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

Stem definitionDrug idCAS RN
anorexics 195 300-62-9

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • amphetamine aspartate monohydrate
  • benzadrine
  • amphetamine
  • adderall
  • 1-Benzylethylamine
  • phenedrine
  • (+/-)-1-Phenyl-2-aminopropane
  • amfetamine
  • amphetamine sulfate
  • amphetamine aspartate
  • amphetamine adipate
  • amphetamine resin complex
A powerful central nervous system stimulant and sympathomimetic. Amphetamine has multiple mechanisms of action including blocking uptake of adrenergics and dopamine, stimulation of release of monamines, and inhibiting monoamine oxidase. Amphetamine is also a drug of abuse and a psychotomimetic. The l- and the d,l-forms are included here. The l-form has less central nervous system activity but stronger cardiovascular effects. The d-form is DEXTROAMPHETAMINE.
  • 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
15 mg P

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 0 Benet LZ, Broccatelli F, Oprea TI
S (Water solubility) 30 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
Vd (Volume of distribution) 6.10 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 9.70 mL/min/kg Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma) 0.80 % Lombardo F, Berellini G, Obach RS
t_half (Half-life) 7.30 hours Lombardo F, Berellini G, Obach RS

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
Completed suicide 471.58 15.16 471 23592 145449 46516550
Drug abuse 359.71 15.16 282 23781 63126 46598873
Toxicity to various agents 297.60 15.16 449 23614 211317 46450682
Prescribed overdose 233.52 15.16 112 23951 10337 46651662
Pre-existing condition improved 231.40 15.16 97 23966 6515 46655484
Product substitution issue 187.16 15.16 109 23954 14922 46647077
Anxiety 171.32 15.16 323 23740 181634 46480365
Depression 141.84 15.16 287 23776 169817 46492182
Cardio-respiratory arrest 141.19 15.16 164 23899 59705 46602294
Suicidal ideation 138.94 15.16 158 23905 56224 46605775
Product physical issue 119.83 15.16 56 24007 4871 46657128
Feeling abnormal 117.51 15.16 222 23841 124838 46537161
Respiratory arrest 113.97 15.16 112 23951 33704 46628295
Product quality issue 100.06 15.16 107 23956 35541 46626458
Sleep apnoea syndrome 95.00 15.16 84 23979 22117 46639882
Disturbance in attention 90.82 15.16 96 23967 31464 46630535
Therapeutic response unexpected 87.38 15.16 69 23994 15547 46646452
Drug ineffective 80.78 15.16 610 23453 677228 45984771
Coronary artery dissection 73.26 15.16 23 24040 667 46661332
Somnolence 71.93 15.16 210 23853 156311 46505688
Migraine 71.58 15.16 129 23934 69897 46592102
Poisoning 70.17 15.16 58 24005 13936 46648063
Irritability 69.36 15.16 80 23983 28866 46633133
Inappropriate schedule of product administration 66.75 15.16 120 23943 64893 46597106
Somnambulism 61.28 15.16 36 24027 5001 46656998
Anaemia 57.64 15.16 30 24033 255749 46406250
Cataplexy 54.29 15.16 21 24042 1142 46660857
Surgery 50.42 15.16 68 23995 28717 46633282
Panic attack 50.27 15.16 57 24006 20185 46641814
Multiple sclerosis relapse 50.09 15.16 83 23980 42042 46619957
Anger 47.05 15.16 43 24020 11809 46650190
Diarrhoea 44.84 15.16 144 23919 559458 46102541
Asthma exercise induced 44.37 15.16 11 24052 129 46661870
Cardiac arrest 43.11 15.16 123 23940 90276 46571723
Pyrexia 42.14 15.16 72 23991 348730 46313269
Complication of device insertion 41.67 15.16 28 24035 4916 46657083
Pneumonia 40.77 15.16 83 23980 376237 46285762
Device expulsion 40.72 15.16 60 24003 27482 46634517
Headache 40.11 15.16 399 23664 477953 46184046
Rheumatoid arthritis 39.91 15.16 39 24024 240176 46421823
Intentional product misuse 39.71 15.16 80 23983 47048 46614951
Attention deficit hyperactivity disorder 38.78 15.16 20 24043 2152 46659847
Hyponatraemia 38 15.16 4 24059 101328 46560671
Exposure via ingestion 37.56 15.16 23 24040 3444 46658555
Product dose omission issue 37.47 15.16 179 23884 168341 46493658
Febrile neutropenia 37.45 15.16 3 24060 94624 46567375
Compartment syndrome 37.41 15.16 19 24044 1980 46660019
Drug tolerance 36.54 15.16 22 24041 3196 46658803
Acute kidney injury 35.06 15.16 42 24021 235813 46426186
Drug diversion 34.77 15.16 14 24049 847 46661152
Memory impairment 34.73 15.16 103 23960 77234 46584765
Serotonin syndrome 34.71 15.16 52 24011 24168 46637831
Stress cardiomyopathy 32.39 15.16 29 24034 7755 46654244
Agitation 32.05 15.16 81 23982 55334 46606665
Overdose 31.72 15.16 120 23943 101859 46560140
Suspected suicide 31.37 15.16 23 24040 4638 46657361
Oedema peripheral 31.36 15.16 22 24041 159684 46502315
Thrombocytopenia 31.33 15.16 13 24050 126568 46535431
Renal failure 30.93 15.16 10 24053 113584 46548415
Haemoglobin decreased 30.71 15.16 14 24049 128935 46533064
Stress 30.49 15.16 76 23987 51475 46610524
Hunger 30.41 15.16 21 24042 3854 46658145
Cardiac failure 30.38 15.16 3 24060 79945 46582054
Snoring 30.23 15.16 20 24043 3422 46658577
Abnormal sleep-related event 29.66 15.16 12 24051 735 46661264
Tachyphrenia 29.29 15.16 14 24049 1280 46660719
Extra dose administered 28.94 15.16 22 24041 4685 46657314
Cardiac failure congestive 28.94 15.16 6 24057 91744 46570255
Product tampering 28.09 15.16 7 24056 84 46661915
Wrong technique in product usage process 27.85 15.16 76 23987 54346 46607653
Device dislocation 27.32 15.16 44 24019 21758 46640241
Multiple sclerosis 27.02 15.16 47 24016 24744 46637255
No adverse event 26.35 15.16 56 24007 34175 46627824
Blood creatinine increased 26.26 15.16 4 24059 76399 46585600
Enuresis 26.20 15.16 15 24048 1985 46660014
Renal impairment 25.32 15.16 4 24059 74368 46587631
Oxygen saturation decreased 25.25 15.16 3 24060 69161 46592838
Platelet count decreased 25.19 15.16 10 24053 100014 46561985
Tremor 25.08 15.16 122 23941 115517 46546482
Leukopenia 24.86 15.16 3 24060 68340 46593659
Dyspnoea 24.79 15.16 160 23903 515388 46146611
Mood altered 24.73 15.16 32 24031 12975 46649024
Gastrointestinal haemorrhage 24.52 15.16 5 24058 77368 46584631
Postural orthostatic tachycardia syndrome 24.18 15.16 10 24053 648 46661351
Infusion related reaction 24.08 15.16 11 24052 101197 46560802
Sleep paralysis 23.76 15.16 9 24054 462 46661537
Hypokalaemia 23.52 15.16 8 24055 88016 46573983
Hangover 23.34 15.16 12 24051 1283 46660716
Seizure like phenomena 23.24 15.16 11 24052 984 46661015
Illness 23.13 15.16 30 24033 12194 46649805
Pleural effusion 23.12 15.16 7 24056 82945 46579054
Product preparation error 22.92 15.16 18 24045 4021 46657978
Uterine perforation 22.50 15.16 23 24040 7244 46654755
Intentional product use issue 22.46 15.16 69 23994 52711 46609288
Atrial fibrillation 22.06 15.16 13 24050 103577 46558422
Insomnia 22.02 15.16 153 23910 164771 46497228
Disease progression 21.60 15.16 10 24053 91290 46570709
Feeling drunk 21.36 15.16 17 24046 3870 46658129
Drug screen positive 21.35 15.16 17 24046 3874 46658125
Joint swelling 21.20 15.16 33 24030 166040 46495959
Unevaluable event 21.19 15.16 62 24001 46113 46615886
Drug intolerance 20.97 15.16 27 24036 147022 46514977
Post-traumatic stress disorder 20.75 15.16 17 24046 4031 46657968
Mood swings 20.63 15.16 33 24030 16219 46645780
Substance abuse 20.32 15.16 17 24046 4150 46657849
Paranoia 20.04 15.16 26 24037 10571 46651428
Thinking abnormal 20.01 15.16 25 24038 9789 46652210
Nephrolithiasis 19.83 15.16 49 24014 33002 46628997
Therapeutic response changed 19.81 15.16 9 24054 733 46661266
Road traffic accident 19.69 15.16 40 24023 23651 46638348
Acne 19.45 15.16 36 24027 19883 46642116
Sepsis 19.37 15.16 25 24038 135989 46526010
Initial insomnia 19.34 15.16 17 24046 4435 46657564
Withdrawal syndrome 19.27 15.16 34 24029 18100 46643899
Feeling jittery 19.26 15.16 26 24037 10982 46651017
Victim of crime 19.03 15.16 5 24058 75 46661924
General physical health deterioration 18.96 15.16 19 24044 115750 46546249
Embedded device 18.75 15.16 14 24049 2902 46659097
Complication of device removal 18.62 15.16 15 24048 3475 46658524
Victim of abuse 18.34 15.16 5 24058 87 46661912
Treatment failure 18.03 15.16 13 24050 93074 46568925
Septic shock 17.82 15.16 4 24059 57889 46604110
Disability 17.77 15.16 24 24039 10143 46651856
Change in sustained attention 17.64 15.16 3 24060 3 46661996
Bipolar disorder 17.46 15.16 20 24043 7157 46654842
Dry mouth 17.36 15.16 65 23998 54861 46607138
Alcoholism 17.36 15.16 12 24051 2206 46659793
Substance use 17.31 15.16 7 24056 428 46661571
Device breakage 17.12 15.16 23 24040 9669 46652330
Drug dependence 17.01 15.16 34 24029 19867 46642132
Lower respiratory tract infection 16.57 15.16 4 24059 55085 46606914
Educational problem 16.45 15.16 6 24057 277 46661722
Impulsive behaviour 16.28 15.16 10 24053 1505 46660494
Arteritis infective 16.21 15.16 4 24059 46 46661953
Bruxism 16.16 15.16 13 24050 3004 46658995
Hysterectomy 16.10 15.16 20 24043 7786 46654213
Blood testosterone increased 15.83 15.16 5 24058 148 46661851
Drug withdrawal syndrome 15.80 15.16 40 24023 27344 46634655
Crying 15.60 15.16 34 24029 21107 46640892
White blood cell count decreased 15.60 15.16 21 24042 112210 46549789
Arthralgia 15.59 15.16 117 23946 364486 46297513
Dermatillomania 15.25 15.16 5 24058 167 46661832

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
Drug abuse 1103.54 18.71 598 13175 81474 29857231
Toxicity to various agents 945.46 18.71 720 13053 176463 29762242
Completed suicide 348.99 18.71 319 13454 99173 29839532
Respiratory arrest 174.29 18.71 128 13645 29130 29909575
Product substitution issue 153.05 18.71 80 13693 9955 29928750
Suicidal ideation 124.50 18.71 115 13658 35999 29902706
Prescribed overdose 118.54 18.71 64 13709 8497 29930208
Anxiety 116.66 18.71 173 13600 89698 29849007
Drug ineffective 116.33 18.71 381 13392 340006 29598699
Poisoning 106.65 18.71 66 13707 11316 29927389
Intentional product misuse 103.53 18.71 102 13671 34565 29904140
Cardio-respiratory arrest 102.63 18.71 129 13644 57177 29881528
Overdose 97.64 18.71 154 13619 84183 29854522
Aggression 91.05 18.71 98 13675 36809 29901896
Oppositional defiant disorder 88.15 18.71 23 13750 379 29938326
Cardiac arrest 88.00 18.71 155 13618 92695 29846010
Product quality issue 87.38 18.71 71 13702 18703 29920002
Irritability 86.45 18.71 77 13696 22973 29915732
Decreased eye contact 86.35 18.71 23 13750 412 29938293
Feeling abnormal 81.94 18.71 115 13658 56641 29882064
Drug dependence 79.59 18.71 71 13702 21224 29917481
Crying 77.82 18.71 42 13731 5567 29933138
Depression 76.83 18.71 144 13629 90293 29848412
Bruxism 75.33 18.71 27 13746 1332 29937373
Product physical issue 73.08 18.71 30 13743 2144 29936561
Homicidal ideation 66.20 18.71 29 13744 2434 29936271
Tic 61.43 18.71 26 13747 2006 29936699
Substance abuse 61.35 18.71 39 13734 7001 29931704
Pneumonia 57.69 18.71 42 13731 334264 29604441
Anaemia 56.95 18.71 13 13760 207979 29730726
Insomnia 56.16 18.71 129 13644 93207 29845498
Psychotic disorder 54.56 18.71 58 13715 21457 29917248
Brain oedema 53.73 18.71 45 13728 12353 29926352
Disturbance in attention 53.21 18.71 58 13715 22071 29916634
Incorrect route of product administration 53.07 18.71 43 13730 11272 29927433
Abnormal behaviour 52.83 18.71 62 13711 25561 29913144
Psychomotor hyperactivity 51.21 18.71 37 13736 8187 29930518
Internal injury 50.63 18.71 9 13764 17 29938688
Anger 47.44 18.71 40 13733 11080 29927625
Exposure via ingestion 46.13 18.71 23 13750 2588 29936117
No adverse event 46.01 18.71 48 13725 17371 29921334
Impulsive behaviour 45.98 18.71 21 13752 1944 29936761
Intentional overdose 42.82 18.71 72 13701 41409 29897296
Pre-existing condition improved 42.51 18.71 20 13753 1981 29936724
Dyspnoea 39.23 18.71 58 13715 333237 29605468
Somnolence 38.88 18.71 115 13658 96648 29842057
Choreoathetosis 38.60 18.71 15 13758 928 29937777
Sleep apnoea syndrome 38.47 18.71 43 13730 16814 29921891
Sepsis 38.37 18.71 10 13763 146385 29792320
Depressed mood 38.11 18.71 43 13730 16986 29921719
Mood altered 37.94 18.71 31 13742 8219 29930486
Febrile neutropenia 37.75 18.71 3 13770 106690 29832015
Accidental overdose 37.29 18.71 44 13729 18231 29920474
Neutropenia 37.27 18.71 7 13766 128533 29810172
Pyrexia 35.87 18.71 50 13723 294439 29644266
Amphetamines positive 35.50 18.71 8 13765 68 29938637
Affect lability 35.03 18.71 21 13752 3397 29935308
Thrombocytopenia 34.71 18.71 10 13763 137034 29801671
Acute kidney injury 33.83 18.71 46 13727 273796 29664909
Poor quality sleep 32.86 18.71 27 13746 7214 29931491
Withdrawal syndrome 31.51 18.71 32 13741 11218 29927487
Somnambulism 31.01 18.71 19 13754 3195 29935510
Hypotension 31.00 18.71 28 13745 200537 29738168
Trismus 30.84 18.71 17 13756 2348 29936357
Electrocardiogram QRS complex prolonged 30.71 18.71 21 13752 4256 29934449
Coordination abnormal 28.56 18.71 25 13748 7280 29931425
Platelet count decreased 28.27 18.71 7 13766 106122 29832583
Respiratory depression 27.38 18.71 30 13743 11473 29927232
Inappropriate schedule of product administration 27.33 18.71 58 13715 39670 29899035
Thyrotoxic crisis 26.94 18.71 9 13764 359 29938346
Paranoia 26.77 18.71 28 13745 10160 29928545
Cluster headache 26.48 18.71 10 13763 572 29938133
Attention deficit hyperactivity disorder 26.25 18.71 14 13759 1810 29936895
Disturbance in social behaviour 26.11 18.71 13 13760 1458 29937247
Sleep disorder 25.93 18.71 43 13730 24436 29914269
Restless legs syndrome 25.83 18.71 23 13750 6849 29931856
Diarrhoea 25.81 18.71 74 13699 334029 29604676
Gastrointestinal haemorrhage 25.37 18.71 4 13769 83442 29855263
Agitation 25.35 18.71 68 13705 54005 29884700
Renal failure 25.17 18.71 14 13759 128952 29809753
Substance use 25.01 18.71 9 13764 449 29938256
Bladder hypertrophy 24.81 18.71 8 13765 285 29938420
Migraine 24.63 18.71 30 13743 12844 29925861
Sleep-related eating disorder 24.62 18.71 8 13765 292 29938413
Haemoglobin decreased 24.34 18.71 11 13762 114087 29824618
Educational problem 24.14 18.71 8 13765 311 29938394
Asphyxia 24.14 18.71 20 13753 5405 29933300
General physical health deterioration 24.02 18.71 8 13765 99936 29838769
Cataplexy 22.91 18.71 8 13765 365 29938340
Oedema peripheral 22.90 18.71 10 13763 105822 29832883
Drug diversion 22.10 18.71 10 13763 906 29937799
Purpura fulminans 22.04 18.71 6 13767 117 29938588
Therapeutic response shortened 21.96 18.71 16 13757 3584 29935121
Hyperkinesia 21.78 18.71 13 13760 2085 29936620
Renal impairment 21.56 18.71 6 13767 84178 29854527
Bladder dilatation 21.54 18.71 11 13762 1301 29937404
Pulmonary oedema 21.31 18.71 56 13717 43919 29894786
Myocardial infarction 21.29 18.71 16 13757 125609 29813096
Serotonin syndrome 21.09 18.71 33 13740 17858 29920847
Mixed delusion 20.96 18.71 4 13769 13 29938692
Speech disorder 20.71 18.71 39 13734 24473 29914232
Therapeutic product effect decreased 20.63 18.71 43 13730 29033 29909672
Muscle necrosis 20.32 18.71 9 13764 775 29937930
Streptococcal infection 20.21 18.71 17 13756 4691 29934014
Physical abuse 19.93 18.71 4 13769 18 29938687
Disease progression 19.89 18.71 6 13767 79868 29858837
Cardiogenic shock 19.74 18.71 31 13742 16830 29921875
Post-traumatic stress disorder 19.40 18.71 11 13762 1604 29937101
Vertebral artery dissection 19.11 18.71 4 13769 23 29938682
Drug screen positive 19.09 18.71 16 13757 4391 29934314
Emotional disorder 19.05 18.71 17 13756 5077 29933628
Sedation 19.02 18.71 30 13743 16343 29922362
Malignant neoplasm progression 18.80 18.71 5 13768 72282 29866423

Pharmacologic Action:

SourceCodeDescription
ATC N06BA01 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
MeSH PA D018663 Adrenergic Agents
MeSH PA D018759 Adrenergic Uptake 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
MeSH PA D018373 Peripheral Nervous System Agents
MeSH PA D013566 Sympathomimetics
CHEBI has role CHEBI:35523 bronchodilator agents
CHEBI has role CHEBI:35524 sympathomimetic
CHEBI has role CHEBI:35640 adrenergic uptake inhibitors
CHEBI has role CHEBI:35703 xenobiotic
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
CHEBI has role CHEBI:78298 environmental contaminants

Drug Use (View source of the data)

DiseaseRelationSNOMED_IDDOID
Narcolepsy indication 60380001 DOID:8986
Attention deficit hyperactivity disorder indication 406506008
Obesity indication 414916001 DOID:9970
Ocular hypertension contraindication 4210003 DOID:9282
Gilles de la Tourette's syndrome contraindication 5158005 DOID:11119
Suicidal thoughts contraindication 6471006
Dependent drug abuse contraindication 6525002
Alcoholism contraindication 7200002
Hyperammonemia contraindication 9360008
Chronic obstructive lung disease contraindication 13645005 DOID:3083
Bipolar disorder contraindication 13746004 DOID:3312
Hepatic encephalopathy contraindication 13920009 DOID:13413
Myocardial infarction contraindication 22298006 DOID:5844
Glaucoma contraindication 23986001 DOID:1686
Feeling agitated contraindication 24199005
Hyperthyroidism contraindication 34486009 DOID:7998
Depressive disorder contraindication 35489007
Hypertensive disorder contraindication 38341003 DOID:10763
Hyperactive behavior contraindication 44548000
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
Hepatic failure contraindication 59927004
Aggressive behavior contraindication 61372001
Substance abuse contraindication 66214007
Psychotic disorder contraindication 69322001
Arteriosclerotic vascular disease contraindication 72092001
Hepatic coma contraindication 72836002 DOID:12550
Diabetes mellitus contraindication 73211009 DOID:9351
Sleep apnea contraindication 73430006 DOID:0050847
Open-angle glaucoma contraindication 84494001 DOID:1067
Cardiomyopathy contraindication 85898001 DOID:0050700
Weight loss contraindication 89362005
Kidney disease contraindication 90708001 DOID:557
Structural disorder of heart contraindication 128599005
Seizure disorder contraindication 128613002
Motor tic disorder contraindication 230337001
Cerebrovascular accident contraindication 230690007
Mania contraindication 231494001
Disease of liver contraindication 235856003 DOID:409
Sleep automatism contraindication 247962006
Anemia contraindication 271737000 DOID:2355
Pregnancy, function contraindication 289908002
Thrombocytopenic disorder contraindication 302215000 DOID:1588
Neutropenic disorder contraindication 303011007 DOID:1227
Angle-closure glaucoma contraindication 392291006 DOID:13550
Cardiovascular event risk contraindication 395112001
Visual impairment contraindication 397540003
Respiratory insufficiency contraindication 409623005
Breastfeeding (mother) contraindication 413712001
Disorder of coronary artery contraindication 414024009
Myocardial ischemia contraindication 414795007 DOID:3393
Myocardial infarction in recovery phase contraindication 418044006
Porphyria contraindication 418470004
Hypertensive urgency contraindication 443482000
Acute exacerbation of asthma contraindication 708038006

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 noradrenaline transporter Transporter RELEASING AGENT CHEMBL CHEMBL
Sodium-dependent dopamine transporter Transporter RELEASING AGENT Ki 6.94 PDSP CHEMBL
Sodium-dependent serotonin transporter Transporter Ki 5.75 PDSP
Cocaine- and amphetamine-regulated transcript protein Transcription factor WOMBAT-PK
Alpha-1A adrenergic receptor GPCR WOMBAT-PK
Trace amine-associated receptor 1 GPCR AGONIST EC50 6.22 SCIENTIFIC LITERATURE
Alpha-2A adrenergic receptor GPCR WOMBAT-PK
Sodium-dependent dopamine transporter Transporter IC50 6.02 CHEMBL
Sodium-dependent serotonin transporter Transporter IC50 4.35 CHEMBL
Transporter Transporter IC50 6.70 CHEMBL
5-hydroxytryptamine receptor 2B GPCR Kd 5.27 CHEMBL
Serotonin 2 (5-HT2) receptor GPCR Ki 4.37 CHEMBL
Serotonin (5-HT) receptor GPCR Kd 5.27 CHEMBL
Amine oxidase [flavin-containing] A Enzyme Ki 4.91 CHEMBL
Sodium-dependent noradrenaline transporter Transporter IC50 6 CHEMBL
Serotonin 1 (5-HT1) receptor GPCR Ki 5.12 CHEMBL

External reference:

IDSource
CK833KGX7E UNII
4019611 VUID
N0000147705 NUI
D02074 KEGG_DRUG
64770-51-0 SECONDARY_CAS_RN
C0290795 UMLSCUI
CHEBI:2679 CHEBI
CHEMBL405 ChEMBL_ID
CHEMBL1200387 ChEMBL_ID
CHEMBL1200377 ChEMBL_ID
CHEMBL501 ChEMBL_ID
DB00182 DRUGBANK_ID
D000661 MESH_DESCRIPTOR_UI
3007 PUBCHEM_CID
377 INN_ID
C090411 MESH_SUPPLEMENTAL_RECORD_UI
4804 IUPHAR_LIGAND_ID
221057 RXNORM
290726 MMSL
31375 MMSL
4188 MMSL
4189 MMSL
6025 MMSL
d00803 MMSL
001790 NDDF
001791 NDDF
001792 NDDF
006719 NDDF
116344009 SNOMEDCT_US
22672005 SNOMEDCT_US
703842006 SNOMEDCT_US
87148003 SNOMEDCT_US
4018832 VANDF
4018833 VANDF
4018834 VANDF
4019611 VANDF
4022215 VANDF

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 Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate HUMAN PRESCRIPTION DRUG LABEL 4 0185-0831 TABLET 1.25 mg ORAL ANDA 21 sections
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate HUMAN PRESCRIPTION DRUG LABEL 4 0185-0831 TABLET 1.25 mg ORAL ANDA 21 sections
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate HUMAN PRESCRIPTION DRUG LABEL 4 0185-0842 TABLET 2.50 mg ORAL ANDA 21 sections
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate HUMAN PRESCRIPTION DRUG LABEL 4 0185-0842 TABLET 2.50 mg ORAL ANDA 21 sections
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate HUMAN PRESCRIPTION DRUG LABEL 4 0185-0853 TABLET 5 mg ORAL ANDA 21 sections
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate HUMAN PRESCRIPTION DRUG LABEL 4 0185-0853 TABLET 5 mg ORAL ANDA 21 sections