modafinil ๐Ÿถ Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definitionDrug idCAS RN
1826 68693-11-8

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • modafinil
  • (+/-)-Modafinil
  • modaphonil
  • modiodal
A benzhydryl acetamide compound, central nervous system stimulant, and CYP3A4 inducing agent that is used in the treatment of NARCOLEPSY and SLEEP WAKE DISORDERS.
  • Molecular weight: 273.35
  • Formula: C15H15NO2S
  • CLOGP: 0.94
  • LIPINSKI: 0
  • HAC: 3
  • HDO: 1
  • TPSA: 60.16
  • ALOGS: -2.64
  • ROTB: 5

  • Status: OFP

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

Drug dosage:

DoseUnitRoute
0.30 g O

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 2 Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine) 8 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 20.90 ยตM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability) 80 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H

Approvals:

DateAgencyCompanyOrphan
Dec. 24, 1998 FDA CEPHALON
Feb. 21, 2020 PMDA Alfresa Pharma Corporation

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
Multiple sclerosis relapse 410.60 11.29 272 31506 48206 63409038
Multiple sclerosis 303.72 11.29 175 31603 24197 63433047
Depression 231.87 11.29 379 31399 196113 63261131
Pre-existing condition improved 223.05 11.29 100 31678 8144 63449100
Cataplexy 218.76 11.29 61 31717 1195 63456049
Sleep apnoea syndrome 178.03 11.29 134 31644 28999 63428245
Suicidal ideation 159.82 11.29 176 31602 62245 63394999
Anxiety 140.02 11.29 325 31453 217216 63240028
Contraindicated product administered 95.34 11.29 3 31775 217645 63239599
Joint swelling 92.29 11.29 25 31753 327641 63129603
Somnambulism 88.80 11.29 47 31731 5496 63451748
Synovitis 80.37 11.29 3 31775 186915 63270329
Somnolence 76.05 11.29 229 31549 178456 63278788
Product administration interrupted 71.85 11.29 39 31739 4797 63452447
Balance disorder 71.32 11.29 141 31637 84281 63372963
Snoring 71.22 11.29 37 31741 4165 63453079
Influenza like illness 69.45 11.29 122 31656 66702 63390542
Hand deformity 67.06 11.29 3 31775 159454 63297790
Enuresis 65.75 11.29 30 31748 2543 63454701
Treatment failure 64.51 11.29 11 31767 199032 63258212
Off label use 64.05 11.29 153 31625 674309 62782935
Glossodynia 62.32 11.29 8 31770 178868 63278376
Infusion related reaction 61.50 11.29 23 31755 245498 63211746
Memory impairment 60.71 11.29 150 31628 104108 63353136
Migraine 59.46 11.29 148 31630 103198 63354046
Fall 58.08 11.29 365 31413 391969 63065275
Rheumatoid arthritis 56.85 11.29 28 31750 253791 63203453
Major depression 53.72 11.29 39 31739 7979 63449265
Gait disturbance 53.47 11.29 207 31571 182971 63274273
Therapeutic response unexpected 51.65 11.29 55 31723 18704 63438540
Lower respiratory tract infection 48.36 11.29 5 31773 132302 63324942
Seizure 48.16 11.29 161 31617 132473 63324771
Pericarditis 48.03 11.29 5 31773 131574 63325670
Feeling abnormal 47.70 11.29 173 31605 148219 63309025
Systemic lupus erythematosus 46.84 11.29 23 31755 208895 63248349
Arthropathy 46.68 11.29 30 31748 234762 63222482
Muscle spasticity 46.55 11.29 56 31722 21738 63435506
Blood pressure measurement 45.10 11.29 13 31765 288 63456956
Wound 43.09 11.29 14 31764 163249 63293995
General physical health deterioration 42.46 11.29 24 31754 201378 63255866
Feeling drunk 41.84 11.29 26 31752 4116 63453128
Narcolepsy 41.41 11.29 18 31760 1360 63455884
Product use issue 41.40 11.29 30 31748 220490 63236754
Disturbance in attention 41.33 11.29 71 31707 38118 63419126
Surgery 40.49 11.29 68 31710 35844 63421400
Restless legs syndrome 40.20 11.29 48 31730 18483 63438761
Tremor 39.84 11.29 151 31627 132088 63325156
Acute kidney injury 39.68 11.29 44 31734 263371 63193873
Urinary incontinence 39.31 11.29 63 31715 31951 63425293
Psychotic disorder 39.25 11.29 56 31722 25656 63431588
Sleep paralysis 38.79 11.29 14 31764 646 63456598
Death 38.63 11.29 81 31697 374300 63082944
Magnetic resonance imaging abnormal 38.00 11.29 22 31756 3063 63454181
Muscular weakness 37.93 11.29 141 31637 122212 63335032
Hypoaesthesia 37.27 11.29 175 31603 168218 63289026
Rash 36.99 11.29 150 31628 560721 62896523
Drug intolerance 36.95 11.29 61 31717 308600 63148644
Pregnancy on oral contraceptive 35.98 11.29 15 31763 1022 63456222
Stress 35.30 11.29 93 31685 67074 63390170
Dysstasia 35.14 11.29 48 31730 21118 63436126
Heart rate 34.62 11.29 8 31770 70 63457174
Neutropenia 33.90 11.29 23 31755 174982 63282262
Hypersomnia 33.13 11.29 43 31735 18012 63439232
Blood pressure increased 32.68 11.29 164 31614 161898 63295346
Drug ineffective 32.47 11.29 351 31427 1044414 62412830
Thrombocytopenia 31.87 11.29 18 31760 151139 63306105
Hypnagogic hallucination 31.64 11.29 9 31769 190 63457054
Muscle spasms 31.47 11.29 158 31620 155992 63301252
Insomnia 30.98 11.29 199 31579 215053 63242191
Substance use 30.30 11.29 11 31767 516 63456728
Mania 30.12 11.29 34 31744 12333 63444911
Parasomnia 29.96 11.29 11 31767 533 63456711
Hypersensitivity vasculitis 29.84 11.29 21 31757 4091 63453153
Febrile neutropenia 29.79 11.29 11 31767 118438 63338806
Postural orthostatic tachycardia syndrome 29.73 11.29 14 31764 1275 63455969
Post-traumatic stress disorder 29.53 11.29 23 31755 5228 63452016
Abnormal dreams 29.24 11.29 31 31747 10485 63446759
Bipolar disorder 28.66 11.29 27 31751 7933 63449311
Abdominal discomfort 28.62 11.29 75 31703 320810 63136434
Alopecia 28.52 11.29 81 31697 337455 63119789
Secondary progressive multiple sclerosis 28.38 11.29 14 31764 1413 63455831
Irritability 28.03 11.29 54 31724 31640 63425604
Diarrhoea 27.88 11.29 227 31551 715139 62742105
Malignant neoplasm progression 27.81 11.29 4 31774 82117 63375127
Weight decreased 27.34 11.29 234 31544 276564 63180680
Central nervous system lesion 27.21 11.29 30 31748 10605 63446639
Loss of consciousness 27.03 11.29 124 31654 117997 63339247
Intervertebral disc protrusion 26.87 11.29 45 31733 23664 63433580
Histoplasmosis 26.81 11.29 15 31763 1956 63455288
Paranoia 26.57 11.29 31 31747 11648 63445596
Panic attack 26.13 11.29 43 31735 22288 63434956
Pancytopenia 26.12 11.29 8 31770 96925 63360319
Lymphocyte count decreased 26.09 11.29 51 31727 30206 63427038
Vision blurred 26.07 11.29 103 31675 91821 63365423
Optic neuritis 25.49 11.29 26 31752 8409 63448835
Periodic limb movement disorder 25.26 11.29 8 31770 246 63456998
Blister 25.22 11.29 17 31761 129797 63327447
Hallucination, auditory 24.25 11.29 31 31747 12793 63444451
Polycystic ovaries 23.88 11.29 19 31759 4452 63452792
Asthma exercise induced 23.50 11.29 8 31770 310 63456934
Amnesia 23.37 11.29 71 31707 55514 63401730
Enterococcal sepsis 22.65 11.29 12 31766 1406 63455838
Disease progression 22.63 11.29 17 31761 122741 63334503
Peroneal nerve palsy 22.58 11.29 19 31759 4816 63452428
Muscle injury 22.55 11.29 3 31775 65342 63391902
Hypertension 22.47 11.29 226 31552 279077 63178167
Headache 22.19 11.29 442 31336 632799 62824445
Crying 22.17 11.29 41 31737 23302 63433942
Sleep-related eating disorder 21.99 11.29 10 31768 841 63456403
White blood cells urine positive 21.51 11.29 19 31759 5139 63452105
Urinary tract infection 21.21 11.29 214 31564 264470 63192774
Trigeminal neuralgia 21.07 11.29 16 31762 3503 63453741
Bruxism 21.04 11.29 16 31762 3509 63453735
Discomfort 21.02 11.29 32 31746 167342 63289902
Nephrolithiasis 20.91 11.29 57 31721 41927 63415317
Peripheral swelling 20.88 11.29 66 31712 265876 63191368
Paraesthesia 20.68 11.29 142 31636 156824 63300420
Liver injury 20.37 11.29 3 31775 60517 63396727
Neuralgia 20.32 11.29 42 31736 25884 63431360
Cervical spinal stenosis 20.15 11.29 13 31765 2195 63455049
Withdrawal syndrome 20.10 11.29 36 31742 19961 63437283
Drug withdrawal syndrome 20.09 11.29 43 31735 27151 63430093
Urine analysis abnormal 19.97 11.29 18 31760 4998 63452246
Hypnopompic hallucination 19.91 11.29 5 31773 64 63457180
Swelling 19.81 11.29 71 31707 275307 63181937
Cardiac failure 19.68 11.29 10 31768 89132 63368112
Dyskinesia 19.63 11.29 47 31731 31955 63425289
Helicobacter infection 19.62 11.29 11 31767 92774 63364470
Hysterectomy 19.62 11.29 24 31754 9475 63447769
Anaemia 19.58 11.29 78 31700 293352 63163892
Abnormal sleep-related event 19.49 11.29 9 31769 784 63456460
Endometriosis 19.06 11.29 18 31760 5302 63451942
Arthralgia 18.99 11.29 188 31590 569522 62887722
Abdominal pain 18.96 11.29 79 31699 293377 63163867
C-reactive protein increased 18.94 11.29 12 31766 94695 63362549
Hunger 18.90 11.29 18 31760 5361 63451883
Spinal operation 18.89 11.29 22 31756 8249 63448995
Attention deficit hyperactivity disorder 18.45 11.29 14 31764 3062 63454182
Lymphopenia 18.43 11.29 33 31745 18294 63438950
Hangover 18.40 11.29 11 31767 1625 63455619
Product use in unapproved indication 18.22 11.29 39 31739 179041 63278203
Vitamin D deficiency 17.96 11.29 28 31750 13864 63443380
Therapeutic product effect incomplete 17.62 11.29 22 31756 125034 63332210
Incoherent 17.53 11.29 16 31762 4514 63452730
Injection site scar 17.35 11.29 9 31769 1009 63456235
Cognitive disorder 17.01 11.29 64 31714 55751 63401493
Stomatitis 16.96 11.29 27 31751 138698 63318546
Folliculitis 16.90 11.29 7 31771 70310 63386934
Movement disorder 16.87 11.29 35 31743 21626 63435618
Pneumonia 16.81 11.29 147 31631 456620 63000624
Tardive dyskinesia 16.78 11.29 21 31757 8481 63448763
Oedema mouth 16.76 11.29 12 31766 2401 63454843
Progressive multifocal leukoencephalopathy 16.57 11.29 26 31752 12945 63444299
Unevaluable event 16.56 11.29 60 31718 51326 63405918
Dizziness 16.35 11.29 304 31474 429621 63027623
Apnoea 16.13 11.29 20 31758 8002 63449242
Emotional disorder 15.97 11.29 26 31752 13353 63443891
Clumsiness 15.85 11.29 11 31767 2096 63455148
Loss of bladder sensation 15.66 11.29 4 31774 55 63457189
Uterine leiomyoma 15.48 11.29 21 31757 9177 63448067
Coordination abnormal 15.41 11.29 26 31752 13747 63443497
Poor quality sleep 15.28 11.29 32 31746 19903 63437341
Seasonal affective disorder 15.23 11.29 6 31772 353 63456891
Psoriatic arthropathy 15.23 11.29 14 31764 91506 63365738
Obsessive-compulsive disorder 15.05 11.29 14 31764 4046 63453198
Maternal exposure during pregnancy 14.99 11.29 58 31720 220004 63237240
Urine abnormality 14.93 11.29 18 31760 7001 63450243
Depersonalisation/derealisation disorder 14.85 11.29 9 31769 1363 63455881
Abnormal behaviour 14.82 11.29 33 31745 21393 63435851
Platelet count decreased 14.77 11.29 22 31756 116100 63341144
Infection 14.61 11.29 62 31716 229111 63228133
Haemoglobin decreased 14.53 11.29 32 31746 145453 63311791
CD4 lymphocytes decreased 14.52 11.29 9 31769 1418 63455826
Paralysis 14.29 11.29 21 31757 9879 63447365
Nausea 14.28 11.29 542 31236 853929 62603315
Renal impairment 14.14 11.29 14 31764 88341 63368903
International normalised ratio increased 14.10 11.29 3 31775 46422 63410822
Perinatal depression 14.03 11.29 7 31771 724 63456520
Hepatic enzyme increased 13.99 11.29 53 31725 202275 63254969
Brachial plexus injury 13.97 11.29 3 31775 18 63457226
Suicide attempt 13.96 11.29 64 31714 60854 63396390
Road traffic accident 13.75 11.29 45 31733 36587 63420657
Neurogenic bladder 13.50 11.29 12 31766 3273 63453971
Invasive ductal breast carcinoma 13.44 11.29 17 31761 6941 63450303
Wheezing 13.27 11.29 17 31761 95578 63361666
Haemoglobin urine present 13.24 11.29 7 31771 816 63456428
Urinary sediment present 13.15 11.29 10 31768 2193 63455051
Meniscus injury 13.14 11.29 17 31761 7097 63450147
Therapeutic product effect decreased 13.10 11.29 51 31727 193136 63264108
Flushing 13.07 11.29 73 31705 75014 63382230
Ankle fracture 12.92 11.29 28 31750 17827 63439417
Urine leukocyte esterase positive 12.62 11.29 12 31766 3567 63453677
Septic shock 12.57 11.29 9 31769 66620 63390624
Hypoaesthesia oral 12.51 11.29 23 31755 13010 63444234
Impaired healing 12.49 11.29 20 31758 102522 63354722
Spinal osteoarthritis 12.42 11.29 26 31752 16160 63441084
Treatment noncompliance 12.38 11.29 44 31734 37281 63419963
Relapsing-remitting multiple sclerosis 12.37 11.29 6 31772 584 63456660
Injection site reaction 12.33 11.29 60 31718 58464 63398780
Pyrexia 12.24 11.29 164 31614 470314 62986930
Loss of control of legs 12.20 11.29 8 31770 1388 63455856
Fatigue 12.03 11.29 551 31227 887477 62569767
Micturition urgency 11.91 11.29 19 31759 9592 63447652
Tic 11.58 11.29 8 31770 1512 63455732
Bladder disorder 11.52 11.29 18 31760 8928 63448316
Generalised anxiety disorder 11.48 11.29 9 31769 2065 63455179
Product substitution issue 11.48 11.29 25 31753 15971 63441273
B-lymphocyte count decreased 11.39 11.29 7 31771 1087 63456157
Nocturia 11.36 11.29 17 31761 8124 63449120
Papilloma viral infection 11.35 11.29 8 31770 1562 63455682

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
Cataplexy 183.36 14.73 38 12045 288 34944560
Sleep apnoea syndrome 157.17 14.73 94 11989 20227 34924621
Pre-existing condition improved 136.15 14.73 46 12037 2546 34942302
Multiple sclerosis relapse 104.76 14.73 62 12021 13071 34931777
Multiple sclerosis 100.29 14.73 48 12035 6597 34938251
Suicidal ideation 93.80 14.73 91 11992 40297 34904551
Depression 86.89 14.73 135 11948 96963 34847885
Anxiety 83.12 14.73 134 11949 99294 34845554
Product administration interrupted 79.02 14.73 28 12055 1787 34943061
Therapeutic response unexpected 72.46 14.73 44 12039 9713 34935135
Tic 50.82 14.73 21 12062 2037 34942811
Obsessive-compulsive disorder 48.94 14.73 28 12055 5536 34939312
Bipolar disorder 47.86 14.73 24 12059 3645 34941203
Somnambulism 45.76 14.73 22 12061 3050 34941798
Sleep paralysis 45.75 14.73 11 12072 173 34944675
Somnolence 44.37 14.73 110 11973 111006 34833842
Memory impairment 42.59 14.73 63 12020 43255 34901593
Acute kidney injury 40.55 14.73 28 12055 304960 34639888
Cognitive disorder 39.26 14.73 49 12034 28644 34916204
Psychotic disorder 38.76 14.73 45 12038 24407 34920441
Narcolepsy 38.40 14.73 12 12071 517 34944331
Migraine 36.14 14.73 37 12046 17441 34927407
Delusion 36.13 14.73 32 12051 12603 34932245
Feeling abnormal 35.80 14.73 72 12011 63163 34881685
Concussion 34.96 14.73 17 12066 2416 34942432
Foetal malnutrition 32.31 14.73 7 12076 67 34944781
Tourette's disorder 31.94 14.73 7 12076 71 34944777
Anaemia 31.54 14.73 21 12062 233314 34711534
Mania 31.08 14.73 26 12057 9485 34935363
Road traffic accident 30.86 14.73 34 12049 17416 34927432
Insomnia 29.64 14.73 91 11992 103816 34841032
Neutropenia 29.12 14.73 9 12074 156769 34788079
Wrong dose 28.99 14.73 10 12073 589 34944259
Headache 27.91 14.73 140 11943 200495 34744353
Irritability 27.32 14.73 38 12045 24652 34920196
Post-traumatic stress disorder 26.60 14.73 13 12070 1868 34942980
Fall 26.42 14.73 139 11944 202746 34742102
Hypertension 26.34 14.73 105 11978 136338 34808510
Thrombocytopenia 25.58 14.73 11 12072 156236 34788612
Nephrolithiasis 25.43 14.73 41 12042 30292 34914556
Foetal hypokinesia 24.93 14.73 8 12075 376 34944472
Gait disturbance 24.68 14.73 75 12008 85065 34859783
Paranoia 23.96 14.73 25 12058 12043 34932805
Condition aggravated 23.20 14.73 129 11954 192067 34752781
Abnormal sleep-related event 23.06 14.73 8 12075 479 34944369
Post concussion syndrome 22.93 14.73 6 12077 135 34944713
Aggression 22.80 14.73 45 12038 38919 34905929
Blood pressure increased 22.24 14.73 74 12009 88028 34856820
Death 21.87 14.73 68 12015 397981 34546867
Renal failure 21.67 14.73 9 12074 130548 34814300
Abnormal dreams 21.28 14.73 19 12064 7559 34937289
Trismus 20.46 14.73 12 12071 2483 34942365
Snoring 19.62 14.73 13 12070 3333 34941515
Hypotension 19.54 14.73 29 12054 221620 34723228
Urinary tract infection 18.93 14.73 68 12015 84013 34860835
Psychotic symptom 18.70 14.73 10 12073 1733 34943115
Disease progression 18.67 14.73 7 12076 108070 34836778
Periodic limb movement disorder 18.35 14.73 5 12078 132 34944716
Complex regional pain syndrome 18.23 14.73 7 12076 560 34944288
Restless legs syndrome 17.84 14.73 18 12065 8336 34936512
Schizotypal personality disorder 17.62 14.73 3 12080 6 34944842
Magical thinking 17.62 14.73 3 12080 6 34944842
Influenza like illness 17.49 14.73 33 12050 27601 34917247
Hallucination 17.45 14.73 48 12035 51450 34893398
Hypnagogic hallucination 17.20 14.73 4 12079 54 34944794
Secondary progressive multiple sclerosis 16.87 14.73 6 12077 387 34944461
General physical health deterioration 16.70 14.73 12 12071 128257 34816591
Seizure 16.58 14.73 76 12007 104781 34840067
Renal impairment 16.53 14.73 6 12077 94507 34850341
Fatigue 16.52 14.73 198 11885 370455 34574393
Disturbance in attention 16.44 14.73 31 12052 25914 34918934
Rib hypoplasia 16.09 14.73 3 12080 12 34944836
Trigeminal neuralgia 15.91 14.73 8 12075 1221 34943627
Platelet count decreased 15.85 14.73 11 12072 119706 34825142
Hallucination, auditory 15.73 14.73 20 12063 11897 34932951
Antiphospholipid antibodies 15.54 14.73 3 12080 15 34944833
Pulmonary hypoplasia 15.49 14.73 6 12077 491 34944357
Muscle spasms 15.49 14.73 59 12024 74942 34869906
Muscle spasticity 15.04 14.73 14 12069 5874 34938974
Balance disorder 14.89 14.73 39 12044 40615 34904233
Nervousness 14.85 14.73 20 12063 12586 34932262

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
Multiple sclerosis relapse 407.83 11.75 241 29957 46292 79667898
Multiple sclerosis 334.43 11.75 165 30033 22117 79692073
Cataplexy 279.54 11.75 66 30132 868 79713322
Depression 171.66 11.75 300 29898 216490 79497700
Pre-existing condition improved 116.87 11.75 52 30146 5511 79708679
Sleep apnoea syndrome 102.10 11.75 95 30103 36383 79677807
Anxiety 99.81 11.75 261 29937 248251 79465939
Suicidal ideation 91.52 11.75 128 30070 76212 79637978
Memory impairment 84.89 11.75 152 30046 111582 79602608
Fall 80.26 11.75 381 29817 487248 79226942
Acute kidney injury 70.67 11.75 56 30142 519348 79194842
Gait disturbance 66.61 11.75 201 29997 207305 79506885
Somnolence 63.55 11.75 217 29981 238764 79475426
Narcolepsy 58.54 11.75 21 30177 1265 79712925
Muscle spasticity 56.40 11.75 54 30144 21421 79692769
Influenza like illness 56.31 11.75 99 30099 71608 79642582
Urinary tract infection 56.07 11.75 229 29969 274283 79439907
Febrile neutropenia 55.89 11.75 10 30188 230989 79483201
Sleep paralysis 55.56 11.75 17 30181 621 79713569
Balance disorder 53.87 11.75 117 30081 98740 79615450
Feeling abnormal 52.76 11.75 156 30042 159043 79555147
Off label use 50.98 11.75 175 30023 907040 78807150
Joint swelling 50.58 11.75 23 30175 288623 79425567
Migraine 50.49 11.75 106 30092 87387 79626803
Tic 50.46 11.75 24 30174 2962 79711228
Psychotic disorder 50.46 11.75 70 30128 41332 79672858
Therapeutic response unexpected 50.20 11.75 49 30149 19897 79694293
Obsessive-compulsive disorder 50.04 11.75 30 30168 5897 79708293
Somnambulism 48.41 11.75 29 30169 5692 79708498
General physical health deterioration 48.12 11.75 22 30176 275216 79438974
Feeling drunk 48.11 11.75 27 30171 4692 79709498
Blood pressure measurement 47.80 11.75 14 30184 439 79713751
Product administration interrupted 47.22 11.75 25 30173 3874 79710316
Headache 46.90 11.75 414 29784 653358 79060832
Hypoaesthesia 46.89 11.75 162 30036 179190 79535000
Thrombocytopenia 46.69 11.75 21 30177 265238 79448952
Insomnia 46.52 11.75 200 29998 244970 79469220
Mania 46.22 11.75 45 30153 18215 79695975
Seizure 45.46 11.75 166 30032 188668 79525522
Contraindicated product administered 44.90 11.75 4 30194 157534 79556656
Abnormal dreams 44.66 11.75 36 30162 11376 79702814
Neutropenia 44.40 11.75 27 30171 287683 79426507
Enuresis 43.15 11.75 22 30176 3154 79711036
Rheumatoid arthritis 40.80 11.75 14 30184 208456 79505734
Secondary progressive multiple sclerosis 39.08 11.75 16 30182 1381 79712809
Magnetic resonance imaging abnormal 38.58 11.75 21 30177 3438 79710752
Cognitive disorder 38.36 11.75 83 30115 69843 79644347
Anaemia 38.07 11.75 69 30129 444946 79269244
Death 37.66 11.75 101 30097 566413 79147777
Bipolar disorder 36.00 11.75 27 30171 7680 79706510
Malignant neoplasm progression 34.87 11.75 5 30193 135985 79578205
Hypnagogic hallucination 34.35 11.75 9 30189 185 79714005
Muscle spasms 34.25 11.75 144 30054 174586 79539604
Treatment failure 34.14 11.75 11 30187 170475 79543715
Heart rate 33.82 11.75 8 30190 106 79714084
Delusion 33.48 11.75 40 30158 20383 79693807
Disease progression 33.37 11.75 14 30184 184348 79529842
Hyperkalaemia 32.34 11.75 3 30195 114395 79599795
Pregnancy on oral contraceptive 31.82 11.75 12 30186 833 79713357
Optic neuritis 30.98 11.75 27 30171 9493 79704697
Tourette's disorder 30.63 11.75 7 30191 79 79714111
Wrong dose 29.81 11.75 14 30184 1680 79712510
Hypersomnia 29.59 11.75 40 30158 23046 79691144
Snoring 29.39 11.75 21 30177 5545 79708645
Pancytopenia 29.34 11.75 13 30185 165732 79548458
Restless legs syndrome 29.14 11.75 37 30161 20055 79694135
Concussion 29.02 11.75 26 30172 9477 79704713
Urinary incontinence 28.95 11.75 54 30144 40855 79673335
Attention deficit hyperactivity disorder 28.59 11.75 17 30181 3292 79710898
Renal impairment 28.53 11.75 12 30186 157771 79556419
Hallucination, auditory 28.28 11.75 37 30161 20656 79693534
Dysstasia 28.12 11.75 43 30155 27703 79686487
Cardiac failure 27.64 11.75 12 30186 154830 79559360
Lower respiratory tract infection 26.47 11.75 8 30190 129212 79584978
Vision blurred 26.23 11.75 94 30104 105804 79608386
Fatigue 26.07 11.75 495 29703 929232 78784958
Peroneal nerve palsy 25.65 11.75 20 30178 6022 79708168
Histoplasmosis 25.39 11.75 14 30184 2351 79711839
Progressive multifocal leukoencephalopathy 25.35 11.75 35 30163 20565 79693625
Road traffic accident 25.29 11.75 53 30145 43611 79670579
Disturbance in attention 25.27 11.75 58 30140 50743 79663447
Hypersensitivity vasculitis 25.27 11.75 21 30177 6922 79707268
Infusion related reaction 25.24 11.75 30 30168 230207 79483983
Panic attack 25.21 11.75 38 30160 24178 79690012
Muscular weakness 25.17 11.75 124 30074 160605 79553585
Tremor 25.08 11.75 129 30069 169954 79544236
Irritability 25.08 11.75 51 30147 41093 79673097
Amnesia 25.01 11.75 66 30132 62991 79651199
Loss of consciousness 24.50 11.75 127 30071 167816 79546374
Abnormal behaviour 24.44 11.75 47 30151 36374 79677816
Pericarditis 24.16 11.75 5 30193 104231 79609959
Glossodynia 23.86 11.75 5 30193 103332 79610858
White blood cells urine positive 23.42 11.75 19 30179 6056 79708134
Renal failure 23.32 11.75 25 30173 200943 79513247
Dyskinesia 23.25 11.75 52 30146 44721 79669469
Hunger 23.12 11.75 18 30180 5410 79708780
Blood pressure increased 23.09 11.75 148 30050 211212 79502978
Stress 22.63 11.75 74 30124 79538 79634652
Suicide attempt 22.60 11.75 76 30122 82856 79631334
Post-traumatic stress disorder 22.57 11.75 17 30181 4864 79709326
Trigeminal neuralgia 22.31 11.75 15 30183 3594 79710596
Urine analysis abnormal 22.25 11.75 19 30179 6501 79707689
Lymphocyte count decreased 21.36 11.75 52 30146 47237 79666953
Hangover 21.30 11.75 12 30186 2100 79712090
Nervousness 21.06 11.75 42 30156 33373 79680817
Product use in unapproved indication 20.34 11.75 40 30158 250319 79463871
Hypotension 20.13 11.75 92 30106 440225 79273965
Diarrhoea 19.73 11.75 226 29972 880263 78833927
Septic shock 19.67 11.75 11 30187 122790 79591400
Platelet count decreased 19.63 11.75 27 30171 194637 79519553
Oedema mouth 19.63 11.75 13 30185 3038 79711152
Paranoia 19.53 11.75 30 30168 19402 79694788
Tardive dyskinesia 19.50 11.75 22 30176 10549 79703641
Drug withdrawal syndrome 18.79 11.75 41 30157 34677 79679513
Psychotic symptom 18.59 11.75 12 30186 2685 79711505
Laboratory test abnormal 18.58 11.75 36 30162 28012 79686178
Enterococcal sepsis 18.47 11.75 12 30186 2714 79711476
Product use issue 18.39 11.75 32 30166 209790 79504400
International normalised ratio increased 17.80 11.75 5 30193 84716 79629474
Cervical spinal stenosis 17.51 11.75 11 30187 2348 79711842
Endometriosis 17.46 11.75 13 30185 3655 79710535
Poor quality sleep 17.35 11.75 31 30167 22691 79691499
Magical thinking 17.34 11.75 3 30195 6 79714184
Substance use 17.31 11.75 8 30190 926 79713264
Withdrawal syndrome 17.22 11.75 34 30164 26820 79687370
Movement disorder 16.86 11.75 34 30164 27225 79686965
Head injury 16.78 11.75 41 30157 37328 79676862
Interstitial lung disease 16.75 11.75 11 30187 112589 79601601
Urine abnormality 16.71 11.75 18 30180 8201 79705989
Paraesthesia 16.58 11.75 119 30079 176204 79537986
Schizotypal personality disorder 16.48 11.75 3 30195 9 79714181
Sleep attacks 16.41 11.75 5 30193 180 79714010
Nausea 16.38 11.75 476 29722 956720 78757470
Breast cancer 16.18 11.75 38 30160 33743 79680447
Pneumonia 16.15 11.75 166 30032 660080 79054110
Drug intolerance 16.10 11.75 49 30149 264070 79450120
Haemoglobin decreased 15.96 11.75 38 30160 222081 79492109
Incoherent 15.91 11.75 17 30181 7675 79706515
Hypoaesthesia oral 15.90 11.75 23 30175 14101 79700089
Surgery 15.84 11.75 37 30161 32729 79681461
Invasive ductal breast carcinoma 15.82 11.75 15 30183 5877 79708313
Spinal operation 15.50 11.75 17 30181 7900 79706290
Major depression 15.40 11.75 18 30180 8962 79705228
Central nervous system lesion 15.39 11.75 22 30176 13346 79700844
Haematochezia 15.31 11.75 7 30191 87638 79626552
Flushing 15.19 11.75 70 30128 88198 79625992
Abdominal pain 15.18 11.75 86 30112 389483 79324707
Bladder disorder 15.10 11.75 18 30180 9147 79705043
C-reactive protein increased 15.02 11.75 16 30182 129011 79585179
Injection site scar 15.01 11.75 7 30191 826 79713364
Dizziness 14.92 11.75 281 29917 526160 79188030
Rash 14.73 11.75 144 30054 578214 79135976
Arthropathy 14.64 11.75 28 30170 177083 79537107
Depersonalisation/derealisation disorder 14.63 11.75 9 30189 1853 79712337
Hypnopompic hallucination 14.52 11.75 4 30194 100 79714090
Nightmare 14.52 11.75 31 30167 25830 79688360
Urinary sediment present 14.40 11.75 10 30188 2525 79711665
Neuralgia 14.33 11.75 36 30162 33348 79680842
Substance use disorder 14.22 11.75 7 30191 931 79713259
Blood creatinine increased 14.18 11.75 23 30175 155034 79559156
B-lymphocyte count decreased 14.17 11.75 8 30190 1406 79712784
Emotional disorder 14.16 11.75 22 30176 14365 79699825
Hepatic function abnormal 14.14 11.75 5 30193 73102 79641088
Euphoric mood 14.11 11.75 16 30182 7710 79706480
Haemoglobin urine present 14.10 11.75 7 30191 948 79713242
Intervertebral disc protrusion 14.06 11.75 29 30169 23592 79690598
Speech disorder 14.05 11.75 49 30149 54396 79659794
Blood pressure systolic increased 13.99 11.75 4 30194 66982 79647208
Oxygen saturation decreased 13.93 11.75 17 30181 129030 79585160
Neurogenic bladder 13.81 11.75 12 30186 4200 79709990
Delayed sleep phase 13.55 11.75 3 30195 29 79714161
Dyspnoea 13.49 11.75 236 29962 856789 78857401
Product substitution issue 13.41 11.75 26 30172 20230 79693960
Hallucination 13.31 11.75 66 30132 85679 79628511
Electrocardiogram QT prolonged 13.22 11.75 9 30189 90377 79623813
Hysterectomy 13.21 11.75 14 30184 6258 79707932
Erythema 13.20 11.75 42 30156 223248 79490942
Lymphopenia 13.16 11.75 33 30165 30524 79683666
Muscle tightness 13.06 11.75 20 30178 12894 79701296
Extra dose administered 13.01 11.75 16 30182 8399 79705791
Trismus 12.96 11.75 13 30185 5454 79708736
Nephrolithiasis 12.93 11.75 47 30151 53244 79660946
Sleep-related eating disorder 12.87 11.75 6 30192 708 79713482
Somatic delusion 12.84 11.75 6 30192 712 79713478
Haematuria 12.82 11.75 5 30193 68831 79645359
Hypertension 12.82 11.75 186 30012 330806 79383384
Multiple organ dysfunction syndrome 12.82 11.75 16 30182 120230 79593960
Ankle fracture 12.76 11.75 23 30175 16946 79697244
Papilloma viral infection 12.66 11.75 8 30190 1726 79712464
Pyrexia 12.65 11.75 181 30017 678528 79035662
Blister 12.63 11.75 16 30182 119460 79594730
Dihydrotestosterone increased 12.53 11.75 3 30195 42 79714148
Product dose omission issue 12.48 11.75 146 30052 247391 79466799
Asthenia 12.45 11.75 267 29931 511422 79202768
Rash maculo-papular 12.37 11.75 3 30195 56075 79658115
Periodic limb movement disorder 12.36 11.75 4 30194 176 79714014
Stomatitis 12.30 11.75 23 30175 146734 79567456
Bruxism 12.26 11.75 11 30187 4015 79710175
Drug ineffective 12.23 11.75 314 29884 1080599 78633591
Urine leukocyte esterase positive 12.11 11.75 11 30187 4080 79710110
Systemic lupus erythematosus 12.01 11.75 17 30181 121132 79593058
Drug abuser 11.93 11.75 13 30185 6000 79708190
Treatment noncompliance 11.76 11.75 45 30153 52223 79661967

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC N06BA07 NERVOUS SYSTEM
PSYCHOANALEPTICS
PSYCHOSTIMULANTS, AGENTS USED FOR ADHD AND NOOTROPICS
Centrally acting sympathomimetics
MeSH PA D002491 Central Nervous System Agents
MeSH PA D000697 Central Nervous System Stimulants
MeSH PA D065701 Cytochrome P-450 CYP3A Inducers
MeSH PA D065606 Metabolic Side Effects of Drugs and Substances
MeSH PA D064690 Wakefulness-Promoting Agents
FDA PE N0000175651 Increased Sympathetic Activity
FDA PE N0000175729 Central Nervous System Stimulation
FDA EPC N0000175769 Sympathomimetic-like Agent
CHEBI has role CHEBI:35337 analeptic
CHEBI has role CHEBI:77567 wakefulness-promoting agent

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

DiseaseRelationSNOMED_IDDOID
Narcolepsy indication 60380001 DOID:8986
Hypersomnia indication 77692006
Sleepiness Due To Obstructive Sleep Apnea indication
Sleepiness Due To Shift Work Sleep Disorder indication
Suicidal thoughts contraindication 6471006
Alcoholism contraindication 7200002
Myocardial infarction contraindication 22298006 DOID:5844
Depressive disorder contraindication 35489007
Hypertensive disorder contraindication 38341003 DOID:10763
Left ventricular hypertrophy contraindication 55827005
Acute nephropathy contraindication 58574008
Hepatic failure contraindication 59927004
Aggressive behavior contraindication 61372001
Psychotic disorder contraindication 69322001
Mania contraindication 231494001
Acute coronary syndrome contraindication 394659003
Mitral valve prolapse contraindication 409712001
Myocardial ischemia contraindication 414795007 DOID:3393




๐Ÿถ Veterinary Drug Use

None

๐Ÿถ Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 12.23 acidic

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
Sodium-dependent dopamine transporter Transporter INHIBITOR Ki 5.84 DRUG MATRIX CHEMBL
D(3) dopamine receptor GPCR Ki 4.41 CHEMBL
Alpha-1B adrenergic receptor GPCR WOMBAT-PK
Cytochrome P450 1A2 Enzyme Ki 4.40 WOMBAT-PK
Cytochrome P450 2C19 Enzyme WOMBAT-PK
D(2) dopamine receptor GPCR EC50 6.62 WOMBAT-PK
Sodium-dependent serotonin transporter Transporter Ki 4.50 CHEMBL
Sodium-dependent dopamine transporter Transporter Ki 5.60 CHEMBL
Transporter Transporter IC50 4.19 CHEMBL

External reference:

IDSource
4021149 VUID
N0000148602 NUI
D01832 KEGG_DRUG
4021149 VANDF
C0066677 UMLSCUI
CHEBI:31859 CHEBI
CHEMBL1373 ChEMBL_ID
DB00745 DRUGBANK_ID
D000077408 MESH_DESCRIPTOR_UI
4236 PUBCHEM_CID
7555 IUPHAR_LIGAND_ID
6055 INN_ID
R3UK8X3U3D UNII
30125 RXNORM
52652 MMSL
7873 MMSL
d04378 MMSL
005305 NDDF
116082007 SNOMEDCT_US
387004007 SNOMEDCT_US

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Modafinil HUMAN PRESCRIPTION DRUG LABEL 1 0904-6423 TABLET 100 mg ORAL ANDA 29 sections
Modafinil HUMAN PRESCRIPTION DRUG LABEL 1 0904-6424 TABLET 200 mg ORAL ANDA 29 sections
Modafinil HUMAN PRESCRIPTION DRUG LABEL 1 0904-6791 TABLET 100 mg ORAL ANDA 19 sections
Modafinil HUMAN PRESCRIPTION DRUG LABEL 1 0904-6791 TABLET 100 mg ORAL ANDA 19 sections
Modafinil HUMAN PRESCRIPTION DRUG LABEL 1 0904-6792 TABLET 200 mg ORAL ANDA 19 sections
Modafinil HUMAN PRESCRIPTION DRUG LABEL 1 0904-6792 TABLET 200 mg ORAL ANDA 19 sections
PROVIGIL HUMAN PRESCRIPTION DRUG LABEL 1 21695-234 TABLET 100 mg ORAL NDA 25 sections
PROVIGIL HUMAN PRESCRIPTION DRUG LABEL 1 21695-235 TABLET 200 mg ORAL NDA 25 sections
Modafinil Human Prescription Drug Label 1 23155-604 TABLET 100 mg ORAL ANDA 24 sections
Modafinil Human Prescription Drug Label 1 23155-605 TABLET 200 mg ORAL ANDA 24 sections
Modafinil HUMAN PRESCRIPTION DRUG LABEL 1 42043-160 TABLET 100 mg ORAL ANDA 29 sections
Modafinil HUMAN PRESCRIPTION DRUG LABEL 1 42043-161 TABLET 200 mg ORAL ANDA 29 sections
Modafinil HUMAN PRESCRIPTION DRUG LABEL 1 42291-599 TABLET 100 mg ORAL ANDA 30 sections
Modafinil HUMAN PRESCRIPTION DRUG LABEL 1 42291-600 TABLET 200 mg ORAL ANDA 30 sections
MODAFINIL HUMAN PRESCRIPTION DRUG LABEL 1 42549-678 TABLET 200 mg ORAL NDA authorized generic 25 sections
Modafinil HUMAN PRESCRIPTION DRUG LABEL 1 43353-831 TABLET 200 mg ORAL ANDA 28 sections
modafinil HUMAN PRESCRIPTION DRUG LABEL 1 43353-925 TABLET 200 mg ORAL NDA authorized generic 25 sections
Modafinil HUMAN PRESCRIPTION DRUG LABEL 1 43353-956 TABLET 200 mg ORAL NDA authorized generic 28 sections
Modafinil Human Prescription Drug Label 1 46708-385 TABLET 100 mg ORAL ANDA 29 sections
Modafinil Human Prescription Drug Label 1 46708-385 TABLET 100 mg ORAL ANDA 29 sections
Modafinil Human Prescription Drug Label 1 46708-386 TABLET 200 mg ORAL ANDA 29 sections
Modafinil Human Prescription Drug Label 1 46708-386 TABLET 200 mg ORAL ANDA 29 sections
Modafinil Human Prescription Drug Label 1 50090-2472 TABLET 100 mg ORAL ANDA 29 sections
Modafinil Human Prescription Drug Label 1 50090-2473 TABLET 200 mg ORAL ANDA 29 sections
Modafinil HUMAN PRESCRIPTION DRUG LABEL 1 50090-3865 TABLET 100 mg ORAL ANDA 29 sections
Modafinil HUMAN PRESCRIPTION DRUG LABEL 1 50090-4144 TABLET 200 mg ORAL ANDA 19 sections
Modafinil HUMAN PRESCRIPTION DRUG LABEL 1 50268-570 TABLET 100 mg ORAL ANDA 29 sections
Modafinil HUMAN PRESCRIPTION DRUG LABEL 1 50268-570 TABLET 100 mg ORAL ANDA 29 sections
Modafinil HUMAN PRESCRIPTION DRUG LABEL 1 50268-571 TABLET 200 mg ORAL ANDA 29 sections
Modafinil HUMAN PRESCRIPTION DRUG LABEL 1 50268-571 TABLET 200 mg ORAL ANDA 29 sections