atomoxetine ๐Ÿถ 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 256 83015-26-3

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • LY139603
  • strattera
  • atomoxetine
  • tomoxetine
  • (-)-Tomoxetine
  • atomoxetine hydrochloride
  • tomoxetine hydrochloride
  • atomoxetine HCl
  • tomoxetine HCl
A propylamine derivative and selective ADRENERGIC UPTAKE INHIBITOR that is used in the treatment of ATTENTION DEFICIT HYPERACTIVITY DISORDER.
  • Molecular weight: 255.36
  • Formula: C17H21NO
  • CLOGP: 3.94
  • LIPINSKI: 0
  • HAC: 2
  • HDO: 1
  • TPSA: 21.26
  • ALOGS: -4.82
  • ROTB: 6

  • Status: OFP

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

Drug dosage:

DoseUnitRoute
80 mg O

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 1 Benet LZ, Broccatelli F, Oprea TI
S (Water solubility) 27.80 mg/mL Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine) 1.50 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 8.39 ยตM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability) 94 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
Vd (Volume of distribution) 0.85 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 9.30 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) 5.20 hours Lombardo F, Berellini G, Obach RS

Predicted pharmacokinetic/toxicological properties (PK-AZ):

PropertyDescriptionValueUnitConfidenceSimilarity
azlogd74 LogD at pH 7.4 1.308 High 1
caco2-efflux Caco-2 efflux ratio (BA/AB) 0.671 High 1
caco2-intrinsic-papp Caco-2 intrinsic apparent permeability 36.308 10^-6 cm/s High 1
dh-clint Dog hepatocyte intrinsic clearance 32.509 uL/min/10^6 cells High 1
dppb Dog plasma protein binding (% unbound) 12.480 % High 1
fcs-ppb Fetal calf serum protein binding (% unbound) 31.670 % High 1
herg hERG pIC50 5.480 pIC50 High 1
hh-clint Human hepatocyte intrinsic clearance 12.912 uL/min/10^6 cells High 1
hlm-clint Human liver microsomal intrinsic clearance 9.183 uL/min/mg protein High 1
hppb Human plasma protein binding (% unbound) 26.860 % High 1
kinase-safety-class ACVR2A,ACVR2B,AKT1,AKT2,AKT3,AXL,BRAF,BTK,CAMK2B,CAMK2D,CDK4,CDK5,CDK9,DDR1,DYRK1B,EIF2AK3,EPHB4,ERBB2,FLT3,GRK2,ITK,JAK2,JAK3,MAP3K7,MAPK10,MAPK12,MAPK7,MET,NTRK2,PDK2,PDK4,PDPK1,PIM2,PRKDC,SIK2,SIK3,TEK,TGFBR1 38
kinase-selectivity-class AKT3,AXL,BRAF,EIF2AK3,EPHB4,ERBB2,GRK2,PDK4 8
mdck-mdr1-efflux MDCK-MDR1 efflux ratio 0.681 High 1
mh-clint Mouse hepatocyte intrinsic clearance 126.765 High 1
mppb Mouse plasma protein binding (% unbound) 19.170 High 1
nih-mdck-mdr1-efflux NIH MDCK-MDR1 efflux ratio 1.905 High 1
pfas-class PFAS structural alert (1 = True, 0 = False) 0
pppb Pig plasma protein binding (% unbound) 33.490 % High 1
rh-clint Rat hepatocyte intrinsic clearance 212.324 uL/min/10^6 cells High 1
rh-fuinc Rat hepatocyte fraction unbound in incubation 44.500 % High 1
rppb Rat plasma protein binding (% unbound) 18.150 % High 1
solubility-dd Solubility at pH 7.4 in DMSO 879.023 uM High 1

Approvals:

DateAgencyCompanyOrphan
Nov. 26, 2002 FDA LILLY

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
Blepharospasm 919.19 25.34 565 71900 54880 90501102
Epilepsy 754.86 25.34 582 71883 81624 90474358
Taste disorder 714.51 25.34 502 71963 61044 90494938
Onychomadesis 604.29 25.34 405 72060 45593 90510389
Nail disorder 574.67 25.34 433 72032 58634 90497348
Breast cancer stage III 549.91 25.34 490 71975 83957 90472025
Facet joint syndrome 497.17 25.34 496 71969 97893 90458089
Back injury 496.64 25.34 361 72104 46261 90509721
Onychomycosis 420.01 25.34 299 72166 37077 90518905
Hypercholesterolaemia 417.23 25.34 457 72008 100435 90455547
Peripheral venous disease 414.59 25.34 418 72047 83503 90472479
Product quality issue 404.54 25.34 402 72063 78923 90477059
Lip dry 399.71 25.34 447 72018 100508 90455474
Gastrooesophageal reflux disease 373.55 25.34 556 71909 165781 90390201
Bursitis 360.64 25.34 484 71981 131170 90424812
Wound infection 341.28 25.34 423 72042 105979 90450003
Product label confusion 331.12 25.34 214 72251 22636 90533346
Obesity 313.85 25.34 404 72061 105103 90450879
Live birth 298.97 25.34 342 72123 78765 90477217
C-reactive protein increased 291.25 25.34 521 71944 180868 90375114
Type 2 diabetes mellitus 286.55 25.34 552 71913 202692 90353290
Memory impairment 282.12 25.34 539 71926 196705 90359277
Liver injury 263.73 25.34 482 71983 170085 90385897
Adverse reaction 258.63 25.34 204 72261 29508 90526474
Psoriatic arthropathy 256.85 25.34 565 71900 227770 90328212
Grip strength decreased 245.27 25.34 335 72130 92241 90463741
Dry mouth 241.35 25.34 485 71980 183574 90372408
Inflammation 240.66 25.34 476 71989 178116 90377866
Finger deformity 238.35 25.34 203 72262 32694 90523288
Lung disorder 230.96 25.34 423 72042 149460 90406522
Coeliac disease 230.88 25.34 228 72237 44382 90511600
Muscle injury 227.45 25.34 462 72003 176192 90379790
Joint range of motion decreased 227.17 25.34 397 72068 135246 90420736
Night sweats 226.29 25.34 385 72080 128381 90427601
Folliculitis 222.27 25.34 499 71966 203854 90352128
Blood cholesterol increased 218.54 25.34 501 71964 207511 90348471
Anaemia 217.83 25.34 17 72448 352785 90203197
Gait inability 217.71 25.34 407 72058 146049 90409933
Fibromyalgia 205.95 25.34 487 71978 205782 90350200
Hypoaesthesia 204.19 25.34 633 71832 313577 90242405
Paraesthesia 201.90 25.34 545 71920 249781 90306201
Infusion site reaction 201.68 25.34 147 72318 18892 90537090
Acute kidney injury 199.01 25.34 15 72450 320372 90235610
Pericarditis 186.48 25.34 556 71909 269595 90286387
Osteoarthritis 185.57 25.34 453 72012 195277 90360705
Musculoskeletal pain 181.51 25.34 414 72051 170837 90385145
Duodenal ulcer perforation 176.61 25.34 480 71985 220808 90335174
Irritable bowel syndrome 174.65 25.34 459 72006 206989 90348993
Helicobacter infection 174.03 25.34 485 71980 226365 90329617
Neck pain 173.44 25.34 320 72145 113643 90442339
Pyrexia 169.75 25.34 167 72298 660318 89895664
Liver function test increased 169.66 25.34 269 72196 84586 90471396
Drug-induced liver injury 169.24 25.34 278 72187 90040 90465942
Abdominal pain upper 167.29 25.34 615 71850 332059 90223923
Rheumatic fever 166.51 25.34 374 72091 152747 90403235
Sleep disorder 152.46 25.34 424 72041 197606 90358376
Depression 150.49 25.34 555 71910 300046 90255936
Back pain 149.62 25.34 35 72430 317140 90238842
Neutropenia 147.13 25.34 8 72457 224896 90331086
Injection site reaction 146.99 25.34 264 72201 91816 90464166
Anti-cyclic citrullinated peptide antibody positive 145.81 25.34 468 71997 235965 90320017
Urinary tract infection 145.61 25.34 33 72432 305599 90250383
Impaired healing 143.91 25.34 463 72002 233736 90322246
Cough 143.06 25.34 58 72407 368904 90187078
Pruritus 140.11 25.34 136 72329 541389 90014593
Intentional product use issue 138.93 25.34 435 72030 216457 90339525
Muscle spasms 134.48 25.34 475 71990 251408 90304574
Hepatitis 134.21 25.34 219 72246 70520 90485462
Lower respiratory tract infection 133.23 25.34 472 71993 250187 90305795
Abdominal distension 133.12 25.34 311 72154 130290 90425692
C-reactive protein abnormal 132.68 25.34 306 72159 127123 90428859
Thrombocytopenia 128.92 25.34 10 72455 208715 90347267
Hand deformity 124.62 25.34 518 71947 295844 90260138
Overlap syndrome 123.67 25.34 80 72385 8468 90547514
Hypotension 123.15 25.34 53 72412 325344 90230638
Pemphigus 121.90 25.34 551 71914 326313 90229669
Wheezing 121.13 25.34 442 72023 237638 90318344
Maternal exposure during pregnancy 118.99 25.34 586 71879 359477 90196505
Confusional state 118.83 25.34 616 71849 385589 90170393
Wound 116.93 25.34 516 71949 302464 90253518
Erythema 112.74 25.34 23 72442 229223 90326759
Blister 111.35 25.34 451 72014 254547 90301435
Dyspepsia 110.32 25.34 379 72086 197781 90358201
Sepsis 109.96 25.34 9 72456 179805 90376177
Normal newborn 109.14 25.34 113 72352 23249 90532733
Constipation 108.78 25.34 44 72421 280351 90275631
Synovitis 105.61 25.34 532 71933 329220 90226762
Death 103.30 25.34 128 72337 456423 90099559
Systemic lupus erythematosus 100.28 25.34 561 71904 361335 90194647
Dehydration 98.80 25.34 18 72447 194429 90361553
White blood cell count decreased 97.80 25.34 10 72455 167099 90388883
Glossodynia 96.68 25.34 510 71955 321269 90234713
Haemoglobin decreased 96.60 25.34 9 72456 161947 90394035
Hepatic enzyme 92.38 25.34 56 72409 5288 90550694
Rheumatoid arthritis 91.90 25.34 549 71916 362065 90193917
Ill-defined disorder 90.42 25.34 339 72126 184552 90371430
Stomatitis 89.20 25.34 445 72020 274253 90281729
Renal failure 87.76 25.34 4 72461 131003 90424979
Neuropathy peripheral 86.17 25.34 6 72459 136964 90419018
Product use in unapproved indication 80.70 25.34 502 71963 335734 90220248
Prescribed overdose 79.00 25.34 213 72252 97412 90458570
COVID-19 78.84 25.34 19 72446 168824 90387158
Arthropathy 75.87 25.34 527 71938 365715 90190267
Hyponatraemia 75.58 25.34 9 72456 133529 90422453
Influenza 74.96 25.34 11 72454 139253 90416729
Product dose omission issue 74.46 25.34 74 72391 291613 90264369
Injury 71.47 25.34 330 72135 197019 90358963
General physical health deterioration 70.05 25.34 505 71960 354610 90201372
Renal impairment 68.15 25.34 4 72461 105417 90450565
Diarrhoea 67.58 25.34 457 72008 938733 89617249
Arthritis 66.93 25.34 25 72440 167290 90388692
Platelet count decreased 66.78 25.34 14 72451 136955 90419027
Cardiac failure congestive 66.15 25.34 3 72462 98691 90457291
Fatigue 66.09 25.34 598 71867 1153425 89402557
Cerebrovascular accident 65.93 25.34 10 72455 123523 90432459
Urticaria 65.92 25.34 452 72013 312282 90243700
Myocardial infarction 62.89 25.34 6 72459 105966 90450016
Respiratory failure 62.26 25.34 10 72455 118408 90437574
Mobility decreased 61.15 25.34 376 72089 250358 90305624
Tic 60.85 25.34 30 72435 1881 90554101
Pulmonary embolism 60.53 25.34 15 72450 130805 90425177
Herpes zoster 59.95 25.34 4 72461 94640 90461342
Drug interaction 59.88 25.34 80 72385 276373 90279609
Gastrointestinal haemorrhage 59.65 25.34 3 72462 90245 90465737
Blood creatinine increased 59.48 25.34 6 72459 101380 90454602
Hypokalaemia 58.82 25.34 16 72449 131100 90424882
Injection site pain 58.54 25.34 33 72432 173666 90382316
Infection 58.05 25.34 127 72338 361967 90194015
Dyspnoea 57.36 25.34 441 72024 880514 89675468
Drug ineffective 56.77 25.34 774 71691 1383524 89172458
Suicidal ideation 56.62 25.34 158 72307 73697 90482285
Swelling 56.47 25.34 547 71918 418511 90137471
Product tampering 56.20 25.34 19 72446 444 90555538
Infusion related reaction 56.15 25.34 544 71921 416236 90139746
Hypocholesterolaemia 55.50 25.34 44 72421 6405 90549577
Underdose 55.39 25.34 129 72336 53888 90502094
Hepatic enzyme increased 55.22 25.34 484 71981 360252 90195730
Chest discomfort 54.79 25.34 21 72444 138344 90417638
Cellulitis 54.66 25.34 5 72460 91332 90464650
Chills 54.01 25.34 19 72446 131962 90424020
Oropharyngeal pain 53.69 25.34 13 72452 115174 90440808
Breast cancer stage II 53.43 25.34 99 72366 35235 90520747
Therapeutic product effect incomplete 53.22 25.34 300 72165 193596 90362386
Sinusitis 51.23 25.34 125 72340 342963 90213019
Adulterated product 51.12 25.34 17 72448 377 90555605
Contraindicated product administered 50.80 25.34 433 72032 319706 90236276
Exposure during pregnancy 49.27 25.34 343 72122 238067 90317915
Weight decreased 48.09 25.34 150 72315 379760 90176222
Bradycardia 46.59 25.34 6 72459 83841 90472141
Injection site erythema 46.14 25.34 11 72454 98491 90457491
Drug intolerance 45.35 25.34 552 71913 447039 90108943
Anaphylactic reaction 44.66 25.34 8 72457 87516 90468466
Therapeutic product effect decreased 43.27 25.34 374 72091 277197 90278785
Balance disorder 43.25 25.34 12 72453 97068 90458914
Neutrophil count decreased 42.58 25.34 4 72461 71528 90484454
Productive cough 41.66 25.34 6 72459 77057 90478925
Abdominal discomfort 41.35 25.34 572 71893 476756 90079226
Hypertension 41.15 25.34 552 71913 456980 90099002
Rhinorrhoea 41.10 25.34 10 72455 88306 90467676
Upper respiratory tract infection 40.95 25.34 26 72439 128292 90427690
Leukopenia 40.35 25.34 15 72450 100695 90455287
Muscular weakness 40.17 25.34 293 72172 206373 90349609
Atrial fibrillation 40.06 25.34 29 72436 133582 90422400
Claustrophobia 39.79 25.34 20 72445 1307 90554675
Myalgia 39.63 25.34 49 72416 175076 90380906
Congenital anomaly 39.61 25.34 36 72429 6311 90549671
Incorrect route of product administration 38.50 25.34 108 72357 50518 90505464
Dysphagia 38.30 25.34 21 72444 112257 90443725
Pulse abnormal 37.75 25.34 26 72439 3053 90552929
Chronic obstructive pulmonary disease 37.13 25.34 7 72458 73822 90482160
Gastrointestinal disorder 36.48 25.34 339 72126 256348 90299634
Vertigo 36.46 25.34 6 72459 69805 90486177
Dysphonia 36.32 25.34 4 72461 63080 90492902
Blood pressure increased 36.04 25.34 64 72401 197153 90358829
Nausea 35.86 25.34 649 71816 1109667 89446315
Toxicity to various agents 35.46 25.34 115 72350 287731 90268251
Dry eye 35.12 25.34 3 72462 57928 90498054
Pneumonia 34.91 25.34 334 72131 637725 89918257
Thrombosis 34.66 25.34 8 72457 73243 90482739
Hypoglycaemia 34.33 25.34 7 72458 69841 90486141
Cystitis 34.25 25.34 6 72459 66712 90489270
Blood glucose increased 33.69 25.34 17 72448 95229 90460753
Bronchitis 33.35 25.34 44 72421 152883 90403099
Haematochezia 33.05 25.34 8 72457 70905 90485077
Deep vein thrombosis 32.94 25.34 16 72449 91604 90464378
Blood pressure systolic increased 32.84 25.34 4 72461 58341 90497641
Myocarditis 32.14 25.34 47 72418 13759 90542223
Burning sensation 31.94 25.34 6 72459 63446 90492536
Cholelithiasis 31.08 25.34 3 72462 52503 90503479
Rash erythematous 31.03 25.34 7 72458 65097 90490885
Angioedema 30.87 25.34 7 72458 64869 90491113
Diabetes mellitus 30.87 25.34 7 72458 64868 90491114
Attention deficit hyperactivity disorder 30.66 25.34 26 72439 4158 90551824
Influenza like illness 30.66 25.34 13 72452 80598 90475384
Depressed level of consciousness 30.60 25.34 10 72455 72774 90483208
Epistaxis 30.40 25.34 15 72450 85110 90470872
Haemorrhage 30.11 25.34 9 72456 69360 90486622
Abnormal behaviour 30.03 25.34 60 72405 22568 90533414
Hyperglycaemia 29.94 25.34 3 72462 50967 90505015
Adverse event 29.80 25.34 178 72287 117240 90438742
Chronic kidney disease 29.36 25.34 3 72462 50188 90505794
Therapy interrupted 29.30 25.34 3 72462 50105 90505877
Pleural effusion 29.02 25.34 28 72437 111963 90444019
Congestive hepatopathy 28.94 25.34 22 72443 3011 90552971
Weight increased 28.88 25.34 482 71983 417445 90138537
Bone pain 28.87 25.34 7 72458 61976 90494006
Coma 28.79 25.34 11 72454 72621 90483361
Aggression 28.79 25.34 65 72400 26603 90529379
Treatment failure 28.67 25.34 370 72095 303558 90252424
Metabolic acidosis 28.60 25.34 5 72460 55671 90500311
Oedema peripheral 28.43 25.34 108 72357 257807 90298175
Flushing 28.14 25.34 18 72447 88473 90467509
Inappropriate schedule of product administration 27.98 25.34 48 72417 149885 90406097
Dry skin 27.89 25.34 18 72447 88055 90467927
Oxygen saturation decreased 27.70 25.34 27 72438 107456 90448526
Prescribed underdose 27.53 25.34 126 72339 74893 90481089
International normalised ratio increased 27.24 25.34 3 72462 47313 90508669
Supine hypertension 27.06 25.34 7 72458 61 90555921
Impulsive behaviour 27.03 25.34 17 72448 1713 90554269
Respiratory tract infection 26.88 25.34 7 72458 59071 90496911
Hypothyroidism 26.79 25.34 5 72460 53122 90502860
Cognitive disorder 26.71 25.34 11 72454 69396 90486586
Cardiac failure 26.53 25.34 29 72436 109467 90446515
Red blood cell count decreased 26.53 25.34 3 72462 46348 90509634
Trichotillomania 26.38 25.34 8 72457 130 90555852
Blood pressure fluctuation 26.29 25.34 5 72460 52408 90503574
Multiple sclerosis relapse 26.21 25.34 5 72460 52300 90503682
Hepatotoxicity 26.15 25.34 3 72462 45839 90510143
Ulcer haemorrhage 26.04 25.34 62 72403 26259 90529723
Skin exfoliation 25.75 25.34 11 72454 67902 90488080
Cardiac disorder 25.39 25.34 7 72458 56865 90499117

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 715.62 21.93 358 16454 47803 42556720
Tic 622.66 21.93 152 16660 2231 42602292
Aggression 599.56 21.93 309 16503 43854 42560669
Prescribed overdose 467.51 21.93 180 16632 12747 42591776
Abnormal behaviour 369.87 21.93 189 16623 26262 42578261
Anger 270.03 21.93 122 16690 12896 42591627
Irritability 260.16 21.93 153 16659 27975 42576548
Intentional self-injury 216.34 21.93 110 16702 15092 42589431
Crying 213.20 21.93 84 16728 6310 42598213
Psychomotor hyperactivity 190.83 21.93 91 16721 10867 42593656
Agitation 189.01 21.93 175 16637 64139 42540384
Oppositional defiant disorder 172.58 21.93 41 16771 531 42603992
Testicular pain 172.07 21.93 60 16752 3194 42601329
Ejaculation disorder 157.18 21.93 43 16769 1005 42603518
Homicidal ideation 141.91 21.93 50 16762 2744 42601779
Anxiety 136.64 21.93 199 16613 118361 42486162
Suicide attempt 130.64 21.93 123 16689 45977 42558546
Mood swings 128.85 21.93 65 16747 8761 42595762
Urinary hesitation 126.76 21.93 47 16765 2988 42601535
Impulsive behaviour 121.65 21.93 43 16769 2382 42602141
Insomnia 119.89 21.93 187 16625 118066 42486457
Disturbance in attention 115.29 21.93 95 16717 29771 42574752
Heart rate increased 110.42 21.93 120 16692 53135 42551388
Death 107.53 21.93 27 16785 471158 42133365
Psychotic disorder 106.71 21.93 90 16722 29118 42575405
Mood altered 106.15 21.93 61 16751 10657 42593866
Depressed mood 104.36 21.93 81 16731 23303 42581220
Acute kidney injury 103.53 21.93 12 16800 367325 42237198
Decreased eye contact 99.98 21.93 26 16786 497 42604026
Hallucination, auditory 97.34 21.93 65 16747 14799 42589724
Attention deficit hyperactivity disorder 97.20 21.93 39 16773 3069 42601454
Depression 93.76 21.93 162 16650 111201 42493322
Mania 91.23 21.93 55 16757 10492 42594031
Pneumonia 90.98 21.93 27 16785 422122 42182401
Bruxism 88.42 21.93 33 16779 2136 42602387
Seizure 88.24 21.93 165 16647 120396 42484127
Drug screen positive 86.51 21.93 39 16773 4092 42600431
Product substitution issue 85.27 21.93 54 16758 11236 42593287
Somnolence 80.41 21.93 174 16638 140931 42463592
Alanine aminotransferase increased 78.86 21.93 132 16680 88274 42516249
Palpitations 76.20 21.93 97 16715 50700 42553823
Dystonia 74.42 21.93 52 16760 12738 42591785
Feeling abnormal 72.91 21.93 112 16700 69674 42534849
Self-injurious ideation 70.99 21.93 27 16785 1841 42602682
Educational problem 69.72 21.93 20 16792 558 42603965
Tachycardia 68.56 21.93 134 16678 100953 42503570
Aspartate aminotransferase increased 68.52 21.93 115 16697 77048 42527475
Suicidal behaviour 68.46 21.93 25 16787 1521 42603002
Anaemia 65.87 21.93 15 16797 280263 42324260
Penile discharge 65.15 21.93 13 16799 68 42604455
Mydriasis 63.87 21.93 41 16771 8729 42595794
Sepsis 62.88 21.93 4 16808 199330 42405193
Dysuria 62.55 21.93 69 16743 31027 42573496
Choreoathetosis 60.75 21.93 21 16791 1088 42603435
Dyskinesia 59.31 21.93 61 16751 25329 42579194
Blood alkaline phosphatase increased 58.19 21.93 69 16743 33528 42570995
Emotional disorder 57.39 21.93 34 16778 6280 42598243
Generalised tonic-clonic seizure 57.36 21.93 61 16751 26318 42578205
Nervousness 56.32 21.93 45 16767 13487 42591036
Electrocardiogram QT prolonged 54.40 21.93 80 16732 47865 42556658
Diarrhoea 53.52 21.93 62 16750 460787 42143736
Trismus 53.40 21.93 25 16787 2859 42601664
Retching 53.12 21.93 35 16777 7786 42596737
Obsessive-compulsive disorder 52.79 21.93 33 16779 6710 42597813
Febrile neutropenia 52.37 21.93 6 16806 185697 42418826
Manic symptom 47.52 21.93 12 16800 203 42604320
Coordination abnormal 47.46 21.93 33 16779 8017 42596506
Growth hormone-producing pituitary tumour 46.61 21.93 11 16801 138 42604385
Hepatic enzyme increased 45.72 21.93 72 16740 45712 42558811
Affect lability 45.41 21.93 25 16787 4019 42600504
Disease progression 44.94 21.93 3 16809 143653 42460870
Gilbert's syndrome 44.14 21.93 8 16804 22 42604501
Headache 44.11 21.93 199 16613 239170 42365353
Thrombocytopenia 43.05 21.93 11 16801 190268 42414255
Gastric hypomotility 42.56 21.93 11 16801 205 42604318
Growth retardation 41.72 21.93 20 16792 2412 42602111
Social avoidant behaviour 41.12 21.93 22 16790 3342 42601181
Shunt malfunction 39.69 21.93 11 16801 270 42604253
Loss of consciousness 39.58 21.93 102 16710 92252 42512271
Screaming 39.56 21.93 18 16794 1929 42602594
Sexual dysfunction 38.14 21.93 27 16785 6748 42597775
Viral diarrhoea 38.07 21.93 11 16801 315 42604208
General physical health deterioration 37.74 21.93 7 16805 151239 42453284
Panic attack 36.19 21.93 32 16780 11013 42593510
Blood bilirubin increased 36.18 21.93 62 16750 42190 42562333
Trichotillomania 35.47 21.93 8 16804 81 42604442
Physical assault 35.30 21.93 14 16798 1068 42603455
Completed suicide 34.79 21.93 100 16712 96365 42508158
Chest pain 34.39 21.93 127 16685 139403 42465120
Pallor 33.91 21.93 49 16763 28837 42575686
Urinary retention 33.62 21.93 60 16752 42154 42562369
Spontaneous ejaculation 33.52 21.93 6 16806 15 42604508
Reversible cerebral vasoconstriction syndrome 32.89 21.93 12 16800 728 42603795
Personality change 32.67 21.93 23 16789 5696 42598827
Thinking abnormal 32.35 21.93 25 16787 7136 42597387
Hyperkinesia 32.22 21.93 16 16796 2082 42602441
Paranoia 31.49 21.93 33 16779 13993 42590530
Cardiac failure 31.27 21.93 3 16809 106853 42497670
Fight in school 31.26 21.93 5 16807 4 42604519
Renal failure 31.20 21.93 9 16803 143717 42460806
Syncope 31.08 21.93 98 16714 99308 42505215
Negativism 30.92 21.93 10 16802 421 42604102
Enuresis 30.89 21.93 17 16795 2731 42601792
Hyperhidrosis 30.88 21.93 92 16720 90420 42514103
Apathy 30.88 21.93 26 16786 8380 42596143
Blood growth hormone increased 30.71 21.93 11 16801 633 42603890
Vomiting 30.51 21.93 207 16605 289516 42315007
Repetitive speech 30.26 21.93 7 16805 80 42604443
Decreased appetite 30.05 21.93 153 16659 192984 42411539
Scrotal pain 29.82 21.93 12 16800 951 42603572
Pyromania 29.81 21.93 6 16806 33 42604490
Speech disorder 29.35 21.93 46 16766 29075 42575448
Hyponatraemia 29.29 21.93 3 16809 101459 42503064
Pulmonary embolism 28.86 21.93 6 16806 119606 42484917
Hostility 28.21 21.93 11 16801 802 42603721
Abdominal pain upper 28.21 21.93 84 16728 82525 42521998
Respiratory failure 27.85 21.93 8 16804 128124 42476399
Feeling jittery 27.83 21.93 19 16793 4479 42600044
Restlessness 27.82 21.93 45 16767 29204 42575319
Tearfulness 27.07 21.93 17 16795 3483 42601040
Raynaud's phenomenon 26.63 21.93 8 16804 263 42604260
Poor quality sleep 26.34 21.93 25 16787 9415 42595108
Asthenia 26.27 21.93 44 16768 280749 42323774
Eye movement disorder 26.21 21.93 19 16793 4926 42599597
Breath odour 25.98 21.93 11 16801 992 42603531
Pyrexia 25.97 21.93 75 16737 393967 42210556
Shunt occlusion 25.73 21.93 11 16801 1016 42603507
Tourette's disorder 25.67 21.93 6 16806 72 42604451
Dysphoria 25.34 21.93 15 16797 2765 42601758
Peripheral swelling 25.22 21.93 3 16809 90267 42514256
Hallucination, visual 25.17 21.93 36 16776 20984 42583539
Strabismus 24.95 21.93 14 16798 2334 42602189
School refusal 24.62 21.93 5 16807 29 42604494
Erectile dysfunction 24.61 21.93 39 16773 24874 42579649
Dyspnoea 24.51 21.93 91 16721 442530 42161993
Infrequent bowel movements 24.42 21.93 11 16801 1151 42603372
Amphetamines positive 24.28 21.93 7 16805 199 42604324
Pain 24.19 21.93 37 16775 244811 42359712
Semen analysis abnormal 23.94 21.93 5 16807 34 42604489
Drooling 23.89 21.93 17 16795 4282 42600241
Weight increased 23.88 21.93 95 16717 107888 42496635
Insulin-like growth factor increased 23.76 21.93 12 16800 1619 42602904
Oedema peripheral 23.75 21.93 12 16800 136064 42468459
Obsessive-compulsive symptom 23.45 21.93 7 16805 225 42604298
Gastrointestinal haemorrhage 23.37 21.93 5 16807 97721 42506802
Streptococcal infection 22.59 21.93 19 16793 6113 42598410
Infection 22.57 21.93 8 16804 112060 42492463
Arthralgia 22.27 21.93 29 16783 205209 42399314

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
Blepharospasm 863.87 22.55 530 82982 54321 110451466
Epilepsy 666.21 22.55 574 82938 99635 110406152
Taste disorder 650.78 22.55 475 83037 64912 110440875
Onychomadesis 632.94 22.55 407 83105 45256 110460531
Nail disorder 620.34 22.55 440 83072 57495 110448292
Breast cancer stage III 574.72 22.55 477 83035 78640 110427147
Tic 549.35 22.55 172 83340 3321 110502466
Facet joint syndrome 529.69 22.55 497 83015 96331 110409456
Hypercholesterolaemia 486.80 22.55 461 83051 90376 110415411
Back injury 482.16 22.55 349 83163 47050 110458737
Onychomycosis 445.92 22.55 307 83205 38224 110467563
Product quality issue 419.31 22.55 395 83117 76904 110428883
Lip dry 407.96 22.55 438 83074 99645 110406142
Peripheral venous disease 407.63 22.55 404 83108 83713 110422074
Wound infection 398.18 22.55 425 83087 96040 110409747
Suicidal ideation 393.29 22.55 417 83095 93520 110412267
Acute kidney injury 391.29 22.55 22 83490 635408 109870379
Bursitis 373.15 22.55 475 83037 129443 110376344
Type 2 diabetes mellitus 369.30 22.55 555 82957 176677 110329110
Product label confusion 346.34 22.55 215 83297 22462 110483325
Gastrooesophageal reflux disease 336.34 22.55 536 82976 179440 110326347
Psoriatic arthropathy 328.61 22.55 557 82955 196204 110309583
Aggression 327.66 22.55 306 83206 58904 110446883
Muscle injury 325.25 22.55 463 83049 140344 110365443
Anaemia 324.62 22.55 23 83489 547063 109958724
Obesity 321.64 22.55 412 83100 112939 110392848
Live birth 318.75 22.55 324 83188 69160 110436627
Liver injury 314.69 22.55 472 83040 149941 110355846
Prescribed overdose 309.86 22.55 356 83156 87225 110418562
Folliculitis 308.72 22.55 496 83016 167157 110338630
Grip strength decreased 302.54 22.55 337 83175 79837 110425950
Helicobacter infection 286.79 22.55 502 83010 181375 110324412
Fibromyalgia 281.60 22.55 481 83031 170428 110335359
Memory impairment 279.20 22.55 519 82993 196425 110309362
Pericarditis 278.20 22.55 551 82961 218563 110287224
Pemphigus 272.93 22.55 540 82972 214030 110291757
Adverse reaction 271.88 22.55 205 83307 29389 110476398
Blood cholesterol increased 268.27 22.55 492 83020 184293 110321494
Duodenal ulcer perforation 267.96 22.55 481 83031 177219 110328568
Finger deformity 257.96 22.55 208 83304 32884 110472903
Coeliac disease 256.04 22.55 232 83280 42955 110462832
Joint range of motion decreased 254.33 22.55 382 83130 121450 110384337
Gait inability 251.73 22.55 404 83108 135972 110369815
Irritable bowel syndrome 250.78 22.55 447 83065 163768 110342019
Depression 250.37 22.55 661 82851 316674 110189113
Hand deformity 247.27 22.55 524 82988 217982 110287805
Dry mouth 242.05 22.55 493 83019 199455 110306332
C-reactive protein increased 240.15 22.55 517 82995 217402 110288385
Anti-cyclic citrullinated peptide antibody positive 237.44 22.55 463 83049 181521 110324266
Rheumatic fever 237.08 22.55 371 83141 122208 110383579
Night sweats 236.54 22.55 389 83123 133594 110372193
Systemic lupus erythematosus 231.06 22.55 559 82953 253779 110252008
Glossodynia 229.11 22.55 513 82999 221491 110284296
Osteoarthritis 226.65 22.55 455 83057 182168 110323619
Abnormal behaviour 226.11 22.55 207 83305 38832 110466955
Pyrexia 221.07 22.55 212 83300 898053 109607734
Inflammation 219.29 22.55 464 83048 192774 110313013
Impaired healing 215.91 22.55 466 83046 196251 110309536
Wound 213.72 22.55 516 82996 233921 110271866
Maternal exposure during pregnancy 212.34 22.55 542 82970 254341 110251446
Sepsis 208.72 22.55 9 83503 327337 110178450
Hypoaesthesia 205.98 22.55 612 82900 313611 110192176
Sleep disorder 204.91 22.55 459 83053 198185 110307602
Febrile neutropenia 204.35 22.55 8 83504 316759 110189028
Death 204.22 22.55 139 83373 698730 109807057
Abdominal pain upper 196.59 22.55 645 82867 348466 110157321
Thrombocytopenia 194.86 22.55 19 83493 348866 110156921
Lung disorder 190.15 22.55 420 83092 179627 110326160
Musculoskeletal pain 184.39 22.55 419 83093 182604 110323183
Paraesthesia 176.85 22.55 534 82978 275987 110229800
Synovitis 175.00 22.55 529 82983 273563 110232224
Infusion site reaction 174.75 22.55 128 83384 17554 110488233
Anger 170.90 22.55 130 83382 18877 110486910
Injection site reaction 169.99 22.55 268 83244 88802 110416985
Hypotension 169.95 22.55 92 83420 523757 109982030
Neutropenia 168.97 22.55 38 83474 374582 110131205
Neck pain 168.78 22.55 320 83192 122810 110382977
Disease progression 165.16 22.55 4 83508 244030 110261757
Irritability 165.10 22.55 192 83320 47617 110458170
Lower respiratory tract infection 164.49 22.55 479 83033 242627 110263160
Liver function test increased 164.26 22.55 263 83249 88285 110417502
Rheumatoid arthritis 160.11 22.55 544 82968 299069 110206718
Oppositional defiant disorder 159.49 22.55 43 83469 475 110505312
C-reactive protein abnormal 152.38 22.55 316 83196 129379 110376408
Back pain 149.58 22.55 47 83465 370949 110134838
Arthropathy 146.60 22.55 514 82998 287008 110218779
Dyspepsia 145.58 22.55 393 83119 190572 110315215
Ill-defined disorder 142.59 22.55 345 83167 156508 110349279
Blister 142.42 22.55 436 83076 226940 110278847
Psychomotor hyperactivity 138.34 22.55 118 83394 20159 110485628
Urinary tract infection 135.76 22.55 39 83473 326243 110179544
Renal failure 132.86 22.55 10 83502 226564 110279223
Hepatic enzyme increased 132.35 22.55 536 82976 320356 110185431
Cough 130.49 22.55 95 83417 461546 110044241
Muscle spasms 128.84 22.55 482 83030 277675 110228112
Abdominal discomfort 127.62 22.55 612 82900 393246 110112541
Hyponatraemia 126.51 22.55 10 83502 217643 110288144
Overlap syndrome 126.07 22.55 81 83431 8978 110496809
Swelling 125.93 22.55 562 82950 350479 110155308
Wheezing 125.55 22.55 451 83061 254779 110251008
Intentional self-injury 123.73 22.55 147 83365 37282 110468505
Contraindicated product administered 123.23 22.55 440 83072 247827 110257960
Ejaculation disorder 122.93 22.55 36 83476 548 110505239
Dehydration 122.74 22.55 30 83482 279481 110226306
Normal newborn 122.70 22.55 114 83398 21782 110484005
Intentional product use issue 121.89 22.55 438 83074 247468 110258319
Haemoglobin decreased 118.81 22.55 22 83490 248705 110257082
Drug-induced liver injury 118.78 22.55 273 83239 119794 110385993
Renal impairment 117.42 22.55 6 83506 188439 110317348
Pulmonary embolism 113.82 22.55 14 83498 214460 110291327
Hepatitis 112.37 22.55 225 83287 89829 110415958
Pruritus 111.14 22.55 167 83345 581393 109924394
Neuropathy peripheral 110.78 22.55 6 83506 179271 110326516
Erythema 110.38 22.55 41 83471 291406 110214381
Stomatitis 108.70 22.55 448 83064 269794 110235993
Respiratory failure 107.35 22.55 17 83495 215315 110290472
Drug abuse 103.52 22.55 8 83504 177403 110328384
COVID-19 102.46 22.55 29 83483 245031 110260756
Therapeutic product effect decreased 101.40 22.55 409 83103 243907 110261880
Homicidal ideation 100.89 22.55 51 83461 3576 110502211
Gastrointestinal haemorrhage 100.86 22.55 6 83506 165512 110340275
Crying 100.54 22.55 110 83402 25518 110480269
Pneumonia 100.18 22.55 334 83178 876380 109629407
Exposure during pregnancy 100.12 22.55 316 83196 167108 110338679
Hepatic enzyme 99.81 22.55 57 83455 5106 110500681
White blood cell count decreased 98.05 22.55 26 83486 229364 110276423
Alopecia 98.04 22.55 538 82974 364215 110141572
Abdominal distension 97.92 22.55 323 83189 174780 110331007
Confusional state 97.15 22.55 646 82866 468034 110037753
Mood swings 96.68 22.55 102 83410 22710 110483077
Platelet count decreased 94.99 22.55 28 83484 230415 110275372
Cardiac failure congestive 93.47 22.55 5 83507 150995 110354792
Impulsive behaviour 93.34 22.55 47 83465 3268 110502519
Injury 90.35 22.55 317 83195 176948 110328839
Blood creatinine increased 89.90 22.55 15 83497 182874 110322913
Myocardial infarction 89.59 22.55 18 83494 192065 110313722
Constipation 89.43 22.55 83 83429 357703 110148084
Hyperkalaemia 85.63 22.55 4 83508 135792 110369995
Diarrhoea 84.99 22.55 509 83003 1138996 109366791
Mobility decreased 83.47 22.55 378 83134 237044 110268743
Infusion related reaction 82.98 22.55 532 82980 380630 110125157
Urticaria 82.12 22.55 465 83047 318392 110187395
Educational problem 82.07 22.55 26 83486 522 110505265
Testicular pain 82.06 22.55 39 83473 2390 110503397
Dyspnoea 80.65 22.55 498 83014 1106374 109399413
Hypokalaemia 79.26 22.55 20 83492 182428 110323359
Hypoxia 77.99 22.55 5 83507 129510 110376277
Cardiac failure 73.40 22.55 25 83487 187601 110318186
Decreased eye contact 72.66 22.55 27 83485 888 110504899
Insomnia 72.24 22.55 493 83019 360097 110145690
Attention deficit hyperactivity disorder 72.17 22.55 44 83468 4447 110501340
Cerebrovascular accident 69.46 22.55 25 83487 181259 110324528
Atrial fibrillation 69.17 22.55 44 83468 229598 110276189
Weight increased 68.81 22.55 547 82965 419097 110086690
Agitation 68.13 22.55 214 83298 112837 110392950
Pleural effusion 67.26 22.55 25 83487 177684 110328103
Herpes zoster 65.81 22.55 4 83508 108375 110397412
Urinary hesitation 65.68 22.55 42 83470 4616 110501171
Chills 65.40 22.55 31 83481 190549 110315238
Infection 65.32 22.55 108 83404 362092 110143695
Drug intolerance 65.07 22.55 527 82985 405985 110099802
Cellulitis 64.98 22.55 9 83503 126007 110379780
Arthritis 64.40 22.55 23 83489 167563 110338224
Disturbance in attention 63.55 22.55 143 83369 61852 110443935
Chronic obstructive pulmonary disease 63.45 22.55 5 83507 109153 110396634
Trichotillomania 63.37 22.55 17 83495 184 110505603
Drug interaction 63.06 22.55 182 83330 500001 110005786
Mania 62.74 22.55 78 83434 20718 110485069
Productive cough 61.77 22.55 7 83505 114298 110391489
Gastrointestinal disorder 60.39 22.55 350 83162 241602 110264185
Deep vein thrombosis 59.49 22.55 16 83496 139871 110365916
Colitis 58.61 22.55 5 83507 102318 110403469
Multiple organ dysfunction syndrome 57.99 22.55 21 83491 151689 110354098
Hypocholesterolaemia 57.90 22.55 44 83468 6377 110499410
Neutrophil count decreased 57.09 22.55 11 83501 120930 110384857
Anaphylactic reaction 57.00 22.55 9 83503 114291 110391496
Metabolic acidosis 56.79 22.55 5 83507 99739 110406048
Product tampering 56.63 22.55 19 83493 460 110505327
Chest discomfort 55.60 22.55 31 83481 173817 110331970
Product dose omission issue 55.23 22.55 99 83413 321683 110184104
Toxicity to various agents 54.80 22.55 183 83329 480372 110025415
Underdose 54.74 22.55 137 83375 63417 110442370
Balance disorder 52.14 22.55 12 83500 116548 110389239
Ascites 51.91 22.55 5 83507 92803 110412984
Treatment failure 51.36 22.55 372 83140 276862 110228925
Thrombosis 51.04 22.55 10 83502 108652 110397135
Bradycardia 50.80 22.55 27 83485 155490 110350297
General physical health deterioration 50.53 22.55 517 82995 424778 110081009
Oedema peripheral 50.45 22.55 108 83404 328552 110177235
International normalised ratio increased 50.36 22.55 4 83508 86768 110419019
Haematochezia 49.52 22.55 13 83499 115511 110390276
Rhabdomyolysis 48.93 22.55 15 83497 120386 110385401
Pulmonary oedema 47.84 22.55 9 83503 100650 110405137
Breast cancer stage II 47.60 22.55 79 83433 27296 110478491
Obsessive-compulsive disorder 47.08 22.55 41 83471 7200 110498587
Hypertension 45.73 22.55 587 82925 509497 109996290
Acute respiratory failure 45.03 22.55 3 83509 75257 110430530
Oropharyngeal pain 44.90 22.55 23 83489 135253 110370534
Angioedema 44.34 22.55 10 83502 98490 110407297
Penile discharge 44.01 22.55 10 83502 50 110505737
Myalgia 43.23 22.55 63 83449 222318 110283469
Chronic kidney disease 42.96 22.55 4 83508 76287 110429500
Influenza 42.49 22.55 39 83473 169062 110336725
Therapeutic product effect incomplete 42.42 22.55 302 83210 223503 110282284
Bruxism 42.36 22.55 33 83479 4961 110500826
Inappropriate schedule of product administration 42.29 22.55 55 83457 203582 110302205
Hyperglycaemia 41.76 22.55 7 83505 85083 110420704
Injection site erythema 41.52 22.55 10 83502 94166 110411621
Diabetes mellitus 41.07 22.55 12 83500 99369 110406418
Vertigo 40.79 22.55 8 83504 86862 110418925
Coma 40.70 22.55 19 83493 117850 110387937
Haemorrhage 40.38 22.55 15 83497 106677 110399110
Dysphonia 40.16 22.55 5 83507 75924 110429863
Fall 40.01 22.55 279 83233 603203 109902584
Product use issue 39.95 22.55 385 83127 311310 110194477
Self-injurious ideation 39.67 22.55 30 83482 4316 110501471
Hallucination, auditory 39.14 22.55 71 83441 26326 110479461
Growth hormone-producing pituitary tumour 39.09 22.55 11 83501 144 110505643
Dystonia 39.02 22.55 70 83442 25735 110480052
Choreoathetosis 39.00 22.55 21 83491 1677 110504110
Rash maculo-papular 38.98 22.55 5 83507 74217 110431570
Hypoglycaemia 38.15 22.55 20 83492 116084 110389703
Product use in unapproved indication 37.64 22.55 509 83003 446868 110058919
Claustrophobia 37.59 22.55 20 83492 1559 110504228
Suicide attempt 37.33 22.55 166 83346 103228 110402559
Blood pressure fluctuation 37.06 22.55 6 83506 74818 110430969
Pneumonia aspiration 37.06 22.55 8 83504 81225 110424562
Haemoptysis 37.01 22.55 5 83507 71349 110434438
Transient ischaemic attack 36.99 22.55 3 83509 63979 110441808
Product substitution issue 36.73 22.55 64 83448 22997 110482790
Rhinorrhoea 36.30 22.55 16 83496 102650 110403137
Haematuria 36.23 22.55 9 83503 82996 110422791
Manic symptom 36.02 22.55 12 83500 284 110505503
Injection site pain 35.98 22.55 49 83463 177873 110327914
Adverse event 35.81 22.55 170 83342 108639 110397148
Gastric hypomotility 35.67 22.55 12 83500 293 110505494
Skin exfoliation 35.47 22.55 11 83501 87640 110418147
Respiratory distress 35.31 22.55 5 83507 68869 110436918
Acute myocardial infarction 34.83 22.55 10 83502 83767 110422020
Weight decreased 34.77 22.55 209 83303 467848 110037939
Dry skin 34.70 22.55 19 83493 107634 110398153
Adulterated product 34.36 22.55 17 83495 1138 110504649
Nasopharyngitis 34.13 22.55 451 83061 393910 110111877
Oxygen saturation decreased 34.05 22.55 41 83471 156941 110348846
Blood glucose increased 33.95 22.55 30 83482 132466 110373321
Suicidal behaviour 33.84 22.55 25 83487 3472 110502315
Cognitive disorder 33.63 22.55 12 83500 87499 110418288
Hypothyroidism 33.63 22.55 7 83505 72892 110432895
Rash erythematous 33.60 22.55 10 83502 81822 110423965
Gilbert's syndrome 33.39 22.55 7 83505 22 110505765
Growth retardation 33.27 22.55 22 83490 2560 110503227
Respiratory tract infection 32.78 22.55 7 83505 71610 110434177
Bone marrow failure 32.66 22.55 3 83509 57845 110447942
Cholestasis 32.35 22.55 5 83507 64513 110441274
Dislocation of vertebra 32.29 22.55 89 83423 43632 110462155
Disease recurrence 32.15 22.55 4 83508 60780 110445007
Leukopenia 32.13 22.55 39 83473 148752 110357035
Lower limb fracture 31.90 22.55 127 83385 75221 110430566
Mental status changes 31.81 22.55 9 83503 76113 110429674
Somatic symptom disorder 31.51 22.55 23 83489 3136 110502651
Hepatic function abnormal 31.44 22.55 14 83498 89281 110416506
Drug screen positive 31.41 22.55 31 83481 6379 110499408
Psychotic disorder 31.21 22.55 97 83415 50840 110454947
Cystitis 31.17 22.55 6 83506 66030 110439757
Red blood cell count decreased 31.10 22.55 6 83506 65917 110439870
Mood altered 31.07 22.55 57 83455 21318 110484469
Coronary artery disease 30.85 22.55 8 83504 71682 110434105
Mydriasis 30.84 22.55 58 83454 22099 110483688
Blood urea increased 30.63 22.55 3 83509 54954 110450833
Haematoma 30.56 22.55 4 83508 58472 110447315
School refusal 30.49 22.55 7 83505 37 110505750
Dysphagia 30.35 22.55 43 83469 153557 110352230
Upper respiratory tract infection 29.89 22.55 33 83479 131295 110374492
Staphylococcal infection 29.73 22.55 8 83504 69936 110435851
Shunt malfunction 29.68 22.55 11 83501 359 110505428
Spontaneous ejaculation 29.63 22.55 6 83506 15 110505772
Skin ulcer 29.59 22.55 6 83506 63639 110442148
Pancreatitis acute 29.48 22.55 5 83507 60269 110445518
Burning sensation 29.26 22.55 8 83504 69204 110436583
Blood pressure systolic increased 29.24 22.55 13 83499 82978 110422809
Sinusitis 29.19 22.55 120 83392 296568 110209219
Bone pain 28.55 22.55 7 83505 65126 110440661
Cerebral infarction 28.45 22.55 3 83509 51835 110453952
Bipolar I disorder 28.32 22.55 19 83493 2264 110503523
Social avoidant behaviour 28.25 22.55 27 83485 5342 110500445
Injection site bruising 28.05 22.55 3 83509 51260 110454527
Pulse abnormal 28 22.55 24 83488 4125 110501662
Lip swelling 27.63 22.55 3 83509 50664 110455123
Heart rate decreased 27.56 22.55 14 83498 82742 110423045
Swollen tongue 27.43 22.55 6 83506 60356 110445431
Haematocrit decreased 27.29 22.55 8 83504 66109 110439678
Therapy interrupted 27.04 22.55 3 83509 49819 110455968
Drug resistance 26.87 22.55 5 83507 56369 110449418
Cardiac disorder 26.79 22.55 12 83500 76268 110429519
Muscular weakness 26.64 22.55 296 83216 248172 110257615
Clostridium difficile infection 26.23 22.55 4 83508 52125 110453662
Lymphadenopathy 25.85 22.55 8 83504 63827 110441960
Tourette's disorder 25.83 22.55 7 83505 79 110505708
Cholelithiasis 25.59 22.55 8 83504 63414 110442373
Nephrolithiasis 25.58 22.55 9 83503 66203 110439584
Blood potassium decreased 25.37 22.55 5 83507 54109 110451678
Prescribed underdose 25.33 22.55 107 83405 65067 110440720
Rectal haemorrhage 25.25 22.55 32 83480 119801 110385986
Drug eruption 25.07 22.55 5 83507 53654 110452133
Scrotal pain 24.84 22.55 11 83501 572 110505215
Cerebral haemorrhage 24.81 22.55 9 83503 64959 110440828
Acute respiratory distress syndrome 24.76 22.55 5 83507 53193 110452594
Unevaluable event 24.75 22.55 7 83505 59220 110446567
Viral diarrhoea 24.65 22.55 11 83501 583 110505204
Paranoia 24.50 22.55 53 83459 22321 110483466
Physical assault 23.75 22.55 15 83497 1613 110504174
Bronchitis 23.74 22.55 52 83460 156980 110348807
Subcutaneous drug absorption impaired 23.54 22.55 29 83483 7630 110498157
Pain in jaw 23.43 22.55 5 83507 51172 110454615
Angina pectoris 23.17 22.55 9 83503 62286 110443501
Hepatocellular injury 23.08 22.55 5 83507 50637 110455150
Ulcer haemorrhage 23.05 22.55 52 83460 22519 110483268
Dysarthria 22.84 22.55 18 83494 84103 110421684
Multiple sclerosis relapse 22.81 22.55 5 83507 50235 110455552
X-ray abnormal 22.81 22.55 72 83440 38045 110467742
Peripheral swelling 22.74 22.55 430 83082 403604 110102183
Dry eye 22.58 22.55 7 83505 55786 110450001

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC N06BA09 NERVOUS SYSTEM
PSYCHOANALEPTICS
PSYCHOSTIMULANTS, AGENTS USED FOR ADHD AND NOOTROPICS
Centrally acting sympathomimetics
FDA MoA N0000000102 Norepinephrine Uptake Inhibitors
MeSH PA D014179 Neurotransmitter Uptake Inhibitors
MeSH PA D018377 Neurotransmitter Agents
MeSH PA D018663 Adrenergic Agents
MeSH PA D018759 Adrenergic Uptake Inhibitors
MeSH PA D049990 Membrane Transport Modulators
FDA EPC N0000175695 Norepinephrine Reuptake Inhibitor
CHEBI has role CHEBI:35469 antidepressant
CHEBI has role CHEBI:35476 antipsychotic agent
CHEBI has role CHEBI:35526 hypoglycemic agent
CHEBI has role CHEBI:35610 antineoplastic agent
CHEBI has role CHEBI:35640 adrenergic uptake inhibitor
CHEBI has role CHEBI:35703 xenobiotic
CHEBI has role CHEBI:48407 antiparkinson drug
CHEBI has role CHEBI:50514 vasoconstrictor agent
CHEBI has role CHEBI:78298 environmental contaminant

Related Drugs by ATC class:

N06BA Centrally acting sympathomimetics 14 drugs

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

DiseaseRelationSNOMED_IDDOID
Attention deficit hyperactivity disorder indication 406506008
Delay when starting to pass urine contraindication 5972002
Priapism contraindication 6273006 DOID:9286
Suicidal thoughts contraindication 6471006
Sinus tachycardia contraindication 11092001
Bipolar disorder contraindication 13746004 DOID:3312
Hyperbilirubinemia contraindication 14783006 DOID:2741
Myocardial infarction contraindication 22298006 DOID:5844
Feeling agitated contraindication 24199005
Orthostatic hypotension contraindication 28651003
Hypertensive disorder contraindication 38341003 DOID:10763
Conduction disorder of the heart contraindication 44808001
Low blood pressure contraindication 45007003
Chronic heart failure contraindication 48447003
Feeling irritable contraindication 55929007
Aggressive behavior contraindication 61372001
Cerebrovascular disease contraindication 62914000 DOID:6713
Psychotic disorder contraindication 69322001
Cardiomyopathy contraindication 85898001 DOID:0050700
Structural disorder of heart contraindication 128599005
Seizure disorder contraindication 128613002
Liver function tests abnormal contraindication 166603001
Cerebrovascular accident contraindication 230690007
Mania contraindication 231494001
Disease of liver contraindication 235856003 DOID:409
Raynaud's phenomenon contraindication 266261006
Retention of urine contraindication 267064002
Pheochromocytoma contraindication 302835009
Angle-closure glaucoma contraindication 392291006 DOID:13550
Disorder of coronary artery contraindication 414024009
Myocardial infarction in recovery phase contraindication 418044006




๐Ÿถ Veterinary Drug Use

None

๐Ÿถ Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 9.32 Basic

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
Sodium-dependent noradrenaline transporter Transporter INHIBITOR Kd 8.69 CHEMBL CHEMBL
Sodium-dependent serotonin transporter Transporter Kd 8.05 CHEMBL
Sodium-dependent dopamine transporter Transporter Kd 5.97 CHEMBL
Cytochrome P450 2D6 Enzyme Ki 4.77 WOMBAT-PK
G protein-activated inward rectifier potassium channel 2 Ion channel IC50 4.28 WOMBAT-PK
Kir3.1/Kir3.2 Ion channel IC50 4.48 WOMBAT-PK
Kir3.1/Kir3.4 Ion channel IC50 4.85 WOMBAT-PK
Potassium voltage-gated channel subfamily H member 2 Ion channel IC50 5.68 CHEMBL
Krueppel-like factor 10 Nuclear other IC50 4 CHEMBL
Sodium-dependent serotonin transporter Transporter Ki 7.37 CHEMBL
Sodium-dependent dopamine transporter Transporter Ki 5.85 CHEMBL
Transporter Transporter Ki 9.15 CHEMBL
Transporter Transporter Ki 8.40 CHEMBL

External reference:

IDSource
D02574 KEGG_DRUG
82248-59-7 SECONDARY_CAS_RN
353103 RXNORM
C0076823 UMLSCUI
CHEBI:127342 CHEBI
CHEMBL641 ChEMBL_ID
CHEMBL1702 ChEMBL_ID
DB00289 DRUGBANK_ID
D000069445 MESH_DESCRIPTOR_UI
54841 PUBCHEM_CID
7118 IUPHAR_LIGAND_ID
5354 INN_ID
ASW034S0B8 UNII
17042 MMSL
192105 MMSL
31170 MMSL
45567 MMSL
d04827 MMSL
A1LX4 PDB_CHEM_ID
4021364 VANDF
4024296 VANDF
009862 NDDF
009863 NDDF
407037005 SNOMEDCT_US
407038000 SNOMEDCT_US
412577007 SNOMEDCT_US
ASW034S0B8 INXIGHT DRUGS

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Strattera HUMAN PRESCRIPTION DRUG LABEL 1 0002-3227 CAPSULE 10 mg ORAL NDA 36 sections
Strattera HUMAN PRESCRIPTION DRUG LABEL 1 0002-3228 CAPSULE 25 mg ORAL NDA 36 sections
Strattera HUMAN PRESCRIPTION DRUG LABEL 1 0002-3229 CAPSULE 40 mg ORAL NDA 36 sections
Strattera HUMAN PRESCRIPTION DRUG LABEL 1 0002-3238 CAPSULE 18 mg ORAL NDA 36 sections
Strattera HUMAN PRESCRIPTION DRUG LABEL 1 0002-3239 CAPSULE 60 mg ORAL NDA 36 sections
Strattera HUMAN PRESCRIPTION DRUG LABEL 1 0002-3250 CAPSULE 80 mg ORAL NDA 36 sections
Strattera HUMAN PRESCRIPTION DRUG LABEL 1 0002-3251 CAPSULE 100 mg ORAL NDA 36 sections
Atomoxetine HUMAN PRESCRIPTION DRUG LABEL 1 0093-3542 CAPSULE 10 mg ORAL ANDA 32 sections
Atomoxetine HUMAN PRESCRIPTION DRUG LABEL 1 0093-3543 CAPSULE 18 mg ORAL ANDA 32 sections
Atomoxetine HUMAN PRESCRIPTION DRUG LABEL 1 0093-3544 CAPSULE 25 mg ORAL ANDA 32 sections
Atomoxetine HUMAN PRESCRIPTION DRUG LABEL 1 0093-3545 CAPSULE 40 mg ORAL ANDA 32 sections
Atomoxetine HUMAN PRESCRIPTION DRUG LABEL 1 0093-3546 CAPSULE 60 mg ORAL ANDA 32 sections
Atomoxetine HUMAN PRESCRIPTION DRUG LABEL 1 0093-3547 CAPSULE 80 mg ORAL ANDA 32 sections
Atomoxetine HUMAN PRESCRIPTION DRUG LABEL 1 0093-3548 CAPSULE 100 mg ORAL ANDA 32 sections
Atomoxetine hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0781-2260 CAPSULE 10 mg ORAL ANDA 32 sections
Atomoxetine hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0781-2261 CAPSULE 18 mg ORAL ANDA 32 sections
Atomoxetine hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0781-2262 CAPSULE 25 mg ORAL ANDA 32 sections
Atomoxetine hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0781-2263 CAPSULE 40 mg ORAL ANDA 32 sections
Atomoxetine hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0781-2264 CAPSULE 60 mg ORAL ANDA 32 sections
Atomoxetine hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0781-2265 CAPSULE 80 mg ORAL ANDA 32 sections
Atomoxetine hydrochloride HUMAN PRESCRIPTION DRUG LABEL 1 0781-2266 CAPSULE 100 mg ORAL ANDA 32 sections
Atomoxetine HUMAN PRESCRIPTION DRUG LABEL 1 0904-6908 CAPSULE 40 mg ORAL ANDA 32 sections
STRATTERA HUMAN PRESCRIPTION DRUG LABEL 1 16590-337 CAPSULE 10 mg ORAL NDA 35 sections
atomoxetine HUMAN PRESCRIPTION DRUG LABEL 1 16714-755 CAPSULE 10 mg ORAL ANDA 34 sections
atomoxetine HUMAN PRESCRIPTION DRUG LABEL 1 16714-756 CAPSULE 18 mg ORAL ANDA 34 sections
atomoxetine HUMAN PRESCRIPTION DRUG LABEL 1 16714-757 CAPSULE 25 mg ORAL ANDA 34 sections
atomoxetine HUMAN PRESCRIPTION DRUG LABEL 1 16714-758 CAPSULE 40 mg ORAL ANDA 34 sections
atomoxetine HUMAN PRESCRIPTION DRUG LABEL 1 16714-759 CAPSULE 60 mg ORAL ANDA 34 sections
atomoxetine HUMAN PRESCRIPTION DRUG LABEL 1 16714-760 CAPSULE 80 mg ORAL ANDA 34 sections
atomoxetine HUMAN PRESCRIPTION DRUG LABEL 1 16714-761 CAPSULE 100 mg ORAL ANDA 34 sections