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

Stem definitionDrug idCAS RN
humanized origin 4933 375823-41-9

Description:

MoleculeDescription

Synonyms:

  • tocilizumab
  • MRA
  • RoActemra
  • actemra
  • R-1569
a humanised anti-interleukin-6 receptor monoclonal antibody
  • Molecular weight:
  • Formula:
  • CLOGP:
  • LIPINSKI: None
  • HAC: None
  • HDO: None
  • TPSA:
  • ALOGS:
  • ROTB: None

Drug dosage:

DoseUnitRoute
20 mg P

ADMET properties:

None

Approvals:

DateAgencyCompanyOrphan
Jan. 16, 2009 EMA
Jan. 8, 2010 FDA GENENTECH
March 6, 2008 PMDA

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 16278.97 32.47 5305 12914 96319 2243547
Rheumatoid arthritis 12855.24 32.47 3116 15103 16024 2323842
Joint swelling 5511.42 32.47 1564 16655 15255 2324611
Arthralgia 5406.47 32.47 2042 16177 52243 2287623
Drug intolerance 5144.32 32.47 1419 16800 12298 2327568
Pain 4875.40 32.47 1965 16254 59892 2279974
Contraindicated product administered 4694.67 32.47 987 17232 2034 2337832
Synovitis 4678.32 32.47 967 17252 1759 2338107
Treatment failure 4624.47 32.47 1145 17074 6094 2333772
Arthropathy 2702.81 32.47 751 17468 6565 2333301
Rash 2594.22 32.47 1255 16964 58303 2281563
Fatigue 2535.32 32.47 1386 16833 83487 2256379
Drug hypersensitivity 2419.29 32.47 1110 17109 45533 2294333
Therapeutic product effect decreased 2309.53 32.47 726 17493 10063 2329803
Peripheral swelling 2234.87 32.47 799 17420 16798 2323068
C-reactive protein abnormal 2041.62 32.47 396 17823 403 2339463
Swelling 2039.85 32.47 733 17486 15617 2324249
Abdominal discomfort 2000.43 32.47 735 17484 16721 2323145
Condition aggravated 1982.82 32.47 864 17355 31115 2308751
Pemphigus 1937.70 32.47 369 17850 307 2339559
Musculoskeletal stiffness 1934.55 32.47 655 17564 11592 2328274
Infusion related reaction 1863.37 32.47 603 17616 9193 2330673
Infection 1860.10 32.47 703 17516 17326 2322540
Loss of personal independence in daily activities 1775.79 32.47 505 17714 4806 2335060
Headache 1652.59 32.47 1033 17186 79146 2260720
Hepatic enzyme increased 1620.85 32.47 543 17676 9259 2330607
Rheumatoid factor positive 1608.67 32.47 302 17917 210 2339656
Systemic lupus erythematosus 1595.68 32.47 442 17777 3779 2336087
Red blood cell sedimentation rate abnormal 1570.74 32.47 297 17922 226 2339640
Nasopharyngitis 1569.39 32.47 658 17561 21398 2318468
Alopecia 1507.23 32.47 639 17580 21362 2318504
Therapeutic product effect incomplete 1493.25 32.47 520 17699 10011 2329855
Hypersensitivity 1441.37 32.47 632 17587 22961 2316905
Nausea 1409.12 32.47 1065 17154 111124 2228742
Pneumonia 1372.74 32.47 773 17446 48523 2291343
Weight increased 1340.21 32.47 591 17628 21746 2318120
Pain in extremity 1329.20 32.47 720 17499 41820 2298046
C-reactive protein increased 1302.61 32.47 413 17806 5842 2334024
Blood pressure increased 1204.13 32.47 506 17713 16480 2323386
Arthritis 1195.63 32.47 435 17784 9533 2330333
Diarrhoea 1161.66 32.47 845 17374 82719 2257147
Malaise 1144.94 32.47 718 17501 54867 2284999
Off label use 1071.56 32.47 766 17453 72832 2267034
Hand deformity 1053.81 32.47 242 17977 844 2339022
Glossodynia 1009.97 32.47 262 17957 1683 2338183
Lower respiratory tract infection 985.17 32.47 323 17896 5101 2334765
Mobility decreased 984.06 32.47 365 17854 8445 2331421
Fall 960.02 32.47 605 17614 46494 2293372
Herpes zoster 941.79 32.47 363 17856 9362 2330504
Sinusitis 937.55 32.47 421 17798 16105 2323761
Musculoskeletal pain 917.77 32.47 367 17852 10463 2329403
Skin ulcer 915.16 32.47 285 17934 3774 2336092
Bone erosion 910.41 32.47 191 18028 375 2339491
Weight decreased 899.89 32.47 486 17733 27885 2311981
Osteoporosis 866.99 32.47 279 17940 4135 2335731
Diverticulitis 849.79 32.47 271 17948 3894 2335972
Vomiting 841.21 32.47 656 17563 70946 2268920
Cough 803.27 32.47 476 17743 32641 2307225
Hypertension 801.88 32.47 445 17774 26916 2312950
Red blood cell sedimentation rate increased 798.37 32.47 222 17997 1915 2337951
Osteoarthritis 798.22 32.47 294 17925 6652 2333214
Knee arthroplasty 771.74 32.47 232 17987 2703 2337163
Pruritus 764.78 32.47 509 17710 42831 2297035
Dyspnoea 755.13 32.47 641 17578 78092 2261774
Therapeutic response decreased 744.43 32.47 282 17937 6913 2332953
Gait disturbance 738.87 32.47 395 17824 22150 2317716
Interstitial lung disease 725.41 32.47 283 17936 7529 2332337
Bronchitis 700.47 32.47 325 17894 13389 2326477
Joint stiffness 699.73 32.47 232 17987 3791 2336075
Back pain 672.01 32.47 418 17801 31241 2308625
Inflammation 666.14 32.47 250 17969 5963 2333903
Anti-cyclic citrullinated peptide antibody positive 651.53 32.47 122 18097 81 2339785
Blood iron abnormal 592.97 32.47 110 18109 64 2339802
Ill-defined disorder 592.14 32.47 196 18023 3182 2336684
Blood cholesterol increased 591.42 32.47 219 18000 5022 2334844
Influenza 569.05 32.47 277 17942 12701 2327165
Oropharyngeal pain 566.35 32.47 266 17953 11252 2328614
No adverse event 556.30 32.47 248 17971 9280 2330586
Hip arthroplasty 546.81 32.47 161 18058 1733 2338133
Fibromyalgia 544.68 32.47 183 18036 3117 2336749
Urinary tract infection 532.77 32.47 354 17865 29588 2310278
Oxygen saturation decreased 526.18 32.47 223 17996 7363 2332503
Abdominal pain 511.55 32.47 364 17855 34010 2305856
Wound 505.09 32.47 165 18054 2563 2337303
Liver function test increased 492.19 32.47 167 18052 2934 2336932
Contusion 492.18 32.47 250 17969 12560 2327306
Sleep disorder 487.69 32.47 202 18017 6287 2333579
Sciatica 477.71 32.47 149 18070 1976 2337890
Neck pain 477.11 32.47 209 18010 7488 2332378
Urticaria 475.80 32.47 305 17914 23956 2315910
Pyrexia 468.07 32.47 415 17804 53293 2286573
Leukopenia 466.03 32.47 224 17995 9972 2329894
Erythema 465.65 32.47 305 17914 24854 2315012
Rheumatoid nodule 464.29 32.47 112 18107 506 2339360
Blood pressure fluctuation 461.75 32.47 141 18078 1734 2338132
Blood pressure systolic increased 451.37 32.47 146 18073 2193 2337673
Hepatitis 448.43 32.47 189 18030 6148 2333718
Cellulitis 447.54 32.47 211 18008 8990 2330876
Dizziness 446.21 32.47 420 17799 58245 2281621
Hypotension 438.05 32.47 324 17895 32112 2307754
Coeliac disease 426.37 32.47 111 18108 721 2339145
Pulmonary fibrosis 426.11 32.47 144 18075 2496 2337370
Impaired healing 422.01 32.47 173 18046 5238 2334628
Localised infection 421.76 32.47 146 18073 2730 2337136
Heart rate decreased 419.69 32.47 155 18064 3521 2336345
Liver disorder 416.48 32.47 180 18039 6234 2333632
Abdominal pain upper 409.01 32.47 268 17951 21832 2318034
Mouth ulceration 403.06 32.47 153 18066 3759 2336107
Pharyngitis 384.84 32.47 128 18091 2107 2337759
Sepsis 373.58 32.47 237 17982 18251 2321615
Intentional product use issue 371.52 32.47 141 18078 3461 2336405
Hypoaesthesia 366.34 32.47 242 17977 19973 2319893
Deformity 362.71 32.47 88 18131 409 2339457
Immunodeficiency 361.75 32.47 103 18116 973 2338893
Blood pressure diastolic decreased 359.97 32.47 103 18116 992 2338874
Chest pain 357.26 32.47 271 17948 27866 2312000
Grip strength decreased 354.54 32.47 101 18118 956 2338910
Liver function test abnormal 352.60 32.47 168 18051 7322 2332544
Lung disorder 350.56 32.47 158 18061 6054 2333812
Adverse drug reaction 348.40 32.47 172 18047 8111 2331755
Pneumonia viral 346.28 32.47 84 18135 390 2339476
Glaucoma 344.88 32.47 116 18103 1979 2337887
Product use issue 344.78 32.47 194 18025 11975 2327891
Femur fracture 341.35 32.47 159 18060 6580 2333286
White blood cell count decreased 337.22 32.47 221 17998 17987 2321879
Maternal exposure during pregnancy 334.23 32.47 204 18015 14659 2325207
Joint range of motion decreased 330.35 32.47 109 18110 1747 2338119
Loss of consciousness 328.72 32.47 220 17999 18547 2321319
Psoriatic arthropathy 328.68 32.47 132 18087 3782 2336084
Juvenile idiopathic arthritis 327.09 32.47 80 18139 387 2339479
Joint injury 324.50 32.47 115 18104 2309 2337557
Oral herpes 323.66 32.47 112 18107 2090 2337776
Heart rate increased 319.90 32.47 179 18040 10926 2328940
Neutropenia 317.25 32.47 227 17992 21321 2318545
Asthenia 314.91 32.47 314 17905 46612 2293254
Malignant melanoma 307.08 32.47 105 18114 1887 2337979
Breast cancer 306.44 32.47 165 18054 9330 2330536
Gait inability 306.24 32.47 142 18077 5813 2334053
Injection site reaction 304.07 32.47 193 18026 14859 2325007
Anaphylactic reaction 303.06 32.47 165 18054 9540 2330326
Basal cell carcinoma 294.55 32.47 110 18109 2577 2337289
Nail disorder 286.35 32.47 87 18132 1049 2338817
Toothache 285.30 32.47 107 18112 2537 2337329
Colitis microscopic 285.19 32.47 83 18136 853 2339013
Dermatitis allergic 284.81 32.47 100 18119 1951 2337915
Septic shock 283.35 32.47 142 18077 6912 2332954
Onychomycosis 282.56 32.47 74 18145 493 2339373
Haemophagocytic lymphohistiocytosis 281.80 32.47 90 18129 1293 2338573
Burning sensation 280.81 32.47 146 18073 7682 2332184
Musculoskeletal disorder 278.96 32.47 104 18115 2424 2337442
Foot deformity 276.28 32.47 97 18122 1892 2337974
Impaired work ability 273.51 32.47 94 18125 1716 2338150
Bronchitis chronic 269.53 32.47 68 18151 382 2339484
Hepatic steatosis 268.50 32.47 108 18111 3105 2336761
Pulmonary mass 263.97 32.47 93 18126 1833 2338033
Panniculitis 253.08 32.47 67 18152 468 2339398
Cutaneous vasculitis 251.47 32.47 61 18158 283 2339583
Upper respiratory tract infection 250.31 32.47 141 18078 8710 2331156
Drug eruption 249.92 32.47 103 18116 3156 2336710
Visual impairment 248.05 32.47 155 18064 11600 2328266
Oral mucosal exfoliation 247.31 32.47 56 18163 179 2339687
Gastrointestinal disorder 246.63 32.47 140 18079 8777 2331089
Cystitis 245.65 32.47 120 18099 5522 2334344
Immobile 244.47 32.47 67 18152 542 2339324
Myocardial infarction 240.79 32.47 183 18036 18830 2321036
Limb deformity 239.57 32.47 56 18163 214 2339652
Stomatitis 238.16 32.47 141 18078 9569 2330297
Body temperature decreased 236.63 32.47 78 18141 1245 2338621
Renal impairment 235.70 32.47 142 18077 9950 2329916
Granuloma skin 235.56 32.47 48 18171 75 2339791
Nodule 232.59 32.47 88 18131 2138 2337728
Intestinal perforation 232.23 32.47 83 18136 1708 2338158
Chills 231.43 32.47 165 18054 15387 2324479
Alanine aminotransferase increased 230.08 32.47 158 18061 13874 2325992
Therapy non-responder 226.17 32.47 128 18091 7976 2331890
Blood pressure systolic abnormal 223.36 32.47 45 18174 64 2339802
Bedridden 222.72 32.47 76 18143 1356 2338510
Ulcer 220.87 32.47 81 18138 1799 2338067
Disability assessment scale score increased 214.38 32.47 37 18182 2 2339864
Stress 213.86 32.47 117 18102 6821 2333045
Hypercholesterolaemia 213.63 32.47 76 18143 1542 2338324
Diabetes mellitus 213.53 32.47 120 18099 7375 2332491
Bursitis 212.35 32.47 79 18140 1829 2338037
Cataract 211.29 32.47 110 18109 5798 2334068
Asthma 210.93 32.47 138 18081 11176 2328690
Oedema peripheral 208.98 32.47 185 18034 23578 2316288
Insomnia 207.59 32.47 191 18028 25596 2314270
Soft tissue disorder 207.06 32.47 49 18170 200 2339666
Adverse event 205.73 32.47 118 18101 7541 2332325
Blood pressure diastolic abnormal 201.48 32.47 40 18179 50 2339816
Gastrointestinal perforation 200.74 32.47 60 18159 681 2339185
Limb injury 198.13 32.47 81 18138 2429 2337437
Aspartate aminotransferase increased 197.31 32.47 138 18081 12474 2327392
Blood pressure diastolic increased 193.78 32.47 53 18166 425 2339441
Dry eye 193.01 32.47 91 18128 3865 2336001
Pleurisy 191.58 32.47 66 18153 1213 2338653
Dyspepsia 190.67 32.47 123 18096 9721 2330145
Anaemia 190.39 32.47 209 18010 34583 2305283
Rash pruritic 188.88 32.47 111 18108 7424 2332442
Osteomyelitis 187.86 32.47 87 18132 3546 2336320
Ear pain 187.69 32.47 80 18139 2669 2337197
Bone density decreased 187.14 32.47 66 18153 1304 2338562
Blood parathyroid hormone decreased 186.23 32.47 44 18175 178 2339688
Gastroenteritis 185.88 32.47 82 18137 2978 2336888
Spinal stenosis 184.92 32.47 66 18153 1352 2338514
Tooth infection 184.85 32.47 72 18147 1896 2337970
Skin necrosis 183.63 32.47 62 18157 1069 2338797
Body height below normal 182.20 32.47 38 18181 71 2339795
Secretion discharge 181.66 32.47 63 18156 1182 2338684
Foot fracture 178.71 32.47 78 18141 2760 2337106
Productive cough 178.69 32.47 95 18124 5226 2334640
Myalgia 178.44 32.47 168 18051 23165 2316701
Joint laxity 178.38 32.47 34 18185 28 2339838
General physical health deterioration 176.52 32.47 135 18084 14004 2325862
Diverticular perforation 176.37 32.47 49 18170 419 2339447
Joint effusion 176.31 32.47 62 18157 1214 2338652
Peritonitis 176.04 32.47 75 18144 2499 2337367
Pericarditis 175.91 32.47 65 18154 1475 2338391
Psoriasis 175.13 32.47 145 18074 16863 2323003
Gastric disorder 173.82 32.47 83 18136 3627 2336239
Platelet count decreased 173.72 32.47 140 18079 15673 2324193
Presbyacusis 173.23 32.47 33 18186 27 2339839
Blister 173.02 32.47 101 18118 6670 2333196
Joint destruction 172.81 32.47 45 18174 292 2339574
Nephrolithiasis 172.27 32.47 88 18131 4455 2335411
Human antichimeric antibody positive 171.84 32.47 31 18188 11 2339855
Demyelination 171.79 32.47 57 18162 929 2338937
Tenosynovitis 171.63 32.47 49 18170 467 2339399
Poor venous access 170.78 32.47 55 18164 812 2339054
Cyst 170.12 32.47 64 18155 1529 2338337
Arthritis bacterial 169.79 32.47 54 18165 764 2339102
Rhinorrhoea 168.57 32.47 103 18116 7397 2332469
Fracture 168.52 32.47 74 18145 2657 2337209
Ear infection 167.39 32.47 79 18140 3362 2336504
Hyperhidrosis 166.16 32.47 135 18084 15287 2324579
Retinal toxicity 164.63 32.47 39 18180 160 2339706
Intervertebral disc protrusion 164.03 32.47 75 18144 2966 2336900
Obesity 161.46 32.47 61 18158 1475 2338391
Wound infection 160.40 32.47 58 18161 1235 2338631
Helicobacter infection 159.37 32.47 48 18171 560 2339306
Aphthous ulcer 158.84 32.47 59 18160 1359 2338507
Arthrodesis 154.79 32.47 38 18181 187 2339679
Discomfort 153.46 32.47 85 18134 5074 2334792
Thyroid disorder 152.88 32.47 59 18160 1514 2338352
Surgical failure 152.77 32.47 34 18185 98 2339768
Disability 152.59 32.47 50 18169 782 2339084
Rheumatic fever 152.33 32.47 32 18187 63 2339803
Arthritis infective 147.84 32.47 46 18173 603 2339263
Syncope 147.51 32.47 131 18088 16744 2323122
Skin laceration 147.35 32.47 67 18152 2615 2337251
Joint arthroplasty 146.91 32.47 41 18178 357 2339509
Bone disorder 146.20 32.47 71 18148 3221 2336645
Temperature regulation disorder 146.04 32.47 34 18185 127 2339739
Joint dislocation 142.89 32.47 55 18164 1401 2338465
Tooth disorder 142.35 32.47 75 18144 4048 2335818
Pyelonephritis 141.84 32.47 61 18158 2080 2337786
Transaminases increased 140.34 32.47 77 18142 4510 2335356
Lower limb fracture 140.20 32.47 60 18159 2021 2337845
Paraesthesia 138.98 32.47 143 18076 21945 2317921
Eye disorder 138.67 32.47 68 18151 3151 2336715
Tendon rupture 137.14 32.47 54 18165 1464 2338402
Fine motor skill dysfunction 136.80 32.47 37 18182 283 2339583
Finger deformity 136.07 32.47 46 18173 796 2339070
Viral upper respiratory tract infection 135.82 32.47 49 18170 1036 2338830
Gastroenteritis viral 135.11 32.47 62 18157 2472 2337394
Adverse reaction 134.91 32.47 54 18165 1530 2338336
Pleural fibrosis 133.49 32.47 33 18186 168 2339698
Chest discomfort 132.95 32.47 116 18103 14479 2325387
Pulmonary toxicity 132.81 32.47 43 18176 646 2339220
Pneumonitis 129.67 32.47 70 18149 3969 2335897
Rash erythematous 129.00 32.47 80 18139 5896 2333970
Onychomadesis 128.86 32.47 39 18180 463 2339403
Palpitations 128.65 32.47 120 18099 16336 2323530
Large intestine perforation 128.60 32.47 49 18170 1213 2338653
Osteoporotic fracture 127.44 32.47 36 18183 329 2339537
Disseminated intravascular coagulation 127.31 32.47 65 18154 3285 2336581
Skin lesion 127.11 32.47 69 18150 3956 2335910
Constipation 127.06 32.47 135 18084 21494 2318372
Impaired gastric emptying 126.69 32.47 45 18174 908 2338958
Rheumatoid factor negative 125.81 32.47 22 18197 3 2339863
Depression 125.18 32.47 152 18067 27980 2311886
Nasal congestion 124.99 32.47 83 18136 6883 2332983
Hepatotoxicity 124.96 32.47 65 18154 3416 2336450
Body temperature increased 124.80 32.47 63 18156 3108 2336758
Vasculitis 124.48 32.47 57 18162 2261 2337605
Investigation abnormal 123.96 32.47 27 18192 68 2339798
Sjogren's syndrome 123.66 32.47 45 18174 976 2338890
Oral pain 123.57 32.47 64 18155 3333 2336533
Hot flush 122.50 32.47 83 18136 7116 2332750
Fungal infection 122.43 32.47 72 18147 4817 2335049
Spinal column injury 121.03 32.47 32 18187 222 2339644
Exostosis 120.92 32.47 48 18171 1330 2338536
Antibody test positive 120.82 32.47 33 18186 263 2339603
Loose body in joint 120.44 32.47 24 18195 31 2339835
Hepatic function abnormal 120.09 32.47 77 18142 6015 2333851
Neutrophil count decreased 119.65 32.47 79 18140 6488 2333378
Synovial cyst 119.15 32.47 42 18177 828 2339038
Polyarthritis 118.87 32.47 42 18177 834 2339032
Cholelithiasis 118.50 32.47 75 18144 5728 2334138
Hypercalcaemia 118.40 32.47 57 18162 2535 2337331
Fluid retention 116.96 32.47 80 18139 6966 2332900
Adrenal insufficiency 116.72 32.47 47 18172 1353 2338513
Food allergy 116.03 32.47 38 18181 593 2339273
Throat irritation 115.36 32.47 70 18149 4960 2334906
Multiple allergies 115.11 32.47 41 18178 834 2339032
Swelling face 114.84 32.47 89 18130 9404 2330462
Viral infection 114.83 32.47 68 18151 4608 2335258
Pleural thickening 114.48 32.47 25 18194 64 2339802
Hyperkeratosis 114.21 32.47 40 18179 773 2339093
Extremity contracture 112.77 32.47 26 18193 92 2339774
Transaminases abnormal 112.56 32.47 26 18193 93 2339773
Pancytopenia 112.37 32.47 95 18124 11357 2328509
Flushing 111.43 32.47 96 18123 11775 2328091
Lymphoma 111.09 32.47 50 18169 1904 2337962
Skin papilloma 110.93 32.47 36 18183 545 2339321
Lymphadenopathy 109.80 32.47 71 18148 5627 2334239
Surgery 109.20 32.47 70 18149 5465 2334401
Gingival bleeding 108.68 32.47 50 18169 2005 2337861
Drug tolerance decreased 108.65 32.47 30 18189 250 2339616
Cerebrovascular accident 108.08 32.47 120 18099 20066 2319800
Bronchiectasis 107.68 32.47 40 18179 921 2338945
Anxiety 107.51 32.47 144 18075 29215 2310651
Ankle fracture 107.08 32.47 51 18168 2214 2337652
Somnolence 106.26 32.47 128 18091 23357 2316509
Postoperative wound infection 106.13 32.47 42 18177 1154 2338712
Toe amputation 106.00 32.47 31 18188 324 2339542
Spinal disorder 105.65 32.47 42 18177 1168 2338698
Deafness neurosensory 105.24 32.47 34 18185 507 2339359
Pharyngeal oedema 105.10 32.47 58 18161 3435 2336431
Oedema 104.99 32.47 87 18132 10116 2329750
Vertigo 104.95 32.47 84 18135 9300 2330566
Acne 104.62 32.47 56 18163 3120 2336746
Thrombocytopenia 104.62 32.47 115 18104 19016 2320850
Accident 104.17 32.47 38 18181 830 2339036
Cardiac failure 103.89 32.47 93 18126 12001 2327865
Pustular psoriasis 103.49 32.47 38 18181 846 2339020
Abdominal distension 103.45 32.47 87 18132 10324 2329542
Carpal tunnel syndrome 103.13 32.47 48 18171 1977 2337889
Shoulder arthroplasty 102.81 32.47 31 18188 363 2339503
Tenderness 102.47 32.47 47 18172 1871 2337995
Osteopenia 102.08 32.47 47 18172 1888 2337978
Therapy cessation 100.78 32.47 65 18154 5128 2334738
Epigastric discomfort 100.41 32.47 33 18186 521 2339345
Migraine 99.67 32.47 86 18133 10567 2329299
Anaphylactic shock 99.19 32.47 60 18159 4226 2335640
Amnesia 98.79 32.47 73 18146 7180 2332686
White blood cell count increased 98.12 32.47 72 18147 7006 2332860
Skin reaction 97.57 32.47 46 18173 1951 2337915
Hypothyroidism 97.03 32.47 60 18159 4397 2335469
Pulmonary embolism 95.94 32.47 107 18112 17976 2321890
Crohn's disease 95.20 32.47 69 18150 6586 2333280
Eye haemorrhage 94.13 32.47 40 18179 1323 2338543
Wheelchair user 94.08 32.47 30 18189 428 2339438
Eye infection 92.49 32.47 39 18180 1265 2338601
Upper limb fracture 92.47 32.47 49 18170 2674 2337192
Limb mass 92.16 32.47 28 18191 337 2339529
Wrist surgery 91.62 32.47 23 18196 126 2339740
Sinus congestion 91.26 32.47 44 18175 1963 2337903
Haemorrhage 91.09 32.47 83 18136 10956 2328910
Type 2 diabetes mellitus 90.48 32.47 45 18174 2149 2337717
Neoplasm malignant 89.70 32.47 60 18159 5033 2334833
Weight fluctuation 89.47 32.47 32 18187 659 2339207
Ligament sprain 88.17 32.47 39 18180 1424 2338442
Spinal fracture 88.09 32.47 48 18171 2771 2337095
Thrombosis 87.94 32.47 75 18144 9069 2330797
Hyperaesthesia 87.57 32.47 37 18182 1206 2338660
Death 87.49 32.47 236 17983 81232 2258634
Multiple fractures 87.33 32.47 31 18188 624 2339242
Gastric infection 87.11 32.47 27 18192 349 2339517
Hepatocellular injury 86.78 32.47 54 18165 4001 2335865
Abscess limb 86.62 32.47 30 18189 560 2339306
Takayasu's arteritis 85.84 32.47 20 18199 75 2339791
Infected skin ulcer 85.72 32.47 26 18193 311 2339555
Haematoma 84.63 32.47 58 18161 5063 2334803
Limb operation 84.10 32.47 29 18190 534 2339332
Blood magnesium increased 83.53 32.47 22 18197 150 2339716
Pleural effusion 83.38 32.47 81 18138 11587 2328279
Back injury 82.86 32.47 33 18186 922 2338944
Bone cyst 82.79 32.47 22 18197 156 2339710
Influenza like illness 82.66 32.47 82 18137 12032 2327834
Vasculitic rash 82.42 32.47 22 18197 159 2339707
Swollen tongue 82.41 32.47 58 18161 5285 2334581
Respiratory tract infection 82.07 32.47 52 18167 3977 2335889
Rib fracture 80.73 32.47 44 18175 2541 2337325
Pneumocystis jirovecii pneumonia 80.30 32.47 42 18177 2231 2337635
Deep vein thrombosis 79.97 32.47 83 18136 12849 2327017
Upper respiratory tract inflammation 79.29 32.47 24 18195 285 2339581
Muscle spasms 79.25 32.47 106 18113 21460 2318406
Haemoglobin decreased 78.94 32.47 97 18122 18054 2321812
Spinal pain 78.31 32.47 35 18184 1310 2338556
Dysphonia 77.68 32.47 60 18159 6304 2333562
Cerebral infarction 77.48 32.47 52 18167 4385 2335481
Blood pressure decreased 77.29 32.47 70 18149 9166 2330700
Injection site hypersensitivity 76.81 32.47 25 18194 382 2339484
Lung neoplasm malignant 76.68 32.47 45 18174 2997 2336869
Pharyngitis streptococcal 76.61 32.47 36 18183 1515 2338351
Medication error 75.27 32.47 58 18161 6073 2333793
Diverticulum intestinal 74.99 32.47 28 18191 654 2339212
Subarachnoid haemorrhage 74.75 32.47 39 18180 2061 2337805
Tendon disorder 73.61 32.47 29 18190 787 2339079
Crying 73.14 32.47 50 18169 4346 2335520
Tooth abscess 72.26 32.47 38 18181 2041 2337825
Multiple organ dysfunction syndrome 72.10 32.47 62 18157 7579 2332287
Back disorder 72.05 32.47 35 18184 1587 2338279
Dysphagia 71.76 32.47 78 18141 12727 2327139
Intervertebral disc space narrowing 71.64 32.47 18 18201 99 2339767
Product dose omission 71.33 32.47 138 18081 38119 2301747
Blood creatinine increased 71.31 32.47 71 18148 10462 2329404
Feeling hot 71.10 32.47 59 18160 6869 2332997
Night sweats 70.85 32.47 45 18174 3455 2336411
Furuncle 70.82 32.47 30 18189 984 2338882
Hepatic cirrhosis 70.58 32.47 39 18180 2314 2337552
Disease progression 70.56 32.47 89 18130 17006 2322860
Respiratory disorder 70.10 32.47 47 18172 3957 2335909
Abscess 69.39 32.47 39 18180 2392 2337474
Scar 69.38 32.47 36 18183 1881 2337985
Skin disorder 69.34 32.47 45 18174 3586 2336280
Wrist deformity 69.18 32.47 17 18202 84 2339782
Diverticulum 68.99 32.47 33 18186 1446 2338420
Lower respiratory tract congestion 68.95 32.47 19 18200 157 2339709
Mean cell haemoglobin decreased 68.95 32.47 21 18198 255 2339611
Seasonal allergy 68.90 32.47 34 18185 1596 2338270
Foot operation 68.76 32.47 27 18192 726 2339140
Muscular weakness 68.66 32.47 82 18137 14815 2325051
Gastrooesophageal reflux disease 68.49 32.47 65 18154 9030 2330836
Mesenteritis 68.04 32.47 13 18206 11 2339855
Ankle arthroplasty 67.71 32.47 15 18204 42 2339824
Arthropod bite 67.32 32.47 29 18190 992 2338874
Oral disorder 67.18 32.47 32 18187 1389 2338477
White blood cell count abnormal 66.57 32.47 26 18193 689 2339177
Drug-induced liver injury 66.15 32.47 44 18175 3655 2336211
Pregnancy 66.02 32.47 60 18159 7889 2331977
Candida infection 65.91 32.47 40 18179 2833 2337033
Acute respiratory distress syndrome 65.83 32.47 42 18177 3250 2336616
Intervertebral disc compression 65.61 32.47 18 18201 146 2339720
Angina pectoris 65.51 32.47 45 18174 3942 2335924
Tachycardia 65.46 32.47 84 18135 16325 2323541
Mass 65.42 32.47 34 18185 1782 2338084
Colitis 65.38 32.47 50 18169 5176 2334690
Therapy partial responder 65.37 32.47 22 18197 375 2339491
Pruritus allergic 65.29 32.47 18 18201 149 2339717
Duodenal ulcer perforation 64.94 32.47 21 18198 314 2339552
Ulcerative keratitis 64.79 32.47 24 18195 548 2339318
Facial paralysis 64.19 32.47 37 18182 2382 2337484
Erysipelas 64.00 32.47 28 18191 995 2338871
Ankylosing spondylitis 63.64 32.47 25 18194 673 2339193
Intervertebral disc degeneration 63.40 32.47 32 18187 1577 2338289
Tuberculosis 63.39 32.47 34 18185 1901 2337965
Musculoskeletal discomfort 62.93 32.47 35 18184 2103 2337763
Pain in jaw 62.77 32.47 53 18166 6319 2333547
Cardiac murmur 62.62 32.47 32 18187 1619 2338247
Drug specific antibody 62.28 32.47 15 18204 67 2339799
Gastritis 62.13 32.47 46 18173 4535 2335331
Kidney infection 62.12 32.47 37 18182 2532 2337334
Conjunctivitis 61.90 32.47 36 18183 2357 2337509
Effusion 61.70 32.47 19 18200 240 2339626
Colitis ulcerative 61.69 32.47 38 18181 2764 2337102
Mean platelet volume decreased 61.41 32.47 16 18203 104 2339762
Dyspnoea exertional 61.39 32.47 50 18169 5670 2334196
Pancreatitis 61.33 32.47 58 18161 8021 2331845
Rheumatoid vasculitis 61.29 32.47 14 18205 47 2339819
Throat tightness 61.18 32.47 45 18174 4391 2335475
Hiatus hernia 61.03 32.47 34 18185 2050 2337816
Laryngitis 60.70 32.47 30 18189 1413 2338453
Skin warm 60.14 32.47 24 18195 674 2339192
Immunosuppression 59.64 32.47 27 18192 1042 2338824
Feeling abnormal 59.31 32.47 97 18122 23484 2316382
Respiratory rate increased 59.22 32.47 30 18189 1490 2338376
Spinal compression fracture 59.17 32.47 32 18187 1819 2338047
Rheumatoid lung 59.07 32.47 17 18202 167 2339699
Hip fracture 58.76 32.47 45 18174 4667 2335199
Cholecystitis 58.74 32.47 34 18185 2206 2337660
Skin infection 57.61 32.47 29 18190 1421 2338445
Infiltration anaesthesia 57.51 32.47 10 18209 1 2339865
Musculoskeletal deformity 57.33 32.47 12 18207 23 2339843
Atrial fibrillation 57.31 32.47 72 18147 13696 2326170
Eye pain 57.27 32.47 45 18174 4846 2335020
Appendicitis 57.02 32.47 27 18192 1156 2338710
X-ray abnormal 56.75 32.47 16 18203 145 2339721
Gastric ulcer 56.66 32.47 37 18182 2979 2336887
Neck surgery 56.54 32.47 17 18202 197 2339669
Hernia 56.33 32.47 27 18192 1188 2338678
Haematochezia 56.22 32.47 46 18173 5249 2334617
Injection site extravasation 56.10 32.47 31 18188 1839 2338027
Epistaxis 55.54 32.47 60 18159 9719 2330147
Photophobia 55.43 32.47 33 18186 2256 2337610
Post procedural infection 55.20 32.47 26 18193 1100 2338766
Wheezing 54.61 32.47 49 18170 6335 2333531
Infected bite 54.47 32.47 16 18203 170 2339696
Phlebitis 53.87 32.47 25 18194 1022 2338844
Dental caries 53.52 32.47 30 18189 1830 2338036
Road traffic accident 53.41 32.47 41 18178 4267 2335599
Cardiac disorder 53.38 32.47 53 18166 7780 2332086
Mean cell volume decreased 53.34 32.47 17 18202 242 2339624
Skin discolouration 53.22 32.47 45 18174 5375 2334491
Tuberculin test positive 53.05 32.47 21 18198 577 2339289
Wrist fracture 52.90 32.47 29 18190 1694 2338172
Infectious pleural effusion 52.63 32.47 16 18203 193 2339673
Hypertensive crisis 52.59 32.47 33 18186 2480 2337386
Osteosclerosis 52.32 32.47 18 18201 329 2339537
Pyoderma gangrenosum 52.26 32.47 20 18199 501 2339365
Systemic lupus erythematosus rash 52.18 32.47 16 18203 199 2339667
Animal bite 52.16 32.47 19 18200 413 2339453
Tooth fracture 52.15 32.47 29 18190 1742 2338124
Dyslipidaemia 51.84 32.47 22 18197 725 2339141
Colitis ischaemic 51.49 32.47 28 18191 1609 2338257
Blood fibrinogen decreased 51.18 32.47 15 18204 158 2339708
Colon cancer 50.63 32.47 29 18190 1844 2338022
Aortic dissection 50.49 32.47 18 18201 367 2339499
Chronic obstructive pulmonary disease 50.30 32.47 49 18170 7028 2332838
Laboratory test abnormal 50.06 32.47 43 18176 5247 2334619
Gastrointestinal toxicity 49.97 32.47 20 18199 566 2339300
Skin cancer 49.73 32.47 28 18191 1723 2338143
Skin fissures 49.64 32.47 25 18194 1226 2338640
Unevaluable event 49.52 32.47 54 18165 8837 2331029
Low density lipoprotein increased 49.36 32.47 25 18194 1241 2338625
Dry mouth 49.27 32.47 52 18167 8201 2331665
Rhinitis 49.06 32.47 24 18195 1105 2338761
Increased tendency to bruise 49.03 32.47 27 18192 1591 2338275
Red cell distribution width decreased 48.88 32.47 12 18207 59 2339807
Neoplasm 48.78 32.47 24 18195 1119 2338747
Organising pneumonia 48.59 32.47 22 18197 849 2339017
Muscle spasticity 48.49 32.47 27 18192 1626 2338240
Herpes virus infection 48.47 32.47 22 18197 854 2339012
Tonsillitis 48.45 32.47 22 18197 855 2339011
Amyotrophic lateral sclerosis 48.42 32.47 16 18203 257 2339609
Blood triglycerides increased 48.31 32.47 30 18189 2213 2337653
Endocarditis 48.16 32.47 21 18198 740 2339126
Anti-cyclic citrullinated peptide antibody 48.02 32.47 9 18210 6 2339860
Monocyte count increased 47.97 32.47 19 18200 523 2339343
Groin pain 47.84 32.47 25 18194 1325 2338541
Abortion spontaneous 47.71 32.47 65 18154 13380 2326486
Lymphadenectomy 47.22 32.47 14 18205 154 2339712
Gastrointestinal haemorrhage 47.00 32.47 62 18157 12373 2327493
Osteitis 46.98 32.47 20 18199 664 2339202
Pulmonary oedema 46.84 32.47 48 18171 7315 2332551
Gingivitis 46.64 32.47 25 18194 1396 2338470
Immune system disorder 46.55 32.47 25 18194 1401 2338465
Urosepsis 46.52 32.47 28 18191 1953 2337913
Nerve injury 46.50 32.47 23 18196 1085 2338781
Joint lock 46.48 32.47 17 18202 374 2339492
Skin abrasion 46.16 32.47 23 18196 1102 2338764
Lupus-like syndrome 46.09 32.47 28 18191 1986 2337880
Intercepted product storage error 45.90 32.47 9 18210 10 2339856
Staphylococcal infection 45.79 32.47 41 18178 5285 2334581
Abdominal abscess 45.73 32.47 20 18199 710 2339156
Tongue ulceration 45.70 32.47 18 18201 488 2339378
Still's disease 45.61 32.47 13 18206 123 2339743
Diffuse large B-cell lymphoma 45.47 32.47 21 18198 849 2339017
Dry skin 45.31 32.47 45 18174 6607 2333259
Necrotising fasciitis 45.22 32.47 18 18201 502 2339364
Blood pressure systolic decreased 45.08 32.47 20 18199 735 2339131
Otitis media 45.06 32.47 19 18200 616 2339250
Gastrointestinal ulcer 44.66 32.47 16 18203 331 2339535
Pelvic fracture 44.59 32.47 24 18195 1351 2338515
Poor quality sleep 44.13 32.47 27 18192 1940 2337926
Transient ischaemic attack 43.63 32.47 42 18177 5936 2333930
Polyp 43.59 32.47 19 18200 669 2339197
Thermal burn 43.55 32.47 20 18199 798 2339068
Abdominal pain lower 43.28 32.47 31 18188 2902 2336964
Nail infection 43.19 32.47 14 18205 211 2339655
Tinnitus 43.11 32.47 39 18180 5096 2334770
Pallor 42.89 32.47 34 18185 3708 2336158
Bronchospasm 42.43 32.47 31 18188 2993 2336873
Rheumatoid factor increased 42.42 32.47 14 18205 224 2339642
Quality of life decreased 41.94 32.47 19 18200 734 2339132
Red blood cell sedimentation rate 41.80 32.47 9 18210 21 2339845
Squamous cell carcinoma 41.69 32.47 23 18196 1360 2338506
C-reactive protein decreased 41.64 32.47 11 18208 76 2339790
Nervous system disorder 41.60 32.47 31 18188 3085 2336781
Sneezing 41.53 32.47 28 18191 2378 2337488
Fungal skin infection 41.33 32.47 17 18202 517 2339349
Vascular access complication 41.33 32.47 12 18207 122 2339744
Uveitis 41.12 32.47 24 18195 1581 2338285
Haemorrhagic diathesis 41.09 32.47 17 18202 525 2339341
Intestinal ischaemia 40.95 32.47 21 18198 1070 2338796
Disease recurrence 40.94 32.47 32 18187 3419 2336447
Lipids increased 40.89 32.47 14 18205 252 2339614
Small intestine ulcer 40.68 32.47 11 18208 84 2339782
Synovial rupture 40.59 32.47 10 18209 50 2339816
Device related infection 40.36 32.47 31 18188 3228 2336638
Neck mass 40.14 32.47 15 18204 351 2339515
Scoliosis 40.03 32.47 20 18199 964 2338902
Sensitivity to weather change 40.00 32.47 16 18203 452 2339414
Empyema 39.85 32.47 14 18205 273 2339593
Mouth haemorrhage 39.54 32.47 20 18199 990 2338876
Endodontic procedure 39.39 32.47 16 18203 471 2339395
Uterine leiomyoma 39.31 32.47 23 18196 1522 2338344
Lymphoproliferative disorder 39.10 32.47 17 18202 595 2339271
Ovarian cyst 39.02 32.47 25 18194 1948 2337918
Encephalitis 38.84 32.47 21 18198 1193 2338673
Mucosal inflammation 38.69 32.47 37 18182 5187 2334679
Vaginal infection 38.67 32.47 19 18200 883 2338983
Lymphopenia 38.67 32.47 27 18192 2427 2337439
Tendonitis 38.64 32.47 26 18193 2201 2337665
Vitamin D decreased 38.61 32.47 20 18199 1041 2338825
Emphysema 38.18 32.47 20 18199 1065 2338801
Subcutaneous abscess 38.12 32.47 19 18200 911 2338955
Renal failure 37.84 32.47 67 18152 17282 2322584
Memory impairment 37.80 32.47 57 18162 12866 2327000
Femoral neck fracture 37.51 32.47 21 18198 1278 2338588
Lacrimation increased 37.43 32.47 28 18191 2802 2337064
Dehydration 37.40 32.47 77 18142 22218 2317648
Physical disability 37.38 32.47 12 18207 175 2339691
Musculoskeletal chest pain 37.11 32.47 26 18193 2350 2337516
Vascular rupture 37.07 32.47 12 18207 180 2339686
Cerebral haemorrhage 37.05 32.47 37 18182 5467 2334399
Hypoacusis 36.87 32.47 30 18189 3395 2336471
Dry throat 36.67 32.47 19 18200 989 2338877
Nonalcoholic fatty liver disease 36.53 32.47 9 18210 45 2339821
Decreased appetite 36.38 32.47 89 18130 28802 2311064
Platelet count increased 36.16 32.47 25 18194 2212 2337654
Gastrointestinal inflammation 36.14 32.47 17 18202 717 2339149
Injection site bruising 35.81 32.47 54 18165 12189 2327677
Small intestinal perforation 35.67 32.47 13 18206 283 2339583
Swollen joint count increased 35.59 32.47 7 18212 8 2339858
Blood iron decreased 35.31 32.47 20 18199 1245 2338621
Tubo-ovarian abscess 35.16 32.47 9 18210 54 2339812
Intervertebral disc disorder 35.15 32.47 16 18203 625 2339241
Limb discomfort 35.12 32.47 29 18190 3350 2336516
Brachiocephalic artery stenosis 35.07 32.47 6 18213 0 2339866
Diverticulum intestinal haemorrhagic 35.00 32.47 12 18207 217 2339649
Stress fracture 34.95 32.47 20 18199 1269 2338597
Allergic oedema 34.86 32.47 10 18209 97 2339769
Fracture delayed union 34.64 32.47 13 18206 308 2339558
Blood test abnormal 34.54 32.47 20 18199 1298 2338568
Eye inflammation 34.46 32.47 17 18202 797 2339069
Neuropathy peripheral 34.26 32.47 51 18168 11381 2328485
Blood potassium increased 34.23 32.47 24 18195 2172 2337694
Menopause 34.10 32.47 13 18206 322 2339544
Breast cyst excision 33.94 32.47 7 18212 12 2339854
Rash pustular 33.85 32.47 21 18198 1546 2338320
Brain neoplasm 33.65 32.47 17 18202 839 2339027
Product use in unapproved indication 33.61 32.47 50 18169 11150 2328716
Restless legs syndrome 33.50 32.47 24 18195 2247 2337619
Anal abscess 33.37 32.47 15 18204 569 2339297
Rectal haemorrhage 33.36 32.47 36 18183 5820 2334046
Pneumothorax 33.12 32.47 24 18195 2288 2337578
Tremor 33.06 32.47 70 18149 20591 2319275
Renal pain 33.04 32.47 17 18202 872 2338994
Prosthesis user 32.92 32.47 7 18212 15 2339851
Red cell distribution width increased 32.91 32.47 15 18204 588 2339278
Tracheitis 32.86 32.47 10 18209 121 2339745
Extremity necrosis 32.81 32.47 12 18207 264 2339602
Neck deformity 32.80 32.47 9 18210 73 2339793
Bone pain 32.68 32.47 44 18175 8952 2330914
Nasal ulcer 32.64 32.47 12 18207 268 2339598
Head injury 32.61 32.47 30 18189 4004 2335862
Pharyngeal abscess 32.48 32.47 9 18210 76 2339790

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 3082.26 39.60 1136 4037 62665 1678943
Rheumatoid arthritis 2513.19 39.60 553 4620 4032 1737576
Joint swelling 1373.04 39.60 363 4810 5990 1735618
Pain 1037.70 39.60 414 4759 26243 1715365
Arthralgia 999.09 39.60 389 4784 23055 1718553
Contraindicated product administered 783.97 39.60 174 4999 1270 1740338
Synovitis 752.25 39.60 150 5023 595 1741013
Treatment failure 698.83 39.60 198 4975 4203 1737405
Diverticulitis 656.38 39.60 165 5008 2160 1739448
Peripheral swelling 575.06 39.60 196 4977 7775 1733833
Drug intolerance 544.76 39.60 176 4997 5886 1735722
Off label use 503.25 39.60 283 4890 38288 1703320
Bone erosion 491.67 39.60 87 5086 140 1741468
Pneumonia 479.07 39.60 292 4881 45890 1695718
Pain in extremity 465.52 39.60 212 4961 18260 1723348
Therapeutic product effect decreased 442.57 39.60 152 5021 6145 1735463
Apparent death 435.70 39.60 82 5091 218 1741390
C-reactive protein abnormal 413.21 39.60 77 5096 190 1741418
Arthropathy 391.92 39.60 115 5058 2752 1738856
Nasopharyngitis 387.75 39.60 156 5017 9854 1731754
Infusion related reaction 382.38 39.60 138 5035 6455 1735153
Musculoskeletal stiffness 355.75 39.60 127 5046 5749 1735859
Interstitial lung disease 340.82 39.60 141 5032 9555 1732053
Loss of personal independence in daily activities 304.90 39.60 91 5082 2308 1739300
Blood pressure increased 303.88 39.60 134 5039 10619 1730989
Red blood cell sedimentation rate abnormal 288.27 39.60 49 5124 52 1741556
C-reactive protein increased 281.48 39.60 107 5066 5778 1735830
Deep vein thrombosis 274.99 39.60 122 5051 9798 1731810
Mobility decreased 274.12 39.60 95 5078 3925 1737683
Pulmonary embolism 272.89 39.60 132 5041 12927 1728681
Drug hypersensitivity 266.02 39.60 136 5037 14999 1726609
Nausea 260.86 39.60 210 4963 50986 1690622
Weight increased 253.02 39.60 120 5053 11237 1730371
Infection 240.37 39.60 119 5054 12241 1729367
Intentional product use issue 235.72 39.60 77 5096 2642 1738966
Weight decreased 232.01 39.60 143 5030 22610 1718998
Mass 229.76 39.60 62 5111 1076 1740532
Arthritis 225.62 39.60 82 5091 3893 1737715
Dyspnoea 224.43 39.60 194 4979 51865 1689743
Headache 222.91 39.60 163 5010 34213 1707395
Ill-defined disorder 220.17 39.60 67 5106 1814 1739794
Hypertension 218.19 39.60 130 5043 19318 1722290
Knee arthroplasty 217.98 39.60 57 5116 871 1740737
Red blood cell sedimentation rate increased 213.40 39.60 58 5115 1035 1740573
Swelling 213.04 39.60 92 5081 6904 1734704
Sepsis 202.70 39.60 124 5049 19314 1722294
Stomatitis 201.14 39.60 82 5091 5322 1736286
Urticaria 197.64 39.60 104 5069 12137 1729471
Nodule 191.38 39.60 51 5122 841 1740767
Renal failure 186.75 39.60 119 5054 19898 1721710
Skin ulcer 186.52 39.60 65 5108 2723 1738885
Arthritis bacterial 185.34 39.60 47 5126 631 1740977
Limb discomfort 184.77 39.60 55 5118 1377 1740231
Bone cyst 182.85 39.60 32 5141 46 1741562
Oxygen saturation decreased 173.92 39.60 75 5098 5600 1736008
Herpes zoster 172.22 39.60 70 5103 4503 1737105
Impaired work ability 171.19 39.60 49 5124 1064 1740544
Haemophagocytic lymphohistiocytosis 170.80 39.60 52 5121 1408 1740200
Oedema peripheral 169.17 39.60 102 5071 15448 1726160
Osteoarthritis 167.02 39.60 57 5116 2239 1739369
Localised infection 165.42 39.60 53 5120 1704 1739904
Hepatic function abnormal 164.24 39.60 77 5096 6997 1734611
Drug specific antibody present 160.60 39.60 38 5135 374 1741234
Rash 159.83 39.60 141 5032 38552 1703056
Anti-cyclic citrullinated peptide antibody positive 159.60 39.60 27 5146 27 1741581
Heart rate decreased 159.51 39.60 58 5115 2751 1738857
Hypersensitivity 155.15 39.60 84 5089 10360 1731248
Musculoskeletal pain 148.72 39.60 65 5108 5009 1736599
White blood cell count decreased 147.48 39.60 88 5085 13061 1728547
Therapeutic product effect incomplete 147.48 39.60 66 5107 5382 1736226
Juvenile idiopathic arthritis 138.99 39.60 30 5143 186 1741422
Drug eruption 131.81 39.60 51 5122 2875 1738733
Bladder transitional cell carcinoma 130.22 39.60 32 5141 374 1741234
Gait inability 128.36 39.60 52 5121 3311 1738297
Oropharyngeal pain 126.02 39.60 57 5116 4761 1736847
Pulmonary thrombosis 125.46 39.60 36 5137 788 1740820
Cellulitis 121.71 39.60 61 5112 6407 1735201
Disability 120.35 39.60 32 5141 522 1741086
Myocardial infarction 119.98 39.60 103 5070 27071 1714537
Nephrolithiasis 119.75 39.60 52 5121 3940 1737668
Abdominal pain 119.09 39.60 93 5080 21397 1720211
Joint lock 116.62 39.60 26 5147 191 1741417
Diabetes mellitus 115.04 39.60 60 5113 6848 1734760
Cough 114.94 39.60 87 5086 19110 1722498
Disseminated intravascular coagulation 114.72 39.60 49 5124 3565 1738043
Physical disability 114.25 39.60 24 5149 128 1741480
Abscess 113.75 39.60 41 5132 1893 1739715
No adverse event 112.83 39.60 54 5119 5128 1736480
Rheumatoid factor negative 112.25 39.60 17 5156 0 1741608
Liver disorder 111.49 39.60 55 5118 5581 1736027
Epistaxis 110.07 39.60 62 5111 8244 1733364
Back pain 109.99 39.60 80 5093 16533 1725075
Liver function test abnormal 104.77 39.60 53 5120 5673 1735935
Pyrexia 102.96 39.60 121 5052 46279 1695329
Sinusitis 100.42 39.60 50 5123 5173 1736435
Therapy non-responder 100.26 39.60 53 5120 6213 1735395
Pulmonary fibrosis 99.95 39.60 40 5133 2464 1739144
Blood pressure systolic increased 99.72 39.60 36 5137 1669 1739939
Skin mass 99.52 39.60 28 5145 569 1741039
Joint ankylosis 99.43 39.60 18 5155 35 1741573
Influenza 99.20 39.60 54 5119 6713 1734895
Condition aggravated 99.08 39.60 83 5090 21067 1720541
Fatigue 98.97 39.60 124 5049 50657 1690951
Fall 98.02 39.60 92 5081 27122 1714486
Blood pressure diastolic decreased 97.54 39.60 29 5144 721 1740887
Asthenia 96.78 39.60 102 5071 34568 1707040
Bursitis 96.49 39.60 28 5145 638 1740970
Pleural effusion 95.85 39.60 63 5110 11047 1730561
Chest pain 95.03 39.60 79 5094 19835 1721773
Intestinal polyp 94.34 39.60 21 5152 153 1741455
Malaise 93.40 39.60 93 5080 29472 1712136
Erythema 93.14 39.60 68 5105 14120 1727488
Therapeutic response decreased 92.20 39.60 48 5125 5452 1736156
Gastrointestinal disorder 89.93 39.60 45 5128 4703 1736905
Cataract 89.72 39.60 39 5134 2959 1738649
Insomnia 89.13 39.60 70 5103 16206 1725402
Muscle spasms 88.52 39.60 61 5112 11560 1730048
Drug use disorder 87.62 39.60 24 5149 440 1741168
Bronchitis 87.04 39.60 46 5127 5386 1736222
Blood pressure fluctuation 85.42 39.60 30 5143 1282 1740326
Leukopenia 85.32 39.60 53 5120 8427 1733181
Prerenal failure 84.48 39.60 21 5152 258 1741350
Joint stiffness 84.12 39.60 32 5141 1719 1739889
Upper respiratory tract infection 84.08 39.60 41 5132 4052 1737556
Diarrhoea 82.58 39.60 117 5056 53735 1687873
Gastric disorder 81.94 39.60 32 5141 1846 1739762
Hepatic enzyme abnormal 81.02 39.60 23 5150 483 1741125
Thrombosis 80.74 39.60 49 5124 7472 1734136
Hypotension 80.48 39.60 86 5087 29568 1712040
Cytology abnormal 80.02 39.60 14 5159 20 1741588
Tremor 79.58 39.60 60 5113 13071 1728537
Lymphoedema 78.51 39.60 22 5151 440 1741168
Colitis 77.34 39.60 39 5134 4141 1737467
Neutrophil count decreased 76.77 39.60 44 5129 6037 1735571
Still's disease 76.62 39.60 15 5158 52 1741556
Wound 75.40 39.60 29 5144 1605 1740003
Pruritus 75.03 39.60 74 5099 23148 1718460
Septic shock 74.86 39.60 48 5125 8061 1733547
Hepatic cirrhosis 74.48 39.60 33 5140 2620 1738988
Oral surgery 74.31 39.60 17 5156 142 1741466
Poor venous access 73.94 39.60 19 5154 269 1741339
Skin laceration 73.68 39.60 30 5143 1931 1739677
Immobile 73.30 39.60 20 5153 361 1741247
Hepatic enzyme increased 73.29 39.60 44 5129 6577 1735031
Osteolysis 72.92 39.60 19 5154 285 1741323
Alanine aminotransferase abnormal 71.97 39.60 18 5155 227 1741381
Polyarthritis 71.01 39.60 21 5152 512 1741096
Medical device implantation 70.75 39.60 14 5159 52 1741556
Neutropenia 70.04 39.60 64 5109 18196 1723412
Platelet count decreased 69.47 39.60 61 5112 16462 1725146
Heart rate increased 68.81 39.60 42 5131 6468 1735140
Diverticular perforation 68.73 39.60 20 5153 460 1741148
Cardiac failure 68.52 39.60 54 5119 12548 1729060
Decreased appetite 67.87 39.60 71 5102 23800 1717808
Body temperature decreased 67.67 39.60 24 5149 1055 1740553
Terminal state 66.23 39.60 22 5151 792 1740816
Pharyngitis 66.22 39.60 24 5149 1124 1740484
Vomiting 65.77 39.60 88 5085 38227 1703381
Vasculitis 65.76 39.60 26 5147 1549 1740059
Sleep disorder due to general medical condition, insomnia type 65.07 39.60 15 5158 130 1741478
X-ray abnormal 64.54 39.60 14 5159 89 1741519
Neck pain 64.01 39.60 32 5141 3334 1738274
Liver function test increased 62.84 39.60 25 5148 1514 1740094
Impaired healing 62.64 39.60 29 5144 2550 1739058
Blood fibrinogen decreased 61.28 39.60 15 5158 172 1741436
Lymphadenopathy 60.73 39.60 33 5140 4081 1737527
Urinary tract infection 60.61 39.60 46 5127 10107 1731501
Joint injury 59.92 39.60 22 5151 1069 1740539
Gastrointestinal perforation 59.25 39.60 20 5153 757 1740851
Blood pressure diastolic increased 59.05 39.60 16 5157 281 1741327
Drug dependence 58.50 39.60 30 5143 3297 1738311
Rheumatoid factor positive 57.76 39.60 12 5161 60 1741548
Prostate cancer 57.11 39.60 33 5140 4593 1737015
Blood pressure systolic abnormal 55.56 39.60 11 5162 41 1741567
Disability assessment scale score increased 55.44 39.60 9 5164 5 1741603
Renal disorder 55.42 39.60 31 5142 4055 1737553
Abdominal pain upper 55.22 39.60 45 5128 10956 1730652
Joint arthroplasty 54.83 39.60 12 5161 80 1741528
Hypercholesterolaemia 54.09 39.60 21 5152 1191 1740417
Gait disturbance 53.68 39.60 47 5126 12623 1728985
Productive cough 53.54 39.60 29 5144 3562 1738046
Lymphopenia 52.94 39.60 24 5149 2009 1739599
Rheumatoid nodule 52.87 39.60 13 5160 152 1741456
Gastric cancer 52.67 39.60 20 5153 1068 1740540
Pancytopenia 51.90 39.60 44 5129 11313 1730295
Inflammation 51.82 39.60 28 5145 3422 1738186
Lower respiratory tract infection 51.64 39.60 29 5144 3822 1737786
Lung neoplasm malignant 51.12 39.60 27 5146 3152 1738456
Burning sensation 50.68 39.60 27 5146 3208 1738400
Cerebrovascular accident 50.48 39.60 53 5120 17813 1723795
Abdominal discomfort 49.52 39.60 39 5134 9042 1732566
Therapy partial responder 49.04 39.60 14 5159 300 1741308
Peritonitis 49.03 39.60 25 5148 2714 1738894
Enterocolitis 48.86 39.60 18 5155 883 1740725
Chest discomfort 47.73 39.60 35 5138 7296 1734312
Hepatic steatosis 47.46 39.60 24 5149 2560 1739048
Muscular weakness 47.43 39.60 40 5133 10209 1731399
Lung disorder 46.47 39.60 30 5143 5089 1736519
Blood pressure decreased 46.41 39.60 35 5138 7611 1733997
Ulcerative keratitis 46.37 39.60 14 5159 367 1741241
Anaphylactic reaction 46.28 39.60 32 5141 6081 1735527
Nasal congestion 46.03 39.60 25 5148 3086 1738522
Rhinorrhoea 45.85 39.60 27 5146 3890 1737718
Alanine aminotransferase increased 45.02 39.60 42 5131 12236 1729372
Otitis media 44.35 39.60 14 5159 427 1741181
Wound infection 44.18 39.60 17 5156 941 1740667
Blood pressure diastolic abnormal 44.03 39.60 8 5165 16 1741592
Tachycardia 44.01 39.60 42 5131 12586 1729022
Infectious pleural effusion 43.01 39.60 13 5160 342 1741266
Cholelithiasis 42.88 39.60 24 5149 3141 1738467
Pulmonary toxicity 42.70 39.60 16 5157 823 1740785
Upper respiratory tract inflammation 41.35 39.60 12 5161 273 1741335
Large intestine perforation 40.72 39.60 17 5156 1165 1740443
Multiple organ dysfunction syndrome 40.57 39.60 35 5138 9207 1732401
Joint effusion 40.28 39.60 14 5159 579 1741029

Pharmacologic Action:

SourceCodeDescription
ATC L04AC07 ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS
IMMUNOSUPPRESSANTS
IMMUNOSUPPRESSANTS
Interleukin inhibitors
FDA MoA N0000190478 Interleukin 6 Receptor Antagonists
FDA EPC N0000190480 Interleukin-6 Receptor Antagonist

Drug Use (View source of the data)

DiseaseRelationSNOMED_IDDOID
Rheumatoid arthritis indication 69896004 DOID:7148
Angiofollicular lymph node hyperplasia indication 207036003 DOID:0111157
Juvenile rheumatoid arthritis indication 410795001
Giant cell arteritis indication 414341000 DOID:13375
Coronavirus infection off-label use 186747009

Acid dissociation constants calculated using MoKa v3.0.0

None

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
Interleukin-6 receptor Membrane receptor ANTIBODY BINDING DRUG LABEL DRUG LABEL

External reference:

IDSource
D02596 KEGG_DRUG
4029705 VUID
N0000180629 NUI
C1609165 UMLSCUI
I031V2H011 UNII
8394 INN_ID
DB06273 DRUGBANK_ID
CHEMBL1237022 ChEMBL_ID
6881 IUPHAR_LIGAND_ID
C502936 MESH_SUPPLEMENTAL_RECORD_UI
444649004 SNOMEDCT_US
612865 RXNORM
26778 MMSL
d07496 MMSL
4029705 VANDF
444648007 SNOMEDCT_US
013198 NDDF

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
ACTEMRA HUMAN PRESCRIPTION DRUG LABEL 1 50242-135 INJECTION, SOLUTION, CONCENTRATE 20 mg INTRAVENOUS BLA 22 sections
ACTEMRA HUMAN PRESCRIPTION DRUG LABEL 1 50242-136 INJECTION, SOLUTION, CONCENTRATE 20 mg INTRAVENOUS BLA 22 sections
ACTEMRA HUMAN PRESCRIPTION DRUG LABEL 1 50242-137 INJECTION, SOLUTION, CONCENTRATE 20 mg INTRAVENOUS BLA 22 sections
Actemra HUMAN PRESCRIPTION DRUG LABEL 1 50242-138 INJECTION, SOLUTION 180 mg SUBCUTANEOUS BLA 22 sections
Actemra ACTPen HUMAN PRESCRIPTION DRUG LABEL 1 50242-143 INJECTION, SOLUTION 180 mg SUBCUTANEOUS BLA 22 sections