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teriflunomide 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |
| Stem definition | Drug id | CAS RN |
|---|---|---|
| 4634 | 163451-81-8 |
Description:
| Molecule | Description |
|---|---|
|
Synonyms:
|
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.
Legend: OFP - off patent OFM - off market ONP - on patent |
Drug dosage:
| Dose | Unit | Route |
|---|---|---|
| 14 | mg | O |
ADMET properties:
| 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 |
| S (Water solubility) | 0.03 mg/mL | Bocci G, Oprea TI, Benet LZ |
| BA (Bioavailability) | 88 % |
Predicted pharmacokinetic/toxicological properties (PK-AZ):
| Property | Description | Value | Unit | Confidence | Similarity |
|---|---|---|---|---|---|
| pfas-class | PFAS structural alert (1 = True, 0 = False) | 1 |
Approvals:
| Date | Agency | Company | Orphan |
|---|---|---|---|
| Aug. 26, 2013 | EMA | ||
| Sept. 12, 2012 | FDA | SANOFI AVENTIS US |
FDA Adverse Event Reporting System (Female)
| 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 | 6149.17 | 16.26 | 1820 | 39139 | 50485 | 90537003 |
| Alopecia | 1625.17 | 16.26 | 1514 | 39445 | 493557 | 90093931 |
| Paraesthesia | 790.57 | 16.26 | 752 | 40207 | 249574 | 90337914 |
| Hypoaesthesia | 733.83 | 16.26 | 802 | 40157 | 313408 | 90274080 |
| Product dose omission issue | 592.77 | 16.26 | 693 | 40266 | 290994 | 90296494 |
| Balance disorder | 592.58 | 16.26 | 428 | 40531 | 96652 | 90490836 |
| Fall | 424.05 | 16.26 | 770 | 40189 | 481040 | 90106448 |
| Diarrhoea | 382.45 | 16.26 | 1105 | 39854 | 938085 | 89649403 |
| Gait disturbance | 338.28 | 16.26 | 497 | 40462 | 259999 | 90327489 |
| Bladder disorder | 335.34 | 16.26 | 140 | 40819 | 10632 | 90576856 |
| Product dose omission in error | 288.35 | 16.26 | 154 | 40805 | 20349 | 90567139 |
| Fatigue | 263.55 | 16.26 | 1122 | 39837 | 1152901 | 89434587 |
| Off label use | 257.94 | 16.26 | 89 | 40870 | 1102163 | 89485325 |
| Depressed mood | 219.89 | 16.26 | 182 | 40777 | 50040 | 90537448 |
| Muscle spasticity | 208.99 | 16.26 | 153 | 40806 | 35169 | 90552319 |
| Sensory disturbance | 197.88 | 16.26 | 109 | 40850 | 15304 | 90572184 |
| Depression | 188.62 | 16.26 | 418 | 40541 | 300183 | 90287305 |
| Memory impairment | 176.22 | 16.26 | 318 | 40641 | 196926 | 90390562 |
| Infusion related reaction | 173.36 | 16.26 | 3 | 40956 | 416777 | 90170711 |
| Multiple sclerosis | 170.16 | 16.26 | 123 | 40836 | 27717 | 90559771 |
| Visual impairment | 164.93 | 16.26 | 248 | 40711 | 132117 | 90455371 |
| Optic neuritis | 139.74 | 16.26 | 74 | 40885 | 9604 | 90577884 |
| COVID-19 | 136.69 | 16.26 | 261 | 40698 | 168582 | 90418906 |
| Glossodynia | 131.03 | 16.26 | 3 | 40956 | 321776 | 90265712 |
| Synovitis | 130.82 | 16.26 | 4 | 40955 | 329748 | 90257740 |
| Central nervous system lesion | 129.58 | 16.26 | 75 | 40884 | 11571 | 90575917 |
| Cognitive disorder | 127.40 | 16.26 | 157 | 40802 | 69250 | 90518238 |
| Headache | 126.87 | 16.26 | 742 | 40217 | 862004 | 89725484 |
| Contraindicated product administered | 126.57 | 16.26 | 4 | 40955 | 320135 | 90267353 |
| Systemic lupus erythematosus | 123.15 | 16.26 | 11 | 40948 | 361885 | 90225603 |
| Unevaluable event | 120.45 | 16.26 | 136 | 40823 | 54712 | 90532776 |
| Decreased interest | 119.66 | 16.26 | 52 | 40907 | 4355 | 90583133 |
| Limb discomfort | 118.92 | 16.26 | 114 | 40845 | 37946 | 90549542 |
| Pericarditis | 108.15 | 16.26 | 3 | 40956 | 270148 | 90317340 |
| Urinary incontinence | 107.06 | 16.26 | 107 | 40852 | 37459 | 90550029 |
| Rheumatoid arthritis | 106.38 | 16.26 | 18 | 40941 | 362596 | 90224892 |
| Burning sensation | 104.51 | 16.26 | 136 | 40823 | 63316 | 90524172 |
| Maternal exposure during pregnancy | 103.18 | 16.26 | 19 | 40940 | 360044 | 90227444 |
| Joint swelling | 100.59 | 16.26 | 51 | 40908 | 503249 | 90084239 |
| Toxicity to various agents | 97.23 | 16.26 | 9 | 40950 | 287837 | 90299651 |
| Muscular weakness | 94.83 | 16.26 | 255 | 40704 | 206411 | 90381077 |
| Wound | 91.19 | 16.26 | 14 | 40945 | 302966 | 90284522 |
| Therapeutic product effect decreased | 90.32 | 16.26 | 10 | 40949 | 277561 | 90309927 |
| Movement disorder | 87.03 | 16.26 | 85 | 40874 | 28934 | 90558554 |
| Helicobacter infection | 85.67 | 16.26 | 4 | 40955 | 226846 | 90360642 |
| Feeling abnormal | 84.54 | 16.26 | 214 | 40745 | 167021 | 90420467 |
| JC polyomavirus test positive | 82.64 | 16.26 | 31 | 40928 | 1771 | 90585717 |
| Folliculitis | 79.17 | 16.26 | 3 | 40956 | 204350 | 90383138 |
| Lower respiratory tract infection | 79.14 | 16.26 | 10 | 40949 | 250649 | 90336839 |
| Stress | 78.73 | 16.26 | 136 | 40823 | 81259 | 90506229 |
| Drug hypersensitivity | 78.61 | 16.26 | 57 | 40902 | 463552 | 90123936 |
| Tremor | 78.45 | 16.26 | 197 | 40762 | 152976 | 90434512 |
| Acute kidney injury | 77.84 | 16.26 | 24 | 40935 | 320363 | 90267125 |
| Arthropathy | 73.29 | 16.26 | 37 | 40922 | 366205 | 90221283 |
| Intentional product use issue | 72.65 | 16.26 | 7 | 40952 | 216885 | 90370603 |
| Psoriatic arthropathy | 72.35 | 16.26 | 9 | 40950 | 228326 | 90359162 |
| Mobility decreased | 70.34 | 16.26 | 261 | 40698 | 250473 | 90337015 |
| Type 2 diabetes mellitus | 69.57 | 16.26 | 6 | 40953 | 203238 | 90384250 |
| Magnetic resonance imaging abnormal | 65.94 | 16.26 | 32 | 40927 | 3454 | 90584034 |
| Throat clearing | 65.88 | 16.26 | 33 | 40926 | 3814 | 90583674 |
| Wheezing | 65.16 | 16.26 | 14 | 40945 | 238066 | 90349422 |
| Secondary progressive multiple sclerosis | 64.63 | 16.26 | 25 | 40934 | 1554 | 90585934 |
| Condition aggravated | 64.49 | 16.26 | 475 | 40484 | 595070 | 89992418 |
| Fibromyalgia | 63.27 | 16.26 | 9 | 40950 | 206260 | 90381228 |
| Lymphopenia | 63.03 | 16.26 | 64 | 40895 | 22817 | 90564671 |
| Swelling | 61.79 | 16.26 | 59 | 40900 | 418999 | 90168489 |
| Incontinence | 61.51 | 16.26 | 50 | 40909 | 13385 | 90574103 |
| Micturition urgency | 60.48 | 16.26 | 46 | 40913 | 11187 | 90576301 |
| Speech disorder | 60.43 | 16.26 | 88 | 40871 | 45497 | 90541991 |
| Spinal operation | 57.66 | 16.26 | 43 | 40916 | 10153 | 90577335 |
| Pain in extremity | 56.76 | 16.26 | 373 | 40586 | 450156 | 90137332 |
| Oedema | 56.42 | 16.26 | 11 | 40948 | 200284 | 90387204 |
| Expanded disability status scale score increased | 56.11 | 16.26 | 19 | 40940 | 804 | 90586684 |
| Stomatitis | 56.07 | 16.26 | 27 | 40932 | 274671 | 90312817 |
| General physical health deterioration | 55.93 | 16.26 | 47 | 40912 | 355068 | 90232420 |
| Illness | 55.83 | 16.26 | 118 | 40841 | 81851 | 90505637 |
| Vision blurred | 55.56 | 16.26 | 141 | 40818 | 110152 | 90477336 |
| Injury | 55.24 | 16.26 | 11 | 40948 | 197338 | 90390150 |
| Pneumonia | 53.52 | 16.26 | 132 | 40827 | 637927 | 89949561 |
| Completed suicide | 53.35 | 16.26 | 3 | 40956 | 145055 | 90442433 |
| Overdose | 53.04 | 16.26 | 5 | 40954 | 157704 | 90429784 |
| Osteoarthritis | 50.60 | 16.26 | 13 | 40946 | 195717 | 90391771 |
| Therapeutic product effect incomplete | 49.89 | 16.26 | 13 | 40946 | 193883 | 90393605 |
| Hypotension | 48.90 | 16.26 | 45 | 40914 | 325352 | 90262136 |
| Eosinophilic colitis | 48.60 | 16.26 | 13 | 40946 | 241 | 90587247 |
| Peroneal nerve palsy | 48.47 | 16.26 | 31 | 40928 | 5717 | 90581771 |
| Onychoclasis | 48.21 | 16.26 | 34 | 40925 | 7365 | 90580123 |
| Injection site pain | 45.94 | 16.26 | 11 | 40948 | 173688 | 90413800 |
| Breast cancer | 45.79 | 16.26 | 85 | 40874 | 53676 | 90533812 |
| Weight increased | 45.70 | 16.26 | 74 | 40885 | 417853 | 90169635 |
| Hyponatraemia | 45.54 | 16.26 | 4 | 40955 | 133534 | 90453954 |
| Surgery | 44.70 | 16.26 | 76 | 40883 | 44811 | 90542677 |
| Irritable bowel syndrome | 44.50 | 16.26 | 19 | 40940 | 207429 | 90380059 |
| Muscle spasms | 44.36 | 16.26 | 228 | 40731 | 251655 | 90335833 |
| Treatment failure | 43.38 | 16.26 | 44 | 40915 | 303884 | 90283604 |
| Neuropathy peripheral | 43.00 | 16.26 | 148 | 40811 | 136822 | 90450666 |
| Joint range of motion decreased | 41.40 | 16.26 | 6 | 40953 | 135637 | 90451851 |
| Sexual dysfunction | 40.73 | 16.26 | 26 | 40933 | 4778 | 90582710 |
| Confusional state | 40.72 | 16.26 | 70 | 40889 | 386135 | 90201353 |
| Therapy non-responder | 39.58 | 16.26 | 7 | 40952 | 136697 | 90450791 |
| Impaired healing | 39.37 | 16.26 | 29 | 40930 | 234170 | 90353318 |
| Discomfort | 38.82 | 16.26 | 40 | 40919 | 274295 | 90313193 |
| C-reactive protein increased | 38.28 | 16.26 | 17 | 40942 | 181372 | 90406116 |
| Disturbance in attention | 38.27 | 16.26 | 73 | 40886 | 47036 | 90540452 |
| Electric shock sensation | 37.71 | 16.26 | 17 | 40942 | 1553 | 90585935 |
| Anaemia | 37.14 | 16.26 | 64 | 40895 | 352738 | 90234750 |
| Blood pressure increased | 36.45 | 16.26 | 181 | 40778 | 197036 | 90390452 |
| Drug intolerance | 36.39 | 16.26 | 94 | 40865 | 447497 | 90139991 |
| Hair texture abnormal | 36.38 | 16.26 | 24 | 40935 | 4663 | 90582825 |
| Liver injury | 35.98 | 16.26 | 16 | 40943 | 170551 | 90416937 |
| Band sensation | 35.67 | 16.26 | 15 | 40944 | 1158 | 90586330 |
| Dysstasia | 35.60 | 16.26 | 50 | 40909 | 25002 | 90562486 |
| Hemiparesis | 34.53 | 16.26 | 56 | 40903 | 31763 | 90555725 |
| Dyspnoea | 34.47 | 16.26 | 245 | 40714 | 880710 | 89706778 |
| Progressive multiple sclerosis | 34.26 | 16.26 | 15 | 40944 | 1279 | 90586209 |
| Urinary tract infection | 34.25 | 16.26 | 246 | 40713 | 305386 | 90282102 |
| Trigeminal neuralgia | 34.14 | 16.26 | 22 | 40937 | 4109 | 90583379 |
| Drug interaction | 34.07 | 16.26 | 45 | 40914 | 276408 | 90311080 |
| Temperature intolerance | 33.77 | 16.26 | 34 | 40925 | 11996 | 90575492 |
| Anal incontinence | 33.51 | 16.26 | 39 | 40920 | 16191 | 90571297 |
| Asthenia | 33.24 | 16.26 | 378 | 40581 | 533373 | 90054115 |
| Pancytopenia | 33.03 | 16.26 | 7 | 40952 | 120256 | 90467232 |
| Paraparesis | 32.89 | 16.26 | 19 | 40940 | 2919 | 90584569 |
| Product use issue | 32.79 | 16.26 | 62 | 40897 | 329857 | 90257631 |
| Asthma | 32.38 | 16.26 | 37 | 40922 | 242123 | 90345365 |
| Neuralgia | 32.25 | 16.26 | 54 | 40905 | 31446 | 90556042 |
| Cerebral disorder | 32.17 | 16.26 | 24 | 40935 | 5670 | 90581818 |
| Impaired driving ability | 31.93 | 16.26 | 23 | 40936 | 5150 | 90582338 |
| Dysgraphia | 31.39 | 16.26 | 20 | 40939 | 3663 | 90583825 |
| Pyrexia | 31.33 | 16.26 | 173 | 40786 | 660312 | 89927176 |
| Death | 31.21 | 16.26 | 104 | 40855 | 456447 | 90131041 |
| Delirium | 30.97 | 16.26 | 5 | 40954 | 104354 | 90483134 |
| Dizziness | 30.91 | 16.26 | 404 | 40555 | 588880 | 89998608 |
| Aphasia | 30.74 | 16.26 | 63 | 40896 | 42749 | 90544739 |
| Thrombocytopenia | 30.01 | 16.26 | 30 | 40929 | 208695 | 90378793 |
| Wound infection | 29.62 | 16.26 | 6 | 40953 | 106396 | 90481092 |
| Hypercholesterolaemia | 29.57 | 16.26 | 5 | 40954 | 100887 | 90486601 |
| Back pain | 28.72 | 16.26 | 243 | 40716 | 316932 | 90270556 |
| Lung disorder | 28.68 | 16.26 | 16 | 40943 | 149867 | 90437621 |
| Pulmonary fibrosis | 28.05 | 16.26 | 7 | 40952 | 107496 | 90479992 |
| Infection | 27.94 | 16.26 | 78 | 40881 | 362016 | 90225472 |
| Walking aid user | 27.59 | 16.26 | 54 | 40905 | 35452 | 90552036 |
| Myelitis | 27.50 | 16.26 | 15 | 40944 | 2063 | 90585425 |
| Relapsing multiple sclerosis | 27.03 | 16.26 | 8 | 40951 | 217 | 90587271 |
| Oedema peripheral | 26.93 | 16.26 | 47 | 40912 | 257868 | 90329620 |
| Lipase increased | 26.88 | 16.26 | 29 | 40930 | 11082 | 90576406 |
| Red blood cell sedimentation rate increased | 26.78 | 16.26 | 3 | 40956 | 82592 | 90504896 |
| Respiratory failure | 26.77 | 16.26 | 10 | 40949 | 118408 | 90469080 |
| Intentional overdose | 26.74 | 16.26 | 5 | 40954 | 93829 | 90493659 |
| Trichorrhexis | 26.19 | 16.26 | 13 | 40946 | 1474 | 90586014 |
| Vertigo | 26.01 | 16.26 | 80 | 40879 | 69731 | 90517757 |
| Musculoskeletal disorder | 25.95 | 16.26 | 40 | 40919 | 21729 | 90565759 |
| Blood cholesterol increased | 25.48 | 16.26 | 34 | 40925 | 207978 | 90379510 |
| Product quality issue | 25.42 | 16.26 | 3 | 40956 | 79322 | 90508166 |
| Pollakiuria | 25.41 | 16.26 | 50 | 40909 | 32955 | 90554533 |
| Intervertebral disc protrusion | 24.42 | 16.26 | 44 | 40915 | 27152 | 90560336 |
| Pleural effusion | 24.42 | 16.26 | 10 | 40949 | 111981 | 90475507 |
| Blister | 24.39 | 16.26 | 49 | 40910 | 254949 | 90332539 |
| Influenza like illness | 24.33 | 16.26 | 86 | 40873 | 80525 | 90506963 |
| Eye movement disorder | 24.11 | 16.26 | 21 | 40938 | 6177 | 90581311 |
| SARS-CoV-2 test positive | 23.41 | 16.26 | 27 | 40932 | 11101 | 90576387 |
| Arthralgia | 23.41 | 16.26 | 232 | 40727 | 778290 | 89809198 |
| Sinusitis | 22.85 | 16.26 | 79 | 40880 | 343009 | 90244479 |
| Heteroplasia | 22.77 | 16.26 | 4 | 40955 | 7 | 90587481 |
| Haemoglobin decreased | 22.46 | 16.26 | 24 | 40935 | 161932 | 90425556 |
| Hypokalaemia | 22.33 | 16.26 | 16 | 40943 | 131100 | 90456388 |
| Hip arthroplasty | 21.84 | 16.26 | 4 | 40955 | 76204 | 90511284 |
| Adverse event | 21.80 | 16.26 | 13 | 40946 | 117405 | 90470083 |
| Neutropenia | 21.69 | 16.26 | 43 | 40916 | 224861 | 90362627 |
| Pain | 21.64 | 16.26 | 596 | 40363 | 995745 | 89591743 |
| Nausea | 21.60 | 16.26 | 655 | 40304 | 1109661 | 89477827 |
| Ataxia | 21.30 | 16.26 | 33 | 40926 | 18009 | 90569479 |
| Nerve compression | 21.17 | 16.26 | 25 | 40934 | 10541 | 90576947 |
| Hot flush | 21.08 | 16.26 | 67 | 40892 | 59421 | 90528067 |
| Ill-defined disorder | 20.88 | 16.26 | 32 | 40927 | 184859 | 90402629 |
| Needle fatigue | 20.51 | 16.26 | 6 | 40953 | 156 | 90587332 |
| Psoriasis | 20.37 | 16.26 | 22 | 40937 | 147732 | 90439756 |
| Relapsing-remitting multiple sclerosis | 20.30 | 16.26 | 9 | 40950 | 790 | 90586698 |
| Autoimmune disorder | 20.01 | 16.26 | 5 | 40954 | 76739 | 90510749 |
| Bursitis | 20 | 16.26 | 18 | 40941 | 131636 | 90455852 |
| Hypoglycaemia | 19.31 | 16.26 | 4 | 40955 | 69844 | 90517644 |
| Cardiac arrest | 18.95 | 16.26 | 12 | 40947 | 104923 | 90482565 |
| Paternal exposure timing unspecified | 18.76 | 16.26 | 4 | 40955 | 26 | 90587462 |
| Hypersensitivity | 18.43 | 16.26 | 125 | 40834 | 454552 | 90132936 |
| Blood pressure abnormal | 17.91 | 16.26 | 32 | 40927 | 19613 | 90567875 |
| Blood creatinine increased | 17.76 | 16.26 | 12 | 40947 | 101374 | 90486114 |
| Injection site swelling | 17.45 | 16.26 | 3 | 40956 | 59836 | 90527652 |
| Functional gastrointestinal disorder | 17.41 | 16.26 | 16 | 40943 | 5046 | 90582442 |
| Hyperkalaemia | 17.40 | 16.26 | 4 | 40955 | 64960 | 90522528 |
| Faeces soft | 17.12 | 16.26 | 19 | 40940 | 7492 | 90579996 |
| Joint stiffness | 16.96 | 16.26 | 7 | 40952 | 78035 | 90509453 |
| Colitis microscopic | 16.95 | 16.26 | 23 | 40936 | 11136 | 90576352 |
| Heavy menstrual bleeding | 16.90 | 16.26 | 32 | 40927 | 20498 | 90566990 |
| Bladder discomfort | 16.71 | 16.26 | 8 | 40951 | 838 | 90586650 |
| Wheelchair user | 16.56 | 16.26 | 19 | 40940 | 7766 | 90579722 |
| Weight decreased | 16.47 | 16.26 | 252 | 40707 | 379658 | 90207830 |
| Ophthalmic herpes zoster | 16.31 | 16.26 | 12 | 40947 | 2776 | 90584712 |
| Musculoskeletal pain | 16.29 | 16.26 | 33 | 40926 | 171218 | 90416270 |
| Abortion | 16.28 | 16.26 | 12 | 40947 | 2783 | 90584705 |
FDA Adverse Event Reporting System (Male)
| 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 | 1761.27 | 26.37 | 434 | 8079 | 13830 | 42598992 |
| Alopecia | 279.96 | 26.37 | 130 | 8383 | 29146 | 42583676 |
| Hypoaesthesia | 225.33 | 26.37 | 153 | 8360 | 71310 | 42541512 |
| Paraesthesia | 191.40 | 26.37 | 140 | 8373 | 73319 | 42539503 |
| Gait disturbance | 182.23 | 26.37 | 153 | 8360 | 97847 | 42514975 |
| Product dose omission issue | 150.49 | 26.37 | 169 | 8344 | 154196 | 42458626 |
| Balance disorder | 142.86 | 26.37 | 99 | 8414 | 47546 | 42565276 |
| Fatigue | 110.08 | 26.37 | 257 | 8256 | 435384 | 42177438 |
| Fall | 107.49 | 26.37 | 178 | 8335 | 234342 | 42378480 |
| Multiple sclerosis | 105.78 | 26.37 | 44 | 8469 | 7554 | 42605268 |
| Muscle spasticity | 89.91 | 26.37 | 38 | 8475 | 6784 | 42606038 |
| Product dose omission in error | 88.83 | 26.37 | 40 | 8473 | 8314 | 42604508 |
| Visual impairment | 81.34 | 26.37 | 68 | 8445 | 43045 | 42569777 |
| Diarrhoea | 80.45 | 26.37 | 237 | 8276 | 460612 | 42152210 |
| Off label use | 74.97 | 26.37 | 18 | 8495 | 638317 | 41974505 |
| Mobility decreased | 73.54 | 26.37 | 59 | 8454 | 35247 | 42577575 |
| Expanded disability status scale score increased | 66.87 | 26.37 | 16 | 8497 | 438 | 42612384 |
| Memory impairment | 64.81 | 26.37 | 64 | 8449 | 50158 | 42562664 |
| Muscular weakness | 56.15 | 26.37 | 76 | 8437 | 83422 | 42529400 |
| Headache | 55.51 | 26.37 | 137 | 8376 | 239232 | 42373590 |
| Depressed mood | 52.81 | 26.37 | 41 | 8472 | 23343 | 42589479 |
| Acute kidney injury | 47.89 | 26.37 | 8 | 8505 | 367329 | 42245493 |
| Trigeminal neuralgia | 47.25 | 26.37 | 16 | 8497 | 1553 | 42611269 |
| Bladder disorder | 46.73 | 26.37 | 20 | 8493 | 3679 | 42609143 |
| Optic neuritis | 44.56 | 26.37 | 20 | 8493 | 4122 | 42608700 |
| Central nervous system lesion | 43.02 | 26.37 | 24 | 8489 | 7846 | 42604976 |
| Walking aid user | 42.63 | 26.37 | 17 | 8496 | 2616 | 42610206 |
| Decreased interest | 41.95 | 26.37 | 17 | 8496 | 2728 | 42610094 |
| Limb discomfort | 41.68 | 26.37 | 28 | 8485 | 12739 | 42600083 |
| Depression | 39.80 | 26.37 | 76 | 8437 | 111287 | 42501535 |
| Malignant glioma | 39.62 | 26.37 | 7 | 8506 | 38 | 42612784 |
| Drug ineffective | 35.79 | 26.37 | 231 | 8282 | 629966 | 41982856 |
| Condition aggravated | 33.36 | 26.37 | 121 | 8392 | 260633 | 42352189 |
| Secondary progressive multiple sclerosis | 33.21 | 26.37 | 9 | 8504 | 409 | 42612413 |
| Feeling abnormal | 33.17 | 26.37 | 54 | 8459 | 69732 | 42543090 |
| Abdominal discomfort | 32.78 | 26.37 | 56 | 8457 | 75199 | 42537623 |
| Hypotension | 32.69 | 26.37 | 6 | 8507 | 257625 | 42355197 |
| Band sensation | 32.54 | 26.37 | 7 | 8506 | 117 | 42612705 |
| Electric shock sensation | 31.83 | 26.37 | 9 | 8504 | 479 | 42612343 |
| Musculoskeletal stiffness | 30.62 | 26.37 | 47 | 8466 | 57718 | 42555104 |
| Toxicity to various agents | 29.79 | 26.37 | 5 | 8508 | 229131 | 42383691 |
| Upper motor neurone lesion | 29.67 | 26.37 | 7 | 8506 | 180 | 42612642 |
| Pollakiuria | 29.60 | 26.37 | 29 | 8484 | 22476 | 42590346 |
| Pain in extremity | 27.50 | 26.37 | 79 | 8434 | 150525 | 42462297 |
| Unevaluable event | 27.37 | 26.37 | 34 | 8479 | 34254 | 42578568 |
| Hepatic enzyme increased | 26.76 | 26.37 | 39 | 8474 | 45745 | 42567077 |
| Febrile neutropenia | 26.62 | 26.37 | 3 | 8510 | 185700 | 42427122 |
| COVID-19 | 26.39 | 26.37 | 66 | 8447 | 115882 | 42496940 |
FDA Adverse Event Reporting System (Geriatric)
| 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 | 5797.79 | 16.35 | 1624 | 36597 | 48616 | 110502462 |
| Alopecia | 1577.23 | 16.35 | 1170 | 37051 | 363583 | 110187495 |
| Hypoaesthesia | 772.70 | 16.35 | 729 | 37492 | 313494 | 110237584 |
| Paraesthesia | 728.82 | 16.35 | 667 | 37554 | 275854 | 110275224 |
| Balance disorder | 485.53 | 16.35 | 367 | 37854 | 116193 | 110434885 |
| Product dose omission issue | 470.55 | 16.35 | 567 | 37654 | 321215 | 110229863 |
| Gait disturbance | 454.53 | 16.35 | 519 | 37702 | 277689 | 110273389 |
| Fall | 379.09 | 16.35 | 716 | 37505 | 602766 | 109948312 |
| Diarrhoea | 334.35 | 16.35 | 1004 | 37217 | 1138501 | 109412577 |
| Fatigue | 312.19 | 16.35 | 1023 | 37198 | 1214935 | 109336143 |
| Off label use | 264.63 | 16.35 | 95 | 38126 | 1500090 | 109050988 |
| Bladder disorder | 239.53 | 16.35 | 103 | 38118 | 11034 | 110540044 |
| Product dose omission in error | 208.69 | 16.35 | 119 | 38102 | 23393 | 110527685 |
| Multiple sclerosis | 206.70 | 16.35 | 122 | 38099 | 25576 | 110525502 |
| Visual impairment | 206.00 | 16.35 | 243 | 37978 | 134185 | 110416893 |
| Memory impairment | 201.96 | 16.35 | 292 | 37929 | 196652 | 110354426 |
| Muscle spasticity | 190.30 | 16.35 | 131 | 38090 | 35784 | 110515294 |
| Headache | 177.84 | 16.35 | 687 | 37534 | 881690 | 109669388 |
| Depressed mood | 171.97 | 16.35 | 153 | 38068 | 60656 | 110490422 |
| Sensory disturbance | 162.20 | 16.35 | 91 | 38130 | 17338 | 110533740 |
| Depression | 149.41 | 16.35 | 335 | 37886 | 317000 | 110234078 |
| Optic neuritis | 148.61 | 16.35 | 74 | 38147 | 11073 | 110540005 |
| Unevaluable event | 147.91 | 16.35 | 139 | 38082 | 59088 | 110491990 |
| Limb discomfort | 142.55 | 16.35 | 116 | 38105 | 40738 | 110510340 |
| Toxicity to various agents | 134.15 | 16.35 | 8 | 38213 | 480547 | 110070531 |
| Acute kidney injury | 132.38 | 16.35 | 29 | 38192 | 635401 | 109915677 |
| Central nervous system lesion | 125.48 | 16.35 | 74 | 38147 | 15479 | 110535599 |
| Decreased interest | 120.91 | 16.35 | 50 | 38171 | 4858 | 110546220 |
| Muscular weakness | 119.91 | 16.35 | 265 | 37956 | 248203 | 110302875 |
| Infusion related reaction | 117.61 | 16.35 | 3 | 38218 | 381159 | 110169919 |
| Feeling abnormal | 111.07 | 16.35 | 213 | 38008 | 180498 | 110370580 |
| Urinary incontinence | 102.53 | 16.35 | 104 | 38117 | 48483 | 110502595 |
| Burning sensation | 102.46 | 16.35 | 123 | 38098 | 69089 | 110481989 |
| Expanded disability status scale score increased | 102.27 | 16.35 | 29 | 38192 | 889 | 110550189 |
| Febrile neutropenia | 95.84 | 16.35 | 3 | 38218 | 316764 | 110234314 |
| COVID-19 | 93.95 | 16.35 | 239 | 37982 | 244821 | 110306257 |
| Pain in extremity | 92.63 | 16.35 | 373 | 37848 | 486745 | 110064333 |
| Secondary progressive multiple sclerosis | 90.95 | 16.35 | 30 | 38191 | 1539 | 110549539 |
| Mobility decreased | 90.44 | 16.35 | 231 | 37990 | 237191 | 110313887 |
| Cognitive disorder | 85.60 | 16.35 | 127 | 38094 | 87384 | 110463694 |
| Throat clearing | 79.98 | 16.35 | 36 | 38185 | 4297 | 110546781 |
| Hypotension | 79.41 | 16.35 | 41 | 38180 | 523808 | 110027270 |
| Synovitis | 78.18 | 16.35 | 4 | 38217 | 274088 | 110276990 |
| JC polyomavirus test positive | 75.54 | 16.35 | 29 | 38192 | 2318 | 110548760 |
| Magnetic resonance imaging abnormal | 73.53 | 16.35 | 33 | 38188 | 3912 | 110547166 |
| Trigeminal neuralgia | 70.43 | 16.35 | 33 | 38188 | 4319 | 110546759 |
| Movement disorder | 69.75 | 16.35 | 74 | 38147 | 36330 | 110514748 |
| Contraindicated product administered | 69.63 | 16.35 | 4 | 38217 | 248263 | 110302815 |
| Completed suicide | 64.76 | 16.35 | 5 | 38216 | 242376 | 110308702 |
| Tremor | 64.17 | 16.35 | 184 | 38037 | 202048 | 110349030 |
| Glossodynia | 64.07 | 16.35 | 3 | 38218 | 222001 | 110329077 |
| Drug hypersensitivity | 63.82 | 16.35 | 39 | 38182 | 454051 | 110097027 |
| Pericarditis | 63.11 | 16.35 | 3 | 38218 | 219111 | 110331967 |
| Hand deformity | 62.91 | 16.35 | 3 | 38218 | 218503 | 110332575 |
| Stress | 62.03 | 16.35 | 122 | 38099 | 105226 | 110445852 |
| Maternal exposure during pregnancy | 60.98 | 16.35 | 8 | 38213 | 254875 | 110296203 |
| Intentional product use issue | 58.79 | 16.35 | 8 | 38213 | 247898 | 110303180 |
| Wheezing | 58.75 | 16.35 | 9 | 38212 | 255221 | 110295857 |
| Systemic lupus erythematosus | 58.47 | 16.35 | 9 | 38212 | 254329 | 110296749 |
| Condition aggravated | 58.47 | 16.35 | 444 | 37777 | 734392 | 109816686 |
| Lymphopenia | 57.17 | 16.35 | 70 | 38151 | 40100 | 110510978 |
| Speech disorder | 56.85 | 16.35 | 87 | 38134 | 61482 | 110489596 |
| Drug interaction | 56.22 | 16.35 | 54 | 38167 | 500129 | 110050949 |
| Band sensation | 56.08 | 16.35 | 19 | 38202 | 1059 | 110550019 |
| Rheumatoid arthritis | 55.93 | 16.35 | 17 | 38204 | 299596 | 110251482 |
| Lower respiratory tract infection | 54.99 | 16.35 | 9 | 38212 | 243097 | 110307981 |
| Treatment failure | 54.98 | 16.35 | 14 | 38207 | 277220 | 110273858 |
| Pneumonia | 53.72 | 16.35 | 142 | 38079 | 876572 | 109674506 |
| Walking aid user | 53.49 | 16.35 | 54 | 38167 | 25021 | 110526057 |
| Muscle spasms | 52.77 | 16.35 | 213 | 38008 | 277944 | 110273134 |
| Pain | 52.09 | 16.35 | 531 | 37690 | 954424 | 109596654 |
| Therapeutic product effect decreased | 51.09 | 16.35 | 11 | 38210 | 244305 | 110306773 |
| Helicobacter infection | 50.78 | 16.35 | 3 | 38218 | 181874 | 110369204 |
| Anaemia | 50.71 | 16.35 | 69 | 38152 | 547017 | 110004061 |
| Vision blurred | 50.60 | 16.35 | 127 | 38094 | 128895 | 110422183 |
| Hyponatraemia | 49.36 | 16.35 | 8 | 38213 | 217645 | 110333433 |
| Pancytopenia | 49.14 | 16.35 | 7 | 38214 | 209606 | 110341472 |
| Electric shock sensation | 48.55 | 16.35 | 20 | 38201 | 1924 | 110549154 |
| Breast cancer | 48.24 | 16.35 | 63 | 38158 | 38479 | 110512599 |
| Overdose | 47.93 | 16.35 | 11 | 38210 | 233783 | 110317295 |
| Spinal operation | 46.59 | 16.35 | 35 | 38186 | 10937 | 110540141 |
| General physical health deterioration | 46.53 | 16.35 | 47 | 38174 | 425248 | 110125830 |
| Peroneal nerve palsy | 46.38 | 16.35 | 30 | 38191 | 7384 | 110543694 |
| Surgery | 46.36 | 16.35 | 64 | 38157 | 41219 | 110509859 |
| Pollakiuria | 45.90 | 16.35 | 66 | 38155 | 44129 | 110506949 |
| Micturition urgency | 43.78 | 16.35 | 43 | 38178 | 19277 | 110531801 |
| Incontinence | 43.36 | 16.35 | 40 | 38181 | 16595 | 110534483 |
| Folliculitis | 43.29 | 16.35 | 4 | 38217 | 167649 | 110383429 |
| Therapeutic product effect incomplete | 43.05 | 16.35 | 12 | 38209 | 223793 | 110327285 |
| Psoriatic arthropathy | 42.93 | 16.35 | 8 | 38213 | 196753 | 110354325 |
| Joint swelling | 42.92 | 16.35 | 54 | 38167 | 442791 | 110108287 |
| Impaired driving ability | 42.89 | 16.35 | 27 | 38194 | 6343 | 110544735 |
| Therapy non-responder | 42.71 | 16.35 | 3 | 38218 | 157304 | 110393774 |
| Urinary tract infection | 42.67 | 16.35 | 224 | 37997 | 326058 | 110225020 |
| Injection site pain | 41.57 | 16.35 | 6 | 38215 | 177916 | 110373162 |
| Progressive multiple sclerosis | 41.33 | 16.35 | 16 | 38205 | 1308 | 110549770 |
| Stomatitis | 41.13 | 16.35 | 21 | 38200 | 270221 | 110280857 |
| Wound | 40.78 | 16.35 | 15 | 38206 | 234422 | 110316656 |
| Hair texture abnormal | 40.51 | 16.35 | 22 | 38199 | 3932 | 110547146 |
| Sexual dysfunction | 40.26 | 16.35 | 29 | 38192 | 8501 | 110542577 |
| Bradycardia | 39.39 | 16.35 | 4 | 38217 | 155513 | 110395565 |
| Fibromyalgia | 39.38 | 16.35 | 6 | 38215 | 170903 | 110380175 |
| Neutropenia | 39.17 | 16.35 | 43 | 38178 | 374577 | 110176501 |
| Oedema | 39.02 | 16.35 | 12 | 38209 | 209964 | 110341114 |
| Illness | 38.85 | 16.35 | 87 | 38134 | 82084 | 110468994 |
| Back pain | 38.84 | 16.35 | 240 | 37981 | 370756 | 110180322 |
| Thrombocytopenia | 38.79 | 16.35 | 38 | 38183 | 348847 | 110202231 |
| Blood pressure increased | 38.44 | 16.35 | 184 | 38037 | 258189 | 110292889 |
| Paraparesis | 37.55 | 16.35 | 22 | 38199 | 4544 | 110546534 |
| Asthenia | 37.42 | 16.35 | 383 | 37838 | 688616 | 109862462 |
| Disease progression | 37.08 | 16.35 | 19 | 38202 | 244015 | 110307063 |
| Dysstasia | 36.83 | 16.35 | 51 | 38170 | 32935 | 110518143 |
| Death | 36.40 | 16.35 | 122 | 38099 | 698747 | 109852331 |
| Hemiparesis | 36.32 | 16.35 | 59 | 38162 | 43844 | 110507234 |
| Eosinophilic colitis | 36.09 | 16.35 | 12 | 38209 | 631 | 110550447 |
| Hyperkalaemia | 35.71 | 16.35 | 3 | 38218 | 135793 | 110415285 |
| Osteoarthritis | 34.73 | 16.35 | 10 | 38211 | 182613 | 110368465 |
| Dysgraphia | 34.36 | 16.35 | 21 | 38200 | 4684 | 110546394 |
| Nausea | 33.55 | 16.35 | 606 | 37615 | 1235084 | 109315994 |
| Type 2 diabetes mellitus | 33.16 | 16.35 | 10 | 38211 | 177222 | 110373856 |
| Delirium | 32.86 | 16.35 | 4 | 38217 | 135021 | 110416057 |
| Onychoclasis | 32.78 | 16.35 | 24 | 38197 | 7213 | 110543865 |
| Dizziness | 31.87 | 16.35 | 375 | 37846 | 697818 | 109853260 |
| Trichorrhexis | 31.58 | 16.35 | 12 | 38209 | 933 | 110550145 |
| Haemoglobin decreased | 31.39 | 16.35 | 24 | 38197 | 248703 | 110302375 |
| Relapsing-remitting multiple sclerosis | 31.28 | 16.35 | 15 | 38206 | 2067 | 110549011 |
| Malignant glioma | 30.72 | 16.35 | 7 | 38214 | 86 | 110550992 |
| Pyrexia | 30.41 | 16.35 | 184 | 38037 | 898081 | 109652997 |
| C-reactive protein increased | 30.19 | 16.35 | 19 | 38202 | 217900 | 110333178 |
| Intervertebral disc protrusion | 29.69 | 16.35 | 42 | 38179 | 27656 | 110523422 |
| Blood creatinine increased | 29.68 | 16.35 | 13 | 38208 | 182876 | 110368202 |
| Temperature intolerance | 29.67 | 16.35 | 30 | 38191 | 13920 | 110537158 |
| Renal impairment | 29.64 | 16.35 | 14 | 38207 | 188431 | 110362647 |
| Influenza like illness | 29.54 | 16.35 | 82 | 38139 | 88330 | 110462748 |
| Drug intolerance | 29.53 | 16.35 | 60 | 38161 | 406452 | 110144626 |
| Hypoglycaemia | 29.37 | 16.35 | 3 | 38218 | 116101 | 110434977 |
| Lipase increased | 28.96 | 16.35 | 34 | 38187 | 18638 | 110532440 |
| Dyspnoea | 28.63 | 16.35 | 245 | 37976 | 1106627 | 109444451 |
| Disturbance in attention | 28.59 | 16.35 | 65 | 38156 | 61930 | 110489148 |
| Confusional state | 28.57 | 16.35 | 76 | 38145 | 468604 | 110082474 |
| Obesity | 28.48 | 16.35 | 3 | 38218 | 113348 | 110437730 |
| Sensory loss | 28.30 | 16.35 | 36 | 38185 | 21421 | 110529657 |
| Pleural effusion | 28.26 | 16.35 | 13 | 38208 | 177696 | 110373382 |
| Respiratory failure | 28.18 | 16.35 | 20 | 38201 | 215312 | 110335766 |
| Injury | 28.14 | 16.35 | 13 | 38208 | 177252 | 110373826 |
| Platelet count decreased | 28.12 | 16.35 | 23 | 38198 | 230420 | 110320658 |
| Aphasia | 27.36 | 16.35 | 62 | 38159 | 58935 | 110492143 |
| Arthropathy | 26.87 | 16.35 | 36 | 38185 | 287486 | 110263592 |
| Wheelchair user | 26.78 | 16.35 | 22 | 38199 | 7820 | 110543258 |
| Hypokalaemia | 26.55 | 16.35 | 15 | 38206 | 182433 | 110368645 |
| Heteroplasia | 26.07 | 16.35 | 5 | 38216 | 24 | 110551054 |
| Rhabdomyolysis | 26.04 | 16.35 | 5 | 38216 | 120396 | 110430682 |
| Neuralgia | 25.97 | 16.35 | 54 | 38167 | 48424 | 110502654 |
| Septic shock | 25.88 | 16.35 | 11 | 38210 | 157517 | 110393561 |
| Intentional overdose | 25.67 | 16.35 | 7 | 38214 | 132494 | 110418584 |
| Swelling | 25.33 | 16.35 | 52 | 38169 | 350989 | 110200089 |
| Bladder discomfort | 25.28 | 16.35 | 10 | 38211 | 866 | 110550212 |
| Cerebral disorder | 25.11 | 16.35 | 20 | 38201 | 6806 | 110544272 |
| Cardiac arrest | 24.81 | 16.35 | 19 | 38202 | 196734 | 110354344 |
| Cardio-respiratory arrest | 24.65 | 16.35 | 5 | 38216 | 115831 | 110435247 |
| Joint range of motion decreased | 24.43 | 16.35 | 6 | 38215 | 121826 | 110429252 |
| Musculoskeletal stiffness | 24.40 | 16.35 | 173 | 38048 | 279649 | 110271429 |
| Cardiac failure congestive | 24.08 | 16.35 | 11 | 38210 | 150989 | 110400089 |
| Liver injury | 23.92 | 16.35 | 11 | 38210 | 150402 | 110400676 |
| Meningoencephalitis herpetic | 23.60 | 16.35 | 13 | 38208 | 2389 | 110548689 |
| Irritable bowel syndrome | 23.18 | 16.35 | 14 | 38207 | 164201 | 110386877 |
| Weight decreased | 22.93 | 16.35 | 255 | 37966 | 467802 | 110083276 |
| Weight increased | 22.68 | 16.35 | 72 | 38149 | 419572 | 110131506 |
| Electrocardiogram QT prolonged | 22.58 | 16.35 | 5 | 38216 | 108955 | 110442123 |
| Pulmonary oedema | 22.15 | 16.35 | 4 | 38217 | 100655 | 110450423 |
| Abdominal discomfort | 21.83 | 16.35 | 220 | 38001 | 393638 | 110157440 |
| Asthma | 21.74 | 16.35 | 33 | 38188 | 250258 | 110300820 |
| Upper motor neurone lesion | 21.65 | 16.35 | 7 | 38214 | 337 | 110550741 |
| Renal failure | 21.54 | 16.35 | 28 | 38193 | 226546 | 110324532 |
| Hypercholesterolaemia | 21.36 | 16.35 | 3 | 38218 | 90834 | 110460244 |
| Cardiac failure | 21.35 | 16.35 | 20 | 38201 | 187606 | 110363472 |
| Hypoxia | 21.34 | 16.35 | 9 | 38212 | 129506 | 110421572 |
| Multiple organ dysfunction syndrome | 21.32 | 16.35 | 13 | 38208 | 151697 | 110399381 |
| Wound infection | 20.87 | 16.35 | 4 | 38217 | 96461 | 110454617 |
| Heavy menstrual bleeding | 20.87 | 16.35 | 27 | 38194 | 16338 | 110534740 |
| Anaphylactic reaction | 20.40 | 16.35 | 7 | 38214 | 114293 | 110436785 |
| Anal incontinence | 20.22 | 16.35 | 31 | 38190 | 21933 | 110529145 |
| Impaired healing | 20.09 | 16.35 | 23 | 38198 | 196694 | 110354384 |
| Testicular seminoma (pure) stage I | 19.70 | 16.35 | 4 | 38217 | 27 | 110551051 |
| Interstitial lung disease | 19.50 | 16.35 | 12 | 38209 | 139322 | 110411756 |
| Musculoskeletal disorder | 19.49 | 16.35 | 31 | 38190 | 22633 | 110528445 |
| Neuropathy peripheral | 19.38 | 16.35 | 117 | 38104 | 179160 | 110371918 |
| Vertigo | 19.30 | 16.35 | 70 | 38151 | 86800 | 110464278 |
| Ataxia | 19.10 | 16.35 | 36 | 38185 | 30072 | 110521006 |
| Eye movement disorder | 19.03 | 16.35 | 20 | 38201 | 9708 | 110541370 |
| Frustration tolerance decreased | 18.98 | 16.35 | 19 | 38202 | 8712 | 110542366 |
| Loss of personal independence in daily activities | 18.90 | 16.35 | 102 | 38119 | 149918 | 110401160 |
| Oxygen saturation decreased | 18.74 | 16.35 | 16 | 38205 | 156966 | 110394112 |
| Pulmonary fibrosis | 18.65 | 16.35 | 6 | 38215 | 102036 | 110449042 |
| Migraine | 18.53 | 16.35 | 112 | 38109 | 171540 | 110379538 |
| Hallucination | 18.48 | 16.35 | 6 | 38215 | 101426 | 110449652 |
| Gastrointestinal haemorrhage | 18.41 | 16.35 | 18 | 38203 | 165500 | 110385578 |
| Abortion spontaneous | 18.14 | 16.35 | 38 | 38183 | 34244 | 110516834 |
| Oedema peripheral | 18.03 | 16.35 | 56 | 38165 | 328604 | 110222474 |
| Ascites | 17.79 | 16.35 | 5 | 38216 | 92803 | 110458275 |
| Acne | 17.56 | 16.35 | 37 | 38184 | 33483 | 110517595 |
| Furuncle | 17.28 | 16.35 | 18 | 38203 | 8650 | 110542428 |
| Drug ineffective for unapproved indication | 17.18 | 16.35 | 7 | 38214 | 102831 | 110448247 |
| Ophthalmic herpes zoster | 17.08 | 16.35 | 12 | 38209 | 3383 | 110547695 |
| Hypertension | 17.02 | 16.35 | 259 | 37962 | 509825 | 110041253 |
| Carpal tunnel syndrome | 16.85 | 16.35 | 29 | 38192 | 22581 | 110528497 |
| Faeces soft | 16.71 | 16.35 | 20 | 38201 | 11190 | 110539888 |
| Dehydration | 16.51 | 16.35 | 46 | 38175 | 279465 | 110271613 |
| Lung disorder | 16.36 | 16.35 | 23 | 38198 | 180024 | 110371054 |
FDA Adverse Event Reporting System (Pediatric)
| 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 |
|---|---|---|---|---|---|---|
| Paternal exposure timing unspecified | 27.48 | 13.88 | 4 | 6 | 18 | 113925 |
| Alveolar capillary dysplasia | 23.45 | 13.88 | 3 | 7 | 3 | 113940 |
Pharmacologic Action:
| Source | Code | Description |
|---|---|---|
| ATC | L04AK02 | ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS IMMUNOSUPPRESSANTS IMMUNOSUPPRESSANTS Dihydroorotate dehydrogenase (DHODH) inhibitors |
| MeSH PA | D000700 | Analgesics |
| MeSH PA | D000893 | Anti-Inflammatory Agents |
| MeSH PA | D000894 | Anti-Inflammatory Agents, Non-Steroidal |
| MeSH PA | D007155 | Immunologic Factors |
| MeSH PA | D007166 | Immunosuppressive Agents |
| MeSH PA | D018373 | Peripheral Nervous System Agents |
| MeSH PA | D018501 | Antirheumatic Agents |
| MeSH PA | D018689 | Sensory System Agents |
| MeSH PA | D018712 | Analgesics, Non-Narcotic |
| FDA MoA | N0000185501 | Dihydroorotate Dehydrogenase Inhibitors |
| FDA EPC | N0000185502 | Pyrimidine Synthesis Inhibitor |
| CHEBI has role | CHEBI:35475 | non-steroidal anti-inflammatory drug |
| CHEBI has role | CHEBI:35705 | immunosuppressive agent |
| CHEBI has role | CHEBI:38637 | tyrosine kinase inhibitor |
| CHEBI has role | CHEBI:49103 | drug metabolite |
| CHEBI has role | CHEBI:50908 | hepatotoxic agent |
| CHEBI has role | CHEBI:68542 | EC 1.3.98.1 [dihydroorotate oxidase (fumarate)] inhibitor |
| CHEBI has role | CHEBI:231911 | renoprotective agent |
Related Drugs by ATC class:
L04AK Dihydroorotate dehydrogenase (DHODH) inhibitors 1 drug
Drug Use | Suggest Off label Use Form| |View source of the data|
| 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 |
🐶 Veterinary Drug Use
None
🐶 Veterinary products
None
Acid dissociation constants calculated using MoKa v3.0.0
| Dissociation level | Dissociation constant | Type (acidic/basic) |
|---|---|---|
| pKa1 | 5.59 | acidic |
| pKa2 | 10.61 | acidic |
Orange Book patent data (new drug applications)
| 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 |
Orange Book exclusivity data (new drug applications)
None
Bioactivity Summary:
| 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 |
External reference:
| ID | Source |
|---|---|
| D10172 | KEGG_DRUG |
| 4031717 | VANDF |
| CHEBI:68540 | CHEBI |
| CHEMBL973 | ChEMBL_ID |
| C527525 | MESH_SUPPLEMENTAL_RECORD_UI |
| 6844 | IUPHAR_LIGAND_ID |
| DB08880 | DRUGBANK_ID |
| 1C058IKG3B | UNII |
| 1310520 | RXNORM |
| 193228 | MMSL |
| 28846 | MMSL |
| 365635 | MMSL |
| d07905 | MMSL |
| 014643 | NDDF |
| 703785006 | SNOMEDCT_US |
| 703786007 | SNOMEDCT_US |
| C1718383 | UMLSCUI |
| A26 | PDB_CHEM_ID |
| 7761 | INN_ID |
| 54684141 | PUBCHEM_CID |
| 1C058IKG3B | INXIGHT DRUGS |
Pharmaceutical products:
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| Teriflunomide | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0378-0627 | TABLET, FILM COATED | 7 mg | ORAL | ANDA | 31 sections |
| Teriflunomide | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0378-0628 | TABLET, FILM COATED | 14 mg | ORAL | ANDA | 31 sections |
| Teriflunomide | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0480-3156 | TABLET, FILM COATED | 14 mg | ORAL | ANDA | 28 sections |
| Teriflunomide | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0480-3157 | TABLET, FILM COATED | 7 mg | ORAL | ANDA | 28 sections |
| Teriflunomide | HUMAN PRESCRIPTION DRUG LABEL | 1 | 16729-399 | TABLET, FILM COATED | 7 mg | ORAL | ANDA | 29 sections |
| Teriflunomide | HUMAN PRESCRIPTION DRUG LABEL | 1 | 16729-400 | TABLET, FILM COATED | 14 mg | ORAL | ANDA | 29 sections |
| Teriflunomide | HUMAN PRESCRIPTION DRUG LABEL | 1 | 31722-246 | TABLET, FILM COATED | 7 mg | ORAL | ANDA | 28 sections |
| Teriflunomide | HUMAN PRESCRIPTION DRUG LABEL | 1 | 31722-247 | TABLET, FILM COATED | 14 mg | ORAL | ANDA | 28 sections |
| Teriflunomide | HUMAN PRESCRIPTION DRUG LABEL | 1 | 42291-830 | TABLET, FILM COATED | 7 mg | ORAL | ANDA | 28 sections |
| Teriflunomide | HUMAN PRESCRIPTION DRUG LABEL | 1 | 42291-831 | TABLET, FILM COATED | 14 mg | ORAL | ANDA | 28 sections |
| TERIFLUNOMIDE | Human Prescription Drug Label | 1 | 46708-313 | TABLET, FILM COATED | 7 mg | ORAL | ANDA | 29 sections |
| TERIFLUNOMIDE | Human Prescription Drug Label | 1 | 46708-314 | TABLET, FILM COATED | 14 mg | ORAL | ANDA | 29 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 |
| Teriflunomide | Human Prescription Drug Label | 1 | 59651-054 | TABLET | 7 mg | ORAL | ANDA | 29 sections |
| Teriflunomide | Human Prescription Drug Label | 1 | 59651-055 | TABLET | 14 mg | ORAL | ANDA | 29 sections |
| TERIFLUNOMIDE | Human Prescription Drug Label | 1 | 62332-313 | TABLET, FILM COATED | 7 mg | ORAL | ANDA | 29 sections |
| TERIFLUNOMIDE | Human Prescription Drug Label | 1 | 62332-314 | TABLET, FILM COATED | 14 mg | ORAL | ANDA | 29 sections |
| TERIFLUNOMIDE | HUMAN PRESCRIPTION DRUG LABEL | 1 | 68254-5010 | TABLET, FILM COATED | 14 mg | ORAL | ANDA | 25 sections |
| TERIFLUNOMIDE | HUMAN PRESCRIPTION DRUG LABEL | 1 | 68254-5013 | TABLET, FILM COATED | 7 mg | ORAL | ANDA | 25 sections |
| teriflunomide | HUMAN PRESCRIPTION DRUG LABEL | 1 | 68462-423 | TABLET, FILM COATED | 7 mg | ORAL | ANDA | 29 sections |
| teriflunomide | HUMAN PRESCRIPTION DRUG LABEL | 1 | 68462-424 | TABLET, FILM COATED | 14 mg | ORAL | ANDA | 29 sections |
| Teriflunomide | Human Prescription Drug Label | 1 | 69339-169 | TABLET | 7 mg | ORAL | ANDA | 28 sections |
| Teriflunomide | Human Prescription Drug Label | 1 | 69339-170 | TABLET | 14 mg | ORAL | ANDA | 28 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 |
| Teriflunomide | Human Prescription Drug Label | 1 | 69539-315 | TABLET, FILM COATED | 7 mg | ORAL | ANDA | 27 sections |
| Teriflunomide | Human Prescription Drug Label | 1 | 69539-316 | TABLET, FILM COATED | 14 mg | ORAL | ANDA | 27 sections |
| Teriflunomide | HUMAN PRESCRIPTION DRUG LABEL | 1 | 70377-017 | TABLET, FILM COATED | 7 mg | ORAL | ANDA | 29 sections |
| Teriflunomide | HUMAN PRESCRIPTION DRUG LABEL | 1 | 70377-018 | TABLET, FILM COATED | 14 mg | ORAL | ANDA | 29 sections |