dimethyl fumarate 🐶 Veterinary Use | 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
Jan. 30, 2014 EMA BIOGEN NETHERLANDS B.V.
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 4908.91 13.63 1991 53320 73096 63360615
Multiple sclerosis relapse 3712.75 13.63 1443 53868 47035 63386676
Prescribed underdose 687.09 13.63 387 54924 29302 63404409
Lymphopenia 638.15 13.63 314 54997 18013 63415698
Lymphocyte count decreased 511.03 13.63 322 54989 29935 63403776
Abdominal pain upper 367.01 13.63 650 54661 205794 63227917
Central nervous system lesion 366.51 13.63 181 55130 10454 63423257
Hot flush 356.07 13.63 320 54991 50839 63382872
Fall 341.82 13.63 926 54385 391408 63042303
General symptom 334.21 13.63 116 55195 2692 63431019
Gastrointestinal disorder 322.75 13.63 479 54832 130760 63302951
Intentional underdose 284.26 13.63 93 55218 1789 63431922
Memory impairment 269.94 13.63 390 54921 103868 63329843
Underdose 251.06 13.63 201 55110 27255 63406456
Abortion spontaneous 240.97 13.63 249 55062 46946 63386765
Diarrhoea 230.08 13.63 1226 54085 714140 62719571
Off label use 223.75 13.63 158 55153 674304 62759407
Gait disturbance 215.78 13.63 486 54825 182692 63251019
Gastric disorder 214.31 13.63 210 55101 37159 63396552
Magnetic resonance imaging abnormal 204.45 13.63 83 55228 3002 63430709
Balance disorder 201.43 13.63 304 55007 84118 63349593
Seizure 187.37 13.63 379 54932 132255 63301456
Nausea 180.06 13.63 1314 53997 853157 62580554
Pruritus 175.44 13.63 700 54611 360753 63072958
Infusion related reaction 173.64 13.63 10 55301 245511 63188200
Toxicity to various agents 169.13 13.63 12 55299 247238 63186473
Rheumatoid arthritis 168.88 13.63 14 55297 253805 63179906
Multiple sclerosis 162.69 13.63 149 55162 24223 63409488
Breast cancer 160.07 13.63 204 55107 48179 63385532
Vomiting 158.64 13.63 928 54383 558689 62875022
Loss of control of legs 152.08 13.63 54 55257 1342 63432369
Lymphocyte count abnormal 148.24 13.63 45 55266 670 63433041
Burning sensation 147.25 13.63 208 55103 54199 63379512
Product use issue 144.40 13.63 13 55298 220507 63213204
Urinary tract infection 142.49 13.63 530 54781 264154 63169557
Optic neuritis 135.42 13.63 87 55224 8348 63425363
Hypoaesthesia 134.65 13.63 386 54925 168007 63265704
Invasive ductal breast carcinoma 132.51 13.63 80 55231 6878 63426833
Glossodynia 127.32 13.63 7 55304 178869 63254842
Pemphigus 125.36 13.63 9 55302 183717 63249994
Hand deformity 120.89 13.63 4 55307 159453 63274258
Condition aggravated 113.49 13.63 110 55201 402107 63031604
Drug hypersensitivity 113.33 13.63 65 55246 310622 63123089
Joint swelling 111.96 13.63 74 55237 327592 63106119
Muscular weakness 110.18 13.63 293 55018 122060 63311651
Acute kidney injury 109.86 13.63 46 55265 263369 63170342
Paraesthesia 107.71 13.63 341 54970 156625 63277086
Contraindicated product administered 106.39 13.63 29 55282 217619 63216092
Maternal exposure during pregnancy 106.34 13.63 426 54885 219636 63214075
Systemic lupus erythematosus 105.63 13.63 26 55285 208892 63224819
Arthralgia 102.18 13.63 215 55096 569495 62864216
White blood cell count decreased 101.73 13.63 309 55002 138795 63294916
Cognitive disorder 99.17 13.63 176 55135 55639 63378072
Product dose omission issue 95.71 13.63 431 54880 233882 63199829
Dyspnoea 95.63 13.63 279 55032 661034 62772677
Drug interaction 95.55 13.63 40 55271 229091 63204620
Adverse reaction 91.75 13.63 74 55237 10129 63423582
Wound 89.26 13.63 17 55294 163246 63270465
Chromaturia 88.53 13.63 90 55221 16627 63417084
Arthropathy 87.19 13.63 48 55263 234744 63198967
Synovitis 85.71 13.63 28 55283 186890 63246821
Secondary progressive multiple sclerosis 83.07 13.63 35 55276 1392 63432319
Urticaria 80.06 13.63 321 54990 165481 63268230
Injection site pain 76.54 13.63 11 55300 129789 63303922
Completed suicide 75.84 13.63 17 55294 145656 63288055
Exposure during pregnancy 75.48 13.63 21 55290 155526 63278185
Product use in unapproved indication 73.46 13.63 32 55279 179048 63254663
Gait inability 73.09 13.63 150 55161 52809 63380902
Anaemia 72.98 13.63 89 55222 293341 63140370
Discomfort 71.74 13.63 28 55283 167346 63266365
Peroneal nerve palsy 70.60 13.63 47 55264 4788 63428923
Anti-cyclic citrullinated peptide antibody positive 70.54 13.63 9 55302 116203 63317508
Hypotension 69.58 13.63 81 55230 272523 63161188
Stress 67.81 13.63 168 55143 66999 63366712
Feeling hot 67.58 13.63 141 55170 50213 63383498
Malignant melanoma 67.29 13.63 65 55246 11291 63422420
Musculoskeletal disorder 66.60 13.63 86 55225 20558 63413153
Progressive multiple sclerosis 62.32 13.63 27 55284 1151 63432560
Herpes zoster 61.95 13.63 185 55126 82277 63351434
Paternal exposure before pregnancy 61.93 13.63 13 55298 34 63433677
Swelling 61.87 13.63 90 55221 275288 63158423
Yellow skin 61.73 13.63 33 55278 2247 63431464
Hemianaesthesia 61.60 13.63 20 55291 375 63433336
Rheumatoid factor positive 60.98 13.63 3 55308 84403 63349308
Progressive multifocal leukoencephalopathy 60.05 13.63 65 55246 12906 63420805
Oedema peripheral 59.18 13.63 47 55264 189464 63244247
Malignant neoplasm progression 59.07 13.63 3 55308 82118 63351593
Trigeminal neuralgia 58.23 13.63 37 55274 3482 63430229
Therapeutic product effect decreased 57.74 13.63 50 55261 193137 63240574
Injection site erythema 56.92 13.63 4 55307 83170 63350541
Caesarean section 56.59 13.63 72 55239 16960 63416751
Cough 56.17 13.63 106 55205 292637 63141074
Abdominal pain 55.96 13.63 442 54869 293014 63140697
Pancytopenia 55.35 13.63 9 55302 96924 63336787
Pericarditis 54.76 13.63 23 55288 131556 63302155
Muscle spasticity 54.08 13.63 80 55231 21714 63411997
Muscle spasms 54.07 13.63 274 55037 155876 63277835
Loss of personal independence in daily activities 53.44 13.63 10 55301 97280 63336431
Thrombocytopenia 51.74 13.63 34 55277 151123 63282588
Oxygen saturation decreased 51.09 13.63 8 55303 88577 63345134
JC polyomavirus test positive 50.85 13.63 25 55286 1428 63432283
Temperature intolerance 50.66 13.63 50 55261 8914 63424797
Blood creatinine increased 50.51 13.63 8 55303 87836 63345875
Relapsing-remitting multiple sclerosis 50.11 13.63 19 55292 571 63433140
Duodenal ulcer perforation 50.01 13.63 8 55303 87201 63346510
Blindness unilateral 49.32 13.63 42 55269 6199 63427512
Stomatitis 49.13 13.63 30 55281 138695 63295016
Neutropenia 49.09 13.63 48 55263 174957 63258754
CD4 lymphocytes decreased 48.30 13.63 24 55287 1403 63432308
Haemoglobin decreased 48.09 13.63 34 55277 145451 63288260
Wheezing 48.08 13.63 12 55299 95583 63338128
Hyponatraemia 47.47 13.63 19 55292 111881 63321830
Decreased immune responsiveness 47.18 13.63 37 55274 4864 63428847
Dyspepsia 47.01 13.63 195 55116 102001 63331710
Agraphia 46.88 13.63 10 55301 29 63433682
Abdominal discomfort 46.47 13.63 455 54856 320430 63113281
Abdominal distension 46.09 13.63 173 55138 86442 63347269
Helicobacter infection 45.99 13.63 12 55299 92773 63340938
Skin burning sensation 45.77 13.63 56 55255 12678 63421033
Sensory disturbance 45.74 13.63 58 55253 13614 63420097
General physical health deterioration 45.04 13.63 66 55245 201336 63232375
Product dose omission in error 44.03 13.63 43 55268 7569 63426142
Papillary thyroid cancer 43.11 13.63 26 55285 2230 63431481
Ocular icterus 42.73 13.63 31 55280 3625 63430086
Renal impairment 42.71 13.63 12 55299 88343 63345368
Nasal congestion 42.59 13.63 4 55307 65656 63368055
Hip fracture 41.27 13.63 84 55227 29390 63404321
Drug abuse 40.81 13.63 7 55304 72511 63361200
Productive cough 40.60 13.63 4 55307 63204 63370507
Disease progression 40.16 13.63 29 55282 122729 63310982
Sinusitis 40.09 13.63 86 55225 226567 63207144
Erythema 39.88 13.63 276 55035 175475 63258236
Band sensation 39.72 13.63 18 55293 855 63432856
Impaired self-care 39.53 13.63 23 55288 1847 63431864
Pleural effusion 37.66 13.63 17 55294 93193 63340518
Depression 37.42 13.63 296 55015 196196 63237515
Micturition urgency 37.39 13.63 44 55267 9567 63424144
Ophthalmic herpes zoster 37.33 13.63 23 55288 2050 63431661
C-reactive protein increased 37.14 13.63 18 55293 94689 63339022
Hemiparesis 37.02 13.63 70 55241 23212 63410499
Dehydration 36.86 13.63 268 55043 173086 63260625
Major depression 36.80 13.63 40 55271 7978 63425733
Hyperkalaemia 35.97 13.63 3 55308 54200 63379511
Relapsing multiple sclerosis 35.22 13.63 11 55300 181 63433530
Drug intolerance 35.06 13.63 417 54894 308244 63125467
Uterine leiomyosarcoma 34.65 13.63 7 55304 14 63433697
Pain 34.15 13.63 448 54863 740180 62693531
Dyspnoea exertional 33.54 13.63 6 55305 60296 63373415
Oedema 33.34 13.63 22 55289 97600 63336111
Hypertension 33.22 13.63 128 55183 279175 63154536
Paraparesis 33.18 13.63 22 55289 2226 63431485
Flatulence 33.13 13.63 85 55226 34617 63399094
Thyroid cancer 33.02 13.63 32 55279 5579 63428132
Prolonged labour 33.01 13.63 14 55297 566 63433145
Ankle fracture 32.59 13.63 57 55254 17798 63415913
Head injury 32.50 13.63 73 55238 27323 63406388
Motor dysfunction 31.88 13.63 43 55268 10718 63422993
Mental disorder 31.80 13.63 70 55241 25849 63407862
Blindness 31.76 13.63 63 55248 21636 63412075
Myelitis 31.64 13.63 18 55293 1385 63432326
Hypoglycaemia 31.27 13.63 7 55304 60058 63373653
Hypoxia 31.06 13.63 7 55304 59785 63373926
Ataxia 31.04 13.63 51 55260 15144 63418567
Depressed level of consciousness 30.81 13.63 8 55303 62070 63371641
Mobility decreased 30.31 13.63 195 55116 120964 63312747
Intraductal proliferative breast lesion 30.02 13.63 23 55288 2922 63430789
Urosepsis 29.83 13.63 56 55255 18468 63415243
Visual impairment 29.77 13.63 149 55162 84297 63349414
International normalised ratio increased 29.65 13.63 3 55308 46422 63387289
Blood pressure fluctuation 29.57 13.63 3 55308 46314 63387397
Therapy cessation 29.49 13.63 75 55236 30382 63403329
Cervix carcinoma 29.39 13.63 23 55288 3014 63430697
Appendicitis 29.27 13.63 36 55275 8193 63425518
Cardio-respiratory arrest 29.24 13.63 8 55303 59951 63373760
Fibromyalgia 29.01 13.63 17 55294 80403 63353308
Multiple organ dysfunction syndrome 28.77 13.63 7 55304 56745 63376966
CD8 lymphocytes decreased 28.22 13.63 9 55302 159 63433552
Hysterectomy 28.21 13.63 38 55273 9461 63424250
Hypokalaemia 27.36 13.63 30 55281 103774 63329937
Death 27.33 13.63 468 54843 373913 63059798
Breast cancer female 27.01 13.63 45 55266 13514 63420197
C-reactive protein abnormal 26.94 13.63 4 55307 46092 63387619
Bladder disorder 26.89 13.63 36 55275 8910 63424801
Cardiac failure 26.70 13.63 23 55288 89119 63344592
Coronavirus infection 26.31 13.63 25 55286 4253 63429458
Wrong technique in product usage process 25.76 13.63 11 55300 62329 63371382
Blood pressure systolic increased 25.75 13.63 5 55306 47392 63386319
Electrocardiogram QT prolonged 25.42 13.63 10 55301 59520 63374191
Myelitis transverse 25.32 13.63 15 55296 1245 63432466
Neoplasm malignant 25.32 13.63 70 55241 29791 63403920
Pyrexia 25.29 13.63 275 55036 470203 62963508
Lower respiratory tract infection 25.26 13.63 48 55263 132259 63301452
Ascites 25.08 13.63 3 55308 40725 63392986
Lower limb fracture 24.87 13.63 61 55250 24160 63409551
Neuropathy peripheral 24.66 13.63 38 55273 113629 63320082
Dysstasia 24.66 13.63 56 55255 21110 63412601
Asthenia 24.64 13.63 470 54841 383134 63050577
Herpes zoster meningomyelitis 24.19 13.63 4 55307 0 63433711
Folliculitis 23.80 13.63 16 55295 70301 63363410
Asthma 23.72 13.63 47 55264 127514 63306197
Eosinophilic cellulitis 23.72 13.63 6 55305 43 63433668
Influenza like illness 23.62 13.63 118 55193 66706 63367005
Feeding disorder 23.54 13.63 42 55269 13320 63420391
Hypersensitivity 23.23 13.63 371 54940 292314 63141397
Gallbladder operation 23.23 13.63 18 55293 2325 63431386
Lactic acidosis 23.14 13.63 3 55308 38284 63395427
Gastrointestinal haemorrhage 23.05 13.63 22 55289 81154 63352557
Injury 23.05 13.63 18 55293 73229 63360482
Gastrointestinal pain 22.99 13.63 35 55276 9741 63423970
Liver injury 22.98 13.63 12 55299 60508 63373203
Weight increased 22.53 13.63 134 55177 260658 63173053
Accident 22.45 13.63 27 55284 6005 63427706
Glioblastoma 22.34 13.63 12 55299 825 63432886
Urinary incontinence 22.32 13.63 70 55241 31944 63401767
Blister 22.32 13.63 50 55261 129764 63303947
Cervical spinal stenosis 21.97 13.63 17 55294 2191 63431520
Muscle tightness 21.73 13.63 38 55273 11862 63421849
Concussion 21.60 13.63 33 55278 9211 63424500
Invasive lobular breast carcinoma 21.59 13.63 12 55299 883 63432828
Injection site bruising 21.58 13.63 5 55306 41905 63391806
Diplopia 21.50 13.63 57 55254 23671 63410040
Hepatic enzyme increased 21.39 13.63 97 55214 202231 63231480
Sedation 21.28 13.63 4 55307 38805 63394906
Decubitus ulcer 21.07 13.63 35 55276 10485 63423226
Psoriasis 20.92 13.63 27 55284 86930 63346781
Tachycardia 20.73 13.63 45 55266 118111 63315600
Miliaria 20.51 13.63 13 55298 1218 63432493
Renal failure 20.48 13.63 45 55266 117607 63316104
Sleep disorder due to general medical condition, insomnia type 20.35 13.63 10 55301 52207 63381504
Gastric bypass 20.32 13.63 15 55296 1802 63431909
Pancreatic failure 20.31 13.63 12 55299 991 63432720
Respiratory failure 20.29 13.63 36 55275 101822 63331889
COVID-19 20.22 13.63 168 55143 112935 63320776
Cervical dysplasia 20.18 13.63 19 55292 3195 63430516
Bradycardia 19.48 13.63 21 55290 73206 63360505
Psoriatic arthropathy 19.47 13.63 31 55280 91489 63342222
Rhabdomyolysis 19.40 13.63 7 55304 43944 63389767
Muscle injury 19.40 13.63 17 55294 65328 63368383
Road traffic accident 19.33 13.63 73 55238 36559 63397152
Peripheral swelling 19.27 13.63 144 55167 265798 63167913
T-lymphocyte count decreased 19.23 13.63 8 55303 308 63433403
Therapy interrupted 19.09 13.63 67 55244 32388 63401323
Blood cholesterol increased 18.94 13.63 33 55278 93999 63339712
Musculoskeletal pain 18.94 13.63 32 55279 92245 63341466
Meningioma 18.92 13.63 20 55291 3865 63429846
Primary progressive multiple sclerosis 18.71 13.63 6 55305 108 63433603
Upper limb fracture 18.66 13.63 47 55264 18921 63414790
Noninfectious myelitis 18.65 13.63 4 55307 12 63433699
Facial spasm 18.60 13.63 10 55301 689 63433022
Pneumonitis 18.54 13.63 4 55307 35218 63398493
Nephrolithiasis 18.43 13.63 79 55232 41905 63391806
Inflammation 18.33 13.63 27 55284 82246 63351465
Dysphagia 18.26 13.63 136 55175 88449 63345262
Herpes simplex encephalitis 18.25 13.63 8 55303 351 63433360
Foetal heart rate increased 18.14 13.63 3 55308 0 63433711
Abortion 18.11 13.63 16 55295 2480 63431231
Limb discomfort 18.05 13.63 62 55249 29654 63404057
Needle fatigue 18.02 13.63 6 55305 122 63433589
Pulmonary hypertension 18.01 13.63 5 55306 37118 63396593
Appendicitis perforated 18.01 13.63 14 55297 1816 63431895
Feeling abnormal 17.93 13.63 203 55108 148189 63285522
Tibia fracture 17.57 13.63 22 55289 5098 63428613
Human papilloma virus test positive 17.50 13.63 9 55302 566 63433145
Impaired healing 17.22 13.63 40 55271 102502 63331209
Expanded disability status scale score increased 17.19 13.63 9 55302 587 63433124
Bronchitis 17.02 13.63 54 55257 124881 63308830
Hepatic failure 16.94 13.63 5 55306 35651 63398060
Gait spastic 16.65 13.63 7 55304 277 63433434
Genital hypoaesthesia 16.57 13.63 4 55307 23 63433688
Dermatitis allergic 16.46 13.63 39 55272 15109 63418602
Injection site reaction 16.45 13.63 16 55295 58508 63375203
Skin warm 16.40 13.63 22 55289 5454 63428257
Blood pressure increased 16.35 13.63 79 55232 161983 63271728
Hyperglycaemia 16.34 13.63 8 55303 41859 63391852
Medication error 16.26 13.63 13 55298 52271 63381440
Cholestasis 16.21 13.63 3 55308 29431 63404280
Overdose 16.20 13.63 49 55262 115029 63318682
Hepatotoxicity 16.18 13.63 6 55305 37035 63396676
Malignant neoplasm of unknown primary site 16.17 13.63 7 55304 298 63433413
Neurogenic bladder 16.15 13.63 17 55294 3268 63430443
Nasal sinus cancer 16.02 13.63 4 55307 27 63433684
Lymphocyte percentage abnormal 16.02 13.63 4 55307 27 63433684
Mental impairment 16.00 13.63 37 55274 14114 63419597
Accidental exposure to product by child 15.99 13.63 11 55300 1182 63432529
Anal incontinence 15.91 13.63 36 55275 13540 63420171
Hypocalcaemia 15.90 13.63 4 55307 31709 63402002
Uterine cancer 15.71 13.63 20 55291 4713 63428998
Therapeutic product effect incomplete 15.70 13.63 56 55255 125000 63308711
Cardiac arrest 15.62 13.63 36 55275 92509 63341202
Drug reaction with eosinophilia and systemic symptoms 15.61 13.63 5 55306 33831 63399880
Metabolic acidosis 15.59 13.63 10 55301 45059 63388652
Intentional product use issue 15.58 13.63 58 55253 127834 63305877
Pulmonary oedema 15.43 13.63 15 55296 54858 63378853
Hypervolaemia 15.43 13.63 3 55308 28410 63405301
Squamous cell carcinoma of the vulva 15.43 13.63 4 55307 32 63433679
Osteoarthritis 15.36 13.63 38 55273 95305 63338406
Vertigo 15.35 13.63 97 55214 59790 63373921
Somnolence 15.32 13.63 92 55219 178593 63255118
Bipolar disorder 15.30 13.63 26 55285 7934 63425777
Partial seizures 15.30 13.63 22 55289 5820 63427891
Paraplegia 15.28 13.63 15 55296 2657 63431054
Hospitalisation 15.26 13.63 32 55279 85049 63348662
Adenocarcinoma of the cervix 15.13 13.63 6 55305 204 63433507
Nasopharyngitis 15.12 13.63 145 55166 254112 63179599
Incorrect dose administered 15.07 13.63 18 55293 59950 63373761
Mouth ulceration 15.00 13.63 5 55306 32979 63400732
Pyramidal tract syndrome 15.00 13.63 7 55304 356 63433355
Melaena 14.90 13.63 4 55307 30361 63403350
Joint stiffness 14.89 13.63 9 55302 41860 63391851
Protein S increased 14.85 13.63 3 55308 6 63433705
Premature delivery 14.84 13.63 4 55307 30277 63403434
Inappropriate schedule of product administration 14.83 13.63 44 55267 103921 63329790
Cardiac failure congestive 14.77 13.63 37 55274 92396 63341315
Platelet count decreased 14.58 13.63 52 55259 116070 63317641
Speech disorder 14.53 13.63 72 55239 40557 63393154
Decreased interest 14.53 13.63 16 55295 3238 63430473
Chronic kidney disease 14.48 13.63 11 55300 45387 63388324
Alopecia 14.27 13.63 390 54921 337146 63096565
Epistaxis 14.21 13.63 26 55285 72699 63361012
Malignant melanoma stage I 14.20 13.63 4 55307 45 63433666
Bone pain 14.17 13.63 16 55295 54625 63379086
Appendicectomy 14.08 13.63 15 55296 2924 63430787
Foetal heart rate abnormal 13.90 13.63 8 55303 629 63433082
Macular oedema 13.85 13.63 17 55294 3860 63429851
Pneumonia 13.85 13.63 298 55013 456469 62977242
Musculoskeletal stiffness 13.83 13.63 99 55212 184519 63249192
Aphasia 13.65 13.63 61 55250 32939 63400772

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 1760.54 20.86 494 13600 12639 34930198
Flushing 1151.70 20.86 447 13647 31973 34910864
Prescribed underdose 232.99 20.86 99 13995 8834 34934003
Central nervous system lesion 214.07 20.86 85 14009 6378 34936459
Lymphopenia 195.46 20.86 106 13988 16229 34926608
Lymphocyte count decreased 178.39 20.86 112 13982 22510 34920327
Relapsing-remitting multiple sclerosis 174.86 20.86 47 14047 1003 34941834
Balance disorder 170.80 20.86 137 13957 40517 34902320
Fall 170.74 20.86 298 13796 202587 34740250
Memory impairment 163.16 20.86 137 13957 43181 34899656
Muscle spasticity 142.78 20.86 62 14032 5826 34937011
Gait spastic 136.23 20.86 39 14055 1057 34941780
Needle fatigue 130.67 20.86 36 14058 845 34941992
General symptom 130.55 20.86 36 14058 848 34941989
Gait disturbance 122.72 20.86 161 13933 84979 34857858
Hypertonic bladder 111.88 20.86 38 14056 1826 34941011
Gastric disorder 111.82 20.86 67 14027 12374 34930463
Multiple sclerosis 107.96 20.86 53 14041 6592 34936245
Urinary tract infection 98.61 20.86 144 13950 83937 34858900
Monoparesis 96 20.86 36 14058 2310 34940527
Abdominal discomfort 93.76 20.86 118 13976 59717 34883120
Ataxia 85.77 20.86 59 14035 13794 34929043
Acute kidney injury 81.19 20.86 13 14081 304975 34637862
Hypoaesthesia 79.01 20.86 110 13984 61334 34881503
Gastrointestinal disorder 78.65 20.86 82 14012 33866 34908971
Hot flush 73.90 20.86 60 14034 18006 34924831
Micturition urgency 71.55 20.86 40 14054 6485 34936352
Product dose omission issue 68.72 20.86 150 13944 119561 34823276
Toxicity to various agents 68.12 20.86 3 14091 200359 34742478
Loss of control of legs 64.60 20.86 20 14074 713 34942124
Magnetic resonance imaging abnormal 62.66 20.86 24 14070 1632 34941205
Abdominal pain upper 62.39 20.86 107 13987 71383 34871454
Anaemia 59.71 20.86 11 14083 233324 34709513
Mobility decreased 59.66 20.86 67 14027 30061 34912776
Movement disorder 59.43 20.86 45 14049 12203 34930634
Underdose 56.85 20.86 46 14048 13734 34929103
Muscular weakness 55.75 20.86 103 13991 72794 34870043
Progressive multiple sclerosis 54.27 20.86 14 14080 253 34942584
Intentional underdose 53.75 20.86 17 14077 651 34942186
Paraesthesia 53.31 20.86 94 14000 64078 34878759
CD8 lymphocytes decreased 52.40 20.86 11 14083 75 34942762
Seizure 51.95 20.86 124 13970 104733 34838104
Pollakiuria 51.90 20.86 51 14043 19623 34923214
Cognitive disorder 47.15 20.86 58 14036 28635 34914202
Off label use 46.35 20.86 61 14033 419463 34523374
Nocturia 46.22 20.86 36 14058 10174 34932663
Hypotension 46.03 20.86 16 14078 221633 34721204
Dysarthria 45.76 20.86 63 14031 34719 34908118
Herpes zoster 44.80 20.86 62 14032 34337 34908500
Musculoskeletal disorder 42.16 20.86 28 14066 6176 34936661
Gait inability 40.81 20.86 46 14048 20712 34922125
Lymphocyte count abnormal 40.50 20.86 16 14078 1182 34941655
Adverse reaction 39.96 20.86 21 14073 3010 34939827
T-lymphocyte count decreased 37.66 20.86 10 14084 203 34942634
Erectile dysfunction 37.65 20.86 44 14050 20593 34922244
Thrombocytopenia 36.59 20.86 9 14085 156238 34786599
Neutropenia 33.07 20.86 11 14083 156767 34786070
Road traffic accident 31.49 20.86 37 14057 17413 34925424
Optic neuritis 31.46 20.86 19 14075 3555 34939282
Haemoglobin decreased 30.20 20.86 6 14088 120766 34822071
Progressive multifocal leukoencephalopathy 28.94 20.86 27 14067 9737 34933100
Dyspnoea 28.70 20.86 69 14025 376713 34566124
Congenital supraventricular tachycardia 28.59 20.86 5 14089 10 34942827
Renal impairment 27.52 20.86 3 14091 94510 34848327
Secondary progressive multiple sclerosis 27.52 20.86 9 14085 384 34942453
Oedema peripheral 25.98 20.86 8 14086 119804 34823033
Anxiety 25.45 20.86 93 14001 99335 34843502
Treatment failure 25.02 20.86 57 14037 46640 34896197
Testicular seminoma (pure) stage I 24.81 20.86 5 14089 27 34942810
Drug intolerance 24.80 20.86 66 14028 59504 34883333
Hemiparesis 24.48 20.86 31 14063 15747 34927090
Insomnia 23.96 20.86 94 14000 103813 34839024
Hemianaesthesia 23.88 20.86 6 14088 97 34942740
Trigeminal neuralgia 23.60 20.86 11 14083 1218 34941619
Diarrhoea 23.49 20.86 250 13844 389662 34553175
Chromaturia 23.28 20.86 29 14065 14491 34928346
Band sensation 23.02 20.86 6 14088 113 34942724
Urosepsis 22.86 20.86 27 14067 12772 34930065
Pleural effusion 22.73 20.86 3 14091 81543 34861294
Product dose omission in error 22.40 20.86 13 14081 2261 34940576
Congenital coronary artery malformation 21.28 20.86 5 14089 60 34942777
Feeling hot 20.96 20.86 32 14062 19340 34923497
Nausea 20.95 20.86 219 13875 339689 34603148
Multiple organ dysfunction syndrome 20.90 20.86 3 14091 76563 34866274
Hyponatraemia 20.89 20.86 4 14090 82687 34860150

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
Flushing 4276.12 15.09 1715 47718 86553 79608402
Multiple sclerosis relapse 3954.59 15.09 1367 48066 45166 79649789
Prescribed underdose 747.05 15.09 365 49068 29149 79665806
Lymphopenia 658.87 15.09 339 49094 30218 79664737
Lymphocyte count decreased 448.89 15.09 309 49124 46980 79647975
Central nervous system lesion 432.68 15.09 196 49237 13172 79681783
Abdominal pain upper 429.85 15.09 607 48826 223212 79471743
Fall 403.43 15.09 914 48519 486715 79208240
Hot flush 344.84 15.09 280 49153 54597 79640358
General symptom 280.05 15.09 91 49342 2443 79692512
Intentional underdose 270.19 15.09 87 49346 2267 79692688
Underdose 246.77 15.09 187 49246 32964 79661991
Memory impairment 230.48 15.09 314 49119 111420 79583535
Gait disturbance 227.04 15.09 437 48996 207069 79487886
Diarrhoea 226.29 15.09 1109 48324 879380 78815575
Balance disorder 219.48 15.09 288 49145 98569 79596386
Toxicity to various agents 219.32 15.09 10 49423 421530 79273425
Nausea 206.85 15.09 1149 48284 956047 78738908
Abortion spontaneous 196.86 15.09 156 49277 29351 79665604
Off label use 195.43 15.09 166 49267 907049 78787906
Multiple sclerosis 193.60 15.09 138 49295 22144 79672811
Acute kidney injury 179.60 15.09 50 49383 519354 79175601
Pruritus 178.82 15.09 594 48839 394054 79300901
Gastric disorder 178.16 15.09 163 49270 37270 79657685
Urinary tract infection 176.54 15.09 468 48965 274044 79420911
Hypoaesthesia 171.27 15.09 357 49076 178995 79515960
Loss of control of legs 171.19 15.09 59 49374 1906 79693049
Vomiting 165.78 15.09 832 48601 664996 79029959
Gastrointestinal disorder 160.91 15.09 279 49154 121926 79573029
Relapsing-remitting multiple sclerosis 157.56 15.09 52 49381 1467 79693488
Drug interaction 155.06 15.09 34 49399 415149 79279806
Product dose omission issue 143.13 15.09 406 49027 247131 79447824
Muscle spasticity 139.95 15.09 112 49321 21363 79673592
Invasive ductal breast carcinoma 137.47 15.09 69 49364 5823 79689132
Magnetic resonance imaging abnormal 135.44 15.09 58 49375 3401 79691554
Maternal exposure during pregnancy 131.70 15.09 273 49160 136265 79558690
Burning sensation 130.34 15.09 171 49262 58461 79636494
Gait spastic 128.27 15.09 42 49391 1155 79693800
Needle fatigue 127.13 15.09 39 49394 863 79694092
Seizure 125.40 15.09 326 49107 188508 79506447
Optic neuritis 121.62 15.09 75 49358 9445 79685510
Condition aggravated 121.30 15.09 81 49352 501043 79193912
Breast cancer 119.38 15.09 125 49308 33656 79661299
Paraesthesia 114.61 15.09 302 49131 176021 79518934
Abdominal discomfort 107.68 15.09 371 49062 250356 79444599
Anaemia 107.57 15.09 72 49361 444943 79250012
Hypotension 106.76 15.09 71 49362 440246 79254709
Infusion related reaction 98.75 15.09 13 49420 230224 79464731
Rheumatoid arthritis 96.40 15.09 9 49424 208461 79486494
Herpes zoster 93.12 15.09 189 49244 92894 79602061
Micturition urgency 91.16 15.09 70 49363 12571 79682384
White blood cell count decreased 89.14 15.09 288 49145 188000 79506955
Drug hypersensitivity 87.31 15.09 38 49395 298878 79396077
Completed suicide 86.03 15.09 23 49410 245744 79449211
Pancytopenia 85.86 15.09 4 49429 165741 79529214
Lymphocyte count abnormal 85.66 15.09 33 49400 1470 79693485
Urticaria 85.61 15.09 281 49152 184920 79510035
Muscular weakness 85.46 15.09 256 49177 160473 79534482
Product use issue 85.00 15.09 14 49419 209808 79485147
Hypertonic bladder 80.20 15.09 43 49390 4158 79690797
Blood creatinine increased 79.49 15.09 4 49429 155053 79539902
Dyspnoea 79.22 15.09 270 49163 856755 78838200
Gait inability 76.81 15.09 134 49299 58783 79636172
Thrombocytopenia 73.92 15.09 36 49397 265223 79429732
Neutropenia 71.56 15.09 45 49388 287665 79407290
Malignant neoplasm progression 71.36 15.09 3 49430 135987 79558968
Monoparesis 70.02 15.09 37 49396 3474 79691481
Feeling hot 69.12 15.09 129 49304 59605 79635350
Progressive multifocal leukoencephalopathy 68.82 15.09 74 49359 20526 79674429
Hemianaesthesia 68.69 15.09 21 49412 459 79694496
Ataxia 68.40 15.09 81 49352 24958 79669997
Dyspepsia 67.37 15.09 183 49250 108504 79586451
Secondary progressive multiple sclerosis 66.75 15.09 27 49406 1370 79693585
Haemoglobin decreased 63.64 15.09 29 49404 222090 79472865
Drug abuse 63.39 15.09 12 49421 162679 79532276
Oedema peripheral 63.37 15.09 39 49394 252249 79442706
Progressive multiple sclerosis 63.28 15.09 25 49408 1192 79693763
Musculoskeletal disorder 62.96 15.09 72 49361 21376 79673579
Renal impairment 62.85 15.09 11 49422 157772 79537183
General physical health deterioration 59.40 15.09 50 49383 275188 79419767
Caesarean section 58.48 15.09 54 49379 12481 79682474
Injection site pain 56.45 15.09 7 49426 129831 79565124
Hyponatraemia 56.19 15.09 20 49413 177828 79517127
Oxygen saturation decreased 56.00 15.09 7 49426 129040 79565915
Hyperkalaemia 55.46 15.09 4 49429 114394 79580561
Hip fracture 55.27 15.09 81 49352 30680 79664275
Abdominal pain 54.81 15.09 421 49012 389148 79305807
Pollakiuria 54.10 15.09 89 49344 37228 79657727
Skin burning sensation 53.98 15.09 53 49380 13219 79681736
Multiple organ dysfunction syndrome 53.47 15.09 6 49427 120240 79574715
Mobility decreased 53.42 15.09 182 49251 121993 79572962
Product use in unapproved indication 53.38 15.09 46 49387 250313 79444642
Cough 53.23 15.09 91 49342 366698 79328257
Disease progression 52.91 15.09 24 49409 184338 79510617
Trigeminal neuralgia 52.74 15.09 31 49402 3578 79691377
CD8 lymphocytes decreased 52.66 15.09 15 49418 254 79694701
Decreased immune responsiveness 52.42 15.09 36 49397 5439 79689516
Muscle spasms 51.67 15.09 230 49203 174500 79520455
Ankle fracture 49.86 15.09 57 49376 16912 79678043
Hand deformity 49.34 15.09 4 49429 103915 79591040
Stress 48.28 15.09 133 49300 79479 79615476
Arthralgia 47.52 15.09 188 49245 571615 79123340
Band sensation 47.42 15.09 18 49415 770 79694185
Glossodynia 46.34 15.09 5 49428 103332 79591623
CD4 lymphocytes decreased 44.85 15.09 25 49408 2609 79692346
Peroneal nerve palsy 44.75 15.09 34 49399 6008 79688947
Malignant melanoma 44.14 15.09 50 49383 14691 79680264
JC polyomavirus test positive 44.08 15.09 21 49412 1581 79693374
Alopecia 43.77 15.09 269 49164 231086 79463869
Hypersensitivity 42.94 15.09 294 49139 261945 79433010
T-lymphocyte count decreased 41.66 15.09 15 49418 552 79694403
Sensory disturbance 41.55 15.09 49 49384 15028 79679927
Pleural effusion 41.54 15.09 19 49414 145243 79549712
Gastrointestinal haemorrhage 41.19 15.09 20 49413 147699 79547256
Loss of personal independence in daily activities 41.18 15.09 7 49426 102573 79592382
Cognitive disorder 40.60 15.09 115 49318 69811 79625144
Prolonged labour 40.56 15.09 14 49419 454 79694501
Joint swelling 39.71 15.09 74 49359 288572 79406383
Product dose omission in error 39.17 15.09 35 49398 7753 79687202
International normalised ratio increased 38.24 15.09 4 49429 84717 79610238
Cardiac failure 37.40 15.09 25 49408 154817 79540138
Rhabdomyolysis 37.32 15.09 9 49424 103122 79591833
Papillary thyroid cancer 37.23 15.09 22 49411 2564 79692391
Flatulence 37.19 15.09 82 49351 42642 79652313
Road traffic accident 37.10 15.09 83 49350 43581 79651374
Wheezing 37.05 15.09 13 49420 116651 79578304
Ophthalmic herpes zoster 36.47 15.09 22 49411 2662 79692293
Renal failure 35.91 15.09 43 49390 200925 79494030
Productive cough 35.51 15.09 6 49427 88325 79606630
Hypoxia 35.47 15.09 10 49423 103233 79591722
Pemphigus 35.43 15.09 9 49424 99573 79595382
Head injury 35.14 15.09 74 49359 37295 79657660
Wound 35.12 15.09 14 49419 116165 79578790
Abdominal distension 34.97 15.09 157 49276 119493 79575462
Arthropathy 34.83 15.09 35 49398 177076 79517879
Dyspnoea exertional 34.82 15.09 6 49427 87067 79607888
Contraindicated product administered 34.73 15.09 28 49405 157510 79537445
Injection site erythema 34.52 15.09 4 49429 78193 79616762
Urosepsis 34.18 15.09 60 49373 26435 79668520
Headache 33.86 15.09 581 48852 653191 79041764
Myelitis 33.53 15.09 20 49413 2371 79692584
Ascites 33.02 15.09 4 49429 75558 79619397
Cardio-respiratory arrest 32.93 15.09 13 49420 108497 79586458
Hypoglycaemia 32.81 15.09 11 49422 101583 79593372
Intraductal proliferative breast lesion 32.77 15.09 20 49413 2471 79692484
Uterine leiomyosarcoma 32.44 15.09 6 49427 10 79694945
Respiratory failure 32.01 15.09 39 49394 180872 79514083
Thyroid cancer 31.91 15.09 27 49406 5561 79689394
Paraparesis 31.75 15.09 23 49410 3780 79691175
Synovitis 31.74 15.09 28 49405 150706 79544249
Platelet count decreased 31.34 15.09 45 49388 194619 79500336
Nasal congestion 31.22 15.09 5 49428 76547 79618408
Exposure during pregnancy 30.88 15.09 12 49421 101120 79593835
Oedema 30.68 15.09 18 49415 119562 79575393
Blood pressure systolic increased 30.66 15.09 3 49430 66983 79627972
Electrocardiogram QT prolonged 30.59 15.09 9 49424 90377 79604578
Depressed level of consciousness 30.29 15.09 11 49422 96641 79598314
Agraphia 30.06 15.09 7 49426 50 79694905
Stomatitis 30.02 15.09 28 49405 146729 79548226
Dehydration 29.86 15.09 259 49174 247928 79447027
Dysstasia 29.72 15.09 58 49375 27688 79667267
C-reactive protein increased 29.62 15.09 22 49411 129005 79565950
Decubitus ulcer 29.18 15.09 42 49391 15645 79679310
Chromaturia 29.03 15.09 55 49378 25691 79669264
Hemiparesis 28.52 15.09 64 49369 33669 79661286
Visual impairment 28.52 15.09 123 49310 92008 79602947
Erythema 28.44 15.09 236 49197 223054 79471901
Invasive lobular breast carcinoma 28.09 15.09 12 49421 699 79694256
Major depression 27.81 15.09 31 49402 8949 79686006
Systemic lupus erythematosus 27.37 15.09 21 49412 121128 79573827
Pyrexia 27.33 15.09 279 49154 678430 79016525
Dysarthria 27.18 15.09 98 49335 67524 79627431
Anti-cyclic citrullinated peptide antibody positive 26.85 15.09 9 49424 83134 79611821
Discomfort 26.85 15.09 23 49410 125594 79569361
Rheumatoid factor positive 26.56 15.09 3 49430 59836 79635119
Cardiac arrest 26.52 15.09 41 49392 172055 79522900
Cystitis 26.13 15.09 82 49351 52650 79642305
Decreased interest 25.62 15.09 20 49413 3677 79691278
Bladder disorder 25.61 15.09 30 49403 9135 79685820
Eosinophilic cellulitis 25.55 15.09 7 49426 102 79694853
Gastrointestinal pain 25.47 15.09 31 49402 9824 79685131
Erectile dysfunction 25.45 15.09 38 49395 14626 79680329
Depression 25.43 15.09 225 49208 216565 79478390
Motor dysfunction 25.32 15.09 38 49395 14695 79680260
Death 25.28 15.09 492 48941 566022 79128933
Insomnia 25.03 15.09 247 49186 244923 79450032
Metabolic acidosis 24.85 15.09 10 49423 82519 79612436
Pneumonitis 24.76 15.09 4 49429 60856 79634099
Muscle tightness 24.65 15.09 35 49398 12879 79682076
Nocturia 24.53 15.09 36 49397 13645 79681310
Septic shock 24.45 15.09 24 49409 122777 79572178
Cervix carcinoma 24.42 15.09 16 49417 2237 79692718
Therapeutic product effect decreased 24.34 15.09 40 49393 163823 79531132
Lower limb fracture 24.22 15.09 48 49385 23167 79671788
Feeding disorder 23.87 15.09 39 49394 16215 79678740
Gallbladder operation 23.60 15.09 15 49418 1990 79692965
Therapy non-responder 23.53 15.09 14 49419 92291 79602664
Hypokalaemia 23.47 15.09 33 49400 144007 79550948
Pulmonary oedema 23.04 15.09 13 49420 88241 79606714
Cardiac failure congestive 22.84 15.09 33 49400 142369 79552586
Somnolence 22.83 15.09 74 49359 238907 79456048
Tachycardia 22.35 15.09 48 49385 177720 79517235
Product administered to patient of inappropriate age 22.25 15.09 22 49411 5531 79689424
Overdose 22.12 15.09 51 49382 184155 79510800
Hyperglycaemia 22.05 15.09 8 49425 70327 79624628
Asthenia 21.67 15.09 441 48992 511248 79183707
Chronic kidney disease 21.65 15.09 7 49426 66147 79628808
Neutrophil count decreased 21.59 15.09 16 49417 93943 79601012
Cervical spinal stenosis 21.38 15.09 15 49418 2344 79692611
Pericarditis 21.18 15.09 20 49413 104216 79590739
Movement disorder 21.15 15.09 50 49383 27209 79667746
Temperature intolerance 21.08 15.09 28 49405 9677 79685278
Tibia fracture 21.04 15.09 21 49412 5340 79689615
Limb discomfort 21.03 15.09 56 49377 32794 79662161
Glioblastoma 21.00 15.09 13 49420 1647 79693308
Hypocalcaemia 20.95 15.09 3 49430 49921 79645034
Hepatic failure 20.89 15.09 6 49427 61206 79633749
Epistaxis 20.84 15.09 23 49410 111492 79583463
Drug reaction with eosinophilia and systemic symptoms 20.67 15.09 7 49426 64237 79630718
Accidental exposure to product by child 20.65 15.09 16 49417 2910 79692045
Inappropriate schedule of product administration 20.43 15.09 32 49401 133596 79561359
Abortion 20.31 15.09 12 49421 1398 79693557
Cervical dysplasia 20.20 15.09 14 49419 2147 79692808
Sedation 19.84 15.09 4 49429 51891 79643064
Treatment failure 19.83 15.09 48 49385 170438 79524517
Hypertension 19.83 15.09 122 49311 330870 79364085
Koebner phenomenon 19.80 15.09 5 49428 52 79694903
Gastroenteritis viral 19.76 15.09 46 49387 24785 79670170
Neuropathy peripheral 19.61 15.09 36 49397 141269 79553686
Relapsing multiple sclerosis 19.42 15.09 6 49427 136 79694819
Lung cancer metastatic 19.35 15.09 17 49416 3682 79691273
Depressed mood 19.26 15.09 70 49363 48410 79646545
Expanded disability status scale score increased 19.22 15.09 9 49424 652 79694303
Anti-myelin-associated glycoprotein antibodies positive 19.16 15.09 3 49430 0 79694955
Helicobacter duodenitis 19.16 15.09 3 49430 0 79694955
Therapy cessation 19.15 15.09 59 49374 37503 79657452
Miliaria 19.01 15.09 12 49421 1574 79693381
Malignant melanoma stage I 18.98 15.09 6 49427 147 79694808
Pancreatic failure 18.72 15.09 12 49421 1616 79693339
Delirium 18.69 15.09 15 49418 84612 79610343
Dizziness 18.57 15.09 442 48991 525999 79168956
Gastric bypass 18.55 15.09 11 49422 1290 79693665
Concussion 18.50 15.09 26 49407 9477 79685478
Blood pressure increased 18.46 15.09 68 49365 211292 79483663
Accident 18.45 15.09 25 49408 8806 79686149
Duodenal ulcer perforation 18.40 15.09 9 49424 66202 79628753
Hysterectomy 18.31 15.09 21 49412 6251 79688704
Noninfectious myelitis 18.23 15.09 4 49429 21 79694934
Haemoptysis 18.19 15.09 6 49427 55993 79638962
Agitation 18.16 15.09 21 49412 99694 79595261
Product prescribing error 18.11 15.09 3 49430 44810 79650145
Vision blurred 18.06 15.09 120 49313 105778 79589177
C-reactive protein abnormal 17.93 15.09 4 49429 48363 79646592
Testicular seminoma (pure) stage I 17.92 15.09 4 49429 23 79694932
Pulmonary hypertension 17.78 15.09 4 49429 48076 79646879
COVID-19 17.64 15.09 162 49271 157512 79537443
Fibromyalgia 17.50 15.09 9 49424 64331 79630624
Adverse reaction 17.42 15.09 25 49408 9289 79685666
Impaired self-care 17.38 15.09 14 49419 2693 79692262
Upper limb fracture 17.38 15.09 36 49397 17931 79677024
Herpes zoster meningomyelitis 17.37 15.09 4 49429 27 79694928
Respiratory arrest 17.28 15.09 7 49426 57543 79637412
Dermatitis allergic 17.16 15.09 36 49397 18094 79676861
Testicular neoplasm 17.08 15.09 3 49430 3 79694952
Hospitalisation 16.99 15.09 20 49413 94216 79600739
Pyramidal tract syndrome 16.96 15.09 8 49425 589 79694366
Blindness unilateral 16.93 15.09 23 49410 8123 79686832
Blood creatine phosphokinase increased 16.88 15.09 10 49423 66080 79628875
Myelitis transverse 16.77 15.09 12 49421 1935 79693020
Haematuria 16.77 15.09 11 49422 68825 79626130
Mental disorder 16.74 15.09 50 49383 31252 79663703
Tumefactive multiple sclerosis 16.63 15.09 5 49428 103 79694852
Red blood cell sedimentation rate increased 16.63 15.09 4 49429 45938 79649017
Vitamin D decreased 16.59 15.09 25 49408 9700 79685255
Cardiogenic shock 16.51 15.09 3 49430 41911 79653044
Unintentional use for unapproved indication 16.38 15.09 6 49427 232 79694723
Lymphocyte percentage abnormal 16.36 15.09 4 49429 36 79694919
Fatigue 16.34 15.09 718 48715 929009 78765946
Heavy menstrual bleeding 15.88 15.09 30 49403 13981 79680974
Squamous cell carcinoma of the vulva 15.87 15.09 3 49430 6 79694949
Melaena 15.85 15.09 9 49424 60881 79634074
Asthma 15.74 15.09 38 49395 135057 79559898
Acute respiratory distress syndrome 15.64 15.09 4 49429 44063 79650892
Diplopia 15.63 15.09 51 49382 33415 79661540
Neurogenic bladder 15.62 15.09 16 49417 4196 79690759
Herpes zoster oticus 15.60 15.09 7 49426 459 79694496
Urinary incontinence 15.35 15.09 58 49375 40851 79654104
Coronavirus infection 15.32 15.09 21 49412 7476 79687479
Coronary artery disease 15.24 15.09 11 49422 65463 79629492
Incorrect dose administered 15.22 15.09 15 49418 76615 79618340

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:76924 plant metabolites
CHEBI has role CHEBI:77746 Homo sapiens metabolite
CHEBI has role CHEBI:50748 antipsoriatic drug
CHEBI has role CHEBI:50846 Immunologic factor

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 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
120MG TECFIDERA BIOGEN INC N204063 March 27, 2013 RX CAPSULE, DELAYED RELEASE ORAL 11246850 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
240MG TECFIDERA BIOGEN INC 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)

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 0093-9218 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 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 28 sections
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 0378-0396 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 0378-0399 CAPSULE, DELAYED RELEASE 240 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 16729-416 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 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 24979-127 CAPSULE, DELAYED RELEASE 120 mg ORAL ANDA 18 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 24979-128 CAPSULE, DELAYED RELEASE 240 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 31722-657 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 31722-658 CAPSULE, DELAYED RELEASE 240 mg ORAL ANDA 26 sections
DIMETHYL FUMARATE HUMAN PRESCRIPTION DRUG LABEL 1 43547-024 CAPSULE, DELAYED RELEASE 120 mg ORAL ANDA 25 sections
DIMETHYL FUMARATE HUMAN PRESCRIPTION DRUG LABEL 1 43547-025 CAPSULE, DELAYED RELEASE 240 mg ORAL ANDA 25 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 43598-429 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 43598-430 CAPSULE, DELAYED RELEASE 240 mg ORAL ANDA 25 sections