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 10513.78 12.83 5078 35841 320301 50243904
Hospitalisation 4464.45 12.83 1769 39150 66168 50498037
Investigation 1139.50 12.83 262 40657 1290 50562915
Haemodialysis 1031.64 12.83 348 40571 8014 50556191
Aplasia pure red cell 958.75 12.83 280 40639 3935 50560270
Transplant 505.33 12.83 115 40804 535 50563670
Arteriovenous fistula site complication 469.63 12.83 103 40816 390 50563815
Dialysis 403.26 12.83 182 40737 9256 50554949
Haemoglobin decreased 295.01 12.83 434 40485 126782 50437423
Terminal state 237.33 12.83 82 40837 2028 50562177
Drug ineffective 229.26 12.83 197 40722 819136 49745069
Peritoneal dialysis 212.65 12.83 51 40868 310 50563895
Anaemia 211.84 12.83 561 40358 251895 50312310
Renal disorder 192.18 12.83 167 40752 27338 50536867
Shunt stenosis 190.59 12.83 48 40871 367 50563838
Renal transplant 183.45 12.83 59 40860 1160 50563045
Shunt occlusion 180.22 12.83 48 40871 468 50563737
Haemoglobin abnormal 166.25 12.83 78 40841 4334 50559871
Therapeutic response decreased 148.51 12.83 187 40732 47044 50517161
Palliative care 142.98 12.83 37 40882 319 50563886
Rheumatoid arthritis 131.93 12.83 8 40911 202542 50361663
Anti-erythropoietin antibody positive 111.01 12.83 31 40888 366 50563839
Renal impairment 105.54 12.83 206 40713 75455 50488750
Drug hypersensitivity 105.04 12.83 36 40883 250974 50313231
Drug intolerance 103.50 12.83 25 40894 219079 50345126
Headache 102.82 12.83 157 40762 506378 50057827
Transfusion 97.55 12.83 82 40837 12823 50551382
Joint swelling 96.22 12.83 39 40880 245247 50318958
Renal failure 95.30 12.83 243 40676 106390 50457815
Arteriovenous fistula operation 93.05 12.83 24 40895 204 50564001
Peritonitis 92.30 12.83 86 40833 15400 50548805
Condition aggravated 90.62 12.83 65 40854 296993 50267212
Infusion related reaction 89.10 12.83 15 40904 169542 50394663
Arthralgia 87.02 12.83 138 40781 438564 50125641
Product use issue 83.65 12.83 11 40908 149464 50414741
Haemoglobin increased 81.55 12.83 43 40876 3072 50561133
Myelodysplastic syndrome 80.63 12.83 79 40840 15053 50549152
Arthropathy 78.60 12.83 16 40903 157890 50406315
Completed suicide 75.51 12.83 9 40910 131880 50432325
Alopecia 75.51 12.83 53 40866 244994 50319211
Pain 75.36 12.83 230 40689 578673 49985532
Toxicity to various agents 72.29 12.83 41 40878 212458 50351747
Sinusitis 72.11 12.83 24 40895 170534 50393671
Abdominal discomfort 70.19 12.83 51 40868 231590 50332615
Systemic lupus erythematosus 68.44 12.83 15 40904 140607 50423598
Cardiac failure 66.57 12.83 172 40747 75868 50488337
Mineral supplementation 66.54 12.83 24 40895 675 50563530
Hepatic enzyme increased 66.16 12.83 15 40904 137365 50426840
Glossodynia 63.47 12.83 9 40910 115560 50448645
Unevaluable event 62.47 12.83 124 40795 45942 50518263
Swelling 62.45 12.83 43 40876 200829 50363376
Weight increased 59.15 12.83 46 40873 201845 50362360
Rehabilitation therapy 58.22 12.83 26 40893 1287 50562918
Hip fracture 57.82 12.83 87 40832 25844 50538361
Nephrogenic systemic fibrosis 56.19 12.83 38 40881 4284 50559921
Azotaemia 53.93 12.83 36 40883 3972 50560233
Treatment failure 53.73 12.83 22 40897 137615 50426590
Refractory cytopenia with unilineage dysplasia 49.71 12.83 18 40901 512 50563693
Transformation to acute myeloid leukaemia 49.11 12.83 14 40905 179 50564026
Thrombocytopenia 48.35 12.83 218 40701 127455 50436750
Cardiac output decreased 47.00 12.83 20 40899 880 50563325
Musculoskeletal stiffness 46.29 12.83 23 40896 128458 50435747
Wound 46.27 12.83 14 40905 105780 50458425
Nasopharyngitis 45.91 12.83 53 40866 192874 50371331
Therapeutic product effect decreased 45.17 12.83 27 40892 136023 50428182
Psoriasis 44.06 12.83 3 40916 68997 50495208
Injection site erythema 43.16 12.83 5 40914 74931 50489274
Hypervolaemia 42.50 12.83 75 40844 25424 50538781
Reticulocyte count decreased 42.41 12.83 15 40904 398 50563807
Hypersensitivity 42.24 12.83 68 40851 215093 50349112
End stage renal disease 40.38 12.83 35 40884 5702 50558503
Pleural effusion 40.24 12.83 151 40768 81303 50482902
Chronic kidney disease 40.11 12.83 95 40824 39676 50524529
Haemodialysis complication 39.67 12.83 12 40907 191 50564014
Occupational exposure to product 39.21 12.83 22 40897 1778 50562427
Arteriovenous fistula site infection 39.00 12.83 9 40910 45 50564160
Peripheral swelling 38.64 12.83 67 40852 205869 50358336
Anti-erythropoietin antibody negative 38.26 12.83 10 40909 90 50564115
Hepatic cyst infection 37.59 12.83 10 40909 97 50564108
Living in residential institution 36.96 12.83 14 40905 453 50563752
Therapeutic product effect incomplete 36.73 12.83 14 40905 91501 50472704
Discomfort 36.69 12.83 21 40898 108359 50455846
Drug specific antibody absent 36.68 12.83 9 40910 61 50564144
Drug interaction 36.50 12.83 66 40853 199555 50364650
Nausea 36.09 12.83 381 40538 705017 49859188
Disease progression 35.76 12.83 163 40756 95703 50468502
Rash 35.55 12.83 208 40711 437263 50126942
Blood parathyroid hormone increased 34.52 12.83 24 40895 2830 50561375
Cardiac disorder 34.33 12.83 94 40825 42885 50521320
Intentional product use issue 33.95 12.83 10 40909 76908 50487297
Suicidal ideation 33.70 12.83 3 40916 55382 50508823
Somnolence 33.29 12.83 46 40873 154939 50409266
Fall 33.21 12.83 415 40504 334517 50229688
Leukopenia 33.19 12.83 125 40794 67403 50496802
Reticulocyte count abnormal 32.89 12.83 8 40911 52 50564153
Renal cyst infection 31.94 12.83 9 40910 110 50564095
Plasma cell myeloma 31.78 12.83 75 40844 31247 50532958
Pancytopenia 30.68 12.83 142 40777 83888 50480317
Iron deficiency 30.10 12.83 30 40889 5832 50558373
Depression 29.96 12.83 55 40864 165368 50398837
Urinary tract infection 29.68 12.83 294 40625 223726 50340479
Shunt infection 29.12 12.83 7 40912 43 50564162
Blood cholesterol increased 28.72 12.83 5 40914 55210 50508995
Pericarditis 28.46 12.83 14 40905 78675 50485530
Anti-erythropoietin antibody 28.26 12.83 5 40914 3 50564202
Sepsis 28.14 12.83 194 40725 132731 50431474
Dizziness 27.93 12.83 165 40754 346204 50218001
Pneumonia 27.90 12.83 445 40474 377956 50186249
Neoplasm malignant 27.64 12.83 60 40859 23655 50540550
Serum ferritin increased 27.41 12.83 27 40892 5175 50559030
Marasmus 27.10 12.83 11 40908 429 50563776
Diabetic complication 26.69 12.83 13 40906 785 50563420
Duodenal ulcer perforation 26.37 12.83 3 40916 45608 50518597
Product use in unapproved indication 26.28 12.83 33 40886 115786 50448419
Fungal endocarditis 26.26 12.83 9 40910 217 50563988
Bone marrow failure 25.73 12.83 64 40855 27560 50536645
Arthritis 25.06 12.83 20 40899 86701 50477504
Home care 24.48 12.83 4 40915 0 50564205
Blood creatinine increased 24.42 12.83 124 40795 76036 50488169
Premature delivery 24.37 12.83 57 40862 23606 50540599
Sleep disorder 24.29 12.83 8 40911 57275 50506930
Irritable bowel syndrome 23.99 12.83 6 40913 51435 50512770
Product dose omission issue 23.81 12.83 73 40846 183765 50380440
Migraine 23.52 12.83 16 40903 75264 50488941
Arteriovenous fistula thrombosis 23.37 12.83 8 40911 192 50564013
Hypertension 23.21 12.83 267 40652 210936 50353269
Skin induration 23.04 12.83 19 40900 2892 50561313
Eye infection bacterial 22.99 12.83 7 40912 114 50564091
Off label use 22.64 12.83 522 40397 473904 50090301
Injection site pruritus 22.52 12.83 3 40916 40408 50523797
Memory impairment 22.07 12.83 19 40900 79341 50484864
Transplant failure 22.05 12.83 14 40905 1419 50562786
Pain in extremity 21.97 12.83 130 40789 272735 50291470
Insomnia 21.55 12.83 71 40848 174794 50389411
Infective aneurysm 21.28 12.83 9 40910 390 50563815
Hyperphosphataemia 20.93 12.83 15 40904 1856 50562349
Myelodysplastic syndrome transformation 20.77 12.83 9 40910 414 50563791
Asthma 20.74 12.83 25 40894 89312 50474893
Cellulitis 20.45 12.83 112 40807 70686 50493519
Product storage error 20.43 12.83 36 40883 12188 50552017
Nasal congestion 20.21 12.83 8 40911 51112 50513093
Blood erythropoietin increased 20.10 12.83 4 40915 8 50564197
Kidney transplant rejection 19.73 12.83 20 40899 3967 50560238
Blood potassium increased 19.69 12.83 42 40877 16356 50547849
Angina pectoris 19.65 12.83 56 40863 26132 50538073
Exposure during pregnancy 19.53 12.83 43 40876 120972 50443233
Visual impairment 19.41 12.83 16 40903 68259 50495946
Loss of personal independence in daily activities 19.20 12.83 17 40902 70033 50494172
Haemolysis 19.18 12.83 24 40895 5992 50558213
Extramedullary haemopoiesis 18.84 12.83 5 40914 48 50564157
Iron overload 18.83 12.83 10 40909 725 50563480
Gastrointestinal disorder 18.37 12.83 30 40889 94426 50469779
Natural killer cell count 18.06 12.83 4 40915 16 50564189
Amegakaryocytic thrombocytopenia 18.06 12.83 4 40915 16 50564189
Urine odour abnormal 18.04 12.83 22 40897 5351 50558854
Hypocalcaemia 17.89 12.83 55 40864 26761 50537444
Hyperparathyroidism secondary 17.86 12.83 12 40907 1338 50562867
Leg amputation 17.76 12.83 14 40905 1999 50562206
Epistaxis 17.69 12.83 100 40819 63854 50500351
Renal transplant failure 17.59 12.83 9 40910 604 50563601
Parakeratosis 17.57 12.83 7 40912 260 50563945
Folliculitis 17.49 12.83 5 40914 39220 50524985
Oedema peripheral 17.48 12.83 200 40719 157761 50406444
Anxiety 17.45 12.83 79 40840 177527 50386678
Knee arthroplasty 17.07 12.83 4 40915 35842 50528363
Gait disturbance 17.07 12.83 63 40856 149942 50414263
Blood product transfusion dependent 17.01 12.83 6 40913 158 50564047
Dialysis related complication 16.99 12.83 5 40914 72 50564133
Macrophages increased 16.87 12.83 4 40915 23 50564182
Blister 16.73 12.83 27 40892 85391 50478814
Dry eye 16.49 12.83 3 40916 32092 50532113
Maternal condition affecting foetus 16.40 12.83 6 40913 176 50564029
Arteriovenous fistula site haemorrhage 16.27 12.83 6 40913 180 50564025
Skin hypertrophy 16.19 12.83 16 40903 3079 50561126
Uterine atony 16.08 12.83 6 40913 186 50564019
Blood test abnormal 15.98 12.83 31 40888 11288 50552917
Serum ferritin abnormal 15.93 12.83 6 40913 191 50564014
Agitation 15.82 12.83 12 40907 53372 50510833
Abortion spontaneous 15.77 12.83 7 40912 41765 50522440
Neutropenia 15.77 12.83 186 40733 147779 50416426
Impaired healing 15.70 12.83 20 40899 69766 50494439
Intermittent claudication 15.66 12.83 12 40907 1643 50562562
Cough 15.42 12.83 123 40796 241141 50323064
Nephrogenic anaemia 15.35 12.83 12 40907 1693 50562512
Arteriovenous fistula occlusion 15.21 12.83 7 40912 372 50563833
Marrow hyperplasia 15.20 12.83 8 40911 569 50563636
Acute myeloid leukaemia 15.18 12.83 36 40883 15038 50549167
Shunt thrombosis 15.11 12.83 4 40915 38 50564167
Osteoarthritis 15.09 12.83 20 40899 68586 50495619
Proteinuria 14.98 12.83 38 40881 16559 50547646
Ischaemic stroke 14.90 12.83 37 40882 15911 50548294
Skin fibrosis 14.75 12.83 9 40910 850 50563355
Flushing 14.27 12.83 20 40899 66995 50497210
Overdose 14.07 12.83 38 40881 99689 50464516
Maternal exposure during pregnancy 14.00 12.83 74 40845 159704 50404501
Vascular shunt 13.97 12.83 3 40916 10 50564195
Cerebrovascular accident 13.87 12.83 127 40792 94553 50469652
Anaphylactic reaction 13.78 12.83 14 40905 54041 50510164
Medication error 13.71 12.83 6 40913 36098 50528107
No adverse event 13.70 12.83 5 40914 33573 50530632
Product quality issue 13.63 12.83 4 40915 30854 50533351
Myalgia 13.63 12.83 53 40866 124266 50439939
Wrong technique in product usage process 13.46 12.83 15 40904 55495 50508710
Mycobacterial peritonitis 13.38 12.83 4 40915 61 50564144
Device related infection 13.34 12.83 42 40877 20693 50543512
Hyperkalaemia 13.17 12.83 75 40844 48014 50516191
Urticaria 13.10 12.83 57 40862 129504 50434701
Renal lymphocele 13.09 12.83 4 40915 66 50564139
Fatigue 13.08 12.83 455 40464 707146 49857059
Hepatotoxicity 13.04 12.83 3 40916 27223 50536982
Upper limb fracture 12.95 12.83 35 40884 15838 50548367

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 12162.71 13.47 6959 37619 335125 29194824
Hospitalisation 4887.36 13.47 2015 42563 43973 29485976
Aplasia pure red cell 1176.78 13.47 404 44174 5087 29524862
Haemodialysis 1033.17 13.47 431 44147 9523 29520426
Investigation 879.60 13.47 214 44364 650 29529299
Arteriovenous fistula site complication 708.77 13.47 157 44421 265 29529684
Transplant 426.19 13.47 115 44463 582 29529367
Dialysis 399.85 13.47 227 44351 9981 29519968
Peritoneal dialysis 262.39 13.47 74 44504 453 29529496
Haemoglobin abnormal 243.35 13.47 111 44467 3050 29526899
Haemoglobin decreased 233.05 13.47 508 44070 107867 29422082
Anti-erythropoietin antibody positive 190.81 13.47 65 44513 795 29529154
Shunt stenosis 189.52 13.47 59 44519 530 29529419
Renal disorder 174.39 13.47 192 44386 22403 29507546
Therapeutic response decreased 172.01 13.47 199 44379 24512 29505437
Terminal state 159.54 13.47 86 44492 3408 29526541
Appendicolith 140.56 13.47 79 44499 3401 29526548
Transfusion 138.49 13.47 103 44475 7195 29522754
Shunt occlusion 126.48 13.47 46 44532 690 29529259
Toxicity to various agents 126.22 13.47 52 44526 173609 29356340
Palliative care 110.70 13.47 37 44541 425 29529524
Renal transplant 109.57 13.47 52 44526 1566 29528383
Arteriovenous fistula operation 102.37 13.47 27 44551 123 29529826
Reticulocyte count decreased 92.81 13.47 34 44544 521 29529428
Drug ineffective 87.45 13.47 270 44308 362900 29167049
Drug interaction 86.76 13.47 102 44476 197283 29332666
Haemoglobin increased 81.39 13.47 52 44526 2834 29527115
Appendicitis 80.86 13.47 82 44496 8697 29521252
Transformation to acute myeloid leukaemia 78.47 13.47 32 44546 663 29529286
Anaemia 74.59 13.47 538 44040 200413 29329536
Myelodysplastic syndrome 73.56 13.47 111 44467 17683 29512266
Product use in unapproved indication 73.51 13.47 20 44558 86855 29443094
Peritonitis 70.78 13.47 99 44479 14725 29515224
Lower respiratory tract infection 69.44 13.47 135 44443 26367 29503582
Neoplasm malignant 66.33 13.47 103 44475 16822 29513127
Hip fracture 63.93 13.47 79 44499 10413 29519536
Product use issue 61.75 13.47 4 44574 51440 29478509
Mineral supplementation 60.82 13.47 16 44562 72 29529877
Living in residential institution 60.20 13.47 21 44557 277 29529672
Headache 59.62 13.47 107 44471 173900 29356049
Nephrogenic systemic fibrosis 56.16 13.47 47 44531 3895 29526054
Azotaemia 54.17 13.47 49 44529 4508 29525441
Chronic kidney disease 51.81 13.47 146 44432 36270 29493679
Arteriovenous fistula site infection 47.81 13.47 13 44565 68 29529881
Arteriovenous fistula thrombosis 46.83 13.47 18 44560 317 29529632
Product storage error 46.49 13.47 53 44525 6417 29523532
Cardiogenic shock 44.59 13.47 93 44485 19097 29510852
Alanine aminotransferase increased 44.24 13.47 26 44552 70918 29459031
Unevaluable event 43.76 13.47 121 44457 29730 29500219
Product dose omission issue 42.05 13.47 50 44528 96333 29433616
Aggression 41.95 13.47 3 44575 35538 29494411
Somnolence 41.79 13.47 48 44530 93907 29436042
Rehabilitation therapy 41.60 13.47 20 44558 620 29529329
Intentional product use issue 41.60 13.47 7 44571 42491 29487458
Angina pectoris 40.93 13.47 113 44465 27737 29502212
Suicidal ideation 40.78 13.47 3 44575 34713 29495236
Arthralgia 39.25 13.47 96 44482 139521 29390428
Overdose 38.59 13.47 38 44540 79781 29450168
Hyperparathyroidism secondary 38.52 13.47 24 44554 1251 29528698
Hyperhidrosis 38.37 13.47 25 44553 64515 29465434
Refractory cytopenia with unilineage dysplasia 38.16 13.47 17 44561 441 29529508
Condition aggravated 37.75 13.47 105 44473 146190 29383759
Depression 37.32 13.47 44 44534 85103 29444846
Zoonotic bacterial infection 37.32 13.47 10 44568 49 29529900
Urinary tract infection 36.77 13.47 210 44368 72144 29457805
Hypervolaemia 36.15 13.47 81 44497 17464 29512485
Weight increased 35.37 13.47 38 44540 76629 29453320
Intermittent claudication 34.68 13.47 27 44551 2018 29527931
Sepsis 34.26 13.47 347 44231 142335 29387614
Joint swelling 34.17 13.47 16 44562 49614 29480335
Ascites 34.08 13.47 127 44451 36492 29493457
Infusion related reaction 33.70 13.47 12 44566 43874 29486075
Normochromic normocytic anaemia 33.37 13.47 34 44544 3624 29526325
Hallucination 33.04 13.47 13 44565 44699 29485250
Home care 32.99 13.47 6 44572 0 29529949
Leg amputation 32.32 13.47 26 44552 2038 29527911
Treatment failure 32.18 13.47 8 44570 36931 29493018
Aspartate aminotransferase increased 31.78 13.47 26 44552 59699 29470250
Erythropoiesis abnormal 31.56 13.47 12 44566 205 29529744
Drug hypersensitivity 31.44 13.47 34 44544 68372 29461577
Dizziness 30.93 13.47 164 44414 189520 29340429
Renal cyst haemorrhage 30.47 13.47 14 44564 391 29529558
Agitation 30.32 13.47 20 44558 51284 29478665
Intraductal papillary mucinous neoplasm 29.55 13.47 13 44565 327 29529622
Stress 29.43 13.47 85 44493 21405 29508544
Hepatic cyst infection 29.07 13.47 7 44571 20 29529929
Rectal prolapse 28.97 13.47 12 44566 259 29529690
Sinusitis 28.86 13.47 8 44570 34342 29495607
Mycobacterium marinum infection 28.15 13.47 12 44566 279 29529670
Reticulocytopenia 27.53 13.47 9 44569 96 29529853
Angiodysplasia 27.27 13.47 14 44564 501 29529448
Tremor 27.18 13.47 43 44535 73495 29456454
Rhabdomyolysis 27.09 13.47 31 44547 60777 29469172
Tachycardia 27.09 13.47 42 44536 72368 29457581
Hepatic enzyme increased 26.36 13.47 9 44569 33790 29496159
Rheumatoid arthritis 26.07 13.47 8 44570 32144 29497805
Catheter removal 25.72 13.47 10 44568 182 29529767
Lactic acidosis 25.49 13.47 7 44571 30240 29499709
Renal artery stenosis 25.12 13.47 22 44556 1939 29528010
Marasmus 24.90 13.47 13 44565 482 29529467
Vena cava injury 24.49 13.47 10 44568 208 29529741
Gangrene 24.48 13.47 31 44547 4187 29525762
Interstitial lung disease 24.05 13.47 31 44547 57687 29472262
SARS-CoV-2 antibody test positive 23.84 13.47 10 44568 223 29529726
Blood iron abnormal 23.65 13.47 7 44571 52 29529897
Parvovirus B19 test positive 23.54 13.47 8 44570 97 29529852
Delayed graft function 23.45 13.47 21 44557 1906 29528043
Chest discomfort 23.26 13.47 21 44557 45962 29483987
Irritability 23.17 13.47 3 44575 22149 29507800
Anxiety 22.95 13.47 60 44518 85305 29444644
Respiratory failure 22.66 13.47 73 44505 97058 29432891
Blood creatine phosphokinase increased 22.49 13.47 17 44561 40627 29489322
Drug-induced liver injury 22.49 13.47 3 44575 21652 29508297
Transferrin saturation increased 22.47 13.47 7 44571 63 29529886
Rash 22.36 13.47 181 44397 189638 29340311
Myalgia 22.30 13.47 49 44529 73970 29455979
Peritoneal catheter insertion 22.00 13.47 4 44574 0 29529949
Anti-erythropoietin antibody 22.00 13.47 4 44574 0 29529949
Pleural effusion 21.83 13.47 184 44394 71724 29458225
Peripheral arterial occlusive disease 21.45 13.47 32 44546 5044 29524905
Cardio-respiratory arrest 21.26 13.47 27 44551 50574 29479375
End stage renal disease 21.24 13.47 40 44538 7624 29522325
Pyrexia 21.11 13.47 306 44272 287316 29242633
Multiple organ dysfunction syndrome 21.05 13.47 165 44413 62951 29466998
Procalcitonin abnormal 21.04 13.47 10 44568 302 29529647
Angioedema 20.89 13.47 11 44567 31904 29498045
Catheter placement 20.88 13.47 13 44565 677 29529272
Cognitive disorder 20.64 13.47 5 44573 23494 29506455
Weight decreased 20.59 13.47 138 44440 150767 29379182
Inappropriate schedule of product administration 20.55 13.47 22 44556 44450 29485499
Non-neutralising antibodies positive 20.52 13.47 7 44571 86 29529863
Asthma 20.26 13.47 13 44565 33836 29496113
Acute respiratory distress syndrome 19.91 13.47 5 44573 22930 29507019
Muscle spasms 19.67 13.47 43 44535 65039 29464910
Renal cyst infection 19.67 13.47 6 44572 50 29529899
Cardiac failure 19.56 13.47 194 44384 79093 29450856
Nausea 19.43 13.47 313 44265 288942 29241007
Hyperparathyroidism 19.26 13.47 15 44563 1122 29528827
Metastatic neoplasm 19.25 13.47 22 44556 2670 29527279
Musculoskeletal stiffness 19.07 13.47 17 44561 37441 29492508
Iron overload 19.05 13.47 15 44563 1140 29528809
Hyperphosphataemia 18.97 13.47 20 44558 2218 29527731
Renal transplant failure 18.93 13.47 14 44564 969 29528980
Skin fibrosis 18.62 13.47 14 44564 993 29528956
Skin induration 18.57 13.47 19 44559 2035 29527914
Febrile neutropenia 18.28 13.47 97 44481 112143 29417806
Pain in extremity 18.23 13.47 95 44483 110338 29419611
Sleep disorder 18.16 13.47 7 44571 24379 29505570
Memory impairment 18.04 13.47 17 44561 36453 29493496
Disturbance in attention 17.97 13.47 5 44573 21419 29508530
Insomnia 17.85 13.47 71 44507 88690 29441259
Toe amputation 17.81 13.47 19 44559 2136 29527813
Arteriovenous fistula occlusion 17.68 13.47 7 44571 134 29529815
Delirium 17.64 13.47 20 44558 39377 29490572
Erectile dysfunction 17.54 13.47 3 44575 18006 29511943
Depressed level of consciousness 17.37 13.47 18 44560 36924 29493025
Blood product transfusion dependent 17.36 13.47 9 44569 329 29529620
Fracture 17.29 13.47 32 44546 6021 29523928
Reticulocyte count abnormal 17 13.47 4 44574 10 29529939
Visual impairment 16.99 13.47 12 44566 29696 29500253
Serotonin syndrome 16.88 13.47 3 44575 17509 29512440
Dyspnoea 16.85 13.47 370 44208 326362 29203587
Benign neoplasm 16.82 13.47 7 44571 153 29529796
Pneumonia 16.65 13.47 614 43964 319558 29210391
Cardiac valve disease 16.64 13.47 21 44557 2827 29527122
Electrocardiogram QT prolonged 16.55 13.47 18 44560 36119 29493830
Oedema due to renal disease 16.50 13.47 3 44575 0 29529949
Inadequate osteointegration 16.47 13.47 4 44574 12 29529937
Vision blurred 16.30 13.47 22 44556 40154 29489795
Abdominal pain upper 16.29 13.47 43 44535 60950 29468999
Fall 16.20 13.47 365 44213 176813 29353136
Coronary artery disease 16.17 13.47 26 44552 44164 29485785
Arteriovenous fistula site haemorrhage 16.03 13.47 6 44572 98 29529851
Abdominal discomfort 15.88 13.47 30 44548 47873 29482076
Heart rate decreased 15.70 13.47 9 44569 24903 29505046
Skin tightness 15.68 13.47 17 44561 1947 29528002
Coma 15.60 13.47 22 44556 39428 29490521
Depressed mood 15.46 13.47 3 44575 16445 29513504
Blood bilirubin increased 15.40 13.47 17 44561 33876 29496073
Hepatotoxicity 15.31 13.47 4 44574 17863 29512086
Mucosal inflammation 15.31 13.47 15 44563 31580 29498369
Serum ferritin increased 15.28 13.47 29 44549 5559 29524390
Haematochezia 15.26 13.47 20 44558 36963 29492986
Encephalomalacia 15.12 13.47 11 44567 742 29529207
Abnormal behaviour 15.09 13.47 8 44570 23119 29506830
Dry mouth 15.02 13.47 7 44571 21777 29508172
Anti-erythropoietin antibody negative 14.96 13.47 7 44571 204 29529745
Heart valve operation 14.84 13.47 5 44573 59 29529890
Hypoaesthesia 14.81 13.47 37 44541 53430 29476519
Blood potassium increased 14.63 13.47 52 44526 14599 29515350
Dysgeusia 14.57 13.47 8 44570 22666 29507283
Enterocolitis viral 14.54 13.47 5 44573 63 29529886
Skin hypertrophy 14.48 13.47 18 44560 2385 29527564
Hepatic function abnormal 14.46 13.47 23 44555 39236 29490713
Arteriovenous graft thrombosis 14.42 13.47 3 44575 3 29529946
Dental restoration failure 14.25 13.47 4 44574 24 29529925
Abdominal distension 14.20 13.47 118 44460 45793 29484156
Acute kidney injury 14.06 13.47 299 44279 264968 29264981
Diabetic complication 14.03 13.47 10 44568 653 29529296
Dialysis device insertion 13.98 13.47 4 44574 26 29529923
Hepatitis 13.84 13.47 7 44571 20776 29509173
Seizure 13.79 13.47 83 44495 93040 29436909
Fatigue 13.79 13.47 368 44210 316453 29213496
Wheezing 13.69 13.47 18 44560 33222 29496727
Kidney infection 13.68 13.47 25 44553 4658 29525291
Gallbladder disorder 13.68 13.47 28 44550 5672 29524277
Abdominal wall haemorrhage 13.67 13.47 7 44571 249 29529700
Malignant neoplasm progression 13.66 13.47 61 44517 73798 29456151
Loss of personal independence in daily activities 13.62 13.47 11 44567 25429 29504520
Bradycardia 13.51 13.47 52 44526 65577 29464372

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 16628.62 12.50 8271 53052 474434 63962975
Hospitalisation 6291.10 12.50 2440 58883 72767 64364642
Investigation 2084.10 12.50 473 60850 1779 64435630
Aplasia pure red cell 1453.60 12.50 450 60873 6564 64430845
Arteriovenous fistula site complication 1194.67 12.50 255 61068 661 64436748
Haemodialysis 947.57 12.50 415 60908 16662 64420747
Dialysis 460.66 12.50 253 61070 16667 64420742
Transplant 432.74 12.50 111 61212 767 64436642
Shunt stenosis 392.56 12.50 107 61216 960 64436449
Haemoglobin abnormal 359.32 12.50 154 61169 5850 64431559
Haemoglobin decreased 339.88 12.50 640 60683 194423 64242986
Shunt occlusion 289.36 12.50 87 61236 1140 64436269
Peritoneal dialysis 245.05 12.50 68 61255 656 64436753
Terminal state 208.13 12.50 96 61227 4348 64433061
Drug ineffective 202.20 12.50 305 61018 839942 63597467
Renal transplant 186.94 12.50 73 61250 2175 64435234
Appendicolith 175.26 12.50 79 61244 3390 64434019
Completed suicide 170.08 12.50 11 61312 224403 64213006
Headache 159.82 12.50 161 61162 529306 63908103
Anti-erythropoietin antibody positive 158.66 12.50 48 61275 643 64436766
Transfusion 156.97 12.50 133 61190 17861 64419548
Anaemia 148.58 12.50 732 60591 377948 64059461
Toxicity to various agents 141.94 12.50 85 61238 363428 64073981
Renal disorder 139.27 12.50 170 61153 35195 64402214
Transformation to acute myeloid leukaemia 136.14 12.50 45 61278 816 64436593
Arteriovenous fistula operation 127.12 12.50 35 61288 327 64437082
Arthralgia 118.55 12.50 148 61175 442112 63995297
Azotaemia 118.15 12.50 79 61244 7423 64429986
Joint swelling 115.50 12.50 31 61292 215351 64222058
Rheumatoid arthritis 108.60 12.50 14 61309 164280 64273129
Drug intolerance 102.80 12.50 26 61297 187966 64249443
Product use issue 102.55 12.50 12 61311 151703 64285706
Drug hypersensitivity 100.91 12.50 50 61273 237765 64199644
Myelodysplastic syndrome 94.96 12.50 124 61199 27455 64409954
Cardiac failure 93.78 12.50 308 61015 132065 64305344
Infusion related reaction 93.36 12.50 21 61302 164446 64272963
Chronic kidney disease 93.18 12.50 184 61139 57735 64379674
Nephrogenic systemic fibrosis 92.68 12.50 62 61261 5830 64431579
Appendicitis 90.09 12.50 86 61237 13483 64423926
Contraindicated product administered 89.01 12.50 3 61320 107826 64329583
Condition aggravated 86.44 12.50 138 61185 372288 64065121
Sepsis 84.99 12.50 438 60885 229903 64207506
Rehabilitation therapy 84.95 12.50 37 61286 1461 64435948
Haemoglobin increased 84.88 12.50 56 61267 5145 64432264
Peritonitis 80.75 12.50 109 61214 24914 64412495
Renal impairment 80.73 12.50 297 61026 134720 64302689
Sinusitis 80.12 12.50 20 61303 145908 64291501
Pain 78.64 12.50 267 61056 553244 63884165
End stage renal disease 78.45 12.50 71 61252 10404 64427005
Mineral supplementation 77.82 12.50 29 61294 758 64436651
Angina pectoris 74.67 12.50 145 61178 44936 64392473
Alopecia 74.66 12.50 32 61291 165658 64271751
Hip fracture 74.04 12.50 109 61214 26990 64410419
Neoplasm malignant 71.38 12.50 102 61221 24586 64412823
Palliative care 70.48 12.50 26 61297 660 64436749
Arteriovenous fistula site infection 70.45 12.50 19 61304 163 64437246
Hepatic enzyme increased 69.06 12.50 19 61304 129924 64307485
Weight increased 68.71 12.50 61 61262 213287 64224122
Arthropathy 67.53 12.50 16 61307 120951 64316458
Therapeutic response decreased 66.75 12.50 151 61172 52037 64385372
Drug interaction 65.87 12.50 155 61168 361928 64075481
Hypervolaemia 64.45 12.50 124 61199 38161 64399248
Somnolence 62.31 12.50 61 61262 203584 64233825
Reticulocyte count decreased 62.09 12.50 24 61299 695 64436714
Marasmus 61.10 12.50 25 61298 843 64436566
Intermittent claudication 60.08 12.50 37 61286 3017 64434392
Hypersensitivity 59.92 12.50 59 61264 196393 64241016
Refractory cytopenia with unilineage dysplasia 58.47 12.50 24 61299 816 64436593
Hepatic cyst infection 58.25 12.50 16 61307 148 64437261
Arteriovenous fistula thrombosis 57.87 12.50 21 61302 508 64436901
Abdominal discomfort 56.48 12.50 54 61269 182268 64255141
Product use in unapproved indication 56.26 12.50 51 61272 176567 64260842
Suicide attempt 55.20 12.50 3 61320 71004 64366405
Systemic lupus erythematosus 52.77 12.50 6 61317 77606 64359803
Suicidal ideation 51.15 12.50 3 61320 66539 64370870
Dizziness 50.41 12.50 224 61099 429939 64007470
Treatment failure 50.36 12.50 24 61299 116792 64320617
Renal failure 50.21 12.50 320 61003 181368 64256041
Pneumonia 50.19 12.50 778 60545 558798 63878611
Peripheral swelling 49.88 12.50 76 61247 209077 64228332
Depression 49.34 12.50 61 61262 183230 64254179
Hyperparathyroidism secondary 47.81 12.50 29 61294 2301 64435108
Intentional product use issue 46.96 12.50 16 61307 95348 64342061
Renal cyst infection 46.66 12.50 14 61309 182 64437227
Musculoskeletal stiffness 46.34 12.50 30 61293 123176 64314233
Renal cyst haemorrhage 45.59 12.50 17 61306 445 64436964
Anxiety 45.16 12.50 77 61246 202572 64234837
Anti-erythropoietin antibody negative 45.07 12.50 15 61308 278 64437131
Living in residential institution 44.67 12.50 18 61305 583 64436826
Unevaluable event 44.62 12.50 127 61196 50362 64387047
Ascites 44.52 12.50 145 61178 61856 64375553
Nausea 44.41 12.50 506 60817 785294 63652115
Reticulocyte count abnormal 44.35 12.50 11 61312 65 64437344
Glossodynia 43.99 12.50 5 61318 64691 64372718
Peripheral arterial occlusive disease 43.96 12.50 43 61280 6944 64430465
Rash 43.41 12.50 257 61066 458292 63979117
Injection site erythema 42.30 12.50 8 61315 70792 64366617
Leg amputation 42.10 12.50 31 61292 3396 64434013
Cardiogenic shock 41.65 12.50 94 61229 32333 64405076
Nasopharyngitis 41.43 12.50 77 61246 195996 64241413
Product storage error 41.43 12.50 57 61266 13261 64424148
Pleural effusion 40.74 12.50 232 61091 126327 64311082
Zoonotic bacterial infection 40.48 12.50 10 61313 58 64437351
Hyperphosphataemia 40.10 12.50 32 61291 3949 64433460
Iron overload 38.79 12.50 22 61301 1540 64435869
Fracture 38.22 12.50 66 61257 18689 64418720
Renal artery stenosis 36.80 12.50 27 61296 2942 64434467
Asthma 36.06 12.50 23 61300 95202 64342207
Plasma cell myeloma 36.05 12.50 111 61212 45964 64391445
Alanine aminotransferase increased 34.62 12.50 49 61274 138982 64298427
Overdose 34.30 12.50 62 61261 159504 64277905
Fatigue 34.18 12.50 504 60819 748226 63689183
Thrombocytopenia 34.17 12.50 344 60979 223457 64213952
Product dose omission issue 34.06 12.50 85 61238 194662 64242747
Multiple organ dysfunction syndrome 34.02 12.50 188 61135 101225 64336184
Hypoaesthesia 33.68 12.50 50 61273 139058 64298351
Pain in extremity 33.57 12.50 161 61162 302924 64134485
Memory impairment 33.41 12.50 20 61303 85662 64351747
Mycobacterium marinum infection 33.20 12.50 13 61310 390 64437019
Therapeutic product effect incomplete 32.79 12.50 30 61293 103452 64333957
Renal transplant failure 32.59 12.50 20 61303 1620 64435789
Hyperhidrosis 32.13 12.50 43 61280 124877 64312532
Arthritis 32.07 12.50 20 61303 83794 64353615
Cardiac output decreased 31.89 12.50 20 61303 1684 64435725
Cough 31.46 12.50 164 61159 301984 64135425
Blood cholesterol increased 31.35 12.50 5 61318 50061 64387348
Hyperparathyroidism 31.05 12.50 24 61299 2828 64434581
Visual impairment 30.74 12.50 16 61307 74061 64363348
Skin induration 30.67 12.50 28 61295 4147 64433262
Diabetic complication 30.67 12.50 17 61306 1138 64436271
Migraine 30.03 12.50 11 61312 62666 64374743
Transferrin saturation increased 29.78 12.50 9 61314 120 64437289
Delayed graft function 29.72 12.50 24 61299 3012 64434397
Arteriovenous fistula occlusion 29.32 12.50 13 61310 536 64436873
Shunt infection 29.12 12.50 9 61314 130 64437279
Swelling 28.74 12.50 69 61254 160149 64277260
Skin hypertrophy 28.73 12.50 28 61295 4501 64432908
Erythropoiesis abnormal 28.70 12.50 12 61311 428 64436981
Arteriovenous fistula site haemorrhage 28.54 12.50 11 61312 316 64437093
Vena cava injury 28.45 12.50 10 61313 220 64437189
Gangrene 28.43 12.50 35 61288 7303 64430106
Cardiac failure congestive 28.39 12.50 217 61106 130363 64307046
Intraductal papillary mucinous neoplasm 28.28 12.50 13 61310 584 64436825
Insomnia 28.27 12.50 95 61228 197741 64239668
Pericarditis 28.26 12.50 12 61311 62504 64374905
Loss of personal independence in daily activities 28.12 12.50 17 61306 72437 64364972
Sleep disorder 27.73 12.50 11 61312 59698 64377711
SARS-CoV-2 antibody test positive 27.67 12.50 10 61313 239 64437170
Discomfort 27.39 12.50 22 61301 80856 64356553
Cardiac valve disease 27.28 12.50 29 61294 5166 64432243
Blood parathyroid hormone increased 26.99 12.50 23 61300 3111 64434298
Hallucination 26.99 12.50 18 61305 72770 64364639
Serotonin syndrome 26.79 12.50 3 61320 39279 64398130
Agitation 26.39 12.50 27 61296 88340 64349069
Tachycardia 26.37 12.50 65 61258 149514 64287895
Sedation 26.28 12.50 4 61319 41458 64395951
Depressed mood 25.89 12.50 4 61319 41008 64396401
Myalgia 25.63 12.50 72 61251 158545 64278864
Therapeutic product effect decreased 25.52 12.50 44 61279 115307 64322102
Procalcitonin abnormal 25.38 12.50 10 61313 305 64437104
Flushing 24.68 12.50 23 61300 78625 64358784
Anti-erythropoietin antibody 24.31 12.50 5 61318 10 64437399
Iron deficiency 24.28 12.50 32 61291 7145 64430264
Angiodysplasia 24.23 12.50 13 61310 816 64436593
Injection site swelling 24.02 12.50 5 61318 41348 64396061
Home care 23.84 12.50 4 61319 0 64437409
Gait disturbance 23.70 12.50 84 61239 172071 64265338
Oropharyngeal pain 23.45 12.50 30 61293 88837 64348572
Nasal congestion 23.15 12.50 14 61309 59644 64377765
Duodenal ulcer perforation 22.74 12.50 3 61320 34622 64402787
Tremor 22.70 12.50 69 61254 148161 64289248
Blood erythropoietin increased 22.64 12.50 5 61318 16 64437393
Blood potassium increased 22.61 12.50 65 61258 25915 64411494
Psoriasis 22.46 12.50 21 61302 71682 64365727
Dry mouth 22.32 12.50 15 61308 60403 64377006
Haemodialysis complication 22.21 12.50 9 61314 296 64437113
Skin fibrosis 22.10 12.50 15 61308 1444 64435965
Gastrointestinal disorder 21.94 12.50 32 61291 89677 64347732
Metastatic neoplasm 21.93 12.50 24 61299 4418 64432991
Premature delivery 21.80 12.50 52 61271 18537 64418872
Osteoarthritis 21.73 12.50 17 61306 63319 64374090
Coma 21.68 12.50 31 61292 87584 64349825
Serum ferritin increased 21.61 12.50 33 61290 8435 64428974
Weight decreased 21.59 12.50 171 61152 285568 64151841
Skin tightness 21.41 12.50 25 61298 4936 64432473
Peritonitis bacterial 21.35 12.50 34 61289 9009 64428400
Feeling abnormal 21.32 12.50 61 61262 133541 64303868
Heart rate decreased 21.26 12.50 13 61310 55054 64382355
Abdominal pain upper 21.14 12.50 90 61233 174940 64262469
Cardiac disorder 21.13 12.50 107 61216 55709 64381700
Injection site pruritus 21.11 12.50 5 61318 37821 64399588
Hepatotoxicity 20.93 12.50 6 61317 39956 64397453
Haemorrhage 20.81 12.50 138 61185 79213 64358196
Irritable bowel syndrome 20.73 12.50 5 61318 37364 64400045
Irritability 20.22 12.50 5 61318 36741 64400668
Hepatitis 20.20 12.50 9 61314 45573 64391836
Serum ferritin abnormal 20.03 12.50 9 61314 383 64437026
Neutralising antibodies positive 19.86 12.50 8 61315 259 64437150
Dysgeusia 19.76 12.50 10 61313 47037 64390372
Balance disorder 19.50 12.50 31 61292 83895 64353514
Fibromyalgia 19.40 12.50 5 61318 35726 64401683
Lactic acidosis 19.22 12.50 18 61305 61392 64376017
Toe amputation 19.20 12.50 20 61303 3480 64433929
Injection site pain 19.18 12.50 49 61274 111359 64326050
Ischaemic stroke 19.15 12.50 66 61257 28969 64408440
Stomatitis 19.03 12.50 48 61275 109557 64327852
Wound 18.98 12.50 27 61296 76450 64360959
Urticaria 18.89 12.50 74 61249 147243 64290166
Aspartate aminotransferase increased 18.88 12.50 55 61268 119733 64317676
Haemolysis 18.87 12.50 36 61287 11003 64426406
Drug-induced liver injury 18.74 12.50 11 61312 47632 64389777
Product quality issue 18.60 12.50 3 61320 29796 64407613
Vision blurred 18.59 12.50 36 61287 90280 64347129
Psychotic disorder 18.47 12.50 5 61318 34573 64402836
Normochromic normocytic anaemia 18.40 12.50 27 61296 6663 64430746
Inadequate osteointegration 18.30 12.50 4 61319 12 64437397
Lymphocele 18.28 12.50 14 61309 1627 64435782
Complications of transplanted kidney 18.03 12.50 24 61299 5411 64431998
Volume blood increased 17.88 12.50 3 61320 0 64437409
Cytomegalovirus pancreatitis 17.88 12.50 3 61320 0 64437409
Fungal endocarditis 17.88 12.50 9 61314 495 64436914
Blister 17.80 12.50 31 61292 80936 64356473
Abnormal behaviour 17.70 12.50 5 61318 33617 64403792
Blood product transfusion dependent 17.68 12.50 8 61315 346 64437063
Parakeratosis 17.66 12.50 8 61315 347 64437062
Eye infection bacterial 17.60 12.50 7 61316 219 64437190
Drug ineffective for unapproved indication 17.60 12.50 4 61319 31129 64406280
Liver function test increased 17.47 12.50 4 61319 30966 64406443
Haematocrit decreased 17.45 12.50 100 61223 54555 64382854
Gastroenteritis 17.43 12.50 65 61258 29646 64407763
Natural killer cell count 17.41 12.50 4 61319 16 64437393
Shunt malfunction 17.37 12.50 7 61316 227 64437182
Feeling hot 17.32 12.50 11 61312 45652 64391757
Anaphylactic reaction 17.28 12.50 24 61299 68640 64368769
Angioedema 17.23 12.50 20 61303 61801 64375608
Amegakaryocytic thrombocytopenia 17.22 12.50 4 61319 17 64437392
Hypocalcaemia 17.20 12.50 82 61241 41671 64395738
Dialysis device insertion 17.18 12.50 5 61318 58 64437351
Influenza like illness 17.15 12.50 20 61303 61682 64375727
Rhinorrhoea 17.15 12.50 19 61304 59950 64377459
Hyperuricaemia 17.14 12.50 33 61290 10158 64427251
Throat irritation 16.97 12.50 5 61318 32706 64404703
Maternal condition affecting foetus 16.82 12.50 6 61317 138 64437271
Folliculitis 16.73 12.50 4 61319 30073 64407336
Hyperkalaemia 16.66 12.50 158 61165 100971 64336438
Acute leukaemia 16.43 12.50 13 61310 1585 64435824
Sopor 16.39 12.50 4 61319 29657 64407752
Gastrointestinal haemorrhage 16.31 12.50 195 61128 132117 64305292
Kidney transplant rejection 16.24 12.50 31 61292 9480 64427929
Upper respiratory tract inflammation 16.23 12.50 19 61304 3763 64433646
Gastric cancer 16.14 12.50 25 61298 6468 64430941
Interstitial lung disease 16.05 12.50 44 61279 97688 64339721
Blood test abnormal 16.04 12.50 37 61286 12906 64424503
Encephalomalacia 16.01 12.50 11 61312 1080 64436329
Diabetic gangrene 15.92 12.50 6 61317 162 64437247
Haematochezia 15.92 12.50 24 61299 66349 64371060
Upper respiratory tract infection 15.88 12.50 28 61295 72757 64364652
Dry eye 15.87 12.50 4 61319 29015 64408394
PO2 decreased 15.78 12.50 16 61307 2697 64434712
Uterine atony 15.68 12.50 6 61317 169 64437240
Dyskinesia 15.62 12.50 9 61314 39379 64398030
Myelodysplastic syndrome transformation 15.61 12.50 9 61314 650 64436759
Disturbance in attention 15.44 12.50 10 61313 41064 64396345
Lung neoplasm malignant 15.24 12.50 50 61273 21398 64416011
Electrocardiogram QT prolonged 15.22 12.50 33 61290 79415 64357994
Reticulocytopenia 15.14 12.50 6 61317 186 64437223
Chest discomfort 15.09 12.50 58 61265 116048 64321361
Muscle spasms 14.96 12.50 76 61247 140947 64296462
Oxygen saturation decreased 14.94 12.50 52 61271 107124 64330285
PCO2 decreased 14.88 12.50 16 61307 2886 64434523
Retinal artery occlusion 14.88 12.50 16 61307 2887 64434522
Injection site bruising 14.88 12.50 8 61315 36365 64401044
Nephrogenic anaemia 14.76 12.50 17 61306 3308 64434101
Coombs test positive 14.67 12.50 6 61317 202 64437207
Peritoneal dialysis complication 14.56 12.50 14 61309 2214 64435195
Urine odour abnormal 14.52 12.50 21 61302 5115 64432294
Aneurysm 14.44 12.50 16 61307 2986 64434423
Abdominal distension 14.36 12.50 147 61176 95847 64341562
Dialysis related complication 14.32 12.50 6 61317 215 64437194
Exposure during pregnancy 14.28 12.50 33 61290 77642 64359767
General physical health deterioration 14.17 12.50 273 61050 204152 64233257
Cognitive disorder 14.12 12.50 19 61304 55068 64382341
Joint contracture 14.08 12.50 14 61309 2305 64435104
Product prescribing error 14.07 12.50 8 61315 35261 64402148
Renal lymphocele 13.98 12.50 5 61318 116 64437293
Hot flush 13.95 12.50 14 61309 46221 64391188
Ventricular fibrillation 13.83 12.50 52 61271 23808 64413601
Shunt thrombosis 13.82 12.50 5 61318 120 64437289
Cardiac arrest 13.64 12.50 214 61109 153850 64283559
Acute myeloid leukaemia 13.62 12.50 57 61266 27406 64410003
Extramedullary haemopoiesis 13.55 12.50 5 61318 127 64437282
Rectal prolapse 13.52 12.50 12 61311 1714 64435695
Abdominal wall haemorrhage 13.37 12.50 7 61316 418 64436991
Back pain 13.30 12.50 163 61160 250008 64187401
Thrombosis in device 13.28 12.50 20 61303 5051 64432358
Ear infection 13.24 12.50 3 61320 23401 64414008
Infective aneurysm 13.24 12.50 9 61314 869 64436540
Palpitations 13.06 12.50 53 61270 104435 64332974
Medication error 13.04 12.50 17 61306 49949 64387460
Delirium 13.04 12.50 29 61294 69165 64368244
Heart rate increased 13.01 12.50 49 61274 98626 64338783
Pulmonary arterial hypertension 12.94 12.50 4 61319 25363 64412046
Colitis ulcerative 12.93 12.50 3 61320 23025 64414384
Benign neoplasm 12.93 12.50 9 61314 903 64436506
Disease complication 12.92 12.50 18 61305 4237 64433172
Abortion spontaneous 12.76 12.50 4 61319 25139 64412270
Inappropriate schedule of product administration 12.71 12.50 45 61278 92241 64345168
Dyspnoea 12.60 12.50 557 60766 718117 63719292
Red blood cell sedimentation rate increased 12.59 12.50 7 61316 31228 64406181
Coronary artery disease 12.52 12.50 24 61299 60409 64377000
Device related infection 12.51 12.50 60 61263 30566 64406843

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
385608005 SNOMEDCT_US
385610007 SNOMEDCT_US
009195 NDDF

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
ARANESP HUMAN PRESCRIPTION DRUG LABEL 1 55513-002 SOLUTION 25 ug INTRAVENOUS BLA 29 sections
ARANESP HUMAN PRESCRIPTION DRUG LABEL 1 55513-003 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 55513-005 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 55513-021 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 55513-025 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 55513-028 INJECTION, SOLUTION 200 ug INTRAVENOUS BLA 29 sections
ARANESP HUMAN PRESCRIPTION DRUG LABEL 1 55513-032 INJECTION, SOLUTION 500 ug INTRAVENOUS BLA 29 sections
ARANESP HUMAN PRESCRIPTION DRUG LABEL 1 55513-057 INJECTION, SOLUTION 25 ug INTRAVENOUS BLA 29 sections
ARANESP HUMAN PRESCRIPTION DRUG LABEL 1 55513-098 INJECTION, SOLUTION 10 ug INTRAVENOUS BLA 29 sections
ARANESP HUMAN PRESCRIPTION DRUG LABEL 1 55513-110 SOLUTION 300 ug INTRAVENOUS BLA 29 sections
ARANESP HUMAN PRESCRIPTION DRUG LABEL 1 55513-111 INJECTION, SOLUTION 300 ug INTRAVENOUS BLA 29 sections