Stem definition | Drug id | CAS RN |
---|---|---|
4634 | 163451-81-8 |
Dose | Unit | Route |
---|---|---|
14 | mg | O |
Property | Value | Reference |
---|---|---|
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 |
Date | Agency | Company | Orphan |
---|---|---|---|
Aug. 26, 2013 | EMA | ||
Sept. 12, 2012 | FDA | SANOFI AVENTIS US |
MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients 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 |
MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients 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 |
MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients 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 |
None
Source | Code | Description |
---|---|---|
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 |
Disease | Relation | SNOMED_ID | DOID |
---|---|---|---|
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 |
None
None
Dissociation level | Dissociation constant | Type (acidic/basic) |
---|---|---|
pKa1 | 5.59 | acidic |
pKa2 | 10.61 | acidic |
Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Patent number | Patent expiration date | Patent 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 |
Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Exclusivity date | Description |
---|---|---|---|---|---|---|---|---|---|
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 |
Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA 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 |
ID | Source |
---|---|
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 |
Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
---|---|---|---|---|---|---|---|---|
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 |