dimethyl fumarate Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definitionDrug idCAS RN
4757 624-49-7

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • dimethyl fumarate
  • tecfidera
  • methyl fumarate
  • boletic acid dimethyl ester
  • BG-12
A fumarate derivative that is used as a DERMATOLOGIC AGENT in the treatment of PSORIASIS and SKIN DISEASES. It also may be used as an IMMUNOSUPPRESSIVE AGENT in the treatment of MULTIPLE SCLEROSIS.
  • Molecular weight: 144.13
  • Formula: C6H8O4
  • CLOGP: 0.78
  • LIPINSKI: 0
  • HAC: 4
  • HDO: 0
  • TPSA: 52.60
  • ALOGS: -1.05
  • ROTB: 4

  • Status: OFP

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

Drug dosage:

DoseUnitRoute
0.48 g O

ADMET properties:

None

Approvals:

DateAgencyCompanyOrphan
March 27, 2013 FDA BIOGEN IDEC 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
Flushing 4189.16 14.90 1782 48032 68818 53230434
Multiple sclerosis relapse 3175.42 14.90 1286 48528 43567 53255685
Multiple sclerosis 1706.15 14.90 716 49098 26437 53272815
Prescribed underdose 863.92 14.90 377 49437 15290 53283962
Lymphopenia 551.34 14.90 283 49531 16560 53282692
Lymphocyte count decreased 434.16 14.90 290 49524 27762 53271490
Abdominal pain upper 390.31 14.90 616 49198 165675 53133577
General symptom 338.86 14.90 116 49698 2399 53296853
Gastrointestinal disorder 299.76 14.90 394 49420 89610 53209642
Central nervous system lesion 296.09 14.90 158 49656 10004 53289248
Hot flush 282.54 14.90 280 49534 46880 53252372
Memory impairment 266.81 14.90 361 49453 84396 53214856
Intentional underdose 265.90 14.90 91 49723 1880 53297372
Rheumatoid arthritis 254.14 14.90 9 49805 314522 52984730
Underdose 252.73 14.90 188 49626 21334 53277918
Gastric disorder 226.42 14.90 203 49611 29962 53269290
Diarrhoea 210.95 14.90 1142 48672 624404 52674848
Abortion spontaneous 196.68 14.90 230 49584 46405 53252847
Gait disturbance 186.55 14.90 439 49375 158403 53140849
Magnetic resonance imaging abnormal 180.98 14.90 76 49738 2793 53296459
Fall 175.56 14.90 730 49084 357710 52941542
Pruritus 170.18 14.90 631 49183 293201 53006051
Toxicity to various agents 168.30 14.90 9 49805 219589 53079663
Nausea 164.49 14.90 1235 48579 754856 52544396
Off label use 155.60 14.90 128 49686 472084 52827168
Balance disorder 153.40 14.90 258 49556 72949 53226303
Burning sensation 145.66 14.90 201 49613 47812 53251440
Vomiting 143.03 14.90 871 48943 496268 52802984
Seizure 140.23 14.90 347 49467 129162 53170090
Hypoaesthesia 138.40 14.90 351 49463 132644 53166608
Lymphocyte count abnormal 133.40 14.90 42 49772 660 53298592
Maternal exposure during pregnancy 132.10 14.90 381 49433 155258 53143994
Breast cancer 131.15 14.90 194 49620 49164 53250088
Optic neuritis 123.54 14.90 80 49734 7255 53291997
Acute kidney injury 122.75 14.90 42 49772 253826 53045426
Invasive ductal breast carcinoma 117.53 14.90 75 49739 6632 53292620
Drug hypersensitivity 113.33 14.90 53 49761 265189 53034063
Loss of control of legs 111.59 14.90 44 49770 1371 53297881
Urinary tract infection 110.48 14.90 480 49334 239423 53059829
Drug interaction 106.50 14.90 36 49778 219293 53079959
Paraesthesia 102.25 14.90 306 49508 127209 53172043
Muscular weakness 101.34 14.90 263 49551 100729 53198523
Dyspnoea 100.79 14.90 252 49562 585980 52713272
Product use issue 100.16 14.90 8 49806 139576 53159676
Cognitive disorder 96.67 14.90 160 49654 44618 53254634
Adverse reaction 95.52 14.90 74 49740 8913 53290339
Joint swelling 94.03 14.90 51 49763 234587 53064665
Condition aggravated 93.46 14.90 84 49730 297050 53002202
White blood cell count decreased 92.61 14.90 291 49523 124184 53175068
Chromaturia 85.06 14.90 89 49725 15861 53283391
Contraindicated product administered 84.18 14.90 13 49801 135616 53163636
Gait inability 80.17 14.90 135 49679 38176 53261076
Anaemia 79.18 14.90 85 49729 276633 53022619
Urticaria 78.54 14.90 292 49522 135593 53163659
Completed suicide 77.71 14.90 17 49797 138184 53161068
Glossodynia 77.11 14.90 4 49810 100287 53198965
Arthralgia 77.05 14.90 187 49627 439596 52859656
Secondary progressive multiple sclerosis 76.44 14.90 33 49781 1299 53297953
Abdominal discomfort 75.46 14.90 406 49408 220656 53078596
Relapsing-remitting multiple sclerosis 71.82 14.90 25 49789 544 53298708
Exposure during pregnancy 70.93 14.90 15 49799 124845 53174407
Hypotension 70.53 14.90 80 49734 253996 53045256
Injection site pain 70.06 14.90 11 49803 113380 53185872
Systemic lupus erythematosus 69.36 14.90 16 49798 125398 53173854
Drug intolerance 68.49 14.90 375 49439 205118 53094134
Synovitis 65.46 14.90 11 49803 107882 53191370
Product dose omission issue 65.42 14.90 352 49462 191268 53107984
Progressive multiple sclerosis 62.95 14.90 25 49789 794 53298458
Stress 62.80 14.90 154 49660 56930 53242322
Feeling hot 62.49 14.90 127 49687 41417 53257835
Oedema peripheral 61.57 14.90 42 49772 170745 53128507
Musculoskeletal disorder 60.30 14.90 78 49736 17421 53281831
Herpes zoster 58.68 14.90 177 49637 73842 53225410
Dyspepsia 58.20 14.90 182 49632 77418 53221834
Pancytopenia 58.07 14.90 8 49806 90920 53208332
Yellow skin 57.85 14.90 32 49782 2174 53297078
Thrombocytopenia 57.23 14.90 29 49785 138698 53160554
Cough 57.09 14.90 95 49719 256798 53042454
Product use in unapproved indication 57.00 14.90 17 49797 112272 53186980
Injection site erythema 56.61 14.90 4 49810 77245 53222007
Paternal exposure before pregnancy 55.90 14.90 12 49802 33 53299219
Peroneal nerve palsy 54.97 14.90 40 49774 4383 53294869
Mobility decreased 54.56 14.90 176 49638 76095 53223157
Malignant neoplasm progression 54.53 14.90 3 49811 71538 53227714
Malignant melanoma 53.57 14.90 58 49756 10744 53288508
Trigeminal neuralgia 53.52 14.90 35 49779 3226 53296026
Arthropathy 53.41 14.90 33 49781 141420 53157832
Stomatitis 53.33 14.90 13 49801 98145 53201107
Haemoglobin decreased 51.89 14.90 32 49782 137275 53161977
Blood creatinine increased 51.10 14.90 8 49806 82654 53216598
Hyponatraemia 50.66 14.90 19 49795 108588 53190664
Abdominal pain 50.07 14.90 409 49405 255494 53043758
Decreased immune responsiveness 49.34 14.90 36 49778 3961 53295291
Hemianaesthesia 48.96 14.90 18 49796 461 53298791
Neutropenia 48.79 14.90 46 49768 159139 53140113
Oxygen saturation decreased 48.40 14.90 7 49807 76718 53222534
Progressive multifocal leukoencephalopathy 48.09 14.90 58 49756 12071 53287181
Therapeutic product effect decreased 47.87 14.90 29 49785 125626 53173626
Muscle spasms 46.90 14.90 249 49565 134546 53164706
Renal impairment 45.32 14.90 11 49803 83307 53215945
Wound 44.44 14.90 15 49799 91542 53207710
Agraphia 43.92 14.90 10 49804 39 53299213
Caesarean section 43.02 14.90 66 49748 17254 53281998
CD4 lymphocytes decreased 42.76 14.90 24 49790 1677 53297575
Loss of personal independence in daily activities 42.60 14.90 7 49807 69808 53229444
Blindness unilateral 41.87 14.90 38 49776 5689 53293563
Abdominal distension 41.58 14.90 166 49648 79624 53219628
Hypersensitivity 40.80 14.90 336 49478 210329 53088923
Pleural effusion 40.47 14.90 16 49798 88563 53210689
Swelling 40.31 14.90 73 49741 191032 53108220
Papillary thyroid cancer 40.17 14.90 25 49789 2115 53297137
Ophthalmic herpes zoster 39.25 14.90 23 49791 1744 53297508
Drug abuse 39.04 14.90 7 49807 65519 53233733
Productive cough 38.66 14.90 4 49810 56725 53242527
Alopecia 37.61 14.90 359 49455 234224 53065028
Impaired self-care 37.32 14.90 23 49791 1912 53297340
Dyspnoea exertional 37.17 14.90 4 49810 54996 53244256
Wheezing 36.73 14.90 8 49806 65267 53233985
Erythema 36.31 14.90 261 49553 156708 53142544
Sinusitis 35.89 14.90 64 49750 168500 53130752
Hypoglycaemia 35.82 14.90 6 49808 59007 53240245
Skin burning sensation 35.77 14.90 49 49765 11561 53287691
Nasal congestion 35.69 14.90 4 49810 53283 53245969
Temperature intolerance 35.66 14.90 41 49773 8112 53291140
Disease progression 35.48 14.90 26 49788 101894 53197358
Hypoxia 35.31 14.90 5 49809 55675 53243577
Discomfort 35.03 14.90 23 49791 95449 53203803
Motor dysfunction 34.99 14.90 41 49773 8277 53290975
Ocular icterus 34.96 14.90 29 49785 3850 53295402
Sensory disturbance 34.70 14.90 51 49763 12835 53286417
Flatulence 34.62 14.90 85 49729 31432 53267820
Blindness 33.90 14.90 62 49752 18701 53280551
Thyroid cancer 33.82 14.90 30 49784 4360 53294892
Lower limb fracture 33.70 14.90 53 49761 14152 53285100
Relapsing multiple sclerosis 33.65 14.90 10 49804 128 53299124
International normalised ratio increased 33.52 14.90 3 49811 47758 53251494
Cardiac failure 32.43 14.90 20 49794 85824 53213428
Band sensation 32.19 14.90 15 49799 708 53298544
Hip fracture 31.88 14.90 77 49737 28180 53271072
Electrocardiogram QT prolonged 31.56 14.90 7 49807 56396 53242856
JC polyomavirus test positive 31.55 14.90 17 49797 1096 53298156
Exposure via father 31.53 14.90 12 49802 339 53298913
Hemiparesis 31.52 14.90 65 49749 21410 53277842
Cardio-respiratory arrest 31.48 14.90 8 49806 58750 53240502
Major depression 31.28 14.90 37 49777 7545 53291707
Multiple organ dysfunction syndrome 30.97 14.90 7 49807 55670 53243582
Wrong technique in product usage process 30.62 14.90 9 49805 60023 53239229
Visual impairment 29.07 14.90 140 49674 72772 53226480
Adverse event 28.67 14.90 94 49720 40967 53258285
Dehydration 28.60 14.90 261 49553 168149 53131103
Hypertension 28.56 14.90 111 49703 225320 53073932
Hypokalaemia 28.28 14.90 29 49785 96488 53202764
Depressed level of consciousness 28.05 14.90 8 49806 54420 53244832
Hysterectomy 27.70 14.90 37 49777 8524 53290728
Urosepsis 27.65 14.90 53 49761 16557 53282695
Bradycardia 27.62 14.90 16 49798 71040 53228212
Intraductal proliferative breast lesion 27.38 14.90 22 49792 2792 53296460
Pyrexia 27.27 14.90 243 49571 402950 52896302
Renal failure 27.03 14.90 43 49771 118409 53180843
Neuropathy peripheral 26.97 14.90 34 49780 103153 53196099
Psoriasis 26.86 14.90 25 49789 87064 53212188
Ankle fracture 26.64 14.90 52 49762 16463 53282789
Ascites 26.57 14.90 3 49811 39732 53259520
Feeding disorder 26.43 14.90 42 49772 11312 53287940
CD8 lymphocytes decreased 26.20 14.90 9 49805 188 53299064
Therapy cessation 26.06 14.90 71 49743 27954 53271298
Gastrointestinal haemorrhage 26.05 14.90 22 49792 80308 53218944
Depression 25.86 14.90 273 49541 182779 53116473
Pericarditis 25.75 14.90 14 49800 64392 53234860
Prolonged labour 25.49 14.90 12 49802 580 53298672
C-reactive protein increased 25.38 14.90 16 49798 67870 53231382
Pain 24.99 14.90 393 49421 588005 52711247
Lower respiratory tract infection 24.82 14.90 29 49785 90952 53208300
Oedema 24.56 14.90 20 49794 74326 53224926
Lactic acidosis 24.44 14.90 3 49811 37250 53262002
Appendicitis 24.32 14.90 31 49783 6823 53292429
Uterine leiomyosarcoma 24.08 14.90 6 49808 37 53299215
Tachycardia 24.01 14.90 40 49774 108172 53191080
Herpes zoster meningomyelitis 23.91 14.90 4 49810 0 53299252
Road traffic accident 23.89 14.90 65 49749 25566 53273686
Respiratory failure 23.39 14.90 36 49778 100476 53198776
Plasma cell myeloma 22.95 14.90 8 49806 47866 53251386
Blood pressure fluctuation 22.92 14.90 3 49811 35467 53263785
Mental disorder 22.91 14.90 62 49752 24314 53274938
Muscle spasticity 22.74 14.90 51 49763 17787 53281465
Asthma 22.62 14.90 42 49772 108930 53190322
Dysstasia 22.57 14.90 53 49761 19046 53280206
Miliaria 22.40 14.90 13 49801 968 53298284
Neoplasm malignant 21.97 14.90 63 49751 25538 53273714
Overdose 21.95 14.90 42 49772 107694 53191558
Gallbladder operation 21.88 14.90 17 49797 2055 53297197
Gastric bypass 21.79 14.90 15 49799 1505 53297747
Rhabdomyolysis 21.65 14.90 7 49807 43916 53255336
Myelitis 21.64 14.90 14 49800 1267 53297985
Myelitis transverse 21.25 14.90 13 49801 1067 53298185
Glioblastoma 21.23 14.90 12 49802 850 53298402
Cervix carcinoma 20.98 14.90 19 49795 2836 53296416
Weight increased 20.93 14.90 109 49705 204458 53094794
General physical health deterioration 20.82 14.90 69 49745 146873 53152379
Hyperglycaemia 20.45 14.90 6 49808 40078 53259174
Duodenal ulcer perforation 20.44 14.90 4 49810 35179 53264073
Cardiac arrest 20.43 14.90 35 49779 93632 53205620
Peripheral swelling 20.43 14.90 111 49703 205997 53093255
Injection site bruising 20.41 14.90 5 49809 37641 53261611
Genital hypoaesthesia 20.25 14.90 4 49810 6 53299246
Pulmonary hypertension 20.11 14.90 5 49809 37265 53261987
Cervical spinal stenosis 19.53 14.90 16 49798 2087 53297165
Bladder disorder 19.50 14.90 30 49784 7858 53291394
Gastrointestinal pain 19.46 14.90 31 49783 8368 53290884
Coronavirus infection 19.44 14.90 19 49795 3121 53296131
Invasive lobular breast carcinoma 19.30 14.90 11 49803 792 53298460
Noninfectious myelitis 19.20 14.90 4 49810 9 53299243
Somnolence 19.12 14.90 86 49728 167648 53131604
T-lymphocyte count decreased 19.10 14.90 8 49806 292 53298960
Hospitalisation 18.97 14.90 23 49791 70989 53228263
Hepatic failure 18.94 14.90 5 49809 35801 53263451
Micturition urgency 18.90 14.90 31 49783 8571 53290681
Primary progressive multiple sclerosis 18.73 14.90 6 49808 100 53299152
Diplopia 18.70 14.90 52 49762 20713 53278539
COVID-19 18.61 14.90 76 49738 36812 53262440
Drug reaction with eosinophilia and systemic symptoms 18.49 14.90 4 49810 32796 53266456
Blood pressure systolic increased 18.44 14.90 5 49809 35172 53264080
Concussion 18.35 14.90 29 49785 7775 53291477
Pancreatic failure 18.33 14.90 11 49803 872 53298380
Pulmonary oedema 18.31 14.90 14 49800 53709 53245543
Influenza like illness 18.20 14.90 108 49706 60751 53238501
Cardiac failure congestive 18.17 14.90 37 49777 92720 53206532
Decubitus ulcer 18.11 14.90 34 49780 10459 53288793
Nephrolithiasis 17.98 14.90 75 49739 36672 53262580
Facial spasm 17.72 14.90 10 49804 706 53298546
Lymphocyte percentage abnormal 17.69 14.90 4 49810 15 53299237
Epistaxis 17.58 14.90 23 49791 68687 53230565
Tibia fracture 17.46 14.90 22 49792 4785 53294467
Cholestasis 17.23 14.90 3 49811 28692 53270560
Pneumonia 17.22 14.90 272 49542 406897 52892355
Head injury 17.02 14.90 58 49756 25775 53273477
Fibromyalgia 17.02 14.90 10 49804 44065 53255187
Pneumonitis 16.95 14.90 4 49810 30884 53268368
Bronchitis 16.94 14.90 51 49763 111848 53187404
Squamous cell carcinoma of the vulva 16.76 14.90 4 49810 20 53299232
Unevaluable event 16.74 14.90 13 49801 49485 53249767
Intentional overdose 16.68 14.90 23 49791 67182 53232070
Accident 16.56 14.90 23 49791 5498 53293754
Gait spastic 16.52 14.90 7 49807 263 53298989
Chronic kidney disease 16.52 14.90 10 49804 43360 53255892
Fluid overload 16.52 14.90 3 49811 27828 53271424
Injury 16.47 14.90 14 49800 50957 53248295
Dermatitis allergic 16.42 14.90 38 49776 13530 53285722
Bone pain 16.31 14.90 14 49800 50708 53248544
Neurogenic bladder 16.20 14.90 17 49797 3039 53296213
Cervical dysplasia 16.08 14.90 17 49797 3064 53296188
Blood pressure increased 16.02 14.90 72 49742 140407 53158845
Nasal sinus cancer 16.01 14.90 4 49810 25 53299227
Sedation 15.97 14.90 4 49810 29671 53269581
Malignant neoplasm of unknown primary site 15.92 14.90 7 49807 288 53298964
Uterine cancer 15.87 14.90 19 49795 3922 53295330
Septic shock 15.75 14.90 21 49793 62208 53237044
Metabolic acidosis 15.73 14.90 10 49804 42232 53257020
Hypocalcaemia 15.70 14.90 4 49810 29333 53269919
Haematoma 15.64 14.90 6 49808 33838 53265414
Breast cancer female 15.61 14.90 25 49789 6779 53292473
Musculoskeletal pain 15.59 14.90 29 49785 75171 53224081
Melaena 15.54 14.90 4 49810 29125 53270127
Herpes simplex encephalitis 15.53 14.90 7 49807 306 53298946
Injection site reaction 15.41 14.90 15 49799 51151 53248101
Ataxia 15.40 14.90 39 49775 14698 53284554
Human papilloma virus test positive 15.40 14.90 8 49806 479 53298773
Amnesia 15.28 14.90 83 49731 45205 53254047
Accidental exposure to product by child 15.18 14.90 11 49803 1197 53298055
Platelet count decreased 15.15 14.90 51 49763 108048 53191204
Premature delivery 15.09 14.90 3 49811 26101 53273151
Impaired healing 14.93 14.90 23 49791 64182 53235070

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
Multiple sclerosis relapse 1494.81 20.42 422 12325 11359 32489420
Multiple sclerosis 1019.30 20.42 285 12462 7359 32493420
Flushing 996.50 20.42 395 12352 30732 32470047
Prescribed underdose 228.58 20.42 96 12651 8563 32492216
Lymphopenia 178.80 20.42 95 12652 14361 32486418
Lymphocyte count decreased 165.29 20.42 103 12644 21016 32479763
Central nervous system lesion 141.74 20.42 61 12686 5771 32495008
General symptom 131.23 20.42 36 12711 856 32499923
Relapsing-remitting multiple sclerosis 129.24 20.42 33 12714 589 32500190
Memory impairment 129.02 20.42 115 12632 40364 32460415
Balance disorder 111.87 20.42 105 12642 39354 32461425
Gastric disorder 108.01 20.42 63 12684 11393 32489386
Gait disturbance 100.71 20.42 140 12607 80268 32420511
Fall 98.66 20.42 229 12518 195972 32304807
Urinary tract infection 87.94 20.42 131 12616 79940 32420839
Muscle spasticity 85.71 20.42 43 12704 5762 32495017
Abdominal discomfort 78.72 20.42 100 12647 52524 32448255
Gait spastic 76.59 20.42 21 12726 498 32500281
Acute kidney injury 74.12 20.42 13 12734 293455 32207324
Gastrointestinal disorder 72.12 20.42 74 12673 30857 32469922
Hot flush 69.68 20.42 54 12693 15592 32485187
Needle fatigue 66.17 20.42 18 12729 414 32500365
Abdominal pain upper 65.22 20.42 104 12643 67234 32433545
Loss of control of legs 64.91 20.42 19 12728 574 32500205
Mobility decreased 60.92 20.42 65 12682 28344 32472435
Magnetic resonance imaging abnormal 59.79 20.42 23 12724 1628 32499151
Toxicity to various agents 57.54 20.42 3 12744 178038 32322741
Muscular weakness 55.21 20.42 97 12650 67832 32432947
Progressive multiple sclerosis 52.35 20.42 13 12734 206 32500573
CD8 lymphocytes decreased 52.33 20.42 11 12736 78 32500701
Hypertonic bladder 52.32 20.42 20 12727 1391 32499388
Paraesthesia 51.60 20.42 87 12660 58857 32441922
Intentional underdose 49.84 20.42 17 12730 851 32499928
Underdose 49.44 20.42 41 12706 13028 32487751
Hypoaesthesia 48.28 20.42 84 12663 58269 32442510
Ataxia 48.26 20.42 40 12707 12701 32488078
Cognitive disorder 48.16 20.42 55 12692 25839 32474940
Herpes zoster 46.03 20.42 60 12687 32281 32468498
Hypotension 45.72 20.42 14 12733 216096 32284683
Lymphocyte count abnormal 45.55 20.42 15 12732 673 32500106
Seizure 45.34 20.42 115 12632 103739 32397040
Product dose omission issue 41.09 20.42 110 12637 102465 32398314
Monoparesis 40.44 20.42 18 12729 1843 32498936
Adverse reaction 40.39 20.42 21 12726 3029 32497750
Anaemia 39.80 20.42 19 12728 223605 32277174
Gait inability 39.70 20.42 44 12703 20003 32480776
Malignant melanoma stage I 38.95 20.42 9 12738 103 32500676
Musculoskeletal disorder 38.02 20.42 25 12722 5577 32495202
T-lymphocyte count decreased 33.21 20.42 9 12738 204 32500575
Off label use 33.16 20.42 43 12704 306277 32194502
Thrombocytopenia 32.45 20.42 9 12738 148290 32352489
Secondary progressive multiple sclerosis 31.96 20.42 10 12737 380 32500399
Haemoglobin decreased 30.79 20.42 5 12742 119666 32381113
Micturition urgency 29.36 20.42 21 12726 5365 32495414
Road traffic accident 29.12 20.42 35 12712 17346 32483433
Neutropenia 28.64 20.42 10 12737 142165 32358614
Optic neuritis 27.61 20.42 17 12730 3385 32497394
Progressive multifocal leukoencephalopathy 26.27 20.42 25 12722 9506 32491273
Trigeminal neuralgia 25.70 20.42 11 12736 1025 32499754
Dyspnoea 24.87 20.42 67 12680 361978 32138801
Oedema peripheral 24.80 20.42 7 12740 114084 32386695
Diarrhoea 24.56 20.42 234 12513 364568 32136211
Hemianaesthesia 24.35 20.42 6 12741 92 32500687
Feeling hot 23.50 20.42 31 12716 16855 32483924
Drug ineffective 23.39 20.42 241 12506 383236 32117543
Drug intolerance 23.32 20.42 57 12690 50178 32450601
Renal impairment 23.30 20.42 4 12743 91968 32408811
Hemiparesis 22.26 20.42 29 12718 15578 32485201
Ear canal stenosis 21.60 20.42 4 12743 13 32500766
Movement disorder 21.54 20.42 24 12723 10967 32489812
Decreased immune responsiveness 21.49 20.42 11 12736 1536 32499243
Dysarthria 21.44 20.42 43 12704 33158 32467621
Pleural effusion 21.00 20.42 3 12744 78989 32421790
Keratoacanthoma 20.97 20.42 8 12739 553 32500226
Chromaturia 20.80 20.42 27 12720 14451 32486328
Nausea 20.67 20.42 204 12543 320645 32180134
Depression 20.65 20.42 84 12663 96976 32403803

Pharmacologic Action:

SourceCodeDescription
ATC L04AX07 ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS
IMMUNOSUPPRESSANTS
IMMUNOSUPPRESSANTS
Other immunosuppressants
MeSH PA D003879 Dermatologic Agents
MeSH PA D007155 Immunologic Factors
MeSH PA D007166 Immunosuppressive Agents
MeSH PA D011838 Radiation-Sensitizing Agents
CHEBI has role CHEBI:76924 plant metabolites
CHEBI has role CHEBI:77746 H. sapiens metabolites
CHEBI has role CHEBI:50748 antipsoriatic agent
CHEBI has role CHEBI:50846 Biomodulator

Drug Use (View source of the data)

DiseaseRelationSNOMED_IDDOID
Plaque psoriasis indication 200965009
Relapsing remitting multiple sclerosis indication 426373005 DOID:2378

Acid dissociation constants calculated using MoKa v3.0.0

None

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
120MG TECFIDERA BIOGEN INC N204063 March 27, 2013 RX CAPSULE, DELAYED RELEASE ORAL 8399514 Feb. 7, 2028 METHOD OF TREATING MULTIPLE SCLEROSIS
240MG TECFIDERA BIOGEN INC N204063 March 27, 2013 RX CAPSULE, DELAYED RELEASE ORAL 8399514 Feb. 7, 2028 METHOD OF TREATING MULTIPLE SCLEROSIS
120MG TECFIDERA BIOGEN INC N204063 March 27, 2013 RX CAPSULE, DELAYED RELEASE ORAL 10391160 March 13, 2035 METHOD OF TREATING RELAPSING FORMS OF MULTIPLE SCLEROSIS BEFORE AND AFTER ADMINISTERING AN INACTIVE VACCINE
120MG TECFIDERA BIOGEN INC N204063 March 27, 2013 RX CAPSULE, DELAYED RELEASE ORAL 10555993 March 13, 2035 METHOD OF TREATING RELAPSING FORMS OF MULTIPLE SCLEROSIS BEFORE AND AFTER ADMINISTERING AN INACTIVE VACCINE
120MG TECFIDERA BIOGEN INC N204063 March 27, 2013 RX CAPSULE, DELAYED RELEASE ORAL 10994003 March 13, 2035 METHOD OF TREATING RELAPSING FORMS OF MULTIPLE SCLEROSIS BEFORE AND AFTER ADMINISTERING AN INACTIVE VACCINE
240MG TECFIDERA BIOGEN INC N204063 March 27, 2013 RX CAPSULE, DELAYED RELEASE ORAL 10391160 March 13, 2035 METHOD OF TREATING RELAPSING FORMS OF MULTIPLE SCLEROSIS BEFORE AND AFTER ADMINISTERING AN INACTIVE VACCINE
240MG TECFIDERA BIOGEN INC N204063 March 27, 2013 RX CAPSULE, DELAYED RELEASE ORAL 10555993 March 13, 2035 METHOD OF TREATING RELAPSING FORMS OF MULTIPLE SCLEROSIS BEFORE AND AFTER ADMINISTERING AN INACTIVE VACCINE
240MG TECFIDERA BIOGEN INC N204063 March 27, 2013 RX CAPSULE, DELAYED RELEASE ORAL 10994003 March 13, 2035 METHOD OF TREATING RELAPSING FORMS OF MULTIPLE SCLEROSIS BEFORE AND AFTER ADMINISTERING AN INACTIVE VACCINE
120MG TECFIDERA BIOGEN INC N204063 March 27, 2013 RX CAPSULE, DELAYED RELEASE ORAL 10959972 Nov. 16, 2035 METHOD OF TREATING MULTIPLE SCLEROSIS
120MG TECFIDERA BIOGEN INC N204063 March 27, 2013 RX CAPSULE, DELAYED RELEASE ORAL 11007166 Nov. 16, 2035 METHOD OF TREATING MULTIPLE SCLEROSIS
120MG TECFIDERA BIOGEN INC N204063 March 27, 2013 RX CAPSULE, DELAYED RELEASE ORAL 11007167 Nov. 16, 2035 METHOD OF TREATING MULTIPLE SCLEROSIS
120MG TECFIDERA BIOGEN INC N204063 March 27, 2013 RX CAPSULE, DELAYED RELEASE ORAL 11129806 Nov. 16, 2035 METHOD OF TREATING MULTIPLE SCLEROSIS
240MG TECFIDERA BIOGEN INC N204063 March 27, 2013 RX CAPSULE, DELAYED RELEASE ORAL 10959972 Nov. 16, 2035 METHOD OF TREATING MULTIPLE SCLEROSIS
240MG TECFIDERA BIOGEN INC N204063 March 27, 2013 RX CAPSULE, DELAYED RELEASE ORAL 11007166 Nov. 16, 2035 METHOD OF TREATING MULTIPLE SCLEROSIS
240MG TECFIDERA BIOGEN INC N204063 March 27, 2013 RX CAPSULE, DELAYED RELEASE ORAL 11007167 Nov. 16, 2035 METHOD OF TREATING MULTIPLE SCLEROSIS
240MG TECFIDERA BIOGEN INC N204063 March 27, 2013 RX CAPSULE, DELAYED RELEASE ORAL 11129806 Nov. 16, 2035 METHOD OF TREATING MULTIPLE SCLEROSIS

Orange Book exclusivity data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
120MG TECFIDERA BIOGEN INC N204063 March 27, 2013 RX CAPSULE, DELAYED RELEASE ORAL Feb. 5, 2023 INFORMATION ADDED TO THE LABELING DESCRIBING A RANDOMIZED, OPEN-LABEL STUDY THAT EXAMINED THE CONCOMITANT USE OF DIMETHYL FUMARATE AND SEVERAL NON-LIVE VACCINES IN ADULTS 27-55 YEARS OF AGE WITH RELAPSING FORMS OF MULTIPLE SCLEROSIS
240MG TECFIDERA BIOGEN INC N204063 March 27, 2013 RX CAPSULE, DELAYED RELEASE ORAL Feb. 5, 2023 INFORMATION ADDED TO THE LABELING DESCRIBING A RANDOMIZED, OPEN-LABEL STUDY THAT EXAMINED THE CONCOMITANT USE OF DIMETHYL FUMARATE AND SEVERAL NON-LIVE VACCINES IN ADULTS 27-55 YEARS OF AGE WITH RELAPSING FORMS OF MULTIPLE SCLEROSIS

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
Kelch-like ECH-associated protein 1 Cytosolic other INHIBITOR CHEMBL CHEMBL
Hydroxycarboxylic acid receptor 2 GPCR Ki 6.74 CHEMBL

External reference:

IDSource
FO2303MNI2 UNII
D03846 KEGG_DRUG
4032290 VUID
N0000186952 NUI
4032290 VANDF
C0058218 UMLSCUI
CHEBI:76004 CHEBI
9HB PDB_CHEM_ID
CHEMBL2107333 ChEMBL_ID
637568 PUBCHEM_CID
DB08908 DRUGBANK_ID
CHEMBL589586 ChEMBL_ID
D000069462 MESH_DESCRIPTOR_UI
7045 IUPHAR_LIGAND_ID
1373478 RXNORM
200501 MMSL
29369 MMSL
337937 MMSL
d08079 MMSL
009199 NDDF
724035008 SNOMEDCT_US
764365009 SNOMEDCT_US

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
dimethyl fumarate HUMAN PRESCRIPTION DRUG LABEL 1 0093-9218 CAPSULE 120 mg ORAL NDA 26 sections
dimethyl fumarate HUMAN PRESCRIPTION DRUG LABEL 1 0093-9219 CAPSULE 240 mg ORAL NDA 26 sections
Dimethyl fumarate HUMAN PRESCRIPTION DRUG LABEL 1 0378-0396 CAPSULE, DELAYED RELEASE 120 mg ORAL ANDA 27 sections
Dimethyl fumarate HUMAN PRESCRIPTION DRUG LABEL 1 0378-0399 CAPSULE, DELAYED RELEASE 240 mg ORAL ANDA 27 sections
dimethyl fumarate HUMAN PRESCRIPTION DRUG LABEL 1 24979-127 CAPSULE, DELAYED RELEASE 120 mg ORAL ANDA 18 sections
dimethyl fumarate HUMAN PRESCRIPTION DRUG LABEL 1 24979-128 CAPSULE, DELAYED RELEASE 240 mg ORAL ANDA 18 sections
Dimethyl Fumarate Human Prescription Drug Label 1 31722-657 CAPSULE, DELAYED RELEASE 120 mg ORAL ANDA 26 sections
Dimethyl Fumarate Human Prescription Drug Label 1 31722-658 CAPSULE, DELAYED RELEASE 240 mg ORAL ANDA 26 sections
Dimethyl Fumarate HUMAN PRESCRIPTION DRUG LABEL 1 43598-429 CAPSULE, DELAYED RELEASE 120 mg ORAL ANDA 25 sections
Dimethyl Fumarate HUMAN PRESCRIPTION DRUG LABEL 1 43598-430 CAPSULE, DELAYED RELEASE 240 mg ORAL ANDA 25 sections
Dimethyl Fumarate Human Prescription Drug Label 1 50090-5288 CAPSULE, DELAYED RELEASE 240 mg ORAL ANDA 26 sections
dimethyl fumarate HUMAN PRESCRIPTION DRUG LABEL 1 51407-441 CAPSULE, DELAYED RELEASE 240 mg ORAL ANDA 18 sections
dimethyl fumarate HUMAN PRESCRIPTION DRUG LABEL 1 51407-442 CAPSULE, DELAYED RELEASE 120 mg ORAL ANDA 18 sections
TECFIDERA HUMAN PRESCRIPTION DRUG LABEL 1 64406-005 CAPSULE 120 mg ORAL NDA 25 sections
TECFIDERA HUMAN PRESCRIPTION DRUG LABEL 1 64406-006 CAPSULE 240 mg ORAL NDA 25 sections
Dimethyl fumarate Human Prescription Drug Label 1 67877-555 CAPSULE, DELAYED RELEASE 120 mg ORAL ANDA 26 sections
Dimethyl fumarate Human Prescription Drug Label 1 67877-556 CAPSULE, DELAYED RELEASE 240 mg ORAL ANDA 26 sections
DIMETHYL FUMARATE HUMAN PRESCRIPTION DRUG LABEL 1 68180-776 CAPSULE, DELAYED RELEASE 120 mg ORAL ANDA 26 sections
DIMETHYL FUMARATE HUMAN PRESCRIPTION DRUG LABEL 1 68180-777 CAPSULE, DELAYED RELEASE 240 mg ORAL ANDA 26 sections
DIMETHYL FUMARATE HUMAN PRESCRIPTION DRUG LABEL 1 68462-307 CAPSULE 120 mg ORAL ANDA 26 sections
DIMETHYL FUMARATE HUMAN PRESCRIPTION DRUG LABEL 1 68462-308 CAPSULE 240 mg ORAL ANDA 26 sections
DIMETHYL FUMARATE HUMAN PRESCRIPTION DRUG LABEL 1 69097-322 CAPSULE, DELAYED RELEASE 120 mg ORAL ANDA 24 sections
DIMETHYL FUMARATE HUMAN PRESCRIPTION DRUG LABEL 1 69097-323 CAPSULE, DELAYED RELEASE 240 mg ORAL ANDA 24 sections
Dimethyl Fumarate HUMAN PRESCRIPTION DRUG LABEL 1 69238-1318 CAPSULE, DELAYED RELEASE 120 mg ORAL ANDA 25 sections
Dimethyl Fumarate HUMAN PRESCRIPTION DRUG LABEL 1 69238-1319 CAPSULE, DELAYED RELEASE 240 mg ORAL ANDA 25 sections
Dimethyl Fumarate Human Prescription Drug Label 1 69539-042 CAPSULE, DELAYED RELEASE 120 mg ORAL ANDA 24 sections
Dimethyl Fumarate Human Prescription Drug Label 1 69539-043 CAPSULE, DELAYED RELEASE 240 mg ORAL ANDA 24 sections
dimethyl fumarate HUMAN PRESCRIPTION DRUG LABEL 1 70710-1204 CAPSULE, DELAYED RELEASE 120 mg ORAL ANDA 24 sections
dimethyl fumarate HUMAN PRESCRIPTION DRUG LABEL 1 70710-1205 CAPSULE, DELAYED RELEASE 240 mg ORAL ANDA 24 sections
dimethyl fumarate HUMAN PRESCRIPTION DRUG LABEL 1 70771-1530 CAPSULE, DELAYED RELEASE 120 mg ORAL ANDA 1 sections