dexamfetamine Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definitionDrug idCAS RN
anorexics 841 51-64-9

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • dextroamphetamine
  • S-Amphetamine
  • D-Amphetamine
  • dexadrine
  • dexamfetamine
  • dextroamphetamine sulfate
  • dextroamphetamine saccharate
  • dextroamphetamine adipate
  • dextroamphetamine resin complex
The d-form of AMPHETAMINE. It is a central nervous system stimulant and a sympathomimetic. It has also been used in the treatment of narcolepsy and of attention deficit disorders and hyperactivity in children. Dextroamphetamine has multiple mechanisms of action including blocking uptake of adrenergics and dopamine, stimulating release of monamines, and inhibiting monoamine oxidase. It is also a drug of abuse and a psychotomimetic.
  • Molecular weight: 135.21
  • Formula: C9H13N
  • CLOGP: 1.74
  • LIPINSKI: 0
  • HAC: 1
  • HDO: 1
  • TPSA: 26.02
  • ALOGS: -1.89
  • ROTB: 2

  • Status: OFP

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

Drug dosage:

DoseUnitRoute
15 mg O

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 0 Benet LZ, Broccatelli F, Oprea TI
S (Water solubility) 1 mg/mL Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine) 40 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 7.40 ┬ÁM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability) 75 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H

Approvals:

DateAgencyCompanyOrphan
Sept. 9, 1955 FDA UCB INC

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
Pre-existing condition improved 248.91 13.94 103 24642 6509 46654808
Prescribed overdose 242.65 13.94 116 24629 10333 46650984
Anxiety 210.71 13.94 359 24386 181598 46479719
Product substitution issue 189.58 13.94 111 24634 14920 46646397
Depression 179.15 13.94 322 24423 169782 46491535
Suicidal ideation 161.08 13.94 173 24572 56209 46605108
Feeling abnormal 148.84 13.94 250 24495 124810 46536507
Migraine 129.24 13.94 172 24573 69854 46591463
Sleep apnoea syndrome 125.91 13.94 100 24645 22101 46639216
Product physical issue 121.41 13.94 57 24688 4870 46656447
Product quality issue 115.42 13.94 117 24628 35531 46625786
Drug ineffective 106.27 13.94 666 24079 677172 45984145
Disturbance in attention 104.76 13.94 105 24640 31455 46629862
Therapeutic response unexpected 100.88 13.94 76 24669 15540 46645777
Somnolence 85.89 13.94 228 24517 156293 46505024
Cataplexy 79.48 13.94 28 24717 1135 46660182
Inappropriate schedule of product administration 70.69 13.94 125 24620 64888 46596429
Irritability 69.20 13.94 81 24664 28865 46632452
Neutropenia 63.32 13.94 3 24742 143201 46518116
Somnambulism 62.96 13.94 37 24708 5000 46656317
Headache 61.93 13.94 449 24296 477903 46183414
Coronary artery dissection 60.41 13.94 20 24725 670 46660647
Surgery 58.18 13.94 74 24671 28711 46632606
Multiple sclerosis relapse 57.88 13.94 90 24655 42035 46619282
Panic attack 57.54 13.94 62 24683 20180 46641137
Anaemia 56.16 13.94 33 24712 255746 46405571
Death 47.68 13.94 65 24680 335483 46325834
Device expulsion 45.24 13.94 64 24681 27478 46633839
Anger 44.11 13.94 42 24703 11810 46649507
Asthma exercise induced 44.06 13.94 11 24734 129 46661188
Memory impairment 42.68 13.94 113 24632 77224 46584093
Snoring 42.28 13.94 25 24720 3417 46657900
Complication of device insertion 40.96 13.94 28 24717 4916 46656401
Hyponatraemia 39.37 13.94 4 24741 101328 46559989
Febrile neutropenia 38.75 13.94 3 24742 94624 46566693
Product dose omission issue 38.48 13.94 184 24561 168336 46492981
Pyrexia 38.09 13.94 80 24665 348722 46312595
Stress 37.73 13.94 84 24661 51467 46609850
Acute kidney injury 37.34 13.94 42 24703 235813 46425504
Hunger 37.06 13.94 24 24721 3851 46657466
Compartment syndrome 36.91 13.94 19 24726 1980 46659337
Tremor 36.23 13.94 139 24606 115500 46545817
Attention deficit hyperactivity disorder 35.43 13.94 19 24726 2153 46659164
Rheumatoid arthritis 34.62 13.94 46 24699 240169 46421148
Thrombocytopenia 34.50 13.94 12 24733 126569 46534748
Pancytopenia 33.99 13.94 3 24742 85055 46576262
Abnormal sleep-related event 32.79 13.94 13 24732 734 46660583
Stress cardiomyopathy 31.69 13.94 29 24716 7755 46653562
Completed suicide 31.63 13.94 157 24588 145763 46515554
Insomnia 31.30 13.94 171 24574 164753 46496564
Drug tolerance 30.95 13.94 20 24725 3198 46658119
Oedema peripheral 30.47 13.94 24 24721 159682 46501635
Post-traumatic stress disorder 29.06 13.94 21 24724 4027 46657290
Cardiac failure 28.96 13.94 4 24741 79944 46581373
Tachyphrenia 28.92 13.94 14 24731 1280 46660037
No adverse event 28.75 13.94 59 24686 34172 46627145
Renal impairment 28.72 13.94 3 24742 74369 46586948
Enuresis 28.49 13.94 16 24729 1984 46659333
Extra dose administered 28.39 13.94 22 24723 4685 46656632
Serotonin syndrome 28.17 13.94 48 24697 24172 46637145
Unevaluable event 28.08 13.94 70 24675 46105 46615212
Product tampering 27.89 13.94 7 24738 84 46661233
Suspected product quality issue 27.57 13.94 8 24737 171 46661146
Illness 27.22 13.94 33 24712 12191 46649126
Mood altered 27.16 13.94 34 24711 12973 46648344
Sleep paralysis 27.16 13.94 10 24735 461 46660856
Wrong technique in product usage process 26.52 13.94 76 24669 54346 46606971
Device dislocation 26.41 13.94 44 24701 21758 46639559
Diarrhoea 25.99 13.94 182 24563 559420 46101897
Hangover 25.93 13.94 13 24732 1282 46660035
Bipolar disorder 25.88 13.94 25 24720 7152 46654165
Feeling drunk 25.28 13.94 19 24726 3868 46657449
General physical health deterioration 25.27 13.94 15 24730 115754 46545563
Pneumonia 24.76 13.94 109 24636 376211 46285106
Cardiac failure congestive 24.48 13.94 9 24736 91741 46569576
Drug diversion 24.47 13.94 11 24734 850 46660467
Nephrolithiasis 24.34 13.94 54 24691 32997 46628320
Paranoia 24.23 13.94 29 24716 10568 46650749
Oxygen saturation decreased 23.82 13.94 4 24741 69160 46592157
Haemoglobin decreased 23.82 13.94 20 24725 128929 46532388
Agitation 23.79 13.94 74 24671 55341 46605976
Multiple sclerosis 23.56 13.94 45 24700 24746 46636571
Dry mouth 23.26 13.94 73 24672 54853 46606464
Weight decreased 23.25 13.94 191 24554 210658 46450659
Atrial fibrillation 23.21 13.94 13 24732 103577 46557740
Therapeutic response changed 22.75 13.94 10 24735 732 46660585
Thinking abnormal 22.68 13.94 27 24718 9787 46651530
Product preparation error 22.47 13.94 18 24727 4021 46657296
Uterine perforation 21.96 13.94 23 24722 7244 46654073
Joint swelling 21.74 13.94 34 24711 166039 46495278
Dyspnoea 21.38 13.94 173 24572 515375 46145942
Mood swings 21.31 13.94 34 24711 16218 46645099
Intentional product use issue 21.30 13.94 69 24676 52711 46608606
Drug interaction 20.95 13.94 48 24697 203046 46458271
Initial insomnia 20.94 13.94 18 24727 4434 46656883
Postural orthostatic tachycardia syndrome 20.61 13.94 9 24736 649 46660668
Hypnagogic hallucination 20.60 13.94 6 24739 130 46661187
Platelet count decreased 20.41 13.94 14 24731 100010 46561307
Complication of device removal 20.37 13.94 16 24729 3474 46657843
Disability 20.32 13.94 26 24719 10141 46651176
Feeling jittery 20.21 13.94 27 24718 10981 46650336
Bruxism 20.18 13.94 15 24730 3002 46658315
Aggression 20.05 13.94 40 24705 22704 46638613
Acne 19.97 13.94 37 24708 19882 46641435
Seizure like phenomena 19.95 13.94 10 24735 985 46660332
Muscle twitching 19.66 13.94 31 24714 14641 46646676
Crying 19.63 13.94 38 24707 21103 46640214
Infusion related reaction 19.56 13.94 15 24730 101193 46560124
Blood creatinine increased 19.54 13.94 8 24737 76395 46584922
Renal failure 19.33 13.94 19 24726 113575 46547742
Pleural effusion 19.18 13.94 10 24735 82942 46578375
Victim of crime 18.89 13.94 5 24740 75 46661242
Shoulder operation 18.81 13.94 12 24733 1876 46659441
Suicide attempt 18.75 13.94 68 24677 54968 46606349
Hypotension 18.74 13.94 62 24683 232527 46428790
Muscle spasms 18.42 13.94 120 24625 122993 46538324
Embedded device 18.40 13.94 14 24731 2902 46658415
Gastrointestinal haemorrhage 18.38 13.94 9 24736 77364 46583953
Disease progression 18.33 13.94 13 24732 91287 46570030
Victim of abuse 18.20 13.94 5 24740 87 46661230
Weight increased 18.12 13.94 149 24596 164324 46496993
Condition aggravated 18.10 13.94 204 24541 244848 46416469
Tic 17.91 13.94 10 24735 1226 46660091
Road traffic accident 17.77 13.94 39 24706 23652 46637665
Treatment failure 17.73 13.94 14 24731 93073 46568244
Sepsis 17.65 13.94 28 24717 135986 46525331
Change in sustained attention 17.55 13.94 3 24742 3 46661314
Colitis ischaemic 17.31 13.94 24 24721 10108 46651209
Injury 17.26 13.94 57 24688 43970 46617347
Lower respiratory tract infection 17.26 13.94 4 24741 55085 46606232
Hysterectomy 17.26 13.94 21 24724 7785 46653532
Hyperhidrosis 17.18 13.94 93 24652 89215 46572102
Respiratory failure 17.14 13.94 15 24730 94801 46566516
Substance use 17.12 13.94 7 24738 428 46660889
Myocardial infarction 16.96 13.94 16 24729 97512 46563805
Depressed mood 16.68 13.94 47 24698 33272 46628045
Arthralgia 16.66 13.94 119 24626 364484 46296833
Device breakage 16.62 13.94 23 24722 9669 46651648
Educational problem 16.28 13.94 6 24739 277 46661040
Libido increased 16.20 13.94 8 24737 764 46660553
Leukopenia 16.16 13.94 8 24737 68335 46592982
Withdrawal syndrome 16.11 13.94 32 24713 18102 46643215
Drug withdrawal syndrome 16.10 13.94 41 24704 27343 46633974
Narcolepsy 15.78 13.94 9 24736 1150 46660167
Drug intolerance 15.77 13.94 34 24711 147015 46514302
Multiple organ dysfunction syndrome 15.72 13.94 4 24741 51706 46609611
Blood testosterone increased 15.69 13.94 5 24740 148 46661169
White blood cell count decreased 15.63 13.94 22 24723 112209 46549108
Pulmonary oedema 15.45 13.94 4 24741 51101 46610216
Dermatillomania 15.11 13.94 5 24740 167 46661150
Therapeutic response shortened 14.90 13.94 16 24729 5183 46656134
Interstitial lung disease 14.89 13.94 5 24740 53944 46607373
Alcoholism 14.78 13.94 11 24734 2207 46659110
Dysphoria 14.72 13.94 15 24730 4574 46656743
Victim of spousal abuse 14.43 13.94 3 24742 14 46661303
Overdose 14.40 13.94 98 24647 101881 46559436
Dyspareunia 14.23 13.94 11 24734 2333 46658984
Fatigue 14.14 13.94 422 24323 608275 46053042
Breast atrophy 14.10 13.94 3 24742 16 46661301
Parasomnia 14.06 13.94 6 24739 409 46660908
Therapeutic product effect increased 14.03 13.94 8 24737 1022 46660295

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 substitution issue 217.25 18.26 95 10968 9940 29931475
Drug ineffective 200.49 18.26 407 10656 339980 29601435
Anxiety 148.36 18.26 174 10889 89697 29851718
Prescribed overdose 147.08 18.26 69 10994 8492 29932923
Suicidal ideation 131.62 18.26 108 10955 36006 29905409
Aggression 115.25 18.26 101 10962 36806 29904609
Product quality issue 113.12 18.26 76 10987 18698 29922717
Feeling abnormal 110.78 18.26 120 10943 56636 29884779
Depression 109.32 18.26 150 10913 90287 29851128
Irritability 107.98 18.26 80 10983 22970 29918445
Crying 83.53 18.26 41 11022 5568 29935847
Oppositional defiant disorder 83.16 18.26 21 11042 381 29941034
Insomnia 81.49 18.26 133 10930 93203 29848212
Product physical issue 79.46 18.26 30 11033 2144 29939271
Sleep apnoea syndrome 77.79 18.26 58 11005 16799 29924616
Decreased eye contact 76.66 18.26 20 11043 415 29941000
Impulsive behaviour 71.40 18.26 27 11036 1938 29939477
Bruxism 69.34 18.26 24 11039 1335 29940080
Anger 69.32 18.26 46 11017 11074 29930341
Abnormal behaviour 66.02 18.26 63 11000 25560 29915855
Tic 63.42 18.26 25 11038 2007 29939408
Homicidal ideation 58.77 18.26 25 11038 2438 29938977
Disturbance in attention 58.13 18.26 55 11008 22074 29919341
Psychomotor hyperactivity 56.10 18.26 36 11027 8188 29933227
Somnolence 54.25 18.26 114 10949 96649 29844766
Psychotic disorder 51.84 18.26 51 11012 21464 29919951
Educational problem 48.27 18.26 13 11050 306 29941109
Affect lability 47.97 18.26 24 11039 3394 29938021
Depressed mood 47.95 18.26 44 11019 16985 29924430
Coordination abnormal 47.42 18.26 31 11032 7274 29934141
Acute kidney injury 45.87 18.26 22 11041 273820 29667595
Poor quality sleep 45.23 18.26 30 11033 7211 29934204
Mood altered 44.00 18.26 31 11032 8219 29933196
Pre-existing condition improved 43.44 18.26 19 11044 1982 29939433
Pneumonia 42.23 18.26 37 11026 334269 29607146
Anaemia 40.91 18.26 13 11050 207979 29733436
Therapeutic response unexpected 39.65 18.26 30 11033 8873 29932542
No adverse event 39.58 18.26 40 11023 17379 29924036
Choreoathetosis 38.07 18.26 14 11049 929 29940486
Completed suicide 38.05 18.26 101 10962 99391 29842024
Inappropriate schedule of product administration 37.86 18.26 59 11004 39669 29901746
Therapeutic product effect decreased 37.72 18.26 50 11013 29026 29912389
Electrocardiogram QRS complex prolonged 37.54 18.26 22 11041 4255 29937160
Migraine 35.72 18.26 33 11030 12841 29928574
Somnambulism 34.89 18.26 19 11044 3195 29938220
Restless legs syndrome 34.75 18.26 25 11038 6847 29934568
Death 33.75 18.26 50 11013 357233 29584182
Disturbance in social behaviour 32.04 18.26 14 11049 1457 29939958
Agitation 31.77 18.26 65 10998 54008 29887407
Trismus 31.41 18.26 16 11047 2349 29939066
Intentional overdose 29.42 18.26 54 11009 41427 29899988
Emotional disorder 29.17 18.26 20 11043 5074 29936341
Thyrotoxic crisis 28.88 18.26 9 11054 359 29941056
Headache 28.59 18.26 138 10925 182168 29759247
Sleep disorder 28.57 18.26 40 11023 24439 29916976
Incorrect route of product administration 27.58 18.26 27 11036 11288 29930127
Speech disorder 27.05 18.26 39 11024 24473 29916942
Substance use 26.94 18.26 9 11054 449 29940966
Weight increased 26.56 18.26 74 10989 74839 29866576
Sleep-related eating disorder 26.35 18.26 8 11055 292 29941123
Febrile neutropenia 26.31 18.26 4 11059 106689 29834726
Attention deficit hyperactivity disorder 26.16 18.26 13 11050 1811 29939604
Muscle necrosis 25.71 18.26 10 11053 774 29940641
Sepsis 25.64 18.26 11 11052 146384 29795031
Product dose omission issue 25.41 18.26 83 10980 91548 29849867
Neutropenia 25.30 18.26 8 11055 128532 29812883
Fatigue 25.14 18.26 203 10860 320470 29620945
Therapeutic response shortened 25.14 18.26 16 11047 3584 29937831
Cataplexy 24.63 18.26 8 11055 365 29941050
Post-traumatic stress disorder 24.62 18.26 12 11051 1603 29939812
Unevaluable event 24.61 18.26 43 11020 31742 29909673
Paranoia 24.25 18.26 24 11039 10164 29931251
Pyrexia 24.24 18.26 45 11018 294444 29646971
Renal failure 23.71 18.26 9 11054 128957 29812458
Memory impairment 22.19 18.26 45 11018 37129 29904286
Hypotension 22.03 18.26 25 11038 200540 29740875
Sexual dysfunction 21.93 18.26 18 11045 5983 29935432
Drug abuse 21.55 18.26 73 10990 81999 29859416
Streptococcal infection 21.26 18.26 16 11047 4692 29936723
Renal impairment 21.11 18.26 3 11060 84181 29857234
Amphetamines positive 20.94 18.26 5 11058 71 29941344
Enuresis 20.69 18.26 11 11052 1763 29939652
Mood swings 20.10 18.26 19 11044 7607 29933808
Dystonia 19.68 18.26 21 11042 9706 29931709
Intentional product misuse 19.56 18.26 41 11022 34626 29906789
Libido decreased 19.48 18.26 15 11048 4551 29936864
Supraventricular extrasystoles 19.20 18.26 13 11050 3231 29938184
Hyperkinesia 18.96 18.26 11 11052 2087 29939328
Wrong technique in product usage process 18.93 18.26 38 11025 31117 29910298
Hyperhidrosis 18.79 18.26 61 11002 67029 29874386
Seizure 18.73 18.26 79 10984 98396 29843019
Gastrointestinal haemorrhage 18.69 18.26 4 11059 83442 29857973
Thrombocytopenia 18.69 18.26 14 11049 137030 29804385
Platelet count decreased 18.53 18.26 8 11055 106121 29835294
Hypertensive emergency 18.28 18.26 8 11055 836 29940579

Pharmacologic Action:

SourceCodeDescription
ATC N06BA02 NERVOUS SYSTEM
PSYCHOANALEPTICS
PSYCHOSTIMULANTS, AGENTS USED FOR ADHD AND NOOTROPICS
Centrally acting sympathomimetics
FDA PE N0000175729 Central Nervous System Stimulation
FDA EPC N0000175739 Central Nervous System Stimulant
CHEBI has role CHEBI:35524 sympathomimetic
CHEBI has role CHEBI:35640 adrenergic uptake inhibitors
CHEBI has role CHEBI:37962 adrenergic neuron agents
CHEBI has role CHEBI:48560 dopamine agents
CHEBI has role CHEBI:50910 agente neurotoxico
CHEBI has role CHEBI:51039 dopamine reuptake inhibitors
MeSH PA D002491 Central Nervous System Agents
MeSH PA D000697 Central Nervous System Stimulants
MeSH PA D015259 Dopamine Agents
MeSH PA D018765 Dopamine Uptake Inhibitors
MeSH PA D049990 Membrane Transport Modulators
MeSH PA D018377 Neurotransmitter Agents
MeSH PA D014179 Neurotransmitter Uptake Inhibitors

Drug Use (View source of the data)

DiseaseRelationSNOMED_IDDOID
Narcolepsy indication 60380001 DOID:8986
Attention deficit hyperactivity disorder indication 406506008
Gilles de la Tourette's syndrome contraindication 5158005 DOID:11119
Dependent drug abuse contraindication 6525002
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
Disorder of cardiovascular system contraindication 49601007 DOID:1287
Anorexia nervosa contraindication 56882008 DOID:8689
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
Cardiovascular event risk contraindication 395112001
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

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 9.89 Basic

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
12.5MG;12.5MG;12.5MG;12.5MG MYDAYIS TAKEDA PHARMS USA N022063 June 20, 2017 RX CAPSULE, EXTENDED RELEASE ORAL Sept. 13, 2022 INFORMATION ADDED TO THE LABELING TO DESCRIBE A TRIAL EVALUATING A LOWER DOSE THAN THOSE APPROVED FOR PEDIATRIC PATIENTS 13 TO 17 YEARS OF AGE
3.125MG;3.125MG;3.125MG;3.125MG MYDAYIS TAKEDA PHARMS USA N022063 June 20, 2017 RX CAPSULE, EXTENDED RELEASE ORAL Sept. 13, 2022 INFORMATION ADDED TO THE LABELING TO DESCRIBE A TRIAL EVALUATING A LOWER DOSE THAN THOSE APPROVED FOR PEDIATRIC PATIENTS 13 TO 17 YEARS OF AGE
6.25MG;6.25MG;6.25MG;6.25MG MYDAYIS TAKEDA PHARMS USA N022063 June 20, 2017 RX CAPSULE, EXTENDED RELEASE ORAL Sept. 13, 2022 INFORMATION ADDED TO THE LABELING TO DESCRIBE A TRIAL EVALUATING A LOWER DOSE THAN THOSE APPROVED FOR PEDIATRIC PATIENTS 13 TO 17 YEARS OF AGE
9.375MG;9.375MG;9.375MG;9.375MG MYDAYIS TAKEDA PHARMS USA N022063 June 20, 2017 RX CAPSULE, EXTENDED RELEASE ORAL Sept. 13, 2022 INFORMATION ADDED TO THE LABELING TO DESCRIBE A TRIAL EVALUATING A LOWER DOSE THAN THOSE APPROVED FOR PEDIATRIC PATIENTS 13 TO 17 YEARS OF AGE
12.5MG;12.5MG;12.5MG;12.5MG MYDAYIS TAKEDA PHARMS USA N022063 June 20, 2017 RX CAPSULE, EXTENDED RELEASE ORAL March 13, 2023 PEDIATRIC EXCLUSIVITY
3.125MG;3.125MG;3.125MG;3.125MG MYDAYIS TAKEDA PHARMS USA N022063 June 20, 2017 RX CAPSULE, EXTENDED RELEASE ORAL March 13, 2023 PEDIATRIC EXCLUSIVITY
6.25MG;6.25MG;6.25MG;6.25MG MYDAYIS TAKEDA PHARMS USA N022063 June 20, 2017 RX CAPSULE, EXTENDED RELEASE ORAL March 13, 2023 PEDIATRIC EXCLUSIVITY
9.375MG;9.375MG;9.375MG;9.375MG MYDAYIS TAKEDA PHARMS USA N022063 June 20, 2017 RX CAPSULE, EXTENDED RELEASE ORAL March 13, 2023 PEDIATRIC EXCLUSIVITY

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
Sodium-dependent dopamine transporter Transporter RELEASING AGENT Ki 6.68 WOMBAT-PK CHEMBL
Synaptic vesicular amine transporter Transporter INHIBITOR CHEMBL CHEMBL
Sodium-dependent noradrenaline transporter Transporter INHIBITOR Ki 7 IUPHAR CHEMBL
Sodium-dependent serotonin transporter Transporter Ki 5.24 CHEMBL
5-hydroxytryptamine receptor 1A GPCR Ki 5.18 PDSP
Trace amine-associated receptor 1 GPCR EC50 6.87 WOMBAT-PK
Cocaine- and amphetamine-regulated transcript protein Transcription factor WOMBAT-PK
Alpha-1A adrenergic receptor GPCR WOMBAT-PK
Alpha-2A adrenergic receptor GPCR WOMBAT-PK
Amine oxidase [flavin-containing] A Enzyme Ki 4.84 CHEMBL
Trace amine-associated receptor 1 GPCR EC50 7.25 CHEMBL
Trace amine-associated receptor 1 GPCR EC50 8.70 CHEMBL
Serotonin (5-HT) receptor GPCR Kd 5.35 CHEMBL
Trace amine-associated receptor 1 GPCR EC50 6 CHEMBL
Amine oxidase [flavin-containing] A Enzyme Ki 4.91 CHEMBL
Sodium-dependent dopamine transporter Transporter IC50 5.31 CHEMBL

External reference:

IDSource
4019978 VUID
N0000148062 NUI
D02078 KEGG_DRUG
64770-52-1 SECONDARY_CAS_RN
4018004 VANDF
4018005 VANDF
4018835 VANDF
4019978 VANDF
C0011812 UMLSCUI
CHEBI:4469 CHEBI
1WE PDB_CHEM_ID
CHEMBL612 ChEMBL_ID
CHEMBL1200782 ChEMBL_ID
CHEMBL3989844 ChEMBL_ID
CHEMBL3544971 ChEMBL_ID
DB01576 DRUGBANK_ID
D003913 MESH_DESCRIPTOR_UI
5826 PUBCHEM_CID
2147 IUPHAR_LIGAND_ID
1430 INN_ID
TZ47U051FI UNII
221088 RXNORM
1604 MMSL
4563 MMSL
4564 MMSL
d00804 MMSL
001793 NDDF
001795 NDDF
006720 NDDF
387022005 SNOMEDCT_US
387278002 SNOMEDCT_US
45207006 SNOMEDCT_US
50868004 SNOMEDCT_US

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate HUMAN PRESCRIPTION DRUG LABEL 4 0115-1328 CAPSULE, EXTENDED RELEASE 1.25 mg ORAL NDA AUTHORIZED GENERIC 36 sections
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate HUMAN PRESCRIPTION DRUG LABEL 4 0115-1328 CAPSULE, EXTENDED RELEASE 1.25 mg ORAL NDA AUTHORIZED GENERIC 36 sections
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate HUMAN PRESCRIPTION DRUG LABEL 4 0115-1329 CAPSULE, EXTENDED RELEASE 2.50 mg ORAL NDA AUTHORIZED GENERIC 36 sections
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate HUMAN PRESCRIPTION DRUG LABEL 4 0115-1329 CAPSULE, EXTENDED RELEASE 2.50 mg ORAL NDA AUTHORIZED GENERIC 36 sections
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate HUMAN PRESCRIPTION DRUG LABEL 4 0115-1330 CAPSULE, EXTENDED RELEASE 3.75 mg ORAL NDA AUTHORIZED GENERIC 36 sections
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate HUMAN PRESCRIPTION DRUG LABEL 4 0115-1330 CAPSULE, EXTENDED RELEASE 3.75 mg ORAL NDA AUTHORIZED GENERIC 36 sections
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate HUMAN PRESCRIPTION DRUG LABEL 4 0115-1331 CAPSULE, EXTENDED RELEASE 5 mg ORAL NDA AUTHORIZED GENERIC 36 sections
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate HUMAN PRESCRIPTION DRUG LABEL 4 0115-1331 CAPSULE, EXTENDED RELEASE 5 mg ORAL NDA AUTHORIZED GENERIC 36 sections
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate HUMAN PRESCRIPTION DRUG LABEL 4 0115-1332 CAPSULE, EXTENDED RELEASE 6.25 mg ORAL NDA AUTHORIZED GENERIC 36 sections
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate HUMAN PRESCRIPTION DRUG LABEL 4 0115-1332 CAPSULE, EXTENDED RELEASE 6.25 mg ORAL NDA AUTHORIZED GENERIC 36 sections
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate HUMAN PRESCRIPTION DRUG LABEL 4 0115-1333 CAPSULE, EXTENDED RELEASE 7.50 mg ORAL NDA AUTHORIZED GENERIC 36 sections
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate HUMAN PRESCRIPTION DRUG LABEL 4 0115-1333 CAPSULE, EXTENDED RELEASE 7.50 mg ORAL NDA AUTHORIZED GENERIC 36 sections
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate HUMAN PRESCRIPTION DRUG LABEL 4 0115-1486 CAPSULE 1.25 mg ORAL ANDA 29 sections
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate HUMAN PRESCRIPTION DRUG LABEL 4 0115-1486 CAPSULE 1.25 mg ORAL ANDA 29 sections
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate HUMAN PRESCRIPTION DRUG LABEL 4 0115-1487 CAPSULE 2.50 mg ORAL ANDA 29 sections
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate HUMAN PRESCRIPTION DRUG LABEL 4 0115-1487 CAPSULE 2.50 mg ORAL ANDA 29 sections
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate HUMAN PRESCRIPTION DRUG LABEL 4 0115-1488 CAPSULE 3.75 mg ORAL ANDA 29 sections
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate HUMAN PRESCRIPTION DRUG LABEL 4 0115-1488 CAPSULE 3.75 mg ORAL ANDA 29 sections
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate HUMAN PRESCRIPTION DRUG LABEL 4 0115-1489 CAPSULE 5 mg ORAL ANDA 29 sections
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate HUMAN PRESCRIPTION DRUG LABEL 4 0115-1489 CAPSULE 5 mg ORAL ANDA 29 sections
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate HUMAN PRESCRIPTION DRUG LABEL 4 0115-1490 CAPSULE 6.25 mg ORAL ANDA 29 sections
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate HUMAN PRESCRIPTION DRUG LABEL 4 0115-1490 CAPSULE 6.25 mg ORAL ANDA 29 sections
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate HUMAN PRESCRIPTION DRUG LABEL 4 0115-1491 CAPSULE 7.50 mg ORAL ANDA 29 sections
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate HUMAN PRESCRIPTION DRUG LABEL 4 0115-1491 CAPSULE 7.50 mg ORAL ANDA 29 sections
Dextroamphetamine SulfateExtended-ReleaseExtended-Release HUMAN PRESCRIPTION DRUG LABEL 1 0115-1702 CAPSULE, EXTENDED RELEASE 5 mg ORAL NDA AUTHORIZED GENERIC 23 sections
Dextroamphetamine SulfateExtended-ReleaseExtended-Release HUMAN PRESCRIPTION DRUG LABEL 1 0115-1703 CAPSULE, EXTENDED RELEASE 10 mg ORAL NDA AUTHORIZED GENERIC 23 sections
Dextroamphetamine SulfateExtended-ReleaseExtended-Release HUMAN PRESCRIPTION DRUG LABEL 1 0115-1704 CAPSULE, EXTENDED RELEASE 15 mg ORAL NDA AUTHORIZED GENERIC 23 sections
Dextroamphetamine SulfateExtended-Release HUMAN PRESCRIPTION DRUG LABEL 1 0115-9927 CAPSULE, EXTENDED RELEASE 5 mg ORAL NDA AUTHORIZED GENERIC 16 sections
Dextroamphetamine SulfateExtended-Release HUMAN PRESCRIPTION DRUG LABEL 1 0115-9928 CAPSULE, EXTENDED RELEASE 10 mg ORAL NDA AUTHORIZED GENERIC 16 sections
Dextroamphetamine SulfateExtended-Release HUMAN PRESCRIPTION DRUG LABEL 1 0115-9929 CAPSULE, EXTENDED RELEASE 15 mg ORAL NDA AUTHORIZED GENERIC 16 sections