paliperidone palmitate 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definitionDrug idCAS RN
4498 199739-10-1

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • paliperidone palmitate
  • RO92670
  • invega sustenna
A benzisoxazole derivative and active metabolite of RISPERIDONE that functions as a DOPAMINE D2 RECEPTOR ANTAGONIST and SEROTONIN 5-HT2 RECEPTOR ANTAGONIST. It is an ANTIPSYCHOTIC AGENT used in the treatment of SCHIZOPHRENIA.
  • Molecular weight: 664.91
  • Formula: C39H57FN4O4
  • CLOGP: 9.34
  • LIPINSKI: 2
  • HAC: 8
  • HDO: 0
  • TPSA: 88.24
  • ALOGS: -4.98
  • ROTB: 20

  • Status: OFP

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

Drug dosage:

None

ADMET properties:

PropertyValueReference
S (Water solubility) 0.03 mg/mL Bocci G, Oprea TI, Benet LZ

Approvals:

DateAgencyCompanyOrphan
July 31, 2009 FDA JANSSEN PHARMS
Sept. 20, 2013 PMDA JANSSEN PHARMACEUTICAL K.K.

FDA Adverse Event Reporting System (Female)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
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

FDA Adverse Event Reporting System (Male)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
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

FDA Adverse Event Reporting System (Geriatric)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
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

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
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

Drug Use | Suggest Off label Use Form| |View source of the data|

DiseaseRelationSNOMED_IDDOID
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




🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 7.78 Basic
pKa2 1.52 Basic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent 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

Orange Book exclusivity data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
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

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA 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

External reference:

IDSource
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

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
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