dimethyl fumarate 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | 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

Predicted pharmacokinetic/toxicological properties (PK-AZ):

PropertyDescriptionValueUnitConfidenceSimilarity
azlogd74 LogD at pH 7.4 0.061 Moderate 0.76
caco2-efflux Caco-2 efflux ratio (BA/AB) 0.300 Moderate 0.76
caco2-intrinsic-papp Caco-2 intrinsic apparent permeability 69.663 10^-6 cm/s Moderate 0.76
dh-clint Dog hepatocyte intrinsic clearance 1183.042 uL/min/10^6 cells Moderate 0.76
dppb Dog plasma protein binding (% unbound) 94.650 % Moderate 0.76
fcs-ppb Fetal calf serum protein binding (% unbound) 88.040 % Moderate 0.76
herg hERG pIC50 3.509 pIC50 Moderate 0.76
hh-clint Human hepatocyte intrinsic clearance 799.834 uL/min/10^6 cells Moderate 0.76
hlm-clint Human liver microsomal intrinsic clearance 130.017 uL/min/mg protein Moderate 0.76
hppb Human plasma protein binding (% unbound) 88.950 % Moderate 0.76
kinase-safety-class ACVR2A,ACVR2B,ACVRL1,AURKA,AXL,BRAF,BTK,CAMK2B,CAMK2D,CDK4,CDK5,CDK9,DDR1,DYRK1B,EGFR,EIF2AK3,EPHB4,ERBB2,FLT3,GRK2,GSK3B,IKBKB,ITK,JAK1,JAK2,JAK3,MAP2K6,MAP3K21,MAP3K7,MAPK7,MAPK9,MAPKAPK2,MTOR,NTRK2,PDK1,PDK2,PDK4,PDPK1,PIK3CB,PIK3CD,PIK3CG,PIM2,PLK1,PRKCD,PRKDC,SIK2,SIK3,STK33,SYK,TEK,TTK,ULK1,ZAP70 53
kinase-selectivity-class ACVR2B,AXL,BRAF,CDK9,DDR1,DYRK1B,EPHB4,ERBB2,GRK2,MAP2K6,MAPK7,PDK4,PRKDC,STK33,SYK,TEK,TTK 17
mdck-mdr1-efflux MDCK-MDR1 efflux ratio 2.259 Moderate 0.76
mh-clint Mouse hepatocyte intrinsic clearance 432.514 Moderate 0.76
mppb Mouse plasma protein binding (% unbound) 96.710 Moderate 0.76
nih-mdck-mdr1-efflux NIH MDCK-MDR1 efflux ratio 0.101 Moderate 0.76
pfas-class PFAS structural alert (1 = True, 0 = False) 0
pppb Pig plasma protein binding (% unbound) 91.830 % Moderate 0.76
rh-clint Rat hepatocyte intrinsic clearance 207.491 uL/min/10^6 cells Moderate 0.76
rh-fuinc Rat hepatocyte fraction unbound in incubation 99.920 % Moderate 0.76
rppb Rat plasma protein binding (% unbound) 91.300 % Moderate 0.76
solubility-dd Solubility at pH 7.4 in DMSO 5.176 uM Moderate 0.76

Approvals:

DateAgencyCompanyOrphan
March 27, 2013 FDA BIOGEN IDEC INC
Jan. 30, 2014 EMA BIOGEN NETHERLANDS B.V.

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 5342.59 13.39 2033 55814 86458 90484142
Multiple sclerosis relapse 4537.35 13.39 1572 56275 50733 90519867
Lymphopenia 825.44 13.39 365 57482 22516 90548084
Lymphocyte count decreased 600.27 13.39 337 57510 34713 90535887
Prescribed underdose 485.31 13.39 394 57453 74625 90495975
Central nervous system lesion 433.52 13.39 190 57657 11456 90559144
Hot flush 415.78 13.39 327 57520 59161 90511439
Fall 414.53 13.39 934 56913 480876 90089724
Abortion spontaneous 332.91 13.39 276 57571 53780 90516820
Abdominal pain upper 323.35 13.39 678 57169 331996 90238604
Intentional underdose 300.69 13.39 92 57755 1957 90568643
Gastric disorder 282.97 13.39 206 57641 33178 90537422
Gastrointestinal disorder 281.20 13.39 550 57297 256137 90314463
Diarrhoea 276.24 13.39 1256 56591 937934 89632666
Off label use 275.13 13.39 184 57663 1102068 89468532
Multiple sclerosis 245.55 13.39 176 57671 27664 90542936
Seizure 244.97 13.39 387 57460 152242 90418358
Balance disorder 241.97 13.39 304 57543 96776 90473824
Magnetic resonance imaging abnormal 241.60 13.39 89 57758 3397 90567203
Nausea 237.56 13.39 1358 56489 1108958 89461642
Breast cancer 232.75 13.39 225 57622 53536 90517064
Gait disturbance 218.84 13.39 501 57346 259995 90310605
Urinary tract infection 207.97 13.39 542 57305 305090 90265510
Infusion related reaction 205.59 13.39 16 57831 416764 90153836
Burning sensation 193.09 13.39 220 57627 63232 90507368
General symptom 185.42 13.39 116 57731 14552 90556048
Underdose 184.55 13.39 199 57648 53818 90516782
Rheumatoid arthritis 184.36 13.39 12 57835 362602 90207998
Memory impairment 184.32 13.39 396 57451 196848 90373752
Glossodynia 178.53 13.39 6 57841 321773 90248827
Hand deformity 174.03 13.39 3 57844 296359 90274241
Pemphigus 162.70 13.39 12 57835 326852 90243748
Loss of control of legs 162.48 13.39 53 57794 1397 90569203
Vomiting 161.27 13.39 954 56893 787339 89783261
Invasive ductal breast carcinoma 158.21 13.39 84 57763 7734 90562866
Product use issue 153.68 13.39 16 57831 329903 90240697
Lymphocyte count abnormal 152.58 13.39 45 57802 840 90569760
Optic neuritis 152.00 13.39 88 57759 9590 90561010
Pruritus 151.54 13.39 715 57132 540810 90029790
Systemic lupus erythematosus 144.27 13.39 28 57819 361868 90208732
Joint swelling 142.11 13.39 72 57775 503228 90067372
Toxicity to various agents 139.24 13.39 12 57835 287834 90282766
Wound 137.79 13.39 16 57831 302964 90267636
White blood cell count decreased 137.52 13.39 319 57528 166790 90403810
Drug hypersensitivity 126.90 13.39 69 57778 463540 90107060
Cognitive disorder 122.47 13.39 184 57663 69223 90501377
Condition aggravated 122.36 13.39 120 57727 595425 89975175
Synovitis 122.31 13.39 30 57817 329722 90240878
Product dose omission issue 118.32 13.39 432 57415 291255 90279345
Contraindicated product administered 115.14 13.39 31 57816 320108 90250492
Product use in unapproved indication 114.62 13.39 36 57811 336200 90234400
Duodenal ulcer perforation 113.37 13.39 7 57840 221281 90349319
Chromaturia 109.88 13.39 94 57753 19093 90551507
Wheezing 109.67 13.39 12 57835 238068 90332532
Anti-cyclic citrullinated peptide antibody positive 108.70 13.39 12 57835 236421 90334179
Arthropathy 105.41 13.39 51 57796 366191 90204409
Herpes zoster 100.01 13.39 200 57647 94444 90476156
Arthralgia 99.15 13.39 219 57628 778303 89792297
Secondary progressive multiple sclerosis 97.33 13.39 37 57810 1542 90569058
Malignant melanoma 96.22 13.39 73 57774 12503 90558097
Helicobacter infection 95.93 13.39 15 57832 226835 90343765
Pericarditis 95.55 13.39 27 57820 270124 90300476
Discomfort 94.15 13.39 29 57818 274306 90296294
Progressive multifocal leukoencephalopathy 88.23 13.39 76 57771 15579 90555021
Maternal exposure during pregnancy 88.09 13.39 458 57389 359605 90210995
Paraesthesia 87.71 13.39 354 57493 249972 90320628
Febrile neutropenia 87.60 13.39 3 57844 158346 90412254
Stomatitis 87.40 13.39 33 57814 274665 90295935
Musculoskeletal disorder 86.53 13.39 87 57760 21682 90548918
Muscular weakness 85.35 13.39 308 57539 206358 90364242
Hypoaesthesia 81.97 13.39 407 57440 313803 90256797
Acute kidney injury 81.50 13.39 52 57795 320335 90250265
Stress 78.90 13.39 166 57681 81229 90489371
Exposure during pregnancy 78.62 13.39 27 57820 238383 90332217
General physical health deterioration 78.23 13.39 67 57780 355048 90215552
Fibromyalgia 77.95 13.39 18 57829 206251 90364349
Folliculitis 76.90 13.39 18 57829 204335 90366265
Peroneal nerve palsy 76.55 13.39 47 57800 5701 90564899
Swelling 76.49 13.39 93 57754 418965 90151635
Dyspnoea 75.70 13.39 298 57549 880657 89689943
Breast cancer female 75.36 13.39 68 57779 14818 90555782
Injury 75.02 13.39 17 57830 197332 90373268
Drug interaction 74.33 13.39 42 57805 276411 90294189
Injection site pain 72.27 13.39 12 57835 173687 90396913
Abdominal pain 71.15 13.39 464 57383 395257 90175343
Liver injury 70.49 13.39 12 57835 170555 90400045
Caesarean section 69.76 13.39 72 57775 18505 90552095
Hemianaesthesia 68.29 13.39 20 57827 364 90570236
Progressive multiple sclerosis 67.98 13.39 27 57820 1267 90569333
Oedema 67.23 13.39 22 57825 200273 90370327
Yellow skin 66.38 13.39 33 57814 2648 90567952
JC polyomavirus test positive 65.75 13.39 29 57818 1773 90568827
C-reactive protein abnormal 65.34 13.39 4 57843 127425 90443175
Therapeutic product effect decreased 64.06 13.39 50 57797 277521 90293079
Sensory disturbance 63.85 13.39 63 57784 15350 90555250
Trigeminal neuralgia 63.38 13.39 37 57810 4094 90566506
CD4 lymphocytes decreased 63.32 13.39 27 57820 1520 90569080
Dehydration 62.60 13.39 268 57579 194179 90376421
Joint range of motion decreased 62.03 13.39 7 57840 135636 90434964
Relapsing-remitting multiple sclerosis 61.33 13.39 22 57825 777 90569823
C-reactive protein increased 60.74 13.39 20 57827 181369 90389231
Muscle injury 60.00 13.39 19 57828 176635 90393965
Hypertension 58.69 13.39 128 57719 457404 90113196
Blindness unilateral 57.19 13.39 44 57803 7692 90562908
Oedema peripheral 56.36 13.39 49 57798 257866 90312734
Type 2 diabetes mellitus 55.89 13.39 30 57817 203214 90367386
Malignant neoplasm progression 55.88 13.39 3 57844 106867 90463733
Feeling hot 55.63 13.39 141 57706 77867 90492733
Impaired healing 55.55 13.39 41 57806 234158 90336442
Paternal exposure before pregnancy 55.18 13.39 13 57834 95 90570505
Temperature intolerance 55.16 13.39 52 57795 11978 90558622
Skin burning sensation 54.61 13.39 65 57782 19546 90551054
Erythema 53.51 13.39 288 57559 228958 90341642
Loss of personal independence in daily activities 53.19 13.39 11 57836 136094 90434506
Hip fracture 53.15 13.39 84 57763 32993 90537607
Hypercholesterolaemia 52.23 13.39 3 57844 100889 90469711
Lower respiratory tract infection 51.94 13.39 50 57797 250609 90319991
Psoriatic arthropathy 51.58 13.39 42 57805 228293 90342307
Hemiparesis 51.39 13.39 81 57766 31738 90538862
Blood cholesterol increased 51.19 13.39 35 57812 207977 90362623
Inflammation 51.13 13.39 25 57822 178567 90392033
Anaemia 50.99 13.39 92 57755 352710 90217890
Death 50.76 13.39 479 57368 456072 90114528
Blister 50.40 13.39 53 57794 254945 90315655
Muscle spasticity 50.38 13.39 85 57762 35237 90535363
Thrombocytopenia 50.20 13.39 36 57811 208689 90361911
Sinusitis 50.00 13.39 89 57758 342999 90227601
Adverse reaction 49.89 13.39 77 57770 29635 90540965
Papillary thyroid cancer 49.71 13.39 27 57820 2600 90568000
Hypotension 49.63 13.39 82 57765 325315 90245285
Agraphia 49.48 13.39 10 57837 31 90570569
Asthma 49.37 13.39 49 57798 242111 90328489
Ocular icterus 49.10 13.39 31 57816 3949 90566651
Pancytopenia 48.51 13.39 9 57838 120254 90450346
Impaired self-care 47.54 13.39 23 57824 1739 90568861
Cough 47.48 13.39 103 57744 368859 90201741
Completed suicide 46.82 13.39 17 57830 145041 90425559
Drug intolerance 45.54 13.39 461 57386 447130 90123470
Therapeutic response decreased 45.45 13.39 3 57844 89726 90480874
Abdominal discomfort 45.44 13.39 485 57362 476843 90093757
Sleep disorder due to general medical condition, insomnia type 45.22 13.39 13 57834 128681 90441919
Wound infection 45.04 13.39 7 57840 106395 90464205
Micturition urgency 44.84 13.39 45 57802 11188 90559412
Blindness 44.81 13.39 69 57778 26499 90544101
Ankle fracture 44.78 13.39 60 57787 20310 90550290
Band sensation 43.20 13.39 19 57828 1154 90569446
Flatulence 43.17 13.39 87 57760 41280 90529320
Hepatic enzyme increased 42.94 13.39 105 57742 360631 90209969
Injection site erythema 42.80 13.39 6 57841 98496 90472104
Abdominal distension 42.78 13.39 181 57666 130420 90440180
Breast cancer stage III 42.26 13.39 3 57844 84444 90486156
Therapy cessation 42.24 13.39 80 57767 36281 90534319
Head injury 41.79 13.39 73 57774 31115 90539485
Grip strength decreased 41.77 13.39 5 57842 92571 90478029
Major depression 41.53 13.39 41 57806 9994 90560606
Relapsing multiple sclerosis 41.25 13.39 12 57835 213 90570387
Ataxia 40.98 13.39 54 57793 17988 90552612
Osteoarthritis 40.59 13.39 39 57808 195691 90374909
Thyroid cancer 40.57 13.39 33 57814 6251 90564349
Ophthalmic herpes zoster 40.23 13.39 24 57823 2764 90567836
Blood creatinine increased 40.02 13.39 8 57839 101378 90469222
Lung disorder 39.93 13.39 23 57824 149860 90420740
Neoplasm malignant 39.92 13.39 75 57772 33805 90536795
Oxygen saturation decreased 39.38 13.39 10 57837 107473 90463127
Musculoskeletal pain 39.30 13.39 31 57816 171220 90399380
Weight increased 39.29 13.39 136 57711 417791 90152809
Nasal congestion 38.91 13.39 4 57843 83410 90487190
Mental disorder 38.65 13.39 72 57775 32246 90538354
Decreased immune responsiveness 38.56 13.39 37 57810 8711 90561889
Cervix carcinoma 38.51 13.39 25 57822 3341 90567259
Urosepsis 38.45 13.39 57 57790 21175 90549425
Bursitis 38.34 13.39 18 57829 131636 90438964
Feeling abnormal 38.26 13.39 209 57638 167026 90403574
Sleep disorder 37.10 13.39 43 57804 197987 90372613
Prolonged labour 36.43 13.39 14 57833 601 90569999
Hyponatraemia 36.28 13.39 20 57827 133518 90437082
Irritable bowel syndrome 35.77 13.39 48 57799 207400 90363200
Uterine leiomyosarcoma 35.60 13.39 7 57840 18 90570582
Intraductal proliferative breast lesion 35.52 13.39 24 57823 3429 90567171
Productive cough 35.17 13.39 4 57843 77059 90493541
Renal impairment 34.63 13.39 12 57835 105409 90465191
Muscle spasms 34.58 13.39 277 57570 251606 90318994
Paraparesis 34.05 13.39 22 57825 2916 90567684
Influenza like illness 33.97 13.39 121 57726 80490 90490110
Appendicitis 33.71 13.39 37 57810 10194 90560406
Expanded disability status scale score increased 32.49 13.39 14 57833 809 90569791
Bladder disorder 32.15 13.39 37 57810 10735 90559865
Peripheral swelling 32.09 13.39 145 57702 412961 90157639
Eosinophilic cellulitis 32.07 13.39 10 57837 227 90570373
Product quality issue 31.85 13.39 6 57841 79319 90491281
Intentional product use issue 31.81 13.39 56 57791 216836 90353764
Hysterectomy 31.61 13.39 38 57809 11546 90559054
Dysstasia 31.46 13.39 57 57790 24995 90545605
Psoriasis 31.15 13.39 29 57818 147725 90422875
Gastrointestinal pain 30.97 13.39 37 57810 11169 90559431
Pain 30.96 13.39 449 57398 995892 89574708
Hyperkalaemia 30.60 13.39 3 57844 64961 90505639
Urticaria 30.29 13.39 319 57528 312415 90258185
Myelitis 30.27 13.39 18 57829 2060 90568540
Pleural effusion 30.09 13.39 17 57830 111974 90458626
Neutropenia 29.56 13.39 62 57785 224842 90345758
Drug abuse 29.52 13.39 8 57839 82339 90488261
Urinary incontinence 28.99 13.39 70 57777 37496 90533104
CD8 lymphocytes decreased 28.83 13.39 9 57838 205 90570395
Haemoglobin decreased 28.40 13.39 37 57810 161919 90408681
Nasopharyngitis 28.09 13.39 149 57698 406955 90163645
Accident 28.02 13.39 28 57819 6926 90563674
Pyrexia 28.00 13.39 278 57569 660207 89910393
Dyspnoea exertional 27.92 13.39 6 57841 72282 90498318
Depression 27.88 13.39 304 57543 300297 90270303
Delirium 27.81 13.39 16 57831 104343 90466257
Prescribed overdose 27.43 13.39 14 57833 97611 90472989
Meningioma 27.32 13.39 24 57823 5047 90565553
Nephrolithiasis 27.29 13.39 81 57766 49004 90521596
Diplopia 27.16 13.39 58 57789 28656 90541944
Myelitis transverse 27.05 13.39 15 57832 1505 90569095
Ill-defined disorder 26.88 13.39 48 57799 184843 90385757
Dysphagia 26.81 13.39 142 57705 112136 90458464
Decubitus ulcer 26.28 13.39 35 57812 11778 90558822
Taste disorder 26.16 13.39 4 57843 61542 90509058
Macular oedema 25.99 13.39 23 57824 4886 90565714
Adjustment disorder with depressed mood 25.76 13.39 3 57844 56750 90513850
Upper limb fracture 25.71 13.39 48 57799 21530 90549070
Coronavirus infection 25.59 13.39 24 57823 5491 90565109
Gallbladder operation 25.53 13.39 18 57829 2753 90567847
Joint stiffness 25.43 13.39 9 57838 78033 90492567
Therapy interrupted 25.35 13.39 80 57767 50028 90520572
Dislocation of vertebra 25.30 13.39 3 57844 55965 90514635
Primary progressive multiple sclerosis 25.16 13.39 7 57840 105 90570495
Concussion 24.88 13.39 33 57814 11058 90559542
Feeding disorder 24.78 13.39 42 57805 17470 90553130
Hypoglycaemia 24.64 13.39 7 57840 69841 90500759
Vertigo 24.62 13.39 99 57748 69712 90500888
Glioblastoma 24.51 13.39 12 57835 931 90569669
Basal cell carcinoma 24.47 13.39 61 57786 33328 90537272
Depressed level of consciousness 24.40 13.39 8 57839 72776 90497824
Musculoskeletal stiffness 24.28 13.39 102 57745 296430 90274170
Muscle tightness 24.22 13.39 36 57811 13403 90557197
Cervical spinal stenosis 24.01 13.39 17 57830 2618 90567982
Product substitution issue 23.93 13.39 42 57805 17966 90552634
Multiple organ dysfunction syndrome 23.82 13.39 7 57840 68329 90502271
Asthenia 23.71 13.39 475 57372 533276 90037324
Exostosis 23.65 13.39 3 57844 53131 90517469
Cervical dysplasia 23.58 13.39 20 57827 4014 90566586
Invasive lobular breast carcinoma 23.52 13.39 12 57835 1017 90569583
Motor dysfunction 23.19 13.39 43 57804 19187 90551413
Abortion 23.11 13.39 17 57830 2778 90567822
Autoimmune disorder 23.11 13.39 10 57837 76734 90493866
Hypokalaemia 22.94 13.39 30 57817 131086 90439514
Gastric bypass 22.87 13.39 15 57832 2039 90568561
Hypoxia 22.50 13.39 9 57838 72390 90498210
Dermatitis allergic 22.49 13.39 40 57807 17287 90553313
Gamma-glutamyltransferase increased 22.42 13.39 64 57783 37888 90532712
Speech disorder 22.35 13.39 72 57775 45513 90525087
Mental impairment 22.22 13.39 39 57808 16681 90553919
Lactic acidosis 22.10 13.39 3 57844 50460 90520140
Miliaria 22.08 13.39 13 57834 1461 90569139
Gait spastic 21.80 13.39 8 57839 302 90570298
Herpes zoster oticus 21.50 13.39 9 57838 484 90570116
Limb discomfort 21.34 13.39 63 57784 37997 90532603
Product dose omission in error 21.25 13.39 43 57804 20460 90550140
Therapy non-responder 21.24 13.39 34 57813 136670 90433930
Tumefactive multiple sclerosis 21.15 13.39 6 57841 97 90570503
Blood pressure fluctuation 20.97 13.39 4 57843 52409 90518191
Electrocardiogram QT prolonged 20.95 13.39 10 57837 72446 90498154
Herpes zoster meningomyelitis 20.72 13.39 4 57843 9 90570591
Noninfectious myelitis 20.72 13.39 4 57843 9 90570591
Disease progression 20.72 13.39 43 57804 156572 90414028
Cystitis 20.71 13.39 91 57756 66627 90503973
T-lymphocyte count decreased 20.70 13.39 8 57839 349 90570251
Multiple lentigines syndrome 20.66 13.39 7 57840 208 90570392
Ascites 20.52 13.39 3 57844 47737 90522863
Meningitis staphylococcal 20.50 13.39 6 57841 109 90570491
Facial spasm 20.45 13.39 10 57837 774 90569826
Uterine cancer 20.45 13.39 21 57826 5364 90565236
Progressive relapsing multiple sclerosis 20.30 13.39 5 57842 45 90570555
Blood pressure systolic increased 20.30 13.39 6 57841 58339 90512261
International normalised ratio increased 20.28 13.39 3 57844 47313 90523287
Cardiac failure 20.26 13.39 24 57823 109472 90461128
Vision blurred 20.17 13.39 130 57717 110163 90460437
COVID-19 20.15 13.39 180 57667 168663 90401937
Tibia fracture 20.03 13.39 22 57825 6065 90564535
Appendicitis perforated 19.91 13.39 14 57833 2132 90568468
Dyspepsia 19.57 13.39 203 57644 197957 90372643
Diabetic retinal oedema 19.40 13.39 8 57839 414 90570186
Herpes simplex encephalitis 19.38 13.39 8 57839 415 90570185
Cardio-respiratory arrest 19.38 13.39 8 57839 63132 90507468
Pancreatic failure 19.36 13.39 12 57835 1480 90569120
Foetal heart rate increased 19.07 13.39 3 57844 0 90570600
Bipolar disorder 19.04 13.39 26 57821 8959 90561641
Neurogenic bladder 19.01 13.39 17 57830 3661 90566939
Injection site bruising 18.90 13.39 5 57842 52302 90518298
Genital hypoaesthesia 18.81 13.39 4 57843 17 90570583
Ectopic pregnancy 18.80 13.39 16 57831 3225 90567375
Aphasia 18.66 13.39 65 57782 42747 90527853
Sedation 18.60 13.39 4 57843 48167 90522433
Medication error 18.57 13.39 16 57831 84636 90485964
Partial seizures 18.49 13.39 23 57824 7237 90563363
Needle fatigue 18.47 13.39 6 57841 156 90570444
Visual impairment 18.38 13.39 146 57701 132219 90438381
Human papilloma virus test positive 18.33 13.39 9 57838 703 90569897
Paraplegia 18.09 13.39 16 57831 3396 90567204
Drug ineffective for unapproved indication 18.07 13.39 10 57837 66634 90503966
Accidental exposure to product by child 18.01 13.39 11 57836 1322 90569278
Anal incontinence 17.98 13.39 35 57812 16195 90554405
Tachycardia 17.88 13.39 47 57800 157626 90412974
Malignant neoplasm of unknown primary site 17.72 13.39 7 57840 324 90570276
Nasal sinus cancer 17.66 13.39 4 57843 24 90570576
Wrong technique in product usage process 17.65 13.39 12 57835 71559 90499041
Tremor 17.61 13.39 162 57685 153011 90417589
Immune reconstitution inflammatory syndrome 17.49 13.39 22 57825 6997 90563603
Lupus-like syndrome 17.03 13.39 5 57842 48841 90521759
Herpes zoster reactivation 17.03 13.39 6 57841 201 90570399
Pollakiuria 16.97 13.39 53 57794 32952 90537648
Therapeutic product effect incomplete 16.93 13.39 65 57782 193831 90376769
Sciatica 16.92 13.39 24 57823 101358 90469242
Inappropriate schedule of product administration 16.77 13.39 45 57802 149888 90420712
Coeliac disease 16.63 13.39 4 57843 44606 90525994
Pneumonitis 16.39 13.39 4 57843 44166 90526434
Abortion missed 16.26 13.39 12 57835 1970 90568630
Fear 16.21 13.39 34 57813 16588 90554012
Neuropathy peripheral 16.17 13.39 40 57807 136930 90433670
Adenocarcinoma of the cervix 16.06 13.39 6 57841 238 90570362
Breech presentation 15.96 13.39 10 57837 1257 90569343
Dysarthria 15.92 13.39 73 57774 54409 90516191
Skin warm 15.92 13.39 22 57825 7665 90562935
Infection 15.90 13.39 151 57696 361943 90208657
Protein S increased 15.78 13.39 3 57844 6 90570594
Malignant melanoma in situ 15.66 13.39 9 57838 967 90569633
Paralysis 15.55 13.39 27 57820 11451 90559149
Blepharospasm 15.50 13.39 8 57839 55437 90515163
Appendicectomy 15.46 13.39 15 57832 3581 90567019
Hospitalisation 15.44 13.39 37 57810 128063 90442537
Hypocalcaemia 15.40 13.39 4 57843 42364 90528236
Cataract subcapsular 15.20 13.39 8 57839 723 90569877
Injection site reaction 15.17 13.39 22 57825 92058 90478542
Dysgraphia 15.15 13.39 15 57832 3668 90566932
Fibula fracture 15.15 13.39 16 57831 4221 90566379
Malignant melanoma stage I 15.13 13.39 4 57843 49 90570551
Overdose 15.01 13.39 51 57796 157658 90412942
Macular degeneration 14.97 13.39 3 57844 37967 90532633
Rhabdomyolysis 14.93 13.39 7 57840 51249 90519351
White blood cell count abnormal 14.83 13.39 21 57826 7483 90563117
Skin cancer 14.79 13.39 29 57818 13490 90557110
Squamous cell carcinoma of the vulva 14.70 13.39 4 57843 55 90570545
Dry mouth 14.63 13.39 64 57783 183995 90386605
Decreased interest 14.63 13.39 16 57831 4391 90566209
Fluid retention 14.56 13.39 21 57826 88070 90482530
Noninfective encephalitis 14.52 13.39 7 57840 525 90570075
Gait inability 14.44 13.39 150 57697 146306 90424294
Headache 14.27 13.39 680 57167 862066 89708534
Pyramidal tract syndrome 14.19 13.39 7 57840 552 90570048
Faeces pale 14.15 13.39 11 57836 1952 90568648
Cholestasis 14.04 13.39 3 57844 36296 90534304
Hepatic cirrhosis 13.82 13.39 12 57835 63241 90507359
Drug reaction with eosinophilia and systemic symptoms 13.81 13.39 5 57842 42753 90527847
Hip arthroplasty 13.78 13.39 17 57830 76191 90494409
Depressed mood 13.73 13.39 66 57781 50156 90520444
Decreased appetite 13.71 13.39 164 57683 376376 90194224
Incontinence 13.71 13.39 28 57819 13407 90557193
Pulmonary hypertension 13.69 13.39 5 57842 42518 90528082
Respiratory failure 13.65 13.39 35 57812 118383 90452217

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 2083.09 21.05 560 14774 13704 42592297
Flushing 1214.20 21.05 467 14867 36561 42569440
Central nervous system lesion 256.01 21.05 99 15235 7771 42598230
Lymphopenia 230.66 21.05 125 15209 21438 42584563
Prescribed underdose 230.41 21.05 99 15235 10183 42595818
Relapsing-remitting multiple sclerosis 209.45 21.05 57 15277 1438 42604563
Balance disorder 204.06 21.05 155 15179 47490 42558511
Lymphocyte count decreased 193.53 21.05 122 15212 27687 42578314
Fall 192.78 21.05 320 15014 234200 42371801
Memory impairment 179.76 21.05 147 15187 50075 42555926
Muscle spasticity 177.28 21.05 73 15261 6749 42599252
Gait spastic 175.57 21.05 49 15285 1360 42604641
Needle fatigue 168.76 21.05 46 15288 1167 42604834
Multiple sclerosis 166.41 21.05 72 15262 7526 42598475
Gait disturbance 161.01 21.05 187 15147 97813 42508188
Hypertonic bladder 158.36 21.05 51 15283 2330 42603671
Monoparesis 135.94 21.05 48 15286 2912 42603089
General symptom 127.77 21.05 36 15298 1035 42604966
Gastric disorder 121.57 21.05 67 15267 11855 42594146
Gastrointestinal disorder 115.76 21.05 111 15223 46542 42559459
Ataxia 107.78 21.05 69 15265 16056 42589945
Hypoaesthesia 98.71 21.05 125 15209 71338 42534663
Abdominal discomfort 98.25 21.05 128 15206 75127 42530874
Urinary tract infection 95.67 21.05 146 15188 99138 42506863
Acute kidney injury 87.19 21.05 14 15320 367323 42238678
Movement disorder 83.90 21.05 57 15277 14641 42591360
Micturition urgency 77.25 21.05 50 15284 11848 42594153
Off label use 69.28 21.05 77 15257 638258 41967743
Hot flush 68.72 21.05 60 15274 22291 42583710
Pollakiuria 68.36 21.05 60 15274 22445 42583556
Magnetic resonance imaging abnormal 67.58 21.05 25 15309 1733 42604268
Nocturia 66.82 21.05 46 15288 12066 42593935
Toxicity to various agents 66.54 21.05 4 15330 229132 42376869
Loss of control of legs 63.95 21.05 20 15314 829 42605172
Abdominal pain upper 63.88 21.05 110 15224 82499 42523502
Paraesthesia 63.73 21.05 103 15231 73356 42532645
Anaemia 63.55 21.05 12 15322 280266 42325735
Progressive multiple sclerosis 61.32 21.05 15 15319 244 42605757
Mobility decreased 60.58 21.05 69 15265 35237 42570764
Muscular weakness 60.44 21.05 108 15226 83390 42522611
Dysarthria 60.33 21.05 73 15261 39734 42566267
Product dose omission issue 59.95 21.05 155 15179 154210 42451791
Underdose 57.90 21.05 48 15286 16618 42589383
Seizure 54.13 21.05 128 15206 120433 42485568
Intentional underdose 53.71 21.05 17 15317 733 42605268
CD8 lymphocytes decreased 53.39 21.05 11 15323 77 42605924
Erectile dysfunction 52.01 21.05 54 15280 24859 42581142
Herpes zoster 50.48 21.05 66 15268 38811 42567190
Hypotension 47.04 21.05 17 15317 257614 42348387
Musculoskeletal disorder 45.82 21.05 29 15305 6609 42599392
Cognitive disorder 44.34 21.05 58 15276 34114 42571887
Gait inability 43.24 21.05 47 15287 22786 42583215
Treatment failure 42.75 21.05 79 15255 62545 42543456
Adverse reaction 39.48 21.05 22 15312 3971 42602030
Thrombocytopenia 39.33 21.05 10 15324 190269 42415732
Drug intolerance 37.82 21.05 87 15247 80337 42525664
Secondary progressive multiple sclerosis 36.37 21.05 11 15323 407 42605594
Optic neuritis 36.06 21.05 21 15313 4121 42601880
T-lymphocyte count decreased 35.77 21.05 10 15324 279 42605722
Lymphocyte count abnormal 32.99 21.05 16 15318 2171 42603830
Road traffic accident 32.20 21.05 37 15297 19056 42586945
Insomnia 31.63 21.05 104 15230 118149 42487852
Anxiety 31.47 21.05 104 15230 118456 42487545
Dyspnoea 30.34 21.05 72 15262 442549 42163452
JC polyomavirus test positive 30.10 21.05 12 15322 1019 42604982
Progressive multifocal leukoencephalopathy 29.62 21.05 28 15306 11508 42594493
Haemoglobin decreased 29.28 21.05 6 15328 132465 42473536
Congenital supraventricular tachycardia 29.16 21.05 5 15329 10 42605991
Renal impairment 28.96 21.05 3 15331 110225 42495776
Hemiparesis 28.18 21.05 33 15301 17343 42588658
CD4 lymphocytes decreased 25.84 21.05 13 15321 1908 42604093
Testicular seminoma (pure) stage I 24.79 21.05 5 15329 31 42605970
Oedema peripheral 24.77 21.05 9 15325 136067 42469934
Pleural effusion 24.62 21.05 3 15331 97163 42508838
Multiple organ dysfunction syndrome 24.58 21.05 3 15331 97032 42508969
Hemianaesthesia 24.50 21.05 6 15328 98 42605903
Neutropenia 23.82 21.05 22 15312 199409 42406592
Hyponatraemia 23.69 21.05 4 15330 101458 42504543
Chromaturia 23.68 21.05 29 15305 15960 42590041
Band sensation 23.46 21.05 6 15328 118 42605883
Mucocutaneous leishmaniasis 23.41 21.05 6 15328 119 42605882
Expanded disability status scale score increased 23.30 21.05 8 15326 446 42605555
Feeling hot 23.22 21.05 35 15299 23447 42582554
Nausea 22.70 21.05 230 15104 396569 42209432
Trigeminal neuralgia 22.24 21.05 11 15323 1558 42604443
Disease progression 22.21 21.05 12 15322 143644 42462357
Congenital coronary artery malformation 22.09 21.05 5 15329 57 42605944
Urosepsis 21.86 21.05 27 15307 14993 42591008

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 4722.11 14.17 1488 50479 48752 110488580
Flushing 4522.88 14.17 1735 50232 103001 110434331
Lymphopenia 857.04 14.17 405 51562 39765 110497567
Prescribed underdose 583.65 14.17 370 51597 64804 110472528
Central nervous system lesion 516.39 14.17 214 51753 15339 110521993
Lymphocyte count decreased 510.07 14.17 324 51643 56919 110480413
Fall 462.19 14.17 930 51037 602552 109934780
Abdominal pain upper 377.09 14.17 625 51342 348486 110188846
Hot flush 374.20 14.17 283 51684 65753 110471579
Multiple sclerosis 307.89 14.17 176 51791 25522 110511810
Intentional underdose 282.72 14.17 86 51881 2466 110534866
Balance disorder 270.66 14.17 303 51664 116257 110421075
Gait disturbance 263.25 14.17 470 51497 277738 110259594
Off label use 249.18 14.17 205 51762 1499980 109037352
Diarrhoea 249.06 14.17 1125 50842 1138380 109398952
Nausea 240.19 14.17 1179 50788 1234511 109302821
Abortion spontaneous 235.20 14.17 165 51802 34117 110503215
Gastric disorder 229.90 14.17 161 51806 33196 110504136
Urinary tract infection 216.44 14.17 475 51492 325807 110211525
Relapsing-remitting multiple sclerosis 204.59 14.17 64 51903 2018 110535314
General symptom 194.07 14.17 91 51876 8755 110528577
Toxicity to various agents 185.10 14.17 10 51957 480545 110056787
Memory impairment 182.65 14.17 330 51637 196614 110340718
Underdose 182.48 14.17 185 51782 63369 110473963
Breast cancer 179.07 14.17 147 51820 38395 110498937
Loss of control of legs 178.43 14.17 58 51909 2074 110535258
Gait spastic 175.01 14.17 53 51914 1496 110535836
Needle fatigue 167.84 14.17 49 51918 1215 110536117
Vomiting 167.18 14.17 856 51111 909819 109627513
Magnetic resonance imaging abnormal 164.56 14.17 64 51903 3881 110533451
Burning sensation 162.43 14.17 181 51786 69031 110468301
Seizure 158.01 14.17 332 51635 220853 110316479
Invasive ductal breast carcinoma 153.96 14.17 71 51896 6575 110530757
Pruritus 149.36 14.17 604 51363 580956 109956376
Product dose omission issue 148.83 14.17 408 51559 321374 110215958
Acute kidney injury 147.77 14.17 57 51910 635373 109901959
Muscle spasticity 146.31 14.17 127 51840 35788 110501544
Drug interaction 135.70 14.17 34 51933 500149 110037183
Febrile neutropenia 134.34 14.17 3 51964 316764 110220568
Hypoaesthesia 134.10 14.17 387 51580 313836 110223496
Optic neuritis 132.57 14.17 76 51891 11071 110526261
Condition aggravated 130.92 14.17 93 51874 734743 109802589
Herpes zoster 128.86 14.17 203 51764 108176 110429156
Hypertonic bladder 120.82 14.17 56 51911 5246 110532086
Gastrointestinal disorder 119.07 14.17 314 51653 241638 110295694
Infusion related reaction 115.51 14.17 20 51947 381142 110156190
Rheumatoid arthritis 112.95 14.17 7 51960 299606 110237726
White blood cell count decreased 111.14 14.17 296 51671 229094 110308238
Monoparesis 109.73 14.17 50 51917 4503 110532829
Micturition urgency 105.40 14.17 81 51886 19239 110518093
Drug hypersensitivity 103.40 14.17 42 51925 454048 110083284
Ataxia 98.22 14.17 94 51873 30014 110507318
Progressive multifocal leukoencephalopathy 97.13 14.17 86 51881 24870 110512462
Paraesthesia 96.89 14.17 318 51649 276203 110261129
Product use issue 93.02 14.17 17 51950 311678 110225654
Anaemia 91.25 14.17 74 51893 547012 109990320
Hand deformity 89.18 14.17 3 51964 218503 110318829
Maternal exposure during pregnancy 88.28 14.17 292 51675 254591 110282741
Glossodynia 87.37 14.17 4 51963 222000 110315332
Hypotension 85.94 14.17 72 51895 523777 110013555
Product use in unapproved indication 84.44 14.17 53 51914 447324 110090008
Pancytopenia 81.77 14.17 4 51963 209609 110327723
Secondary progressive multiple sclerosis 78.24 14.17 29 51938 1540 110535792
Musculoskeletal disorder 78.21 14.17 73 51894 22591 110514741
Wheezing 78.16 14.17 13 51954 255217 110282115
Abdominal discomfort 78.09 14.17 379 51588 393479 110143853
General physical health deterioration 78.05 14.17 52 51915 425243 110112089
Lymphocyte count abnormal 75.86 14.17 32 51935 2394 110534938
Pollakiuria 74.88 14.17 98 51869 44097 110493235
Hemianaesthesia 74.83 14.17 21 51946 450 110536882
Muscular weakness 72.49 14.17 269 51698 248199 110289133
Blood creatinine increased 69.74 14.17 4 51963 182885 110354447
Wound 69.47 14.17 13 51954 234424 110302908
Malignant neoplasm progression 69.17 14.17 3 51964 174564 110362768
Thrombocytopenia 69.09 14.17 39 51928 348846 110188486
Progressive multiple sclerosis 67.96 14.17 25 51942 1299 110536033
Caesarean section 66.90 14.17 54 51913 13763 110523569
Dyspnoea 65.43 14.17 283 51684 1106589 109430743
Hip fracture 64.35 14.17 81 51886 35070 110502262
JC polyomavirus test positive 63.67 14.17 28 51939 2319 110535013
Pemphigus 63.36 14.17 12 51955 214558 110322774
Abdominal pain 62.61 14.17 434 51533 512555 110024777
Malignant melanoma 61.37 14.17 56 51911 16835 110520497
Joint swelling 60.93 14.17 71 51896 442774 110094558
CD4 lymphocytes decreased 60.35 14.17 29 51938 2945 110534387
Systemic lupus erythematosus 58.70 14.17 23 51944 254315 110283017
Sensory disturbance 57.95 14.17 55 51912 17374 110519958
Oedema peripheral 57.87 14.17 42 51925 328618 110208714
Injection site pain 56.89 14.17 8 51959 177914 110359418
Duodenal ulcer perforation 56.79 14.17 8 51959 177692 110359640
Feeling hot 56.17 14.17 129 51838 90977 110446355
Synovitis 55.18 14.17 30 51937 274062 110263270
Renal impairment 54.67 14.17 11 51956 188434 110348898
CD8 lymphocytes decreased 54.52 14.17 15 51952 298 110537034
Skin burning sensation 54.51 14.17 59 51908 21766 110515566
Completed suicide 54.18 14.17 23 51944 242358 110294974
Peroneal nerve palsy 53.92 14.17 37 51930 7377 110529955
Ankle fracture 53.79 14.17 56 51911 19763 110517569
Trigeminal neuralgia 52.63 14.17 30 51937 4322 110533010
Stomatitis 52.37 14.17 31 51936 270211 110267121
Cognitive disorder 51.86 14.17 122 51845 87389 110449943
Arthralgia 50.60 14.17 192 51775 779440 109757892
Multiple organ dysfunction syndrome 50.48 14.17 6 51961 151704 110385628
Oedema 50.11 14.17 18 51949 209958 110327374
Anti-cyclic citrullinated peptide antibody positive 50.00 14.17 12 51955 181972 110355360
Fibromyalgia 49.53 14.17 10 51957 170899 110366433
Dehydration 49.05 14.17 260 51707 279251 110258081
Arthropathy 49.00 14.17 38 51929 287484 110249848
Hyperkalaemia 48.77 14.17 4 51963 135792 110401540
Hyponatraemia 48.09 14.17 21 51946 217632 110319700
Cough 47.91 14.17 90 51877 461551 110075781
Band sensation 46.78 14.17 18 51949 1060 110536272
Drug abuse 46.26 14.17 13 51954 177398 110359934
C-reactive protein abnormal 46.08 14.17 4 51963 129691 110407641
Stress 46.05 14.17 131 51836 105217 110432115
Contraindicated product administered 45.99 14.17 30 51937 248237 110289095
Rheumatic fever 45.77 14.17 3 51964 122576 110414756
Flatulence 45.26 14.17 85 51882 52064 110485268
Loss of personal independence in daily activities 45.13 14.17 8 51959 150012 110387320
C-reactive protein increased 45.11 14.17 23 51944 217896 110319436
Urticaria 44.45 14.17 279 51688 318578 110218754
T-lymphocyte count decreased 44.27 14.17 15 51952 611 110536721
Pericarditis 44.07 14.17 24 51943 219090 110318242
Prolonged labour 43.85 14.17 14 51953 472 110536860
Oxygen saturation decreased 43.82 14.17 10 51957 156972 110380360
Lung disorder 43.70 14.17 15 51952 180032 110357300
Haemoglobin decreased 43.50 14.17 32 51935 248695 110288637
Neutropenia 43.47 14.17 68 51899 374552 110162780
Papillary thyroid cancer 43.41 14.17 23 51944 2871 110534461
Dyspepsia 43.12 14.17 191 51776 190774 110346558
Erectile dysfunction 42.60 14.17 48 51919 18508 110518824
Nocturia 42.55 14.17 46 51921 16944 110520388
Discomfort 42.49 14.17 24 51943 214683 110322649
Hemiparesis 42.46 14.17 75 51892 43828 110493504
Exposure during pregnancy 42.31 14.17 13 51954 167411 110369921
Decreased immune responsiveness 41.21 14.17 35 51932 9571 110527761
Helicobacter infection 41.06 14.17 17 51950 181860 110355472
Death 41.01 14.17 505 51462 698364 109838968
Paraparesis 41.01 14.17 26 51941 4540 110532792
Head injury 40.98 14.17 73 51894 42944 110494388
Dysarthria 40.12 14.17 108 51859 84013 110453319
Joint range of motion decreased 40.09 14.17 5 51962 121827 110415505
Urosepsis 40.00 14.17 60 51907 30615 110506717
Ophthalmic herpes zoster 39.97 14.17 23 51944 3372 110533960
Erythema 39.36 14.17 253 51714 291194 110246138
Expanded disability status scale score increased 38.67 14.17 15 51952 903 110536429
Myelitis 38.45 14.17 22 51945 3191 110534141
Thyroid cancer 38.22 14.17 28 51939 6186 110531146
Disease progression 38.20 14.17 35 51932 243999 110293333
Intraductal proliferative breast lesion 37.77 14.17 21 51946 2884 110534448
Inflammation 37.66 14.17 22 51945 193216 110344116
Cystitis 36.90 14.17 90 51877 65946 110471386
Eosinophilic cellulitis 36.75 14.17 11 51956 298 110537034
Headache 36.69 14.17 600 51367 881777 109655555
Pleural effusion 36.42 14.17 19 51948 177690 110359642
Chromaturia 36.27 14.17 56 51911 29304 110508028
Injury 36.26 14.17 19 51948 177246 110360086
Lip dry 35.79 14.17 3 51964 100080 110437252
Movement disorder 34.96 14.17 62 51905 36342 110500990
Muscle spasms 34.85 14.17 237 51730 277920 110259412
Asthma 34.53 14.17 40 51927 250251 110287081
Folliculitis 34.24 14.17 18 51949 167635 110369697
Dysstasia 34.05 14.17 58 51909 32928 110504404
Breast cancer female 33.43 14.17 35 51932 12433 110524899
Decubitus ulcer 33.34 14.17 42 51925 18194 110519138
Hypertension 32.79 14.17 126 51841 509958 110027374
Uterine leiomyosarcoma 32.76 14.17 6 51961 14 110537318
Therapeutic product effect decreased 32.69 14.17 40 51927 244276 110293056
Productive cough 32.47 14.17 7 51960 114298 110423034
Type 2 diabetes mellitus 32.03 14.17 22 51945 177210 110360122
Rhabdomyolysis 31.05 14.17 9 51958 120392 110416940
Liver injury 30.94 14.17 16 51951 150397 110386935
Agraphia 30.86 14.17 7 51960 60 110537272
Major depression 30.62 14.17 31 51936 10590 110526742
Therapy non-responder 30.52 14.17 18 51949 157289 110380043
Cardiac failure 30.46 14.17 26 51941 187600 110349732
Dyspnoea exertional 30.33 14.17 6 51961 104054 110433278
Abdominal distension 30.09 14.17 162 51805 174941 110362391
Nasal congestion 30.08 14.17 5 51962 98277 110439055
Ascites 30.07 14.17 4 51963 92804 110444528
Cervix carcinoma 29.60 14.17 17 51950 2484 110534848
Invasive lobular breast carcinoma 29.45 14.17 12 51955 822 110536510
Hypoxia 29.40 14.17 12 51955 129503 110407829
Bladder disorder 29.39 14.17 31 51936 11106 110526226
Hypercholesterolaemia 29.23 14.17 4 51963 90833 110446499
Dizziness 29.06 14.17 475 51492 697718 109839614
Hypersensitivity 28.63 14.17 303 51664 403695 110133637
Injection site erythema 28.37 14.17 5 51962 94171 110443161
Blood cholesterol increased 28.33 14.17 27 51940 184758 110352574
Delirium 28.32 14.17 14 51953 135011 110402321
Feeling abnormal 28.26 14.17 163 51804 180548 110356784
Gait inability 28.24 14.17 133 51834 136243 110401089
Gastrointestinal pain 27.78 14.17 31 51936 11829 110525503
Inappropriate schedule of product administration 27.60 14.17 33 51934 203604 110333728
Therapy cessation 27.07 14.17 63 51904 44794 110492538
Vision blurred 26.84 14.17 126 51841 128896 110408436
Gastrointestinal haemorrhage 26.79 14.17 23 51944 165495 110371837
Breast cancer stage III 26.64 14.17 3 51964 79114 110458218
Electrocardiogram QT prolonged 26.57 14.17 9 51958 108951 110428381
Lower respiratory tract infection 26.44 14.17 46 51921 243060 110294272
Respiratory failure 26.01 14.17 38 51929 215294 110322038
Drug ineffective for unapproved indication 25.95 14.17 8 51959 102830 110434502
Blood pressure systolic increased 25.90 14.17 4 51963 82987 110454345
Decreased interest 25.51 14.17 20 51947 4888 110532444
Muscle tightness 25.41 14.17 33 51934 14729 110522603
International normalised ratio increased 25.29 14.17 5 51962 86767 110450565
Alopecia 25.11 14.17 272 51695 364481 110172851
Bursitis 25.02 14.17 15 51952 129903 110407429
Swelling 25.01 14.17 83 51884 350958 110186374
Gallbladder operation 24.99 14.17 15 51952 2378 110534954
Depressed level of consciousness 24.53 14.17 11 51956 112267 110425065
Tumefactive multiple sclerosis 24.52 14.17 7 51960 160 110537172
Herpes zoster oticus 24.48 14.17 10 51957 690 110536642
Hypoglycaemia 24.40 14.17 12 51955 116092 110421240
Abortion 24.40 14.17 13 51954 1641 110535691
Feeding disorder 23.98 14.17 39 51928 21323 110516009
Red blood cell sedimentation rate increased 23.93 14.17 4 51963 78298 110459034
Platelet count decreased 23.81 14.17 45 51922 230398 110306934
Renal failure 23.63 14.17 44 51923 226530 110310802
Basal cell carcinoma 23.50 14.17 60 51907 45210 110492122
Accidental exposure to product by child 23.35 14.17 16 51951 3182 110534150
Osteoarthritis 23.28 14.17 31 51936 182592 110354740
Limb discomfort 23.16 14.17 56 51911 40798 110496534
Cervical dysplasia 23.12 14.17 15 51952 2725 110534607
Treatment failure 23.04 14.17 61 51906 277173 110260159
Cardio-respiratory arrest 22.83 14.17 13 51954 115823 110421509
Pyrexia 22.67 14.17 292 51675 897973 109639359
Relapsing multiple sclerosis 22.64 14.17 7 51960 212 110537120
Grip strength decreased 22.59 14.17 5 51962 80169 110457163
Musculoskeletal pain 22.40 14.17 32 51935 182991 110354341
Tibia fracture 22.31 14.17 21 51946 6564 110530768
Muscle injury 22.26 14.17 20 51947 140787 110396545
Diplopia 22.24 14.17 56 51911 41838 110495494
Depressed mood 22.21 14.17 71 51896 60738 110476594
Temperature intolerance 22.19 14.17 30 51937 13920 110523412
Dermatitis allergic 22.16 14.17 38 51929 21686 110515646
Cervical spinal stenosis 22.15 14.17 15 51952 2927 110534405
Blindness unilateral 21.93 14.17 25 51942 9761 110527571
Upper limb fracture 21.92 14.17 37 51930 20851 110516481
Septic shock 21.91 14.17 25 51942 157503 110379829
Glioblastoma 21.85 14.17 13 51954 2027 110535305
Asthenia 21.74 14.17 449 51518 688550 109848782
Lung cancer metastatic 21.59 14.17 17 51950 4181 110533151
Multiple lentigines syndrome 21.57 14.17 7 51960 249 110537083
Impaired self-care 21.54 14.17 14 51953 2550 110534782
Progressive relapsing multiple sclerosis 21.44 14.17 5 51962 49 110537283
Metabolic acidosis 21.44 14.17 10 51957 99734 110437598
Diabetic retinal oedema 21.38 14.17 8 51959 436 110536896
Hypokalaemia 21.25 14.17 33 51934 182415 110354917
Gastroenteritis viral 21.24 14.17 46 51921 31180 110506152
Gamma-glutamyltransferase increased 20.97 14.17 70 51897 61239 110476093
Psoriasis 20.82 14.17 21 51946 139972 110397360
Hypocalcaemia 20.75 14.17 3 51964 65363 110471969
Impaired healing 20.69 14.17 38 51929 196679 110340653
Neutrophil count decreased 20.57 14.17 16 51951 120925 110416407
Product administered to patient of inappropriate age 20.55 14.17 22 51945 8014 110529318
Fatigue 20.47 14.17 730 51237 1215228 109322104
Sedation 20.34 14.17 4 51963 69679 110467653
Intentional product use issue 20.25 14.17 55 51912 247851 110289481
Weight increased 20.25 14.17 115 51852 419529 110117803
Wound infection 20.23 14.17 10 51957 96455 110440877
Malignant melanoma stage I 20.21 14.17 6 51961 158 110537174
Visual impairment 20.20 14.17 120 51847 134308 110403024
Concussion 20.19 14.17 26 51941 11512 110525820
Gastric bypass 20.15 14.17 11 51956 1458 110535874
Anti-myelin-associated glycoprotein antibodies positive 19.99 14.17 3 51964 0 110537332
Miliaria 19.91 14.17 12 51955 1917 110535415
Noninfectious myelitis 19.84 14.17 4 51963 18 110537314
Accident 19.66 14.17 25 51942 10927 110526405
Drug reaction with eosinophilia and systemic symptoms 19.64 14.17 7 51960 82088 110455244
Influenza like illness 19.61 14.17 88 51879 88324 110449008
Insomnia 19.57 14.17 257 51710 360333 110176999
Depression 19.29 14.17 231 51736 317104 110220228
Sleep disorder due to general medical condition, insomnia type 19.24 14.17 13 51954 105630 110431702
Pneumonitis 19.23 14.17 6 51961 76525 110460807
Agranulocytosis 19.22 14.17 3 51964 61757 110475575
Koebner phenomenon 19.19 14.17 5 51962 80 110537252
Psoriatic arthropathy 18.97 14.17 40 51927 196721 110340611
Urinary incontinence 18.92 14.17 58 51909 48529 110488803
Confusional state 18.75 14.17 136 51831 468544 110068788
Tachycardia 18.73 14.17 50 51917 226595 110310737
Nephrolithiasis 18.71 14.17 71 51896 66141 110471191
Hysterectomy 18.65 14.17 21 51946 8093 110529239
Unintentional use for unapproved indication 18.63 14.17 7 51960 386 110536946
Heavy menstrual bleeding 18.53 14.17 30 51937 16335 110520997
Testicular seminoma (pure) stage I 18.48 14.17 4 51963 27 110537305
Hospitalisation 18.35 14.17 24 51943 142469 110394863
Overdose 18.26 14.17 53 51914 233741 110303591
Mobility decreased 18.19 14.17 181 51786 237241 110300091
Herpes zoster meningomyelitis 18.11 14.17 4 51963 30 110537302
Herpes zoster reactivation 18.02 14.17 7 51960 423 110536909
Motor dysfunction 17.81 14.17 37 51930 24369 110512963
Pancreatic failure 17.72 14.17 12 51955 2342 110534990
Neuropathy peripheral 17.66 14.17 36 51931 179241 110358091
Blindness 17.65 14.17 47 51920 36312 110501020
Pulmonary oedema 17.52 14.17 13 51954 100646 110436686
Somnolence 17.51 14.17 76 51891 297373 110239959
Myelitis transverse 17.50 14.17 12 51955 2389 110534943
Blister 17.43 14.17 52 51915 227324 110310008
Chronic kidney disease 17.42 14.17 7 51960 76284 110461048
Cardiogenic shock 17.36 14.17 3 51964 57335 110479997
Meningioma 17.18 14.17 17 51950 5648 110531684
Sleep disorder 17.04 14.17 43 51924 198601 110338731
Abortion missed 17.00 14.17 10 51957 1527 110535805
Dysphagia 16.97 14.17 127 51840 153473 110383859
Neurogenic bladder 16.83 14.17 16 51951 5063 110532269
Intervertebral disc protrusion 16.82 14.17 39 51928 27659 110509673
Mental disorder 16.71 14.17 48 51919 38743 110498589
Taste disorder 16.65 14.17 5 51962 65382 110471950
Cardiac arrest 16.56 14.17 43 51924 196710 110340622
Herpes simplex encephalitis 16.42 14.17 8 51959 837 110536495
Pyramidal tract syndrome 16.40 14.17 8 51959 839 110536493
Hyperglycaemia 16.13 14.17 10 51957 85080 110452252
Tubulointerstitial nephritis 16.09 14.17 3 51964 54281 110483051
Vertigo 16.03 14.17 82 51885 86788 110450544
Clear cell renal cell carcinoma 16.01 14.17 12 51955 2744 110534588
Hepatic enzyme increased 15.98 14.17 87 51880 320805 110216527
Uterine leiomyoma 15.93 14.17 19 51948 7781 110529551
Protein S increased 15.84 14.17 3 51964 9 110537323
Squamous cell carcinoma of the vulva 15.84 14.17 3 51964 9 110537323
Epistaxis 15.74 14.17 23 51944 130349 110406983
Haemoptysis 15.57 14.17 7 51960 71347 110465985
Thyroid cancer metastatic 15.40 14.17 5 51962 178 110537154
Bipolar disorder 15.29 14.17 20 51947 8987 110528345
Bone contusion 15.24 14.17 9 51958 1385 110535947
Appendicitis perforated 15.04 14.17 13 51954 3639 110533693
Incorrect dose administered 14.90 14.17 16 51951 103625 110433707
Product prescribing error 14.87 14.17 3 51964 51328 110486004
Vitamin D decreased 14.67 14.17 23 51944 12192 110525140
Nasal sinus cancer 14.61 14.17 4 51963 78 110537254
Hepatic failure 14.60 14.17 7 51960 68732 110468600
Agitation 14.60 14.17 19 51948 113032 110424300
Pulmonary hypertension 14.47 14.17 4 51963 55216 110482116
Coronavirus infection 14.39 14.17 20 51947 9525 110527807
Fibula fracture 14.32 14.17 14 51953 4584 110532748
Breech presentation 14.32 14.17 7 51960 738 110536594
COVID-19 14.28 14.17 177 51790 244883 110292449
Fluid retention 14.19 14.17 14 51953 94293 110443039

FDA Adverse Event Reporting System (Pediatric)

None

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:22587 antiviral agent
CHEBI has role CHEBI:35610 antineoplastic agent
CHEBI has role CHEBI:35705 immunosuppressive agent
CHEBI has role CHEBI:35842 antirheumatic drug
CHEBI has role CHEBI:50748 antipsoriatic
CHEBI has role CHEBI:50846 immunomodulator

Related Drugs by ATC class:

L04AX Other immunosuppressants 8 drugs
azathioprinediroximel fumaratelenalidomidemethotrexatepirfenidonepomalidomidetegomil fumaratethalidomide

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

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




🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

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 N204063 March 27, 2013 RX CAPSULE, DELAYED RELEASE ORAL 8399514 Feb. 7, 2028 METHOD OF TREATING MULTIPLE SCLEROSIS
240MG TECFIDERA BIOGEN N204063 March 27, 2013 RX CAPSULE, DELAYED RELEASE ORAL 8399514 Feb. 7, 2028 METHOD OF TREATING MULTIPLE SCLEROSIS
120MG TECFIDERA BIOGEN 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 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 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 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 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 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 N204063 March 27, 2013 RX CAPSULE, DELAYED RELEASE ORAL 10959972 Nov. 16, 2035 METHOD OF TREATING MULTIPLE SCLEROSIS
120MG TECFIDERA BIOGEN N204063 March 27, 2013 RX CAPSULE, DELAYED RELEASE ORAL 11007166 Nov. 16, 2035 METHOD OF TREATING MULTIPLE SCLEROSIS
120MG TECFIDERA BIOGEN N204063 March 27, 2013 RX CAPSULE, DELAYED RELEASE ORAL 11007167 Nov. 16, 2035 METHOD OF TREATING MULTIPLE SCLEROSIS
120MG TECFIDERA BIOGEN N204063 March 27, 2013 RX CAPSULE, DELAYED RELEASE ORAL 11129806 Nov. 16, 2035 METHOD OF TREATING MULTIPLE SCLEROSIS
120MG TECFIDERA BIOGEN N204063 March 27, 2013 RX CAPSULE, DELAYED RELEASE ORAL 11246850 Nov. 16, 2035 METHOD OF TREATING MULTIPLE SCLEROSIS
240MG TECFIDERA BIOGEN N204063 March 27, 2013 RX CAPSULE, DELAYED RELEASE ORAL 10959972 Nov. 16, 2035 METHOD OF TREATING MULTIPLE SCLEROSIS
240MG TECFIDERA BIOGEN N204063 March 27, 2013 RX CAPSULE, DELAYED RELEASE ORAL 11007166 Nov. 16, 2035 METHOD OF TREATING MULTIPLE SCLEROSIS
240MG TECFIDERA BIOGEN N204063 March 27, 2013 RX CAPSULE, DELAYED RELEASE ORAL 11007167 Nov. 16, 2035 METHOD OF TREATING MULTIPLE SCLEROSIS
240MG TECFIDERA BIOGEN N204063 March 27, 2013 RX CAPSULE, DELAYED RELEASE ORAL 11129806 Nov. 16, 2035 METHOD OF TREATING MULTIPLE SCLEROSIS
240MG TECFIDERA BIOGEN N204063 March 27, 2013 RX CAPSULE, DELAYED RELEASE ORAL 11246850 Nov. 16, 2035 METHOD OF TREATING MULTIPLE SCLEROSIS

Orange Book exclusivity data (new drug applications)

None

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
Nuclear factor erythroid 2-related factor 2 Transcription factor EC50 5.29 CHEMBL

External reference:

IDSource
FO2303MNI2 UNII
D03846 KEGG_DRUG
4032290 VUID
N0000186952 NUI
4032290 VANDF
C0058218 UMLSCUI
9HB PDB_CHEM_ID
CHEMBL2107333 ChEMBL_ID
637568 PUBCHEM_CID
DB08908 DRUGBANK_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
CHEBI:76004 CHEBI
FO2303MNI2 INXIGHT DRUGS

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Dimethyl fumarate HUMAN PRESCRIPTION DRUG LABEL 1 0378-0396 CAPSULE, DELAYED RELEASE 120 mg ORAL ANDA 28 sections
Dimethyl fumarate HUMAN PRESCRIPTION DRUG LABEL 1 0378-0399 CAPSULE, DELAYED RELEASE 240 mg ORAL ANDA 28 sections
DIMETHYL FUMARATE HUMAN PRESCRIPTION DRUG LABEL 1 16729-416 CAPSULE, DELAYED RELEASE 120 mg ORAL ANDA 26 sections
DIMETHYL FUMARATE HUMAN PRESCRIPTION DRUG LABEL 1 16729-417 CAPSULE, DELAYED RELEASE 240 mg ORAL ANDA 26 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 33342-349 CAPSULE, DELAYED RELEASE 120 mg ORAL ANDA 27 sections
Dimethyl Fumarate Human Prescription Drug Label 1 33342-350 CAPSULE, DELAYED RELEASE 240 mg ORAL ANDA 27 sections
DIMETHYL FUMARATE HUMAN PRESCRIPTION DRUG LABEL 1 43547-024 CAPSULE, DELAYED RELEASE 120 mg ORAL ANDA 26 sections
DIMETHYL FUMARATE HUMAN PRESCRIPTION DRUG LABEL 1 43547-025 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 26 sections
Dimethyl Fumarate HUMAN PRESCRIPTION DRUG LABEL 1 43598-429 CAPSULE, DELAYED RELEASE 120 mg ORAL ANDA 26 sections
Dimethyl Fumarate HUMAN PRESCRIPTION DRUG LABEL 1 43598-430 CAPSULE, DELAYED RELEASE 240 mg ORAL ANDA 26 sections
Dimethyl Fumarate HUMAN PRESCRIPTION DRUG LABEL 1 43598-430 CAPSULE, DELAYED RELEASE 240 mg ORAL ANDA 26 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
Dimethyl Fumarate Human Prescription Drug Label 1 59651-083 CAPSULE, DELAYED RELEASE 120 mg ORAL ANDA 27 sections
Dimethyl Fumarate Human Prescription Drug Label 1 59651-084 CAPSULE, DELAYED RELEASE 240 mg ORAL ANDA 27 sections
TECFIDERA HUMAN PRESCRIPTION DRUG LABEL 1 64406-005 CAPSULE 120 mg ORAL NDA 26 sections
TECFIDERA HUMAN PRESCRIPTION DRUG LABEL 1 64406-006 CAPSULE 240 mg ORAL NDA 26 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 27 sections
DIMETHYL FUMARATE HUMAN PRESCRIPTION DRUG LABEL 1 68462-308 CAPSULE 240 mg ORAL ANDA 27 sections
DIMETHYL FUMARATE HUMAN PRESCRIPTION DRUG LABEL 1 69097-322 CAPSULE, DELAYED RELEASE 120 mg ORAL ANDA 26 sections