vortioxetine 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |

Stem definitionDrug idCAS RN
serotonin and/or norepinephrine reuptake inhibitors, fluoxetine derivatives 4806 508233-74-7

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • vortioxetine-DL-lactate
  • vortioxetine DL-lactate
  • brintellix
  • Lu AA21004
  • vortioxetine
  • vortioxetine hydrobromide
A piperazine derivative that acts as a serotonin reuptake inhibitor, as a 5-HT3 receptor antagonist, and 5-HT1A receptor agonist. It is used for the treatment of anxiety and depression.
  • Molecular weight: 298.45
  • Formula: C18H22N2S
  • CLOGP: 4.72
  • LIPINSKI: 0
  • HAC: 2
  • HDO: 1
  • TPSA: 15.27
  • ALOGS: -4.92
  • ROTB: 3
  • Status: ONP
    • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

DoseUnitRoute
10 mg O

ADMET properties:

PropertyValueReference
Vd (Volume of distribution) 35.30 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 5.80 mL/min/kg Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma) 0.02 % Lombardo F, Berellini G, Obach RS
t_half (Half-life) 72 hours Lombardo F, Berellini G, Obach RS

Predicted pharmacokinetic/toxicological properties (PK-AZ):

PropertyDescriptionValueUnitConfidenceSimilarity
azlogd74 LogD at pH 7.4 3.085 High 1
caco2-efflux Caco-2 efflux ratio (BA/AB) 3.926 High 1
caco2-intrinsic-papp Caco-2 intrinsic apparent permeability 19.907 10^-6 cm/s High 1
dh-clint Dog hepatocyte intrinsic clearance 23.442 uL/min/10^6 cells High 1
dppb Dog plasma protein binding (% unbound) 2 % High 1
fcs-ppb Fetal calf serum protein binding (% unbound) 7.450 % High 1
herg hERG pIC50 5.672 pIC50 High 1
hh-clint Human hepatocyte intrinsic clearance 3.228 uL/min/10^6 cells High 1
hlm-clint Human liver microsomal intrinsic clearance 13.335 uL/min/mg protein High 1
hppb Human plasma protein binding (% unbound) 2.480 % High 1
kinase-safety-class ACVR2A,ACVR2B,AKT1,AKT2,AKT3,AURKA,AXL,BRAF,BTK,CAMK2B,CAMK2D,CDK5,CDK9,CHEK1,DDR1,DYRK1B,EIF2AK3,EPHB4,ERBB2,FLT3,GRK2,ITK,JAK2,JAK3,MAP3K21,MAP3K7,MAPK10,MAPK12,MAPK7,MAPK9,MAPKAPK2,MARK4,MET,MTOR,NTRK2,PDK2,PDK4,PDPK1,PIK3CB,PIM2,PRKCD,PRKDC,SIK2,SIK3,STK33,SYK,TEK,TGFBR1,TTK 49
kinase-selectivity-class AXL,ERBB2,GRK2,PDK4,SIK2,SIK3 6
mdck-mdr1-efflux MDCK-MDR1 efflux ratio 1.871 High 1
mh-clint Mouse hepatocyte intrinsic clearance 105.682 High 1
mppb Mouse plasma protein binding (% unbound) 2.330 High 1
nih-mdck-mdr1-efflux NIH MDCK-MDR1 efflux ratio 7.228 High 1
pfas-class PFAS structural alert (1 = True, 0 = False) 0
pppb Pig plasma protein binding (% unbound) 7.840 % High 1
rh-clint Rat hepatocyte intrinsic clearance 381.066 uL/min/10^6 cells High 1
rh-fuinc Rat hepatocyte fraction unbound in incubation 8.250 % High 1
rppb Rat plasma protein binding (% unbound) 2.740 % High 1
solubility-dd Solubility at pH 7.4 in DMSO 80.353 uM High 1

Approvals:

DateAgencyCompanyOrphan
Sept. 20, 2019 PMDA Takeda Pharmaceutical Company Limited
Sept. 30, 2013 FDA TAKEDA PHARMS USA
Dec. 18, 2013 EMA

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
Suicidal ideation 808.88 16.38 388 22646 73467 90531946
Suicide attempt 402.16 16.38 246 22788 75153 90530260
Nausea 377.71 16.38 851 22183 1109465 89495948
Serotonin syndrome 239.41 16.38 138 22896 37749 90567664
Anxiety 165.20 16.38 288 22746 309484 90295929
Intentional overdose 159.34 16.38 155 22879 93679 90511734
Irritability 156.59 16.38 103 22931 35559 90569854
No adverse event 156.01 16.38 133 22901 67849 90537564
Somnolence 152.05 16.38 224 22810 208860 90396553
Sopor 127.62 16.38 79 22955 24565 90580848
Feeling abnormal 127.09 16.38 183 22851 167052 90438361
Pruritus 124.86 16.38 360 22674 541165 90064248
Reaction to excipient 120.48 16.38 36 22998 1824 90603589
Nightmare 118.51 16.38 72 22962 21653 90583760
Tremor 115.48 16.38 167 22867 153006 90452407
Parkinsonism 112.87 16.38 60 22974 14005 90591408
Sedation 109.99 16.38 94 22940 48077 90557336
Libido increased 105.40 16.38 32 23002 1712 90603701
Urinary retention 101.51 16.38 81 22953 37663 90567750
Mania 101.50 16.38 56 22978 14068 90591345
Anger 97.50 16.38 54 22980 13666 90591747
Peripheral circulatory failure 95.10 16.38 29 23005 1575 90603838
Bradykinesia 93.84 16.38 42 22992 6746 90598667
Product administered to patient of inappropriate age 91.61 16.38 37 22997 4616 90600797
Soft tissue injury 91.54 16.38 30 23004 2062 90603351
Intentional self-injury 89.85 16.38 68 22966 29266 90576147
Hostility 89.09 16.38 30 23004 2243 90603170
Neuroglycopenia 87.29 16.38 25 23009 1090 90604323
Post-traumatic neck syndrome 86.13 16.38 30 23004 2484 90602929
Decompression sickness 83.97 16.38 16 23018 106 90605307
Sternal fracture 82.08 16.38 30 23004 2857 90602556
Blood cholesterol decreased 81.71 16.38 27 23007 1904 90603509
Sexual dysfunction 80.35 16.38 34 23000 4770 90600643
Agitation 80.24 16.38 92 22942 67006 90538407
Inappropriate antidiuretic hormone secretion 79.97 16.38 54 22980 19451 90585962
Joint swelling 78.93 16.38 16 23018 503284 90102129
Depression 77.10 16.38 208 22826 300393 90305020
Wrong technique in product usage process 75.43 16.38 92 22942 71479 90533934
Drug abuse 74.35 16.38 98 22936 82249 90523164
Abnormal dreams 73.73 16.38 42 22992 11215 90594198
Stupor 72.86 16.38 33 23001 5449 90599964
Infusion related reaction 70.21 16.38 11 23023 416769 90188644
Muscle rigidity 69.37 16.38 44 22990 14265 90591148
Glossodynia 69.00 16.38 3 23031 321776 90283637
Crying 68.87 16.38 55 22979 25590 90579823
Initial insomnia 67.13 16.38 37 22997 9273 90596140
Systemic lupus erythematosus 67.11 16.38 7 23027 361889 90243524
Drug intolerance 66.58 16.38 16 23018 447575 90157838
Dementia 65.85 16.38 52 22982 23809 90581604
Hyperhidrosis 63.89 16.38 120 22914 136185 90469228
Muscle twitching 63.07 16.38 51 22983 24151 90581262
Rheumatoid arthritis 62.38 16.38 9 23025 362605 90242808
Completed suicide 62.23 16.38 123 22911 144935 90460478
Electrocardiogram QT prolonged 61.99 16.38 84 22950 72372 90533041
Drug interaction 61.76 16.38 182 22852 276271 90329142
Gastric polyps 61.70 16.38 28 23006 4644 90600769
Arthropathy 60.93 16.38 10 23024 366232 90239181
Akathisia 60.90 16.38 37 22997 11122 90594291
Hallucination 60.32 16.38 79 22955 65880 90539533
Overdose 57.41 16.38 125 22909 157584 90447829
Vertigo 56.81 16.38 79 22955 69732 90535681
Multiple drug therapy 56.51 16.38 30 23004 6979 90598434
Hyponatraemia 55.79 16.38 112 22922 133426 90471987
Dissociation 54.87 16.38 29 23005 6686 90598727
Myoglobinuria 54.72 16.38 14 23020 396 90605017
Product use in unapproved indication 53.26 16.38 197 22837 336039 90269374
Insomnia 52.50 16.38 195 22839 333279 90272134
Swelling 51.57 16.38 21 23013 419037 90186376
Pneumonia 51.29 16.38 52 22982 638007 89967406
Atrioventricular block first degree 51.07 16.38 30 23004 8481 90596932
Hallucination, auditory 51.07 16.38 38 22996 15937 90589476
Middle insomnia 49.46 16.38 38 22996 16713 90588700
Disturbance in attention 48.72 16.38 60 22974 47049 90558364
Pericarditis 48.12 16.38 6 23028 270145 90335268
Blister 47.08 16.38 5 23029 254993 90350420
Hypersensitivity 46.63 16.38 29 23005 454648 90150765
Vomiting 46.09 16.38 350 22684 787943 89817470
Infection 44.78 16.38 18 23016 362076 90243337
Dizziness 44.08 16.38 278 22756 589006 90016407
Concussion 43.78 16.38 30 23004 11061 90594352
Treatment failure 42.99 16.38 12 23022 303916 90301497
Drug hypersensitivity 42.99 16.38 33 23001 463576 90141837
Personality disorder 42.94 16.38 31 23003 12413 90593000
Underdose 42.27 16.38 60 22974 53957 90551456
Restless legs syndrome 41.66 16.38 39 22995 22431 90582982
Feelings of worthlessness 40.68 16.38 11 23023 387 90605026
Psychomotor hyperactivity 39.89 16.38 30 23004 12783 90592630
Hepatic enzyme increased 39.84 16.38 21 23013 360715 90244698
Contraindicated product administered 39.44 16.38 16 23018 320123 90285290
Lower respiratory tract infection 39.18 16.38 8 23026 250651 90354762
Wheezing 38.47 16.38 7 23027 238073 90367340
Drug dependence 38.10 16.38 42 22992 29285 90576128
Body temperature increased 36.97 16.38 51 22983 44659 90560754
Stomatitis 36.76 16.38 12 23022 274686 90330727
Poor quality sleep 36.73 16.38 38 22996 24655 90580758
Cognitive disorder 36.16 16.38 64 22970 69343 90536070
Restlessness 36.14 16.38 45 22989 35675 90569738
Hypoglycaemia 35.87 16.38 64 22970 69784 90535629
Ill-defined disorder 35.78 16.38 3 23031 184888 90420525
Maternal exposure during pregnancy 35.49 16.38 24 23010 360039 90245374
Tachyphrenia 35.08 16.38 14 23020 1692 90603721
C-reactive protein increased 34.95 16.38 3 23031 181386 90424027
Panic attack 34.67 16.38 38 22996 26327 90579086
Hepatic infiltration eosinophilic 34.43 16.38 6 23028 22 90605391
Blood cholesterol increased 33.86 16.38 6 23028 208006 90397407
Dyspnoea 33.22 16.38 114 22920 880841 89724572
Pain 32.36 16.38 137 22897 996204 89609209
Psoriatic arthropathy 32.31 16.38 9 23025 228326 90377087
Dysgeusia 32.06 16.38 52 22982 52508 90552905
Diabetes mellitus inadequate control 31.92 16.38 31 23003 18653 90586760
Anaemia 31.57 16.38 26 23008 352776 90252637
Syncope 31.17 16.38 89 22945 132574 90472839
General physical health deterioration 30.76 16.38 27 23007 355088 90250325
Blood creatine increased 30.27 16.38 20 23014 6947 90598466
Major depression 30.14 16.38 23 23011 10012 90595401
Liver injury 29.85 16.38 4 23030 170563 90434850
Injury 29.41 16.38 7 23027 197342 90408071
Motor dysfunction 29.34 16.38 30 23004 19200 90586213
Discomfort 28.79 16.38 17 23017 274318 90331095
Depressed mood 28.37 16.38 48 22986 50174 90555239
Irritable bowel syndrome 27.86 16.38 9 23025 207439 90397974
Withdrawal syndrome 27.10 16.38 31 23003 22493 90582920
Oedema peripheral 27.04 16.38 16 23018 257899 90347514
Energy increased 26.95 16.38 14 23020 3116 90602297
Mental disorder 26.92 16.38 37 22997 32281 90573132
Dysuria 26.83 16.38 41 22993 39360 90566053
Pain in extremity 26.66 16.38 46 22988 450483 90154930
Tardive dyskinesia 26.31 16.38 22 23012 10908 90594505
Melaena 26.26 16.38 38 22996 34759 90570654
Negative thoughts 26.08 16.38 10 23024 1087 90604326
Hypotonia 25.46 16.38 22 23012 11404 90594009
Labelled drug-drug interaction issue 25.06 16.38 12 23022 2246 90603167
Depressive symptom 24.99 16.38 16 23018 5269 90600144
Thrombocytopenia 24.78 16.38 11 23023 208714 90396699
Rib fracture 24.68 16.38 32 23002 26403 90579010
Adverse drug reaction 24.28 16.38 75 22959 116626 90488787
Hyperaldosteronism 24.06 16.38 7 23027 323 90605090
Constipation 23.90 16.38 137 22897 280258 90325155
Drug screen false positive 23.87 16.38 9 23025 934 90604479
Antipsychotic drug level above therapeutic 23.83 16.38 10 23024 1374 90604039
Bipolar disorder 23.55 16.38 19 23015 8966 90596447
Inflammation 23.53 16.38 8 23026 178584 90426829
Weight increased 23.45 16.38 184 22850 417743 90187670
Migraine 23.27 16.38 103 22931 190289 90415124
Hypersomnia 23.19 16.38 28 23006 21503 90583910
Musculoskeletal stiffness 22.83 16.38 25 23009 296507 90308906
Headache 22.41 16.38 325 22709 862421 89742992
Prescription form tampering 22.33 16.38 8 23026 719 90604694
Type 2 diabetes mellitus 22.17 16.38 12 23022 203232 90402181
Antipsychotic drug level increased 21.83 16.38 13 23021 3766 90601647
Mental impairment 21.81 16.38 24 23010 16696 90588717
Activation syndrome 21.45 16.38 6 23028 240 90605173
Aggression 21.42 16.38 30 23004 26638 90578775
White blood cell count decreased 21.14 16.38 8 23026 167101 90438312
Peripheral swelling 21.11 16.38 46 22988 413060 90192353
Self-injurious ideation 21.10 16.38 12 23022 3191 90602222
Hiatus hernia 21.07 16.38 29 23005 25332 90580081
Embolic stroke 20.94 16.38 13 23021 4059 90601354
Seizure 20.52 16.38 85 22949 152544 90452869
Lymphocytic hypophysitis 20.29 16.38 6 23028 293 90605120
Oedema 20.19 16.38 13 23021 200282 90405131
Product name confusion 20.09 16.38 5 23029 126 90605287
Haemoglobin decreased 20.08 16.38 8 23026 161948 90443465
Sinusitis 19.41 16.38 36 22998 343052 90262361
Osteoarthritis 19.33 16.38 13 23021 195717 90409696
Libido decreased 19.19 16.38 11 23023 2971 90602442
Micturition disorder 19.06 16.38 11 23023 3009 90602404
Anorgasmia 18.89 16.38 7 23027 693 90604720
Fibromyalgia 18.69 16.38 15 23019 206254 90399159
Therapeutic product effect decreased 18.64 16.38 26 23008 277545 90327868
Miosis 18.62 16.38 17 23017 9467 90595946
Coma 18.30 16.38 50 22984 72582 90532831
Drug titration error 18.21 16.38 8 23026 1229 90604184
Polydipsia 18.03 16.38 12 23022 4219 90601194
Hypothermia 18.01 16.38 21 23013 15554 90589859
Cor pulmonale acute 17.92 16.38 6 23028 441 90604972
Febrile neutropenia 17.79 16.38 9 23025 158340 90447073
Tic 17.76 16.38 9 23025 1902 90603511
Malignant neoplasm progression 17.57 16.38 3 23031 106867 90498546
Palpitations 17.48 16.38 75 22959 136653 90468760
Musculoskeletal pain 17.42 16.38 11 23023 171240 90434173
Nervousness 17.22 16.38 31 23003 34025 90571388
Mydriasis 16.96 16.38 20 23014 14992 90590421
Galactorrhoea 16.95 16.38 12 23022 4660 90600753
Acute kidney injury 16.92 16.38 35 22999 320352 90285061
Derealisation 16.81 16.38 8 23026 1477 90603936
Pleural effusion 16.63 16.38 4 23030 111987 90493426
Tinnitus 16.62 16.38 35 22999 43067 90562346

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
Suicidal ideation 404.67 23.21 202 9241 47959 42563933
Completed suicide 234.91 23.21 184 9259 96281 42515611
Erectile dysfunction 158.78 23.21 87 9356 24826 42587066
Sexual dysfunction 141.12 23.21 54 9389 6721 42605171
Serotonin syndrome 123.92 23.21 75 9368 25770 42586122
Dissociation 119.26 23.21 41 9402 3757 42608135
Dystonic tremor 118.60 23.21 25 9418 338 42611554
Suicide attempt 114.22 23.21 89 9354 46011 42565881
Anxiety 98.36 23.21 126 9317 118434 42493458
Nausea 96.39 23.21 246 9197 396553 42215339
Intentional overdose 93.44 23.21 83 9360 51373 42560519
Product use in unapproved indication 76.27 23.21 142 9301 184314 42427578
Restlessness 64.98 23.21 53 9390 29196 42582696
Depressed mood 59.72 23.21 46 9397 23338 42588554
Akathisia 59.72 23.21 34 9409 10417 42601475
Tremor 59.25 23.21 89 9354 96840 42515052
Intentional self-injury 55.10 23.21 37 9406 15165 42596727
Drug interaction 52.02 23.21 153 9290 266846 42345046
Disturbance in attention 51.85 23.21 47 9396 29819 42582073
Agitation 51.11 23.21 67 9376 64247 42547645
Drug ineffective 47.26 23.21 268 9175 629929 41981963
Mania 46.41 23.21 29 9414 10518 42601374
Irritability 46.36 23.21 43 9400 28085 42583807
Abulia 44.92 23.21 13 9430 677 42611215
Negative thoughts 44.34 23.21 13 9430 709 42611183
Dystonia 43.66 23.21 30 9413 12760 42599132
Insomnia 42.61 23.21 86 9357 118167 42493725
Feeling abnormal 42.50 23.21 64 9379 69722 42542170
Thinking abnormal 40.11 23.21 23 9420 7138 42604754
Anorgasmia 38.53 23.21 13 9430 1124 42610768
Urinary retention 38.31 23.21 47 9396 42167 42569725
Feeling of despair 37.76 23.21 13 9430 1195 42610697
Product administered to patient of inappropriate age 37.00 23.21 19 9424 4742 42607150
Depression 36.60 23.21 78 9365 111285 42500607
Libido decreased 35.78 23.21 19 9424 5079 42606813
Neuroleptic malignant syndrome 35.72 23.21 33 9410 21439 42590453
Painful ejaculation 34.50 23.21 8 9435 171 42611721
Sopor 33.76 23.21 26 9417 13176 42598716
Anhedonia 33.60 23.21 21 9422 7619 42604273
Dissociative disorder 32.23 23.21 10 9433 662 42611230
Prescribed overdose 32.06 23.21 25 9418 12902 42598990
Muscle contracture 31.90 23.21 12 9431 1423 42610469
No adverse event 31.52 23.21 41 9402 38980 42572912
Panic attack 31.00 23.21 23 9420 11022 42600870
Febrile neutropenia 30.37 23.21 3 9440 185700 42426192
Tardive dyskinesia 30.36 23.21 19 9424 6905 42604987
Anger 29.76 23.21 24 9419 12994 42598898
Arterial disorder 29.43 23.21 11 9432 1281 42610611
Pneumonia 28.51 23.21 31 9412 422118 42189774
Underdose 28.47 23.21 26 9417 16640 42595252
Pyrexia 27.65 23.21 28 9415 394014 42217878
Reduced facial expression 27.60 23.21 11 9432 1522 42610370
Depressive symptom 26.03 23.21 14 9429 3839 42608053
Self esteem decreased 26.01 23.21 8 9435 514 42611378
Starvation 25.80 23.21 8 9435 528 42611364
Death 25.29 23.21 41 9402 471144 42140748
Vomiting 24.75 23.21 128 9315 289595 42322297
Apathy 24.71 23.21 18 9425 8388 42603504
Central pain syndrome 24.68 23.21 6 9437 158 42611734
Mental impairment 24.60 23.21 21 9422 12296 42599596
Reaction to excipient 24.14 23.21 8 9435 654 42611238
Poisoning 23.30 23.21 22 9421 14677 42597215
Dyspnoea 23.29 23.21 39 9404 442582 42169310

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
Suicidal ideation 934.51 16.96 458 26871 93479 110468491
Suicide attempt 446.19 16.96 292 27037 103102 110458868
Serotonin syndrome 325.41 16.96 195 27134 58958 110503012
Nausea 240.33 16.96 758 26571 1234932 109327038
Completed suicide 217.26 16.96 283 27046 242098 110319872
Intentional overdose 215.45 16.96 211 27118 132290 110429680
Anxiety 194.82 16.96 324 27005 344754 110217216
Sopor 161.79 16.96 105 27224 36441 110525529
Irritability 160.99 16.96 116 27213 47693 110514277
Dissociation 147.79 16.96 64 27265 9778 110552192
Sexual dysfunction 139.75 16.96 59 27270 8471 110553499
Somnolence 133.81 16.96 253 27076 297196 110264774
Tremor 127.75 16.96 200 27129 202032 110359938
Intentional self-injury 124.14 16.96 90 27239 37339 110524631
Sedation 122.67 16.96 116 27213 69567 110492403
Dystonic tremor 120.52 16.96 26 27303 351 110561619
Product administered to patient of inappropriate age 119.82 16.96 52 27277 7984 110553986
Urinary retention 118.87 16.96 114 27215 69569 110492401
Erectile dysfunction 117.34 16.96 67 27262 18489 110543481
Drug interaction 107.75 16.96 319 27010 499864 110062106
Feeling abnormal 100.86 16.96 169 27160 180542 110381428
Parkinsonism 96.36 16.96 63 27266 22124 110539846
Product use in unapproved indication 96.00 16.96 285 27044 447092 110114878
Libido increased 94.46 16.96 32 27297 2507 110559463
Peripheral circulatory failure 92.30 16.96 29 27300 1790 110560180
Akathisia 90.37 16.96 55 27274 17058 110544912
Restlessness 90.24 16.96 89 27240 56170 110505800
Soft tissue injury 89.88 16.96 30 27299 2246 110559724
Inappropriate antidiuretic hormone secretion 89.28 16.96 71 27258 33780 110528190
Mania 87.76 16.96 58 27271 20738 110541232
Neuroglycopenia 87.74 16.96 25 27304 1101 110560869
Bradykinesia 87.71 16.96 46 27283 10742 110551228
Post-traumatic neck syndrome 86.02 16.96 30 27299 2565 110559405
Hostility 84.90 16.96 30 27299 2666 110559304
Agitation 83.00 16.96 120 27209 112931 110449039
Depression 82.64 16.96 217 27112 317118 110244852
Sternal fracture 78.84 16.96 30 27299 3286 110558684
Decompression sickness 77.94 16.96 15 27314 109 110561861
Disturbance in attention 77.78 16.96 86 27243 61909 110500061
Insomnia 77.56 16.96 230 27099 360360 110201610
Nightmare 76.73 16.96 69 27260 38794 110523176
Blood cholesterol decreased 73.44 16.96 27 27302 2689 110559281
Initial insomnia 69.70 16.96 39 27290 10350 110551620
Anger 68.30 16.96 48 27281 18959 110543011
Underdose 66.02 16.96 80 27249 63474 110498496
Pneumonia 64.62 16.96 73 27256 876641 109685329
Pruritus 64.21 16.96 299 27030 581261 109980709
Hyperhidrosis 63.64 16.96 142 27187 187156 110374814
Drug intolerance 63.10 16.96 12 27317 406500 110155470
Negative thoughts 62.24 16.96 21 27308 1625 110560345
Drug abuse 61.96 16.96 136 27193 177275 110384695
Stupor 60.88 16.96 33 27296 8232 110553738
Dizziness 58.97 16.96 333 26996 697860 109864110
Gastric polyps 57.97 16.96 28 27301 5495 110556475
Joint swelling 57.32 16.96 19 27310 442826 110119144
Hyponatraemia 56.77 16.96 149 27180 217504 110344466
Hallucination 56.73 16.96 95 27234 101337 110460633
Coma 56.32 16.96 103 27226 117766 110444204
Abulia 54.62 16.96 18 27311 1295 110560675
Depressed mood 54.34 16.96 71 27258 60738 110501232
Electrocardiogram QT prolonged 54.33 16.96 97 27232 108863 110453107
Muscle rigidity 54.14 16.96 46 27283 23985 110537985
Infusion related reaction 53.62 16.96 14 27315 381148 110180822
Multiple drug therapy 53.53 16.96 30 27299 7984 110553986
Crying 51.57 16.96 46 27283 25582 110536388
Systemic lupus erythematosus 50.79 16.96 3 27326 254335 110307635
Vertigo 50.78 16.96 83 27246 86787 110475183
Feelings of worthlessness 50.05 16.96 14 27315 576 110561394
Drug hypersensitivity 49.82 16.96 25 27304 454065 110107905
Dystonia 49.33 16.96 45 27284 25760 110536210
Panic attack 48.67 16.96 47 27282 28893 110533077
Concussion 48.24 16.96 32 27297 11506 110550464
Anaemia 47.88 16.96 39 27290 547047 110014923
Personality disorder 47.48 16.96 33 27296 12804 110549166
Muscle twitching 47.33 16.96 47 27282 29888 110532082
Hallucination, auditory 46.54 16.96 44 27285 26353 110535617
Anhedonia 46.43 16.96 35 27294 15393 110546577
Wound 46.11 16.96 3 27326 234434 110327536
Arthropathy 45.65 16.96 8 27321 287514 110274456
Abnormal dreams 45.28 16.96 32 27297 12748 110549222
Dementia 45.11 16.96 47 27282 31626 110530344
Stomatitis 44.06 16.96 7 27322 270235 110291735
Febrile neutropenia 43.86 16.96 12 27317 316755 110245215
Glossodynia 43.19 16.96 3 27326 222001 110339969
Dyspnoea 42.85 16.96 136 27193 1106736 109455234
Poor quality sleep 42.40 16.96 43 27286 28034 110533936
Rheumatoid arthritis 42.14 16.96 11 27318 299602 110262368
Libido decreased 41.78 16.96 23 27306 5912 110556058
No adverse event 41.07 16.96 69 27260 73770 110488200
Swelling 40.53 16.96 18 27311 351023 110210947
Mental impairment 40.41 16.96 38 27291 22601 110539369
Myoglobinuria 39.95 16.96 14 27315 1214 110560756
Middle insomnia 39.68 16.96 36 27293 20466 110541504
Anorgasmia 39.52 16.96 15 27314 1631 110560339
Haemoglobin decreased 39.31 16.96 7 27322 248720 110313250
Tardive dyskinesia 39.09 16.96 30 27299 13549 110548421
Hypersensitivity 38.96 16.96 26 27303 403972 110157998
Ocular discomfort 38.94 16.96 25 27304 8508 110553462
Mental disorder 38.94 16.96 48 27281 38743 110523227
Wrong technique in product usage process 38.81 16.96 74 27255 87274 110474696
Wheezing 38.61 16.96 8 27321 255222 110306748
Psychomotor hyperactivity 38.06 16.96 35 27294 20242 110541728
Atrioventricular block first degree 37.85 16.96 30 27299 14195 110547775
Restless legs syndrome 37.71 16.96 38 27291 24588 110537382
Painful ejaculation 37.58 16.96 8 27321 101 110561869
Amaurosis fugax 37.38 16.96 16 27313 2374 110559596
Blister 36.81 16.96 6 27323 227370 110334600
Overdose 36.61 16.96 134 27195 233660 110328310
Death 36.17 16.96 74 27255 698795 109863175
Lower respiratory tract infection 36.00 16.96 8 27321 243098 110318872
Vomiting 35.95 16.96 363 26966 910312 109651658
Antipsychotic drug level increased 35.64 16.96 22 27307 6993 110554977
Feeling guilty 35.50 16.96 12 27317 934 110561036
Oedema peripheral 34.69 16.96 19 27310 328641 110233329
Depressive symptom 34.37 16.96 23 27306 8391 110553579
Infection 34.00 16.96 24 27305 362176 110199794
Altered state of consciousness 33.59 16.96 55 27274 57571 110504399
Hepatic enzyme increased 33.22 16.96 19 27310 320873 110241097
Bipolar disorder 32.95 16.96 23 27306 8984 110552986
Pericarditis 32.87 16.96 7 27322 219107 110342863
General physical health deterioration 32.82 16.96 34 27295 425261 110136709
Cognitive disorder 32.72 16.96 69 27260 87442 110474528
C-reactive protein increased 32.61 16.96 7 27322 217912 110344058
Motor dysfunction 32.59 16.96 35 27294 24371 110537599
Syncope 32.48 16.96 117 27212 202419 110359551
Disease progression 32.38 16.96 10 27319 244024 110317946
Dissociative disorder 32.22 16.96 12 27317 1239 110560731
Labelled drug-drug interaction issue 31.96 16.96 17 27312 4084 110557886
Major depression 31.75 16.96 24 27305 10597 110551373
Tachycardia 31.45 16.96 125 27204 226520 110335450
Tachyphrenia 31.11 16.96 14 27315 2342 110559628
Poisoning deliberate 30.41 16.96 35 27294 26296 110535674
Feeling of despair 30.32 16.96 16 27313 3782 110558188
Tinnitus 30.30 16.96 54 27275 60486 110501484
Self esteem decreased 30.21 16.96 11 27318 1066 110560904
Thinking abnormal 30.11 16.96 27 27302 15113 110546857
Malignant neoplasm progression 29.66 16.96 4 27325 174563 110387407
Body temperature increased 28.94 16.96 50 27279 54663 110507307
Pain in extremity 28.34 16.96 48 27281 487070 110074900
Haemorrhagic stroke 28.24 16.96 25 27304 13764 110548206
Activation syndrome 27.65 16.96 8 27321 372 110561598
Drug dependence 26.83 16.96 46 27283 49974 110511996
Cardiac failure congestive 26.78 16.96 3 27326 150997 110410973
Drug ineffective 26.76 16.96 525 26804 1520015 109041955
Headache 26.72 16.96 334 26995 882043 109679927
Lung disorder 26.50 16.96 6 27323 180041 110381929
Pleural effusion 26.00 16.96 6 27323 177703 110384267
Dysgeusia 25.95 16.96 55 27274 69930 110492040
Muscle contracture 25.79 16.96 13 27316 2795 110559175
Thrombocytopenia 25.68 16.96 29 27300 348856 110213114
Withdrawal syndrome 25.52 16.96 35 27294 31345 110530625
Bradyphrenia 25.50 16.96 22 27307 11706 110550264
Inflammation 25.49 16.96 8 27321 193230 110368740
White blood cell count decreased 24.58 16.96 13 27316 229377 110332593
Urinary tract disorder 23.93 16.96 16 27313 5828 110556142
Hypersomnia 23.88 16.96 32 27297 28029 110533941
Acute kidney injury 23.87 16.96 79 27250 635351 109926619
Oedema 23.86 16.96 11 27318 209965 110352005
Blood creatine increased 23.82 16.96 21 27308 11500 110550470
Pyrexia 23.67 16.96 128 27201 898137 109663833
Ill-defined disorder 23.54 16.96 5 27324 156848 110405122
Starvation 23.41 16.96 9 27320 1014 110560956
Migraine 23.26 16.96 94 27235 171558 110390412
Weight increased 23.07 16.96 180 27149 419464 110142506
Apathy 22.95 16.96 24 27305 16215 110545755
Psoriatic arthropathy 22.84 16.96 10 27319 196751 110365219
Arterial disorder 22.54 16.96 11 27318 2208 110559762
Energy increased 22.51 16.96 13 27316 3661 110558309
Diabetes mellitus inadequate control 22.41 16.96 32 27297 29743 110532227
Hyperprolactinaemia 22.22 16.96 16 27313 6559 110555411
Rib fracture 22.12 16.96 34 27295 33736 110528234
Blood cholesterol increased 22.07 16.96 9 27320 184776 110377194
Melaena 22.07 16.96 51 27278 68706 110493264
Neuroleptic malignant syndrome 21.90 16.96 34 27295 34025 110527945
Pain 21.51 16.96 143 27186 954812 109607158
Irritable bowel syndrome 21.30 16.96 7 27322 164208 110397762
Hiatus hernia 21.26 16.96 30 27299 27576 110534394
Prescription form tampering 21.10 16.96 7 27322 514 110561456
Hallucination, visual 20.69 16.96 36 27293 39569 110522401
Peripheral swelling 20.68 16.96 43 27286 403991 110157979
Therapeutic product effect decreased 20.63 16.96 18 27311 244298 110317672
Injury 20.59 16.96 9 27320 177256 110384714
Self-injurious ideation 20.49 16.96 13 27316 4333 110557637
Diplopia 20.49 16.96 37 27292 41857 110520113
Sinusitis 20.41 16.96 26 27303 296662 110265308
Social avoidant behaviour 20.32 16.96 14 27315 5355 110556615
Maternal exposure during pregnancy 20.08 16.96 20 27309 254863 110307107
Hypotonia 20.01 16.96 22 27307 15723 110546247
Septic shock 19.94 16.96 7 27322 157521 110404449
Derealisation 19.85 16.96 10 27319 2148 110559822
Micturition disorder 19.57 16.96 13 27316 4685 110557285
Hyperaldosteronism 19.53 16.96 7 27322 648 110561322
Feeling jittery 19.46 16.96 21 27308 14701 110547269
Hypothermia 19.40 16.96 28 27301 26274 110535696
Hypoglycaemia 19.40 16.96 68 27261 116036 110445934
Lymphocytic hypophysitis 19.15 16.96 7 27322 686 110561284
Antipsychotic drug level above therapeutic 18.69 16.96 10 27319 2430 110559540
Obsessive-compulsive disorder 18.69 16.96 15 27314 7226 110554744
Poisoning 18.64 16.96 29 27300 29076 110532894
Dysuria 18.59 16.96 44 27285 60187 110501783
Dyskinesia 18.58 16.96 40 27289 51406 110510564
Aggression 18 16.96 43 27286 59167 110502803
Adverse drug reaction 17.79 16.96 62 27267 105497 110456473
Type 2 diabetes mellitus 17.62 16.96 11 27318 177221 110384749
Drug use disorder 17.55 16.96 22 27307 18052 110543918
Extrapyramidal disorder 17.43 16.96 28 27301 28839 110533131
Neutropenia 17.43 16.96 42 27287 374578 110187392
Osteoarthritis 17.25 16.96 12 27317 182611 110379359
Fall 17.19 16.96 226 27103 603256 109958714

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC N06AX26 NERVOUS SYSTEM
PSYCHOANALEPTICS
ANTIDEPRESSANTS
Other antidepressants
MeSH PA D000928 Antidepressive Agents
MeSH PA D002492 Central Nervous System Depressants
MeSH PA D011619 Psychotropic Drugs
MeSH PA D012702 Serotonin Antagonists
MeSH PA D014151 Anti-Anxiety Agents
MeSH PA D014179 Neurotransmitter Uptake Inhibitors
MeSH PA D017366 Serotonin Receptor Agonists
MeSH PA D017367 Selective Serotonin Reuptake Inhibitors
MeSH PA D018377 Neurotransmitter Agents
MeSH PA D018490 Serotonin Agents
MeSH PA D049990 Membrane Transport Modulators
MeSH PA D058825 Serotonin 5-HT1 Receptor Agonists
MeSH PA D058831 Serotonin 5-HT3 Receptor Antagonists
CHEBI has role CHEBI:35469 antidepressant
CHEBI has role CHEBI:35474 anxiolytic drug
CHEBI has role CHEBI:35941 serotonergic agonist
CHEBI has role CHEBI:48279 serotonergic antagonist
CHEBI has role CHEBI:35476 antipsychotic agent

Related Drugs by ATC class:

N06AX Other antidepressants 28 drugs
agomelatinebifemelanebrexanolonebupropiondesvenlafaxinedextromethorphanduloxetineesketaminegepironelevomilnacipranmedifoxaminemianserin show all 28 →

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

DiseaseRelationSNOMED_IDDOID
Major depressive disorder indication 370143000
Monoamine oxidase inhibitors contraindication




🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 9.02 Basic
pKa2 1.85 Basic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
EQ 10MG BASE TRINTELLIX TAKEDA PHARMS USA N204447 Sept. 30, 2013 RX TABLET ORAL 7144884 June 17, 2026 METHOD OF TREATING AN AFFECTIVE DISORDER SUCH AS DEPRESSION
EQ 15MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TRINTELLIX TAKEDA PHARMS USA N204447 Sept. 30, 2013 DISCN TABLET ORAL 7144884 June 17, 2026 METHOD OF TREATING AN AFFECTIVE DISORDER SUCH AS DEPRESSION
EQ 20MG BASE TRINTELLIX TAKEDA PHARMS USA N204447 Sept. 30, 2013 RX TABLET ORAL 7144884 June 17, 2026 METHOD OF TREATING AN AFFECTIVE DISORDER SUCH AS DEPRESSION
EQ 5MG BASE TRINTELLIX TAKEDA PHARMS USA N204447 Sept. 30, 2013 RX TABLET ORAL 7144884 June 17, 2026 METHOD OF TREATING AN AFFECTIVE DISORDER SUCH AS DEPRESSION
EQ 10MG BASE TRINTELLIX TAKEDA PHARMS USA N204447 Sept. 30, 2013 RX TABLET ORAL 11458134 June 15, 2027 USE OF TRINTELLIX FOR THE TREATMENT OF MAJOR DEPRESSIVE DISORDER (MDD) IN ADULTS
EQ 10MG BASE TRINTELLIX TAKEDA PHARMS USA N204447 Sept. 30, 2013 RX TABLET ORAL 8969355 June 15, 2027 METHOD OF TREATING DEPRESSION OR MAJOR DEPRESSIVE DISORDER
EQ 10MG BASE TRINTELLIX TAKEDA PHARMS USA N204447 Sept. 30, 2013 RX TABLET ORAL 9125908 June 15, 2027 USE IN THE TREATMENT OF MAJOR DEPRESSIVE DISORDER TO IMPROVE PROCESSING SPEED, AN ASPECT OF COGNITIVE FUNCTION
EQ 10MG BASE TRINTELLIX TAKEDA PHARMS USA N204447 Sept. 30, 2013 RX TABLET ORAL 9125909 June 15, 2027 USE IN THE TREATMENT OF MAJOR DEPRESSIVE DISORDER TO IMPROVE PROCESSING SPEED, AN ASPECT OF COGNITIVE FUNCTION
EQ 10MG BASE TRINTELLIX TAKEDA PHARMS USA N204447 Sept. 30, 2013 RX TABLET ORAL 9125910 June 15, 2027 USE IN THE TREATMENT OF MAJOR DEPRESSIVE DISORDER TO IMPROVE PROCESSING SPEED, AN ASPECT OF COGNITIVE FUNCTION
EQ 10MG BASE TRINTELLIX TAKEDA PHARMS USA N204447 Sept. 30, 2013 RX TABLET ORAL 9227946 June 15, 2027 METHOD OF TREATING DEPRESSION OR MAJOR DEPRESSIVE DISORDER
EQ 10MG BASE TRINTELLIX TAKEDA PHARMS USA N204447 Sept. 30, 2013 RX TABLET ORAL 9861630 June 15, 2027 METHOD OF TREATING DEPRESSION OR MAJOR DEPRESSIVE DISORDER
EQ 15MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TRINTELLIX TAKEDA PHARMS USA N204447 Sept. 30, 2013 DISCN TABLET ORAL 11458134 June 15, 2027 USE OF TRINTELLIX FOR THE TREATMENT OF MAJOR DEPRESSIVE DISORDER (MDD) IN ADULTS
EQ 15MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TRINTELLIX TAKEDA PHARMS USA N204447 Sept. 30, 2013 DISCN TABLET ORAL 8969355 June 15, 2027 METHOD OF TREATING DEPRESSION OR MAJOR DEPRESSIVE DISORDER
EQ 15MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TRINTELLIX TAKEDA PHARMS USA N204447 Sept. 30, 2013 DISCN TABLET ORAL 9125908 June 15, 2027 USE IN THE TREATMENT OF MAJOR DEPRESSIVE DISORDER TO IMPROVE PROCESSING SPEED, AN ASPECT OF COGNITIVE FUNCTION
EQ 15MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TRINTELLIX TAKEDA PHARMS USA N204447 Sept. 30, 2013 DISCN TABLET ORAL 9125909 June 15, 2027 USE IN THE TREATMENT OF MAJOR DEPRESSIVE DISORDER TO IMPROVE PROCESSING SPEED, AN ASPECT OF COGNITIVE FUNCTION
EQ 15MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TRINTELLIX TAKEDA PHARMS USA N204447 Sept. 30, 2013 DISCN TABLET ORAL 9125910 June 15, 2027 USE IN THE TREATMENT OF MAJOR DEPRESSIVE DISORDER TO IMPROVE PROCESSING SPEED, AN ASPECT OF COGNITIVE FUNCTION
EQ 15MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TRINTELLIX TAKEDA PHARMS USA N204447 Sept. 30, 2013 DISCN TABLET ORAL 9227946 June 15, 2027 METHOD OF TREATING DEPRESSION OR MAJOR DEPRESSIVE DISORDER
EQ 15MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TRINTELLIX TAKEDA PHARMS USA N204447 Sept. 30, 2013 DISCN TABLET ORAL 9861630 June 15, 2027 METHOD OF TREATING DEPRESSION OR MAJOR DEPRESSIVE DISORDER
EQ 20MG BASE TRINTELLIX TAKEDA PHARMS USA N204447 Sept. 30, 2013 RX TABLET ORAL 11458134 June 15, 2027 USE OF TRINTELLIX FOR THE TREATMENT OF MAJOR DEPRESSIVE DISORDER (MDD) IN ADULTS
EQ 20MG BASE TRINTELLIX TAKEDA PHARMS USA N204447 Sept. 30, 2013 RX TABLET ORAL 8969355 June 15, 2027 METHOD OF TREATING DEPRESSION OR MAJOR DEPRESSIVE DISORDER
EQ 20MG BASE TRINTELLIX TAKEDA PHARMS USA N204447 Sept. 30, 2013 RX TABLET ORAL 9125908 June 15, 2027 USE IN THE TREATMENT OF MAJOR DEPRESSIVE DISORDER TO IMPROVE PROCESSING SPEED, AN ASPECT OF COGNITIVE FUNCTION
EQ 20MG BASE TRINTELLIX TAKEDA PHARMS USA N204447 Sept. 30, 2013 RX TABLET ORAL 9125909 June 15, 2027 USE IN THE TREATMENT OF MAJOR DEPRESSIVE DISORDER TO IMPROVE PROCESSING SPEED, AN ASPECT OF COGNITIVE FUNCTION
EQ 20MG BASE TRINTELLIX TAKEDA PHARMS USA N204447 Sept. 30, 2013 RX TABLET ORAL 9125910 June 15, 2027 USE IN THE TREATMENT OF MAJOR DEPRESSIVE DISORDER TO IMPROVE PROCESSING SPEED, AN ASPECT OF COGNITIVE FUNCTION
EQ 20MG BASE TRINTELLIX TAKEDA PHARMS USA N204447 Sept. 30, 2013 RX TABLET ORAL 9227946 June 15, 2027 METHOD OF TREATING DEPRESSION OR MAJOR DEPRESSIVE DISORDER
EQ 20MG BASE TRINTELLIX TAKEDA PHARMS USA N204447 Sept. 30, 2013 RX TABLET ORAL 9861630 June 15, 2027 METHOD OF TREATING DEPRESSION OR MAJOR DEPRESSIVE DISORDER
EQ 5MG BASE TRINTELLIX TAKEDA PHARMS USA N204447 Sept. 30, 2013 RX TABLET ORAL 11458134 June 15, 2027 USE OF TRINTELLIX FOR THE TREATMENT OF MAJOR DEPRESSIVE DISORDER (MDD) IN ADULTS
EQ 5MG BASE TRINTELLIX TAKEDA PHARMS USA N204447 Sept. 30, 2013 RX TABLET ORAL 8969355 June 15, 2027 METHOD OF TREATING DEPRESSION OR MAJOR DEPRESSIVE DISORDER
EQ 5MG BASE TRINTELLIX TAKEDA PHARMS USA N204447 Sept. 30, 2013 RX TABLET ORAL 9125908 June 15, 2027 USE IN THE TREATMENT OF MAJOR DEPRESSIVE DISORDER TO IMPROVE PROCESSING SPEED, AN ASPECT OF COGNITIVE FUNCTION
EQ 5MG BASE TRINTELLIX TAKEDA PHARMS USA N204447 Sept. 30, 2013 RX TABLET ORAL 9125909 June 15, 2027 USE IN THE TREATMENT OF MAJOR DEPRESSIVE DISORDER TO IMPROVE PROCESSING SPEED, AN ASPECT OF COGNITIVE FUNCTION
EQ 5MG BASE TRINTELLIX TAKEDA PHARMS USA N204447 Sept. 30, 2013 RX TABLET ORAL 9125910 June 15, 2027 USE IN THE TREATMENT OF MAJOR DEPRESSIVE DISORDER TO IMPROVE PROCESSING SPEED, AN ASPECT OF COGNITIVE FUNCTION
EQ 5MG BASE TRINTELLIX TAKEDA PHARMS USA N204447 Sept. 30, 2013 RX TABLET ORAL 9227946 June 15, 2027 METHOD OF TREATING DEPRESSION OR MAJOR DEPRESSIVE DISORDER
EQ 5MG BASE TRINTELLIX TAKEDA PHARMS USA N204447 Sept. 30, 2013 RX TABLET ORAL 9861630 June 15, 2027 METHOD OF TREATING DEPRESSION OR MAJOR DEPRESSIVE DISORDER
EQ 10MG BASE TRINTELLIX TAKEDA PHARMS USA N204447 Sept. 30, 2013 RX TABLET ORAL 9278096 March 21, 2032 USE IN THE TREATMENT OF MAJOR DEPRESSIVE DISORDER TO IMPROVE TREATMENT EMERGENT SEXUAL DYSFUNCTION (TESD) INDUCED BY PRIOR SEROTONIN REUPTAKE INHIBITOR TREATMENT
EQ 15MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TRINTELLIX TAKEDA PHARMS USA N204447 Sept. 30, 2013 DISCN TABLET ORAL 9278096 March 21, 2032 USE IN THE TREATMENT OF MAJOR DEPRESSIVE DISORDER TO IMPROVE TREATMENT EMERGENT SEXUAL DYSFUNCTION (TESD) INDUCED BY PRIOR SEROTONIN REUPTAKE INHIBITOR TREATMENT
EQ 20MG BASE TRINTELLIX TAKEDA PHARMS USA N204447 Sept. 30, 2013 RX TABLET ORAL 9278096 March 21, 2032 USE IN THE TREATMENT OF MAJOR DEPRESSIVE DISORDER TO IMPROVE TREATMENT EMERGENT SEXUAL DYSFUNCTION (TESD) INDUCED BY PRIOR SEROTONIN REUPTAKE INHIBITOR TREATMENT
EQ 5MG BASE TRINTELLIX TAKEDA PHARMS USA N204447 Sept. 30, 2013 RX TABLET ORAL 9278096 March 21, 2032 USE IN THE TREATMENT OF MAJOR DEPRESSIVE DISORDER TO IMPROVE TREATMENT EMERGENT SEXUAL DYSFUNCTION (TESD) INDUCED BY PRIOR SEROTONIN REUPTAKE INHIBITOR TREATMENT

Orange Book exclusivity data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
EQ 10MG BASE TRINTELLIX TAKEDA PHARMS USA N204447 Sept. 30, 2013 RX TABLET ORAL Aug. 23, 2026 INFORMATION ADDED TO SECTION 8.4 OF THE LABELING TO DESCRIBE THE RESULTS FROM PEDIATRIC STUDIES
EQ 15MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TRINTELLIX TAKEDA PHARMS USA N204447 Sept. 30, 2013 DISCN TABLET ORAL Aug. 23, 2026 INFORMATION ADDED TO SECTION 8.4 OF THE LABELING TO DESCRIBE THE RESULTS FROM PEDIATRIC STUDIES
EQ 20MG BASE TRINTELLIX TAKEDA PHARMS USA N204447 Sept. 30, 2013 RX TABLET ORAL Aug. 23, 2026 INFORMATION ADDED TO SECTION 8.4 OF THE LABELING TO DESCRIBE THE RESULTS FROM PEDIATRIC STUDIES
EQ 5MG BASE TRINTELLIX TAKEDA PHARMS USA N204447 Sept. 30, 2013 RX TABLET ORAL Aug. 23, 2026 INFORMATION ADDED TO SECTION 8.4 OF THE LABELING TO DESCRIBE THE RESULTS FROM PEDIATRIC STUDIES
EQ 10MG BASE TRINTELLIX TAKEDA PHARMS USA N204447 Sept. 30, 2013 RX TABLET ORAL Feb. 23, 2027 PEDIATRIC EXCLUSIVITY
EQ 15MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TRINTELLIX TAKEDA PHARMS USA N204447 Sept. 30, 2013 DISCN TABLET ORAL Feb. 23, 2027 PEDIATRIC EXCLUSIVITY
EQ 20MG BASE TRINTELLIX TAKEDA PHARMS USA N204447 Sept. 30, 2013 RX TABLET ORAL Feb. 23, 2027 PEDIATRIC EXCLUSIVITY
EQ 5MG BASE TRINTELLIX TAKEDA PHARMS USA N204447 Sept. 30, 2013 RX TABLET ORAL Feb. 23, 2027 PEDIATRIC EXCLUSIVITY

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])		Mechanism
action		Bioact sourceMoA source
Sodium-dependent serotonin transporter Transporter INHIBITOR Ki 8.80 SCIENTIFIC LITERATURE SCIENTIFIC LITERATURE
5-hydroxytryptamine receptor 1A GPCR AGONIST Ki 7.82 SCIENTIFIC LITERATURE SCIENTIFIC LITERATURE
5-hydroxytryptamine receptor 7 GPCR ANTAGONIST Ki 7.72 SCIENTIFIC LITERATURE SCIENTIFIC LITERATURE
5-hydroxytryptamine receptor 1B GPCR AGONIST Ki 7.48 SCIENTIFIC LITERATURE SCIENTIFIC LITERATURE
5-hydroxytryptamine receptor 3A Ion channel ANTAGONIST Ki 8.43 SCIENTIFIC LITERATURE SCIENTIFIC LITERATURE
5-hydroxytryptamine receptor 1D GPCR ANTAGONIST Ki 7.27 DRUG LABEL DRUG LABEL
5-hydroxytryptamine receptor 6 GPCR Ki 6.48 CHEMBL
Histamine H1 receptor GPCR Ki 6.74 CHEMBL
Histamine H2 receptor GPCR Ki 6.74 CHEMBL
5-hydroxytryptamine receptor 5A GPCR Ki 6.66 CHEMBL
Beta-1 adrenergic receptor GPCR Ki 7.34 CHEMBL
Beta-2 adrenergic receptor GPCR Ki 6.25 CHEMBL
Prostaglandin G/H synthase 2 Enzyme IC50 8.51 CHEMBL
Prostaglandin G/H synthase 1 Enzyme IC50 8.29 CHEMBL
5-hydroxytryptamine receptor 2A GPCR Ki 6.74 CHEMBL
5-hydroxytryptamine receptor 2C GPCR Ki 6.74 CHEMBL
Sodium-dependent dopamine transporter Transporter IC50 6.05 CHEMBL
5-hydroxytryptamine receptor 3A Ion channel Ki 6.64 CHEMBL
5-hydroxytryptamine receptor 1D GPCR ANTAGONIST IC50 5.40 IUPHAR
5-hydroxytryptamine receptor 7 GPCR Ki 6.70 SCIENTIFIC LITERATURE
Sodium-dependent serotonin transporter Transporter IC50 8.28 CHEMBL

External reference:

IDSource
3O2K1S3WQV UNII
D10184 KEGG_DRUG
1253056-29-9 SECONDARY_CAS_RN
960203-27-4 SECONDARY_CAS_RN
4032784 VANDF
C3661282 UMLSCUI
CHEBI:76016 CHEBI
VTX PDB_CHEM_ID
CHEMBL2104993 ChEMBL_ID
9966051 PUBCHEM_CID
DB09068 DRUGBANK_ID
CHEMBL2107387 ChEMBL_ID
D000078784 MESH_DESCRIPTOR_UI
9279 INN_ID
7351 IUPHAR_LIGAND_ID
1439824 RXNORM
206222 MMSL
235694 MMSL
29689 MMSL
d08125 MMSL
015226 NDDF
015227 NDDF
708717008 SNOMEDCT_US
712748004 SNOMEDCT_US
768282000 SNOMEDCT_US
3O2K1S3WQV INXIGHT DRUGS

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Trintellix HUMAN PRESCRIPTION DRUG LABEL 1 55154-0256 TABLET, FILM COATED 10 mg ORAL NDA 30 sections
Trintellix HUMAN PRESCRIPTION DRUG LABEL 1 55154-0257 TABLET, FILM COATED 20 mg ORAL NDA 30 sections
Trintellix HUMAN PRESCRIPTION DRUG LABEL 1 64764-720 TABLET, FILM COATED 5 mg ORAL NDA 30 sections
Trintellix HUMAN PRESCRIPTION DRUG LABEL 1 64764-730 TABLET, FILM COATED 10 mg ORAL NDA 30 sections
Trintellix HUMAN PRESCRIPTION DRUG LABEL 1 64764-750 TABLET, FILM COATED 20 mg ORAL NDA 30 sections
Trintellix HUMAN PRESCRIPTION DRUG LABEL 1 70518-4284 TABLET, FILM COATED 10 mg ORAL NDA 29 sections
Trintellix HUMAN PRESCRIPTION DRUG LABEL 1 70518-4483 TABLET, FILM COATED 5 mg ORAL NDA 29 sections