Stem definition | Drug id | CAS RN |
---|---|---|
4498 | 199739-10-1 |
None
None
Date | Agency | Company | Orphan |
---|---|---|---|
July 31, 2009 | FDA | JANSSEN PHARMS | |
Sept. 20, 2013 | PMDA | JANSSEN PHARMACEUTICAL K.K. |
MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
---|---|---|---|---|---|---|
Blood prolactin increased | 1848.84 | 30.00 | 363 | 13234 | 2736 | 50588791 |
Galactorrhoea | 1699.80 | 30.00 | 349 | 13248 | 3374 | 50588153 |
Amenorrhoea | 943.09 | 30.00 | 253 | 13344 | 8231 | 50583296 |
Injection site nodule | 877.78 | 30.00 | 199 | 13398 | 3149 | 50588378 |
Product dose omission issue | 575.11 | 30.00 | 439 | 13158 | 183399 | 50408128 |
Blood prolactin abnormal | 541.47 | 30.00 | 124 | 13473 | 2051 | 50589476 |
Inappropriate schedule of product administration | 534.29 | 30.00 | 296 | 13301 | 71535 | 50519992 |
Psychotic disorder | 446.87 | 30.00 | 181 | 13416 | 21631 | 50569896 |
Disturbance in social behaviour | 421.10 | 30.00 | 107 | 13490 | 2787 | 50588740 |
Anosognosia | 376.92 | 30.00 | 93 | 13504 | 2141 | 50589386 |
Hospitalisation | 372.67 | 30.00 | 230 | 13367 | 67707 | 50523820 |
Sexual dysfunction | 359.88 | 30.00 | 97 | 13500 | 3195 | 50588332 |
Hyperprolactinaemia | 357.77 | 30.00 | 97 | 13500 | 3268 | 50588259 |
Off label use | 347.21 | 30.00 | 522 | 13075 | 473904 | 50117623 |
Hallucination, auditory | 342.10 | 30.00 | 123 | 13474 | 10605 | 50580922 |
Dystonia | 329.40 | 30.00 | 123 | 13474 | 11803 | 50579724 |
Metabolic disorder | 306.03 | 30.00 | 95 | 13502 | 5191 | 50586336 |
Extrapyramidal disorder | 298.29 | 30.00 | 114 | 13483 | 11656 | 50579871 |
Injection site mass | 293.36 | 30.00 | 122 | 13475 | 15558 | 50575969 |
Personality change | 291.62 | 30.00 | 93 | 13504 | 5552 | 50585975 |
Sedation | 288.68 | 30.00 | 148 | 13449 | 30462 | 50561065 |
Weight increased | 281.75 | 30.00 | 307 | 13290 | 201584 | 50389943 |
Akathisia | 276.12 | 30.00 | 98 | 13499 | 8131 | 50583396 |
Incorrect dose administered | 270.58 | 30.00 | 166 | 13431 | 48248 | 50543279 |
Breast discharge | 252.66 | 30.00 | 56 | 13541 | 791 | 50590736 |
Dyskinesia | 251.99 | 30.00 | 131 | 13466 | 27730 | 50563797 |
Treatment noncompliance | 233.92 | 30.00 | 128 | 13469 | 30022 | 50561505 |
Syringe issue | 201.00 | 30.00 | 56 | 13541 | 2088 | 50589439 |
Suicide attempt | 195.54 | 30.00 | 139 | 13458 | 51593 | 50539934 |
Psychotic symptom | 187.09 | 30.00 | 47 | 13550 | 1165 | 50590362 |
Tardive dyskinesia | 175.43 | 30.00 | 68 | 13529 | 7211 | 50584316 |
Product use in unapproved indication | 174.97 | 30.00 | 184 | 13413 | 115635 | 50475892 |
Delusion | 170.29 | 30.00 | 74 | 13523 | 10495 | 50581032 |
Refusal of treatment by patient | 168.80 | 30.00 | 60 | 13537 | 4993 | 50586534 |
Injection site pain | 163.45 | 30.00 | 174 | 13423 | 110850 | 50480677 |
Paranoia | 162.00 | 30.00 | 71 | 13526 | 10277 | 50581250 |
Device leakage | 131.37 | 30.00 | 52 | 13545 | 5826 | 50585701 |
Therapeutic response decreased | 121.48 | 30.00 | 101 | 13496 | 47130 | 50544397 |
Blood glucose increased | 116.01 | 30.00 | 118 | 13479 | 71206 | 50520321 |
Underdose | 111.77 | 30.00 | 69 | 13528 | 20209 | 50571318 |
Diarrhoea | 106.21 | 30.00 | 16 | 13581 | 588460 | 50003067 |
Product administered at inappropriate site | 104.87 | 30.00 | 35 | 13562 | 2408 | 50589119 |
Aggression | 104.23 | 30.00 | 67 | 13530 | 21049 | 50570478 |
Nausea | 101.53 | 30.00 | 32 | 13565 | 705366 | 49886161 |
Insurance issue | 84.12 | 30.00 | 30 | 13567 | 2518 | 50589009 |
Drooling | 79.35 | 30.00 | 31 | 13566 | 3353 | 50588174 |
Product quality issue | 79.33 | 30.00 | 66 | 13531 | 30792 | 50560735 |
Injection site abscess | 78.54 | 30.00 | 23 | 13574 | 1026 | 50590501 |
Pain | 78.43 | 30.00 | 29 | 13568 | 578874 | 50012653 |
Arthralgia | 76.62 | 30.00 | 13 | 13584 | 438689 | 50152838 |
Condition aggravated | 74.58 | 30.00 | 211 | 13386 | 296847 | 50294680 |
Injection site reaction | 70.98 | 30.00 | 77 | 13520 | 49955 | 50541572 |
Injection site swelling | 69.48 | 30.00 | 70 | 13527 | 41703 | 50549824 |
Abnormal behaviour | 65.50 | 30.00 | 49 | 13548 | 19609 | 50571918 |
Accidental exposure to product | 62.78 | 30.00 | 51 | 13546 | 23006 | 50568521 |
Breast enlargement | 59.65 | 30.00 | 20 | 13577 | 1395 | 50590132 |
Parkinsonism | 58.87 | 30.00 | 34 | 13563 | 8813 | 50582714 |
Fatigue | 58.14 | 30.00 | 63 | 13534 | 707538 | 49883989 |
Hallucination | 57.94 | 30.00 | 67 | 13530 | 46590 | 50544937 |
Drug ineffective | 55.43 | 30.00 | 392 | 13205 | 818941 | 49772586 |
Injection site induration | 55.16 | 30.00 | 32 | 13565 | 8365 | 50583162 |
Suicidal ideation | 54.94 | 30.00 | 71 | 13526 | 55314 | 50536213 |
Cough | 52.75 | 30.00 | 3 | 13594 | 241261 | 50350266 |
Headache | 52.60 | 30.00 | 36 | 13561 | 506499 | 50085028 |
Imprisonment | 52.10 | 30.00 | 12 | 13585 | 203 | 50591324 |
Lactation disorder | 51.78 | 30.00 | 13 | 13584 | 321 | 50591206 |
Product use issue | 51.75 | 30.00 | 120 | 13477 | 149355 | 50442172 |
Neuroleptic malignant syndrome | 51.68 | 30.00 | 34 | 13563 | 11096 | 50580431 |
Dyspnoea | 51.64 | 30.00 | 43 | 13554 | 547565 | 50043962 |
Abdominal discomfort | 50.27 | 30.00 | 3 | 13594 | 231638 | 50359889 |
Needle issue | 48.52 | 30.00 | 28 | 13569 | 7247 | 50584280 |
Joint swelling | 48.15 | 30.00 | 5 | 13592 | 245281 | 50346246 |
Drug hypersensitivity | 47.07 | 30.00 | 6 | 13591 | 251004 | 50340523 |
Adverse event | 46.40 | 30.00 | 58 | 13539 | 43705 | 50547822 |
Schizophrenia | 45.45 | 30.00 | 27 | 13570 | 7370 | 50584157 |
Breast tenderness | 45.00 | 30.00 | 18 | 13579 | 2070 | 50589457 |
Menstruation irregular | 44.54 | 30.00 | 25 | 13572 | 6137 | 50585390 |
Product administration error | 44.23 | 30.00 | 39 | 13558 | 19660 | 50571867 |
Tremor | 43.94 | 30.00 | 96 | 13501 | 114807 | 50476720 |
Vomiting | 43.62 | 30.00 | 36 | 13561 | 460722 | 50130805 |
Prolactin-producing pituitary tumour | 43.27 | 30.00 | 9 | 13588 | 92 | 50591435 |
Anaemia | 42.86 | 30.00 | 8 | 13589 | 252448 | 50339079 |
Drug intolerance | 41.65 | 30.00 | 5 | 13592 | 219099 | 50372428 |
Wrong technique in product usage process | 41.33 | 30.00 | 62 | 13535 | 55448 | 50536079 |
Abdominal pain | 41.16 | 30.00 | 7 | 13590 | 236221 | 50355306 |
Abnormal weight gain | 40.14 | 30.00 | 15 | 13582 | 1437 | 50590090 |
Social avoidant behaviour | 39.93 | 30.00 | 18 | 13579 | 2779 | 50588748 |
Pneumonia | 39.08 | 30.00 | 27 | 13570 | 378374 | 50213153 |
Mania | 38.13 | 30.00 | 28 | 13569 | 10888 | 50580639 |
Catatonia | 37.89 | 30.00 | 19 | 13578 | 3717 | 50587810 |
Nasopharyngitis | 37.67 | 30.00 | 4 | 13593 | 192923 | 50398604 |
Product leakage | 36.92 | 30.00 | 11 | 13586 | 521 | 50591006 |
Blunted affect | 35.97 | 30.00 | 9 | 13588 | 219 | 50591308 |
Pruritus | 35.36 | 30.00 | 16 | 13581 | 283552 | 50307975 |
Back pain | 35.22 | 30.00 | 8 | 13589 | 220022 | 50371505 |
Psychiatric decompensation | 34.79 | 30.00 | 13 | 13584 | 1245 | 50590282 |
Pyrexia | 34.38 | 30.00 | 31 | 13566 | 380172 | 50211355 |
Pituitary tumour benign | 33.75 | 30.00 | 14 | 13583 | 1767 | 50589760 |
Breast engorgement | 31.97 | 30.00 | 7 | 13590 | 93 | 50591434 |
Adverse drug reaction | 31.96 | 30.00 | 55 | 13542 | 55167 | 50536360 |
Acute kidney injury | 31.48 | 30.00 | 11 | 13586 | 228047 | 50363480 |
Peripheral swelling | 30.07 | 30.00 | 9 | 13588 | 205927 | 50385600 |
Asthenia | 30.05 | 30.00 | 25 | 13572 | 319017 | 50272510 |
MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
---|---|---|---|---|---|---|
Product dose omission issue | 1297.66 | 27.24 | 774 | 17182 | 95609 | 29460962 |
Inappropriate schedule of product administration | 1084.94 | 27.24 | 531 | 17425 | 43941 | 29512630 |
Psychotic disorder | 799.02 | 27.24 | 339 | 17617 | 20015 | 29536556 |
Blood prolactin increased | 654.75 | 27.24 | 158 | 17798 | 1376 | 29555195 |
Hospitalisation | 654.04 | 27.24 | 384 | 17572 | 45604 | 29510967 |
Off label use | 499.80 | 27.24 | 749 | 17207 | 300051 | 29256520 |
Treatment noncompliance | 454.68 | 27.24 | 243 | 17713 | 23984 | 29532587 |
Hallucination, auditory | 433.94 | 27.24 | 177 | 17779 | 9416 | 29547155 |
Incorrect dose administered | 430.77 | 27.24 | 261 | 17695 | 32723 | 29523848 |
Injection site nodule | 430.45 | 27.24 | 112 | 17844 | 1358 | 29555213 |
Akathisia | 402.11 | 27.24 | 152 | 17804 | 6590 | 29549981 |
Gynaecomastia | 397.06 | 27.24 | 159 | 17797 | 8058 | 29548513 |
Extrapyramidal disorder | 354.72 | 27.24 | 159 | 17797 | 10672 | 29545899 |
Weight increased | 307.34 | 27.24 | 300 | 17656 | 76367 | 29480204 |
Therapeutic response decreased | 300.60 | 27.24 | 187 | 17769 | 24524 | 29532047 |
Paranoia | 288.74 | 27.24 | 134 | 17822 | 9743 | 29546828 |
Syringe issue | 272.52 | 27.24 | 98 | 17858 | 3680 | 29552891 |
Sexual dysfunction | 261.86 | 27.24 | 107 | 17849 | 5707 | 29550864 |
Delusion | 257.68 | 27.24 | 129 | 17827 | 11087 | 29545484 |
Refusal of treatment by patient | 237.71 | 27.24 | 94 | 17862 | 4600 | 29551971 |
Psychotic symptom | 230.29 | 27.24 | 68 | 17888 | 1346 | 29555225 |
Drug ineffective | 225.22 | 27.24 | 600 | 17356 | 362570 | 29194001 |
Therapeutic product effect decreased | 224.62 | 27.24 | 167 | 17789 | 29284 | 29527287 |
Dystonia | 223.55 | 27.24 | 112 | 17844 | 9637 | 29546934 |
Blood prolactin abnormal | 215.81 | 27.24 | 58 | 17898 | 802 | 29555769 |
Sedation | 209.76 | 27.24 | 131 | 17825 | 17274 | 29539297 |
Aggression | 205.17 | 27.24 | 171 | 17785 | 35370 | 29521201 |
Underdose | 189.16 | 27.24 | 107 | 17849 | 11762 | 29544809 |
Tardive dyskinesia | 168.26 | 27.24 | 76 | 17880 | 5182 | 29551389 |
Anosognosia | 162.87 | 27.24 | 46 | 17910 | 772 | 29555799 |
Injection site pain | 158.60 | 27.24 | 142 | 17814 | 32304 | 29524267 |
Disturbance in social behaviour | 156.80 | 27.24 | 53 | 17903 | 1649 | 29554922 |
Dyskinesia | 144.52 | 27.24 | 110 | 17846 | 19951 | 29536620 |
Suicidal ideation | 140.89 | 27.24 | 137 | 17819 | 34579 | 29521992 |
Galactorrhoea | 139.77 | 27.24 | 35 | 17921 | 359 | 29556212 |
Erectile dysfunction | 134.71 | 27.24 | 101 | 17855 | 17908 | 29538663 |
Neuroleptic malignant syndrome | 133.04 | 27.24 | 96 | 17860 | 16052 | 29540519 |
Product administered at inappropriate site | 125.45 | 27.24 | 45 | 17911 | 1675 | 29554896 |
Device leakage | 125.16 | 27.24 | 59 | 17897 | 4436 | 29552135 |
Injection site mass | 123.04 | 27.24 | 62 | 17894 | 5393 | 29551178 |
Condition aggravated | 121.05 | 27.24 | 271 | 17685 | 146024 | 29410547 |
Product leakage | 113.10 | 27.24 | 30 | 17926 | 393 | 29556178 |
Schizophrenia | 112.23 | 27.24 | 62 | 17894 | 6503 | 29550068 |
Abnormal behaviour | 110.56 | 27.24 | 100 | 17856 | 23027 | 29533544 |
Breast enlargement | 110.54 | 27.24 | 30 | 17926 | 431 | 29556140 |
Diarrhoea | 110.01 | 27.24 | 33 | 17923 | 332665 | 29223906 |
Suicide attempt | 104.83 | 27.24 | 116 | 17840 | 33994 | 29522577 |
Product quality issue | 103.25 | 27.24 | 82 | 17874 | 15813 | 29540758 |
Adverse event | 101.72 | 27.24 | 80 | 17876 | 15211 | 29541360 |
Psychosexual disorder | 101.22 | 27.24 | 21 | 17935 | 82 | 29556489 |
Drooling | 97.70 | 27.24 | 44 | 17912 | 2977 | 29553594 |
Product administration error | 97.64 | 27.24 | 76 | 17880 | 14234 | 29542337 |
Needle issue | 90.56 | 27.24 | 48 | 17908 | 4635 | 29551936 |
Hallucination | 90.25 | 27.24 | 123 | 17833 | 44589 | 29511982 |
Product use issue | 89.77 | 27.24 | 132 | 17824 | 51312 | 29505259 |
Hyperprolactinaemia | 88.02 | 27.24 | 32 | 17924 | 1238 | 29555333 |
Mania | 86.56 | 27.24 | 58 | 17898 | 8605 | 29547966 |
Acute kidney injury | 86.34 | 27.24 | 27 | 17929 | 265240 | 29291331 |
Metabolic disorder | 86.28 | 27.24 | 43 | 17913 | 3652 | 29552919 |
Imprisonment | 86.10 | 27.24 | 25 | 17931 | 465 | 29556106 |
Accidental exposure to product | 84.17 | 27.24 | 62 | 17894 | 10691 | 29545880 |
Parkinsonism | 83.16 | 27.24 | 53 | 17903 | 7225 | 29549346 |
Anaemia | 80.23 | 27.24 | 13 | 17943 | 200938 | 29355633 |
Product use in unapproved indication | 79.74 | 27.24 | 168 | 17788 | 86707 | 29469864 |
Psychiatric symptom | 77.15 | 27.24 | 38 | 17918 | 3146 | 29553425 |
Pneumonia | 74.39 | 27.24 | 52 | 17904 | 320120 | 29236451 |
Sepsis | 70.52 | 27.24 | 4 | 17952 | 142678 | 29413893 |
Catatonia | 70.39 | 27.24 | 40 | 17916 | 4428 | 29552143 |
Injection site reaction | 68.99 | 27.24 | 56 | 17900 | 11132 | 29545439 |
Personality change | 66.36 | 27.24 | 39 | 17917 | 4599 | 29551972 |
Wrong technique in product usage process | 64.21 | 27.24 | 87 | 17869 | 31341 | 29525230 |
Agitation | 63.95 | 27.24 | 113 | 17843 | 51191 | 29505380 |
Eye movement disorder | 63.42 | 27.24 | 35 | 17921 | 3661 | 29552910 |
Retrograde ejaculation | 63.39 | 27.24 | 18 | 17938 | 308 | 29556263 |
Dyspnoea | 61.35 | 27.24 | 65 | 17891 | 326667 | 29229904 |
Social avoidant behaviour | 59.28 | 27.24 | 31 | 17925 | 2911 | 29553660 |
Abdominal pain | 58.10 | 27.24 | 7 | 17949 | 135350 | 29421221 |
Nausea | 57.17 | 27.24 | 55 | 17901 | 289200 | 29267371 |
Breast tenderness | 56.91 | 27.24 | 20 | 17936 | 700 | 29555871 |
Anxiety | 55.22 | 27.24 | 144 | 17812 | 85221 | 29471350 |
Flat affect | 55.05 | 27.24 | 20 | 17936 | 772 | 29555799 |
Priapism | 54.57 | 27.24 | 34 | 17922 | 4454 | 29552117 |
Incorrect route of product administration | 54.15 | 27.24 | 48 | 17908 | 10753 | 29545818 |
Toxicity to various agents | 52.39 | 27.24 | 20 | 17936 | 173641 | 29382930 |
Pyrexia | 51.98 | 27.24 | 59 | 17897 | 287563 | 29269008 |
Muscle rigidity | 45.55 | 27.24 | 41 | 17915 | 9370 | 29547201 |
Haemoglobin decreased | 45.53 | 27.24 | 6 | 17950 | 108369 | 29448202 |
Cough | 44.67 | 27.24 | 11 | 17945 | 126716 | 29429855 |
Breast discharge | 44.49 | 27.24 | 9 | 17947 | 30 | 29556541 |
Fatigue | 43.42 | 27.24 | 79 | 17877 | 316742 | 29239829 |
Product packaging issue | 42.49 | 27.24 | 15 | 17941 | 532 | 29556039 |
Wrong product administered | 42.08 | 27.24 | 29 | 17927 | 4502 | 29552069 |
Intentional self-injury | 41.07 | 27.24 | 44 | 17912 | 12417 | 29544154 |
Mental impairment | 40.68 | 27.24 | 38 | 17918 | 9103 | 29547468 |
Arthralgia | 40.58 | 27.24 | 17 | 17939 | 139600 | 29416971 |
Thinking abnormal | 40.54 | 27.24 | 30 | 17926 | 5206 | 29551365 |
Restlessness | 40.29 | 27.24 | 58 | 17898 | 22087 | 29534484 |
Asthenia | 40.10 | 27.24 | 43 | 17913 | 215207 | 29341364 |
Investigation | 39.22 | 27.24 | 16 | 17940 | 848 | 29555723 |
Irritability | 38.82 | 27.24 | 57 | 17899 | 22095 | 29534476 |
Device malfunction | 37.16 | 27.24 | 35 | 17921 | 8472 | 29548099 |
Renal failure | 36.85 | 27.24 | 13 | 17943 | 118586 | 29437985 |
Rash | 36.38 | 27.24 | 37 | 17919 | 189782 | 29366789 |
Medication error | 36.33 | 27.24 | 54 | 17902 | 21157 | 29535414 |
Pruritus | 35.98 | 27.24 | 13 | 17943 | 116836 | 29439735 |
Cardiac failure congestive | 35.33 | 27.24 | 3 | 17953 | 76578 | 29479993 |
Blood creatinine increased | 35.05 | 27.24 | 5 | 17951 | 85097 | 29471474 |
Atrial fibrillation | 33.83 | 27.24 | 11 | 17945 | 105635 | 29450936 |
Hypotension | 32.78 | 27.24 | 42 | 17914 | 194312 | 29362259 |
Extra dose administered | 31.69 | 27.24 | 21 | 17935 | 3056 | 29553515 |
Adverse drug reaction | 31.32 | 27.24 | 54 | 17902 | 23966 | 29532605 |
Respiratory failure | 31.30 | 27.24 | 10 | 17946 | 97121 | 29459450 |
Ejaculation failure | 30.75 | 27.24 | 13 | 17943 | 754 | 29555817 |
Psychiatric decompensation | 30.74 | 27.24 | 16 | 17940 | 1488 | 29555083 |
Decreased appetite | 30.58 | 27.24 | 26 | 17930 | 145316 | 29411255 |
Infection | 30.49 | 27.24 | 5 | 17951 | 76746 | 29479825 |
Tremor | 29.54 | 27.24 | 105 | 17851 | 73433 | 29483138 |
Drug interaction | 29.00 | 27.24 | 47 | 17909 | 197338 | 29359233 |
Injection site rash | 28.90 | 27.24 | 21 | 17935 | 3543 | 29553028 |
Injection site abscess | 28.37 | 27.24 | 12 | 17944 | 697 | 29555874 |
Vomiting | 28.06 | 27.24 | 54 | 17902 | 212206 | 29344365 |
Persecutory delusion | 28.01 | 27.24 | 17 | 17939 | 2124 | 29554447 |
Homicidal ideation | 27.88 | 27.24 | 18 | 17938 | 2506 | 29554065 |
MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
---|---|---|---|---|---|---|
Blood prolactin increased | 1080.80 | 23.77 | 245 | 19967 | 3283 | 64475237 |
Inappropriate schedule of product administration | 913.79 | 23.77 | 484 | 19728 | 91802 | 64386718 |
Product dose omission issue | 791.48 | 23.77 | 579 | 19633 | 194168 | 64284352 |
Galactorrhoea | 749.78 | 23.77 | 179 | 20033 | 3040 | 64475480 |
Psychotic disorder | 643.18 | 23.77 | 280 | 19932 | 34298 | 64444222 |
Injection site nodule | 571.43 | 23.77 | 144 | 20068 | 3086 | 64475434 |
Off label use | 565.17 | 23.77 | 829 | 19383 | 631977 | 63846543 |
Blood prolactin abnormal | 559.63 | 23.77 | 137 | 20075 | 2595 | 64475925 |
Disturbance in social behaviour | 530.66 | 23.77 | 141 | 20071 | 3746 | 64474774 |
Sexual dysfunction | 515.42 | 23.77 | 154 | 20058 | 6317 | 64472203 |
Anosognosia | 510.85 | 23.77 | 128 | 20084 | 2677 | 64475843 |
Extrapyramidal disorder | 486.77 | 23.77 | 195 | 20017 | 19357 | 64459163 |
Hospitalisation | 483.53 | 23.77 | 298 | 19914 | 74909 | 64403611 |
Dystonia | 479.55 | 23.77 | 191 | 20021 | 18674 | 64459846 |
Incorrect dose administered | 450.67 | 23.77 | 264 | 19948 | 60501 | 64418019 |
Hallucination, auditory | 446.25 | 23.77 | 176 | 20036 | 16763 | 64461757 |
Treatment noncompliance | 446.18 | 23.77 | 234 | 19978 | 43248 | 64435272 |
Akathisia | 402.13 | 23.77 | 147 | 20065 | 11363 | 64467157 |
Sedation | 385.53 | 23.77 | 209 | 20003 | 41253 | 64437267 |
Amenorrhoea | 374.88 | 23.77 | 121 | 20091 | 6418 | 64472102 |
Metabolic disorder | 371.27 | 23.77 | 125 | 20087 | 7572 | 64470948 |
Dyskinesia | 361.90 | 23.77 | 197 | 20015 | 39191 | 64439329 |
Personality change | 346.29 | 23.77 | 122 | 20090 | 8471 | 64470049 |
Suicide attempt | 316.53 | 23.77 | 224 | 19988 | 70783 | 64407737 |
Syringe issue | 285.77 | 23.77 | 89 | 20123 | 4197 | 64474323 |
Hyperprolactinaemia | 277.71 | 23.77 | 86 | 20126 | 3979 | 64474541 |
Gynaecomastia | 263.87 | 23.77 | 91 | 20121 | 5925 | 64472595 |
Delusion | 252.78 | 23.77 | 120 | 20092 | 17894 | 64460626 |
Weight increased | 252.66 | 23.77 | 322 | 19890 | 213026 | 64265494 |
Tardive dyskinesia | 240.34 | 23.77 | 95 | 20117 | 9083 | 64469437 |
Paranoia | 229.65 | 23.77 | 109 | 20103 | 16243 | 64462277 |
Psychotic symptom | 228.57 | 23.77 | 64 | 20148 | 2074 | 64476446 |
Refusal of treatment by patient | 206.81 | 23.77 | 83 | 20129 | 8256 | 64470264 |
Aggression | 197.01 | 23.77 | 142 | 20070 | 46090 | 64432430 |
Injection site mass | 182.81 | 23.77 | 95 | 20117 | 17175 | 64461345 |
Product use in unapproved indication | 177.21 | 23.77 | 246 | 19966 | 176372 | 64302148 |
Neuroleptic malignant syndrome | 173.01 | 23.77 | 104 | 20108 | 24892 | 64453628 |
Injection site pain | 152.31 | 23.77 | 181 | 20031 | 111227 | 64367293 |
Underdose | 142.33 | 23.77 | 93 | 20119 | 25736 | 64452784 |
Product administered at inappropriate site | 140.08 | 23.77 | 48 | 20164 | 3062 | 64475458 |
Therapeutic response decreased | 139.80 | 23.77 | 122 | 20090 | 52066 | 64426454 |
Device leakage | 134.38 | 23.77 | 61 | 20151 | 8205 | 64470315 |
Suicidal ideation | 132.74 | 23.77 | 132 | 20080 | 66410 | 64412110 |
Diarrhoea | 125.17 | 23.77 | 36 | 20176 | 722668 | 63755852 |
Abnormal behaviour | 124.62 | 23.77 | 95 | 20117 | 33527 | 64444993 |
Product use issue | 119.88 | 23.77 | 189 | 20023 | 151526 | 64326994 |
Parkinsonism | 118.48 | 23.77 | 67 | 20145 | 14306 | 64464214 |
Drug ineffective | 117.52 | 23.77 | 546 | 19666 | 839701 | 63638819 |
Blood glucose increased | 115.71 | 23.77 | 148 | 20064 | 97925 | 64380595 |
Drooling | 111.66 | 23.77 | 47 | 20165 | 5272 | 64473248 |
Nausea | 108.22 | 23.77 | 56 | 20156 | 785744 | 63692776 |
Schizophrenia | 102.84 | 23.77 | 56 | 20156 | 11112 | 64467408 |
Insurance issue | 98.30 | 23.77 | 36 | 20176 | 2790 | 64475730 |
Product leakage | 95.17 | 23.77 | 25 | 20187 | 633 | 64477887 |
Erectile dysfunction | 93.77 | 23.77 | 55 | 20157 | 12572 | 64465948 |
Breast discharge | 93.52 | 23.77 | 24 | 20188 | 553 | 64477967 |
Arthralgia | 90.62 | 23.77 | 15 | 20197 | 442245 | 64036275 |
Needle issue | 89.58 | 23.77 | 48 | 20164 | 9224 | 64469296 |
Catatonia | 89.56 | 23.77 | 45 | 20167 | 7575 | 64470945 |
Psychiatric symptom | 88.60 | 23.77 | 42 | 20170 | 6231 | 64472289 |
Hallucination | 82.92 | 23.77 | 108 | 20104 | 72680 | 64405840 |
Accidental exposure to product | 73.32 | 23.77 | 63 | 20149 | 26301 | 64452219 |
Dyspnoea | 70.55 | 23.77 | 73 | 20139 | 718601 | 63759919 |
Injection site abscess | 68.55 | 23.77 | 23 | 20189 | 1375 | 64477145 |
Abdominal pain | 67.61 | 23.77 | 9 | 20203 | 312366 | 64166154 |
Pain | 66.80 | 23.77 | 46 | 20166 | 553465 | 63925055 |
Sudden death | 66.25 | 23.77 | 53 | 20159 | 20043 | 64458477 |
Injection site reaction | 65.63 | 23.77 | 77 | 20135 | 46587 | 64431933 |
Anaemia | 65.11 | 23.77 | 19 | 20193 | 378661 | 64099859 |
Cough | 62.38 | 23.77 | 10 | 20202 | 302138 | 64176382 |
Mania | 60.29 | 23.77 | 46 | 20166 | 16240 | 64462280 |
Condition aggravated | 59.92 | 23.77 | 253 | 19959 | 372173 | 64106347 |
Tremor | 58.92 | 23.77 | 138 | 20074 | 148092 | 64330428 |
Product administration error | 57.23 | 23.77 | 56 | 20156 | 27587 | 64450933 |
Fatigue | 56.07 | 23.77 | 93 | 20119 | 748637 | 63729883 |
Acute kidney injury | 55.96 | 23.77 | 36 | 20176 | 449204 | 64029316 |
Breast enlargement | 53.83 | 23.77 | 19 | 20193 | 1323 | 64477197 |
Mental impairment | 53.65 | 23.77 | 43 | 20169 | 16300 | 64462220 |
Imprisonment | 52.50 | 23.77 | 15 | 20197 | 523 | 64477997 |
Joint swelling | 52.29 | 23.77 | 4 | 20208 | 215378 | 64263142 |
Incorrect route of product administration | 51.63 | 23.77 | 49 | 20163 | 23249 | 64455271 |
Social avoidant behaviour | 50.89 | 23.77 | 26 | 20186 | 4531 | 64473989 |
Eye movement disorder | 50.37 | 23.77 | 30 | 20182 | 7049 | 64471471 |
Pruritus | 49.57 | 23.77 | 18 | 20194 | 312382 | 64166138 |
Psychiatric decompensation | 49.16 | 23.77 | 21 | 20191 | 2442 | 64476078 |
Pulmonary embolism | 48.38 | 23.77 | 127 | 20085 | 146229 | 64332291 |
Adverse drug reaction | 47.97 | 23.77 | 65 | 20147 | 45399 | 64433121 |
Vomiting | 47.49 | 23.77 | 62 | 20150 | 551055 | 63927465 |
Pneumonia | 47.16 | 23.77 | 64 | 20148 | 559512 | 63919008 |
Drug hypersensitivity | 46.61 | 23.77 | 9 | 20203 | 237806 | 64240714 |
Restlessness | 45.23 | 23.77 | 59 | 20153 | 39726 | 64438794 |
Injection site swelling | 44.97 | 23.77 | 60 | 20152 | 41293 | 64437227 |
Product quality issue | 44.97 | 23.77 | 51 | 20161 | 29748 | 64448772 |
Retrograde ejaculation | 44.67 | 23.77 | 11 | 20201 | 213 | 64478307 |
Anxiety | 44.36 | 23.77 | 152 | 20060 | 202497 | 64276023 |
Pyrexia | 43.05 | 23.77 | 68 | 20144 | 558576 | 63919944 |
Breast tenderness | 42.65 | 23.77 | 18 | 20194 | 2031 | 64476489 |
Sepsis | 42.51 | 23.77 | 10 | 20202 | 230331 | 64248189 |
Muscle rigidity | 41.12 | 23.77 | 38 | 20174 | 17435 | 64461085 |
Abdominal pain upper | 40.44 | 23.77 | 4 | 20208 | 175026 | 64303494 |
Psychosexual disorder | 40.12 | 23.77 | 9 | 20203 | 114 | 64478406 |
Headache | 39.33 | 23.77 | 66 | 20146 | 529401 | 63949119 |
Intentional self-injury | 39.30 | 23.77 | 47 | 20165 | 28997 | 64449523 |
Injection site induration | 39.30 | 23.77 | 28 | 20184 | 8904 | 64469616 |
Abdominal discomfort | 37.68 | 23.77 | 6 | 20206 | 182316 | 64296204 |
Agitation | 36.98 | 23.77 | 84 | 20128 | 88283 | 64390237 |
Haemoglobin decreased | 36.93 | 23.77 | 8 | 20204 | 195055 | 64283465 |
Adverse event | 36.51 | 23.77 | 53 | 20159 | 39436 | 64439084 |
Mental disorder | 36.12 | 23.77 | 43 | 20169 | 26402 | 64452118 |
Rash | 36.07 | 23.77 | 55 | 20157 | 458494 | 64020026 |
Wrong technique in product usage process | 35.63 | 23.77 | 69 | 20143 | 64905 | 64413615 |
Back pain | 35.50 | 23.77 | 17 | 20195 | 250154 | 64228366 |
Toxicity to various agents | 35.45 | 23.77 | 37 | 20175 | 363476 | 64115044 |
Device malfunction | 35.16 | 23.77 | 35 | 20177 | 17598 | 64460922 |
Asthenia | 34.97 | 23.77 | 50 | 20162 | 427994 | 64050526 |
Nasopharyngitis | 33.35 | 23.77 | 10 | 20202 | 196063 | 64282457 |
Blunted affect | 33.25 | 23.77 | 10 | 20202 | 418 | 64478102 |
Drug intolerance | 33.06 | 23.77 | 9 | 20203 | 187983 | 64290537 |
Oculogyric crisis | 32.83 | 23.77 | 16 | 20196 | 2522 | 64475998 |
Infection | 32.24 | 23.77 | 9 | 20203 | 184871 | 64293649 |
Irritability | 32.07 | 23.77 | 48 | 20164 | 36698 | 64441822 |
Blood creatine phosphokinase increased | 30.67 | 23.77 | 61 | 20151 | 58497 | 64420023 |
Rhabdomyolysis | 29.68 | 23.77 | 79 | 20133 | 91647 | 64386873 |
Prolactin-producing pituitary tumour | 29.57 | 23.77 | 7 | 20205 | 114 | 64478406 |
Extra dose administered | 29.33 | 23.77 | 21 | 20191 | 6729 | 64471791 |
Terminal dribbling | 29.23 | 23.77 | 5 | 20207 | 12 | 64478508 |
Investigation | 28.54 | 23.77 | 14 | 20198 | 2238 | 64476282 |
Saccadic eye movement | 28.21 | 23.77 | 7 | 20205 | 140 | 64478380 |
Urinary tract infection | 28.18 | 23.77 | 19 | 20193 | 231577 | 64246943 |
Therapeutic product effect decreased | 27.41 | 23.77 | 89 | 20123 | 115262 | 64363258 |
Alopecia | 27.20 | 23.77 | 9 | 20203 | 165681 | 64312839 |
Pain in extremity | 27.19 | 23.77 | 33 | 20179 | 303052 | 64175468 |
Peripheral swelling | 27.04 | 23.77 | 16 | 20196 | 209137 | 64269383 |
Menstruation irregular | 26.97 | 23.77 | 17 | 20195 | 4418 | 64474102 |
Depression | 26.69 | 23.77 | 121 | 20091 | 183170 | 64295350 |
Renal failure | 26.30 | 23.77 | 12 | 20200 | 181676 | 64296844 |
Ejaculation failure | 26.18 | 23.77 | 8 | 20204 | 353 | 64478167 |
Soliloquy | 26.15 | 23.77 | 9 | 20203 | 581 | 64477939 |
Delirium | 25.92 | 23.77 | 63 | 20149 | 69131 | 64409389 |
Cardiac failure congestive | 25.44 | 23.77 | 5 | 20207 | 130575 | 64347945 |
Product packaging issue | 25.14 | 23.77 | 10 | 20202 | 970 | 64477550 |
Thinking abnormal | 25.02 | 23.77 | 24 | 20188 | 11532 | 64466988 |
Flat affect | 24.90 | 23.77 | 12 | 20200 | 1845 | 64476675 |
Injection site infection | 24.85 | 23.77 | 12 | 20200 | 1853 | 64476667 |
Wrong product administered | 24.67 | 23.77 | 20 | 20192 | 7700 | 64470820 |
Libido disorder | 24.42 | 23.77 | 7 | 20205 | 247 | 64478273 |
Pleural effusion | 24.34 | 23.77 | 5 | 20207 | 126554 | 64351966 |
Tension | 24.05 | 23.77 | 15 | 20197 | 3825 | 64474695 |
Neuropathy peripheral | 23.98 | 23.77 | 4 | 20208 | 117521 | 64360999 |
Decreased appetite | 23.80 | 23.77 | 32 | 20180 | 281257 | 64197263 |
None
Source | Code | Description |
---|---|---|
FDA EPC | N0000175430 | Atypical Antipsychotic |
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 | D065127 | Dopamine D2 Receptor Antagonists |
MeSH PA | D018377 | Neurotransmitter Agents |
MeSH PA | D011619 | Psychotropic Drugs |
MeSH PA | D058830 | Serotonin 5-HT2 Receptor Antagonists |
MeSH PA | D018490 | Serotonin Agents |
MeSH PA | D012702 | Serotonin Antagonists |
MeSH PA | D014149 | Tranquilizing Agents |
CHEBI has role | CHEBI:35471 | psychotropic drugs |
CHEBI has role | CHEBI:37890 | alpha-adrenergic receptor blockaders |
CHEBI has role | CHEBI:37955 | H1 receptor antagonists |
CHEBI has role | CHEBI:48279 | serotonin antagonists |
CHEBI has role | CHEBI:48561 | dopaminergic antagonists |
CHEBI has role | CHEBI:49103 | drug metabolites |
CHEBI has role | CHEBI:63726 | neuroprotective agents |
CHEBI has role | CHEBI:65191 | atypical antipsychotic agent |
Disease | Relation | SNOMED_ID | DOID |
---|---|---|---|
Schizophrenia | indication | 58214004 | DOID:5419 |
Priapism | contraindication | 6273006 | DOID:9286 |
Suicidal thoughts | contraindication | 6471006 | |
Weight gain finding | contraindication | 8943002 | |
Neuroleptic malignant syndrome | contraindication | 15244003 | DOID:14464 |
Senile dementia | contraindication | 15662003 | |
Agranulocytosis | contraindication | 17182001 | DOID:12987 |
Lowered convulsive threshold | contraindication | 19260006 | |
Myocardial infarction | contraindication | 22298006 | DOID:5844 |
Stenosis of intestine | contraindication | 23065003 | |
Short bowel syndrome | contraindication | 26629001 | DOID:10605 |
Hypovolemia | contraindication | 28560003 | |
Orthostatic hypotension | contraindication | 28651003 | |
Torsades de pointes | contraindication | 31722008 | |
Parkinsonism | contraindication | 32798002 | |
Crohn's disease | contraindication | 34000006 | |
Dehydration | contraindication | 34095006 | |
Hypokalemia | contraindication | 43339004 | |
Conduction disorder of the heart | contraindication | 44808001 | |
Low blood pressure | contraindication | 45007003 | |
Chronic heart failure | contraindication | 48447003 | |
Hyperlipidemia | contraindication | 55822004 | DOID:1168 |
Cerebrovascular disease | contraindication | 62914000 | DOID:6713 |
Substance abuse | contraindication | 66214007 | |
Diabetes mellitus | contraindication | 73211009 | DOID:9351 |
Extrapyramidal disease | contraindication | 76349003 | |
Diffuse Lewy body disease | contraindication | 80098002 | |
Hyperglycemia | contraindication | 80394007 | DOID:4195 |
Leukopenia | contraindication | 84828003 | DOID:615 |
Tardive dyskinesia | contraindication | 102449007 | |
Increased intestinal motility | contraindication | 102624003 | |
Prolonged QT interval | contraindication | 111975006 | |
Seizure disorder | contraindication | 128613002 | |
Hypomagnesemia | contraindication | 190855004 | |
Angina pectoris | contraindication | 194828000 | |
Impaired renal function disorder | contraindication | 197663003 | |
Metabolic syndrome X | contraindication | 237602007 | DOID:14221 |
Hyperprolactinemia | contraindication | 237662005 | DOID:12700 |
Esophageal dysmotility | contraindication | 266434009 | DOID:9192 |
Neutropenic disorder | contraindication | 303011007 | DOID:1227 |
At risk for aspiration | contraindication | 371736008 | |
Impaired cognition | contraindication | 386806002 | |
Breastfeeding (mother) | contraindication | 413712001 | |
Obesity | contraindication | 414916001 | DOID:9970 |
Gastrointestinal hypomotility | contraindication | 421807004 | |
Acquired torsion dystonia | contraindication | 433493000 | |
Congenital long QT syndrome | contraindication | 442917000 | |
Carcinoma of female breast | contraindication | 447782002 | |
Esophageal Compression | contraindication | ||
Intestinal Cystic Fibrosis | contraindication |
None
None
Dissociation level | Dissociation constant | Type (acidic/basic) |
---|---|---|
pKa1 | 7.78 | Basic |
pKa2 | 1.52 | Basic |
Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Patent number | Patent expiration date | Patent use |
---|---|---|---|---|---|---|---|---|---|---|
117MG/0.75ML (117MG/0.75ML) | INVEGA SUSTENNA | JANSSEN PHARMS | N022264 | July 31, 2009 | RX | SUSPENSION, EXTENDED RELEASE | INTRAMUSCULAR | 9439906 | Jan. 26, 2031 | DOSING REGIMEN FOR THE TREATMENT OF SCHIZOAFFECTIVE DISORDER IN ADULTS AS A MONOTHERAPY AND AS AN ADJUNCT TO MOOD STABILIZERS OR ANTIDEPRESSANTS BY ADMINISTERING TWO LOADING DOSES OF PALIPERIDONE PALMITATE FOLLOWED BY MAINTENANCE DOSE(S) |
117MG/0.75ML (117MG/0.75ML) | INVEGA SUSTENNA | JANSSEN PHARMS | N022264 | July 31, 2009 | RX | SUSPENSION, EXTENDED RELEASE | INTRAMUSCULAR | 9439906 | Jan. 26, 2031 | DOSING REGIMEN FOR THE TREATMENT OF SCHIZOPHRENIA IN ADULTS BY ADMINISTERING TWO LOADING DOSES OF PALIPERIDONE PALMITATE FOLLOWED BY MAINTENANCE DOSE(S) |
117MG/0.75ML (117MG/0.75ML) | INVEGA SUSTENNA | JANSSEN PHARMS | N022264 | July 31, 2009 | RX | SUSPENSION, EXTENDED RELEASE | INTRAMUSCULAR | 9439906 | Jan. 26, 2031 | TREATMENT OF SCHIZOAFFECTIVE DISORDER AS A MONOTHERAPY AND AS AN ADJUNCT TO MOOD STABILIZERS OR ANTIDEPRESSANTS |
117MG/0.75ML (117MG/0.75ML) | INVEGA SUSTENNA | JANSSEN PHARMS | N022264 | July 31, 2009 | RX | SUSPENSION, EXTENDED RELEASE | INTRAMUSCULAR | 9439906 | Jan. 26, 2031 | TREATMENT OF SCHIZOPHRENIA |
156MG/ML (156MG/ML) | INVEGA SUSTENNA | JANSSEN PHARMS | N022264 | July 31, 2009 | RX | SUSPENSION, EXTENDED RELEASE | INTRAMUSCULAR | 9439906 | Jan. 26, 2031 | DOSING REGIMEN FOR THE TREATMENT OF SCHIZOAFFECTIVE DISORDER IN ADULTS AS A MONOTHERAPY AND AS AN ADJUNCT TO MOOD STABILIZERS OR ANTIDEPRESSANTS BY ADMINISTERING TWO LOADING DOSES OF PALIPERIDONE PALMITATE FOLLOWED BY MAINTENANCE DOSE(S) |
156MG/ML (156MG/ML) | INVEGA SUSTENNA | JANSSEN PHARMS | N022264 | July 31, 2009 | RX | SUSPENSION, EXTENDED RELEASE | INTRAMUSCULAR | 9439906 | Jan. 26, 2031 | DOSING REGIMEN FOR THE TREATMENT OF SCHIZOPHRENIA IN ADULTS BY ADMINISTERING TWO LOADING DOSES OF PALIPERIDONE PALMITATE FOLLOWED BY MAINTENANCE DOSE(S) |
156MG/ML (156MG/ML) | INVEGA SUSTENNA | JANSSEN PHARMS | N022264 | July 31, 2009 | RX | SUSPENSION, EXTENDED RELEASE | INTRAMUSCULAR | 9439906 | Jan. 26, 2031 | TREATMENT OF SCHIZOAFFECTIVE DISORDER AS A MONOTHERAPY AND AS AN ADJUNCT TO MOOD STABILIZERS OR ANTIDEPRESSANTS |
156MG/ML (156MG/ML) | INVEGA SUSTENNA | JANSSEN PHARMS | N022264 | July 31, 2009 | RX | SUSPENSION, EXTENDED RELEASE | INTRAMUSCULAR | 9439906 | Jan. 26, 2031 | TREATMENT OF SCHIZOPHRENIA |
234MG/1.5ML (156MG/ML) | INVEGA SUSTENNA | JANSSEN PHARMS | N022264 | July 31, 2009 | RX | SUSPENSION, EXTENDED RELEASE | INTRAMUSCULAR | 9439906 | Jan. 26, 2031 | DOSING REGIMEN FOR THE TREATMENT OF SCHIZOAFFECTIVE DISORDER IN ADULTS AS A MONOTHERAPY AND AS AN ADJUNCT TO MOOD STABILIZERS OR ANTIDEPRESSANTS BY ADMINISTERING TWO LOADING DOSES OF PALIPERIDONE PALMITATE FOLLOWED BY MAINTENANCE DOSE(S) |
234MG/1.5ML (156MG/ML) | INVEGA SUSTENNA | JANSSEN PHARMS | N022264 | July 31, 2009 | RX | SUSPENSION, EXTENDED RELEASE | INTRAMUSCULAR | 9439906 | Jan. 26, 2031 | DOSING REGIMEN FOR THE TREATMENT OF SCHIZOPHRENIA IN ADULTS BY ADMINISTERING TWO LOADING DOSES OF PALIPERIDONE PALMITATE FOLLOWED BY MAINTENANCE DOSE(S) |
234MG/1.5ML (156MG/ML) | INVEGA SUSTENNA | JANSSEN PHARMS | N022264 | July 31, 2009 | RX | SUSPENSION, EXTENDED RELEASE | INTRAMUSCULAR | 9439906 | Jan. 26, 2031 | TREATMENT OF SCHIZOAFFECTIVE DISORDER AS A MONOTHERAPY AND AS AN ADJUNCT TO MOOD STABILIZERS OR ANTIDEPRESSANTS |
234MG/1.5ML (156MG/ML) | INVEGA SUSTENNA | JANSSEN PHARMS | N022264 | July 31, 2009 | RX | SUSPENSION, EXTENDED RELEASE | INTRAMUSCULAR | 9439906 | Jan. 26, 2031 | TREATMENT OF SCHIZOPHRENIA |
39MG/0.25ML (39MG/0.25ML) | INVEGA SUSTENNA | JANSSEN PHARMS | N022264 | July 31, 2009 | RX | SUSPENSION, EXTENDED RELEASE | INTRAMUSCULAR | 9439906 | Jan. 26, 2031 | DOSING REGIMEN FOR THE TREATMENT OF SCHIZOAFFECTIVE DISORDER IN ADULTS AS A MONOTHERAPY AND AS AN ADJUNCT TO MOOD STABILIZERS OR ANTIDEPRESSANTS BY ADMINISTERING TWO LOADING DOSES OF PALIPERIDONE PALMITATE FOLLOWED BY MAINTENANCE DOSE(S) |
39MG/0.25ML (39MG/0.25ML) | INVEGA SUSTENNA | JANSSEN PHARMS | N022264 | July 31, 2009 | RX | SUSPENSION, EXTENDED RELEASE | INTRAMUSCULAR | 9439906 | Jan. 26, 2031 | DOSING REGIMEN FOR THE TREATMENT OF SCHIZOPHRENIA IN ADULTS BY ADMINISTERING TWO LOADING DOSES OF PALIPERIDONE PALMITATE FOLLOWED BY MAINTENANCE DOSE(S) |
39MG/0.25ML (39MG/0.25ML) | INVEGA SUSTENNA | JANSSEN PHARMS | N022264 | July 31, 2009 | RX | SUSPENSION, EXTENDED RELEASE | INTRAMUSCULAR | 9439906 | Jan. 26, 2031 | TREATMENT OF SCHIZOAFFECTIVE DISORDER AS A MONOTHERAPY AND AS AN ADJUNCT TO MOOD STABILIZERS OR ANTIDEPRESSANTS |
39MG/0.25ML (39MG/0.25ML) | INVEGA SUSTENNA | JANSSEN PHARMS | N022264 | July 31, 2009 | RX | SUSPENSION, EXTENDED RELEASE | INTRAMUSCULAR | 9439906 | Jan. 26, 2031 | TREATMENT OF SCHIZOPHRENIA |
78MG/0.5ML (78MG/0.5ML) | INVEGA SUSTENNA | JANSSEN PHARMS | N022264 | July 31, 2009 | RX | SUSPENSION, EXTENDED RELEASE | INTRAMUSCULAR | 9439906 | Jan. 26, 2031 | DOSING REGIMEN FOR THE TREATMENT OF SCHIZOAFFECTIVE DISORDER IN ADULTS AS A MONOTHERAPY AND AS AN ADJUNCT TO MOOD STABILIZERS OR ANTIDEPRESSANTS BY ADMINISTERING TWO LOADING DOSES OF PALIPERIDONE PALMITATE FOLLOWED BY MAINTENANCE DOSE(S) |
78MG/0.5ML (78MG/0.5ML) | INVEGA SUSTENNA | JANSSEN PHARMS | N022264 | July 31, 2009 | RX | SUSPENSION, EXTENDED RELEASE | INTRAMUSCULAR | 9439906 | Jan. 26, 2031 | DOSING REGIMEN FOR THE TREATMENT OF SCHIZOPHRENIA IN ADULTS BY ADMINISTERING TWO LOADING DOSES OF PALIPERIDONE PALMITATE FOLLOWED BY MAINTENANCE DOSE(S) |
78MG/0.5ML (78MG/0.5ML) | INVEGA SUSTENNA | JANSSEN PHARMS | N022264 | July 31, 2009 | RX | SUSPENSION, EXTENDED RELEASE | INTRAMUSCULAR | 9439906 | Jan. 26, 2031 | TREATMENT OF SCHIZOAFFECTIVE DISORDER AS A MONOTHERAPY AND AS AN ADJUNCT TO MOOD STABILIZERS OR ANTIDEPRESSANTS |
78MG/0.5ML (78MG/0.5ML) | INVEGA SUSTENNA | JANSSEN PHARMS | N022264 | July 31, 2009 | RX | SUSPENSION, EXTENDED RELEASE | INTRAMUSCULAR | 9439906 | Jan. 26, 2031 | TREATMENT OF SCHIZOPHRENIA |
273MG/0.875ML (273MG/0.875ML) | INVEGA TRINZA | JANSSEN PHARMS | N207946 | May 18, 2015 | RX | SUSPENSION, EXTENDED RELEASE | INTRAMUSCULAR | 10143693 | April 5, 2036 | REINITIATION OF SCHIZOPHRENIA TREATMENT FOLLOWING A MISSED DOSE 4-9 MONTHS AGO |
273MG/0.875ML (273MG/0.875ML) | INVEGA TRINZA | JANSSEN PHARMS | N207946 | May 18, 2015 | RX | SUSPENSION, EXTENDED RELEASE | INTRAMUSCULAR | 10143693 | April 5, 2036 | REINITIATION OF SCHIZOPHRENIA TREATMENT FOLLOWING A MISSED DOSE MORE THAN 9 MONTHS AGO |
410MG/1.315ML (311.79MG/ML) | INVEGA TRINZA | JANSSEN PHARMS | N207946 | May 18, 2015 | RX | SUSPENSION, EXTENDED RELEASE | INTRAMUSCULAR | 10143693 | April 5, 2036 | REINITIATION OF SCHIZOPHRENIA TREATMENT FOLLOWING A MISSED DOSE 4-9 MONTHS AGO |
410MG/1.315ML (311.79MG/ML) | INVEGA TRINZA | JANSSEN PHARMS | N207946 | May 18, 2015 | RX | SUSPENSION, EXTENDED RELEASE | INTRAMUSCULAR | 10143693 | April 5, 2036 | REINITIATION OF SCHIZOPHRENIA TREATMENT FOLLOWING A MISSED DOSE MORE THAN 9 MONTHS AGO |
546MG/1.75ML (312MG/ML) | INVEGA TRINZA | JANSSEN PHARMS | N207946 | May 18, 2015 | RX | SUSPENSION, EXTENDED RELEASE | INTRAMUSCULAR | 10143693 | April 5, 2036 | REINITIATION OF SCHIZOPHRENIA TREATMENT FOLLOWING A MISSED DOSE 4-9 MONTHS AGO |
546MG/1.75ML (312MG/ML) | INVEGA TRINZA | JANSSEN PHARMS | N207946 | May 18, 2015 | RX | SUSPENSION, EXTENDED RELEASE | INTRAMUSCULAR | 10143693 | April 5, 2036 | REINITIATION OF SCHIZOPHRENIA TREATMENT FOLLOWING A MISSED DOSE MORE THAN 9 MONTHS AGO |
819MG/2.625ML (312MG/ML) | INVEGA TRINZA | JANSSEN PHARMS | N207946 | May 18, 2015 | RX | SUSPENSION, EXTENDED RELEASE | INTRAMUSCULAR | 10143693 | April 5, 2036 | REINITIATION OF SCHIZOPHRENIA TREATMENT FOLLOWING A MISSED DOSE 4-9 MONTHS AGO |
819MG/2.625ML (312MG/ML) | INVEGA TRINZA | JANSSEN PHARMS | N207946 | May 18, 2015 | RX | SUSPENSION, EXTENDED RELEASE | INTRAMUSCULAR | 10143693 | April 5, 2036 | REINITIATION OF SCHIZOPHRENIA TREATMENT FOLLOWING A MISSED DOSE MORE THAN 9 MONTHS AGO |
1.092GM/3.5ML (312MG/ML) | INVEGA HAFYERA | JANSSEN PHARMS | N207946 | Aug. 30, 2021 | RX | SUSPENSION, EXTENDED RELEASE | INTRAMUSCULAR | 11304951 | May 7, 2041 | REINITIATION OF SCHIZOPHRENIA TREATMENT WHEREIN MORE THAN 6 MONTHS 3 WEEKS BUT LESS THAN 8 MONTHS HAVE ELAPSED SINCE THE LAST DOSE |
1.092GM/3.5ML (312MG/ML) | INVEGA HAFYERA | JANSSEN PHARMS | N207946 | Aug. 30, 2021 | RX | SUSPENSION, EXTENDED RELEASE | INTRAMUSCULAR | 11324751 | May 7, 2041 | TREATMENT OF SCHIZOPHRENIA BY ADMINISTERING A DOSE UP TO TWO WEEKS BEFORE OR THREE WEEKS AFTER THE SCHEDULED SIX-MONTH DOSE |
1.560GM/5ML (312MG/ML) | INVEGA HAFYERA | JANSSEN PHARMS | N207946 | Aug. 30, 2021 | RX | SUSPENSION, EXTENDED RELEASE | INTRAMUSCULAR | 11304951 | May 7, 2041 | REINITIATION OF SCHIZOPHRENIA TREATMENT WHEREIN MORE THAN 6 MONTHS 3 WEEKS BUT LESS THAN 8 MONTHS HAVE ELAPSED SINCE THE LAST DOSE |
1.560GM/5ML (312MG/ML) | INVEGA HAFYERA | JANSSEN PHARMS | N207946 | Aug. 30, 2021 | RX | SUSPENSION, EXTENDED RELEASE | INTRAMUSCULAR | 11324751 | May 7, 2041 | TREATMENT OF SCHIZOPHRENIA BY ADMINISTERING A DOSE UP TO TWO WEEKS BEFORE OR THREE WEEKS AFTER THE SCHEDULED SIX-MONTH DOSE |
Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Exclusivity date | Description |
---|---|---|---|---|---|---|---|---|---|
1.092GM/3.5ML (312MG/ML) | INVEGA HAFYERA | JANSSEN PHARMS | N207946 | Aug. 30, 2021 | RX | SUSPENSION, EXTENDED RELEASE | INTRAMUSCULAR | Aug. 30, 2024 | NEW STRENGTH |
1.560GM/5ML (312MG/ML) | INVEGA HAFYERA | JANSSEN PHARMS | N207946 | Aug. 30, 2021 | RX | SUSPENSION, EXTENDED RELEASE | INTRAMUSCULAR | Aug. 30, 2024 | NEW STRENGTH |
Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA source |
---|---|---|---|---|---|---|---|---|---|
D(2) dopamine receptor | GPCR | ANTAGONIST | DRUG LABEL | DRUG LABEL | |||||
5-hydroxytryptamine receptor 2A | GPCR | ANTAGONIST | DRUG LABEL | DRUG LABEL | |||||
Potassium voltage-gated channel subfamily H member 2 | Ion channel | IC50 | 5.89 | CHEMBL |
ID | Source |
---|---|
D05340 | KEGG_DRUG |
4029217 | VUID |
N0000181687 | NUI |
4025875 | VANDF |
4029217 | VANDF |
CHEBI:83807 | CHEBI |
CHEBI:82978 | CHEBI |
CHEMBL2107360 | ChEMBL_ID |
R8P8USM8FR | UNII |
9852746 | PUBCHEM_CID |
115237 | PUBCHEM_CID |
DB01267 | DRUGBANK_ID |
679314 | RXNORM |
166838 | MMSL |
23004 | MMSL |
26654 | MMSL |
d06297 | MMSL |
011888 | NDDF |
013207 | NDDF |
117004004 | SNOMEDCT_US |
425483000 | SNOMEDCT_US |
426276000 | SNOMEDCT_US |
706896003 | SNOMEDCT_US |
D000068882 | MESH_DESCRIPTOR_UI |
C2719626 | UMLSCUI |
C0753678 | UMLSCUI |
7977 | INN_ID |
Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
---|---|---|---|---|---|---|---|---|
INVEGA SUSTENNA | HUMAN PRESCRIPTION DRUG LABEL | 1 | 50458-560 | INJECTION | 39 mg | INTRAMUSCULAR | NDA | 35 sections |
INVEGA SUSTENNA | HUMAN PRESCRIPTION DRUG LABEL | 1 | 50458-561 | INJECTION | 78 mg | INTRAMUSCULAR | NDA | 35 sections |
INVEGA SUSTENNA | HUMAN PRESCRIPTION DRUG LABEL | 1 | 50458-562 | INJECTION | 117 mg | INTRAMUSCULAR | NDA | 35 sections |
INVEGA SUSTENNA | HUMAN PRESCRIPTION DRUG LABEL | 1 | 50458-563 | INJECTION | 156 mg | INTRAMUSCULAR | NDA | 35 sections |
INVEGA SUSTENNA | HUMAN PRESCRIPTION DRUG LABEL | 1 | 50458-564 | INJECTION | 234 mg | INTRAMUSCULAR | NDA | 35 sections |
INVEGA TRINZA | HUMAN PRESCRIPTION DRUG LABEL | 1 | 50458-606 | INJECTION, SUSPENSION, EXTENDED RELEASE | 273 mg | INTRAMUSCULAR | NDA | 40 sections |
INVEGA TRINZA | HUMAN PRESCRIPTION DRUG LABEL | 1 | 50458-606 | INJECTION, SUSPENSION, EXTENDED RELEASE | 273 mg | INTRAMUSCULAR | NDA | 40 sections |
INVEGA TRINZA | HUMAN PRESCRIPTION DRUG LABEL | 1 | 50458-607 | INJECTION, SUSPENSION, EXTENDED RELEASE | 410 mg | INTRAMUSCULAR | NDA | 40 sections |
INVEGA TRINZA | HUMAN PRESCRIPTION DRUG LABEL | 1 | 50458-607 | INJECTION, SUSPENSION, EXTENDED RELEASE | 410 mg | INTRAMUSCULAR | NDA | 40 sections |
INVEGA TRINZA | HUMAN PRESCRIPTION DRUG LABEL | 1 | 50458-608 | INJECTION, SUSPENSION, EXTENDED RELEASE | 546 mg | INTRAMUSCULAR | NDA | 40 sections |
INVEGA TRINZA | HUMAN PRESCRIPTION DRUG LABEL | 1 | 50458-608 | INJECTION, SUSPENSION, EXTENDED RELEASE | 546 mg | INTRAMUSCULAR | NDA | 40 sections |
INVEGA TRINZA | HUMAN PRESCRIPTION DRUG LABEL | 1 | 50458-609 | INJECTION, SUSPENSION, EXTENDED RELEASE | 819 mg | INTRAMUSCULAR | NDA | 40 sections |
INVEGA TRINZA | HUMAN PRESCRIPTION DRUG LABEL | 1 | 50458-609 | INJECTION, SUSPENSION, EXTENDED RELEASE | 819 mg | INTRAMUSCULAR | NDA | 40 sections |
INVEGA HAFYERA | HUMAN PRESCRIPTION DRUG LABEL | 1 | 50458-611 | INJECTION, SUSPENSION, EXTENDED RELEASE | 1092 mg | INTRAMUSCULAR | NDA | 38 sections |
INVEGA HAFYERA | HUMAN PRESCRIPTION DRUG LABEL | 1 | 50458-612 | INJECTION, SUSPENSION, EXTENDED RELEASE | 1560 mg | INTRAMUSCULAR | NDA | 38 sections |