modafinil 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | 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 µM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability) 80 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H

Predicted pharmacokinetic/toxicological properties (PK-AZ):

PropertyDescriptionValueUnitConfidenceSimilarity
kinase-safety-class ACVR2A,ACVR2B,AKT2,AKT3,AURKA,AXL,BRAF,BTK,CAMK2B,CAMK2D,CDK5,CDK9,DDR1,DYRK1B,EIF2AK3,EPHB4,ERBB2,FLT3,GRK2,GSK3B,IGF1R,ITK,JAK2,JAK3,MAP2K6,MAP3K21,MAP3K7,MAPK10,MAPK7,MAPK8,MAPK9,MAPKAPK2,MARK4,MET,MTOR,NTRK2,PDK1,PDK2,PDK4,PDPK1,PIK3CB,PIK3CD,PIM2,PRKCD,PRKDC,SIK2,SIK3,STK33,SYK,TEK,TTK,ULK1,ZAP70 53
kinase-selectivity-class AXL,ERBB2,GRK2,MAP2K6,PDK4,SIK2,TEK 7
pfas-class PFAS structural alert (1 = True, 0 = False) 0
pld-class Phospholipidosis risk class (1 = positive, 0 = negative) 0 High 1

Approvals:

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

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 478.17 10.86 285 36386 52020 90539756
Multiple sclerosis 333.26 10.86 181 36490 27659 90564117
Product administration interrupted 330.29 10.86 140 36531 12352 90579424
Pre-existing condition improved 276.92 10.86 113 36558 9056 90582720
Cataplexy 252.66 10.86 68 36603 1452 90590324
Depression 243.60 10.86 436 36235 300165 90291611
Suicidal ideation 199.14 10.86 194 36477 73661 90518115
Sleep apnoea syndrome 197.96 10.86 136 36535 31611 90560165
Anxiety 169.93 10.86 382 36289 309390 90282386
Somnambulism 114.05 10.86 54 36617 6174 90585602
Somnolence 113.57 10.86 257 36414 208827 90382949
Synovitis 112.23 10.86 5 36666 329747 90262029
Snoring 111.23 10.86 50 36621 5076 90586700
Joint swelling 110.99 10.86 33 36638 503267 90088509
Hand deformity 102.50 10.86 4 36667 296358 90295418
Glossodynia 100.09 10.86 8 36663 321771 90270005
Contraindicated product administered 96.74 10.86 9 36662 320130 90271646
Balance disorder 95.86 10.86 154 36517 96926 90494850
Enuresis 89.35 10.86 38 36633 3376 90588400
Pericarditis 86.04 10.86 6 36665 270145 90321631
Fall 85.93 10.86 404 36267 481406 90110370
Infusion related reaction 83.71 10.86 32 36639 416748 90175028
Feeling abnormal 82.48 10.86 198 36473 167037 90424739
Surgery 82.08 10.86 96 36575 44791 90546985
Wound 80.59 10.86 13 36658 302967 90288809
Lower respiratory tract infection 78.58 10.86 6 36665 250653 90341123
Systemic lupus erythematosus 73.98 10.86 27 36644 361869 90229907
Tremor 69.85 10.86 176 36495 152997 90438779
Influenza like illness 69.04 10.86 120 36551 80491 90511285
Arthropathy 68.88 10.86 31 36640 366211 90225565
General physical health deterioration 68.46 10.86 29 36642 355086 90236690
Seizure 66.10 10.86 172 36499 152457 90439319
Therapeutic response unexpected 63.70 10.86 60 36611 21820 90569956
Treatment failure 63.26 10.86 22 36649 303906 90287870
Psychotic disorder 62.51 10.86 70 36601 31160 90560616
Rheumatoid arthritis 61.73 10.86 35 36636 362579 90229197
Muscle injury 59.03 10.86 3 36668 176651 90415125
Major depression 57.88 10.86 41 36630 9994 90581782
Off label use 57.86 10.86 240 36431 1102012 89489764
Helicobacter infection 57.54 10.86 11 36660 226839 90364937
Urinary incontinence 56.79 10.86 73 36598 37493 90554283
Liver injury 56.67 10.86 3 36668 170564 90421212
Sleep paralysis 56.55 10.86 19 36652 879 90590897
Folliculitis 56.08 10.86 8 36663 204345 90387431
Restless legs syndrome 54.93 10.86 56 36615 22414 90569362
Product use issue 54.51 10.86 33 36638 329886 90261890
Disturbance in attention 53.86 10.86 80 36591 47029 90544747
Narcolepsy 53.60 10.86 21 36650 1511 90590265
Neuralgia 52.06 10.86 64 36607 31436 90560340
Feeling drunk 51.59 10.86 29 36642 4729 90587047
Stress 50.91 10.86 106 36565 81289 90510487
Gait disturbance 50.46 10.86 224 36447 260272 90331504
Hypersomnia 49.64 10.86 52 36619 21479 90570297
Parasomnia 49.38 10.86 16 36655 660 90591116
Blister 48.84 10.86 21 36650 254977 90336799
Intentional dose omission 48.42 10.86 47 36624 17736 90574040
Blood pressure measurement 48.40 10.86 14 36657 392 90591384
Post-traumatic stress disorder 46.72 10.86 31 36640 6797 90584979
Panic attack 45.90 10.86 55 36616 26310 90565466
Wheezing 44.97 10.86 20 36651 238060 90353716
Paranoia 44.65 10.86 39 36632 12869 90578907
Urinary tract infection 44.32 10.86 242 36429 305390 90286386
Migraine 44.12 10.86 173 36498 190219 90401557
Memory impairment 43.92 10.86 177 36494 197067 90394709
Impaired healing 43.73 10.86 20 36651 234179 90357597
Mania 43.56 10.86 40 36631 14084 90577692
Irritability 42.85 10.86 62 36609 35600 90556176
Stomatitis 41.95 10.86 30 36641 274668 90317108
Rash 40.65 10.86 175 36496 795925 89795851
Loss of consciousness 40.59 10.86 137 36534 140101 90451675
Bruxism 40.40 10.86 24 36647 4339 90587437
Blood pressure increased 40.01 10.86 172 36499 197045 90394731
Magnetic resonance imaging abnormal 39.85 10.86 22 36649 3464 90588312
Sleep-related eating disorder 39.54 10.86 15 36656 989 90590787
Bipolar disorder 39.09 10.86 31 36640 8954 90582822
Vision blurred 38.55 10.86 115 36556 110178 90481598
Drug intolerance 38.40 10.86 77 36594 447514 90144262
Dysstasia 38.36 10.86 49 36622 25003 90566773
Hunger 38.28 10.86 27 36644 6536 90585240
Pregnancy on oral contraceptive 38.01 10.86 15 36656 1100 90590676
Psoriatic arthropathy 37.48 10.86 23 36648 228312 90363464
Optic neuritis 37.06 10.86 31 36640 9647 90582129
Abnormal dreams 36.92 10.86 33 36638 11224 90580552
C-reactive protein increased 36.25 10.86 14 36657 181375 90410401
Hypnagogic hallucination 36.16 10.86 10 36661 237 90591539
Type 2 diabetes mellitus 35.46 10.86 19 36652 203225 90388551
Weight decreased 35.43 10.86 269 36402 379641 90212135
Swelling 35.17 10.86 73 36598 418985 90172791
Polycystic ovaries 34.71 10.86 24 36647 5630 90586146
Abdominal discomfort 34.56 10.86 90 36581 477238 90114538
Hepatic enzyme increased 34.54 10.86 58 36613 360678 90231098
Lymphopenia 33.86 10.86 44 36627 22837 90568939
Substance use 33.56 10.86 14 36657 1185 90590591
Muscle spasticity 33.43 10.86 55 36616 35267 90556509
Acute kidney injury 33.05 10.86 49 36622 320338 90271438
Secondary progressive multiple sclerosis 32.98 10.86 15 36656 1564 90590212
Peripheral swelling 32.97 10.86 74 36597 413032 90178744
Alopecia 32.40 10.86 98 36573 494973 90096803
Discomfort 32.34 10.86 38 36633 274297 90317479
Inflammation 32.18 10.86 16 36655 178576 90413200
Central nervous system lesion 32.12 10.86 31 36640 11615 90580161
Wound infection 32.08 10.86 3 36668 106399 90485377
Febrile neutropenia 32.01 10.86 12 36659 158337 90433439
Crying 31.41 10.86 45 36626 25600 90566176
Ill-defined disorder 31.21 10.86 18 36653 184873 90406903
Lymphocyte count decreased 31.07 10.86 53 36618 34997 90556779
Insomnia 31.01 10.86 236 36435 333238 90258538
Muscle spasms 30.99 10.86 191 36480 251692 90340084
Headache 29.77 10.86 502 36169 862244 89729532
Spinal operation 29.75 10.86 28 36643 10168 90581608
Joint range of motion decreased 29.64 10.86 9 36662 135634 90456142
Nephrolithiasis 29.61 10.86 63 36608 49022 90542754
Dyskinesia 29.48 10.86 53 36618 36481 90555295
Thrombocytopenia 29.07 10.86 25 36646 208700 90383076
Neutropenia 28.89 10.86 29 36642 224875 90366901
Hypersensitivity vasculitis 28.74 10.86 19 36652 4140 90587636
Clumsiness 28.57 10.86 16 36655 2591 90589185
Hangover 28.33 10.86 15 36656 2174 90589602
Histoplasmosis 28.23 10.86 15 36656 2189 90589587
Nausea 28.08 10.86 616 36055 1109700 89482076
Product dose omission issue 28.00 10.86 208 36463 291479 90300297
Peroneal nerve palsy 27.54 10.86 21 36650 5727 90586049
Malignant neoplasm progression 27.48 10.86 5 36666 106865 90484911
Obsessive-compulsive disorder 27.37 10.86 19 36652 4485 90587291
Emotional disorder 27.28 10.86 32 36639 14965 90576811
Therapeutic product effect incomplete 27.28 10.86 23 36648 193873 90397903
Hallucination, auditory 27.27 10.86 33 36638 15942 90575834
Periodic limb movement disorder 27.27 10.86 10 36661 600 90591176
Abnormal sleep-related event 27.20 10.86 11 36660 860 90590916
Hysterectomy 26.74 10.86 28 36643 11556 90580220
Death 26.67 10.86 95 36576 456456 90135320
Pancytopenia 26.24 10.86 8 36663 120255 90471521
Muscular weakness 26.23 10.86 158 36513 206508 90385268
Drug withdrawal syndrome 26.21 10.86 44 36627 28679 90563097
Nocturia 25.87 10.86 26 36645 10229 90581547
Withdrawal syndrome 25.38 10.86 38 36633 22486 90569290
Intervertebral disc protrusion 25.27 10.86 42 36629 27154 90564622
Irritable bowel syndrome 25.24 10.86 28 36643 207420 90384356
Postural orthostatic tachycardia syndrome 25.05 10.86 14 36657 2258 90589518
Bursitis 24.94 10.86 11 36660 131643 90460133
Vitamin D deficiency 24.80 10.86 33 36638 17523 90574253
Maternal exposure during pregnancy 24.46 10.86 70 36601 359993 90231783
Trigeminal neuralgia 24.11 10.86 17 36654 4114 90587662
Perinatal depression 23.94 10.86 10 36661 849 90590927
Attention deficit hyperactivity disorder 23.91 10.86 17 36654 4167 90587609
Unevaluable event 23.91 10.86 62 36609 54786 90536990
Enterococcal sepsis 23.57 10.86 12 36659 1604 90590172
Lung disorder 23.36 10.86 16 36655 149867 90441909
White blood cells urine positive 23.21 10.86 20 36651 6478 90585298
Cervical spinal stenosis 23.12 10.86 14 36657 2621 90589155
Cognitive disorder 22.96 10.86 71 36600 69336 90522440
Poor quality sleep 22.76 10.86 38 36633 24655 90567121
Urine analysis abnormal 22.68 10.86 18 36653 5203 90586573
Breast cancer 22.65 10.86 60 36611 53701 90538075
Dissociation 22.65 10.86 20 36651 6695 90585081
Abnormal behaviour 22.45 10.86 36 36635 22592 90569184
Gastrointestinal disorder 22.12 10.86 44 36627 256643 90335133
Dizziness 21.80 10.86 347 36324 588937 90002839
Product use in unapproved indication 21.66 10.86 67 36604 336169 90255607
Asthma exercise induced 21.61 10.86 8 36663 493 90591283
Diarrhoea 21.54 10.86 260 36411 938930 89652846
Loss of bladder sensation 21.50 10.86 5 36666 57 90591719
Abdominal pain 21.37 10.86 85 36586 395636 90196140
Bladder disorder 21.31 10.86 24 36647 10748 90581028
Incoherent 21.28 10.86 17 36654 4960 90586816
Uterine leiomyoma 21.14 10.86 24 36647 10840 90580936
Head injury 21.13 10.86 42 36629 31146 90560630
Illness 21.05 10.86 77 36594 81892 90509884
Tardive dyskinesia 21.02 10.86 24 36647 10906 90580870
Cardiac failure 20.98 10.86 9 36662 109487 90482289
Nightmare 20.79 10.86 34 36637 21691 90570085
Concussion 20.73 10.86 24 36647 11067 90580709
Hypnopompic hallucination 20.55 10.86 5 36666 70 90591706
Hypersensitivity 20.17 10.86 105 36566 454572 90137204
Pyrexia 20.02 10.86 171 36500 660314 89931462
Fatigue 19.98 10.86 609 36062 1153414 89438362
Endometriosis 19.86 10.86 18 36653 6230 90585546
Product substitution issue 19.75 10.86 30 36641 17978 90573798
Drug-induced liver injury 19.72 10.86 6 36665 90312 90501464
Breast cancer stage III 19.57 10.86 5 36666 84442 90507334
Suicide attempt 19.50 10.86 71 36600 75328 90516448
Pneumonia 19.43 10.86 165 36506 637894 89953882
Infection 19.41 10.86 78 36593 362016 90229760
Oedema mouth 19.21 10.86 12 36659 2374 90589402
Disease progression 19.20 10.86 21 36650 156594 90435182
Vertigo 19.14 10.86 67 36604 69744 90522032
Treatment noncompliance 19.08 10.86 55 36616 51672 90540104
Red blood cell sedimentation rate increased 18.93 10.86 5 36666 82590 90509186
Feeling jittery 18.87 10.86 27 36644 15344 90576432
Liver disorder 18.82 10.86 13 36658 121256 90470520
Heart rate 18.79 10.86 6 36665 236 90591540
Apnoea 18.66 10.86 21 36650 9393 90582383
Progressive multifocal leukoencephalopathy 18.49 10.86 27 36644 15628 90576148
Mobility decreased 18.33 10.86 47 36624 250687 90341089
Drug ineffective 18.33 10.86 424 36247 1383874 89207902
Speech disorder 18.32 10.86 50 36621 45535 90546241
Palpitations 18.28 10.86 106 36565 136622 90455154
Hypoaesthesia 18.28 10.86 201 36470 314009 90277767
T-lymphocyte count increased 18.23 10.86 6 36665 260 90591516
Anger 18.18 10.86 25 36646 13695 90578081
Therapeutic product effect decreased 18.09 10.86 55 36616 277516 90314260
Agitation 18.05 10.86 64 36607 67034 90524742
Anal incontinence 17.74 10.86 27 36644 16203 90575573
Live birth 17.74 10.86 5 36666 79102 90512674
Injury 17.72 10.86 33 36638 197316 90394460
Choking 17.58 10.86 23 36648 12010 90579766
Drug titration error 17.51 10.86 9 36662 1228 90590548
Injection site scar 17.37 10.86 9 36662 1248 90590528
Post procedural complication 17.15 10.86 29 36642 19013 90572763
Back pain 17.14 10.86 200 36471 316975 90274801
Grip strength decreased 17.12 10.86 8 36663 92568 90499208
Musculoskeletal stiffness 17.10 10.86 62 36609 296470 90295306
Flushing 17.03 10.86 76 36595 88415 90503361
Ankle fracture 17.01 10.86 30 36641 20340 90571436
JC polyomavirus test positive 16.92 10.86 10 36661 1792 90589984
Blood cholesterol increased 16.79 10.86 37 36634 207975 90383801
Libido decreased 16.77 10.86 12 36659 2970 90588806
Hypercholesterolaemia 16.77 10.86 10 36661 100882 90490894
Urine abnormality 16.62 10.86 18 36653 7719 90584057
Spinal stenosis 16.31 10.86 27 36644 17397 90574379
Photophobia 16.07 10.86 30 36641 21239 90570537
Wrong dose 16.03 10.86 10 36661 1974 90589802
Urinary sediment 15.83 10.86 4 36667 66 90591710
Seasonal affective disorder 15.75 10.86 6 36665 400 90591376
Urine leukocyte esterase positive 15.74 10.86 12 36659 3270 90588506
Spinal osteoarthritis 15.73 10.86 28 36643 19120 90572656
Hypoaesthesia oral 15.73 10.86 25 36646 15575 90576201
Meniscus injury 15.69 10.86 18 36653 8219 90583557
Micturition urgency 15.69 10.86 21 36650 11212 90580564
Paraesthesia 15.42 10.86 162 36509 250164 90341612
Paralysis 15.33 10.86 21 36650 11457 90580319
Adverse event 15.23 10.86 15 36656 117403 90474373
Urinary sediment present 15.19 10.86 10 36661 2164 90589612
Depersonalisation/derealisation disorder 15.17 10.86 9 36662 1623 90590153
Arthralgia 15.10 10.86 223 36448 778299 89813477
Haemoglobin urine present 14.99 10.86 7 36664 775 90591001
Therapy non-responder 14.99 10.86 20 36651 136684 90455092
Movement disorder 14.98 10.86 35 36636 28984 90562792
Appendicectomy 14.78 10.86 12 36659 3584 90588192
Coordination abnormal 14.76 10.86 29 36642 21327 90570449
Invasive ductal breast carcinoma 14.75 10.86 17 36654 7801 90583975
Impaired driving ability 14.70 10.86 14 36657 5159 90586617
Liver function test increased 14.69 10.86 8 36663 84847 90506929
Temperature intolerance 14.57 10.86 21 36650 12009 90579767
Neurogenic bladder 14.54 10.86 12 36659 3666 90588110
Drug effect less than expected 14.46 10.86 15 36656 6123 90585653
Blood pressure systolic increased 14.43 10.86 3 36668 58342 90533434
Nervousness 14.33 10.86 38 36633 34018 90557758
Muscle tightness 14.19 10.86 22 36649 13417 90578359
Euphoric mood 14.17 10.86 14 36657 5395 90586381
Brachial plexus injury 13.86 10.86 3 36668 24 90591752
Fear of surgery 13.86 10.86 3 36668 24 90591752
Intervertebral disc degeneration 13.86 10.86 25 36646 17249 90574527
Depressed mood 13.59 10.86 48 36623 50174 90541602
Disorientation 13.56 10.86 44 36627 44070 90547706
Loss of control of legs 13.49 10.86 8 36663 1442 90590334
B-lymphocyte count decreased 13.39 10.86 8 36663 1461 90590315
Muscle twitching 13.39 10.86 30 36641 24172 90567604
Muscle strain 13.36 10.86 18 36653 9669 90582107
Abortion spontaneous 13.22 10.86 50 36621 54006 90537770
Bipolar I disorder 13.16 10.86 9 36662 2073 90589703
Laboratory test abnormal 13.09 10.86 42 36629 41812 90549964
Renal impairment 13.07 10.86 14 36657 105407 90486369
CD4 lymphocytes decreased 13.01 10.86 8 36663 1539 90590237
Scoliosis 12.98 10.86 17 36654 8890 90582886
Hypothyroidism 12.88 10.86 49 36622 53078 90538698
Metabolic surgery 12.71 10.86 8 36663 1603 90590173
Musculoskeletal pain 12.59 10.86 32 36639 171219 90420557
Pain of skin 12.55 10.86 23 36648 16059 90575717
Aphasia 12.53 10.86 42 36629 42770 90549006
Malignant melanoma 12.47 10.86 20 36651 12556 90579220
Accident at home 12.34 10.86 4 36667 165 90591611
Platelet count decreased 12.21 10.86 23 36648 136946 90454830
COVID-19 12.21 10.86 113 36558 168730 90423046
Cholecystectomy 12.07 10.86 19 36652 11736 90580040
Sciatica 11.98 10.86 14 36657 101368 90490408
Adjustment disorder with depressed mood 11.98 10.86 4 36667 56749 90535027
Papilloma viral infection 11.97 10.86 8 36663 1774 90590002
Neck injury 11.91 10.86 9 36662 2423 90589353
Hypertension 11.85 10.86 255 36416 457277 90134499
Septic shock 11.81 10.86 10 36661 84150 90507626
Laryngitis 11.77 10.86 3 36668 50750 90541026
Eye pain 11.77 10.86 42 36629 44126 90547650
Anaemia 11.74 10.86 89 36582 352713 90239063
Blepharospasm 11.54 10.86 4 36667 55441 90536335
Foot fracture 11.52 10.86 30 36641 26576 90565200
Mood altered 11.51 10.86 23 36648 17121 90574655
Tic 11.47 10.86 8 36663 1903 90589873
Pain 11.30 10.86 312 36359 996029 89595747
Heart rate abnormal 11.29 10.86 13 36658 5958 90585818
Incision site pain 11.27 10.86 7 36664 1371 90590405
Immune reconstitution inflammatory syndrome 11.18 10.86 14 36657 7005 90584771
Gastrectomy 11.16 10.86 6 36665 896 90590880
Autonomic nervous system imbalance 11.09 10.86 10 36661 3440 90588336
Nail disorder 11.08 10.86 5 36666 59062 90532714
Device interaction 11.04 10.86 4 36667 232 90591544
Pelvic floor dysfunction 10.97 10.86 3 36668 68 90591708
Gastric bypass 10.95 10.86 8 36663 2046 90589730
Retching 10.88 10.86 24 36647 19135 90572641

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 227.12 14.60 47 13767 380 42607141
Product administration interrupted 192.09 14.60 69 13745 4897 42602624
Sleep apnoea syndrome 149.63 14.60 91 13723 21517 42586004
Pre-existing condition improved 136.90 14.60 47 13767 2916 42604605
Multiple sclerosis relapse 108.93 14.60 64 13750 14200 42593321
Anxiety 108.63 14.60 161 13653 118399 42489122
Multiple sclerosis 103.09 14.60 50 13764 7548 42599973
Suicidal ideation 101.60 14.60 100 13714 48061 42559460
Depression 91.77 14.60 144 13670 111219 42496302
Therapeutic response unexpected 71.31 14.60 45 13769 11336 42596185
Somnambulism 66.84 14.60 29 13785 3386 42604135
Memory impairment 59.07 14.60 77 13737 50145 42557376
Tic 52.47 14.60 22 13792 2361 42605160
Bipolar disorder 50.77 14.60 25 13789 3897 42603624
Somnolence 49.72 14.60 128 13686 140977 42466544
Obsessive-compulsive disorder 48.19 14.60 29 13785 6714 42600807
Acute kidney injury 47.99 14.60 30 13784 367307 42240214
Feeling abnormal 47.66 14.60 83 13731 69703 42537818
Narcolepsy 44.70 14.60 14 13800 649 42606872
Sleep paralysis 44.19 14.60 12 13802 334 42607187
Insomnia 42.39 14.60 108 13706 118145 42489376
Psychotic disorder 41.08 14.60 49 13765 29159 42578362
Mania 40.80 14.60 31 13783 10516 42597005
Cognitive disorder 39.56 14.60 52 13762 34120 42573401
Anaemia 39.26 14.60 21 13793 280257 42327264
Delusion 37.54 14.60 34 13780 14700 42592821
Snoring 36.16 14.60 20 13794 3953 42603568
Neutropenia 36.08 14.60 10 13804 199421 42408100
Concussion 33.72 14.60 17 13797 2785 42604736
Tourette's disorder 32.39 14.60 7 13807 71 42607450
Road traffic accident 31.86 14.60 35 13779 19058 42588463
Abnormal sleep-related event 31.59 14.60 10 13804 480 42607041
Hypertension 30.55 14.60 121 13693 167083 42440438
Thrombocytopenia 30.12 14.60 12 13802 190267 42417254
Migraine 29.91 14.60 39 13775 25375 42582146
Irritability 29.80 14.60 41 13773 28087 42579434
Foetal malnutrition 29.69 14.60 7 13807 108 42607413
Affective disorder 28.69 14.60 20 13794 5940 42601581
Enuresis 28.26 14.60 15 13799 2733 42604788
Nephrolithiasis 28.03 14.60 46 13768 36784 42570737
Post-traumatic stress disorder 27.90 14.60 14 13800 2271 42605250
Fall 27.49 14.60 149 13665 234371 42373150
Paranoia 27.47 14.60 28 13786 13998 42593523
Headache 27.34 14.60 151 13663 239218 42368303
Wrong dose 27.24 14.60 11 13803 1073 42606448
Gait disturbance 25.75 14.60 80 13734 97920 42509601
Drug tolerance 25.73 14.60 15 13799 3275 42604246
Sleep-related eating disorder 25.68 14.60 8 13806 364 42607157
Foetal hypokinesia 25.31 14.60 8 13806 382 42607139
Disturbance in attention 25.06 14.60 39 13775 29827 42577694
Abnormal dreams 24.92 14.60 21 13793 8250 42599271
Death 23.90 14.60 76 13738 471109 42136412
Surgery 23.86 14.60 29 13785 17587 42589934
Trigeminal neuralgia 23.33 14.60 11 13803 1558 42605963
Disease progression 22.82 14.60 9 13805 143647 42463874
Hallucination 22.13 14.60 54 13760 57453 42550068
Post concussion syndrome 21.93 14.60 6 13808 172 42607349
Complex regional pain syndrome 21.37 14.60 8 13806 637 42606884
Urine sodium increased 21.34 14.60 5 13809 75 42607446
Hypotension 20.91 14.60 32 13782 257599 42349922
Aggression 20.89 14.60 45 13769 44118 42563403
Secondary progressive multiple sclerosis 20.75 14.60 7 13807 411 42607110
Blood pressure increased 20.42 14.60 76 13738 101852 42505669
Product use in unapproved indication 20.24 14.60 18 13796 184438 42423083
General physical health deterioration 20.18 14.60 12 13802 151234 42456287
Parasomnia 19.96 14.60 7 13807 462 42607059
Renal failure 19.75 14.60 11 13803 143715 42463806
Condition aggravated 19.59 14.60 148 13666 260606 42346915
Trismus 19.57 14.60 12 13802 2872 42604649
Renal impairment 19.05 14.60 6 13808 110222 42497299
Abnormal behaviour 18.74 14.60 32 13782 26419 42581102
Malignant neoplasm progression 18.56 14.60 6 13808 108394 42499127
Fatigue 18.54 14.60 219 13595 435422 42172099
Platelet count decreased 18.48 14.60 11 13803 138570 42468951
Diarrhoea 18.36 14.60 82 13732 460767 42146754
Periodic limb movement disorder 18.35 14.60 5 13809 141 42607380
Hypoosmolar state 18.02 14.60 5 13809 151 42607370
Panic attack 18.00 14.60 20 13794 11025 42596496
Muscle spasticity 17.88 14.60 16 13798 6806 42600715
Nervousness 17.88 14.60 22 13792 13510 42594011
Schizotypal personality disorder 17.81 14.60 3 13811 6 42607515
Pyrexia 17.63 14.60 67 13747 393975 42213546
Hypoaesthesia 17.53 14.60 57 13757 71406 42536115
Hypnagogic hallucination 17.53 14.60 4 13810 53 42607468
Wrong technique in product usage process 17.44 14.60 41 13773 42594 42564927
Rib hypoplasia 16.95 14.60 3 13811 9 42607512
Feeling jittery 16.91 14.60 13 13801 4485 42603036
Influenza like illness 16.88 14.60 34 13780 31806 42575715
Urinary tract infection 16.63 14.60 70 13744 99214 42508307
Seizure 16.46 14.60 80 13734 120481 42487040
Hallucination, auditory 16.24 14.60 22 13792 14842 42592679
Tremor 15.97 14.60 68 13746 96861 42510660
Septic shock 15.82 14.60 5 13809 91667 42515854
Off label use 15.78 14.60 132 13682 638203 41969318
Antiphospholipid antibodies 15.73 14.60 3 13811 15 42607506
Pulmonary hypoplasia 15.67 14.60 6 13808 508 42607013
Agitation 15.51 14.60 51 13763 64263 42543258
Drug dependence 15.34 14.60 31 13783 29063 42578458
Restless legs syndrome 14.97 14.60 17 13797 9597 42597924
Withdrawal syndrome 14.84 14.60 21 13793 14754 42592767
Muscle spasms 14.67 14.60 61 13753 85983 42521538

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 447.73 12.13 248 35087 49992 110503972
Multiple sclerosis 350.71 12.13 169 35166 25529 110528435
Cataplexy 339.10 12.13 78 35257 1091 110552873
Product administration interrupted 304.32 12.13 120 35215 11172 110542792
Depression 183.41 12.13 348 34987 316987 110236977
Pre-existing condition improved 143.70 12.13 60 35275 6466 110547498
Anxiety 130.77 12.13 319 35016 344759 110209205
Sleep apnoea syndrome 130.11 12.13 106 35229 40341 110513623
Suicidal ideation 118.35 12.13 148 35187 93789 110460175
Fall 103.68 12.13 424 34911 603058 109950906
Feeling abnormal 86.06 12.13 183 35152 180528 110373436
Urinary tract infection 82.20 12.13 260 35075 326022 110227942
Somnolence 80.47 12.13 243 35092 297206 110256758
Memory impairment 75.49 12.13 183 35152 196761 110357203
Narcolepsy 72.95 12.13 25 35310 1563 110552401
Synovitis 71.33 12.13 4 35331 274088 110279876
Balance disorder 69.88 12.13 130 35205 116430 110437534
General physical health deterioration 68.74 12.13 25 35310 425270 110128694
Mania 67.92 12.13 55 35280 20741 110533223
Gait disturbance 66.69 12.13 218 35117 277990 110275974
Acute kidney injury 66.59 12.13 63 35272 635367 109918597
Febrile neutropenia 65.92 12.13 11 35324 316756 110237208
Somnambulism 60.81 12.13 33 35302 6372 110547592
Joint swelling 60.62 12.13 33 35302 442812 110111152
Sleep paralysis 60.55 12.13 19 35316 899 110553065
Psychotic disorder 59.00 12.13 77 35258 50860 110503104
Therapeutic response unexpected 57.45 12.13 53 35282 23790 110530174
Obsessive-compulsive disorder 57.03 12.13 33 35302 7208 110546756
Enuresis 56.04 12.13 27 35308 4069 110549895
Tic 53.85 12.13 25 35310 3468 110550496
Seizure 53.60 12.13 174 35161 221011 110332953
Influenza like illness 53.47 12.13 99 35236 88313 110465651
Headache 53.16 12.13 471 34864 881906 109672058
Glossodynia 52.73 12.13 5 35330 221999 110331965
Blood pressure measurement 52.43 12.13 15 35320 515 110553449
Off label use 52.13 12.13 275 35060 1499910 109054054
Surgery 51.90 12.13 65 35270 41218 110512746
Abnormal dreams 50.87 12.13 38 35297 12742 110541222
Pericarditis 49.33 12.13 6 35329 219108 110334856
Contraindicated product administered 48.68 12.13 10 35325 248257 110305707
Snoring 48.39 12.13 29 35306 6755 110547209
Insomnia 47.92 12.13 235 35100 360355 110193609
Lower respiratory tract infection 47.24 12.13 10 35325 243096 110310868
Secondary progressive multiple sclerosis 46.96 12.13 18 35317 1551 110552413
Rheumatoid arthritis 46.09 12.13 19 35316 299594 110254370
Feeling drunk 45.82 12.13 26 35309 5474 110548490
Bipolar disorder 45.57 12.13 31 35304 8976 110544988
Hypersomnia 44.92 12.13 50 35285 28011 110525953
Cognitive disorder 44.40 12.13 91 35244 87420 110466544
Neutropenia 44.29 12.13 33 35302 374587 110179377
Thrombocytopenia 43.52 12.13 29 35306 348856 110205108
Concussion 43.03 12.13 33 35302 11505 110542459
Tremor 42.75 12.13 152 35183 202080 110351884
Muscle spasticity 42.69 12.13 55 35280 35860 110518104
Urinary incontinence 42.21 12.13 64 35271 48523 110505441
Panic attack 41.98 12.13 49 35286 28891 110525073
Disturbance in attention 40.77 12.13 72 35263 61923 110492041
Magnetic resonance imaging abnormal 39.34 12.13 21 35314 3924 110550040
Delusion 39.19 12.13 43 35292 23712 110530252
Malignant neoplasm progression 38.75 12.13 5 35330 174562 110379402
Restless legs syndrome 37.92 12.13 43 35292 24583 110529381
Loss of consciousness 37.66 12.13 143 35192 196163 110357801
Optic neuritis 37.50 12.13 30 35305 11117 110542847
Treatment failure 37.42 12.13 21 35314 277213 110276751
Irritability 37.39 12.13 60 35275 47749 110506215
Sleep-related eating disorder 36.49 12.13 13 35322 912 110553052
Fatigue 35.55 12.13 565 34770 1215393 109338571
Neuralgia 35.42 12.13 59 35276 48419 110505545
Muscle spasms 35.32 12.13 179 35156 277978 110275986
Infusion related reaction 35.16 12.13 42 35293 381120 110172844
Parasomnia 34.88 12.13 12 35323 759 110553205
Abnormal behaviour 34.73 12.13 52 35283 38987 110514977
Hypnagogic hallucination 34.38 12.13 9 35326 220 110553744
Dyskinesia 34.15 12.13 60 35275 51386 110502578
Liver injury 34.14 12.13 4 35331 150409 110403555
Attention deficit hyperactivity disorder 34.13 12.13 20 35315 4471 110549493
Hunger 34.06 12.13 23 35312 6581 110547383
Wheezing 33.49 12.13 20 35315 255210 110298754
Systemic lupus erythematosus 33.28 12.13 20 35315 254318 110299646
Migraine 32.89 12.13 125 35210 171527 110382437
Wound 32.74 12.13 17 35318 234420 110319544
Pregnancy on oral contraceptive 32.71 12.13 12 35323 916 110553048
Vision blurred 32.60 12.13 103 35232 128919 110425045
Intentional dose omission 32.52 12.13 36 35299 20044 110533920
Hyperkalaemia 32.40 12.13 3 35332 135793 110418171
Folliculitis 32.35 12.13 7 35328 167646 110386318
Hypoaesthesia 32.35 12.13 191 35144 314032 110239932
Product dose omission issue 32.11 12.13 194 35141 321588 110232376
Tourette's disorder 31.81 12.13 7 35328 79 110553885
Post-traumatic stress disorder 31.72 12.13 22 35313 6574 110547390
Anaemia 31.62 12.13 81 35254 547005 110006959
Muscle injury 31.33 12.13 4 35331 140803 110413161
Pancytopenia 31.10 12.13 14 35321 209599 110344365
Disease progression 30.81 12.13 20 35315 244014 110309950
Hallucination, auditory 30.71 12.13 40 35295 26357 110527607
Helicobacter infection 30.55 12.13 10 35325 181867 110372097
Stomatitis 30.41 12.13 25 35310 270217 110283747
Stress 30.27 12.13 88 35247 105260 110448704
Blister 29.58 12.13 18 35317 227358 110326606
Trigeminal neuralgia 29.49 12.13 18 35317 4334 110549630
Arthropathy 29.49 12.13 29 35306 287493 110266471
Dysstasia 29.43 12.13 44 35291 32942 110521022
Peroneal nerve palsy 29.40 12.13 22 35313 7392 110546572
Paranoia 29.36 12.13 36 35299 22338 110531626
Death 28.93 12.13 120 35215 698749 109855215
Renal impairment 28.89 12.13 12 35323 188433 110365531
Cardiac failure 28.68 12.13 12 35323 187614 110366350
Blood pressure increased 28.51 12.13 160 35175 258213 110295751
Breast cancer 28.28 12.13 47 35288 38495 110515469
C-reactive protein increased 27.32 12.13 18 35317 217901 110336063
Nervousness 27.12 12.13 45 35290 36806 110517158
Nausea 26.82 12.13 548 34787 1235142 109318822
Major depression 26.35 12.13 24 35311 10597 110543367
Progressive multifocal leukoencephalopathy 26.25 12.13 36 35299 24920 110529044
Emotional disorder 26.22 12.13 29 35306 16131 110537833
Wrong dose 26.13 12.13 14 35321 2635 110551329
Product use in unapproved indication 26.02 12.13 66 35269 447311 110106653
Inflammation 25.55 12.13 15 35320 193223 110360741
Treatment noncompliance 24.97 12.13 65 35270 72925 110481039
White blood cells urine positive 24.78 12.13 20 35315 7504 110546460
Histoplasmosis 24.71 12.13 14 35321 2939 110551025
Head injury 24.55 12.13 47 35288 42970 110510994
Poor quality sleep 24.41 12.13 37 35298 28040 110525924
Urine analysis abnormal 24.14 12.13 19 35316 6878 110547086
Product use issue 24.08 12.13 39 35296 311656 110242308
Hangover 24.06 12.13 13 35322 2489 110551475
Hypersensitivity vasculitis 24.04 12.13 19 35316 6918 110547046
Product substitution issue 23.86 12.13 33 35302 23028 110530936
Suicide attempt 23.82 12.13 80 35255 103314 110450650
Spinal operation 23.78 12.13 23 35312 10949 110543015
Impaired healing 23.66 12.13 17 35318 196700 110357264
Drug withdrawal syndrome 23.49 12.13 43 35292 38011 110515953
Swelling 23.48 12.13 48 35287 350993 110202971
Dizziness 22.85 12.13 331 35004 697862 109856102
Psoriatic arthropathy 22.39 12.13 18 35317 196743 110357221
Hepatic enzyme increased 22.22 12.13 43 35292 320849 110233115
Dissociation 22.02 12.13 21 35314 9821 110544143
Lymphocyte count decreased 21.70 12.13 53 35282 57190 110496774
Bladder disorder 21.64 12.13 22 35313 11115 110542849
Tardive dyskinesia 21.40 12.13 24 35311 13555 110540409
Withdrawal syndrome 21.35 12.13 37 35298 31343 110522621
Oedema mouth 21.35 12.13 13 35322 3117 110550847
Wound infection 20.84 12.13 3 35332 96462 110457502
Intervertebral disc protrusion 20.62 12.13 34 35301 27664 110526300
Sleep attacks 20.46 12.13 6 35329 225 110553739
Hallucination 20.36 12.13 75 35260 101357 110452607
T-lymphocyte count increased 20.14 12.13 6 35329 238 110553726
Muscular weakness 20.01 12.13 142 35193 248326 110305638
Drug intolerance 19.95 12.13 65 35270 406447 110147517
Diarrhoea 19.91 12.13 251 35084 1139254 109414710
Flushing 19.83 12.13 76 35259 104660 110449304
Lung disorder 19.83 12.13 17 35318 180030 110373934
Muscle tightness 19.77 12.13 24 35311 14738 110539226
Agitation 19.76 12.13 80 35255 112971 110440993
Affective disorder 19.68 12.13 21 35314 11220 110542744
Pyrexia 19.61 12.13 188 35147 898077 109655887
Ill-defined disorder 19.59 12.13 13 35322 156840 110397124
Rash 19.58 12.13 168 35167 820796 109733168
Bipolar I disorder 19.58 12.13 11 35324 2272 110551692
Platelet count decreased 19.57 12.13 27 35308 230416 110323548
Cervical spinal stenosis 19.50 12.13 12 35323 2930 110551034
Hysterectomy 19.48 12.13 18 35317 8096 110545868
JC polyomavirus test positive 19.29 12.13 11 35324 2336 110551628
Clumsiness 19.10 12.13 13 35322 3767 110550197
Heart rate 19.06 12.13 6 35329 287 110553677
Post procedural complication 18.88 12.13 32 35303 26626 110527338
Psychotic symptom 18.83 12.13 13 35322 3854 110550110
Central nervous system lesion 18.77 12.13 24 35311 15529 110538435
Bursitis 18.77 12.13 9 35326 129909 110424055
Nephrolithiasis 18.72 12.13 55 35280 66157 110487807
Hypoaesthesia oral 18.60 12.13 25 35310 16977 110536987
Septic shock 18.44 12.13 14 35321 157514 110396450
Joint range of motion decreased 18.28 12.13 8 35327 121824 110432140
Speech disorder 18.23 12.13 52 35283 61517 110492447
Enterococcal sepsis 18.20 12.13 12 35323 3300 110550664
Interstitial lung disease 18.16 12.13 11 35324 139323 110414641
Type 2 diabetes mellitus 18.02 12.13 18 35317 177214 110376750
Bruxism 18.00 12.13 14 35321 4980 110548984
Spinal stenosis 17.84 12.13 26 35309 19030 110534934
Drug-induced liver injury 17.84 12.13 8 35327 120059 110433905
Renal failure 17.82 12.13 28 35307 226546 110327418
Urine abnormality 17.73 12.13 18 35317 9078 110544886
Endometriosis 17.50 12.13 13 35322 4321 110549643
Liver disorder 17.49 12.13 12 35323 142231 110411733
Movement disorder 17.46 12.13 37 35298 36367 110517597
Drug effect less than expected 17.11 12.13 16 35319 7304 110546660
Urinary sediment 16.77 12.13 4 35331 66 110553898
Schizotypal personality disorder 16.75 12.13 3 35332 10 110553954
Hepatic function abnormal 16.68 12.13 4 35331 89291 110464673
Abdominal pain 16.62 12.13 96 35239 512893 110041071
Unevaluable event 16.56 12.13 49 35286 59178 110494786
Hypotension 16.46 12.13 99 35236 523750 110030214
Anger 16.45 12.13 25 35310 18982 110534982
Invasive ductal breast carcinoma 16.45 12.13 15 35320 6631 110547333
Vertigo 16.41 12.13 63 35272 86807 110467157
Urine sodium increased 16.24 12.13 5 35330 222 110553742
Choking 16.20 12.13 22 35313 15088 110538876
Urinary sediment present 15.97 12.13 10 35325 2518 110551446
Crying 15.87 12.13 29 35306 25599 110528365
Ankle fracture 15.67 12.13 25 35310 19794 110534170
Aggression 15.62 12.13 48 35287 59162 110494802
Abnormal sleep-related event 15.59 12.13 7 35328 899 110553065
Drug dependence 15.55 12.13 43 35292 49977 110503987
Gastrointestinal disorder 15.41 12.13 34 35301 241918 110312046
Haemoglobin urine present 15.40 12.13 7 35328 925 110553039
Incoherent 15.32 12.13 16 35319 8342 110545622
Loss of bladder sensation 15.23 12.13 4 35331 99 110553865
B-lymphocyte count decreased 15.22 12.13 9 35326 2046 110551918
Cholecystectomy 15.17 12.13 18 35317 10791 110543173
Lymphopenia 15.02 12.13 37 35298 40133 110513831
Drug abuser 14.96 12.13 13 35322 5396 110548568
Amnesia 14.91 12.13 70 35265 105338 110448626
Lumbosacral radiculopathy 14.88 12.13 6 35329 591 110553373
Multiple organ dysfunction syndrome 14.75 12.13 16 35319 151694 110402270
Depersonalisation/derealisation disorder 14.72 12.13 9 35326 2172 110551792
Liver function test increased 14.63 12.13 5 35330 88543 110465421
Back pain 14.63 12.13 182 35153 370814 110183150
Euphoric mood 14.59 12.13 16 35319 8811 110545153
Pneumonia 14.59 12.13 195 35140 876519 109677445
Fear of surgery 14.56 12.13 3 35332 24 110553940
Rash maculo-papular 14.52 12.13 3 35332 74219 110479745
Dementia with Lewy bodies 14.50 12.13 7 35328 1059 110552905
Urine leukocyte esterase positive 14.49 12.13 11 35324 3775 110550189
Temperature intolerance 14.49 12.13 20 35315 13930 110540034
Drug titration error 14.30 12.13 8 35327 1639 110552325
International normalised ratio increased 14.17 12.13 5 35330 86767 110467197
Injection site scar 14.06 12.13 7 35328 1133 110552831
Spinal osteoarthritis 13.99 12.13 24 35311 20159 110533805
Disorientation 13.97 12.13 52 35283 70619 110483345
Hypokalaemia 13.92 12.13 23 35312 182425 110371539
Haematochezia 13.86 12.13 10 35325 115514 110438450
Post concussion syndrome 13.85 12.13 6 35329 707 110553257
Discomfort 13.81 12.13 30 35305 214677 110339287
Therapeutic product effect incomplete 13.80 12.13 32 35303 223773 110330191
Anal incontinence 13.78 12.13 25 35310 21939 110532025
Maternal exposure during pregnancy 13.75 12.13 39 35296 254844 110299120
Nightmare 13.69 12.13 35 35300 38828 110515136
Neurogenic bladder 13.63 12.13 12 35323 5067 110548897
Peripheral swelling 13.41 12.13 75 35260 403959 110150005
Hyperhidrosis 13.35 12.13 104 35231 187194 110366770
Hypoosmolar state 13.24 12.13 5 35330 414 110553550
Compulsions 13.22 12.13 5 35330 415 110553549
Live birth 13.20 12.13 3 35332 69481 110484483
Blood pressure systolic increased 13.18 12.13 5 35330 82986 110470978
Impaired driving ability 13.14 12.13 13 35322 6357 110547607
Dihydrotestosterone increased 13.04 12.13 3 35332 42 110553922
Melaena 13.00 12.13 3 35332 68754 110485210
Laboratory test abnormal 12.83 12.13 37 35298 44042 110509922
Periodic limb movement disorder 12.82 12.13 5 35330 451 110553513
Palpitations 12.82 12.13 91 35244 159121 110394843
Vitamin D deficiency 12.78 12.13 22 35313 18530 110535434
Paralysis 12.78 12.13 20 35315 15580 110538384
Trismus 12.76 12.13 13 35322 6583 110547381
Oxygen saturation decreased 12.73 12.13 19 35316 156963 110397001
Incorrect dose administered 12.65 12.13 66 35269 103575 110450389
Perinatal depression 12.48 12.13 5 35330 485 110553479
Grip strength decreased 12.45 12.13 5 35330 80169 110473795
Loss of control of legs 12.39 12.13 8 35327 2124 110551840
Paraesthesia 12.38 12.13 139 35196 276382 110277582
Papilloma viral infection 12.37 12.13 8 35327 2130 110551834
Irritable bowel syndrome 12.25 12.13 21 35314 164194 110389770
Feeling jittery 12.23 12.13 19 35316 14703 110539261
Blood creatinine increased 12.23 12.13 25 35310 182864 110371100
Polycystic ovaries 12.22 12.13 11 35324 4785 110549179
Breast cancer stage III 12.18 12.13 5 35330 79112 110474852
Asthenia 12.16 12.13 297 35038 688702 109865262
Upper limb fracture 12.14 12.13 23 35312 20865 110533099
Photophobia 12.13 12.13 26 35309 25745 110528219

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 D000697 Central Nervous System Stimulants
MeSH PA D064690 Wakefulness-Promoting Agents
MeSH PA D065701 Cytochrome P-450 CYP3A Inducers
FDA PE N0000175651 Increased Sympathetic Activity
FDA PE N0000175729 Central Nervous System Stimulation
FDA EPC N0000175769 Sympathomimetic-like Agent
CHEBI has role CHEBI:35337 central nervous system stimulant
CHEBI has role CHEBI:35469 antidepressant
CHEBI has role CHEBI:35476 antipsychotic agent
CHEBI has role CHEBI:35480 analgesic
CHEBI has role CHEBI:35610 antineoplastic agent
CHEBI has role CHEBI:35705 immunosuppressive agent
CHEBI has role CHEBI:48407 antiparkinson drug
CHEBI has role CHEBI:50514 vasoconstrictor agent
CHEBI has role CHEBI:77567 eugeroic

Related Drugs by ATC class:

N06BA Centrally acting sympathomimetics 14 drugs
amfetaminearmodafinilatomoxetinedexamfetaminedexmethylphenidatefencamfaminfenetyllinefenozolonelisdexamfetaminemethamphetaminemethylphenidatepemoline show all 14 →

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




🐶 Veterinary Drug Use

None

🐶 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
R3UK8X3U3D INXIGHT DRUGS

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
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
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 23155-862 TABLET 200 mg ORAL ANDA 24 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 46708-386 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 50268-571 TABLET 200 mg ORAL ANDA 29 sections
Modafinil HUMAN PRESCRIPTION DRUG LABEL 1 51407-928 TABLET 100 mg ORAL ANDA 19 sections
Modafinil HUMAN PRESCRIPTION DRUG LABEL 1 51407-960 TABLET 100 mg ORAL ANDA 28 sections
Modafinil HUMAN PRESCRIPTION DRUG LABEL 1 51407-961 TABLET 200 mg ORAL ANDA 28 sections
PROVIGIL HUMAN PRESCRIPTION DRUG LABEL 1 54868-4492 TABLET 100 mg ORAL NDA 25 sections
PROVIGIL HUMAN PRESCRIPTION DRUG LABEL 1 54868-4897 TABLET 200 mg ORAL NDA 25 sections
Modafinil HUMAN PRESCRIPTION DRUG LABEL 1 55253-801 TABLET 100 mg ORAL NDA authorized generic 29 sections
Modafinil HUMAN PRESCRIPTION DRUG LABEL 1 55253-802 TABLET 200 mg ORAL NDA authorized generic 29 sections
Modafinil Human Prescription Drug Label 1 57237-154 TABLET 100 mg ORAL ANDA 29 sections
Modafinil Human Prescription Drug Label 1 57237-155 TABLET 200 mg ORAL ANDA 29 sections
Provigil HUMAN PRESCRIPTION DRUG LABEL 1 60429-009 TABLET 100 mg ORAL NDA 29 sections
Provigil HUMAN PRESCRIPTION DRUG LABEL 1 60429-010 TABLET 200 mg ORAL NDA 29 sections
Modafinil HUMAN PRESCRIPTION DRUG LABEL 1 60505-2526 TABLET 100 mg ORAL ANDA 19 sections
Modafinil HUMAN PRESCRIPTION DRUG LABEL 1 60505-2527 TABLET 200 mg ORAL ANDA 19 sections