topiramate 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 ┬ÁM/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 1109.79 10.25 325 86708 1814 46597215
Seizure 1101.30 10.25 1248 85785 121806 46477223
Migraine 772.55 10.25 794 86239 69232 46529797
Myopia 449.65 10.25 147 86886 1240 46597789
Product substitution issue 420.81 10.25 292 86741 14739 46584290
Epilepsy 328.41 10.25 305 86728 23433 46575596
Status epilepticus 323.64 10.25 242 86791 13737 46585292
Choroidal effusion 316.15 10.25 86 86947 348 46598681
Visual perseveration 316.03 10.25 62 86971 13 46599016
Completed suicide 273.85 10.25 740 86293 145180 46453849
Renal tubular acidosis 258.84 10.25 101 86932 1482 46597547
Intentional self-injury 253.45 10.25 267 86766 23899 46575130
Suicidal ideation 230.88 10.25 393 86640 55989 46543040
Rheumatoid arthritis 207.79 10.25 94 86939 240121 46358908
Intentional overdose 197.17 10.25 398 86635 64546 46534483
Exposure during pregnancy 172.80 10.25 518 86515 107694 46491335
Generalised tonic-clonic seizure 172.21 10.25 232 86801 26890 46572139
Depression 169.06 10.25 696 86337 169408 46429621
Nephrolithiasis 150.87 10.25 242 86791 32809 46566220
Metabolic acidosis 149.14 10.25 263 86770 38517 46560512
Anaemia 146.01 10.25 157 86876 255622 46343407
Paraesthesia 141.56 10.25 511 86522 116926 46482103
Petit mal epilepsy 141.05 10.25 83 86950 3137 46595892
Multiple-drug resistance 133.52 10.25 74 86959 2491 46596538
Toxicity to various agents 130.07 10.25 755 86278 211011 46388018
Psychotic disorder 124.96 10.25 181 86852 22440 46576589
Overdose 123.09 10.25 444 86589 101535 46497494
Joint swelling 123.00 10.25 79 86954 165994 46433035
Hyperammonaemic encephalopathy 122.24 10.25 64 86969 1918 46597111
Myokymia 121.60 10.25 23 87010 0 46599029
Somnolence 119.85 10.25 593 86440 155928 46443101
Acute kidney injury 119.41 10.25 159 86874 235696 46363333
Abortion spontaneous 118.98 10.25 256 86777 43390 46555639
Drug ineffective for unapproved indication 114.39 10.25 147 86886 16266 46582763
Irritability 112.18 10.25 197 86836 28749 46570280
Pneumonia 111.71 10.25 346 86687 375974 46223055
Aggression 108.57 10.25 170 86863 22574 46576455
Memory impairment 106.62 10.25 352 86681 76985 46522044
Disturbance in attention 106.13 10.25 202 86831 31358 46567671
Cognitive disorder 104.76 10.25 220 86813 36663 46562366
Febrile neutropenia 102.69 10.25 25 87008 94602 46504427
Acidosis hyperchloraemic 102.04 10.25 34 86999 306 46598723
Focal dyscognitive seizures 101.07 10.25 64 86969 2764 46596265
Headache 99.44 10.25 1342 85691 477010 46122019
Blindness 93.66 10.25 137 86896 17132 46581897
Ciliary body disorder 92.44 10.25 19 87014 10 46599019
Anorexia nervosa 91.22 10.25 27 87006 157 46598872
Diarrhoea 88.53 10.25 646 86387 558956 46040073
Flat anterior chamber of eye 87.38 10.25 21 87012 44 46598985
Acute myopia 87.05 10.25 23 87010 81 46598948
Suicide attempt 86.37 10.25 262 86771 54774 46544255
Cardiac failure congestive 85.52 10.25 32 87001 91718 46507311
Malignant neoplasm progression 81.37 10.25 12 87021 64914 46534115
Vision blurred 81.29 10.25 329 86704 79379 46519650
Dyspnoea 80.60 10.25 597 86436 514951 46084078
Synovitis 79.60 10.25 10 87023 61065 46537964
Cerebral venous thrombosis 75.67 10.25 48 86985 2079 46596950
Diplopia 75.09 10.25 132 86901 19273 46579756
Haemoglobin decreased 74.75 10.25 78 86955 128871 46470158
Drug interaction 74.45 10.25 639 86394 202455 46396574
Atrial fibrillation 74.33 10.25 51 86982 103539 46495490
Choroidal detachment 74.07 10.25 23 87010 161 46598868
Aphasia 73.79 10.25 164 86869 28403 46570626
Drug ineffective 72.69 10.25 1712 85321 676126 45922903
Abnormal behaviour 72.30 10.25 136 86897 20922 46578107
Intraocular pressure increased 71.85 10.25 71 86962 5886 46593143
Pemphigus 71.43 10.25 3 87030 45271 46553758
Pyrexia 70.95 10.25 372 86661 348430 46250599
Hyperammonaemia 69.88 10.25 63 86970 4653 46594376
Disease progression 69.53 10.25 42 86991 91258 46507771
Pancytopenia 67.81 10.25 37 86996 85021 46514008
Infusion related reaction 67.22 10.25 54 86979 101154 46497875
Maculopathy 66.58 10.25 40 86993 1571 46597458
Cardiac failure 66.36 10.25 33 87000 79915 46519114
Pleural effusion 66.25 10.25 36 86997 82916 46516113
Hypocitraturia 63.44 10.25 12 87021 0 46599029
Myoclonic epilepsy 63.26 10.25 32 87001 891 46598138
Arthralgia 62.87 10.25 410 86623 364193 46234836
Contraindicated product administered 61.97 10.25 36 86997 79911 46519118
Therapeutic response unexpected 61.43 10.25 107 86926 15509 46583520
Anxiety 61.24 10.25 562 86471 181395 46417634
Plasma cell myeloma 61.19 10.25 6 87027 44472 46554557
Multiple sclerosis relapse 60.96 10.25 195 86838 41930 46557099
Partial seizures 60.96 10.25 60 86973 4950 46594079
Coma blister 60.82 10.25 19 87014 136 46598893
Death 59.53 10.25 374 86659 335174 46263855
Bipolar disorder 59.23 10.25 70 86963 7107 46591922
Speech disorder 58.45 10.25 174 86859 35993 46563036
Infantile spasms 58.40 10.25 21 87012 242 46598787
Hyponatraemia 57.92 10.25 62 86971 101270 46497759
Tremor 57.55 10.25 391 86642 115248 46483781
Thrombocytopenia 56.50 10.25 93 86940 126488 46472541
Propofol infusion syndrome 56.24 10.25 28 87005 753 46598276
Amnesia 56.01 10.25 188 86845 41443 46557586
Mitochondrial DNULL mutation 55.57 10.25 20 87013 231 46598798
Necrotising colitis 55.27 10.25 25 87008 539 46598490
Aura 55.25 10.25 30 87003 969 46598060
Neutropenia 55.25 10.25 115 86918 143089 46455940
Sepsis 55.24 10.25 106 86927 135908 46463121
Self-induced vomiting 55.15 10.25 12 87021 12 46599017
Cough 54.72 10.25 232 86801 230017 46369012
Mucosal inflammation 54.30 10.25 5 87028 38971 46560058
Weight decreased 54.10 10.25 616 86417 210233 46388796
Weight increased 53.32 10.25 504 86529 163969 46435060
Amenorrhoea 53.29 10.25 74 86959 8821 46590208
Mania 53.05 10.25 82 86951 10764 46588265
Infection 52.62 10.25 106 86927 133486 46465543
Drug withdrawal convulsions 52.09 10.25 32 87001 1309 46597720
Gastrointestinal haemorrhage 51.73 10.25 41 86992 77332 46521697
General physical health deterioration 51.72 10.25 85 86948 115684 46483345
C-reactive protein increased 50.44 10.25 23 87010 58567 46540462
Anhidrosis 49.59 10.25 15 87018 95 46598934
Corneal oedema 48.46 10.25 33 87000 1613 46597416
Benign familial pemphigus 47.58 10.25 9 87024 0 46599029
Blindness transient 46.69 10.25 43 86990 3264 46595765
Hallucination, auditory 46.67 10.25 77 86956 10679 46588350
Alexia 45.96 10.25 10 87023 10 46599019
Abdominal discomfort 45.40 10.25 138 86895 151027 46448002
Lower respiratory tract infection 45.32 10.25 23 87010 55066 46543963
Pregnancy 45.22 10.25 132 86901 27005 46572024
Oligomenorrhoea 44.77 10.25 23 87010 662 46598367
Mood altered 44.64 10.25 84 86949 12923 46586106
Tonic convulsion 44.52 10.25 27 87006 1079 46597950
Hand deformity 44.23 10.25 6 87027 34568 46564461
Sluggishness 44.20 10.25 49 86984 4642 46594387
Myocardial infarction 44.12 10.25 71 86962 97457 46501572
Dysarthria 44.11 10.25 162 86871 37336 46561693
Renal failure 43.99 10.25 91 86942 113503 46485526
Salivary gland calculus 43.98 10.25 15 87018 146 46598883
Bradyphrenia 43.72 10.25 56 86977 6174 46592855
Peripheral swelling 43.51 10.25 150 86883 157921 46441108
Blood creatinine increased 43.38 10.25 47 86986 76356 46522673
Crying 42.35 10.25 110 86923 21031 46577998
Product physical issue 42.23 10.25 49 86984 4878 46594151
Renal impairment 41.94 10.25 46 86987 74326 46524703
Hypoaesthesia 41.92 10.25 371 86662 118498 46480531
Slow speech 41.72 10.25 28 87005 1336 46597693
Visual field defect 41.63 10.25 54 86979 6029 46593000
Mood swings 41.62 10.25 93 86940 16159 46582870
Withdrawal syndrome 41.21 10.25 99 86934 18035 46580994
Eye pain 41.02 10.25 130 86903 27810 46571219
Visual impairment 40.95 10.25 238 86795 66451 46532578
Drug resistance 40.74 10.25 96 86937 17272 46581757
Bezoar 40.71 10.25 28 87005 1391 46597638
Iris adhesions 40.19 10.25 17 87016 310 46598719
Product use in unapproved indication 40.10 10.25 297 86736 89976 46509053
Osteonecrosis of jaw 39.50 10.25 8 87025 34394 46564635
Interstitial lung disease 39.43 10.25 26 87007 53923 46545106
Road traffic accident 39.25 10.25 115 86918 23576 46575453
Visual acuity reduced 39.21 10.25 110 86923 22003 46577026
Multiple sclerosis 38.85 10.25 118 86915 24673 46574356
Muscle twitching 38.75 10.25 85 86948 14587 46584442
Iridocyclitis 38.39 10.25 31 87002 1969 46597060
Ammonia increased 38.31 10.25 44 86989 4333 46594696
Photophobia 38.12 10.25 84 86949 14460 46584569
Hypophosphataemic osteomalacia 38.07 10.25 13 87020 127 46598902
Dehydration 37.10 10.25 162 86871 159378 46439651
Arthropathy 37.07 10.25 63 86970 84637 46514392
Nephrocalcinosis 36.94 10.25 23 87010 964 46598065
Sedation 36.80 10.25 110 86923 22800 46576229
Rash 36.71 10.25 457 86576 356055 46242974
Change in seizure presentation 36.32 10.25 15 87018 257 46598772
Dysphemia 35.92 10.25 32 87001 2326 46596703
Angiofibroma 35.92 10.25 12 87021 109 46598920
Sudden unexplained death in epilepsy 35.44 10.25 15 87018 274 46598755
Nasopharyngitis 35.43 10.25 157 86876 153841 46445188
Alice in wonderland syndrome 35.41 10.25 9 87024 26 46599003
Atonic seizures 35.35 10.25 19 87014 601 46598428
Fanconi syndrome 34.99 10.25 22 87011 938 46598091
Anticonvulsant drug level decreased 34.41 10.25 24 87009 1220 46597809
Simple partial seizures 33.94 10.25 18 87015 554 46598475
Medication overuse headache 33.88 10.25 17 87016 465 46598564
Bone marrow failure 33.85 10.25 7 87026 29662 46569367
Wound 33.55 10.25 19 87014 42783 46556246
Paranoia 33.38 10.25 66 86967 10531 46588498
Erythema 33.22 10.25 145 86888 142675 46456354
Suicidal behaviour 32.96 10.25 31 87002 2417 46596612
Gene mutation 32.62 10.25 22 87011 1058 46597971
Mental disorder 32.61 10.25 104 86929 22321 46576708
Cholecystitis chronic 32.60 10.25 65 86968 10434 46588595
Nystagmus 32.05 10.25 46 86987 5653 46593376
Ciliary muscle spasm 31.72 10.25 6 87027 0 46599029
Ataxia 31.60 10.25 76 86957 13854 46585175
Tardive dyskinesia 31.39 10.25 53 86980 7490 46591539
Septic shock 31.35 10.25 37 86996 57856 46541173
Productive cough 31.30 10.25 29 87004 50686 46548343
Hyperkalaemia 31.29 10.25 29 87004 50680 46548349
Brugada syndrome 31.25 10.25 13 87020 227 46598802
Granuloma annulare 31.23 10.25 16 87017 458 46598571
Somnambulism 30.31 10.25 42 86991 4995 46594034
Glossodynia 30.30 10.25 23 87010 44350 46554679
Affective disorder 30.26 10.25 41 86992 4774 46594255
Intentional product misuse 30.11 10.25 170 86863 46958 46552071
Fluid overload 29.83 10.25 7 87026 27178 46571851
Stomatitis 29.70 10.25 51 86982 68246 46530783
Coronary artery disease 29.44 10.25 13 87020 33739 46565290
Dizziness 29.26 10.25 836 86197 339578 46259451
Cervix neoplasm 29.19 10.25 12 87021 203 46598826
Blood prolactin increased 29.18 10.25 32 87001 2995 46596034
Bulimia nervosa 29.13 10.25 16 87017 529 46598500
Thalamic infarction 29.13 10.25 16 87017 529 46598500
Blepharospasm 29.10 10.25 28 87005 2246 46596783
Platelet count decreased 28.82 10.25 93 86940 99931 46499098
Cellulitis 28.32 10.25 55 86978 70233 46528796
Acute myocardial infarction 28.31 10.25 12 87021 31912 46567117
Hypoxia 28.20 10.25 33 87000 51805 46547224
Psychogenic seizure 28.11 10.25 21 87012 1189 46597840
Hypomagnesaemia 28.06 10.25 4 87029 22206 46576823
Feeling abnormal 27.92 10.25 356 86677 124704 46474325
Major depression 27.83 10.25 47 86986 6643 46592386
Pulmonary arterial hypertension 27.82 10.25 7 87026 25921 46573108
Respiratory alkalosis 27.81 10.25 29 87004 2562 46596467
Malaise 27.55 10.25 443 86590 330789 46268240
Melaena 27.04 10.25 9 87024 27763 46571266
Retinogram abnormal 26.86 10.25 10 87023 128 46598901
Blood gases abnormal 26.78 10.25 16 87017 622 46598407
Galactorrhoea 26.44 10.25 34 86999 3763 46595266
Angiomyolipoma 26.29 10.25 11 87022 195 46598834
Lennox-Gastaut syndrome 26.27 10.25 12 87021 265 46598764
Ascites 26.24 10.25 18 87015 36566 46562463
Cardiac malposition 26.01 10.25 8 87025 54 46598975
Granulomatous dermatitis 25.65 10.25 9 87024 96 46598933
Conjunctival oedema 25.41 10.25 15 87018 570 46598459
Anticonvulsant drug level above therapeutic 24.89 10.25 14 87019 485 46598544
Iris disorder 24.73 10.25 8 87025 65 46598964
Hypersomnia 24.67 10.25 74 86959 15365 46583664
Macular detachment 24.62 10.25 8 87025 66 46598963
Heat stroke 24.56 10.25 15 87018 607 46598422
Retinitis pigmentosa 24.55 10.25 9 87024 110 46598919
Paradoxical drug reaction 24.45 10.25 26 87007 2350 46596679
Lymphangioleiomyomatosis 24.39 10.25 10 87023 168 46598861
Phonophobia 24.30 10.25 12 87021 317 46598712
Tearfulness 24.17 10.25 34 86999 4101 46594928
Anger 24.08 10.25 62 86971 11790 46587239
Drug withdrawal syndrome 24.00 10.25 108 86925 27276 46571753
Insomnia 23.85 10.25 436 86597 164488 46434541
Apathy 23.78 10.25 46 86987 7222 46591807
Injury 23.77 10.25 152 86881 43875 46555154
Systemic lupus erythematosus 23.74 10.25 54 86979 65126 46533903
Necrotising enterocolitis neonatal 23.71 10.25 10 87023 181 46598848
Off label use 23.66 10.25 898 86135 378943 46220086
Respiratory arrest 23.63 10.25 125 86908 33691 46565338
Frontal lobe epilepsy 23.50 10.25 5 87028 4 46599025
Swelling 23.47 10.25 136 86897 124375 46474654
Drug abuse 23.42 10.25 200 86833 63208 46535821
Persistent left superior vena cava 23.33 10.25 7 87026 43 46598986
Skin ulcer 23.24 10.25 16 87017 32442 46566587
Fluid retention 23.23 10.25 37 86996 51009 46548020
Affect lability 22.95 10.25 48 86985 7972 46591057
Pericarditis 22.87 10.25 8 87025 23919 46575110
Agitation 22.73 10.25 179 86854 55236 46543793
Eating disorder 22.26 10.25 69 86964 14585 46584444
Neoplasm progression 22.15 10.25 11 87022 26672 46572357
Blood bicarbonate decreased 21.95 10.25 27 87006 2858 46596171
Eye movement disorder 21.73 10.25 35 86998 4758 46594271
Hypohidrosis 21.73 10.25 6 87027 26 46599003
Pulmonary hypertension 21.72 10.25 21 87012 35972 46563057
Anomalous pulmonary venous connection 21.62 10.25 7 87026 57 46598972
Pulmonary oedema 21.46 10.25 39 86994 51066 46547963
Drug screen positive 21.28 10.25 31 87002 3860 46595169
Vertigo 21.28 10.25 168 86865 51880 46547149
Acquired haemophilia 21.28 10.25 16 87017 915 46598114
Myoclonus 21.27 10.25 67 86966 14285 46584744
Ureterolithiasis 21.25 10.25 21 87012 1741 46597288
Application site discolouration 21.22 10.25 15 87018 779 46598250
Biliary dyskinesia 21.17 10.25 26 87007 2747 46596282
Anticonvulsant drug level increased 21.10 10.25 19 87014 1401 46597628
Blood pressure systolic increased 20.86 10.25 14 87019 28773 46570256
Intellectual disability 20.86 10.25 14 87019 668 46598361
Hypertension 20.80 10.25 250 86783 196106 46402923
Musculoskeletal stiffness 20.70 10.25 103 86930 97890 46501139
Electroencephalogram abnormal 20.67 10.25 30 87003 3724 46595305
Thinking abnormal 20.62 10.25 52 86981 9762 46589267
Lymphomatoid papulosis 20.46 10.25 8 87025 118 46598911
Anoxia 20.43 10.25 10 87023 259 46598770
Convulsive threshold lowered 20.10 10.25 11 87022 361 46598668
Balance disorder 20.02 10.25 196 86837 64325 46534704
Small for dates baby 19.93 10.25 29 87004 3608 46595421
Apnoea 19.93 10.25 43 86990 7296 46591733
Idiopathic intracranial hypertension 19.93 10.25 24 87009 2485 46596544
Depressed mood 19.85 10.25 118 86915 33201 46565828
Open angle glaucoma 19.82 10.25 10 87023 277 46598752
Screaming 19.79 10.25 27 87006 3164 46595865
Calculus urinary 19.73 10.25 15 87018 872 46598157
Dyspnoea exertional 19.70 10.25 40 86993 50249 46548780
Metastases to liver 19.68 10.25 6 87027 19579 46579450
Neuropathy peripheral 19.51 10.25 95 86938 90798 46508231
Oedema peripheral 19.43 10.25 197 86836 159509 46439520
Blastocystis infection 19.29 10.25 5 87028 16 46599013
Knee arthroplasty 19.28 10.25 10 87023 23655 46575374
Psychomotor hyperactivity 19.23 10.25 50 86983 9563 46589466
Heart rate 19.20 10.25 6 87027 43 46598986
Lung disorder 19.13 10.25 32 87001 43272 46555757
Epistaxis 19.07 10.25 59 86974 64246 46534783
Osteoarthritis 19.05 10.25 56 86977 61969 46537060
Homicidal ideation 19.04 10.25 20 87013 1782 46597247
Drug level decreased 18.84 10.25 37 86996 5875 46593154
Disseminated intravascular coagulation 18.78 10.25 6 87027 18999 46580030
Decreased interest 18.55 10.25 26 87007 3126 46595903
Urinary tract infection 18.48 10.25 294 86739 219972 46379057
Laryngeal stenosis 18.36 10.25 13 87020 677 46598352
Acidosis 18.28 10.25 54 86979 11120 46587909
Pre-existing condition improved 18.25 10.25 39 86994 6573 46592456
Pruritus 18.22 10.25 330 86703 242022 46357007
Central nervous system lesion 18.21 10.25 49 86984 9566 46589463
Migraine with aura 18.20 10.25 21 87012 2078 46596951
Vestibular migraine 18.11 10.25 7 87026 100 46598929
Rectal haemorrhage 18.10 10.25 27 87006 38228 46560801
Hypotension 18.02 10.25 315 86718 232274 46366755
Osteonecrosis 18.02 10.25 13 87020 25731 46573298
Confusional state 17.91 10.25 407 86626 159485 46439544
Hip fracture 17.83 10.25 14 87019 26542 46572487
Drug dependence 17.82 10.25 79 86954 19822 46579207
Bone pain 17.77 10.25 38 86995 46852 46552177
Gallbladder disorder 17.63 10.25 72 86961 17426 46581603
Cleft lip and palate 17.58 10.25 10 87023 354 46598675
Retinal detachment 17.58 10.25 33 87000 5067 46593962
C-reactive protein abnormal 17.31 10.25 9 87024 21261 46577768
Hallucinations, mixed 17.30 10.25 28 87005 3821 46595208
Toxic epidermal necrolysis 17.30 10.25 10 87023 22268 46576761
Benzodiazepine drug level increased 17.29 10.25 8 87025 182 46598847
Borderline personality disorder 17.26 10.25 13 87020 745 46598284
Cleft lip 17.22 10.25 7 87026 115 46598914
Pulmonary fibrosis 17.11 10.25 8 87025 20084 46578945
Libido increased 17.05 10.25 13 87020 759 46598270
Product administered to patient of inappropriate age 17.01 10.25 23 87010 2673 46596356
Respiratory disorder neonatal 17.00 10.25 14 87019 914 46598115
Nodular rash 16.94 10.25 8 87025 191 46598838
Asthenia 16.92 10.25 446 86587 310629 46288400
Personality change 16.86 10.25 33 87000 5225 46593804
Developmental hip dysplasia 16.80 10.25 16 87017 1267 46597762
Hypotonia 16.67 10.25 43 86990 8186 46590843
Congenital hand malformation 16.65 10.25 9 87024 288 46598741
Pneumocystis jirovecii pneumonia 16.59 10.25 4 87029 15244 46583785
Wheezing 16.54 10.25 48 86985 53338 46545691
Mental impairment 16.52 10.25 56 86977 12400 46586629
Therapeutic product effective for unapproved indication 16.47 10.25 6 87027 72 46598957
Metastases to bone 16.43 10.25 6 87027 17470 46581559
Posterior reversible encephalopathy syndrome 16.41 10.25 4 87029 15137 46583892
Dysmorphism 16.40 10.25 19 87014 1888 46597141
Occipital neuralgia 16.34 10.25 9 87024 299 46598730
Self esteem decreased 16.27 10.25 11 87022 531 46598498
Oedema 16.25 10.25 67 86966 67004 46532025
Dystonia 16.18 10.25 52 86981 11205 46587824
Neonatal seizure 16.15 10.25 9 87024 306 46598723
Central obesity 16.12 10.25 13 87020 824 46598205
Disorientation 16.11 10.25 121 86912 36797 46562232
Congenital mitral valve incompetence 16.10 10.25 5 87028 35 46598994
Blood thyroid stimulating hormone normal 16.10 10.25 7 87026 137 46598892
Coma 16.07 10.25 173 86860 58176 46540853
Urine calcium/creatinine ratio increased 16.05 10.25 7 87026 138 46598891
Depressed level of consciousness 15.99 10.25 147 86886 47422 46551607
Lactic acidosis 15.98 10.25 24 87009 33885 46565144
Hydrocele 15.86 10.25 3 87030 0 46599029
Partial seizures with secondary generalisation 15.81 10.25 9 87024 319 46598710
Hip arthroplasty 15.75 10.25 7 87026 18105 46580924
Status migrainosus 15.69 10.25 6 87027 83 46598946
Prescribed overdose 15.69 10.25 49 86984 10400 46588629
Temperature intolerance 15.66 10.25 40 86993 7567 46591462
Endometriosis 15.65 10.25 27 87006 3883 46595146
Drug level increased 15.61 10.25 72 86961 18369 46580660
Brain oedema 15.60 10.25 55 86978 12423 46586606
Acute myeloid leukaemia 15.56 10.25 5 87028 15773 46583256
Red blood cell sedimentation rate increased 15.45 10.25 12 87021 22877 46576152
Failed induction of labour 15.39 10.25 9 87024 336 46598693
Emotional distress 15.35 10.25 104 86929 30603 46568426
Lichen planus 15.33 10.25 18 87015 1815 46597214
Night blindness 15.22 10.25 9 87024 343 46598686
Carbon dioxide decreased 15.18 10.25 18 87015 1833 46597196
Congenital anomaly in offspring 15.14 10.25 7 87026 159 46598870
Herpes zoster 15.11 10.25 70 86963 67802 46531227
Diverticulitis 14.98 10.25 24 87009 33015 46566014
Post-traumatic stress disorder 14.97 10.25 27 87006 4021 46595008
Panic attack 14.95 10.25 76 86957 20166 46578863
Bacteraemia 14.88 10.25 4 87029 14175 46584854
Atrial septal defect 14.85 10.25 35 86998 6297 46592732
Arthritis 14.80 10.25 84 86949 77232 46521797
Breast cancer 14.78 10.25 40 86993 45478 46553551
Congenital diaphragmatic eventration 14.74 10.25 4 87029 16 46599013
Plasmodium falciparum infection 14.72 10.25 5 87028 48 46598981
Seizure cluster 14.71 10.25 7 87026 170 46598859
International normalised ratio increased 14.63 10.25 42 86991 46841 46552188
Amino acid level increased 14.63 10.25 8 87025 262 46598767
Pregnancy on oral contraceptive 14.44 10.25 15 87018 1319 46597710
Cytomegalovirus infection 14.29 10.25 8 87025 18136 46580893
Hostility 14.18 10.25 15 87018 1347 46597682
Obsessive thoughts 14.12 10.25 10 87023 521 46598508
Slow response to stimuli 14.10 10.25 12 87021 820 46598209
Breast cancer metastatic 14.09 10.25 4 87029 13674 46585355
Enuresis 14.07 10.25 18 87015 1982 46597047
Dysgeusia 14.06 10.25 126 86907 40365 46558664
Ovarian germ cell cancer stage II 14.03 10.25 5 87028 56 46598973
Ejection fraction decreased 14 10.25 8 87025 17929 46581100
Toxic skin eruption 13.97 10.25 3 87030 12384 46586645
Bursitis 13.91 10.25 10 87023 19832 46579197
Illogical thinking 13.87 10.25 5 87028 58 46598971
Psychomotor retardation 13.83 10.25 23 87010 3210 46595819
Potassium wasting nephropathy 13.80 10.25 5 87028 59 46598970
Ventricular septal defect 13.78 10.25 26 87007 4008 46595021
Cerebral venous sinus thrombosis 13.75 10.25 17 87016 1808 46597221
Impaired healing 13.74 10.25 30 87003 36713 46562316
Self-injurious ideation 13.57 10.25 19 87014 2281 46596748
Blood lactate dehydrogenase increased 13.52 10.25 11 87022 20489 46578540
Basal cell carcinoma 13.50 10.25 11 87022 20476 46578553
Full blood count decreased 13.35 10.25 13 87020 22198 46576831
Product counterfeit 13.32 10.25 6 87027 128 46598901
Serous retinal detachment 13.32 10.25 6 87027 128 46598901
Serotonin syndrome 13.31 10.25 84 86949 24136 46574893
Lethargy 13.30 10.25 150 86883 51021 46548008
Glycosuria 13.28 10.25 13 87020 1065 46597964
Therapeutic response changed 13.19 10.25 11 87022 731 46598298
Intracranial hypotension 13.16 10.25 8 87025 321 46598708
Hypersensitivity 13.15 10.25 199 86834 150122 46448907
Cleft palate 13.10 10.25 12 87021 905 46598124
Familial periodic paralysis 13.09 10.25 5 87028 69 46598960
Blood chloride increased 13.09 10.25 20 87013 2599 46596430
Gambling disorder 13.01 10.25 14 87019 1282 46597747
Hyperventilation 13.01 10.25 31 87002 5616 46593413
Optic neuritis 12.99 10.25 35 86998 6836 46592193
Blood lactic acid increased 12.97 10.25 31 87002 5626 46593403
Inflammation 12.93 10.25 47 86986 48734 46550295
Fear 12.86 10.25 62 86971 16110 46582919
Presyncope 12.84 10.25 16 87017 24438 46574591
Sleep apnoea syndrome 12.83 10.25 78 86955 22123 46576906
Photopsia 12.81 10.25 25 87008 3951 46595078
Hypopnoea 12.78 10.25 19 87014 2409 46596620
Snoring 12.78 10.25 23 87010 3419 46595610
Housebound 12.75 10.25 7 87026 231 46598798
Blood bilirubin increased 12.71 10.25 28 87005 34156 46564873
Product dispensing error 12.68 10.25 42 86991 9191 46589838
Accommodation disorder 12.60 10.25 8 87025 347 46598682
Psychotic behaviour 12.59 10.25 10 87023 620 46598409
Pneumonitis 12.55 10.25 21 87012 28399 46570630
Exposure via breast milk 12.53 10.25 14 87019 1338 46597691
Hereditary angioedema 12.41 10.25 30 87003 5486 46593543
Pulmonary eosinophilia 12.41 10.25 7 87026 244 46598785
Femur fracture 12.40 10.25 32 87001 36965 46562064
Myelodysplastic syndrome 12.27 10.25 7 87026 15704 46583325
Suspiciousness 12.24 10.25 8 87025 365 46598664
Oral pain 12.23 10.25 17 87016 24780 46574249
Papilloedema 12.15 10.25 23 87010 3554 46595475
Hepatic function abnormal 12.14 10.25 29 87004 34392 46564637
Lack of spontaneous speech 12.13 10.25 6 87027 159 46598870
Depersonalisation/derealisation disorder 12.11 10.25 12 87021 998 46598031
Binge eating 12.10 10.25 8 87025 372 46598657
Complex regional pain syndrome 12.09 10.25 17 87016 2049 46596980
Neutrophil count decreased 12.07 10.25 41 86992 43385 46555644
Delusion 12.05 10.25 47 86986 11141 46587888
Motor developmental delay 11.98 10.25 5 87028 88 46598941
Dissociative disorder 11.96 10.25 6 87027 164 46598865
Inappropriate affect 11.90 10.25 11 87022 839 46598190
Cholestasis 11.76 10.25 20 87013 26873 46572156
Impaired driving ability 11.76 10.25 25 87008 4199 46594830
Condition aggravated 11.76 10.25 564 86469 244488 46354541
Cluster headache 11.71 10.25 9 87024 532 46598497
Spinal fracture 11.70 10.25 7 87026 15298 46583731
Educational problem 11.63 10.25 7 87026 276 46598753
Concussion 11.60 10.25 34 86999 6969 46592060
Crystal urine present 11.60 10.25 13 87020 1246 46597783
Basilar migraine 11.54 10.25 4 87029 41 46598988
Bipolar II disorder 11.49 10.25 7 87026 282 46598747
Sialoadenitis 11.43 10.25 13 87020 1267 46597762
Hypercalciuria 11.39 10.25 6 87027 182 46598847
Application site erythema 11.38 10.25 27 87006 4877 46594152
Psychomotor skills impaired 11.36 10.25 17 87016 2169 46596860
Maternal drugs affecting foetus 11.35 10.25 29 87004 5489 46593540
Lack of injection site rotation 11.33 10.25 6 87027 184 46598845
Migraine without aura 11.27 10.25 6 87027 186 46598843
Oxygen saturation decreased 11.25 10.25 79 86954 69085 46529944
Disinhibition 11.25 10.25 11 87022 900 46598129
Impulsive behaviour 11.24 10.25 14 87019 1501 46597528
Blunted affect 11.22 10.25 6 87027 188 46598841
Bronchitis 11.18 10.25 135 86898 105844 46493185
Granulocytopenia 11.14 10.25 28 87005 5245 46593784
Hemiplegic migraine 11.13 10.25 4 87029 46 46598983
Fungal infection 11.12 10.25 24 87009 29496 46569533
Multiple organ dysfunction syndrome 11.12 10.25 54 86979 51656 46547373
Mydriasis 11.09 10.25 44 86989 10509 46588520
Helicobacter infection 11.08 10.25 4 87029 11732 46587297
Delayed sleep phase 11.05 10.25 3 87030 12 46599017
Calcinosis 11.02 10.25 15 87018 1754 46597275
Haemoptysis 10.98 10.25 20 87013 26169 46572860
Blood pressure increased 10.97 10.25 168 86865 126498 46472531
Blood urea increased 10.95 10.25 19 87014 25333 46573696
Muscle contractions involuntary 10.93 10.25 16 87017 2002 46597027
Oral herpes 10.92 10.25 12 87021 19378 46579651
Bronchospasm 10.90 10.25 8 87025 15699 46583330
Exophthalmos 10.86 10.25 12 87021 1133 46597896
Congenital anomaly 10.83 10.25 14 87019 1558 46597471
Therapeutic product ineffective for unapproved indication 10.82 10.25 6 87027 202 46598827
Device related infection 10.81 10.25 14 87019 21027 46578002
Gallbladder cholesterolosis 10.73 10.25 10 87023 771 46598258
White blood cell count decreased 10.72 10.25 146 86887 112085 46486944
Limb malformation 10.71 10.25 8 87025 453 46598576
Corneal pigmentation 10.68 10.25 3 87030 14 46599015
Dropped head syndrome 10.68 10.25 5 87028 117 46598912
Poisoning 10.66 10.25 53 86980 13941 46585088
Tongue ulceration 10.64 10.25 20 87013 3073 46595956
Social avoidant behaviour 10.58 10.25 19 87014 2820 46596209
Cerebral infarction 10.57 10.25 17 87016 23349 46575680
Developmental delay 10.54 10.25 12 87021 1170 46597859
Circadian rhythm sleep disorder 10.53 10.25 6 87027 213 46598816
Decreased nasolabial fold 10.51 10.25 3 87030 15 46599014
Jaundice 10.42 10.25 24 87009 28821 46570208
Haematoma 10.36 10.25 28 87005 31844 46567185
Bed rest 10.36 10.25 4 87029 57 46598972
Vertebral osteophyte 10.32 10.25 7 87026 340 46598689
Threatened labour 10.30 10.25 10 87023 811 46598218

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 1090.83 12.84 832 27570 97643 29826433
Status epilepticus 365.47 12.84 188 28214 10884 29913192
Angle closure glaucoma 295.62 12.84 79 28323 655 29923421
Epilepsy 291.52 12.84 201 28201 19968 29904108
Heat stroke 246.22 12.84 71 28331 799 29923277
Drug ineffective 191.50 12.84 730 27672 339657 29584419
Aggression 178.87 12.84 197 28205 36710 29887366
Somnolence 171.17 12.84 319 28083 96444 29827632
Myopia 169.70 12.84 49 28353 554 29923522
Hyperammonaemia 162.88 12.84 87 28315 5433 29918643
Generalised tonic-clonic seizure 147.84 12.84 133 28269 19418 29904658
Migraine 144.20 12.84 110 28292 12764 29911312
Sedation 135.01 12.84 117 28285 16256 29907820
Ataxia 132.94 12.84 100 28302 11362 29912714
Product substitution issue 126.37 12.84 92 28310 9943 29914133
Infantile spasms 119.54 12.84 32 28370 267 29923809
Choroidal effusion 117.08 12.84 28 28374 139 29923937
Nephrolithiasis 115.95 12.84 130 28272 24680 29899396
Foetal exposure during pregnancy 115.55 12.84 158 28244 36713 29887363
Multiple-drug resistance 114.83 12.84 56 28346 2885 29921191
Partial seizures 107.29 12.84 58 28344 3709 29920367
Cognitive disorder 98.70 12.84 117 28285 23573 29900503
Anhidrosis 97.07 12.84 22 28380 82 29923994
Sudden unexplained death in epilepsy 85.42 12.84 27 28375 423 29923653
Anaemia 83.22 12.84 47 28355 207945 29716131
Hyperammonaemic encephalopathy 80.77 12.84 38 28364 1806 29922270
Dyspnoea 78.59 12.84 122 28280 333173 29590903
Focal dyscognitive seizures 73.15 12.84 32 28370 1281 29922795
Hypospadias 72.83 12.84 40 28362 2639 29921437
Abnormal behaviour 70.18 12.84 103 28299 25520 29898556
Myokymia 69.70 12.84 16 28386 64 29924012
Psychotic disorder 68.58 12.84 93 28309 21422 29902654
Death 68.04 12.84 149 28253 357134 29566942
Ammonia increased 67.73 12.84 45 28357 4196 29919880
Flat anterior chamber of eye 66.59 12.84 15 28387 54 29924022
Disturbance in attention 66.54 12.84 93 28309 22036 29902040
Petit mal epilepsy 65.29 12.84 37 28365 2594 29921482
Memory impairment 64.85 12.84 122 28280 37052 29887024
Drug resistance 64.13 12.84 87 28315 20046 29904030
Febrile neutropenia 63.73 12.84 12 28390 106681 29817395
Suicidal ideation 62.35 12.84 118 28284 35996 29888080
Acidosis hyperchloraemic 61.76 12.84 19 28383 271 29923805
Pneumonia 61.51 12.84 142 28260 334164 29589912
Acute kidney injury 60.94 12.84 104 28298 273738 29650338
Hyperthermia 59.73 12.84 60 28342 10039 29914037
Speech disorder 59.28 12.84 93 28309 24419 29899657
Cleft lip 59.17 12.84 19 28383 314 29923762
Developmental delay 58.29 12.84 32 28370 2109 29921967
Intentional self-injury 58.28 12.84 68 28334 13464 29910612
Renal tubular acidosis 57.37 12.84 30 28372 1792 29922284
Maculopathy 50.45 12.84 22 28380 874 29923202
Encephalopathy 50.44 12.84 101 28301 32104 29891972
Diarrhoea 50.04 12.84 157 28245 333946 29590130
Metabolic acidosis 48.83 12.84 109 28293 37352 29886724
Drug interaction 47.69 12.84 338 28064 199230 29724846
Drug ineffective for unapproved indication 47.40 12.84 55 28347 10825 29913251
Irritability 47.02 12.84 81 28321 22969 29901107
Myoclonus 46.19 12.84 60 28342 13252 29910824
Exposure during pregnancy 45.78 12.84 50 28352 9211 29914865
Drug withdrawal convulsions 45.03 12.84 22 28380 1137 29922939
Angular cheilitis 43.82 12.84 12 28390 110 29923966
Atrial fibrillation 43.79 12.84 24 28378 108100 29815976
Multiple drug therapy 43.51 12.84 14 28388 233 29923843
Cardiac failure congestive 43.49 12.84 13 28389 84394 29839682
Interstitial lung disease 42.50 12.84 4 28398 60193 29863883
Nystagmus 41.94 12.84 34 28368 4304 29919772
Small for dates baby 41.72 12.84 30 28372 3178 29920898
Malignant neoplasm progression 41.34 12.84 9 28393 72278 29851798
Dysmorphism 41.18 12.84 25 28377 1992 29922084
Delusion of replacement 40.90 12.84 12 28390 144 29923932
Premature baby 39.90 12.84 63 28339 16628 29907448
Behaviour disorder 39.50 12.84 26 28376 2386 29921690
Anticonvulsant drug level increased 39.48 12.84 22 28380 1493 29922583
Toxicity to various agents 38.80 12.84 294 28108 176889 29747187
Acid-base balance disorder mixed 38.57 12.84 7 28395 4 29924072
Hyperchloraemia 38.44 12.84 15 28387 447 29923629
Drug level fluctuating 38.32 12.84 15 28387 451 29923625
Congenital hand malformation 38.32 12.84 15 28387 451 29923625
Atrial septal defect 38.14 12.84 39 28363 6662 29917414
Cardiac failure 37.60 12.84 16 28386 83402 29840674
Completed suicide 37.52 12.84 190 28212 99302 29824774
Nasal septum disorder 36.94 12.84 9 28393 49 29924027
Fanconi syndrome 36.24 12.84 22 28380 1753 29922323
Agitation 35.99 12.84 123 28279 53950 29870126
Intellectual disability 35.87 12.84 17 28385 821 29923255
Lethargy 35.70 12.84 100 28302 39419 29884657
Plagiocephaly 35.61 12.84 13 28389 321 29923755
Priapism 35.30 12.84 32 28370 4711 29919365
Blood homocysteine increased 34.65 12.84 12 28390 253 29923823
Autonomic nervous system imbalance 34.63 12.84 24 28378 2397 29921679
Patient dissatisfaction with treatment 34.52 12.84 9 28393 67 29924009
Tremor 34.29 12.84 152 28250 75211 29848865
Vision blurred 34.09 12.84 102 28300 41714 29882362
Hallucination, auditory 33.77 12.84 44 28358 9745 29914331
Intentional overdose 33.65 12.84 101 28301 41380 29882696
Microcephaly 33.46 12.84 15 28387 637 29923439
Hypothermia 33.00 12.84 43 28359 9524 29914552
Cleft lip and palate 32.96 12.84 12 28390 294 29923782
Partial seizures with secondary generalisation 32.40 12.84 11 28391 218 29923858
Bradyphrenia 32.04 12.84 28 28374 3929 29920147
Gait disturbance 31.92 12.84 148 28254 74629 29849447
Mood altered 31.49 12.84 39 28363 8211 29915865
Depressed mood 31.07 12.84 57 28345 16972 29907104
Low birth weight baby 30.37 12.84 33 28369 6043 29918033
Non-24-hour sleep-wake disorder 30.11 12.84 7 28395 30 29924046
Hypotonia 30.05 12.84 35 28367 6913 29917163
Rhinolithiasis 29.81 12.84 5 28397 0 29924076
Ehlers-Danlos syndrome 29.23 12.84 7 28395 35 29924041
Pleural effusion 29.17 12.84 17 28385 74049 29850027
Hyperexplexia 28.90 12.84 7 28395 37 29924039
Social avoidant behaviour 28.87 12.84 23 28379 2840 29921236
Electroencephalogram abnormal 28.15 12.84 21 28381 2353 29921723
Optic atrophy 27.98 12.84 14 28388 762 29923314
Plasma cell myeloma 27.96 12.84 8 28394 53454 29870622
Persecutory delusion 27.80 12.84 20 28382 2120 29921956
Therapeutic response unexpected 27.62 12.84 38 28364 8865 29915211
Haemoglobin decreased 27.49 12.84 41 28361 114057 29810019
Hypotension 27.36 12.84 98 28304 200467 29723609
Product administered to patient of inappropriate age 26.87 12.84 21 28381 2522 29921554
Cough 26.69 12.84 49 28353 125593 29798483
Perseveration 26.68 12.84 8 28394 104 29923972
Myocardial infarction 26.68 12.84 49 28353 125576 29798500
Staring 26.68 12.84 17 28385 1476 29922600
Disease progression 26.59 12.84 22 28380 79852 29844224
Intensive care unit acquired weakness 26.44 12.84 14 28388 858 29923218
Off label use 26.41 12.84 356 28046 248934 29675142
Erectile dysfunction 26.24 12.84 55 28347 18047 29906029
Coagulation disorder neonatal 26.14 12.84 6 28396 24 29924052
Tooth discolouration 25.98 12.84 10 28392 287 29923789
Renal failure 25.91 12.84 52 28350 128914 29795162
Sleep-related eating disorder 25.88 12.84 10 28392 290 29923786
Product use issue 25.80 12.84 99 28303 45917 29878159
Pyrexia 25.59 12.84 169 28233 294320 29629756
Dissociation 25.57 12.84 15 28387 1122 29922954
Hypohidrosis 25.42 12.84 9 28393 203 29923873
Madarosis 24.93 12.84 9 28393 215 29923861
Hyperkalaemia 24.81 12.84 16 28386 65994 29858082
Retinal disorder 24.79 12.84 14 28388 975 29923101
Renal impairment 24.71 12.84 26 28376 84158 29839918
Bicuspid aortic valve 24.47 12.84 9 28393 227 29923849
Myoclonic epilepsy 24.31 12.84 13 28389 813 29923263
Gastrointestinal haemorrhage 24.24 12.84 26 28376 83420 29840656
Pseudomyopia 23.85 12.84 4 28398 0 29924076
Ascites 23.79 12.84 3 28399 35918 29888158
Psychomotor retardation 23.75 12.84 19 28383 2360 29921716
Abdominal pain 23.73 12.84 59 28343 135595 29788481
Retinal vein occlusion 23.59 12.84 16 28386 1543 29922533
Hypoxia 23.52 12.84 8 28394 47846 29876230
Hippocampal sclerosis 23.35 12.84 7 28395 91 29923985
Atonic seizures 23.31 12.84 8 28394 164 29923912
Affective disorder 23.19 12.84 21 28381 3087 29920989
Pancytopenia 23.08 12.84 28 28374 85024 29839052
Arthralgia 23.03 12.84 60 28342 135731 29788345
Medication error 22.93 12.84 57 28345 20915 29903161
Platelet count decreased 22.88 12.84 41 28361 106088 29817988
Therapeutic product effect incomplete 22.53 12.84 77 28325 33757 29890319
Aorticopulmonary septal defect 22.42 12.84 5 28397 17 29924059
Neonatal respiratory depression 22.34 12.84 10 28392 423 29923653
Neuromyopathy 22.33 12.84 13 28389 959 29923117
Slow speech 22.01 12.84 13 28389 985 29923091
Condition aggravated 21.34 12.84 212 28190 137654 29786422
Anger 21.27 12.84 38 28364 11082 29912994
Asthenia 21.27 12.84 123 28279 221167 29702909
Hyperthermia malignant 21.25 12.84 16 28386 1818 29922258
Ultrasound liver abnormal 21.09 12.84 7 28395 129 29923947
Oedema peripheral 20.97 12.84 43 28359 105789 29818287
Hypermetropia 20.30 12.84 8 28394 245 29923831
Cryptorchism 20.26 12.84 15 28387 1662 29922414
Ischaemic gastritis 19.81 12.84 4 28398 7 29924069
Tic 19.80 12.84 16 28386 2016 29922060
Overdose 19.57 12.84 142 28260 84195 29839881
Headache 19.54 12.84 261 28141 182045 29742031
Pyloric stenosis 19.52 12.84 10 28392 572 29923504
Blood creatinine increased 19.07 12.84 36 28366 91339 29832737
Drug withdrawal syndrome neonatal 19.02 12.84 19 28383 3156 29920920
Sepsis 18.98 12.84 73 28329 146322 29777754
Teratogenicity 18.97 12.84 5 28397 39 29924037
Tonic clonic movements 18.83 12.84 12 28390 1042 29923034
Paraesthesia 18.56 12.84 101 28301 54226 29869850
Lip oedema 18.45 12.84 16 28386 2221 29921855
Phonophobia 18.37 12.84 6 28396 105 29923971
Distractibility 18.36 12.84 8 28394 317 29923759
Drug level decreased 18.34 12.84 25 28377 5780 29918296
Product use in unapproved indication 18.21 12.84 126 28276 73567 29850509
Cerebrovascular accident 18.21 12.84 32 28370 83445 29840631
Talipes 18.06 12.84 14 28388 1661 29922415
Vascular headache 17.89 12.84 3 28399 0 29924076
Premature ejaculation 17.81 12.84 6 28396 116 29923960
Neonatal hypotension 17.71 12.84 6 28396 118 29923958
Maternal drugs affecting foetus 17.61 12.84 21 28381 4252 29919824
Speech disorder developmental 17.60 12.84 12 28390 1167 29922909
Seizure cluster 17.57 12.84 6 28396 121 29923955
Change in seizure presentation 17.52 12.84 5 28397 54 29924022
Chronic kidney disease 17.45 12.84 7 28395 37831 29886245
Foetal growth restriction 17.10 12.84 19 28383 3566 29920510
Nausea 16.99 12.84 190 28212 296767 29627309
Suspiciousness 16.98 12.84 8 28394 381 29923695
Bradykinesia 16.95 12.84 18 28384 3212 29920864
Body height below normal 16.72 12.84 7 28395 251 29923825
Insomnia 16.66 12.84 148 28254 93188 29830888
Unmasking of previously unidentified disease 16.45 12.84 9 28393 589 29923487
Disorientation 16.31 12.84 66 28336 31352 29892724
General physical health deterioration 16.30 12.84 45 28357 99899 29824177
Developmental hip dysplasia 16.27 12.84 7 28395 269 29923807
Weight increased 16.17 12.84 124 28278 74789 29849287
Septic shock 16.15 12.84 22 28380 63585 29860491
Periventricular haemorrhage neonatal 16.09 12.84 4 28398 24 29924052
Chondrodystrophy 16.09 12.84 4 28398 24 29924052
Pain 16.02 12.84 97 28305 172544 29751532
Psychomotor skills impaired 16.01 12.84 14 28388 1965 29922111
Tonic convulsion 15.96 12.84 10 28392 843 29923233
Lower respiratory tract infection 15.94 12.84 3 28399 26711 29897365
Suicide attempt 15.91 12.84 73 28329 36624 29887452
Haematuria traumatic 15.90 12.84 6 28396 163 29923913
Urticaria 15.87 12.84 17 28385 54589 29869487
Depressed level of consciousness 15.81 12.84 75 28327 38147 29885929
Ganglioglioma 15.81 12.84 3 28399 3 29924073
Transient epileptic amnesia 15.81 12.84 3 28399 3 29924073
Hand fracture 15.71 12.84 13 28389 1694 29922382
Granulocytopenia 15.57 12.84 24 28378 6202 29917874
Joint swelling 15.53 12.84 13 28389 46933 29877143
Abdominal pain upper 15.52 12.84 22 28380 62529 29861547
Body dysmorphic disorder 15.49 12.84 5 28397 84 29923992
Neonatal cholestasis 15.43 12.84 4 28398 29 29924047
Hyperglycinaemia 15.35 12.84 3 28399 4 29924072
Renal colic 15.28 12.84 13 28389 1759 29922317
Floppy infant 15.28 12.84 5 28397 88 29923988
Somnambulism 15.27 12.84 17 28385 3197 29920879
Respiratory failure 15.19 12.84 47 28355 100595 29823481
Congenital arterial malformation 15.02 12.84 5 28397 93 29923983
Infusion related reaction 15.01 12.84 10 28392 40554 29883522
Dysarthria 15.00 12.84 63 28339 30427 29893649
Chronic obstructive pulmonary disease 14.98 12.84 13 28389 46113 29877963
Coronary artery disease 14.98 12.84 15 28387 49697 29874379
Angioedema 14.85 12.84 7 28395 34377 29889699
Necrotising colitis 14.73 12.84 10 28392 966 29923110
Myasthenia gravis crisis 14.68 12.84 7 28395 343 29923733
Mania 14.67 12.84 29 28373 9125 29914951
Postictal psychosis 14.64 12.84 5 28397 101 29923975
Asterixis 14.62 12.84 11 28391 1248 29922828
Retinogram abnormal 14.59 12.84 5 28397 102 29923974
Pneumonitis 14.55 12.84 4 28398 27450 29896626
Necrotising enterocolitis neonatal 14.50 12.84 5 28397 104 29923972
Depression 14.43 12.84 140 28262 90297 29833779
Angina pectoris 14.39 12.84 5 28397 29513 29894563
Choroidal detachment 14.34 12.84 7 28395 361 29923715
Hypotonia neonatal 14.25 12.84 10 28392 1019 29923057
Corneal oedema 14.22 12.84 11 28391 1301 29922775
Lennox-Gastaut syndrome 14.21 12.84 4 28398 41 29924035
Apathy 14.17 12.84 23 28379 6209 29917867
Frustration tolerance decreased 14.09 12.84 13 28389 1957 29922119
Drop attacks 14.03 12.84 8 28394 567 29923509
Lactic acidosis 14.03 12.84 6 28396 31207 29892869
Skeletal dysplasia 14.03 12.84 5 28397 115 29923961
Cerebral ventricle dilatation 14.00 12.84 9 28393 793 29923283
Congenital genital malformation male 14.00 12.84 3 28399 8 29924068
Essential tremor 13.95 12.84 9 28393 798 29923278
Binocular eye movement disorder 13.87 12.84 4 28398 45 29924031
Retrognathia 13.86 12.84 6 28396 234 29923842
Visual field defect 13.86 12.84 19 28383 4417 29919659
Chills 13.81 12.84 30 28372 72308 29851768
Selective eating disorder 13.80 12.84 12 28390 1672 29922404
Anterior chamber disorder 13.75 12.84 5 28397 122 29923954
Hereditary optic atrophy 13.74 12.84 3 28399 9 29924067
Respiratory alkalosis 13.63 12.84 11 28391 1383 29922693
Blood bilirubin increased 13.60 12.84 9 28393 36627 29887449
Haematemesis 13.55 12.84 4 28398 26199 29897877
Dry mouth 13.49 12.84 50 28352 22800 29901276
Therapy partial responder 13.37 12.84 17 28385 3674 29920402
Emotional disorder 13.25 12.84 20 28382 5074 29919002
Neutropenia 13.11 12.84 70 28332 128470 29795606
Coma 13.01 12.84 74 28328 40375 29883701
Rheumatoid arthritis 12.91 12.84 12 28390 41185 29882891
Otitis media 12.91 12.84 14 28388 2557 29921519

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 antiepileptic
CHEBI has role CHEBI:38633 sodium channel blockers

Drug Use (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

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)

None

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

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

External reference:

IDSource
4021026 VUID
N0000148493 NUI
D00537 KEGG_DRUG
4021026 VANDF
C4704732 UMLSCUI
CHEBI:63631 CHEBI
TOR PDB_CHEM_ID
CHEMBL220492 ChEMBL_ID
D000077236 MESH_DESCRIPTOR_UI
131714623 PUBCHEM_CID
6099 INN_ID
DB00273 DRUGBANK_ID
0H73WJJ391 UNII
6849 IUPHAR_LIGAND_ID
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 0093-7336 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 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
TOPIRAMATE HUMAN PRESCRIPTION DRUG LABEL 1 13668-031 TABLET 25 mg ORAL ANDA 29 sections
TOPIRAMATE HUMAN PRESCRIPTION DRUG LABEL 1 13668-032 TABLET 50 mg ORAL ANDA 29 sections
TOPIRAMATE HUMAN PRESCRIPTION DRUG LABEL 1 13668-032 TABLET 50 mg ORAL ANDA 29 sections
TOPIRAMATE HUMAN PRESCRIPTION DRUG LABEL 1 13668-033 TABLET 100 mg ORAL ANDA 29 sections