evolocumab 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | 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

Predicted pharmacokinetic/toxicological properties (PK-AZ):

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
Device difficult to use 18066.60 24.73 4087 91894 13438 90519028
Wrong technique in product usage process 17041.13 24.73 5209 90772 66362 90466104
Accidental exposure to product 12270.90 24.73 3594 92387 38772 90493694
Drug dose omission by device 10099.12 24.73 2307 93674 7924 90524542
Injection site pain 7754.83 24.73 3733 92248 169966 90362500
Injection site bruising 4366.43 24.73 1751 94230 50556 90481910
Product dose omission issue 3006.83 24.73 2474 93507 289213 90243253
Injection site haemorrhage 2891.16 24.73 1098 94883 27220 90505246
Device use error 2631.05 24.73 735 95246 6486 90525980
Myalgia 2380.69 24.73 1752 94229 173373 90359093
Rhinorrhoea 2219.87 24.73 1299 94682 87017 90445449
Incorrect dose administered by device 2195.72 24.73 607 95374 5130 90527336
Device issue 1727.51 24.73 769 95212 28768 90503698
Influenza like illness 1723.29 24.73 1069 94912 79542 90452924
Back pain 1625.06 24.73 1833 94148 315342 90217124
Product storage error 1618.62 24.73 658 95323 19583 90512883
Injury associated with device 1425.30 24.73 410 95571 4054 90528412
Low density lipoprotein increased 1193.35 24.73 412 95569 7673 90524793
Occupational exposure to product 1052.72 24.73 286 95695 2245 90530221
Injection site swelling 1022.90 24.73 690 95291 59149 90473317
Incorrect disposal of product 949.44 24.73 218 95763 760 90531706
Underdose 937.91 24.73 629 95352 53388 90479078
Intercepted product administration error 849.50 24.73 196 95785 702 90531764
Injection site erythema 841.90 24.73 753 95228 97749 90434717
Muscle spasms 817.42 24.73 1161 94820 250722 90281744
Injection site mass 817.07 24.73 420 95561 21670 90510796
Product communication issue 788.14 24.73 204 95777 1297 90531169
Drug ineffective 561.73 24.73 393 95588 1383905 89148561
Wrong technique in device usage process 540.36 24.73 211 95770 5624 90526842
Low density lipoprotein decreased 484.22 24.73 100 95881 175 90532291
Pain in extremity 473.63 24.73 1290 94691 449239 90083227
Blood glucose increased 451.12 24.73 530 95451 94716 90437750
Device defective 431.83 24.73 156 95825 3330 90529136
Oropharyngeal pain 414.90 24.73 559 95422 114628 90417838
Infusion related reaction 410.60 24.73 6 95975 416774 90115692
Product preparation error 408.21 24.73 205 95776 10056 90522410
Condition aggravated 397.63 24.73 75 95906 595470 89936996
Injection site pruritus 370.17 24.73 365 95616 53469 90478997
Injection site discolouration 349.73 24.73 179 95802 9141 90523325
Device malfunction 346.50 24.73 237 95744 20740 90511726
Injection site discomfort 341.68 24.73 153 95828 5787 90526679
Feeling abnormal 329.94 24.73 616 95365 166619 90365847
Fear of injection 326.67 24.73 166 95815 8349 90524117
Systemic lupus erythematosus 310.92 24.73 18 95963 361878 90170588
Circumstance or information capable of leading to medication error 305.19 24.73 134 95847 4833 90527633
Blood triglycerides increased 304.93 24.73 187 95794 13574 90518892
Contraindicated product administered 297.96 24.73 9 95972 320130 90212336
Product use issue 290.95 24.73 14 95967 329905 90202561
General physical health deterioration 286.69 24.73 24 95957 355091 90177375
Maternal exposure during pregnancy 286.16 24.73 26 95955 360037 90172429
Treatment failure 281.20 24.73 9 95972 303919 90228547
Blood cholesterol decreased 264.09 24.73 93 95888 1838 90530628
Acute kidney injury 263.22 24.73 20 95961 320367 90212099
Injection site urticaria 259.10 24.73 187 95794 17824 90514642
Wound 257.38 24.73 16 95965 302964 90229502
Injection site rash 255.62 24.73 209 95772 23964 90508502
Pyrexia 255.46 24.73 196 95785 660289 89872177
Pericarditis 253.54 24.73 7 95974 270144 90262322
Product use in unapproved indication 249.97 24.73 31 95950 336205 90196261
Glossodynia 248.40 24.73 26 95955 321753 90210713
Rheumatoid arthritis 241.01 24.73 46 95935 362568 90169898
Infection 240.53 24.73 46 95935 362048 90170418
Drug interaction 227.79 24.73 17 95964 276436 90256030
Vomiting 224.21 24.73 305 95676 787988 89744478
Neutropenia 218.13 24.73 4 95977 224900 90307566
Drug intolerance 212.99 24.73 104 95877 447487 90084979
Anaemia 206.26 24.73 59 95922 352743 90179723
Joint swelling 197.45 24.73 147 95834 503153 90029313
Therapeutic response unexpected 192.07 24.73 170 95811 21710 90510756
Stomatitis 188.64 24.73 32 95949 274666 90257800
Intentional product use issue 188.61 24.73 10 95971 216882 90315584
Psoriatic arthropathy 185.39 24.73 15 95966 228320 90304146
Lower respiratory tract infection 184.09 24.73 24 95957 250635 90281831
Inappropriate schedule of product administration 182.18 24.73 454 95527 149479 90382987
Impaired healing 180.49 24.73 19 95962 234180 90298286
Arthropathy 178.94 24.73 82 95899 366160 90166306
Thrombocytopenia 174.32 24.73 12 95969 208713 90323753
Injury 160.10 24.73 13 95968 197336 90335130
Pneumonia 156.16 24.73 273 95708 637786 89894680
Injection site induration 155.86 24.73 111 95870 10357 90522109
Low density lipoprotein abnormal 154.96 24.73 41 95940 287 90532179
Muscle injury 154.04 24.73 8 95973 176646 90355820
Hepatic enzyme increased 153.88 24.73 96 95885 360640 90171826
Glycosylated haemoglobin increased 152.98 24.73 129 95852 15433 90517033
Cough 152.09 24.73 782 95199 368180 90164286
Disease progression 147.10 24.73 4 95977 156611 90375855
Swelling 146.27 24.73 137 95844 418921 90113545
Type 2 diabetes mellitus 145.57 24.73 21 95960 203223 90329243
Influenza 144.91 24.73 398 95583 138866 90393600
Injection site vesicles 138.53 24.73 74 95907 4126 90528340
Oedema peripheral 138.51 24.73 50 95931 257865 90274601
Drug hypersensitivity 135.98 24.73 175 95806 463434 90069032
Overdose 131.87 24.73 9 95972 157700 90374766
Injection site extravasation 130.53 24.73 94 95887 8925 90523541
Osteoarthritis 129.58 24.73 25 95956 195705 90336761
C-reactive protein increased 129.30 24.73 19 95962 181370 90351096
Confusional state 129.27 24.73 131 95850 386074 90146392
Product administered at inappropriate site 128.16 24.73 70 95911 4081 90528385
Injection site indentation 127.33 24.73 35 95946 288 90532178
Nasopharyngitis 125.77 24.73 799 95182 406305 90126161
Discomfort 125.51 24.73 67 95914 274268 90258198
Blister 124.63 24.73 57 95924 254941 90277525
Oedema 123.62 24.73 30 95951 200265 90332201
White blood cell count decreased 120.28 24.73 17 95964 167092 90365374
Stent placement 116.44 24.73 66 95915 4137 90528329
Haemoglobin decreased 110.84 24.73 19 95962 161937 90370529
Wheezing 110.58 24.73 57 95924 238023 90294443
Hyponatraemia 110.54 24.73 8 95973 133530 90398936
Muscle disorder 110.14 24.73 70 95911 5409 90527057
Hypotension 109.29 24.73 110 95871 325287 90207179
Incorrect dose administered 107.62 24.73 250 95731 78680 90453786
Device failure 107.01 24.73 75 95906 6822 90525644
Irritable bowel syndrome 106.73 24.73 43 95938 207405 90325061
Hypokalaemia 102.64 24.73 10 95971 131106 90401360
Dysphonia 100.88 24.73 213 95768 62871 90469595
Unevaluable event 100.56 24.73 196 95785 54652 90477814
Joint range of motion decreased 99.51 24.73 13 95968 135630 90396836
Wound infection 98.87 24.73 3 95978 106399 90426067
Platelet count decreased 96.11 24.73 15 95966 136954 90395512
Gastrointestinal disorder 95.41 24.73 79 95902 256608 90275858
Seizure 93.90 24.73 23 95958 152606 90379860
Leukopenia 93.00 24.73 3 95978 100707 90431759
Inflammation 91.89 24.73 37 95944 178555 90353911
Cardiac operation 90.90 24.73 55 95926 3894 90528572
Device dispensing error 90.83 24.73 24 95957 167 90532299
Respiratory failure 90.19 24.73 10 95971 118408 90414058
Delirium 90.10 24.73 5 95976 104354 90428112
Hypercholesterolaemia 89.77 24.73 4 95977 100888 90431578
Sinus disorder 87.52 24.73 142 95839 34305 90498161
Pulmonary fibrosis 87.39 24.73 7 95974 107496 90424970
Arthralgia 87.36 24.73 1230 94751 777292 89755174
Tachycardia 87.32 24.73 29 95952 157644 90374822
Lip dry 86.66 24.73 5 95976 100950 90431516
Sepsis 86.59 24.73 41 95940 179773 90352693
Hypoacusis 86.50 24.73 126 95855 27724 90504742
Decreased appetite 85.83 24.73 168 95813 376372 90156094
Bursitis 84.66 24.73 18 95963 131636 90400830
Lung disorder 84.00 24.73 27 95954 149856 90382610
Pulmonary embolism 83.89 24.73 18 95963 130802 90401664
Intentional product misuse 80.50 24.73 243 95738 89361 90443105
Obesity 77.66 24.73 10 95971 105497 90426969
Oxygen saturation decreased 77.18 24.73 11 95970 107472 90424994
Paranasal sinus hypersecretion 76.51 24.73 52 95929 4499 90527967
Blood cholesterol abnormal 73.70 24.73 43 95938 2847 90529619
Medication error 73.25 24.73 4 95977 84648 90447818
Pleural effusion 72.65 24.73 15 95966 111976 90420490
Injection site warmth 70.72 24.73 90 95891 17425 90515041
Sneezing 70.34 24.73 119 95862 29750 90502716
Therapeutic product effect decreased 70.27 24.73 116 95865 277455 90255011
Injection site injury 68.08 24.73 29 95952 970 90531496
Depression 67.72 24.73 135 95846 300466 90232000
Injection site reaction 67.56 24.73 233 95748 91847 90440619
Nasal congestion 67.35 24.73 218 95763 83196 90449270
Septic shock 66.98 24.73 6 95975 84154 90448312
Injection site irritation 65.67 24.73 53 95928 5962 90526504
Hypertension 65.49 24.73 256 95725 457276 90075190
Red blood cell sedimentation rate increased 65.43 24.73 6 95975 82589 90449877
Coma 64.22 24.73 3 95978 72629 90459837
Fibromyalgia 63.38 24.73 75 95906 206194 90326272
Grip strength decreased 63.02 24.73 11 95970 92565 90439901
Abdominal pain 62.16 24.73 213 95768 395508 90136958
Depressed level of consciousness 61.28 24.73 4 95977 72780 90459686
Incorrect dose administered by product 61.09 24.73 19 95962 250 90532216
Therapy interrupted 61.07 24.73 152 95829 49956 90482510
Asthma 60.54 24.73 102 95879 242058 90290408
Lack of injection site rotation 60.07 24.73 26 95955 905 90531561
Product quality issue 59.65 24.73 7 95974 79318 90453148
Sleep disorder due to general medical condition, insomnia type 59.45 24.73 31 95950 128663 90403803
Interstitial lung disease 59.34 24.73 6 95975 76399 90456067
Drug-induced liver injury 58.78 24.73 12 95969 90306 90442160
Hypoxia 58.05 24.73 5 95976 72394 90460072
Nervousness 57.97 24.73 118 95863 33938 90498528
Bone pain 57.47 24.73 170 95811 61813 90470653
Hepatitis 56.41 24.73 5 95976 70734 90461732
Abdominal discomfort 56.30 24.73 287 95694 477041 90055425
Cardiac arrest 55.19 24.73 21 95960 104914 90427552
Application site swelling 55.01 24.73 22 95959 625 90531841
Coronary artery bypass 54.80 24.73 33 95948 2316 90530150
Psoriasis 53.01 24.73 47 95934 147707 90384759
Upper-airway cough syndrome 52.21 24.73 72 95909 15063 90517403
Lower limb fracture 51.91 24.73 13 95968 85000 90447466
Musculoskeletal stiffness 51.88 24.73 152 95829 296380 90236086
Product dispensing error 51.03 24.73 64 95917 12209 90520257
Injection site hypersensitivity 50.72 24.73 33 95948 2654 90529812
Deep vein thrombosis 50.45 24.73 17 95964 91603 90440863
Musculoskeletal disorder 50.29 24.73 86 95895 21683 90510783
Rash pruritic 50.17 24.73 196 95785 82018 90450448
Neutrophil count decreased 49.80 24.73 8 95973 71524 90460942
Memory impairment 49.41 24.73 368 95613 196876 90335590
Lipoprotein (a) increased 48.95 24.73 12 95969 59 90532407
Throat irritation 48.46 24.73 137 95844 48558 90483908
Alopecia 48.03 24.73 317 95664 494754 90037712
Rectal haemorrhage 47.98 24.73 14 95967 82730 90449736
Drug ineffective for unapproved indication 47.43 24.73 7 95974 66637 90465829
Bradycardia 47.15 24.73 15 95966 83832 90448634
Road traffic accident 46.71 24.73 28 95953 107598 90424868
Constipation 46.71 24.73 147 95834 280248 90252218
Rubber sensitivity 46.71 24.73 32 95949 2805 90529661
Fall 46.49 24.73 309 95672 481501 90050965
Somnolence 46.12 24.73 95 95886 208989 90323477
Hyperkalaemia 45.82 24.73 7 95974 64957 90467509
Liver disorder 45.43 24.73 37 95944 121232 90411234
Sleep disorder 45.38 24.73 88 95893 197942 90334524
Night sweats 44.95 24.73 42 95939 128724 90403742
No adverse event 44.30 24.73 9 95972 67973 90464493
Limb discomfort 43.82 24.73 113 95868 37947 90494519
Multiple sclerosis relapse 43.66 24.73 3 95978 52302 90480164
Colitis ulcerative 43.66 24.73 6 95975 60260 90472206
Osteoporosis 43.48 24.73 24 95957 96507 90435959
Muscle tightness 43.48 24.73 62 95919 13377 90519089
Injection site paraesthesia 43.37 24.73 19 95962 681 90531785
Pulmonary oedema 43.09 24.73 7 95974 62073 90470393
Death 42.94 24.73 295 95686 456256 90076210
Cardiac failure 42.80 24.73 32 95949 109464 90423002
Respiratory tract congestion 42.02 24.73 91 95890 27319 90505147
Alanine aminotransferase increased 42.02 24.73 38 95943 118300 90414166
Hepatic cirrhosis 42.01 24.73 8 95973 63245 90469221
Suicidal ideation 41.91 24.73 13 95968 73842 90458624
Therapy cessation 41.91 24.73 108 95873 36253 90496213
Needle issue 41.77 24.73 62 95919 13872 90518594
Aspartate aminotransferase increased 41.65 24.73 29 95952 102908 90429558
Dehydration 41.51 24.73 90 95891 194357 90338109
Blepharospasm 41.42 24.73 5 95976 55440 90477026
Autoimmune disorder 40.95 24.73 15 95966 76729 90455737
Dizziness 40.46 24.73 861 95120 588423 89944043
Increased tendency to bruise 40.17 24.73 56 95925 11834 90520632
Application site pain 40.08 24.73 36 95945 4684 90527782
Application site haemorrhage 39.76 24.73 21 95960 1144 90531322
Exostosis 39.18 24.73 5 95976 53129 90479337
Loss of personal independence in daily activities 39.17 24.73 52 95929 136053 90396413
Foot deformity 38.66 24.73 8 95973 59643 90472823
Renal failure 37.76 24.73 50 95931 130957 90401509
Gastrointestinal haemorrhage 37.08 24.73 25 95956 90223 90442243
Loss of consciousness 36.98 24.73 57 95924 140181 90392285
Blood creatinine increased 36.67 24.73 32 95949 101354 90431112
White blood cell count increased 36.12 24.73 13 95968 67228 90465238
Nail disorder 36.12 24.73 9 95972 59058 90473408
Coeliac disease 35.99 24.73 3 95978 44607 90487859
Ill-defined disorder 35.91 24.73 90 95891 184801 90347665
Dyspepsia 35.80 24.73 100 95881 198060 90334406
Aphonia 35.76 24.73 54 95927 12265 90520201
Abortion spontaneous 35.55 24.73 7 95974 54049 90478417
Myocardial infarction 35.12 24.73 212 95769 105760 90426706
Immunodeficiency 34.62 24.73 3 95978 43231 90489235
Lipids increased 34.45 24.73 20 95961 1312 90531154
Acute respiratory failure 34.31 24.73 3 95978 42915 90489551
Anxiety 33.85 24.73 191 95790 309581 90222885
Vascular graft 33.80 24.73 17 95964 836 90531630
Hypocalcaemia 33.76 24.73 3 95978 42365 90490101
Dyspnoea 33.62 24.73 695 95286 880260 89652206
Mental status changes 33.45 24.73 4 95977 44675 90487791
Insomnia 33.08 24.73 212 95769 333262 90199204
Pneumonitis 32.95 24.73 4 95977 44166 90488300
Encephalopathy 32.77 24.73 5 95976 46439 90486027
Red blood cell count decreased 32.68 24.73 5 95976 46346 90486120
High density lipoprotein decreased 32.47 24.73 25 95956 2626 90529840
Surgery 32.40 24.73 113 95868 44774 90487692
Gastrooesophageal reflux disease 32.28 24.73 81 95900 166256 90366210
Burning sensation 32.22 24.73 143 95838 63309 90469157
Device delivery system issue 31.53 24.73 21 95960 1757 90530709
Coronary artery occlusion 31.49 24.73 42 95939 8512 90523954
Therapy non-responder 31.40 24.73 250 95731 136454 90396012
Taste disorder 31.24 24.73 13 95968 61533 90470933
Hypoglycaemia 30.55 24.73 18 95963 69830 90462636
Syncope 30.34 24.73 59 95922 132604 90399862
Hepatotoxicity 30.01 24.73 6 95975 45836 90486630
Haematochezia 30.00 24.73 19 95962 70894 90461572
Pneumonia aspiration 29.83 24.73 4 95977 40936 90491530
Rash maculo-papular 29.83 24.73 4 95977 40929 90491537
Unresponsive to stimuli 29.58 24.73 3 95978 38118 90494348
Intercepted product storage error 29.37 24.73 13 95968 478 90531988
International normalised ratio increased 29.34 24.73 7 95974 47309 90485157
Hip arthroplasty 28.85 24.73 23 95958 76185 90456281
Joint dislocation 28.85 24.73 6 95975 44576 90487890
Renal impairment 28.61 24.73 42 95939 105379 90427087
Haematocrit decreased 28.40 24.73 5 95976 41827 90490639
Cellulitis 28.26 24.73 33 95948 91304 90441162
Subclavian vein thrombosis 28.23 24.73 21 95960 2095 90530371
Blood glucose abnormal 28.11 24.73 42 95939 9450 90523016
Treatment noncompliance 27.79 24.73 10 95971 51717 90480749
Dry mouth 27.57 24.73 101 95880 183958 90348508
Plasma cell myeloma 27.46 24.73 5 95976 40823 90491643
Platelet aggregation abnormal 27.33 24.73 6 95975 16 90532450
Agitation 27.01 24.73 19 95962 67079 90465387
Disease recurrence 26.69 24.73 4 95977 37649 90494817
Staphylococcal infection 26.65 24.73 9 95972 48430 90484036
Colitis 26.62 24.73 21 95960 69921 90462545
Device leakage 26.49 24.73 42 95939 9949 90522517
Hepatic failure 26.43 24.73 5 95976 39723 90492743
Blood alkaline phosphatase increased 26.33 24.73 9 95972 48070 90484396
Orthostatic hypotension 26.31 24.73 6 95975 41821 90490645
Muscular weakness 26.11 24.73 334 95647 206332 90326134
Sleep disorder due to a general medical condition 25.95 24.73 105 95876 44633 90487833
Hypercalcaemia 25.79 24.73 3 95978 34237 90498229
Emotional distress 25.74 24.73 4 95977 36658 90495808
Injection site hypoaesthesia 25.61 24.73 13 95968 652 90531814
Flatulence 25.54 24.73 99 95882 41268 90491198
Liver function test abnormal 25.39 24.73 11 95970 50834 90481632
Haematemesis 25.29 24.73 3 95978 33723 90498743
Swelling face 25.23 24.73 160 95821 81192 90451274
Adverse reaction 25.20 24.73 79 95902 29633 90502833
Body temperature increased 25.13 24.73 8 95973 44702 90487764
Coronary arterial stent insertion 24.79 24.73 22 95959 2818 90529648
Gamma-glutamyltransferase increased 24.78 24.73 5 95976 37947 90494519

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 11924.21 26.44 3820 61038 38815 42517662
Device difficult to use 10967.25 26.44 2281 62577 2315 42554162
Accidental exposure to product 7574.43 26.44 2277 62581 18116 42538361
Drug dose omission by device 6207.43 26.44 1500 63358 4386 42552091
Injection site pain 3223.53 26.44 1626 63232 56172 42500305
Injection site bruising 2278.48 26.44 800 64058 10725 42545752
Myalgia 2233.03 26.44 1534 63324 94546 42461931
Product dose omission issue 2196.13 26.44 1837 63021 152528 42403949
Injection site haemorrhage 2078.93 26.44 751 64107 10985 42545492
Incorrect dose administered by device 1925.35 26.44 506 64352 2250 42554227
Rhinorrhoea 1805.53 26.44 907 63951 30887 42525590
Influenza like illness 1684.58 26.44 866 63992 30974 42525503
Device use error 1625.42 26.44 457 64401 2740 42553737
Back pain 1475.16 26.44 1416 63442 140360 42416117
Product storage error 1303.16 26.44 527 64331 10613 42545864
Device issue 1156.57 26.44 512 64346 12997 42543480
Low density lipoprotein decreased 1049.26 26.44 268 64590 1036 42555441
Injection site swelling 854.64 26.44 447 64411 16526 42539951
Underdose 696.76 26.44 388 64470 16278 42540199
Muscle spasms 692.93 26.44 750 64108 85294 42471183
Injury associated with device 675.04 26.44 192 64666 1205 42555272
Low density lipoprotein increased 648.97 26.44 260 64598 5095 42551382
Injection site mass 638.56 26.44 295 64563 8280 42548197
Incorrect disposal of product 561.13 26.44 130 64728 292 42556185
Nasopharyngitis 560.10 26.44 664 64194 83332 42473145
Intercepted product administration error 551.00 26.44 135 64723 420 42556057
Arthralgia 511.81 26.44 1027 63831 204211 42352266
Blood cholesterol decreased 488.75 26.44 142 64716 971 42555506
Acute kidney injury 431.93 26.44 34 64824 367303 42189174
Product communication issue 376.50 26.44 116 64742 993 42555484
Product preparation error 373.30 26.44 170 64688 4608 42551869
Injection site discomfort 370.06 26.44 138 64720 2208 42554269
Injection site erythema 358.85 26.44 275 64583 19920 42536557
Drug ineffective 351.76 26.44 269 64589 629928 41926549
Device defective 317.26 26.44 113 64745 1575 42554902
Pain in extremity 315.88 26.44 703 64155 149901 42406576
Anaemia 305.18 26.44 35 64823 280243 42276234
Wrong technique in device usage process 303.60 26.44 125 64733 2632 42553845
Drug interaction 294.06 26.44 32 64826 266967 42289510
Neutropenia 282.86 26.44 4 64854 199427 42357050
Device malfunction 266.59 26.44 189 64669 12138 42544339
Condition aggravated 259.21 26.44 43 64815 260711 42295766
Circumstance or information capable of leading to medication error 256.10 26.44 108 64750 2420 42554057
Oropharyngeal pain 250.40 26.44 316 64542 42194 42514283
Pneumonia 246.80 26.44 171 64687 421978 42134499
Thrombocytopenia 227.80 26.44 16 64842 190263 42366214
Blood glucose increased 225.28 26.44 403 64455 73296 42483181
Occupational exposure to product 215.34 26.44 61 64797 376 42556101
Pyrexia 213.00 26.44 173 64685 393869 42162608
Hypotension 212.88 26.44 64 64794 257567 42298910
Feeling abnormal 203.61 26.44 374 64484 69412 42487065
Sepsis 202.20 26.44 31 64827 199303 42357174
Injection site discolouration 197.50 26.44 83 64775 1843 42554634
Product use in unapproved indication 190.97 26.44 27 64831 184429 42372048
Musculoskeletal pain 183.98 26.44 240 64618 33100 42523377
Injection site pruritus 182.39 26.44 135 64723 9270 42547207
Injection site urticaria 178.46 26.44 92 64766 3291 42553186
General physical health deterioration 169.21 26.44 17 64841 151229 42405248
Low density lipoprotein abnormal 165.34 26.44 49 64809 362 42556115
Respiratory failure 164.97 26.44 7 64851 128125 42428352
Therapeutic response unexpected 161.71 26.44 136 64722 11245 42545232
Platelet count decreased 156.53 26.44 15 64843 138566 42417911
Vomiting 149.22 26.44 133 64725 289590 42266887
Blood triglycerides increased 146.20 26.44 149 64709 15747 42540730
Disease progression 141.88 26.44 24 64834 143632 42412845
Pancytopenia 137.70 26.44 11 64847 117732 42438745
Injection site rash 133.81 26.44 92 64766 5620 42550857
Haemoglobin decreased 133.34 26.44 21 64837 132450 42424027
White blood cell count decreased 132.85 26.44 9 64849 110387 42446090
Hyponatraemia 132.42 26.44 5 64853 101457 42455020
Nasal congestion 130.63 26.44 191 64667 29310 42527167
Adverse event 130.12 26.44 170 64688 23470 42533007
Product administered at inappropriate site 129.03 26.44 72 64786 3026 42553451
Completed suicide 128.54 26.44 4 64854 96461 42460016
Injection site vesicles 125.77 26.44 54 64804 1266 42555211
Overdose 125.45 26.44 9 64849 105255 42451222
Fractional exhaled nitric oxide increased 124.88 26.44 57 64801 1552 42554925
Device failure 120.41 26.44 66 64792 2677 42553800
Renal failure 119.84 26.44 35 64823 143691 42412786
Injection site reaction 117.46 26.44 132 64726 15589 42540888
Sinus disorder 116.02 26.44 97 64761 7953 42548524
Fear of injection 115.94 26.44 58 64800 1945 42554532
Oedema peripheral 111.87 26.44 34 64824 136042 42420435
Decreased appetite 111.47 26.44 79 64779 193058 42363419
Multiple organ dysfunction syndrome 110.88 26.44 10 64848 97025 42459452
Septic shock 108.76 26.44 8 64850 91664 42464813
Glycosylated haemoglobin increased 102.56 26.44 112 64746 12812 42543665
Hyperkalaemia 101.55 26.44 5 64853 80453 42476024
Seizure 101.15 26.44 29 64829 120532 42435945
Incorrect dose administered by product 97.69 26.44 22 64836 41 42556436
Application site mass 97.64 26.44 19 64839 8 42556469
Gastrointestinal haemorrhage 97.18 26.44 16 64842 97710 42458767
Dehydration 95.81 26.44 48 64810 141719 42414758
Plantar fasciitis 95.32 26.44 59 64799 3011 42553466
Pulmonary embolism 92.84 26.44 33 64825 119579 42436898
Dysphonia 89.94 26.44 158 64700 28292 42528185
Influenza 89.67 26.44 252 64606 61923 42494554
Hypokalaemia 88.81 26.44 5 64853 71716 42484761
Myoglobin blood increased 87.89 26.44 60 64798 3622 42552855
Leukopenia 87.32 26.44 7 64851 74739 42481738
Adverse reaction 85.80 26.44 61 64797 3932 42552545
Inappropriate schedule of product administration 85.45 26.44 330 64528 95572 42460905
Sensation of foreign body 84.17 26.44 58 64800 3555 42552922
Tachycardia 83.53 26.44 25 64833 101062 42455415
Blood cholesterol increased 82.59 26.44 147 64711 26594 42529883
Pleural effusion 82.18 26.44 23 64835 97143 42459334
Memory impairment 80.87 26.44 212 64646 50010 42506467
Fall 80.73 26.44 146 64712 234374 42322103
Cardiac failure 80.36 26.44 31 64827 106825 42449652
Secretion discharge 80.28 26.44 77 64781 7558 42548919
Hypoacusis 79.77 26.44 119 64739 18583 42537894
Paranasal sinus hypersecretion 79.76 26.44 38 64820 1143 42555334
Blood creatinine increased 79.34 26.44 34 64824 109969 42446508
Hypoxia 77.58 26.44 8 64850 69778 42486699
Confusional state 75.77 26.44 86 64772 167511 42388966
Intentional product use issue 75.47 26.44 10 64848 71823 42484654
Injection site induration 74.30 26.44 53 64805 3434 42553043
Cardiac arrest 73.87 26.44 37 64821 109283 42447194
Muscular weakness 73.30 26.44 286 64572 83212 42473265
Oxygen saturation decreased 73.00 26.44 7 64851 64680 42491797
Neutrophil count decreased 71.20 26.44 7 64851 63408 42493069
Treatment failure 70.08 26.44 7 64851 62617 42493860
Stent placement 69.91 26.44 61 64797 5299 42551178
Bradycardia 69.08 26.44 22 64836 85462 42471015
Respiratory tract congestion 68.83 26.44 71 64787 7607 42548870
Device dispensing error 68.61 26.44 18 64840 79 42556398
Mobility decreased 68.42 26.44 160 64698 35146 42521331
Pain 68.28 26.44 619 64239 244229 42312248
Agitation 67.45 26.44 9 64849 64305 42492172
Interstitial lung disease 67.42 26.44 18 64840 78444 42478033
Deep vein thrombosis 67.38 26.44 17 64841 76940 42479537
Constipation 67.32 26.44 89 64769 162202 42394275
Ascites 67.06 26.44 5 64853 56673 42499804
Coma 65.48 26.44 4 64854 53550 42502927
Somnolence 65.31 26.44 71 64787 141034 42415443
Cardiac operation 64.90 26.44 50 64808 3645 42552832
Delirium 63.99 26.44 4 64854 52515 42503962
Unevaluable event 63.85 26.44 153 64705 34135 42522342
Upper-airway cough syndrome 63.72 26.44 53 64805 4313 42552164
Infection 61.80 26.44 48 64810 112020 42444457
Intentional product misuse 58.41 26.44 217 64641 61683 42494794
High density lipoprotein decreased 58.32 26.44 48 64810 3849 42552628
Cough 56.80 26.44 464 64394 177639 42378838
Abdominal pain 55.81 26.44 130 64728 190341 42366136
C-reactive protein increased 55.72 26.44 14 64844 63546 42492931
Musculoskeletal disorder 55.25 26.44 59 64799 6579 42549898
Renal impairment 54.94 26.44 52 64806 110176 42446301
Product use issue 54.88 26.44 24 64834 76727 42479750
Brain natriuretic peptide increased 54.29 26.44 59 64799 6711 42549766
Sneezing 53.74 26.44 57 64801 6306 42550171
Hallucination 53.74 26.44 11 64847 57496 42498981
Lactic acidosis 53.52 26.44 4 64854 45257 42511220
Rash pruritic 53.21 26.44 141 64717 33462 42523015
Pneumonia aspiration 52.53 26.44 7 64851 50071 42506406
International normalised ratio increased 52.32 26.44 6 64852 48162 42508315
Haematuria 52.10 26.44 12 64846 57787 42498690
Syncope 51.80 26.44 45 64813 99361 42457116
Injection site injury 51.55 26.44 20 64838 358 42556119
Lack of injection site rotation 51.50 26.44 22 64836 509 42555968
Plasma cell myeloma 51.49 26.44 6 64852 47572 42508905
Pneumonitis 51.36 26.44 3 64855 41715 42514762
Death 51.14 26.44 465 64393 470720 42085757
Muscle tightness 50.95 26.44 52 64806 5501 42550976
Hypoglycaemia 50.91 26.44 14 64844 59840 42496637
Muscle disorder 50.65 26.44 40 64818 3024 42553453
Injection site extravasation 49.98 26.44 40 64818 3082 42553395
Injection site irritation 49.19 26.44 31 64827 1633 42554844
Exostosis 48.55 26.44 51 64807 5580 42550897
Injection site hypoaesthesia 48.41 26.44 15 64843 131 42556346
Cardio-respiratory arrest 47.52 26.44 15 64843 58621 42497856
No adverse event 47.45 26.44 3 64855 39018 42517459
Rectal haemorrhage 47.38 26.44 9 64849 49597 42506880
Headache 46.27 26.44 562 64296 238807 42317670
Rhabdomyolysis 46.16 26.44 31 64827 77988 42478489
Hepatic failure 46.12 26.44 3 64855 38097 42518380
Haematochezia 45.52 26.44 16 64842 58420 42498057
Injection site indentation 45.14 26.44 12 64846 56 42556421
Haemoptysis 44.90 26.44 8 64850 46159 42510318
Fatigue 44.27 26.44 918 63940 434723 42121754
Mental status changes 43.90 26.44 6 64852 42109 42514368
Incorrect dose administered 43.69 26.44 178 64680 52796 42503681
Hypersensitivity 42.46 26.44 220 64638 72150 42484327
Stomatitis 42.38 26.44 12 64846 50317 42506160
Aggression 42.21 26.44 8 64850 44155 42512322
Product dispensing error 42.12 26.44 55 64803 7584 42548893
Melaena 41.65 26.44 5 64853 38741 42517736
Colitis 41.32 26.44 10 64848 46562 42509915
Therapy cessation 41.06 26.44 94 64764 20356 42536121
Thrombosis 40.82 26.44 27 64831 68484 42487993
Needle issue 40.80 26.44 58 64800 8669 42547808
Drug resistance 40.57 26.44 3 64855 34245 42522232
Blood creatine phosphokinase increased 40.32 26.44 163 64695 48175 42508302
Chest discomfort 39.85 26.44 197 64661 63419 42493058
Respiratory distress 39.07 26.44 8 64850 41812 42514665
Medication error 39.00 26.44 3 64855 33151 42523326
Haematocrit decreased 38.79 26.44 4 64854 34904 42521573
Coronary artery bypass 38.71 26.44 42 64816 4768 42551709
Cellulitis 38.44 26.44 23 64835 61562 42494915
Injection site paraesthesia 37.74 26.44 13 64845 163 42556314
Blood bilirubin increased 37.62 26.44 9 64849 42243 42514234
Pulmonary oedema 37.54 26.44 17 64841 53255 42503222
Cardiac failure congestive 37.49 26.44 45 64813 85557 42470920
Cardiogenic shock 37.33 26.44 5 64853 35635 42520842
Acute respiratory failure 37.22 26.44 7 64851 38851 42517626
Injection site laceration 36.73 26.44 9 64849 28 42556449
Transaminases increased 35.95 26.44 4 64854 32881 42523596
Haemorrhage 35.91 26.44 24 64834 60539 42495938
Jaundice 35.88 26.44 5 64853 34584 42521893
Application site swelling 35.86 26.44 15 64843 329 42556148
White blood cell count increased 35.71 26.44 12 64846 45075 42511402
Lipoprotein (a) increased 35.04 26.44 15 64843 349 42556128
Therapy interrupted 34.85 26.44 93 64765 22157 42534320
Blood alkaline phosphatase increased 34.52 26.44 5 64853 33592 42522885
Oedema 34.51 26.44 18 64840 51983 42504494
Hepatic function abnormal 34.00 26.44 18 64840 51549 42504928
Blood triglycerides decreased 33.65 26.44 11 64847 116 42556361
Chronic obstructive pulmonary disease 33.57 26.44 28 64830 63086 42493391
Psychotic disorder 33.37 26.44 3 64855 29205 42527272
Suicidal ideation 32.96 26.44 16 64842 48145 42508332
High density lipoprotein increased 32.67 26.44 15 64843 414 42556063
Device physical property issue 32.50 26.44 23 64835 1471 42555006
Alanine aminotransferase increased 32.21 26.44 53 64805 88353 42468124
Musculoskeletal discomfort 31.73 26.44 54 64804 9422 42547055
Vascular graft 31.66 26.44 23 64835 1533 42554944
Aspartate aminotransferase increased 31.27 26.44 43 64815 77120 42479357
COVID-19 30.91 26.44 83 64775 115865 42440612
Shock 30.71 26.44 4 64854 29117 42527360
Sinus congestion 30.60 26.44 45 64813 6935 42549542
Hepatic cytolysis 30.03 26.44 3 64855 26841 42529636
Neck pain 29.79 26.44 107 64751 29907 42526570
Cerebral haemorrhage 29.78 26.44 11 64847 38955 42517522
Anaphylactic reaction 29.56 26.44 14 64844 42729 42513748
Injection site haematoma 29.41 26.44 24 64834 1901 42554576
Unresponsive to stimuli 29.35 26.44 6 64852 31397 42525080
Dysarthria 29.17 26.44 12 64846 39795 42516682
Urinary retention 28.93 26.44 14 64844 42200 42514277
Urinary tract infection 28.85 26.44 68 64790 99216 42457261
Injection site scab 28.56 26.44 8 64850 47 42556430
Throat irritation 28.51 26.44 62 64796 12974 42543503
Sleep disorder due to general medical condition, insomnia type 28.28 26.44 21 64837 1448 42555029
Injection site warmth 28.09 26.44 27 64831 2656 42553821
Application site haemorrhage 28.08 26.44 14 64844 466 42556011
Sluggishness 27.88 26.44 32 64826 3864 42552613
Pneumocystis jirovecii pneumonia 27.69 26.44 3 64855 25178 42531299
Ventricular fibrillation 27.65 26.44 6 64852 30117 42526360
Acute respiratory distress syndrome 27.63 26.44 6 64852 30102 42526375
Chronic kidney disease 27.63 26.44 19 64839 47222 42509255
Pulmonary fibrosis 27.34 26.44 4 64854 26677 42529800
Increased upper airway secretion 27.29 26.44 26 64832 2530 42553947
Abnormal behaviour 27.03 26.44 4 64854 26447 42530030
Tremor 26.90 26.44 68 64790 96861 42459616
Gamma-glutamyltransferase increased 26.89 26.44 8 64850 32489 42523988
Blood cholesterol abnormal 26.78 26.44 23 64835 1956 42554521

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 28493.88 22.89 8292 121621 79056 110380330
Device difficult to use 26117.26 22.89 5703 124210 13102 110446284
Accidental exposure to product 17163.36 22.89 4953 124960 45055 110414331
Drug dose omission by device 15059.92 22.89 3474 126439 11042 110448344
Injection site pain 8573.04 22.89 4167 125746 173755 110285631
Injection site bruising 4947.25 22.89 1962 127951 49301 110410085
Product dose omission issue 4941.12 22.89 3604 126309 318178 110141208
Injection site haemorrhage 4417.86 22.89 1605 128308 31423 110427963
Device use error 4200.17 22.89 1140 128773 7949 110451437
Incorrect dose administered by device 4082.55 22.89 1050 128863 5764 110453622
Device issue 2978.32 22.89 1220 128693 33315 110426071
Myalgia 2934.47 22.89 2279 127634 220102 110239284
Rhinorrhoea 2901.67 22.89 1690 128223 100976 110358410
Influenza like illness 2462.30 22.89 1442 128471 86970 110372416
Back pain 2388.46 22.89 2539 127374 368457 110090929
Product storage error 1945.93 22.89 789 129124 20939 110438447
Injury associated with device 1765.90 22.89 494 129419 3895 110455491
Underdose 1483.07 22.89 926 128987 62628 110396758
Injection site swelling 1405.85 22.89 886 129027 60904 110398482
Incorrect disposal of product 1364.23 22.89 316 129597 1012 110458374
Injection site mass 1153.43 22.89 568 129345 24045 110435341
Product communication issue 1122.97 22.89 307 129606 2199 110457187
Low density lipoprotein decreased 1104.98 22.89 270 129643 1152 110458234
Muscle spasms 1096.68 22.89 1486 128427 276671 110182715
Low density lipoprotein increased 885.47 22.89 367 129546 10299 110449087
Wrong technique in device usage process 857.33 22.89 318 129595 6583 110452803
Injection site erythema 847.95 22.89 776 129137 93400 110365986
Product preparation error 841.67 22.89 356 129557 10523 110448863
Device defective 795.99 22.89 259 129654 3563 110455823
Drug ineffective 746.74 22.89 433 129480 1520107 108939279
Device malfunction 676.73 22.89 404 129509 25154 110434232
Intercepted product administration error 664.48 22.89 163 129750 709 110458677
Pain in extremity 611.14 22.89 1590 128323 485528 109973858
Blood cholesterol decreased 602.11 22.89 193 129720 2523 110456863
Acute kidney injury 582.65 22.89 43 129870 635387 109823999
Oropharyngeal pain 564.73 22.89 744 129169 134532 110324854
Injection site discomfort 547.54 22.89 230 129683 6677 110452709
Condition aggravated 537.15 22.89 106 129807 734730 109724656
Feeling abnormal 512.72 22.89 828 129085 179883 110279503
Injection site discolouration 438.07 22.89 214 129699 8889 110450497
Drug interaction 425.54 22.89 46 129867 500137 109959249
Infusion related reaction 421.05 22.89 5 129908 381157 110078229
Blood glucose increased 417.19 22.89 637 129276 131859 110327527
Neutropenia 400.74 22.89 8 129905 374612 110084774
Anaemia 399.31 22.89 79 129834 547007 109912379
Product use in unapproved indication 388.65 22.89 38 129875 447339 110012047
Pyrexia 385.20 22.89 296 129617 897969 109561417
Fear of injection 382.99 22.89 194 129719 8717 110450669
General physical health deterioration 372.40 22.89 35 129878 425260 110034126
Injection site pruritus 340.73 22.89 358 129555 50900 110408486
Thrombocytopenia 339.34 22.89 17 129896 348868 110110518
Arthralgia 335.12 22.89 1800 128113 777832 109681554
Vomiting 330.76 22.89 350 129563 910325 109549061
Nasopharyngitis 330.10 22.89 1116 128797 393245 110066141
Blood triglycerides increased 290.19 22.89 234 129679 23692 110435694
Therapeutic response unexpected 284.55 22.89 231 129682 23612 110435774
Injection site urticaria 283.24 22.89 202 129711 17013 110442373
Pneumonia 282.82 22.89 370 129543 876344 109583042
Treatment failure 277.79 22.89 11 129902 277223 110182163
Circumstance or information capable of leading to medication error 275.96 22.89 131 129782 5102 110454284
Completed suicide 263.98 22.89 4 129909 242377 110217009
Device failure 252.92 22.89 137 129776 7070 110452316
Product use issue 251.78 22.89 34 129879 311661 110147725
Hypotension 250.26 22.89 153 129760 523696 109935690
Product administered at inappropriate site 239.35 22.89 120 129793 5273 110454113
Systemic lupus erythematosus 236.25 22.89 16 129897 254322 110205064
Pemphigus 236.01 22.89 3 129910 214567 110244819
Contraindicated product administered 229.49 22.89 16 129897 248251 110211135
Intentional product use issue 229.09 22.89 16 129897 247890 110211496
Overdose 225.35 22.89 12 129901 233782 110225604
Maternal exposure during pregnancy 222.92 22.89 21 129892 254862 110204524
Stomatitis 219.38 22.89 29 129884 270213 110189173
Infection 219.05 22.89 76 129837 362124 110097262
Injection site rash 218.44 22.89 197 129716 23222 110436164
Sepsis 215.36 22.89 59 129854 327287 110132099
Rheumatoid arthritis 212.72 22.89 46 129867 299567 110159819
Pericarditis 208.84 22.89 12 129901 219102 110240284
Hyponatraemia 207.21 22.89 12 129901 217641 110241745
Respiratory failure 201.59 22.89 13 129900 215319 110244067
Pancytopenia 201.26 22.89 11 129902 209602 110249784
Unevaluable event 200.92 22.89 295 129618 58932 110400454
Oedema peripheral 200.39 22.89 68 129845 328592 110130794
Platelet count decreased 198.85 22.89 20 129893 230423 110228963
Wound 198.05 22.89 22 129891 234415 110224971
Drug intolerance 197.90 22.89 116 129797 406396 110052990
Disease progression 193.80 22.89 28 129885 244006 110215380
White blood cell count decreased 192.59 22.89 22 129891 229368 110230018
Helicobacter infection 190.05 22.89 5 129908 181872 110277514
Injection site vesicles 188.23 22.89 96 129817 4375 110455011
Incorrect dose administered 186.06 22.89 390 129523 103251 110356135
Inappropriate schedule of product administration 185.95 22.89 594 129319 203043 110256343
Haemoglobin decreased 185.31 22.89 34 129879 248693 110210693
Injection site induration 181.37 22.89 131 129782 11252 110448134
Injection site extravasation 180.49 22.89 125 129788 10044 110449342
Psoriatic arthropathy 178.07 22.89 14 129899 196747 110262639
Glossodynia 175.06 22.89 26 129887 221978 110237408
Injection site indentation 169.64 22.89 44 129869 250 110459136
C-reactive protein increased 168.47 22.89 27 129886 217892 110241494
Sinus disorder 168.36 22.89 200 129713 32528 110426858
Lower respiratory tract infection 167.19 22.89 40 129873 243066 110216320
Influenza 166.12 22.89 506 129407 168595 110290791
Confusional state 165.42 22.89 184 129729 468496 109990890
Folliculitis 163.46 22.89 8 129905 167645 110291741
Hypokalaemia 159.59 22.89 15 129898 182433 110276953
Stent placement 157.54 22.89 101 129812 7133 110452253
Cough 155.04 22.89 1000 128913 460641 109998745
Decreased appetite 151.88 22.89 202 129711 475644 109983742
Injury 151.32 22.89 16 129897 177249 110282137
Occupational exposure to product 151.26 22.89 51 129862 788 110458598
Oedema 149.49 22.89 32 129881 209944 110249442
Leukopenia 148.67 22.89 6 129907 148785 110310601
Hypoacusis 145.81 22.89 193 129720 34998 110424388
Low density lipoprotein abnormal 145.42 22.89 45 129868 520 110458866
Impaired healing 144.15 22.89 28 129885 196689 110262697
Dysphonia 143.64 22.89 292 129621 75637 110383749
Glycosylated haemoglobin increased 142.92 22.89 157 129756 23462 110435924
Seizure 141.48 22.89 42 129871 221143 110238243
Joint swelling 141.30 22.89 188 129725 442657 110016729
Device dispensing error 140.55 22.89 36 129877 193 110459193
Drug hypersensitivity 139.64 22.89 198 129715 453892 110005494
Multiple organ dysfunction syndrome 139.52 22.89 10 129903 151700 110307686
Incorrect dose administered by product 138.74 22.89 37 129876 238 110459148
Tachycardia 137.92 22.89 47 129866 226598 110232788
Septic shock 137.64 22.89 13 129900 157515 110301871
Oxygen saturation decreased 137.05 22.89 13 129900 156969 110302417
Nasal congestion 132.20 22.89 330 129583 97952 110361434
Pulmonary embolism 131.34 22.89 44 129869 214430 110244956
Muscle disorder 130.27 22.89 87 129826 6585 110452801
Liver injury 127.30 22.89 14 129899 150399 110308987
Delirium 126.81 22.89 8 129905 135017 110324369
Arthropathy 122.49 22.89 95 129818 287427 110171959
Hepatic enzyme increased 122.17 22.89 118 129795 320774 110138612
Hyperkalaemia 121.91 22.89 10 129903 135786 110323600
Cardiac operation 121.47 22.89 80 129833 5915 110453471
Hypoxia 120.66 22.89 8 129905 129507 110329879
Coma 120.36 22.89 4 129909 117865 110341521
Abdominal pain 120.35 22.89 265 129648 512724 109946662
Paranasal sinus hypersecretion 119.38 22.89 72 129841 4562 110454824
Depressed level of consciousness 117.61 22.89 3 129910 112275 110347111
Inflammation 115.97 22.89 41 129872 193197 110266189
Cardiac arrest 112.63 22.89 45 129868 196708 110262678
Osteoarthritis 112.63 22.89 37 129876 182586 110276800
Muscle injury 112.12 22.89 16 129897 140791 110318595
Medication error 109.67 22.89 3 129910 105363 110354023
Pleural effusion 106.14 22.89 38 129875 177671 110281715
Injection site injury 105.37 22.89 42 129871 1062 110458324
Type 2 diabetes mellitus 103.99 22.89 39 129874 177193 110282193
Interstitial lung disease 103.85 22.89 19 129894 139315 110320071
Cardiac failure 102.45 22.89 46 129867 187580 110271806
Lung disorder 101.72 22.89 42 129871 180005 110279381
Renal failure 101.49 22.89 71 129842 226503 110232883
Gastrointestinal haemorrhage 101.25 22.89 34 129879 165484 110293902
Bradycardia 100.41 22.89 29 129884 155488 110303898
Needle issue 100.07 22.89 114 129799 17726 110441660
Myelosuppression 97.04 22.89 3 129910 94337 110365049
Epilepsy 96.97 22.89 5 129908 100204 110359182
Wound infection 95.99 22.89 4 129909 96461 110362925
Wheezing 95.80 22.89 95 129818 255135 110204251
Neutrophil count decreased 95.70 22.89 14 129899 120927 110338459
Swelling 95.56 22.89 166 129747 350875 110108511
Therapeutic product effect decreased 93.95 22.89 89 129824 244227 110215159
Blister 93.23 22.89 78 129835 227298 110232088
Somnolence 93.07 22.89 128 129785 297321 110162065
Lack of injection site rotation 92.98 22.89 39 129874 1127 110458259
Dehydration 92.87 22.89 115 129798 279396 110179990
Obesity 92.33 22.89 12 129901 113339 110346047
Lactic acidosis 91.85 22.89 4 129909 92807 110366579
Drug ineffective for unapproved indication 91.14 22.89 8 129905 102830 110356556
Blood creatinine increased 90.61 22.89 51 129862 182838 110276548
Fall 89.29 22.89 385 129528 603097 109856289
Therapy cessation 89.00 22.89 176 129737 44681 110414705
Hepatitis 88.73 22.89 4 129909 90050 110369336
Ascites 88.66 22.89 5 129908 92803 110366583
Bursitis 88.07 22.89 22 129891 129896 110329490
Sneezing 87.09 22.89 144 129769 31840 110427546
Cardio-respiratory arrest 85.88 22.89 16 129897 115820 110343566
Joint range of motion decreased 85.81 22.89 19 129894 121813 110337573
Memory impairment 85.64 22.89 457 129456 196487 110262899
Irritable bowel syndrome 85.45 22.89 43 129870 164172 110295214
Peripheral venous disease 85.37 22.89 3 129910 84114 110375272
Product dispensing error 84.25 22.89 100 129813 16245 110443141
Upper-airway cough syndrome 83.36 22.89 98 129815 15759 110443627
Lip dry 82.97 22.89 10 129903 100073 110359313
Respiratory tract congestion 82.77 22.89 138 129775 30719 110428667
Pulmonary fibrosis 82.64 22.89 11 129902 102031 110357355
High density lipoprotein decreased 82.38 22.89 62 129851 5671 110453715
Asthma 82.08 22.89 104 129809 250187 110209199
Deep vein thrombosis 81.69 22.89 31 129882 139856 110319530
Musculoskeletal disorder 79.91 22.89 115 129798 22549 110436837
Rectal haemorrhage 79.87 22.89 21 129892 119812 110339574
Muscle tightness 78.88 22.89 92 129821 14670 110444716
Blood cholesterol abnormal 78.36 22.89 51 129862 3695 110455691
Application site mass 77.80 22.89 17 129896 38 110459348
Musculoskeletal pain 77.07 22.89 421 129492 182602 110276784
Hypertension 76.91 22.89 323 129590 509761 109949625
Gastrointestinal disorder 76.81 22.89 103 129810 241849 110217537
Constipation 76.52 22.89 194 129719 357592 110101794
Application site swelling 75.22 22.89 31 129882 856 110458530
Rash maculo-papular 74.11 22.89 3 129910 74219 110385167
Bone pain 73.61 22.89 205 129708 64928 110394458
International normalised ratio increased 73.61 22.89 8 129905 86764 110372622
Rash pruritic 71.88 22.89 266 129647 97803 110361583
Drug-induced liver injury 71.13 22.89 26 129887 120041 110339345
Coronary artery bypass 70.95 22.89 58 129855 5984 110453402
Renal impairment 70.87 22.89 70 129843 188375 110271011
Hypercholesterolaemia 70.75 22.89 11 129902 90826 110368560
Encephalopathy 69.98 22.89 7 129906 81048 110378338
Pneumonitis 67.69 22.89 6 129907 76525 110382861
Liver disorder 67.16 22.89 42 129871 142201 110317185
Agitation 66.10 22.89 25 129888 113026 110346360
Alanine aminotransferase increased 66.01 22.89 71 129842 183702 110275684
Intentional product misuse 65.88 22.89 320 129593 132584 110326802
Sedation 65.81 22.89 4 129909 69679 110389707
Injection site irritation 65.80 22.89 51 129862 4873 110454513
Hypoglycaemia 65.71 22.89 27 129886 116077 110343309
Injection site warmth 65.33 22.89 91 129822 17314 110442072
Nervousness 65.31 22.89 138 129775 36713 110422673
Pneumonia aspiration 65.21 22.89 9 129904 81224 110378162
Depression 64.84 22.89 176 129737 317159 110142227
Aspartate aminotransferase increased 64.16 22.89 56 129857 159880 110299506
Injection site reaction 63.12 22.89 239 129674 88831 110370555
Discomfort 62.62 22.89 97 129816 214610 110244776
Application site haemorrhage 62.62 22.89 32 129881 1464 110457922
Fibromyalgia 62.54 22.89 65 129848 170844 110288542
Mental status changes 62.14 22.89 8 129905 76114 110383272
Haematochezia 62 22.89 29 129884 115495 110343891
Blood bilirubin increased 61.98 22.89 8 129905 75964 110383422
Therapy interrupted 61.50 22.89 162 129751 49660 110409726
Limb discomfort 61.15 22.89 143 129770 40711 110418675
Pulmonary oedema 60.99 22.89 21 129892 100638 110358748
Hypocalcaemia 60.99 22.89 4 129909 65362 110394024
Red blood cell sedimentation rate increased 59.82 22.89 10 129903 78292 110381094
Melaena 59.19 22.89 6 129907 68751 110390635
Injection site paraesthesia 58.95 22.89 25 129888 743 110458643
Acute respiratory failure 58.87 22.89 9 129904 75251 110384135
Musculoskeletal discomfort 58.81 22.89 102 129811 23436 110435950
Hypomagnesaemia 58.45 22.89 3 129910 60367 110399019
Syncope 57.65 22.89 93 129820 202443 110256943
Colitis 57.57 22.89 24 129889 102299 110357087
No adverse event 57.37 22.89 9 129904 73830 110385556
White blood cell count increased 57.32 22.89 21 129892 96821 110362565
Device delivery system issue 57.17 22.89 34 129879 2099 110457287
Haematemesis 57.03 22.89 3 129910 59105 110400281
Lower limb fracture 56.73 22.89 10 129903 75338 110384048
Hepatotoxicity 55.99 22.89 5 129908 63395 110395991
Fractional exhaled nitric oxide increased 55.41 22.89 24 129889 752 110458634
Anaphylactic reaction 55.00 22.89 33 129880 114267 110345119
Lipoprotein (a) increased 54.66 22.89 15 129898 109 110459277
Muscular weakness 53.31 22.89 485 129428 247983 110211403
Hepatic cirrhosis 53.10 22.89 8 129905 67618 110391768
Suicidal ideation 52.90 22.89 22 129891 93915 110365471
Coronary artery occlusion 52.66 22.89 78 129835 15694 110443692
Altered state of consciousness 52.40 22.89 4 129909 57622 110401764
Injection site haematoma 51.38 22.89 45 129868 5101 110454285
Throat irritation 51.37 22.89 159 129754 53393 110405993
Increased tendency to bruise 51.05 22.89 66 129847 11692 110447694
Rhabdomyolysis 50.96 22.89 40 129873 120361 110339025
Application site pain 50.77 22.89 46 129867 5453 110453933
Colitis ulcerative 50.72 22.89 14 129899 77349 110382037
Device physical property issue 50.06 22.89 39 129874 3755 110455631
Myocardial infarction 49.70 22.89 391 129522 191692 110267694
Haematocrit decreased 49.29 22.89 9 129904 66108 110393278
Lymphocyte count decreased 49.27 22.89 5 129908 57238 110402148
Unresponsive to stimuli 49.06 22.89 8 129905 63782 110395604
Hepatic function abnormal 48.56 22.89 22 129891 89273 110370113
Cellulitis 48.31 22.89 46 129867 125970 110333416
Osteoporosis 48.14 22.89 21 129892 87131 110372255
Grip strength decreased 48.10 22.89 17 129896 80157 110379229
Blood alkaline phosphatase increased 48.10 22.89 12 129901 70923 110388463
Hallucination 47.81 22.89 30 129883 101402 110357984
Haematuria 47.46 22.89 19 129894 82986 110376400
Product quality issue 47.05 22.89 16 129897 77283 110382103
Jaundice 46.53 22.89 7 129906 59229 110400157
Plasma cell myeloma 46.00 22.89 9 129904 62927 110396459
Off label use 45.41 22.89 1380 128533 1498805 108960581
Shock 45.30 22.89 5 129908 53583 110405803
Red blood cell count decreased 44.99 22.89 11 129902 65912 110393474
Injection site hypoaesthesia 44.90 22.89 20 129893 671 110458715
Hepatocellular injury 44.71 22.89 4 129909 50638 110408748
Night sweats 44.61 22.89 55 129858 133928 110325458
Autoimmune disorder 44.55 22.89 11 129902 65472 110393914
Headache 44.41 22.89 1353 128560 881024 109578362
Aggression 44.27 22.89 8 129905 59202 110400184
Multiple sclerosis relapse 44.26 22.89 4 129909 50236 110409150
Respiratory distress 44.16 22.89 13 129900 68861 110390525
Dysarthria 43.79 22.89 22 129891 84099 110375287
Leukocytosis 43.12 22.89 6 129907 53822 110405564
Hypercalcaemia 43.10 22.89 3 129910 46654 110412732
Loss of consciousness 43.06 22.89 105 129808 196201 110263185
Alopecia 42.84 22.89 252 129661 364501 110094885
Acute respiratory distress syndrome 42.45 22.89 6 129907 53192 110406194
Cardiogenic shock 42.33 22.89 8 129905 57330 110402056
Gamma-glutamyltransferase increased 42.29 22.89 10 129903 61299 110398087
Gait disturbance 42.13 22.89 506 129407 277702 110181684
Drug level increased 41.51 22.89 4 129909 47715 110411671
Adverse event 40.98 22.89 243 129670 108566 110350820
Taste disorder 40.74 22.89 13 129900 65374 110394012
Road traffic accident 40.25 22.89 40 129873 107358 110352028
Sluggishness 40.16 22.89 47 129866 7520 110451866
Pulmonary hypertension 40.14 22.89 8 129905 55212 110404174
Psychotic disorder 40.05 22.89 6 129907 50931 110408455
Blood pressure systolic increased 39.87 22.89 24 129889 82967 110376419
Orthostatic hypotension 39.83 22.89 14 129899 66235 110393151
Blepharospasm 39.76 22.89 8 129905 54843 110404543
Haemoptysis 39.72 22.89 17 129896 71337 110388049
Coeliac disease 39.26 22.89 3 129910 43184 110416202
Psoriasis 39.16 22.89 65 129848 139928 110319458
Nail disorder 38.89 22.89 10 129903 57925 110401461
Basal cell carcinoma 38.84 22.89 4 129909 45266 110414120
Transaminases increased 38.79 22.89 13 129900 63377 110396009
Cerebral haemorrhage 38.59 22.89 14 129899 64954 110394432
Dyspnoea 38.58 22.89 998 128915 1105874 109353512
Hypervolaemia 38.49 22.89 6 129907 49454 110409932
Bacteraemia 38.38 22.89 3 129910 42387 110416999
COVID-19 38.24 22.89 153 129760 244907 110214479
Burning sensation 37.47 22.89 171 129742 69041 110390345
Vascular graft 37.42 22.89 26 129887 2099 110457287
Respiratory arrest 37.38 22.89 11 129902 58288 110401098
Clostridium difficile colitis 37.22 22.89 4 129909 43774 110415612
Dizziness 36.55 22.89 1076 128837 697117 109762269
Haemorrhage 36.36 22.89 43 129870 106649 110352737
Blood glucose abnormal 36.30 22.89 59 129854 12857 110446529
Anxiety 36.10 22.89 247 129666 344831 110114555
Stevens-Johnson syndrome 35.80 22.89 6 129907 46895 110412491
Surgery 35.44 22.89 118 129795 41165 110418221
Treatment noncompliance 35.22 22.89 21 129892 72969 110386417
Device related infection 35.21 22.89 3 129910 39516 110419870
Injection site laceration 35.09 22.89 11 129902 133 110459253
Clostridium difficile infection 34.99 22.89 9 129904 52120 110407266
Disease recurrence 34.61 22.89 14 129899 60770 110398616
Sleep disorder due to a general medical condition 34.60 22.89 137 129776 51975 110407411
Liver function test abnormal 34.46 22.89 19 129894 68931 110390455
Circulatory collapse 33.95 22.89 5 129908 42988 110416398
Body temperature increased 33.87 22.89 11 129902 54702 110404684
Drug resistance 33.74 22.89 12 129901 56362 110403024
Thrombosis 33.72 22.89 47 129866 108615 110350771
Neck pain 33.71 22.89 254 129659 122876 110336510
High density lipoprotein increased 33.20 22.89 21 129892 1448 110457938
Fatigue 33.13 22.89 1745 128168 1214213 109245173
Blood lactate dehydrogenase increased 33.12 22.89 6 129907 44328 110415058
Myelodysplastic syndrome 32.98 22.89 3 129910 37481 110421905
Intentional self-injury 32.92 22.89 3 129910 37426 110421960
Pericardial effusion 32.87 22.89 13 129900 57204 110402182
Secretion discharge 32.66 22.89 73 129840 20171 110439215
Staphylococcal infection 32.53 22.89 21 129892 69923 110389463
Aphonia 32.48 22.89 56 129857 12804 110446582
Head discomfort 32.34 22.89 70 129843 18930 110440456
Adverse reaction 32.31 22.89 92 129821 29502 110429884
Urinary retention 32.30 22.89 21 129892 69662 110389724
Ventricular fibrillation 32.18 22.89 5 129908 41308 110418078
Pallor 32.16 22.89 13 129900 56454 110402932
Lipids increased 32.10 22.89 23 129890 1950 110457436
Nausea 31.81 22.89 1160 128753 1234530 109224856
Full blood count abnormal 31.77 22.89 13 129900 56039 110403347
Drug delivery system malfunction 31.73 22.89 18 129895 1017 110458369
Hyperglycaemia 31.53 22.89 32 129881 85058 110374328
Sleep disorder due to general medical condition, insomnia type 31.49 22.89 47 129866 105596 110353790
Oral candidiasis 31.47 22.89 7 129906 44753 110414633
Blood pressure diastolic decreased 31.23 22.89 3 129910 35882 110423504
Candida infection 30.89 22.89 9 129904 48000 110411386
Loss of personal independence in daily activities 30.77 22.89 83 129830 149937 110309449
Hemiparesis 30.60 22.89 7 129906 43896 110415490
Injection site scab 30.52 22.89 15 129898 631 110458755
Cardiac disorder 30.44 22.89 173 129740 76107 110383279
Blood pressure fluctuation 30.24 22.89 26 129887 74798 110384588
Rubber sensitivity 30.06 22.89 24 129889 2394 110456992
Back disorder 29.97 22.89 72 129841 20850 110438536
Emotional distress 29.61 22.89 8 129905 44839 110414547
Coagulopathy 29.58 22.89 6 129907 40905 110418481
Ejection fraction decreased 29.55 22.89 6 129907 40874 110418512
Application site urticaria 29.24 22.89 11 129902 237 110459149
Dry mouth 29.23 22.89 128 129785 199820 110259566
Chronic kidney disease 29.06 22.89 28 129885 76263 110383123
Diabetic ketoacidosis 28.74 22.89 7 129906 42051 110417335
Blood calcium decreased 28.70 22.89 4 129909 35841 110423545
Cardiomyopathy 28.66 22.89 3 129910 33522 110425864
Coronary arterial stent insertion 28.54 22.89 35 129878 5880 110453506
Sleep disorder 28.53 22.89 128 129785 198516 110260870
Spinal operation 28.01 22.89 48 129865 10924 110448462
Drug eruption 27.98 22.89 14 129899 53645 110405741
Haematoma 27.96 22.89 17 129896 58459 110400927
Lacrimation increased 27.95 22.89 90 129823 30860 110428526
Foot deformity 27.87 22.89 11 129902 48469 110410917
COVID-19 pneumonia 27.81 22.89 5 129908 37138 110422248
Plantar fasciitis 27.60 22.89 32 129881 5069 110454317
Injection site hypersensitivity 27.51 22.89 23 129890 2448 110456938
Immunodeficiency 27.46 22.89 6 129907 38832 110420554
Neutrophil count increased 27.43 22.89 4 129909 34648 110424738
Blood creatine phosphokinase increased 27.38 22.89 163 129750 72914 110386472
Catheterisation cardiac 27.27 22.89 35 129878 6156 110453230
Small intestinal obstruction 27.24 22.89 3 129910 32210 110427176
Bacterial infection 27.21 22.89 10 129903 46026 110413360
Abortion spontaneous 27.04 22.89 4 129909 34278 110425108
Increased upper airway secretion 26.95 22.89 32 129881 5200 110454186
Chronic obstructive pulmonary disease 26.69 22.89 55 129858 109103 110350283
Proteinuria 26.69 22.89 7 129906 40011 110419375
Iron deficiency anaemia 26.54 22.89 3 129910 31556 110427830
Angioedema 26.39 22.89 47 129866 98453 110360933
Withdrawal syndrome 26.34 22.89 3 129910 31377 110428009
Metastases to bone 26.33 22.89 3 129910 31369 110428017
Blood triglycerides decreased 26.09 22.89 10 129903 227 110459159
Sinus congestion 26.09 22.89 87 129826 30372 110429014
Anaphylactic shock 26.06 22.89 14 129899 51532 110407854
Metastases to liver 25.99 22.89 5 129908 35381 110424005
Blood triglycerides abnormal 25.83 22.89 13 129900 576 110458810
Finger deformity 25.78 22.89 4 129909 33088 110426298
Abnormal behaviour 25.71 22.89 7 129906 39032 110420354
Dry throat 25.70 22.89 42 129871 9196 110450190
Urosepsis 25.58 22.89 3 129910 30672 110428714
Myoglobin blood increased 25.37 22.89 28 129885 4204 110455182
Intercepted product storage error 25.33 22.89 14 129899 752 110458634
Atelectasis 25.30 22.89 6 129907 36706 110422680
Vascular stent stenosis 25.28 22.89 18 129895 1511 110457875
Acute hepatic failure 25.05 22.89 6 129907 36462 110422924
Cardiac failure congestive 25.01 22.89 92 129821 150908 110308478
Pruritus 24.86 22.89 875 129038 580685 109878701
Full blood count decreased 24.74 22.89 4 129909 32095 110427291
Intestinal obstruction 24.73 22.89 16 129897 53211 110406175
Skin lesion 24.70 22.89 15 129898 51616 110407770
Hallucination, visual 24.45 22.89 8 129905 39597 110419789
Mouth ulceration 24.45 22.89 13 129900 48125 110411261
Osteonecrosis 24.29 22.89 5 129908 33736 110425650
Therapeutic response decreased 24.13 22.89 48 129865 96451 110362935
Atrial fibrillation 23.69 22.89 165 129748 229477 110229909
Glycosylated haemoglobin decreased 23.64 22.89 14 129899 858 110458528
Heart rate decreased 23.53 22.89 38 129875 82718 110376668
Gastrooesophageal reflux disease 23.49 22.89 120 129793 179856 110279530
Application site discomfort 23.47 22.89 11 129902 416 110458970
Osteomyelitis 23.29 22.89 7 129906 36593 110422793
Gastric disorder 23.20 22.89 89 129824 33268 110426118
Sensation of foreign body 23.19 22.89 37 129876 7938 110451448
Laboratory test abnormal 23.19 22.89 108 129805 43971 110415415
Subdural haematoma 23.15 22.89 7 129906 36447 110422939

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 D000091362 PCSK9 Inhibitors
MeSH PA D000924 Anticholesteremic Agents
MeSH PA D000960 Hypolipidemic Agents
MeSH PA D000963 Antimetabolites
MeSH PA D004791 Enzyme Inhibitors
MeSH PA D011480 Protease Inhibitors
MeSH PA D015842 Serine Proteinase Inhibitors
MeSH PA D057847 Lipid Regulating Agents
FDA MoA N0000191730 PCSK9 Inhibitors
FDA EPC N0000191731 PCSK9 Inhibitor
CHEBI has role CHEBI:22587 antiviral agent
CHEBI has role CHEBI:35554 cardiovascular drug
CHEBI has role CHEBI:35610 antineoplastic agent
CHEBI has role CHEBI:35821 anticholesteremic drug

Related Drugs by ATC class:

C10AX Other lipid modifying agents 15 drugs

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
CHEBI:755001 CHEBI
CHEMBL2364655 ChEMBL_ID
C577155 MESH_SUPPLEMENTAL_RECORD_UI
7343 IUPHAR_LIGAND_ID
DB09303 DRUGBANK_ID
1665684 RXNORM
236233 MMSL
31213 MMSL
d08383 MMSL
016368 NDDF
716068004 SNOMEDCT_US
763586000 SNOMEDCT_US
C3529352 UMLSCUI
9643 INN_ID
LKC0U3A8NJ UNII

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
REPATHA HUMAN PRESCRIPTION DRUG LABEL 1 72511-143 INJECTION, SOLUTION 140 mg SUBCUTANEOUS BLA 33 sections
REPATHA HUMAN PRESCRIPTION DRUG LABEL 1 72511-393 INJECTION, SOLUTION 140 mg SUBCUTANEOUS BLA 33 sections
REPATHA HUMAN PRESCRIPTION DRUG LABEL 1 72511-501 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