topiramate ๐Ÿถ 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 ยตM/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 1128.08 10.31 326 94683 1708 50508407
Seizure 1063.54 10.31 1205 93804 116669 50393446
Migraine 600.26 10.31 723 94286 74557 50435558
Myopia 447.95 10.31 150 94859 1363 50508752
Product substitution issue 441.47 10.31 294 94715 13763 50496352
Completed suicide 382.71 10.31 796 94213 131093 50379022
Choroidal effusion 363.14 10.31 97 94912 357 50509758
Visual perseveration 315.59 10.31 62 94947 13 50510102
Renal tubular acidosis 304.61 10.31 113 94896 1421 50508694
Intentional self-injury 302.70 10.31 289 94720 22823 50487292
Suicidal ideation 254.22 10.31 408 94601 54977 50455138
Status epilepticus 246.12 10.31 203 94806 13203 50496912
Intentional overdose 227.02 10.31 415 94594 62089 50448026
Joint swelling 224.31 10.31 90 94919 245196 50264919
Multiple-drug resistance 212.24 10.31 110 94899 3204 50506911
Pemphigus 209.91 10.31 3 95006 120163 50389952
Depression 209.69 10.31 735 94274 164688 50345427
Epilepsy 208.45 10.31 229 94780 21338 50488777
Abortion spontaneous 196.16 10.31 311 94698 41461 50468654
Paraesthesia 187.11 10.31 573 94436 119670 50390445
Generalised tonic-clonic seizure 182.68 10.31 236 94773 26074 50484041
Synovitis 182.31 10.31 13 94996 123852 50386263
Drug ineffective for unapproved indication 176.92 10.31 209 94800 21072 50489043
Metabolic acidosis 176.73 10.31 285 94724 38540 50471575
Somnolence 174.71 10.31 663 94346 154322 50355793
Nephrolithiasis 166.62 10.31 261 94748 34432 50475683
Hand deformity 161.62 10.31 6 95003 100193 50409922
Exposure during pregnancy 161.34 10.31 547 94462 120468 50389647
Memory impairment 160.51 10.31 416 94593 78944 50431171
Toxicity to various agents 158.52 10.31 803 94206 211696 50298419
Hyperammonaemic encephalopathy 150.41 10.31 74 94935 1925 50508190
Overdose 150.23 10.31 470 94539 99257 50410858
Contraindicated product administered 149.13 10.31 47 94962 148911 50361204
Petit mal epilepsy 146.72 10.31 86 94923 3203 50506912
Glossodynia 142.56 10.31 23 94986 115546 50394569
Infusion related reaction 138.15 10.31 73 94936 169484 50340631
Rheumatoid arthritis 135.47 10.31 109 94900 202441 50307674
Disturbance in attention 135.25 10.31 224 94785 30962 50479153
Arthropathy 134.63 10.31 64 94945 157842 50352273
Choroidal detachment 134.16 10.31 37 94972 158 50509957
Anaemia 131.19 10.31 169 94840 252287 50257828
Wound 130.61 10.31 21 94988 105773 50404342
Psychotic disorder 130.53 10.31 182 94827 21630 50488485
Irritability 128.44 10.31 208 94801 28218 50481897
Abdominal discomfort 123.53 10.31 152 94857 231489 50278626
Myokymia 121.44 10.31 23 94986 0 50510115
Aggression 120.15 10.31 172 94837 20944 50489171
Cognitive disorder 114.71 10.31 255 94754 43868 50466247
Flat anterior chamber of eye 110.18 10.31 25 94984 35 50510080
Febrile neutropenia 108.68 10.31 25 94984 97642 50412473
Pericarditis 108.26 10.31 11 94998 78678 50431437
Acute myopia 104.83 10.31 26 94983 65 50510050
Acute kidney injury 104.30 10.31 167 94842 227891 50282224
Suicide attempt 102.32 10.31 269 94740 51463 50458652
Headache 102.26 10.31 1422 93587 505113 50005002
Acidosis hyperchloraemic 102 10.31 34 94975 304 50509811
Blindness 98.74 10.31 141 94868 17128 50492987
Drug interaction 97.41 10.31 675 94334 198946 50311169
Systemic lupus erythematosus 97.36 10.31 73 94936 140549 50369566
Swelling 96.72 10.31 142 94867 200730 50309385
Lower respiratory tract infection 95.31 10.31 30 94979 95171 50414944
Pneumonia 94.51 10.31 378 94631 378023 50132092
Anorexia nervosa 94.24 10.31 28 94981 164 50509951
Vision blurred 93.95 10.31 343 94666 78304 50431811
Arthralgia 93.49 10.31 465 94544 438237 50071878
Ciliary body disorder 92.30 10.31 19 94990 10 50510105
Anxiety 91.67 10.31 609 94400 176997 50333118
Focal dyscognitive seizures 90.26 10.31 59 94950 2673 50507442
Medication overuse headache 87.88 10.31 36 94973 599 50509516
Intraocular pressure increased 87.86 10.31 77 94932 5439 50504676
Malignant neoplasm progression 87.58 10.31 12 94997 68112 50442003
Infection 87.49 10.31 118 94891 172836 50337279
Aphasia 82.45 10.31 172 94837 28322 50481793
Peripheral swelling 81.39 10.31 165 94844 205771 50304344
Pyrexia 79.79 10.31 405 94604 379798 50130317
Paradoxical drug reaction 79.27 10.31 61 94948 3586 50506529
Blepharospasm 79.15 10.31 56 94953 2892 50507223
Myoclonic epilepsy 79.09 10.31 38 94971 937 50509178
Rash 78.82 10.31 490 94519 436981 50073134
General physical health deterioration 78.49 10.31 91 94918 142343 50367772
Cerebral venous thrombosis 78.43 10.31 47 94962 1824 50508291
Tremor 77.79 10.31 423 94586 114480 50395635
Weight decreased 77.49 10.31 693 94316 220552 50289563
Abnormal behaviour 77.04 10.31 135 94874 19523 50490592
Drug ineffective 76.94 10.31 2045 92964 817288 49692827
Helicobacter infection 73.72 10.31 5 95004 49697 50460418
Diplopia 72.55 10.31 130 94879 19130 50490985
Multiple sclerosis relapse 71.69 10.31 210 94799 42754 50467361
Cardiac failure congestive 70.66 10.31 35 94974 84347 50425768
Diarrhoea 70.58 10.31 736 94273 587740 49922375
Atrial fibrillation 70.17 10.31 53 94956 101692 50408423
Dyspnoea 69.33 10.31 676 94333 546932 49963183
Drug resistance 68.77 10.31 126 94883 18863 50491252
Therapeutic response unexpected 68.57 10.31 114 94895 15801 50494314
Stomatitis 68.36 10.31 54 94955 101290 50408825
Amnesia 66.19 10.31 202 94807 42058 50468057
Haemoglobin decreased 66.15 10.31 85 94924 127131 50382984
Maculopathy 66.12 10.31 43 94966 1931 50508184
Product use in unapproved indication 65.77 10.31 407 94602 115412 50394703
Hypoaesthesia 64.78 10.31 435 94574 126822 50383293
Disease progression 64.76 10.31 51 94958 95815 50414300
Multiple sclerosis 64.38 10.31 128 94881 20365 50489750
Corneal oedema 63.80 10.31 37 94972 1350 50508765
Hyperammonaemia 63.59 10.31 60 94949 4664 50505451
Discomfort 63.27 10.31 66 94943 108314 50401801
Sluggishness 63.16 10.31 58 94951 4355 50505760
Nasopharyngitis 63.06 10.31 171 94838 192756 50317359
Thrombocytopenia 62.64 10.31 89 94920 127584 50382531
Pancytopenia 61.59 10.31 41 94968 83989 50426126
Speech disorder 61.47 10.31 176 94833 35372 50474743
Coma blister 60.69 10.31 19 94990 136 50509979
Neovascularisation 60.24 10.31 32 94977 981 50509134
Impaired healing 59.87 10.31 28 94981 69758 50440357
Pleural effusion 59.35 10.31 40 94969 81414 50428701
Bipolar disorder 58.88 10.31 68 94941 6689 50503426
Infantile spasms 58.74 10.31 20 94989 192 50509923
Self-induced vomiting 58.50 10.31 12 94997 6 50510109
Aura 58.46 10.31 31 94978 947 50509168
Hypocitraturia 58.08 10.31 11 94998 0 50510115
Anhidrosis 57.44 10.31 17 94992 98 50510017
Necrotising colitis 57.28 10.31 25 94984 490 50509625
Muscle injury 57.26 10.31 3 95006 37108 50473007
Blister 56.99 10.31 46 94963 85372 50424743
Propofol infusion syndrome 56.57 10.31 28 94981 738 50509377
Neutropenia 56.36 10.31 121 94888 147844 50362271
Cardiac failure 55.86 10.31 37 94972 76003 50434112
Amenorrhoea 55.61 10.31 74 94935 8410 50501705
Mitochondrial DNA mutation 55.51 10.31 20 94989 230 50509885
Bradyphrenia 55.44 10.31 63 94946 6089 50504026
Muscle twitching 55.38 10.31 102 94907 15329 50494786
Partial seizures 54.69 10.31 56 94953 4809 50505306
Mucosal inflammation 54.21 10.31 6 95003 40136 50469979
Drug withdrawal convulsions 54.17 10.31 33 94976 1320 50508795
Crying 53.05 10.31 118 94891 20298 50489817
Dysarthria 51.47 10.31 171 94838 37232 50472883
Eye pain 51.28 10.31 143 94866 28306 50481809
Hypersensitivity 51.06 10.31 219 94790 214942 50295173
Withdrawal syndrome 50.67 10.31 106 94903 17484 50492631
Photophobia 50.43 10.31 96 94913 14791 50495324
Dizziness 50.22 10.31 921 94088 345448 50164667
Alexia 50.18 10.31 10 94999 3 50510112
Product physical issue 48.95 10.31 50 94959 4282 50505833
Slow speech 48.10 10.31 30 94979 1252 50508863
C-reactive protein increased 47.95 10.31 33 94976 66441 50443674
Hallucination, auditory 47.77 10.31 78 94931 10650 50499465
Benign familial pemphigus 47.52 10.31 9 95000 0 50510115
Visual acuity reduced 47.46 10.31 112 94897 20027 50490088
Sleep disorder due to general medical condition, insomnia type 47.12 10.31 3 95006 31444 50478671
Intentional product misuse 46.94 10.31 193 94816 46541 50463574
Visual field defect 46.77 10.31 56 94953 5723 50504392
Mania 46.76 10.31 78 94931 10838 50499277
Cough 46.63 10.31 264 94745 241000 50269115
Road traffic accident 46.48 10.31 125 94884 24227 50485888
Hyponatraemia 46.18 10.31 68 94941 96071 50414044
Drug abuse 45.77 10.31 228 94781 59618 50450497
Sepsis 45.56 10.31 115 94894 132810 50377305
Blood creatinine increased 44.87 10.31 46 94963 76114 50434001
Oligomenorrhoea 44.71 10.31 23 94986 659 50509456
Mood altered 44.05 10.31 83 94926 12690 50497425
Hepatic enzyme increased 43.94 10.31 123 94886 137257 50372858
Iridocyclitis 43.94 10.31 34 94975 2015 50508100
Salivary gland calculus 43.87 10.31 15 94994 146 50509969
Blindness transient 43.34 10.31 41 94968 3197 50506918
Ammonia increased 42.65 10.31 46 94963 4195 50505920
Visual impairment 42.62 10.31 246 94763 68029 50442086
Gastrointestinal haemorrhage 42.39 10.31 45 94964 73276 50436839
Bezoar 41.84 10.31 28 94981 1320 50508795
Interstitial lung disease 41.66 10.31 24 94985 53152 50456963
Musculoskeletal stiffness 41.11 10.31 115 94894 128366 50381749
Tonic convulsion 41.09 10.31 26 94983 1113 50509002
Renal impairment 40.94 10.31 49 94960 75612 50434503
Iris adhesions 40.33 10.31 17 94992 305 50509810
Suicidal behaviour 40.05 10.31 34 94975 2300 50507815
Sedation 38.65 10.31 136 94873 30474 50479641
Feeling abnormal 38.32 10.31 382 94627 125110 50385005
Atonic seizures 38.29 10.31 20 94989 592 50509523
Weight increased 38.17 10.31 561 94448 201330 50308785
Major depression 37.59 10.31 55 94954 6829 50503286
Nephrocalcinosis 37.07 10.31 23 94986 951 50509164
Death 36.81 10.31 412 94597 324967 50185148
Mood swings 36.81 10.31 88 94921 15866 50494249
Renal failure 36.73 10.31 92 94917 106541 50403574
Paranoia 36.63 10.31 68 94941 10280 50499835
Libido increased 36.62 10.31 25 94984 1218 50508897
Dysphemia 36.34 10.31 32 94977 2274 50507841
Change in seizure presentation 36.00 10.31 15 94994 261 50509854
Respiratory arrest 35.91 10.31 131 94878 29878 50480237
Angiofibroma 35.83 10.31 12 94997 109 50510006
Anticonvulsant drug level decreased 35.57 10.31 24 94985 1147 50508968
Hypophosphataemic osteomalacia 35.44 10.31 13 94996 158 50509957
Alice in wonderland syndrome 35.34 10.31 9 95000 26 50510089
Pruritus 35.34 10.31 351 94658 283217 50226898
Sudden unexplained death in epilepsy 35.14 10.31 15 94994 278 50509837
Plasma cell myeloma 34.86 10.31 8 95001 31314 50478801
Osteonecrosis of jaw 34.85 10.31 9 95000 32517 50477598
Knee arthroplasty 34.63 10.31 12 94997 35834 50474281
Simple partial seizures 34.58 10.31 18 94991 529 50509586
Phonophobia 34.37 10.31 15 94994 294 50509821
Ataxia 33.94 10.31 78 94931 13708 50496407
Somnambulism 33.90 10.31 44 94965 4880 50505235
Affective disorder 33.66 10.31 45 94964 5136 50504979
Blood bicarbonate decreased 33.64 10.31 33 94976 2692 50507423
Blood prolactin increased 33.63 10.31 35 94974 3064 50507051
Bulimia nervosa 33.43 10.31 16 94993 391 50509724
Hip arthroplasty 33.42 10.31 8 95001 30421 50479694
Myocardial infarction 32.90 10.31 74 94935 88953 50421162
Hostility 32.73 10.31 27 94982 1755 50508360
Cervix neoplasm 32.60 10.31 13 94996 201 50509914
Tardive dyskinesia 32.51 10.31 53 94956 7226 50502889
Anger 32.30 10.31 68 94941 11265 50498850
Pre-existing condition improved 32.14 10.31 52 94957 7045 50503070
Thalamic infarction 32.01 10.31 16 94993 431 50509684
Alopecia 31.93 10.31 300 94709 244747 50265368
Electroencephalogram abnormal 31.81 10.31 36 94973 3463 50506652
Agitation 31.79 10.31 190 94819 53194 50456921
Status migrainosus 31.73 10.31 11 94998 112 50510003
Ciliary muscle spasm 31.68 10.31 6 95003 0 50510115
Mental disorder 31.56 10.31 102 94907 21889 50488226
Gene mutation 31.50 10.31 23 94986 1248 50508867
Fanconi syndrome 31.47 10.31 22 94987 1114 50509001
Drug withdrawal syndrome 31.29 10.31 111 94898 24970 50485145
Nystagmus 31.19 10.31 45 94964 5516 50504599
Cholecystitis chronic 31.10 10.31 61 94948 9608 50500507
Ill-defined disorder 31.08 10.31 34 94975 54620 50455495
Bone marrow failure 30.86 10.31 7 95002 27617 50482498
Hyperkalaemia 30.71 10.31 27 94982 48062 50462053
Brugada syndrome 30.27 10.31 14 94995 316 50509799
Respiratory alkalosis 30.16 10.31 30 94979 2489 50507626
Apathy 29.78 10.31 52 94957 7496 50502619
Heat stroke 29.17 10.31 17 94992 626 50509489
Septic shock 28.88 10.31 39 94970 57136 50452979
Dysgeusia 28.86 10.31 147 94862 38769 50471346
Migraine with aura 28.82 10.31 28 94981 2257 50507858
Vertigo 28.67 10.31 181 94828 51651 50458464
Granulomatous dermatitis 28.49 10.31 10 94999 106 50510009
Therapeutic product effect decreased 28.39 10.31 145 94864 135905 50374210
Galactorrhoea 28.38 10.31 35 94974 3688 50506427
Central nervous system lesion 28.29 10.31 58 94951 9431 50500684
Hypomagnesaemia 27.67 10.31 5 95004 23151 50486964
Apnoea 27.50 10.31 48 94961 6918 50503197
Concussion 26.84 10.31 50 94959 7578 50502537
Granuloma annulare 26.77 10.31 15 94994 512 50509603
Erythema 26.77 10.31 163 94846 146251 50363864
Blood gases abnormal 26.65 10.31 16 94993 623 50509492
Hypersomnia 26.64 10.31 76 94933 15238 50494877
Hyposthenuria 26.40 10.31 5 95004 0 50510115
Lichen planus 26.38 10.31 25 94984 1954 50508161
Blood pressure systolic increased 26.37 10.31 17 94992 35432 50474683
Retinogram abnormal 26.31 10.31 10 94999 135 50509980
Acute myocardial infarction 26.27 10.31 11 94998 29262 50480853
Pseudomyopia 26.22 10.31 8 95001 52 50510063
Cardiac malposition 26.22 10.31 8 95001 52 50510063
Skin ulcer 26.18 10.31 17 94992 35301 50474814
Neoplasm progression 26.10 10.31 11 94998 29146 50480969
Melaena 25.93 10.31 9 95000 26855 50483260
Migraine without aura 25.70 10.31 12 94997 277 50509838
Vestibular migraine 25.66 10.31 11 94998 206 50509909
Psychomotor hyperactivity 25.57 10.31 55 94954 9246 50500869
Depressed mood 25.57 10.31 129 94880 33894 50476221
Serotonin syndrome 25.56 10.31 103 94906 24610 50485505
Angiomyolipoma 25.47 10.31 11 94998 210 50509905
Tearfulness 25.46 10.31 33 94976 3654 50506461
Heart rate 25.35 10.31 8 95001 59 50510056
Retinitis pigmentosa 25.34 10.31 9 95000 99 50510016
Hyperthermia 25.29 10.31 49 94960 7647 50502468
Post-traumatic neck syndrome 25.21 10.31 24 94985 1886 50508229
Therapeutic response changed 25.13 10.31 17 94992 816 50509299
Gastrointestinal disorder 25.00 10.31 92 94917 94364 50415751
Necrotising enterocolitis neonatal 25.00 10.31 10 94999 156 50509959
Lymphangioleiomyomatosis 25.00 10.31 10 94999 156 50509959
Red blood cell sedimentation rate increased 24.92 10.31 12 94997 29404 50480711
Anoxia 24.91 10.31 11 94998 222 50509893
Dehydration 24.70 10.31 176 94833 152273 50357842
Productive cough 24.59 10.31 38 94971 52656 50457459
Persistent left superior vena cava 24.48 10.31 7 95002 35 50510080
Anticonvulsant drug level above therapeutic 24.44 10.31 14 94995 499 50509616
Cellulitis 24.44 10.31 61 94948 70737 50439378
Myoclonus 24.39 10.31 71 94938 14399 50495716
Eye movement disorder 24.36 10.31 36 94973 4509 50505606
Drug screen positive 24.36 10.31 31 94978 3371 50506744
Iris disorder 24.36 10.31 8 95001 68 50510047
Screaming 24.33 10.31 29 94980 2949 50507166
Amino acid level increased 24.25 10.31 12 94997 316 50509799
Soft tissue injury 24.21 10.31 21 94988 1463 50508652
C-reactive protein abnormal 24.09 10.31 11 94998 27798 50482317
Conjunctival oedema 24.00 10.31 15 94994 628 50509487
Pulmonary fibrosis 23.91 10.31 8 95001 24429 50485686
Coronary artery disease 23.88 10.31 13 94996 29713 50480402
Hypervolaemia 23.84 10.31 9 95000 25490 50484625
Wrong patient received product 23.66 10.31 22 94987 1678 50508437
Macular detachment 23.48 10.31 8 95001 77 50510038
Frontal lobe epilepsy 23.47 10.31 5 95004 4 50510111
Intellectual disability 23.47 10.31 16 94993 778 50509337
Insomnia 23.21 10.31 459 94550 174406 50335709
Emotional distress 23.20 10.31 111 94898 28552 50481563
Lennox-Gastaut syndrome 23.09 10.31 11 94998 266 50509849
Borderline personality disorder 23.07 10.31 15 94994 673 50509442
Ascites 23.06 10.31 20 94989 35841 50474274
Extrapyramidal disorder 23.05 10.31 61 94948 11709 50498406
Psychogenic seizure 23.01 10.31 21 94988 1564 50508551
Disorientation 22.89 10.31 129 94880 35355 50474760
Biliary dyskinesia 22.78 10.31 26 94983 2524 50507591
Panic attack 22.77 10.31 84 94925 19258 50490857
Nightmare 22.53 10.31 74 94935 16012 50494103
Sternal fracture 22.42 10.31 23 94986 1979 50508136
Platelet count decreased 22.37 10.31 105 94904 100621 50409494
Fluid retention 22.25 10.31 38 94971 50611 50459504
Lung disorder 22.18 10.31 31 94978 44768 50465347
Hypohidrosis 22.07 10.31 6 95003 24 50510091
Application site discolouration 21.90 10.31 15 94994 735 50509380
Coma 21.85 10.31 182 94827 56697 50453418
Acquired haemophilia 21.61 10.31 16 94993 887 50509228
Anomalous pulmonary venous connection 21.47 10.31 7 95002 58 50510057
Tinnitus 21.37 10.31 107 94902 28025 50482090
Thinking abnormal 21.24 10.31 52 94957 9515 50500600
Mental impairment 21.17 10.31 60 94949 11984 50498131
Decreased interest 21.12 10.31 27 94982 2949 50507166
Open angle glaucoma 21.10 10.31 10 94999 239 50509876
Blood pressure measurement 21.10 10.31 10 94999 239 50509876
Hypopyon 21.01 10.31 14 94995 655 50509460
Wheezing 21.00 10.31 54 94955 61993 50448122
Calculus urinary 20.92 10.31 16 94993 932 50509183
Convulsive threshold lowered 20.80 10.31 11 94998 334 50509781
Papilloedema 20.80 10.31 29 94980 3444 50506671
Metastases to liver 20.72 10.31 6 95003 20098 50490017
Off label use 20.60 10.31 1088 93921 473338 50036777
Small for dates baby 20.60 10.31 29 94980 3476 50506639
Self-injurious ideation 20.38 10.31 23 94986 2206 50507909
Lymphomatoid papulosis 20.34 10.31 8 95001 119 50509996
Brain oedema 20.18 10.31 60 94949 12310 50497805
Personality disorder 20.01 10.31 32 94977 4292 50505823
Ureterolithiasis 19.95 10.31 20 94989 1675 50508440
Homicidal ideation 19.88 10.31 20 94989 1682 50508433
Hypertension 19.52 10.31 279 94730 210924 50299191
Oedema peripheral 19.45 10.31 196 94813 157765 50352350
Cardio-respiratory arrest 19.42 10.31 170 94839 53722 50456393
Idiopathic intracranial hypertension 19.40 10.31 23 94986 2326 50507789
Pregnancy 19.39 10.31 108 94901 29469 50480646
Drug dependence 19.36 10.31 81 94928 19678 50490437
Hypoxia 19.28 10.31 42 94967 51081 50459034
Blastocystis infection 19.25 10.31 5 95004 16 50510099
Eating disorder 19.05 10.31 68 94941 15341 50494774
Affect lability 19.02 10.31 48 94961 8950 50501165
Arthritis 18.90 10.31 91 94918 86630 50423485
Pulmonary hypertension 18.77 10.31 21 94988 33396 50476719
Osteoarthritis 18.70 10.31 66 94943 68540 50441575
Inappropriate affect 18.65 10.31 14 94995 793 50509322
Occipital neuralgia 18.64 10.31 10 94999 313 50509802
Malaise 18.50 10.31 484 94525 335048 50175067
Blood chloride increased 18.34 10.31 23 94986 2465 50507650
Plasmodium falciparum infection 18.20 10.31 5 95004 21 50510094
Oedema 18.15 10.31 69 94940 70112 50440003
Acidosis 18.03 10.31 51 94958 10176 50499939
Disseminated intravascular coagulation 17.87 10.31 5 95004 17130 50492985
Temperature intolerance 17.84 10.31 42 94967 7497 50502618
Product quality issue 17.84 10.31 109 94900 30749 50479366
Pulmonary oedema 17.81 10.31 41 94968 48897 50461218
Dyspnoea exertional 17.79 10.31 44 94965 51189 50458926
Product counterfeit 17.69 10.31 7 95002 106 50510009
Cleft lip 17.69 10.31 7 95002 106 50510009
Pulmonary arterial hypertension 17.66 10.31 8 95001 20311 50489804
Basal cell carcinoma 17.64 10.31 11 94998 23345 50486770
Cleft lip and palate 17.54 10.31 10 94999 353 50509762
Anticonvulsant drug level increased 17.53 10.31 17 94992 1367 50508748
Neuropathy peripheral 17.53 10.31 108 94901 96649 50413466
Osmotic demyelination syndrome 17.52 10.31 12 94997 588 50509527
Gallbladder disorder 17.49 10.31 70 94939 16672 50493443
Injury 17.45 10.31 154 94855 48771 50461344
Metastases to bone 17.42 10.31 6 95003 17989 50492126
Benzodiazepine drug level increased 17.36 10.31 8 95001 179 50509936
Product administered to patient of inappropriate age 17.33 10.31 23 94986 2607 50507508
Stillbirth 17.29 10.31 36 94973 5916 50504199
Urine calcium/creatinine ratio increased 17.28 10.31 7 95002 113 50510002
Retinal detachment 17.28 10.31 33 94976 5096 50505019
Fatigue 17.18 10.31 1122 93887 706479 49803636
Blood thyroid stimulating hormone normal 17.11 10.31 7 95002 116 50509999
Loss of consciousness 17.03 10.31 283 94726 104070 50406045
Rectal haemorrhage 16.87 10.31 29 94980 38529 50471586
Dystonia 16.82 10.31 55 94954 11871 50498244
Hypotonia 16.79 10.31 43 94966 8091 50502024
Respiratory disorder neonatal 16.75 10.31 14 94995 927 50509188
Congenital diaphragmatic eventration 16.74 10.31 4 95005 8 50510107
Ovarian germ cell cancer stage II 16.73 10.31 5 95004 30 50510085
Carbon dioxide decreased 16.70 10.31 19 94990 1838 50508277
Nodular rash 16.66 10.31 8 95001 197 50509918
Tension headache 16.65 10.31 23 94986 2708 50507407
Hyporesponsive to stimuli 16.61 10.31 14 94995 938 50509177
Laryngeal stenosis 16.60 10.31 13 94996 784 50509331
Hypopnoea 16.59 10.31 21 94988 2272 50507843
Epistaxis 16.46 10.31 63 94946 63891 50446224
Lethargy 16.31 10.31 153 94856 49279 50460836
Posterior reversible encephalopathy syndrome 16.24 10.31 4 95005 14924 50495191
Congenital mitral valve incompetence 16.19 10.31 5 95004 34 50510081
Post-traumatic stress disorder 16.15 10.31 29 94980 4274 50505841
Narcolepsy 16.12 10.31 15 94994 1145 50508970
Failed induction of labour 16.09 10.31 9 95000 306 50509809
Endometriosis 15.98 10.31 28 94981 4047 50506068
Myelosuppression 15.97 10.31 3 95006 13514 50496601
Mydriasis 15.89 10.31 50 94959 10577 50499538
Blunted affect 15.85 10.31 8 95001 220 50509895
Hydrocele 15.84 10.31 3 95006 0 50510115
Pneumocystis jirovecii pneumonia 15.82 10.31 4 95005 14659 50495456
Partial seizures with secondary generalisation 15.81 10.31 9 95000 317 50509798
Pain 15.77 10.31 908 94101 577995 49932120
Depressed level of consciousness 15.77 10.31 158 94851 51795 50458320
Gambling disorder 15.76 10.31 15 94994 1179 50508936
Central obesity 15.74 10.31 14 94995 1008 50509107
Self esteem decreased 15.72 10.31 11 94998 558 50509557
Toxic epidermal necrolysis 15.70 10.31 10 94999 20982 50489133
Balance disorder 15.69 10.31 202 94807 70388 50439727
Lactic acidosis 15.61 10.31 24 94985 33331 50476784
Snoring 15.60 10.31 25 94984 3359 50506756
Congenital anomaly in offspring 15.38 10.31 7 95002 152 50509963
Cholestasis 15.35 10.31 15 94994 25386 50484729
Therapeutic product effective for unapproved indication 15.33 10.31 6 95003 88 50510027
Fear 15.33 10.31 61 94948 14488 50495627
Osteonecrosis 15.17 10.31 12 94997 22505 50487610
Psychomotor skills impaired 15.08 10.31 19 94990 2045 50508070
Drug level decreased 15.03 10.31 36 94973 6497 50503618
Herpes zoster 15.01 10.31 75 94934 70711 50439404
Visual snow syndrome 14.92 10.31 4 95005 15 50510100
Cerebral venous sinus thrombosis 14.89 10.31 17 94992 1651 50508464
Narrow anterior chamber angle 14.87 10.31 5 95004 46 50510069
Bipolar II disorder 14.86 10.31 8 95001 252 50509863
Optic neuritis 14.82 10.31 37 94972 6853 50503262
Potassium wasting nephropathy 14.78 10.31 5 95004 47 50510068
Intracranial hypotension 14.75 10.31 8 95001 256 50509859
Hallucination, visual 14.73 10.31 66 94943 16516 50493599
Inflammation 14.68 10.31 56 94953 56856 50453259
Acute myeloid leukaemia 14.64 10.31 5 95004 15069 50495046
Enuresis 14.62 10.31 19 94990 2110 50508005
Mobility decreased 14.60 10.31 89 94920 79859 50430256
Hallucinations, mixed 14.57 10.31 27 94982 4076 50506039
Neonatal seizure 14.48 10.31 9 95000 373 50509742
Dropped head syndrome 14.47 10.31 6 95003 103 50510012
Obsessive thoughts 14.44 10.31 10 94999 499 50509616
Drug level increased 14.44 10.31 73 94936 19195 50490920
Asthenia 14.38 10.31 473 94536 318569 50191546
Myocarditis 14.37 10.31 40 94969 7907 50502208
Ischaemic cerebral infarction 14.30 10.31 14 94995 1139 50508976
Cytomegalovirus infection 14.22 10.31 8 95001 17954 50492161
Night blindness 14.19 10.31 9 95000 387 50509728
Cerebral vasoconstriction 14.12 10.31 13 94996 979 50509136
Neutrophil count decreased 14.12 10.31 42 94967 45984 50464131
Uveitis 14.10 10.31 44 94965 9266 50500849
Magnetic resonance imaging head abnormal 14.02 10.31 17 94992 1760 50508355
Blood pressure diastolic decreased 13.98 10.31 7 95002 16774 50493341
Photopsia 13.96 10.31 26 94983 3940 50506175
Poisoning 13.82 10.31 53 94956 12376 50497739
Pregnancy with implant contraceptive 13.81 10.31 18 94991 2005 50508110
Hip fracture 13.80 10.31 17 94992 25914 50484201
Hyperventilation 13.75 10.31 31 94978 5378 50504737
Gastrointestinal mucosal exfoliation 13.73 10.31 6 95003 118 50509997
Full blood count decreased 13.73 10.31 13 94996 22333 50487782
Blood lactate dehydrogenase increased 13.72 10.31 10 94999 19552 50490563
Illogical thinking 13.69 10.31 5 95004 60 50510055
Near drowning 13.67 10.31 4 95005 22 50510093
Hereditary angioedema 13.63 10.31 31 94978 5411 50504704
Ejection fraction decreased 13.61 10.31 9 95000 18511 50491604
Atrial septal defect 13.59 10.31 34 94975 6307 50503808
Diverticulitis 13.59 10.31 26 94983 33156 50476959
Slow response to stimuli 13.58 10.31 12 94997 857 50509258
Familial periodic paralysis 13.54 10.31 5 95004 62 50510053
Self-medication 13.48 10.31 19 94990 2280 50507835
Product dispensing error 13.45 10.31 42 94967 8849 50501266
Pulmonary eosinophilia 13.44 10.31 7 95002 206 50509909
Conjunctival hyperaemia 13.40 10.31 18 94991 2064 50508051
Delusion 13.38 10.31 47 94962 10522 50499593
Creatinine renal clearance decreased 13.29 10.31 3 95006 11878 50498237
Breast cancer 13.26 10.31 39 94970 42851 50467264
Seizure cluster 13.17 10.31 7 95002 215 50509900
Bone pain 13.16 10.31 45 94964 47184 50462931
Poor quality sleep 13.13 10.31 64 94945 16582 50493533
Crystal urine present 13.12 10.31 15 94994 1459 50508656
Pneumonitis 13.09 10.31 22 94987 29488 50480627
White blood cell count decreased 13.08 10.31 148 94861 116574 50393541
Housebound 13.05 10.31 7 95002 219 50509896
Glycosuria 13.04 10.31 13 94996 1081 50509034
Suspiciousness 13.04 10.31 8 95001 324 50509791
Hemiparesis 13.00 10.31 73 94936 19975 50490140
Sleep apnoea syndrome 12.98 10.31 83 94926 23785 50486330
Developmental hip dysplasia 12.98 10.31 14 94995 1277 50508838
Personality change 12.87 10.31 31 94978 5614 50504501
High-pitched crying 12.85 10.31 4 95005 28 50510087
Stress 12.84 10.31 156 94853 53637 50456478
Dysmorphism 12.84 10.31 18 94991 2149 50507966
Psychomotor retardation 12.78 10.31 23 94986 3395 50506720
Impaired driving ability 12.75 10.31 25 94984 3936 50506179
Hyperaldosteronism 12.71 10.31 7 95002 231 50509884
Coordination abnormal 12.67 10.31 49 94960 11485 50498630
Application site erythema 12.66 10.31 27 94982 4511 50505604
Pregnancy on oral contraceptive 12.57 10.31 12 94997 946 50509169
Cleft palate 12.52 10.31 12 94997 951 50509164
Cerebellar infarction 12.48 10.31 16 94993 1753 50508362
Complex regional pain syndrome 12.48 10.31 17 94992 1976 50508139
Middle insomnia 12.45 10.31 44 94965 9877 50500238
Bursitis 12.33 10.31 14 94995 22121 50487994
Disinhibition 12.29 10.31 11 94998 799 50509316
Toxic skin eruption 12.27 10.31 3 95006 11248 50498867
Spinal fracture 12.23 10.31 7 95002 15566 50494549
Lack of spontaneous speech 12.16 10.31 6 95003 157 50509958
Sputum discoloured 12.07 10.31 5 95004 13390 50496725
Educational problem 12.07 10.31 8 95001 371 50509744
Blood lactic acid increased 12.02 10.31 30 94979 5555 50504560
Tri-iodothyronine free abnormal 11.88 10.31 4 95005 37 50510078
Cluster headache 11.74 10.31 9 95000 526 50509589
Congenital floppy infant 11.70 10.31 3 95006 9 50510106
Parasomnia 11.64 10.31 8 95001 394 50509721
Dysstasia 11.63 10.31 65 94944 17754 50492361
Femur fracture 11.63 10.31 34 94975 37430 50472685
Myelodysplastic syndrome 11.61 10.31 7 95002 15125 50494990
Exophthalmos 11.60 10.31 13 94996 1237 50508878
Impulsive behaviour 11.59 10.31 14 94995 1444 50508671
Behaviour disorder 11.55 10.31 18 94991 2362 50507753
Blood bilirubin increased 11.53 10.31 27 94982 32011 50478104
Staring 11.46 10.31 14 94995 1460 50508655
Retinal disorder 11.44 10.31 14 94995 1463 50508652
Muscle contractions involuntary 11.44 10.31 16 94993 1906 50508209
International normalised ratio increased 11.43 10.31 42 94967 43110 50467005
Basilar migraine 11.43 10.31 4 95005 42 50510073
Heart rate decreased 11.42 10.31 33 94976 36464 50473651
Haemoptysis 11.40 10.31 19 94990 25554 50484561
Localised infection 11.30 10.31 19 94990 25466 50484649
Enlarged uvula 11.29 10.31 6 95003 184 50509931
Lack of injection site rotation 11.27 10.31 7 95002 290 50509825
Congenital hand malformation 11.27 10.31 7 95002 290 50509825
Gallbladder cholesterolosis 11.22 10.31 10 94999 722 50509393
Psychotic behaviour 11.19 10.31 9 95000 564 50509551
Tenosynovitis 11.17 10.31 3 95006 10562 50499553
Granulocytopenia 11.16 10.31 28 94981 5203 50504912
Vascular malformation 11.14 10.31 7 95002 296 50509819
Congenital anomaly 11.11 10.31 14 94995 1507 50508608
Urinary tract infection 11.08 10.31 328 94681 223692 50286423
Restless legs syndrome 11.06 10.31 59 94950 15838 50494277
Delayed sleep phase 11.03 10.31 3 95006 12 50510103
Vertebral osteophyte 10.97 10.31 7 95002 304 50509811
Pleural rub 10.95 10.31 4 95005 48 50510067
Leukopenia 10.91 10.31 78 94931 67450 50442665
Bed rest 10.88 10.31 4 95005 49 50510066
Altered visual depth perception 10.87 10.31 7 95002 309 50509806
Coma acidotic 10.85 10.31 5 95004 112 50510003
Presyncope 10.77 10.31 18 94991 24180 50485935
Lung neoplasm malignant 10.75 10.31 8 95001 15476 50494639
Hypercalcaemia 10.74 10.31 17 94992 23335 50486780
Application site burn 10.72 10.31 10 94999 766 50509349
Body temperature decreased 10.72 10.31 9 95000 16386 50493729
Social avoidant behaviour 10.69 10.31 19 94990 2778 50507337
Therapeutic product ineffective for unapproved indication 10.68 10.31 6 95003 206 50509909
Chorioretinal folds 10.66 10.31 3 95006 14 50510101
Red blood cell sedimentation rate abnormal 10.65 10.31 9 95000 16334 50493781
Tongue ulceration 10.60 10.31 20 94989 3060 50507055
Threatened labour 10.60 10.31 10 94999 777 50509338
Conversion disorder 10.58 10.31 14 94995 1582 50508533
Taste disorder 10.52 10.31 37 94972 8287 50501828
Gingival hypertrophy 10.52 10.31 13 94996 1373 50508742
Exposure via breast milk 10.50 10.31 14 94995 1594 50508521
Social fear 10.49 10.31 3 95006 15 50510100
Dextrocardia 10.49 10.31 3 95006 15 50510100
CSF oligoclonal band present 10.49 10.31 5 95004 121 50509994
Decreased nasolabial fold 10.49 10.31 3 95006 15 50510100
Drug effect less than expected 10.49 10.31 8 95001 464 50509651
Sialoadenitis 10.41 10.31 13 94996 1387 50508728
Dissociative disorder 10.34 10.31 6 95003 219 50509896
Depersonalisation/derealisation disorder 10.34 10.31 12 94997 1186 50508929
Automatism 10.33 10.31 4 95005 57 50510058

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 955.98 12.69 786 30344 92337 29451060
Status epilepticus 307.14 12.69 172 30958 10622 29532775
Angle closure glaucoma 278.30 12.69 79 31051 746 29542651
Drug ineffective 269.63 12.69 914 30216 362256 29181141
Heat stroke 244.47 12.69 73 31057 836 29542561
Aggression 200.64 12.69 216 30914 35325 29508072
Sedation 181.89 12.69 149 30981 17256 29526141
Multiple-drug resistance 179.84 12.69 86 31044 3814 29539583
Nephrolithiasis 179.38 12.69 174 30956 25160 29518237
Somnolence 174.75 12.69 336 30794 93619 29449778
Hyperammonaemia 171.35 12.69 94 31036 5569 29537828
Myopia 153.13 12.69 52 31078 924 29542473
Generalised tonic-clonic seizure 138.37 12.69 133 30997 19006 29524391
Ataxia 129.35 12.69 105 31025 11998 29531399
Epilepsy 129.32 12.69 126 31004 18306 29525091
Product substitution issue 125.17 12.69 92 31038 9080 29534317
Migraine 122.74 12.69 103 31027 12327 29531070
Foetal exposure during pregnancy 122.21 12.69 164 30966 33703 29509694
Cognitive disorder 115.65 12.69 133 30997 23366 29520031
Hyperammonaemic encephalopathy 113.95 12.69 51 31079 1939 29541458
Choroidal effusion 111.46 12.69 27 31103 126 29543271
Hypospadias 102.48 12.69 54 31076 2948 29540449
Petit mal epilepsy 95.87 12.69 50 31080 2672 29540725
Anaemia 89.83 12.69 50 31080 200901 29342496
Partial seizures 89.25 12.69 54 31076 3849 29539548
Anhidrosis 89.11 12.69 21 31109 85 29543312
Dyspnoea 86.24 12.69 132 30998 326600 29216797
Myokymia 81.41 12.69 19 31111 73 29543324
Drug resistance 78.73 12.69 105 31025 21435 29521962
Sudden unexplained death in epilepsy 78.29 12.69 26 31104 430 29542967
Febrile neutropenia 76.63 12.69 13 31117 112227 29431170
Abnormal behaviour 72.93 12.69 105 31025 23022 29520375
Ammonia increased 72.72 12.69 48 31082 3983 29539414
Death 72.59 12.69 158 30972 341926 29201471
Focal dyscognitive seizures 71.55 12.69 32 31098 1214 29542183
Memory impairment 70.80 12.69 133 30997 36337 29507060
Completed suicide 68.67 12.69 230 30900 90016 29453381
Disturbance in attention 68.62 12.69 98 31032 21326 29522071
Flat anterior chamber of eye 67.37 12.69 15 31115 44 29543353
Suicidal ideation 66.64 12.69 126 31004 34590 29508807
Intentional self-injury 65.49 12.69 73 31057 12388 29531009
Psychotic disorder 65.04 12.69 93 31037 20261 29523136
Acute kidney injury 62.64 12.69 115 31015 265152 29278245
Pneumonia 61.38 12.69 156 30974 320016 29223381
Speech disorder 60.32 12.69 97 31033 23419 29519978
Diarrhoea 59.33 12.69 168 30962 332530 29210867
Acidosis hyperchloraemic 59.12 12.69 20 31110 351 29543046
Hyperthermia 57.92 12.69 60 31070 9370 29534027
Renal tubular acidosis 54.73 12.69 30 31100 1773 29541624
Drug ineffective for unapproved indication 54.57 12.69 71 31059 14143 29529254
Atrial fibrillation 52.08 12.69 23 31107 105623 29437774
Toxicity to various agents 51.71 12.69 336 30794 173325 29370072
Encephalopathy 51.50 12.69 106 31024 30937 29512460
Infantile spasms 50.04 12.69 15 31115 174 29543223
Malignant neoplasm progression 49.41 12.69 9 31121 73850 29469547
Maculopathy 49.28 12.69 22 31108 831 29542566
Myoclonus 48.81 12.69 65 31065 13244 29530153
Irritability 48.32 12.69 85 31045 22067 29521330
Developmental delay 47.90 12.69 31 31099 2487 29540910
Myoclonic epilepsy 46.47 12.69 22 31108 953 29542444
Interstitial lung disease 45.92 12.69 4 31126 57714 29485683
Cleft lip 45.82 12.69 16 31114 310 29543087
Organic brain syndrome 45.28 12.69 15 31115 246 29543151
Cardiac failure congestive 43.96 12.69 13 31117 76568 29466829
Failure to suspend medication 42.94 12.69 16 31114 376 29543021
Drug withdrawal convulsions 42.82 12.69 22 31108 1139 29542258
Autonomic nervous system imbalance 42.15 12.69 28 31102 2348 29541049
Delusion of replacement 41.92 12.69 12 31118 117 29543280
Nystagmus 41.07 12.69 35 31095 4274 29539123
Intensive care unit acquired weakness 41.06 12.69 20 31110 923 29542474
Metabolic acidosis 40.97 12.69 109 31021 37553 29505844
Angular cheilitis 38.93 12.69 12 31118 154 29543243
Hyperchloraemia 38.21 12.69 15 31115 408 29542989
Agitation 37.42 12.69 129 31001 51175 29492222
Multiple drug therapy 36.65 12.69 14 31116 353 29543044
Erectile dysfunction 36.59 12.69 67 31063 17942 29525455
Dysmorphism 36.52 12.69 28 31102 2943 29540454
Intentional overdose 36.47 12.69 106 31024 38422 29504975
Exposure during pregnancy 36.43 12.69 45 31085 8509 29534888
Fanconi syndrome 36.25 12.69 22 31108 1576 29541821
Nightmare 36.22 12.69 52 31078 11365 29532032
Drug level fluctuating 36.16 12.69 15 31115 472 29542925
Lethargy 36.16 12.69 104 31026 37476 29505921
Small for dates baby 36.02 12.69 30 31100 3549 29539848
Nasal septum disorder 36.00 12.69 9 31121 49 29543348
Priapism 35.88 12.69 33 31097 4455 29538942
Anticonvulsant drug level increased 35.37 12.69 21 31109 1445 29541952
Drug interaction 35.02 12.69 339 30791 197046 29346351
Blood homocysteine increased 34.88 12.69 12 31118 222 29543175
Atrial septal defect 34.35 12.69 39 31091 6750 29536647
Hallucination, auditory 33.87 12.69 46 31084 9547 29533850
Bradyphrenia 33.72 12.69 31 31099 4183 29539214
Vitamin D deficiency 33.63 12.69 35 31095 5494 29537903
Congenital hand malformation 33.61 12.69 15 31115 566 29542831
Cardiac failure 33.54 12.69 21 31109 79266 29464131
Mood altered 33.47 12.69 42 31088 8069 29535328
Bladder hypertrophy 33.08 12.69 15 31115 588 29542809
Patient dissatisfaction with treatment 33.02 12.69 9 31121 72 29543325
Urge incontinence 32.41 12.69 14 31116 488 29542909
Hypothermia 32.16 12.69 44 31086 9195 29534202
Intellectual disability 31.99 12.69 18 31112 1119 29542278
Depressed mood 31.92 12.69 60 31070 16388 29527009
Pyrexia 31.54 12.69 176 30954 287446 29255951
Tremor 31.54 12.69 157 30973 73381 29470016
Non-24-hour sleep-wake disorder 31.32 12.69 7 31123 21 29543376
Cleft lip and palate 31.11 12.69 12 31118 311 29543086
Hypotension 31.06 12.69 103 31027 194251 29349146
Affective disorder 31.04 12.69 26 31104 3100 29540297
Pleural effusion 30.48 12.69 19 31111 71889 29471508
Product administered to patient of inappropriate age 30.41 12.69 24 31106 2631 29540766
Haemoglobin decreased 30.19 12.69 42 31088 108333 29435064
Partial seizures with secondary generalisation 30.12 12.69 11 31119 244 29543153
Microcephaly 29.96 12.69 15 31115 735 29542662
Psychogenic seizure 29.91 12.69 12 31118 346 29543051
Tonic convulsion 29.59 12.69 16 31114 920 29542477
Dissociation 29.42 12.69 17 31113 1112 29542285
Rhinolithiasis 29.29 12.69 5 31125 0 29543397
Vision blurred 29.27 12.69 101 31029 40075 29503322
Hyperexplexia 29.20 12.69 7 31123 31 29543366
Ehlers-Danlos syndrome 28.50 12.69 7 31123 35 29543362
Therapeutic response unexpected 28.37 12.69 40 31090 8598 29534799
Social avoidant behaviour 28.25 12.69 24 31106 2918 29540479
Psychomotor skills impaired 28.24 12.69 23 31107 2638 29540759
Abdominal pain 28.17 12.69 63 31067 135294 29408103
Ascites 27.91 12.69 3 31127 36616 29506781
Renal failure 27.38 12.69 52 31078 118547 29424850
Slow speech 27.14 12.69 15 31115 901 29542496
Optic atrophy 26.63 12.69 14 31116 760 29542637
Pancytopenia 26.56 12.69 29 31101 83139 29460258
Cough 26.35 12.69 59 31071 126668 29416729
Staring 26.29 12.69 17 31113 1362 29542035
Renal colic 26.28 12.69 18 31112 1587 29541810
Persecutory delusion 25.92 12.69 20 31110 2121 29541276
Arthralgia 25.89 12.69 69 31061 139548 29403849
Myocardial infarction 25.78 12.69 48 31082 110248 29433149
Perseveration 25.72 12.69 8 31122 106 29543291
Acid-base balance disorder mixed 25.68 12.69 7 31123 56 29543341
Atonic seizures 25.56 12.69 9 31121 179 29543218
Coagulation disorder neonatal 25.52 12.69 6 31124 24 29543373
Depression 25.42 12.69 165 30965 84982 29458415
Therapeutic product effect incomplete 25.39 12.69 95 31035 39210 29504187
Low birth weight baby 25.35 12.69 33 31097 6575 29536822
Premature baby 25.19 12.69 56 31074 17224 29526173
Neonatal respiratory depression 25.00 12.69 11 31119 401 29542996
Platelet count decreased 24.95 12.69 45 31085 104627 29438770
Gait disturbance 24.95 12.69 147 30983 73202 29470195
Tooth discolouration 24.87 12.69 10 31120 290 29543107
General physical health deterioration 24.72 12.69 44 31086 102813 29440584
Madarosis 24.67 12.69 9 31121 199 29543198
Retinal disorder 24.65 12.69 14 31116 886 29542511
Dry mouth 24.65 12.69 64 31066 21720 29521677
Disease progression 24.60 12.69 30 31100 81886 29461511
Asthenia 24.50 12.69 130 31000 215120 29328277
Bicuspid aortic valve 24.21 12.69 9 31121 210 29543187
Off label use 24.05 12.69 447 30683 300353 29243044
Gastrointestinal haemorrhage 24.02 12.69 29 31101 79504 29463893
Behaviour disorder 24.01 12.69 24 31106 3592 29539805
Accidental death 23.95 12.69 19 31111 2099 29541298
Hypoxia 23.83 12.69 10 31120 47369 29496028
Pseudomyopia 23.43 12.69 4 31126 0 29543397
Product use in unapproved indication 23.33 12.69 164 30966 86711 29456686
Plagiocephaly 22.92 12.69 11 31119 491 29542906
Sepsis 22.51 12.69 76 31054 142606 29400791
Head discomfort 22.42 12.69 22 31108 3220 29540177
Retinal vein occlusion 22.40 12.69 16 31114 1509 29541888
Hippocampal sclerosis 22.35 12.69 7 31123 95 29543302
Hyperthermia malignant 22.33 12.69 17 31113 1767 29541630
Electroencephalogram abnormal 22.32 12.69 19 31111 2316 29541081
Phonophobia 22.31 12.69 8 31122 168 29543229
Overdose 22.21 12.69 152 30978 79667 29463730
Headache 22.15 12.69 280 30850 173727 29369670
Psychomotor retardation 22.09 12.69 21 31109 2955 29540442
Haemoptysis 22.05 12.69 3 31127 30547 29512850
Neuromyopathy 22.01 12.69 13 31117 886 29542511
Tic 21.91 12.69 17 31113 1818 29541579
Aorticopulmonary septal defect 21.90 12.69 5 31125 17 29543380
Insomnia 21.79 12.69 164 30966 88597 29454800
Tonic clonic movements 21.54 12.69 13 31117 922 29542475
Retinogram abnormal 21.41 12.69 7 31123 110 29543287
Hypohidrosis 21.35 12.69 8 31122 191 29543206
Mental disorder 21.31 12.69 44 31086 12861 29530536
Urticaria 21.09 12.69 16 31114 54644 29488753
Infusion related reaction 20.91 12.69 10 31120 43876 29499521
Necrotising enterocolitis neonatal 20.90 12.69 8 31122 203 29543194
Ultrasound liver abnormal 20.74 12.69 7 31123 122 29543275
Medication error 20.68 12.69 59 31071 21152 29522245
Disorientation 20.46 12.69 73 31057 29442 29513955
Product use issue 20.07 12.69 107 31023 51337 29492060
Blood creatinine increased 19.91 12.69 37 31093 85065 29458332
Hypotonia 19.82 12.69 30 31100 6872 29536525
Change in seizure presentation 19.61 12.69 6 31124 75 29543322
Bradykinesia 19.50 12.69 21 31109 3426 29539971
Ischaemic gastritis 19.39 12.69 4 31126 7 29543390
Paranoia 19.12 12.69 36 31094 9841 29533556
Muscle twitching 19.07 12.69 32 31098 7994 29535403
Anger 19.02 12.69 38 31092 10852 29532545
Hyperkalaemia 18.95 12.69 22 31108 61370 29482027
Hypercapnic coma 18.73 12.69 7 31123 166 29543231
Multiple sclerosis 18.65 12.69 26 31104 5528 29537869
Suicide attempt 18.45 12.69 78 31052 34032 29509365
Hypermetropia 18.44 12.69 9 31121 417 29542980
Paraesthesia 18.35 12.69 108 31022 53737 29489660
Thinking abnormal 18.32 12.69 25 31105 5211 29538186
Lower respiratory tract infection 18.22 12.69 3 31127 26499 29516898
Necrotising colitis 18.17 12.69 12 31118 996 29542401
Haematuria traumatic 18.12 12.69 7 31123 182 29543215
Distractibility 18.12 12.69 8 31122 294 29543103
Condition aggravated 18.01 12.69 234 30896 146061 29397336
Suspiciousness 18.00 12.69 8 31122 299 29543098
Chronic kidney disease 17.81 12.69 8 31122 36408 29506989
Initial insomnia 17.66 12.69 18 31112 2757 29540640
Renal impairment 17.61 12.69 37 31093 81296 29462101
Teratogenicity 17.53 12.69 5 31125 48 29543349
Cerebrovascular accident 17.50 12.69 34 31096 76877 29466520
Maternal drugs affecting foetus 17.42 12.69 21 31109 3872 29539525
Depressed level of consciousness 17.36 12.69 81 31049 36861 29506536
Angioedema 17.27 12.69 6 31124 31909 29511488
Lip oedema 17.22 12.69 16 31114 2188 29541209
Speech disorder developmental 17.18 12.69 15 31115 1892 29541505
Seizure cluster 17.10 12.69 6 31124 118 29543279
Premature ejaculation 17.01 12.69 6 31124 120 29543277
Cryptorchism 16.94 12.69 15 31115 1927 29541470
Pre-existing condition improved 16.92 12.69 16 31114 2237 29541160
Suspected suicide 16.88 12.69 21 31109 3999 29539398
Plasma cell myeloma 16.87 12.69 9 31121 37106 29506291
Weight increased 16.79 12.69 138 30992 76529 29466868
Wrong patient received product 16.75 12.69 16 31114 2266 29541131
Chills 16.67 12.69 31 31099 71269 29472128
Abdominal pain upper 16.61 12.69 24 31106 60969 29482428
Body height below normal 16.56 12.69 7 31123 231 29543166
Respiratory failure 16.52 12.69 50 31080 97081 29446316
Oxygen saturation decreased 16.27 12.69 14 31116 44923 29498474
Malaise 16.19 12.69 100 31030 159502 29383895
Pyloric stenosis 16.18 12.69 10 31120 740 29542657
Joint swelling 16.18 12.69 17 31113 49613 29493784
Hypertelorism 16.14 12.69 9 31121 550 29542847
Mental impairment 16.08 12.69 32 31098 9109 29534288
Anterior chamber disorder 16.02 12.69 5 31125 67 29543330
Talipes 15.95 12.69 14 31116 1778 29541619
Hallucination, visual 15.86 12.69 43 31087 14972 29528425
Chest discomfort 15.85 12.69 15 31115 45968 29497429
Neonatal hypotension 15.76 12.69 6 31124 150 29543247
Somnambulism 15.75 12.69 17 31113 2781 29540616
Photophobia 15.73 12.69 25 31105 5970 29537427
Periventricular haemorrhage neonatal 15.67 12.69 4 31126 24 29543373
Pneumonitis 15.65 12.69 5 31125 28039 29515358
Psychiatric symptom 15.61 12.69 18 31112 3166 29540231
Therapy partial responder 15.50 12.69 23 31107 5176 29538221
Ganglioglioma 15.50 12.69 3 31127 3 29543394
Angina pectoris 15.48 12.69 5 31125 27845 29515552
Sleep-related eating disorder 15.33 12.69 7 31123 279 29543118
Developmental hip dysplasia 15.21 12.69 7 31123 284 29543113
Apathy 15.20 12.69 25 31105 6146 29537251
Hand fracture 15.14 12.69 13 31117 1604 29541793
Hyperglycinaemia 15.04 12.69 3 31127 4 29543393
Delusion 14.85 12.69 35 31095 11181 29532216
Congenital arterial malformation 14.66 12.69 5 31125 90 29543307
Coronary artery disease 14.56 12.69 15 31115 44175 29499222
Chronic obstructive pulmonary disease 14.54 12.69 13 31117 40942 29502455
Muscle contracture 14.46 12.69 11 31119 1142 29542255
Blood bilirubin increased 14.29 12.69 9 31121 33884 29509513
Transient epileptic amnesia 14.28 12.69 3 31127 6 29543391
Hereditary optic atrophy 14.28 12.69 3 31127 6 29543391
Lactic acidosis 14.25 12.69 7 31123 30240 29513157
Enuresis 14.15 12.69 14 31116 2070 29541327
Pain in extremity 14.09 12.69 64 31066 110369 29433028
Fear 14.07 12.69 31 31099 9473 29533924
Essential tremor 14.01 12.69 9 31121 713 29542684
Unmasking of previously unidentified disease 14.00 12.69 9 31121 714 29542683
Hepatitis fulminant 13.96 12.69 18 31112 3553 29539844
Septic shock 13.93 12.69 28 31102 62532 29480865
Lennox-Gastaut syndrome 13.88 12.69 4 31126 40 29543357
Ear infection 13.83 12.69 28 31102 8072 29535325
Floppy infant 13.81 12.69 5 31125 108 29543289
Product used for unknown indication 13.76 12.69 7 31123 355 29543042
Skeletal dysplasia 13.73 12.69 5 31125 110 29543287
Mania 13.68 12.69 29 31101 8634 29534763
Choroidal detachment 13.67 12.69 7 31123 360 29543037
Drug level decreased 13.65 12.69 24 31106 6223 29537174
Cross sensitivity reaction 13.58 12.69 11 31119 1251 29542146
Anaphylactic reaction 13.57 12.69 6 31124 27567 29515830
Adjustment disorder 13.56 12.69 10 31120 991 29542406
Melaena 13.53 12.69 8 31122 31168 29512229
Body dysmorphic disorder 13.48 12.69 5 31125 116 29543281
Prostate cancer 13.47 12.69 5 31125 25522 29517875
Drop attacks 13.47 12.69 8 31122 551 29542846
Neonatal cholestasis 13.46 12.69 4 31126 45 29543352
Idiopathic generalised epilepsy 13.46 12.69 4 31126 45 29543352
Visual field defect 13.42 12.69 19 31111 4097 29539300
Congenital genital malformation male 13.42 12.69 3 31127 9 29543388
COVID-19 13.31 12.69 11 31119 36003 29507394
Oedema peripheral 13.22 12.69 60 31070 103497 29439900
Galactorrhoea 13.20 12.69 7 31123 387 29543010
Salivary hypersecretion 13.11 12.69 26 31104 7383 29536014
Abdominal wall haematoma 13.08 12.69 12 31118 1615 29541782
Peroneal nerve palsy 13.08 12.69 15 31115 2624 29540773
Granulocytopenia 13.06 12.69 23 31107 5971 29537426
Malabsorption 13.06 12.69 13 31117 1935 29541462
Oedema 13.04 12.69 14 31116 40469 29502928
Peripheral swelling 12.97 12.69 30 31100 63709 29479688
Stomatitis 12.91 12.69 12 31118 37101 29506296
Skull fracture 12.91 12.69 9 31121 817 29542580
Selective eating disorder 12.85 12.69 12 31118 1651 29541746
Haematochezia 12.82 12.69 12 31118 36971 29506426
Craniocerebral injury 12.76 12.69 15 31115 2693 29540704
Asterixis 12.76 12.69 10 31120 1085 29542312
Binocular eye movement disorder 12.72 12.69 4 31126 55 29543342
Haematemesis 12.70 12.69 5 31125 24621 29518776

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 1277.52 10.80 363 96897 2294 64399178
Seizure 1201.05 10.80 1365 95895 165527 64235945
Migraine 644.03 10.80 621 96639 62056 64339416
Myopia 590.51 10.80 182 97078 1576 64399896
Choroidal effusion 499.41 10.80 127 97133 485 64400987
Completed suicide 458.47 10.80 1031 96229 223383 64178089
Intentional self-injury 364.58 10.80 322 96938 28722 64372750
Status epilepticus 341.70 10.80 274 96986 21389 64380083
Renal tubular acidosis 328.98 10.80 135 97125 2844 64398628
Visual perseveration 326.72 10.80 62 97198 16 64401456
Multiple-drug resistance 291.12 10.80 158 97102 6344 64395128
Drug ineffective 289.43 10.80 2207 95053 838040 63563432
Suicidal ideation 262.32 10.80 406 96854 66136 64335336
Somnolence 260.98 10.80 786 96474 202859 64198613
Epilepsy 256.96 10.80 284 96976 33247 64368225
Intentional overdose 256.58 10.80 475 96785 89469 64312003
Product substitution issue 254.58 10.80 213 97047 17648 64383824
Hyperammonaemic encephalopathy 252.28 10.80 123 97137 3935 64397537
Aggression 251.55 10.80 329 96931 45903 64355569
Generalised tonic-clonic seizure 233.12 10.80 294 96966 39563 64361909
Heat stroke 228.07 10.80 85 97175 1370 64400102
Nephrolithiasis 227.08 10.80 304 96956 43379 64358093
Toxicity to various agents 211.69 10.80 1094 96166 362419 64039053
Memory impairment 203.58 10.80 419 96841 85263 64316209
Hyperammonaemia 201.89 10.80 146 97114 9758 64391714
Drug ineffective for unapproved indication 197.10 10.80 239 97021 30894 64370578
Acute kidney injury 190.42 10.80 239 97021 449001 63952471
Anaemia 188.69 10.80 176 97084 378504 64022968
Myokymia 187.68 10.80 42 97218 76 64401396
Metabolic acidosis 182.89 10.80 359 96901 70599 64330873
Disturbance in attention 179.45 10.80 263 96997 40811 64360661
Petit mal epilepsy 178.51 10.80 105 97155 4927 64396545
Febrile neutropenia 175.14 10.80 35 97225 187622 64213850
Cognitive disorder 171.13 10.80 302 96958 54785 64346687
Flat anterior chamber of eye 159.82 10.80 39 97221 120 64401352
Depression 157.09 10.80 619 96641 182672 64218800
Acidosis hyperchloraemic 156.23 10.80 53 97207 639 64400833
Psychotic disorder 149.01 10.80 220 97040 34358 64367114
Paraesthesia 148.09 10.80 493 96767 134029 64267443
Ataxia 140.53 10.80 170 97090 21914 64379558
Pneumonia 136.69 10.80 413 96847 559163 63842309
Choroidal detachment 136.21 10.80 45 97215 497 64400975
Joint swelling 134.41 10.80 79 97181 215303 64186169
Overdose 131.17 10.80 532 96728 159034 64242438
Maculopathy 129.70 10.80 67 97193 2429 64399043
Irritability 129.35 10.80 213 97047 36533 64364939
Malignant neoplasm progression 118.89 10.80 15 97245 112856 64288616
Headache 117.17 10.80 1266 95994 528201 63873271
Atrial fibrillation 116.66 10.80 56 97204 171033 64230439
Myoclonic epilepsy 116.01 10.80 54 97206 1554 64399918
Synovitis 115.24 10.80 9 97251 99081 64302391
Partial seizures 114.30 10.80 92 97168 7215 64394257
Ciliary body disorder 112.74 10.80 22 97238 10 64401462
Acute myopia 112.69 10.80 27 97233 75 64401397
Dyspnoea 110.88 10.80 634 96626 718040 63683432
Pyrexia 109.16 10.80 453 96807 558191 63843281
Focal dyscognitive seizures 104.64 10.80 64 97196 3226 64398246
Anhidrosis 100.21 10.80 29 97231 197 64401275
Abnormal behaviour 100.12 10.80 181 97079 33441 64368031
Anorexia nervosa 97.03 10.80 27 97233 156 64401316
Speech disorder 96.82 10.80 221 97039 48220 64353252
Sudden unexplained death in epilepsy 96.09 10.80 36 97224 589 64400883
Pancytopenia 96.03 10.80 48 97212 143261 64258211
Suicide attempt 95.42 10.80 279 96981 70728 64330744
Vision blurred 94.92 10.80 326 96934 89990 64311482
Cardiac failure congestive 94.89 10.80 39 97221 130541 64270931
Drug interaction 92.46 10.80 892 96368 361191 64040281
Infusion related reaction 92.18 10.80 68 97192 164399 64237073
Renal failure 88.51 10.80 86 97174 181602 64219870
Drug resistance 88.47 10.80 176 97084 34926 64366546
Interstitial lung disease 87.51 10.80 20 97240 97712 64303760
Anxiety 85.73 10.80 561 96699 202088 64199384
General physical health deterioration 85.11 10.80 110 97150 204315 64197157
Cardiac failure 83.32 10.80 48 97212 132325 64269147
Drug withdrawal convulsions 82.38 10.80 47 97213 2081 64399391
Product use in unapproved indication 82.18 10.80 501 96759 176117 64225355
Hand deformity 81.34 10.80 3 97257 62768 64338704
Medication overuse headache 81.21 10.80 33 97227 677 64400795
Haemoglobin decreased 81.17 10.80 105 97155 194958 64206514
Corneal oedema 78.18 10.80 47 97213 2296 64399176
Infantile spasms 77.19 10.80 25 97235 258 64401214
Ammonia increased 77.02 10.80 72 97188 6905 64394567
Cerebral venous thrombosis 76.40 10.80 47 97213 2394 64399078
Diarrhoea 75.46 10.80 712 96548 721992 63679480
Lower respiratory tract infection 74.20 10.80 25 97235 94589 64306883
Blepharospasm 73.95 10.80 52 97208 3323 64398149
Intraocular pressure increased 73.61 10.80 76 97184 8226 64393246
Sluggishness 73.40 10.80 64 97196 5606 64395866
Rheumatoid arthritis 73.03 10.80 84 97176 164210 64237262
Pleural effusion 72.64 10.80 51 97209 126508 64274964
Sepsis 71.59 10.80 150 97110 230191 64171281
Slow speech 70.93 10.80 42 97218 1995 64399477
Tremor 69.91 10.80 422 96838 147808 64253664
Wound 69.78 10.80 15 97245 76462 64325010
Arthralgia 69.15 10.80 388 96872 441872 63959600
Disease progression 69.06 10.80 67 97193 141613 64259859
Fanconi syndrome 67.88 10.80 44 97216 2457 64399015
Therapeutic response unexpected 67.31 10.80 104 97156 16897 64384575
Hyperthermia 67.07 10.80 99 97161 15451 64386021
Bradyphrenia 65.78 10.80 76 97184 9330 64392142
Mood altered 65.02 10.80 99 97161 15880 64385592
Renal impairment 64.48 10.80 65 97195 134952 64266520
Neovascularisation 64.29 10.80 32 97228 1071 64400401
Pericarditis 64.17 10.80 9 97251 62507 64338965
Depressed mood 62.80 10.80 169 97091 40843 64360629
Arthropathy 62.76 10.80 54 97206 120913 64280559
Peripheral swelling 62.66 10.80 139 97121 209014 64192458
Sedation 61.63 10.80 169 97091 41293 64360179
Paradoxical drug reaction 61.56 10.80 60 97200 6060 64395412
Thrombocytopenia 61.27 10.80 156 97104 223645 64177827
Blindness 61.10 10.80 115 97145 21904 64379568
Myocardial infarction 60.37 10.80 98 97162 165723 64235749
Neutropenia 60.37 10.80 174 97086 239450 64162022
Death 59.97 10.80 454 96806 482251 63919221
Gastrointestinal haemorrhage 59.50 10.80 67 97193 132245 64269227
Hypoaesthesia 59.33 10.80 386 96874 138722 64262750
Mitochondrial DNA mutation 59.11 10.80 20 97240 239 64401233
Muscle twitching 58.77 10.80 104 97156 18894 64382578
Tonic convulsion 58.32 10.80 36 97224 1845 64399627
Diplopia 57.84 10.80 126 97134 26639 64374833
C-reactive protein increased 57.49 10.80 36 97224 94873 64306599
Coma blister 56.93 10.80 19 97241 217 64401255
Multiple sclerosis 56.43 10.80 102 97158 18839 64382633
Nystagmus 56.37 10.80 69 97191 8999 64392473
Myoclonus 56.29 10.80 120 97140 24998 64376474
Weight decreased 55.62 10.80 667 96593 285072 64116400
Visual acuity reduced 55.53 10.80 125 97135 27016 64374456
Blood creatinine increased 55.53 10.80 74 97186 135708 64265764
Multiple sclerosis relapse 54.64 10.80 161 97099 40974 64360498
Hyponatraemia 54.63 10.80 87 97173 148252 64253220
Aphasia 54.24 10.80 160 97100 40746 64360726
Amnesia 54.02 10.80 178 97082 48091 64353381
Infection 53.64 10.80 125 97135 184755 64216717
Stomatitis 53.21 10.80 52 97208 109553 64291919
Oligomenorrhoea 52.92 10.80 23 97237 561 64400911
Hyperkalaemia 52.63 10.80 45 97215 101084 64300388
Intentional product misuse 51.56 10.80 231 97029 72064 64329408
Psychogenic seizure 51.47 10.80 33 97227 1808 64399664
Cough 51.10 10.80 258 97002 301890 64099582
Visual field defect 50.67 10.80 62 97198 8084 64393388
Dysarthria 50.28 10.80 200 97060 59206 64342266
Paranoia 49.91 10.80 89 97171 16263 64385209
Pseudomyopia 49.87 10.80 13 97247 56 64401416
Intellectual disability 49.30 10.80 26 97234 984 64400488
Self-induced vomiting 49.16 10.80 12 97248 37 64401435
Mania 48.89 10.80 88 97172 16198 64385274
Mental disorder 48.84 10.80 117 97143 26328 64375144
Photophobia 48.83 10.80 91 97169 17202 64384270
Iris adhesions 48.25 10.80 21 97239 514 64400958
Propofol infusion syndrome 47.74 10.80 30 97230 1587 64399885
Amenorrhoea 47.70 10.80 54 97206 6485 64394987
Affective disorder 47.42 10.80 54 97206 6526 64394946
Atonic seizures 46.95 10.80 22 97238 643 64400829
Iridocyclitis 46.90 10.80 38 97222 3007 64398465
Electroencephalogram abnormal 46.79 10.80 48 97212 5155 64396317
Angiofibroma 45.64 10.80 14 97246 119 64401353
Benign familial pemphigus 45.52 10.80 9 97251 5 64401467
Abdominal discomfort 45.45 10.80 133 97127 182189 64219283
Contraindicated product administered 44.87 10.80 58 97202 107771 64293701
Weight increased 44.59 10.80 505 96755 212843 64188629
Glossodynia 44.33 10.80 21 97239 64675 64336797
Retinogram abnormal 44.14 10.80 17 97243 301 64401171
Hallucination, auditory 43.97 10.80 86 97174 16853 64384619
Alexia 43.26 10.80 9 97251 9 64401463
Helicobacter infection 43.18 10.80 4 97256 38358 64363114
Platelet count decreased 42.79 10.80 121 97139 167590 64233882
Respiratory alkalosis 42.60 10.80 40 97220 3857 64397615
Plasma cell myeloma 42.10 10.80 9 97251 46066 64355406
Agitation 41.90 10.80 252 97008 88115 64313357
Eye pain 41.26 10.80 123 97137 31502 64369970
Ascites 41.16 10.80 21 97239 61980 64339492
Change in seizure presentation 41.15 10.80 16 97244 291 64401181
Bulimia nervosa 41.11 10.80 15 97245 227 64401245
Feeling abnormal 41.09 10.80 343 96917 133259 64268213
Visual impairment 40.88 10.80 220 97040 73857 64327615
Concussion 40.85 10.80 55 97205 7883 64393589
Crying 40.51 10.80 92 97168 19998 64381474
Encephalopathy 40.48 10.80 186 97074 58633 64342839
Partial seizures with secondary generalisation 40.14 10.80 18 97242 474 64400998
Nephrocalcinosis 40.01 10.80 25 97235 1309 64400163
Nightmare 39.98 10.80 94 97166 20899 64380573
Septic shock 39.61 10.80 61 97199 105376 64296096
Impaired healing 39.38 10.80 21 97239 60452 64341020
Coronary artery disease 39.33 10.80 21 97239 60412 64341060
Galactorrhoea 39.00 10.80 35 97225 3184 64398288
Aura 38.78 10.80 21 97239 839 64400633
Off label use 38.43 10.80 1236 96024 631570 63769902
Hypoxia 38.15 10.80 46 97214 88103 64313369
Bipolar disorder 38.13 10.80 49 97211 6712 64394760
Libido increased 37.88 10.80 27 97233 1763 64399709
Phonophobia 37.39 10.80 17 97243 463 64401009
Social avoidant behaviour 37.34 10.80 40 97220 4517 64396955
Anticonvulsant drug level increased 37.33 10.80 30 97230 2347 64399125
Melaena 37.28 10.80 17 97243 53531 64347941
Withdrawal syndrome 37.17 10.80 98 97162 23394 64378078
Hypomagnesaemia 36.93 10.80 6 97254 37370 64364102
Cervix neoplasm 36.88 10.80 13 97247 177 64401295
Insomnia 36.80 10.80 458 96802 197378 64204094
Apathy 36.71 10.80 63 97197 11169 64390303
Cytomegalovirus infection 36.70 10.80 6 97254 37193 64364279
Blood prolactin increased 36.26 10.80 35 97225 3493 64397979
Wrong patient received product 36.20 10.80 36 97224 3726 64397746
Anger 36.19 10.80 76 97184 15665 64385807
Suicidal behaviour 36.19 10.80 32 97228 2855 64398617
Swelling 35.64 10.80 123 97137 160095 64241377
Delusion of replacement 35.50 10.80 12 97248 143 64401329
Bezoar 35.01 10.80 28 97232 2175 64399297
Nasopharyngitis 34.51 10.80 165 97095 195908 64205564
Cholecystitis chronic 34.25 10.80 55 97205 9232 64392240
Folliculitis 34.22 10.80 3 97257 30074 64371398
Osteonecrosis of jaw 33.99 10.80 9 97251 39816 64361656
Failure to suspend medication 33.63 10.80 15 97245 390 64401082
Oedema peripheral 33.61 10.80 183 97077 210134 64191338
Blood lactate dehydrogenase increased 33.39 10.80 5 97255 33073 64368399
Salivary gland calculus 33.30 10.80 13 97247 239 64401233
Disorientation 33.00 10.80 169 97091 55659 64345813
Hypocitraturia 32.99 10.80 6 97254 0 64401472
Ciliary muscle spasm 32.99 10.80 6 97254 0 64401472
Hostility 32.85 10.80 27 97233 2180 64399292
Angiomyolipoma 32.39 10.80 12 97248 190 64401282
Serotonin syndrome 32.23 10.80 131 97129 39151 64362321
Rash 32.23 10.80 492 96768 458057 63943415
Dysphemia 32.17 10.80 31 97229 3088 64398384
Post-traumatic neck syndrome 32.00 10.80 25 97235 1877 64399595
Respiratory arrest 31.74 10.80 161 97099 52824 64348648
Autonomic nervous system imbalance 31.64 10.80 35 97225 4097 64397375
Respiratory disorder neonatal 31.51 10.80 9 97251 58 64401414
Lennox-Gastaut syndrome 31.29 10.80 12 97248 210 64401262
Hypertension 31.10 10.80 246 97014 259015 64142457
Retinal disorder 31.07 10.80 24 97236 1772 64399700
Hypophosphataemic osteomalacia 30.99 10.80 13 97247 290 64401182
Asthenia 30.85 10.80 457 96803 427587 63973885
Lethargy 30.65 10.80 201 97059 72393 64329079
Road traffic accident 30.56 10.80 109 97151 30636 64370836
Erythema 30.31 10.80 162 97098 186908 64214564
Blister 30.25 10.80 47 97213 80920 64320552
Blindness transient 30.00 10.80 34 97226 4088 64397384
Hypersomnia 29.93 10.80 81 97179 19636 64381836
Alice in wonderland syndrome 29.72 10.80 8 97252 40 64401432
Macular detachment 29.30 10.80 11 97249 181 64401291
Bone marrow failure 29.29 10.80 18 97242 47934 64353538
Retinal deposits 29.08 10.80 10 97250 126 64401346
Lactic acidosis 28.81 10.80 30 97230 61380 64340092
Blood homocysteine increased 28.66 10.80 13 97247 352 64401120
Somnambulism 28.59 10.80 37 97223 5104 64396368
Neoplasm progression 28.52 10.80 13 97247 40951 64360521
Hypervolaemia 28.51 10.80 11 97249 38274 64363198
Myelodysplastic syndrome 28.23 10.80 4 97256 27575 64373897
Dehydration 28.21 10.80 201 97059 216562 64184910
Lymphangioleiomyomatosis 28.18 10.80 10 97250 139 64401333
Pulmonary oedema 28.14 10.80 47 97213 78627 64322845
Upper gastrointestinal haemorrhage 28.14 10.80 9 97251 35211 64366261
Coma 28.03 10.80 227 97033 87388 64314084
Psychomotor hyperactivity 27.84 10.80 65 97195 14386 64387086
Haemoptysis 27.82 10.80 20 97240 49028 64352444
Mood swings 27.76 10.80 73 97187 17395 64384077
Depressed level of consciousness 27.70 10.80 214 97046 81222 64320250
Priapism 27.63 10.80 32 97228 3938 64397534
Rhinolithiasis 27.49 10.80 5 97255 0 64401472
Hyposthenuria 27.49 10.80 5 97255 0 64401472
Frontal lobe epilepsy 27.49 10.80 5 97255 0 64401472
Acute myocardial infarction 27.48 10.80 39 97221 69679 64331793
Heart rate 27.44 10.80 8 97252 56 64401416
Extrapyramidal disorder 27.38 10.80 78 97182 19474 64381998
Renal colic 27.37 10.80 25 97235 2327 64399145
Hypohidrosis 27.19 10.80 11 97249 223 64401249
Soft tissue injury 27.10 10.80 21 97239 1558 64399914
Malaise 26.86 10.80 428 96832 395819 64005653
Thinking abnormal 26.81 10.80 56 97204 11500 64389972
Gait disturbance 26.81 10.80 386 96874 171769 64229703
Abortion spontaneous 26.60 10.80 91 97169 25052 64376420
Anticonvulsant drug level decreased 26.43 10.80 22 97238 1808 64399664
Exposure during pregnancy 26.36 10.80 204 97056 77471 64324001
Haematochezia 26.29 10.80 37 97223 66336 64335136
Pneumocystis jirovecii pneumonia 26.08 10.80 5 97255 27629 64373843
Hyperexplexia 26 10.80 7 97253 35 64401437
Oedema 25.97 10.80 63 97197 91872 64309600
Lung disorder 25.92 10.80 32 97228 60668 64340804
Acute myeloid leukaemia 25.85 10.80 5 97255 27458 64374014
Retinitis pigmentosa 25.84 10.80 9 97251 118 64401354
Major depression 25.75 10.80 44 97216 7772 64393700
Toxic encephalopathy 25.68 10.80 50 97210 9765 64391707
Seizure cluster 25.57 10.80 12 97248 352 64401120
Psychomotor retardation 25.50 10.80 35 97225 5108 64396364
Suspiciousness 25.45 10.80 14 97246 577 64400895
Biliary dyskinesia 25.27 10.80 24 97236 2348 64399124
Non-24-hour sleep-wake disorder 25.22 10.80 7 97253 40 64401432
Vitamin D deficiency 25.21 10.80 55 97205 11637 64389835
Dystonia 25.20 10.80 74 97186 18791 64382681
Fear 24.95 10.80 77 97183 20094 64381378
Staring 24.94 10.80 24 97236 2386 64399086
Fluid retention 24.85 10.80 32 97228 59574 64341898
Skin ulcer 24.85 10.80 18 97242 43956 64357516
Emotional distress 24.82 10.80 114 97146 35924 64365548
Patient dissatisfaction with treatment 24.80 10.80 9 97251 134 64401338
Peritonitis 24.76 10.80 4 97256 25019 64376453
Conjunctival oedema 24.73 10.80 17 97243 1047 64400425
Eating disorder 24.47 10.80 68 97192 16737 64384735
Sternal fracture 24.44 10.80 23 97237 2224 64399248
Pneumonitis 24.31 10.80 24 97236 50341 64351131
Cerebral infarction 24.26 10.80 16 97244 41028 64360444
Respiratory failure 24.25 10.80 143 97117 161040 64240432
Gene mutation 23.98 10.80 22 97238 2060 64399412
C-reactive protein abnormal 23.97 10.80 7 97253 29040 64372432
Migraine with aura 23.88 10.80 23 97237 2289 64399183
Granuloma annulare 23.88 10.80 13 97247 525 64400947
Simple partial seizures 23.80 10.80 14 97246 657 64400815
Migraine without aura 23.71 10.80 10 97250 226 64401246
Hyperchloraemia 23.61 10.80 16 97244 963 64400509
Blood gases abnormal 23.55 10.80 16 97244 967 64400505
Granulocytopenia 23.53 10.80 50 97210 10390 64391082
Angina pectoris 23.52 10.80 20 97240 45061 64356411
Psychomotor skills impaired 23.48 10.80 29 97231 3816 64397656
Hypermetropia 23.48 10.80 12 97248 425 64401047
Intensive care unit acquired weakness 23.38 10.80 20 97240 1707 64399765
Neutrophil count decreased 23.34 10.80 51 97209 77145 64324327
Pulmonary fibrosis 23.23 10.80 8 97252 29870 64371602
Red blood cell sedimentation rate increased 23.21 10.80 9 97251 31226 64370246
Hyperventilation 23.19 10.80 39 97221 6801 64394671
Anoxia 23.09 10.80 11 97249 334 64401138
Blood bilirubin increased 22.88 10.80 32 97228 57521 64343951
Anticonvulsant drug level above therapeutic 22.87 10.80 16 97244 1014 64400458
Dizziness 22.70 10.80 827 96433 429336 63972136
Mental impairment 22.69 10.80 65 97195 16278 64385194
Product quality issue 22.59 10.80 97 97163 29702 64371770
Affect lability 22.55 10.80 45 97215 8945 64392527
Erectile dysfunction 22.39 10.80 55 97205 12572 64388900
Product administered to patient of inappropriate age 22.35 10.80 31 97229 4570 64396902
Blood pressure systolic increased 22.26 10.80 25 97235 49428 64352044
Right ventricular failure 22.25 10.80 3 97257 21468 64380004
Calculus urinary 22.12 10.80 20 97240 1837 64399635
Posterior reversible encephalopathy syndrome 21.98 10.80 4 97256 22942 64378530
Tearfulness 21.97 10.80 31 97229 4642 64396830
Lichen planus 21.89 10.80 22 97238 2306 64399166
Angular cheilitis 21.87 10.80 12 97248 492 64400980
Personality disorder 21.78 10.80 31 97229 4680 64396792
Thalamic infarction 21.77 10.80 16 97244 1096 64400376
Haematuria 21.74 10.80 36 97224 60435 64341037
Behaviour disorder 21.58 10.80 30 97230 4432 64397040
Hypotension 21.51 10.80 425 96835 380549 64020923
Pulmonary hypertension 21.47 10.80 20 97240 43119 64358353
Panic attack 21.44 10.80 75 97185 20878 64380594
Hypoglycaemia 21.36 10.80 67 97193 89825 64311647
Ehlers-Danlos syndrome 21.29 10.80 8 97252 132 64401340
Metastases to liver 21.22 10.80 5 97255 23936 64377536
Vertigo 21.15 10.80 157 97103 58854 64342618
Hypotonia 21.13 10.80 50 97210 11162 64390310
Drug abuse 21.08 10.80 298 96962 132076 64269396
Self-injurious ideation 20.97 10.80 25 97235 3172 64398300
Ureterolithiasis 20.95 10.80 25 97235 3176 64398296
Blunted affect 20.84 10.80 11 97249 417 64401055
Gingival hypertrophy 20.57 10.80 23 97237 2724 64398748
Screaming 20.57 10.80 26 97234 3503 64397969
Head discomfort 20.41 10.80 51 97209 11783 64389689
Musculoskeletal stiffness 20.34 10.80 106 97154 123100 64278372
Temperature intolerance 20.33 10.80 41 97219 8214 64393258
Herpes zoster 20.28 10.80 57 97203 79130 64322342
Discomfort 20.14 10.80 59 97201 80819 64320653
Drug withdrawal syndrome 20.10 10.80 97 97163 31194 64370278
Neuropathy peripheral 20.03 10.80 100 97160 117425 64284047
Pruritus 19.98 10.80 341 96919 312059 64089413
Prostate cancer 19.96 10.80 3 97257 19792 64381680
Acid-base balance disorder mixed 19.95 10.80 7 97253 94 64401378
Idiopathic intracranial hypertension 19.92 10.80 22 97238 2571 64398901
Hallucination, visual 19.88 10.80 89 97171 27745 64373727
Systemic lupus erythematosus 19.78 10.80 56 97204 77556 64323916
Delusion 19.76 10.80 66 97194 17948 64383524
Inappropriate affect 19.68 10.80 16 97244 1272 64400200
Optic atrophy 19.62 10.80 18 97242 1685 64399787
International normalised ratio increased 19.53 10.80 58 97202 79109 64322363
Product physical issue 19.45 10.80 25 97235 3424 64398048
Epistaxis 19.42 10.80 79 97181 98052 64303420
Hypothermia 19.40 10.80 70 97190 19786 64381686
Subdural haematoma 19.38 10.80 9 97251 28045 64373427
Microcephaly 19.25 10.80 8 97252 174 64401298
Open angle glaucoma 19.19 10.80 10 97250 369 64401103
Apnoea 19.12 10.80 46 97214 10376 64391096
Laryngeal stenosis 19.01 10.80 13 97247 794 64400678
Oxygen saturation decreased 18.96 10.80 90 97170 107086 64294386
Dyspnoea exertional 18.93 10.80 53 97207 73677 64327795
Therapeutic response changed 18.91 10.80 14 97246 970 64400502
Blood pressure measurement 18.78 10.80 10 97250 386 64401086
Borderline personality disorder 18.77 10.80 13 97247 811 64400661
Hereditary angioedema 18.65 10.80 26 97234 3850 64397622
Angioedema 18.56 10.80 41 97219 61780 64339692
Productive cough 18.52 10.80 53 97207 73150 64328322
Hypersensitivity 18.51 10.80 198 97062 196254 64205218
Sleep-related eating disorder 18.51 10.80 12 97248 670 64400802
Blood thyroid stimulating hormone normal 18.49 10.80 7 97253 118 64401354
Injury 18.41 10.80 146 97114 55846 64345626
Hypopyon 18.35 10.80 14 97246 1015 64400457
Blood pressure increased 18.31 10.80 169 97091 172383 64229089
Premature ejaculation 18.26 10.80 6 97254 65 64401407
Developmental delay 18.25 10.80 14 97246 1023 64400449
Drug level decreased 18.21 10.80 48 97212 11455 64390017
Papilloedema 18.15 10.80 31 97229 5474 64395998
Occipital neuralgia 18.11 10.80 9 97251 300 64401172
Uveitis 18.09 10.80 51 97209 12657 64388815
Pregnancy with implant contraceptive 17.90 10.80 16 97244 1448 64400024
Hyperglycaemia 17.84 10.80 41 97219 60927 64340545
Small for dates baby 17.81 10.80 10 97250 429 64401043
Wheezing 17.81 10.80 62 97198 80517 64320955
Brugada syndrome 17.77 10.80 14 97246 1064 64400408
Rectal haemorrhage 17.75 10.80 42 97218 61775 64339697
Pulmonary arterial hypertension 17.74 10.80 8 97252 25359 64376113
Taste disorder 17.70 10.80 42 97218 9391 64392081
Benzodiazepine drug level increased 17.69 10.80 8 97252 215 64401257
Full blood count decreased 17.64 10.80 6 97254 22576 64378896
Hippocampal sclerosis 17.58 10.80 7 97253 136 64401336
Illogical thinking 17.56 10.80 6 97254 74 64401398
Transfusion 17.53 10.80 3 97257 17991 64383481
Pericardial effusion 17.50 10.80 20 97240 39234 64362238
Anterior chamber disorder 17.48 10.80 7 97253 138 64401334
Vestibular migraine 17.44 10.80 7 97253 139 64401333
Organic brain syndrome 17.42 10.80 10 97250 448 64401024
Urine calcium/creatinine ratio increased 17.34 10.80 7 97253 141 64401331
Jaundice 17.33 10.80 29 97231 48483 64352989
Urge incontinence 17.28 10.80 13 97247 923 64400549
Ejection fraction decreased 17.22 10.80 11 97249 28696 64372776
Cytokine release syndrome 17.22 10.80 5 97255 20824 64380648
Foetal exposure during pregnancy 17.18 10.80 27 97233 4449 64397023
Toxic skin eruption 17.15 10.80 4 97256 19280 64382192
Hepatic enzyme increased 17.13 10.80 120 97140 129823 64271649
Multiple drug therapy 17.10 10.80 19 97241 2235 64399237
Conjunctival hyperaemia 17.07 10.80 25 97235 3874 64397598
Failed induction of labour 17.07 10.80 8 97252 234 64401238
Chills 17.02 10.80 129 97131 137135 64264337
Endometriosis 16.96 10.80 21 97239 2771 64398701
Cellulitis 16.94 10.80 78 97182 93579 64307893
Status migrainosus 16.91 10.80 5 97255 37 64401435
Haematemesis 16.88 10.80 28 97232 46971 64354501
Decreased interest 16.86 10.80 23 97237 3337 64398135
Hepatic function abnormal 16.68 10.80 46 97214 64267 64337205
Tinnitus 16.59 10.80 98 97162 34035 64367437
White blood cell count decreased 16.57 10.80 155 97105 157682 64243790
Acquired haemophilia 16.52 10.80 16 97244 1604 64399868
Ischaemic gastritis 16.47 10.80 4 97256 12 64401460
Poisoning 16.42 10.80 71 97189 21808 64379664
Anaphylactic shock 16.39 10.80 13 97247 30315 64371157
Asterixis 16.37 10.80 19 97241 2344 64399128
Perseveration 16.32 10.80 9 97251 373 64401099
Tardive dyskinesia 16.30 10.80 40 97220 9138 64392334
Anticonvulsant drug level below therapeutic 16.24 10.80 13 97247 1011 64400461
Thyroxine free decreased 16.21 10.80 12 97248 831 64400641
Poor quality sleep 16.19 10.80 64 97196 18887 64382585
Hip arthroplasty 16.12 10.80 6 97254 21345 64380127
Brain oedema 16.08 10.80 71 97189 22004 64379468
Eye movement disorder 16.07 10.80 34 97226 7045 64394427
Cholestasis 15.87 10.80 27 97233 44845 64356627
Cardio-respiratory arrest 15.86 10.80 222 97038 98171 64303301
Educational problem 15.85 10.80 9 97251 395 64401077
Blastocystis infection 15.78 10.80 4 97256 15 64401457
Blood chloride increased 15.77 10.80 27 97233 4776 64396696
Multiple organ dysfunction syndrome 15.77 10.80 89 97171 101324 64300148
Blood bicarbonate decreased 15.67 10.80 27 97233 4802 64396670
Haematuria traumatic 15.66 10.80 7 97253 183 64401289
Therapeutic product effective for unapproved indication 15.59 10.80 6 97254 106 64401366
Ultrasound liver abnormal 15.59 10.80 7 97253 185 64401287
Application site discolouration 15.56 10.80 11 97249 709 64400763
Dissociative disorder 15.50 10.80 9 97251 412 64401060
Bladder hypertrophy 15.50 10.80 10 97250 554 64400918
Chronic obstructive pulmonary disease 15.48 10.80 55 97205 70993 64330479
Enuresis 15.39 10.80 20 97240 2770 64398702
Aspergillus infection 15.38 10.80 3 97257 16376 64385096
Knee arthroplasty 15.32 10.80 11 97249 26988 64374484
Acute coronary syndrome 15.31 10.80 5 97255 19305 64382167
Tension headache 15.26 10.80 22 97238 3361 64398111
Bacteraemia 15.23 10.80 11 97249 26900 64374572
Blood urea increased 15.22 10.80 27 97233 44126 64357346
Drug dependence 15.15 10.80 94 97166 33218 64368254
Periarthritis 15.10 10.80 19 97241 2548 64398924
Optic neuritis 15.08 10.80 36 97224 8080 64393392
Cardiogenic shock 15.03 10.80 16 97244 32411 64369061
Condition aggravated 15.03 10.80 696 96564 371730 64029742
Ischaemic stroke 15.00 10.80 13 97247 29022 64372450
Metastases to bone 15 10.80 6 97254 20429 64381043
Nodular rash 14.95 10.80 8 97252 312 64401160
Gallbladder disorder 14.94 10.80 58 97202 16972 64384500
Glycosuria 14.91 10.80 17 97243 2057 64399415
Orthostatic hypotension 14.86 10.80 30 97230 46708 64354764
Amino acid level increased 14.86 10.80 10 97250 595 64400877
Therapeutic product ineffective for unapproved indication 14.81 10.80 6 97254 122 64401350
Hemiparesis 14.73 10.80 86 97174 29741 64371731
Visual snow syndrome 14.70 10.80 4 97256 21 64401451
Encephalocele 14.70 10.80 4 97256 21 64401451
Pre-existing condition improved 14.64 10.80 26 97234 4736 64396736
Tubulointerstitial nephritis 14.61 10.80 15 97245 30894 64370578
Plasmodium falciparum infection 14.54 10.80 5 97255 63 64401409
Persecutory delusion 14.49 10.80 24 97236 4134 64397338
Myelosuppression 14.48 10.80 9 97251 23821 64377651
Iris disorder 14.47 10.80 8 97252 333 64401139
Transient epileptic amnesia 14.42 10.80 3 97257 3 64401469
Granulomatous dermatitis 14.36 10.80 8 97252 338 64401134
Blood pressure decreased 14.31 10.80 74 97186 86125 64315347
Distractibility 14.26 10.80 10 97250 636 64400836
Cerebral vasoconstriction 14.24 10.80 13 97247 1209 64400263
Dissociation 14.20 10.80 20 97240 2991 64398481
Intracranial hypotension 14.15 10.80 8 97252 348 64401124
Hyperthermia malignant 14.15 10.80 18 97242 2441 64399031
Central obesity 14.14 10.80 14 97246 1441 64400031
Renal injury 14.12 10.80 3 97257 15426 64386046
Blood lactic acid increased 14.09 10.80 41 97219 10360 64391112
Lupus pleurisy 13.96 10.80 3 97257 4 64401468
Neck pain 13.90 10.80 148 97112 61385 64340087
Localised infection 13.85 10.80 15 97245 30146 64371326
Illiteracy 13.84 10.80 4 97256 27 64401445
Accommodation disorder 13.81 10.80 9 97251 507 64400965
Tonic clonic movements 13.79 10.80 16 97244 1973 64399499
Aspartate aminotransferase increased 13.73 10.80 115 97145 119673 64281799
Sopor 13.68 10.80 84 97176 29577 64371895
Postictal psychosis 13.67 10.80 6 97254 150 64401322
Emotional disorder 13.66 10.80 46 97214 12561 64388911
Accidental death 13.65 10.80 22 97238 3703 64397769
Hepatocellular injury 13.58 10.80 30 97230 45205 64356267
Hyperaldosteronism 13.55 10.80 8 97252 378 64401094
Sputum discoloured 13.51 10.80 5 97255 17851 64383621
Dysgeusia 13.51 10.80 119 97141 46928 64354544
Product dispensing error 13.51 10.80 43 97217 11407 64390065
Osteomyelitis 13.48 10.80 13 97247 27574 64373898
Basal cell carcinoma 13.44 10.80 16 97244 30822 64370650
Bronchospasm 13.44 10.80 8 97252 21674 64379798
Drug level increased 13.42 10.80 93 97167 34103 64367369
Essential tremor 13.40 10.80 13 97247 1306 64400166
Convulsive threshold lowered 13.39 10.80 11 97249 888 64400584
Automatism 13.38 10.80 6 97254 158 64401314
Retinal detachment 13.36 10.80 34 97226 7942 64393530
Hypopnoea 13.29 10.80 20 97240 3174 64398298
Slow response to stimuli 13.29 10.80 14 97246 1551 64399921
Intermenstrual bleeding 13.27 10.80 26 97234 5099 64396373
Near drowning 13.25 10.80 4 97256 32 64401440
Self esteem decreased 13.20 10.80 11 97249 906 64400566
Restless legs syndrome 13.19 10.80 56 97204 17060 64384412
Muscle contractions involuntary 13.18 10.80 20 97240 3197 64398275
Bradykinesia 13.18 10.80 30 97230 6530 64394942
Low birth weight baby 13.17 10.80 9 97251 549 64400923
Lung neoplasm malignant 13.17 10.80 8 97252 21440 64380032
Coordination abnormal 13.16 10.80 51 97209 14913 64386559
Hereditary optic atrophy 13.15 10.80 4 97256 33 64401439
Alanine aminotransferase increased 13.14 10.80 140 97120 138891 64262581
Euphoric mood 13.08 10.80 30 97230 6561 64394911
Colitis 13.06 10.80 45 97215 58629 64342843
Cerebral haemorrhage 12.91 10.80 37 97223 51053 64350419
Blood pressure fluctuation 12.79 10.80 38 97222 51833 64349639
Acidosis 12.78 10.80 57 97203 17738 64383734
Central nervous system lesion 12.63 10.80 43 97217 11806 64389666
Ill-defined disorder 12.59 10.80 30 97230 44022 64357450
Balance disorder 12.58 10.80 187 97073 83739 64317733
Suspected suicide 12.58 10.80 35 97225 8619 64392853
Toxic epidermal necrolysis 12.57 10.80 23 97237 37143 64364329
Dyskinesia 12.56 10.80 102 97158 39286 64362186
Renal tubular necrosis 12.56 10.80 9 97251 22101 64379371
Drug reaction with eosinophilia and systemic symptoms 12.53 10.80 131 97129 54086 64347386
Post laminectomy syndrome 12.52 10.80 7 97253 298 64401174
Presyncope 12.51 10.80 21 97239 35068 64366404
Liver disorder 12.51 10.80 40 97220 53311 64348161
Cross sensitivity reaction 12.50 10.80 20 97240 3347 64398125
Breast disorder 12.44 10.80 14 97246 1670 64399802
Binge eating 12.42 10.80 8 97252 442 64401030
Application site burn 12.40 10.80 10 97250 786 64400686
Communication disorder 12.39 10.80 21 97239 3685 64397787
Cortical dysplasia 12.35 10.80 3 97257 9 64401463
Tri-iodothyronine free abnormal 12.29 10.80 4 97256 42 64401430
Developmental regression 12.29 10.80 4 97256 42 64401430
Angina unstable 12.27 10.80 4 97256 15463 64386009
Arthritis 12.26 10.80 75 97185 83739 64317733
Osmotic demyelination syndrome 12.25 10.80 12 97248 1219 64400253
Abortion 12.21 10.80 12 97248 1224 64400248
Pleural rub 12.20 10.80 4 97256 43 64401429
Vascular headache 12.12 10.80 4 97256 44 64401428
Bipolar II disorder 12.10 10.80 7 97253 318 64401154
Lymphomatoid papulosis 12.08 10.80 7 97253 319 64401153
Hallucination 12.04 10.80 165 97095 72623 64328849
Inflammation 12.04 10.80 54 97206 65246 64336226
Rales 11.98 10.80 4 97256 15225 64386247
Gastric bypass 11.91 10.80 11 97249 1039 64400433
Psychiatric symptom 11.85 10.80 28 97232 6245 64395227
Cluster headache 11.80 10.80 10 97250 843 64400629
Gout 11.80 10.80 9 97251 21404 64380068
Tic 11.77 10.80 17 97243 2602 64398870
Heart rate decreased 11.75 10.80 43 97217 55024 64346448
Skull fracture 11.71 10.80 13 97247 1528 64399944
Hyporesponsive to stimuli 11.70 10.80 14 97246 1783 64399689
Myofascial pain syndrome 11.70 10.80 14 97246 1784 64399688
Hamartoma 11.69 10.80 3 97257 12 64401460
Clostridium difficile infection 11.68 10.80 23 97237 36140 64365332
Astrocytoma, low grade 11.66 10.80 4 97256 50 64401422
Haemophagocytic lymphohistiocytosis 11.63 10.80 6 97254 17603 64383869
Red blood cell sedimentation rate abnormal 11.63 10.80 5 97255 16301 64385171
Homicidal ideation 11.62 10.80 19 97241 3238 64398234
Incoherent 11.57 10.80 30 97230 7088 64394384
Hyperbilirubinaemia 11.57 10.80 9 97251 21196 64380276
Narcolepsy 11.55 10.80 11 97249 1080 64400392
Blood pressure diastolic decreased 11.50 10.80 10 97250 22291 64379181
Idiopathic generalised epilepsy 11.45 10.80 4 97256 53 64401419
Retinal vein occlusion 11.44 10.80 18 97242 2970 64398502
Polyneuropathy 11.43 10.80 8 97252 19886 64381586
Transplant rejection 11.39 10.80 6 97254 17395 64384077
Product dose omission issue 11.38 10.80 379 96881 194368 64207104
Loss of libido 11.38 10.80 16 97244 2388 64399084
Cerebral venous sinus thrombosis 11.34 10.80 14 97246 1841 64399631
Diverticulitis 11.27 10.80 26 97234 38592 64362880
Drug effect less than expected 11.27 10.80 8 97252 519 64400953
Catatonia 11.26 10.80 31 97229 7589 64393883
Coma acidotic 11.21 10.80 5 97255 130 64401342
Electrocardiogram T wave abnormal 11.20 10.80 19 97241 3337 64398135
Decreased nasolabial fold 11.14 10.80 3 97257 15 64401457
Ovarian germ cell cancer stage II 11.14 10.80 3 97257 15 64401457
Fever neonatal 11.14 10.80 3 97257 15 64401457
Heart rate irregular 11.14 10.80 15 97245 27398 64374074
Photopsia 11.12 10.80 23 97237 4691 64396781
Gambling disorder 11.11 10.80 14 97246 1880 64399592
Dropped head syndrome 11.10 10.80 6 97254 239 64401233
Depersonalisation/derealisation disorder 11.05 10.80 13 97247 1627 64399845
Basilar migraine 10.99 10.80 4 97256 60 64401412
Creatinine renal clearance decreased 10.98 10.80 4 97256 14417 64387055
Hypertensive crisis 10.94 10.80 7 97253 18241 64383231
Poor feeding infant 10.93 10.80 5 97255 138 64401334
Osteonecrosis 10.92 10.80 16 97244 28213 64373259
Crystal urine present 10.91 10.80 14 97246 1915 64399557
CSF oligoclonal band present 10.90 10.80 5 97255 139 64401333
Hypercapnic coma 10.89 10.80 7 97253 385 64401087
Gastrooesophageal reflux disease 10.85 10.80 181 97079 82962 64318510
Haemorrhage intracranial 10.83 10.80 12 97248 23872 64377600

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
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




๐Ÿถ Veterinary Drug Use

None

๐Ÿถ Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 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 USE OF QSYMIA (PHENTERMINE AND TOPIRAMATE) FOR WEIGHT MANAGEMENT, INCLUDING, BUT NOT LIMITED TO EFFECTING WEIGHT LOSS, TREATING OBESITY, AND/OR TREATING OVERWEIGHT
EQ 11.25MG BASE;69MG QSYMIA VIVUS N022580 July 17, 2012 RX CAPSULE, EXTENDED RELEASE ORAL 9011906 June 9, 2028 USE OF QSYMIA (PHENTERMINE AND TOPIRAMATE) FOR WEIGHT MANAGEMENT, INCLUDING, BUT NOT LIMITED TO EFFECTING WEIGHT LOSS, TREATING OBESITY, AND/OR TREATING OVERWEIGHT
EQ 15MG BASE;92MG QSYMIA VIVUS N022580 July 17, 2012 RX CAPSULE, EXTENDED RELEASE ORAL 8895057 June 9, 2028 USE OF QSYMIA (PHENTERMINE AND TOPIRAMATE) FOR WEIGHT MANAGEMENT, INCLUDING, BUT NOT LIMITED TO EFFECTING WEIGHT LOSS, TREATING OBESITY, AND/OR TREATING OVERWEIGHT
EQ 15MG BASE;92MG QSYMIA VIVUS N022580 July 17, 2012 RX CAPSULE, EXTENDED RELEASE ORAL 9011906 June 9, 2028 USE OF QSYMIA (PHENTERMINE AND TOPIRAMATE) FOR WEIGHT MANAGEMENT, INCLUDING, BUT NOT LIMITED TO EFFECTING WEIGHT LOSS, TREATING OBESITY, AND/OR TREATING OVERWEIGHT
EQ 3.75MG BASE;23MG QSYMIA VIVUS N022580 July 17, 2012 RX CAPSULE, EXTENDED RELEASE ORAL 8895057 June 9, 2028 USE OF QSYMIA (PHENTERMINE AND TOPIRAMATE) FOR WEIGHT MANAGEMENT, INCLUDING, BUT NOT LIMITED TO EFFECTING WEIGHT LOSS, TREATING OBESITY, AND/OR TREATING OVERWEIGHT
EQ 3.75MG BASE;23MG QSYMIA VIVUS N022580 July 17, 2012 RX CAPSULE, EXTENDED RELEASE ORAL 9011906 June 9, 2028 USE OF QSYMIA (PHENTERMINE AND TOPIRAMATE) FOR WEIGHT MANAGEMENT, INCLUDING, BUT NOT LIMITED TO EFFECTING WEIGHT LOSS, TREATING OBESITY, AND/OR TREATING OVERWEIGHT
EQ 7.5MG BASE;46MG QSYMIA VIVUS N022580 July 17, 2012 RX CAPSULE, EXTENDED RELEASE ORAL 8895057 June 9, 2028 USE OF QSYMIA (PHENTERMINE AND TOPIRAMATE) FOR WEIGHT MANAGEMENT, INCLUDING, BUT NOT LIMITED TO EFFECTING WEIGHT LOSS, TREATING OBESITY, AND/OR TREATING OVERWEIGHT
EQ 7.5MG BASE;46MG QSYMIA VIVUS N022580 July 17, 2012 RX CAPSULE, EXTENDED RELEASE ORAL 9011906 June 9, 2028 USE OF QSYMIA (PHENTERMINE AND TOPIRAMATE) FOR WEIGHT MANAGEMENT, INCLUDING, BUT NOT LIMITED TO EFFECTING WEIGHT LOSS, TREATING OBESITY, AND/OR TREATING OVERWEIGHT
EQ 11.25MG BASE;69MG QSYMIA VIVUS N022580 July 17, 2012 RX CAPSULE, EXTENDED RELEASE ORAL 8580299 June 14, 2029 USE OF QSYMIA (PHENTERMINE AND TOPIRAMATE) FOR WEIGHT MANAGEMENT, INCLUDING, BUT NOT LIMITED TO EFFECTING WEIGHT LOSS, TREATING OBESITY, AND/OR TREATING OVERWEIGHT
EQ 15MG BASE;92MG QSYMIA VIVUS N022580 July 17, 2012 RX CAPSULE, EXTENDED RELEASE ORAL 8580299 June 14, 2029 USE OF QSYMIA (PHENTERMINE AND TOPIRAMATE) FOR WEIGHT MANAGEMENT, INCLUDING, BUT NOT LIMITED TO EFFECTING WEIGHT LOSS, TREATING OBESITY, AND/OR TREATING OVERWEIGHT
EQ 3.75MG BASE;23MG QSYMIA VIVUS N022580 July 17, 2012 RX CAPSULE, EXTENDED RELEASE ORAL 8580299 June 14, 2029 USE OF QSYMIA (PHENTERMINE AND TOPIRAMATE) FOR WEIGHT MANAGEMENT, INCLUDING, BUT NOT LIMITED TO EFFECTING WEIGHT LOSS, TREATING OBESITY, AND/OR TREATING OVERWEIGHT
EQ 7.5MG BASE;46MG QSYMIA VIVUS N022580 July 17, 2012 RX CAPSULE, EXTENDED RELEASE ORAL 8580299 June 14, 2029 USE OF QSYMIA (PHENTERMINE AND TOPIRAMATE) FOR WEIGHT MANAGEMENT, INCLUDING, BUT NOT LIMITED TO EFFECTING WEIGHT LOSS, TREATING OBESITY, AND/OR TREATING OVERWEIGHT
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

Orange Book exclusivity data (new drug applications)

None

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 0245-1072 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 0245-1074 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
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 0615-8139 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 0832-1071 CAPSULE, EXTENDED RELEASE 25 mg ORAL NDA authorized generic 32 sections
Topiramate HUMAN PRESCRIPTION DRUG LABEL 1 0832-1072 CAPSULE, EXTENDED RELEASE 50 mg ORAL NDA authorized generic 32 sections
Topiramate HUMAN PRESCRIPTION DRUG LABEL 1 0832-1073 CAPSULE, EXTENDED RELEASE 200 mg ORAL NDA authorized generic 32 sections
Topiramate HUMAN PRESCRIPTION DRUG LABEL 1 0832-1074 CAPSULE, EXTENDED RELEASE 100 mg ORAL NDA authorized generic 32 sections
Topiramate HUMAN PRESCRIPTION DRUG LABEL 1 0832-1075 CAPSULE, EXTENDED RELEASE 150 mg ORAL NDA authorized generic 32 sections
topiramate HUMAN PRESCRIPTION DRUG LABEL 1 0904-6928 TABLET, FILM COATED 25 mg ORAL ANDA 28 sections
topiramate HUMAN PRESCRIPTION DRUG LABEL 1 0904-6929 TABLET, FILM COATED 100 mg ORAL ANDA 28 sections
Topiramate HUMAN PRESCRIPTION DRUG LABEL 1 10544-489 TABLET, FILM COATED 100 mg ORAL ANDA 33 sections
Topiramate HUMAN PRESCRIPTION DRUG LABEL 1 10544-628 TABLET 25 mg ORAL ANDA 32 sections
Topiramate HUMAN PRESCRIPTION DRUG LABEL 1 10544-847 TABLET, FILM COATED 50 mg ORAL ANDA 33 sections
Topiramate HUMAN PRESCRIPTION DRUG LABEL 1 12634-083 TABLET, FILM COATED 100 mg ORAL ANDA 28 sections
Topiramate HUMAN PRESCRIPTION DRUG LABEL 1 12634-452 TABLET 25 mg ORAL ANDA 28 sections
Topiramate HUMAN PRESCRIPTION DRUG LABEL 1 12634-453 TABLET 50 mg ORAL ANDA 28 sections
TOPIRAMATE HUMAN PRESCRIPTION DRUG LABEL 1 13668-031 TABLET 25 mg ORAL ANDA 29 sections