risperidone Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definitionDrug idCAS RN
antipsychotics, risperidone derivatives 2389 106266-06-2

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • risperidone
  • ripedon
  • rispadal
  • risperdal
  • risperidal
  • R 64,766
A selective blocker of DOPAMINE D2 RECEPTORS and SEROTONIN 5-HT2 RECEPTORS that acts as an atypical antipsychotic agent. It has been shown to improve both positive and negative symptoms in the treatment of SCHIZOPHRENIA.
  • Molecular weight: 410.49
  • Formula: C23H27FN4O2
  • CLOGP: 2.71
  • LIPINSKI: 0
  • HAC: 6
  • HDO: 0
  • TPSA: 61.94
  • ALOGS: -3.38
  • ROTB: 4

  • Status: OFP

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

Drug dosage:

DoseUnitRoute
5 mg O
2.70 mg P

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 1 Benet LZ, Broccatelli F, Oprea TI
S (Water solubility) 0.25 mg/mL Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine) 3 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 0.56 ┬ÁM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability) 66 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
Vd (Volume of distribution) 1.10 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 5.40 mL/min/kg Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma) 0.10 % Lombardo F, Berellini G, Obach RS
t_half (Half-life) 3.20 hours Lombardo F, Berellini G, Obach RS

Approvals:

DateAgencyCompanyOrphan
Dec. 29, 1993 FDA JANSSEN PHARMS

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
Extrapyramidal disorder 1687.66 36.39 367 9757 1980 2345981
Neuroleptic malignant syndrome 1606.38 36.39 345 9779 1735 2346226
Suicide attempt 1551.06 36.39 471 9653 10811 2337150
Somnolence 1471.40 36.39 542 9582 22943 2325018
Hyperprolactinaemia 1449.26 36.39 266 9858 456 2347505
Intentional overdose 1316.48 36.39 416 9708 10905 2337056
Blood prolactin increased 1236.95 36.39 248 9876 819 2347142
Galactorrhoea 1199.91 36.39 250 9874 1049 2346912
Drug interaction 1140.74 36.39 479 9645 28684 2319277
Completed suicide 1028.93 36.39 406 9718 20628 2327333
Intentional self-injury 1020.62 36.39 273 9851 3854 2344107
Psychotic disorder 959.03 36.39 267 9857 4412 2343549
Sedation 910.17 36.39 239 9885 3123 2344838
Weight increased 902.53 36.39 376 9748 21961 2326000
Treatment noncompliance 892.63 36.39 262 9862 5272 2342689
Toxicity to various agents 791.67 36.39 385 9739 32369 2315592
Parkinsonism 788.67 36.39 182 9942 1323 2346638
Dyskinesia 738.17 36.39 219 9905 4570 2343391
Schizophrenia 720.86 36.39 166 9958 1193 2346768
Fall 719.20 36.39 407 9717 46692 2301269
Dystonia 695.74 36.39 177 9947 2017 2345944
Tardive dyskinesia 683.51 36.39 166 9958 1538 2346423
Overdose 674 36.39 296 9828 19611 2328350
Tachycardia 654.25 36.39 274 9850 16135 2331826
Hypothermia 625.83 36.39 162 9962 1986 2345975
Catatonia 615.73 36.39 134 9990 716 2347245
Aggression 609.42 36.39 189 9935 4597 2343364
Hypotension 586.99 36.39 314 9810 32122 2315839
Agitation 576.38 36.39 224 9900 10827 2337134
Electrocardiogram QT prolonged 575.05 36.39 204 9920 7610 2340351
Drug ineffective 550.20 36.39 463 9661 101161 2246800
Hyponatraemia 549.29 36.39 228 9896 13097 2334864
Off label use 545.84 36.39 404 9720 73194 2274767
Akathisia 540.19 36.39 137 9987 1537 2346424
Amenorrhoea 528.72 36.39 143 9981 2096 2345865
Hallucination, auditory 522.31 36.39 141 9983 2051 2345910
Confusional state 515.36 36.39 262 9862 24082 2323879
Sopor 501.04 36.39 156 9968 3839 2344122
Tremor 489.22 36.39 240 9884 20421 2327540
Muscle rigidity 484.63 36.39 128 9996 1703 2346258
Coma 484.22 36.39 187 9937 8869 2339092
Condition aggravated 477.71 36.39 273 9851 31706 2316255
Suicidal ideation 414.17 36.39 177 9947 10910 2337051
Delusion 414.00 36.39 116 10008 1949 2346012
Abnormal behaviour 391.04 36.39 135 9989 4625 2343336
Restlessness 377.11 36.39 130 9994 4433 2343528
Delirium 367.45 36.39 132 9992 5091 2342870
Depressed level of consciousness 363.97 36.39 145 9979 7459 2340502
Exposure during pregnancy 348.77 36.39 205 9919 25014 2322947
Anxiety 342.59 36.39 214 9910 29145 2318816
Pneumonia aspiration 334.15 36.39 113 10011 3629 2344332
Hallucination 333.90 36.39 139 9985 8009 2339952
Diabetes mellitus 331.35 36.39 135 9989 7360 2340601
Rhabdomyolysis 321.36 36.39 128 9996 6576 2341385
Altered state of consciousness 319.01 36.39 110 10014 3750 2344211
Pleurothotonus 308.84 36.39 62 10062 204 2347757
Urinary retention 285.66 36.39 100 10024 3567 2344394
Product use in unapproved indication 285.36 36.39 137 9987 11063 2336898
Blood creatine phosphokinase increased 284.75 36.39 109 10015 5027 2342934
Salivary hypersecretion 283.23 36.39 77 10047 1148 2346813
Leukopenia 266.67 36.39 127 9997 10069 2337892
Cardio-respiratory arrest 261.00 36.39 121 10003 9025 2338936
Miosis 260.09 36.39 72 10052 1152 2346809
Serotonin syndrome 258.44 36.39 92 10032 3448 2344513
Pulmonary embolism 241.86 36.39 144 9980 17939 2330022
Blood prolactin abnormal 236.35 36.39 43 10081 67 2347894
Dysarthria 229.76 36.39 99 10025 6203 2341758
Depression 224.25 36.39 162 9962 27970 2319991
Pituitary tumour benign 222.47 36.39 49 10075 278 2347683
Dysphagia 222.42 36.39 121 10003 12684 2335277
Acute kidney injury 219.74 36.39 160 9964 27962 2319999
Disorientation 218.92 36.39 96 10028 6276 2341685
Constipation 215.72 36.39 143 9981 21486 2326475
Insomnia 213.54 36.39 152 9972 25635 2322326
Cardiac arrest 210.36 36.39 123 10001 14807 2333154
Death 209.99 36.39 249 9875 81219 2266742
Oculogyric crisis 207.20 36.39 47 10077 311 2347650
Drug abuse 207.08 36.39 113 10011 11913 2336048
Seizure 204.37 36.39 145 9979 24321 2323640
Mastitis 201.87 36.39 49 10075 450 2347511
Disturbance in social behaviour 199.77 36.39 41 10083 155 2347806
Gait disturbance 198.49 36.39 138 9986 22407 2325554
Type 2 diabetes mellitus 194.77 36.39 66 10058 2128 2345833
Bradycardia 192.07 36.39 101 10023 9880 2338081
Mania 191.74 36.39 67 10057 2373 2345588
Paranoia 189.47 36.39 64 10060 2043 2345918
Orthostatic hypotension 188.30 36.39 69 10055 2810 2345151
Sudden death 185.17 36.39 61 10063 1799 2346162
Product use issue 184.01 36.39 105 10019 12064 2335897
Sinus tachycardia 182.19 36.39 70 10054 3255 2344706
Loss of consciousness 182.06 36.39 122 10002 18645 2329316
Sluggishness 181.97 36.39 52 10072 938 2347023
Sexual dysfunction 178.24 36.39 41 10083 291 2347670
Metabolic disorder 176.84 36.39 46 10078 572 2347389
Urinary incontinence 175.90 36.39 73 10051 4160 2343801
Disturbance in attention 173.97 36.39 79 10045 5606 2342355
Hospitalisation 172.17 36.39 108 10016 14745 2333216
Hypokalaemia 172.09 36.39 96 10028 10558 2337403
Pyrexia 170.22 36.39 183 9941 53525 2294436
Syncope 169.21 36.39 112 10012 16763 2331198
Musculoskeletal stiffness 167.47 36.39 99 10025 12148 2335813
Medication error 165.18 36.39 78 10046 6053 2341908
Gestational diabetes 164.67 36.39 52 10072 1335 2346626
Social avoidant behaviour 161.85 36.39 42 10082 517 2347444
Anosognosia 158.30 36.39 29 10095 48 2347913
Cogwheel rigidity 157.22 36.39 35 10089 210 2347751
Cognitive disorder 155.92 36.39 72 10052 5309 2342652
Respiratory arrest 152.45 36.39 74 10050 6104 2341857
Aphasia 152.41 36.39 69 10055 4859 2343102
Speech disorder 152.24 36.39 75 10049 6389 2341572
Inappropriate antidiuretic hormone secretion 149.72 36.39 55 10069 2254 2345707
Personality change 148.90 36.39 44 10080 897 2347064
Obsessive-compulsive disorder 145.14 36.39 40 10084 628 2347333
Affective disorder 144.32 36.39 42 10082 810 2347151
General physical health deterioration 142.09 36.39 94 10030 14045 2333916
Rabbit syndrome 140.47 36.39 26 10098 47 2347914
Mutism 140.31 36.39 33 10091 261 2347700
Dehydration 134.78 36.39 109 10015 22186 2325775
Deep vein thrombosis 132.42 36.39 87 10037 12845 2335116
Lethargy 131.04 36.39 75 10049 8655 2339306
Torsade de pointes 129.18 36.39 49 10075 2197 2345764
Neutropenia 127.40 36.39 104 10020 21444 2326517
Hepatitis 127.20 36.39 66 10058 6271 2341690
Irritability 126.32 36.39 66 10058 6361 2341600
Hyperthermia 125.73 36.39 43 10081 1425 2346536
Stupor 125.66 36.39 36 10088 655 2347306
Psychomotor retardation 122.47 36.39 34 10090 549 2347412
Arrhythmia 121.62 36.39 63 10061 5965 2341996
Dizziness 119.93 36.39 160 9964 58505 2289456
Major depression 119.31 36.39 38 10086 1003 2346958
Movement disorder 118.24 36.39 49 10075 2779 2345182
Psychomotor hyperactivity 114.41 36.39 43 10081 1879 2346082
Blood glucose increased 112.18 36.39 77 10047 12213 2335748
Ileus paralytic 112.01 36.39 34 10090 762 2347199
Cystoid macular oedema 110.00 36.39 29 10095 381 2347580
Malaise 109.62 36.39 149 9975 55436 2292525
Psychiatric symptom 108.42 36.39 34 10090 852 2347109
Myoclonus 107.12 36.39 44 10080 2439 2345522
Thrombocytopenia 106.11 36.39 89 10035 19042 2328919
Hallucination, visual 105.88 36.39 46 10078 2933 2345028
Generalised tonic-clonic seizure 105.09 36.39 55 10069 5317 2342644
Encephalopathy 104.64 36.39 52 10072 4509 2343452
Psychomotor skills impaired 104.43 36.39 28 10096 394 2347567
Schizoaffective disorder 103.72 36.39 25 10099 222 2347739
Inappropriate schedule of product administration 103.29 36.39 73 10051 12131 2335830
Bradykinesia 102.95 36.39 30 10094 581 2347380
Pancytopenia 102.75 36.39 71 10053 11381 2336580
Intentional product misuse 102.41 36.39 66 10058 9423 2338538
Vomiting 102.39 36.39 165 9959 71437 2276524
Mental disorder 101.86 36.39 49 10075 3958 2344003
Polydipsia 101.76 36.39 30 10094 606 2347355
Mydriasis 101.47 36.39 41 10083 2178 2345783
Hypertonia 101.33 36.39 35 10089 1195 2346766
Hepatocellular injury 101.30 36.39 49 10075 4006 2343955
Intracranial pressure increased 100.79 36.39 33 10091 953 2347008
Mental status changes 100.29 36.39 54 10070 5528 2342433
Fatigue 99.49 36.39 179 9945 84694 2263267
Hyperhidrosis 98.69 36.39 78 10046 15344 2332617
Dementia 97.25 36.39 42 10082 2639 2345322
Urinary tract infection 94.58 36.39 102 10022 29840 2318121
Incorrect dose administered 93.84 36.39 63 10061 9632 2338329
Torticollis 93.75 36.39 25 10099 344 2347617
Ataxia 93.55 36.39 40 10084 2452 2345509
Pneumonia 90.91 36.39 128 9996 49168 2298793
Persecutory delusion 90.85 36.39 26 10098 471 2347490
Autonomic nervous system imbalance 90.72 36.39 25 10099 392 2347569
Floppy iris syndrome 88.69 36.39 16 10108 23 2347938
Inappropriate affect 87.60 36.39 22 10102 235 2347726
Psychotic symptom 87.37 36.39 21 10103 184 2347777
Cerebrovascular accident 86.20 36.39 81 10043 20105 2327856
Hypokinesia 85.71 36.39 34 10090 1720 2346241
Bradyphrenia 85.63 36.39 30 10094 1069 2346892
Liver function test abnormal 85.54 36.39 54 10070 7436 2340525
Somatic symptom disorder of pregnancy 83.38 36.39 15 10109 21 2347940
Obesity 82.90 36.39 32 10092 1504 2346457
Reduced facial expression 82.83 36.39 20 10104 179 2347782
Thinking abnormal 82.36 36.39 34 10090 1908 2346053
Drooling 80.95 36.39 26 10098 705 2347256
Maternal exposure during pregnancy 80.03 36.39 68 10056 14795 2333166
Mental impairment 78.07 36.39 35 10089 2405 2345556
Cerebral atrophy 77.99 36.39 26 10098 795 2347166
Memory impairment 75.53 36.39 62 10062 12861 2335100
Substance abuse 75.32 36.39 23 10101 526 2347435
Oromandibular dystonia 74.15 36.39 16 10108 81 2347880
Prolactin-producing pituitary tumour 73.01 36.39 15 10109 57 2347904
Cardiac failure 72.73 36.39 59 10065 12035 2335926
Apathy 72.48 36.39 28 10096 1319 2346642
Weight decreased 71.49 36.39 86 10038 28285 2319676
Balance disorder 70.42 36.39 53 10071 9694 2338267
Menstrual disorder 69.97 36.39 25 10099 944 2347017
Electroencephalogram abnormal 69.93 36.39 24 10100 803 2347158
Sinus bradycardia 69.77 36.39 31 10093 2085 2345876
Logorrhoea 69.28 36.39 21 10103 468 2347493
Ventricular extrasystoles 68.69 36.39 30 10094 1936 2346025
Decreased appetite 68.62 36.39 85 10039 28806 2319155
Drug level increased 67.56 36.39 33 10091 2754 2345207
Poisoning 67.19 36.39 33 10091 2787 2345174
Intestinal obstruction 66.57 36.39 38 10086 4355 2343606
Heart rate increased 66.40 36.39 54 10070 11051 2336910
Blood pressure decreased 66.23 36.39 50 10074 9186 2338775
Pemphigoid 65.90 36.39 24 10100 958 2347003
Abnormal weight gain 65.63 36.39 18 10106 277 2347684
Anticholinergic syndrome 65.57 36.39 18 10106 278 2347683
White blood cell count decreased 64.53 36.39 66 10058 18142 2329819
Head injury 64.11 36.39 36 10088 3998 2343963
Circulatory collapse 64.06 36.39 35 10089 3685 2344276
Brain oedema 64.06 36.39 30 10094 2280 2345681
Asthenia 64.03 36.39 106 10018 46820 2301141
Hyperammonaemic encephalopathy 63.69 36.39 18 10106 311 2347650
Compartment syndrome 63.65 36.39 19 10105 401 2347560
Impaired self-care 62.63 36.39 18 10106 331 2347630
Hypertension 62.58 36.39 79 10045 27282 2320679
Aspiration 62.16 36.39 26 10098 1508 2346453
Epilepsy 62.03 36.39 37 10087 4602 2343359
Sepsis 61.89 36.39 65 10059 18423 2329538
Eating disorder 61.33 36.39 29 10095 2252 2345709
Myocarditis 60.78 36.39 24 10100 1199 2346762
Refusal of treatment by patient 60.06 36.39 24 10100 1237 2346724
Mood swings 59.76 36.39 32 10092 3237 2344724
Withdrawal syndrome 59.14 36.39 32 10092 3305 2344656
Lactation disorder 58.94 36.39 14 10110 116 2347845
Muscle twitching 58.93 36.39 30 10094 2735 2345226
Communication disorder 58.64 36.39 18 10106 419 2347542
Maternal drugs affecting foetus 58.62 36.39 25 10099 1522 2346439
Negativism 58.21 36.39 14 10110 123 2347838
Idiopathic intracranial hypertension 58.17 36.39 19 10105 544 2347417
Drug withdrawal syndrome neonatal 57.85 36.39 18 10106 439 2347522
Prescribed overdose 57.83 36.39 26 10098 1798 2346163
Pancreatitis acute 57.50 36.39 33 10091 3820 2344141
Hypoglycaemia 56.95 36.39 44 10080 8363 2339598
Myocardial infarction 56.89 36.39 63 10061 18950 2329011
Oedema peripheral 56.55 36.39 70 10054 23693 2324268
Respiratory depression 56.54 36.39 27 10097 2143 2345818
Hypophagia 56.35 36.39 33 10091 3967 2343994
Adverse event 56.10 36.39 42 10082 7617 2340344
Headache 56.09 36.39 137 9987 80042 2267919
Foetal exposure during pregnancy 55.33 36.39 36 10088 5216 2342745
Agranulocytosis 55.13 36.39 31 10093 3451 2344510
Loss of personal independence in daily activities 54.97 36.39 36 10088 5275 2342686
Breast cancer 54.31 36.39 45 10079 9450 2338511
Renal impairment 53.95 36.39 46 10078 10046 2337915
Accidental overdose 53.94 36.39 32 10092 3940 2344021
Adverse drug reaction 53.18 36.39 42 10082 8241 2339720
Tachypnoea 52.85 36.39 26 10098 2203 2345758
Unresponsive to stimuli 52.79 36.39 34 10090 4842 2343119
Incoherent 52.74 36.39 20 10104 895 2347066
Precocious puberty 52.67 36.39 12 10112 81 2347880
Feeling abnormal 52.19 36.39 67 10057 23514 2324447
Leukocytosis 51.69 36.39 30 10094 3546 2344415
Wrong product administered 51.26 36.39 22 10102 1360 2346601
Insurance issue 50.89 36.39 16 10108 404 2347557
Sleep disorder 50.70 36.39 37 10087 6452 2341509
Parkinsonian gait 50.56 36.39 12 10112 99 2347862
Bundle branch block right 50.51 36.39 19 10105 831 2347130
Bedridden 50.51 36.39 22 10102 1410 2346551
Increased appetite 50.39 36.39 22 10102 1418 2346543
Alanine aminotransferase increased 49.95 36.39 51 10073 13981 2333980
Breast discharge 49.79 36.39 15 10109 327 2347634
Hemivertebra 49.46 36.39 9 10115 14 2347947
Treatment failure 49.27 36.39 38 10086 7201 2340760
Hepatic steatosis 49.24 36.39 28 10096 3185 2344776
Faecaloma 49.15 36.39 19 10105 896 2347065
Choking 49.00 36.39 22 10102 1516 2346445
Water intoxication 48.86 36.39 12 10112 116 2347845
Drug resistance 48.84 36.39 26 10098 2598 2345363
Vertigo 48.59 36.39 42 10082 9342 2338619
Drug ineffective for unapproved indication 48.58 36.39 27 10097 2939 2345022
Slow response to stimuli 48.15 36.39 13 10111 188 2347773
Abortion spontaneous 48.10 36.39 49 10075 13396 2334565
Menstruation irregular 47.76 36.39 22 10102 1609 2346352
Poisoning deliberate 47.63 36.39 20 10104 1171 2346790
Diabetic ketoacidosis 46.54 36.39 28 10096 3536 2344425
Posture abnormal 46.21 36.39 15 10109 421 2347540
Akinesia 46.06 36.39 14 10110 315 2347646
Hypernatraemia 46.03 36.39 18 10106 876 2347085
Hypotonia neonatal 46.02 36.39 13 10111 224 2347737
Breast tenderness 45.47 36.39 16 10108 577 2347384
Autoimmune thyroiditis 45.37 36.39 16 10108 581 2347380
Dyspnoea 45.23 36.39 125 9999 78608 2269353
Hallucinations, mixed 45.11 36.39 16 10108 591 2347370
Hyperkalaemia 44.68 36.39 33 10091 5860 2342101
Visual impairment 44.17 36.39 44 10080 11711 2336250
Acute psychosis 43.96 36.39 15 10109 493 2347468
Type 1 diabetes mellitus 43.90 36.39 16 10108 640 2347321
Oesophageal atresia 43.84 36.39 11 10113 117 2347844
Hypotonia 43.48 36.39 21 10103 1709 2346252
Aspartate aminotransferase increased 43.37 36.39 45 10079 12567 2335394
Retinal vein occlusion 43.17 36.39 15 10109 521 2347440
Cholestasis 42.90 36.39 27 10097 3694 2344267
Substance-induced psychotic disorder 42.58 36.39 13 10111 297 2347664
Optic atrophy 42.54 36.39 13 10111 298 2347663
Bipolar disorder 42.46 36.39 19 10105 1299 2346662
Subileus 42.24 36.39 15 10109 556 2347405
Disease recurrence 42.21 36.39 26 10098 3425 2344536
Polycystic ovaries 42.20 36.39 12 10112 212 2347749
Eye movement disorder 41.99 36.39 18 10106 1109 2346852
Psychiatric decompensation 41.94 36.39 12 10112 217 2347744
Breast pain 41.74 36.39 19 10105 1352 2346609
Oligomenorrhoea 41.69 36.39 12 10112 222 2347739
Acute generalised exanthematous pustulosis 41.29 36.39 20 10104 1638 2346323
Blindness 41.08 36.39 26 10098 3592 2344369
Diet refusal 40.55 36.39 11 10113 162 2347799
Bipolar I disorder 40.49 36.39 13 10111 352 2347609
Impulsive behaviour 40.31 36.39 13 10111 357 2347604
Personality disorder 40.28 36.39 13 10111 358 2347603
Breast enlargement 40.21 36.39 13 10111 360 2347601
Ventricular tachycardia 40.21 36.39 24 10100 2987 2344974
Anaemia 40.10 36.39 73 10051 34719 2313242
Gait inability 39.96 36.39 31 10093 5924 2342037
Gamma-glutamyltransferase increased 39.61 36.39 30 10094 5532 2342429
Decreased activity 39.61 36.39 16 10108 848 2347113
Drug hypersensitivity 39.49 36.39 86 10038 46557 2301404
Hepatic function abnormal 39.33 36.39 31 10093 6061 2341900
Depressive symptom 39.19 36.39 14 10110 528 2347433
Parkinson's disease 39.18 36.39 18 10106 1308 2346653
Depressed mood 39.17 36.39 29 10095 5169 2342792
Pituitary tumour 39.14 36.39 11 10113 186 2347775
Hyperreflexia 38.96 36.39 16 10108 885 2347076
C-reactive protein increased 38.61 36.39 31 10093 6224 2341737
Dyslipidaemia 38.31 36.39 15 10109 732 2347229
Abdominal pain 38.20 36.39 71 10053 34303 2313658
Renal failure 37.91 36.39 49 10075 17300 2330661
Amaurosis 37.88 36.39 10 10114 132 2347829
Vision blurred 37.79 36.39 45 10079 14623 2333338
Product substitution issue 37.57 36.39 28 10096 5041 2342920
Locked-in syndrome 37.42 36.39 9 10115 79 2347882
Abulia 37.32 36.39 9 10115 80 2347881
Diabetic neuropathy 37.32 36.39 13 10111 455 2347506
Paradoxical drug reaction 37.18 36.39 13 10111 460 2347501
Activation syndrome 37.12 36.39 9 10115 82 2347879
Homicidal ideation 37.10 36.39 13 10111 463 2347498
Dry mouth 36.89 36.39 34 10090 8219 2339742
Tachyarrhythmia 36.84 36.39 14 10110 630 2347331
Hyperammonaemia 36.75 36.39 15 10109 817 2347144
Cortisol increased 36.46 36.39 9 10115 89 2347872

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
Neuroleptic malignant syndrome 2269.58 34.59 556 11133 2592 1732500
Extrapyramidal disorder 2047.85 34.59 485 11204 1892 1733200
Gynaecomastia 1270.93 34.59 324 11365 1808 1733284
Somnolence 1156.32 34.59 497 11192 16242 1718850
Intentional overdose 1132.60 34.59 396 11293 7274 1727818
Drug interaction 1079.15 34.59 555 11134 27403 1707689
Suicide attempt 1031.88 34.59 366 11323 7015 1728077
Treatment noncompliance 1001.54 34.59 328 11361 4873 1730219
Weight increased 991.59 34.59 399 11290 10958 1724134
Psychotic disorder 970.03 34.59 318 11371 4738 1730354
Aggression 946.22 34.59 352 11337 7763 1727329
Dystonia 910.84 34.59 246 11443 1768 1733324
Intentional self-injury 895.27 34.59 258 11431 2415 1732677
Drug ineffective 877.29 34.59 655 11034 63146 1671946
Off label use 794.97 34.59 509 11180 38062 1697030
Sedation 794.89 34.59 249 11440 3168 1731924
Agitation 787.96 34.59 336 11353 10690 1724402
Tardive dyskinesia 744.68 34.59 187 11502 965 1734127
Parkinsonism 707.84 34.59 186 11503 1183 1733909
Tachycardia 706.12 34.59 324 11365 12304 1722788
Catatonia 689.87 34.59 167 11522 718 1734374
Rhabdomyolysis 655.96 34.59 296 11393 10794 1724298
Schizophrenia 642.67 34.59 188 11501 1858 1733234
Dyskinesia 639.39 34.59 217 11472 3602 1731490
Priapism 629.68 34.59 172 11517 1292 1733800
Muscle rigidity 612.24 34.59 177 11512 1671 1733421
Blood creatine phosphokinase increased 599.60 34.59 260 11429 8596 1726496
Akathisia 594.34 34.59 161 11528 1167 1733925
Coma 587.49 34.59 242 11447 7020 1728072
Completed suicide 575.68 34.59 306 11383 16006 1719086
Abnormal behaviour 573.60 34.59 229 11460 6113 1728979
Hyperprolactinaemia 542.68 34.59 109 11580 137 1734955
Condition aggravated 519.64 34.59 313 11376 20837 1714255
Confusional state 499.83 34.59 306 11383 20972 1714120
Blood prolactin increased 492.82 34.59 113 11576 361 1734731
Tremor 490.41 34.59 256 11433 12875 1722217
Toxicity to various agents 471.96 34.59 332 11357 28809 1706283
Product use in unapproved indication 446.61 34.59 216 11473 9206 1725886
Salivary hypersecretion 422.17 34.59 126 11563 1339 1733753
Overdose 414.50 34.59 249 11440 16452 1718640
Fall 410.33 34.59 297 11392 26917 1708175
Delusion 401.66 34.59 134 11555 2097 1732995
Hallucination, auditory 388.47 34.59 129 11560 1988 1733104
Seizure 377.95 34.59 253 11436 20188 1714904
Hyponatraemia 366.06 34.59 186 11503 8814 1726278
Pneumonia aspiration 350.65 34.59 153 11536 5113 1729979
Hypothermia 342.72 34.59 112 11577 1636 1733456
Insomnia 336.15 34.59 216 11473 16060 1719032
Delirium 335.28 34.59 157 11532 6205 1728887
Dysphagia 333.51 34.59 182 11507 9986 1725106
Restlessness 325.42 34.59 137 11552 4184 1730908
Pleurothotonus 308.49 34.59 64 11625 105 1734987
Electrocardiogram QT prolonged 305.06 34.59 141 11548 5404 1729688
Suicidal ideation 303.14 34.59 161 11528 8357 1726735
Hallucination 300.88 34.59 158 11531 8012 1727080
Emotional distress 287.80 34.59 100 11589 1778 1733314
Leukopenia 284.13 34.59 154 11535 8326 1726766
Neutropenia 283.17 34.59 203 11486 18057 1717035
Anxiety 276.65 34.59 188 11501 15339 1719753
Oculogyric crisis 274.65 34.59 67 11622 298 1734794
Dysarthria 271.52 34.59 128 11561 5131 1729961
Sopor 262.74 34.59 95 11594 1906 1733186
Musculoskeletal stiffness 260.98 34.59 129 11560 5747 1729345
Hypotension 259.94 34.59 236 11453 29418 1705674
Diabetes mellitus 258.29 34.59 135 11554 6773 1728319
Depressed level of consciousness 255.57 34.59 132 11557 6460 1728632
Cognitive disorder 247.16 34.59 113 11576 4217 1730875
Urinary incontinence 230.41 34.59 94 11595 2642 1732450
Speech disorder 229.53 34.59 109 11580 4439 1730653
Depression 223.81 34.59 170 11519 16499 1718593
Galactorrhoea 219.13 34.59 45 11644 68 1735024
Altered state of consciousness 217.77 34.59 97 11592 3400 1731692
Obsessive-compulsive disorder 216.02 34.59 66 11623 762 1734330
Cogwheel rigidity 211.37 34.59 49 11640 166 1734926
Serotonin syndrome 208.48 34.59 88 11601 2700 1732392
Pulmonary embolism 206.41 34.59 147 11542 12912 1722180
Paranoia 204.61 34.59 81 11608 2100 1732992
Medication error 201.31 34.59 101 11588 4642 1730450
Irritability 197.89 34.59 105 11584 5427 1729665
Bradycardia 195.69 34.59 131 11558 10403 1724689
Psychomotor hyperactivity 194.15 34.59 75 11614 1818 1733274
Psychotic symptom 188.66 34.59 45 11644 178 1734914
Hyperthermia 187.79 34.59 71 11618 1620 1733472
Hyperhidrosis 186.87 34.59 136 11553 12352 1722740
Gait disturbance 185.11 34.59 136 11553 12534 1722558
Drug abuse 182.31 34.59 139 11550 13550 1721542
Product use issue 182.19 34.59 116 11573 8455 1726637
Increased appetite 181.34 34.59 60 11629 911 1734181
Hospitalisation 175.84 34.59 132 11557 12568 1722524
Sluggishness 170.46 34.59 53 11636 651 1734441
Incorrect dose administered 169.32 34.59 105 11584 7304 1727788
Pyrexia 166.85 34.59 232 11457 46168 1688924
Urinary retention 164.10 34.59 92 11597 5303 1729789
Type 2 diabetes mellitus 163.15 34.59 66 11623 1812 1733280
Mania 158.36 34.59 67 11622 2066 1733026
Conduction disorder 158.19 34.59 44 11645 354 1734738
Apathy 153.30 34.59 57 11632 1239 1733853
Mental impairment 153.24 34.59 64 11625 1909 1733183
Obesity 152.03 34.59 54 11635 1025 1734067
Loss of consciousness 151.23 34.59 129 11560 14746 1720346
General physical health deterioration 150.46 34.59 122 11567 12996 1722096
Sinus tachycardia 147.32 34.59 67 11622 2465 1732627
Sexual dysfunction 144.50 34.59 60 11629 1763 1733329
Inappropriate antidiuretic hormone secretion 143.52 34.59 59 11630 1689 1733403
Blood prolactin abnormal 142.68 34.59 28 11661 28 1735064
Miosis 142.49 34.59 56 11633 1422 1733670
Withdrawal syndrome 140.91 34.59 63 11626 2225 1732867
Sudden death 140.78 34.59 68 11621 2872 1732220
Thrombocytopenia 140.37 34.59 145 11544 21104 1713988
Weight decreased 137.39 34.59 148 11541 22605 1712487
Drooling 136.49 34.59 46 11643 741 1734351
Disturbance in attention 136.40 34.59 75 11614 4159 1730933
Hypertension 136.25 34.59 137 11552 19311 1715781
Fatigue 134.17 34.59 220 11469 50561 1684531
Product substitution issue 133.60 34.59 68 11621 3218 1731874
Acute kidney injury 133.39 34.59 180 11509 34764 1700328
Tic 130.48 34.59 44 11645 710 1734382
Disorientation 128.71 34.59 79 11610 5390 1729702
Unresponsive to stimuli 127.49 34.59 74 11615 4555 1730537
Epilepsy 127.17 34.59 70 11619 3889 1731203
Cardio-respiratory arrest 125.03 34.59 95 11594 9198 1725894
Polydipsia 123.62 34.59 42 11647 694 1734398
Cardiometabolic syndrome 122.62 34.59 34 11655 270 1734822
Lethargy 120.65 34.59 84 11605 7100 1727992
Vomiting 120.57 34.59 180 11509 38135 1696957
Hepatocellular injury 120.23 34.59 63 11626 3168 1731924
Sinus bradycardia 118.31 34.59 53 11636 1880 1733212
Hallucination, visual 115.25 34.59 57 11632 2535 1732557
Oromandibular dystonia 115.22 34.59 27 11662 97 1734995
Blood triglycerides increased 115.08 34.59 57 11632 2543 1732549
Hypertonia 114.82 34.59 47 11642 1330 1733762
Posture abnormal 113.48 34.59 34 11655 365 1734727
Emotional disorder 110.24 34.59 43 11646 1069 1734023
Social avoidant behaviour 109.43 34.59 37 11652 602 1734490
Psychomotor retardation 109.37 34.59 34 11655 417 1734675
Erectile dysfunction 108.46 34.59 66 11623 4431 1730661
Type 1 diabetes mellitus 107.29 34.59 39 11650 793 1734299
Incontinence 106.42 34.59 41 11648 985 1734107
Movement disorder 106.08 34.59 47 11642 1623 1733469
Wrong product administered 105.03 34.59 42 11647 1117 1733975
Psychiatric symptom 104.75 34.59 38 11651 768 1734324
Myoclonus 103.61 34.59 51 11638 2244 1732848
Choking 102.48 34.59 40 11649 996 1734096
Cardiac arrest 102.05 34.59 107 11582 15823 1719269
Opisthotonus 101.22 34.59 26 11663 148 1734944
Arrhythmia 100.20 34.59 70 11619 5946 1729146
Hepatitis 100.11 34.59 65 11624 4890 1730202
Torticollis 100.11 34.59 29 11660 274 1734818
Antipsychotic drug level below therapeutic 99.09 34.59 26 11663 163 1734929
Hyperglycaemia 97.65 34.59 65 11624 5100 1729992
Accidental overdose 97.57 34.59 60 11629 4104 1730988
Persecutory delusion 97.51 34.59 31 11658 411 1734681
Thinking abnormal 96.66 34.59 41 11648 1271 1733821
Dyslipidaemia 96.51 34.59 36 11653 789 1734303
Oropharyngeal spasm 95.20 34.59 20 11669 36 1735056
Disturbance in social behaviour 95.18 34.59 26 11663 194 1734898
Inappropriate schedule of product administration 93.20 34.59 73 11616 7386 1727706
C-reactive protein increased 92.27 34.59 66 11623 5819 1729273
Pneumonia 92.03 34.59 177 11512 46005 1689087
Therapeutic response decreased 91.60 34.59 64 11625 5436 1729656
Hypoglycaemia 91.48 34.59 76 11613 8362 1726730
Abnormal weight gain 90.72 34.59 24 11665 156 1734936
Mental disorder 90.55 34.59 50 11639 2793 1732299
Refusal of treatment by patient 90.16 34.59 38 11651 1159 1733933
Hyperammonaemic encephalopathy 89.29 34.59 28 11661 354 1734738
Polydipsia psychogenic 89.13 34.59 19 11670 38 1735054
Floppy iris syndrome 88.36 34.59 22 11667 108 1734984
Mutism 87.63 34.59 24 11665 181 1734911
Blood cholesterol increased 84.96 34.59 49 11640 2977 1732115
Liver function test abnormal 84.71 34.59 62 11627 5664 1729428
Death 84.70 34.59 253 11436 87190 1647902
Adverse event 84.05 34.59 57 11632 4611 1730481
Dizziness 84.03 34.59 144 11545 34217 1700875
Eye movement disorder 82.82 34.59 33 11656 869 1734223
Euphoric mood 81.38 34.59 32 11657 813 1734279
Intentional product misuse 81.27 34.59 67 11622 7291 1727801
Drug withdrawal syndrome 80.87 34.59 55 11634 4470 1730622
Blood glucose increased 80.40 34.59 78 11611 10506 1724586
Hypokinesia 79.98 34.59 35 11654 1172 1733920
Alanine aminotransferase increased 79.55 34.59 83 11606 12195 1722897
Disinhibition 79.51 34.59 25 11664 319 1734773
Generalised tonic-clonic seizure 79.09 34.59 52 11637 3994 1731098
Respiratory distress 78.92 34.59 57 11632 5100 1729992
Illusion 78.32 34.59 22 11667 184 1734908
Bradykinesia 77.16 34.59 27 11662 489 1734603
Ataxia 76.63 34.59 42 11647 2311 1732781
Aphasia 76.35 34.59 48 11641 3413 1731679
Water intoxication 75.60 34.59 20 11669 130 1734962
Dementia 75.49 34.59 40 11649 2056 1733036
Leukocytosis 75.44 34.59 48 11641 3485 1731607
Stupor 75.21 34.59 28 11661 610 1734482
Deep vein thrombosis 75.15 34.59 73 11616 9847 1725245
Blunted affect 74.70 34.59 18 11671 75 1735017
Blood sodium decreased 74.69 34.59 41 11648 2263 1732829
Psychomotor skills impaired 74.62 34.59 24 11665 331 1734761
Therapeutic product effect incomplete 73.90 34.59 56 11633 5392 1729700
Aspartate aminotransferase increased 73.81 34.59 75 11614 10681 1724411
White blood cell count increased 73.37 34.59 63 11626 7249 1727843
Mental status changes 72.75 34.59 58 11631 6017 1729075
Product dispensing error 72.16 34.59 36 11653 1630 1733462
Poisoning 71.08 34.59 41 11648 2491 1732601
Alcohol abuse 69.65 34.59 26 11663 571 1734521
Depressed mood 69.48 34.59 43 11646 2973 1732119
Constipation 69.20 34.59 85 11604 14915 1720177
Brain injury 68.65 34.59 30 11659 1001 1734091
Transaminases increased 68.54 34.59 47 11642 3870 1731222
Agranulocytosis 67.57 34.59 45 11644 3531 1731561
Dehydration 67.25 34.59 91 11598 17567 1717525
Syncope 64.88 34.59 80 11609 14089 1721003
Illness anxiety disorder 64.40 34.59 14 11675 32 1735060
Protrusion tongue 64.02 34.59 16 11673 80 1735012
Diabetic ketoacidosis 63.69 34.59 42 11647 3241 1731851
Diet refusal 63.54 34.59 17 11672 116 1734976
Enuresis 63.15 34.59 22 11667 393 1734699
White blood cell count decreased 63.06 34.59 76 11613 13073 1722019
Palpitations 62.91 34.59 56 11633 6758 1728334
Urinary tract infection 62.84 34.59 67 11622 10086 1725006
Posturing 62.56 34.59 17 11672 124 1734968
Hepatic steatosis 62.48 34.59 38 11651 2546 1732546
Anticholinergic syndrome 62.33 34.59 18 11671 168 1734924
Waxy flexibility 62.17 34.59 14 11675 40 1735052
Accidental exposure to product 62.00 34.59 45 11644 4056 1731036
Renal failure 61.31 34.59 93 11596 19924 1715168
Muscle twitching 60.99 34.59 33 11656 1769 1733323
Malaise 60.84 34.59 115 11574 29450 1705642
Drug ineffective for unapproved indication 60.53 34.59 33 11656 1796 1733296
Tachypnoea 60.44 34.59 36 11653 2322 1732770
Reduced facial expression 60.33 34.59 17 11672 144 1734948
Electroencephalogram abnormal 60.08 34.59 24 11665 636 1734456
Colitis ischaemic 59.65 34.59 26 11663 862 1734230
Respiratory depression 59.41 34.59 35 11654 2212 1732880
Schizoaffective disorder 59.18 34.59 18 11671 204 1734888
Anosognosia 58.96 34.59 14 11675 54 1735038
Autonomic nervous system imbalance 58.74 34.59 21 11668 406 1734686
Hypercholesterolaemia 57.89 34.59 28 11661 1184 1733908
Flat affect 57.72 34.59 18 11671 223 1734869
Motor dysfunction 57.48 34.59 27 11662 1069 1734023
Orthostatic hypotension 57.28 34.59 40 11649 3391 1731701
Self-injurious ideation 57.27 34.59 20 11669 360 1734732
Tongue disorder 56.95 34.59 22 11667 532 1734560
Feeling abnormal 55.94 34.59 66 11623 11100 1723992
Pituitary tumour benign 55.24 34.59 17 11672 201 1734891
Affective disorder 54.76 34.59 23 11666 695 1734397
Drug-induced liver injury 54.65 34.59 38 11651 3199 1731893
Autism spectrum disorder 54.61 34.59 19 11670 338 1734754
Metabolic disorder 54.24 34.59 21 11668 511 1734581
Eating disorder 53.86 34.59 27 11662 1235 1733857
Hypotonia 53.83 34.59 29 11660 1541 1733551
Cerebral atrophy 53.82 34.59 23 11666 726 1734366
Staring 53.65 34.59 19 11670 357 1734735
Gaze palsy 53.62 34.59 18 11671 286 1734806
Product administration error 53.01 34.59 36 11653 2917 1732175
Bladder dilatation 52.55 34.59 16 11673 182 1734910
Drug withdrawal syndrome neonatal 52.34 34.59 22 11667 666 1734426
Wellens' syndrome 52.08 34.59 9 11680 0 1735092
Atrioventricular block first degree 52.01 34.59 24 11665 912 1734180
Language disorder 51.91 34.59 17 11672 249 1734843
Communication disorder 51.90 34.59 19 11670 394 1734698
Status epilepticus 51.82 34.59 31 11658 2015 1733077
Heart rate increased 51.34 34.59 49 11640 6461 1728631
Myopathy toxic 51.18 34.59 14 11675 105 1734987
Rapid eye movement sleep behaviour disorder 50.64 34.59 11 11678 25 1735067
Treatment failure 50.52 34.59 41 11648 4360 1730732
Dysphemia 50.49 34.59 18 11671 345 1734747
Memory impairment 50.38 34.59 49 11640 6614 1728478
Impaired self-care 49.32 34.59 15 11674 170 1734922
Sleep disorder 49.08 34.59 39 11650 4024 1731068
Metabolic acidosis 49.07 34.59 44 11645 5358 1729734
Paroxysmal perceptual alteration 48.78 34.59 9 11680 4 1735088
Asthenia 48.26 34.59 115 11574 34555 1700537
Poisoning deliberate 48.07 34.59 22 11667 820 1734272
Breast enlargement 47.25 34.59 14 11675 144 1734948
Dyspnoea 46.78 34.59 147 11542 51912 1683180
Respiratory arrest 46.14 34.59 44 11645 5795 1729297
Myocarditis 46.04 34.59 28 11661 1875 1733217
Choreoathetosis 46.00 34.59 14 11675 159 1734933
Behaviour disorder 45.53 34.59 14 11675 165 1734927
Pancytopenia 45.46 34.59 60 11629 11297 1723795
Therapeutic product effect variable 45.24 34.59 13 11676 119 1734973
Ileus paralytic 45.16 34.59 22 11667 945 1734147
Spasmodic dysphonia 45.09 34.59 10 11679 26 1735066
Hypokalaemia 44.71 34.59 45 11644 6329 1728763
Keratoconus 44.55 34.59 10 11679 28 1735064
Body temperature increased 44.20 34.59 31 11658 2646 1732446
Adverse drug reaction 43.84 34.59 39 11650 4699 1730393
Wrong patient received product 43.80 34.59 14 11675 189 1734903
Facial paralysis 43.32 34.59 27 11662 1889 1733203
Foetal exposure during pregnancy 42.97 34.59 44 11645 6315 1728777
Fear 42.93 34.59 24 11665 1372 1733720
Depressive symptom 42.70 34.59 16 11673 355 1734737
Hepatic function abnormal 42.55 34.59 46 11643 7028 1728064
Drug dependence 42.48 34.59 33 11656 3294 1731798
Product prescribing error 42.35 34.59 29 11660 2381 1732711
Bradyarrhythmia 42.24 34.59 16 11673 366 1734726
Attention deficit/hyperactivity disorder 42.19 34.59 17 11672 461 1734631
Incoherent 42.06 34.59 20 11669 814 1734278
Libido decreased 41.35 34.59 23 11666 1302 1733790
Multiple drug therapy 41.24 34.59 10 11679 43 1735049
Homicidal ideation 40.84 34.59 18 11671 613 1734479
Hypometabolism 40.69 34.59 9 11680 23 1735069
Supraventricular extrasystoles 40.27 34.59 18 11671 634 1734458
Bradyphrenia 39.96 34.59 18 11671 646 1734446
Wolff-Parkinson-White syndrome 39.70 34.59 11 11678 87 1735005
Bundle branch block right 39.59 34.59 22 11667 1243 1733849
Nervous system disorder 39.54 34.59 28 11661 2426 1732666
Cardiogenic shock 39.54 34.59 28 11661 2426 1732666
Major depression 38.73 34.59 18 11671 695 1734397
Hypernatraemia 38.73 34.59 20 11669 974 1734118
Visceral congestion 38.54 34.59 11 11678 98 1734994
Coma scale abnormal 38.49 34.59 17 11672 582 1734510
Hypothyroidism 38.48 34.59 28 11661 2532 1732560
Foetal alcohol syndrome 37.86 34.59 8 11681 15 1735077
Dysstasia 37.86 34.59 24 11665 1730 1733362
Symptom masked 37.66 34.59 10 11679 66 1735026
Anger 37.46 34.59 28 11661 2638 1732454
Headache 37.44 34.59 104 11585 34272 1700820
Respiratory dyskinesia 37.35 34.59 7 11682 4 1735088
Parkinsonian gait 37.15 34.59 10 11679 70 1735022
Asphyxia 37.11 34.59 20 11669 1063 1734029
Cerebral ischaemia 36.86 34.59 20 11669 1078 1734014
Emotional poverty 36.55 34.59 10 11679 75 1735017
Hepatitis C virus test positive 36.54 34.59 11 11678 120 1734972
Bundle branch block left 36.19 34.59 18 11671 809 1734283
Compulsive sexual behaviour 36.17 34.59 9 11680 44 1735048
Shock 36.04 34.59 33 11656 4128 1730964
Physical assault 35.91 34.59 14 11675 347 1734745
Dry mouth 35.79 34.59 32 11657 3881 1731211
Myoglobin blood increased 35.78 34.59 15 11674 451 1734641
Ventricular extrasystoles 35.69 34.59 24 11665 1912 1733180
Acute psychosis 35.68 34.59 15 11674 454 1734638
Faecaloma 35.65 34.59 17 11672 696 1734396
Obsessive thoughts 35.61 34.59 12 11677 193 1734899
Suicidal behaviour 35.54 34.59 14 11675 357 1734735
Brain oedema 35.25 34.59 25 11664 2171 1732921
Immobile 35.18 34.59 14 11675 367 1734725
Product dose omission 35.12 34.59 78 11611 22362 1712730
Mastication disorder 34.83 34.59 12 11677 207 1734885
Somatic symptom disorder 34.79 34.59 11 11678 143 1734949
Dextrocardia 34.75 34.59 8 11681 26 1735066
Blood pressure decreased 34.69 34.59 43 11646 7603 1727489

Pharmacologic Action:

SourceCodeDescription
ATC N05AX08 NERVOUS SYSTEM
PSYCHOLEPTICS
ANTIPSYCHOTICS
Other antipsychotics
MeSH PA D014150 Antipsychotic Agents
MeSH PA D002491 Central Nervous System Agents
MeSH PA D002492 Central Nervous System Depressants
MeSH PA D015259 Dopamine Agents
MeSH PA D018492 Dopamine Antagonists
MeSH PA D018377 Neurotransmitter Agents
MeSH PA D011619 Psychotropic Drugs
MeSH PA D018490 Serotonin Agents
MeSH PA D012702 Serotonin Antagonists
CHEBI has role CHEBI:48561 dopaminergic antagonist
CHEBI has role CHEBI:35471 psychotropic drug
CHEBI has role CHEBI:65191 second generation antipsychotic
CHEBI has role CHEBI:48279 serotonergic antagonist
CHEBI has role CHEBI:37890 alpha-adrenergic antagonist
CHEBI has role CHEBI:37955 H1-receptor antagonist
FDA EPC N0000175430 Atypical Antipsychotic
MeSH PA D014149 Tranquilizing Agents

Drug Use (View source of the data)

DiseaseRelationSNOMED_IDDOID
Mixed bipolar I disorder indication 16506000 DOID:3312
Schizophrenia indication 58214004 DOID:5419
Bipolar disorder in remission indication 85248005
Bipolar affective disorder, current episode manic indication 191618007
Infantile autism indication 408857007
Bipolar affective disorder, current episode depression off-label use 191627008 DOID:3312
Toxoplasmosis associated with acquired immunodeficiency syndrome off-label use 421666009
Depression Treatment Adjunct off-label use
Priapism contraindication 6273006 DOID:9286
Suicidal thoughts contraindication 6471006
Asthenia contraindication 13791008
Neuroleptic malignant syndrome contraindication 15244003 DOID:14464
Senile dementia contraindication 15662003
Agranulocytosis contraindication 17182001 DOID:12987
Myocardial infarction contraindication 22298006 DOID:5844
Hypovolemia contraindication 28560003
Orthostatic hypotension contraindication 28651003
Parkinsonism contraindication 32798002
Dehydration contraindication 34095006
Dysphagia contraindication 40739000
Conduction disorder of the heart contraindication 44808001
Low blood pressure contraindication 45007003
Chronic heart failure contraindication 48447003
Disorder of cardiovascular system contraindication 49601007 DOID:1287
Hyperlipidemia contraindication 55822004 DOID:1168
Acute nephropathy contraindication 58574008
Hepatic failure contraindication 59927004
Cerebrovascular disease contraindication 62914000 DOID:6713
Substance abuse contraindication 66214007
Diabetes mellitus contraindication 73211009 DOID:9351
Diffuse Lewy body disease contraindication 80098002
Hyperglycemia contraindication 80394007 DOID:4195
Leukopenia contraindication 84828003 DOID:615
Tardive dyskinesia contraindication 102449007
Seizure disorder contraindication 128613002
Cerebrovascular accident contraindication 230690007
Disease of liver contraindication 235856003 DOID:409
Metabolic syndrome X contraindication 237602007 DOID:14221
Hyperprolactinemia contraindication 237662005 DOID:12700
Retention of urine contraindication 267064002
Neutropenic disorder contraindication 303011007 DOID:1227
At risk for aspiration contraindication 371736008
Fever contraindication 386661006
Hypothermia contraindication 386689009
Impaired cognition contraindication 386806002
Breastfeeding (mother) contraindication 413712001
Myocardial ischemia contraindication 414795007 DOID:3393
Obesity contraindication 414916001 DOID:9970
Carcinoma of female breast contraindication 447782002
Smokes tobacco daily contraindication 449868002
Predisposed to Torsades de Pointes Cardiac Arrhythmias contraindication

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 7.78 Basic
pKa2 3.45 Basic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
120MG PERSERIS KIT INDIVIOR INC N210655 July 27, 2018 RX FOR SUSPENSION, EXTENDED RELEASE SUBCUTANEOUS 10406160 June 26, 2026 METHOD OF TREATING SCHIZOPHRENIA
90MG PERSERIS KIT INDIVIOR INC N210655 July 27, 2018 RX FOR SUSPENSION, EXTENDED RELEASE SUBCUTANEOUS 10406160 June 26, 2026 METHOD OF TREATING SCHIZOPHRENIA
120MG PERSERIS KIT INDIVIOR INC N210655 July 27, 2018 RX FOR SUSPENSION, EXTENDED RELEASE SUBCUTANEOUS 10058554 Sept. 26, 2026 ADMINISTRATION OF RISPERIDONE
90MG PERSERIS KIT INDIVIOR INC N210655 July 27, 2018 RX FOR SUSPENSION, EXTENDED RELEASE SUBCUTANEOUS 10058554 Sept. 26, 2026 ADMINISTRATION OF RISPERIDONE
120MG PERSERIS KIT INDIVIOR INC N210655 July 27, 2018 RX FOR SUSPENSION, EXTENDED RELEASE SUBCUTANEOUS 10376590 Feb. 13, 2028 METHOD OF TREATING SCHIZOPHRENIA
120MG PERSERIS KIT INDIVIOR INC N210655 July 27, 2018 RX FOR SUSPENSION, EXTENDED RELEASE SUBCUTANEOUS 9186413 Feb. 13, 2028 TREATMENT OF SCHIZOPHRENIA
90MG PERSERIS KIT INDIVIOR INC N210655 July 27, 2018 RX FOR SUSPENSION, EXTENDED RELEASE SUBCUTANEOUS 10376590 Feb. 13, 2028 METHOD OF TREATING SCHIZOPHRENIA
90MG PERSERIS KIT INDIVIOR INC N210655 July 27, 2018 RX FOR SUSPENSION, EXTENDED RELEASE SUBCUTANEOUS 9186413 Feb. 13, 2028 TREATMENT OF SCHIZOPHRENIA

Orange Book exclusivity data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
120MG PERSERIS KIT INDIVIOR INC N210655 July 27, 2018 RX FOR SUSPENSION, EXTENDED RELEASE SUBCUTANEOUS July 27, 2021 NEW PRODUCT
90MG PERSERIS KIT INDIVIOR INC N210655 July 27, 2018 RX FOR SUSPENSION, EXTENDED RELEASE SUBCUTANEOUS July 27, 2021 NEW PRODUCT

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
D(2) dopamine receptor GPCR ANTAGONIST Ki 8.49 WOMBAT-PK CHEMBL
5-hydroxytryptamine receptor 2A GPCR ANTAGONIST Ki 9.36 WOMBAT-PK CHEMBL
D(3) dopamine receptor GPCR ANTAGONIST Ki 8.07 WOMBAT-PK
Histamine H2 receptor GPCR Ki 6.92 PDSP
D(1B) dopamine receptor GPCR Ki 7.02 PDSP
Muscarinic acetylcholine receptor M3 GPCR Ki 5 PDSP
Muscarinic acetylcholine receptor M4 GPCR Ki 5.54 PDSP
Muscarinic acetylcholine receptor M2 GPCR Ki 5.43 PDSP
Alpha-1D adrenergic receptor GPCR ANTAGONIST Ki 7.40 IUPHAR
5-hydroxytryptamine receptor 1F GPCR ANTAGONIST Ki 5.90 IUPHAR
5-hydroxytryptamine receptor 1E GPCR ANTAGONIST Ki 5.90 IUPHAR
Cytochrome P450 2D6 Enzyme IC50 5.28 DRUG MATRIX
5-hydroxytryptamine receptor 2C GPCR ANTAGONIST Ki 7.70 WOMBAT-PK
5-hydroxytryptamine receptor 5A GPCR Ki 6.69 WOMBAT-PK
Alpha-1B adrenergic receptor GPCR Ki 8.48 WOMBAT-PK
Alpha-2C adrenergic receptor GPCR Ki 8.49 WOMBAT-PK
5-hydroxytryptamine receptor 1D GPCR ANTAGONIST Ki 7.60 WOMBAT-PK
5-hydroxytryptamine receptor 1B GPCR ANTAGONIST Ki 7.49 WOMBAT-PK
Histamine H1 receptor GPCR Ki 7.48 WOMBAT-PK
Alpha-2B adrenergic receptor GPCR Ki 7.77 WOMBAT-PK
Alpha-1A adrenergic receptor GPCR Ki 8.55 WOMBAT-PK
5-hydroxytryptamine receptor 7 GPCR Ki 8.47 WOMBAT-PK
5-hydroxytryptamine receptor 2B GPCR Ki 7.42 WOMBAT-PK
5-hydroxytryptamine receptor 1A GPCR Ki 6.44 WOMBAT-PK
Potassium voltage-gated channel subfamily H member 2 Ion channel IC50 6.79 WOMBAT-PK
Alpha-2A adrenergic receptor GPCR Ki 8 WOMBAT-PK
Beta-2 adrenergic receptor GPCR Ki 5.30 PDSP
Beta-1 adrenergic receptor GPCR Ki 5.30 PDSP
Solute carrier family 22 member 2 Transporter IC50 4.96 CHEMBL
Muscarinic acetylcholine receptor M1 GPCR Ki 5.55 CHEMBL
D(1A) dopamine receptor GPCR Ki 7.68 CHEMBL
Sodium-dependent serotonin transporter Transporter Ki 5.85 CHEMBL
Sigma non-opioid intracellular receptor 1 Membrane receptor Ki 5.37 CHEMBL
Multidrug and toxin extrusion protein 1 Transporter IC50 5.80 CHEMBL
5-hydroxytryptamine receptor 6 GPCR Ki 6.65 CHEMBL
Glycine receptor subunit alpha-1 Ion channel EC50 6.49 CHEMBL
D(4) dopamine receptor GPCR ANTAGONIST Ki 8 WOMBAT-PK
Alpha-1B adrenergic receptor GPCR Ki 8.97 DRUG MATRIX
Transporter Transporter Ki 4.55 CHEMBL
Histamine H1 receptor GPCR Ki 7.66 CHEMBL
5-hydroxytryptamine receptor 7 GPCR Ki 8.85 CHEMBL
D(2) dopamine receptor GPCR IC50 7.64 CHEMBL
D(3) dopamine receptor GPCR Ki 8.01 CHEMBL
Serotonin 2 (5-HT2) receptor GPCR Ki 9.85 CHEMBL
D(1A) dopamine receptor GPCR Ki 7.66 CHEMBL
Alpha-2A adrenergic receptor GPCR Ki 7.60 CHEMBL
Histamine H1 receptor GPCR IC50 7.10 CHEMBL
5-hydroxytryptamine receptor 2C GPCR Ki 7.84 CHEMBL
5-hydroxytryptamine receptor 1A GPCR IC50 6.37 CHEMBL
5-hydroxytryptamine receptor 2A GPCR Ki 9.82 CHEMBL
Beta-1 adrenergic receptor GPCR Ki 4.66 CHEMBL
Alpha-1A adrenergic receptor GPCR Ki 7.89 CHEMBL
Serotonin 1 (5-HT1) receptor GPCR Ki 6.47 CHEMBL
5-hydroxytryptamine receptor 1A GPCR Ki 6.89 CHEMBL
Serotonin 2 (5-HT2) receptor GPCR IC50 8.82 CHEMBL
D(2) dopamine receptor GPCR Ki 8.74 CHEMBL
5-hydroxytryptamine receptor 6 GPCR ANTAGONIST Ki 6.40 IUPHAR

External reference:

IDSource
4020840 VUID
N0000148350 NUI
C0073393 UMLSCUI
D00426 KEGG_DRUG
108386000 SNOMEDCT_US
4020840 VANDF
004392 NDDF
35636 RXNORM
146973 MMSL
d03180 MMSL
386840002 SNOMEDCT_US
5429 MMSL
CHEMBL85 ChEMBL_ID
DB00734 DRUGBANK_ID
L6UH7ZF8HC UNII
6085 INN_ID
CHEBI:8871 CHEBI
D018967 MESH_DESCRIPTOR_UI
5073 PUBCHEM_CID
96 IUPHAR_LIGAND_ID

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Risperidone HUMAN PRESCRIPTION DRUG LABEL 1 0054-0063 SOLUTION 1 mg ORAL ANDA 20 sections
Risperidone HUMAN PRESCRIPTION DRUG LABEL 1 0378-3502 TABLET, FILM COATED 0.25 mg ORAL ANDA 18 sections
Risperidone HUMAN PRESCRIPTION DRUG LABEL 1 0378-3505 TABLET, FILM COATED 0.50 mg ORAL ANDA 18 sections
Risperidone HUMAN PRESCRIPTION DRUG LABEL 1 0378-3511 TABLET, FILM COATED 1 mg ORAL ANDA 18 sections
Risperidone HUMAN PRESCRIPTION DRUG LABEL 1 0378-3512 TABLET, FILM COATED 2 mg ORAL ANDA 18 sections
Risperidone HUMAN PRESCRIPTION DRUG LABEL 1 0378-3513 TABLET, FILM COATED 3 mg ORAL ANDA 18 sections
Risperidone HUMAN PRESCRIPTION DRUG LABEL 1 0378-3514 TABLET, FILM COATED 4 mg ORAL ANDA 18 sections
Risperidone HUMAN PRESCRIPTION DRUG LABEL 1 0615-8196 TABLET 0.25 mg ORAL ANDA 19 sections
Risperidone HUMAN PRESCRIPTION DRUG LABEL 1 0615-8197 TABLET 0.50 mg ORAL ANDA 19 sections
Risperidone HUMAN PRESCRIPTION DRUG LABEL 1 0615-8198 TABLET 1 mg ORAL ANDA 19 sections
Risperidone HUMAN PRESCRIPTION DRUG LABEL 1 0615-8265 TABLET 3 mg ORAL ANDA 19 sections
Risperidone HUMAN PRESCRIPTION DRUG LABEL 1 0615-8288 TABLET 2 mg ORAL ANDA 19 sections
Risperidone HUMAN PRESCRIPTION DRUG LABEL 1 0781-5310 TABLET, ORALLY DISINTEGRATING 0.50 mg ORAL ANDA 18 sections
Risperidone HUMAN PRESCRIPTION DRUG LABEL 1 0781-5311 TABLET, ORALLY DISINTEGRATING 1 mg ORAL ANDA 18 sections
Risperidone HUMAN PRESCRIPTION DRUG LABEL 1 0781-5312 TABLET, ORALLY DISINTEGRATING 2 mg ORAL ANDA 18 sections
Risperidone HUMAN PRESCRIPTION DRUG LABEL 1 0781-5313 TABLET, ORALLY DISINTEGRATING 3 mg ORAL ANDA 18 sections
Risperidone HUMAN PRESCRIPTION DRUG LABEL 1 0781-5314 TABLET, ORALLY DISINTEGRATING 4 mg ORAL ANDA 18 sections
Risperidone HUMAN PRESCRIPTION DRUG LABEL 1 0904-6357 TABLET 0.25 mg ORAL ANDA 20 sections
Risperidone HUMAN PRESCRIPTION DRUG LABEL 1 0904-6358 TABLET 0.50 mg ORAL ANDA 20 sections
Risperidone HUMAN PRESCRIPTION DRUG LABEL 1 0904-6359 TABLET 1 mg ORAL ANDA 20 sections
Risperidone HUMAN PRESCRIPTION DRUG LABEL 1 0904-6360 TABLET 2 mg ORAL ANDA 20 sections
Risperidone HUMAN PRESCRIPTION DRUG LABEL 1 0904-6361 TABLET 3 mg ORAL ANDA 20 sections
Risperidone HUMAN PRESCRIPTION DRUG LABEL 1 0904-6362 TABLET 4 mg ORAL ANDA 20 sections
PERSERIS HUMAN PRESCRIPTION DRUG LABEL 1 12496-0090 KIT 90 mg SUBCUTANEOUS NDA 17 sections
PERSERIS HUMAN PRESCRIPTION DRUG LABEL 1 12496-0120 KIT 120 mg SUBCUTANEOUS NDA 17 sections
Risperidone HUMAN PRESCRIPTION DRUG LABEL 1 13107-119 TABLET, FILM COATED 0.25 mg ORAL ANDA 20 sections
Risperidone HUMAN PRESCRIPTION DRUG LABEL 1 13107-120 TABLET, FILM COATED 0.50 mg ORAL ANDA 20 sections
Risperidone HUMAN PRESCRIPTION DRUG LABEL 1 13107-121 TABLET, FILM COATED 1 mg ORAL ANDA 20 sections
Risperidone HUMAN PRESCRIPTION DRUG LABEL 1 13107-122 TABLET, FILM COATED 2 mg ORAL ANDA 20 sections
Risperidone HUMAN PRESCRIPTION DRUG LABEL 1 13107-123 TABLET, FILM COATED 3 mg ORAL ANDA 20 sections