evolocumab 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definitionDrug idCAS RN
human origin 5000 1256937-27-5

Description:

MoleculeDescription

Synonyms:

  • evolocumab
  • repatha
  • AMG-145
  • AMG 145
Evolocumab is a human monoclonal IgG2 directed against human proprotein convertase subtilisin kexin 9 (PCSK9). Evolocumab binds to PCSK9 and inhibits circulating PCSK9 from binding to the low density lipoprotein (LDL) receptor (LDLR), preventing PCSK9-mediated LDLR degradation and permitting LDLR to recycle back to the liver cell surface. By inhibiting the binding of PCSK9 to LDLR, evolocumab increases the number of LDLRs available to clear LDL from the blood, thereby lowering LDL-C levels.
  • Molecular weight:
  • Formula:
  • CLOGP:
  • LIPINSKI: None
  • HAC: None
  • HDO: None
  • TPSA:
  • ALOGS:
  • ROTB: None

Drug dosage:

DoseUnitRoute
10 mg P

ADMET properties:

None

Approvals:

DateAgencyCompanyOrphan
Jan. 22, 2016 PMDA Astellas Pharma
Aug. 28, 2015 FDA REPATHA
May 21, 2015 EMA

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
Wrong technique in product usage process 12649.78 27.46 4269 73236 51241 50476378
Accidental exposure to product 8968.64 27.46 2672 74833 20385 50507234
Injection site pain 6965.46 27.46 3381 74124 107643 50419976
Device difficult to use 4675.78 27.46 1336 76169 8550 50519069
Injection site bruising 3958.54 27.46 1639 75866 35129 50492490
Product dose omission issue 3064.66 27.46 2405 75100 181433 50346186
Injection site haemorrhage 2425.08 27.46 990 76515 20356 50507263
Rhinorrhoea 2278.57 27.46 1246 76259 50337 50477282
Myalgia 1940.75 27.46 1568 75937 122751 50404868
Device issue 1747.97 27.46 770 76735 19202 50508417
Influenza like illness 1511.59 27.46 995 76510 56464 50471155
Device use error 1450.08 27.46 470 77035 4796 50522823
Back pain 1443.00 27.46 1726 75779 218304 50309315
Incorrect dose administered by device 1373.18 27.46 409 77096 3066 50524553
Underdose 1242.57 27.46 611 76894 19667 50507952
Injury associated with device 1090.30 27.46 334 77171 2783 50524836
Muscle spasms 981.16 27.46 1080 76425 124473 50403146
Drug dose omission by device 968.68 27.46 295 77210 2404 50525215
Injection site swelling 842.74 27.46 615 76890 41158 50486461
Low density lipoprotein increased 716.79 27.46 284 77221 5362 50522257
Injection site mass 694.20 27.46 380 77125 15300 50512319
Product storage error 624.78 27.46 326 77179 11898 50515721
Injection site erythema 593.76 27.46 650 76855 74286 50453333
Drug ineffective 571.75 27.46 273 77232 819060 49708559
Occupational exposure to product 570.98 27.46 179 77326 1621 50525998
Wrong technique in device usage process 537.45 27.46 185 77320 2301 50525318
Incorrect disposal of product 528.71 27.46 132 77373 450 50527169
Device defective 527.09 27.46 156 77349 1139 50526480
Pain in extremity 479.17 27.46 1192 76313 271673 50255946
Oropharyngeal pain 376.76 27.46 527 76978 77274 50450345
Low density lipoprotein decreased 356.89 27.46 80 77425 143 50527476
Device malfunction 342.31 27.46 239 77266 14882 50512737
Blood glucose increased 334.73 27.46 476 77029 70848 50456771
Injection site discomfort 324.34 27.46 144 77361 3646 50523973
Condition aggravated 306.94 27.46 45 77460 297013 50230606
Acute kidney injury 300.99 27.46 11 77494 228047 50299572
Injection site discolouration 289.33 27.46 162 77343 6812 50520807
Blood cholesterol decreased 266.42 27.46 82 77423 694 50526925
Fear of injection 262.01 27.46 145 77360 5958 50521661
Drug interaction 255.44 27.46 12 77493 199609 50328010
Anaemia 252.19 27.46 42 77463 252414 50275205
Feeling abnormal 251.57 27.46 578 76927 124914 50402705
Nasopharyngitis 245.42 27.46 750 76755 192177 50335442
Infusion related reaction 235.36 27.46 5 77500 169552 50358067
Injection site pruritus 229.48 27.46 296 77209 40115 50487504
Blood triglycerides increased 222.09 27.46 164 77341 11148 50516471
Pyrexia 210.36 27.46 165 77340 380038 50147581
Rheumatoid arthritis 208.32 27.46 31 77474 202519 50325100
Contraindicated product administered 208.29 27.46 4 77501 148954 50378665
Maternal exposure during pregnancy 203.09 27.46 10 77495 159768 50367851
Vomiting 201.81 27.46 246 77259 460512 50067107
Inappropriate schedule of product administration 194.11 27.46 374 77131 71457 50456162
Product use issue 187.93 27.46 10 77495 149465 50378154
Treatment failure 187.37 27.46 5 77500 137632 50389987
Injection site urticaria 183.14 27.46 151 77354 12066 50515553
Thrombocytopenia 180.25 27.46 3 77502 127670 50399949
Therapeutic response unexpected 178.89 27.46 167 77338 15748 50511871
Injection site rash 174.66 27.46 166 77339 16011 50511608
Systemic lupus erythematosus 163.37 27.46 14 77491 140608 50387011
Drug intolerance 161.09 27.46 67 77438 219037 50308582
Hypotension 159.18 27.46 81 77424 235388 50292231
Infection 157.38 27.46 36 77469 172918 50354701
General physical health deterioration 148.24 27.46 21 77484 142413 50385206
Influenza 146.87 27.46 382 77123 89156 50438463
Haemoglobin decreased 144.19 27.46 14 77491 127202 50400417
White blood cell count decreased 143.05 27.46 9 77496 116713 50410906
Product use in unapproved indication 141.74 27.46 9 77496 115810 50411809
Memory impairment 137.84 27.46 346 77159 79014 50448605
Oedema peripheral 133.86 27.46 38 77467 157923 50369696
Pneumonia 126.07 27.46 243 77262 378158 50149461
Overdose 124.30 27.46 7 77498 99720 50427899
Injection site vesicles 123.21 27.46 66 77439 2539 50525080
Hyponatraemia 122.17 27.46 6 77499 96133 50431486
Death 121.92 27.46 194 77311 325185 50202434
Cough 120.68 27.46 705 76800 240559 50287060
Seizure 118.92 27.46 19 77486 117855 50409764
Sepsis 118.27 27.46 29 77476 132896 50394723
Arthralgia 117.85 27.46 1105 76400 437597 50090022
Wound 116.38 27.46 13 77492 105781 50421838
Injection site extravasation 115.12 27.46 94 77411 7407 50520212
Sleep disorder due to a general medical condition 114.45 27.46 93 77412 7278 50520341
Injection site induration 113.93 27.46 98 77407 8299 50519320
Hypokalaemia 113.40 27.46 5 77500 87987 50439632
Platelet count decreased 111.75 27.46 12 77493 100714 50426905
Pulmonary embolism 110.61 27.46 13 77492 101691 50425928
Product administered at inappropriate site 110.25 27.46 60 77445 2383 50525236
Glycosylated haemoglobin increased 109.12 27.46 106 77399 10500 50517119
Pericarditis 106.53 27.46 3 77502 78686 50448933
Glossodynia 105.20 27.46 24 77481 115545 50412074
Joint swelling 104.95 27.46 133 77372 245153 50282466
Respiratory failure 103.39 27.46 10 77495 91171 50436448
Intentional product misuse 101.01 27.46 222 77283 46512 50481107
Drug hypersensitivity 99.41 27.46 144 77361 250866 50276753
Sinus disorder 98.21 27.46 131 77374 18327 50509292
Sneezing 96.02 27.46 113 77392 13931 50513688
Dysphonia 93.57 27.46 193 77312 38699 50488920
Device failure 92.76 27.46 73 77432 5455 50522164
Tachycardia 92.24 27.46 20 77485 99743 50427876
Pleural effusion 92.18 27.46 9 77496 81445 50446174
Oxygen saturation decreased 88.69 27.46 6 77499 73242 50454377
Intentional product use issue 88.37 27.46 8 77497 76910 50450709
Stomatitis 86.52 27.46 24 77481 101320 50426299
Musculoskeletal pain 85.43 27.46 274 77231 71903 50455716
Arthropathy 85.25 27.46 70 77435 157836 50369783
Fall 83.73 27.46 250 77255 334682 50192937
Muscle disorder 82.98 27.46 62 77443 4288 50523331
Device dispensing error 81.88 27.46 21 77484 82 50527537
Cardiac arrest 81.03 27.46 15 77490 83636 50443983
Lower respiratory tract infection 80.43 27.46 23 77482 95178 50432441
Injection site indentation 80.20 27.46 23 77482 148 50527471
Dehydration 78.14 27.46 71 77434 152378 50375241
Incorrect dose administered 76.72 27.46 204 77301 48210 50479409
Swelling 75.85 27.46 119 77386 200753 50326866
Septic shock 74.49 27.46 3 77502 57172 50470447
Paranasal sinus hypersecretion 74.22 27.46 51 77454 3091 50524528
Mobility decreased 72.55 27.46 278 77227 79670 50447949
Low density lipoprotein abnormal 71.34 27.46 21 77484 150 50527469
Deep vein thrombosis 71.31 27.46 13 77492 73291 50454328
Muscular weakness 70.14 27.46 310 77195 94703 50432916
C-reactive protein increased 68.66 27.46 10 77495 66464 50461155
Interstitial lung disease 68.58 27.46 3 77502 53173 50474446
Renal failure 65.75 27.46 41 77464 106592 50421027
Stent placement 65.58 27.46 49 77456 3389 50524230
Cardiac operation 65.16 27.46 45 77460 2750 50524869
Somnolence 64.20 27.46 86 77419 154899 50372720
Nasal congestion 64.09 27.46 198 77307 50922 50476697
Lack of injection site rotation 63.79 27.46 22 77483 275 50527344
Depressed level of consciousness 63.65 27.46 4 77501 51949 50475670
Injection site injury 63.30 27.46 26 77479 540 50527079
Gastrointestinal haemorrhage 63.26 27.46 17 77488 73304 50454315
Confusional state 62.11 27.46 119 77386 185809 50341810
Loss of consciousness 61.78 27.46 42 77463 104311 50423308
Alanine aminotransferase increased 61.73 27.46 29 77476 88330 50439289
Bradycardia 61.44 27.46 12 77493 64414 50463205
Suicidal ideation 60.40 27.46 7 77498 55378 50472241
Rash pruritic 59.68 27.46 185 77320 47661 50479958
Respiratory tract congestion 59.61 27.46 90 77415 14109 50513510
Injection site reaction 59.24 27.46 190 77315 49842 50477777
Adverse reaction 58.55 27.46 69 77436 8517 50519102
Osteoarthritis 57.16 27.46 17 77488 68589 50459030
Aspartate aminotransferase increased 57 27.46 24 77481 77974 50449645
Impaired healing 56.87 27.46 18 77487 69768 50457851
Syncope 56.39 27.46 45 77460 102957 50424662
Circumstance or information capable of leading to medication error 55.44 27.46 43 77462 3145 50524474
Hyperkalaemia 55.23 27.46 5 77500 48084 50479535
Cardiac failure 54.61 27.46 24 77481 76016 50451603
Blood cholesterol increased 54.25 27.46 197 77308 55018 50472601
Pulmonary oedema 53.83 27.46 6 77499 48932 50478687
Multiple sclerosis relapse 53.56 27.46 3 77502 42961 50484658
Hepatic enzyme increased 53.16 27.46 80 77425 137300 50390319
Constipation 52.80 27.46 130 77375 185578 50342041
Application site swelling 52.73 27.46 22 77483 476 50527143
Needle issue 52.17 27.46 60 77445 7215 50520404
Incorrect dose administered by product 51.71 27.46 16 77489 138 50527481
Blood cholesterol abnormal 51.66 27.46 36 77469 2232 50525387
Decreased appetite 50.83 27.46 149 77356 200774 50326845
Blood creatinine increased 50.19 27.46 27 77478 76133 50451486
Device delivery system issue 50.09 27.46 21 77484 460 50527159
Injection site warmth 50.04 27.46 82 77423 13784 50513835
Throat irritation 49.50 27.46 129 77376 30110 50497509
Discomfort 49.22 27.46 56 77449 108324 50419295
Hypoacusis 49.11 27.46 102 77403 20545 50507074
Upper-airway cough syndrome 49.08 27.46 63 77442 8487 50519132
Abdominal pain 48.97 27.46 191 77314 236037 50291582
Abortion spontaneous 48.91 27.46 4 77501 41768 50485851
Therapy non-responder 46.74 27.46 178 77327 50844 50476775
Pruritus 45.90 27.46 648 76857 282920 50244699
Injection site irritation 45.73 27.46 44 77461 4306 50523313
Renal impairment 45.39 27.46 30 77475 75631 50451988
Cellulitis 45.35 27.46 26 77479 70772 50456847
Depression 45.31 27.46 118 77387 165305 50362314
Liver function test abnormal 45.03 27.46 7 77498 44332 50483287
Oedema 44.63 27.46 26 77479 70155 50457464
Dizziness 44.07 27.46 760 76745 345609 50182010
Mental status changes 43.82 27.46 3 77502 36269 50491350
Medication error 43.57 27.46 3 77502 36101 50491518
International normalised ratio increased 43.40 27.46 7 77498 43145 50484474
Therapeutic product effect decreased 42.91 27.46 90 77415 135960 50391659
Injury 40.98 27.46 12 77493 48913 50478706
Adverse event 40.35 27.46 153 77352 43610 50484009
Bone pain 40.20 27.46 161 77344 47068 50480551
Encephalopathy 40.11 27.46 3 77502 33708 50493911
Dyspnoea 39.83 27.46 595 76910 547013 49980606
Agitation 39.69 27.46 16 77489 53368 50474251
Hepatic function abnormal 38.62 27.46 3 77502 32678 50494941
Psoriatic arthropathy 38.55 27.46 12 77493 47020 50480599
Unevaluable event 38.39 27.46 156 77349 45910 50481709
Neck pain 38.22 27.46 181 77324 56886 50470733
Product communication issue 38.19 27.46 16 77489 350 50527269
White blood cell count increased 37.96 27.46 9 77496 42231 50485388
Limb discomfort 37.93 27.46 102 77403 24255 50503364
Red blood cell count decreased 37.59 27.46 4 77501 33831 50493788
Musculoskeletal disorder 37.00 27.46 82 77423 17267 50510352
Blister 36.79 27.46 46 77459 85372 50442247
Hypoglycaemia 36.78 27.46 18 77487 53563 50474056
Pneumonia aspiration 36.21 27.46 3 77502 31001 50496618
Application site haemorrhage 35.58 27.46 21 77484 976 50526643
Hepatic failure 35.40 27.46 4 77501 32279 50495340
Atrial fibrillation 34.93 27.46 64 77441 101681 50425938
Chronic kidney disease 34.72 27.46 9 77496 39762 50487857
Pulmonary hypertension 34.56 27.46 5 77500 33412 50494207
Nervousness 34.55 27.46 107 77398 27544 50500075
Hepatitis 34.23 27.46 4 77501 31449 50496170
Pneumonitis 34.07 27.46 3 77502 29507 50498112
Injection site paraesthesia 33.86 27.46 16 77489 469 50527150
Blood alkaline phosphatase increased 33.71 27.46 8 77497 37518 50490101
Application site pain 33.63 27.46 35 77470 3763 50523856
Femur fracture 33.63 27.46 8 77497 37456 50490163
Staphylococcal infection 33.19 27.46 7 77498 35609 50492010
Muscle injury 33.17 27.46 8 77497 37103 50490516
Muscle tightness 32.09 27.46 57 77448 10223 50517396
Headache 32.08 27.46 1008 76497 505527 50022092
High density lipoprotein decreased 31.91 27.46 24 77481 1676 50525943
Cardiac failure congestive 31.80 27.46 50 77455 84332 50443287
Device leakage 31.70 27.46 42 77463 5836 50521783
Plasma cell myeloma 31.68 27.46 5 77500 31317 50496302
Gamma-glutamyltransferase increased 31.67 27.46 4 77501 29619 50498000
Haematemesis 31.52 27.46 3 77502 27722 50499897
Back disorder 30.87 27.46 53 77452 9252 50518367
Hepatotoxicity 30.81 27.46 3 77502 27223 50500396
Injection site hypersensitivity 30.70 27.46 24 77481 1776 50525843
Increased tendency to bruise 30.66 27.46 53 77452 9303 50518316
Neuropathy peripheral 30.50 27.46 64 77441 96693 50430926
Melaena 30.30 27.46 3 77502 26861 50500758
Rash maculo-papular 29.98 27.46 3 77502 26638 50500981
Dysarthria 29.85 27.46 10 77495 37393 50490226
Jaundice 29.68 27.46 3 77502 26426 50501193
Coronary artery bypass 29.57 27.46 26 77479 2267 50525352
Drug-induced liver injury 29.54 27.46 4 77501 28091 50499528
Body temperature increased 29.54 27.46 6 77499 31335 50496284
Red blood cell sedimentation rate increased 29.07 27.46 5 77500 29411 50498208
Aphonia 29.07 27.46 49 77456 8429 50519190
Psoriasis 28.84 27.46 38 77467 68962 50458657
Laboratory test abnormal 28.25 27.46 89 77416 23119 50504500

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
Wrong technique in product usage process 9807.41 29.88 3164 48598 28264 29494501
Accidental exposure to product 6257.29 29.88 1756 50006 8997 29513768
Injection site pain 3425.35 29.88 1481 50281 30965 29491800
Device difficult to use 3012.93 29.88 670 51092 916 29521849
Product dose omission issue 2632.24 29.88 1790 49972 94593 29428172
Injection site bruising 2323.03 29.88 757 51005 6823 29515942
Myalgia 1998.57 29.88 1367 50395 72652 29450113
Rhinorrhoea 1934.49 29.88 879 50883 20640 29502125
Injection site haemorrhage 1893.57 29.88 666 51096 7720 29515045
Influenza like illness 1602.11 29.88 804 50958 23666 29499099
Back pain 1551.55 29.88 1341 50421 100943 29421822
Incorrect dose administered by device 1485.00 29.88 376 51386 1163 29521602
Device issue 1368.34 29.88 514 51248 7266 29515499
Device use error 1052.93 29.88 307 51455 1815 29520950
Injection site swelling 938.59 29.88 414 51348 9003 29513762
Low density lipoprotein decreased 904.36 29.88 233 51529 787 29521978
Drug dose omission by device 795.21 29.88 217 51545 965 29521800
Underdose 717.49 29.88 370 51392 11499 29511266
Injection site mass 649.29 29.88 272 51490 5183 29517582
Muscle spasms 619.86 29.88 662 51100 64420 29458345
Product storage error 598.28 29.88 270 51492 6200 29516565
Injury associated with device 566.70 29.88 155 51607 696 29522069
Arthralgia 564.63 29.88 932 50830 138685 29384080
Nasopharyngitis 531.43 29.88 586 51176 59079 29463686
Blood cholesterol decreased 460.69 29.88 135 51627 813 29521952
Device defective 450.96 29.88 115 51647 368 29522397
Low density lipoprotein increased 435.69 29.88 186 51576 3718 29519047
Injection site discomfort 412.88 29.88 134 51628 1183 29521582
Acute kidney injury 389.71 29.88 18 51744 265249 29257516
Injection site erythema 361.04 29.88 252 51510 13704 29509061
Pain in extremity 352.14 29.88 665 51097 109768 29412997
Wrong technique in device usage process 346.66 29.88 112 51650 973 29521792
Device malfunction 303.91 29.88 188 51574 8319 29514446
Oropharyngeal pain 281.94 29.88 300 51462 28985 29493780
Incorrect disposal of product 277.50 29.88 71 51691 231 29522534
Drug interaction 272.39 29.88 19 51743 197366 29325399
Anaemia 256.42 29.88 27 51735 200924 29321841
Drug ineffective 230.55 29.88 180 51582 362990 29159775
Pneumonia 215.65 29.88 149 51613 320023 29202742
Hypotension 209.09 29.88 43 51719 194311 29328454
Injection site discolouration 206.71 29.88 80 51682 1227 29521538
Injection site urticaria 204.76 29.88 84 51678 1512 29521253
Blood glucose increased 197.32 29.88 363 51399 58621 29464144
Thrombocytopenia 194.85 29.88 10 51752 134813 29387952
Injection site pruritus 193.16 29.88 123 51639 5726 29517039
Feeling abnormal 190.92 29.88 342 51420 54103 29468662
Musculoskeletal pain 175.00 29.88 234 51528 28719 29494046
Sepsis 172.37 29.88 23 51739 142659 29380106
Pyrexia 171.79 29.88 151 51611 287471 29235294
Therapeutic response unexpected 171.45 29.88 133 51629 8505 29514260
Condition aggravated 171.09 29.88 26 51736 146269 29376496
Nasal congestion 161.79 29.88 182 51580 18697 29504068
Adverse event 154.84 29.88 161 51601 15130 29507635
Respiratory failure 151.27 29.88 4 51758 97127 29425638
Injection site vesicles 149.03 29.88 50 51712 494 29522271
Inappropriate schedule of product administration 142.78 29.88 269 51493 44203 29478562
Platelet count decreased 141.55 29.88 11 51751 104661 29418104
Completed suicide 139.48 29.88 4 51758 90242 29432523
Haemoglobin decreased 136.92 29.88 15 51747 108360 29414405
Device failure 136.76 29.88 68 51694 1948 29520817
General physical health deterioration 128.01 29.88 15 51747 102842 29419923
Blood triglycerides increased 127.91 29.88 134 51628 12700 29510065
Renal failure 127.88 29.88 26 51736 118573 29404192
Product administered at inappropriate site 125.58 29.88 61 51701 1659 29521106
Sinus disorder 125.43 29.88 95 51667 5860 29516905
Fear of injection 125.28 29.88 49 51713 774 29521991
Vomiting 123.47 29.88 114 51648 212146 29310619
Product use in unapproved indication 120.69 29.88 8 51754 86867 29435898
White blood cell count decreased 117.83 29.88 7 51755 83355 29439410
Pancytopenia 117.51 29.88 7 51755 83161 29439604
Influenza 115.86 29.88 238 51524 41643 29481122
Injection site rash 112.85 29.88 73 51689 3491 29519274
Occupational exposure to product 111.28 29.88 35 51727 276 29522489
Intentional product misuse 109.17 29.88 208 51554 34453 29488312
Overdose 106.19 29.88 9 51753 79810 29442955
Seizure 101.23 29.88 20 51742 93103 29429662
Oedema peripheral 101.18 29.88 28 51734 103529 29419236
Hyponatraemia 100.95 29.88 4 51758 67629 29455136
Death 100.90 29.88 288 51474 341796 29180969
Dehydration 99.83 29.88 38 51724 114710 29408055
Disease progression 99.33 29.88 13 51749 81903 29440862
Gastrointestinal haemorrhage 97.95 29.88 12 51750 79521 29443244
Injection site reaction 97.79 29.88 109 51653 11079 29511686
Low density lipoprotein abnormal 95.89 29.88 30 51732 232 29522533
Application site mass 95.70 29.88 19 51743 7 29522758
Decreased appetite 93.10 29.88 71 51691 145271 29377494
Hyperkalaemia 90.39 29.88 4 51758 61388 29461377
Adverse reaction 88.26 29.88 57 51705 2718 29520047
Blood creatinine increased 86.97 29.88 21 51741 85081 29437684
Pain 86.40 29.88 554 51208 170878 29351887
Paranasal sinus hypersecretion 84.95 29.88 37 51725 777 29521988
Memory impairment 84.54 29.88 193 51569 36277 29486488
Mobility decreased 84.01 29.88 157 51605 25623 29497142
Pleural effusion 83.47 29.88 13 51749 71895 29450870
Respiratory tract congestion 83.41 29.88 71 51691 5178 29517587
Fall 82.39 29.88 114 51648 177064 29345701
Injection site induration 82.14 29.88 53 51709 2523 29520242
Cardiac failure 82.13 29.88 19 51743 79268 29443497
Blood cholesterol increased 82.13 29.88 118 51644 15477 29507288
Glycosylated haemoglobin increased 80.95 29.88 91 51671 9335 29513430
Septic shock 80.66 29.88 8 51754 62552 29460213
Multiple organ dysfunction syndrome 79.00 29.88 9 51753 63107 29459658
Interstitial lung disease 78.17 29.88 6 51756 57712 29465053
Deep vein thrombosis 77.64 29.88 6 51756 57393 29465372
Leukopenia 76.89 29.88 5 51757 55198 29467567
Hypokalaemia 74.80 29.88 3 51759 50200 29472565
Incorrect dose administered by product 74.54 29.88 16 51746 16 29522749
Pulmonary embolism 74.16 29.88 21 51741 76513 29446252
Confusional state 70.38 29.88 72 51690 127805 29394960
Device dispensing error 67.43 29.88 16 51746 34 29522731
Cardiac arrest 67.01 29.88 33 51729 85558 29437207
Hypoxia 66.86 29.88 4 51758 47375 29475390
Muscular weakness 66.40 29.88 249 51513 61803 29460962
Sleep disorder due to a general medical condition 65.83 29.88 50 51712 3096 29519669
Bradycardia 65.48 29.88 17 51745 65612 29457153
Sneezing 64.67 29.88 57 51705 4357 29518408
Tachycardia 64.59 29.88 23 51739 72387 29450378
Fatigue 63.76 29.88 839 50923 315982 29206783
Needle issue 63.71 29.88 58 51704 4625 29518140
Agitation 62.51 29.88 8 51754 51296 29471469
Syncope 61.28 29.88 33 51729 81338 29441427
Rash pruritic 59.36 29.88 125 51637 22238 29500527
Upper-airway cough syndrome 59.06 29.88 46 51716 2957 29519808
Hypoacusis 58.87 29.88 97 51665 14326 29508439
Rhabdomyolysis 56.52 29.88 18 51744 60790 29461975
Dysphonia 56.51 29.88 112 51650 19084 29503681
International normalised ratio increased 56.35 29.88 6 51756 44366 29478399
Injection site hypoaesthesia 56.02 29.88 15 51747 61 29522704
Intentional product use issue 55.93 29.88 5 51757 42493 29480272
Incorrect dose administered 55.91 29.88 155 51607 32829 29489936
Oxygen saturation decreased 54.77 29.88 7 51755 44930 29477835
Musculoskeletal disorder 54.51 29.88 56 51706 5184 29517581
Headache 53.31 29.88 501 51261 173506 29349259
Cough 52.75 29.88 391 51371 126336 29396429
Injection site irritation 52.67 29.88 29 51733 1028 29521737
Muscle disorder 52.15 29.88 38 51724 2208 29520557
Pneumonia aspiration 52.14 29.88 3 51759 36734 29486031
Hallucination 52.06 29.88 8 51754 44704 29478061
Muscle tightness 51.85 29.88 50 51712 4288 29518477
C-reactive protein increased 51.35 29.88 8 51754 44255 29478510
Hypoglycaemia 51.23 29.88 11 51751 48335 29474430
Cardiac operation 51.02 29.88 40 51722 2596 29520169
Cardiac failure congestive 49.50 29.88 37 51725 76544 29446221
Injection site extravasation 49.44 29.88 38 51724 2395 29520370
Secretion discharge 49.34 29.88 48 51714 4162 29518603
Atrial fibrillation 49.01 29.88 68 51694 105578 29417187
Cardio-respiratory arrest 48.79 29.88 14 51748 50587 29472178
Constipation 48.58 29.88 78 51684 114082 29408683
Infection 48.44 29.88 38 51724 76713 29446052
Device physical property issue 47.46 29.88 23 51739 622 29522143
Haematuria 46.85 29.88 10 51752 44129 29478636
Stent placement 46.58 29.88 47 51715 4259 29518506
Ascites 46.37 29.88 5 51757 36614 29486151
Product use issue 44.75 29.88 17 51745 51427 29471338
Plasma cell myeloma 44.70 29.88 6 51756 37109 29485656
Renal impairment 44.48 29.88 46 51716 81287 29441478
Hypersensitivity 44.43 29.88 197 51565 52706 29470059
Mental status changes 43.64 29.88 5 51757 34922 29487843
Oedema 43.32 29.88 9 51753 40474 29482291
High density lipoprotein decreased 40.73 29.88 37 51725 2942 29519823
Aggression 39.94 29.88 7 51755 35534 29487231
Throat irritation 39.85 29.88 62 51700 8723 29514042
Abdominal pain 39.67 29.88 114 51648 135243 29387522
Lack of injection site rotation 39.43 29.88 13 51749 121 29522644
Application site swelling 39.24 29.88 15 51747 222 29522543
Somnolence 39.21 29.88 65 51697 93890 29428875
Pulmonary oedema 39.09 29.88 13 51749 42722 29480043
Lactic acidosis 38.63 29.88 4 51758 30243 29492522
Rectal haemorrhage 38.40 29.88 7 51755 34542 29488223
Unevaluable event 38.11 29.88 127 51635 29724 29493041
Device delivery system issue 37.54 29.88 16 51746 318 29522447
Injection site injury 37.53 29.88 14 51748 193 29522572
Blood bilirubin increased 37.39 29.88 7 51755 33886 29488879
Dysarthria 37.22 29.88 5 51757 30906 29491859
White blood cell count increased 36.87 29.88 10 51752 37506 29485259
Cerebral haemorrhage 35.73 29.88 6 51756 31420 29491345
Fractional exhaled nitric oxide increased 35.72 29.88 16 51746 360 29522405
Injection site paraesthesia 35.63 29.88 12 51750 120 29522645
Neck pain 35.56 29.88 100 51662 21347 29501418
Musculoskeletal discomfort 34.88 29.88 49 51713 6292 29516473
Jaundice 34.66 29.88 5 51757 29291 29493474
Respiratory distress 34.64 29.88 7 51755 32099 29490666
Stomatitis 34.45 29.88 11 51751 37102 29485663
Haemorrhage 34.32 29.88 18 51744 45054 29477711
Cellulitis 33.90 29.88 19 51743 45821 29476944
Sinus congestion 33.71 29.88 41 51721 4571 29518194
Circumstance or information capable of leading to medication error 33.62 29.88 25 51737 1499 29521266
Pruritus 33.53 29.88 332 51430 116517 29406248
High density lipoprotein increased 33.51 29.88 15 51747 337 29522428
Blood alkaline phosphatase increased 33.25 29.88 5 51757 28401 29494364
Spinal operation 33.04 29.88 30 51732 2384 29520381
Haematochezia 32.53 29.88 12 51750 36971 29485794
Acute respiratory failure 32.44 29.88 4 51758 26398 29496367
Haemoptysis 32.26 29.88 7 51755 30543 29492222
Injection site laceration 31.75 29.88 8 51754 24 29522741
Alanine aminotransferase increased 31.57 29.88 47 51715 70897 29451868
Colitis 31.33 29.88 8 51754 31240 29491525
Sluggishness 31.00 29.88 32 51730 2979 29519786
Head discomfort 30.78 29.88 33 51729 3209 29519556
Gamma-glutamyltransferase increased 30.63 29.88 5 51757 26732 29496033
Unresponsive to stimuli 30.40 29.88 4 51758 25122 29497643
Thrombosis 30.20 29.88 19 51743 43026 29479739
Blood triglycerides decreased 29.92 29.88 9 51753 60 29522705

FDA Adverse Event Reporting System (Geriatric)

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
Wrong technique in product usage process 21920.05 25.37 6822 98300 58152 64335458
Accidental exposure to product 13384.30 25.37 3809 101313 22555 64371055
Injection site pain 7893.30 25.37 3765 101357 107643 64285967
Device difficult to use 7184.20 25.37 1894 103228 7904 64385706
Product dose omission issue 5274.71 25.37 3503 101619 191244 64202366
Injection site bruising 4579.44 25.37 1847 103275 34526 64359084
Injection site haemorrhage 3766.78 25.37 1435 103687 22843 64370767
Device issue 3101.76 25.37 1223 103899 21425 64372185
Rhinorrhoea 3074.33 25.37 1633 103489 58336 64335274
Incorrect dose administered by device 2819.24 25.37 754 104368 3343 64390267
Myalgia 2502.16 25.37 2066 103056 156551 64237059
Device use error 2457.08 25.37 749 104373 5722 64387888
Influenza like illness 2308.53 25.37 1367 103755 60335 64333275
Back pain 2288.23 25.37 2404 102718 247767 64145843
Underdose 1868.08 25.37 889 104233 24940 64368670
Drug dose omission by device 1633.60 25.37 474 104648 2983 64390627
Injury associated with device 1422.99 25.37 408 104714 2445 64391165
Muscle spasms 1302.77 25.37 1365 103757 139658 64253952
Injection site swelling 1264.06 25.37 806 104316 40547 64353063
Product storage error 1066.24 25.37 492 104630 12826 64380784
Injection site mass 1037.52 25.37 524 104598 16746 64376864
Device defective 1001.22 25.37 261 104861 1022 64392588
Low density lipoprotein decreased 944.39 25.37 241 104881 849 64392761
Wrong technique in device usage process 881.94 25.37 283 104839 2599 64391011
Incorrect disposal of product 718.63 25.37 184 104938 659 64392951
Device malfunction 693.25 25.37 404 104718 17229 64376381
Injection site erythema 655.56 25.37 687 104435 70113 64323497
Pain in extremity 650.42 25.37 1487 103635 301598 64092012
Acute kidney injury 628.55 25.37 24 105098 449216 63944394
Drug ineffective 627.12 25.37 295 104827 839952 63553658
Low density lipoprotein increased 625.86 25.37 288 104834 7452 64386158
Blood cholesterol decreased 574.75 25.37 175 104947 1327 64392283
Oropharyngeal pain 553.88 25.37 703 104419 88164 64305446
Injection site discomfort 551.87 25.37 221 104901 4020 64389590
Nasopharyngitis 505.71 25.37 1037 104085 195036 64198574
Drug interaction 478.30 25.37 28 105094 362055 64031555
Arthralgia 437.24 25.37 1645 103477 440615 63952995
Feeling abnormal 428.11 25.37 775 104347 132827 64260783
Anaemia 421.16 25.37 59 105063 378621 64014989
Condition aggravated 398.18 25.37 65 105057 372361 64021249
Injection site discolouration 387.77 25.37 200 104922 6675 64386935
Completed suicide 344.32 25.37 4 105118 224410 64169200
Thrombocytopenia 334.73 25.37 6 105116 223795 64169815
Pyrexia 334.29 25.37 254 104868 558390 63835220
Hypotension 328.81 25.37 106 105016 380868 64012742
Blood glucose increased 326.92 25.37 579 104543 97494 64296116
Fear of injection 324.85 25.37 169 104953 5743 64387867
Vomiting 278.75 25.37 293 104829 550824 63842786
Therapeutic response unexpected 278.33 25.37 227 104895 16774 64376836
Injection site pruritus 254.24 25.37 311 104811 37515 64356095
Infusion related reaction 247.57 25.37 4 105118 164463 64229147
Pneumonia 245.12 25.37 333 104789 559243 63834367
Injection site urticaria 241.47 25.37 176 104946 11005 64382605
Device failure 241.22 25.37 137 104985 5555 64388055
Inappropriate schedule of product administration 238.49 25.37 489 104633 91797 64301813
Sepsis 237.61 25.37 44 105078 230297 64163313
Haemoglobin decreased 234.93 25.37 23 105099 195040 64198570
Product use in unapproved indication 228.90 25.37 15 105107 176603 64217007
General physical health deterioration 226.64 25.37 32 105090 204393 64189217
Blood triglycerides increased 220.53 25.37 208 104914 18658 64374952
Platelet count decreased 218.06 25.37 14 105108 167697 64225913
Respiratory failure 217.10 25.37 11 105111 161172 64232438
Overdose 214.57 25.37 11 105111 159555 64234055
Product administered at inappropriate site 212.31 25.37 103 105019 3007 64390603
White blood cell count decreased 205.73 25.37 13 105109 157824 64235786
Hyponatraemia 203.41 25.37 9 105113 148330 64245280
Sinus disorder 202.60 25.37 189 104933 16719 64376891
Pancytopenia 202.26 25.37 7 105115 143302 64250308
Oedema peripheral 193.12 25.37 52 105070 210265 64183345
Influenza 188.33 25.37 486 104636 106045 64287565
Musculoskeletal pain 188.27 25.37 412 104710 80882 64312728
Disease progression 183.66 25.37 12 105110 141668 64251942
Injection site vesicles 181.93 25.37 88 105034 2552 64391058
Memory impairment 181.40 25.37 419 104703 85263 64308347
Injection site rash 175.34 25.37 169 104953 15573 64378037
Sleep disorder due to a general medical condition 171.91 25.37 127 104995 8107 64385503
Treatment failure 171.11 25.37 4 105118 116812 64276798
Seizure 169.67 25.37 33 105089 166859 64226751
Incorrect dose administered 168.90 25.37 332 104790 60433 64333177
Rheumatoid arthritis 168.06 25.37 32 105090 164262 64229348
Hypokalaemia 165.16 25.37 8 105114 121895 64271715
Injection site extravasation 164.97 25.37 123 104999 7963 64385647
Product use issue 162.94 25.37 26 105096 151689 64241921
Renal failure 148.81 25.37 55 105067 181633 64211977
Injection site induration 147.74 25.37 120 105002 8812 64384798
Nasal congestion 146.88 25.37 310 104812 59348 64334262
Pulmonary embolism 146.54 25.37 30 105092 146326 64247284
Infection 144.77 25.37 60 105062 184820 64208790
Cardiac arrest 143.46 25.37 37 105085 154027 64239583
Contraindicated product administered 140.13 25.37 9 105113 107820 64285790
Gastrointestinal haemorrhage 139.13 25.37 24 105098 132288 64261322
Pleural effusion 137.46 25.37 21 105101 126538 64267072
Septic shock 136.43 25.37 9 105113 105428 64288182
Hyperkalaemia 135.83 25.37 7 105115 101122 64292488
Dehydration 135.15 25.37 94 105028 216669 64176941
Interstitial lung disease 133.73 25.37 6 105116 97726 64295884
Oxygen saturation decreased 133.39 25.37 11 105111 107165 64286445
Multiple organ dysfunction syndrome 133.18 25.37 8 105114 101405 64292205
Cough 131.73 25.37 893 104229 301255 64092355
Tachycardia 131.69 25.37 40 105082 149539 64244071
Coma 128.30 25.37 3 105119 87612 64305998
Fall 127.58 25.37 309 104813 416517 63977093
Needle issue 127.50 25.37 112 105010 9160 64384450
Device dispensing error 127.28 25.37 31 105091 85 64393525
Mobility decreased 127.09 25.37 367 104755 85473 64308137
Sneezing 126.91 25.37 140 104982 15111 64378499
Cardiac failure 126.72 25.37 30 105092 132343 64261267
Drug intolerance 126.10 25.37 75 105047 187917 64205693
Maternal exposure during pregnancy 124.60 25.37 8 105114 95876 64297734
Bradycardia 123.08 25.37 22 105100 118197 64275413
Adverse event 122.35 25.37 226 104896 39263 64354347
Dysphonia 120.00 25.37 246 104876 46136 64347474
Paranasal sinus hypersecretion 119.16 25.37 70 105052 3026 64390584
Hypoxia 118.70 25.37 6 105116 88143 64305467
Depressed level of consciousness 118.44 25.37 3 105119 81433 64312177
Death 116.88 25.37 400 104722 482305 63911305
Blood creatinine increased 116.51 25.37 38 105084 135744 64257866
Intentional product use issue 115.40 25.37 11 105111 95353 64298257
Respiratory tract congestion 115.27 25.37 137 104985 16028 64377582
Deep vein thrombosis 115.26 25.37 17 105105 105165 64288445
Glycosylated haemoglobin increased 112.97 25.37 135 104987 15884 64377726
Incorrect dose administered by product 112.07 25.37 30 105092 133 64393477
Occupational exposure to product 111.98 25.37 41 105081 577 64393033
Decreased appetite 110.54 25.37 180 104942 281109 64112501
Cardio-respiratory arrest 109.92 25.37 15 105107 98378 64295232
Confusional state 109.42 25.37 160 104962 260984 64132626
Muscle disorder 109.32 25.37 79 105043 4872 64388738
Unevaluable event 109.12 25.37 249 104873 50240 64343370
Neutrophil count decreased 108.09 25.37 4 105118 77192 64316418
C-reactive protein increased 107.15 25.37 14 105108 94895 64298715
Stomatitis 106.58 25.37 24 105098 109581 64284029
Injection site indentation 102.18 25.37 28 105094 138 64393472
Intentional product misuse 102.12 25.37 304 104818 71991 64321619
Muscular weakness 101.47 25.37 444 104678 126894 64266716
Device delivery system issue 100.60 25.37 34 105088 372 64393238
Delirium 98.95 25.37 3 105119 69191 64324419
International normalised ratio increased 98.85 25.37 8 105114 79159 64314451
Adverse reaction 98.05 25.37 89 105033 7598 64386012
Somnolence 96.31 25.37 114 105008 203531 64190079
Syncope 96.07 25.37 70 105052 157565 64236045
Abdominal pain 95.15 25.37 232 104890 312143 64081467
Stent placement 94.58 25.37 76 105046 5495 64388115
Cardiac operation 92.50 25.37 67 105055 4147 64389463
Blood cholesterol increased 90.04 25.37 230 104892 49836 64343774
Low density lipoprotein abnormal 88.59 25.37 29 105093 285 64393325
Upper-airway cough syndrome 88.09 25.37 89 105033 8681 64384929
Alanine aminotransferase increased 87.00 25.37 60 105062 138971 64254639
Rash pruritic 85.49 25.37 246 104876 57158 64336452
Hypoacusis 85.15 25.37 152 104970 25715 64367895
Pericarditis 84.99 25.37 4 105118 62512 64331098
Injection site injury 84.75 25.37 34 105088 621 64392989
Circumstance or information capable of leading to medication error 84.69 25.37 58 105064 3282 64390328
Oedema 83.81 25.37 23 105099 91912 64301698
Renal impairment 83.51 25.37 59 105063 134958 64258652
Lactic acidosis 83.25 25.37 4 105118 61406 64332204
Systemic lupus erythematosus 81.74 25.37 14 105108 77598 64316012
Ascites 81.06 25.37 5 105117 61996 64331614
Agitation 80.76 25.37 22 105100 88345 64305265
Drug hypersensitivity 79.38 25.37 168 104954 237647 64155963
Encephalopathy 79.20 25.37 4 105118 58815 64334795
Pulmonary oedema 78.99 25.37 16 105106 78658 64314952
Atrial fibrillation 78.52 25.37 98 105024 170991 64222619
Injection site reaction 77.40 25.37 208 104914 46456 64347154
Hypoglycaemia 77.37 25.37 25 105097 89867 64303743
Aspartate aminotransferase increased 77.23 25.37 50 105072 119738 64273872
Pneumonia aspiration 76.84 25.37 5 105117 59266 64334344
Rhabdomyolysis 76.36 25.37 27 105095 91699 64301911
Haematocrit decreased 75.94 25.37 3 105119 54652 64338958
Application site swelling 75.10 25.37 31 105091 611 64392999
Lack of injection site rotation 74.39 25.37 26 105096 317 64393293
Application site mass 74.21 25.37 17 105105 32 64393578
Melaena 74.20 25.37 3 105119 53545 64340065
Mental status changes 74.13 25.37 7 105115 61155 64332455
Blood bilirubin increased 71.34 25.37 6 105116 57547 64336063
Constipation 69.25 25.37 171 104951 229166 64164444
Loss of consciousness 69.11 25.37 84 105038 148281 64245329
Medication error 68.56 25.37 3 105119 49963 64343647
Wound 68.10 25.37 20 105102 76457 64317153
Muscle tightness 67.65 25.37 87 105035 11028 64382582
Headache 67.40 25.37 1224 103898 528243 63865367
Neck pain 65.49 25.37 235 104887 61298 64332312
Acute respiratory failure 65.36 25.37 4 105118 49930 64343680
Musculoskeletal disorder 65.17 25.37 110 105012 17796 64375814
Rash maculo-papular 63.95 25.37 3 105119 47023 64346587
Haematemesis 63.91 25.37 3 105119 46996 64346614
Suicidal ideation 63.82 25.37 15 105107 66527 64327083
Bone pain 63.37 25.37 196 104926 47376 64346234
Hepatic function abnormal 62.67 25.37 14 105108 64299 64329311
Product communication issue 62.04 25.37 25 105097 462 64393148
Dysarthria 61.93 25.37 11 105111 59395 64334215
Cellulitis 61.87 25.37 38 105084 93619 64299991
Hepatitis 61.69 25.37 3 105119 45579 64348031
Throat irritation 61.66 25.37 153 104969 32558 64361052
Unresponsive to stimuli 60.46 25.37 6 105116 50387 64343223
Lower respiratory tract infection 60.29 25.37 40 105082 94574 64299036
Blood cholesterol abnormal 59.70 25.37 43 105079 2638 64390972
Cardiac failure congestive 59.69 25.37 75 105047 130505 64263105
White blood cell count increased 59.26 25.37 17 105105 65997 64327613
High density lipoprotein decreased 58.98 25.37 50 105072 3896 64389714
Device physical property issue 58.77 25.37 39 105083 2094 64391516
Pruritus 58.40 25.37 771 104351 311629 64081981
Application site haemorrhage 58.32 25.37 32 105090 1212 64392398
Hepatocellular injury 58.09 25.37 4 105118 45231 64348379
Blood alkaline phosphatase increased 57.43 25.37 11 105111 56268 64337342
Fatigue 57.22 25.37 1610 103512 747120 63646490
Injection site irritation 56.71 25.37 45 105077 3195 64390415
Anaphylactic reaction 55.81 25.37 21 105101 68643 64324967
Liver function test abnormal 55.77 25.37 14 105108 59387 64334223
Haematuria 55.35 25.37 15 105107 60456 64333154
Sedation 55.25 25.37 3 105119 41459 64352151
Jaundice 55.12 25.37 7 105115 48505 64345105
Joint swelling 55.07 25.37 174 104948 215208 64178402
Orthostatic hypotension 54.95 25.37 6 105116 46732 64346878
Red blood cell count decreased 54.93 25.37 7 105115 48379 64345231
Pulmonary hypertension 54.86 25.37 4 105118 43135 64350475
Cerebral haemorrhage 54.27 25.37 9 105113 51081 64342529
Hallucination 53.21 25.37 26 105096 72762 64320848
Injection site paraesthesia 53.10 25.37 23 105099 513 64393097
Injury 52.95 25.37 13 105109 55979 64337631
Gamma-glutamyltransferase increased 52.76 25.37 8 105114 48502 64345108
Respiratory arrest 52.72 25.37 11 105111 52974 64340636
Respiratory distress 51.79 25.37 11 105111 52320 64341290
Multiple sclerosis relapse 51.79 25.37 4 105118 41131 64352479
Rectal haemorrhage 51.78 25.37 18 105104 61799 64331811
Aggression 51.74 25.37 7 105115 46225 64347385
Musculoskeletal discomfort 51.47 25.37 94 105028 16183 64377427
Dyspnoea 50.90 25.37 845 104277 717829 63675781
Injection site warmth 50.73 25.37 84 105038 13378 64380232
Back disorder 49.85 25.37 71 105051 9919 64383691
Leukocytosis 49.46 25.37 3 105119 37737 64355873
Depression 49.04 25.37 145 104977 183146 64210464
Haemorrhage 48.63 25.37 35 105087 79316 64314294
Injection site hypoaesthesia 48.51 25.37 20 105102 393 64393217
Therapeutic product effect decreased 47.93 25.37 71 105051 115280 64278330
Glossodynia 47.45 25.37 23 105099 64673 64328937
Hypervolaemia 47.43 25.37 4 105118 38281 64355329
Shock 47.36 25.37 4 105118 38236 64355374
Plasma cell myeloma 47.02 25.37 9 105113 46066 64347544
Altered state of consciousness 46.84 25.37 4 105118 37898 64355712
Product dispensing error 46.62 25.37 74 105048 11376 64382234
Haematochezia 46.59 25.37 25 105097 66348 64327262
Application site pain 46.16 25.37 45 105077 4203 64389407
Limb discomfort 45.94 25.37 122 105000 27053 64366557
Acute respiratory distress syndrome 45.77 25.37 5 105117 38930 64354680
Gait disturbance 45.69 25.37 455 104667 171700 64221910
Pain 45.52 25.37 1202 103920 552309 63841301
Nervousness 45.29 25.37 128 104994 29428 64364182
Chronic kidney disease 44.97 25.37 19 105103 57900 64335710
Helicobacter infection 44.91 25.37 5 105117 38357 64355253
Psychotic disorder 44.57 25.37 3 105119 34575 64359035
Emotional distress 44.00 25.37 4 105118 36034 64357576
Angioedema 43.81 25.37 23 105099 61798 64331812
Epilepsy 42.96 25.37 3 105119 33528 64360082
Transaminases increased 42.86 25.37 10 105112 44584 64349026
Colitis 42.82 25.37 21 105101 58653 64334957
Therapy cessation 42.47 25.37 133 104989 32356 64361254
Blood lactate dehydrogenase increased 42.26 25.37 3 105119 33075 64360535
Haemoptysis 41.57 25.37 14 105108 49034 64344576
Psoriatic arthropathy 41.02 25.37 10 105112 43271 64350339
Dizziness 39.72 25.37 949 104173 429214 63964396
Pericardial effusion 39.36 25.37 8 105114 39246 64354364
Increased tendency to bruise 39.33 25.37 61 105061 9194 64384416
Drug ineffective for unapproved indication 39.27 25.37 3 105119 31130 64362480
Clostridium difficile infection 39.24 25.37 6 105116 36157 64357453
Arthropathy 39.04 25.37 87 105035 120880 64272730
Stevens-Johnson syndrome 38.77 25.37 5 105117 34244 64359366
Osteoarthritis 38.72 25.37 28 105094 63308 64330302
Circulatory collapse 38.00 25.37 5 105117 33727 64359883
Impaired healing 37.94 25.37 26 105096 60447 64333163
Coronary artery bypass 37.74 25.37 47 105075 5768 64387842
Treatment noncompliance 37.57 25.37 12 105110 43470 64350140
Sluggishness 37.08 25.37 46 105076 5624 64387986
Laboratory test abnormal 36.66 25.37 104 105018 23959 64369651
Drug-induced liver injury 36.39 25.37 16 105106 47627 64345983
Drug delivery system malfunction 36.29 25.37 17 105105 458 64393152
Thrombosis 36.16 25.37 37 105085 70605 64323005
Basal cell carcinoma 36.15 25.37 4 105118 30834 64362776
Intentional self-injury 36.07 25.37 3 105119 29041 64364569
Injection site haematoma 36.02 25.37 38 105084 3898 64389712
Hyperglycaemia 35.93 25.37 28 105094 60940 64332670
Head discomfort 35.73 25.37 67 105055 11767 64381843
Staphylococcal infection 35.70 25.37 19 105103 50659 64342951
Blood pressure systolic increased 35.63 25.37 18 105104 49435 64344175
Drug resistance 35.52 25.37 7 105115 35095 64358515
No adverse event 35.33 25.37 3 105119 28558 64365052
Haematoma 34.60 25.37 16 105106 46234 64347376
Neuropathy peripheral 34.38 25.37 89 105033 117436 64276174
Blood glucose abnormal 34.10 25.37 56 105066 8857 64384753
Myelodysplastic syndrome 33.84 25.37 3 105119 27576 64366034
Dyskinesia 33.81 25.37 11 105111 39377 64354233
Abnormal behaviour 33.41 25.37 7 105115 33615 64359995
Sinus congestion 33.18 25.37 76 105046 15363 64378247
Hepatic enzyme increased 33.17 25.37 105 105017 129838 64263772
Coagulopathy 33.08 25.37 6 105116 31914 64361696
Device leakage 33.07 25.37 53 105069 8213 64385397
Drug eruption 33.00 25.37 9 105113 36127 64357483
Bacteraemia 32.82 25.37 3 105119 26908 64366702
Urinary retention 32.43 25.37 20 105102 49181 64344429
Candida infection 32.35 25.37 6 105116 31413 64362197
Osteonecrosis 32.25 25.37 4 105118 28225 64365385
Blood urea increased 31.92 25.37 16 105106 44137 64349473
Body temperature increased 31.89 25.37 10 105112 36656 64356954
Cardiogenic shock 31.71 25.37 7 105115 32420 64361190
Urinary tract infection 31.67 25.37 234 104888 231362 64162248
Proteinuria 31.49 25.37 4 105118 27719 64365891
Adverse drug reaction 31.34 25.37 152 104970 45312 64348298
Pallor 31.28 25.37 12 105110 38769 64354841
High density lipoprotein increased 31.25 25.37 20 105102 1009 64392601
Swelling 30.89 25.37 145 104977 160073 64233537
Blood calcium decreased 30.76 25.37 3 105119 25551 64368059
Inflammation 30.36 25.37 37 105085 65263 64328347
Liver injury 30.22 25.37 6 105116 29926 64363684
Neutrophil count increased 30.19 25.37 3 105119 25171 64368439
Therapy interrupted 29.95 25.37 86 105036 19950 64373660
Aphonia 29.77 25.37 52 105070 8645 64384965
Intestinal obstruction 29.65 25.37 11 105111 36275 64357335
Lacrimation increased 29.64 25.37 81 105041 18265 64375345
Osteoporosis 29.31 25.37 16 105106 42064 64351546
Injection site scab 29.29 25.37 13 105109 308 64393302
Chronic obstructive pulmonary disease 29.24 25.37 44 105078 71004 64322606
Blood pressure fluctuation 29.10 25.37 25 105097 51846 64341764
Injection site laceration 28.98 25.37 10 105112 117 64393493
Ischaemic stroke 28.94 25.37 6 105116 29029 64364581
Atelectasis 28.52 25.37 5 105117 27261 64366349
Spinal operation 28.29 25.37 42 105080 6091 64387519
Hypertension 28.26 25.37 278 104844 258983 64134627
Haemorrhage intracranial 28.24 25.37 3 105119 23881 64369729
Pulmonary fibrosis 28.13 25.37 7 105115 29871 64363739
Red blood cell sedimentation rate increased 28.11 25.37 8 105114 31227 64362383
Diabetic ketoacidosis 28.08 25.37 7 105115 29838 64363772
Anxiety 28.07 25.37 204 104918 202445 64191165
Hemiparesis 28.06 25.37 7 105115 29820 64363790
Full blood count abnormal 27.96 25.37 7 105115 29750 64363860
Small intestinal obstruction 27.78 25.37 3 105119 23570 64370040
Withdrawal syndrome 27.65 25.37 3 105119 23489 64370121
Subdural haematoma 27.55 25.37 6 105116 28048 64365562
Obstructive airways disorder 27.19 25.37 3 105119 23182 64370428
Osteomyelitis 26.89 25.37 6 105116 27581 64366029
Femur fracture 26.81 25.37 11 105111 34124 64359486
Folliculitis 26.53 25.37 8 105114 30069 64363541
Pneumothorax 26.44 25.37 4 105118 24294 64369316
Nausea 26.18 25.37 1032 104090 784768 63608842
Amnesia 26.15 25.37 151 104971 48118 64345492
Pancreatitis acute 26.12 25.37 19 105103 42836 64350774
Blood pressure diastolic decreased 25.87 25.37 3 105119 22298 64371312
Heart rate decreased 25.81 25.37 31 105091 55036 64338574
Blood triglycerides decreased 25.58 25.37 10 105112 170 64393440

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC C10AX13 CARDIOVASCULAR SYSTEM
LIPID MODIFYING AGENTS
LIPID MODIFYING AGENTS, PLAIN
Other lipid modifying agents
FDA CS M0001357 Antibodies, Monoclonal
MeSH PA D000924 Anticholesteremic Agents
MeSH PA D000963 Antimetabolites
MeSH PA D004791 Enzyme Inhibitors
MeSH PA D000960 Hypolipidemic Agents
MeSH PA D057847 Lipid Regulating Agents
MeSH PA D000091362 PCSK9 Inhibitors
MeSH PA D011480 Protease Inhibitors
MeSH PA D015842 Serine Proteinase Inhibitors
FDA MoA N0000191730 PCSK9 Inhibitors
FDA EPC N0000191731 PCSK9 Inhibitor

Drug Use | Suggest Off label Use Form| |View source of the data|

DiseaseRelationSNOMED_IDDOID
Hypercholesterolemia indication 13644009
Cardiovascular disease indication 49601007 DOID:1287
Familial hypercholesterolemia - homozygous indication 238078005
Familial hypercholesterolemia - heterozygous indication 238079002
Complex dyslipidemia indication 109041000119107




🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

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
Proprotein convertase subtilisin/kexin type 9 Enzyme INHIBITOR Kd 9.72 IUPHAR SCIENTIFIC LITERATURE

External reference:

IDSource
D10557 KEGG_DRUG
4034786 VANDF
CHEMBL2364655 ChEMBL_ID
C577155 MESH_SUPPLEMENTAL_RECORD_UI
7343 IUPHAR_LIGAND_ID
9643 INN_ID
DB09303 DRUGBANK_ID
LKC0U3A8NJ UNII
1665684 RXNORM
236233 MMSL
31213 MMSL
d08383 MMSL
716068004 SNOMEDCT_US
763586000 SNOMEDCT_US
C3529352 UMLSCUI
016368 NDDF

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
REPATHA HUMAN PRESCRIPTION DRUG LABEL 1 55513-750 INJECTION, SOLUTION 140 mg SUBCUTANEOUS BLA 33 sections
REPATHA HUMAN PRESCRIPTION DRUG LABEL 1 55513-760 INJECTION, SOLUTION 140 mg SUBCUTANEOUS BLA 33 sections
REPATHA HUMAN PRESCRIPTION DRUG LABEL 1 72511-750 INJECTION, SOLUTION 140 mg SUBCUTANEOUS BLA 33 sections
REPATHA HUMAN PRESCRIPTION DRUG LABEL 1 72511-760 INJECTION, SOLUTION 140 mg SUBCUTANEOUS BLA 33 sections