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 | 2417.44 | 16.79 | 875 | 24059 | 42089 | 50538101 |
Alopecia | 1254.93 | 16.79 | 1002 | 23932 | 244045 | 50336145 |
Paraesthesia | 524.73 | 16.79 | 450 | 24484 | 119793 | 50460397 |
Hypoaesthesia | 500.63 | 16.79 | 449 | 24485 | 126808 | 50453382 |
Product dose omission issue | 434.43 | 16.79 | 492 | 24442 | 183346 | 50396844 |
Diarrhoea | 234.18 | 16.79 | 726 | 24208 | 587750 | 49992440 |
Gait disturbance | 196.63 | 16.79 | 301 | 24633 | 149704 | 50430486 |
Balance disorder | 186.94 | 16.79 | 201 | 24733 | 70389 | 50509801 |
Product dose omission in error | 165.14 | 16.79 | 57 | 24877 | 2343 | 50577847 |
Fall | 153.12 | 16.79 | 435 | 24499 | 334497 | 50245693 |
Unevaluable event | 132.25 | 16.79 | 137 | 24797 | 45929 | 50534261 |
Memory impairment | 125.23 | 16.79 | 174 | 24760 | 79186 | 50501004 |
Bladder disorder | 113.47 | 16.79 | 61 | 24873 | 7482 | 50572708 |
Off label use | 112.07 | 16.79 | 47 | 24887 | 474379 | 50105811 |
Depression | 108.91 | 16.79 | 247 | 24687 | 165176 | 50415014 |
Fatigue | 104.13 | 16.79 | 648 | 24286 | 706953 | 49873237 |
Depressed mood | 100.91 | 16.79 | 103 | 24831 | 33920 | 50546270 |
Multiple sclerosis | 99.95 | 16.79 | 82 | 24852 | 20411 | 50559779 |
Optic neuritis | 98.85 | 16.79 | 54 | 24880 | 6836 | 50573354 |
Muscular weakness | 89.96 | 16.79 | 165 | 24769 | 94848 | 50485342 |
COVID-19 | 80.67 | 16.79 | 107 | 24827 | 46555 | 50533635 |
Toxicity to various agents | 73.80 | 16.79 | 9 | 24925 | 212490 | 50367700 |
Acute kidney injury | 73.73 | 16.79 | 12 | 24922 | 228046 | 50352144 |
Headache | 72.37 | 16.79 | 461 | 24473 | 506074 | 50074116 |
Rheumatoid arthritis | 71.78 | 16.79 | 8 | 24926 | 202542 | 50377648 |
Visual impairment | 70.27 | 16.79 | 123 | 24811 | 68152 | 50512038 |
Drug hypersensitivity | 69.31 | 16.79 | 19 | 24915 | 250991 | 50329199 |
Limb discomfort | 69.07 | 16.79 | 72 | 24862 | 24285 | 50555905 |
JC polyomavirus test positive | 67.34 | 16.79 | 24 | 24910 | 1085 | 50579105 |
Central nervous system lesion | 66.18 | 16.79 | 47 | 24887 | 9442 | 50570748 |
Muscle spasticity | 64.06 | 16.79 | 59 | 24875 | 17125 | 50563065 |
Mobility decreased | 61.22 | 16.79 | 127 | 24807 | 79821 | 50500369 |
Sensory disturbance | 61.19 | 16.79 | 49 | 24885 | 11780 | 50568410 |
Condition aggravated | 56.46 | 16.79 | 292 | 24642 | 296766 | 50283424 |
Burning sensation | 56.30 | 16.79 | 89 | 24845 | 45357 | 50534833 |
Completed suicide | 52.84 | 16.79 | 3 | 24931 | 131886 | 50448304 |
Magnetic resonance imaging abnormal | 52.47 | 16.79 | 26 | 24908 | 2692 | 50577498 |
Maternal exposure during pregnancy | 50.30 | 16.79 | 9 | 24925 | 159769 | 50420421 |
Therapeutic product effect decreased | 49.13 | 16.79 | 5 | 24929 | 136045 | 50444145 |
Synovitis | 49.06 | 16.79 | 3 | 24931 | 123862 | 50456328 |
Urinary incontinence | 47.68 | 16.79 | 64 | 24870 | 28144 | 50552046 |
Cognitive disorder | 44.74 | 16.79 | 79 | 24855 | 44044 | 50536146 |
Throat clearing | 40.72 | 16.79 | 17 | 24917 | 1181 | 50579009 |
Injection site pain | 40.29 | 16.79 | 4 | 24930 | 111020 | 50469170 |
Joint swelling | 40.20 | 16.79 | 37 | 24897 | 245249 | 50334941 |
Decreased interest | 39.06 | 16.79 | 22 | 24912 | 2954 | 50577236 |
Feeling abnormal | 38.86 | 16.79 | 143 | 24791 | 125349 | 50454841 |
Electric shock sensation | 38.76 | 16.79 | 11 | 24923 | 234 | 50579956 |
Systemic lupus erythematosus | 38.11 | 16.79 | 11 | 24923 | 140611 | 50439579 |
Micturition urgency | 38.06 | 16.79 | 32 | 24902 | 8232 | 50571958 |
Drug interaction | 37.87 | 16.79 | 26 | 24908 | 199595 | 50380595 |
Lymphopenia | 36.99 | 16.79 | 42 | 24892 | 15579 | 50564611 |
Hypotension | 36.86 | 16.79 | 37 | 24897 | 235432 | 50344758 |
Hyponatraemia | 36.13 | 16.79 | 3 | 24931 | 96136 | 50484054 |
Death | 35.92 | 16.79 | 66 | 24868 | 325313 | 50254877 |
Overdose | 35.15 | 16.79 | 4 | 24930 | 99723 | 50480467 |
Exposure during pregnancy | 35.06 | 16.79 | 135 | 24799 | 120880 | 50459310 |
Breast cancer | 33.83 | 16.79 | 69 | 24865 | 42821 | 50537369 |
Incontinence | 32.85 | 16.79 | 32 | 24902 | 9953 | 50570237 |
Anaemia | 32.75 | 16.79 | 46 | 24888 | 252410 | 50327780 |
Walking aid user | 31.90 | 16.79 | 26 | 24908 | 6407 | 50573783 |
Muscle spasms | 30.00 | 16.79 | 132 | 24802 | 125421 | 50454769 |
Peroneal nerve palsy | 29.37 | 16.79 | 21 | 24913 | 4262 | 50575928 |
Lower respiratory tract infection | 28.60 | 16.79 | 6 | 24928 | 95195 | 50484995 |
Pericarditis | 28.12 | 16.79 | 3 | 24931 | 78686 | 50501504 |
Vision blurred | 28.11 | 16.79 | 94 | 24840 | 78553 | 50501637 |
Hepatic enzyme increased | 28.09 | 16.79 | 138 | 24796 | 137242 | 50442948 |
Onychoclasis | 27.89 | 16.79 | 22 | 24912 | 5174 | 50575016 |
Pneumonia | 27.56 | 16.79 | 95 | 24839 | 378306 | 50201884 |
Stress | 27.51 | 16.79 | 73 | 24861 | 53720 | 50526470 |
Wound | 27.36 | 16.79 | 9 | 24925 | 105785 | 50474405 |
Secondary progressive multiple sclerosis | 27.11 | 16.79 | 13 | 24921 | 1253 | 50578937 |
Hypertension | 25.64 | 16.79 | 185 | 24749 | 211018 | 50369172 |
Therapeutic product effect incomplete | 25.08 | 16.79 | 7 | 24927 | 91508 | 50488682 |
Intentional product use issue | 24.93 | 16.79 | 4 | 24930 | 76914 | 50503276 |
Lipase increased | 23.76 | 16.79 | 25 | 24909 | 8516 | 50571674 |
Paraparesis | 23.73 | 16.79 | 14 | 24920 | 2050 | 50578140 |
SARS-CoV-2 test positive | 23.46 | 16.79 | 19 | 24915 | 4640 | 50575550 |
Pain in extremity | 23.44 | 16.79 | 221 | 24713 | 272644 | 50307546 |
Respiratory failure | 23.15 | 16.79 | 8 | 24926 | 91173 | 50489017 |
Hair texture abnormal | 22.97 | 16.79 | 17 | 24917 | 3639 | 50576551 |
Heteroplasia | 22.42 | 16.79 | 4 | 24930 | 7 | 50580183 |
Arthropathy | 22.28 | 16.79 | 27 | 24907 | 157879 | 50422311 |
Pancytopenia | 21.99 | 16.79 | 7 | 24927 | 84023 | 50496167 |
Weight decreased | 21.98 | 16.79 | 185 | 24749 | 221060 | 50359130 |
Blood pressure increased | 21.92 | 16.79 | 126 | 24808 | 133006 | 50447184 |
Haemoglobin decreased | 21.04 | 16.79 | 19 | 24915 | 127197 | 50452993 |
Dysstasia | 20.83 | 16.79 | 34 | 24900 | 17785 | 50562405 |
Trigeminal neuralgia | 20.73 | 16.79 | 15 | 24919 | 3100 | 50577090 |
Hemiparesis | 20.45 | 16.79 | 36 | 24898 | 20012 | 50560178 |
Hypokalaemia | 20.23 | 16.79 | 9 | 24925 | 87983 | 50492207 |
General physical health deterioration | 19.42 | 16.79 | 25 | 24909 | 142409 | 50437781 |
Pleural effusion | 19.25 | 16.79 | 8 | 24926 | 81446 | 50498744 |
Paternal exposure timing unspecified | 19.15 | 16.79 | 4 | 24930 | 21 | 50580169 |
Temperature intolerance | 19.10 | 16.79 | 21 | 24913 | 7518 | 50572672 |
Cardiac failure congestive | 18.83 | 16.79 | 9 | 24925 | 84373 | 50495817 |
Dyspnoea | 18.80 | 16.79 | 176 | 24758 | 547432 | 50032758 |
Liver function test increased | 18.79 | 16.79 | 40 | 24894 | 25566 | 50554624 |
Spinal operation | 18.63 | 16.79 | 19 | 24915 | 6241 | 50573949 |
Asthenia | 18.46 | 16.79 | 239 | 24695 | 318803 | 50261387 |
Pollakiuria | 18.36 | 16.79 | 38 | 24896 | 23813 | 50556377 |
Abortion | 18.32 | 16.79 | 12 | 24922 | 2112 | 50578078 |
Neuralgia | 18.22 | 16.79 | 36 | 24898 | 21827 | 50558363 |
Neutropenia | 18.15 | 16.79 | 28 | 24906 | 147937 | 50432253 |
Band sensation | 17.61 | 16.79 | 8 | 24926 | 682 | 50579508 |
Impaired driving ability | 17.55 | 16.79 | 15 | 24919 | 3946 | 50576244 |
Swelling | 17.03 | 16.79 | 47 | 24887 | 200825 | 50379365 |
Pharyngeal abscess | 16.99 | 16.79 | 6 | 24928 | 264 | 50579926 |
Treatment failure | 16.93 | 16.79 | 26 | 24908 | 137611 | 50442579 |
Progressive multiple sclerosis | 16.92 | 16.79 | 8 | 24926 | 747 | 50579443 |
Hypoglycaemia | 16.89 | 16.79 | 3 | 24931 | 53578 | 50526612 |
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 | 902.89 | 26.35 | 235 | 4723 | 11184 | 29558385 |
Alopecia | 207.60 | 26.35 | 88 | 4870 | 18996 | 29550573 |
Product dose omission issue | 154.34 | 26.35 | 128 | 4830 | 96255 | 29473314 |
Gait disturbance | 102.05 | 26.35 | 90 | 4868 | 73259 | 29496310 |
Hypoaesthesia | 100.21 | 26.35 | 78 | 4880 | 53389 | 29516180 |
Paraesthesia | 97.55 | 26.35 | 77 | 4881 | 53768 | 29515801 |
Multiple sclerosis | 82.22 | 26.35 | 32 | 4926 | 5522 | 29564047 |
Diarrhoea | 69.86 | 26.35 | 164 | 4794 | 332534 | 29237035 |
Balance disorder | 66.02 | 26.35 | 52 | 4906 | 36118 | 29533451 |
Product dose omission in error | 63.62 | 26.35 | 16 | 4942 | 648 | 29568921 |
Fatigue | 63.01 | 26.35 | 153 | 4805 | 316668 | 29252901 |
Fall | 54.08 | 26.35 | 102 | 4856 | 177076 | 29392493 |
Mobility decreased | 44.74 | 26.35 | 36 | 4922 | 25744 | 29543825 |
Headache | 43.25 | 26.35 | 92 | 4866 | 173915 | 29395654 |
Memory impairment | 39.49 | 26.35 | 39 | 4919 | 36431 | 29533138 |
Optic neuritis | 35.94 | 26.35 | 15 | 4943 | 3094 | 29566475 |
Visual impairment | 34.46 | 26.35 | 33 | 4925 | 29675 | 29539894 |
Unevaluable event | 32.45 | 26.35 | 32 | 4926 | 29819 | 29539750 |
Depression | 30.95 | 26.35 | 53 | 4905 | 85094 | 29484475 |
Meningoencephalitis herpetic | 29.35 | 26.35 | 9 | 4949 | 760 | 29568809 |
Trigeminal neuralgia | 26.83 | 26.35 | 9 | 4949 | 1013 | 29568556 |
Acute kidney injury | 26.60 | 26.35 | 6 | 4952 | 265261 | 29304308 |
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 | 2434.62 | 18.01 | 813 | 23506 | 40322 | 64434091 |
Alopecia | 1391.70 | 18.01 | 830 | 23489 | 164860 | 64309553 |
Hypoaesthesia | 534.33 | 18.01 | 432 | 23887 | 138676 | 64335737 |
Paraesthesia | 510.77 | 18.01 | 415 | 23904 | 134107 | 64340306 |
Product dose omission issue | 393.66 | 18.01 | 423 | 23896 | 194324 | 64280089 |
Gait disturbance | 266.45 | 18.01 | 326 | 23993 | 171829 | 64302584 |
Diarrhoea | 234.82 | 18.01 | 698 | 23621 | 722006 | 63752407 |
Balance disorder | 197.29 | 18.01 | 198 | 24121 | 83728 | 64390685 |
Fall | 167.66 | 18.01 | 436 | 23883 | 416390 | 64058023 |
Fatigue | 159.74 | 18.01 | 629 | 23690 | 748101 | 63726312 |
Unevaluable event | 158.68 | 18.01 | 140 | 24179 | 50349 | 64424064 |
Memory impairment | 150.02 | 18.01 | 173 | 24146 | 85509 | 64388904 |
Product dose omission in error | 132.77 | 18.01 | 46 | 24273 | 2513 | 64471900 |
Headache | 129.28 | 18.01 | 465 | 23854 | 529002 | 63945411 |
Multiple sclerosis | 122.96 | 18.01 | 81 | 24238 | 18860 | 64455553 |
Acute kidney injury | 111.51 | 18.01 | 18 | 24301 | 449222 | 64025191 |
Off label use | 109.64 | 18.01 | 51 | 24268 | 632755 | 63841658 |
Optic neuritis | 107.00 | 18.01 | 55 | 24264 | 8061 | 64466352 |
Toxicity to various agents | 106.68 | 18.01 | 8 | 24311 | 363505 | 64110908 |
Depression | 99.71 | 18.01 | 216 | 24103 | 183075 | 64291338 |
Visual impairment | 96.52 | 18.01 | 129 | 24190 | 73948 | 64400465 |
Muscular weakness | 90.73 | 18.01 | 168 | 24151 | 127170 | 64347243 |
Limb discomfort | 90.67 | 18.01 | 78 | 24241 | 27097 | 64447316 |
Depressed mood | 84.10 | 18.01 | 90 | 24229 | 40922 | 64433491 |
Bladder disorder | 83.66 | 18.01 | 46 | 24273 | 7721 | 64466692 |
Mobility decreased | 73.75 | 18.01 | 123 | 24196 | 85717 | 64388696 |
Completed suicide | 65.60 | 18.01 | 5 | 24314 | 224409 | 64250004 |
Feeling abnormal | 65.35 | 18.01 | 151 | 24168 | 133451 | 64340962 |
Muscle spasticity | 64.21 | 18.01 | 52 | 24267 | 16617 | 64457796 |
Central nervous system lesion | 63.44 | 18.01 | 45 | 24274 | 11804 | 64462609 |
JC polyomavirus test positive | 62.83 | 18.01 | 22 | 24297 | 1240 | 64473173 |
Magnetic resonance imaging abnormal | 61.92 | 18.01 | 28 | 24291 | 3095 | 64471318 |
Throat clearing | 61.57 | 18.01 | 22 | 24297 | 1316 | 64473097 |
Burning sensation | 59.39 | 18.01 | 83 | 24236 | 49581 | 64424832 |
Drug interaction | 58.32 | 18.01 | 32 | 24287 | 362051 | 64112362 |
Sensory disturbance | 56.88 | 18.01 | 44 | 24275 | 13164 | 64461249 |
Hypotension | 56.69 | 18.01 | 37 | 24282 | 380937 | 64093476 |
COVID-19 | 55.48 | 18.01 | 93 | 24226 | 65047 | 64409366 |
Drug hypersensitivity | 49.79 | 18.01 | 14 | 24305 | 237801 | 64236612 |
Pain in extremity | 48.28 | 18.01 | 234 | 24085 | 302851 | 64171562 |
Condition aggravated | 46.63 | 18.01 | 269 | 24050 | 372157 | 64102256 |
Decreased interest | 44.95 | 18.01 | 23 | 24296 | 3337 | 64471076 |
Anaemia | 44.87 | 18.01 | 46 | 24273 | 378634 | 64095779 |
Secondary progressive multiple sclerosis | 44.52 | 18.01 | 17 | 24302 | 1226 | 64473187 |
Hyponatraemia | 44.21 | 18.01 | 3 | 24316 | 148336 | 64326077 |
Muscle spasms | 44.10 | 18.01 | 135 | 24184 | 140888 | 64333525 |
Walking aid user | 43.54 | 18.01 | 28 | 24291 | 6253 | 64468160 |
Electric shock sensation | 42.74 | 18.01 | 12 | 24307 | 324 | 64474089 |
Urinary incontinence | 42.60 | 18.01 | 60 | 24259 | 36091 | 64438322 |
Rheumatoid arthritis | 42.00 | 18.01 | 6 | 24313 | 164288 | 64310125 |
Hepatic enzyme increased | 38.41 | 18.01 | 122 | 24197 | 129821 | 64344592 |
Trigeminal neuralgia | 37.92 | 18.01 | 20 | 24299 | 3089 | 64471324 |
Pancytopenia | 37.18 | 18.01 | 5 | 24314 | 143304 | 64331109 |
Cognitive disorder | 37.09 | 18.01 | 71 | 24248 | 55016 | 64419397 |
Lymphopenia | 37.00 | 18.01 | 47 | 24272 | 25610 | 64448803 |
Neutropenia | 35.97 | 18.01 | 23 | 24296 | 239601 | 64234812 |
Breast cancer | 35.27 | 18.01 | 49 | 24270 | 29099 | 64445314 |
Micturition urgency | 35.08 | 18.01 | 30 | 24289 | 10329 | 64464084 |
Death | 34.83 | 18.01 | 82 | 24237 | 482623 | 63991790 |
Disease progression | 34.35 | 18.01 | 6 | 24313 | 141674 | 64332739 |
Pollakiuria | 33.74 | 18.01 | 50 | 24269 | 31480 | 64442933 |
Bradycardia | 33.51 | 18.01 | 3 | 24316 | 118216 | 64356197 |
Pain | 32.57 | 18.01 | 335 | 23984 | 553176 | 63921237 |
Overdose | 32.27 | 18.01 | 10 | 24309 | 159556 | 64314857 |
Pneumonia | 32.25 | 18.01 | 106 | 24213 | 559470 | 63914943 |
Heteroplasia | 31.48 | 18.01 | 5 | 24314 | 4 | 64474409 |
Stress | 31.32 | 18.01 | 70 | 24249 | 60464 | 64413949 |
Dysstasia | 31.09 | 18.01 | 41 | 24278 | 23174 | 64451239 |
Band sensation | 30.78 | 18.01 | 11 | 24308 | 658 | 64473755 |
Impaired driving ability | 30.43 | 18.01 | 20 | 24299 | 4634 | 64469779 |
Nausea | 30.32 | 18.01 | 439 | 23880 | 785361 | 63689052 |
Renal impairment | 30.06 | 18.01 | 7 | 24312 | 135010 | 64339403 |
Weight decreased | 29.19 | 18.01 | 196 | 24123 | 285543 | 64188870 |
Haemoglobin decreased | 28.89 | 18.01 | 19 | 24300 | 195044 | 64279369 |
Vision blurred | 27.78 | 18.01 | 86 | 24233 | 90230 | 64384183 |
Paraparesis | 27.77 | 18.01 | 17 | 24302 | 3485 | 64470928 |
Asthenia | 27.53 | 18.01 | 264 | 24055 | 427780 | 64046633 |
Incontinence | 27.41 | 18.01 | 28 | 24291 | 12053 | 64462360 |
Synovitis | 26.82 | 18.01 | 3 | 24316 | 99087 | 64375326 |
Lipase increased | 26.72 | 18.01 | 30 | 24289 | 14372 | 64460041 |
Migraine | 26.49 | 18.01 | 67 | 24252 | 62610 | 64411803 |
Abdominal discomfort | 26.31 | 18.01 | 137 | 24182 | 182185 | 64292228 |
Therapeutic product effect decreased | 25.64 | 18.01 | 6 | 24313 | 115345 | 64359068 |
Progressive multiple sclerosis | 25.36 | 18.01 | 10 | 24309 | 786 | 64473627 |
Platelet count decreased | 25.29 | 18.01 | 16 | 24303 | 167695 | 64306718 |
Lupus vulgaris | 25.22 | 18.01 | 6 | 24313 | 82 | 64474331 |
Renal failure | 25.19 | 18.01 | 19 | 24300 | 181669 | 64292744 |
Cardiac failure congestive | 24.97 | 18.01 | 9 | 24310 | 130571 | 64343842 |
Hair texture abnormal | 24.89 | 18.01 | 15 | 24304 | 2989 | 64471424 |
Exposure during pregnancy | 24.86 | 18.01 | 75 | 24244 | 77600 | 64396813 |
Hypertension | 24.79 | 18.01 | 175 | 24144 | 259086 | 64215327 |
Cardiac arrest | 24.21 | 18.01 | 14 | 24305 | 154050 | 64320363 |
Sensory loss | 23.86 | 18.01 | 24 | 24295 | 10145 | 64464268 |
Hypoglycaemia | 23.64 | 18.01 | 3 | 24316 | 89889 | 64384524 |
Maternal exposure during pregnancy | 23.37 | 18.01 | 4 | 24315 | 95880 | 64378533 |
Blood creatinine increased | 23.31 | 18.01 | 11 | 24308 | 135771 | 64338642 |
Multiple organ dysfunction syndrome | 23.09 | 18.01 | 5 | 24314 | 101408 | 64373005 |
Blood pressure increased | 23.09 | 18.01 | 127 | 24192 | 172425 | 64301988 |
Expanded disability status scale score increased | 22.59 | 18.01 | 8 | 24311 | 466 | 64473947 |
Treatment failure | 22.43 | 18.01 | 8 | 24311 | 116808 | 64357605 |
Thrombocytopenia | 22.40 | 18.01 | 31 | 24288 | 223770 | 64250643 |
Hypokalaemia | 22.32 | 18.01 | 9 | 24310 | 121894 | 64352519 |
Temperature intolerance | 22.21 | 18.01 | 21 | 24298 | 8234 | 64466179 |
Pleural effusion | 22.12 | 18.01 | 10 | 24309 | 126549 | 64347864 |
Cardio-respiratory arrest | 22.10 | 18.01 | 5 | 24314 | 98388 | 64376025 |
Rhabdomyolysis | 21.98 | 18.01 | 4 | 24315 | 91722 | 64382691 |
General physical health deterioration | 21.81 | 18.01 | 27 | 24292 | 204398 | 64270015 |
Therapeutic product effect incomplete | 21.81 | 18.01 | 6 | 24313 | 103476 | 64370937 |
Neuralgia | 21.77 | 18.01 | 37 | 24282 | 26147 | 64448266 |
Peroneal nerve palsy | 21.34 | 18.01 | 17 | 24302 | 5304 | 64469109 |
Onychoclasis | 21.31 | 18.01 | 16 | 24303 | 4576 | 64469837 |
Respiratory failure | 20.91 | 18.01 | 18 | 24301 | 161165 | 64313248 |
Dysgraphia | 20.49 | 18.01 | 14 | 24305 | 3457 | 64470956 |
Urinary tract infection | 20.22 | 18.01 | 153 | 24166 | 231443 | 64242970 |
Testicular seminoma (pure) stage I | 19.91 | 18.01 | 4 | 24315 | 23 | 64474390 |
Dizziness | 19.66 | 18.01 | 248 | 24071 | 429915 | 64044498 |
Speech disorder | 19.66 | 18.01 | 51 | 24268 | 48390 | 64426023 |
Cardiac failure | 19.45 | 18.01 | 13 | 24306 | 132360 | 64342053 |
Gastrointestinal haemorrhage | 19.43 | 18.01 | 13 | 24306 | 132299 | 64342114 |
Intentional product use issue | 19.23 | 18.01 | 6 | 24313 | 95358 | 64379055 |
Septic shock | 18.95 | 18.01 | 8 | 24311 | 105429 | 64368984 |
Wheelchair user | 18.89 | 18.01 | 15 | 24304 | 4657 | 64469756 |
Dehydration | 18.85 | 18.01 | 33 | 24286 | 216730 | 64257683 |
Depressed level of consciousness | 18.57 | 18.01 | 4 | 24315 | 81432 | 64392981 |
Dyspnoea | 18.35 | 18.01 | 178 | 24141 | 718496 | 63755917 |
Hemiparesis | 18.32 | 18.01 | 37 | 24282 | 29790 | 64444623 |
Oedema peripheral | 18.31 | 18.01 | 32 | 24287 | 210285 | 64264128 |
Pyrexia | 18.03 | 18.01 | 130 | 24189 | 558514 | 63915899 |
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 |
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 |
54684141 | PUBCHEM_CID |
1310520 | RXNORM |
193228 | MMSL |
28846 | MMSL |
d07905 | MMSL |
014643 | NDDF |
703785006 | SNOMEDCT_US |
703786007 | SNOMEDCT_US |
C1718383 | UMLSCUI |
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 |