Stem definition | Drug id | CAS RN |
---|---|---|
4498 | 199739-10-1 |
None
Property | Value | Reference |
---|---|---|
S (Water solubility) | 0.03 mg/mL | Bocci G, Oprea TI, Benet LZ |
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 | 2000.32 | 29.74 | 388 | 14759 | 3115 | 63470760 |
Galactorrhoea | 1826.76 | 29.74 | 370 | 14777 | 3785 | 63470090 |
Amenorrhoea | 1018.64 | 29.74 | 271 | 14876 | 9643 | 63464232 |
Injection site nodule | 950.30 | 29.74 | 213 | 14934 | 3622 | 63470253 |
Blood prolactin abnormal | 617.49 | 29.74 | 144 | 15003 | 2935 | 63470940 |
Product dose omission issue | 609.66 | 29.74 | 478 | 14669 | 233835 | 63240040 |
Hospitalisation | 506.61 | 29.74 | 291 | 14856 | 84790 | 63389085 |
Inappropriate schedule of product administration | 497.90 | 29.74 | 309 | 14838 | 103656 | 63370219 |
Disturbance in social behaviour | 495.85 | 29.74 | 127 | 15020 | 3866 | 63470009 |
Psychotic disorder | 459.24 | 29.74 | 187 | 14960 | 25525 | 63448350 |
Anosognosia | 448.01 | 29.74 | 112 | 15035 | 3084 | 63470791 |
Sexual dysfunction | 432.35 | 29.74 | 116 | 15031 | 4243 | 63469632 |
Dystonia | 411.40 | 29.74 | 146 | 15001 | 13673 | 63460202 |
Hyperprolactinaemia | 392.52 | 29.74 | 105 | 15042 | 3795 | 63470080 |
Metabolic disorder | 377.83 | 29.74 | 114 | 15033 | 6389 | 63467486 |
Hallucination, auditory | 353.50 | 29.74 | 128 | 15019 | 12696 | 63461179 |
Personality change | 353.12 | 29.74 | 110 | 15037 | 6863 | 63467012 |
Sedation | 340.71 | 29.74 | 172 | 14975 | 38637 | 63435238 |
Off label use | 339.71 | 29.74 | 587 | 14560 | 673875 | 62800000 |
Injection site mass | 320.43 | 29.74 | 132 | 15015 | 18524 | 63455351 |
Extrapyramidal disorder | 319.70 | 29.74 | 120 | 15027 | 13164 | 63460711 |
Dyskinesia | 310.98 | 29.74 | 152 | 14995 | 31850 | 63442025 |
Treatment noncompliance | 297.42 | 29.74 | 155 | 14992 | 37170 | 63436705 |
Akathisia | 292.67 | 29.74 | 102 | 15045 | 9044 | 63464831 |
Incorrect dose administered | 280.89 | 29.74 | 176 | 14971 | 59792 | 63414083 |
Weight increased | 273.47 | 29.74 | 323 | 14824 | 260469 | 63213406 |
Breast discharge | 260.34 | 29.74 | 58 | 15089 | 953 | 63472922 |
Suicide attempt | 248.71 | 29.74 | 164 | 14983 | 60754 | 63413121 |
Psychotic symptom | 225.21 | 29.74 | 56 | 15091 | 1505 | 63472370 |
Syringe issue | 222.71 | 29.74 | 63 | 15084 | 2806 | 63471069 |
Tardive dyskinesia | 197.97 | 29.74 | 75 | 15072 | 8427 | 63465448 |
Delusion | 192.71 | 29.74 | 81 | 15066 | 11936 | 63461939 |
Injection site pain | 179.23 | 29.74 | 186 | 14961 | 129614 | 63344261 |
Refusal of treatment by patient | 178.51 | 29.74 | 62 | 15085 | 5435 | 63468440 |
Paranoia | 178.22 | 29.74 | 76 | 15071 | 11603 | 63462272 |
Blood glucose increased | 151.06 | 29.74 | 139 | 15008 | 83617 | 63390258 |
Product use in unapproved indication | 144.55 | 29.74 | 195 | 14952 | 178885 | 63294990 |
Underdose | 134.51 | 29.74 | 83 | 15064 | 27373 | 63446502 |
Device leakage | 131.30 | 29.74 | 53 | 15094 | 7043 | 63466832 |
Aggression | 130.51 | 29.74 | 77 | 15070 | 23421 | 63450454 |
Therapeutic response decreased | 118.52 | 29.74 | 106 | 15041 | 61419 | 63412456 |
Diarrhoea | 115.25 | 29.74 | 17 | 15130 | 715349 | 62758526 |
Nausea | 109.92 | 29.74 | 34 | 15113 | 854437 | 62619438 |
Product administered at inappropriate site | 107.98 | 29.74 | 37 | 15110 | 3112 | 63470763 |
Pain | 94.22 | 29.74 | 30 | 15117 | 740598 | 62733277 |
Drooling | 89.59 | 29.74 | 34 | 15113 | 3834 | 63470041 |
Arthralgia | 88.35 | 29.74 | 15 | 15132 | 569695 | 62904180 |
Injection site abscess | 82.64 | 29.74 | 24 | 15123 | 1174 | 63472701 |
Product quality issue | 79.56 | 29.74 | 67 | 15080 | 35798 | 63438077 |
Insurance issue | 77.68 | 29.74 | 35 | 15112 | 6086 | 63467789 |
Condition aggravated | 74.82 | 29.74 | 238 | 14909 | 401979 | 63071896 |
Injection site swelling | 74.35 | 29.74 | 73 | 15074 | 47499 | 63426376 |
Abnormal behaviour | 73.81 | 29.74 | 52 | 15095 | 21374 | 63452501 |
Injection site reaction | 73.76 | 29.74 | 80 | 15067 | 58444 | 63415431 |
Neuroleptic malignant syndrome | 70.86 | 29.74 | 41 | 15106 | 12015 | 63461860 |
Hallucination | 69.20 | 29.74 | 75 | 15072 | 54742 | 63419133 |
Fatigue | 67.28 | 29.74 | 68 | 15079 | 887960 | 62585915 |
Parkinsonism | 65.37 | 29.74 | 37 | 15110 | 10402 | 63463473 |
Suicidal ideation | 64.53 | 29.74 | 77 | 15070 | 62344 | 63411531 |
Accidental exposure to product | 64.52 | 29.74 | 53 | 15094 | 27352 | 63446523 |
Abdominal discomfort | 64.02 | 29.74 | 3 | 15144 | 320882 | 63152993 |
Needle issue | 60.22 | 29.74 | 35 | 15112 | 10341 | 63463534 |
Joint swelling | 59.60 | 29.74 | 5 | 15142 | 327661 | 63146214 |
Breast tenderness | 59.31 | 29.74 | 22 | 15125 | 2328 | 63471547 |
Breast enlargement | 59.13 | 29.74 | 20 | 15127 | 1616 | 63472259 |
Injection site induration | 58.58 | 29.74 | 33 | 15114 | 9193 | 63464682 |
Headache | 58.33 | 29.74 | 40 | 15107 | 633201 | 62840674 |
Drug ineffective | 57.66 | 29.74 | 435 | 14712 | 1044330 | 62429545 |
Drug intolerance | 55.35 | 29.74 | 5 | 15142 | 308656 | 63165219 |
Cough | 54.55 | 29.74 | 4 | 15143 | 292739 | 63181136 |
Dyspnoea | 54.26 | 29.74 | 47 | 15100 | 661266 | 62812609 |
Tremor | 54.19 | 29.74 | 106 | 15041 | 132133 | 63341742 |
Drug hypersensitivity | 53.19 | 29.74 | 6 | 15141 | 310681 | 63163194 |
Imprisonment | 52.61 | 29.74 | 12 | 15135 | 220 | 63473655 |
Lactation disorder | 51.31 | 29.74 | 13 | 15134 | 377 | 63473498 |
Schizophrenia | 51.05 | 29.74 | 31 | 15116 | 9921 | 63463954 |
Wrong technique in product usage process | 50.32 | 29.74 | 68 | 15079 | 62272 | 63411603 |
Product leakage | 49.92 | 29.74 | 15 | 15132 | 826 | 63473049 |
Menstruation irregular | 49.82 | 29.74 | 27 | 15120 | 6977 | 63466898 |
Mania | 49.66 | 29.74 | 33 | 15114 | 12334 | 63461541 |
Prolactin-producing pituitary tumour | 49.19 | 29.74 | 10 | 15137 | 103 | 63473772 |
Personality change due to a general medical condition | 48.16 | 29.74 | 11 | 15136 | 203 | 63473672 |
Abdominal pain | 47.02 | 29.74 | 7 | 15140 | 293449 | 63180426 |
Vomiting | 46.81 | 29.74 | 39 | 15108 | 559578 | 62914297 |
Psychiatric decompensation | 46.24 | 29.74 | 16 | 15131 | 1385 | 63472490 |
Product administration error | 45.90 | 29.74 | 40 | 15107 | 22357 | 63451518 |
Nasopharyngitis | 45.89 | 29.74 | 4 | 15143 | 254253 | 63219622 |
Abnormal weight gain | 45.70 | 29.74 | 17 | 15130 | 1813 | 63472062 |
Adverse drug reaction | 44.31 | 29.74 | 73 | 15074 | 79641 | 63394234 |
Anaemia | 42.67 | 29.74 | 9 | 15138 | 293421 | 63180454 |
Social avoidant behaviour | 40.84 | 29.74 | 18 | 15129 | 2970 | 63470905 |
Blunted affect | 40.78 | 29.74 | 10 | 15137 | 253 | 63473622 |
Pruritus | 40.19 | 29.74 | 18 | 15129 | 361435 | 63112440 |
Catatonia | 39.68 | 29.74 | 20 | 15127 | 4457 | 63469418 |
Back pain | 38.61 | 29.74 | 8 | 15139 | 264137 | 63209738 |
Breast engorgement | 38.08 | 29.74 | 8 | 15139 | 98 | 63473777 |
Adverse event | 37.71 | 29.74 | 62 | 15085 | 67497 | 63406378 |
Pituitary tumour benign | 37.24 | 29.74 | 15 | 15132 | 1980 | 63471895 |
Pyrexia | 36.66 | 29.74 | 35 | 15112 | 470443 | 63003432 |
Product use issue | 35.96 | 29.74 | 125 | 15022 | 220395 | 63253480 |
Peripheral swelling | 35.07 | 29.74 | 10 | 15137 | 265932 | 63207943 |
Asthenia | 34.22 | 29.74 | 25 | 15122 | 383579 | 63090296 |
Psychiatric symptom | 34.02 | 29.74 | 19 | 15128 | 5204 | 63468671 |
Pneumonia | 33.28 | 29.74 | 36 | 15111 | 456731 | 63017144 |
Infection | 31.37 | 29.74 | 8 | 15139 | 229165 | 63244710 |
Acute kidney injury | 31.06 | 29.74 | 12 | 15135 | 263403 | 63210472 |
Flat affect | 30.91 | 29.74 | 12 | 15135 | 1438 | 63472437 |
Device malfunction | 30.90 | 29.74 | 29 | 15118 | 17828 | 63456047 |
Terminal dribbling | 30.59 | 29.74 | 5 | 15142 | 12 | 63473863 |
Alopecia | 30.10 | 29.74 | 22 | 15125 | 337514 | 63136361 |
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 | 1490.70 | 26.72 | 904 | 19665 | 118807 | 34817555 |
Inappropriate schedule of product administration | 1032.23 | 26.72 | 568 | 20001 | 61728 | 34874634 |
Hospitalisation | 934.51 | 26.72 | 516 | 20053 | 56386 | 34879976 |
Psychotic disorder | 826.13 | 26.72 | 363 | 20206 | 24089 | 34912273 |
Blood prolactin increased | 698.87 | 26.72 | 170 | 20399 | 1590 | 34934772 |
Treatment noncompliance | 541.85 | 26.72 | 284 | 20285 | 27816 | 34908546 |
Gynaecomastia | 519.13 | 26.72 | 203 | 20366 | 9977 | 34926385 |
Hallucination, auditory | 515.32 | 26.72 | 211 | 20358 | 11706 | 34924656 |
Off label use | 473.44 | 26.72 | 863 | 19706 | 418661 | 34517701 |
Akathisia | 453.64 | 26.72 | 173 | 20396 | 7936 | 34928426 |
Incorrect dose administered | 445.14 | 26.72 | 284 | 20285 | 40231 | 34896131 |
Injection site nodule | 433.10 | 26.72 | 115 | 20454 | 1568 | 34934794 |
Extrapyramidal disorder | 379.52 | 26.72 | 174 | 20395 | 12706 | 34923656 |
Therapeutic response decreased | 338.06 | 26.72 | 212 | 20357 | 29101 | 34907261 |
Paranoia | 327.44 | 26.72 | 154 | 20415 | 11914 | 34924448 |
Weight increased | 326.70 | 26.72 | 334 | 20235 | 92699 | 34843663 |
Psychotic symptom | 304.99 | 26.72 | 88 | 20481 | 1655 | 34934707 |
Syringe issue | 299.42 | 26.72 | 116 | 20453 | 5548 | 34930814 |
Sexual dysfunction | 294.31 | 26.72 | 118 | 20451 | 6185 | 34930177 |
Delusion | 281.78 | 26.72 | 141 | 20428 | 12494 | 34923868 |
Aggression | 252.56 | 26.72 | 198 | 20371 | 38766 | 34897596 |
Dystonia | 244.69 | 26.72 | 122 | 20447 | 10723 | 34925639 |
Refusal of treatment by patient | 244.63 | 26.72 | 97 | 20472 | 4935 | 34931427 |
Blood prolactin abnormal | 234.08 | 26.72 | 63 | 20506 | 906 | 34935456 |
Underdose | 230.87 | 26.72 | 127 | 20442 | 13653 | 34922709 |
Sedation | 224.82 | 26.72 | 145 | 20424 | 20861 | 34915501 |
Therapeutic product effect decreased | 223.93 | 26.72 | 176 | 20393 | 34567 | 34901795 |
Drug ineffective | 206.44 | 26.72 | 661 | 19908 | 456090 | 34480272 |
Tardive dyskinesia | 182.39 | 26.72 | 82 | 20487 | 5708 | 34930654 |
Anosognosia | 174.12 | 26.72 | 50 | 20519 | 923 | 34935439 |
Injection site pain | 172.15 | 26.72 | 159 | 20410 | 38846 | 34897516 |
Neuroleptic malignant syndrome | 170.50 | 26.72 | 115 | 20454 | 17819 | 34918543 |
Disturbance in social behaviour | 169.75 | 26.72 | 57 | 20512 | 1794 | 34934568 |
Galactorrhoea | 161.01 | 26.72 | 40 | 20529 | 410 | 34935952 |
Suicidal ideation | 156.09 | 26.72 | 153 | 20416 | 40235 | 34896127 |
Dyskinesia | 154.04 | 26.72 | 118 | 20451 | 22295 | 34914067 |
Abnormal behaviour | 140.71 | 26.72 | 117 | 20452 | 24852 | 34911510 |
Product administered at inappropriate site | 140.58 | 26.72 | 52 | 20517 | 2184 | 34934178 |
Erectile dysfunction | 140.39 | 26.72 | 108 | 20461 | 20529 | 34915833 |
Device leakage | 133.77 | 26.72 | 69 | 20500 | 6506 | 34929856 |
Injection site mass | 130.40 | 26.72 | 68 | 20501 | 6558 | 34929804 |
Diarrhoea | 127.67 | 26.72 | 36 | 20533 | 389876 | 34546486 |
Product leakage | 124.00 | 26.72 | 34 | 20535 | 526 | 34935836 |
Needle issue | 120.55 | 26.72 | 63 | 20506 | 6102 | 34930260 |
Product quality issue | 113.34 | 26.72 | 88 | 20481 | 16947 | 34919415 |
Psychosexual disorder | 111.75 | 26.72 | 23 | 20546 | 89 | 34936273 |
Suicide attempt | 111.49 | 26.72 | 126 | 20443 | 38990 | 34897372 |
Product administration error | 109.98 | 26.72 | 85 | 20484 | 16259 | 34920103 |
Breast enlargement | 109.30 | 26.72 | 30 | 20539 | 466 | 34935896 |
Hallucination | 107.94 | 26.72 | 142 | 20427 | 51356 | 34885006 |
Drooling | 106.83 | 26.72 | 48 | 20521 | 3334 | 34933028 |
Condition aggravated | 106.63 | 26.72 | 300 | 20269 | 191896 | 34744466 |
Schizophrenia | 105.63 | 26.72 | 65 | 20504 | 8601 | 34927761 |
Hyperprolactinaemia | 103.59 | 26.72 | 38 | 20531 | 1558 | 34934804 |
Accidental exposure to product | 102.72 | 26.72 | 74 | 20495 | 12728 | 34923634 |
Parkinsonism | 101.65 | 26.72 | 62 | 20507 | 8076 | 34928286 |
Mania | 100.08 | 26.72 | 65 | 20504 | 9446 | 34926916 |
Imprisonment | 98.73 | 26.72 | 28 | 20541 | 493 | 34935869 |
Acute kidney injury | 94.56 | 26.72 | 31 | 20538 | 304957 | 34631405 |
Adverse event | 93.16 | 26.72 | 82 | 20487 | 18795 | 34917567 |
Metabolic disorder | 93.08 | 26.72 | 47 | 20522 | 4236 | 34932126 |
Anaemia | 91.71 | 26.72 | 14 | 20555 | 233321 | 34703041 |
Product use issue | 80.37 | 26.72 | 138 | 20431 | 63078 | 34873284 |
Pneumonia | 77.83 | 26.72 | 60 | 20509 | 362567 | 34573795 |
Sepsis | 75.45 | 26.72 | 6 | 20563 | 166555 | 34769807 |
Psychiatric symptom | 74.73 | 26.72 | 38 | 20531 | 3475 | 34932887 |
Personality change | 74.21 | 26.72 | 43 | 20526 | 5096 | 34931266 |
Wrong technique in product usage process | 73.47 | 26.72 | 98 | 20471 | 35888 | 34900474 |
Agitation | 72.55 | 26.72 | 125 | 20444 | 57274 | 34879088 |
Catatonia | 72.44 | 26.72 | 42 | 20527 | 4983 | 34931379 |
Retrograde ejaculation | 71.92 | 26.72 | 21 | 20548 | 412 | 34935950 |
Injection site reaction | 71.17 | 26.72 | 60 | 20509 | 12973 | 34923389 |
Abdominal pain | 71.12 | 26.72 | 7 | 20562 | 163611 | 34772751 |
Dyspnoea | 65.94 | 26.72 | 75 | 20494 | 376707 | 34559655 |
Nausea | 65.86 | 26.72 | 62 | 20507 | 339846 | 34596516 |
Muscle rigidity | 64.92 | 26.72 | 52 | 20517 | 10466 | 34925896 |
Anxiety | 64.86 | 26.72 | 165 | 20404 | 99263 | 34837099 |
Social avoidant behaviour | 64.26 | 26.72 | 33 | 20536 | 3081 | 34933281 |
Product use in unapproved indication | 61.67 | 26.72 | 180 | 20389 | 117319 | 34819043 |
Eye movement disorder | 60.84 | 26.72 | 35 | 20534 | 4092 | 34932270 |
Toxicity to various agents | 59.19 | 26.72 | 22 | 20547 | 200340 | 34736022 |
Incorrect route of product administration | 56.84 | 26.72 | 56 | 20513 | 14789 | 34921573 |
Pyrexia | 56.38 | 26.72 | 68 | 20501 | 332945 | 34603417 |
Breast tenderness | 56.19 | 26.72 | 20 | 20549 | 751 | 34935611 |
Flat affect | 53.96 | 26.72 | 20 | 20549 | 844 | 34935518 |
Priapism | 52.21 | 26.72 | 34 | 20535 | 4960 | 34931402 |
Cough | 50.57 | 26.72 | 13 | 20556 | 150127 | 34786235 |
Irritability | 50.01 | 26.72 | 67 | 20502 | 24623 | 34911739 |
Arthralgia | 49.65 | 26.72 | 19 | 20550 | 170022 | 34766340 |
Breast discharge | 48.94 | 26.72 | 10 | 20559 | 37 | 34936325 |
Haemoglobin decreased | 47.94 | 26.72 | 7 | 20562 | 120765 | 34815597 |
Wrong product administered | 47.80 | 26.72 | 33 | 20536 | 5301 | 34931061 |
Depression | 47.37 | 26.72 | 145 | 20424 | 96953 | 34839409 |
Asthenia | 47.11 | 26.72 | 45 | 20524 | 245206 | 34691156 |
Thinking abnormal | 45.87 | 26.72 | 34 | 20535 | 6103 | 34930259 |
Rash | 45.00 | 26.72 | 39 | 20530 | 222713 | 34713649 |
Persecutory delusion | 43.79 | 26.72 | 24 | 20545 | 2556 | 34933806 |
Fatigue | 43.69 | 26.72 | 96 | 20473 | 370557 | 34565805 |
Emotional disorder | 43.47 | 26.72 | 32 | 20537 | 5684 | 34930678 |
Mental impairment | 41.50 | 26.72 | 40 | 20529 | 10282 | 34926080 |
Pruritus | 41.21 | 26.72 | 16 | 20553 | 141965 | 34794397 |
Restlessness | 41.06 | 26.72 | 62 | 20507 | 25420 | 34910942 |
Hypotension | 41.02 | 26.72 | 42 | 20527 | 221607 | 34714755 |
Product packaging issue | 40.34 | 26.72 | 15 | 20554 | 639 | 34935723 |
Intentional self-injury | 40.29 | 26.72 | 45 | 20524 | 13726 | 34922636 |
Investigation | 38.56 | 26.72 | 16 | 20553 | 914 | 34935448 |
Renal failure | 37.41 | 26.72 | 15 | 20554 | 130542 | 34805820 |
Ejaculation failure | 37.24 | 26.72 | 15 | 20554 | 794 | 34935568 |
Atrial fibrillation | 36.85 | 26.72 | 13 | 20556 | 122380 | 34813982 |
Oculogyric crisis | 36.21 | 26.72 | 18 | 20551 | 1568 | 34934794 |
Respiratory failure | 35.41 | 26.72 | 10 | 20559 | 108562 | 34827800 |
Tremor | 35.40 | 26.72 | 118 | 20451 | 82469 | 34853893 |
Cardiac failure congestive | 35.02 | 26.72 | 4 | 20565 | 83266 | 34853096 |
Decreased appetite | 34.98 | 26.72 | 28 | 20541 | 166364 | 34769998 |
Homicidal ideation | 34.94 | 26.72 | 21 | 20548 | 2661 | 34933701 |
Soliloquy | 34.65 | 26.72 | 12 | 20557 | 415 | 34935947 |
Adverse drug reaction | 34.58 | 26.72 | 62 | 20507 | 29280 | 34907082 |
Infection | 34.42 | 26.72 | 6 | 20563 | 90909 | 34845453 |
Blood creatinine increased | 34.40 | 26.72 | 7 | 20562 | 94969 | 34841393 |
Extra dose administered | 34.05 | 26.72 | 24 | 20545 | 3985 | 34932377 |
Medication error | 34.02 | 26.72 | 57 | 20512 | 25508 | 34910854 |
Substance abuse | 33.37 | 26.72 | 31 | 20538 | 7610 | 34928752 |
Drug interaction | 32.30 | 26.72 | 52 | 20517 | 225894 | 34710468 |
Device malfunction | 32.12 | 26.72 | 35 | 20534 | 10386 | 34925976 |
Injection site rash | 31.02 | 26.72 | 23 | 20546 | 4130 | 34932232 |
Vomiting | 30.90 | 26.72 | 62 | 20507 | 247559 | 34688803 |
Libido decreased | 30.65 | 26.72 | 24 | 20545 | 4672 | 34931690 |
Neuropathy peripheral | 30.44 | 26.72 | 6 | 20563 | 83257 | 34853105 |
Mental disorder | 30.38 | 26.72 | 41 | 20528 | 15168 | 34921194 |
Pain | 30.30 | 26.72 | 46 | 20523 | 204629 | 34731733 |
Platelet count decreased | 29.35 | 26.72 | 17 | 20552 | 119700 | 34816662 |
Physical assault | 29.15 | 26.72 | 14 | 20555 | 1131 | 34935231 |
Back pain | 28.86 | 26.72 | 18 | 20551 | 121771 | 34814591 |
Insomnia | 28.57 | 26.72 | 129 | 20440 | 103778 | 34832584 |
Product outer packaging issue | 28.26 | 26.72 | 5 | 20564 | 6 | 34936356 |
Loss of libido | 28.22 | 26.72 | 18 | 20551 | 2534 | 34933828 |
Interstitial lung disease | 27.79 | 26.72 | 3 | 20566 | 65279 | 34871083 |
Constipation | 27.61 | 26.72 | 24 | 20545 | 136958 | 34799404 |
Sudden death | 27.40 | 26.72 | 39 | 20530 | 15162 | 34921200 |
Thrombocytopenia | 27.33 | 26.72 | 31 | 20538 | 156216 | 34780146 |
Schizoaffective disorder | 27.20 | 26.72 | 14 | 20555 | 1313 | 34935049 |
Multiple organ dysfunction syndrome | 26.99 | 26.72 | 6 | 20563 | 76560 | 34859802 |
Urinary tract infection | 26.94 | 26.72 | 8 | 20561 | 84073 | 34852289 |
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 | 1114.69 | 25.07 | 254 | 23050 | 3757 | 79717327 |
Product dose omission issue | 930.86 | 25.07 | 683 | 22621 | 246854 | 79474230 |
Inappropriate schedule of product administration | 867.71 | 25.07 | 519 | 22785 | 133109 | 79587975 |
Galactorrhoea | 801.91 | 25.07 | 191 | 23113 | 3455 | 79717629 |
Hospitalisation | 727.93 | 25.07 | 410 | 22894 | 93826 | 79627258 |
Psychotic disorder | 670.64 | 25.07 | 298 | 23006 | 41104 | 79679980 |
Blood prolactin abnormal | 645.46 | 25.07 | 160 | 23144 | 3441 | 79717643 |
Sexual dysfunction | 619.00 | 25.07 | 182 | 23122 | 7581 | 79713503 |
Disturbance in social behaviour | 613.19 | 25.07 | 164 | 23140 | 4806 | 79716278 |
Injection site nodule | 593.17 | 25.07 | 151 | 23153 | 3629 | 79717455 |
Anosognosia | 588.88 | 25.07 | 150 | 23154 | 3614 | 79717470 |
Dystonia | 577.69 | 25.07 | 222 | 23082 | 21177 | 79699907 |
Treatment noncompliance | 557.04 | 25.07 | 282 | 23022 | 51986 | 79669098 |
Off label use | 556.27 | 25.07 | 964 | 22340 | 906251 | 78814833 |
Extrapyramidal disorder | 526.72 | 25.07 | 211 | 23093 | 22468 | 79698616 |
Hallucination, auditory | 524.20 | 25.07 | 205 | 23099 | 20488 | 79700596 |
Incorrect dose administered | 453.64 | 25.07 | 281 | 23023 | 76349 | 79644735 |
Metabolic disorder | 444.82 | 25.07 | 147 | 23157 | 9023 | 79712061 |
Akathisia | 443.44 | 25.07 | 161 | 23143 | 13098 | 79707986 |
Sedation | 439.04 | 25.07 | 240 | 23064 | 51655 | 79669429 |
Dyskinesia | 426.26 | 25.07 | 224 | 23080 | 44549 | 79676535 |
Personality change | 410.44 | 25.07 | 142 | 23162 | 10028 | 79711056 |
Amenorrhoea | 391.97 | 25.07 | 128 | 23176 | 7564 | 79713520 |
Suicide attempt | 368.15 | 25.07 | 254 | 23050 | 82678 | 79638406 |
Gynaecomastia | 368.00 | 25.07 | 122 | 23182 | 7559 | 79713525 |
Syringe issue | 342.04 | 25.07 | 110 | 23194 | 6188 | 79714896 |
Hyperprolactinaemia | 322.29 | 25.07 | 98 | 23206 | 4578 | 79716506 |
Delusion | 289.25 | 25.07 | 134 | 23170 | 20289 | 79700795 |
Aggression | 274.12 | 25.07 | 176 | 23128 | 50782 | 79670302 |
Paranoia | 270.54 | 25.07 | 126 | 23178 | 19306 | 79701778 |
Psychotic symptom | 267.57 | 25.07 | 75 | 23229 | 2622 | 79718462 |
Tardive dyskinesia | 258 | 25.07 | 102 | 23202 | 10469 | 79710615 |
Weight increased | 244.58 | 25.07 | 350 | 22954 | 277036 | 79444048 |
Neuroleptic malignant syndrome | 220.64 | 25.07 | 123 | 23181 | 27436 | 79693648 |
Refusal of treatment by patient | 220.27 | 25.07 | 87 | 23217 | 8904 | 79712180 |
Injection site mass | 194.83 | 25.07 | 102 | 23202 | 20082 | 79701002 |
Underdose | 172.05 | 25.07 | 112 | 23192 | 33039 | 79688045 |
Injection site pain | 169.29 | 25.07 | 199 | 23105 | 129639 | 79591445 |
Abnormal behaviour | 164.83 | 25.07 | 113 | 23191 | 36308 | 79684776 |
Suicidal ideation | 154.70 | 25.07 | 148 | 23156 | 76192 | 79644892 |
Product use in unapproved indication | 147.44 | 25.07 | 263 | 23041 | 250096 | 79470988 |
Product administered at inappropriate site | 147.02 | 25.07 | 52 | 23252 | 3913 | 79717171 |
Diarrhoea | 143.87 | 25.07 | 40 | 23264 | 880449 | 78840635 |
Blood glucose increased | 142.89 | 25.07 | 172 | 23132 | 114803 | 79606281 |
Parkinsonism | 140.91 | 25.07 | 77 | 23227 | 16507 | 79704577 |
Device leakage | 140.62 | 25.07 | 67 | 23237 | 10789 | 79710295 |
Therapeutic response decreased | 140.00 | 25.07 | 132 | 23172 | 66721 | 79654363 |
Nausea | 123.83 | 25.07 | 63 | 23241 | 957133 | 78763951 |
Drooling | 123.23 | 25.07 | 51 | 23253 | 5883 | 79715201 |
Product leakage | 119.55 | 25.07 | 32 | 23272 | 938 | 79720146 |
Needle issue | 117.49 | 25.07 | 63 | 23241 | 13005 | 79708079 |
Drug ineffective | 112.59 | 25.07 | 615 | 22689 | 1080298 | 78640786 |
Arthralgia | 111.74 | 25.07 | 17 | 23287 | 571786 | 79149298 |
Hallucination | 106.04 | 25.07 | 128 | 23176 | 85617 | 79635467 |
Schizophrenia | 105.05 | 25.07 | 62 | 23242 | 15378 | 79705706 |
Product use issue | 99.37 | 25.07 | 201 | 23103 | 209621 | 79511463 |
Catatonia | 95.32 | 25.07 | 48 | 23256 | 8708 | 79712376 |
Breast discharge | 95.05 | 25.07 | 25 | 23279 | 684 | 79720400 |
Insurance issue | 95.02 | 25.07 | 42 | 23262 | 5691 | 79715393 |
Erectile dysfunction | 94.85 | 25.07 | 57 | 23247 | 14607 | 79706477 |
Psychiatric symptom | 92.89 | 25.07 | 44 | 23260 | 6991 | 79714093 |
Accidental exposure to product | 89.90 | 25.07 | 74 | 23230 | 31248 | 79689836 |
Pain | 82.68 | 25.07 | 52 | 23252 | 703750 | 79017334 |
Abdominal pain | 82.24 | 25.07 | 9 | 23295 | 389560 | 79331524 |
Dyspnoea | 77.51 | 25.07 | 82 | 23222 | 856943 | 78864141 |
Mania | 74.06 | 25.07 | 53 | 23251 | 18207 | 79702877 |
Anaemia | 71.01 | 25.07 | 21 | 23283 | 444994 | 79276090 |
Injection site abscess | 70.42 | 25.07 | 24 | 23280 | 1616 | 79719468 |
Cough | 69.11 | 25.07 | 12 | 23292 | 366777 | 79354307 |
Tremor | 68.96 | 25.07 | 153 | 23151 | 169930 | 79551154 |
Sudden death | 68.42 | 25.07 | 55 | 23249 | 22456 | 79698628 |
Joint swelling | 65.36 | 25.07 | 5 | 23299 | 288641 | 79432443 |
Injection site reaction | 64.80 | 25.07 | 80 | 23224 | 54705 | 79666379 |
Fatigue | 63.72 | 25.07 | 109 | 23195 | 929618 | 78791466 |
Product administration error | 63.05 | 25.07 | 61 | 23243 | 31785 | 79689299 |
Depression | 62.40 | 25.07 | 171 | 23133 | 216619 | 79504465 |
Acute kidney injury | 60.06 | 25.07 | 39 | 23265 | 519365 | 79201719 |
Muscle rigidity | 59.21 | 25.07 | 48 | 23256 | 19834 | 79701250 |
Imprisonment | 57.41 | 25.07 | 16 | 23288 | 547 | 79720537 |
Social avoidant behaviour | 57.17 | 25.07 | 28 | 23276 | 4786 | 79716298 |
Pruritus | 57.07 | 25.07 | 22 | 23282 | 394626 | 79326458 |
Retrograde ejaculation | 56.44 | 25.07 | 14 | 23290 | 301 | 79720783 |
Drug hypersensitivity | 55.81 | 25.07 | 10 | 23294 | 298906 | 79422178 |
Adverse drug reaction | 55.68 | 25.07 | 82 | 23222 | 66310 | 79654774 |
Vomiting | 55.43 | 25.07 | 68 | 23236 | 665760 | 79055324 |
Rhabdomyolysis | 55.07 | 25.07 | 104 | 23200 | 103027 | 79618057 |
Mental impairment | 54.67 | 25.07 | 45 | 23259 | 18991 | 79702093 |
Condition aggravated | 54.34 | 25.07 | 289 | 23015 | 500835 | 79220249 |
Abdominal discomfort | 52.35 | 25.07 | 6 | 23298 | 250721 | 79470363 |
Breast enlargement | 51.99 | 25.07 | 19 | 23285 | 1570 | 79719514 |
Agitation | 51.32 | 25.07 | 99 | 23205 | 99616 | 79621468 |
Product quality issue | 50.90 | 25.07 | 56 | 23248 | 33884 | 79687200 |
Rash | 50.33 | 25.07 | 57 | 23247 | 578301 | 79142783 |
Pulmonary embolism | 48.97 | 25.07 | 135 | 23169 | 171519 | 79549565 |
Eye movement disorder | 48.88 | 25.07 | 30 | 23274 | 7981 | 79713103 |
Breast tenderness | 48.81 | 25.07 | 20 | 23284 | 2248 | 79718836 |
Injection site swelling | 48.14 | 25.07 | 64 | 23240 | 47068 | 79674016 |
Incorrect route of product administration | 47.88 | 25.07 | 55 | 23249 | 34874 | 79686210 |
Pyrexia | 47.86 | 25.07 | 78 | 23226 | 678631 | 79042453 |
Mental disorder | 47.55 | 25.07 | 52 | 23252 | 31250 | 79689834 |
Psychiatric decompensation | 46.91 | 25.07 | 23 | 23281 | 3940 | 79717144 |
Oculogyric crisis | 46.91 | 25.07 | 21 | 23283 | 2931 | 79718153 |
Anxiety | 46.56 | 25.07 | 169 | 23135 | 248343 | 79472741 |
Blood creatine phosphokinase increased | 46.13 | 25.07 | 75 | 23229 | 66015 | 79655069 |
Restlessness | 45.76 | 25.07 | 62 | 23242 | 46430 | 79674654 |
Irritability | 45.34 | 25.07 | 58 | 23246 | 41086 | 79679998 |
Abdominal pain upper | 45.15 | 25.07 | 6 | 23298 | 223813 | 79497271 |
Headache | 44.36 | 25.07 | 77 | 23227 | 653695 | 79067389 |
Nasopharyngitis | 44.24 | 25.07 | 10 | 23294 | 253871 | 79467213 |
Drug intolerance | 42.94 | 25.07 | 12 | 23292 | 264107 | 79456977 |
Asthenia | 42.81 | 25.07 | 52 | 23252 | 511637 | 79209447 |
Pneumonia | 41.91 | 25.07 | 81 | 23223 | 660165 | 79060919 |
Soliloquy | 41.55 | 25.07 | 13 | 23291 | 667 | 79720417 |
Wrong technique in product usage process | 41.30 | 25.07 | 76 | 23228 | 73799 | 79647285 |
Infection | 41.17 | 25.07 | 10 | 23294 | 241702 | 79479382 |
Intentional self-injury | 41.03 | 25.07 | 49 | 23255 | 32370 | 79688714 |
Sepsis | 40.65 | 25.07 | 14 | 23290 | 269414 | 79451670 |
Psychosexual disorder | 40.32 | 25.07 | 9 | 23295 | 120 | 79720964 |
Personality change due to a general medical condition | 39.59 | 25.07 | 10 | 23294 | 232 | 79720852 |
Disease progression | 39.53 | 25.07 | 4 | 23300 | 184358 | 79536726 |
Back pain | 39.16 | 25.07 | 20 | 23284 | 304160 | 79416924 |
Injection site induration | 38.67 | 25.07 | 28 | 23276 | 9791 | 79711293 |
Toxicity to various agents | 37.23 | 25.07 | 41 | 23263 | 421499 | 79299585 |
Substance abuse | 36.93 | 25.07 | 28 | 23276 | 10498 | 79710586 |
Blunted affect | 36.75 | 25.07 | 11 | 23293 | 486 | 79720598 |
Alopecia | 36.70 | 25.07 | 11 | 23293 | 231344 | 79489740 |
Haemoglobin decreased | 36.27 | 25.07 | 10 | 23294 | 222109 | 79498975 |
Salivary hypersecretion | 33.47 | 25.07 | 30 | 23274 | 14194 | 79706890 |
Thinking abnormal | 33.45 | 25.07 | 29 | 23275 | 13132 | 79707952 |
Device malfunction | 33.22 | 25.07 | 36 | 23268 | 21412 | 79699672 |
Extra dose administered | 33.15 | 25.07 | 24 | 23280 | 8391 | 79712693 |
Investigation | 31.94 | 25.07 | 15 | 23289 | 2336 | 79718748 |
Peripheral swelling | 31.44 | 25.07 | 20 | 23284 | 269597 | 79451487 |
Swelling | 31.43 | 25.07 | 12 | 23292 | 216699 | 79504385 |
Urinary tract infection | 31.15 | 25.07 | 21 | 23283 | 274491 | 79446593 |
Flat affect | 30.78 | 25.07 | 14 | 23290 | 2027 | 79719057 |
Contraindicated product administered | 29.97 | 25.07 | 5 | 23299 | 157533 | 79563551 |
Prolactin-producing pituitary tumour | 29.77 | 25.07 | 7 | 23297 | 119 | 79720965 |
Injection site infection | 29.71 | 25.07 | 14 | 23290 | 2198 | 79718886 |
Terminal dribbling | 29.58 | 25.07 | 5 | 23299 | 12 | 79721072 |
Hypertension | 29.42 | 25.07 | 32 | 23272 | 330960 | 79390124 |
Homicidal ideation | 29.21 | 25.07 | 16 | 23288 | 3441 | 79717643 |
Pain in extremity | 28.44 | 25.07 | 39 | 23265 | 364499 | 79356585 |
Neuropathy peripheral | 27.99 | 25.07 | 4 | 23300 | 141301 | 79579783 |
Saccadic eye movement | 27.53 | 25.07 | 7 | 23297 | 167 | 79720917 |
Poor personal hygiene | 27.49 | 25.07 | 9 | 23295 | 535 | 79720549 |
Wrong product administered | 27.34 | 25.07 | 22 | 23282 | 8990 | 79712094 |
Product outer packaging issue | 26.91 | 25.07 | 5 | 23299 | 24 | 79721060 |
Ejaculation failure | 26.65 | 25.07 | 8 | 23296 | 357 | 79720727 |
Adverse event | 26.46 | 25.07 | 56 | 23248 | 60158 | 79660926 |
Decreased appetite | 26.34 | 25.07 | 37 | 23267 | 342381 | 79378703 |
Menstruation irregular | 26.07 | 25.07 | 17 | 23287 | 5019 | 79716065 |
Urticaria | 25.64 | 25.07 | 11 | 23293 | 185190 | 79535894 |
Tension | 25.62 | 25.07 | 16 | 23288 | 4388 | 79716696 |
Treatment failure | 25.46 | 25.07 | 9 | 23295 | 170477 | 79550607 |
Bronchitis | 25.18 | 25.07 | 4 | 23300 | 130640 | 79590444 |
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 |
1.092GM/3.5ML (312MG/ML) | INVEGA HAFYERA | JANSSEN PHARMS | N207946 | Aug. 30, 2021 | RX | SUSPENSION, EXTENDED RELEASE | INTRAMUSCULAR | 11666697 | Nov. 24, 2041 | TREATMENT OF SCHIZOPHRENIA BY ADMINISTRATION OF A SIX-MONTH PALIPERIDONE PALMITATE INJECTABLE SUSPENSION FILLED SYRINGE THAT HAS BEEN SHIPPED AND STORED IN A HORIZONAL POSITION |
1.560GM/5ML (312MG/ML) | INVEGA HAFYERA | JANSSEN PHARMS | N207946 | Aug. 30, 2021 | RX | SUSPENSION, EXTENDED RELEASE | INTRAMUSCULAR | 11666697 | Nov. 24, 2041 | TREATMENT OF SCHIZOPHRENIA BY ADMINISTRATION OF A SIX-MONTH PALIPERIDONE PALMITATE INJECTABLE SUSPENSION FILLED SYRINGE THAT HAS BEEN SHIPPED AND STORED IN A HORIZONAL POSITION |
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 |
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 |