leflunomide Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definitionDrug idCAS RN
1552 75706-12-6

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • leflunomide medac
  • leflunomide
  • arava
  • avara
  • leflunomida
  • leflunomidum
  • lefumide
  • repso
An isoxazole derivative that inhibits dihydroorotate dehydrogenase, the fourth enzyme in the pyrimidine biosynthetic pathway. It is used an immunosuppressive agent in the treatment of RHEUMATOID ARTHRITIS and PSORIATIC ARTHRITIS.
  • Molecular weight: 270.21
  • Formula: C12H9F3N2O2
  • CLOGP: 2.32
  • LIPINSKI: 0
  • HAC: 4
  • HDO: 1
  • TPSA: 55.13
  • ALOGS: -3.51
  • ROTB: 3

  • Status: OFP

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

Drug dosage:

DoseUnitRoute
20 mg O

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 2 Benet LZ, Broccatelli F, Oprea TI
S (Water solubility) 0.02 mg/mL Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine) 1 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 1.23 ┬ÁM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability) 80 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H

Approvals:

DateAgencyCompanyOrphan
Sept. 10, 1998 FDA SANOFI AVENTIS US

FDA Adverse Event Reporting System (Female)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Drug ineffective 19074.91 45.32 5382 7137 96242 2249324
Rheumatoid arthritis 15519.85 45.32 3353 9166 15787 2329779
Drug intolerance 8270.88 45.32 1909 10610 11808 2333758
Treatment failure 5233.53 45.32 1175 11344 6064 2339502
Joint swelling 5155.00 45.32 1366 11153 15453 2330113
Contraindicated product administered 4947.15 45.32 966 11553 2055 2343511
Drug hypersensitivity 3945.38 45.32 1409 11110 45234 2300332
Pain 3786.57 45.32 1473 11046 60384 2285182
Synovitis 3590.26 45.32 728 11791 1998 2343568
Arthralgia 3264.53 45.32 1279 11240 53006 2292560
Therapeutic product effect incomplete 3003.73 45.32 812 11707 9719 2335847
Abdominal discomfort 2793.52 45.32 858 11661 16598 2328968
Condition aggravated 2577.78 45.32 937 11582 31042 2314524
Therapeutic product effect decreased 2403.14 45.32 686 11833 10103 2335463
Alopecia 2385.47 45.32 805 11714 21196 2324370
Rash 2369.44 45.32 1048 11471 58510 2287056
Arthropathy 2337.11 45.32 618 11901 6698 2338868
Nausea 2152.17 45.32 1200 11319 110989 2234577
Pemphigus 2124.24 45.32 376 12143 300 2345266
Fatigue 1948.68 45.32 1025 11494 83848 2261718
Hepatic enzyme increased 1851.36 45.32 549 11970 9253 2336313
Peripheral swelling 1841.16 45.32 628 11891 16969 2328597
C-reactive protein abnormal 1829.43 45.32 340 12179 459 2345107
Swelling 1699.84 45.32 581 11938 15769 2329797
Diarrhoea 1659.79 45.32 918 11601 82646 2262920
Loss of personal independence in daily activities 1647.56 45.32 439 12080 4872 2340694
Systemic lupus erythematosus 1569.49 45.32 403 12116 3818 2341748
Infection 1399.15 45.32 516 12003 17513 2328053
Musculoskeletal stiffness 1384.55 45.32 464 12055 11783 2333783
Rheumatoid factor positive 1300.62 45.32 238 12281 274 2345292
Exposure during pregnancy 1264.83 45.32 526 11993 24693 2320873
Red blood cell sedimentation rate abnormal 1199.29 45.32 223 12296 300 2345266
Hand deformity 1122.07 45.32 238 12281 848 2344718
Vomiting 1113.02 45.32 673 11846 70929 2274637
Glossodynia 1077.15 45.32 256 12263 1689 2343877
C-reactive protein increased 1030.53 45.32 316 12203 5939 2339627
Headache 1022.97 45.32 665 11854 79514 2266052
Gastrointestinal disorder 979.32 45.32 331 12188 8586 2336980
Mobility decreased 979.28 45.32 330 12189 8480 2337086
Bone erosion 933.33 45.32 183 12336 383 2345183
Alanine aminotransferase increased 921.31 45.32 356 12163 13676 2331890
Pneumonia 891.33 45.32 512 12007 48784 2296782
Gait disturbance 859.17 45.32 388 12131 22157 2323409
Anti-cyclic citrullinated peptide antibody positive 840.29 45.32 143 12376 60 2345506
Hypersensitivity 826.61 45.32 383 12136 23210 2322356
Knee arthroplasty 821.03 45.32 224 12295 2711 2342855
Aspartate aminotransferase increased 820.59 45.32 318 12201 12294 2333272
Pain in extremity 814.53 45.32 459 12060 42081 2303485
Arthritis 769.95 45.32 285 12234 9683 2335883
Osteoporosis 739.21 45.32 226 12293 4188 2341378
Liver function test increased 731.14 45.32 207 12312 2894 2342672
Malaise 715.77 45.32 465 12054 55120 2290446
Osteoarthritis 704.01 45.32 243 12276 6703 2338863
Off label use 703.25 45.32 512 12007 73086 2272480
Therapeutic response decreased 676.43 45.32 238 12281 6957 2338609
Weight decreased 675.16 45.32 354 12165 28017 2317549
Adverse drug reaction 669.62 45.32 245 12274 8038 2337528
Red blood cell sedimentation rate increased 662.78 45.32 177 12342 1960 2343606
Blood iron abnormal 654.69 45.32 113 12406 61 2345505
Interstitial lung disease 634.88 45.32 232 12287 7580 2337986
Leukopenia 616.58 45.32 244 12275 9952 2335614
Psoriatic arthropathy 611.21 45.32 190 12329 3724 2341842
Liver function test abnormal 599.58 45.32 220 12299 7270 2338296
Rheumatoid nodule 595.70 45.32 128 12391 490 2345076
Fibromyalgia 573.81 45.32 174 12345 3126 2342440
Hip arthroplasty 568.98 45.32 153 12366 1741 2343825
Pharyngitis 543.89 45.32 153 12366 2082 2343484
Inflammation 540.11 45.32 194 12325 6019 2339547
Sinusitis 533.72 45.32 254 12265 16272 2329294
Musculoskeletal disorder 516.42 45.32 151 12368 2377 2343189
Ear infection 516.08 45.32 162 12357 3279 2342287
Skin ulcer 497.80 45.32 164 12355 3895 2341671
Musculoskeletal pain 477.83 45.32 207 12312 10623 2334943
Deafness transitory 463.92 45.32 85 12434 98 2345468
Joint stiffness 463.19 45.32 155 12364 3868 2341698
Maternal exposure during pregnancy 460.17 45.32 222 12297 14641 2330925
Hypertension 457.51 45.32 271 12248 27090 2318476
Disability 457.49 45.32 109 12410 723 2344843
Abdominal pain upper 447.33 45.32 248 12271 21852 2323714
Hepatotoxicity 444.36 45.32 145 12374 3336 2342230
Gastrointestinal pain 436.50 45.32 111 12408 995 2344571
Decreased appetite 436.17 45.32 268 12251 28623 2316943
Mouth ulceration 427.75 45.32 145 12374 3767 2341799
Sleep disorder 422.61 45.32 164 12355 6325 2339241
Lower respiratory tract infection 421.57 45.32 156 12363 5268 2340298
Joint range of motion decreased 415.16 45.32 119 12400 1737 2343829
Infusion related reaction 402.04 45.32 178 12341 9618 2335948
Impaired work ability 395.69 45.32 114 12405 1696 2343870
Sciatica 390.57 45.32 117 12402 2008 2343558
Blood alkaline phosphatase increased 375.68 45.32 151 12368 6394 2339172
Granuloma skin 363.08 45.32 65 12454 58 2345508
Dizziness 362.67 45.32 317 12202 58348 2287218
Deformity 357.48 45.32 81 12438 416 2345150
Blood cholesterol increased 357.38 45.32 137 12382 5104 2340462
Non-Hodgkin's lymphoma 356.96 45.32 91 12428 824 2344742
Adverse event 356.06 45.32 152 12367 7507 2338059
Adverse reaction 351.74 45.32 101 12418 1483 2344083
Gamma-glutamyltransferase increased 345.95 45.32 136 12383 5426 2340140
Pulmonary mass 345.13 45.32 104 12415 1822 2343744
Tenosynovitis 343.73 45.32 79 12440 437 2345129
Shoulder arthroplasty 337.02 45.32 74 12445 320 2345246
Back pain 327.38 45.32 232 12287 31427 2314139
Cough 320.26 45.32 233 12286 32884 2312682
Finger deformity 319.92 45.32 82 12437 760 2344806
Panniculitis 314.48 45.32 74 12445 461 2345105
Neck pain 312.93 45.32 139 12380 7558 2338008
Pulmonary fibrosis 312.85 45.32 104 12415 2536 2343030
Dyspnoea 311.80 45.32 333 12186 78400 2267166
Nodule 309.59 45.32 99 12420 2127 2343439
Blood lactate dehydrogenase increased 307.08 45.32 110 12409 3374 2342192
Blood parathyroid hormone decreased 306.85 45.32 62 12457 160 2345406
Visual impairment 302.59 45.32 155 12364 11600 2333966
Hepatitis 301.90 45.32 128 12391 6209 2339357
Anaphylactic reaction 300.20 45.32 145 12374 9560 2336006
Drug eruption 298.98 45.32 106 12413 3153 2342413
Asthenia 298.58 45.32 258 12261 46668 2298898
Fall 295.73 45.32 257 12262 46842 2298724
Foot deformity 291.23 45.32 92 12427 1897 2343669
Stomatitis 291.08 45.32 142 12377 9568 2335998
Lung disorder 291.03 45.32 124 12395 6088 2339478
Skin necrosis 282.18 45.32 79 12440 1052 2344514
Deafness 279.07 45.32 96 12423 2605 2342961
General physical health deterioration 275.69 45.32 155 12364 13984 2331582
Pyrexia 274.35 45.32 261 12258 53447 2292119
Hepatic steatosis 270.23 45.32 98 12421 3115 2342451
Herpes zoster 270.02 45.32 135 12384 9590 2335976
Ill-defined disorder 269.14 45.32 99 12420 3279 2342287
Nasopharyngitis 268.84 45.32 179 12340 21877 2323689
Stress 268.28 45.32 121 12398 6817 2338749
Urticaria 258.04 45.32 181 12338 24080 2321486
Gastric disorder 256.50 45.32 98 12421 3612 2341954
Hypophagia 256.39 45.32 100 12419 3900 2341666
Foot operation 255.35 45.32 67 12452 686 2344880
Therapy non-responder 250.33 45.32 121 12398 7983 2337583
Product use issue 246.99 45.32 137 12382 12032 2333534
Wound 243.65 45.32 87 12432 2641 2342925
Pneumonitis 237.93 45.32 95 12424 3944 2341622
Depression 234.04 45.32 181 12338 27951 2317615
Soft tissue disorder 231.00 45.32 50 12469 199 2345367
Dyspepsia 228.05 45.32 121 12398 9723 2335843
Joint effusion 224.68 45.32 68 12451 1208 2344358
Femur fracture 224.50 45.32 106 12413 6633 2338933
Impaired healing 223.97 45.32 99 12420 5312 2340254
Diabetes mellitus 222.73 45.32 109 12410 7386 2338180
Ulcer 222.46 45.32 74 12445 1806 2343760
International normalised ratio fluctuation 222.17 45.32 51 12468 280 2345286
Spinal stenosis 221.80 45.32 69 12450 1349 2344217
Transaminases increased 216.24 45.32 92 12427 4495 2341071
Abdominal pain 212.28 45.32 186 12333 34188 2311378
Limb deformity 204.98 45.32 46 12473 224 2345342
Pruritus 204.83 45.32 202 12317 43138 2302428
Breast cancer 203.94 45.32 111 12408 9384 2336182
Bronchitis 203.34 45.32 126 12393 13588 2331978
Basal cell carcinoma 200.26 45.32 75 12444 2612 2342954
Breast cancer stage III 198.36 45.32 41 12478 123 2345443
Drug tolerance decreased 192.52 45.32 44 12475 236 2345330
Loss of consciousness 192.43 45.32 137 12382 18630 2326936
Insomnia 190.98 45.32 155 12364 25632 2319934
Eye disorder 190.57 45.32 76 12443 3143 2342423
Rash pruritic 189.84 45.32 98 12421 7437 2338129
Hypoaesthesia 187.78 45.32 139 12380 20076 2325490
Retinal toxicity 184.82 45.32 40 12479 159 2345407
Fine motor skill dysfunction 181.45 45.32 43 12476 277 2345289
Localised infection 181.09 45.32 71 12448 2805 2342761
Hypercalcaemia 181.04 45.32 69 12450 2523 2343043
Oral mucosal exfoliation 178.20 45.32 40 12479 195 2345371
Neutropenia 177.69 45.32 138 12381 21410 2324156
Palpitations 177.66 45.32 124 12395 16332 2329234
Drug-induced liver injury 177.02 45.32 75 12444 3624 2341942
Gait inability 175.09 45.32 86 12433 5869 2339697
Back injury 172.89 45.32 52 12467 903 2344663
Bronchitis chronic 171.77 45.32 44 12475 406 2345160
White blood cell count decreased 170.88 45.32 126 12393 18082 2327484
Liver disorder 169.03 45.32 86 12433 6328 2339238
Cutaneous vasculitis 168.12 45.32 41 12478 303 2345263
Anaemia 167.68 45.32 164 12355 34628 2310938
Impaired gastric emptying 164.40 45.32 50 12469 903 2344663
Joint injury 163.81 45.32 63 12456 2361 2343205
Feeding disorder 163.01 45.32 55 12464 1403 2344163
Demyelination 162.72 45.32 50 12469 936 2344630
Diverticulitis 162.07 45.32 73 12446 4092 2341474
Surgical failure 159.64 45.32 33 12486 99 2345467
Tuberculin test positive 154.77 45.32 43 12476 555 2345011
X-ray abnormal 153.11 45.32 33 12486 128 2345438
Erythema 152.89 45.32 135 12384 25024 2320542
Renal impairment 152.78 45.32 94 12425 9998 2335568
Pustular psoriasis 150.87 45.32 46 12473 838 2344728
Carpal tunnel syndrome 148.98 45.32 56 12463 1969 2343597
Rheumatoid lung 148.72 45.32 33 12486 151 2345415
Bedridden 148.27 45.32 51 12468 1381 2344185
Enthesopathy 146.32 45.32 32 12487 135 2345431
Helicobacter infection 144.96 45.32 41 12478 567 2344999
Osteopenia 144.13 45.32 54 12465 1881 2343685
Colitis microscopic 144.08 45.32 45 12474 891 2344675
Pulmonary toxicity 139.89 45.32 41 12478 648 2344918
Joint arthroplasty 137.75 45.32 36 12483 362 2345204
Blood pressure increased 136.10 45.32 107 12412 16879 2328687
Secretion discharge 135.38 45.32 46 12473 1199 2344367
Ankylosing spondylitis 134.99 45.32 40 12479 658 2344908
Bronchiectasis 134.63 45.32 43 12476 918 2344648
Multiple allergies 134.40 45.32 42 12477 833 2344733
Oral pain 133.62 45.32 60 12459 3337 2342229
Wrist surgery 133.05 45.32 29 12490 120 2345446
Unevaluable event 132.50 45.32 82 12437 8809 2336757
Pneumonia viral 131.51 45.32 36 12483 438 2345128
Jaundice 131.15 45.32 69 12450 5439 2340127
Foot fracture 130.67 45.32 56 12463 2782 2342784
Respiratory disorder 130.28 45.32 62 12457 3942 2341624
Abortion induced 129.80 45.32 59 12460 3377 2342189
Crohn's disease 129.67 45.32 73 12446 6582 2338984
Sensitivity to weather change 127.32 45.32 35 12484 433 2345133
Immobile 127.00 45.32 37 12482 572 2344994
Joint laxity 126.56 45.32 24 12495 38 2345528
Night sweats 125.62 45.32 58 12461 3442 2342124
Thyroid disorder 124.86 45.32 46 12473 1527 2344039
Ovarian neoplasm 123.98 45.32 29 12490 175 2345391
Joint destruction 123.98 45.32 32 12487 305 2345261
Discomfort 123.89 45.32 65 12454 5094 2340472
Spinal column injury 122.73 45.32 30 12489 224 2345342
Tuberculosis 122.61 45.32 48 12471 1887 2343679
Fear of injection 120.15 45.32 39 12480 878 2344688
Neck deformity 119.87 45.32 24 12495 58 2345508
Scar 119.52 45.32 47 12472 1870 2343696
Pharyngeal oedema 119.52 45.32 56 12463 3437 2342129
Influenza like illness 118.49 45.32 86 12433 12028 2333538
Cataract 118.35 45.32 66 12453 5842 2339724
Extremity contracture 116.81 45.32 25 12494 93 2345473
Bone density abnormal 116.47 45.32 32 12487 395 2345171
Red blood cell sedimentation rate 116.32 45.32 20 12499 10 2345556
Hypercholesterolaemia 116.32 45.32 44 12475 1574 2343992
Blood bilirubin increased 116.13 45.32 63 12456 5282 2340284
Arthrodesis 116.00 45.32 28 12491 197 2345369
Urinary tract infection 114.97 45.32 125 12394 29817 2315749
Abortion spontaneous 114.87 45.32 88 12431 13357 2332209
Sepsis 113.83 45.32 100 12419 18388 2327178
Pancytopenia 113.60 45.32 82 12437 11370 2334196
Neoplasm malignant 110.56 45.32 60 12459 5033 2340533
White blood cell count increased 109.83 45.32 67 12452 7011 2338555
Platelet count decreased 108.47 45.32 91 12428 15722 2329844
Myocardial infarction 107.48 45.32 98 12421 18915 2326651
Skin reaction 107.33 45.32 44 12475 1953 2343613
Musculoskeletal deformity 106.61 45.32 19 12500 16 2345550
Staphylococcal infection 105.32 45.32 59 12460 5267 2340299
Renal failure 105.12 45.32 93 12426 17256 2328310
Candida infection 104.32 45.32 48 12471 2825 2342741
Bone disorder 104.13 45.32 50 12469 3242 2342324
Chest pain 103.73 45.32 115 12404 28022 2317544
Amnesia 103.27 45.32 65 12454 7188 2338378
Hepatic function abnormal 103.16 45.32 61 12458 6031 2339535
Injection site reaction 101.96 45.32 86 12433 14966 2330600
Functional gastrointestinal disorder 99.97 45.32 29 12490 441 2345125
Limb discomfort 99.88 45.32 49 12470 3330 2342236
Bursitis 99.02 45.32 41 12478 1867 2343699
Loose body in joint 98.03 45.32 19 12500 36 2345530
Haemoglobin decreased 97.62 45.32 91 12428 18060 2327506
Migraine 96.00 45.32 72 12447 10581 2334985
Red blood cell count decreased 94.66 45.32 51 12468 4215 2341351
Transaminases abnormal 94.29 45.32 21 12498 98 2345468
Irritable bowel syndrome 93.65 45.32 39 12480 1802 2343764
Osteoporotic fracture 93.32 45.32 26 12493 339 2345227
Neck mass 93.25 45.32 26 12493 340 2345226
Psoriasis 90.94 45.32 85 12434 16923 2328643
Limb operation 90.56 45.32 28 12491 535 2345031
Exostosis 90.19 45.32 35 12484 1343 2344223
Accident 90.19 45.32 31 12488 837 2344729
Dry eye 89.76 45.32 48 12471 3908 2341658
Skin papilloma 89.70 45.32 28 12491 553 2345013
Photosensitivity reaction 89.53 45.32 41 12478 2386 2343180
Lower limb fracture 89.04 45.32 39 12480 2042 2343524
Joint dislocation 88.32 45.32 35 12484 1421 2344145
Surgery 87.42 45.32 53 12466 5482 2340084
Encephalitis 87.21 45.32 33 12486 1181 2344385
Neuropathy peripheral 87.20 45.32 70 12449 11362 2334204
Incorrect dosage administered 87.18 45.32 25 12494 364 2345202
Dermatitis 87.15 45.32 40 12479 2340 2343226
Respiratory failure 86.92 45.32 75 12444 13453 2332113
Pericarditis 86.42 45.32 35 12484 1505 2344061
Blood pressure fluctuation 86.31 45.32 37 12482 1838 2343728
Hepatic failure 86.08 45.32 53 12466 5636 2339930
Pleural effusion 85.95 45.32 70 12449 11598 2333968
Ankle arthroplasty 85.22 45.32 17 12502 40 2345526
Polyneuropathy 85.16 45.32 36 12483 1727 2343839
Physical disability 84.85 45.32 21 12498 166 2345400
Ear pain 84.66 45.32 41 12478 2708 2342858
Dislocation of vertebra 84.40 45.32 19 12500 94 2345472
Paraesthesia 84.36 45.32 92 12427 21996 2323570
Thrombocytopenia 84.30 45.32 86 12433 19045 2326521
Disease susceptibility 83.74 45.32 16 12503 27 2345539
Spinal disorder 83.71 45.32 32 12487 1178 2344388
Toxicity to various agents 83.38 45.32 111 12408 32643 2312923
Dermatitis allergic 83.12 45.32 37 12482 2014 2343552
Multiple fractures 82.34 45.32 27 12492 628 2344938
Treatment noncompliance 82.32 45.32 51 12468 5483 2340083
Iron deficiency anaemia 82.30 45.32 37 12482 2062 2343504
Contusion 82.26 45.32 71 12448 12739 2332827
Tenderness 82.24 45.32 36 12483 1882 2343684
Polyarthritis 82.21 45.32 29 12490 847 2344719
Inflammatory marker increased 81.70 45.32 26 12493 548 2345018
Back disorder 81.29 45.32 34 12485 1588 2343978
Wrist deformity 81.00 45.32 18 12501 83 2345483
Septic shock 80.38 45.32 55 12464 6999 2338567
Weight increased 80.07 45.32 90 12429 22247 2323319
Platelet count increased 80.04 45.32 37 12482 2200 2343366
Rhinorrhoea 79.65 45.32 56 12463 7444 2338122
Bloody discharge 79.17 45.32 19 12500 130 2345436
Rheumatoid factor negative 78.98 45.32 14 12505 11 2345555
Synovial cyst 78.60 45.32 28 12491 842 2344724
Hepatic cirrhosis 78.26 45.32 37 12482 2316 2343250
Wound infection 78.14 45.32 31 12488 1262 2344304
Thyroid neoplasm 77.98 45.32 26 12493 638 2344928
Upper respiratory tract infection 77.92 45.32 59 12460 8792 2336774
Intervertebral disc protrusion 77.83 45.32 40 12479 3001 2342565
Mucosal inflammation 77.34 45.32 48 12471 5176 2340390
Blood creatinine increased 77.17 45.32 63 12456 10470 2335096
Skin disorder 76.65 45.32 42 12477 3589 2341977
Liver injury 75.78 45.32 36 12483 2278 2343288
Gastroenteritis 74.72 45.32 39 12480 3021 2342545
Intentional product use issue 74.20 45.32 41 12478 3561 2342005
Myalgia 73.55 45.32 88 12431 23245 2322321
Lymphadenopathy 73.51 45.32 48 12471 5650 2339916
Intervertebral disc space narrowing 73.04 45.32 17 12502 100 2345466
Presbyacusis 72.55 45.32 15 12504 45 2345521
Multiple organ dysfunction syndrome 71.87 45.32 53 12466 7588 2337978
Abdominal distension 71.54 45.32 60 12459 10351 2335215
Dyspnoea exertional 70.91 45.32 47 12472 5673 2339893
Sjogren's syndrome 70.62 45.32 27 12492 994 2344572
Blister 70.60 45.32 50 12469 6721 2338845
Vasculitic rash 70.55 45.32 18 12501 163 2345403
Nephrolithiasis 70.45 45.32 43 12476 4500 2341066
Haematocrit decreased 69.87 45.32 42 12477 4276 2341290
Eye haemorrhage 69.75 45.32 29 12490 1334 2344232
Arthritis bacterial 68.92 45.32 25 12494 793 2344773
Seronegative arthritis 68.63 45.32 15 12504 63 2345503
Nonalcoholic fatty liver disease 68.22 45.32 14 12505 40 2345526
Rotator cuff syndrome 67.85 45.32 31 12488 1794 2343772
Disease recurrence 67.59 45.32 38 12481 3413 2342153
Anaphylactic shock 67.57 45.32 41 12478 4245 2341321
Eating disorder 67.18 45.32 33 12486 2248 2343318
Nasal congestion 67.05 45.32 49 12470 6917 2338649
Labile blood pressure 66.83 45.32 18 12501 205 2345361
Pleural thickening 66.66 45.32 15 12504 74 2345492
Hepatic fibrosis 66.13 45.32 22 12497 536 2345030
Swelling face 65.82 45.32 55 12464 9438 2336128
Investigation abnormal 65.69 45.32 15 12504 80 2345486
Lung neoplasm 65.25 45.32 25 12494 926 2344640
Skin lesion 64.74 45.32 39 12480 3986 2341580
Gingival bleeding 64.34 45.32 31 12488 2024 2343542
Ankle deformity 64.21 45.32 14 12505 58 2345508
Mean cell volume decreased 64.16 45.32 18 12501 241 2345325
Mean cell haemoglobin decreased 63.03 45.32 18 12501 258 2345308
Pancreatitis 62.73 45.32 50 12469 8029 2337537
Intervertebral disc compression 62.41 45.32 16 12503 148 2345418
Oral herpes 62.30 45.32 31 12488 2171 2343395
Cyst 62.19 45.32 28 12491 1565 2344001
Viral upper respiratory tract infection 62.05 45.32 25 12494 1060 2344506
Cardiac failure 61.86 45.32 59 12460 12035 2333531
Fracture 61.56 45.32 33 12486 2698 2342868
Hot flush 61.18 45.32 47 12472 7152 2338414
Syncope 60.46 45.32 68 12451 16807 2328759
Pyelonephritis 60.16 45.32 30 12489 2111 2343455
Body temperature increased 59.63 45.32 34 12485 3137 2342429
Respiratory tract infection 59.58 45.32 37 12482 3992 2341574
Pleural fibrosis 59.18 45.32 16 12503 185 2345381
Red cell distribution width decreased 58.84 45.32 13 12506 58 2345508
Oral disorder 58.75 45.32 26 12493 1395 2344171
Gastric ulcer 58.50 45.32 33 12486 2983 2342583
Pneumocystis jirovecii pneumonia 58.46 45.32 30 12489 2243 2343323
Cholecystectomy 58.41 45.32 27 12492 1605 2343961
Bone swelling 57.89 45.32 16 12503 202 2345364
Gallbladder disorder 57.66 45.32 32 12487 2802 2342764
Laboratory test abnormal 57.33 45.32 40 12479 5250 2340316
Mean platelet volume decreased 57.09 45.32 14 12505 106 2345460
Acute hepatic failure 56.97 45.32 31 12488 2611 2342955
Blood magnesium increased 56.84 45.32 15 12504 157 2345409
Radiculopathy 56.59 45.32 21 12498 711 2344855
Oral candidiasis 56.59 45.32 28 12491 1937 2343629
Bone cyst 56.33 45.32 15 12504 163 2345403
Chills 56.28 45.32 63 12456 15489 2330077
Tendonitis 56.14 45.32 29 12490 2198 2343368
Lyme disease 55.75 45.32 18 12501 398 2345168
Gastrooesophageal reflux disease 55.54 45.32 49 12470 9046 2336520
Osteomyelitis 55.34 45.32 34 12485 3599 2341967
Pneumothorax 55.12 45.32 29 12490 2283 2343283
C-reactive protein 55.11 45.32 11 12508 26 2345540
Glaucoma 54.89 45.32 28 12491 2067 2343499
Feeling abnormal 54.05 45.32 76 12443 23505 2322061
Tooth infection 53.60 45.32 27 12492 1941 2343625
Dysphagia 53.56 45.32 56 12463 12749 2332817
Systemic lupus erythematosus rash 53.52 45.32 15 12504 200 2345366
Endodontic procedure 52.96 45.32 18 12501 469 2345097
Hypogammaglobulinaemia 52.73 45.32 20 12499 720 2344846
Steatohepatitis 52.55 45.32 12 12507 64 2345502
Anxiety 52.16 45.32 84 12435 29275 2316291
Elbow deformity 52.09 45.32 12 12507 67 2345499
Crying 51.79 45.32 35 12484 4361 2341205
Pulmonary embolism 51.78 45.32 65 12454 18018 2327548
Bacteriuria 51.63 45.32 13 12506 111 2345455
No adverse event 51.63 45.32 48 12471 9480 2336086
Anti-cyclic citrullinated peptide antibody 51.39 45.32 9 12510 6 2345560
Influenza 51.17 45.32 55 12464 12923 2332643
Deafness neurosensory 51.11 45.32 18 12501 523 2345043
Intraocular pressure increased 51.01 45.32 24 12495 1485 2344081
Angioedema 50.80 45.32 45 12474 8351 2337215
Vascular access complication 50.63 45.32 13 12506 121 2345445
Abnormal loss of weight 50.58 45.32 19 12500 666 2344900
Bursitis infective 50.14 45.32 12 12507 81 2345485
Neck surgery 49.06 45.32 14 12505 200 2345366
Muscle spasticity 48.93 45.32 24 12495 1629 2343937
Muscular weakness 48.26 45.32 57 12462 14840 2330726
Bone marrow failure 48.05 45.32 37 12482 5649 2339917
Productive cough 47.99 45.32 36 12483 5285 2340281
Arthritis infective 47.91 45.32 18 12501 631 2344935
Pruritus allergic 47.80 45.32 13 12506 154 2345412
Urosepsis 47.65 45.32 25 12494 1956 2343610
Hypermobility syndrome 47.65 45.32 10 12509 33 2345533
Infiltration anaesthesia 47.22 45.32 8 12511 3 2345563
Hyperhidrosis 46.67 45.32 57 12462 15365 2330201
Skin warm 46.64 45.32 18 12501 680 2344886
Drug resistance 46.31 45.32 27 12492 2597 2342969
Poor venous access 46.23 45.32 19 12500 848 2344718
Keratoacanthoma 45.87 45.32 12 12507 121 2345445
Diabetic eye disease 45.79 45.32 9 12510 19 2345547
Mood swings 45.77 45.32 29 12490 3240 2342326
Stress at work 45.61 45.32 12 12507 124 2345442
Sleep disorder due to general medical condition, insomnia type 45.37 45.32 15 12504 358 2345208

FDA Adverse Event Reporting System (Male)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Drug ineffective 4093.59 50.85 1212 1910 62589 1681070
Rheumatoid arthritis 2379.62 50.85 482 2640 4103 1739556
Drug intolerance 1319.60 50.85 314 2808 5748 1737911
Joint swelling 1247.93 50.85 303 2819 6050 1737609
Treatment failure 887.46 50.85 215 2907 4186 1739473
Contraindicated product administered 849.39 50.85 170 2952 1274 1742385
Pain 752.43 50.85 285 2837 26372 1717287
Pneumonia 607.41 50.85 287 2835 45895 1697764
C-reactive protein abnormal 599.76 50.85 98 3024 169 1743490
Arthralgia 575.32 50.85 227 2895 23217 1720442
Drug hypersensitivity 566.67 50.85 200 2922 14935 1728724
Stomatitis 565.58 50.85 157 2965 5247 1738412
Synovitis 554.74 50.85 107 3015 638 1743021
Drug eruption 532.61 50.85 132 2990 2794 1740865
Pain in extremity 524.12 50.85 199 2923 18273 1725386
Loss of personal independence in daily activities 485.99 50.85 118 3004 2281 1741378
Bone erosion 464.91 50.85 77 3045 150 1743509
Urticaria 458.26 50.85 162 2960 12079 1731580
Hypersensitivity 455.68 50.85 155 2967 10289 1733370
Hepatic function abnormal 421.45 50.85 133 2989 6941 1736718
Apparent death 396.40 50.85 70 3052 230 1743429
Mobility decreased 375.33 50.85 107 3015 3913 1739746
Diverticulitis 373.41 50.85 95 3027 2230 1741429
Arthropathy 372.66 50.85 99 3023 2768 1740891
Epistaxis 364.65 50.85 124 2998 8182 1735477
Muscle spasms 364.12 50.85 135 2987 11486 1732173
Therapeutic product effect decreased 336.12 50.85 109 3013 6188 1737471
Nausea 330.54 50.85 199 2923 50997 1692662
Red blood cell sedimentation rate abnormal 327.99 50.85 51 3071 50 1743609
Condition aggravated 314.18 50.85 144 2978 21006 1722653
Alanine aminotransferase increased 306.73 50.85 121 3001 12157 1731502
Peripheral swelling 299.41 50.85 106 3016 7865 1735794
Impaired work ability 272.97 50.85 64 3058 1049 1742610
Sleep disorder due to general medical condition, insomnia type 267.47 50.85 45 3077 100 1743559
Limb discomfort 261.96 50.85 65 3057 1367 1742292
Therapeutic product effect incomplete 257.10 50.85 86 3036 5362 1738297
Renal failure 255.92 50.85 123 2999 19894 1723765
Diarrhoea 246.80 50.85 169 2953 53683 1689976
Disability 241.32 50.85 51 3071 503 1743156
Aspartate aminotransferase increased 226.96 50.85 94 3028 10662 1732997
Hand deformity 224.55 50.85 42 3080 204 1743455
Musculoskeletal stiffness 223.66 50.85 79 3043 5797 1737862
Infection 220.90 50.85 96 3026 12264 1731395
Knee arthroplasty 220.35 50.85 52 3070 876 1742783
C-reactive protein increased 219.73 50.85 78 3044 5807 1737852
Gastrointestinal disorder 216.20 50.85 73 3049 4675 1738984
Liver function test increased 198.97 50.85 53 3069 1486 1742173
Off label use 197.60 50.85 130 2992 38441 1705218
Anti-cyclic citrullinated peptide antibody positive 195.70 50.85 30 3092 24 1743635
Interstitial lung disease 191.88 50.85 81 3041 9615 1734044
Alopecia 183.87 50.85 61 3061 3692 1739967
Headache 178.68 50.85 117 3005 34259 1709400
Bone cyst 177.53 50.85 29 3093 49 1743610
Hypertension 176.64 50.85 95 3027 19353 1724306
Pulmonary embolism 174.87 50.85 83 3039 12976 1730683
Dyspnoea 173.39 50.85 135 2987 51924 1691735
Osteoarthritis 169.33 50.85 51 3071 2245 1741414
Drug specific antibody present 168.38 50.85 36 3086 376 1743283
Deep vein thrombosis 160.72 50.85 72 3050 9848 1733811
Herpes zoster 160.71 50.85 58 3064 4515 1739144
Nodule 160.57 50.85 40 3082 852 1742807
Rash 159.12 50.85 114 3008 38579 1705080
Alanine aminotransferase abnormal 156.42 50.85 31 3091 214 1743445
Enthesopathy 156.11 50.85 27 3095 75 1743584
Abdominal discomfort 153.79 50.85 68 3054 9013 1734646
Psoriatic arthropathy 152.09 50.85 47 3075 2256 1741403
Malaise 147.04 50.85 98 3024 29467 1714192
Swelling 143.47 50.85 60 3062 6936 1736723
Rheumatoid nodule 136.86 50.85 26 3096 139 1743520
Weight decreased 136.70 50.85 85 3037 22668 1720991
Sepsis 135.77 50.85 80 3042 19358 1724301
Fatigue 135.76 50.85 116 3006 50665 1692994
Acne cystic 135.16 50.85 23 3099 56 1743603
Tenosynovitis 133.14 50.85 28 3094 268 1743391
Blood alkaline phosphatase increased 132.05 50.85 52 3070 5143 1738516
Mass 132.02 50.85 36 3086 1102 1742557
Gait inability 130.77 50.85 46 3076 3317 1740342
Erythema 130.56 50.85 70 3052 14118 1729541
Lymphoma 127.02 50.85 40 3082 2042 1741617
Asthenia 123.96 50.85 94 3028 34576 1709083
Joint ankylosis 122.70 50.85 20 3102 33 1743626
Rheumatoid factor negative 120.85 50.85 17 3105 0 1743659
Drug use disorder 120.61 50.85 28 3094 436 1743223
Red blood cell sedimentation rate increased 119.48 50.85 33 3089 1060 1742599
Therapy non-responder 119.30 50.85 51 3071 6215 1737444
Drug tolerance decreased 118.24 50.85 23 3099 142 1743517
Pulmonary thrombosis 114.17 50.85 30 3092 794 1742865
Liver disorder 111.02 50.85 47 3075 5589 1738070
Rheumatoid factor positive 109.77 50.85 19 3103 53 1743606
Diabetes mellitus 104.97 50.85 48 3074 6860 1736799
Pulmonary fibrosis 104.04 50.85 36 3086 2468 1741191
Pancytopenia 101.50 50.85 55 3067 11302 1732357
Gamma-glutamyltransferase increased 98.68 50.85 42 3080 5056 1738603
Hepatic enzyme abnormal 97.62 50.85 24 3098 482 1743177
White blood cell count decreased 93.98 50.85 55 3067 13094 1730565
Insomnia 93.04 50.85 59 3063 16217 1727442
Back pain 91.93 50.85 59 3063 16554 1727105
Cough 91.26 50.85 62 3060 19135 1724524
Liver function test abnormal 90.80 50.85 41 3081 5685 1737974
Blood lactate dehydrogenase increased 90.58 50.85 36 3086 3639 1740020
Tongue disorder 90.50 50.85 23 3099 531 1743128
Pyrexia 90.50 50.85 89 3033 46311 1697348
Prerenal failure 89.55 50.85 20 3102 259 1743400
Hepatotoxicity 89.44 50.85 34 3088 3050 1740609
Hepatic enzyme increased 88.16 50.85 42 3080 6579 1737080
Cytology abnormal 87.10 50.85 14 3108 20 1743639
Depression 86.83 50.85 57 3065 16612 1727047
Musculoskeletal pain 85.78 50.85 38 3084 5036 1738623
Arthritis 84.45 50.85 35 3087 3940 1739719
Foot deformity 84.11 50.85 21 3101 450 1743209
Chondropathy 83.21 50.85 17 3105 139 1743520
Osteolysis 82.48 50.85 19 3103 285 1743374
Onychoclasis 82.24 50.85 18 3104 211 1743448
Skin ulcer 81.79 50.85 31 3091 2757 1740902
Leukopenia 81.14 50.85 43 3079 8437 1735222
Exposure via body fluid 79.77 50.85 16 3106 118 1743541
Hip arthroplasty 78.25 50.85 22 3100 754 1742905
Hepatic cirrhosis 76.02 50.85 29 3093 2624 1741035
Intentional product use issue 75.33 50.85 29 3093 2690 1740969
Tooth loss 73.65 50.85 20 3102 601 1743058
Muscular weakness 73.52 50.85 43 3079 10206 1733453
Drug dependence 73.05 50.85 30 3092 3297 1740362
Tendonitis 72.91 50.85 24 3098 1409 1742250
Sarcoidosis 71.84 50.85 19 3103 515 1743144
Polyomavirus-associated nephropathy 70.39 50.85 18 3104 426 1743233
Ill-defined disorder 70.29 50.85 25 3097 1856 1741803
Skin mass 69.74 50.85 19 3103 578 1743081
Immobile 68.09 50.85 17 3105 364 1743295
Pruritus 67.77 50.85 56 3066 23166 1720493
Atlantoaxial instability 67.02 50.85 10 3112 5 1743654
Stress 65.50 50.85 26 3096 2615 1741044
Hepatic failure 65.26 50.85 33 3089 5870 1737789
Pneumonitis 65.12 50.85 29 3093 3886 1739773
Medical device implantation 64.85 50.85 12 3110 54 1743605
Lymphoedema 64.84 50.85 17 3105 445 1743214
Spinal instability 64.66 50.85 10 3112 9 1743650
Steatorrhoea 63.98 50.85 13 3109 103 1743556
Upper respiratory tract infection 63.88 50.85 29 3093 4064 1739595
Thrombosis 63.19 50.85 35 3087 7486 1736173
Transaminases increased 61.91 50.85 28 3094 3889 1739770
Neuropathy peripheral 61.58 50.85 37 3085 9216 1734443
Therapeutic response decreased 61.54 50.85 31 3091 5469 1738190
Mineral metabolism disorder 60.10 50.85 10 3112 20 1743639
Terminal state 59.59 50.85 18 3104 796 1742863
Jaundice 58.69 50.85 31 3091 6031 1737628
Fracture 58.66 50.85 19 3103 1059 1742600
Tuberculin test positive 58.06 50.85 15 3107 370 1743289
Haemoglobin decreased 57.83 50.85 45 3077 17069 1726590
Joint contracture 57.66 50.85 13 3109 176 1743483
Feeling abnormal 57.62 50.85 38 3084 11128 1732531
Exposure during pregnancy 57.10 50.85 24 3098 2793 1740866
Colitis 57.08 50.85 27 3095 4153 1739506
Joint stiffness 56.92 50.85 21 3101 1730 1741929
Dislocation of vertebra 55.40 50.85 10 3112 38 1743621
Rheumatoid lung 54.85 50.85 11 3111 81 1743578
Joint arthroplasty 54.85 50.85 11 3111 81 1743578
Tooth fracture 54.66 50.85 15 3107 469 1743190
Ankle deformity 53.76 50.85 9 3113 19 1743640
General physical health deterioration 52.08 50.85 38 3084 13080 1730579
Lung disorder 51.89 50.85 27 3095 5092 1738567
Intervertebral disc space narrowing 51.78 50.85 10 3112 59 1743600
Lymphadenopathy 51.39 50.85 25 3097 4089 1739570
Joint range of motion decreased 51.26 50.85 16 3106 790 1742869
Skin laceration 51.06 50.85 20 3102 1941 1741718
Histoplasmosis 50.97 50.85 13 3109 304 1743355

Pharmacologic Action:

SourceCodeDescription
ATC L04AA13 ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS
IMMUNOSUPPRESSANTS
IMMUNOSUPPRESSANTS
Selective immunosuppressants
FDA EPC N0000175713 Antirheumatic Agent
CHEBI has role CHEBI:35475 non-steroidal anti-inflammatory drug
CHEBI has role CHEBI:35610 antineoplastic agent
CHEBI has role CHEBI:35442 antiparasitic agent
CHEBI has role CHEBI:50266 prodrug
CHEBI has role CHEBI:35705 immunosuppressive agent
MeSH PA D004791 Enzyme Inhibitors
MeSH PA D007155 Immunologic Factors
MeSH PA D007166 Immunosuppressive Agents

Drug Use (View source of the data)

DiseaseRelationSNOMED_IDDOID
Psoriasis with arthropathy indication 33339001
Rheumatoid arthritis indication 69896004 DOID:7148
Inactive tuberculosis contraindication 11999007
Agranulocytosis contraindication 17182001 DOID:12987
Acute tuberculosis contraindication 25629007
Immunosuppression contraindication 38013005
Hepatic failure contraindication 59927004
Chronic type B viral hepatitis contraindication 61977001
Acute infectious disease contraindication 63171007
Interstitial pneumonia contraindication 64667001
Aspergillosis contraindication 65553006 DOID:13564
Viral hepatitis type B contraindication 66071002 DOID:2043
Kidney disease contraindication 90708001 DOID:557
Pancytopenia contraindication 127034005 DOID:12450
Chronic hepatitis C contraindication 128302006
Liver function tests abnormal contraindication 166603001
Disease of liver contraindication 235856003 DOID:409
Acute hepatitis C contraindication 235866006
Anemia contraindication 271737000 DOID:2355
Pregnancy, function contraindication 289908002
Thrombocytopenic disorder contraindication 302215000 DOID:1588
Peripheral nerve disease contraindication 302226006
Neutropenic disorder contraindication 303011007 DOID:1227
Breastfeeding (mother) contraindication 413712001
Pneumocystosis jiroveci pneumonia contraindication 415125002 DOID:11339
Severe Bone Marrow Depression contraindication

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 12.31 acidic

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
Dihydroorotate dehydrogenase (quinone), mitochondrial Enzyme INHIBITOR IC50 5 CHEMBL CHEMBL
Sodium-dependent dopamine transporter Transporter Ki 5.64 DRUG MATRIX
Cytochrome P450 1A2 Enzyme IC50 6.30 DRUG MATRIX
Amine oxidase [flavin-containing] A Enzyme IC50 4.68 DRUG MATRIX
Sodium/nucleoside cotransporter 1 Transporter Ki 5.29 DRUG MATRIX
Sodium-dependent noradrenaline transporter Transporter Ki 5.34 DRUG MATRIX
Dihydroorotate dehydrogenase (quinone), mitochondrial Enzyme IC50 8.05 CHEMBL
Dihydroorotate dehydrogenase (quinone), mitochondrial Enzyme IC50 7.52 CHEMBL

External reference:

IDSource
D000077339 MESH_DESCRIPTOR_UI
4021132 VUID
N0000148586 NUI
C0063041 UMLSCUI
D00749 KEGG_DRUG
109143003 SNOMEDCT_US
4021132 VANDF
63949 MMSL
007642 NDDF
d04349 MMSL
7491 MMSL
27169 RXNORM
386981009 SNOMEDCT_US
CHEBI:6402 CHEBI
CHEMBL960 ChEMBL_ID
DB01097 DRUGBANK_ID
G162GK9U4W UNII
5079 INN_ID
3899 PUBCHEM_CID
6825 IUPHAR_LIGAND_ID
DB08880 DRUGBANK_ID

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Arava HUMAN PRESCRIPTION DRUG LABEL 1 0088-2160 TABLET, FILM COATED 10 mg ORAL NDA 18 sections
Arava HUMAN PRESCRIPTION DRUG LABEL 1 0088-2161 TABLET, FILM COATED 20 mg ORAL NDA 18 sections
Arava HUMAN PRESCRIPTION DRUG LABEL 1 0088-2162 TABLET, FILM COATED 100 mg ORAL NDA 18 sections
Leflunomide HUMAN PRESCRIPTION DRUG LABEL 1 0955-1735 TABLET, FILM COATED 10 mg ORAL NDA 18 sections
Leflunomide HUMAN PRESCRIPTION DRUG LABEL 1 0955-1737 TABLET, FILM COATED 20 mg ORAL NDA 18 sections
Leflunomide HUMAN PRESCRIPTION DRUG LABEL 1 10702-277 TABLET 10 mg ORAL ANDA 16 sections
Leflunomide HUMAN PRESCRIPTION DRUG LABEL 1 10702-278 TABLET 20 mg ORAL ANDA 16 sections
Leflunomide HUMAN PRESCRIPTION DRUG LABEL 1 23155-043 TABLET 10 mg ORAL ANDA 17 sections
Leflunomide HUMAN PRESCRIPTION DRUG LABEL 1 23155-044 TABLET 20 mg ORAL ANDA 17 sections
LEFLUNOMIDE HUMAN PRESCRIPTION DRUG LABEL 1 42291-420 TABLET 10 mg ORAL ANDA 17 sections
LEFLUNOMIDE HUMAN PRESCRIPTION DRUG LABEL 1 42291-421 TABLET 20 mg ORAL ANDA 17 sections
Leflunomide HUMAN PRESCRIPTION DRUG LABEL 1 46708-436 TABLET 10 mg ORAL ANDA 17 sections
Leflunomide HUMAN PRESCRIPTION DRUG LABEL 1 46708-437 TABLET 20 mg ORAL ANDA 17 sections
Leflunomide HUMAN PRESCRIPTION DRUG LABEL 1 54868-2319 TABLET, FILM COATED 20 mg ORAL ANDA 15 sections
Leflunomide HUMAN PRESCRIPTION DRUG LABEL 1 54868-6170 TABLET, FILM COATED 10 mg ORAL ANDA 15 sections
LEFLUNOMIDE HUMAN PRESCRIPTION DRUG LABEL 1 60505-2502 TABLET 10 mg ORAL ANDA 17 sections
LEFLUNOMIDE HUMAN PRESCRIPTION DRUG LABEL 1 60505-2503 TABLET 20 mg ORAL ANDA 17 sections
Leflunomide HUMAN PRESCRIPTION DRUG LABEL 1 62332-061 TABLET 10 mg ORAL ANDA 17 sections
Leflunomide HUMAN PRESCRIPTION DRUG LABEL 1 62332-062 TABLET 20 mg ORAL ANDA 17 sections
Leflunomide HUMAN PRESCRIPTION DRUG LABEL 1 68258-2992 TABLET 20 mg ORAL ANDA 14 sections
leflunomide HUMAN PRESCRIPTION DRUG LABEL 1 70710-1157 TABLET, FILM COATED 10 mg ORAL ANDA 17 sections
leflunomide HUMAN PRESCRIPTION DRUG LABEL 1 70710-1158 TABLET, FILM COATED 20 mg ORAL ANDA 17 sections
Leflunomide HUMAN PRESCRIPTION DRUG LABEL 1 70748-129 TABLET, FILM COATED 10 mg ORAL ANDA 18 sections
Leflunomide HUMAN PRESCRIPTION DRUG LABEL 1 70748-130 TABLET, FILM COATED 20 mg ORAL ANDA 18 sections
leflunomide HUMAN PRESCRIPTION DRUG LABEL 1 70771-1491 TABLET, FILM COATED 10 mg ORAL ANDA 17 sections
leflunomide HUMAN PRESCRIPTION DRUG LABEL 1 70771-1492 TABLET, FILM COATED 20 mg ORAL ANDA 17 sections