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

Stem definitionDrug idCAS RN
erythropoietin type blood factors 5157 209810-58-2

Description:

MoleculeDescription

Synonyms:

  • darbepoetin alfa
  • aranesp
acts exactly like the natural erythropoietin made by the body to stimulate red blood cell production, but it is very slightly different in its structure
  • Molecular weight:
  • Formula:
  • CLOGP:
  • LIPINSKI: None
  • HAC: None
  • HDO: None
  • TPSA:
  • ALOGS:
  • ROTB: None

Drug dosage:

DoseUnitRoute
4.50 mcg P

ADMET properties:

None

Approvals:

DateAgencyCompanyOrphan
Sept. 17, 2001 FDA AMGEN

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
Death 11037.94 13.09 5174 37339 369207 63077302
Hospitalisation 4459.77 13.09 1786 40727 83295 63363214
Investigation 1179.90 13.09 262 42251 1343 63445166
Haemodialysis 1077.00 13.09 349 42164 8598 63437911
Aplasia pure red cell 1034.63 13.09 289 42224 4198 63442311
Transplant 524.99 13.09 119 42394 679 63445830
Arteriovenous fistula site complication 484.90 13.09 103 42410 410 63446099
Dialysis 458.35 13.09 194 42319 10233 63436276
Haemoglobin decreased 328.30 13.09 444 42069 145041 63301468
Anaemia 254.83 13.09 588 41925 292842 63153667
Shunt stenosis 247.10 13.09 60 42453 480 63446029
Terminal state 246.19 13.09 82 42431 2200 63444309
Drug ineffective 231.34 13.09 217 42296 1044548 62401961
Shunt occlusion 224.91 13.09 58 42455 607 63445902
Peritoneal dialysis 216.06 13.09 52 42461 399 63446110
Renal disorder 195.25 13.09 168 42345 32806 63413703
Renal transplant 191.36 13.09 60 42453 1320 63445189
Haemoglobin abnormal 172.82 13.09 79 42434 5009 63441500
Therapeutic response decreased 138.85 13.09 188 42325 61337 63385172
Rheumatoid arthritis 137.82 13.09 8 42505 253811 63192698
Palliative care 133.48 13.09 37 42476 520 63445989
Anti-erythropoietin antibody positive 129.81 13.09 34 42479 380 63446129
Drug intolerance 129.27 13.09 25 42488 308636 63137873
Renal impairment 121.87 13.09 215 42298 88140 63358369
Renal failure 115.51 13.09 248 42265 117404 63329105
Infusion related reaction 111.39 13.09 16 42497 245505 63201004
Joint swelling 110.01 13.09 41 42472 327625 63118884
Headache 107.94 13.09 161 42352 633080 62813429
Condition aggravated 106.84 13.09 69 42444 402148 63044361
Arthropathy 104.89 13.09 16 42497 234776 63211733
Drug hypersensitivity 104.08 13.09 39 42474 310648 63135861
Product use issue 103.29 13.09 13 42500 220507 63226002
Peritonitis 100.71 13.09 87 42426 17067 63429442
Arthralgia 99.83 13.09 142 42371 569568 62876941
Transfusion 99.25 13.09 82 42431 15135 63431374
Arteriovenous fistula operation 96.62 13.09 24 42489 213 63446296
Alopecia 95.06 13.09 54 42459 337482 63109027
Systemic lupus erythematosus 91.59 13.09 15 42498 208903 63237606
Abdominal discomfort 90.84 13.09 51 42462 320834 63125675
Cardiac failure 88.72 13.09 189 42324 88953 63357556
Pain 88.51 13.09 232 42281 740396 62706113
Myelodysplastic syndrome 88.43 13.09 80 42433 16674 63429835
Glossodynia 87.63 13.09 9 42504 178867 63267642
Hepatic enzyme increased 85.47 13.09 16 42497 202312 63244197
Sinusitis 83.70 13.09 24 42489 226629 63219880
Haemoglobin increased 82.81 13.09 43 42470 3603 63442906
Swelling 79.03 13.09 43 42470 275335 63171174
Unevaluable event 75.99 13.09 129 42384 51257 63395252
Mineral supplementation 69.34 13.09 24 42489 725 63445784
Treatment failure 68.28 13.09 24 42489 199019 63247490
Toxicity to various agents 67.52 13.09 41 42472 247209 63199300
Completed suicide 64.86 13.09 10 42503 145663 63300846
Weight increased 64.83 13.09 48 42465 260744 63185765
Wound 64.63 13.09 15 42498 163248 63283261
Nephrogenic systemic fibrosis 63.45 13.09 39 42474 4517 63441992
Musculoskeletal stiffness 62.06 13.09 23 42490 184595 63261914
Hip fracture 61.85 13.09 87 42426 29387 63417122
Azotaemia 61.57 13.09 38 42475 4433 63442076
Thrombocytopenia 60.20 13.09 230 42283 150927 63295582
Therapeutic product effect decreased 60.18 13.09 27 42486 193160 63253349
Rehabilitation therapy 57.23 13.09 26 42487 1624 63444885
Refractory cytopenia with unilineage dysplasia 56.23 13.09 19 42494 533 63445976
Discomfort 56.01 13.09 21 42492 167353 63279156
Hypersensitivity 55.14 13.09 69 42444 292616 63153893
Occupational exposure to product 54.47 13.09 27 42486 2051 63444458
Nasopharyngitis 53.26 13.09 55 42458 254202 63192307
Reticulocyte count decreased 51.17 13.09 17 42496 452 63446057
Cardiac output decreased 49.16 13.09 20 42493 952 63445557
Pericarditis 48.42 13.09 14 42499 131565 63314944
Hypervolaemia 48.32 13.09 76 42437 28337 63418172
Intentional product use issue 48.19 13.09 13 42500 127879 63318630
End stage renal disease 47.72 13.09 38 42475 6655 63439854
Transformation to acute myeloid leukaemia 47.44 13.09 14 42499 249 63446260
Chronic kidney disease 47.17 13.09 98 42415 45300 63401209
Product storage error 47.02 13.09 54 42459 14902 63431607
Psoriasis 46.37 13.09 3 42510 86954 63359555
Pleural effusion 45.80 13.09 152 42361 93058 63353451
Blood cholesterol increased 45.34 13.09 5 42508 94027 63352482
Fall 44.92 13.09 430 42083 391904 63054605
Duodenal ulcer perforation 43.71 13.09 4 42509 87205 63359304
Peripheral swelling 42.86 13.09 70 42443 265872 63180637
Shunt infection 42.47 13.09 10 42503 69 63446440
Fibromyalgia 42.22 13.09 3 42510 80417 63366092
Rash 41.51 13.09 214 42299 560657 62885852
Haemodialysis complication 41.06 13.09 12 42501 206 63446303
Arteriovenous fistula site infection 40.69 13.09 9 42504 45 63446464
Sepsis 40.38 13.09 206 42307 152917 63293592
Leukopenia 39.73 13.09 128 42385 77162 63369347
Urinary tract infection 39.65 13.09 308 42205 264376 63182133
Hepatic cyst infection 39.01 13.09 10 42503 102 63446407
Injection site erythema 38.67 13.09 5 42508 83169 63363340
Pancytopenia 38.16 13.09 147 42366 96786 63349723
Therapeutic product effect incomplete 38.12 13.09 18 42495 125038 63321471
Living in residential institution 37.55 13.09 14 42499 526 63445983
Anti-erythropoietin antibody negative 37.38 13.09 10 42503 122 63446387
Blood parathyroid hormone increased 37.27 13.09 24 42489 3014 63443495
Cardiac disorder 36.61 13.09 95 42418 50721 63395788
Product use in unapproved indication 36.07 13.09 40 42473 179040 63267469
Pneumonia 35.96 13.09 465 42048 456302 62990207
Irritable bowel syndrome 35.90 13.09 6 42507 82406 63364103
Drug specific antibody absent 35.63 13.09 9 42504 86 63446423
Plasma cell myeloma 35.54 13.09 76 42437 35829 63410680
Disease progression 35.09 13.09 169 42344 122589 63323920
Reticulocyte count abnormal 34.39 13.09 8 42505 52 63446457
Renal cyst infection 32.84 13.09 9 42504 121 63446388
Bone marrow failure 32.52 13.09 65 42448 29225 63417284
Nausea 32.31 13.09 392 42121 854079 62592430
Sleep disorder 31.28 13.09 8 42505 81558 63364951
Suicidal ideation 30.91 13.09 3 42510 62418 63384091
Folliculitis 30.89 13.09 5 42508 70312 63376197
Arthritis 30.54 13.09 20 42493 115901 63330608
Migraine 29.80 13.09 16 42497 103330 63343179
Serum ferritin increased 29.67 13.09 28 42485 6154 63440355
Blood creatinine increased 29.63 13.09 127 42386 87717 63358792
Dizziness 29.57 13.09 168 42345 429757 63016752
Iron deficiency 29.57 13.09 30 42483 7200 63439309
Drug interaction 29.37 13.09 69 42444 229062 63217447
Anti-erythropoietin antibody 29.20 13.09 5 42508 3 63446506
Premature delivery 27.59 13.09 62 42451 30219 63416290
Asthma 27.36 13.09 27 42486 127534 63318975
Diabetic complication 27.35 13.09 13 42500 900 63445609
Fungal endocarditis 27.28 13.09 9 42504 234 63446275
Liver injury 27.28 13.09 4 42509 60516 63385993
Marasmus 27.23 13.09 11 42502 514 63445995
Somnolence 26.96 13.09 49 42464 178636 63267873
Depression 26.96 13.09 57 42456 196435 63250074
Intercepted product administration error 26.72 13.09 10 42503 380 63446129
Blister 26.13 13.09 29 42484 129785 63316724
Neoplasm malignant 25.95 13.09 60 42453 29801 63416708
Product dose omission issue 25.89 13.09 76 42437 234237 63212272
Transplant failure 25.79 13.09 15 42498 1570 63444939
Gastrointestinal disorder 25.68 13.09 30 42483 131209 63315300
Loss of personal independence in daily activities 25.34 13.09 17 42496 97273 63349236
Home care 25.24 13.09 4 42509 0 63446509
Skin induration 24.49 13.09 19 42494 3204 63443305
Cellulitis 24.26 13.09 114 42399 81844 63364665
Impaired healing 24.02 13.09 20 42493 102522 63343987
Arteriovenous fistula thrombosis 23.86 13.09 8 42505 219 63446290
Kidney transplant rejection 23.73 13.09 21 42492 4250 63442259
Memory impairment 23.61 13.09 21 42492 104237 63342272
Knee arthroplasty 23.49 13.09 4 42509 54202 63392307
Type 2 diabetes mellitus 23.11 13.09 7 42506 63861 63382648
Hyperkalaemia 22.81 13.09 84 42429 54119 63392390
Infective aneurysm 22.71 13.09 9 42504 400 63446109
Illness 22.68 13.09 3 42510 49056 63397453
Angina pectoris 22.45 13.09 57 42456 30021 63416488
Haemolysis 22.23 13.09 25 42488 6743 63439766
Myelodysplastic syndrome transformation 22.15 13.09 9 42504 427 63446082
Blood potassium increased 21.99 13.09 42 42471 18267 63428242
Iron overload 21.66 13.09 11 42502 880 63445629
Leg amputation 21.51 13.09 15 42498 2149 63444360
Epistaxis 21.41 13.09 101 42412 72624 63373885
Hyperphosphataemia 20.99 13.09 15 42498 2233 63444276
Nasal congestion 20.71 13.09 9 42504 65651 63380858
Exposure during pregnancy 20.60 13.09 46 42467 155501 63291008
Maternal condition affecting foetus 20.56 13.09 7 42506 201 63446308
Neutropenia 20.55 13.09 193 42320 174812 63271697
Hypocalcaemia 20.53 13.09 57 42456 31656 63414853
Visual impairment 20.37 13.09 16 42497 84430 63362079
Injection site pruritus 20.29 13.09 3 42510 45113 63401396
Renal transplant failure 20.27 13.09 10 42503 752 63445757
Insomnia 20.20 13.09 75 42438 215177 63231332
Eye infection bacterial 20.11 13.09 7 42506 215 63446294
Blood erythropoietin increased 19.96 13.09 4 42509 11 63446498
Pain in extremity 19.93 13.09 135 42378 331351 63115158
Oedema peripheral 19.81 13.09 204 42309 189307 63257202
Osteoarthritis 19.51 13.09 21 42492 95322 63351187
Extramedullary haemopoiesis 19.33 13.09 5 42508 53 63446456
Dehydration 19.27 13.09 189 42324 173165 63273344
Maternal exposure during pregnancy 19.16 13.09 79 42434 219983 63226526
Hyperparathyroidism secondary 19.02 13.09 12 42501 1455 63445054
Natural killer cell count 18.81 13.09 4 42509 16 63446493
Amegakaryocytic thrombocytopenia 18.81 13.09 4 42509 16 63446493
Anxiety 18.38 13.09 79 42434 217462 63229047
Urine odour abnormal 18.31 13.09 22 42491 6367 63440142
Parakeratosis 18.17 13.09 7 42506 288 63446221
Device related infection 18.16 13.09 45 42468 23347 63423162
Marrow hyperplasia 18.09 13.09 9 42504 689 63445820
Ischaemic stroke 17.76 13.09 38 42475 17919 63428590
Hypertension 17.75 13.09 274 42239 279029 63167480
Dialysis related complication 17.74 13.09 5 42508 75 63446434
Dry eye 17.68 13.09 3 42510 40758 63405751
Macrophages increased 17.62 13.09 4 42509 23 63446486
Skin hypertrophy 17.51 13.09 16 42497 3375 63443134
Proteinuria 17.22 13.09 39 42474 19106 63427403
Gait disturbance 17.07 13.09 64 42449 183114 63263395
Blood product transfusion dependent 17.07 13.09 6 42507 190 63446319
Adverse drug reaction 16.94 13.09 17 42496 79697 63366812
Deep vein thrombosis 16.93 13.09 105 42408 83695 63362814
Cerebrovascular accident 16.86 13.09 127 42386 107897 63338612
Uterine atony 16.83 13.09 6 42507 198 63446311
Medication error 16.75 13.09 7 42506 52277 63394232
Arteriovenous fistula site haemorrhage 16.63 13.09 6 42507 205 63446304
Acute myeloid leukaemia 16.63 13.09 36 42477 17111 63429398
Intermittent claudication 16.55 13.09 12 42501 1827 63444682
Cerebral infarction 16.52 13.09 44 42469 23849 63422660
Arteriovenous fistula occlusion 16.48 13.09 7 42506 372 63446137
Cardiac failure congestive 16.35 13.09 112 42401 92321 63354188
Skin fibrosis 16.13 13.09 9 42504 871 63445638
Dry mouth 16.10 13.09 17 42496 77846 63368663
Serum ferritin abnormal 15.86 13.09 6 42507 235 63446274
Fatigue 15.74 13.09 464 42049 887564 62558945
Fracture 15.55 13.09 38 42475 19546 63426963
Hepatotoxicity 15.47 13.09 3 42510 37038 63409471
Urticaria 15.40 13.09 58 42455 165744 63280765
Neutralising antibodies positive 15.30 13.09 6 42507 259 63446250
Calciphylaxis 14.91 13.09 14 42499 3058 63443451
Nephrogenic anaemia 14.83 13.09 12 42501 2150 63444359
Peripheral arterial occlusive disease 14.63 13.09 16 42497 4185 63442324
Hyperuricaemia 14.59 13.09 18 42495 5352 63441157
Cardiac arrest 14.55 13.09 109 42404 92436 63354073
Peritonitis bacterial 14.31 13.09 17 42496 4862 63441647
Blood test abnormal 14.24 13.09 32 42481 15597 63430912
Myocardial infarction 14.23 13.09 115 42398 99778 63346731
Mycobacterial peritonitis 14.13 13.09 4 42509 61 63446448
Platelet count decreased 14.09 13.09 129 42384 115993 63330516
Abortion spontaneous 14.06 13.09 7 42506 47188 63399321
Haemorrhage 13.96 13.09 79 42434 60943 63385566
Renal lymphocele 13.83 13.09 4 42509 66 63446443
Eyelid oedema 13.79 13.09 25 42488 10454 63436055
Prescribed overdose 13.78 13.09 3 42510 34150 63412359
Hypoaesthesia 13.71 13.09 62 42451 168331 63278178
Agitation 13.57 13.09 12 42501 59745 63386764
Bursitis 13.51 13.09 4 42509 37037 63409472
Shunt thrombosis 13.46 13.09 4 42509 73 63446436
Peritoneal dialysis complication 13.41 13.09 9 42504 1211 63445298
Vascular shunt 13.40 13.09 3 42510 16 63446493
Thrombosis in device 13.32 13.09 13 42500 2977 63443532
Off label use 13.32 13.09 565 41948 673897 62772612
Pulmonary fibrosis 13.29 13.09 5 42508 39804 63406705
Upper limb fracture 13.19 13.09 35 42478 18933 63427576
Polycythaemia 13.17 13.09 8 42505 907 63445602
Gastric antral vascular ectasia 13.12 13.09 7 42506 620 63445889

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
Death 12058.00 13.62 7154 42312 390895 34516570
Hospitalisation 4660.53 13.62 2036 47430 54866 34852599
Aplasia pure red cell 1258.81 13.62 430 49036 5702 34901763
Haemodialysis 1056.29 13.62 437 49029 10089 34897376
Investigation 877.33 13.62 214 49252 716 34906749
Arteriovenous fistula site complication 702.78 13.62 157 49309 310 34907155
Dialysis 439.33 13.62 244 49222 10964 34896501
Transplant 432.46 13.62 119 49347 707 34906758
Shunt stenosis 272.22 13.62 82 49384 700 34906765
Peritoneal dialysis 270.73 13.62 77 49389 525 34906940
Haemoglobin decreased 243.21 13.62 531 48935 120241 34787224
Haemoglobin abnormal 240.43 13.62 115 49351 3765 34903700
Appendicolith 234.09 13.62 148 49318 8453 34899012
Anti-erythropoietin antibody positive 200.20 13.62 67 49399 828 34906637
Appendicitis 168.35 13.62 151 49315 14656 34892809
Renal disorder 167.09 13.62 193 49273 25287 34882178
Shunt occlusion 162.87 13.62 57 49409 813 34906652
Terminal state 155.06 13.62 86 49380 3848 34903617
Therapeutic response decreased 154.78 13.62 199 49267 29114 34878351
Toxicity to various agents 142.18 13.62 53 49413 200309 34707156
Transfusion 131.54 13.62 104 49362 8481 34898984
Cardiogenic shock 113.62 13.62 163 49303 26455 34881010
Drug ineffective 113.47 13.62 305 49161 456446 34451019
Renal transplant 109.09 13.62 53 49413 1796 34905669
Arteriovenous fistula operation 103.88 13.62 27 49439 124 34907341
Palliative care 100.55 13.62 38 49428 682 34906783
Drug interaction 100.53 13.62 103 49363 225843 34681622
Blood phosphorus increased 98.32 13.62 84 49382 7637 34899828
Reticulocyte count decreased 94.45 13.62 36 49430 662 34906803
Stress 89.61 13.62 157 49309 30190 34877275
Ascites 84.80 13.62 197 49269 46374 34861091
Transformation to acute myeloid leukaemia 83.91 13.62 34 49432 740 34906725
Product use in unapproved indication 81.72 13.62 32 49434 117467 34789998
Haemoglobin increased 76.49 13.62 52 49414 3357 34904108
Myelodysplastic syndrome 73.85 13.62 112 49354 19096 34888369
Hip fracture 70.98 13.62 86 49380 11839 34895626
Peritonitis 70.97 13.62 101 49365 16264 34891201
Anaemia 69.80 13.62 566 48900 232769 34674696
Ventricular fibrillation 66.78 13.62 118 49348 22836 34884629
Hyperparathyroidism secondary 63.77 13.62 35 49431 1533 34905932
Chronic kidney disease 62.97 13.62 163 49303 41047 34866418
Product storage error 62.64 13.62 67 49399 8055 34899410
Lower respiratory tract infection 62.21 13.62 138 49328 31499 34875966
Sepsis 61.03 13.62 424 49042 166137 34741328
Neoplasm malignant 60.08 13.62 104 49362 19801 34887664
Product use issue 59.85 13.62 9 49457 63207 34844258
Mineral supplementation 59.79 13.62 16 49450 84 34907381
Renal cyst haemorrhage 58.90 13.62 25 49441 614 34906851
Rectal prolapse 58.15 13.62 23 49443 469 34906996
Nephrogenic systemic fibrosis 58.11 13.62 47 49419 3958 34903507
Intentional product use issue 57.83 13.62 8 49458 59808 34847657
Headache 56.62 13.62 125 49341 200510 34706955
Azotaemia 55.15 13.62 50 49416 4917 34902548
Multiple organ dysfunction syndrome 54.69 13.62 234 49232 76332 34831133
Arthralgia 53.90 13.62 99 49367 169942 34737523
Intraductal papillary mucinous neoplasm 52.89 13.62 22 49444 513 34906952
Living in residential institution 52.74 13.62 21 49445 436 34907029
Abdominal distension 50.77 13.62 190 49276 58302 34849163
Product dose omission issue 49.36 13.62 58 49408 119653 34787812
Arteriovenous fistula site infection 47.85 13.62 13 49453 73 34907392
Arteriovenous fistula thrombosis 47.53 13.62 18 49448 325 34907140
Renal artery stenosis 47.22 13.62 33 49433 2228 34905237
Alanine aminotransferase increased 47.03 13.62 28 49438 80787 34826678
Delayed graft function 45.41 13.62 32 49434 2189 34905276
Suicidal ideation 45.34 13.62 3 49463 40385 34867080
Weight increased 45.29 13.62 39 49427 92994 34814471
Unevaluable event 43.84 13.62 123 49343 32467 34874998
Aggression 43.43 13.62 3 49463 38961 34868504
Hyperhidrosis 42.97 13.62 27 49439 75665 34831800
Vena cava injury 40.55 13.62 16 49450 324 34907141
SARS-CoV-2 antibody test positive 40.45 13.62 17 49449 407 34907058
Hyperphosphataemia 40.36 13.62 40 49426 4397 34903068
Depression 40.06 13.62 47 49419 97051 34810414
Angina pectoris 39.88 13.62 116 49350 31247 34876218
Refractory cytopenia with unilineage dysplasia 39.35 13.62 18 49448 531 34906934
Treatment failure 39.17 13.62 9 49457 46688 34860777
Joint swelling 38.91 13.62 18 49448 59872 34847593
Abdominal wall haemorrhage 38.09 13.62 17 49449 473 34906992
Zoonotic bacterial infection 37.94 13.62 10 49456 49 34907416
Hallucination 37.50 13.62 13 49453 51485 34855980
Rehabilitation therapy 36.73 13.62 20 49446 862 34906603
Vascular anastomotic haemorrhage 35.97 13.62 14 49452 273 34907192
Infusion related reaction 35.96 13.62 15 49451 53042 34854423
Hypervolaemia 35.44 13.62 83 49383 19626 34887839
Leg amputation 34.40 13.62 27 49439 2177 34905288
Intermittent claudication 33.45 13.62 27 49439 2267 34905198
Home care 33.37 13.62 6 49460 0 34907465
Agitation 33.23 13.62 20 49446 57379 34850086
Perineal cyst 33.14 13.62 13 49453 259 34907206
Dizziness 33.09 13.62 178 49288 218343 34689122
Sinusitis 32.75 13.62 9 49457 41393 34866072
Erythropoiesis abnormal 32.14 13.62 12 49454 208 34907257
Tachycardia 31.89 13.62 44 49422 84728 34822737
Urinary tract infection 31.88 13.62 216 49250 83865 34823600
General physical health deterioration 31.39 13.62 298 49168 127971 34779494
Blood uric acid increased 31.30 13.62 52 49414 9572 34897893
Aspartate aminotransferase increased 31.09 13.62 30 49436 67753 34839712
Rheumatoid arthritis 30.84 13.62 8 49458 38230 34869235
Iron deficiency 30.71 13.62 38 49428 5343 34902122
Normochromic normocytic anaemia 30.68 13.62 34 49432 4253 34903212
Rash 30.22 13.62 188 49278 222564 34684901
Drug-induced liver injury 29.98 13.62 3 49463 28829 34878636
Hepatic enzyme increased 29.98 13.62 9 49457 39071 34868394
Peripheral arterial occlusive disease 29.61 13.62 39 49427 5835 34901630
Carotid arteriosclerosis 29.52 13.62 23 49443 1835 34905630
Rhabdomyolysis 29.19 13.62 32 49434 68131 34839334
Vascular compression 29.08 13.62 13 49453 363 34907102
Mycobacterium marinum infection 28.64 13.62 12 49454 285 34907180
Hepatic cyst infection 28.12 13.62 7 49459 26 34907439
Inappropriate schedule of product administration 28.08 13.62 28 49438 62268 34845197
Anxiety 27.95 13.62 62 49404 99366 34808099
Mean cell volume increased 27.78 13.62 28 49438 3141 34904324
Chest discomfort 27.59 13.62 22 49444 54508 34852957
Blood iron abnormal 27.58 13.62 8 49458 59 34907406
Overdose 27.09 13.62 55 49411 91004 34816461
Lactic acidosis 26.69 13.62 8 49458 34764 34872701
Reticulocytopenia 26.47 13.62 9 49457 117 34907348
Tremor 26.20 13.62 48 49418 82539 34824926
Marasmus 26.13 13.62 14 49452 584 34906881
Gangrene 25.55 13.62 32 49434 4554 34902911
Catheter removal 25.14 13.62 10 49456 207 34907258
Respiratory failure 24.92 13.62 75 49391 108497 34798968
Non-neutralising antibodies positive 24.91 13.62 8 49458 86 34907379
Angioedema 24.63 13.62 11 49455 37363 34870102
Myasthenia gravis 24.61 13.62 39 49427 6901 34900564
Pyrexia 24.60 13.62 328 49138 332685 34574780
Irritability 24.58 13.62 3 49463 24687 34882778
Febrile neutropenia 24.46 13.62 105 49361 136744 34770721
Interstitial lung disease 24.43 13.62 34 49432 65248 34842217
Weight decreased 24.30 13.62 148 49318 176153 34731312
Psychotic disorder 24.28 13.62 3 49463 24449 34883016
Blood creatine phosphokinase increased 24.10 13.62 17 49449 44840 34862625
Angiodysplasia 24.00 13.62 14 49452 690 34906775
Renal cyst infection 23.97 13.62 7 49459 53 34907412
Complications of transplanted kidney 23.85 13.62 31 49435 4578 34902887
Aortic arteriosclerosis 23.71 13.62 31 49435 4605 34902860
Aortic dilatation 23.69 13.62 18 49448 1383 34906082
Abdominal discomfort 23.57 13.62 30 49436 59805 34847660
Hyperparathyroidism 23.56 13.62 17 49449 1207 34906258
Shunt aneurysm 23.55 13.62 6 49460 25 34907440
Intervertebral disc space narrowing 23.45 13.62 16 49450 1039 34906426
Dialysis hypotension 23.37 13.62 6 49460 26 34907439
Drug ineffective for unapproved indication 23.32 13.62 3 49463 23712 34883753
Cognitive disorder 23.14 13.62 6 49460 28687 34878778
Asthma 23.14 13.62 16 49450 42640 34864825
Blood 25-hydroxycholecalciferol decreased 23.07 13.62 10 49456 259 34907206
Blood potassium increased 22.91 13.62 63 49403 16432 34891033
Procalcitonin abnormal 22.69 13.62 11 49455 371 34907094
Muscle spasms 22.56 13.62 45 49421 74956 34832509
End stage renal disease 22.54 13.62 43 49423 8818 34898647
Cardio-respiratory arrest 22.52 13.62 27 49439 55246 34852219
Memory impairment 22.51 13.62 17 49449 43301 34864164
Peritoneal catheter insertion 22.25 13.62 4 49462 0 34907465
Anti-erythropoietin antibody 22.25 13.62 4 49462 0 34907465
Musculoskeletal stiffness 22.18 13.62 20 49446 46660 34860805
Pain in extremity 22.04 13.62 98 49368 126415 34781050
Parvovirus B19 test positive 21.96 13.62 8 49458 129 34907336
Analgesic therapy 21.86 13.62 15 49451 983 34906482
Acute respiratory distress syndrome 21.79 13.62 5 49461 25964 34881501
Disturbance in attention 21.76 13.62 5 49461 25940 34881525
Hyponatraemia 21.66 13.62 195 49271 82496 34824969
Visual impairment 21.39 13.62 12 49454 35790 34871675
Fatigue 21.28 13.62 383 49083 370270 34537195
Pleural effusion 21.21 13.62 192 49274 81354 34826111
Serum ferritin increased 21.06 13.62 34 49432 6112 34901353
Haematochezia 20.87 13.62 21 49445 46513 34860952
Cardiac failure 20.84 13.62 209 49257 91039 34816426
Depressed level of consciousness 20.78 13.62 18 49448 42823 34864642
Mucosal inflammation 20.27 13.62 15 49451 38607 34868858
Iron overload 20.10 13.62 16 49450 1317 34906148
Transferrin saturation increased 20.05 13.62 7 49459 99 34907366
Drug therapy 20.05 13.62 15 49451 1126 34906339
Constipation 19.96 13.62 288 49178 136694 34770771
Catheter placement 19.90 13.62 13 49453 785 34906680
Erectile dysfunction 19.38 13.62 3 49463 20634 34886831
Vision blurred 19.21 13.62 22 49444 45941 34861524
Diverticulum intestinal 19.20 13.62 26 49440 3995 34903470
Coma 18.95 13.62 22 49444 45656 34861809
Skin fibrosis 18.87 13.62 14 49452 1038 34906427
Skin induration 18.84 13.62 19 49447 2132 34905333
Loss of personal independence in daily activities 18.59 13.62 12 49454 33167 34874298
Serotonin syndrome 18.49 13.62 3 49463 19930 34887535
Hepatosplenomegaly 18.47 13.62 26 49440 4143 34903322
Heart rate decreased 18.46 13.62 11 49455 31734 34875731
Metastatic neoplasm 18.44 13.62 22 49444 2978 34904487
Hepatotoxicity 18.30 13.62 4 49462 21481 34885984
Renal transplant failure 18.24 13.62 14 49452 1092 34906373
Drug hypersensitivity 18.20 13.62 56 49410 80473 34826992
Abdominal pain upper 18.16 13.62 47 49419 71443 34836022
Arteriovenous fistula occlusion 17.96 13.62 7 49459 137 34907328
Electrocardiogram QT prolonged 17.78 13.62 19 49447 40933 34866532
Depressed mood 17.71 13.62 3 49463 19314 34888151
Cough 17.70 13.62 132 49334 150008 34757457
Hypoaesthesia 17.52 13.62 38 49428 61406 34846059
Blood bilirubin increased 17.50 13.62 17 49449 38279 34869186
Delirium 17.38 13.62 22 49444 43969 34863496
Malignant neoplasm progression 17.33 13.62 65 49401 87981 34819484
Gait disturbance 17.32 13.62 62 49404 85078 34822387
Feeling abnormal 17.30 13.62 40 49426 63195 34844270
Reticulocyte count abnormal 17.25 13.62 4 49462 10 34907455
Coronary artery disease 17.24 13.62 26 49440 48279 34859186
Insomnia 17.19 13.62 82 49384 103825 34803640
Sleep disorder therapy 16.98 13.62 13 49453 1010 34906455
Intercepted product administration error 16.86 13.62 8 49458 257 34907208
Inadequate osteointegration 16.72 13.62 4 49462 12 34907453
Encephalomalacia 16.71 13.62 12 49454 846 34906619
Oedema due to renal disease 16.69 13.62 3 49463 0 34907465
Myalgia 16.62 13.62 62 49404 84048 34823417
Spinal stenosis 16.51 13.62 28 49438 5241 34902224
Blood product transfusion dependent 16.40 13.62 9 49457 394 34907071
Toe amputation 16.33 13.62 19 49447 2505 34904960
Cardiac valve disease 16.18 13.62 21 49445 3097 34904368
PCO2 decreased 16.13 13.62 16 49450 1760 34905705
Neurotoxicity 16.07 13.62 3 49463 18007 34889458
Seizure 16.06 13.62 85 49381 104772 34802693
Wheezing 16.06 13.62 21 49445 41381 34866084
Swelling of eyelid 16.04 13.62 13 49453 1098 34906367
Pain 16.03 13.62 199 49267 204476 34702989
Fracture 15.92 13.62 32 49434 6817 34900648
Dyspnoea 15.89 13.62 409 49057 376373 34531092
Fall 15.76 13.62 387 49079 202498 34704967
Arteriovenous fistula site haemorrhage 15.76 13.62 6 49460 110 34907355
Dysgeusia 15.66 13.62 9 49457 26488 34880977
Therapeutic product effect incomplete 15.47 13.62 30 49436 50511 34856954
Abnormal behaviour 15.46 13.62 8 49458 24961 34882504
Drug level increased 15.37 13.62 6 49460 22090 34885375
Blood glucose increased 15.36 13.62 46 49420 66672 34840793
Anti-erythropoietin antibody negative 15.19 13.62 7 49459 210 34907255
Foetal exposure during pregnancy 15.11 13.62 19 49447 38082 34869383
Sleep apnoea syndrome 15.01 13.62 5 49461 20316 34887149
Heart valve operation 14.92 13.62 5 49461 62 34907403
Tinnitus 14.78 13.62 5 49461 20113 34887352
Hepatic function abnormal 14.77 13.62 25 49441 44338 34863127
Oxygen saturation decreased 14.76 13.62 34 49432 53784 34853681
Psoriasis 14.73 13.62 20 49446 38792 34868673
Benign neoplasm 14.66 13.62 7 49459 228 34907237
Skin tightness 14.64 13.62 17 49449 2236 34905229
Arteriovenous graft thrombosis 14.61 13.62 3 49463 3 34907462
Dental restoration failure 14.50 13.62 4 49462 24 34907441
Hepatitis 14.30 13.62 8 49458 23896 34883569
Pneumonia 14.25 13.62 638 48828 361989 34545476
Diabetic complication 14.23 13.62 10 49456 681 34906784
Hot flush 14.15 13.62 4 49462 18062 34889403
Dyskinesia 14.15 13.62 7 49459 22406 34885059
Diabetic gangrene 14.14 13.62 7 49459 247 34907218
Peripheral swelling 14.11 13.62 58 49408 76483 34830982
Skin hypertrophy 14.10 13.62 18 49448 2611 34904854
Dialysis device insertion 14.10 13.62 4 49462 27 34907438
Actinic keratosis 13.95 13.62 24 49442 4543 34902922

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
Death 16900.04 12.40 8484 58776 558030 79119098
Hospitalisation 6091.94 12.40 2456 64804 91780 79585348
Investigation 2120.08 12.40 473 66787 1878 79675250
Aplasia pure red cell 1582.51 12.40 479 66781 7331 79669797
Arteriovenous fistula site complication 1205.57 12.40 255 67005 734 79676394
Haemodialysis 977.16 12.40 417 66843 17751 79659377
Shunt stenosis 540.36 12.40 142 67118 1249 79675879
Dialysis 479.54 12.40 257 67003 18205 79658923
Transplant 430.71 12.40 111 67149 897 79676231
Shunt occlusion 373.33 12.40 108 67152 1396 79675732
Haemoglobin decreased 371.60 12.40 669 66591 221450 79455678
Haemoglobin abnormal 362.97 12.40 157 67103 6897 79670231
Appendicolith 303.51 12.40 147 67113 8404 79668724
Peritoneal dialysis 250.96 12.40 70 67190 786 79676342
Drug ineffective 228.02 12.40 351 66909 1080562 78596566
Terminal state 210.36 12.40 96 67164 4793 79672335
Appendicitis 198.25 12.40 154 67106 20640 79656488
Renal transplant 190.10 12.40 74 67186 2473 79674655
Anti-erythropoietin antibody positive 175.80 12.40 51 67209 666 79676462
Headache 170.94 12.40 180 67080 653592 79023536
Anaemia 167.84 12.40 781 66479 444234 79232894
Completed suicide 161.38 12.40 12 67248 245755 79431373
Arthralgia 152.14 12.40 155 67105 571648 79105480
Transfusion 151.16 12.40 133 67127 21197 79655931
Toxicity to various agents 148.03 12.40 86 67174 421454 79255674
Transformation to acute myeloid leukaemia 142.96 12.40 47 67213 950 79676178
Joint swelling 142.85 12.40 34 67226 288612 79388516
Sepsis 142.52 12.40 525 66735 268903 79408225
Renal disorder 135.00 12.40 172 67088 41933 79635195
Arteriovenous fistula operation 130.61 12.40 35 67225 334 79676794
Azotaemia 127.04 12.40 82 67178 8194 79668934
Rheumatoid arthritis 126.60 12.40 14 67246 208456 79468672
Cardiogenic shock 121.60 12.40 163 67097 41751 79635377
Blood phosphorus increased 119.53 12.40 86 67174 10261 79666867
Contraindicated product administered 118.63 12.40 3 67257 157535 79519593
Infusion related reaction 118.16 12.40 25 67235 230212 79446916
Product use issue 118.02 12.40 18 67242 209804 79467324
Chronic kidney disease 113.84 12.40 202 67058 65952 79611176
Cardiac failure 113.37 12.40 337 66923 154505 79522623
Ascites 109.12 12.40 214 67046 75348 79601780
Alopecia 103.68 12.40 33 67227 231322 79445806
Pain 100.95 12.40 284 66976 703518 78973610
Sinusitis 100.77 12.40 21 67239 195480 79481648
Myelodysplastic syndrome 100.65 12.40 126 67134 30175 79646953
Nephrogenic systemic fibrosis 99.43 12.40 63 67197 6097 79671031
Drug intolerance 98.29 12.40 50 67210 264069 79413059
Arthropathy 95.57 12.40 17 67243 177094 79500034
Ventricular fibrillation 93.89 12.40 125 67135 31801 79645327
Hepatic enzyme increased 93.33 12.40 20 67240 182590 79494538
Multiple organ dysfunction syndrome 90.18 12.40 264 66996 119982 79557146
Drug hypersensitivity 88.88 12.40 73 67187 298843 79378285
End stage renal disease 88.19 12.40 77 67183 12143 79664985
Weight increased 87.21 12.40 64 67196 277322 79399806
Renal impairment 87.16 12.40 312 66948 157471 79519657
Peritonitis 85.90 12.40 112 67148 27924 79649204
Abdominal discomfort 83.94 12.40 54 67206 250673 79426455
Hip fracture 83.73 12.40 116 67144 30645 79646483
Haemoglobin increased 82.59 12.40 56 67204 6076 79671052
Hypersensitivity 81.80 12.40 61 67199 262178 79414950
Rehabilitation therapy 81.20 12.40 37 67223 1840 79675288
Renal cyst haemorrhage 80.97 12.40 28 67232 664 79676464
Mineral supplementation 79.36 12.40 29 67231 811 79676317
Systemic lupus erythematosus 79.24 12.40 6 67254 121143 79555985
Angina pectoris 77.71 12.40 149 67111 51583 79625545
Hyperparathyroidism secondary 77.49 12.40 40 67220 2620 79674508
Treatment failure 73.43 12.40 26 67234 170460 79506668
Reticulocyte count decreased 73.36 12.40 28 67232 886 79676242
Arteriovenous fistula site infection 72.71 12.40 19 67241 163 79676965
Hyperphosphataemia 71.38 12.40 52 67208 6324 79670804
Intentional product use issue 69.38 12.40 21 67239 152091 79525037
Palliative care 68.10 12.40 27 67233 948 79676180
Renal failure 67.79 12.40 342 66918 200626 79476502
Drug interaction 66.71 12.40 158 67102 415025 79262103
Marasmus 66.71 12.40 27 67233 1001 79676127
Hypervolaemia 66.64 12.40 125 67135 42565 79634563
Refractory cytopenia with unilineage dysplasia 65.95 12.40 26 67234 899 79676229
Musculoskeletal stiffness 65.27 12.40 33 67227 174975 79502153
Glossodynia 65.15 12.40 6 67254 103331 79573797
Product use in unapproved indication 64.02 12.40 70 67190 250289 79426839
Peripheral swelling 62.95 12.40 81 67179 269536 79407592
Neoplasm malignant 62.43 12.40 103 67157 31707 79645421
Renal artery stenosis 62.24 12.40 38 67222 3444 79673684
Intermittent claudication 59.80 12.40 37 67223 3434 79673694
Hepatic cyst infection 59.03 12.40 16 67244 160 79676968
Arteriovenous fistula thrombosis 58.76 12.40 21 67239 550 79676578
Rash 58.46 12.40 270 66990 578088 79099040
Suicide attempt 57.53 12.40 3 67257 82929 79594199
Peripheral arterial occlusive disease 57.52 12.40 51 67209 8207 79668921
Dizziness 56.06 12.40 241 67019 526200 79150928
Pneumonia 55.49 12.40 822 66438 659424 79017704
Intraductal papillary mucinous neoplasm 55.39 12.40 22 67238 776 79676352
Therapeutic response decreased 55.19 12.40 152 67108 66701 79610427
Delayed graft function 54.45 12.40 35 67225 3472 79673656
Anxiety 53.65 12.40 79 67181 248433 79428695
Abdominal distension 52.47 12.40 220 67040 119430 79557698
Suicidal ideation 52.22 12.40 3 67257 76337 79600791
Pericarditis 52.06 12.40 12 67248 104224 79572904
Renal cyst infection 51.55 12.40 15 67245 198 79676930
Condition aggravated 49.99 12.40 235 67025 500889 79176239
Blood uric acid increased 49.96 12.40 59 67201 13301 79663827
Depression 49.70 12.40 66 67194 216724 79460404
Stress 49.66 12.40 164 67096 79448 79597680
Unevaluable event 49.52 12.40 130 67130 55455 79621673
Fatigue 49.44 12.40 524 66736 929203 78747925
Discomfort 49.42 12.40 22 67238 125595 79551533
SARS-CoV-2 antibody test positive 48.43 12.40 17 67243 422 79676706
Product storage error 48.43 12.40 64 67196 16162 79660966
Leg amputation 48.23 12.40 33 67227 3633 79673495
Vena cava injury 48.09 12.40 16 67244 336 79676792
Nasopharyngitis 48.00 12.40 88 67172 253793 79423335
Shunt infection 47.23 12.40 14 67246 198 79676930
Asthma 46.70 12.40 28 67232 135067 79542061
Iron deficiency 46.54 12.40 51 67209 10603 79666525
Reticulocyte count abnormal 45.66 12.40 11 67249 65 79677063
Anti-erythropoietin antibody negative 45.04 12.40 15 67245 316 79676812
Pleural effusion 43.99 12.40 240 67020 145022 79532106
Therapeutic product effect decreased 43.91 12.40 44 67216 163819 79513309
Living in residential institution 43.86 12.40 18 67242 692 79676436
Arthritis 43.83 12.40 21 67239 114859 79562269
Thrombocytopenia 43.63 12.40 377 66883 264882 79412246
Vascular anastomotic haemorrhage 43.05 12.40 14 67246 273 79676855
Iron overload 42.99 12.40 24 67236 1840 79675288
Hypoaesthesia 41.72 12.40 54 67206 179298 79497830
Zoonotic bacterial infection 41.52 12.40 10 67250 59 79677069
Product dose omission issue 41.49 12.40 92 67168 247445 79429683
Duodenal ulcer perforation 41.32 12.40 4 67256 66207 79610921
Injection site erythema 41.10 12.40 8 67252 78189 79598939
Abdominal wall haemorrhage 40.86 12.40 17 67243 677 79676451
Fracture 40.65 12.40 69 67191 21732 79655396
Loss of personal independence in daily activities 40.30 12.40 18 67242 102562 79574566
Memory impairment 40.27 12.40 22 67238 111712 79565416
Migraine 40.03 12.40 12 67248 87481 79589647
Perineal cyst 39.86 12.40 13 67247 256 79676872
Pain in extremity 38.07 12.40 168 67092 364370 79312758
Fibromyalgia 37.36 12.40 5 67255 64335 79612793
Plasma cell myeloma 37.12 12.40 114 67146 53145 79623983
Rectal prolapse 36.97 12.40 23 67237 2155 79674973
Hyperhidrosis 36.92 12.40 44 67216 151448 79525680
Therapeutic product effect incomplete 36.86 12.40 39 67221 141606 79535522
Visual impairment 36.45 12.40 16 67244 92115 79585013
Complications of transplanted kidney 35.99 12.40 35 67225 6331 79670797
Irritable bowel syndrome 35.76 12.40 5 67255 62236 79614892
Hyperparathyroidism 35.42 12.40 26 67234 3198 79673930
Cough 34.80 12.40 175 67085 366614 79310514
Alanine aminotransferase increased 34.75 12.40 52 67208 162518 79514610
Renal transplant failure 34.57 12.40 21 67239 1886 79675242
Blood potassium increased 34.16 12.40 76 67184 29199 79647929
Gastrointestinal disorder 33.68 12.40 32 67228 122173 79554955
Cardiac failure congestive 33.33 12.40 220 67040 142182 79534946
Folliculitis 32.89 12.40 4 67256 55376 79621752
Carotid arteriosclerosis 32.81 12.40 23 67237 2633 79674495
Mycobacterium marinum infection 32.80 12.40 13 67247 456 79676672
Cardiac output decreased 32.70 12.40 20 67240 1818 79675310
Erythropoiesis abnormal 32.66 12.40 13 67247 461 79676667
Skin induration 31.62 12.40 28 67232 4497 79672631
Wound 31.35 12.40 31 67229 116148 79560980
Nausea 31.10 12.40 595 66665 956601 78720527
Blister 30.97 12.40 33 67227 119443 79557685
Diabetic complication 30.96 12.40 17 67243 1262 79675866
Gangrene 30.92 12.40 38 67222 8926 79668202
Arteriovenous fistula occlusion 30.75 12.40 13 67247 539 79676589
Osteoarthritis 30.31 12.40 18 67242 87291 79589837
Vascular compression 30.26 12.40 13 67247 561 79676567
Sedation 30.21 12.40 4 67256 51891 79625237
Transferrin saturation increased 30.19 12.40 9 67251 130 79676998
Skin hypertrophy 29.57 12.40 28 67232 4900 79672228
Analgesic therapy 28.89 12.40 15 67245 994 79676134
Arteriovenous fistula site haemorrhage 28.88 12.40 11 67249 346 79676782
Stomatitis 28.50 12.40 50 67210 146707 79530421
Tachycardia 28.22 12.40 68 67192 177700 79499428
Serum ferritin increased 28.10 12.40 38 67222 9809 79667319
Gait disturbance 27.97 12.40 86 67174 207420 79469708
Myasthenia gravis 27.97 12.40 39 67221 10360 79666768
Hallucination 27.95 12.40 19 67241 85726 79591402
Procalcitonin abnormal 27.94 12.40 11 67249 379 79676749
Aortic dilatation 27.92 12.40 18 67242 1794 79675334
Cardiac valve disease 27.75 12.40 29 67231 5712 79671416
Psoriasis 27.70 12.40 21 67239 89566 79587562
Nasal congestion 27.69 12.40 15 67245 76537 79600591
Depressed mood 27.60 12.40 4 67256 48476 79628652
Blood parathyroid hormone increased 27.49 12.40 23 67237 3422 79673706
Oropharyngeal pain 27.46 12.40 31 67229 109322 79567806
Mean cell volume increased 27.43 12.40 30 67230 6223 79670905
Insomnia 27.42 12.40 110 67150 245060 79432068
Serotonin syndrome 27.37 12.40 3 67257 45024 79632104
General physical health deterioration 27.20 12.40 353 66907 274885 79402243
Drug-induced liver injury 26.93 12.40 11 67249 66106 79611022
Haemorrhage 26.54 12.40 149 67111 90969 79586159
Weight decreased 26.49 12.40 183 67077 355015 79322113
Agitation 26.45 12.40 27 67233 99688 79577440
Drug therapy 26.44 12.40 15 67245 1186 79675942
Constipation 26.30 12.40 359 66901 282691 79394437
Urticaria 26.23 12.40 75 67185 185126 79492002
Intervertebral disc space narrowing 26.16 12.40 17 67243 1718 79675410
Abdominal pain upper 25.94 12.40 99 67161 223720 79453408
Agranulocytosis 25.65 12.40 90 67170 44940 79632188
Liver injury 25.47 12.40 8 67252 56606 79620522
Hepatotoxicity 25.46 12.40 6 67254 51346 79625782
Shunt aneurysm 24.69 12.40 6 67254 37 79677091
Blood 25-hydroxycholecalciferol decreased 24.50 12.40 10 67250 379 79676749
Flushing 24.45 12.40 23 67237 88245 79588883
Feeling abnormal 24.40 12.40 62 67198 159137 79517991
Injection site swelling 24.40 12.40 5 67255 47127 79630001
Home care 24.32 12.40 4 67256 0 79677128
Shunt malfunction 24.29 12.40 9 67251 262 79676866
Type 2 diabetes mellitus 24.09 12.40 9 67251 57113 79620015
Muscle injury 23.44 12.40 6 67254 48555 79628573
Anti-erythropoietin antibody 23.23 12.40 5 67255 16 79677112
Skin fibrosis 23.14 12.40 15 67245 1509 79675619
Sleep disorder therapy 23.11 12.40 13 67247 1011 79676117
Premature delivery 23.09 12.40 57 67203 23410 79653718
Hepatosplenomegaly 23.02 12.40 27 67233 6042 79671086
Peritonitis bacterial 22.98 12.40 34 67226 9533 79667595
Hyperkalaemia 22.81 12.40 170 67090 114228 79562900
Haemodialysis complication 22.78 12.40 9 67251 313 79676815
Feeling hot 22.66 12.40 11 67249 59723 79617405
Blood erythropoietin increased 22.57 12.40 5 67255 19 79677109
Heart rate decreased 22.36 12.40 16 67244 70300 79606828
Angiodysplasia 22.23 12.40 13 67247 1089 79676039
Rhinorrhoea 22.06 12.40 19 67241 76055 79601073
Haemolysis 21.87 12.40 39 67221 12773 79664355
Metastatic neoplasm 21.79 12.40 24 67236 5018 79672110
Balance disorder 21.73 12.40 31 67229 98826 79578302
Skin tightness 21.67 12.40 25 67235 5497 79671631
Inappropriate schedule of product administration 21.30 12.40 51 67209 133577 79543551
Diverticulum intestinal 21.27 12.40 31 67229 8574 79668554
Injection site pain 21.13 12.40 49 67211 129789 79547339
PCO2 decreased 21.02 12.40 19 67241 3135 79673993
Injection site pruritus 20.85 12.40 5 67255 42278 79634850
Impaired healing 20.78 12.40 26 67234 87629 79589499
Vision blurred 20.63 12.40 36 67224 105862 79571266
Upper respiratory tract inflammation 20.62 12.40 21 67239 4014 79673114
Maternal condition affecting foetus 20.44 12.40 7 67253 161 79676967
Aortic arteriosclerosis 20.43 12.40 31 67229 8887 79668241
Muscle spasms 20.43 12.40 77 67183 174653 79502475
Serum ferritin abnormal 20.41 12.40 9 67251 414 79676714
Haematocrit decreased 20.40 12.40 104 67156 61208 79615920
Overdose 20.37 12.40 83 67177 184123 79493005
Thrombosis 20.32 12.40 131 67129 83969 79593159
Gastrointestinal haemorrhage 20.25 12.40 202 67058 147517 79529611
Hyperuricaemia 20.24 12.40 36 67224 11763 79665365
Swelling 20.18 12.40 104 67156 216607 79460521
Neutralising antibodies positive 20.12 12.40 8 67252 283 79676845
Drug ineffective for unapproved indication 20.10 12.40 9 67251 51229 79625899
Medication error 20.08 12.40 17 67243 68625 79608503
Irritability 20.02 12.40 5 67255 41139 79635989
Throat irritation 19.88 12.40 5 67255 40941 79636187
Tremor 19.85 12.40 75 67185 170008 79507120
Paraesthesia 19.78 12.40 79 67181 176244 79500884
Red blood cell sedimentation rate increased 19.78 12.40 7 67253 45935 79631193
Haematochezia 19.75 12.40 27 67233 87618 79589510
Angioedema 19.70 12.40 21 67239 76014 79601114
Hyponatraemia 19.66 12.40 233 67027 177615 79499513
Knee arthroplasty 19.66 12.40 6 67254 43242 79633886
Ischaemic stroke 19.55 12.40 67 67193 33064 79644064
Dysgeusia 19.54 12.40 12 67248 57165 79619963
Lymphocele 19.48 12.40 14 67246 1667 79675461
Colitis ulcerative 19.47 12.40 3 67257 34739 79642389
Cardiac disorder 19.46 12.40 108 67152 65649 79611479
Squamous cell carcinoma of skin 19.35 12.40 39 67221 13994 79663134
Toe amputation 19.35 12.40 20 67240 3891 79673237
Gastroenteritis 19.31 12.40 68 67192 34014 79643114
Ear infection 19.24 12.40 3 67257 34429 79642699
Hypocalcaemia 18.99 12.40 88 67172 49836 79627292
Dry eye 18.95 12.40 4 67256 36927 79640201
Product quality issue 18.86 12.40 3 67257 33937 79643191
Inadequate osteointegration 18.78 12.40 4 67256 12 79677116
Lactic acidosis 18.72 12.40 19 67241 70340 79606788
Diabetic gangrene 18.69 12.40 7 67253 210 79676918
Anaphylactic reaction 18.66 12.40 26 67234 83717 79593411
Hepatitis 18.63 12.40 12 67248 55715 79621413
Dyspepsia 18.52 12.40 40 67220 108647 79568481
Myalgia 18.49 12.40 87 67173 185554 79491574
Influenza like illness 18.36 12.40 20 67240 71687 79605441
Psychotic disorder 18.36 12.40 6 67254 41396 79635732
Large intestine polyp 18.34 12.40 36 67224 12672 79664456
Encephalomalacia 18.32 12.40 12 67248 1229 79675899
Exposure during pregnancy 18.26 12.40 36 67224 101096 79576032
Volume blood increased 18.24 12.40 3 67257 0 79677128
Cytomegalovirus pancreatitis 18.24 12.40 3 67257 0 79677128
Wheezing 18.21 12.40 45 67215 116619 79560509
Inflammation 18.14 12.40 32 67228 93721 79583407
PO2 decreased 18.09 12.40 17 67243 2946 79674182
Coma 18.03 12.40 36 67224 100613 79576515
Normochromic normocytic anaemia 17.90 12.40 27 67233 7700 79669428
Natural killer cell count 17.89 12.40 4 67256 16 79677112
Reticulocytopenia 17.87 12.40 7 67253 238 79676890
Parakeratosis 17.78 12.40 8 67252 386 79676742
Upper respiratory tract infection 17.75 12.40 31 67229 91137 79585991
Cerebral infarction 17.73 12.40 81 67179 45595 79631533
Amegakaryocytic thrombocytopenia 17.70 12.40 4 67256 17 79677111
Prescribed overdose 17.68 12.40 5 67255 37878 79639250
Dialysis device insertion 17.47 12.40 5 67255 62 79677066
Cognitive disorder 17.36 12.40 20 67240 69906 79607222
Kidney transplant rejection 17.24 12.40 31 67229 10215 79666913
Fungal endocarditis 17.22 12.40 9 67251 605 79676523
Blood product transfusion dependent 17.10 12.40 8 67252 423 79676705
Aspartate aminotransferase increased 16.92 12.40 60 67200 138581 79538547
Acute leukaemia 16.92 12.40 13 67247 1713 79675415
Disturbance in attention 16.90 12.40 11 67249 50790 79626338
Sleep disorder 16.80 12.40 29 67231 85648 79591480
Actinic keratosis 16.76 12.40 23 67237 6019 79671109
Chest discomfort 16.68 12.40 60 67200 137984 79539144
Back pain 16.65 12.40 170 67090 304010 79373118
Abnormal behaviour 16.65 12.40 5 67255 36416 79640712
Device related infection 16.56 12.40 65 67195 34229 79642899
Parvovirus B19 infection 16.41 12.40 12 67248 1468 79675660
Night sweats 16.37 12.40 12 67248 52083 79625045
Cardiac arrest 16.26 12.40 219 67041 171877 79505251
Myelodysplastic syndrome transformation 16.24 12.40 9 67251 680 79676448
Sopor 16.09 12.40 4 67256 33006 79644122
Uterine atony 16.08 12.40 6 67254 178 79676950
Nephrogenic anaemia 15.88 12.40 18 67242 3884 79673244
Dyskinesia 15.86 12.40 9 67251 44764 79632364
Liver function test increased 15.58 12.40 7 67253 39766 79637362
Heart rate increased 15.58 12.40 51 67209 120673 79556455
Hot flush 15.55 12.40 14 67246 54863 79622265
Sudden death 15.51 12.40 48 67212 22463 79654665
Adverse drug reaction 15.42 12.40 20 67240 66372 79610756
Peritoneal dialysis complication 15.33 12.40 14 67246 2340 79674788
Palpitations 15.32 12.40 55 67205 126555 79550573
Acute myeloid leukaemia 15.29 12.40 59 67201 30826 79646302
Bone marrow failure 15.16 12.40 84 67176 51023 79626105
Eye infection bacterial 15.10 12.40 7 67253 362 79676766
Oxygen saturation decreased 14.99 12.40 57 67203 128990 79548138
Injection site bruising 14.88 12.40 8 67252 40994 79636134
Neoplasm progression 14.87 12.40 13 67247 51669 79625459
Retinal artery occlusion 14.79 12.40 16 67244 3278 79673850
Delirium 14.54 12.40 31 67229 84596 79592532
Lung neoplasm malignant 14.51 12.40 54 67206 27738 79649390
Joint contracture 14.50 12.40 14 67246 2510 79674618
Renal lymphocele 14.48 12.40 5 67255 118 79677010
Activated partial thromboplastin time prolonged 14.47 12.40 35 67225 14193 79662935
Aortic valve stenosis 14.46 12.40 20 67240 5274 79671854
Pruritus 14.43 12.40 240 67020 394408 79282720
Coombs test positive 14.35 12.40 6 67254 242 79676886
Diabetes mellitus 14.24 12.40 114 67146 78276 79598852
Oedema peripheral 14.21 12.40 295 66965 251993 79425135
Left ventricular hypertrophy 14.13 12.40 30 67230 11161 79665967
Fall 14.05 12.40 523 66737 487106 79190022
Thrombosis in device 14.03 12.40 20 67240 5422 79671706
Electrocardiogram QT prolonged 14.00 12.40 35 67225 90351 79586777
Extramedullary haemopoiesis 13.92 12.40 5 67255 133 79676995
Productive cough 13.84 12.40 34 67226 88297 79588831
Aneurysm 13.82 12.40 16 67244 3532 79673596
Dialysis related complication 13.81 12.40 6 67254 266 79676862
Prescribed underdose 13.58 12.40 4 67256 29510 79647618
Abortion spontaneous 13.58 12.40 4 67256 29503 79647625
Interstitial lung disease 13.56 12.40 49 67211 112551 79564577
Occupational exposure to product 13.44 12.40 8 67252 692 79676436
Blood test abnormal 13.37 12.40 39 67221 17671 79659457
Dysphonia 13.34 12.40 17 67243 56855 79620273
Respiratory disorder 13.25 12.40 11 67249 44845 79632283
Urine odour abnormal 13.24 12.40 21 67239 6252 79670876
Febrile bone marrow aplasia 13.21 12.40 32 67228 12988 79664140
Cytokine release syndrome 13.10 12.40 7 67253 35991 79641137
Infective aneurysm 13.09 12.40 9 67251 999 79676129
Calciphylaxis 13.03 12.40 16 67244 3754 79673374
Shunt thrombosis 13.02 12.40 5 67255 161 79676967
Bursitis 13.00 12.40 7 67253 35837 79641291
Blood creatinine increased 12.92 12.40 193 67067 154864 79522264
Nightmare 12.86 12.40 3 67257 25858 79651270
Pulmonary fibrosis 12.81 12.40 11 67249 44101 79633027
Mycobacterial peritonitis 12.76 12.40 4 67256 69 79677059
Eye pain 12.69 12.40 8 67252 37570 79639558
Renal cyst 12.65 12.40 34 67226 14698 79662430
Blood glucose increased 12.58 12.40 52 67208 114923 79562205
Gastric cancer 12.52 12.40 27 67233 10152 79666976
Disease complication 12.52 12.40 18 67242 4919 79672209
Benign neoplasm 12.50 12.40 9 67251 1074 79676054
Spinal compression fracture 12.47 12.40 37 67223 16921 79660207
Poisoning 12.44 12.40 3 67257 25269 79651859
Nephrolithiasis 12.43 12.40 16 67244 53275 79623853

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC B03XA02 BLOOD AND BLOOD FORMING ORGANS
ANTIANEMIC PREPARATIONS
OTHER ANTIANEMIC PREPARATIONS
Other antianemic preparations
FDA CS M0007726 Erythropoietin
FDA PE N0000009319 Increased Erythroid Cell Production
MeSH PA D006397 Hematinics
MeSH PA D006401 Hematologic Agents
FDA EPC N0000175665 Erythropoiesis-stimulating Agent

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

DiseaseRelationSNOMED_IDDOID
Anemia of renal disease indication 234348004
Anemia due to and following chemotherapy indication 767657005
Hypertensive disorder contraindication 38341003 DOID:10763




🐶 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
Erythropoietin receptor Membrane receptor AGONIST DRUG LABEL DRUG LABEL

External reference:

IDSource
15UQ94PT4P UNII
4021274 VANDF
C0937950 UMLSCUI
CHEMBL1201566 ChEMBL_ID
DB00012 DRUGBANK_ID
D000068256 MESH_DESCRIPTOR_UI
D03651 KEGG_DRUG
8073 INN_ID
283838 RXNORM
16174 MMSL
235606 MMSL
42263 MMSL
d04771 MMSL
009195 NDDF
385608005 SNOMEDCT_US
385610007 SNOMEDCT_US

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
ARANESP HUMAN PRESCRIPTION DRUG LABEL 1 55513-002 SOLUTION 25 ug INTRAVENOUS BLA 29 sections
ARANESP HUMAN PRESCRIPTION DRUG LABEL 1 55513-002 SOLUTION 25 ug INTRAVENOUS BLA 29 sections
ARANESP HUMAN PRESCRIPTION DRUG LABEL 1 55513-002 SOLUTION 25 ug INTRAVENOUS BLA 29 sections
ARANESP HUMAN PRESCRIPTION DRUG LABEL 1 55513-003 SOLUTION 40 ug INTRAVENOUS BLA 29 sections
ARANESP HUMAN PRESCRIPTION DRUG LABEL 1 55513-003 SOLUTION 40 ug INTRAVENOUS BLA 29 sections
ARANESP HUMAN PRESCRIPTION DRUG LABEL 1 55513-003 SOLUTION 40 ug INTRAVENOUS BLA 29 sections
ARANESP HUMAN PRESCRIPTION DRUG LABEL 1 55513-004 SOLUTION 60 ug INTRAVENOUS BLA 29 sections
ARANESP HUMAN PRESCRIPTION DRUG LABEL 1 55513-004 SOLUTION 60 ug INTRAVENOUS BLA 29 sections
ARANESP HUMAN PRESCRIPTION DRUG LABEL 1 55513-004 SOLUTION 60 ug INTRAVENOUS BLA 29 sections
ARANESP HUMAN PRESCRIPTION DRUG LABEL 1 55513-005 SOLUTION 100 ug INTRAVENOUS BLA 29 sections
ARANESP HUMAN PRESCRIPTION DRUG LABEL 1 55513-005 SOLUTION 100 ug INTRAVENOUS BLA 29 sections
ARANESP HUMAN PRESCRIPTION DRUG LABEL 1 55513-005 SOLUTION 100 ug INTRAVENOUS BLA 29 sections
ARANESP HUMAN PRESCRIPTION DRUG LABEL 1 55513-006 SOLUTION 200 ug INTRAVENOUS BLA 29 sections
ARANESP HUMAN PRESCRIPTION DRUG LABEL 1 55513-006 SOLUTION 200 ug INTRAVENOUS BLA 29 sections
ARANESP HUMAN PRESCRIPTION DRUG LABEL 1 55513-006 SOLUTION 200 ug INTRAVENOUS BLA 29 sections
ARANESP HUMAN PRESCRIPTION DRUG LABEL 1 55513-021 INJECTION, SOLUTION 40 ug INTRAVENOUS BLA 29 sections
ARANESP HUMAN PRESCRIPTION DRUG LABEL 1 55513-021 INJECTION, SOLUTION 40 ug INTRAVENOUS BLA 29 sections
ARANESP HUMAN PRESCRIPTION DRUG LABEL 1 55513-021 INJECTION, SOLUTION 40 ug INTRAVENOUS BLA 29 sections
ARANESP HUMAN PRESCRIPTION DRUG LABEL 1 55513-023 INJECTION, SOLUTION 60 ug INTRAVENOUS BLA 29 sections
ARANESP HUMAN PRESCRIPTION DRUG LABEL 1 55513-023 INJECTION, SOLUTION 60 ug INTRAVENOUS BLA 29 sections
ARANESP HUMAN PRESCRIPTION DRUG LABEL 1 55513-023 INJECTION, SOLUTION 60 ug INTRAVENOUS BLA 29 sections
ARANESP HUMAN PRESCRIPTION DRUG LABEL 1 55513-025 INJECTION, SOLUTION 100 ug INTRAVENOUS BLA 29 sections
ARANESP HUMAN PRESCRIPTION DRUG LABEL 1 55513-025 INJECTION, SOLUTION 100 ug INTRAVENOUS BLA 29 sections
ARANESP HUMAN PRESCRIPTION DRUG LABEL 1 55513-025 INJECTION, SOLUTION 100 ug INTRAVENOUS BLA 29 sections
ARANESP HUMAN PRESCRIPTION DRUG LABEL 1 55513-027 INJECTION, SOLUTION 150 ug INTRAVENOUS BLA 29 sections
ARANESP HUMAN PRESCRIPTION DRUG LABEL 1 55513-027 INJECTION, SOLUTION 150 ug INTRAVENOUS BLA 29 sections
ARANESP HUMAN PRESCRIPTION DRUG LABEL 1 55513-027 INJECTION, SOLUTION 150 ug INTRAVENOUS BLA 29 sections
ARANESP HUMAN PRESCRIPTION DRUG LABEL 1 55513-028 INJECTION, SOLUTION 200 ug INTRAVENOUS BLA 29 sections
ARANESP HUMAN PRESCRIPTION DRUG LABEL 1 55513-028 INJECTION, SOLUTION 200 ug INTRAVENOUS BLA 29 sections
ARANESP HUMAN PRESCRIPTION DRUG LABEL 1 55513-028 INJECTION, SOLUTION 200 ug INTRAVENOUS BLA 29 sections