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

Stem definitionDrug idCAS RN
pituitary hormone-release stimulating peptides 1559 53714-56-0

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • leuprorelin
  • leuprolide acetate
  • eligard
  • leupline
  • leuprolide
  • leuprorelin acetate
  • leuprorelin mesilate
A potent synthetic long-acting agonist of GONADOTROPIN-RELEASING HORMONE that regulates the synthesis and release of pituitary gonadotropins, LUTEINIZING HORMONE and FOLLICLE STIMULATING HORMONE.
  • Molecular weight: 1209.42
  • Formula: C59H84N16O12
  • CLOGP: -3.18
  • LIPINSKI: 3
  • HAC: 28
  • HDO: 16
  • TPSA: 429.04
  • ALOGS: -4.55
  • ROTB: 32
  • Status: OFP
    • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

DoseUnitRoute
60 mcg implant
1 mg P
0.13 mg P

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 1 Benet LZ, Broccatelli F, Oprea TI
S (Water solubility) 66.66 mg/mL Bocci G, Oprea TI, Benet LZ
EoM (Fraction excreted unchanged in urine) 2 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 0.01 µM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
Vd (Volume of distribution) 0.38 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 2 mL/min/kg Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma) 0.54 % Lombardo F, Berellini G, Obach RS
t_half (Half-life) 2.90 hours Lombardo F, Berellini G, Obach RS

Predicted pharmacokinetic/toxicological properties (PK-AZ):

PropertyDescriptionValueUnitConfidenceSimilarity
azlogd74 LogD at pH 7.4 -0.169 Moderate 0.67
caco2-efflux Caco-2 efflux ratio (BA/AB) 0.923 Moderate 0.67
caco2-intrinsic-papp Caco-2 intrinsic apparent permeability 0.243 10^-6 cm/s Moderate 0.67
dh-clint Dog hepatocyte intrinsic clearance 1.637 uL/min/10^6 cells Moderate 0.67
dppb Dog plasma protein binding (% unbound) 43.590 % Moderate 0.67
fcs-ppb Fetal calf serum protein binding (% unbound) 37.110 % Moderate 0.67
herg hERG pIC50 4.247 pIC50 Moderate 0.67
hh-clint Human hepatocyte intrinsic clearance 15.631 uL/min/10^6 cells Moderate 0.67
hlm-clint Human liver microsomal intrinsic clearance 13.900 uL/min/mg protein Moderate 0.67
hppb Human plasma protein binding (% unbound) 51.380 % Moderate 0.67
kinase-safety-class ACVR2B,AXL,BRAF,CAMK2D,CDK5,CDK9,EIF2AK3,ERBB2,GRK2,ITK,MAPK7,NTRK2,PDK1,PDK2,PDK4,PIK3CA,PRKDC,TEK,TGFBR1 19
kinase-selectivity-class PDK1 1
mdck-mdr1-efflux MDCK-MDR1 efflux ratio 0.514 Moderate 0.67
mh-clint Mouse hepatocyte intrinsic clearance 21.727 Moderate 0.67
mppb Mouse plasma protein binding (% unbound) 35.040 Moderate 0.67
nih-mdck-mdr1-efflux NIH MDCK-MDR1 efflux ratio 0.845 Moderate 0.67
pfas-class PFAS structural alert (1 = True, 0 = False) 0
pppb Pig plasma protein binding (% unbound) 44.040 % Moderate 0.67
rh-clint Rat hepatocyte intrinsic clearance 17.022 uL/min/10^6 cells Moderate 0.67
rh-fuinc Rat hepatocyte fraction unbound in incubation 31.620 % Moderate 0.67
rppb Rat plasma protein binding (% unbound) 29.610 % Moderate 0.67
solubility-dd Solubility at pH 7.4 in DMSO 216.272 uM Moderate 0.67

Approvals:

DateAgencyCompanyOrphan
April 9, 1985 FDA
May 24, 2022 EMA ACCORD HEALTHCARE S.L.U.

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
Intercepted product preparation error 2404.12 16.83 384 18345 936 90608782
Syringe issue 1620.11 16.83 325 18404 3677 90606041
Device leakage 1208.08 16.83 302 18427 9689 90600029
Hot flush 793.94 16.83 337 18392 59151 90550567
Occupational exposure to product 560.49 16.83 125 18604 2406 90607312
Off label use 557.09 16.83 886 17843 1101366 89508352
Ovarian hyperstimulation syndrome 382.97 16.83 109 18620 5753 90603965
Pelvic pain 378.70 16.83 136 18593 15221 90594497
Injection site abscess 328.42 16.83 73 18656 1381 90608337
Vaginal haemorrhage 313.03 16.83 145 18584 31126 90578592
Wrong technique in product usage process 282.83 16.83 179 18550 71392 90538326
Heavy menstrual bleeding 223.66 16.83 101 18628 20429 90589289
Injury associated with device 221.16 16.83 67 18662 4397 90605321
Abscess sterile 183.90 16.83 27 18702 26 90609692
Product physical consistency issue 162.17 16.83 38 18691 916 90608802
Hysterectomy 148.80 16.83 64 18665 11520 90598198
Intermenstrual bleeding 142.09 16.83 58 18671 9165 90600553
Injection site abscess sterile 134.85 16.83 19 18710 9 90609709
Mood swings 130.04 16.83 70 18659 20632 90589086
Injection site pain 127.64 16.83 168 18561 173531 90436187
Oestradiol increased 123.21 16.83 21 18708 85 90609633
Product packaging quantity issue 101.06 16.83 29 18700 1573 90608145
Device occlusion 98.96 16.83 45 18684 9237 90600481
Menstrual disorder 89.11 16.83 37 18692 6101 90603617
Uterine leiomyoma 86.24 16.83 43 18686 10821 90598897
Uterine haemorrhage 83.99 16.83 33 18696 4719 90604999
Haemorrhage 82.55 16.83 86 18643 69283 90540435
Injection site mass 81.58 16.83 53 18676 22037 90587681
Blood luteinising hormone increased 79.79 16.83 15 18714 116 90609602
Blood oestrogen increased 77.51 16.83 16 18713 209 90609509
Epiphysiolysis 77.43 16.83 13 18716 47 90609671
Ovarian cyst 75.09 16.83 46 18683 17272 90592446
Injection site discharge 72.81 16.83 22 18707 1429 90608289
Dysmenorrhoea 70.66 16.83 29 18700 4643 90605075
Joint swelling 66.32 16.83 12 18717 503288 90106430
Amenorrhoea 66.32 16.83 37 18692 11685 90598033
Aplastic anaemia 64.67 16.83 38 18691 13231 90596487
Product administration error 64.03 16.83 49 18680 26374 90583344
Malignant neoplasm progression 60.06 16.83 91 18638 106779 90502939
Intercepted product administration error 59.99 16.83 17 18712 881 90608837
Rheumatoid arthritis 59.35 16.83 4 18725 362610 90247108
Infusion related reaction 59.28 16.83 8 18721 416772 90192946
Injection site erythema 58.39 16.83 86 18643 98416 90511302
Metastases to liver 58.19 16.83 48 18681 28759 90580959
Anger 55.83 16.83 35 18694 13685 90596033
Surgery 54.02 16.83 56 18673 44831 90564887
Suicidal ideation 53.49 16.83 71 18658 73784 90535934
Pneumonia 53.41 16.83 33 18696 638026 89971692
Fall 50.96 16.83 18 18711 481792 90127926
Neoplasm progression 50.85 16.83 54 18675 44432 90565286
Blood follicle stimulating hormone increased 50.52 16.83 11 18718 188 90609530
Metastases to bone 50.48 16.83 42 18687 25463 90584255
Product dispensing error 49.16 16.83 31 18698 12242 90597476
Contraindicated product administered 48.35 16.83 5 18724 320134 90289584
Breast cancer metastatic 47.91 16.83 33 18696 15099 90594619
Wound 47.70 16.83 4 18725 302976 90306742
Abdominal discomfort 45.32 16.83 21 18708 477307 90132411
Breast enlargement 44.96 16.83 16 18713 1739 90607979
Blood luteinising hormone abnormal 44.91 16.83 6 18723 0 90609718
Portal hypertension 44.52 16.83 21 18708 4680 90605038
Focal nodular hyperplasia 44.37 16.83 13 18716 759 90608959
Vulvovaginal dryness 44.20 16.83 19 18710 3412 90606306
Pericarditis 44.13 16.83 3 18726 270148 90339570
Endometrial stromal sarcoma 44.07 16.83 7 18722 16 90609702
Genital haemorrhage 42.61 16.83 25 18704 8677 90601041
Endometriosis 41.68 16.83 22 18707 6226 90603492
Hepatic cytolysis 41.64 16.83 41 18688 30875 90578843
Product administered by wrong person 41.57 16.83 8 18721 71 90609647
Leiomyosarcoma recurrent 40.27 16.83 6 18723 7 90609711
Arthropathy 39.89 16.83 13 18716 366229 90243489
Confusional state 39.85 16.83 15 18714 386190 90223528
Adnexal torsion 39.74 16.83 11 18718 523 90609195
Sinusitis 39.50 16.83 11 18718 343077 90266641
Injection site swelling 39.50 16.83 55 18674 59784 90549934
Infection 39.18 16.83 13 18716 362081 90247637
Abdominal pain 38.63 16.83 173 18556 395548 90214170
Drug intolerance 36.24 16.83 24 18705 447567 90162151
Adnexa uteri pain 36.05 16.83 10 18719 479 90609239
Injection site induration 35.93 16.83 24 18705 10444 90599274
Toxicity to various agents 35.51 16.83 8 18721 287838 90321880
Nasopharyngitis 34.09 16.83 21 18708 407083 90202635
Blood follicle stimulating hormone abnormal 33.96 16.83 5 18724 5 90609713
Depression 33.62 16.83 137 18592 300464 90309254
Drug hypersensitivity 33.49 16.83 28 18701 463581 90146137
Injection site inflammation 33.19 16.83 17 18712 4524 90605194
General physical health deterioration 33.11 16.83 16 18713 355099 90254619
Premature menarche 32.65 16.83 5 18724 8 90609710
Ovarian cyst ruptured 32.57 16.83 12 18717 1440 90608278
Blister 31.62 16.83 7 18722 254991 90354727
Meningioma 31.42 16.83 17 18712 5054 90604664
Menstruation irregular 31.39 16.83 20 18709 8040 90601678
Hypertransaminasaemia 31.19 16.83 26 18703 15799 90593919
Pituitary apoplexy 30.88 16.83 7 18722 145 90609573
Injection site nodule 30.55 16.83 16 18713 4457 90605261
Maternal exposure before pregnancy 29.84 16.83 22 18707 11191 90598527
Wrong product administered 29.80 16.83 19 18710 7646 90602072
Needle issue 29.78 16.83 24 18705 13910 90595808
Headache 29.70 16.83 290 18439 862456 89747262
Product leakage 29.25 16.83 11 18718 1397 90608321
Expired product administered 29.02 16.83 18 18711 6904 90602814
White blood cell count decreased 28.93 16.83 88 18641 167021 90442697
Reversible cerebral vasoconstriction syndrome 28.86 16.83 15 18714 4115 90605603
Neutropenia 28.80 16.83 107 18622 224797 90384921
Ascites 28.73 16.83 42 18687 47698 90562020
Blood luteinising hormone decreased 28.31 16.83 5 18724 26 90609692
Gastrointestinal disorder 28.13 16.83 9 18720 256678 90353040
Dyspareunia 28.10 16.83 13 18716 2773 90606945
Impaired healing 27.91 16.83 7 18722 234192 90375526
Expulsion of medication 27.29 16.83 5 18724 33 90609685
Blood cholesterol increased 27.27 16.83 5 18724 208007 90401711
Osteoarthritis 27.23 16.83 4 18725 195726 90413992
Device issue 27.14 16.83 32 18697 29505 90580213
Depressed mood 27.12 16.83 42 18687 50180 90559538
Neuroendocrine breast tumour 27.03 16.83 5 18724 35 90609683
Incorrect dose administered 26.99 16.83 54 18675 78876 90530842
Menopausal symptoms 26.87 16.83 13 18716 3065 90606653
Adhesion 26.71 16.83 10 18719 1254 90608464
Type 2 diabetes mellitus 26.40 16.83 5 18724 203239 90406479
Oestrogen receptor assay positive 26.26 16.83 8 18721 534 90609184
Calcium deficiency 26.20 16.83 10 18719 1323 90608395
Uterine adhesions 25.18 16.83 5 18724 53 90609665
Therapeutic product effect decreased 25.12 16.83 13 18716 277558 90332160
Idiopathic intracranial hypertension 25.00 16.83 13 18716 3568 90606150
Liver injury 24.89 16.83 3 18726 170564 90439154
Haematocolpos 24.61 16.83 5 18724 60 90609658
Virilism foetal 24.40 16.83 4 18725 12 90609706
Hypotension 24.29 16.83 19 18710 325378 90284340
Ovarian failure 24.17 16.83 10 18719 1633 90608085
Irritability 23.86 16.83 33 18696 35629 90574089
Mood altered 23.58 16.83 23 18706 17121 90592597
Periprosthetic metallosis 23.51 16.83 4 18725 16 90609702
Growth accelerated 23.51 16.83 4 18725 16 90609702
Bone pain 23.13 16.83 44 18685 61939 90547779
Ill-defined disorder 23.07 16.83 5 18724 184886 90424832
Prosopagnosia 22.99 16.83 5 18724 85 90609633
Injection site granuloma 22.99 16.83 5 18724 85 90609633
Urinary tract infection 22.62 16.83 18 18711 305614 90304104
Menarche 22.45 16.83 3 18726 0 90609718
Breast cancer 22.37 16.83 40 18689 53721 90555997
Crying 22.27 16.83 27 18702 25618 90584100
Myomectomy 22.16 16.83 4 18725 24 90609694
Arthritis 21.97 16.83 4 18725 167311 90442407
Coronary artery dissection 21.83 16.83 8 18721 946 90608772
Wheezing 21.76 16.83 11 18718 238069 90371649
Hormone level abnormal 21.71 16.83 11 18718 2862 90606856
Injury 21.48 16.83 7 18722 197342 90412376
Disease progression 21.29 16.83 76 18653 156539 90453179
Treatment failure 21.14 16.83 19 18710 303909 90305809
Laparoscopy 20.86 16.83 5 18724 133 90609585
Product preparation error 20.51 16.83 17 18712 10244 90599474
Product storage error 20.40 16.83 23 18706 20218 90589500
Injection site oedema 20.23 16.83 9 18720 1754 90607964
Hepatic enzyme increased 20.19 16.83 27 18702 360709 90249009
Uterine pain 20.07 16.83 6 18723 376 90609342
Oophorectomy 20.04 16.83 7 18722 720 90608998
Vision blurred 19.94 16.83 59 18670 110234 90499484
Irritable bowel syndrome 19.85 16.83 9 18720 207439 90402279
Neurological decompensation 19.66 16.83 11 18718 3490 90606228
Injection site warmth 19.55 16.83 21 18708 17494 90592224
Bronchitis 19.36 16.83 4 18725 152923 90456795
Virilism 19.32 16.83 4 18725 53 90609665
Migraine 19.11 16.83 84 18645 190308 90419410
Swelling 19.07 16.83 36 18693 419022 90190696
Injection site discomfort 18.91 16.83 13 18716 5927 90603791
Intercepted medication error 18.61 16.83 7 18722 890 90608828
Epiphyses premature fusion 18.56 16.83 4 18725 65 90609653
Oestradiol abnormal 18.56 16.83 4 18725 65 90609653
Ovarian disorder 18.53 16.83 7 18722 900 90608818
Libido decreased 18.49 16.83 10 18719 2972 90606746
Intentional product use issue 18.40 16.83 11 18718 216881 90392837
Joint range of motion decreased 18.34 16.83 3 18726 135640 90474078
Cell death 18.26 16.83 10 18719 3045 90606673
Injection site cellulitis 18.21 16.83 8 18721 1513 90608205
Placenta accreta 18.10 16.83 5 18724 236 90609482
Discomfort 18.08 16.83 18 18711 274317 90335401
Atrial fibrillation 17.97 16.83 3 18726 133608 90476110
Completed suicide 17.94 16.83 4 18725 145054 90464664
Blood oestrogen abnormal 17.84 16.83 3 18726 11 90609707
Diarrhoea 17.53 16.83 118 18611 939072 89670646
Pituitary haemorrhage 17.37 16.83 4 18725 89 90609629
Abdominal pain lower 17.37 16.83 26 18703 30151 90579567
Stomatitis 17.01 16.83 19 18710 274679 90335039
Asthma 17.00 16.83 15 18714 242145 90367573
Retinopathy 16.90 16.83 10 18719 3524 90606194

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
Intercepted product preparation error 34200.08 14.23 6614 76590 775 42537356
Syringe issue 27289.85 14.23 5620 77584 2936 42535195
Device leakage 20266.06 14.23 4549 78655 5736 42532395
Wrong technique in product usage process 9566.99 14.23 3454 79750 39181 42498950
Product physical consistency issue 3358.79 14.23 686 82518 287 42537844
Prostatic specific antigen increased 3098.08 14.23 1185 82019 15740 42522391
Hot flush 2965.99 14.23 1241 81963 21110 42517021
Device occlusion 1683.61 14.23 630 82574 7820 42530311
Death 1437.69 14.23 2954 80250 468231 42069900
Product packaging quantity issue 1329.54 14.23 343 82861 1010 42537121
Blood testosterone abnormal 1247.80 14.23 276 82928 293 42537838
Blood testosterone increased 992.71 14.23 281 82923 1286 42536845
Prostate cancer metastatic 844.27 14.23 358 82846 6271 42531860
Intercepted medication error 818.38 14.23 192 83012 321 42537810
Intercepted product administration error 808.54 14.23 193 83011 362 42537769
Metastases to bone 731.10 14.23 419 82785 14390 42523741
Prostatic specific antigen abnormal 687.56 14.23 188 83016 736 42537395
Needle issue 642.02 14.23 322 82882 8405 42529726
Product administration error 539.93 14.23 374 82830 17969 42520162
Product preparation error 431.84 14.23 203 83001 4575 42533556
Hormone-refractory prostate cancer 375.79 14.23 120 83084 884 42537247
Terminal state 357.37 14.23 174 83030 4249 42533882
Product leakage 329.83 14.23 103 83101 699 42537432
Osteonecrosis of jaw 320.80 14.23 279 82925 18770 42519361
Device connection issue 311.34 14.23 90 83114 450 42537681
Prostate cancer 308.03 14.23 407 82797 44236 42493895
Toxicity to various agents 284.35 14.23 52 83152 229084 42309047
Malignant neoplasm progression 274.37 14.23 634 82570 107766 42430365
Product reconstitution quality issue 266.46 14.23 66 83138 155 42537976
Injection site pain 258.73 14.23 430 82774 57368 42480763
Injection site mass 243.27 14.23 171 83033 8404 42529727
Palliative care 213.67 14.23 82 83122 1092 42537039
Injection site induration 189.14 14.23 105 83099 3382 42534749
Diarrhoea 180.24 14.23 396 82808 460453 42077678
Pyrexia 176.05 14.23 313 82891 393729 42144402
Prostate cancer recurrent 173.64 14.23 69 83135 1014 42537117
Acute kidney injury 172.12 14.23 283 82921 367054 42171077
Off label use 166.20 14.23 664 82540 637671 41900460
Metastases to lymph nodes 157.22 14.23 114 83090 5884 42532247
Condition aggravated 144.67 14.23 178 83026 260576 42277555
Hypotension 142.79 14.23 176 83028 257455 42280676
Drug interaction 142.19 14.23 188 83016 266811 42271320
Intercepted product storage error 140.73 14.23 45 83159 333 42537798
Marasmus 139.69 14.23 56 83148 843 42537288
Completed suicide 135.55 14.23 15 83189 96450 42441681
Injection site granuloma 131.60 14.23 27 83177 12 42538119
Circumstance or information capable of leading to medication error 125.94 14.23 72 83132 2456 42535675
Vomiting 122.23 14.23 238 82966 289485 42248646
Injection site haemorrhage 122.14 14.23 132 83072 11604 42526527
Fatigue 121.62 14.23 1341 81863 434300 42103831
Dyspnoea 121.53 14.23 450 82754 442171 42095960
Intentional dose omission 118.84 14.23 115 83089 8871 42529260
Cough 118.53 14.23 104 83100 177999 42360132
Overdose 112.32 14.23 33 83171 105231 42432900
Incorrect route of product administration 110.23 14.23 182 83022 24123 42514008
Fall 105.60 14.23 801 82403 233719 42304412
Drug hypersensitivity 104.51 14.23 32 83172 99357 42438774
Product colour issue 100.15 14.23 40 83164 596 42537535
Rash 98.34 14.23 250 82954 276704 42261427
Nausea 97.06 14.23 422 82782 396377 42141754
Injection site ulcer 95.77 14.23 34 83170 358 42537773
Neutropenia 95.65 14.23 151 83053 199280 42338851
Male sexual dysfunction 91.99 14.23 33 83171 359 42537772
Somnolence 90.74 14.23 85 83119 141020 42397111
Febrile neutropenia 90.58 14.23 139 83065 185564 42352567
Underdose 89.70 14.23 135 83069 16531 42521600
Expired product administered 88.88 14.23 70 83134 4093 42534038
Blood creatinine increased 87.75 14.23 53 83151 109950 42428181
Injection site abscess 87.59 14.23 42 83162 990 42537141
Asthma 84.29 14.23 11 83193 62303 42475828
Pituitary apoplexy 84.02 14.23 24 83180 114 42538017
Bone pain 81.96 14.23 158 83046 23634 42514497
Foetal exposure during pregnancy 79.13 14.23 3 83201 47308 42490823
Intercepted product selection error 77.34 14.23 17 83187 17 42538114
Product use in unapproved indication 77.26 14.23 152 83052 184304 42353827
Sepsis 76.18 14.23 173 83031 199161 42338970
Abdominal pain 75.50 14.23 162 83042 190309 42347822
Injection site necrosis 74.82 14.23 32 83172 572 42537559
Hydronephrosis 73.90 14.23 103 83101 11762 42526369
Pruritus 71.18 14.23 165 83039 188606 42349525
Epidural lipomatosis 70.73 14.23 44 83160 1756 42536375
Victim of child abuse 70.56 14.23 38 83166 1151 42536980
Drug administered in wrong device 70.19 14.23 20 83184 94 42538037
Metastases to lung 69.41 14.23 98 83106 11326 42526805
Platelet count decreased 69.21 14.23 102 83102 138479 42399652
Tachycardia 68.44 14.23 58 83146 101029 42437102
Gynaecomastia 67.92 14.23 102 83102 12465 42525666
Suicide attempt 67.79 14.23 6 83198 46094 42492037
White blood cell count decreased 66.92 14.23 70 83134 110326 42427805
Agitation 65.30 14.23 22 83182 64292 42473839
Nocturia 65.02 14.23 98 83106 12014 42526117
Seizure 63.92 14.23 85 83119 120476 42417655
Lipid metabolism disorder 63.78 14.23 27 83177 470 42537661
Infection 63.61 14.23 75 83129 111993 42426138
Cardiac arrest 63.30 14.23 72 83132 109248 42428883
Pelvic mass 63.07 14.23 22 83182 219 42537912
Pneumonia 62.93 14.23 525 82679 421624 42116507
Thrombocytopenia 62.74 14.23 178 83026 190101 42348030
Coma 62.45 14.23 14 83190 53540 42484591
Psoriasis 62.43 14.23 10 83194 48594 42489537
Intercepted product prescribing error 62.31 14.23 20 83184 150 42537981
Metastasis 61.81 14.23 60 83144 4645 42533486
Mucosal inflammation 61.56 14.23 11 83193 49363 42488768
Infusion related reaction 61.39 14.23 21 83183 60785 42477346
Extra dose administered 61.16 14.23 65 83139 5604 42532527
Occupational exposure to product 60.30 14.23 25 83179 412 42537719
Renal failure 59.67 14.23 119 83085 143607 42394524
Pollakiuria 58.30 14.23 133 83071 22372 42515759
Product quality issue 58.25 14.23 116 83088 17766 42520365
Juvenile idiopathic arthritis 57.69 14.23 45 83159 2594 42535537
Child abuse 57.14 14.23 30 83174 862 42537269
Headache 56.90 14.23 257 82947 239112 42299019
Injection site nodule 56.46 14.23 41 83163 2120 42536011
Septic shock 55.70 14.23 58 83146 91614 42446517
Cancer pain 55.54 14.23 50 83154 3517 42534614
Incorrect dose administered 54.98 14.23 227 82977 52747 42485384
Chest discomfort 54.54 14.23 28 83176 63588 42474543
C-reactive protein increased 54.45 14.23 28 83176 63532 42474599
Diabetes mellitus 54.33 14.23 247 82957 59840 42478291
Renal impairment 54.18 14.23 82 83122 110146 42427985
Tremor 53.80 14.23 66 83138 96863 42441268
Device defective 53.38 14.23 36 83168 1652 42536479
Cystitis radiation 53.37 14.23 17 83187 124 42538007
Intercepted product dispensing error 52.91 14.23 16 83188 96 42538035
Sinusitis 51.95 14.23 14 83190 47278 42490853
Gastrointestinal haemorrhage 51.69 14.23 69 83135 97657 42440474
Pancytopenia 51.03 14.23 95 83109 117648 42420483
Multiple organ dysfunction syndrome 50.83 14.23 69 83135 96966 42441165
Metabolic acidosis 50.49 14.23 19 83185 51839 42486292
Drug abuse 50.48 14.23 79 83125 104692 42433439
Bone cancer 50.24 14.23 36 83168 1823 42536308
Radiation proctitis 49.48 14.23 17 83187 161 42537970
Cardiogenic shock 48.90 14.23 6 83198 35634 42502497
Liquid product physical issue 48.41 14.23 26 83178 783 42537348
Hip fracture 48.28 14.23 91 83113 13381 42524750
Urticaria 48.26 14.23 44 83160 73992 42464139
Haemoptysis 48.26 14.23 15 83189 46152 42491979
Product temperature excursion issue 48.11 14.23 22 83182 464 42537667
Colon cancer stage III 47.97 14.23 17 83187 178 42537953
Angioedema 47.76 14.23 12 83192 42465 42495666
Sedation 47.55 14.23 3 83201 30472 42507659
Pancreatitis 47.17 14.23 13 83191 43255 42494876
Fracture 47.00 14.23 68 83136 8035 42530096
Femur fracture 46.54 14.23 75 83129 9737 42528394
Hereditary optic atrophy 46.36 14.23 13 83191 57 42538074
International normalised ratio increased 46.31 14.23 18 83186 48150 42489981
BRCA1 gene mutation 45.64 14.23 13 83191 61 42538070
Bradycardia 45.57 14.23 60 83144 85424 42452707
Anxiety 45.16 14.23 103 83101 118457 42419674
Oxygen saturation decreased 45.15 14.23 36 83168 64651 42473480
Hypersensitivity 44.85 14.23 45 83159 72325 42465806
Product storage error 44.67 14.23 79 83125 11061 42527070
Hyperkalaemia 44.42 14.23 55 83149 80403 42457728
Stress urinary incontinence 44.09 14.23 14 83190 101 42538030
Chest pain 42.74 14.23 135 83069 139395 42398736
Metastatic salivary gland cancer 42.58 14.23 9 83195 6 42538125
Rheumatoid arthritis 42.24 14.23 15 83189 42425 42495706
Post procedural diarrhoea 42.04 14.23 13 83191 85 42538046
Bone cancer metastatic 42.04 14.23 16 83188 208 42537923
Injection site abscess sterile 41.93 14.23 8 83196 0 42538131
Metastases to spine 41.85 14.23 40 83164 3037 42535094
Therapeutic product effect incomplete 41.84 14.23 46 83158 70893 42467238
Incorrect dose administered by device 41.67 14.23 38 83166 2718 42535413
Drug ineffective for unapproved indication 41.57 14.23 19 83185 46144 42491987
Haematochezia 41.44 14.23 32 83172 58404 42479727
Erythema 41.04 14.23 95 83109 108698 42429433
Reproductive toxicity 40.95 14.23 9 83195 9 42538122
Therapy non-responder 40.75 14.23 27 83177 53332 42484799
Hypoxia 40.34 14.23 46 83158 69740 42468391
Leukopenia 40.32 14.23 52 83152 74694 42463437
Ascites 40.24 14.23 31 83173 56647 42481484
Lactic acidosis 40.18 14.23 19 83185 45242 42492889
Hypoglycaemia 39.69 14.23 35 83169 59819 42478312
Bone lesion 39.64 14.23 41 83163 3425 42534706
Metastases to liver 38.49 14.23 93 83111 16233 42521898
Humerus fracture 38.48 14.23 39 83165 3181 42534950
Urinary tract toxicity 38.36 14.23 10 83194 31 42538100
Abdominal pain upper 38.18 14.23 64 83140 82545 42455586
Injection site infection 37.98 14.23 25 83179 1101 42537030
Blood urea abnormal 37.74 14.23 25 83179 1113 42537018
Interstitial lung disease 37.45 14.23 272 82932 78190 42459941
Injection site erythema 37.31 14.23 105 83099 20090 42518041
BRCA2 gene mutation 37.25 14.23 11 83193 60 42538071
Stress 37.09 14.23 20 83184 44192 42493939
Obstructive airways disorder 37.01 14.23 3 83201 24756 42513375
Respiratory failure 36.47 14.23 128 83076 128004 42410127
Drug ineffective 36.47 14.23 945 82259 629252 41908879
Asthenia 36.44 14.23 759 82445 280034 42258097
Prostatic specific antigen decreased 36.37 14.23 14 83190 188 42537943
Wheezing 36.37 14.23 32 83172 54749 42483382
Anaphylactic reaction 36.35 14.23 19 83185 42724 42495407
Cytokine release syndrome 36.12 14.23 21 83183 44506 42493625
Product prescribing error 35.47 14.23 122 83082 25990 42512141
Blood pressure increased 35.31 14.23 93 83111 101835 42436296
Tubulointerstitial nephritis 35.30 14.23 9 83195 31539 42506592
Radical prostatectomy 35.10 14.23 10 83194 47 42538084
Product solubility abnormal 35.00 14.23 19 83185 585 42537546
Respiratory distress 34.96 14.23 19 83185 41801 42496330
Drug level increased 34.53 14.23 5 83199 26195 42511936
Full blood count abnormal 34.45 14.23 8 83196 29868 42508263
Muscle atrophy 34.44 14.23 60 83144 8301 42529830
Dysuria 34.44 14.23 136 83068 30960 42507171
Osteoporosis 34.17 14.23 84 83120 14822 42523309
Lower respiratory tract infection 34.05 14.23 19 83185 41187 42496944
Joint swelling 33.99 14.23 50 83154 67972 42470159
Product physical issue 33.31 14.23 36 83168 3163 42534968
Toxic epidermal necrolysis 33.25 14.23 6 83198 26744 42511387
Pelvic pain 32.81 14.23 36 83168 3218 42534913
Nasopharyngitis 32.77 14.23 72 83132 83924 42454207
Bone density decreased 32.54 14.23 30 83174 2176 42535955
Drug reaction with eosinophilia and systemic symptoms 32.52 14.23 21 83183 42054 42496077
Neurotoxicity 32.40 14.23 4 83200 23647 42514484
Blood creatine phosphokinase increased 32.37 14.23 28 83176 48310 42489821
Foreign body reaction 32.26 14.23 10 83194 66 42538065
Haematuria 32.11 14.23 208 82996 57591 42480540
Abscess sterile 31.94 14.23 8 83196 20 42538111
Agranulocytosis 31.90 14.23 10 83194 30602 42507529
Product dispensing error 31.70 14.23 55 83149 7584 42530547
Pancreatitis acute 31.51 14.23 13 83191 33551 42504580
Premature baby 31.51 14.23 4 83200 23149 42514982
Plasma cell myeloma 31.33 14.23 28 83176 47550 42490581
Neutrophil count decreased 31.31 14.23 47 83157 63368 42474763
Liver function test abnormal 31.31 14.23 12 83192 32379 42505752
Hepatic enzyme increased 31.30 14.23 26 83178 45758 42492373
Mental status changes 31.24 14.23 22 83182 42093 42496038
Induration 31.16 14.23 22 83182 1088 42537043
Polyneuropathy in malignant disease 30.99 14.23 15 83189 361 42537770
Drug intolerance 30.50 14.23 70 83134 80354 42457777
Oropharyngeal pain 30.50 14.23 23 83181 42487 42495644
Eosinophilia 30.47 14.23 13 83191 32886 42505245
Hyponatraemia 30.47 14.23 99 83105 101363 42436768
Skin exfoliation 30.43 14.23 22 83182 41531 42496600
Compression fracture 30.34 14.23 37 83167 3705 42534426
White blood cell count increased 30.34 14.23 26 83178 45061 42493070
Aggression 30.29 14.23 25 83179 44138 42493993
Blood electrolytes abnormal 30.21 14.23 21 83183 1013 42537118
Anti-androgen withdrawal syndrome 30.10 14.23 7 83197 11 42538120
Productive cough 29.79 14.23 34 83170 51533 42486598
Swelling 29.78 14.23 38 83166 54847 42483284
Wrong device used 29.73 14.23 8 83196 29 42538102
Loss of personal independence in daily activities 29.71 14.23 32 83172 49784 42488347
Respiratory depression 29.07 14.23 92 83112 18776 42519355
Malignant transformation 28.89 14.23 20 83184 958 42537173
Pituitary haemorrhage 28.77 14.23 12 83192 201 42537930
Lymphopenia 28.69 14.23 4 83200 21559 42516572
Spinal compression fracture 28.64 14.23 52 83152 7431 42530700
Urinary retention 28.60 14.23 160 83044 42054 42496077
Ankle fracture 28.46 14.23 41 83163 4825 42533306
Product dosage form issue 28.36 14.23 8 83196 36 42538095
Colitis ulcerative 28.28 14.23 8 83196 26167 42511964
Psychotic disorder 27.93 14.23 11 83193 29197 42508934
Administration site induration 27.82 14.23 6 83198 5 42538126
Blood bilirubin increased 27.66 14.23 25 83179 42227 42495904
Myelosuppression 27.63 14.23 23 83181 40438 42497693
Encephalopathy 27.61 14.23 24 83180 41309 42496822
Neuroendocrine carcinoma of prostate 27.35 14.23 8 83196 42 42538089
Stomatitis 27.15 14.23 35 83169 50294 42487837
Migraine 27.02 14.23 8 83196 25406 42512725
Dementia 26.91 14.23 82 83122 16398 42521733
Mobility decreased 26.76 14.23 138 83066 35168 42502963
Urinary tract obstruction 26.61 14.23 36 83168 3995 42534136
Bladder neck obstruction 26.55 14.23 10 83194 126 42538005
Injection site swelling 26.37 14.23 83 83121 16890 42521241
Injection site inflammation 26.36 14.23 20 83184 1106 42537025
Injection site discharge 26.28 14.23 15 83189 510 42537621
Device breakage 26.27 14.23 34 83170 3615 42534516
Testicular atrophy 26.24 14.23 16 83188 616 42537515
Shock 26.20 14.23 12 83192 29109 42509022
Erectile dysfunction 26.02 14.23 107 83097 24806 42513325
Hepatic cytolysis 25.85 14.23 10 83194 26834 42511297
Treatment failure 25.83 14.23 52 83152 62572 42475559
Abdominal discomfort 25.80 14.23 69 83135 75186 42462945
Palpitations 25.71 14.23 37 83167 50760 42487371
Injection site discomfort 25.49 14.23 27 83177 2319 42535812
Vasculitis 25.47 14.23 3 83201 18391 42519740
Fungal infection 25.45 14.23 4 83200 19718 42518413
Coagulopathy 25.42 14.23 6 83198 22156 42515975
Bronchitis 25.28 14.23 33 83171 47168 42490963
Neuropathy peripheral 24.97 14.23 108 83096 101745 42436386
Product dose omission issue 24.72 14.23 188 83016 154177 42383954
Acute respiratory distress syndrome 24.70 14.23 14 83190 30094 42508037
Inappropriate schedule of product administration 24.19 14.23 290 82914 95612 42442519
Frequent bowel movements 24.15 14.23 6 83198 21401 42516730
Second primary malignancy 24.15 14.23 56 83148 9519 42528612
Macroenzyme creatine kinase 23.68 14.23 6 83198 16 42538115
Influenza 23.67 14.23 54 83150 62121 42476010
Bone marrow failure 23.61 14.23 18 83186 33075 42505056
Depressed level of consciousness 23.25 14.23 36 83168 47934 42490197
Product administered by wrong person 23.15 14.23 7 83197 42 42538089
Chronic obstructive pulmonary disease 23.08 14.23 56 83148 63058 42475073
Cellulitis 23.03 14.23 54 83150 61531 42476600
Confusional state 22.83 14.23 213 82991 167384 42370747
Appendicitis 22.83 14.23 6 83198 20607 42517524
Product preparation issue 22.78 14.23 18 83186 1057 42537074
Loss of libido 22.72 14.23 29 83175 3041 42535090
Lymphocyte count decreased 22.72 14.23 13 83191 27796 42510335
Back pain 22.71 14.23 396 82808 141380 42396751
Gastrointestinal disorder 22.62 14.23 35 83169 46618 42491513
Candida infection 22.62 14.23 7 83197 21603 42516528
Oncologic complication 22.56 14.23 13 83191 450 42537681
Femoral neck fracture 22.51 14.23 34 83170 4175 42533956
Allodynia 22.51 14.23 18 83186 1076 42537055
Epistaxis 22.36 14.23 62 83142 66764 42471367
Drug-induced liver injury 22.36 14.23 25 83179 38248 42499883
Respiratory arrest 22.22 14.23 14 83190 28410 42509721
Pulmonary oedema 22.17 14.23 44 83160 53228 42484903
Abnormal behaviour 22.13 14.23 12 83192 26439 42511692
Small cell carcinoma 22.12 14.23 9 83195 141 42537990
Breast tenderness 22.04 14.23 16 83188 827 42537304
Therapeutic response decreased 21.82 14.23 24 83180 36988 42501143
Brain oedema 21.79 14.23 3 83201 16324 42521807
Gastrooesophageal reflux disease 21.62 14.23 34 83170 44989 42493142
Staphylococcal infection 21.54 14.23 25 83179 37618 42500513
Bacteraemia 21.48 14.23 11 83193 25029 42513102
Therapeutic product effect decreased 21.35 14.23 27 83177 39123 42499008
Muscle spasms 21.23 14.23 91 83113 85953 42452178
Metastases to bladder 21.23 14.23 8 83196 101 42538030
Heart rate decreased 21.19 14.23 24 83180 36508 42501623
No adverse event 21.19 14.23 27 83177 38994 42499137
Thrombosis 21.16 14.23 66 83138 68445 42469686
Metastases to penis 21.07 14.23 5 83199 9 42538122
Use of accessory respiratory muscles 21.03 14.23 13 83191 513 42537618
Administration site ulcer 20.96 14.23 4 83200 0 42538131
Bronchopulmonary aspergillosis 20.87 14.23 6 83198 19423 42518708
Myoclonus 20.84 14.23 4 83200 17061 42521070
Pericardial effusion 20.79 14.23 16 83188 29259 42508872
Accidental overdose 20.74 14.23 15 83189 28315 42509816
Radiation injury 20.67 14.23 13 83191 529 42537602
Generalised tonic-clonic seizure 20.61 14.23 13 83191 26366 42511765
Labelled drug-drug interaction medication error 20.47 14.23 3 83201 15579 42522552
Status epilepticus 20.47 14.23 3 83201 15575 42522556
Bronchiectasis 20.43 14.23 5 83199 18014 42520117
Blood pressure decreased 20.36 14.23 53 83151 58279 42479852
Wrong technique in device usage process 20.34 14.23 26 83178 2731 42535400
Lip swelling 20.25 14.23 6 83198 19047 42519084
Blood pressure systolic increased 20.23 14.23 15 83189 27953 42510178
Upper respiratory tract infection 20.10 14.23 32 83172 42141 42495990
Bacterial infection 20.10 14.23 15 83189 27864 42510267
Dry skin 20.05 14.23 40 83164 48298 42489833
Metastases to soft tissue 20.03 14.23 12 83192 447 42537684
Carcinoid tumour 19.99 14.23 10 83194 259 42537872
Muscular weakness 19.97 14.23 250 82954 83248 42454883
Pleural effusion 19.79 14.23 110 83094 97056 42441075
Colitis 19.78 14.23 38 83166 46534 42491597
Extrapyramidal disorder 19.72 14.23 4 83200 16408 42521723
Neutrophil count increased 19.70 14.23 7 83197 19797 42518334
Glomerular filtration rate decreased 19.62 14.23 4 83200 16347 42521784
Peritonitis 19.57 14.23 6 83198 18627 42519504
Euthanasia 19.56 14.23 6 83198 38 42538093
Pubic pain 19.43 14.23 6 83198 39 42538092
Urogenital haemorrhage 19.35 14.23 14 83190 720 42537411
Thrombotic microangiopathy 19.07 14.23 3 83201 14779 42523352
Radiotherapy 19.06 14.23 15 83189 876 42537255
Diabetic ketoacidosis 18.93 14.23 10 83194 22357 42515774
Traumatic fracture 18.93 14.23 11 83193 387 42537744
Hormone-dependent prostate cancer 18.93 14.23 6 83198 43 42538088
Neutropenic sepsis 18.93 14.23 4 83200 15942 42522189
Activated partial thromboplastin time prolonged 18.85 14.23 4 83200 15899 42522232
Injection site pustule 18.83 14.23 5 83199 17 42538114
Foot fracture 18.78 14.23 39 83165 6152 42531979
Rib fracture 18.77 14.23 73 83131 16498 42521633
Hallucination 18.76 14.23 54 83150 57453 42480678
Aspergillus infection 18.74 14.23 4 83200 15833 42522298
Urine flow decreased 18.74 14.23 18 83186 1375 42536756
Rash erythematous 18.71 14.23 21 83183 32070 42506061
Blood testosterone decreased 18.68 14.23 34 83170 4868 42533263
Deep vein thrombosis 18.61 14.23 82 83122 76875 42461256
Pulmonary congestion 18.56 14.23 4 83200 15726 42522405
Dehydration 18.53 14.23 182 83022 141585 42396546
Oral candidiasis 18.41 14.23 3 83201 14402 42523729
Chills 18.34 14.23 108 83096 93958 42444173
Drug dependence 18.22 14.23 108 83096 28986 42509145
Ectopic ACTH syndrome 18.20 14.23 5 83199 20 42538111
Metastases to pelvis 18.19 14.23 11 83193 417 42537714
Neuroendocrine carcinoma 18.16 14.23 12 83192 532 42537599
Embolic stroke 18.00 14.23 34 83170 5006 42533125
Transitional cell carcinoma 17.95 14.23 24 83180 2634 42535497
Dyskinesia 17.87 14.23 14 83190 25376 42512755
Sinus tachycardia 17.83 14.23 9 83195 20644 42517487
Abdominal distension 17.61 14.23 76 83128 71659 42466472
Pneumonia aspiration 17.61 14.23 162 83042 49916 42488215
Injection site reaction 17.60 14.23 69 83135 15652 42522479
Haemorrhage 17.55 14.23 60 83144 60503 42477628
Pituitary tumour benign 17.51 14.23 15 83189 987 42537144
Body temperature increased 17.38 14.23 9 83195 20349 42517782
Cyanosis 17.38 14.23 4 83200 15027 42523104
Hypervolaemia 17.25 14.23 12 83192 23113 42515018
Swollen tongue 17.23 14.23 10 83194 21221 42516910
Meningioma 17.23 14.23 19 83185 1708 42536423
Pulmonary fibrosis 17.21 14.23 16 83188 26665 42511466
Metastatic neoplasm 17.16 14.23 27 83177 3434 42534697
Acute respiratory failure 17.13 14.23 31 83173 38827 42499304
Lower limb fracture 17.12 14.23 33 83171 4934 42533197
Crystal arthropathy 17.09 14.23 6 83198 61 42538070
Proteinuria 17.05 14.23 12 83192 22971 42515160
Eye pain 16.98 14.23 6 83198 17024 42521107
Alanine aminotransferase increased 16.97 14.23 102 83102 88304 42449827
Therapeutic response shortened 16.93 14.23 3 83201 13551 42524580
Flushing 16.81 14.23 29 83175 36999 42501132
Orthostatic hypotension 16.75 14.23 21 83183 30549 42507582
Myocarditis 16.73 14.23 8 83196 18930 42519201
Skin lesion 16.71 14.23 17 83187 27157 42510974
Metastases to breast 16.58 14.23 4 83200 8 42538123
Arthropathy 16.57 14.23 20 83184 29577 42508554
Blood urea increased 16.48 14.23 24 83180 32769 42505362
Nasal congestion 16.45 14.23 20 83184 29481 42508650
Injection site extravasation 16.38 14.23 25 83179 3097 42535034
Hyperbilirubinaemia 16.36 14.23 10 83194 20625 42517506
Liver disorder 16.28 14.23 33 83171 39611 42498520
Ventricular tachycardia 16.24 14.23 21 83183 30139 42507992
Nightmare 16.13 14.23 15 83189 24997 42513134
Restlessness 16.13 14.23 20 83184 29229 42508902
Product selection error 16.07 14.23 7 83197 131 42538000
Disorientation 16.07 14.23 29 83175 36360 42501771
Ulcer 16.04 14.23 6 83198 16435 42521696
Heart rate increased 15.95 14.23 52 83152 53203 42484928
Clostridium difficile colitis 15.89 14.23 11 83193 21241 42516890
Suicidal ideation 15.88 14.23 45 83159 48116 42490015
Urethral stenosis 15.85 14.23 14 83190 960 42537171
Bronchospasm 15.78 14.23 3 83201 12882 42525249
Treatment noncompliance 15.77 14.23 31 83173 37641 42500490
Groin pain 15.72 14.23 36 83168 6068 42532063
Blood testosterone normal 15.72 14.23 3 83201 0 42538131
Blood luteinising hormone abnormal 15.72 14.23 3 83201 0 42538131
Pathological fracture 15.66 14.23 33 83171 5260 42532871
Product use issue 15.56 14.23 87 83117 76664 42461467
Ataxia 15.54 14.23 6 83198 16119 42522012
Metastases to spinal cord 15.52 14.23 5 83199 38 42538093
Urethral intrinsic sphincter deficiency 15.44 14.23 4 83200 12 42538119
Splenomegaly 15.37 14.23 7 83197 17040 42521091
Haemoglobin decreased 15.31 14.23 175 83029 132296 42405835
Anaphylactic shock 15.29 14.23 14 83190 23503 42514628
Hydroureter 15.26 14.23 10 83194 437 42537694
Pseudomonas infection 15.22 14.23 6 83198 15917 42522214
Tachypnoea 15.18 14.23 12 83192 21650 42516481
Medication error 15.02 14.23 26 83178 33128 42505003
Aplastic anaemia 14.92 14.23 3 83201 12381 42525750
Jaundice 14.89 14.23 28 83176 34561 42503570
Unresponsive to stimuli 14.81 14.23 24 83180 31379 42506752
Renal injury 14.74 14.23 3 83201 12277 42525854
Hepatic failure 14.57 14.23 33 83171 38067 42500064
Vipoma 14.56 14.23 4 83200 16 42538115
Body temperature decreased 14.50 14.23 5 83199 14408 42523723
Melaena 14.46 14.23 34 83170 38712 42499419
Upper gastrointestinal haemorrhage 14.43 14.23 23 83181 30276 42507855
Impaired work ability 14.42 14.23 3 83201 12088 42526043
Lymphadenopathy 14.40 14.23 113 83091 33252 42504879
Hepatocellular injury 14.35 14.23 15 83189 23663 42514468
Rhinorrhoea 14.34 14.23 25 83179 31769 42506362
Aspartate aminotransferase increased 14.30 14.23 90 83114 77073 42461058
Musculoskeletal stiffness 14.30 14.23 61 83143 57704 42480427
Diverticulitis 14.29 14.23 14 83190 22759 42515372
Hyperglycaemia 14.28 14.23 44 83160 45815 42492316

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
Intercepted product preparation error 31908.55 13.24 5279 72105 1541 110510374
Syringe issue 24753.33 13.24 4469 72915 5056 110506859
Device leakage 17670.42 13.24 3669 73715 12379 110499536
Wrong technique in product usage process 7318.71 13.24 2617 74767 84731 110427184
Prostatic specific antigen increased 3167.70 13.24 875 76509 11636 110500279
Product physical consistency issue 2862.52 13.24 541 76843 899 110511016
Hot flush 2077.45 13.24 984 76400 65052 110446863
Device occlusion 1680.74 13.24 562 76822 14623 110497292
Product packaging quantity issue 1197.28 13.24 273 77111 1526 110510389
Blood testosterone abnormal 877.06 13.24 159 77225 178 110511737
Blood testosterone increased 769.81 13.24 182 77202 1220 110510695
Death 730.95 13.24 1547 75837 697322 109814593
Intercepted product administration error 715.16 13.24 157 77227 715 110511200
Intercepted medication error 601.03 13.24 145 77239 1071 110510844
Metastases to bone 597.82 13.24 334 77050 31038 110480877
Prostate cancer metastatic 578.85 13.24 191 77193 4752 110507163
Needle issue 506.12 13.24 248 77136 17592 110494323
Prostatic specific antigen abnormal 505.84 13.24 113 77271 566 110511349
Prostate cancer 439.67 13.24 293 77091 37348 110474567
Malignant neoplasm progression 403.92 13.24 552 76832 174015 110337900
Product administration error 399.63 13.24 275 77109 36942 110474973
Osteonecrosis of jaw 312.10 13.24 263 77121 47754 110464161
Injection site abscess 285.92 13.24 90 77294 1916 110509999
Hormone-refractory prostate cancer 278.57 13.24 74 77310 836 110511079
Product reconstitution quality issue 256.95 13.24 58 77326 307 110511608
Product preparation error 249.46 13.24 131 77253 10748 110501167
Device connection issue 236.36 13.24 70 77314 1204 110510711
Injection site pain 228.08 13.24 430 76954 177492 110334423
Prostate cancer recurrent 214.60 13.24 61 77323 901 110511014
Product leakage 207.56 13.24 67 77317 1551 110510364
Toxicity to various agents 189.60 13.24 51 77333 480504 110031411
Drug hypersensitivity 183.32 13.24 46 77338 454044 110057871
Pelvic pain 178.68 13.24 121 77263 15821 110496094
Synovitis 176.55 13.24 3 77381 274089 110237826
Injection site abscess sterile 174.51 13.24 30 77354 17 110511898
Joint swelling 172.80 13.24 48 77336 442797 110069118
Infusion related reaction 171.53 13.24 30 77354 381132 110130783
Injection site mass 170.68 13.24 140 77244 24473 110487442
Rheumatoid arthritis 160.76 13.24 13 77371 299600 110212315
Ovarian hyperstimulation syndrome 153.45 13.24 75 77309 5285 110506630
Sinusitis 145.82 13.24 18 77366 296670 110215245
Injection site induration 143.56 13.24 93 77291 11290 110500625
Injection site granuloma 135.46 13.24 28 77356 89 110511826
Arthropathy 130.71 13.24 22 77362 287500 110224415
Occupational exposure to product 129.46 13.24 40 77344 799 110511116
Systemic lupus erythematosus 128.55 13.24 14 77370 254324 110257591
Male sexual dysfunction 126.92 13.24 32 77352 289 110511626
Terminal state 126.41 13.24 67 77317 5600 110506315
Pemphigus 124.96 13.24 6 77378 214564 110297351
Pericarditis 124.86 13.24 7 77377 219107 110292808
Abscess sterile 123.07 13.24 24 77360 51 110511864
Drug intolerance 122.34 13.24 66 77318 406446 110105469
Lower respiratory tract infection 121.31 13.24 14 77370 243092 110268823
Wound 120.81 13.24 12 77372 234425 110277490
Hypersensitivity 118.10 13.24 68 77316 403930 110107985
Pituitary apoplexy 117.63 13.24 30 77354 285 110511630
Maternal exposure during pregnancy 114.75 13.24 20 77364 254863 110257052
Completed suicide 113.65 13.24 17 77367 242364 110269551
Diabetes mellitus 113.63 13.24 229 77155 99152 110412763
Psoriatic arthropathy 113.00 13.24 6 77378 196755 110315160
Nasopharyngitis 111.59 13.24 69 77315 394292 110117623
Injection site haemorrhage 110.87 13.24 126 77258 32902 110479013
Asthma 109.75 13.24 21 77363 250270 110261645
Gynaecomastia 108.67 13.24 73 77311 9417 110502498
Epidural lipomatosis 107.72 13.24 44 77340 2023 110509892
Hepatic enzyme increased 107.42 13.24 45 77339 320847 110191068
Victim of child abuse 107.38 13.24 38 77346 1173 110510742
Diarrhoea 107.12 13.24 423 76961 1139082 109372833
Swelling 107.08 13.24 56 77328 350985 110160930
Rash 106.62 13.24 263 77121 820701 109691214
Abdominal discomfort 105.89 13.24 73 77311 393785 110118130
Condition aggravated 104.61 13.24 224 77160 734612 109777303
Infection 104.39 13.24 62 77322 362138 110149777
Folliculitis 103.40 13.24 3 77381 167650 110344265
Metastases to lymph nodes 101.08 13.24 84 77300 14948 110496967
Hydronephrosis 98.34 13.24 95 77289 20570 110491345
Product colour issue 97.50 13.24 34 77350 1004 110510911
Cough 97.00 13.24 108 77276 461533 110050382
Vaginal haemorrhage 96.90 13.24 103 77281 24971 110486944
Therapeutic product effect decreased 96.13 13.24 26 77358 244290 110267625
Metastases to liver 95.79 13.24 121 77263 35265 110476650
Intercepted product storage error 91.29 13.24 30 77354 736 110511179
Intentional dose omission 91.23 13.24 90 77294 19990 110491925
Child abuse 86.91 13.24 30 77354 859 110511056
Lipid metabolism disorder 83.56 13.24 27 77357 627 110511288
Wheezing 83.48 13.24 37 77347 255193 110256722
Irritable bowel syndrome 83.06 13.24 9 77375 164206 110347709
Vomiting 82.97 13.24 342 77042 910333 109601582
Injection site ulcer 79.50 13.24 28 77356 852 110511063
Overdose 79.49 13.24 32 77352 233762 110278153
Circumstance or information capable of leading to medication error 79.19 13.24 48 77336 5185 110506730
Gastrointestinal disorder 77.69 13.24 36 77348 241916 110269999
Blister 77.51 13.24 31 77353 227345 110284570
Haematuria 76.18 13.24 175 77209 82830 110429085
Blood cholesterol increased 75.89 13.24 18 77366 184767 110327148
Stomatitis 75.42 13.24 48 77336 270194 110241721
Dyspnoea 74.45 13.24 462 76922 1106410 109405505
Discomfort 73.63 13.24 29 77355 214678 110297237
Impaired healing 73.58 13.24 23 77361 196694 110315221
Fibromyalgia 73.52 13.24 15 77369 170894 110341021
Intercepted product selection error 72.96 13.24 13 77371 12 110511903
Palliative care 71.62 13.24 31 77353 1649 110510266
Bursitis 71.46 13.24 5 77379 129913 110382002
Type 2 diabetes mellitus 71.35 13.24 18 77366 177214 110334701
Interstitial lung disease 71.13 13.24 237 77147 139097 110372818
Metastases to lung 70.74 13.24 84 77300 22979 110488936
Drug administered in wrong device 70.40 13.24 17 77367 126 110511789
Pruritus 70.27 13.24 193 77191 581367 109930548
Erectile dysfunction 69.54 13.24 75 77309 18481 110493434
Pyrexia 68.95 13.24 359 77025 897906 109614009
Juvenile idiopathic arthritis 68.28 13.24 46 77338 5961 110505954
Abdominal pain upper 67.63 13.24 87 77297 349024 110162891
Ill-defined disorder 66.99 13.24 14 77370 156839 110355076
Nocturia 66.01 13.24 70 77314 16920 110494995
Bone pain 65.01 13.24 142 77242 64991 110446924
Marasmus 64.96 13.24 29 77355 1662 110510253
Product prescribing error 64.37 13.24 123 77261 51208 110460707
Urticaria 64.34 13.24 77 77307 318780 110193135
Incorrect route of product administration 64.32 13.24 140 77244 63921 110447994
Hypotension 63.90 13.24 173 77211 523676 109988239
Nausea 63.77 13.24 556 76828 1235134 109276781
Incorrect dose administered 63.69 13.24 188 77196 103453 110408462
Joint range of motion decreased 63.37 13.24 6 77378 121826 110390089
Injection site discharge 62.44 13.24 27 77357 1433 110510482
Metastasis 61.49 13.24 49 77335 8218 110503697
Treatment failure 61.38 13.24 62 77322 277172 110234743
Expired product administered 61.21 13.24 49 77335 8271 110503644
Therapeutic product effect incomplete 60.75 13.24 41 77343 223764 110288151
Injury 60.68 13.24 24 77360 177241 110334674
Oestradiol increased 58.31 13.24 14 77370 101 110511814
Blood luteinising hormone increased 58.10 13.24 16 77368 209 110511706
Extra dose administered 58.05 13.24 56 77328 12103 110499812
Epiphysiolysis 57.68 13.24 15 77369 155 110511760
Respiratory depression 57.62 13.24 90 77294 31911 110480004
Cystitis radiation 55.93 13.24 16 77368 242 110511673
Hereditary optic atrophy 55.93 13.24 13 77371 80 110511835
Heavy menstrual bleeding 55.89 13.24 63 77321 16302 110495613
Pollakiuria 55.54 13.24 106 77278 44089 110467826
Cancer pain 54.39 13.24 42 77342 6730 110505185
Musculoskeletal stiffness 53.90 13.24 70 77314 279752 110232163
Radiation proctitis 53.64 13.24 15 77369 208 110511707
Psoriasis 53.01 13.24 16 77368 139977 110371938
Pelvic mass 52.96 13.24 24 77360 1425 110510490
Pneumonia aspiration 52.45 13.24 150 77234 81083 110430832
Exposure during pregnancy 52.07 13.24 26 77358 167398 110344517
Dysuria 52.00 13.24 124 77260 60107 110451808
Metastatic salivary gland cancer 51.80 13.24 9 77375 6 110511909
Somnolence 51.75 13.24 80 77304 297369 110214546
Blood oestrogen increased 49.94 13.24 14 77370 196 110511719
Drug dependence 49.86 13.24 109 77275 49911 110462004
Fatigue 49.44 13.24 1155 76229 1214803 109297112
Prescribed overdose 49.26 13.24 3 77381 87578 110424337
Liver injury 48.86 13.24 22 77362 150391 110361524
Loss of personal independence in daily activities 48.64 13.24 22 77362 149998 110361917
Disease progression 48.16 13.24 314 77070 243720 110268195
Blood testosterone decreased 47.99 13.24 28 77356 2820 110509095
Mood swings 47.99 13.24 69 77315 22743 110489172
Incorrect dose administered by device 47.74 13.24 39 77345 6775 110505140
Hysterectomy 47.73 13.24 42 77342 8072 110503843
Coma 47.38 13.24 12 77372 117857 110394058
Blood urea abnormal 46.84 13.24 24 77360 1870 110510045
Injection site nodule 46.74 13.24 33 77351 4613 110507302
Alopecia 46.32 13.24 118 77266 364635 110147280
Dry mouth 45.07 13.24 44 77340 199904 110312011
Injection site infection 45.04 13.24 26 77358 2567 110509348
Metastases to spine 44.80 13.24 34 77350 5309 110506606
Intercepted product dispensing error 44.48 13.24 13 77371 213 110511702
Sciatica 44.41 13.24 6 77378 92393 110419522
Bone lesion 44.35 13.24 38 77346 7049 110504866
Product temperature excursion issue 43.96 13.24 18 77366 833 110511082
C-reactive protein increased 43.54 13.24 53 77331 217866 110294049
Urinary tract obstruction 43.54 13.24 33 77351 5144 110506771
Urinary retention 43.37 13.24 127 77257 69556 110442359
Product administered by wrong person 43.08 13.24 11 77373 105 110511810
Meningioma 43.04 13.24 34 77350 5631 110506284
Intermenstrual bleeding 43.03 13.24 37 77347 6897 110505018
Injection site necrosis 42.59 13.24 22 77362 1744 110510171
Inflammation 41.87 13.24 44 77340 193194 110318721
Polyneuropathy in malignant disease 41.70 13.24 15 77369 486 110511429
Osteoarthritis 41.38 13.24 40 77344 182583 110329332
Arthritis 41.22 13.24 34 77350 167552 110344363
Pituitary haemorrhage 39.79 13.24 13 77371 313 110511602
Bronchitis 39.69 13.24 31 77353 157001 110354914
Prostatic specific antigen decreased 39.69 13.24 10 77374 90 110511825
Malignant transformation 39.69 13.24 20 77364 1505 110510410
Pain 39.43 13.24 453 76931 954502 109557413
Drug interaction 39.36 13.24 198 77186 499985 110011930
Liquid product physical issue 38.78 13.24 20 77364 1580 110510335
Bone cancer 38.26 13.24 23 77361 2447 110509468
Sleep disorder 37.93 13.24 50 77334 198594 110313321
Therapy non-responder 37.36 13.24 33 77351 157274 110354641
Anti-androgen withdrawal syndrome 37.26 13.24 7 77377 11 110511904
Fall 37.23 13.24 611 76773 602871 109909044
Tachycardia 36.57 13.24 64 77320 226581 110285334
Peripheral swelling 36.50 13.24 152 77232 403882 110108033
Confusional state 36.03 13.24 187 77197 468493 110043422
Frequent bowel movements 35.87 13.24 4 77380 71386 110440529
Headache 35.86 13.24 420 76964 881957 109629958
Chest discomfort 35.02 13.24 42 77342 173806 110338109
Grip strength decreased 34.55 13.24 7 77377 80167 110431748
Dyspepsia 34.52 13.24 50 77334 190915 110321000
Product dosage form issue 33.65 13.24 8 77376 55 110511860
Blood electrolytes abnormal 33.62 13.24 20 77364 2088 110509827
Product physical issue 33.56 13.24 28 77356 5008 110506907
Pancreatitis 33.11 13.24 12 77372 93521 110418394
Wound infection 33.11 13.24 13 77371 96452 110415463
Pulmonary fibrosis 33.02 13.24 15 77369 102027 110409888
Foreign body reaction 32.98 13.24 10 77374 187 110511728
Injection site inflammation 32.78 13.24 27 77357 4744 110507171
Injury associated with device 32.61 13.24 26 77358 4363 110507552
Oesophageal ulcer haemorrhage 32.38 13.24 15 77369 937 110510978
Gastrooesophageal reflux disease 31.68 13.24 48 77336 179928 110331987
Oedema 31.48 13.24 62 77322 209914 110302001
Neuroendocrine carcinoma of prostate 31.34 13.24 7 77377 35 110511880
Administration site ulcer 31.33 13.24 5 77379 0 110511915
Blood luteinising hormone abnormal 31.33 13.24 5 77379 0 110511915
Angioedema 31.07 13.24 15 77369 98485 110413430
Post procedural diarrhoea 31.01 13.24 12 77372 478 110511437
Product storage error 30.93 13.24 55 77329 21673 110490242
Menstrual disorder 30.65 13.24 26 77358 4758 110507157
Administration site induration 30.41 13.24 7 77377 41 110511874
Endometrial stromal sarcoma 30.38 13.24 6 77378 14 110511901
Lymphadenopathy 30.30 13.24 106 77278 63729 110448186
Bladder neck obstruction 30.23 13.24 8 77376 89 110511826
Liver disorder 30.13 13.24 33 77351 142210 110369705
Use of accessory respiratory muscles 29.83 13.24 13 77371 703 110511212
Lung disorder 29.82 13.24 50 77334 179997 110331918
Radical prostatectomy 29.81 13.24 6 77378 16 110511899
Leiomyosarcoma recurrent 29.81 13.24 6 77378 16 110511899
Acute kidney injury 29.58 13.24 293 77091 635137 109876778
Lactic acidosis 29.48 13.24 14 77370 92797 110419118
Anxiety 29.22 13.24 133 77251 344945 110166970
Urogenital haemorrhage 29.13 13.24 14 77370 950 110510965
Oropharyngeal pain 29.08 13.24 31 77353 135245 110376670
Metabolic acidosis 28.80 13.24 17 77367 99727 110412188
Embolic stroke 28.74 13.24 33 77351 8710 110503205
Inappropriate schedule of product administration 28.73 13.24 242 77142 203395 110308520
Compression fracture 28.73 13.24 34 77350 9265 110502650
Allodynia 28.70 13.24 18 77366 2065 110509850
Loss of libido 28.65 13.24 21 77363 3112 110508803
Inguinal hernia 28.55 13.24 31 77353 7694 110504221
Hypercholesterolaemia 28.40 13.24 14 77370 90823 110421092
Transitional cell carcinoma 28.40 13.24 21 77363 3154 110508761
Sedation 28.18 13.24 7 77377 69676 110442239
Oncologic complication 28.17 13.24 11 77373 449 110511466
Bone cancer metastatic 28.15 13.24 10 77374 312 110511603
Product dispensing error 28.09 13.24 45 77339 16300 110495615
Underdose 28.00 13.24 103 77281 63451 110448464
Wrong device used 27.79 13.24 7 77377 63 110511852
Product use in unapproved indication 27.78 13.24 191 77193 447186 110064729
Medication error 27.65 13.24 20 77364 105346 110406569
Tremor 27.57 13.24 63 77321 202169 110309746
Erythema 27.34 13.24 108 77276 291339 110220576
Breast enlargement 26.87 13.24 16 77368 1673 110510242
Focal nodular hyperplasia 26.81 13.24 13 77371 900 110511015
Chest pain 26.81 13.24 154 77230 376221 110135694
Humerus fracture 26.27 13.24 35 77349 10741 110501174
Asthenia 26.21 13.24 649 76735 688350 109823565
Product use issue 25.88 13.24 121 77263 311574 110200341
Musculoskeletal pain 25.78 13.24 56 77328 182967 110328948
Liver function test increased 25.70 13.24 15 77369 88533 110423382
Testicular atrophy 25.66 13.24 10 77374 406 110511509
Hypoglycaemia 25.64 13.24 26 77358 116078 110395837
Injection site erythema 25.63 13.24 132 77252 94044 110417871
Injection site swelling 25.45 13.24 98 77286 61692 110450223
Intercepted product prescribing error 25.43 13.24 10 77374 416 110511499
Suicide attempt 25.39 13.24 21 77363 103373 110408542
Radiation injury 25.35 13.24 13 77371 1015 110510900
Adnexal torsion 25.20 13.24 10 77374 426 110511489
Neuroendocrine carcinoma 24.92 13.24 12 77372 818 110511097
Second primary malignancy 24.78 13.24 45 77339 18023 110493892
Fracture 24.68 13.24 54 77330 24734 110487181
Macroenzyme creatine kinase 24.41 13.24 5 77379 15 110511900
Toxic epidermal necrolysis 24.34 13.24 5 77379 56722 110455193
Injection site discomfort 24.29 13.24 27 77357 6880 110505035
Spinal compression fracture 24.21 13.24 45 77339 18347 110493568
Malaise 24.17 13.24 328 77056 671491 109840424
Stress 23.94 13.24 23 77361 105325 110406590
Dysmenorrhoea 23.91 13.24 20 77364 3590 110508325
Pneumonia 23.89 13.24 451 76933 876263 109635652
Product solubility abnormal 23.85 13.24 13 77371 1149 110510766
Hip fracture 23.75 13.24 66 77318 35085 110476830
Foot deformity 23.65 13.24 3 77381 48477 110463438
Sleep disorder due to a general medical condition 23.63 13.24 4 77380 52108 110459807
Metastases to soft tissue 23.44 13.24 11 77373 708 110511207
International normalised ratio increased 23.39 13.24 16 77368 86756 110425159
Pathological fracture 23.29 13.24 35 77349 11997 110499918
Uterine leiomyoma 23.25 13.24 28 77356 7772 110504143
Pregnancy 22.98 13.24 4 77380 51063 110460852
Blood pressure systolic increased 22.78 13.24 15 77369 82976 110428939
Adnexa uteri pain 22.71 13.24 9 77375 382 110511533
Blood creatinine increased 22.56 13.24 60 77324 182829 110329086
Uterine haemorrhage 22.41 13.24 19 77365 3475 110508440
Libido decreased 22.26 13.24 24 77360 5911 110506004
Expulsion of medication 22.25 13.24 6 77378 72 110511843
Carcinoid tumour 22.21 13.24 10 77374 585 110511330
Obstructive airways disorder 22.17 13.24 3 77381 46146 110465769
Oxygen saturation decreased 22.13 13.24 48 77336 156934 110354981
Haematochezia 22.13 13.24 29 77355 115495 110396420
Knee arthroplasty 21.88 13.24 9 77375 64939 110446976
Metastases to pelvis 21.66 13.24 11 77373 841 110511074
Blood pressure increased 21.62 13.24 100 77284 258273 110253642
Contusion 21.55 13.24 87 77297 233274 110278641
Septic shock 21.53 13.24 49 77335 157479 110354436
Product quality issue 21.49 13.24 109 77275 77190 110434725
Adverse event 21.16 13.24 27 77357 108782 110403133
Neuroendocrine breast tumour 20.96 13.24 5 77379 35 110511880
Cardiogenic shock 20.91 13.24 7 77377 57331 110454584
Muscle spasms 20.79 13.24 112 77272 278045 110233870
Muscle atrophy 20.76 13.24 35 77349 13219 110498696
Injection site oedema 20.60 13.24 14 77370 1840 110510075
Road traffic accident 20.53 13.24 27 77357 107371 110404544
Rib fracture 20.49 13.24 61 77323 33709 110478206
Epilepsy 20.40 13.24 24 77360 100185 110411730
Metastases to penis 20.35 13.24 4 77380 9 110511906
Hypoaesthesia 20.06 13.24 133 77251 314090 110197825
Laryngitis 19.81 13.24 3 77381 42408 110469507
Therapeutic response decreased 19.77 13.24 23 77361 96476 110415439
Onychomadesis 19.65 13.24 4 77380 45659 110466256
Induration 19.59 13.24 15 77369 2374 110509541
Liver function test abnormal 19.56 13.24 12 77372 68938 110442977
Nasal congestion 19.52 13.24 24 77360 98258 110413657
Haematocolpos 19.46 13.24 5 77379 49 110511866
Rhinorrhoea 19.43 13.24 26 77358 102640 110409275
Pituitary tumour benign 19.33 13.24 16 77368 2831 110509084
Oral candidiasis 19.09 13.24 4 77380 44756 110467159
Agitation 19.08 13.24 31 77353 113020 110398895
Back pain 19.05 13.24 365 77019 370631 110141284
Urine flow decreased 19.00 13.24 12 77372 1394 110510521
Device defective 19.00 13.24 18 77366 3804 110508111
Hyponatraemia 18.95 13.24 83 77301 217570 110294345
Skin exfoliation 18.93 13.24 20 77364 87631 110424284
Hepatic function abnormal 18.89 13.24 117 77267 89178 110422737
Urethral intrinsic sphincter deficiency 18.84 13.24 4 77380 15 110511900
Premature menarche 18.80 13.24 3 77381 0 110511915
Blood testosterone normal 18.80 13.24 3 77381 0 110511915
Upper respiratory tract infection 18.64 13.24 40 77344 131288 110380627
Colitis ulcerative 18.64 13.24 16 77368 77347 110434568
Arnold-Chiari malformation 18.50 13.24 7 77377 262 110511653
Migraine 18.49 13.24 60 77324 171592 110340323
Eye pain 18.47 13.24 6 77378 50093 110461822
Hydroureter 18.20 13.24 10 77374 898 110511017
Urethral stenosis 18.11 13.24 11 77373 1193 110510722
Mobility decreased 18.07 13.24 95 77289 237327 110274588
Neck pain 17.90 13.24 37 77347 123093 110388822
Ocular hyperaemia 17.85 13.24 3 77381 39283 110472632
Stress urinary incontinence 17.77 13.24 13 77371 1920 110509995
Cardiac arrest 17.76 13.24 74 77310 196679 110315236
Wrong technique in device usage process 17.73 13.24 23 77361 6878 110505037
Bradycardia 17.71 13.24 53 77331 155464 110356451
Prostatic obstruction 17.64 13.24 5 77379 73 110511842
Immunodeficiency 17.57 13.24 3 77381 38835 110473080
Ankle fracture 17.32 13.24 41 77343 19778 110492137
Prostatic mass 17.30 13.24 4 77380 24 110511891
Bladder outlet obstruction 17.21 13.24 6 77378 177 110511738
Agranulocytosis 17.17 13.24 11 77373 61749 110450166
Drug withdrawal syndrome 17.08 13.24 3 77381 38051 110473864
Growth accelerated 17.02 13.24 4 77380 26 110511889
Device issue 16.95 13.24 58 77326 34477 110477438
Metastases to bladder 16.85 13.24 7 77377 336 110511579
Adverse drug reaction 16.85 13.24 30 77354 105529 110406386
Metastases to prostate 16.72 13.24 3 77381 3 110511912
Cardiac ventricular scarring 16.72 13.24 3 77381 3 110511912
Breast cancer male 16.70 13.24 7 77377 344 110511571
Portal hypertension 16.54 13.24 25 77359 8612 110503303
Neoplasm progression 16.51 13.24 89 77295 64506 110447409
Swollen tongue 16.45 13.24 11 77373 60351 110451564
Prosopagnosia 16.42 13.24 5 77379 95 110511820
Drug ineffective 16.38 13.24 884 76500 1519656 108992259
Drug reaction with eosinophilia and systemic symptoms 16.35 13.24 20 77364 82075 110429840
Renal impairment 16.32 13.24 72 77312 188373 110323542
Blood follicle stimulating hormone abnormal 16.26 13.24 3 77381 4 110511911
Follicular cystitis 16.26 13.24 3 77381 4 110511911
Rash erythematous 16.23 13.24 20 77364 81812 110430103
Depressed level of consciousness 16.10 13.24 34 77350 112244 110399671
Joint stiffness 16.09 13.24 14 77370 67229 110444686
Exostosis 16.09 13.24 6 77378 45950 110465965
Anaphylactic reaction 16.07 13.24 35 77349 114265 110397650
Device breakage 16.05 13.24 32 77352 13737 110498178
Tubulointerstitial nephritis 16.03 13.24 9 77375 54275 110457640
Emotional disorder 15.86 13.24 35 77349 16125 110495790
Blood pressure diastolic decreased 15.74 13.24 3 77381 35882 110476033
Vulvovaginal dryness 15.72 13.24 14 77370 2733 110509182
Throat irritation 15.64 13.24 9 77375 53543 110458372
Fungal infection 15.62 13.24 8 77376 50798 110461117
Heart rate decreased 15.62 13.24 21 77363 82735 110429180
Femoral neck fracture 15.61 13.24 30 77354 12537 110499378
Hydrocalyx 15.51 13.24 3 77381 6 110511909
Drug level increased 15.46 13.24 7 77377 47712 110464203
Pubic pain 15.32 13.24 6 77378 247 110511668
Product size issue 15.28 13.24 9 77375 922 110510993
Metastases to spinal cord 15.27 13.24 6 77378 249 110511666
Eosinophilia 15.20 13.24 11 77373 57925 110453990
Crystal arthropathy 15.07 13.24 6 77378 258 110511657
Weight increased 15.03 13.24 205 77179 419439 110092476
Hypervolaemia 14.90 13.24 8 77376 49452 110462463
Ovarian failure 14.89 13.24 9 77375 967 110510948
Fluid retention 14.87 13.24 27 77357 94280 110417635
Metastases to pleura 14.86 13.24 12 77372 2051 110509864
Product packaging issue 14.83 13.24 11 77373 1660 110510255
Intentional self-injury 14.68 13.24 4 77380 37425 110474490
Ovarian cyst 14.62 13.24 31 77353 13899 110498016
Transurethral prostatectomy 14.60 13.24 6 77378 280 110511635
Respiratory distress 14.56 13.24 16 77368 68858 110443057
Ulcer 14.48 13.24 6 77378 43110 110468805
Lymphopenia 14.48 13.24 5 77379 40165 110471750
Gastrointestinal haemorrhage 14.48 13.24 63 77321 165455 110346460
Bone marrow tumour cell infiltration 14.47 13.24 4 77380 53 110511862
Influenza 14.41 13.24 65 77319 169036 110342879
Body temperature decreased 14.39 13.24 4 77380 36931 110474984
Eye haematoma 14.33 13.24 6 77378 294 110511621
Acute coronary syndrome 14.26 13.24 42 77342 23070 110488845
Eye irritation 14.25 13.24 3 77381 33449 110478466
Hypoxia 14.14 13.24 45 77339 129470 110382445
Femur fracture 14.01 13.24 65 77319 44404 110467511
Single component of a two-component product administered 13.98 13.24 3 77381 12 110511903
Myoclonus 13.97 13.24 3 77381 32995 110478920
Vasogenic cerebral oedema 13.91 13.24 12 77372 2246 110509669
Ear infection 13.90 13.24 14 77370 62718 110449197
Mucosal inflammation 13.88 13.24 29 77355 96112 110415803
Eye pruritus 13.84 13.24 3 77381 32772 110479143
Extradural neoplasm 13.78 13.24 3 77381 13 110511902
Anaplastic meningioma 13.78 13.24 3 77381 13 110511902
Vasculitis 13.76 13.24 4 77380 35869 110476046
Productive cough 13.71 13.24 38 77346 114267 110397648
Intestinal metastasis 13.70 13.24 7 77377 542 110511373
Hyperkalaemia 13.58 13.24 49 77335 135747 110376168
Culture positive 13.46 13.24 9 77375 1152 110510763
Myomectomy 13.43 13.24 3 77381 15 110511900
Traumatic fracture 13.34 13.24 9 77375 1169 110510746
White blood cell count increased 13.33 13.24 30 77354 96812 110415103
Calcium deficiency 13.31 13.24 9 77375 1173 110510742

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC L02AE02 ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS
ENDOCRINE THERAPY
HORMONES AND RELATED AGENTS
Gonadotropin releasing hormone analogues
ATC L02AE51 ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS
ENDOCRINE THERAPY
HORMONES AND RELATED AGENTS
Gonadotropin releasing hormone analogues
CHEBI has role CHEBI:35480 analgesic
CHEBI has role CHEBI:35610 antineoplastic agent
CHEBI has role CHEBI:50751 anti-estrogen
CHEBI has role CHEBI:63533 gonadotropin releasing hormone agonist
CHEBI has role CHEBI:64946 anti-HIV agent
CHEBI has role CHEBI:74518 anti-obesity agent
FDA MoA N0000175654 Gonadotropin Releasing Hormone Receptor Agonists
FDA EPC N0000175655 Gonadotropin Releasing Hormone Receptor Agonist
MeSH PA D000970 Antineoplastic Agents
MeSH PA D005300 Fertility Agents, Female
MeSH PA D012102 Reproductive Control Agents
MeSH PA D018931 Antineoplastic Agents, Hormonal
CHEBI has role CHEBI:35469 antidepressant
CHEBI has role CHEBI:35674 antihypertensive agent

Related Drugs by ATC class:

L02AE Gonadotropin releasing hormone analogues 5 drugs
bicalutamidebuserelingoserelinhistrelintriptorelin

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

DiseaseRelationSNOMED_IDDOID
Endometriosis indication 129103003
Precocious puberty indication 400179000
Anemia due to Bleeding Uterine Leiomyoma indication
Advanced Prostatic Carcinoma indication
Malignant tumor of ovary off-label use 363443007 DOID:2394
Urinary tract obstruction contraindication 7163005 DOID:5200
Hypercholesterolemia contraindication 13644009
Myocardial infarction contraindication 22298006 DOID:5844
Hypertensive disorder contraindication 38341003 DOID:10763
Diabetes mellitus contraindication 73211009 DOID:9351
Hyperglycemia contraindication 80394007 DOID:4195
Cerebrovascular accident contraindication 230690007
Orchiectomy contraindication 236334001
Pregnancy, function contraindication 289908002
Osteopenia contraindication 312894000
Cardiovascular event risk contraindication 395112001
Breastfeeding (mother) contraindication 413712001
Obesity contraindication 414916001 DOID:9970
Smokes tobacco daily contraindication 449868002
Vertebral Metastases contraindication




🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 9.65 acidic
pKa2 11.9 acidic
pKa3 12.73 acidic
pKa4 13.09 acidic
pKa5 13.39 acidic
pKa6 13.69 acidic
pKa7 10.75 Basic
pKa8 6.69 Basic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
45MG LUPRON DEPOT-PED KIT ABBVIE ENDOCRINE INC N020263 April 14, 2023 RX POWDER INTRAMUSCULAR 9617303 March 22, 2028 TREATMENT OF PEDIATRIC PATIENTS WITH CENTRAL PRECOCIOUS PUBERTY
45MG LUPRON DEPOT ABBVIE ENDOCRINE INC N020517 June 17, 2011 RX INJECTABLE INJECTION 9617303 March 22, 2028 TREATMENT OF ADVANCED PROSTATIC CANCER
45MG LUPRON DEPOT ABBVIE ENDOCRINE INC N020517 June 17, 2011 RX INJECTABLE INJECTION 8921326 Feb. 5, 2031 PALLIATIVE TREATMENT OF PROSTATE CANCER
7.5MG ELIGARD KIT TOLMAR N021343 Jan. 23, 2002 RX POWDER SUBCUTANEOUS 12397120 Dec. 22, 2041 TREATMENT OF ADVANCED PROSTATIC CANCER
22.5MG ELIGARD KIT TOLMAR N021379 July 24, 2002 RX POWDER SUBCUTANEOUS 12397120 Dec. 22, 2041 TREATMENT OF ADVANCED PROSTATIC CANCER
30MG ELIGARD KIT TOLMAR N021488 Feb. 13, 2003 RX POWDER SUBCUTANEOUS 12397120 Dec. 22, 2041 TREATMENT OF ADVANCED PROSTATIC CANCER
45MG ELIGARD KIT TOLMAR N021731 Dec. 14, 2004 RX POWDER SUBCUTANEOUS 12397120 Dec. 22, 2041 TREATMENT OF ADVANCED PROSTATIC CANCER
45MG FENSOLVI KIT TOLMAR N213150 May 1, 2020 RX POWDER SUBCUTANEOUS 12397120 Dec. 22, 2041 TREATMENT OF PEDIATRIC PATIENTS WITH CENTRAL PRECOCIOUS PUBERTY

Orange Book exclusivity data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
45MG LUPRON DEPOT-PED KIT ABBVIE ENDOCRINE INC N020263 April 14, 2023 RX POWDER INTRAMUSCULAR April 14, 2026 NEW STRENGTH

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])		Mechanism
action		Bioact sourceMoA source
Gonadotropin-releasing hormone receptor GPCR AGONIST IC50 9.52 WOMBAT-PK CHEMBL
Gonadotropin-releasing hormone receptor GPCR IC50 9.30 CHEMBL

External reference:

IDSource
4019800 VUID
N0000147889 NUI
D00989 KEGG_DRUG
74381-53-6 SECONDARY_CAS_RN
4018977 VANDF
4019800 VANDF
C0085272 UMLSCUI
CHEBI:6427 CHEBI
CHEMBL1201199 ChEMBL_ID
CHEMBL1200775 ChEMBL_ID
DB00007 DRUGBANK_ID
C493311 MESH_SUPPLEMENTAL_RECORD_UI
657181 PUBCHEM_CID
203217 RXNORM
11929 MMSL
43716 MMSL
4966 MMSL
8763 MMSL
d01353 MMSL
002675 NDDF
004751 NDDF
008314 NDDF
008315 NDDF
350364005 SNOMEDCT_US
397198002 SNOMEDCT_US
70562007 SNOMEDCT_US
D016729 MESH_DESCRIPTOR_UI
CHEMBL4802223 ChEMBL_ID
1175 IUPHAR_LIGAND_ID
5025 INN_ID
37JNS02E7V UNII
37JNS02E7V INXIGHT DRUGS

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
LEUPROLIDE ACETATE HUMAN PRESCRIPTION DRUG LABEL 1 42023-259 INJECTION 1 mg SUBCUTANEOUS ANDA 26 sections
Fensolvi HUMAN PRESCRIPTION DRUG LABEL 1 62935-163 INJECTION, SUSPENSION, EXTENDED RELEASE 45 mg SUBCUTANEOUS NDA 25 sections
Eligard HUMAN PRESCRIPTION DRUG LABEL 1 62935-227 INJECTION, SUSPENSION, EXTENDED RELEASE 22.50 mg SUBCUTANEOUS NDA 24 sections
Eligard HUMAN PRESCRIPTION DRUG LABEL 1 62935-306 INJECTION, SUSPENSION, EXTENDED RELEASE 30 mg SUBCUTANEOUS NDA 24 sections
Eligard HUMAN PRESCRIPTION DRUG LABEL 1 62935-461 INJECTION, SUSPENSION, EXTENDED RELEASE 45 mg SUBCUTANEOUS NDA 24 sections
Eligard HUMAN PRESCRIPTION DRUG LABEL 1 62935-756 INJECTION, SUSPENSION, EXTENDED RELEASE 7.50 mg SUBCUTANEOUS NDA 24 sections
Vabrinty HUMAN PRESCRIPTION DRUG LABEL 1 85043-025 INJECTION, SUSPENSION, EXTENDED RELEASE 22.50 mg SUBCUTANEOUS NDA authorized generic 24 sections
Vabrinty HUMAN PRESCRIPTION DRUG LABEL 1 85043-030 INJECTION, SUSPENSION, EXTENDED RELEASE 30 mg SUBCUTANEOUS NDA authorized generic 24 sections
Vabrinty HUMAN PRESCRIPTION DRUG LABEL 1 85043-045 INJECTION, SUSPENSION, EXTENDED RELEASE 45 mg SUBCUTANEOUS NDA authorized generic 24 sections
Vabrinty HUMAN PRESCRIPTION DRUG LABEL 1 85043-075 INJECTION, SUSPENSION, EXTENDED RELEASE 7.50 mg SUBCUTANEOUS NDA authorized generic 24 sections