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 | 1895.99 | 30.45 | 372 | 14086 | 2937 | 56274672 |
Galactorrhoea | 1770.27 | 30.45 | 361 | 14097 | 3534 | 56274075 |
Amenorrhoea | 977.69 | 30.45 | 261 | 14197 | 8725 | 56268884 |
Injection site nodule | 925.64 | 30.45 | 208 | 14250 | 3311 | 56274298 |
Schizophrenia | 774.84 | 30.45 | 225 | 14233 | 10274 | 56267335 |
Product dose omission issue | 585.06 | 30.45 | 455 | 14003 | 204298 | 56073311 |
Blood prolactin abnormal | 549.59 | 30.45 | 125 | 14333 | 2100 | 56275509 |
Inappropriate schedule of product administration | 521.33 | 30.45 | 302 | 14156 | 83085 | 56194524 |
Psychotic disorder | 472.13 | 30.45 | 190 | 14268 | 23368 | 56254241 |
Disturbance in social behaviour | 430.48 | 30.45 | 109 | 14349 | 2932 | 56274677 |
Hospitalisation | 419.69 | 30.45 | 253 | 14205 | 74747 | 56202862 |
Anosognosia | 383.89 | 30.45 | 94 | 14364 | 2195 | 56275414 |
Hyperprolactinaemia | 367.95 | 30.45 | 100 | 14358 | 3561 | 56274048 |
Sexual dysfunction | 366.15 | 30.45 | 98 | 14360 | 3290 | 56274319 |
Off label use | 348.46 | 30.45 | 556 | 13902 | 555624 | 55721985 |
Hallucination, auditory | 346.38 | 30.45 | 125 | 14333 | 11399 | 56266210 |
Dystonia | 340.91 | 30.45 | 126 | 14332 | 12295 | 56265314 |
Metabolic disorder | 311.41 | 30.45 | 96 | 14362 | 5365 | 56272244 |
Injection site mass | 307.42 | 30.45 | 127 | 14331 | 16666 | 56260943 |
Extrapyramidal disorder | 305.07 | 30.45 | 116 | 14342 | 12240 | 56265369 |
Personality change | 297.12 | 30.45 | 94 | 14364 | 5723 | 56271886 |
Sedation | 282.46 | 30.45 | 150 | 14308 | 34704 | 56242905 |
Akathisia | 279.41 | 30.45 | 99 | 14359 | 8553 | 56269056 |
Incorrect dose administered | 277.57 | 30.45 | 171 | 14287 | 52376 | 56225233 |
Weight increased | 272.25 | 30.45 | 314 | 14144 | 229389 | 56048220 |
Breast discharge | 258.49 | 30.45 | 57 | 14401 | 824 | 56276785 |
Dyskinesia | 257.88 | 30.45 | 133 | 14325 | 28975 | 56248634 |
Treatment noncompliance | 254.77 | 30.45 | 137 | 14321 | 32486 | 56245123 |
Syringe issue | 214.06 | 30.45 | 60 | 14398 | 2396 | 56275213 |
Psychotic symptom | 198.30 | 30.45 | 50 | 14408 | 1319 | 56276290 |
Suicide attempt | 193.98 | 30.45 | 142 | 14316 | 57694 | 56219915 |
Tardive dyskinesia | 186.02 | 30.45 | 72 | 14386 | 7959 | 56269650 |
Delusion | 182.38 | 30.45 | 78 | 14380 | 11137 | 56266472 |
Paranoia | 182.27 | 30.45 | 77 | 14381 | 10667 | 56266942 |
Refusal of treatment by patient | 174.29 | 30.45 | 61 | 14397 | 5077 | 56272532 |
Injection site pain | 172.90 | 30.45 | 180 | 14278 | 116938 | 56160671 |
Product use in unapproved indication | 167.20 | 30.45 | 193 | 14265 | 140629 | 56136980 |
Device leakage | 129.55 | 30.45 | 52 | 14406 | 6323 | 56271286 |
Schizoaffective disorder | 127.47 | 30.45 | 42 | 14416 | 2907 | 56274702 |
Underdose | 121.96 | 30.45 | 76 | 14382 | 23681 | 56253928 |
Blood glucose increased | 120.77 | 30.45 | 121 | 14337 | 75030 | 56202579 |
Therapeutic response decreased | 119.75 | 30.45 | 103 | 14355 | 52655 | 56224954 |
Diarrhoea | 111.52 | 30.45 | 16 | 14442 | 638491 | 55639118 |
Aggression | 109.44 | 30.45 | 69 | 14389 | 21937 | 56255672 |
Product administered at inappropriate site | 107.32 | 30.45 | 36 | 14422 | 2634 | 56274975 |
Nausea | 103.58 | 30.45 | 34 | 14424 | 764144 | 55513465 |
Pain | 90.69 | 30.45 | 29 | 14429 | 663155 | 55614454 |
Arthralgia | 82.04 | 30.45 | 15 | 14443 | 501654 | 55775955 |
Accidental exposure to product | 81.37 | 30.45 | 60 | 14398 | 24587 | 56253022 |
Product quality issue | 80.31 | 30.45 | 66 | 14392 | 31670 | 56245939 |
Drooling | 79.74 | 30.45 | 31 | 14427 | 3463 | 56274146 |
Injection site abscess | 78.78 | 30.45 | 23 | 14435 | 1063 | 56276546 |
Injection site reaction | 75.14 | 30.45 | 80 | 14378 | 53167 | 56224442 |
Insurance issue | 73.83 | 30.45 | 30 | 14428 | 3762 | 56273847 |
Injection site swelling | 71.48 | 30.45 | 71 | 14387 | 43507 | 56234102 |
Abnormal behaviour | 66.13 | 30.45 | 49 | 14409 | 20223 | 56257386 |
Condition aggravated | 63.89 | 30.45 | 214 | 14244 | 344684 | 55932925 |
Fatigue | 63.18 | 30.45 | 66 | 14392 | 788486 | 55489123 |
Hallucination | 60.93 | 30.45 | 69 | 14389 | 49080 | 56228529 |
Parkinsonism | 60.54 | 30.45 | 35 | 14423 | 9511 | 56268098 |
Breast enlargement | 59.91 | 30.45 | 20 | 14438 | 1441 | 56276168 |
Abdominal discomfort | 58.88 | 30.45 | 3 | 14455 | 277271 | 56000338 |
Injection site induration | 58.42 | 30.45 | 33 | 14425 | 8582 | 56269027 |
Suicidal ideation | 58.29 | 30.45 | 73 | 14385 | 57669 | 56219940 |
Neuroleptic malignant syndrome | 57.07 | 30.45 | 36 | 14422 | 11442 | 56266167 |
Headache | 56.81 | 30.45 | 37 | 14421 | 559007 | 55718602 |
Joint swelling | 56.10 | 30.45 | 5 | 14453 | 289795 | 55987814 |
Dyspnoea | 52.76 | 30.45 | 45 | 14413 | 592532 | 55685077 |
Imprisonment | 51.88 | 30.45 | 12 | 14446 | 217 | 56277392 |
Cough | 51.65 | 30.45 | 4 | 14454 | 259957 | 56017652 |
Product leakage | 51.61 | 30.45 | 15 | 14443 | 682 | 56276927 |
Lactation disorder | 51.36 | 30.45 | 13 | 14445 | 348 | 56277261 |
Drug ineffective | 51.26 | 30.45 | 406 | 14052 | 918583 | 55359026 |
Drug intolerance | 50.10 | 30.45 | 5 | 14453 | 264813 | 56012796 |
Needle issue | 50.06 | 30.45 | 30 | 14428 | 8708 | 56268901 |
Drug hypersensitivity | 50.03 | 30.45 | 6 | 14452 | 275199 | 56002410 |
Breast tenderness | 48.83 | 30.45 | 19 | 14439 | 2126 | 56275483 |
Prolactin-producing pituitary tumour | 48.54 | 30.45 | 10 | 14448 | 102 | 56277507 |
Tremor | 48.06 | 30.45 | 100 | 14358 | 120989 | 56156620 |
Wrong technique in product usage process | 45.60 | 30.45 | 65 | 14393 | 58103 | 56219506 |
Menstruation irregular | 44.72 | 30.45 | 25 | 14433 | 6371 | 56271238 |
Vomiting | 44.11 | 30.45 | 38 | 14420 | 498190 | 55779419 |
Abnormal weight gain | 43.86 | 30.45 | 16 | 14442 | 1499 | 56276110 |
Abdominal pain | 43.84 | 30.45 | 7 | 14451 | 258798 | 56018811 |
Product administration error | 43.70 | 30.45 | 39 | 14419 | 20890 | 56256719 |
Anaemia | 43.63 | 30.45 | 8 | 14450 | 267503 | 56010106 |
Adverse event | 43.58 | 30.45 | 62 | 14396 | 55314 | 56222295 |
Product use issue | 43.20 | 30.45 | 125 | 14333 | 185916 | 56091693 |
Nasopharyngitis | 42.24 | 30.45 | 4 | 14454 | 220955 | 56056654 |
Psychiatric decompensation | 41.99 | 30.45 | 15 | 14443 | 1323 | 56276286 |
Social avoidant behaviour | 40.37 | 30.45 | 18 | 14440 | 2834 | 56274775 |
Mania | 37.91 | 30.45 | 28 | 14430 | 11492 | 56266117 |
Catatonia | 37.63 | 30.45 | 19 | 14439 | 3945 | 56273664 |
Pyrexia | 36.96 | 30.45 | 32 | 14426 | 418741 | 55858868 |
Back pain | 36.77 | 30.45 | 8 | 14450 | 237162 | 56040447 |
Pituitary tumour benign | 36.67 | 30.45 | 15 | 14443 | 1913 | 56275696 |
Pruritus | 36.32 | 30.45 | 18 | 14440 | 316605 | 55961004 |
Blunted affect | 35.84 | 30.45 | 9 | 14449 | 233 | 56277376 |
Pneumonia | 34.85 | 30.45 | 32 | 14426 | 407066 | 55870543 |
Peripheral swelling | 34.26 | 30.45 | 9 | 14449 | 234717 | 56042892 |
Breast engorgement | 32.28 | 30.45 | 7 | 14451 | 93 | 56277516 |
Adverse drug reaction | 32.16 | 30.45 | 59 | 14399 | 65073 | 56212536 |
Acute kidney injury | 31.93 | 30.45 | 11 | 14447 | 240752 | 56036857 |
Asthenia | 31.74 | 30.45 | 25 | 14433 | 342948 | 55934661 |
Psychiatric symptom | 31.35 | 30.45 | 18 | 14440 | 4826 | 56272783 |
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 | 1366.83 | 28.23 | 830 | 18620 | 104756 | 31573138 |
Schizophrenia | 1159.70 | 28.23 | 378 | 19072 | 10452 | 31667442 |
Inappropriate schedule of product administration | 1049.31 | 28.23 | 544 | 18906 | 50279 | 31627615 |
Psychotic disorder | 877.04 | 28.23 | 373 | 19077 | 21920 | 31655974 |
Hospitalisation | 736.30 | 28.23 | 428 | 19022 | 49379 | 31628515 |
Blood prolactin increased | 669.52 | 28.23 | 163 | 19287 | 1461 | 31676433 |
Treatment noncompliance | 483.32 | 28.23 | 259 | 19191 | 25425 | 31652469 |
Off label use | 481.80 | 28.23 | 801 | 18649 | 346473 | 31331421 |
Hallucination, auditory | 469.57 | 28.23 | 192 | 19258 | 10168 | 31667726 |
Gynaecomastia | 453.97 | 28.23 | 181 | 19269 | 8973 | 31668921 |
Incorrect dose administered | 441.41 | 28.23 | 274 | 19176 | 35478 | 31642416 |
Injection site nodule | 425.97 | 28.23 | 112 | 19338 | 1402 | 31676492 |
Akathisia | 411.05 | 28.23 | 158 | 19292 | 7095 | 31670799 |
Extrapyramidal disorder | 355.87 | 28.23 | 164 | 19286 | 11614 | 31666280 |
Therapeutic response decreased | 324.03 | 28.23 | 202 | 19248 | 26307 | 31651587 |
Weight increased | 310.04 | 28.23 | 314 | 19136 | 82633 | 31595261 |
Paranoia | 306.49 | 28.23 | 143 | 19307 | 10412 | 31667482 |
Syringe issue | 279.43 | 28.23 | 107 | 19343 | 4749 | 31673145 |
Psychotic symptom | 279.00 | 28.23 | 81 | 19369 | 1491 | 31676403 |
Delusion | 277.22 | 28.23 | 139 | 19311 | 11858 | 31666036 |
Sexual dysfunction | 271.64 | 28.23 | 111 | 19339 | 5857 | 31672037 |
Refusal of treatment by patient | 238.91 | 28.23 | 95 | 19355 | 4666 | 31673228 |
Dystonia | 234.84 | 28.23 | 118 | 19332 | 10107 | 31667787 |
Blood prolactin abnormal | 223.67 | 28.23 | 60 | 19390 | 814 | 31677080 |
Sedation | 220.30 | 28.23 | 140 | 19310 | 18825 | 31659069 |
Therapeutic product effect decreased | 218.95 | 28.23 | 170 | 19280 | 31452 | 31646442 |
Aggression | 214.79 | 28.23 | 180 | 19270 | 37111 | 31640783 |
Drug ineffective | 208.84 | 28.23 | 621 | 18829 | 394952 | 31282942 |
Underdose | 206.13 | 28.23 | 116 | 19334 | 12491 | 31665403 |
Tardive dyskinesia | 172.81 | 28.23 | 79 | 19371 | 5480 | 31672414 |
Anosognosia | 170.60 | 28.23 | 48 | 19402 | 785 | 31677109 |
Schizoaffective disorder | 162.89 | 28.23 | 51 | 19399 | 1224 | 31676670 |
Injection site pain | 162.85 | 28.23 | 149 | 19301 | 34485 | 31643409 |
Disturbance in social behaviour | 162.24 | 28.23 | 55 | 19395 | 1708 | 31676186 |
Dyskinesia | 152.51 | 28.23 | 116 | 19334 | 20794 | 31657100 |
Galactorrhoea | 151.96 | 28.23 | 38 | 19412 | 383 | 31677511 |
Suicidal ideation | 145.19 | 28.23 | 143 | 19307 | 36263 | 31641631 |
Neuroleptic malignant syndrome | 141.93 | 28.23 | 102 | 19348 | 16767 | 31661127 |
Erectile dysfunction | 136.52 | 28.23 | 105 | 19345 | 19130 | 31658764 |
Device leakage | 122.87 | 28.23 | 62 | 19388 | 5351 | 31672543 |
Abnormal behaviour | 122.81 | 28.23 | 108 | 19342 | 23720 | 31654174 |
Product administered at inappropriate site | 121.54 | 28.23 | 45 | 19405 | 1815 | 31676079 |
Diarrhoea | 120.20 | 28.23 | 34 | 19416 | 352375 | 31325519 |
Product leakage | 119.62 | 28.23 | 32 | 19418 | 429 | 31677465 |
Injection site mass | 118.18 | 28.23 | 62 | 19388 | 5802 | 31672092 |
Condition aggravated | 113.19 | 28.23 | 285 | 19165 | 163724 | 31514170 |
Breast enlargement | 109.27 | 28.23 | 30 | 19420 | 446 | 31677448 |
Accidental exposure to product | 107.11 | 28.23 | 74 | 19376 | 11421 | 31666473 |
Suicide attempt | 105.44 | 28.23 | 122 | 19328 | 37126 | 31640768 |
Drooling | 102.56 | 28.23 | 46 | 19404 | 3049 | 31674845 |
Product quality issue | 101.50 | 28.23 | 82 | 19368 | 16029 | 31661865 |
Psychosexual disorder | 101.00 | 28.23 | 21 | 19429 | 82 | 31677812 |
Product administration error | 99.02 | 28.23 | 79 | 19371 | 15168 | 31662726 |
Hallucination | 97.66 | 28.23 | 131 | 19319 | 46279 | 31631615 |
Adverse event | 96.82 | 28.23 | 81 | 19369 | 16624 | 31661270 |
Acute kidney injury | 95.24 | 28.23 | 27 | 19423 | 279687 | 31398207 |
Hyperprolactinaemia | 93.50 | 28.23 | 35 | 19415 | 1456 | 31676438 |
Needle issue | 92.93 | 28.23 | 51 | 19399 | 5222 | 31672672 |
Mania | 90.05 | 28.23 | 61 | 19389 | 9116 | 31668778 |
Metabolic disorder | 88.67 | 28.23 | 45 | 19405 | 3929 | 31673965 |
Anaemia | 88.35 | 28.23 | 13 | 19437 | 213509 | 31464385 |
Parkinsonism | 87.68 | 28.23 | 56 | 19394 | 7580 | 31670314 |
Product use issue | 85.73 | 28.23 | 137 | 19313 | 56622 | 31621272 |
Imprisonment | 85.68 | 28.23 | 25 | 19425 | 468 | 31677426 |
Pneumonia | 78.78 | 28.23 | 55 | 19395 | 335257 | 31342637 |
Sepsis | 76.84 | 28.23 | 4 | 19446 | 151925 | 31525969 |
Psychiatric symptom | 75.36 | 28.23 | 38 | 19412 | 3273 | 31674621 |
Product use in unapproved indication | 72.11 | 28.23 | 176 | 19274 | 98995 | 31578899 |
Injection site reaction | 70.64 | 28.23 | 58 | 19392 | 11593 | 31666301 |
Personality change | 69.99 | 28.23 | 41 | 19409 | 4754 | 31673140 |
Catatonia | 67.22 | 28.23 | 40 | 19410 | 4774 | 31673120 |
Wrong technique in product usage process | 66.90 | 28.23 | 92 | 19358 | 33251 | 31644643 |
Agitation | 66.20 | 28.23 | 119 | 19331 | 54050 | 31623844 |
Dyspnoea | 65.24 | 28.23 | 69 | 19381 | 343410 | 31334484 |
Abdominal pain | 64.89 | 28.23 | 7 | 19443 | 145945 | 31531949 |
Eye movement disorder | 61.65 | 28.23 | 35 | 19415 | 3826 | 31674068 |
Retrograde ejaculation | 61.49 | 28.23 | 18 | 19432 | 341 | 31677553 |
Social avoidant behaviour | 61.11 | 28.23 | 32 | 19418 | 2981 | 31674913 |
Nausea | 60.56 | 28.23 | 60 | 19390 | 307887 | 31370007 |
Incorrect route of product administration | 58.30 | 28.23 | 52 | 19398 | 11621 | 31666273 |
Toxicity to various agents | 57.24 | 28.23 | 20 | 19430 | 181467 | 31496427 |
Breast tenderness | 56.52 | 28.23 | 20 | 19430 | 707 | 31677187 |
Muscle rigidity | 55.29 | 28.23 | 47 | 19403 | 9850 | 31668044 |
Flat affect | 54.57 | 28.23 | 20 | 19430 | 783 | 31677111 |
Pyrexia | 54.40 | 28.23 | 64 | 19386 | 303776 | 31374118 |
Anxiety | 54.26 | 28.23 | 150 | 19300 | 90883 | 31587011 |
Priapism | 53.33 | 28.23 | 34 | 19416 | 4586 | 31673308 |
Arthralgia | 47.19 | 28.23 | 17 | 19433 | 151407 | 31526487 |
Wrong product administered | 46.31 | 28.23 | 32 | 19418 | 4936 | 31672958 |
Haemoglobin decreased | 46.21 | 28.23 | 7 | 19443 | 112668 | 31565226 |
Cough | 45.79 | 28.23 | 13 | 19437 | 134801 | 31543093 |
Asthenia | 43.87 | 28.23 | 44 | 19406 | 224711 | 31453183 |
Breast discharge | 43.52 | 28.23 | 9 | 19441 | 34 | 31677860 |
Fatigue | 42.48 | 28.23 | 89 | 19361 | 335117 | 31342777 |
Rash | 42.19 | 28.23 | 37 | 19413 | 201449 | 31476445 |
Irritability | 41.22 | 28.23 | 60 | 19390 | 22829 | 31655065 |
Product packaging issue | 41.20 | 28.23 | 15 | 19435 | 576 | 31677318 |
Mental impairment | 40.87 | 28.23 | 39 | 19411 | 9493 | 31668401 |
Thinking abnormal | 40.78 | 28.23 | 31 | 19419 | 5542 | 31672352 |
Restlessness | 40.29 | 28.23 | 60 | 19390 | 23301 | 31654593 |
Pruritus | 39.08 | 28.23 | 14 | 19436 | 125153 | 31552741 |
Investigation | 39.02 | 28.23 | 16 | 19434 | 850 | 31677044 |
Atrial fibrillation | 38.58 | 28.23 | 11 | 19439 | 113772 | 31564122 |
Intentional self-injury | 38.29 | 28.23 | 44 | 19406 | 13271 | 31664623 |
Renal failure | 38.15 | 28.23 | 14 | 19436 | 123316 | 31554578 |
Hypotension | 37.74 | 28.23 | 42 | 19408 | 204576 | 31473318 |
Cardiac failure congestive | 37.41 | 28.23 | 3 | 19447 | 79384 | 31598510 |
Medication error | 37.16 | 28.23 | 57 | 19393 | 22715 | 31655179 |
Decreased appetite | 34.72 | 28.23 | 26 | 19424 | 153191 | 31524703 |
Device malfunction | 34.32 | 28.23 | 35 | 19415 | 9231 | 31668663 |
Adverse drug reaction | 34.18 | 28.23 | 58 | 19392 | 25143 | 31652751 |
Respiratory failure | 34.04 | 28.23 | 10 | 19440 | 101439 | 31576455 |
Persecutory delusion | 34.03 | 28.23 | 20 | 19430 | 2332 | 31675562 |
Ejaculation failure | 33.90 | 28.23 | 14 | 19436 | 757 | 31677137 |
Blood creatinine increased | 33.33 | 28.23 | 7 | 19443 | 89071 | 31588823 |
Infection | 31.57 | 28.23 | 6 | 19444 | 81925 | 31595969 |
Pain | 30.58 | 28.23 | 42 | 19408 | 186717 | 31491177 |
Vomiting | 30.44 | 28.23 | 57 | 19393 | 223916 | 31453978 |
Drug interaction | 30.20 | 28.23 | 51 | 19399 | 208492 | 31469402 |
Injection site rash | 30.05 | 28.23 | 22 | 19428 | 3714 | 31674180 |
Extra dose administered | 29.59 | 28.23 | 21 | 19429 | 3379 | 31674515 |
Psychiatric decompensation | 29.11 | 28.23 | 17 | 19433 | 1959 | 31675935 |
Tremor | 29.09 | 28.23 | 108 | 19342 | 76312 | 31601582 |
Libido decreased | 28.82 | 28.23 | 23 | 19427 | 4413 | 31673481 |
Platelet count decreased | 28.74 | 28.23 | 16 | 19434 | 110419 | 31567475 |
Depression | 28.65 | 28.23 | 121 | 19329 | 90694 | 31587200 |
Back pain | 28.26 | 28.23 | 16 | 19434 | 109397 | 31568497 |
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 |
---|---|---|---|---|---|---|
Schizophrenia | 1430.32 | 25.28 | 419 | 21518 | 16349 | 70890158 |
Blood prolactin increased | 1079.48 | 25.28 | 247 | 21690 | 3507 | 70903000 |
Inappropriate schedule of product administration | 882.42 | 25.28 | 496 | 21441 | 107059 | 70799448 |
Product dose omission issue | 833.67 | 25.28 | 621 | 21316 | 216847 | 70689660 |
Galactorrhoea | 769.30 | 25.28 | 184 | 21753 | 3194 | 70903313 |
Psychotic disorder | 707.47 | 25.28 | 306 | 21631 | 37395 | 70869112 |
Injection site nodule | 596.93 | 25.28 | 150 | 21787 | 3220 | 70903287 |
Blood prolactin abnormal | 573.48 | 25.28 | 140 | 21797 | 2656 | 70903851 |
Off label use | 560.52 | 25.28 | 894 | 21043 | 742166 | 70164341 |
Disturbance in social behaviour | 545.09 | 25.28 | 145 | 21792 | 3922 | 70902585 |
Hospitalisation | 544.70 | 25.28 | 331 | 21606 | 82237 | 70824270 |
Sexual dysfunction | 529.84 | 25.28 | 158 | 21779 | 6523 | 70899984 |
Anosognosia | 523.86 | 25.28 | 131 | 21806 | 2754 | 70903753 |
Dystonia | 505.13 | 25.28 | 200 | 21737 | 19506 | 70887001 |
Extrapyramidal disorder | 491.68 | 25.28 | 199 | 21738 | 20551 | 70885956 |
Treatment noncompliance | 487.77 | 25.28 | 253 | 21684 | 46321 | 70860186 |
Hallucination, auditory | 473.21 | 25.28 | 187 | 21750 | 18141 | 70888366 |
Incorrect dose administered | 456.71 | 25.28 | 274 | 21663 | 66445 | 70840062 |
Akathisia | 405.56 | 25.28 | 150 | 21787 | 12143 | 70894364 |
Sedation | 388.96 | 25.28 | 218 | 21719 | 46513 | 70859994 |
Amenorrhoea | 381.66 | 25.28 | 124 | 21813 | 6806 | 70899701 |
Metabolic disorder | 379.31 | 25.28 | 128 | 21809 | 7912 | 70898595 |
Dyskinesia | 375.89 | 25.28 | 204 | 21733 | 40870 | 70865637 |
Personality change | 355.48 | 25.28 | 125 | 21812 | 8745 | 70897762 |
Gynaecomastia | 315.45 | 25.28 | 107 | 21830 | 6716 | 70899791 |
Suicide attempt | 312.01 | 25.28 | 231 | 21706 | 79279 | 70827228 |
Syringe issue | 304.24 | 25.28 | 98 | 21839 | 5230 | 70901277 |
Hyperprolactinaemia | 292.73 | 25.28 | 91 | 21846 | 4322 | 70902185 |
Delusion | 268.47 | 25.28 | 127 | 21810 | 19038 | 70887469 |
Paranoia | 265.21 | 25.28 | 122 | 21815 | 17166 | 70889341 |
Psychotic symptom | 252.56 | 25.28 | 71 | 21866 | 2367 | 70904140 |
Tardive dyskinesia | 248.12 | 25.28 | 99 | 21838 | 9830 | 70896677 |
Weight increased | 244.62 | 25.28 | 336 | 21601 | 241995 | 70664512 |
Refusal of treatment by patient | 213.54 | 25.28 | 85 | 21852 | 8385 | 70898122 |
Aggression | 213.27 | 25.28 | 151 | 21786 | 48295 | 70858212 |
Schizoaffective disorder | 205.40 | 25.28 | 58 | 21879 | 1965 | 70904542 |
Neuroleptic malignant syndrome | 191.26 | 25.28 | 112 | 21825 | 25895 | 70880612 |
Injection site mass | 181.41 | 25.28 | 96 | 21841 | 18247 | 70888260 |
Product use in unapproved indication | 166.02 | 25.28 | 258 | 21679 | 207220 | 70699287 |
Underdose | 158.79 | 25.28 | 104 | 21833 | 29279 | 70877228 |
Injection site pain | 156.05 | 25.28 | 187 | 21750 | 117432 | 70789075 |
Product administered at inappropriate site | 140.68 | 25.28 | 49 | 21888 | 3327 | 70903180 |
Suicidal ideation | 140.25 | 25.28 | 138 | 21799 | 69458 | 70837049 |
Abnormal behaviour | 138.58 | 25.28 | 102 | 21835 | 34607 | 70871900 |
Diarrhoea | 136.71 | 25.28 | 37 | 21900 | 783304 | 70123203 |
Therapeutic response decreased | 135.04 | 25.28 | 125 | 21812 | 58328 | 70848179 |
Device leakage | 134.36 | 25.28 | 63 | 21874 | 9245 | 70897262 |
Parkinsonism | 123.31 | 25.28 | 70 | 21867 | 15255 | 70891252 |
Blood glucose increased | 119.30 | 25.28 | 153 | 21784 | 102829 | 70803678 |
Product leakage | 114.92 | 25.28 | 30 | 21907 | 751 | 70905756 |
Nausea | 114.22 | 25.28 | 61 | 21876 | 852027 | 70054480 |
Drooling | 111.27 | 25.28 | 47 | 21890 | 5389 | 70901118 |
Product use issue | 110.69 | 25.28 | 199 | 21738 | 179738 | 70726769 |
Drug ineffective | 107.05 | 25.28 | 571 | 21366 | 939181 | 69967326 |
Arthralgia | 103.73 | 25.28 | 16 | 21921 | 503374 | 70403133 |
Insurance issue | 96.67 | 25.28 | 38 | 21899 | 3623 | 70902884 |
Hallucination | 94.16 | 25.28 | 117 | 21820 | 76143 | 70830364 |
Accidental exposure to product | 93.40 | 25.28 | 74 | 21863 | 27977 | 70878530 |
Breast discharge | 92.50 | 25.28 | 24 | 21913 | 586 | 70905921 |
Needle issue | 90.90 | 25.28 | 51 | 21886 | 10864 | 70895643 |
Erectile dysfunction | 90.80 | 25.28 | 55 | 21882 | 13507 | 70893000 |
Psychiatric symptom | 89.86 | 25.28 | 43 | 21894 | 6601 | 70899906 |
Catatonia | 87.35 | 25.28 | 45 | 21892 | 8088 | 70898419 |
Pain | 79.82 | 25.28 | 48 | 21889 | 628768 | 70277739 |
Abdominal pain | 74.85 | 25.28 | 9 | 21928 | 342118 | 70564389 |
Dyspnoea | 74.82 | 25.28 | 77 | 21860 | 769983 | 70136524 |
Anaemia | 70.27 | 25.28 | 19 | 21918 | 403404 | 70503103 |
Injection site abscess | 68.08 | 25.28 | 23 | 21914 | 1423 | 70905084 |
Injection site reaction | 65.59 | 25.28 | 79 | 21858 | 49773 | 70856734 |
Sudden death | 64.66 | 25.28 | 53 | 21884 | 21011 | 70885496 |
Cough | 63.29 | 25.28 | 12 | 21925 | 325365 | 70581142 |
Joint swelling | 62.54 | 25.28 | 4 | 21933 | 253207 | 70653300 |
Tremor | 62.15 | 25.28 | 144 | 21793 | 155480 | 70751027 |
Acute kidney injury | 60.48 | 25.28 | 36 | 21901 | 474588 | 70431919 |
Fatigue | 60.05 | 25.28 | 102 | 21835 | 824217 | 70082290 |
Mania | 58.65 | 25.28 | 46 | 21891 | 17128 | 70889379 |
Product administration error | 56.57 | 25.28 | 57 | 21880 | 29466 | 70877041 |
Mental impairment | 56.32 | 25.28 | 45 | 21892 | 17210 | 70889297 |
Incorrect route of product administration | 54.19 | 25.28 | 53 | 21884 | 26439 | 70880068 |
Social avoidant behaviour | 53.60 | 25.28 | 27 | 21910 | 4629 | 70901878 |
Breast enlargement | 53.50 | 25.28 | 19 | 21918 | 1365 | 70905142 |
Imprisonment | 52.34 | 25.28 | 15 | 21922 | 536 | 70905971 |
Pruritus | 51.88 | 25.28 | 21 | 21916 | 345539 | 70560968 |
Vomiting | 51.32 | 25.28 | 65 | 21872 | 593046 | 70313461 |
Condition aggravated | 51.13 | 25.28 | 264 | 21673 | 427371 | 70479136 |
Drug hypersensitivity | 50.35 | 25.28 | 10 | 21927 | 262449 | 70644058 |
Eye movement disorder | 49.35 | 25.28 | 30 | 21907 | 7410 | 70899097 |
Muscle rigidity | 49.18 | 25.28 | 43 | 21894 | 18607 | 70887900 |
Psychiatric decompensation | 48.68 | 25.28 | 22 | 21915 | 2965 | 70903542 |
Adverse drug reaction | 47.73 | 25.28 | 70 | 21867 | 53274 | 70853233 |
Pulmonary embolism | 47.32 | 25.28 | 130 | 21807 | 155737 | 70750770 |
Pyrexia | 47.03 | 25.28 | 72 | 21865 | 606880 | 70299627 |
Abdominal discomfort | 46.05 | 25.28 | 6 | 21931 | 214652 | 70691855 |
Rash | 45.14 | 25.28 | 55 | 21882 | 510507 | 70396000 |
Injection site swelling | 45.09 | 25.28 | 61 | 21876 | 43096 | 70863411 |
Pneumonia | 44.98 | 25.28 | 72 | 21865 | 596160 | 70310347 |
Restlessness | 44.71 | 25.28 | 60 | 21877 | 42068 | 70864439 |
Product quality issue | 44.46 | 25.28 | 51 | 21886 | 30510 | 70875997 |
Mental disorder | 44.28 | 25.28 | 49 | 21888 | 28191 | 70878316 |
Headache | 43.86 | 25.28 | 70 | 21867 | 580335 | 70326172 |
Retrograde ejaculation | 43.84 | 25.28 | 11 | 21926 | 234 | 70906273 |
Blood creatine phosphokinase increased | 43.13 | 25.28 | 72 | 21865 | 61191 | 70845316 |
Abdominal pain upper | 42.53 | 25.28 | 5 | 21932 | 193597 | 70712910 |
Breast tenderness | 42.47 | 25.28 | 18 | 21919 | 2080 | 70904427 |
Agitation | 42.41 | 25.28 | 91 | 21846 | 93284 | 70813223 |
Anxiety | 42.36 | 25.28 | 157 | 21780 | 220173 | 70686334 |
Drug intolerance | 40.45 | 25.28 | 10 | 21927 | 225677 | 70680830 |
Psychosexual disorder | 40.24 | 25.28 | 9 | 21928 | 114 | 70906393 |
Sepsis | 39.83 | 25.28 | 13 | 21924 | 244532 | 70661975 |
Rhabdomyolysis | 39.73 | 25.28 | 90 | 21847 | 95670 | 70810837 |
Nasopharyngitis | 39.53 | 25.28 | 10 | 21927 | 222196 | 70684311 |
Injection site induration | 38.97 | 25.28 | 28 | 21909 | 9140 | 70897367 |
Asthenia | 38.68 | 25.28 | 51 | 21886 | 457615 | 70448892 |
Toxicity to various agents | 38.38 | 25.28 | 37 | 21900 | 382135 | 70524372 |
Back pain | 38.26 | 25.28 | 18 | 21919 | 271134 | 70635373 |
Intentional self-injury | 36.56 | 25.28 | 47 | 21890 | 31603 | 70874904 |
Infection | 36.51 | 25.28 | 10 | 21927 | 210775 | 70695732 |
Wrong technique in product usage process | 35.96 | 25.28 | 71 | 21866 | 68627 | 70837880 |
Depression | 35.93 | 25.28 | 139 | 21798 | 198835 | 70707672 |
Irritability | 35.41 | 25.28 | 51 | 21886 | 38174 | 70868333 |
Haemoglobin decreased | 35.04 | 25.28 | 10 | 21927 | 205149 | 70701358 |
Device malfunction | 35.02 | 25.28 | 36 | 21901 | 19048 | 70887459 |
Disease progression | 34.52 | 25.28 | 4 | 21933 | 156668 | 70749839 |
Blunted affect | 32.76 | 25.28 | 10 | 21927 | 446 | 70906061 |
Oculogyric crisis | 32.10 | 25.28 | 16 | 21921 | 2682 | 70903825 |
Alopecia | 31.54 | 25.28 | 11 | 21926 | 198479 | 70708028 |
Peripheral swelling | 31.43 | 25.28 | 17 | 21920 | 236546 | 70669961 |
Adverse event | 30.71 | 25.28 | 55 | 21882 | 49406 | 70857101 |
Injection site infection | 30.54 | 25.28 | 14 | 21923 | 1950 | 70904557 |
Extra dose administered | 30.42 | 25.28 | 22 | 21915 | 7255 | 70899252 |
Urinary tract infection | 30.07 | 25.28 | 20 | 21917 | 248749 | 70657758 |
Bipolar disorder | 29.54 | 25.28 | 22 | 21915 | 7586 | 70898921 |
Pain in extremity | 29.32 | 25.28 | 35 | 21902 | 328047 | 70578460 |
Hypertension | 29.31 | 25.28 | 29 | 21908 | 296004 | 70610503 |
Terminal dribbling | 29.29 | 25.28 | 5 | 21932 | 12 | 70906495 |
Prolactin-producing pituitary tumour | 29.16 | 25.28 | 7 | 21930 | 123 | 70906384 |
Investigation | 28.60 | 25.28 | 14 | 21923 | 2257 | 70904250 |
Decreased appetite | 27.78 | 25.28 | 32 | 21905 | 304748 | 70601759 |
Flat affect | 27.70 | 25.28 | 13 | 21924 | 1910 | 70904597 |
Delirium | 27.53 | 25.28 | 67 | 21870 | 74547 | 70831960 |
Swelling | 27.39 | 25.28 | 12 | 21925 | 188527 | 70717980 |
Poor personal hygiene | 27.25 | 25.28 | 9 | 21928 | 519 | 70905988 |
Saccadic eye movement | 27.17 | 25.28 | 7 | 21930 | 166 | 70906341 |
Salivary hypersecretion | 26.69 | 25.28 | 26 | 21911 | 12899 | 70893608 |
Menstruation irregular | 26.64 | 25.28 | 17 | 21920 | 4571 | 70901936 |
Thinking abnormal | 26.32 | 25.28 | 25 | 21912 | 12026 | 70894481 |
Cardiac failure congestive | 26.30 | 25.28 | 5 | 21932 | 135452 | 70771055 |
Ejaculation failure | 26.27 | 25.28 | 8 | 21929 | 354 | 70906153 |
Neuropathy peripheral | 26.14 | 25.28 | 4 | 21933 | 126892 | 70779615 |
Soliloquy | 26.14 | 25.28 | 9 | 21928 | 590 | 70905917 |
Tension | 26.11 | 25.28 | 16 | 21921 | 4008 | 70902499 |
Contraindicated product administered | 26.07 | 25.28 | 5 | 21932 | 134607 | 70771900 |
Renal failure | 25.98 | 25.28 | 13 | 21924 | 189057 | 70717450 |
Pleural effusion | 25.59 | 25.28 | 5 | 21932 | 132859 | 70773648 |
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 |
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 |
C2719626 | UMLSCUI |
D000068882 | MESH_DESCRIPTOR_UI |
C0753678 | UMLSCUI |
9852746 | PUBCHEM_CID |
7977 | INN_ID |
115237 | PUBCHEM_CID |
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 | 50458-560 | 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 | 50458-561 | 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 | 50458-562 | 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 | 50458-563 | INJECTION | 156 mg | INTRAMUSCULAR | NDA | 35 sections |
INVEGA SUSTENNA | HUMAN PRESCRIPTION DRUG LABEL | 1 | 50458-564 | INJECTION | 234 mg | INTRAMUSCULAR | NDA | 35 sections |
INVEGA 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 |