95382 63285166
Hypervolaemia 22.75 10.27 10 108464 28403 63352145
Product administered to patient of inappropriate age 22.73 10.27 28 108446 3240 63377308
Macular detachment 22.64 10.27 8 108466 96 63380452
Frontal lobe epilepsy 22.50 10.27 5 108469 7 63380541
Affect lability 22.37 10.27 55 108419 11096 63369452
Anomalous pulmonary venous connection 22.12 10.27 7 108467 58 63380490
Coronary artery disease 22.09 10.27 14 108460 32363 63348185
Application site discolouration 21.95 10.27 15 108459 806 63379742
Mydriasis 21.93 10.27 57 108417 11899 63368649
Convulsive threshold lowered 21.57 10.27 11 108463 341 63380207
Antipsychotic drug level decreased 21.54 10.27 11 108463 342 63380206
Snoring 21.53 10.27 31 108443 4171 63376377
Fatigue 21.44 10.27 1271 107203 886757 62493791
Malaise 21.41 10.27 544 107930 415410 62965138
Brain oedema 21.40 10.27 63 108411 14132 63366416
Cleft lip 21.26 10.27 8 108466 116 63380432
Hypohidrosis 21.22 10.27 7 108467 67 63380481
Small for dates baby 21.19 10.27 29 108445 3722 63376826
Ascites 21.13 10.27 23 108451 40705 63339843
Hypoxia 21.11 10.27 44 108430 59748 63320800
Open angle glaucoma 21.08 10.27 10 108464 264 63380284
Hypopyon 21.07 10.27 14 108460 718 63379830
Temperature intolerance 21.02 10.27 47 108427 8917 63371631
Fluid retention 21.01 10.27 44 108430 59642 63320906
Basal cell carcinoma 20.66 10.27 11 108463 27980 63352568
Lymphomatoid papulosis 20.60 10.27 8 108466 127 63380421
Stress 20.58 10.27 190 108284 66977 63313571
Wrong patient received product 20.58 10.27 22 108452 2185 63378363
Insomnia 20.51 10.27 497 107977 214755 63165793
Self-injurious ideation 20.49 10.27 24 108450 2635 63377913
Hallucination, visual 20.45 10.27 76 108398 19222 63361326
Magnetic resonance imaging head abnormal 20.44 10.27 21 108453 1992 63378556
Transferrin saturation decreased 20.39 10.27 14 108460 758 63379790
Post-traumatic stress disorder 20.27 10.27 34 108440 5217 63375331
Depressed level of consciousness 20.25 10.27 178 108296 61900 63318648
Platelet count decreased 20.18 10.27 116 108358 116006 63264542
Aspartate aminotransferase decreased 20.13 10.27 14 108460 774 63379774
Hyporesponsive to stimuli 20.10 10.27 16 108458 1088 63379460
Dyspnoea exertional 19.95 10.27 46 108428 60256 63320292
Irritable bowel syndrome 19.87 10.27 73 108401 82339 63298209
Blood bilirubin decreased 19.86 10.27 14 108460 791 63379757
Hyperacusis 19.59 10.27 21 108453 2092 63378456
Metastases to liver 19.44 10.27 8 108466 23631 63356917
Complex regional pain syndrome 19.39 10.27 22 108452 2335 63378213
Product counterfeit 19.38 10.27 8 108466 150 63380398
Fear 19.20 10.27 65 108409 15701 63364847
Metastases to bone 19.18 10.27 6 108468 21013 63359535
Ureterolithiasis 19.16 10.27 20 108454 1932 63378616
Acidosis 19.03 10.27 52 108422 11181 63369367
Sinus tachycardia 18.95 10.27 87 108387 24181 63356367
Myocardial infarction 18.89 10.27 97 108377 99796 63280752
Cellulitis 18.85 10.27 74 108400 81884 63298664
Product dispensing error 18.77 10.27 49 108425 10256 63370292
Myocarditis 18.70 10.27 49 108425 10276 63370272
Blood chloride increased 18.68 10.27 23 108451 2661 63377887
Toxic epidermal necrolysis 18.64 10.27 10 108464 25324 63355224
Inflammation 18.47 10.27 75 108399 82198 63298350
Tinnitus 18.41 10.27 114 108360 35514 63345034
Night blindness 18.32 10.27 11 108463 472 63380076
Inappropriate affect 18.27 10.27 14 108460 900 63379648
Disseminated intravascular coagulation 18.19 10.27 5 108469 19046 63361502
Creatinine renal clearance decreased 18.18 10.27 3 108471 16305 63364243
Plasmodium falciparum infection 18.12 10.27 5 108469 24 63380524
Pulmonary oedema 18.04 10.27 42 108432 54831 63325717
Lethargy 17.96 10.27 160 108314 55847 63324701
Urine calcium/creatinine ratio increased 17.92 10.27 7 108467 113 63380435
Benzodiazepine drug level increased 17.88 10.27 8 108466 184 63380364
Enuresis 17.83 10.27 22 108452 2551 63377997
Hyperphosphaturia 17.79 10.27 5 108469 26 63380522
Blood thyroid stimulating hormone normal 17.75 10.27 7 108467 116 63380432
Stillbirth 17.67 10.27 37 108437 6713 63373835
Anticonvulsant drug level increased 17.57 10.27 17 108457 1500 63379048
Hyperuricosuria 17.46 10.27 4 108470 7 63380541
Osmotic demyelination syndrome 17.46 10.27 12 108462 651 63379897
Prescribed underdose 17.46 10.27 15 108459 29674 63350874
Nodular rash 17.38 10.27 8 108466 197 63380351
Lactic acidosis 17.36 10.27 24 108450 38263 63342285
Gallbladder disorder 17.36 10.27 71 108403 18771 63361777
Ischaemic cerebral infarction 17.34 10.27 16 108458 1330 63379218
Near drowning 17.33 10.27 5 108469 29 63380519
Maternal exposure during pregnancy 17.31 10.27 268 108206 219794 63160754
Cerebral venous sinus thrombosis 17.24 10.27 19 108455 1953 63378595
Cholestasis 17.15 10.27 15 108459 29419 63351129
Type 2 diabetes mellitus 17.15 10.27 54 108420 63814 63316734
Congenital diaphragmatic eventration 17.12 10.27 4 108470 8 63380540
Neutrophil count decreased 17.11 10.27 45 108429 56361 63324187
Idiopathic intracranial hypertension 17.07 10.27 23 108451 2908 63377640
Narcolepsy 17.02 10.27 16 108458 1362 63379186
Pneumocystis jirovecii pneumonia 16.99 10.27 4 108470 16910 63363638
Calculus urinary 16.96 10.27 16 108458 1368 63379180
Liver disorder 16.93 10.27 42 108432 53645 63326903
Ovarian germ cell cancer stage II 16.90 10.27 6 108468 73 63380475
Dystonia 16.85 10.27 57 108417 13762 63366786
Hypotonia 16.75 10.27 44 108430 9241 63371307
Congenital mitral valve incompetence 16.66 10.27 5 108469 34 63380514
Blood pressure diastolic decreased 16.65 10.27 9 108465 22697 63357851
Productive cough 16.58 10.27 54 108420 63154 63317394
Personality disorder 16.57 10.27 33 108441 5778 63374770
Hyperventilation 16.57 10.27 34 108440 6082 63374466
Pulmonary arterial hypertension 16.48 10.27 9 108465 22568 63357980
Restless legs syndrome 16.42 10.27 69 108405 18462 63362086
Gambling disorder 16.36 10.27 15 108459 1237 63379311
Eating disorder 16.23 10.27 70 108404 18946 63361602
Ejection fraction decreased 16.16 10.27 9 108465 22323 63358225
Hydrocele 16.12 10.27 3 108471 0 63380548
Carbon dioxide decreased 16.11 10.27 19 108455 2102 63378446
Shock 16.07 10.27 81 108393 23382 63357166
Bursitis 16.02 10.27 24 108450 37017 63343531
Psychomotor skills impaired 16.01 10.27 20 108454 2348 63378200
Neuropathy peripheral 15.98 10.27 121 108353 113546 63267002
Retinal detachment 15.95 10.27 33 108441 5936 63374612
Pain 15.94 10.27 1071 107403 739557 62640991
Cytomegalovirus infection 15.81 10.27 8 108466 20944 63359604
Failed induction of labour 15.76 10.27 9 108465 351 63380197
Posterior reversible encephalopathy syndrome 15.74 10.27 5 108469 17340 63363208
Occipital neuralgia 15.74 10.27 10 108464 475 63380073
Congenital anomaly in offspring 15.73 10.27 7 108467 159 63380389
Herpes zoster 15.63 10.27 80 108394 82382 63298166
Hypophosphataemia 15.62 10.27 49 108425 11377 63369171
Electrocardiogram QT prolonged 15.60 10.27 163 108311 59367 63321181
White blood cell count decreased 15.60 10.27 157 108317 138947 63241601
Blood pressure diastolic abnormal 15.51 10.27 3 108471 14539 63366009
Blunted affect 15.49 10.27 8 108466 255 63380293
Acute myeloid leukaemia 15.46 10.27 5 108469 17142 63363406
Therapeutic product effective for unapproved indication 15.41 10.27 6 108468 96 63380452
Blood lactic acid increased 15.34 10.27 36 108438 7050 63373498
Blastocystis infection 15.34 10.27 5 108469 46 63380502
Vascular malformation 15.31 10.27 9 108465 371 63380177
Glycosuria 15.29 10.27 14 108460 1152 63379396
Dysstasia 15.16 10.27 74 108400 21092 63359456
Pneumonitis 15.06 10.27 23 108451 35199 63345349
Self esteem decreased 14.99 10.27 11 108463 662 63379886
Pregnancy 14.93 10.27 111 108363 36725 63343823
Regressive behaviour 14.93 10.27 7 108467 180 63380368
Diverticulitis 14.92 10.27 28 108446 39529 63341019
Endometriosis 14.91 10.27 30 108444 5290 63375258
Osteonecrosis 14.91 10.27 12 108462 24518 63356030
Hip fracture 14.90 10.27 17 108457 29457 63351091
Potassium wasting nephropathy 14.88 10.27 5 108469 51 63380497
Basilar migraine 14.88 10.27 5 108469 51 63380497
Cerebral vasoconstriction 14.87 10.27 14 108460 1194 63379354
Psychomotor retardation 14.86 10.27 25 108449 3845 63376703
Central obesity 14.74 10.27 14 108460 1207 63379341
Macular degeneration 14.72 10.27 12 108462 24364 63356184
Parasomnia 14.69 10.27 10 108464 534 63380014
Pregnancy on oral contraceptive 14.68 10.27 13 108461 1024 63379524
Photopsia 14.57 10.27 27 108447 4482 63376066
Poisoning 14.55 10.27 54 108420 13646 63366902
Negativism 14.54 10.27 9 108465 408 63380140
Respiratory disorder neonatal 14.51 10.27 14 108460 1231 63379317
Poor quality sleep 14.49 10.27 70 108404 19865 63360683
Mastoiditis 14.49 10.27 13 108461 1042 63379506
Hallucinations, mixed 14.47 10.27 28 108446 4801 63375747
Blood lactate dehydrogenase increased 14.44 10.27 11 108463 23105 63357443
Intracranial hypotension 14.40 10.27 8 108466 296 63380252
Tenosynovitis 14.39 10.27 3 108471 13792 63366756
Full blood count decreased 14.29 10.27 14 108460 26010 63354538
Laryngeal stenosis 14.25 10.27 13 108461 1065 63379483
Drug tolerance decreased 14.23 10.27 6 108468 17467 63363081
Atrioventricular septal defect 14.11 10.27 8 108466 308 63380240
Heart rate decreased 14.09 10.27 36 108438 45524 63335024
Musculoskeletal pain 14.05 10.27 96 108378 92181 63288367
Pleural rub 14.00 10.27 5 108469 62 63380486
Obsessive thoughts 13.94 10.27 10 108464 581 63379967
Illogical thinking 13.93 10.27 5 108469 63 63380485
Balance disorder 13.91 10.27 212 108262 84210 63296338
Haematochezia 13.87 10.27 46 108428 53498 63327050
Drug level decreased 13.76 10.27 37 108437 7882 63372666
Prinzmetal angina 13.75 10.27 11 108463 753 63379795
Atrial septal defect 13.68 10.27 34 108440 6904 63373644
Communication disorder 13.63 10.27 19 108455 2481 63378067
Hypercalcaemia 13.61 10.27 17 108457 28305 63352243
Self-medication 13.60 10.27 20 108454 2743 63377805
Body temperature decreased 13.57 10.27 9 108465 20310 63360238
Asthenia 13.57 10.27 527 107947 383077 62997471
Housebound 13.44 10.27 7 108467 227 63380321
Blood bilirubin increased 13.39 10.27 27 108447 37113 63343435
Altered visual depth perception 13.37 10.27 8 108466 341 63380207
Developmental hip dysplasia 13.37 10.27 14 108460 1358 63379190
Dysmorphism 13.35 10.27 18 108456 2278 63378270
Familial periodic paralysis 13.32 10.27 5 108469 72 63380476
Severe myoclonic epilepsy of infancy 13.32 10.27 5 108469 72 63380476
Wrong technique in product usage process 13.31 10.27 164 108310 62176 63318372
Cleft lip and palate 13.30 10.27 10 108464 625 63379923
Hepatotoxicity 13.29 10.27 27 108447 37014 63343534
Optic neuritis 13.26 10.27 38 108436 8397 63372151
Gastrointestinal mucosal exfoliation 13.25 10.27 6 108468 142 63380406
Application site erythema 13.24 10.27 27 108447 4808 63375740
High-pitched crying 13.23 10.27 4 108470 28 63380520
Treatment failure 13.19 10.27 250 108224 198793 63181755
Anhedonia 13.15 10.27 45 108429 10929 63369619
Hyperaldosteronism 13.11 10.27 7 108467 239 63380309
Seizure cluster 13.06 10.27 7 108467 241 63380307
Toxic skin eruption 13.04 10.27 3 108471 12882 63367666
Epistaxis 12.98 10.27 72 108402 72653 63307895
Cleft palate 12.98 10.27 12 108462 1000 63379548
Red blood cell sedimentation rate abnormal 12.89 10.27 9 108465 19773 63360775
Crystal urine present 12.87 10.27 15 108459 1639 63378909
Conjunctival hyperaemia 12.85 10.27 18 108456 2361 63378187
Hereditary angioedema 12.80 10.27 35 108439 7527 63373021
Bipolar II disorder 12.80 10.27 8 108466 369 63380179
Slow response to stimuli 12.78 10.27 12 108462 1020 63379528
Suspiciousness 12.76 10.27 8 108466 371 63380177
Rales 12.76 10.27 3 108471 12694 63367854
Gingival hypertrophy 12.74 10.27 15 108459 1656 63378892
Accommodation disorder 12.72 10.27 8 108466 373 63380175
Lung neoplasm malignant 12.71 10.27 9 108465 19624 63360924
Neonatal seizure 12.70 10.27 9 108465 513 63380035
Speech disorder developmental 12.69 10.27 10 108464 670 63379878
Psoriatic arthropathy 12.59 10.27 98 108376 91422 63289126
Drug level increased 12.54 10.27 74 108400 22662 63357886
Pulmonary hypertension 12.54 10.27 28 108446 37095 63343453
Lack of spontaneous speech 12.49 10.27 6 108468 163 63380385
Disinhibition 12.36 10.27 11 108463 872 63379676
Hemiparesis 12.35 10.27 75 108399 23207 63357341
Sciatica 12.33 10.27 25 108449 34299 63346249
Rheumatoid nodule 12.29 10.27 7 108467 17148 63363400
Educational problem 12.26 10.27 8 108466 398 63380150
Tri-iodothyronine free abnormal 12.25 10.27 4 108470 37 63380511
Paranasal cyst 12.24 10.27 8 108466 399 63380149
Joint range of motion decreased 12.19 10.27 23 108451 32405 63348143
Femur fracture 12.15 10.27 34 108440 41722 63338826
Necrotising retinitis 12.15 10.27 8 108466 404 63380144
Sopor 12.14 10.27 72 108402 22092 63358456
Impaired driving ability 12.13 10.27 25 108449 4486 63376062
Cerebellar infarction 12 10.27 16 108458 2003 63378545
Coordination abnormal 11.98 10.27 51 108423 13722 63366826
Night sweats 11.92 10.27 43 108431 48771 63331777
Blood cholesterol increased 11.89 10.27 103 108371 93929 63286619
Dropped head syndrome 11.86 10.27 6 108468 183 63380365
Hyphaema 11.83 10.27 7 108467 292 63380256
Enlarged uvula 11.83 10.27 6 108468 184 63380364
Myelodysplastic syndrome 11.77 10.27 7 108467 16747 63363801
Corneal disorder 11.75 10.27 15 108459 1799 63378749
Congenital hand malformation 11.75 10.27 7 108467 296 63380252
Impulsive behaviour 11.72 10.27 14 108460 1569 63378979
Serum ferritin decreased 11.69 10.27 16 108458 2054 63378494
Oxygen saturation decreased 11.66 10.27 96 108378 88489 63292059
Renal pain 11.63 10.27 31 108443 6568 63373980
Depersonalisation/derealisation disorder 11.61 10.27 13 108461 1359 63379189
Psychotic behaviour 11.58 10.27 9 108465 591 63379957
Immune thrombocytopenia 11.54 10.27 42 108432 10514 63370034
Personality change 11.53 10.27 32 108442 6941 63373607
Bone pain 11.53 10.27 51 108423 54590 63325958
Hypoalbuminaemia 11.45 10.27 3 108471 11802 63368746
Behaviour disorder 11.41 10.27 20 108454 3179 63377369
Granulocytopenia 11.40 10.27 28 108446 5644 63374904
Staring 11.39 10.27 14 108460 1616 63378932
Sleep apnoea syndrome 11.36 10.27 87 108387 29046 63351502
Vertebral osteophyte 11.28 10.27 7 108467 319 63380229
Pregnancy with implant contraceptive 11.21 10.27 18 108456 2665 63377883
Gallbladder cholesterolosis 11.20 10.27 10 108464 796 63379752
Transfusion 11.20 10.27 6 108468 15211 63365337
Eczema 11.20 10.27 24 108450 32267 63348281
Blood pressure fluctuation 11.18 10.27 41 108433 46276 63334272
Coma acidotic 11.18 10.27 5 108469 115 63380433
Cytopenia 11.16 10.27 3 108471 11598 63368950
Cardiac arrest 11.13 10.27 221 108253 92324 63288224
Delayed sleep phase 11.12 10.27 3 108471 13 63380535
Sialoadenitis 11.11 10.27 14 108460 1658 63378890
Bed rest 11.10 10.27 4 108470 51 63380497
Calcinosis 11.09 10.27 16 108458 2156 63378392
Social avoidant behaviour 11.08 10.27 19 108455 2969 63377579
Spinal fracture 11.03 10.27 9 108465 18262 63362286
Retinal disorder 10.99 10.27 14 108460 1676 63378872
Chorioretinal folds 10.94 10.27 3 108471 14 63380534
Breast cancer 10.93 10.27 44 108430 48339 63332209
Application site burn 10.91 10.27 10 108464 824 63379724
Incoherent 10.90 10.27 24 108450 4506 63376042
Mean cell haemoglobin concentration decreased 10.89 10.27 21 108453 3591 63376957
Localised infection 10.86 10.27 22 108452 30188 63350360
Therapeutic product ineffective for unapproved indication 10.85 10.27 6 108468 220 63380328
Panniculitis 10.85 10.27 3 108471 11382 63369166
Joint effusion 10.81 10.27 8 108466 17052 63363496
Developmental delay 10.79 10.27 13 108461 1470 63379078
Congenital floppy infant 10.77 10.27 3 108471 15 63380533
Decreased nasolabial fold 10.77 10.27 3 108471 15 63380533
Hyperbilirubinaemia 10.74 10.27 3 108471 11311 63369237
Psychiatric symptom 10.73 10.27 26 108448 5197 63375351
Eyelid ptosis 10.71 10.27 32 108442 7235 63373313
Threatened labour 10.71 10.27 10 108464 844 63379704
Pulmonary eosinophilia 10.69 10.27 7 108467 350 63380198
Emotional poverty 10.66 10.27 7 108467 352 63380196
Oral candidiasis 10.63 10.27 14 108460 22784 63357764
International normalised ratio increased 10.62 10.27 42 108432 46383 63334165
Periarthritis 10.60 10.27 16 108458 2245 63378303
Burning mouth syndrome 10.60 10.27 8 108466 503 63380045
Drop attacks 10.56 10.27 9 108465 673 63379875
Exophthalmos 10.56 10.27 13 108461 1503 63379045
Conversion disorder 10.52 10.27 14 108460 1750 63378798
Rickets 10.51 10.27 4 108470 60 63380488
Cervicogenic headache 10.46 10.27 3 108471 17 63380531
Congenital anomaly 10.44 10.27 14 108460 1762 63378786
Restlessness 10.42 10.27 86 108388 29367 63351181
Bone density decreased 10.41 10.27 6 108468 14606 63365942
Haematoma 10.40 10.27 28 108446 34792 63345756
Cluster headache 10.39 10.27 9 108465 688 63379860
Automatism 10.39 10.27 4 108470 62 63380486
Middle insomnia 10.38 10.27 46 108428 12597 63367951
Ventricular septal defect 10.32 10.27 23 108451 4355 63376193
Broad ligament tear 10.32 10.27 3 108471 18 63380530
Social fear 10.32 10.27 3 108471 18 63380530

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 1001.68 13.17 824 33440 104033 34818634
Drug ineffective 374.64 13.17 1134 33130 455617 34467050
Status epilepticus 341.95 13.17 190 34074 12424 34910243
Angle closure glaucoma 285.63 13.17 82 34182 875 34921792
Multiple-drug resistance 279.37 13.17 125 34139 5114 34917553
Sedation 257.70 13.17 192 34072 20814 34901853
Aggression 254.80 13.17 248 34016 38716 34883951
Nephrolithiasis 254.60 13.17 222 34042 30111 34892556
Heat stroke 245.29 13.17 73 34191 892 34921775
Somnolence 177.84 13.17 358 33906 110758 34811909
Hyperammonaemia 175.49 13.17 97 34167 6270 34916397
Generalised tonic-clonic seizure 165.70 13.17 149 34115 21025 34901642
Epilepsy 157.93 13.17 146 34118 21349 34901318
Myopia 156.76 13.17 54 34210 1082 34921585
Migraine 150.78 13.17 130 34134 17348 34905319
Ataxia 133.83 13.17 110 34154 13743 34908924
Hyperammonaemic encephalopathy 128.85 13.17 57 34207 2267 34920400
Product substitution issue 127.62 13.17 94 34170 10001 34912666
Foetal exposure during pregnancy 126.77 13.17 171 34093 37930 34884737
Cognitive disorder 116.24 13.17 142 34122 28551 34894116
Choroidal effusion 112.13 13.17 28 34236 165 34922502
Drug resistance 104.51 13.17 128 34136 25799 34896868
Hypospadias 102.84 13.17 54 34210 3147 34919520
Anaemia 97.21 13.17 54 34210 233281 34689386
Petit mal epilepsy 96.26 13.17 51 34213 3027 34919640
Dyspnoea 93.31 13.17 141 34123 376641 34546026
Partial seizures 90.37 13.17 57 34207 4703 34917964
Anhidrosis 90.01 13.17 21 34243 88 34922579
Nightmare 89.13 13.17 89 34175 14302 34908365
Febrile neutropenia 86.48 13.17 15 34249 136834 34785833
Death 83.91 13.17 165 34099 397884 34524783
Myokymia 82.75 13.17 19 34245 73 34922594
Sudden unexplained death in epilepsy 78.90 13.17 26 34238 452 34922215
Flat anterior chamber of eye 78.57 13.17 17 34247 46 34922621
Focal dyscognitive seizures 76.97 13.17 34 34230 1347 34921320
Acidosis hyperchloraemic 76.77 13.17 25 34239 418 34922249
Drug ineffective for unapproved indication 76.67 13.17 105 34159 23610 34899057
Completed suicide 74.96 13.17 239 34025 97929 34824738
Memory impairment 74.47 13.17 144 34120 43174 34879493
Abnormal behaviour 73.95 13.17 106 34158 24863 34897804
Ammonia increased 72.31 13.17 48 34216 4321 34918346
Intentional self-injury 70.63 13.17 77 34187 13694 34908973
Hyperthermia 70.31 13.17 68 34196 10509 34912158
Acute kidney injury 68.97 13.17 121 34143 304867 34617800
Suicidal ideation 67.89 13.17 133 34131 40255 34882412
Diarrhoea 65.75 13.17 182 34082 389730 34532937
Head discomfort 65.19 13.17 44 34220 4072 34918595
Product used for unknown indication 63.97 13.17 27 34237 956 34921711
Disturbance in attention 63.81 13.17 101 34163 25844 34896823
Renal tubular acidosis 62.99 13.17 35 34229 2284 34920383
Pneumonia 62.82 13.17 167 34097 362460 34560207
Speech disorder 60.44 13.17 98 34166 25588 34897079
Toxicity to various agents 59.92 13.17 368 33896 199994 34722673
Psychotic disorder 58.50 13.17 94 34170 24358 34898309
Atrial fibrillation 57.48 13.17 24 34240 122369 34800298
Developmental delay 57.15 13.17 35 34229 2740 34919927
Myoclonus 55.01 13.17 70 34194 14655 34908012
Infantile spasms 53.86 13.17 16 34248 194 34922473
Myoclonic epilepsy 53.47 13.17 25 34239 1132 34921535
Malignant neoplasm progression 52.72 13.17 11 34253 88035 34834632
Tonic convulsion 52.58 13.17 25 34239 1176 34921491
Multiple drug therapy 52.49 13.17 19 34245 442 34922225
Irritability 52.47 13.17 90 34174 24600 34898067
Maculopathy 51.79 13.17 23 34241 923 34921744
Encephalopathy 50.72 13.17 109 34155 35210 34887457
Dysmorphism 50.61 13.17 34 34230 3122 34919545
Interstitial lung disease 48.95 13.17 4 34260 65278 34857389
Metabolic acidosis 48.66 13.17 122 34142 43558 34879109
Priapism 46.85 13.17 39 34225 4955 34917712
Cleft lip 46.42 13.17 16 34248 321 34922346
Failure to suspend medication 45.97 13.17 17 34247 421 34922246
Organic brain syndrome 45.51 13.17 15 34249 261 34922406
Drug withdrawal convulsions 44.02 13.17 22 34242 1155 34921512
Agitation 43.08 13.17 139 34125 57260 34865407
Cardiac failure congestive 43.00 13.17 14 34250 83256 34839411
Exposure during pregnancy 42.45 13.17 48 34216 8886 34913781
Autonomic nervous system imbalance 42.15 13.17 28 34236 2523 34920144
Delusion of replacement 41.71 13.17 12 34252 129 34922538
Intensive care unit acquired weakness 40.79 13.17 20 34244 1007 34921660
Intentional overdose 40.54 13.17 114 34150 43560 34879107
Nystagmus 40.50 13.17 35 34229 4680 34917987
Hyperchloraemia 40.08 13.17 16 34248 490 34922177
Angular cheilitis 38.88 13.17 12 34252 167 34922500
Fanconi syndrome 38.80 13.17 23 34241 1697 34920970
Off label use 37.67 13.17 598 33666 418926 34503741
Drug interaction 37.63 13.17 362 33902 225584 34697083
Anticonvulsant drug level increased 37.47 13.17 22 34242 1594 34921073
Product use in unapproved indication 37.07 13.17 219 34045 117280 34805387
Lethargy 36.86 13.17 106 34158 41016 34881651
Abdominal pain 36.81 13.17 65 34199 163553 34759114
Cardiac failure 36.65 13.17 22 34242 91226 34831441
Drug level fluctuating 36.38 13.17 15 34249 500 34922167
Nasal septum disorder 36.19 13.17 9 34255 52 34922615
Erectile dysfunction 35.93 13.17 69 34195 20568 34902099
Mood altered 35.74 13.17 44 34220 8908 34913759
Pyrexia 35.53 13.17 187 34077 332826 34589841
Small for dates baby 35.46 13.17 30 34234 3897 34918770
Product use issue 35.35 13.17 139 34125 63077 34859590
Hypothermia 35.35 13.17 48 34216 10700 34911967
Partial seizures with secondary generalisation 35.12 13.17 13 34251 323 34922344
Disease progression 34.52 13.17 33 34231 108044 34814623
Ascites 34.51 13.17 3 34261 46568 34876099
Blood homocysteine increased 34.30 13.17 12 34252 252 34922415
Congenital hand malformation 34.30 13.17 15 34249 580 34922087
Atrial septal defect 33.90 13.17 39 34225 7353 34915314
Pleural effusion 33.69 13.17 19 34245 81527 34841140
Patient dissatisfaction with treatment 33.02 13.17 9 34255 78 34922589
Affective disorder 32.75 13.17 30 34234 4330 34918337
Bladder hypertrophy 32.48 13.17 15 34249 660 34922007
Bradyphrenia 32.17 13.17 31 34233 4767 34917900
Urge incontinence 32.14 13.17 14 34250 536 34922131
Haemoglobin decreased 31.92 13.17 43 34221 120729 34801938
Depressed mood 31.70 13.17 63 34201 19254 34903413
General physical health deterioration 31.60 13.17 48 34216 128221 34794446
Non-24-hour sleep-wake disorder 31.57 13.17 7 34257 22 34922645
Product administered to patient of inappropriate age 31.49 13.17 26 34238 3265 34919402
Tremor 30.74 13.17 161 34103 82426 34840241
Vitamin D deficiency 30.54 13.17 35 34229 6573 34916094
Intellectual disability 30.46 13.17 18 34246 1320 34921347
Psychogenic seizure 30.42 13.17 12 34252 356 34922311
Hallucination, auditory 30.13 13.17 47 34217 11870 34910797
Hypotension 29.90 13.17 114 34150 221535 34701132
Microcephaly 29.86 13.17 15 34249 796 34921871
Hyperexplexia 29.69 13.17 7 34257 31 34922636
Rhinolithiasis 29.64 13.17 5 34259 0 34922667
Pancytopenia 29.30 13.17 30 34234 95127 34827540
Renal failure 29.23 13.17 52 34212 130505 34792162
Cough 29.15 13.17 65 34199 150075 34772592
Ehlers-Danlos syndrome 28.99 13.17 7 34257 35 34922632
Staring 28.90 13.17 18 34246 1452 34921215
Social avoidant behaviour 28.55 13.17 24 34240 3090 34919577
Necrotising colitis 28.40 13.17 16 34248 1072 34921595
Platelet count decreased 28.34 13.17 46 34218 119671 34802996
Gait disturbance 28.34 13.17 161 34103 84979 34837688
Therapeutic response unexpected 28.26 13.17 41 34223 9716 34912951
Arthralgia 28.06 13.17 80 34184 169961 34752706
Headache 27.93 13.17 310 33954 200325 34722342
Behaviour disorder 27.91 13.17 29 34235 4881 34917786
Neuroleptic malignant syndrome 27.66 13.17 57 34207 17877 34904790
Vision blurred 27.27 13.17 103 34161 45860 34876807
Sepsis 27.02 13.17 79 34185 166482 34756185
Dissociation 26.92 13.17 18 34246 1640 34921027
Accidental death 26.90 13.17 21 34243 2435 34920232
Depression 26.86 13.17 175 34089 96923 34825744
Oesophageal atresia 26.57 13.17 12 34252 501 34922166
Perseveration 26.28 13.17 8 34256 106 34922561
Hippocampal sclerosis 26.28 13.17 8 34256 106 34922561
Phonophobia 26.18 13.17 9 34255 179 34922488
Acid-base balance disorder mixed 26.18 13.17 7 34257 56 34922611
Persecutory delusion 25.99 13.17 21 34243 2559 34920108
Coagulation disorder neonatal 25.94 13.17 6 34258 24 34922643
Psychomotor skills impaired 25.75 13.17 25 34239 3881 34918786
Paranoia 25.65 13.17 44 34220 12024 34910643
Myocardial infarction 25.53 13.17 50 34214 121035 34801632
Hypoxia 25.53 13.17 11 34253 55084 34867583
Neonatal respiratory depression 25.43 13.17 11 34253 414 34922253
Optic atrophy 25.38 13.17 14 34250 900 34921767
Neck pain 25.34 13.17 68 34196 25281 34897386
Renal colic 25.23 13.17 18 34246 1821 34920846
Overdose 25.11 13.17 164 34100 90895 34831772
Retinogram abnormal 25.07 13.17 8 34256 125 34922542
Asthenia 24.85 13.17 140 34124 245111 34677556
Bicuspid aortic valve 24.52 13.17 9 34255 218 34922449
Retinal disorder 24.51 13.17 14 34250 963 34921704
Slow speech 24.34 13.17 15 34249 1187 34921480
Therapeutic product effect incomplete 24.22 13.17 106 34158 50435 34872232
Premature baby 24.16 13.17 57 34207 19576 34903091
Madarosis 24.15 13.17 9 34255 228 34922439
Gastrointestinal haemorrhage 23.88 13.17 31 34233 88446 34834221
Prostate cancer 23.63 13.17 5 34259 39644 34883023
Wrong patient received product 23.40 13.17 20 34244 2634 34920033
Hallucination, visual 23.37 13.17 53 34211 17738 34904929
Atonic seizures 22.94 13.17 9 34255 263 34922404
Plagiocephaly 22.75 13.17 11 34253 537 34922130
Hypotonia 22.74 13.17 33 34231 7820 34914847
Low birth weight baby 22.58 13.17 33 34231 7872 34914795
Electroencephalogram abnormal 22.52 13.17 19 34245 2459 34920208
Urticaria 22.41 13.17 17 34247 62360 34860307
Tooth discolouration 22.13 13.17 10 34254 418 34922249
Aorticopulmonary septal defect 22.03 13.17 5 34259 18 34922649
Haemoptysis 21.73 13.17 4 34260 35002 34887665
Retinal vein occlusion 21.70 13.17 16 34248 1703 34920964
Delusion 21.69 13.17 42 34222 12593 34910074
Tonic clonic movements 21.36 13.17 13 34251 1006 34921661
Dyskinesia 21.28 13.17 59 34205 22354 34900313
Tic 21.26 13.17 17 34247 2041 34920626
Ultrasound liver abnormal 21.22 13.17 7 34257 122 34922545
Hyperkalaemia 21.21 13.17 22 34242 69367 34853300
Neuromyopathy 21.19 13.17 13 34251 1021 34921646
Hypohidrosis 21.13 13.17 8 34256 212 34922455
COVID-19 21.10 13.17 27 34237 77523 34845144
Lower respiratory tract infection 21.01 13.17 3 34261 31634 34891033
Anger 21.01 13.17 40 34224 11844 34910823
Infusion related reaction 21.00 13.17 13 34251 53044 34869623
Mental disorder 20.75 13.17 46 34218 15163 34907504
Hyperthermia malignant 20.42 13.17 17 34247 2160 34920507
Psychomotor hyperactivity 20.34 13.17 35 34229 9587 34913080
Speech disorder developmental 20.26 13.17 17 34247 2183 34920484
Magnetic resonance imaging head abnormal 20.25 13.17 14 34250 1347 34921320
Blood creatinine increased 20.21 13.17 39 34225 94937 34827730
Necrotising enterocolitis neonatal 20.16 13.17 8 34256 241 34922426
Cleft lip and palate 20.06 13.17 12 34252 900 34921767
Muscle twitching 19.88 13.17 36 34228 10262 34912405
Angioedema 19.79 13.17 6 34258 37368 34885299
Psychomotor retardation 19.75 13.17 21 34243 3629 34919038
Ischaemic gastritis 19.68 13.17 4 34260 7 34922660
Disorientation 19.38 13.17 74 34190 33114 34889553
Hypercapnic coma 19.06 13.17 7 34257 170 34922497
Insomnia 19.01 13.17 170 34094 103737 34818930
Malaise 18.84 13.17 106 34158 185719 34736948
Bradykinesia 18.63 13.17 21 34243 3872 34918795
Plasma cell myeloma 18.53 13.17 9 34255 42028 34880639
Maternal drugs affecting foetus 18.32 13.17 21 34243 3944 34918723
Haematuria traumatic 18.26 13.17 7 34257 192 34922475
Thinking abnormal 18.08 13.17 26 34238 6111 34916556
Talipes 18 13.17 15 34249 1908 34920759
Pyloric stenosis 17.94 13.17 11 34253 863 34921804
Multiple sclerosis 17.91 13.17 27 34237 6618 34916049
Chronic kidney disease 17.90 13.17 9 34255 41201 34881466
Cerebrovascular accident 17.89 13.17 35 34229 84776 34837891
Teratogenicity 17.89 13.17 5 34259 48 34922619
Blood ketone body decreased 17.79 13.17 3 34261 0 34922667
Therapy partial responder 17.79 13.17 33 34231 9583 34913084
Suspiciousness 17.78 13.17 8 34256 331 34922336
Depressed level of consciousness 17.67 13.17 86 34178 42755 34879912
Chills 17.48 13.17 33 34231 81010 34841657
Medication error 17.47 13.17 60 34204 25505 34897162
Renal impairment 17.45 13.17 42 34222 94471 34828196
Hypermetropia 17.45 13.17 9 34255 505 34922162
Abdominal pain upper 17.35 13.17 27 34237 71463 34851204
Dystonia 17.35 13.17 35 34229 10810 34911857
Cryptorchism 17.22 13.17 15 34249 2026 34920641
Suicide attempt 17.21 13.17 80 34184 39036 34883631
Joint swelling 17.19 13.17 20 34244 59870 34862797
Premature ejaculation 17.15 13.17 6 34258 126 34922541
Apathy 17.05 13.17 27 34237 6905 34915762
Distractibility 17.03 13.17 8 34256 366 34922301
Pneumonitis 16.95 13.17 6 34258 33872 34888795
Initial insomnia 16.95 13.17 18 34246 3106 34919561
Body dysmorphic disorder 16.93 13.17 6 34258 131 34922536
Body height below normal 16.93 13.17 7 34257 235 34922432
Weight increased 16.91 13.17 152 34112 92881 34829786
Suspected suicide 16.83 13.17 22 34242 4726 34917941
Chronic obstructive pulmonary disease 16.73 13.17 14 34250 48904 34873763
Paraesthesia 16.73 13.17 114 34150 64058 34858609
C-reactive protein increased 16.71 13.17 17 34247 54081 34868586
Cardiogenic shock 16.61 13.17 3 34261 26615 34896052
Seizure cluster 16.52 13.17 6 34258 141 34922526
Hypertelorism 16.40 13.17 9 34255 573 34922094
Haematochezia 16.31 13.17 13 34251 46521 34876146
Choroidal detachment 16.11 13.17 8 34256 414 34922253
Anterior chamber disorder 16.04 13.17 5 34259 72 34922595
Pre-existing condition improved 15.99 13.17 16 34248 2576 34920091
Periventricular haemorrhage neonatal 15.96 13.17 4 34260 24 34922643
Neonatal hypotension 15.95 13.17 6 34258 156 34922511
Change in seizure presentation 15.88 13.17 6 34258 158 34922509
Lip oedema 15.88 13.17 16 34248 2597 34920070
Chest discomfort 15.88 13.17 18 34246 54512 34868155
Hyponatraemia 15.87 13.17 36 34228 82655 34840012
Dry mouth 15.79 13.17 65 34199 30100 34892567
Septic shock 15.71 13.17 29 34235 71805 34850862
Ganglioglioma 15.71 13.17 3 34261 3 34922664
Blood bilirubin increased 15.70 13.17 9 34255 38287 34884380
Sleep-related eating disorder 15.64 13.17 7 34257 286 34922381
Photophobia 15.60 13.17 26 34238 6938 34915729
Somnambulism 15.44 13.17 17 34247 3055 34919612
Enuresis 15.39 13.17 15 34249 2338 34920329
Developmental hip dysplasia 15.37 13.17 7 34257 298 34922369
Vascular malformation 15.28 13.17 5 34259 85 34922582
Hyperglycinaemia 15.25 13.17 3 34261 4 34922663
Oedema peripheral 15.25 13.17 63 34201 119749 34802918
Psychiatric symptom 15.22 13.17 18 34246 3495 34919172
Dysarthria 15.20 13.17 71 34193 34711 34887956
Pain in extremity 15.20 13.17 68 34196 126445 34796222
Mental impairment 14.97 13.17 32 34232 10290 34912377
Peripheral swelling 14.95 13.17 33 34231 76508 34846159
Drug reaction with eosinophilia and systemic symptoms 14.88 13.17 68 34196 32944 34889723
Fear 14.65 13.17 32 34232 10444 34912223
Oedema 14.55 13.17 14 34250 45727 34876940
Abdominal wall haematoma 14.50 13.17 13 34251 1824 34920843
Transient epileptic amnesia 14.50 13.17 3 34261 6 34922661
Hyperhidrosis 14.44 13.17 125 34139 75567 34847100
Muscle contracture 14.42 13.17 11 34253 1233 34921434
Hand fracture 14.39 13.17 14 34250 2178 34920489
Sluggishness 14.38 13.17 17 34247 3300 34919367
White blood cell count decreased 14.23 13.17 47 34217 95398 34827269
Anaphylactic reaction 14.11 13.17 7 34257 32294 34890373
Cerebellar atrophy 14.06 13.17 8 34256 546 34922121
Neutropenia 14.02 13.17 93 34171 156685 34765982
Coronary artery disease 14.00 13.17 16 34248 48289 34874378
Skeletal dysplasia 13.95 13.17 5 34259 113 34922554
Drug intolerance 13.88 13.17 103 34161 59467 34863200
Hyperglycaemia 13.87 13.17 11 34253 39469 34883198
Neuropathy peripheral 13.84 13.17 39 34225 83224 34839443
Floppy infant 13.83 13.17 5 34259 116 34922551
Neonatal cholestasis 13.74 13.17 4 34260 45 34922622
Pseudomyopia 13.74 13.17 4 34260 45 34922622
Essential tremor 13.71 13.17 9 34255 795 34921872
Haematemesis 13.71 13.17 5 34259 27706 34894961
Drop attacks 13.68 13.17 8 34256 575 34922092
Hypotonia neonatal 13.66 13.17 11 34253 1334 34921333
Congenital genital malformation male 13.64 13.17 3 34261 9 34922658
Idiopathic generalised epilepsy 13.58 13.17 4 34260 47 34922620
Melaena 13.55 13.17 9 34255 35371 34887296
Stomatitis 13.54 13.17 13 34251 42501 34880166
Lennox-Gastaut syndrome 13.43 13.17 4 34260 49 34922618
Angina pectoris 13.39 13.17 7 34257 31356 34891311
Oxygen saturation decreased 13.37 13.17 20 34244 53798 34868869
Abdominal distension 13.34 13.17 23 34241 58469 34864198
Cross sensitivity reaction 13.29 13.17 11 34253 1386 34921281
Respiratory failure 13.25 13.17 58 34206 108514 34814153
Mania 13.24 13.17 29 34235 9482 34913185
Visual field defect 13.22 13.17 19 34245 4464 34918203

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
Angle closure glaucoma 1348.37 10.77 381 110066 2595 79631346
Seizure 1299.72 10.77 1449 108998 187385 79446556
Migraine 684.05 10.77 719 109728 86774 79547167
Myopia 599.25 10.77 185 110262 1771 79632170
Choroidal effusion 522.04 10.77 132 110315 545 79633396
Completed suicide 502.92 10.77 1074 109373 244693 79389248
Multiple-drug resistance 457.86 10.77 230 110217 8578 79625363
Drug ineffective 438.39 10.77 2769 107678 1078144 78555797
Drug ineffective for unapproved indication 419.85 10.77 432 110015 50806 79583135
Status epilepticus 408.43 10.77 312 110135 24729 79609212
Intentional self-injury 391.60 10.77 339 110108 32080 79601861
Epilepsy 342.88 10.77 349 110098 40511 79593430
Renal tubular acidosis 331.44 10.77 140 110307 3474 79630467
Visual perseveration 328.88 10.77 62 110385 20 79633921
Nephrolithiasis 305.51 10.77 373 110074 52918 79581023
Aggression 299.17 10.77 361 110086 50597 79583344
Suicidal ideation 292.19 10.77 439 110008 75901 79558040
Intentional overdose 290.31 10.77 524 109923 105436 79528505
Product substitution issue 286.36 10.77 232 110215 20024 79613917
Somnolence 282.00 10.77 848 109599 238133 79395808
Generalised tonic-clonic seizure 262.55 10.77 314 110133 43596 79590345
Heat stroke 254.81 10.77 94 110353 1609 79632332
Hyperammonaemic encephalopathy 254.80 10.77 127 110320 4655 79629286
Toxicity to various agents 240.75 10.77 1187 109260 420353 79213588
Memory impairment 223.13 10.77 484 109963 111250 79522691
Hyperammonaemia 218.72 10.77 155 110292 10938 79623003
Metabolic acidosis 210.72 10.77 396 110051 82133 79551808
Febrile neutropenia 201.34 10.77 38 110409 230961 79402980
Petit mal epilepsy 195.17 10.77 113 110334 5614 79628327
Acidosis hyperchloraemic 193.51 10.77 64 110383 778 79633163
Anaemia 192.04 10.77 200 110247 444815 79189126
Myokymia 188.82 10.77 42 110405 83 79633858
Acute kidney injury 181.80 10.77 274 110173 519130 79114811
Disturbance in attention 180.06 10.77 282 110165 50519 79583422
Cognitive disorder 169.21 10.77 328 110119 69598 79564343
Flat anterior chamber of eye 167.57 10.77 40 110407 122 79633819
Choroidal detachment 165.04 10.77 53 110394 583 79633358
Depression 164.64 10.77 665 109782 216125 79417816
Joint swelling 161.61 10.77 100 110347 288546 79345395
Paraesthesia 160.39 10.77 573 109874 175750 79458191
Myoclonic epilepsy 150.21 10.77 67 110380 1903 79632038
Headache 149.72 10.77 1471 108976 652301 78981640
Synovitis 149.30 10.77 17 110430 150717 79483224
Ataxia 147.92 10.77 178 110269 24861 79609080
Overdose 147.03 10.77 574 109873 183632 79450309
Partial seizures 146.66 10.77 112 110335 8866 79625075
Acute myopia 145.97 10.77 34 110413 90 79633851
Pneumonia 145.64 10.77 451 109996 659795 78974146
Psychotic disorder 144.18 10.77 228 110219 41174 79592767
Irritability 139.74 10.77 224 110223 40920 79593021
Product use in unapproved indication 138.35 10.77 699 109748 249660 79384281
Maculopathy 127.24 10.77 67 110380 2758 79631183
Malignant neoplasm progression 125.90 10.77 19 110428 135971 79497970
Atrial fibrillation 121.63 10.77 61 110386 197825 79436116
Drug resistance 119.66 10.77 212 110235 42001 79591940
Blepharospasm 118.23 10.77 83 110364 5768 79628173
Focal dyscognitive seizures 116.24 10.77 68 110379 3444 79630497
Ciliary body disorder 114.60 10.77 23 110424 19 79633922
Medication overuse headache 113.50 10.77 44 110403 868 79633073
Pyrexia 111.17 10.77 523 109924 678186 78955755
Pemphigus 110.14 10.77 7 110440 99575 79534366
Abnormal behaviour 109.86 10.77 188 110259 36233 79597708
Infusion related reaction 109.07 10.77 95 110352 230142 79403799
Dyspnoea 109.05 10.77 718 109729 856307 78777634
Sedation 108.35 10.77 229 110218 51666 79582275
Hand deformity 104.72 10.77 11 110436 103908 79530033
Pancytopenia 101.98 10.77 51 110396 165694 79468247
Anhidrosis 101.90 10.77 29 110418 203 79633738
Speech disorder 99.78 10.77 228 110219 54217 79579724
Drug interaction 98.60 10.77 942 109505 414241 79219700
Sudden unexplained death in epilepsy 96.74 10.77 36 110411 632 79633309
Suicide attempt 96.38 10.77 293 110154 82639 79551302
Tremor 94.66 10.77 476 109971 169607 79464334
General physical health deterioration 93.43 10.77 148 110299 275090 79358851
Wound 93.25 10.77 23 110424 116156 79517785
Interstitial lung disease 92.93 10.77 21 110426 112579 79521362
Arthropathy 91.49 10.77 67 110380 177044 79456897
Fanconi syndrome 91.12 10.77 54 110393 2802 79631139
Anorexia nervosa 90.34 10.77 27 110420 229 79633712
Renal failure 89.17 10.77 88 110359 200880 79433061
Pericarditis 88.97 10.77 18 110429 104218 79529723
Cardiac failure 88.90 10.77 52 110395 154790 79479151
Vision blurred 87.70 10.77 334 110113 105564 79528377
Disease progression 87.39 10.77 76 110371 184286 79449655
Hyperthermia 87.13 10.77 116 110331 17921 79616020
Drug withdrawal convulsions 86.99 10.77 48 110399 2172 79631769
Off label use 86.36 10.77 1747 108700 905468 78728473
Anti-cyclic citrullinated peptide antibody positive 85.87 10.77 8 110439 83135 79550806
Rheumatoid arthritis 85.01 10.77 98 110349 208372 79425569
Arthralgia 83.10 10.77 459 109988 571344 79062597
Cardiac failure congestive 82.92 10.77 47 110400 142355 79491586
Sluggishness 81.92 10.77 70 110377 6502 79627439
Intraocular pressure increased 81.54 10.77 81 110366 9124 79624817
Pleural effusion 80.30 10.77 51 110396 145211 79488730
Lower respiratory tract infection 79.13 10.77 40 110407 129180 79504761
Peripheral swelling 78.88 10.77 159 110288 269458 79364483
Infantile spasms 78.85 10.77 25 110422 263 79633678
Anxiety 77.37 10.77 599 109848 247913 79386028
Nightmare 77.34 10.77 133 110314 25728 79608213
Corneal oedema 77.02 10.77 47 110400 2573 79631368
Ammonia increased 76.70 10.77 72 110375 7563 79626378
Mitochondrial DNA mutation 76.40 10.77 27 110420 406 79633535
Tonic convulsion 76.17 10.77 44 110403 2176 79631765
Bradyphrenia 75.22 10.77 83 110364 10557 79623384
Diarrhoea 75.18 10.77 819 109628 879670 78754271
Neovascularisation 75.12 10.77 36 110411 1209 79632732
Cerebral venous thrombosis 74.87 10.77 47 110400 2706 79631235
Haemoglobin decreased 73.89 10.77 121 110326 221998 79411943
Sepsis 73.71 10.77 165 110282 269263 79364678
Aphasia 69.92 10.77 181 110266 46551 79587390
Agitation 69.41 10.77 298 110149 99417 79534524
Slow speech 69.15 10.77 43 110404 2435 79631506
Mood altered 68.75 10.77 103 110344 17744 79616197
Neutropenia 68.70 10.77 189 110258 287521 79346420
Stomatitis 67.74 10.77 62 110385 146695 79487246
Death 67.21 10.77 484 109963 566030 79067911
Myoclonus 67.19 10.77 130 110317 27530 79606411
Infection 66.95 10.77 147 110300 241565 79392376
Glossodynia 66.31 10.77 30 110417 103307 79530634
Hyponatraemia 65.82 10.77 90 110357 177758 79456183
Therapeutic response unexpected 65.54 10.77 107 110340 19839 79614102
Paradoxical drug reaction 65.08 10.77 64 110383 7121 79626820
Abdominal discomfort 65.00 10.77 158 110289 250569 79383372
Photophobia 64.60 10.77 108 110339 20420 79613521
Renal impairment 63.42 10.77 75 110372 157708 79476233
Partial seizures with secondary generalisation 62.70 10.77 26 110421 615 79633326
Hypoaesthesia 61.86 10.77 443 110004 178909 79455032
Duodenal ulcer perforation 61.84 10.77 9 110438 66202 79567739
Mental disorder 61.74 10.77 135 110312 31167 79602774
Helicobacter infection 61.68 10.77 11 110436 69693 79564248
Multiple sclerosis 60.70 10.77 110 110337 22172 79611769
Multiple sclerosis relapse 60.36 10.77 171 110276 46362 79587579
Depressed mood 59.84 10.77 175 110272 48305 79585636
Visual field defect 59.57 10.77 68 110379 8977 79624964
Diplopia 58.95 10.77 138 110309 33328 79600613
Blood creatinine increased 58.86 10.77 77 110370 154980 79478961
Dysarthria 58.22 10.77 216 110231 67406 79566535
Coma blister 58.13 10.77 19 110428 222 79633719
Visual acuity reduced 56.88 10.77 126 110321 29343 79604598
Hyperkalaemia 56.86 10.77 45 110402 114353 79519588
Propofol infusion syndrome 56.83 10.77 35 110412 1948 79631993
Nystagmus 56.20 10.77 69 110378 9835 79624106
Mania 56.04 10.77 95 110352 18165 79615776
Paranoia 55.59 10.77 98 110349 19334 79614607
Psychogenic seizure 55.13 10.77 34 110413 1897 79632044
Swelling 55.04 10.77 138 110309 216573 79417368
Blood prolactin increased 54.70 10.77 45 110402 3966 79629975
Gastrointestinal haemorrhage 54.40 10.77 75 110372 147644 79486297
Withdrawal syndrome 54.31 10.77 117 110330 26737 79607204
Impaired healing 53.86 10.77 27 110420 87628 79546313
Drug intolerance 53.81 10.77 581 109866 263538 79370403
Visual snow syndrome 52.77 10.77 13 110434 47 79633894
Muscle twitching 52.52 10.77 110 110337 24654 79609287
Cough 52.33 10.77 296 110151 366493 79267448
CSF oligoclonal band present 51.29 10.77 20 110427 401 79633540
Blindness 51.04 10.77 118 110329 28265 79605676
Myocardial infarction 50.96 10.77 112 110335 184017 79449924
Feeling abnormal 50.77 10.77 386 110061 158813 79475128
Electroencephalogram abnormal 50.33 10.77 49 110398 5385 79628556
Oligomenorrhoea 50.00 10.77 23 110424 703 79633238
Crying 49.62 10.77 103 110344 22940 79611001
Iris adhesions 49.56 10.77 21 110426 525 79633416
Contraindicated product administered 48.57 10.77 90 110357 157448 79476493
Amenorrhoea 47.59 10.77 56 110391 7636 79626305
Hallucination, auditory 47.53 10.77 95 110352 20598 79613343
Retinogram abnormal 47.40 10.77 18 110429 335 79633606
Affective disorder 47.27 10.77 58 110389 8261 79625680
Concussion 47.26 10.77 62 110385 9441 79624500
Weight decreased 47.18 10.77 722 109725 354476 79279465
Muscle injury 46.77 10.77 6 110441 48555 79585386
Angiofibroma 46.51 10.77 14 110433 122 79633819
Benign familial pemphigus 46.28 10.77 9 110438 5 79633936
C-reactive protein increased 46.03 10.77 67 110380 128960 79504981
Coma 46.00 10.77 267 110180 100382 79533559
Galactorrhoea 45.78 10.77 39 110408 3607 79630334
Atonic seizures 45.47 10.77 22 110425 755 79633186
Ascites 45.34 10.77 24 110423 75538 79558403
Thrombocytopenia 45.29 10.77 201 110246 265058 79368883
Iridocyclitis 45.24 10.77 39 110408 3665 79630276
Pseudomyopia 44.96 10.77 13 110434 97 79633844
Self-induced vomiting 44.94 10.77 12 110435 64 79633877
Intellectual disability 44.86 10.77 26 110421 1294 79632647
Folliculitis 44.36 10.77 11 110436 55369 79578572
Encephalopathy 44.28 10.77 198 110249 67199 79566742
Platelet count decreased 44.15 10.77 131 110316 194533 79439408
Phonophobia 44.04 10.77 19 110428 497 79633444
Head discomfort 43.91 10.77 75 110372 14427 79619514
Plasma cell myeloma 43.80 10.77 10 110437 53249 79580692
Product used for unknown indication 43.61 10.77 27 110420 1517 79632424
Nasopharyngitis 43.57 10.77 192 110255 253689 79380252
Alexia 43.54 10.77 9 110438 10 79633931
Amnesia 43.52 10.77 188 110259 62869 79571072
Suicidal behaviour 43.38 10.77 36 110411 3211 79630730
Anticonvulsant drug level increased 43.12 10.77 33 110414 2620 79631321
Blister 42.66 10.77 62 110385 119414 79514527
Septic shock 42.61 10.77 65 110382 122736 79511205
Hypomagnesaemia 42.39 10.77 7 110440 46904 79587037
Respiratory alkalosis 42.06 10.77 40 110407 4271 79629670
C-reactive protein abnormal 42.00 10.77 8 110439 48359 79585582
Intentional product misuse 41.90 10.77 250 110197 94915 79539026
Hypoxia 41.56 10.77 49 110398 103194 79530747
Oedema peripheral 41.38 10.77 194 110253 252094 79381847
Bulimia nervosa 41.19 10.77 15 110432 247 79633694
Eye pain 41.08 10.77 130 110317 37448 79596493
Bipolar disorder 41.02 10.77 52 110395 7655 79626286
Weight increased 40.01 10.77 572 109875 276814 79357127
Oedema 39.87 10.77 65 110382 119515 79514426
Wrong patient received product 39.73 10.77 40 110407 4578 79629363
Mental impairment 39.72 10.77 84 110363 18952 79614989
Libido increased 39.53 10.77 28 110419 1973 79631968
Rash 39.41 10.77 564 109883 577794 79056147
Cytomegalovirus infection 39.35 10.77 6 110441 42638 79591303
Nephrocalcinosis 39.24 10.77 25 110422 1477 79632464
Serotonin syndrome 38.90 10.77 144 110303 44883 79589058
Product use issue 38.82 10.77 453 109994 209369 79424572
Aura 38.66 10.77 21 110426 921 79633020
Anger 38.47 10.77 78 110369 17084 79616857
Social avoidant behaviour 38.34 10.77 40 110407 4774 79629167
Migraine with aura 38.26 10.77 31 110416 2674 79631267
Apathy 37.83 10.77 66 110381 12911 79621030
Cervix neoplasm 37.76 10.77 13 110434 180 79633761
Hypertension 37.63 10.77 286 110161 330706 79303235
Visual impairment 37.39 10.77 237 110210 91894 79542047
Blood lactate dehydrogenase increased 37.34 10.77 5 110442 39165 79594776
Melaena 37.04 10.77 19 110428 60871 79573070
Haematochezia 37.01 10.77 40 110407 87605 79546336
Respiratory arrest 37.00 10.77 168 110279 57382 79576559
Priapism 36.90 10.77 38 110409 4467 79629474
Discomfort 36.77 10.77 74 110373 125543 79508398
Coronary artery disease 36.15 10.77 23 110424 65451 79568490
Hostility 35.94 10.77 28 110419 2282 79631659
Failure to suspend medication 35.75 10.77 16 110431 458 79633483
Taste disorder 35.57 10.77 72 110375 15751 79618190
Delusion of replacement 35.48 10.77 12 110435 157 79633784
Red blood cell sedimentation rate increased 35.14 10.77 10 110437 45932 79588009
Disorientation 35.10 10.77 176 110271 62600 79571341
Cholecystitis chronic 35.09 10.77 55 110392 9851 79624090
Mood swings 35.03 10.77 82 110365 19798 79614143
Prostate cancer 34.89 10.77 3 110444 33265 79600676
Pulmonary fibrosis 34.87 10.77 9 110438 44103 79589838
Neoplasm progression 34.75 10.77 14 110433 51668 79582273
Delusion 34.65 10.77 83 110364 20340 79613601
Somnambulism 34.32 10.77 41 110406 5680 79628261
Change in seizure presentation 34.28 10.77 16 110431 506 79633435
Blood gases abnormal 34.26 10.77 21 110426 1159 79632782
Post-traumatic neck syndrome 33.93 10.77 26 110421 2068 79631873
Hepatic enzyme increased 33.86 10.77 134 110313 182476 79451465
Osteonecrosis of jaw 33.83 10.77 9 110438 43217 79590724
Asthenia 33.79 10.77 502 109945 511187 79122754
Salivary gland calculus 33.74 10.77 13 110434 252 79633689
Blood pressure systolic increased 33.72 10.77 26 110421 66960 79566981
Malaise 33.60 10.77 477 109970 489392 79144549
Thyroxine free decreased 33.58 10.77 20 110427 1047 79632894
Ciliary muscle spasm 33.50 10.77 6 110441 0 79633941
Depressed level of consciousness 33.45 10.77 239 110208 96413 79537528
Angiomyolipoma 33.39 10.77 12 110435 190 79633751
Hypersomnia 33.08 10.77 88 110359 22998 79610943
Hyperchloraemia 32.67 10.77 20 110427 1101 79632840
Lethargy 32.30 10.77 208 110239 81084 79552857
Lennox-Gastaut syndrome 32.28 10.77 12 110435 210 79633731
Bezoar 32.22 10.77 28 110419 2660 79631281
Respiratory disorder neonatal 32.13 10.77 9 110438 59 79633882
Erythema 31.92 10.77 180 110267 223110 79410831
Upper gastrointestinal haemorrhage 31.66 10.77 9 110438 41371 79592570
Insomnia 31.62 10.77 496 109951 244674 79389267
Dysphemia 31.49 10.77 31 110416 3453 79630488
Vertigo 31.39 10.77 183 110264 68899 79565042
Psychomotor hyperactivity 31.35 10.77 71 110376 16778 79617163
Anticonvulsant drug level decreased 31.31 10.77 24 110423 1910 79632031
Pruritus 31.20 10.77 373 110074 394275 79239666
Hip arthroplasty 30.87 10.77 6 110441 35750 79598191
Systemic lupus erythematosus 30.85 10.77 77 110370 121072 79512869
Autonomic nervous system imbalance 30.81 10.77 35 110412 4595 79629346
Pleocytosis 30.45 10.77 21 110426 1418 79632523
Drug abuse 30.42 10.77 352 110095 162339 79471602
Gene mutation 30.24 10.77 27 110420 2659 79631282
Musculoskeletal stiffness 30.22 10.77 132 110315 174876 79459065
Retinal disorder 30.10 10.77 24 110423 2023 79631918
Dystonia 30.09 10.77 81 110366 21318 79612623
Alice in wonderland syndrome 30.07 10.77 8 110439 42 79633899
Blindness transient 29.93 10.77 35 110412 4741 79629200
Hypophosphataemic osteomalacia 29.89 10.77 13 110434 347 79633594
Hallucination, visual 29.39 10.77 106 110341 32623 79601318
Extrapyramidal disorder 29.07 10.77 83 110364 22596 79611345
Pneumocystis jirovecii pneumonia 29.04 10.77 5 110442 32503 79601438
Product administered to patient of inappropriate age 28.82 10.77 37 110410 5516 79628425
Migraine without aura 28.70 10.77 12 110435 290 79633651
Neutrophil count decreased 28.66 10.77 54 110393 93905 79540036
Knee arthroplasty 28.62 10.77 12 110435 43236 79590705
Soft tissue injury 28.61 10.77 22 110425 1759 79632182
Skin ulcer 28.58 10.77 20 110427 54130 79579811
Myelodysplastic syndrome 28.57 10.77 4 110443 30297 79603644
Lung disorder 28.56 10.77 42 110405 80515 79553426
Retinal deposits 28.50 10.77 10 110437 147 79633794
Macular detachment 28.42 10.77 11 110436 216 79633725
Drug withdrawal syndrome 28.31 10.77 109 110338 34609 79599332
Hypocitraturia 28.02 10.77 6 110441 9 79633932
Hypervolaemia 28.00 10.77 12 110435 42678 79591263
Hyposthenuria 27.92 10.77 5 110442 0 79633941
Rhinolithiasis 27.92 10.77 5 110442 0 79633941
Fear 27.74 10.77 80 110367 21906 79612035
Pneumonitis 27.73 10.77 26 110421 60834 79573107
Lymphangioleiomyomatosis 27.55 10.77 10 110437 163 79633778
Blood homocysteine increased 27.51 10.77 13 110434 423 79633518
Dehydration 27.46 10.77 216 110231 247971 79385970
Emotional distress 27.45 10.77 119 110328 39850 79594091
Lichen planus 27.42 10.77 26 110421 2765 79631176
Thinking abnormal 27.37 10.77 58 110389 13103 79620838
Gait disturbance 27.20 10.77 421 110026 207085 79426856
Acute myeloid leukaemia 27.05 10.77 5 110442 30880 79603061
Blood pressure measurement 27.03 10.77 13 110434 440 79633501
Simple partial seizures 26.98 10.77 15 110432 689 79633252
Neck pain 26.97 10.77 188 110259 75229 79558712
Abortion spontaneous 26.87 10.77 96 110351 29411 79604530
Dizziness 26.85 10.77 935 109512 525506 79108435
Bone marrow failure 26.81 10.77 19 110428 51088 79582853
Pulmonary oedema 26.68 10.77 51 110396 88203 79545738
Lactic acidosis 26.63 10.77 35 110412 70324 79563617
Major depression 26.61 10.77 46 110401 8934 79625007
Retinitis pigmentosa 26.59 10.77 9 110438 118 79633823
Hyperexplexia 26.59 10.77 7 110440 35 79633906
Product quality issue 26.41 10.77 105 110342 33835 79600106
Blood bilirubin increased 26.05 10.77 32 110415 66200 79567741
Peritonitis 25.74 10.77 4 110443 28032 79605909
Psychomotor retardation 25.71 10.77 37 110410 6147 79627794
Sternal fracture 25.69 10.77 24 110423 2506 79631435
Toxic encephalopathy 25.65 10.77 52 110395 11388 79622553
Biliary dyskinesia 25.56 10.77 24 110423 2521 79631420
Hypohidrosis 25.56 10.77 11 110436 286 79633655
Non-24-hour sleep-wake disorder 25.52 10.77 7 110440 42 79633899
Vascular malformation 25.52 10.77 12 110435 386 79633555
Cytokine release syndrome 25.46 10.77 9 110438 35989 79597952
Granuloma annulare 25.44 10.77 14 110433 630 79633311
Haemoptysis 25.42 10.77 24 110423 55975 79577966
Seizure cluster 25.40 10.77 12 110435 390 79633551
Suspiciousness 25.38 10.77 14 110433 633 79633308
Renal colic 25.27 10.77 25 110422 2802 79631139
Fluid retention 25.14 10.77 36 110411 69773 79564168
Affect lability 25.03 10.77 51 110396 11208 79622733
Frontal lobe epilepsy 24.98 10.77 5 110442 4 79633937
Tearfulness 24.89 10.77 36 110411 6009 79627932
Staring 24.78 10.77 24 110423 2621 79631320
Conjunctival oedema 24.74 10.77 17 110430 1141 79632800
Arthritis 24.13 10.77 80 110367 114800 79519141
Hyperventilation 24.11 10.77 41 110406 7858 79626083
Myelosuppression 23.88 10.77 13 110434 40283 79593658
Hypotonia 23.68 10.77 54 110393 12816 79621125
Heart rate 23.56 10.77 8 110439 106 79633835
Anoxia 23.50 10.77 11 110436 350 79633591
Hypermetropia 23.43 10.77 12 110435 466 79633475
Granulocytopenia 23.34 10.77 50 110397 11381 79622560
Patient dissatisfaction with treatment 23.24 10.77 9 110438 177 79633764
Panic attack 23.09 10.77 80 110367 24136 79609805
Gingival hypertrophy 23.06 10.77 25 110422 3117 79630824
Neuropathy peripheral 22.95 10.77 109 110338 141196 79492745
Intensive care unit acquired weakness 22.90 10.77 20 110427 1913 79632028
Acute myocardial infarction 22.86 10.77 45 110402 76991 79556950
Ill-defined disorder 22.72 10.77 35 110412 65840 79568101
Wheezing 22.66 10.77 84 110363 116580 79517361
Drug dependence 22.57 10.77 114 110333 40655 79593286
Inappropriate affect 22.57 10.77 18 110429 1518 79632423
Dyspnoea exertional 22.44 10.77 55 110392 87018 79546923
Haematuria 22.40 10.77 38 110409 68798 79565143
Right ventricular failure 22.40 10.77 3 110444 23494 79610447
Behaviour disorder 22.29 10.77 35 110412 6278 79627663
Anticonvulsant drug level above therapeutic 22.25 10.77 16 110431 1155 79632786
Erectile dysfunction 22.14 10.77 57 110390 14607 79619334
Road traffic accident 22.04 10.77 119 110328 43545 79590396
Metastases to liver 21.96 10.77 6 110441 28308 79605633
Oxygen saturation decreased 21.87 10.77 98 110349 128949 79504992
Mobility decreased 21.79 10.77 91 110356 122084 79511857
Liver disorder 21.75 10.77 42 110405 72375 79561566
Temperature intolerance 21.62 10.77 44 110403 9661 79624280
Hypothermia 21.57 10.77 75 110372 22671 79611270
Developmental delay 21.53 10.77 16 110431 1215 79632726
Sleep-related eating disorder 21.48 10.77 13 110434 701 79633240
Posterior reversible encephalopathy syndrome 21.48 10.77 5 110442 26276 79607665
Ehlers-Danlos syndrome 21.42 10.77 8 110439 142 79633799
Neuroleptic malignant syndrome 21.23 10.77 85 110362 27474 79606467
White blood cell count decreased 21.23 10.77 163 110284 188125 79445816
Eating disorder 21.17 10.77 70 110377 20627 79613314
Hypoglycaemia 21.17 10.77 71 110376 101523 79532418
Vitamin D deficiency 21.04 10.77 55 110392 14224 79619717
Optic atrophy 20.91 10.77 19 110428 1914 79632027
Ejection fraction decreased 20.72 10.77 11 110436 34566 79599375
Thalamic infarction 20.68 10.77 16 110431 1291 79632650
Acid-base balance disorder mixed 20.26 10.77 7 110440 98 79633843
Full blood count decreased 20.21 10.77 6 110441 26813 79607128
Cardiogenic shock 20.18 10.77 17 110430 41897 79592044
Blunted affect 20.17 10.77 11 110436 486 79633455
Herpes zoster 20.12 10.77 64 110383 93019 79540922
Screaming 20.09 10.77 26 110421 3907 79630034
Self-injurious ideation 20.08 10.77 25 110422 3613 79630328
Cardio-respiratory arrest 19.93 10.77 234 110213 108276 79525665
Papilloedema 19.89 10.77 33 110414 6200 79627741
Psychomotor skills impaired 19.85 10.77 30 110417 5207 79628734
Microcephaly 19.74 10.77 8 110439 178 79633763
Transfusion 19.68 10.77 3 110444 21327 79612614
Pericardial effusion 19.63 10.77 21 110426 46216 79587725
Hypersensitivity 19.51 10.77 251 110196 261988 79371953
Intentional product use issue 19.43 10.77 127 110320 151985 79481956
Exposure during pregnancy 19.43 10.77 220 110227 100912 79533029
Speech disorder developmental 19.42 10.77 12 110435 672 79633269
Hyperglycaemia 19.26 10.77 43 110404 70292 79563649
Brugada syndrome 19.25 10.77 15 110432 1223 79632718
Apnoea 19.25 10.77 47 110400 11657 79622284
Schizoaffective disorder 19.18 10.77 19 110428 2133 79631808
Pulmonary hypertension 19.15 10.77 23 110424 48057 79585884
Cerebral infarction 19.11 10.77 21 110426 45655 79588286
Blood thyroid stimulating hormone normal 19.07 10.77 7 110440 118 79633823
Ureterolithiasis 18.97 10.77 25 110422 3823 79630118
Blood pressure increased 18.97 10.77 194 110253 211166 79422775
Personality disorder 18.89 10.77 32 110415 6114 79627827
Blood bilirubin decreased 18.86 10.77 14 110433 1061 79632880
Bacteraemia 18.86 10.77 11 110436 32813 79601128
Respiratory failure 18.84 10.77 160 110287 180751 79453190
Product physical issue 18.82 10.77 26 110421 4159 79629782
Calculus urinary 18.81 10.77 20 110427 2440 79631501
Gastrooesophageal reflux disease 18.79 10.77 224 110223 104022 79529919
Toxic skin eruption 18.71 10.77 4 110443 22289 79611652
Premature ejaculation 18.68 10.77 6 110441 66 79633875
Dyskinesia 18.67 10.77 116 110331 44657 79589284
Cholestasis 18.63 10.77 27 110420 52082 79581859
Therapeutic response changed 18.59 10.77 15 110432 1286 79632655
Dysmorphism 18.57 10.77 11 110436 570 79633371
Incoherent 18.49 10.77 36 110411 7656 79626285
International normalised ratio increased 18.49 10.77 58 110389 84663 79549278
Open angle glaucoma 18.44 10.77 10 110437 437 79633504
Aspartate aminotransferase decreased 18.39 10.77 14 110433 1103 79632838
Borderline personality disorder 18.38 10.77 13 110434 914 79633027
Angina pectoris 18.31 10.77 27 110420 51705 79582236
Thrombotic microangiopathy 18.24 10.77 3 110444 20166 79613775
Angular cheilitis 18.23 10.77 12 110435 750 79633191
Decreased interest 18.20 10.77 24 110423 3673 79630268
Hepatic function abnormal 18.20 10.77 47 110400 73060 79560881
Dissociation 18.11 10.77 25 110422 3996 79629945
Hypopyon 18.11 10.77 14 110433 1128 79632813
Transferrin saturation decreased 18.07 10.77 14 110433 1132 79632809
Hereditary angioedema 18.04 10.77 29 110418 5306 79628635
Restless legs syndrome 17.98 10.77 65 110382 20027 79613914
Tardive dyskinesia 17.97 10.77 43 110404 10528 79623413
Urine calcium/creatinine ratio increased 17.92 10.77 7 110440 141 79633800
Benzodiazepine drug level increased 17.91 10.77 8 110439 228 79633713
Small for dates baby 17.85 10.77 10 110437 466 79633475
Illogical thinking 17.85 10.77 6 110441 77 79633864
Enuresis 17.81 10.77 22 110425 3154 79630787
Organic brain syndrome 17.70 10.77 10 110437 474 79633467
Multiple organ dysfunction syndrome 17.68 10.77 96 110351 120150 79513791
Blood pressure fluctuation 17.62 10.77 42 110405 67103 79566838
Foetal exposure during pregnancy 17.60 10.77 30 110417 5760 79628181
Idiopathic intracranial hypertension 17.56 10.77 22 110425 3200 79630741
Metastases to bone 17.46 10.77 6 110441 24421 79609520
Poor quality sleep 17.44 10.77 70 110377 22652 79611289
Vestibular migraine 17.39 10.77 7 110440 153 79633788
Hippocampal sclerosis 17.35 10.77 7 110440 154 79633787
Anterior chamber disorder 17.31 10.77 7 110440 155 79633786
Acquired haemophilia 17.27 10.77 17 110430 1894 79632047
Blood bicarbonate decreased 17.26 10.77 28 110419 5163 79628778
Central nervous system lesion 17.21 10.77 49 110398 13319 79620622
Brain oedema 17.18 10.77 75 110372 25188 79608753
Glycosuria 17.10 10.77 18 110429 2170 79631771
Hemiparesis 17.07 10.77 92 110355 33641 79600300
Blood pressure diastolic abnormal 17.05 10.77 3 110444 19199 79614742
Basal cell carcinoma 16.99 10.77 16 110431 37359 79596582
Appendicitis 16.91 10.77 4 110443 20790 79613151
Drug level decreased 16.83 10.77 51 110396 14351 79619590
Endometriosis 16.82 10.77 23 110424 3645 79630296
Rectal haemorrhage 16.81 10.77 52 110395 76248 79557693
Ischaemic gastritis 16.81 10.77 4 110443 12 79633929
Perseveration 16.71 10.77 9 110438 388 79633553
Blood lactic acid increased 16.69 10.77 47 110400 12697 79621244
Hallucination 16.68 10.77 187 110260 85558 79548383
Gastrointestinal disorder 16.65 10.77 100 110347 122105 79511836
Anticonvulsant drug level below therapeutic 16.60 10.77 13 110434 1068 79632873
Laryngeal stenosis 16.52 10.77 13 110434 1075 79632866
Narrow anterior chamber angle 16.52 10.77 7 110440 175 79633766
Failed induction of labour 16.47 10.77 8 110439 277 79633664
Lung neoplasm malignant 16.42 10.77 9 110438 27783 79606158
Alanine aminotransferase increased 16.38 10.77 145 110302 162425 79471516
Multiple drug therapy 16.37 10.77 24 110423 4054 79629887
Educational problem 16.35 10.77 9 110438 405 79633536
Conjunctival hyperaemia 16.33 10.77 25 110422 4388 79629553
Communication disorder 16.32 10.77 24 110423 4066 79629875
Urge incontinence 16.31 10.77 13 110434 1095 79632846
Eye movement disorder 16.31 10.77 35 110412 7976 79625965
Essential tremor 16.27 10.77 15 110432 1540 79632401
Bradykinesia 16.21 10.77 35 110412 8008 79625933
Ultrasound liver abnormal 16.16 10.77 7 110440 185 79633756
Heart rate decreased 16.16 10.77 47 110400 70269 79563672
Aspartate aminotransferase increased 16.11 10.77 119 110328 138522 79495419
Near drowning 16.09 10.77 5 110442 49 79633892
Subdural haematoma 16.08 10.77 12 110435 31422 79602519
Blood chloride increased 16.05 10.77 27 110420 5129 79628812
Haematuria traumatic 15.99 10.77 7 110440 190 79633751
Jaundice 15.97 10.77 31 110416 53318 79580623
Rales 15.96 10.77 4 110443 19997 79613944
Therapeutic product effective for unapproved indication 15.88 10.77 6 110441 110 79633831
Periarthritis 15.86 10.77 20 110427 2928 79631013
Pregnancy with implant contraceptive 15.83 10.77 16 110431 1840 79632101
Accommodation disorder 15.74 10.77 10 110437 588 79633353
Hepatic cytolysis 15.74 10.77 9 110438 27142 79606799
Hypotension 15.73 10.77 477 109970 439840 79194101
Chills 15.67 10.77 144 110303 160090 79473851
Poisoning 15.67 10.77 73 110374 25199 79608742
Orthostatic hypotension 15.66 10.77 34 110413 56130 79577811
Atrioventricular septal defect 15.64 10.77 6 110441 115 79633826
Pulmonary arterial hypertension 15.61 10.77 10 110437 28356 79605585
Asterixis 15.59 10.77 19 110428 2688 79631253
Nodular rash 15.57 10.77 8 110439 313 79633628
Magnetic resonance imaging head abnormal 15.48 10.77 19 110428 2707 79631234
Accidental death 15.44 10.77 24 110423 4267 79629674
Acute coronary syndrome 15.44 10.77 5 110442 21128 79612813
Inflammation 15.41 10.77 72 110375 93681 79540260
Bladder cancer 15.40 10.77 4 110443 19522 79614419
Sopor 15.35 10.77 88 110359 32922 79601019
Drug screen positive 15.34 10.77 29 110418 6034 79627907
Epistaxis 15.33 10.77 91 110356 111424 79522517
Drug reaction with eosinophilia and systemic symptoms 15.29 10.77 146 110301 64098 79569843
Ischaemic stroke 15.27 10.77 14 110433 33117 79600824
Red blood cell sedimentation rate abnormal 15.24 10.77 5 110442 20958 79612983
Occipital neuralgia 15.18 10.77 9 110438 467 79633474
Pseudomonas infection 15.17 10.77 5 110442 20898 79613043
Haematemesis 15.11 10.77 31 110416 52233 79581708
Toxic epidermal necrolysis 15.07 10.77 24 110423 44557 79589384
Cerebral vasoconstriction 15.03 10.77 14 110433 1456 79632485
Osteomyelitis 15.02 10.77 14 110433 32851 79601090
Cellulitis 14.99 10.77 89 110358 108971 79524970
Aspergillus infection 14.97 10.77 4 110443 19157 79614784
Status migrainosus 14.95 10.77 5 110442 63 79633878
Localised infection 14.94 10.77 18 110429 37557 79596384
Electrocardiogram QT prolonged 14.90 10.77 191 110256 90195 79543746
Basilar migraine 14.88 10.77 5 110442 64 79633877
Tonic clonic movements 14.87 10.77 17 110430 2247 79631694
Bladder hypertrophy 14.85 10.77 10 110437 649 79633292
Pleural rub 14.81 10.77 5 110442 65 79633876
Creatinine renal clearance decreased 14.78 10.77 4 110443 18998 79614943
Colitis 14.75 10.77 52 110395 73255 79560686
Transient epileptic amnesia 14.68 10.77 3 110444 3 79633938
Product dispensing error 14.60 10.77 46 110401 13217 79620724
Application site discolouration 14.60 10.77 11 110436 853 79633088
Haemophagocytic lymphohistiocytosis 14.54 10.77 6 110441 21831 79612110
Iris disorder 14.44 10.77 8 110439 365 79633576
Productive cough 14.42 10.77 68 110379 88263 79545678
Gallbladder disorder 14.38 10.77 59 110388 19281 79614660
Renal injury 14.28 10.77 3 110444 16924 79617017
Hyporesponsive to stimuli 14.26 10.77 16 110431 2072 79631869
Catatonia 14.23 10.77 35 110412 8721 79625220
Lupus pleurisy 14.21 10.77 3 110444 4 79633937
Emotional disorder 14.13 10.77 48 110399 14339 79619602
Blood urea increased 14.05 10.77 29 110418 48761 79585180
Amino acid level increased 13.95 10.77 10 110437 718 79633223
Chronic obstructive pulmonary disease 13.80 10.77 66 110381 85353 79548588
Night blindness 13.79 10.77 9 110438 554 79633387
Ventricular tachycardia 13.78 10.77 23 110424 41912 79592029
Distractibility 13.75 10.77 10 110437 735 79633206
Convulsive threshold lowered 13.71 10.77 11 110436 936 79633005
Cerebral haemorrhage 13.66 10.77 38 110409 57635 79576306
Blood pressure diastolic decreased 13.66 10.77 13 110434 30203 79603738
Intracranial hypotension 13.62 10.77 8 110439 408 79633533
COVID-19 13.62 10.77 146 110301 157528 79476413
Postictal psychosis 13.56 10.77 6 110441 167 79633774
Renal tubular necrosis 13.54 10.77 9 110438 25030 79608911
Granulomatous dermatitis 13.53 10.77 8 110439 413 79633528
Anaphylactic shock 13.52 10.77 18 110429 35978 79597963
Clostridium difficile infection 13.49 10.77 24 110423 42661 79591280
Diverticulitis 13.49 10.77 27 110420 45909 79588032
Hyperacusis 13.45 10.77 16 110431 2207 79631734
Regressive behaviour 13.43 10.77 6 110441 171 79633770
Homicidal ideation 13.38 10.77 20 110427 3437 79630504
Optic neuritis 13.35 10.77 36 110411 9484 79624457
Pre-existing condition improved 13.33 10.77 26 110421 5537 79628404
Mastoiditis 13.29 10.77 14 110433 1690 79632251
Blood pressure decreased 13.23 10.77 82 110365 99384 79534557
Cluster headache 13.22 10.77 11 110436 985 79632956
Product dose omission issue 13.17 10.77 442 110005 247095 79386846
Joint range of motion decreased 13.17 10.77 16 110431 33266 79600675
Self esteem decreased 13.16 10.77 11 110436 991 79632950
Dysgeusia 13.15 10.77 129 110318 57048 79576893
Illiteracy 13.08 10.77 4 110443 37 79633904
Chorioretinal folds 13.08 10.77 4 110443 37 79633904
Persecutory delusion 13.07 10.77 24 110423 4885 79629056
Plasmodium falciparum infection 13.07 10.77 5 110442 95 79633846
Cerebral venous sinus thrombosis 13.06 10.77 16 110431 2275 79631666
Uveitis 13.04 10.77 52 110395 16778 79617163
Automatism 12.99 10.77 6 110441 185 79633756
Low birth weight baby 12.97 10.77 9 110438 614 79633327
Paranasal cyst 12.96 10.77 8 110439 447 79633494
Cytopenia 12.94 10.77 6 110441 20377 79613564
Hyperthermia malignant 12.94 10.77 18 110429 2899 79631042
Central obesity 12.90 10.77 14 110433 1747 79632194
Hereditary optic atrophy 12.89 10.77 4 110443 39 79633902
Hyperaldosteronism 12.88 10.77 8 110439 452 79633489
Therapy partial responder 12.88 10.77 53 110394 17344 79616597
Brain injury 12.73 10.77 40 110407 11477 79622464
Therapeutic product ineffective for unapproved indication 12.70 10.77 6 110441 195 79633746
Hypercalcaemia 12.70 10.77 21 110426 38409 79595532
Narcolepsy 12.67 10.77 12 110435 1274 79632667
Post laminectomy syndrome 12.64 10.77 7 110440 319 79633622
Tri-iodothyronine free abnormal 12.62 10.77 4 110443 42 79633899
Developmental regression 12.62 10.77 4 110443 42 79633899
Alopecia 12.60 10.77 235 110212 231120 79402821
Slow response to stimuli 12.49 10.77 14 110433 1811 79632130
Mydriasis 12.47 10.77 53 110394 17590 79616351
Negativism 12.44 10.77 10 110437 853 79633088
Psychiatric symptom 12.38 10.77 29 110418 7006 79626935
Encephalocele 12.37 10.77 4 110443 45 79633896
COVID-19 pneumonia 12.36 10.77 13 110434 28836 79605105
Application site burn 12.32 10.77 10 110437 865 79633076
Intermenstrual bleeding 12.32 10.77 26 110421 5858 79628083
Cross sensitivity reaction 12.31 10.77 20 110427 3692 79630249
Hepatocellular injury 12.31 10.77 30 110417 47563 79586378
Depersonalisation/derealisation disorder 12.26 10.77 14 110433 1848 79632093
Tinnitus 12.21 10.77 104 110343 44229 79589712
Acidosis 12.19 10.77 57 110390 19705 79614236
Bronchiectasis 12.17 10.77 8 110439 22378 79611563
Presyncope 12.16 10.77 24 110423 41030 79592911
Blastocystis infection 12.14 10.77 4 110443 48 79633893
Binge eating 12.14 10.77 8 110439 501 79633440
Therapeutic product effect decreased 12.12 10.77 157 110290 163706 79470235
Lymphomatoid papulosis 12.12 10.77 7 110440 346 79633595
Red blood cell count decreased 12.11 10.77 40 110407 57473 79576468
Muscle contractions involuntary 12.10 10.77 20 110427 3745 79630196
Retinal detachment 12.01 10.77 34 110413 9213 79624728
Vascular headache 11.99 10.77 4 110443 50 79633891
Hamartoma 11.94 10.77 3 110444 12 79633929
Suspected suicide 11.94 10.77 37 110410 10539 79623402
Transplant rejection 11.92 10.77 6 110441 19431 79614510
Pneumothorax 11.87 10.77 13 110434 28310 79605631
Musculoskeletal pain 11.82 10.77 88 110359 102266 79531675
Ischaemic cerebral infarction 11.78 10.77 16 110431 2519 79631422
Abortion 11.74 10.77 12 110435 1398 79632543
Hyperbilirubinaemia 11.74 10.77 10 110437 24508 79609433
Astrocytoma, low grade 11.71 10.77 4 110443 54 79633887
Head titubation 11.71 10.77 10 110437 928 79633013
Full blood count abnormal 11.70 10.77 24 110423 40450 79593491
Photopsia 11.66 10.77 24 110423 5312 79628629
Euphoric mood 11.63 10.77 30 110417 7696 79626245
Complication of device removal 11.63 10.77 20 110427 3869 79630072
Coma acidotic 11.62 10.77 5 110442 130 79633811
Balance disorder 11.61 10.77 197 110250 98660 79535281
Ovarian germ cell cancer stage II 11.51 10.77 4 110443 57 79633884
Coordination abnormal 11.47 10.77 51 110396 17261 79616680
Lower gastrointestinal haemorrhage 11.46 10.77 4 110443 16121 79617820
Drug level increased 11.45 10.77 94 110353 39557 79594384
Parasomnia 11.43 10.77 8 110439 553 79633388
Eosinophilia 11.40 10.77 29 110418 45316 79588625
Decreased nasolabial fold 11.40 10.77 3 110444 15 79633926
Fever neonatal 11.40 10.77 3 110444 15 79633926
Idiopathic generalised epilepsy 11.39 10.77 4 110443 59 79633882
Gambling disorder 11.31 10.77 14 110433 2012 79631929
Lymphoma 11.30 10.77 5 110442 17455 79616486
Antipsychotic drug level decreased 11.27 10.77 11 110436 1213 79632728
Myofascial pain syndrome 11.25 10.77 14 110433 2023 79631918
Osteonecrosis 11.23 10.77 16 110431 31079 79602862
Cardiomyopathy 11.21 10.77 14 110433 28760 79605181
Complex regional pain syndrome 11.19 10.77 14 110433 2034 79631907
Tic 11.17 10.77 17 110430 2969 79630972
Retinal vein occlusion 11.15 10.77 18 110429 3305 79630636
Calcinosis 11.10 10.77 15 110432 2350 79631591
Cortical dysplasia 11.08 10.77 3 110444 17 79633924
Skull fracture 11.08 10.77 13 110434 1767 79632174
Loss of libido 11.07 10.77 16 110431 2669 79631272
Osmotic demyelination syndrome 11.04 10.77 12 110435 1501 79632440
Serum ferritin decreased 11.03 10.77 15 110432 2365 79631576
Breast disorder 11.01 10.77 14 110433 2067 79631874
Snoring 10.97 10.77 24 110423 5542 79628399
Oral candidiasis 10.94 10.77 15 110432 29613 79604328
Hypercapnic coma 10.94 10.77 7 110440 417 79633524
Wrong technique in product usage process 10.89 10.77 153 110294 73722 79560219
Electrocardiogram T wave abnormal 10.88 10.77 19 110428 3719 79630222
Colour blindness 10.85 10.77 7 110440 423 79633518
Compulsive shopping 10.80 10.77 9 110438 807 79633134
Maternal exposure during pregnancy 10.78 10.77 129 110318 136409 79497532
Tubulointerstitial nephritis 10.78 10.77 23 110424 38212 79595729
Embolism 10.77 10.77 3 110444 13979 79619962

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC A08AA51 ALIMENTARY TRACT AND METABOLISM
ANTIOBESITY PREPARATIONS, EXCL. DIET PRODUCTS
ANTIOBESITY PREPARATIONS, EXCL. DIET PRODUCTS
Centrally acting antiobesity products
ATC N03AX11 NERVOUS SYSTEM
ANTIEPILEPTICS
ANTIEPILEPTICS
Other antiepileptics
FDA PE N0000008486 Decreased Central Nervous System Disorganized Electrical Activity
MeSH PA D000927 Anticonvulsants
MeSH PA D002491 Central Nervous System Agents
MeSH PA D007004 Hypoglycemic Agents
FDA MoA N0000182140 Cytochrome P450 2C19 Inhibitors
FDA MoA N0000185506 Cytochrome P450 3A4 Inducers
CHEBI has role CHEBI:35623 anticonvulsants
CHEBI has role CHEBI:38633 sodium channel blockers

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

DiseaseRelationSNOMED_IDDOID
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
Migraine Prevention indication
Alcoholism off-label use 7200002
Essential tremor off-label use 609558009 DOID:4990
Ocular hypertension contraindication 4210003 DOID:9282
Suicidal thoughts contraindication 6471006
Reduced visual acuity contraindication 13164000
Mood swings contraindication 18963009
Secondary angle-closure glaucoma contraindication 21571006
Depressive disorder contraindication 35489007
Metabolic acidosis contraindication 59455009
Diarrhea contraindication 62315008
Fatigue contraindication 84229001
Kidney disease contraindication 90708001 DOID:557
Paresthesia contraindication 91019004
Kidney stone contraindication 95570007
Diminished sweating contraindication 111980002
Disease of liver contraindication 235856003 DOID:409
Drowsy contraindication 271782001
Pregnancy, function contraindication 289908002
Fever contraindication 386661006
Impaired cognition contraindication 386806002
Memory impairment contraindication 386807006
Dizziness contraindication 404640003
Concentration Difficulty contraindication




🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 8.6 acidic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
100MG TROKENDI XR SUPERNUS PHARMS N201635 Aug. 16, 2013 RX CAPSULE, EXTENDED RELEASE ORAL 10314790 Nov. 16, 2027 USE OF TROKENDI XR FOR PROPHYLACTIC TREATMENT OF MIGRAINE
100MG TROKENDI XR SUPERNUS PHARMS N201635 Aug. 16, 2013 RX CAPSULE, EXTENDED RELEASE ORAL 10314790 Nov. 16, 2027 USE OF TROKENDI XR FOR THE TREATMENT OF EPILEPSY
100MG TROKENDI XR SUPERNUS PHARMS N201635 Aug. 16, 2013 RX CAPSULE, EXTENDED RELEASE ORAL 8298580 Nov. 16, 2027 TREATMENT OF EPILEPSY
100MG TROKENDI XR SUPERNUS PHARMS N201635 Aug. 16, 2013 RX CAPSULE, EXTENDED RELEASE ORAL 8298580 Nov. 16, 2027 USE OF TROKENDI XR FOR PROPHYLACTIC TREATMENT OF MIGRAINE
100MG TROKENDI XR SUPERNUS PHARMS N201635 Aug. 16, 2013 RX CAPSULE, EXTENDED RELEASE ORAL 8663683 Nov. 16, 2027 TREATMENT OF EPILEPSY
100MG TROKENDI XR SUPERNUS PHARMS N201635 Aug. 16, 2013 RX CAPSULE, EXTENDED RELEASE ORAL 8663683 Nov. 16, 2027 USE OF TROKENDI XR FOR PROPHYLACTIC TREATMENT OF MIGRAINE
100MG TROKENDI XR SUPERNUS PHARMS N201635 Aug. 16, 2013 RX CAPSULE, EXTENDED RELEASE ORAL 8877248 Nov. 16, 2027 TREATMENT OF EPILEPSY
100MG TROKENDI XR SUPERNUS PHARMS N201635 Aug. 16, 2013 RX CAPSULE, EXTENDED RELEASE ORAL 8877248 Nov. 16, 2027 USE OF TROKENDI XR FOR PROPHYLACTIC TREATMENT OF MIGRAINE
100MG TROKENDI XR SUPERNUS PHARMS N201635 Aug. 16, 2013 RX CAPSULE, EXTENDED RELEASE ORAL 8889191 Nov. 16, 2027 TREATMENT OF EPILEPSY
100MG TROKENDI XR SUPERNUS PHARMS N201635 Aug. 16, 2013 RX CAPSULE, EXTENDED RELEASE ORAL 8889191 Nov. 16, 2027 USE OF TROKENDI XR FOR PROPHYLACTIC TREATMENT OF MIGRAINE
100MG TROKENDI XR SUPERNUS PHARMS N201635 Aug. 16, 2013 RX CAPSULE, EXTENDED RELEASE ORAL 8992989 Nov. 16, 2027 USE OF TROKENDI XR FOR PROPHYLACTIC TREATMENT OF MIGRAINE
100MG TROKENDI XR SUPERNUS PHARMS N201635 Aug. 16, 2013 RX CAPSULE, EXTENDED RELEASE ORAL 8992989 Nov. 16, 2027 USE OF TROKENDI XR FOR THE TREATMENT OF EPILEPSY
100MG TROKENDI XR SUPERNUS PHARMS N201635 Aug. 16, 2013 RX CAPSULE, EXTENDED RELEASE ORAL 9549940 Nov. 16, 2027 USE OF TROKENDI XR FOR PROPHYLACTIC TREATMENT OF MIGRAINE
100MG TROKENDI XR SUPERNUS PHARMS N201635 Aug. 16, 2013 RX CAPSULE, EXTENDED RELEASE ORAL 9549940 Nov. 16, 2027 USE OF TROKENDI XR FOR THE TREATMENT OF EPILEPSY
100MG TROKENDI XR SUPERNUS PHARMS N201635 Aug. 16, 2013 RX CAPSULE, EXTENDED RELEASE ORAL 9555004 Nov. 16, 2027 USE OF TROKENDI XR FOR PROPHYLACTIC TREATMENT OF MIGRAINE
100MG TROKENDI XR SUPERNUS PHARMS N201635 Aug. 16, 2013 RX CAPSULE, EXTENDED RELEASE ORAL 9555004 Nov. 16, 2027 USE OF TROKENDI XR FOR THE TREATMENT OF EPILEPSY
100MG TROKENDI XR SUPERNUS PHARMS N201635 Aug. 16, 2013 RX CAPSULE, EXTENDED RELEASE ORAL 9622983 Nov. 16, 2027 USE OF TROKENDI XR FOR PROPHYLACTIC TREATMENT OF MIGRAINE
100MG TROKENDI XR SUPERNUS PHARMS N201635 Aug. 16, 2013 RX CAPSULE, EXTENDED RELEASE ORAL 9622983 Nov. 16, 2027 USE OF TROKENDI XR FOR THE TREATMENT OF EPILEPSY
200MG TROKENDI XR SUPERNUS PHARMS N201635 Aug. 16, 2013 RX CAPSULE, EXTENDED RELEASE ORAL 10314790 Nov. 16, 2027 USE OF TROKENDI XR FOR PROPHYLACTIC TREATMENT OF MIGRAINE
200MG TROKENDI XR SUPERNUS PHARMS N201635 Aug. 16, 2013 RX CAPSULE, EXTENDED RELEASE ORAL 10314790 Nov. 16, 2027 USE OF TROKENDI XR FOR THE TREATMENT OF EPILEPSY
200MG TROKENDI XR SUPERNUS PHARMS N201635 Aug. 16, 2013 RX CAPSULE, EXTENDED RELEASE ORAL 8298580 Nov. 16, 2027 TREATMENT OF EPILEPSY
200MG TROKENDI XR SUPERNUS PHARMS N201635 Aug. 16, 2013 RX CAPSULE, EXTENDED RELEASE ORAL 8298580 Nov. 16, 2027 USE OF TROKENDI XR FOR PROPHYLACTIC TREATMENT OF MIGRAINE
200MG TROKENDI XR SUPERNUS PHARMS N201635 Aug. 16, 2013 RX CAPSULE, EXTENDED RELEASE ORAL 8663683 Nov. 16, 2027 TREATMENT OF EPILEPSY
200MG TROKENDI XR SUPERNUS PHARMS N201635 Aug. 16, 2013 RX CAPSULE, EXTENDED RELEASE ORAL 8663683 Nov. 16, 2027 USE OF TROKENDI XR FOR PROPHYLACTIC TREATMENT OF MIGRAINE
200MG TROKENDI XR SUPERNUS PHARMS N201635 Aug. 16, 2013 RX CAPSULE, EXTENDED RELEASE ORAL 8877248 Nov. 16, 2027 TREATMENT OF EPILEPSY
200MG TROKENDI XR SUPERNUS PHARMS N201635 Aug. 16, 2013 RX CAPSULE, EXTENDED RELEASE ORAL 8877248 Nov. 16, 2027 USE OF TROKENDI XR FOR PROPHYLACTIC TREATMENT OF MIGRAINE
200MG TROKENDI XR SUPERNUS PHARMS N201635 Aug. 16, 2013 RX CAPSULE, EXTENDED RELEASE ORAL 8889191 Nov. 16, 2027 TREATMENT OF EPILEPSY
200MG TROKENDI XR SUPERNUS PHARMS N201635 Aug. 16, 2013 RX CAPSULE, EXTENDED RELEASE ORAL 8889191 Nov. 16, 2027 USE OF TROKENDI XR FOR PROPHYLACTIC TREATMENT OF MIGRAINE
200MG TROKENDI XR SUPERNUS PHARMS N201635 Aug. 16, 2013 RX CAPSULE, EXTENDED RELEASE ORAL 8992989 Nov. 16, 2027 USE OF TROKENDI XR FOR PROPHYLACTIC TREATMENT OF MIGRAINE
200MG TROKENDI XR SUPERNUS PHARMS N201635 Aug. 16, 2013 RX CAPSULE, EXTENDED RELEASE ORAL 8992989 Nov. 16, 2027 USE OF TROKENDI XR FOR THE TREATMENT OF EPILEPSY
200MG TROKENDI XR SUPERNUS PHARMS N201635 Aug. 16, 2013 RX CAPSULE, EXTENDED RELEASE ORAL 9549940 Nov. 16, 2027 USE OF TROKENDI XR FOR PROPHYLACTIC TREATMENT OF MIGRAINE
200MG TROKENDI XR SUPERNUS PHARMS N201635 Aug. 16, 2013 RX CAPSULE, EXTENDED RELEASE ORAL 9549940 Nov. 16, 2027 USE OF TROKENDI XR FOR THE TREATMENT OF EPILEPSY
200MG TROKENDI XR SUPERNUS PHARMS N201635 Aug. 16, 2013 RX CAPSULE, EXTENDED RELEASE ORAL 9555004 Nov. 16, 2027 USE OF TROKENDI XR FOR PROPHYLACTIC TREATMENT OF MIGRAINE
200MG TROKENDI XR SUPERNUS PHARMS N201635 Aug. 16, 2013 RX CAPSULE, EXTENDED RELEASE ORAL 9555004 Nov. 16, 2027 USE OF TROKENDI XR FOR THE TREATMENT OF EPILEPSY
200MG TROKENDI XR SUPERNUS PHARMS N201635 Aug. 16, 2013 RX CAPSULE, EXTENDED RELEASE ORAL 9622983 Nov. 16, 2027 USE OF TROKENDI XR FOR PROPHYLACTIC TREATMENT OF MIGRAINE
200MG TROKENDI XR SUPERNUS PHARMS N201635 Aug. 16, 2013 RX CAPSULE, EXTENDED RELEASE ORAL 9622983 Nov. 16, 2027 USE OF TROKENDI XR FOR THE TREATMENT OF EPILEPSY
25MG TROKENDI XR SUPERNUS PHARMS N201635 Aug. 16, 2013 RX CAPSULE, EXTENDED RELEASE ORAL 10314790 Nov. 16, 2027 USE OF TROKENDI XR FOR PROPHYLACTIC TREATMENT OF MIGRAINE
25MG TROKENDI XR SUPERNUS PHARMS N201635 Aug. 16, 2013 RX CAPSULE, EXTENDED RELEASE ORAL 10314790 Nov. 16, 2027 USE OF TROKENDI XR FOR THE TREATMENT OF EPILEPSY
25MG TROKENDI XR SUPERNUS PHARMS N201635 Aug. 16, 2013 RX CAPSULE, EXTENDED RELEASE ORAL 8298580 Nov. 16, 2027 TREATMENT OF EPILEPSY
25MG TROKENDI XR SUPERNUS PHARMS N201635 Aug. 16, 2013 RX CAPSULE, EXTENDED RELEASE ORAL 8298580 Nov. 16, 2027 USE OF TROKENDI XR FOR PROPHYLACTIC TREATMENT OF MIGRAINE
25MG TROKENDI XR SUPERNUS PHARMS N201635 Aug. 16, 2013 RX CAPSULE, EXTENDED RELEASE ORAL 8663683 Nov. 16, 2027 TREATMENT OF EPILEPSY
25MG TROKENDI XR SUPERNUS PHARMS N201635 Aug. 16, 2013 RX CAPSULE, EXTENDED RELEASE ORAL 8663683 Nov. 16, 2027 USE OF TROKENDI XR FOR PROPHYLACTIC TREATMENT OF MIGRAINE
25MG TROKENDI XR SUPERNUS PHARMS N201635 Aug. 16, 2013 RX CAPSULE, EXTENDED RELEASE ORAL 8877248 Nov. 16, 2027 TREATMENT OF EPILEPSY
25MG TROKENDI XR SUPERNUS PHARMS N201635 Aug. 16, 2013 RX CAPSULE, EXTENDED RELEASE ORAL 8877248 Nov. 16, 2027 USE OF TROKENDI XR FOR PROPHYLACTIC TREATMENT OF MIGRAINE
25MG TROKENDI XR SUPERNUS PHARMS N201635 Aug. 16, 2013 RX CAPSULE, EXTENDED RELEASE ORAL 8889191 Nov. 16, 2027 TREATMENT OF EPILEPSY
25MG TROKENDI XR SUPERNUS PHARMS N201635 Aug. 16, 2013 RX CAPSULE, EXTENDED RELEASE ORAL 8889191 Nov. 16, 2027 USE OF TROKENDI XR FOR PROPHYLACTIC TREATMENT OF MIGRAINE
25MG TROKENDI XR SUPERNUS PHARMS N201635 Aug. 16, 2013 RX CAPSULE, EXTENDED RELEASE ORAL 8992989 Nov. 16, 2027 USE OF TROKENDI XR FOR PROPHYLACTIC TREATMENT OF MIGRAINE
25MG TROKENDI XR SUPERNUS PHARMS N201635 Aug. 16, 2013 RX CAPSULE, EXTENDED RELEASE ORAL 8992989 Nov. 16, 2027 USE OF TROKENDI XR FOR THE TREATMENT OF EPILEPSY
25MG TROKENDI XR SUPERNUS PHARMS N201635 Aug. 16, 2013 RX CAPSULE, EXTENDED RELEASE ORAL 9549940 Nov. 16, 2027 USE OF TROKENDI XR FOR PROPHYLACTIC TREATMENT OF MIGRAINE
25MG TROKENDI XR SUPERNUS PHARMS N201635 Aug. 16, 2013 RX CAPSULE, EXTENDED RELEASE ORAL 9549940 Nov. 16, 2027 USE OF TROKENDI XR FOR THE TREATMENT OF EPILEPSY
25MG TROKENDI XR SUPERNUS PHARMS N201635 Aug. 16, 2013 RX CAPSULE, EXTENDED RELEASE ORAL 9555004 Nov. 16, 2027 USE OF TROKENDI XR FOR PROPHYLACTIC TREATMENT OF MIGRAINE
25MG TROKENDI XR SUPERNUS PHARMS N201635 Aug. 16, 2013 RX CAPSULE, EXTENDED RELEASE ORAL 9555004 Nov. 16, 2027 USE OF TROKENDI XR FOR THE TREATMENT OF EPILEPSY
25MG TROKENDI XR SUPERNUS PHARMS N201635 Aug. 16, 2013 RX CAPSULE, EXTENDED RELEASE ORAL 9622983 Nov. 16, 2027 USE OF TROKENDI XR FOR PROPHYLACTIC TREATMENT OF MIGRAINE
25MG TROKENDI XR SUPERNUS PHARMS N201635 Aug. 16, 2013 RX CAPSULE, EXTENDED RELEASE ORAL 9622983 Nov. 16, 2027 USE OF TROKENDI XR FOR THE TREATMENT OF EPILEPSY
50MG TROKENDI XR SUPERNUS PHARMS N201635 Aug. 16, 2013 RX CAPSULE, EXTENDED RELEASE ORAL 10314790 Nov. 16, 2027 USE OF TROKENDI XR FOR PROPHYLACTIC TREATMENT OF MIGRAINE
50MG TROKENDI XR SUPERNUS PHARMS N201635 Aug. 16, 2013 RX CAPSULE, EXTENDED RELEASE ORAL 10314790 Nov. 16, 2027 USE OF TROKENDI XR FOR THE TREATMENT OF EPILEPSY
50MG TROKENDI XR SUPERNUS PHARMS N201635 Aug. 16, 2013 RX CAPSULE, EXTENDED RELEASE ORAL 8298580 Nov. 16, 2027 TREATMENT OF EPILEPSY
50MG TROKENDI XR SUPERNUS PHARMS N201635 Aug. 16, 2013 RX CAPSULE, EXTENDED RELEASE ORAL 8298580 Nov. 16, 2027 USE OF TROKENDI XR FOR PROPHYLACTIC TREATMENT OF MIGRAINE
50MG TROKENDI XR SUPERNUS PHARMS N201635 Aug. 16, 2013 RX CAPSULE, EXTENDED RELEASE ORAL 8663683 Nov. 16, 2027 TREATMENT OF EPILEPSY
50MG TROKENDI XR SUPERNUS PHARMS N201635 Aug. 16, 2013 RX CAPSULE, EXTENDED RELEASE ORAL 8663683 Nov. 16, 2027 USE OF TROKENDI XR FOR PROPHYLACTIC TREATMENT OF MIGRAINE
50MG TROKENDI XR SUPERNUS PHARMS N201635 Aug. 16, 2013 RX CAPSULE, EXTENDED RELEASE ORAL 8877248 Nov. 16, 2027 TREATMENT OF EPILEPSY
50MG TROKENDI XR SUPERNUS PHARMS N201635 Aug. 16, 2013 RX CAPSULE, EXTENDED RELEASE ORAL 8877248 Nov. 16, 2027 USE OF TROKENDI XR FOR PROPHYLACTIC TREATMENT OF MIGRAINE
50MG TROKENDI XR SUPERNUS PHARMS N201635 Aug. 16, 2013 RX CAPSULE, EXTENDED RELEASE ORAL 8889191 Nov. 16, 2027 TREATMENT OF EPILEPSY
50MG TROKENDI XR SUPERNUS PHARMS N201635 Aug. 16, 2013 RX CAPSULE, EXTENDED RELEASE ORAL 8889191 Nov. 16, 2027 USE OF TROKENDI XR FOR PROPHYLACTIC TREATMENT OF MIGRAINE
50MG TROKENDI XR SUPERNUS PHARMS N201635 Aug. 16, 2013 RX CAPSULE, EXTENDED RELEASE ORAL 8992989 Nov. 16, 2027 USE OF TROKENDI XR FOR PROPHYLACTIC TREATMENT OF MIGRAINE
50MG TROKENDI XR SUPERNUS PHARMS N201635 Aug. 16, 2013 RX CAPSULE, EXTENDED RELEASE ORAL 8992989 Nov. 16, 2027 USE OF TROKENDI XR FOR THE TREATMENT OF EPILEPSY
50MG TROKENDI XR SUPERNUS PHARMS N201635 Aug. 16, 2013 RX CAPSULE, EXTENDED RELEASE ORAL 9549940 Nov. 16, 2027 USE OF TROKENDI XR FOR PROPHYLACTIC TREATMENT OF MIGRAINE
50MG TROKENDI XR SUPERNUS PHARMS N201635 Aug. 16, 2013 RX CAPSULE, EXTENDED RELEASE ORAL 9549940 Nov. 16, 2027 USE OF TROKENDI XR FOR THE TREATMENT OF EPILEPSY
50MG TROKENDI XR SUPERNUS PHARMS N201635 Aug. 16, 2013 RX CAPSULE, EXTENDED RELEASE ORAL 9555004 Nov. 16, 2027 USE OF TROKENDI XR FOR PROPHYLACTIC TREATMENT OF MIGRAINE
50MG TROKENDI XR SUPERNUS PHARMS N201635 Aug. 16, 2013 RX CAPSULE, EXTENDED RELEASE ORAL 9555004 Nov. 16, 2027 USE OF TROKENDI XR FOR THE TREATMENT OF EPILEPSY
50MG TROKENDI XR SUPERNUS PHARMS N201635 Aug. 16, 2013 RX CAPSULE, EXTENDED RELEASE ORAL 9622983 Nov. 16, 2027 USE OF TROKENDI XR FOR PROPHYLACTIC TREATMENT OF MIGRAINE
50MG TROKENDI XR SUPERNUS PHARMS N201635 Aug. 16, 2013 RX CAPSULE, EXTENDED RELEASE ORAL 9622983 Nov. 16, 2027 USE OF TROKENDI XR FOR THE TREATMENT OF EPILEPSY
100MG TROKENDI XR SUPERNUS PHARMS N201635 Aug. 16, 2013 RX CAPSULE, EXTENDED RELEASE ORAL 8298576 April 4, 2028 TREATMENT OF EPILEPSY
100MG TROKENDI XR SUPERNUS PHARMS N201635 Aug. 16, 2013 RX CAPSULE, EXTENDED RELEASE ORAL 8298576 April 4, 2028 USE OF TROKENDI XR FOR PROPHYLACTIC TREATMENT OF MIGRAINE
200MG TROKENDI XR SUPERNUS PHARMS N201635 Aug. 16, 2013 RX CAPSULE, EXTENDED RELEASE ORAL 8298576 April 4, 2028 TREATMENT OF EPILEPSY
200MG TROKENDI XR SUPERNUS PHARMS N201635 Aug. 16, 2013 RX CAPSULE, EXTENDED RELEASE ORAL 8298576 April 4, 2028 USE OF TROKENDI XR FOR PROPHYLACTIC TREATMENT OF MIGRAINE
25MG TROKENDI XR SUPERNUS PHARMS N201635 Aug. 16, 2013 RX CAPSULE, EXTENDED RELEASE ORAL 8298576 April 4, 2028 TREATMENT OF EPILEPSY
25MG TROKENDI XR SUPERNUS PHARMS N201635 Aug. 16, 2013 RX CAPSULE, EXTENDED RELEASE ORAL 8298576 April 4, 2028 USE OF TROKENDI XR FOR PROPHYLACTIC TREATMENT OF MIGRAINE
50MG TROKENDI XR SUPERNUS PHARMS N201635 Aug. 16, 2013 RX CAPSULE, EXTENDED RELEASE ORAL 8298576 April 4, 2028 TREATMENT OF EPILEPSY
50MG TROKENDI XR SUPERNUS PHARMS N201635 Aug. 16, 2013 RX CAPSULE, EXTENDED RELEASE ORAL 8298576 April 4, 2028 USE OF TROKENDI XR FOR PROPHYLACTIC TREATMENT OF MIGRAINE
EQ 11.25MG BASE;69MG QSYMIA VIVUS N022580 July 17, 2012 RX CAPSULE, EXTENDED RELEASE ORAL 8895057 June 9, 2028 FOR CHRONIC WEIGHT MANAGEMENT IN ADULTS WITH BMI >=30 KG/M2 OR BMI >=27 KG/M2 WITH A WEIGHT-RELATED COMORBIDITY, AND PATIENTS AGE 12-17 WITH BMI >=25 KG/M2 IN THE 95TH PERCENTILE OR GREATER (STANDARDIZED FOR AGE AND SEX)
EQ 11.25MG BASE;69MG QSYMIA VIVUS N022580 July 17, 2012 RX CAPSULE, EXTENDED RELEASE ORAL 9011906 June 9, 2028 FOR CHRONIC WEIGHT MANAGEMENT IN ADULTS WITH BMI >=30 KG/M2 OR BMI >=27 KG/M2 WITH A WEIGHT-RELATED COMORBIDITY, AND PATIENTS AGE 12-17 WITH BMI >=25 KG/M2 IN THE 95TH PERCENTILE OR GREATER (STANDARDIZED FOR AGE AND SEX)
EQ 15MG BASE;92MG QSYMIA VIVUS N022580 July 17, 2012 RX CAPSULE, EXTENDED RELEASE ORAL 8895057 June 9, 2028 FOR CHRONIC WEIGHT MANAGEMENT IN ADULTS WITH BMI >=30 KG/M2 OR BMI >=27 KG/M2 WITH A WEIGHT-RELATED COMORBIDITY, AND PATIENTS AGE 12-17 WITH BMI >=25 KG/M2 IN THE 95TH PERCENTILE OR GREATER (STANDARDIZED FOR AGE AND SEX)
EQ 15MG BASE;92MG QSYMIA VIVUS N022580 July 17, 2012 RX CAPSULE, EXTENDED RELEASE ORAL 9011906 June 9, 2028 FOR CHRONIC WEIGHT MANAGEMENT IN ADULTS WITH BMI >=30 KG/M2 OR BMI >=27 KG/M2 WITH A WEIGHT-RELATED COMORBIDITY, AND PATIENTS AGE 12-17 WITH BMI >=25 KG/M2 IN THE 95TH PERCENTILE OR GREATER (STANDARDIZED FOR AGE AND SEX)
EQ 3.75MG BASE;23MG QSYMIA VIVUS N022580 July 17, 2012 RX CAPSULE, EXTENDED RELEASE ORAL 8895057 June 9, 2028 FOR CHRONIC WEIGHT MANAGEMENT IN ADULTS WITH BMI >=30 KG/M2 OR BMI >=27 KG/M2 WITH A WEIGHT-RELATED COMORBIDITY, AND PATIENTS AGE 12-17 WITH BMI >=25 KG/M2 IN THE 95TH PERCENTILE OR GREATER (STANDARDIZED FOR AGE AND SEX)
EQ 3.75MG BASE;23MG QSYMIA VIVUS N022580 July 17, 2012 RX CAPSULE, EXTENDED RELEASE ORAL 9011906 June 9, 2028 FOR CHRONIC WEIGHT MANAGEMENT IN ADULTS WITH BMI >=30 KG/M2 OR BMI >=27 KG/M2 WITH A WEIGHT-RELATED COMORBIDITY, AND PATIENTS AGE 12-17 WITH BMI >=25 KG/M2 IN THE 95TH PERCENTILE OR GREATER (STANDARDIZED FOR AGE AND SEX)
EQ 7.5MG BASE;46MG QSYMIA VIVUS N022580 July 17, 2012 RX CAPSULE, EXTENDED RELEASE ORAL 8895057 June 9, 2028 FOR CHRONIC WEIGHT MANAGEMENT IN ADULTS WITH BMI >=30 KG/M2 OR BMI >=27 KG/M2 WITH A WEIGHT-RELATED COMORBIDITY, AND PATIENTS AGE 12-17 WITH BMI >=25 KG/M2 IN THE 95TH PERCENTILE OR GREATER (STANDARDIZED FOR AGE AND SEX)
EQ 7.5MG BASE;46MG QSYMIA VIVUS N022580 July 17, 2012 RX CAPSULE, EXTENDED RELEASE ORAL 9011906 June 9, 2028 FOR CHRONIC WEIGHT MANAGEMENT IN ADULTS WITH BMI >=30 KG/M2 OR BMI >=27 KG/M2 WITH A WEIGHT-RELATED COMORBIDITY, AND PATIENTS AGE 12-17 WITH BMI >=25 KG/M2 IN THE 95TH PERCENTILE OR GREATER (STANDARDIZED FOR AGE AND SEX)
EQ 11.25MG BASE;69MG QSYMIA VIVUS N022580 July 17, 2012 RX CAPSULE, EXTENDED RELEASE ORAL 8580299 June 14, 2029 FOR CHRONIC WEIGHT MANAGEMENT IN ADULTS WITH BMI >=30 KG/M2, AND PATIENTS AGE 12-17 WITH BMI >=30 KG/M2 AND IN THE 95TH PERCENTILE OR GREATER (STANDARDIZED FOR AGE AND SEX), EACH HAVING A WEIGHT-RELATED COMORBIDITY
EQ 15MG BASE;92MG QSYMIA VIVUS N022580 July 17, 2012 RX CAPSULE, EXTENDED RELEASE ORAL 8580299 June 14, 2029 FOR CHRONIC WEIGHT MANAGEMENT IN ADULTS WITH BMI >=30 KG/M2, AND PATIENTS AGE 12-17 WITH BMI >=30 KG/M2 AND IN THE 95TH PERCENTILE OR GREATER (STANDARDIZED FOR AGE AND SEX), EACH HAVING A WEIGHT-RELATED COMORBIDITY
EQ 3.75MG BASE;23MG QSYMIA VIVUS N022580 July 17, 2012 RX CAPSULE, EXTENDED RELEASE ORAL 8580299 June 14, 2029 FOR CHRONIC WEIGHT MANAGEMENT IN ADULTS WITH BMI >=30 KG/M2, AND PATIENTS AGE 12-17 WITH BMI >=30 KG/M2 AND IN THE 95TH PERCENTILE OR GREATER (STANDARDIZED FOR AGE AND SEX), EACH HAVING A WEIGHT-RELATED COMORBIDITY
EQ 7.5MG BASE;46MG QSYMIA VIVUS N022580 July 17, 2012 RX CAPSULE, EXTENDED RELEASE ORAL 8580299 June 14, 2029 FOR CHRONIC WEIGHT MANAGEMENT IN ADULTS WITH BMI >=30 KG/M2, AND PATIENTS AGE 12-17 WITH BMI >=30 KG/M2 AND IN THE 95TH PERCENTILE OR GREATER (STANDARDIZED FOR AGE AND SEX), EACH HAVING A WEIGHT-RELATED COMORBIDITY
100MG QUDEXY XR UPSHER SMITH LABS N205122 March 11, 2014 RX CAPSULE, EXTENDED RELEASE ORAL 10363224 March 19, 2033 TREATMENT OF SEIZURES
150MG QUDEXY XR UPSHER SMITH LABS N205122 March 11, 2014 RX CAPSULE, EXTENDED RELEASE ORAL 10363224 March 19, 2033 TREATMENT OF SEIZURES
200MG QUDEXY XR UPSHER SMITH LABS N205122 March 11, 2014 RX CAPSULE, EXTENDED RELEASE ORAL 10363224 March 19, 2033 TREATMENT OF SEIZURES
25MG QUDEXY XR UPSHER SMITH LABS N205122 March 11, 2014 RX CAPSULE, EXTENDED RELEASE ORAL 10363224 March 19, 2033 TREATMENT OF SEIZURES
50MG QUDEXY XR UPSHER SMITH LABS N205122 March 11, 2014 RX CAPSULE, EXTENDED RELEASE ORAL 10363224 March 19, 2033 TREATMENT OF SEIZURES
25MG/ML EPRONTIA AZURITY N214679 Nov. 5, 2021 RX SOLUTION ORAL 11433046 Aug. 21, 2040 INDICATED AS ADJUNCTIVE THERAPY FOR THE TREATMENT OF PARTIAL-ONSET SEIZURES, PRIMARY GENERALIZED TONIC-CLONIC SEIZURES, AND SEIZURES ASSOCIATED WITH LENNOX-GASTAUT SYNDROME IN PATIENTS 2 YEARS OF AGE AND OLDER
25MG/ML EPRONTIA AZURITY N214679 Nov. 5, 2021 RX SOLUTION ORAL 11433046 Aug. 21, 2040 INDICATED AS INITIAL MONOTHERAPY FOR THE TREATMENT OF PARTIAL-ONSET OR PRIMARY GENERALIZED TONIC-CLONIC SEIZURES IN PATIENTS 2 YEARS OF AGE AND OLDER
25MG/ML EPRONTIA AZURITY N214679 Nov. 5, 2021 RX SOLUTION ORAL 11433046 Aug. 21, 2040 INDICATED FOR THE PREVENTIVE TREATMENT OF MIGRAINE IN PATIENTS 12 YEARS AND OLDER

Orange Book exclusivity data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
EQ 11.25MG BASE;69MG QSYMIA VIVUS N022580 July 17, 2012 RX CAPSULE, EXTENDED RELEASE ORAL June 24, 2025 NEW PATIENT POPULATION
EQ 15MG BASE;92MG QSYMIA VIVUS N022580 July 17, 2012 RX CAPSULE, EXTENDED RELEASE ORAL June 24, 2025 NEW PATIENT POPULATION
EQ 3.75MG BASE;23MG QSYMIA VIVUS N022580 July 17, 2012 RX CAPSULE, EXTENDED RELEASE ORAL June 24, 2025 NEW PATIENT POPULATION
EQ 7.5MG BASE;46MG QSYMIA VIVUS N022580 July 17, 2012 RX CAPSULE, EXTENDED RELEASE ORAL June 24, 2025 NEW PATIENT POPULATION

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])		Mechanism
action		Bioact sourceMoA source
Carbonic anhydrase 4 Enzyme INHIBITOR Ki 5.31 CHEMBL CHEMBL
GABA-A receptor alpha-1/beta-2/gamma-2 Ion channel POSITIVE MODULATOR WOMBAT-PK CHEMBL
Carbonic anhydrase 2 Enzyme INHIBITOR Ki 8.30 CHEMBL CHEMBL
Glutamate receptor ionotropic kainate Ion channel ANTAGONIST CHEMBL CHEMBL
Glutamate receptor ionotropic AMPA Ion channel ANTAGONIST CHEMBL CHEMBL
Sodium channel protein type 1 subunit alpha Ion channel BLOCKER DRUGBANK CHEMBL
Sodium channel protein type 5 subunit alpha Ion channel BLOCKER WOMBAT-PK CHEMBL
Carbonic anhydrase 7 Enzyme Ki 9.06 CHEMBL
Carbonic anhydrase 6 Enzyme Ki 7.35 CHEMBL
Carbonic anhydrase 14 Enzyme Ki 5.84 CHEMBL
Carbonic anhydrase 13 Enzyme Ki 7.33 CHEMBL
Carbonic anhydrase V Enzyme Ki 7.60 CHEMBL
Nuclear receptor subfamily 1 group I member 2 Nuclear hormone receptor WOMBAT-PK
Carbonic anhydrase 1 Enzyme Ki 6.60 CHEMBL
Carbonic anhydrase 9 Enzyme Ki 7.24 CHEMBL
Carbonic anhydrase 12 Enzyme Ki 8.42 CHEMBL
Carbonic anhydrase 5A, mitochondrial Enzyme Kd 7.60 CHEMBL
Carbonic anhydrase 5B, mitochondrial Enzyme Ki 7.52 CHEMBL
Carbonic anhydrase Enzyme Ki 6.76 CHEMBL
Carbonic anhydrase 13 Enzyme Ki 7.33 CHEMBL
Carbonic anhydrase 4 Enzyme Ki 7.27 CHEMBL
Sodium channel protein type 2 subunit alpha Ion channel IC50 4.01 CHEMBL
Carbonic anhydrase 2 Enzyme IC50 5.85 CHEMBL
Carbonic anhydrase Enzyme Ki 6.92 CHEMBL
Carbonic anhydrase Enzyme Ki 4.63 CHEMBL
Carbonic anhydrase 15 Enzyme Ki 7.11 CHEMBL
Carbonic anhydrase Enzyme Ki 6.96 CHEMBL
Carbonic anhydrase Enzyme Ki 8 CHEMBL
Probable transmembrane carbonic anhydrase (Carbonate dehydratase) (Carbonic dehydratase); Transmembrane carbonic anhydrase Enzyme Ki 5.52 CHEMBL
Carbonic anhydrase Enzyme Ki 6.96 CHEMBL
Alpha carbonic anhydrase Enzyme Ki 7.54 CHEMBL
Carbonic anhydrase Enzyme Ki 6.44 CHEMBL
Carbonic anhydrase 2 Enzyme Ki 6.43 CHEMBL
Astrosclerin-3 Enzyme Ki 7.42 CHEMBL
Beta-carbonic anhydrase 1 Enzyme Ki 6.21 CHEMBL
Delta carbonic anhydrase Unclassified Ki 6.41 CHEMBL
Carbonic anhydrase 2 Enzyme Ki 6.32 CHEMBL
Carbonic anhydrase, alpha family Unclassified Ki 6.11 CHEMBL
Carbonate dehydratase Enzyme Ki 8.18 CHEMBL

External reference:

IDSource
4021026 VUID
N0000148493 NUI
D00537 KEGG_DRUG
4021026 VANDF
C0076829 UMLSCUI
CHEBI:63631 CHEBI
TOR PDB_CHEM_ID
CHEMBL220492 ChEMBL_ID
DB00273 DRUGBANK_ID
D000077236 MESH_DESCRIPTOR_UI
5284627 PUBCHEM_CID
6849 IUPHAR_LIGAND_ID
6099 INN_ID
0H73WJJ391 UNII
220343 RXNORM
162273 MMSL
5601 MMSL
6438 MMSL
d04115 MMSL
005453 NDDF
108400009 SNOMEDCT_US
386844006 SNOMEDCT_US

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Topiramate HUMAN PRESCRIPTION DRUG LABEL 1 0093-7335 CAPSULE, COATED PELLETS 15 mg ORAL ANDA 29 sections
Topiramate HUMAN PRESCRIPTION DRUG LABEL 1 0093-7335 CAPSULE, COATED PELLETS 15 mg ORAL ANDA 29 sections
Topiramate HUMAN PRESCRIPTION DRUG LABEL 1 0093-7336 CAPSULE, COATED PELLETS 25 mg ORAL ANDA 29 sections
Topiramate HUMAN PRESCRIPTION DRUG LABEL 1 0093-7336 CAPSULE, COATED PELLETS 25 mg ORAL ANDA 29 sections
QUDEXY XR HUMAN PRESCRIPTION DRUG LABEL 1 0245-1071 CAPSULE, EXTENDED RELEASE 25 mg ORAL NDA 30 sections
QUDEXY XR HUMAN PRESCRIPTION DRUG LABEL 1 0245-1071 CAPSULE, EXTENDED RELEASE 25 mg ORAL NDA 30 sections
QUDEXY XR HUMAN PRESCRIPTION DRUG LABEL 1 0245-1072 CAPSULE, EXTENDED RELEASE 50 mg ORAL NDA 30 sections
QUDEXY XR HUMAN PRESCRIPTION DRUG LABEL 1 0245-1072 CAPSULE, EXTENDED RELEASE 50 mg ORAL NDA 30 sections
QUDEXY XR HUMAN PRESCRIPTION DRUG LABEL 1 0245-1073 CAPSULE, EXTENDED RELEASE 200 mg ORAL NDA 30 sections
QUDEXY XR HUMAN PRESCRIPTION DRUG LABEL 1 0245-1073 CAPSULE, EXTENDED RELEASE 200 mg ORAL NDA 30 sections
QUDEXY XR HUMAN PRESCRIPTION DRUG LABEL 1 0245-1074 CAPSULE, EXTENDED RELEASE 100 mg ORAL NDA 30 sections
QUDEXY XR HUMAN PRESCRIPTION DRUG LABEL 1 0245-1074 CAPSULE, EXTENDED RELEASE 100 mg ORAL NDA 30 sections
QUDEXY XR HUMAN PRESCRIPTION DRUG LABEL 1 0245-1075 CAPSULE, EXTENDED RELEASE 150 mg ORAL NDA 30 sections
QUDEXY XR HUMAN PRESCRIPTION DRUG LABEL 1 0245-1075 CAPSULE, EXTENDED RELEASE 150 mg ORAL NDA 30 sections
Topiramate HUMAN PRESCRIPTION DRUG LABEL 1 0480-2356 CAPSULE, EXTENDED RELEASE 25 mg ORAL ANDA 27 sections
Topiramate HUMAN PRESCRIPTION DRUG LABEL 1 0480-2357 CAPSULE, EXTENDED RELEASE 50 mg ORAL ANDA 27 sections
Topiramate HUMAN PRESCRIPTION DRUG LABEL 1 0480-2358 CAPSULE, EXTENDED RELEASE 100 mg ORAL ANDA 27 sections
Topiramate HUMAN PRESCRIPTION DRUG LABEL 1 0480-2359 CAPSULE, EXTENDED RELEASE 200 mg ORAL ANDA 27 sections
Topiramate HUMAN PRESCRIPTION DRUG LABEL 1 0615-7562 TABLET, FILM COATED 25 mg ORAL ANDA 28 sections
Topiramate HUMAN PRESCRIPTION DRUG LABEL 1 0615-7563 TABLET, FILM COATED 50 mg ORAL ANDA 28 sections
Topiramate HUMAN PRESCRIPTION DRUG LABEL 1 0615-7564 TABLET, FILM COATED 100 mg ORAL ANDA 28 sections
Topiramate HUMAN PRESCRIPTION DRUG LABEL 1 0615-7565 TABLET, FILM COATED 200 mg ORAL ANDA 28 sections
Topiramate HUMAN PRESCRIPTION DRUG LABEL 1 0615-8138 TABLET, FILM COATED 25 mg ORAL ANDA 28 sections
Topiramate HUMAN PRESCRIPTION DRUG LABEL 1 0615-8138 TABLET, FILM COATED 25 mg ORAL ANDA 28 sections
Topiramate HUMAN PRESCRIPTION DRUG LABEL 1 0615-8139 TABLET, FILM COATED 50 mg ORAL ANDA 28 sections
Topiramate HUMAN PRESCRIPTION DRUG LABEL 1 0615-8139 TABLET, FILM COATED 50 mg ORAL ANDA 28 sections
Topiramate HUMAN PRESCRIPTION DRUG LABEL 1 0615-8140 TABLET, FILM COATED 100 mg ORAL ANDA 28 sections
Topiramate HUMAN PRESCRIPTION DRUG LABEL 1 0615-8140 TABLET, FILM COATED 100 mg ORAL ANDA 28 sections
Topiramate HUMAN PRESCRIPTION DRUG LABEL 1 0832-1071 CAPSULE, EXTENDED RELEASE 25 mg ORAL NDA authorized generic 32 sections
Topiramate HUMAN PRESCRIPTION DRUG LABEL 1 0832-1071 CAPSULE, EXTENDED RELEASE 25 mg ORAL NDA authorized generic 32 sections