teriflunomide 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definitionDrug idCAS RN
4634 163451-81-8

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • HMR1726
  • flucyamide
  • aubagio
  • teriflunomide
Teriflunomide, an immunomodulatory agent with anti-inflammatory properties, inhibits dihydroorotate dehydrogenase, a mitochondrial enzyme involved in de novo pyrimidine synthesis. The exact mechanism by which teriflunomide exerts its therapeutic effect in multiple sclerosis is unknown but may involve a reduction in the number of activated lymphocytes in CNS.
  • Molecular weight: 270.21
  • Formula: C12H9F3N2O2
  • CLOGP: 2.33
  • LIPINSKI: 0
  • HAC: 4
  • HDO: 2
  • TPSA: 73.12
  • ALOGS: -4.34
  • ROTB: 3

  • Status: OFP

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

Drug dosage:

DoseUnitRoute
14 mg O

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 4 Hosey CM, Chan R, Benet LZ
Vd (Volume of distribution) 0.16 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 0.01 mL/min/kg Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma) 0.01 % Lombardo F, Berellini G, Obach RS
t_half (Half-life) 350 hours Lombardo F, Berellini G, Obach RS

Approvals:

DateAgencyCompanyOrphan
Aug. 26, 2013 EMA
Sept. 12, 2012 FDA SANOFI AVENTIS US

FDA Adverse Event Reporting System (Female)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Multiple sclerosis relapse 3927.66 17.22 1312 30226 43591 56216938
Alopecia 1434.11 17.22 1233 30305 292225 55968304
Multiple sclerosis 1391.15 17.22 539 30999 27263 56233266
Paraesthesia 687.94 17.22 575 30963 129939 56130590
Hypoaesthesia 669.64 17.22 586 30952 140905 56119624
Product dose omission issue 660.81 17.22 686 30852 204067 56056462
Balance disorder 289.21 17.22 280 31258 76240 56184289
Diarrhoea 285.35 17.22 892 30646 637615 55622914
Gait disturbance 236.88 17.22 368 31170 162953 56097576
Fall 234.99 17.22 576 30962 356934 55903595
Product dose omission in error 221.79 17.22 86 31452 4328 56256201
Memory impairment 189.68 17.22 238 31300 86319 56174210
Bladder disorder 181.32 17.22 89 31449 7935 56252594
Rheumatoid arthritis 168.42 17.22 12 31526 382592 55877937
Off label use 155.44 17.22 59 31479 556121 55704408
Fatigue 155.42 17.22 857 30681 787695 55472834
Depressed mood 152.39 17.22 141 31397 36218 56224311
Depression 145.22 17.22 315 31223 179802 56080727
Muscle spasticity 132.59 17.22 101 31437 19859 56240670
COVID-19 128.49 17.22 183 31355 74875 56185654
Unevaluable event 127.20 17.22 145 31393 47542 56212987
Visual impairment 122.74 17.22 178 31360 74024 56186505
Optic neuritis 112.18 17.22 64 31474 7740 56252789
Mobility decreased 111.04 17.22 199 31339 98792 56161737
Muscular weakness 102.17 17.22 198 31340 104254 56156275
Sensory disturbance 100.31 17.22 71 31467 12472 56248057
Headache 95.50 17.22 586 30952 558458 55702071
Toxicity to various agents 93.29 17.22 9 31529 224555 56035974
Acute kidney injury 91.71 17.22 13 31525 240750 56019779
Contraindicated product administered 87.48 17.22 4 31534 186282 56074247
Limb discomfort 86.77 17.22 90 31448 26532 56233997
Central nervous system lesion 78.88 17.22 56 31482 9882 56250647
Cognitive disorder 75.64 17.22 114 31424 49019 56211510
Therapeutic product effect decreased 75.35 17.22 5 31533 169447 56091082
Synovitis 74.02 17.22 4 31534 161301 56099228
Maternal exposure during pregnancy 68.18 17.22 12 31526 189541 56070988
Throat clearing 67.02 17.22 27 31511 1503 56259026
Decreased interest 66.47 17.22 33 31505 3013 56257516
Drug hypersensitivity 66.04 17.22 36 31502 275169 55985360
JC polyomavirus test positive 65.72 17.22 25 31513 1193 56259336
Systemic lupus erythematosus 65.64 17.22 11 31527 180067 56080462
Joint swelling 65.17 17.22 41 31497 289759 55970770
Completed suicide 62.41 17.22 3 31535 133830 56126699
Burning sensation 61.21 17.22 103 31435 48593 56211936
Condition aggravated 60.85 17.22 365 31173 344533 55915996
Magnetic resonance imaging abnormal 53.66 17.22 28 31510 2838 56257691
Urinary incontinence 51.85 17.22 73 31465 29512 56231017
Hypotension 50.30 17.22 40 31498 250468 56010061
Pericarditis 49.04 17.22 3 31535 108920 56151609
Feeling abnormal 47.79 17.22 174 31364 133428 56127101
Anaemia 47.39 17.22 48 31490 267463 55993066
Micturition urgency 46.68 17.22 39 31499 8742 56251787
Secondary progressive multiple sclerosis 45.91 17.22 20 31518 1355 56259174
Death 45.35 17.22 76 31462 341350 55919179
Drug interaction 45.33 17.22 31 31507 209724 56050805
Wound 45.32 17.22 11 31527 138793 56121736
Electric shock sensation 45.08 17.22 15 31523 482 56260047
Muscle spasms 45.05 17.22 174 31364 137197 56123332
Overdose 44.56 17.22 4 31534 105826 56154703
Movement disorder 43.92 17.22 54 31484 19144 56241385
Illness 43.36 17.22 73 31465 34438 56226091
Injection site pain 43.01 17.22 7 31531 117111 56143418
Hyponatraemia 42.63 17.22 4 31534 102135 56158394
Peroneal nerve palsy 42.16 17.22 28 31510 4433 56256096
Lower respiratory tract infection 41.84 17.22 7 31531 114787 56145742
Stress 41.73 17.22 98 31440 58812 56201717
Arthropathy 41.43 17.22 31 31507 200244 56060285
Onychoclasis 40.96 17.22 30 31508 5555 56254974
Walking aid user 39.79 17.22 35 31503 8408 56252121
Pneumonia 39.57 17.22 108 31430 406990 55853539
Incontinence 38.08 17.22 38 31500 10697 56249832
Lymphopenia 38.08 17.22 47 31491 16727 56243802
Therapeutic product effect incomplete 37.48 17.22 7 31531 106024 56154505
Intentional product use issue 36.53 17.22 6 31532 99727 56160802
Dyspnoea 35.17 17.22 192 31346 592385 55668144
Paraparesis 34.59 17.22 19 31519 2134 56258395
Swelling 34.05 17.22 51 31487 239720 56020809
Vision blurred 32.19 17.22 111 31427 82832 56177697
Treatment failure 31.98 17.22 29 31509 170363 56090166
Temperature intolerance 31.40 17.22 30 31508 8010 56252519
Respiratory failure 30.13 17.22 8 31530 95054 56165475
Expanded disability status scale score increased 29.36 17.22 11 31527 503 56260026
Pancytopenia 29.01 17.22 7 31531 88708 56171821
Hair texture abnormal 28.75 17.22 21 31517 3871 56256658
Pain in extremity 28.59 17.22 273 31265 297158 55963371
General physical health deterioration 28.41 17.22 32 31506 169978 56090551
Progressive multiple sclerosis 28.18 17.22 12 31526 769 56259760
Breast cancer 28.03 17.22 75 31463 48758 56211771
Hypokalaemia 28.00 17.22 9 31529 94428 56166101
Spinal operation 27.88 17.22 27 31511 7329 56253200
Helicobacter infection 27.76 17.22 4 31534 73264 56187265
SARS-CoV-2 test positive 27.72 17.22 25 31513 6204 56254325
Haemoglobin decreased 27.42 17.22 21 31517 134116 56126413
Hypertension 26.92 17.22 231 31307 244047 56016482
Neuralgia 25.71 17.22 47 31491 23648 56236881
Oedema peripheral 25.71 17.22 35 31503 171219 56089310
Pleural effusion 25.60 17.22 8 31530 85472 56175057
Dizziness 25.45 17.22 322 31216 375818 55884711
Weight increased 25.36 17.22 57 31481 229646 56030883
Neutropenia 25.11 17.22 31 31507 158136 56102393
Cardiac failure congestive 24.89 17.22 9 31529 87711 56172818
Trigeminal neuralgia 24.30 17.22 18 31520 3389 56257140
Impaired driving ability 23.46 17.22 19 31519 4077 56256452
Intentional overdose 23.02 17.22 5 31533 68112 56192417
Drug intolerance 22.98 17.22 74 31464 264744 55995785
Surgery 22.95 17.22 54 31484 32432 56228097
Asthenia 22.93 17.22 293 31245 342680 55917849
Thrombocytopenia 22.36 17.22 26 31512 136198 56124331
Discomfort 22.27 17.22 28 31510 141733 56118796
Oedema 22.26 17.22 9 31529 81911 56178618
Blood pressure increased 22.00 17.22 148 31390 145028 56115501
Pyrexia 21.96 17.22 141 31397 418632 55841897
Heteroplasia 21.91 17.22 4 31534 7 56260522
Dysstasia 21.78 17.22 39 31499 19315 56241214
Exposure during pregnancy 21.27 17.22 140 31398 136202 56124327
Hypoglycaemia 21.25 17.22 3 31535 55812 56204717
Cardiac arrest 21.09 17.22 11 31527 86303 56174226
Needle fatigue 21.02 17.22 6 31532 114 56260415
Disease progression 20.82 17.22 17 31521 105156 56155373
Neuropathy peripheral 20.75 17.22 113 31425 102780 56157749
Renal failure 20.49 17.22 19 31519 110481 56150048
Lipase increased 20.12 17.22 25 31513 8954 56251575
Hemiparesis 20.08 17.22 40 31498 21450 56239079
Blood creatinine increased 19.92 17.22 10 31528 80181 56180348
Stomatitis 19.89 17.22 23 31515 120787 56139742
Therapy non-responder 19.75 17.22 5 31533 61350 56199179
Cerebral disorder 19.63 17.22 17 31521 3999 56256530
Oxygen saturation decreased 19.43 17.22 10 31528 79057 56181472
Pollakiuria 19.02 17.22 43 31495 25159 56235370
Band sensation 18.81 17.22 9 31529 758 56259771
Faeces soft 18.78 17.22 18 31520 4824 56255705
Hyperkalaemia 18.75 17.22 3 31535 50862 56209667
Psoriatic arthropathy 18.73 17.22 9 31529 73999 56186530
Paternal exposure timing unspecified 18.63 17.22 4 31534 21 56260508
Osteoarthritis 18.51 17.22 11 31527 80285 56180244
Arthralgia 18.42 17.22 186 31352 501483 55759046
Anal incontinence 18.16 17.22 28 31510 12270 56248259
Gastrointestinal haemorrhage 18.09 17.22 10 31528 75941 56184588
Speech disorder 18.01 17.22 54 31484 37439 56223090
Platelet count decreased 17.79 17.22 20 31518 106363 56154166
Drug effect less than expected 17.52 17.22 9 31529 883 56259646
Renal impairment 17.32 17.22 12 31526 80701 56179828
Infection 17.32 17.22 56 31482 200150 56060379
Migraine 17.28 17.22 95 31443 86702 56173827

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 1262.42 27.76 321 5970 11726 31679327
Multiple sclerosis 539.49 27.76 151 6140 7886 31683167
Alopecia 220.88 27.76 99 6192 20596 31670457
Product dose omission issue 185.70 27.76 159 6132 105427 31585626
Hypoaesthesia 135.85 27.76 102 6189 55920 31635133
Paraesthesia 118.25 27.76 94 6197 55977 31635076
Gait disturbance 116.60 27.76 107 6184 77388 31613665
Product dose omission in error 101.18 27.76 27 6264 1166 31689887
Fatigue 79.30 27.76 192 6099 335014 31356039
Balance disorder 75.11 27.76 61 6230 37361 31653692
Diarrhoea 69.97 27.76 189 6102 352220 31338833
Fall 67.44 27.76 127 6164 185962 31505091
Mobility decreased 59.84 27.76 47 6244 27422 31663631
Memory impairment 52.12 27.76 50 6241 38080 31652973
Headache 50.64 27.76 112 6179 183540 31507513
Visual impairment 50.47 27.76 45 6246 31234 31659819
Muscle spasticity 47.70 27.76 23 6268 5612 31685441
Depressed mood 40.27 27.76 31 6260 17544 31673509
Muscular weakness 36.07 27.76 54 6237 65394 31625659
Drug ineffective 35.91 27.76 164 6127 395409 31295644
Optic neuritis 35.67 27.76 16 6275 3314 31687739
Off label use 34.49 27.76 13 6278 347261 31343792
Feeling abnormal 34.25 27.76 49 6242 56953 31634100
Acute kidney injury 34.21 27.76 7 6284 279707 31411346
Unevaluable event 32.47 27.76 35 6256 30540 31660513
Trigeminal neuralgia 32.08 27.76 11 6280 1116 31689937
Walking aid user 31.65 27.76 12 6279 1624 31689429
Depression 31.54 27.76 61 6230 90754 31600299
Condition aggravated 30.33 27.76 86 6205 163923 31527130
Limb discomfort 30.09 27.76 21 6270 10228 31680825
Decreased interest 28.29 27.76 12 6279 2173 31688880
Hepatic enzyme increased 27.89 27.76 35 6256 35873 31655180

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 3787.94 18.31 1180 28724 41837 70856703
Alopecia 1528.58 18.31 980 28924 197510 70701030
Multiple sclerosis 1434.86 18.31 499 29405 24786 70873754
Hypoaesthesia 679.83 18.31 543 29361 153196 70745344
Paraesthesia 647.59 18.31 516 29388 145021 70753519
Product dose omission issue 537.82 18.31 554 29350 216914 70681626
Gait disturbance 328.55 18.31 397 29507 184709 70713831
Balance disorder 271.15 18.31 256 29648 89872 70808668
Diarrhoea 263.78 18.31 824 29080 782517 70116023
Fall 234.30 18.31 552 29352 443544 70454996
Fatigue 213.78 18.31 795 29109 823524 70075016
Memory impairment 205.12 18.31 223 29681 92418 70806122
Product dose omission in error 179.23 18.31 69 29835 4547 70893993
Headache 157.62 18.31 569 29335 579836 70318704
Unevaluable event 154.76 18.31 147 29757 51916 70846624
Off label use 151.91 18.31 62 29842 742998 70155542
Visual impairment 148.40 18.31 176 29728 80074 70818466
Bladder disorder 143.38 18.31 70 29834 8219 70890321
Acute kidney injury 136.92 18.31 19 29885 474605 70423935
Toxicity to various agents 129.50 18.31 8 29896 382164 70516376
Mobility decreased 126.89 18.31 185 29719 102814 70795726
Depressed mood 121.31 18.31 119 29785 43701 70854839
Depression 118.52 18.31 260 29644 198714 70699826
Optic neuritis 115.70 18.31 62 29842 8838 70889702
Muscular weakness 111.37 18.31 205 29699 138131 70760409
Muscle spasticity 109.64 18.31 80 29824 19609 70878931
Limb discomfort 106.09 18.31 93 29811 29612 70868928
Rheumatoid arthritis 88.14 18.31 10 29894 291795 70606745
COVID-19 87.97 18.31 159 29745 105598 70792942
Throat clearing 86.32 18.31 31 29873 1680 70896860
Sensory disturbance 85.74 18.31 60 29844 13772 70884768
Feeling abnormal 81.32 18.31 183 29721 142136 70756404
Central nervous system lesion 77.15 18.31 54 29850 12399 70886141
Completed suicide 76.14 18.31 5 29899 227130 70671410
Secondary progressive multiple sclerosis 73.63 18.31 26 29878 1341 70897199
Decreased interest 71.57 18.31 33 29871 3408 70895132
Hypotension 71.34 18.31 41 29863 404340 70494200
Drug interaction 69.71 18.31 37 29867 381404 70517136
Magnetic resonance imaging abnormal 64.42 18.31 30 29874 3170 70895370
Burning sensation 63.66 18.31 94 29810 52776 70845764
Anaemia 61.61 18.31 48 29856 403375 70495165
JC polyomavirus test positive 59.72 18.31 22 29882 1282 70897258
Pain in extremity 59.71 18.31 285 29619 327797 70570743
Muscle spasms 59.68 18.31 171 29733 153875 70744665
Cognitive disorder 58.96 18.31 98 29806 60858 70837682
Walking aid user 57.51 18.31 38 29866 7943 70890597
Condition aggravated 56.41 18.31 340 29564 427295 70471245
Urinary incontinence 54.02 18.31 73 29831 37769 70860771
Hyponatraemia 52.26 18.31 4 29900 160083 70738457
Trigeminal neuralgia 47.77 18.31 25 29879 3396 70895144
Electric shock sensation 46.52 18.31 15 29889 584 70897956
Pancytopenia 46.04 18.31 5 29899 151102 70747438
Drug hypersensitivity 45.69 18.31 27 29877 262432 70636108
Micturition urgency 45.65 18.31 38 29866 11276 70887264
Neutropenia 45.41 18.31 26 29878 257130 70641410
Stress 45.21 18.31 93 29811 67873 70830667
Death 44.34 18.31 93 29811 509968 70388572
Pneumonia 42.93 18.31 120 29784 596112 70302428
Contraindicated product administered 42.19 18.31 4 29900 134608 70763932
Overdose 41.95 18.31 10 29894 169735 70728805
Disease progression 41.22 18.31 8 29896 156664 70741876
Therapeutic product effect decreased 40.50 18.31 6 29898 143012 70755528
Band sensation 40.10 18.31 14 29890 698 70897842
Synovitis 40.08 18.31 4 29900 129224 70769316
Bradycardia 38.28 18.31 4 29900 124611 70773929
Injection site pain 38.21 18.31 3 29901 117616 70780924
Paraparesis 38.18 18.31 22 29882 3607 70894933
Pollakiuria 38.14 18.31 58 29846 33403 70865137
Pain 37.37 18.31 417 29487 628399 70270141
Impaired driving ability 37.13 18.31 24 29880 4833 70893707
Migraine 36.95 18.31 89 29815 72149 70826391
Peroneal nerve palsy 36.49 18.31 25 29879 5545 70892995
Movement disorder 35.13 18.31 47 29857 24082 70874458
Lymphopenia 34.89 18.31 50 29854 27309 70871231
Expanded disability status scale score increased 34.81 18.31 12 29892 576 70897964
Illness 34.68 18.31 54 29850 31737 70866803
Renal impairment 34.55 18.31 9 29895 143928 70754612
Haemoglobin decreased 34.45 18.31 22 29882 205137 70693403
Progressive multiple sclerosis 34.41 18.31 13 29891 813 70897727
Breast cancer 33.86 18.31 55 29849 33494 70865046
Treatment failure 32.77 18.31 10 29894 144132 70754408
Hair texture abnormal 32.72 18.31 19 29885 3161 70895379
Vision blurred 32.54 18.31 101 29803 94883 70803657
Temperature intolerance 32.53 18.31 28 29876 8695 70889845
Therapeutic product effect incomplete 31.79 18.31 6 29898 119876 70778664
Dyspnoea 31.58 18.31 193 29711 769867 70128673
Cardiac failure congestive 31.52 18.31 9 29895 135448 70763092
Asthenia 31.12 18.31 312 29592 457354 70441186
Thrombocytopenia 31.04 18.31 33 29871 239077 70659463
Heteroplasia 30.92 18.31 5 29899 4 70898536
Renal failure 30.76 18.31 21 29883 189049 70709491
Dysstasia 30.63 18.31 45 29859 25134 70873406
Blood creatinine increased 30.62 18.31 11 29893 142990 70755550
Maternal exposure during pregnancy 30.11 18.31 6 29898 115339 70783201
Platelet count decreased 30.07 18.31 19 29885 178203 70720337
Hypokalaemia 30.00 18.31 9 29895 131179 70767361
Nausea 29.77 18.31 514 29390 851574 70046966
Multiple organ dysfunction syndrome 29.71 18.31 5 29899 108510 70790030
Onychoclasis 29.45 18.31 21 29883 4963 70893577
Hypoglycaemia 29.05 18.31 3 29901 94361 70804179
Dizziness 28.99 18.31 311 29593 463830 70434710
Pleural effusion 28.82 18.31 10 29894 132854 70765686
Wheelchair user 28.60 18.31 21 29883 5193 70893347
Respiratory failure 28.45 18.31 18 29886 168717 70729823
Cardiac arrest 28.43 18.31 16 29888 159818 70738722
Hepatic enzyme increased 28.21 18.31 136 29768 156854 70741686
Incontinence 28.15 18.31 31 29873 12997 70885543
General physical health deterioration 28.01 18.31 35 29869 235996 70662544
Intentional product use issue 27.92 18.31 8 29896 120134 70778406
Neuralgia 27.66 18.31 46 29858 28557 70869983
Pyrexia 27.61 18.31 147 29757 606805 70291735
Abdominal discomfort 27.15 18.31 169 29735 214489 70684051
Rhabdomyolysis 27.15 18.31 4 29900 95756 70802784
Cardio-respiratory arrest 26.78 18.31 5 29899 100672 70797868
Sensory loss 26.12 18.31 28 29876 11391 70887149
Surgery 26.07 18.31 46 29858 29943 70868597
Cardiac failure 26.06 18.31 14 29890 143527 70755013
Hand deformity 25.99 18.31 3 29901 86479 70812061
Oedema peripheral 25.85 18.31 35 29869 228056 70670484
Musculoskeletal stiffness 25.83 18.31 127 29777 147633 70750907
Pericarditis 25.30 18.31 3 29901 84702 70813838
Septic shock 25.13 18.31 8 29896 112250 70786290
Spinal operation 25.08 18.31 22 29882 7006 70891534
Lower respiratory tract infection 25.01 18.31 8 29896 111905 70786635
Joint swelling 24.72 18.31 43 29861 253168 70645372
Pulmonary oedema 24.36 18.31 3 29901 82275 70816265
Blood pressure increased 24.20 18.31 149 29755 188368 70710172
Gastrointestinal haemorrhage 24.08 18.31 14 29890 137394 70761146
Dehydration 23.38 18.31 37 29867 226105 70672435
Dysgraphia 23.08 18.31 16 29888 3616 70894924
Lipase increased 22.65 18.31 30 29874 15216 70883324
Hypertension 22.65 18.31 207 29697 295826 70602714
Back pain 22.50 18.31 193 29711 270959 70627581
Interstitial lung disease 22.50 18.31 8 29896 104677 70793863
Speech disorder 22.39 18.31 59 29845 50521 70848019
Relapsing multiple sclerosis 22.14 18.31 6 29898 126 70898414
Hypoxia 22.09 18.31 6 29898 93338 70805202
Intentional overdose 22.06 18.31 7 29897 98428 70800112
Depressed level of consciousness 21.89 18.31 5 29899 87426 70811114
Oxygen saturation decreased 21.66 18.31 11 29893 116418 70782122
Delirium 21.42 18.31 3 29901 74611 70823929
Weight decreased 21.22 18.31 212 29692 310276 70588264
Influenza like illness 21.02 18.31 68 29836 65263 70833277
Gait inability 20.85 18.31 55 29849 47120 70851420
Hemiparesis 20.85 18.31 43 29861 31426 70867114
Urinary tract infection 20.60 18.31 177 29727 248592 70649948
Electrocardiogram QT prolonged 20.47 18.31 5 29899 83512 70815028
Systemic lupus erythematosus 19.91 18.31 9 29895 101893 70796647
Faeces soft 19.55 18.31 19 29885 6891 70891649
Testicular seminoma (pure) stage I 19.46 18.31 4 29900 23 70898517
Meningoencephalitis herpetic 18.95 18.31 11 29893 1828 70896712
Oedema 18.95 18.31 10 29894 103571 70794969
Ascites 18.74 18.31 3 29901 67544 70830996
Epistaxis 18.64 18.31 10 29894 102617 70795923
Cerebral disorder 18.54 18.31 16 29888 4983 70893557
Deep vein thrombosis 18.50 18.31 12 29892 111030 70787510

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC L04AA31 ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS
IMMUNOSUPPRESSANTS
IMMUNOSUPPRESSANTS
Selective immunosuppressants
MeSH PA D000700 Analgesics
MeSH PA D018712 Analgesics, Non-Narcotic
MeSH PA D000893 Anti-Inflammatory Agents
MeSH PA D000894 Anti-Inflammatory Agents, Non-Steroidal
MeSH PA D018501 Antirheumatic Agents
MeSH PA D007155 Immunologic Factors
MeSH PA D007166 Immunosuppressive Agents
MeSH PA D018373 Peripheral Nervous System Agents
MeSH PA D018689 Sensory System Agents
FDA MoA N0000185501 Dihydroorotate Dehydrogenase Inhibitors
FDA EPC N0000185502 Pyrimidine Synthesis Inhibitor
CHEBI has role CHEBI:35475 non-steroidal anti-inflammatory agent
CHEBI has role CHEBI:38637 tyrosine kinase inhibitors
CHEBI has role CHEBI:49103 drug metabolites
CHEBI has role CHEBI:50908 agente hepatotoxico
CHEBI has role CHEBI:68542 DHODH inhibitor

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

DiseaseRelationSNOMED_IDDOID
Multiple sclerosis indication 24700007 DOID:2377
Relapsing remitting multiple sclerosis indication 426373005 DOID:2378
Severe hypoproteinaemia contraindication 8900005
Nephrotic syndrome contraindication 52254009 DOID:1184
Significant leucopenia contraindication 84828003 DOID:615
Severe renal impairment undergoing dialysis contraindication 105502003
Severe immunodeficiency state contraindication 234532001 DOID:612
Significant anaemia contraindication 271737000 DOID:2355
Pregnancy, function contraindication 289908002
Significant thrombocytopenia contraindication 302215000 DOID:1588
Significant neutropenia contraindication 303011007 DOID:1227
Breastfeeding (mother) contraindication 413712001
Severe hepatic impairment contraindication 710067001
Severe active infection contraindication




🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 5.59 acidic
pKa2 10.61 acidic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
14MG AUBAGIO SANOFI AVENTIS US N202992 Sept. 12, 2012 RX TABLET ORAL 6794410 Sept. 12, 2026 TREATMENT OF PATIENTS WITH RELAPSING FORMS OF MULTIPLE SCLEROSIS
7MG AUBAGIO SANOFI AVENTIS US N202992 Sept. 12, 2012 RX TABLET ORAL 6794410 Sept. 12, 2026 TREATMENT OF PATIENTS WITH RELAPSING FORMS OF MULTIPLE SCLEROSIS
14MG AUBAGIO SANOFI AVENTIS US N202992 Sept. 12, 2012 RX TABLET ORAL 9186346 Feb. 4, 2034 TREATMENT OF PATIENTS WITH RELAPSING FORMS OF MULTIPLE SCLEROSIS WHILE MANAGING THE RISK OF TERIFLUNOMIDE AND ROSUVASTATIN INTERACTION BY LIMITING THE ROSUVASTATIN DOSE TO NO MORE THAN 10MG AND/OR ADMINISTERING ABOUT HALF THE NORMAL DOSE
7MG AUBAGIO SANOFI AVENTIS US N202992 Sept. 12, 2012 RX TABLET ORAL 9186346 Feb. 4, 2034 TREATMENT OF PATIENTS WITH RELAPSING FORMS OF MULTIPLE SCLEROSIS WHILE MANAGING THE RISK OF TERIFLUNOMIDE AND ROSUVASTATIN INTERACTION BY LIMITING THE ROSUVASTATIN DOSE TO NO MORE THAN 10MG AND/OR ADMINISTERING ABOUT HALF THE NORMAL DOSE

Orange Book exclusivity data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
14MG AUBAGIO SANOFI AVENTIS US N202992 Sept. 12, 2012 RX TABLET ORAL April 30, 2024 REVISIONS TO LABELING BASED ON DATA SUBMITTED IN RESPONSE TO PEDIATRIC WRITTEN REQUEST
7MG AUBAGIO SANOFI AVENTIS US N202992 Sept. 12, 2012 RX TABLET ORAL April 30, 2024 REVISIONS TO LABELING BASED ON DATA SUBMITTED IN RESPONSE TO PEDIATRIC WRITTEN REQUEST
14MG AUBAGIO SANOFI AVENTIS US N202992 Sept. 12, 2012 RX TABLET ORAL Oct. 30, 2024 PEDIATRIC EXCLUSIVITY
7MG AUBAGIO SANOFI AVENTIS US N202992 Sept. 12, 2012 RX TABLET ORAL Oct. 30, 2024 PEDIATRIC EXCLUSIVITY

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
Dihydroorotate dehydrogenase (quinone), mitochondrial Enzyme INHIBITOR Ki 7.52 CHEMBL CHEMBL
Dihydrofolate reductase Enzyme IC50 6.41 CHEMBL
Dihydroorotate dehydrogenase (quinone), mitochondrial Enzyme IC50 8.05 CHEMBL
Dihydroorotate dehydrogenase (quinone), mitochondrial Enzyme IC50 7.16 CHEMBL
Dihydroorotate dehydrogenase Enzyme Ki 4.66 CHEMBL
Dihydroorotate dehydrogenase Enzyme IC50 4.30 CHEMBL

External reference:

IDSource
D10172 KEGG_DRUG
4031717 VANDF
CHEBI:68540 CHEBI
A26 PDB_CHEM_ID
CHEMBL973 ChEMBL_ID
C527525 MESH_SUPPLEMENTAL_RECORD_UI
6844 IUPHAR_LIGAND_ID
7761 INN_ID
DB08880 DRUGBANK_ID
1C058IKG3B UNII
1310520 RXNORM
193228 MMSL
28846 MMSL
d07905 MMSL
014643 NDDF
703785006 SNOMEDCT_US
703786007 SNOMEDCT_US
C1718383 UMLSCUI
54684141 PUBCHEM_CID

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Teriflunomide HUMAN PRESCRIPTION DRUG LABEL 1 0115-1565 TABLET, FILM COATED 14 mg ORAL ANDA 20 sections
Aubagio HUMAN PRESCRIPTION DRUG LABEL 1 58468-0210 TABLET, FILM COATED 14 mg ORAL NDA 32 sections
Aubagio HUMAN PRESCRIPTION DRUG LABEL 1 58468-0210 TABLET, FILM COATED 14 mg ORAL NDA 32 sections
Aubagio HUMAN PRESCRIPTION DRUG LABEL 1 58468-0211 TABLET, FILM COATED 7 mg ORAL NDA 32 sections
Aubagio HUMAN PRESCRIPTION DRUG LABEL 1 58468-0211 TABLET, FILM COATED 7 mg ORAL NDA 32 sections
teriflunomide HUMAN PRESCRIPTION DRUG LABEL 1 68462-311 TABLET, FILM COATED 7 mg ORAL ANDA 29 sections
teriflunomide HUMAN PRESCRIPTION DRUG LABEL 1 68462-312 TABLET, FILM COATED 14 mg ORAL ANDA 29 sections
Teriflunomide HUMAN PRESCRIPTION DRUG LABEL 1 69238-1303 TABLET, FILM COATED 7 mg ORAL ANDA 23 sections
Teriflunomide HUMAN PRESCRIPTION DRUG LABEL 1 69238-1304 TABLET, FILM COATED 14 mg ORAL ANDA 23 sections
Teriflunomide Human Prescription Drug Label 1 69539-032 TABLET, FILM COATED 7 mg ORAL ANDA 27 sections
Teriflunomide Human Prescription Drug Label 1 69539-033 TABLET, FILM COATED 14 mg ORAL ANDA 27 sections