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

Stem definitionDrug idCAS RN
anorexics 4135 608137-32-2

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • lisdexamfetamine
  • lisdexamphetamine
  • lisdexamfetamine dimesylate
  • vyvanse
  • lisdexamfetamine mesilate
A dextroamphetamine drug precursor that also functions as a CENTRAL NERVOUS SYSTEM STIMULANT and DOPAMINE UPTAKE INHIBITOR and is used in the treatment of ATTENTION DEFICIT HYPERACTIVITY DISORDER.
  • Molecular weight: 263.39
  • Formula: C15H25N3O
  • CLOGP: 0.81
  • LIPINSKI: 0
  • HAC: 4
  • HDO: 3
  • TPSA: 81.14
  • ALOGS: -3.48
  • ROTB: 8
  • Status: OFP
    • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

DoseUnitRoute
30 mg O

ADMET properties:

PropertyValueReference
Vd (Volume of distribution) 0.60 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 17 mL/min/kg Lombardo F, Berellini G, Obach RS
t_half (Half-life) 1.20 hours Lombardo F, Berellini G, Obach RS

Predicted pharmacokinetic/toxicological properties (PK-AZ):

PropertyDescriptionValueUnitConfidenceSimilarity
kinase-safety-class ACVR2A,ACVR2B,AKT1,AKT2,AKT3,AXL,BRAF,BTK,CAMK2B,CAMK2D,CDK4,CDK5,CDK9,DDR1,DYRK1B,EGFR,EIF2AK3,EPHB4,ERBB2,FLT3,GRK2,IKBKB,ITK,JAK2,JAK3,MAP2K6,MAP3K7,MAPK12,MAPK7,MET,NTRK2,PDK2,PDK4,PIM2,PRKDC,SIK2,SIK3,STK33,SYK,TEK,TGFBR1 41
kinase-selectivity-class AKT3,CAMK2D,EIF2AK3,PDK4,PRKCD 5
pfas-class PFAS structural alert (1 = True, 0 = False) 0

Approvals:

DateAgencyCompanyOrphan
March 26, 2019 PMDA SHIONOGI & CO., LTD.
Feb. 23, 2007 FDA SHIRE DEVELOPMENT

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
Intentional self-injury 2573.55 16.04 754 28193 28580 90570920
Intentional overdose 1944.32 16.04 823 28124 93011 90506489
Product availability issue 1074.81 16.04 283 28664 7121 90592379
Product physical issue 573.02 16.04 163 28784 5497 90594003
Disturbance in attention 543.18 16.04 276 28671 46833 90552667
Product quality issue 533.72 16.04 326 28621 78999 90520501
Inability to afford medication 320.68 16.04 94 28853 3528 90595972
Suicidal ideation 251.63 16.04 200 28747 73655 90525845
Feeling abnormal 238.18 16.04 280 28667 166955 90432545
Inappropriate schedule of product administration 226.84 16.04 259 28688 149674 90449826
Insurance issue 215.66 16.04 93 28854 10865 90588635
Drug ineffective 213.19 16.04 937 28010 1383361 89216139
Wrong technique in product usage process 206.50 16.04 176 28771 71395 90528105
Dissociation 190.27 16.04 74 28873 6641 90592859
Anxiety 185.90 16.04 345 28602 309427 90290073
No adverse event 181.60 16.04 160 28787 67822 90531678
Product dose omission issue 175.17 16.04 325 28622 291362 90308138
Product administration interrupted 157.97 16.04 78 28869 12414 90587086
Irritability 157.86 16.04 113 28834 35549 90563951
Therapeutic product effect variable 145.33 16.04 42 28905 1497 90598003
Product tampering 140.23 16.04 32 28915 431 90599069
Withdrawal syndrome 124.83 16.04 82 28865 22442 90577058
Therapeutic response shortened 109.37 16.04 76 28871 22803 90576697
Therapeutic product effect increased 103.16 16.04 31 28916 1268 90598232
Sedation 102.68 16.04 100 28847 48071 90551429
Product use issue 102.50 16.04 283 28664 329636 90269864
Attention deficit hyperactivity disorder 100.73 16.04 41 28906 4143 90595357
Mood swings 99.50 16.04 69 28878 20633 90578867
Anger 98.83 16.04 59 28888 13661 90585839
Depression 95.49 16.04 260 28687 300341 90299159
Tic 95.33 16.04 32 28915 1879 90597621
Somnolence 94.30 16.04 207 28740 208877 90390623
Dermatitis atopic 93.94 16.04 70 28877 23402 90576098
Illness 93.64 16.04 123 28824 81846 90517654
Feeling jittery 90.18 16.04 58 28889 15313 90584187
Incorrect dose administered 89.48 16.04 118 28829 78812 90520688
Systemic lupus erythematosus 83.81 16.04 9 28938 361887 90237613
Therapeutic response unexpected 82.57 16.04 63 28884 21817 90577683
Paranoia 81.44 16.04 51 28896 12857 90586643
Wound 74.23 16.04 6 28941 302974 90296526
Glossodynia 72.01 16.04 9 28938 321770 90277730
Acute kidney injury 71.60 16.04 9 28938 320378 90279122
Contraindicated product administered 71.53 16.04 9 28938 320130 90279370
Arthropathy 71.35 16.04 15 28932 366227 90233273
Suicide attempt 70.87 16.04 103 28844 75296 90524204
Joint swelling 69.67 16.04 37 28910 503263 90096237
Pneumonia 69.57 16.04 61 28886 637998 89961502
Rhesus incompatibility 68.89 16.04 14 28933 104 90599396
Product substitution issue 68.28 16.04 52 28895 17956 90581544
Pulse abnormal 66.77 16.04 28 28919 3051 90596449
Heart rate increased 66.59 16.04 125 28822 112777 90486723
Adulterated product 66.53 16.04 17 28930 377 90599123
Abnormal behaviour 65.93 16.04 56 28891 22572 90576928
Aggression 65.70 16.04 60 28887 26608 90572892
Hunger 65.65 16.04 35 28912 6528 90592972
Psychomotor hyperactivity 64.62 16.04 44 28903 12769 90586731
Treatment failure 62.25 16.04 11 28936 303917 90295583
Crying 61.81 16.04 57 28890 25588 90573912
Infusion related reaction 60.11 16.04 29 28918 416751 90182749
Death 59.67 16.04 36 28911 456515 90142985
Agitation 57.81 16.04 88 28859 67010 90532490
Claustrophobia 57.51 16.04 20 28927 1307 90598193
Pre-existing condition improved 57.27 16.04 36 28911 9133 90590367
Palpitations 56.71 16.04 131 28816 136597 90462903
Drug effect less than expected 56.56 16.04 31 28916 6107 90593393
Lower respiratory tract infection 56.10 16.04 7 28940 250652 90348848
Impulsive behaviour 55.95 16.04 21 28926 1709 90597791
Pyrexia 55.66 16.04 78 28869 660407 89939093
General physical health deterioration 55.49 16.04 22 28925 355093 90244407
Insomnia 53.84 16.04 230 28717 333244 90266256
Folliculitis 53.10 16.04 3 28944 204350 90395150
Jaw clicking 52.25 16.04 11 28936 99 90599401
Drug intolerance 52.20 16.04 40 28907 447551 90151949
Dermatillomania 52.15 16.04 13 28934 260 90599240
Euphoric mood 51.73 16.04 28 28919 5381 90594119
Stress 51.61 16.04 93 28854 81302 90518198
Acne 51.27 16.04 54 28893 28453 90571047
Bipolar disorder 50.48 16.04 33 28914 8952 90590548
Amphetamines positive 49.98 16.04 12 28935 204 90599296
Rheumatoid arthritis 49.64 16.04 27 28920 362587 90236913
Amphetamines negative 49.35 16.04 7 28940 0 90599500
Depressed mood 49.23 16.04 70 28877 50152 90549348
Mania 47.51 16.04 38 28909 14086 90585414
Mood altered 47.04 16.04 41 28906 17103 90582397
Impaired healing 46.82 16.04 9 28938 234190 90365310
Logorrhoea 46.71 16.04 21 28926 2706 90596794
Type 2 diabetes mellitus 44.69 16.04 6 28941 203238 90396262
Stomatitis 44.60 16.04 16 28931 274682 90324818
Anaemia 44.45 16.04 29 28918 352773 90246727
Neutropenia 44.21 16.04 9 28938 224895 90374605
Hepatic enzyme increased 43.64 16.04 31 28916 360705 90238795
Emotional disorder 43.45 16.04 37 28910 14960 90584540
Bruxism 42.89 16.04 23 28924 4340 90595160
Amenorrhoea 42.58 16.04 33 28914 11689 90587811
Diarrhoea 42.34 16.04 156 28791 939034 89660466
Hyperhidrosis 42.29 16.04 117 28830 136188 90463312
Somatic symptom disorder 42.06 16.04 21 28926 3420 90596080
Unevaluable event 40.44 16.04 67 28880 54781 90544719
Alopecia 40.15 16.04 60 28887 495011 90104489
Brain injury 40.04 16.04 27 28920 7711 90591789
Mobility decreased 40.03 16.04 15 28932 250719 90348781
Swelling 38.85 16.04 46 28901 419012 90180488
Tachyphrenia 38.63 16.04 16 28931 1690 90597810
Disease progression 38.62 16.04 3 28944 156612 90442888
Blister 37.88 16.04 17 28930 254981 90344519
Suspected product quality issue 37.30 16.04 11 28936 421 90599079
Panic attack 37.20 16.04 44 28903 26321 90573179
Tremor 36.68 16.04 120 28827 153053 90446447
Peripheral swelling 36.56 16.04 47 28900 413059 90186441
Mental disorder 36.12 16.04 48 28899 32270 90567230
Neurological symptom 35.69 16.04 24 28923 6823 90592677
Apathy 35.64 16.04 29 28918 11011 90588489
Oedema 35.47 16.04 10 28937 200285 90399215
Nervousness 34.16 16.04 48 28899 34008 90565492
Thrombocytopenia 34.14 16.04 12 28935 208713 90390787
C-reactive protein increased 34.14 16.04 8 28939 181381 90418119
Febrile neutropenia 34.04 16.04 5 28942 158344 90441156
Mydriasis 33.55 16.04 32 28915 14980 90584520
Serotonin syndrome 33.06 16.04 50 28897 37837 90561663
Change in sustained attention 32.90 16.04 5 28942 3 90599497
Hepatitis viral 32.88 16.04 11 28936 639 90598861
Complication of device insertion 32.82 16.04 27 28920 10409 90589091
Psychotic disorder 32.79 16.04 45 28902 31185 90568315
Hypersensitivity 32.32 16.04 60 28887 454617 90144883
Premature delivery 32.20 16.04 50 28897 38712 90560788
Irritable bowel syndrome 32.14 16.04 13 28934 207435 90392065
Thinking abnormal 32.07 16.04 28 28919 11704 90587796
Total cholesterol/HDL ratio abnormal 31.98 16.04 7 28940 77 90599423
Obsessive-compulsive disorder 31.48 16.04 19 28928 4485 90595015
Hyperphagia 30.95 16.04 16 28931 2802 90596698
Osteoarthritis 30.76 16.04 12 28935 195718 90403782
Vision blurred 30.64 16.04 91 28856 110202 90489298
Distractibility 30.44 16.04 10 28937 549 90598951
Educational problem 30.19 16.04 10 28937 563 90598937
Oedema peripheral 30.10 16.04 23 28924 257892 90341608
Binge eating 29.66 16.04 10 28937 595 90598905
Lung disorder 29.44 16.04 6 28941 149877 90449623
Hyperreflexia 29.23 16.04 21 28926 6636 90592864
Stress cardiomyopathy 28.96 16.04 28 28919 13327 90586173
Fall 28.87 16.04 70 28877 481740 90117760
Haemoglobin decreased 28.83 16.04 8 28939 161948 90437552
Bursitis 28.67 16.04 4 28943 131650 90467850
Somnambulism 28.15 16.04 20 28927 6208 90593292
Anti-transglutaminase antibody increased 27.85 16.04 5 28942 17 90599483
Product taste abnormal 27.11 16.04 14 28933 2446 90597054
Hyponatraemia 26.96 16.04 5 28942 133533 90465967
Arthralgia 26.74 16.04 143 28804 778379 89821121
Injury 26.54 16.04 15 28932 197334 90402166
Rabbit syndrome 26.51 16.04 8 28939 332 90599168
Infection 26.41 16.04 47 28900 362047 90237453
Onychophagia 26.35 16.04 6 28941 80 90599420
Blood cholesterol increased 26.31 16.04 17 28930 207995 90391505
Musculoskeletal pain 26.09 16.04 11 28936 171240 90428260
Frustration tolerance decreased 26.04 16.04 21 28926 7875 90591625
Drug dependence 26.01 16.04 39 28908 29288 90570212
Platelet count decreased 25.85 16.04 6 28941 136963 90462537
Drug hypersensitivity 25.74 16.04 70 28877 463539 90135961
Pica 24.74 16.04 5 28942 36 90599464
Performance status decreased 24.73 16.04 16 28931 4264 90595236
Exposure via skin contact 24.27 16.04 23 28924 10682 90588818
Intentional dose omission 23.97 16.04 29 28918 17754 90581746
Trichotillomania 23.53 16.04 6 28941 132 90599368
Liver disorder 23.52 16.04 5 28942 121264 90478236
White blood cell count decreased 23.50 16.04 12 28935 167097 90432403
Blood pressure increased 23.04 16.04 124 28823 197093 90402407
Initial insomnia 23.03 16.04 21 28926 9289 90590211
Pleural effusion 23.02 16.04 4 28943 111987 90487513
Gait inability 22.97 16.04 9 28938 146447 90453053
Enuresis 22.83 16.04 14 28933 3400 90596100
Device expulsion 22.52 16.04 44 28903 40842 90558658
Product prescribing error 22.45 16.04 37 28910 30108 90569392
Orthodontic procedure 22.41 16.04 4 28943 13 90599487
Autism spectrum disorder 22.28 16.04 10 28937 1283 90598217
Nasopharyngitis 22.19 16.04 62 28885 407042 90192458
Therapeutic product effect decreased 22.04 16.04 158 28789 277413 90322087
Gait disturbance 21.64 16.04 31 28916 260465 90339035
Menstruation irregular 21.56 16.04 19 28928 8041 90591459
Atrial fibrillation 21.30 16.04 8 28939 133603 90465897
Renal impairment 21.17 16.04 4 28943 105417 90494083
Drug diversion 20.97 16.04 9 28938 1038 90598462
Fibromyalgia 20.91 16.04 21 28926 206248 90393252
Poisoning deliberate 20.79 16.04 26 28921 16460 90583040
Inflammation 20.73 16.04 16 28931 178576 90420924
Product dose omission in error 20.71 16.04 29 28918 20474 90579026
Eosinophilic pneumonia acute 20.68 16.04 8 28939 707 90598793
Increased appetite 20.64 16.04 22 28925 11743 90587757
Foetal chromosome abnormality 20.57 16.04 4 28943 23 90599477
Restlessness 20.36 16.04 39 28908 35681 90563819
Cardiac failure 20.26 16.04 5 28942 109491 90490009
Tardive dyskinesia 20.18 16.04 21 28926 10909 90588591
Negativism 20.15 16.04 7 28940 456 90599044
Lip dry 19.91 16.04 4 28943 100951 90498549
Muscle tightness 19.91 16.04 23 28924 13416 90586084
Hypertensive emergency 19.88 16.04 11 28936 2206 90597294
Dyspnoea 19.82 16.04 183 28764 880772 89718728
Drug withdrawal syndrome 19.72 16.04 34 28913 28689 90570811
Grip strength decreased 19.72 16.04 3 28944 92573 90506927
Ill-defined disorder 19.70 16.04 18 28929 184873 90414627
Impaired quality of life 19.42 16.04 30 28917 23114 90576386
Wound infection 19.42 16.04 5 28942 106397 90493103
Cardiac failure congestive 19.28 16.04 4 28943 98690 90500810
Renal failure 19.03 16.04 9 28938 130998 90468502
Contusion 18.86 16.04 32 28915 251184 90348316
Restless legs syndrome 18.68 16.04 29 28918 22441 90577059
Osteoporosis 18.68 16.04 4 28943 96527 90502973
Poor quality product administered 18.42 16.04 13 28934 3995 90595505
Product label issue 18.27 16.04 8 28939 968 90598532
Menopause 18.17 16.04 12 28935 3309 90596191
Pharyngeal swelling 18.17 16.04 19 28928 9925 90589575
Drug screen negative 18.15 16.04 6 28941 336 90599164
Sleep-related eating disorder 18.06 16.04 8 28939 996 90598504
Sympathomimetic effect 18.03 16.04 5 28942 153 90599347
Memory impairment 17.86 16.04 116 28831 197128 90402372
Removal of foreign body from eye 17.85 16.04 3 28944 6 90599494
Rash 17.62 16.04 166 28781 795934 89803566
Sleep inertia 17.54 16.04 3 28944 7 90599493
Pulmonary embolism 17.50 16.04 10 28937 130810 90468690
Electric shock sensation 17.49 16.04 9 28938 1561 90597939
Respiratory failure 17.41 16.04 8 28939 118410 90481090
Product packaging quantity issue 17.32 16.04 9 28938 1593 90597907
Hepatic pain 17.31 16.04 12 28935 3583 90595917
Migraine 17.26 16.04 112 28835 190280 90409220
Dysgeusia 17.17 16.04 46 28901 52514 90546986
Personality change 17.11 16.04 16 28931 7305 90592195
Pain in extremity 17.00 16.04 80 28867 450449 90149051
Eczema 17.00 16.04 46 28901 52824 90546676
COVID-19 16.97 16.04 102 28845 168741 90430759
Neurodegenerative disorder 16.91 16.04 6 28941 416 90599084
Screaming 16.85 16.04 12 28935 3738 90595762
Pain 16.82 16.04 221 28726 996120 89603380
Completed suicide 16.79 16.04 91 28856 144967 90454533
Hypotension 16.67 16.04 51 28896 325346 90274154
Job dissatisfaction 16.50 16.04 4 28943 71 90599429
Surgery 16.43 16.04 41 28906 44846 90554654
Gastrointestinal disorder 16.39 16.04 36 28911 256651 90342849
Sepsis 16.36 16.04 20 28927 179794 90419706
Drug metabolite level high 16.32 16.04 3 28944 12 90599488
Musculoskeletal stiffness 16.27 16.04 45 28902 296487 90303013
Therapy non-responder 16.18 16.04 12 28935 136692 90462808
Peripheral coldness 16.09 16.04 21 28926 13871 90585629

FDA Adverse Event Reporting System (Male)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Product availability issue 708.52 24.30 190 20141 3377 42597627
Product quality issue 707.89 24.30 280 20051 17602 42583402
Intentional self-injury 549.39 24.30 223 20108 14979 42586025
Product physical issue 396.93 24.30 118 20213 3081 42597923
Intentional overdose 326.07 24.30 237 20094 51219 42549785
Disturbance in attention 309.43 24.30 187 20144 29679 42571325
Tic 274.43 24.30 83 20248 2300 42598704
Aggression 251.86 24.30 191 20140 43972 42557032
Inappropriate schedule of product administration 250.98 24.30 267 20064 95635 42505369
Psychomotor hyperactivity 212.48 24.30 104 20227 10854 42590150
Irritability 197.44 24.30 138 20193 27990 42573014
No adverse event 196.87 24.30 157 20174 38864 42562140
Drug ineffective 187.72 24.30 690 19641 629507 41971497
Anxiety 183.55 24.30 253 20078 118307 42482697
Suicidal ideation 179.84 24.30 163 20168 47998 42553006
Insurance issue 171.58 24.30 67 20264 4049 42596955
Inability to afford medication 169.62 24.30 56 20275 2074 42598930
Therapeutic product effect decreased 169.20 24.30 144 20187 39006 42561998
Abnormal behaviour 163.19 24.30 120 20211 26331 42574673
Wrong technique in product usage process 160.54 24.30 145 20186 42490 42558514
Product use issue 158.41 24.30 189 20142 76562 42524442
Therapeutic product effect increased 156.55 24.30 42 20289 745 42600259
Insomnia 154.67 24.30 233 20098 118020 42482984
Acute kidney injury 140.19 24.30 9 20322 367328 42233676
Crying 140.07 24.30 66 20265 6328 42594676
Depression 135.15 24.30 212 20119 111151 42489853
Catarrh 134.86 24.30 63 20268 5923 42595081
Pneumonia 133.70 24.30 21 20310 422128 42178876
Burns second degree 130.70 24.30 62 20269 6034 42594970
Steroid dependence 127.91 24.30 63 20268 6659 42594345
Oppositional defiant disorder 125.55 24.30 33 20298 539 42600465
Death 123.71 24.30 36 20295 471149 42129855
Choreoathetosis 120.73 24.30 37 20294 1072 42599932
Parosmia 119.88 24.30 63 20268 7628 42593376
Gingival pain 116.76 24.30 64 20267 8430 42592574
Hypopnoea 115.62 24.30 62 20269 7820 42593184
Bruxism 114.63 24.30 42 20289 2127 42598877
Disturbance in social behaviour 114.48 24.30 40 20291 1763 42599241
Anaemia 112.68 24.30 5 20326 280273 42320731
Palpitations 111.21 24.30 129 20202 50668 42550336
Impaired work ability 110.61 24.30 70 20261 12021 42588983
Systemic lupus erythematosus 108.53 24.30 63 20268 9261 42591743
Anger 108.31 24.30 71 20260 12947 42588057
Impaired quality of life 107.54 24.30 73 20258 14104 42586900
Dissociation 104.64 24.30 46 20285 3752 42597252
Decreased eye contact 104.45 24.30 28 20303 495 42600509
Alcohol poisoning 103.92 24.30 57 20274 7517 42593487
Agitation 95.98 24.30 135 20196 64179 42536825
Autism spectrum disorder 94.84 24.30 40 20291 2948 42598056
Migraine 94.75 24.30 86 20245 25328 42575676
Rhinitis 94.02 24.30 63 20268 11914 42589090
Emotional disorder 93.54 24.30 50 20281 6264 42594740
Mood altered 92.95 24.30 60 20271 10658 42590346
Cardiac murmur 92.68 24.30 64 20267 12711 42588293
Impulsive behaviour 92.40 24.30 37 20294 2388 42598616
Feeling abnormal 90.38 24.30 137 20194 69649 42531355
Prescribed overdose 87.34 24.30 62 20269 12865 42588139
Homicidal ideation 87.34 24.30 37 20294 2757 42598247
Colitis ulcerative 86.83 24.30 83 20248 26092 42574912
Logorrhoea 83.87 24.30 36 20295 2771 42598233
Educational problem 83.48 24.30 24 20307 554 42600450
Swollen tongue 83.40 24.30 74 20257 21157 42579847
Nightmare 80.49 24.30 78 20253 24934 42576070
Therapeutic response shortened 80.21 24.30 60 20271 13494 42587510
Frequent bowel movements 78.93 24.30 72 20259 21335 42579669
Depressed mood 77.28 24.30 74 20257 23310 42577694
Negativism 76.37 24.30 21 20310 410 42600594
Dyskinesia 75.79 24.30 76 20255 25314 42575690
Sepsis 75.56 24.30 5 20326 199329 42401675
Thrombocytopenia 74.46 24.30 4 20327 190275 42410729
Incorrect dose administered 74.31 24.30 108 20223 52866 42548138
Accidental overdose 74.11 24.30 79 20252 28251 42572753
Stress 73.78 24.30 98 20233 44114 42556890
Affect lability 71.31 24.30 36 20295 4008 42596996
Therapeutic product effect variable 70.89 24.30 33 20298 3076 42597928
Bronchiectasis 69.17 24.30 62 20269 17957 42583047
Attention deficit hyperactivity disorder 67.81 24.30 32 20299 3076 42597928
Neutropenia 67.51 24.30 8 20323 199423 42401581
Trismus 66.96 24.30 31 20300 2853 42598151
Loss of personal independence in daily activities 64.75 24.30 98 20233 49718 42551286
Dyspnoea 64.35 24.30 70 20261 442551 42158453
Headache 63.75 24.30 254 20077 239115 42361889
Dystonia 63.44 24.30 51 20280 12739 42588265
Tinnitus 62.47 24.30 73 20258 28865 42572139
Product tampering 61.54 24.30 12 20319 43 42600961
Feeling jittery 59.36 24.30 33 20298 4465 42596539
Medication error 57.64 24.30 75 20256 33079 42567925
Decreased appetite 56.33 24.30 211 20120 192926 42408078
Trichotillomania 55.78 24.30 12 20319 77 42600927
Eczema 52.97 24.30 73 20258 34013 42566991
Nervousness 52.80 24.30 47 20284 13485 42587519
Product administered to patient of inappropriate age 52.32 24.30 31 20300 4730 42596274
Somnolence 52.31 24.30 167 20164 140938 42460066
Diarrhoea 51.70 24.30 88 20243 460761 42140243
Dysgeusia 51.30 24.30 72 20259 34117 42566887
Haemoglobin decreased 48.24 24.30 4 20327 132467 42468537
Renal failure 48.04 24.30 6 20325 143720 42457284
Asthenia 47.05 24.30 39 20292 280754 42320250
Sleep disorder 46.76 24.30 83 20248 48012 42552992
Sedation 45.46 24.30 64 20267 30411 42570593
Speech disorder 44.69 24.30 62 20269 29059 42571945
Vertigo 43.81 24.30 67 20264 34280 42566724
Paranoia 43.72 24.30 43 20288 13983 42587021
Febrile neutropenia 43.65 24.30 17 20314 185686 42415318
Tubulointerstitial nephritis 42.31 24.30 63 20268 31485 42569519
Hunger 41.93 24.30 20 20311 1968 42599036
Coordination abnormal 41.85 24.30 33 20298 8017 42592987
Breech presentation 41.54 24.30 11 20320 185 42600819
Arthritis 41.41 24.30 73 20258 41992 42559012
Respiratory failure 41.27 24.30 6 20325 128126 42472878
Dermatillomania 40.55 24.30 9 20322 68 42600936
General physical health deterioration 40.55 24.30 11 20320 151235 42449769
Weight decreased 40.40 24.30 201 20130 207747 42393257
Withdrawal syndrome 40.05 24.30 42 20289 14733 42586271
Amphetamines negative 39.89 24.30 6 20325 0 42601004
Atrial fibrillation 39.66 24.30 9 20322 139584 42461420
Product dose omission issue 39.56 24.30 162 20169 154203 42446801
Rectal haemorrhage 38.77 24.30 78 20253 49528 42551476
Product administration interrupted 38.67 24.30 26 20305 4940 42596064
Renal impairment 38.33 24.30 4 20327 110224 42490780
Blood creatinine increased 38.24 24.30 4 20327 109999 42491005
Oedema peripheral 38.21 24.30 9 20322 136067 42464937
Suicidal behaviour 37.09 24.30 17 20314 1529 42599475
Hypotension 37.05 24.30 41 20290 257590 42343414
Drug effect less than expected 36.95 24.30 23 20308 3834 42597170
Amphetamines positive 36.33 24.30 10 20321 196 42600808
Adverse drug reaction 35.61 24.30 64 20267 37370 42563634
Oculogyric crisis 34.94 24.30 17 20314 1748 42599256
Change in sustained attention 34.01 24.30 6 20325 10 42600994
Abdominal discomfort 32.47 24.30 94 20237 75161 42525843
Haematochezia 32.29 24.30 80 20251 58356 42542648
Mania 32.25 24.30 32 20299 10515 42590489
Foetal distress syndrome 31.49 24.30 14 20317 1172 42599832
Poor quality sleep 31.41 24.30 30 20301 9410 42591594
Adverse event 31.40 24.30 47 20284 23593 42577411
Initial insomnia 31.14 24.30 21 20310 4009 42596995
Accidental exposure to product by child 30.74 24.30 15 20316 1552 42599452
Hyperkinesia 29.36 24.30 16 20315 2082 42598922
Psychotic disorder 29.14 24.30 51 20280 29157 42571847
Tardive dyskinesia 28.92 24.30 25 20306 6899 42594105
Hallucination, visual 28.21 24.30 42 20289 20978 42580026
Cardiac failure 28.20 24.30 8 20323 106848 42494156
Pleural effusion 28.12 24.30 6 20325 97160 42503844
White blood cell count decreased 27.81 24.30 9 20322 110387 42490617
Hyperkalaemia 27.76 24.30 3 20328 80455 42520549
Suspected product tampering 27.43 24.30 5 20326 11 42600993
Intentional product use issue 26.55 24.30 85 20246 71748 42529256
Rhesus incompatibility 26.51 24.30 6 20325 50 42600954
Jaundice neonatal 26.09 24.30 15 20316 2164 42598840
Disseminated mycobacterium avium complex infection 25.86 24.30 8 20323 239 42600765
Obsessive-compulsive disorder 25.47 24.30 23 20308 6720 42594284
Streptococcal infection 25.32 24.30 22 20309 6110 42594894
Urinary tract infection 25.17 24.30 8 20323 99276 42501728
Drug tolerance 25.08 24.30 17 20314 3273 42597731
Therapeutic response unexpected 25.03 24.30 29 20302 11352 42589652
Myocardial infarction 25.03 24.30 14 20317 123995 42477009
Neuropathy peripheral 24.45 24.30 9 20322 101844 42499160
Polydipsia psychogenic 24.37 24.30 7 20324 161 42600843

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
Intentional self-injury 2903.66 17.27 884 36046 36545 110515824
Intentional overdose 2040.46 17.27 957 35973 131544 110420825
Product quality issue 616.01 17.27 360 36570 76939 110475430
Disturbance in attention 481.36 17.27 284 36646 61711 110490658
Suicidal ideation 354.19 17.27 275 36655 93662 110458707
Product physical issue 326.78 17.27 104 36826 4932 110547437
Dissociation 315.19 17.27 120 36810 9722 110542647
Product availability issue 314.52 17.27 113 36817 7777 110544592
Tic 311.12 17.27 92 36838 3401 110548968
Aggression 301.73 17.27 208 36722 59002 110493367
Irritability 277.25 17.27 182 36748 47627 110504742
Inappropriate schedule of product administration 260.19 17.27 330 36600 203307 110349062
Anxiety 216.65 17.27 402 36528 344676 110207693
Psychomotor hyperactivity 209.17 17.27 112 36818 20165 110532204
Wrong technique in product usage process 197.45 17.27 191 36739 87157 110465212
Feeling abnormal 188.02 17.27 265 36665 180446 110371923
Therapeutic product effect increased 187.27 17.27 53 36877 1672 110550697
Abnormal behaviour 184.50 17.27 131 36799 38908 110513461
Drug ineffective 173.88 17.27 978 35952 1519562 109032807
Attention deficit hyperactivity disorder 159.21 17.27 59 36871 4432 110547937
Anger 157.76 17.27 91 36839 18916 110533453
Sedation 156.76 17.27 152 36778 69531 110482838
Burns second degree 153.79 17.27 67 36863 7666 110544703
Catarrh 150.61 17.27 65 36865 7270 110545099
Acute kidney injury 150.30 17.27 18 36912 635412 109916957
Agitation 150.27 17.27 187 36743 112864 110439505
Palpitations 147.41 17.27 221 36709 158991 110393378
Steroid dependence 141.64 17.27 65 36865 8404 110543965
Crying 139.92 17.27 94 36836 25534 110526835
Insomnia 133.99 17.27 340 36590 360250 110192119
Pneumonia 133.70 17.27 63 36867 876651 109675718
Depression 131.46 17.27 312 36618 317023 110235346
Oppositional defiant disorder 130.03 17.27 31 36899 487 110551882
Bruxism 128.57 17.27 52 36878 4942 110547427
Autism spectrum disorder 125.43 17.27 40 36890 1908 110550461
Parosmia 125.36 17.27 69 36861 13111 110539258
Hypopnoea 123.41 17.27 65 36865 11315 110541054
Alcohol poisoning 122.56 17.27 60 36870 8960 110543409
Product dose omission issue 122.22 17.27 306 36624 321476 110230893
Logorrhoea 118.69 17.27 49 36881 4908 110547461
Withdrawal syndrome 114.10 17.27 90 36840 31290 110521079
Choreoathetosis 114.02 17.27 36 36894 1662 110550707
Mood altered 113.34 17.27 77 36853 21298 110531071
Gingival pain 111.41 17.27 68 36862 15668 110536701
Impaired quality of life 111.11 17.27 87 36843 29930 110522439
Stress 108.75 17.27 154 36776 105194 110447175
Therapeutic product effect variable 108.59 17.27 39 36891 2679 110549690
Anaemia 108.31 17.27 25 36905 547061 110005308
Product tampering 106.53 17.27 26 36904 453 110551916
Homicidal ideation 104.63 17.27 41 36889 3586 110548783
Impulsive behaviour 104.62 17.27 40 36890 3275 110549094
Paranoia 103.21 17.27 74 36856 22300 110530069
Death 99.32 17.27 55 36875 698814 109853555
Product administration interrupted 98.90 17.27 56 36874 11236 110541133
Decreased eye contact 98.82 17.27 28 36902 887 110551482
Educational problem 93.22 17.27 24 36906 524 110551845
Somnolence 92.78 17.27 263 36667 297186 110255183
Impaired work ability 90.14 17.27 73 36857 26346 110526023
Dysgeusia 90.14 17.27 114 36816 69871 110482498
Product substitution issue 90.05 17.27 69 36861 22992 110529377
Dyskinesia 89.91 17.27 98 36832 51348 110501021
Rhinitis 89.23 17.27 68 36862 22477 110529892
Dermatillomania 88.80 17.27 21 36909 318 110552051
Cardiac murmur 88.18 17.27 70 36860 24558 110527811
No adverse event 86.85 17.27 115 36815 73724 110478645
Insurance issue 85.92 17.27 50 36880 10562 110541807
Depressed mood 84.65 17.27 103 36827 60706 110491663
Nightmare 84.06 17.27 83 36847 38780 110513589
Swollen tongue 82.01 17.27 101 36829 60261 110492108
Neutropenia 80.61 17.27 14 36916 374606 110177763
Feeling jittery 80.36 17.27 54 36876 14668 110537701
Mood swings 79.88 17.27 64 36866 22748 110529621
Dermatitis atopic 79.68 17.27 67 36863 25474 110526895
Inability to afford medication 76.79 17.27 34 36896 4042 110548327
Thrombocytopenia 75.14 17.27 13 36917 348872 110203497
Disturbance in social behaviour 72.80 17.27 35 36895 5023 110547346
Negativism 72.07 17.27 22 36908 907 110551462
General physical health deterioration 68.73 17.27 28 36902 425267 110127102
Accidental overdose 67.64 17.27 85 36845 51749 110500620
Heart rate increased 66.72 17.27 148 36782 143686 110408683
Eczema 64.93 17.27 99 36831 72194 110480175
Joint swelling 64.08 17.27 34 36896 442811 110109558
Trismus 64.02 17.27 35 36895 6561 110545808
Migraine 63.78 17.27 162 36768 171490 110380879
Dystonia 63.15 17.27 59 36871 25746 110526623
Suicide attempt 62.87 17.27 119 36811 103275 110449094
Emotional disorder 62.32 17.27 48 36882 16112 110536257
Diarrhoea 61.90 17.27 186 36744 1139319 109413050
Therapeutic response unexpected 61.23 17.27 56 36874 23787 110528582
Nervousness 60.59 17.27 68 36862 36783 110515586
Therapeutic response shortened 59.96 17.27 61 36869 29522 110522847
Arthropathy 59.16 17.27 12 36918 287510 110264859
Incorrect dose administered 59.00 17.27 116 36814 103525 110448844
Treatment failure 58.24 17.27 11 36919 277223 110275146
Speech disorder 57.68 17.27 86 36844 61483 110490886
Pulse abnormal 57.57 17.27 28 36902 4121 110548248
Euphoric mood 57.05 17.27 36 36894 8791 110543578
Bronchiectasis 56.04 17.27 65 36865 36428 110515941
Hyperhidrosis 55.81 17.27 163 36767 187135 110365234
Trichotillomania 55.53 17.27 13 36917 188 110552181
Sepsis 55.45 17.27 20 36910 327326 110225043
Product administered to patient of inappropriate age 55.03 17.27 34 36896 8002 110544367
Drug intolerance 54.82 17.27 34 36896 406478 110145891
Infusion related reaction 54.06 17.27 30 36900 381132 110171237
Mania 53.71 17.27 49 36881 20747 110531622
Colitis ulcerative 53.31 17.27 94 36836 77269 110475100
Claustrophobia 53.25 17.27 20 36910 1559 110550810
Tinnitus 53.09 17.27 82 36848 60458 110491911
Lower respiratory tract infection 52.46 17.27 9 36921 243097 110309272
Jaw clicking 52.38 17.27 11 36919 93 110552276
Wound 52.11 17.27 8 36922 234429 110317940
Contraindicated product administered 51.83 17.27 10 36920 248257 110304112
Headache 51.34 17.27 484 36446 881893 109670476
Platelet count decreased 50.91 17.27 8 36922 230435 110321934
Illness 50.48 17.27 95 36835 82076 110470293
Psychotic disorder 50.39 17.27 73 36857 50864 110501505
Oedema peripheral 49.37 17.27 24 36906 328636 110223733
Febrile neutropenia 49.33 17.27 22 36908 316745 110235624
Glossodynia 48.38 17.27 8 36922 221996 110330373
Frequent bowel movements 48.23 17.27 86 36844 71304 110481065
Hunger 47.93 17.27 29 36901 6575 110545794
Haemoglobin decreased 47.91 17.27 12 36918 248715 110303654
Adulterated product 47.75 17.27 17 36913 1138 110551231
Drug effect less than expected 47.68 17.27 30 36900 7290 110545079
Stomatitis 46.64 17.27 16 36914 270226 110282143
Malignant neoplasm progression 46.44 17.27 3 36927 174564 110377805
Atrial fibrillation 46.38 17.27 10 36920 229632 110322737
Affect lability 46.35 17.27 43 36887 18594 110533775
Change in sustained attention 46.32 17.27 8 36922 19 110552350
Somatic symptom disorder 45.89 17.27 22 36908 3137 110549232
Tachyphrenia 45.50 17.27 20 36910 2336 110550033
Tubulointerstitial nephritis 45.47 17.27 72 36858 54212 110498157
Tardive dyskinesia 45.22 17.27 37 36893 13542 110538827
Peripheral swelling 45.21 17.27 41 36889 403993 110148376
Serotonin syndrome 44.86 17.27 75 36855 59078 110493291
Rheumatoid arthritis 44.81 17.27 22 36908 299591 110252778
Mobility decreased 44.69 17.27 12 36918 237410 110314959
Therapeutic product effect decreased 43.36 17.27 179 36751 244137 110308232
Vertigo 43.25 17.27 92 36838 86778 110465591
Vision blurred 43.04 17.27 117 36813 128905 110423464
Obsessive-compulsive disorder 43.01 17.27 28 36902 7213 110545156
Dyspnoea 42.98 17.27 207 36723 1106665 109445704
Acne 42.20 17.27 54 36876 33466 110518903
Renal failure 41.62 17.27 12 36918 226562 110325807
Amenorrhoea 41.36 17.27 30 36900 9201 110543168
Swelling 41.24 17.27 34 36896 351007 110201362
C-reactive protein increased 41.04 17.27 11 36919 217908 110334461
Impaired healing 40.89 17.27 8 36922 196709 110355660
Panic attack 40.23 17.27 49 36881 28891 110523478
Accidental exposure to product by child 39.67 17.27 20 36910 3178 110549191
Type 2 diabetes mellitus 39.49 17.27 6 36924 177226 110375143
Renal impairment 38.47 17.27 8 36922 188437 110363932
Arthralgia 36.90 17.27 135 36795 779497 109772872
Osteoarthritis 36.77 17.27 8 36922 182615 110369754
Mydriasis 36.62 17.27 41 36889 22116 110530253
Medication error 36.60 17.27 97 36833 105269 110447100
Cardiac failure 36.23 17.27 9 36921 187617 110364752
Lung disorder 36.03 17.27 8 36922 180039 110372330
Inflammation 35.92 17.27 10 36920 193228 110359141
Thinking abnormal 35.87 17.27 34 36896 15106 110537263
Muscle injury 35.79 17.27 3 36927 140804 110411565
Blister 35.06 17.27 16 36914 227360 110325009
Respiratory failure 35.05 17.27 14 36916 215318 110337051
Hyperkalaemia 34.23 17.27 3 36927 135793 110416576
Loss of personal independence in daily activities 34.12 17.27 119 36811 149901 110402468
Hyperreflexia 34.03 17.27 27 36903 9458 110542911
Cardiac failure congestive 33.90 17.27 5 36925 150995 110401374
Apathy 33.85 17.27 34 36896 16205 110536164
Gastrointestinal haemorrhage 33.84 17.27 7 36923 165511 110386858
Oedema 33.61 17.27 14 36916 209962 110342407
Complication of device insertion 33.53 17.27 26 36904 8812 110543557
Hypotension 33.26 17.27 79 36851 523770 110028599
Bipolar disorder 33.09 17.27 26 36904 8981 110543388
Hallucination 32.85 17.27 91 36839 101341 110451028
Drug hypersensitivity 32.54 17.27 64 36866 454026 110098343
Adverse drug reaction 32.52 17.27 93 36837 105466 110446903
Hyponatraemia 32.51 17.27 16 36914 217637 110334732
Weight decreased 32.44 17.27 267 36663 467790 110084579
Initial insomnia 31.88 17.27 27 36903 10362 110542007
Total cholesterol/HDL ratio abnormal 31.58 17.27 7 36923 78 110552291
Pleural effusion 31.57 17.27 10 36920 177699 110374670
Anti-transglutaminase antibody increased 31.29 17.27 6 36924 30 110552339
White blood cell count decreased 31.16 17.27 19 36911 229371 110322998
Hallucination, visual 31.08 17.27 51 36879 39554 110512815
Restlessness 30.84 17.27 62 36868 56197 110496172
Personality change 30.53 17.27 27 36903 10975 110541394
Fall 29.53 17.27 103 36827 603379 109948990
Hepatic enzyme increased 28.80 17.27 39 36891 320853 110231516
COVID-19 28.52 17.27 159 36771 244901 110307468
Hyperkinesia 28.45 17.27 16 36914 3168 110549201
Gaming disorder 28.35 17.27 5 36925 14 110552355
Sensory overload 28.02 17.27 4 36926 0 110552369
Amphetamines negative 28.02 17.27 4 36926 0 110552369
Hallucination, auditory 27.83 17.27 39 36891 26358 110526011
Adrenergic syndrome 27.77 17.27 8 36922 269 110552100
Neurological symptom 27.73 17.27 30 36900 15578 110536791
Brain injury 27.69 17.27 28 36902 13448 110538921
Myocardial infarction 27.38 17.27 15 36915 192068 110360301
Asthenia 27.16 17.27 128 36802 688871 109863498
Neutrophil count decreased 27.16 17.27 4 36926 120937 110431432
Decreased appetite 26.57 17.27 259 36671 475587 110076782
Fibromyalgia 26.39 17.27 12 36918 170897 110381472
Tachycardia 26.34 17.27 147 36783 226498 110325871
Irritable bowel syndrome 26.19 17.27 11 36919 164204 110388165
Tremor 26.10 17.27 135 36795 202097 110350272
Infection 25.98 17.27 51 36879 362149 110190220
Oculogyric crisis 25.70 17.27 16 36914 3816 110548553
Alopecia 25.61 17.27 52 36878 364701 110187668
Social avoidant behaviour 25.31 17.27 18 36912 5351 110547018
Unevaluable event 25.28 17.27 59 36871 59168 110493201
Mental disorder 25.26 17.27 46 36884 38745 110513624
Rabbit syndrome 25.09 17.27 8 36922 381 110551988
Haematochezia 24.86 17.27 90 36840 115434 110436935
Hypersensitivity 24.78 17.27 62 36868 403936 110148433
Exposure via skin contact 24.64 17.27 26 36904 13121 110539248
Nasopharyngitis 24.60 17.27 60 36870 394301 110158068
Device expulsion 24.54 17.27 40 36890 30851 110521518
Screaming 24.49 17.27 17 36913 4864 110547505
Suicidal behaviour 24.47 17.27 15 36915 3482 110548887
Drug diversion 24.36 17.27 11 36919 1369 110551000
Pre-existing condition improved 24.33 17.27 19 36911 6507 110545862
Affective disorder 24.29 17.27 24 36906 11217 110541152
Stress cardiomyopathy 24.01 17.27 28 36902 15778 110536591
Musculoskeletal pain 23.70 17.27 16 36914 183007 110369362
Hepatitis viral 23.66 17.27 11 36919 1464 110550905
Orthodontic procedure 23.63 17.27 4 36926 8 110552361
Chronic obstructive pulmonary disease 23.63 17.27 4 36926 109154 110443215
Peripheral coldness 23.54 17.27 30 36900 18510 110533859
Coordination abnormal 23.28 17.27 35 36895 25193 110527176
Disseminated mycobacterium avium complex infection 22.85 17.27 8 36922 510 110551859
Amphetamines positive 22.76 17.27 7 36923 296 110552073
Somnambulism 22.48 17.27 18 36912 6387 110545982
Pyrexia 22.46 17.27 192 36738 898073 109654296
Self-destructive behaviour 22.34 17.27 9 36921 846 110551523
Wound infection 22.10 17.27 3 36927 96462 110455907
Polydipsia psychogenic 21.92 17.27 7 36923 335 110552034
Product use issue 21.67 17.27 178 36752 311517 110240852
Blood cholesterol increased 21.56 17.27 18 36912 184767 110367602
Libido decreased 21.52 17.27 17 36913 5918 110546451
Contusion 21.30 17.27 28 36902 233333 110319036
Lactic acidosis 21.00 17.27 3 36927 92808 110459561
Urinary tract infection 20.85 17.27 49 36881 326233 110226136
Saccadic eye movement 20.77 17.27 6 36924 204 110552165
Liver disorder 20.43 17.27 11 36919 142232 110410137
Pica 20.28 17.27 5 36925 91 110552278
Neuropathy peripheral 20.26 17.27 18 36912 179259 110373110
Oxygen saturation decreased 19.96 17.27 14 36916 156968 110395401
Off label use 19.77 17.27 647 36283 1499538 109052831
Drug tolerance 19.75 17.27 26 36904 16559 110535810
Blood HIV RNA increased 19.56 17.27 11 36919 2177 110550192
Thrombosis 19.50 17.27 6 36924 108656 110443713
Streptococcal infection 19.46 17.27 21 36909 10869 110541500
Delusion 19.19 17.27 31 36899 23724 110528645
Poor quality sleep 19.18 17.27 34 36896 28043 110524326
Condition aggravated 19.11 17.27 348 36582 734488 109817881
Onychophagia 19.01 17.27 5 36925 119 110552250
Blood creatinine increased 18.77 17.27 20 36910 182869 110369500
Hypokalaemia 18.67 17.27 20 36910 182428 110369941
Dehydration 18.65 17.27 41 36889 279470 110272899
Increased appetite 18.65 17.27 24 36906 14953 110537416
Product prescribing error 18.58 17.27 48 36882 51283 110501086
Restless legs syndrome 18.37 17.27 31 36899 24595 110527774
Sleep inertia 18.35 17.27 4 36926 41 110552328
Arthritis 18.35 17.27 107 36823 167479 110384890
Social problem 18.34 17.27 10 36920 1864 110550505
Leukopenia 17.97 17.27 14 36916 148777 110403592
Abnormal uterine bleeding 17.81 17.27 9 36921 1438 110550931
Removal of foreign body from eye 17.72 17.27 3 36927 6 110552363
Frustration tolerance decreased 17.68 17.27 18 36912 8713 110543656
Akathisia 17.62 17.27 25 36905 17088 110535281
Hypertensive emergency 17.59 17.27 12 36918 3339 110549030
Injury 17.51 17.27 20 36910 177245 110375124
Sleep disorder 17.51 17.27 120 36810 198524 110353845
Fatigue 17.45 17.27 530 36400 1215428 109336941
Drug metabolite level high 17.34 17.27 4 36926 54 110552315

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC N06BA12 NERVOUS SYSTEM
PSYCHOANALEPTICS
PSYCHOSTIMULANTS, AGENTS USED FOR ADHD AND NOOTROPICS
Centrally acting sympathomimetics
MeSH PA D000697 Central Nervous System Stimulants
MeSH PA D014179 Neurotransmitter Uptake Inhibitors
MeSH PA D015259 Dopamine Agents
MeSH PA D018377 Neurotransmitter Agents
MeSH PA D018765 Dopamine Uptake Inhibitors
MeSH PA D049990 Membrane Transport Modulators
FDA PE N0000175729 Central Nervous System Stimulation
FDA EPC N0000175739 Central Nervous System Stimulant
CHEBI has role CHEBI:35469 antidepressant
CHEBI has role CHEBI:35476 antipsychotic agent
CHEBI has role CHEBI:35705 immunosuppressive agent
CHEBI has role CHEBI:39456 antiglaucoma drug
CHEBI has role CHEBI:74518 anti-obesity agent

Related Drugs by ATC class:

N06BA Centrally acting sympathomimetics 14 drugs
amfetaminearmodafinilatomoxetinedexamfetaminedexmethylphenidatefencamfaminfenetyllinefenozolonemethamphetaminemethylphenidatemodafinilpemoline show all 14 →

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

DiseaseRelationSNOMED_IDDOID
Attention deficit hyperactivity disorder indication 406506008
Binge eating disorder indication 439960005
Narcolepsy off-label use 60380001 DOID:8986
Gilles de la Tourette's syndrome contraindication 5158005 DOID:11119
Bipolar disorder contraindication 13746004 DOID:3312
Myocardial infarction contraindication 22298006 DOID:5844
Glaucoma contraindication 23986001 DOID:1686
Feeling agitated contraindication 24199005
Hyperthyroidism contraindication 34486009 DOID:7998
Hypertensive disorder contraindication 38341003 DOID:10763
Conduction disorder of the heart contraindication 44808001
Chronic heart failure contraindication 48447003
Aggressive behavior contraindication 61372001
Substance abuse contraindication 66214007
Psychotic disorder contraindication 69322001
Arteriosclerotic vascular disease contraindication 72092001
Cardiomyopathy contraindication 85898001 DOID:0050700
Weight loss contraindication 89362005
Structural disorder of heart contraindication 128599005
Seizure disorder contraindication 128613002
Motor tic disorder contraindication 230337001
Cerebrovascular accident contraindication 230690007
Mania contraindication 231494001
Visual impairment contraindication 397540003
Breastfeeding (mother) contraindication 413712001
Disorder of coronary artery contraindication 414024009
Myocardial infarction in recovery phase contraindication 418044006
Hypertensive urgency contraindication 443482000




🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 12.84 acidic
pKa2 10.65 Basic
pKa3 7.51 Basic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
10MG/ML ARYNTA AZURITY N219847 June 16, 2025 RX SOLUTION ORAL 12433859 April 16, 2040 INDICATED FOR THE TREATMENT OF ATTENTION-DEFICIT/HYPERACTIVITY DISORDER (ADHD)

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])		Mechanism
action		Bioact sourceMoA source
Sodium-dependent noradrenaline transporter Transporter RELEASING AGENT CHEMBL CHEMBL
Sodium-dependent dopamine transporter Transporter RELEASING AGENT DRUGBANK CHEMBL
Synaptic vesicular amine transporter Transporter INHIBITOR CHEMBL CHEMBL

External reference:

IDSource
4026030 VUID
N0000176089 NUI
D04747 KEGG_DRUG
608137-33-3 SECONDARY_CAS_RN
4026030 VANDF
4026031 VANDF
C1873633 UMLSCUI
CHEBI:135925 CHEBI
CHEMBL1201222 ChEMBL_ID
CHEMBL1201178 ChEMBL_ID
D000069478 MESH_DESCRIPTOR_UI
DB01255 DRUGBANK_ID
7213 IUPHAR_LIGAND_ID
8690 INN_ID
H645GUL8KJ UNII
11597698 PUBCHEM_CID
673579 RXNORM
108098 MMSL
23471 MMSL
370546 MMSL
d06663 MMSL
011972 NDDF
011987 NDDF
425597005 SNOMEDCT_US
426249000 SNOMEDCT_US
427427002 SNOMEDCT_US
H645GUL8KJ INXIGHT DRUGS

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Lisdexamfetamine Dimesylate HUMAN PRESCRIPTION DRUG LABEL 1 0054-0370 CAPSULE 20 mg ORAL ANDA 29 sections
Lisdexamfetamine Dimesylate HUMAN PRESCRIPTION DRUG LABEL 1 0054-0371 CAPSULE 30 mg ORAL ANDA 29 sections
Lisdexamfetamine Dimesylate HUMAN PRESCRIPTION DRUG LABEL 1 0054-0372 CAPSULE 40 mg ORAL ANDA 29 sections
Lisdexamfetamine Dimesylate HUMAN PRESCRIPTION DRUG LABEL 1 0054-0373 CAPSULE 50 mg ORAL ANDA 29 sections
Lisdexamfetamine Dimesylate HUMAN PRESCRIPTION DRUG LABEL 1 0054-0374 CAPSULE 60 mg ORAL ANDA 29 sections
Lisdexamfetamine Dimesylate HUMAN PRESCRIPTION DRUG LABEL 1 0054-0375 CAPSULE 70 mg ORAL ANDA 29 sections
Lisdexamfetamine Dimesylate HUMAN PRESCRIPTION DRUG LABEL 1 0054-0660 CAPSULE 10 mg ORAL ANDA 29 sections
Lisdexamfetamine Dimesylate HUMAN PRESCRIPTION DRUG LABEL 1 0378-6854 CAPSULE 10 mg ORAL ANDA 34 sections
Lisdexamfetamine Dimesylate HUMAN PRESCRIPTION DRUG LABEL 1 0378-6854 CAPSULE 10 mg ORAL ANDA 34 sections
Lisdexamfetamine Dimesylate HUMAN PRESCRIPTION DRUG LABEL 1 0378-6855 CAPSULE 20 mg ORAL ANDA 34 sections
Lisdexamfetamine Dimesylate HUMAN PRESCRIPTION DRUG LABEL 1 0378-6855 CAPSULE 20 mg ORAL ANDA 34 sections
Lisdexamfetamine Dimesylate HUMAN PRESCRIPTION DRUG LABEL 1 0378-6856 CAPSULE 30 mg ORAL ANDA 34 sections
Lisdexamfetamine Dimesylate HUMAN PRESCRIPTION DRUG LABEL 1 0378-6856 CAPSULE 30 mg ORAL ANDA 34 sections
Lisdexamfetamine Dimesylate HUMAN PRESCRIPTION DRUG LABEL 1 0378-6857 CAPSULE 40 mg ORAL ANDA 34 sections
Lisdexamfetamine Dimesylate HUMAN PRESCRIPTION DRUG LABEL 1 0378-6857 CAPSULE 40 mg ORAL ANDA 34 sections
Lisdexamfetamine Dimesylate HUMAN PRESCRIPTION DRUG LABEL 1 0378-6858 CAPSULE 50 mg ORAL ANDA 34 sections
Lisdexamfetamine Dimesylate HUMAN PRESCRIPTION DRUG LABEL 1 0378-6858 CAPSULE 50 mg ORAL ANDA 34 sections
Lisdexamfetamine Dimesylate HUMAN PRESCRIPTION DRUG LABEL 1 0378-6859 CAPSULE 60 mg ORAL ANDA 34 sections
Lisdexamfetamine Dimesylate HUMAN PRESCRIPTION DRUG LABEL 1 0378-6859 CAPSULE 60 mg ORAL ANDA 34 sections
Lisdexamfetamine Dimesylate HUMAN PRESCRIPTION DRUG LABEL 1 0378-6860 CAPSULE 70 mg ORAL ANDA 34 sections
Lisdexamfetamine Dimesylate HUMAN PRESCRIPTION DRUG LABEL 1 0378-6860 CAPSULE 70 mg ORAL ANDA 34 sections
Lisdexamfetamine Dimesylate HUMAN PRESCRIPTION DRUG LABEL 1 0406-5111 CAPSULE 10 mg ORAL ANDA 37 sections
Lisdexamfetamine Dimesylate HUMAN PRESCRIPTION DRUG LABEL 1 0406-5112 CAPSULE 20 mg ORAL ANDA 37 sections
Lisdexamfetamine Dimesylate HUMAN PRESCRIPTION DRUG LABEL 1 0406-5113 CAPSULE 30 mg ORAL ANDA 37 sections
Lisdexamfetamine Dimesylate HUMAN PRESCRIPTION DRUG LABEL 1 0406-5114 CAPSULE 40 mg ORAL ANDA 37 sections
Lisdexamfetamine Dimesylate HUMAN PRESCRIPTION DRUG LABEL 1 0406-5115 CAPSULE 50 mg ORAL ANDA 37 sections
Lisdexamfetamine Dimesylate HUMAN PRESCRIPTION DRUG LABEL 1 0406-5116 CAPSULE 60 mg ORAL ANDA 37 sections
Lisdexamfetamine Dimesylate HUMAN PRESCRIPTION DRUG LABEL 1 0406-5117 CAPSULE 70 mg ORAL ANDA 37 sections
Lisdexamfetamine Dimesylate HUMAN PRESCRIPTION DRUG LABEL 1 0406-5124 TABLET, CHEWABLE 10 mg ORAL ANDA 37 sections
Lisdexamfetamine Dimesylate HUMAN PRESCRIPTION DRUG LABEL 1 0406-5125 TABLET, CHEWABLE 20 mg ORAL ANDA 37 sections