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

Stem definitionDrug idCAS RN
peptides and glycopeptides 1980 83150-76-9

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • octreotide
  • longastatin
  • octreotide acetate
  • sandostatin
  • SMS-201-995
  • sandostatine
A potent, long-acting synthetic SOMATOSTATIN octapeptide analog that inhibits secretion of GROWTH HORMONE and is used to treat hormone-secreting tumors; DIABETES MELLITUS; HYPOTENSION, ORTHOSTATIC; HYPERINSULINISM; hypergastrinemia; and small bowel fistula.
  • Molecular weight: 1019.25
  • Formula: C49H66N10O10S2
  • CLOGP: 2.53
  • LIPINSKI: 3
  • HAC: 20
  • HDO: 13
  • TPSA: 332.22
  • ALOGS: -4.92
  • ROTB: 17
  • Status: OFP
    • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

DoseUnitRoute
0.70 mg P

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 1 Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine) 32 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 0.02 µM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability) 2 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
Vd (Volume of distribution) 0.19 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 2.38 mL/min/kg Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma) 0.35 % Lombardo F, Berellini G, Obach RS
t_half (Half-life) 1.70 hours Lombardo F, Berellini G, Obach RS

Predicted pharmacokinetic/toxicological properties (PK-AZ):

PropertyDescriptionValueUnitConfidenceSimilarity
azlogd74 LogD at pH 7.4 -0.028 Moderate 0.74
caco2-efflux Caco-2 efflux ratio (BA/AB) 0.834 Moderate 0.74
caco2-intrinsic-papp Caco-2 intrinsic apparent permeability 0.197 10^-6 cm/s Moderate 0.74
dh-clint Dog hepatocyte intrinsic clearance 3.006 uL/min/10^6 cells Moderate 0.74
dppb Dog plasma protein binding (% unbound) 45.860 % Moderate 0.74
fcs-ppb Fetal calf serum protein binding (% unbound) 33.280 % Moderate 0.74
herg hERG pIC50 4.370 pIC50 Moderate 0.74
hh-clint Human hepatocyte intrinsic clearance 18.408 uL/min/10^6 cells Moderate 0.74
hlm-clint Human liver microsomal intrinsic clearance 10.280 uL/min/mg protein Moderate 0.74
hppb Human plasma protein binding (% unbound) 49.020 % Moderate 0.74
kinase-safety-class ACVR2B,AXL,BRAF,CAMK2D,CDK5,ERBB2,GRK2,ITK,NTRK2,PDK1,PDK2,PDK4,PRKDC 13
kinase-selectivity-class AXL,GRK2 2
mdck-mdr1-bcrp-efflux MDCK-MDR1-BCRP efflux ratio 2.673 High 1
mdck-mdr1-efflux MDCK-MDR1 efflux ratio 0.986 Moderate 0.74
mh-clint Mouse hepatocyte intrinsic clearance 25.061 Moderate 0.74
mppb Mouse plasma protein binding (% unbound) 29.610 Moderate 0.74
nih-mdck-mdr1-efflux NIH MDCK-MDR1 efflux ratio 1.146 Moderate 0.74
pfas-class PFAS structural alert (1 = True, 0 = False) 0
pppb Pig plasma protein binding (% unbound) 39.950 % Moderate 0.74
rh-clint Rat hepatocyte intrinsic clearance 14.488 uL/min/10^6 cells Moderate 0.74
rh-fuinc Rat hepatocyte fraction unbound in incubation 48.450 % Moderate 0.74
rppb Rat plasma protein binding (% unbound) 28.520 % Moderate 0.74
solubility-dd Solubility at pH 7.4 in DMSO 578.096 uM Moderate 0.74

Approvals:

DateAgencyCompanyOrphan
Aug. 21, 2020 PMDA Novartis Pharma K.K., Sandoz K.K.
Oct. 21, 1988 FDA NOVARTIS
Dec. 2, 2022 EMA AMRYT PHARMACEUTICALS DAC

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
Needle issue 2348.77 15.14 719 66176 13215 90548337
Blood pressure systolic increased 1459.93 15.14 757 66138 57588 90503964
Body temperature decreased 1156.49 15.14 489 66406 23327 90538225
Malignant neoplasm progression 920.94 15.14 705 66190 106165 90455387
Blood pressure increased 909.64 15.14 911 65984 196306 90365246
Injection site mass 814.92 15.14 374 66521 21716 90539836
Inappropriate schedule of product administration 787.37 15.14 744 66151 149189 90412363
Injection site pain 732.70 15.14 765 66130 172934 90388618
Blood pressure diastolic decreased 552.20 15.14 306 66589 26520 90535032
Blood growth hormone increased 427.24 15.14 95 66800 435 90561117
Heart rate decreased 414.96 15.14 332 66563 53173 90508379
Syringe issue 414.90 15.14 143 66752 3859 90557693
Metastases to liver 365.73 15.14 241 66654 28566 90532986
Flatulence 336.42 15.14 264 66631 41103 90520449
Infusion related reaction 286.96 15.14 4 66891 416776 90144776
Abdominal pain 284.99 15.14 785 66110 394936 90166616
Insulin-like growth factor increased 274.32 15.14 75 66820 899 90560653
Second primary malignancy 254.40 15.14 133 66762 10245 90551307
Blood chromogranin A increased 245.04 15.14 57 66838 331 90561221
Abdominal distension 239.61 15.14 381 66514 130220 90431332
Blood pressure diastolic increased 232.56 15.14 135 66760 12771 90548781
Cholelithiasis 231.20 15.14 237 66658 52269 90509283
Mass 229.09 15.14 143 66752 15434 90546118
Stress 223.85 15.14 288 66607 81107 90480445
Carcinoid crisis 221.56 15.14 50 66845 248 90561304
Hepatic lesion 212.09 15.14 97 66798 5576 90555976
Diarrhoea 208.95 15.14 1293 65602 937897 89623655
Injection site haemorrhage 207.38 15.14 170 66725 28148 90533404
Blood pressure decreased 204.37 15.14 264 66631 74631 90486921
Rheumatoid arthritis 204.27 15.14 17 66878 362597 90198955
Glossodynia 202.78 15.14 8 66887 321771 90239781
Diabetes mellitus 201.49 15.14 244 66651 64631 90496921
Contraindicated product administered 198.28 15.14 9 66886 320130 90241422
Neoplasm progression 198.03 15.14 202 66693 44284 90517268
Pericarditis 180.06 15.14 4 66891 270147 90291405
Hand deformity 175.19 15.14 11 66884 296351 90265201
Intestinal obstruction 175.16 15.14 174 66721 36957 90524595
Injection site discomfort 168.46 15.14 84 66811 5856 90555696
Arthropathy 164.20 15.14 35 66860 366207 90195345
Rash 159.53 15.14 213 66682 795887 89765665
Weight decreased 157.23 15.14 625 66270 379285 90182267
Malaise 156.05 15.14 847 66048 585139 89976413
Drug intolerance 152.26 15.14 70 66825 447521 90114031
Therapeutic product effect decreased 148.35 15.14 16 66879 277555 90283997
Flushing 147.11 15.14 247 66648 88244 90473308
Condition aggravated 144.73 15.14 136 66759 595409 89966143
Maternal exposure during pregnancy 143.01 15.14 44 66851 360019 90201533
Nervousness 139.63 15.14 148 66747 33908 90527644
Blood glucose decreased 139.63 15.14 125 66770 23304 90538248
Underdose 135.89 15.14 183 66712 53834 90507718
Hepatic neoplasm 133.42 15.14 53 66842 2145 90559407
Impaired healing 131.76 15.14 11 66884 234188 90327364
Bowel movement irregularity 130.41 15.14 73 66822 6441 90555111
Treatment failure 128.36 15.14 33 66862 303895 90257657
Death 126.88 15.14 668 66227 455883 90105669
Insulin-like growth factor decreased 126.68 15.14 34 66861 378 90561174
Back pain 126.50 15.14 516 66379 316659 90244893
Neuroendocrine tumour 124.55 15.14 40 66855 861 90560691
Intentional product use issue 122.53 15.14 10 66885 216882 90344670
Hypersensitivity 122.42 15.14 94 66801 454583 90106969
Hepatic pain 117.44 15.14 56 66839 3539 90558013
Hepatic enzyme increased 115.69 15.14 61 66834 360675 90200877
Metastasis 115.37 15.14 66 66829 6071 90555481
Neoplasm 114.21 15.14 75 66820 8828 90552724
Pancreatic neuroendocrine tumour 112.83 15.14 34 66861 588 90560964
Toxicity to various agents 111.03 15.14 37 66858 287809 90273743
Blood pressure systolic decreased 109.07 15.14 74 66821 9196 90552356
Blister 108.99 15.14 27 66868 254971 90306581
Irritable bowel syndrome 108.21 15.14 13 66882 207435 90354117
Injection site hypersensitivity 106.95 15.14 48 66847 2639 90558913
Drug ineffective 106.42 15.14 595 66300 1383703 89177849
Exposure during pregnancy 106.35 15.14 23 66872 238387 90323165
Faeces discoloured 104.43 15.14 102 66793 21218 90540334
Hot flush 104.15 15.14 170 66725 59318 90502234
Feeling abnormal 103.81 15.14 315 66580 166920 90394632
Limb discomfort 101.97 15.14 133 66762 37927 90523625
Hypoglycaemia 101.78 15.14 184 66711 69664 90491888
Blood glucose increased 100.31 15.14 219 66676 95027 90466525
Liver injury 98.78 15.14 7 66888 170560 90390992
Terminal state 98.52 15.14 46 66849 2772 90558780
Polyp 97.10 15.14 64 66831 7580 90553972
Fibromyalgia 95.95 15.14 18 66877 206251 90355301
Pituitary tumour 95.53 15.14 33 66862 896 90560656
Urticaria 91.57 15.14 59 66836 312675 90248877
Serum serotonin increased 90.89 15.14 23 66872 199 90561353
Completed suicide 90.00 15.14 4 66891 145054 90416498
Cough 89.78 15.14 521 66374 368441 90193111
Off label use 87.14 15.14 469 66426 1101783 89459769
Helicobacter infection 86.00 15.14 30 66865 226820 90334732
Carcinoid syndrome 85.96 15.14 22 66873 200 90561352
Injection site induration 85.47 15.14 67 66828 10401 90551151
Asthenia 85.19 15.14 679 66216 533072 90028480
Carcinoid tumour 84.66 15.14 25 66870 402 90561150
Eating disorder 84.55 15.14 104 66791 27969 90533583
Injection site swelling 83.85 15.14 155 66740 59684 90501868
Drug hypersensitivity 82.89 15.14 134 66761 463475 90098077
Carcinoid heart disease 82.87 15.14 16 66879 29 90561523
Acute kidney injury 82.70 15.14 69 66826 320318 90241234
Injury 82.20 15.14 22 66873 197327 90364225
Asthma 80.52 15.14 39 66856 242121 90319431
Loss of personal independence in daily activities 77.62 15.14 6 66889 136099 90425453
Drug interaction 77.11 15.14 55 66840 276398 90285154
Sleep disorder due to general medical condition, insomnia type 75.33 15.14 5 66890 128689 90432863
Incorrect dose administered 74.74 15.14 174 66721 78756 90482796
Sinusitis 74.57 15.14 86 66809 343002 90218550
Wound 73.68 15.14 69 66826 302911 90258641
Nephritic syndrome 72.76 15.14 22 66873 385 90561167
Fall 72.02 15.14 604 66291 481206 90080346
Musculoskeletal stiffness 71.56 15.14 68 66827 296464 90265088
Therapeutic product effect incomplete 69.54 15.14 28 66867 193868 90367684
Abdominal pain lower 69.51 15.14 98 66797 30079 90531473
Overdose 68.73 15.14 16 66879 157693 90403859
Mobility decreased 68.47 15.14 51 66844 250683 90310869
Intestinal haemorrhage 68.36 15.14 42 66853 4405 90557147
Frustration tolerance decreased 67.65 15.14 52 66843 7844 90553708
Ill-defined disorder 67.46 15.14 26 66869 184865 90376687
Infection 67.22 15.14 102 66793 361992 90199560
Thyroid disorder 67.13 15.14 74 66821 17711 90543841
Obesity 65.15 15.14 3 66892 105504 90456048
Joint swelling 64.30 15.14 176 66719 503124 90058428
C-reactive protein increased 63.74 15.14 27 66868 181362 90380190
Productive cough 63.47 15.14 161 66734 76902 90484650
Blood glucose fluctuation 63.21 15.14 42 66853 5041 90556511
Hip fracture 62.65 15.14 98 66797 32979 90528573
Pulmonary fibrosis 60.57 15.14 5 66890 107498 90454054
Psoriasis 60.53 15.14 17 66878 147737 90413815
Acne 60.43 15.14 89 66806 28418 90533134
Abdominal pain upper 60.15 15.14 436 66459 332238 90229314
Hormone level abnormal 59.71 15.14 33 66862 2840 90558712
Adverse event 59.65 15.14 8 66887 117410 90444142
Injection site warmth 59.51 15.14 69 66826 17446 90544106
Influenza 58.96 15.14 231 66664 139033 90422519
Injection site bruising 58.18 15.14 123 66772 52184 90509368
Nephrolithiasis 57.61 15.14 118 66777 48967 90512585
Depressed mood 56.91 15.14 119 66776 50103 90511449
Yellow skin 56.28 15.14 31 66864 2650 90558902
Pancreatic disorder 55.98 15.14 32 66863 2939 90558613
Wheezing 55.80 15.14 56 66839 238024 90323528
Blood growth hormone abnormal 55.31 15.14 11 66884 25 90561527
Heart rate increased 55.06 15.14 196 66699 112706 90448846
Small intestinal obstruction 55.01 15.14 73 66822 21161 90540391
Metastases to pancreas 54.97 15.14 17 66878 322 90561230
Steatorrhoea 53.88 15.14 19 66876 549 90561003
Metastases to bone 53.16 15.14 79 66816 25426 90536126
Brain neoplasm 52.91 15.14 37 66858 4827 90556725
Pollakiuria 52.01 15.14 90 66805 32915 90528637
Ingrowing nail 51.67 15.14 30 66865 2837 90558715
Rectal polyp 51.15 15.14 22 66873 1091 90560461
Pruritus 51.03 15.14 216 66679 541309 90020243
Type 2 diabetes mellitus 50.92 15.14 45 66850 203199 90358353
Wound infection 50.08 15.14 9 66886 106393 90455159
Groin pain 49.92 15.14 53 66842 12160 90549392
Musculoskeletal discomfort 49.58 15.14 69 66826 20922 90540630
Stomatitis 49.41 15.14 79 66816 274619 90286933
Pituitary tumour recurrent 49.41 15.14 12 66883 86 90561466
Crying 48.60 15.14 76 66819 25569 90535983
Sciatic nerve injury 48.40 15.14 19 66876 745 90560807
Intentional product misuse 48.26 15.14 5 66890 89599 90471953
Movement disorder 48.19 15.14 81 66814 28938 90532614
Neutropenia 48.16 15.14 57 66838 224847 90336705
Hepatic mass 47.99 15.14 26 66869 2151 90559401
Faeces pale 47.65 15.14 25 66870 1938 90559614
Bone pain 47.45 15.14 126 66769 61857 90499695
Haemorrhage 47.14 15.14 135 66760 69234 90492318
Pancreatic neuroendocrine tumour metastatic 46.84 15.14 11 66884 67 90561485
Change of bowel habit 46.83 15.14 26 66869 2257 90559295
Red blood cell sedimentation rate increased 46.09 15.14 4 66891 82591 90478961
Drug abuse 45.92 15.14 4 66891 82343 90479209
Breast mass 45.89 15.14 45 66850 9402 90552150
Angina bullosa haemorrhagica 45.77 15.14 12 66883 121 90561431
Skin discolouration 45.62 15.14 101 66794 44214 90517338
Proctalgia 45.43 15.14 42 66853 8156 90553396
Gallbladder disorder 45.14 15.14 64 66831 19739 90541813
Dizziness 44.42 15.14 645 66250 588639 89972913
Nasal discharge discolouration 43.99 15.14 27 66868 2826 90558726
Blood iron decreased 43.87 15.14 60 66835 17899 90543653
Metastases to ovary 43.86 15.14 16 66879 511 90561041
Swelling 43.36 15.14 161 66734 418897 90142655
Lower respiratory tract infection 43.30 15.14 74 66821 250585 90310967
Adverse drug reaction 43.24 15.14 16 66879 116685 90444867
Lip dry 42.50 15.14 11 66884 100944 90460608
Abnormal faeces 42.50 15.14 37 66858 6645 90554907
Metastases to gastrointestinal tract 42.22 15.14 11 66884 108 90561444
Neuroendocrine carcinoma 42.08 15.14 14 66881 338 90561214
Drug-induced liver injury 41.73 15.14 8 66887 90310 90471242
Chikungunya virus infection 41.35 15.14 12 66883 181 90561371
Anxiety 41.35 15.14 379 66516 309393 90252159
Hyperhidrosis 40.89 15.14 204 66691 136101 90425451
Adenoma benign 40.69 15.14 18 66877 956 90560596
Blood glucose abnormal 40.23 15.14 42 66853 9450 90552102
Medication error 40.18 15.14 7 66888 84645 90476907
Urine odour abnormal 39.93 15.14 37 66858 7207 90554345
Recurrent cancer 39.79 15.14 24 66871 2435 90559117
Illness 39.70 15.14 142 66753 81827 90479725
Pain in extremity 39.59 15.14 507 66388 450022 90111530
5-hydroxyindolacetic acid increased 38.64 15.14 7 66888 7 90561545
Rhinorrhoea 38.59 15.14 148 66747 88168 90473384
Muscle swelling 38.28 15.14 15 66880 585 90560967
Heart rate irregular 38.00 15.14 66 66829 24202 90537350
Bartholinitis 37.89 15.14 9 66886 58 90561494
Blood magnesium decreased 37.68 15.14 52 66843 15641 90545911
Product deposit 37.60 15.14 13 66882 354 90561198
Blood growth hormone decreased 37.47 15.14 8 66887 29 90561523
Gastrointestinal neoplasm 37.05 15.14 13 66882 370 90561182
Breast pain 37.01 15.14 42 66853 10376 90551176
Injection site inflammation 36.93 15.14 29 66866 4512 90557040
Sensitisation 36.88 15.14 28 66867 4147 90557405
Neuroendocrine tumour of the lung 36.85 15.14 8 66887 32 90561520
Psychiatric symptom 36.63 15.14 35 66860 7083 90554469
Epilepsy 36.49 15.14 8 66887 82198 90479354
Confusional state 36.37 15.14 154 66741 386051 90175501
Peripheral coldness 36.35 15.14 48 66847 13844 90547708
Febrile neutropenia 36.23 15.14 38 66857 158311 90403241
Metastases to eye 36.09 15.14 11 66884 198 90561354
Muscle contractions involuntary 35.94 15.14 24 66871 2904 90558648
Dry mouth 35.93 15.14 50 66845 184009 90377543
Gait disturbance 35.91 15.14 321 66574 260175 90301377
Feeling cold 35.80 15.14 69 66826 27396 90534156
Head banging 35.52 15.14 13 66882 419 90561133
Bile duct stone 35.08 15.14 27 66868 4080 90557472
Furuncle 34.85 15.14 35 66860 7526 90554026
Benign neoplasm of adrenal gland 34.76 15.14 8 66887 44 90561508
Oropharyngeal pain 34.27 15.14 172 66723 115015 90446537
Respiratory rate increased 33.97 15.14 50 66845 15951 90545601
Blood cholesterol increased 33.59 15.14 64 66831 207948 90353604
Injection site scar 33.37 15.14 17 66878 1240 90560312
Urine abnormality 32.37 15.14 34 66861 7703 90553849
Cardiac valve disease 32.20 15.14 27 66868 4608 90556944
Pregnancy 32.06 15.14 4 66891 62043 90499509
Hypokinesia 31.82 15.14 48 66847 15649 90545903
Facial asymmetry 31.80 15.14 15 66880 925 90560627
Hyponatraemia 31.74 15.14 31 66864 133507 90428045
Dysstasia 31.52 15.14 62 66833 24990 90536562
Muscle strain 30.98 15.14 37 66858 9650 90551902
Neuroendocrine carcinoma metastatic 30.72 15.14 10 66885 225 90561327
Body height increased 30.66 15.14 8 66887 79 90561473
Neoplasm malignant 30.23 15.14 73 66822 33807 90527745
Gingival abscess 30.18 15.14 15 66880 1038 90560514
Polydipsia 30.13 15.14 25 66870 4206 90557346
Injection site hypoaesthesia 30.09 15.14 13 66882 652 90560900
Buttock injury 30.07 15.14 11 66884 354 90561198
Hyperglycaemia 29.72 15.14 94 66801 50876 90510676
Hypercholesterolaemia 29.54 15.14 19 66876 100873 90460679
Fatigue 29.52 15.14 1084 65811 1152939 89408613
Metastatic carcinoid tumour 29.49 15.14 6 66889 16 90561536
Lower limb fracture 29.30 15.14 13 66882 85000 90476552
Dehydration 29.08 15.14 244 66651 194203 90367349
Pancreatolithiasis 29.03 15.14 10 66885 269 90561283
Biliary obstruction 28.49 15.14 22 66873 3340 90558212
Administration site abscess 28.49 15.14 6 66889 20 90561532
Administration site induration 28.49 15.14 6 66889 20 90561532
Labyrinthitis 27.93 15.14 20 66875 2709 90558843
Gout 27.91 15.14 47 66848 16812 90544740
Metastases to abdominal cavity 27.85 15.14 12 66883 598 90560954
Nail disorder 27.78 15.14 5 66890 59062 90502490
Tonsillar inflammation 27.67 15.14 8 66887 119 90561433
Metastases to thyroid 27.63 15.14 6 66889 24 90561528
Metastases to fallopian tube 27.51 15.14 7 66888 62 90561490
Bursitis 27.50 15.14 34 66861 131620 90429932
Administration site discharge 27.44 15.14 6 66889 25 90561527
Respiratory disorder 27.40 15.14 7 66888 64809 90496743
Constipation 27.39 15.14 322 66573 280073 90281479
Unevaluable event 27.24 15.14 4 66891 54844 90506708
Postoperative wound infection 27.14 15.14 41 66854 13385 90548167
Dysuria 27.07 15.14 77 66818 39324 90522228
Thyroid mass 26.93 15.14 26 66869 5329 90556223
Depressed level of consciousness 26.93 15.14 10 66885 72774 90488778
Leukopenia 26.81 15.14 21 66874 100689 90460863
Colitis ulcerative 26.48 15.14 6 66889 60260 90501292
Pancreatic enlargement 26.40 15.14 7 66888 74 90561478
Screaming 26.38 15.14 22 66873 3728 90557824
Product use issue 26.10 15.14 140 66755 329779 90231773
Bone erosion 26.02 15.14 4 66891 53017 90508535
Neuropathy peripheral 25.95 15.14 38 66857 136932 90424620
Soft tissue mass 25.94 15.14 10 66885 373 90561179
No adverse event 25.73 15.14 9 66886 67973 90493579
Liver abscess 25.61 15.14 21 66874 3475 90558077
Metastases to breast 25.55 15.14 10 66885 389 90561163
Decreased appetite 25.54 15.14 405 66490 376135 90185417
Administration site odour 25.21 15.14 6 66889 39 90561513
Alopecia 25.07 15.14 239 66656 494832 90066720
Renal disorder 25.06 15.14 73 66822 37786 90523766
Erythema 24.98 15.14 269 66626 228977 90332575
Tooth abscess 24.87 15.14 44 66851 16369 90545183
Skin sensitisation 24.85 15.14 13 66882 1002 90560550
Biliary colic 24.84 15.14 22 66873 4041 90557511
Urine viscosity increased 24.83 15.14 6 66889 42 90561510
5-hydroxyindolacetic acid in urine 24.67 15.14 5 66890 13 90561539
Musculoskeletal chest pain 24.29 15.14 54 66841 23696 90537856
Alanine aminotransferase increased 24.26 15.14 31 66864 118307 90443245
Angioedema 23.85 15.14 9 66886 64867 90496685
Joint stiffness 23.82 15.14 14 66881 78028 90483524
Respiratory tract infection 23.81 15.14 7 66888 59071 90502481
Pallor 23.70 15.14 67 66828 34098 90527454
Injection site cyst 23.62 15.14 7 66888 114 90561438
Anaphylactic reaction 23.62 15.14 18 66877 87506 90474046
Pancreatectomy 23.44 15.14 5 66890 18 90561534
Dengue fever 23.37 15.14 12 66883 890 90560662
Mesenteritis 23.29 15.14 9 66886 338 90561214
Deep vein thrombosis 23.28 15.14 20 66875 91600 90469952
Haemorrhoids 23.25 15.14 57 66838 26645 90534907
Fear 23.20 15.14 43 66852 16579 90544973
Small intestine carcinoma 23.01 15.14 10 66885 509 90561043
Scar 22.98 15.14 41 66854 15354 90546198
Cardiac disorder 22.97 15.14 93 66802 56779 90504773
Seizure 22.90 15.14 49 66846 152580 90408972
Faeces soft 22.89 15.14 28 66867 7483 90554069
Pituitary tumour benign 22.68 15.14 16 66879 2116 90559436
SARS-CoV-2 test positive 22.52 15.14 34 66861 11094 90550458
Metastases to peritoneum 22.47 15.14 21 66874 4134 90557418
Large intestine polyp 22.38 15.14 31 66864 9355 90552197
White blood cell count decreased 22.38 15.14 57 66838 167052 90394500
Injection site vesicles 22.28 15.14 21 66874 4179 90557373
Administration site haemorrhage 22.25 15.14 6 66889 68 90561484
Lactic acidosis 22.22 15.14 5 66890 50458 90511094
Tumour compression 22.17 15.14 6 66889 69 90561483
Renal pain 22.17 15.14 28 66867 7731 90553821
Pancytopenia 22.16 15.14 34 66861 120229 90441323
Tumour pain 22.05 15.14 15 66880 1872 90559680
Metastases to pelvis 22.01 15.14 10 66885 566 90560986
Product dose omission issue 21.86 15.14 126 66769 291561 90269991
Blood gastrin increased 21.80 15.14 5 66890 27 90561525
Syncope 21.74 15.14 170 66725 132493 90429059
Foetal exposure during pregnancy 21.65 15.14 3 66892 42972 90518580
Dysphonia 21.51 15.14 98 66797 62986 90498566
Insulin-like growth factor abnormal 21.35 15.14 5 66890 30 90561522
Frequent bowel movements 21.35 15.14 91 66804 56844 90504708
Thirst 21.32 15.14 41 66854 16254 90545298
Road traffic accident 21.24 15.14 29 66866 107597 90453955
Chondroma 21.21 15.14 5 66890 31 90561521
Oxygen saturation decreased 21.17 15.14 29 66866 107454 90454098
Metastases to neck 20.96 15.14 6 66889 86 90561466
Pancreatic carcinoma recurrent 20.96 15.14 6 66889 86 90561466
Gastric dilatation 20.89 15.14 13 66882 1394 90560158
Blood urine present 20.82 15.14 42 66853 17236 90544316
Diaphragmatic spasm 20.81 15.14 4 66891 7 90561545
Sedation 20.76 15.14 5 66890 48166 90513386
Electrocardiogram QT prolonged 20.73 15.14 14 66881 72442 90489110
Fear-related avoidance of activities 20.48 15.14 7 66888 184 90561368
Bile output increased 20.45 15.14 5 66890 37 90561515
Gastroenteropancreatic neuroendocrine tumour disease 20.45 15.14 5 66890 37 90561515
Feeding disorder 20.43 15.14 42 66853 17470 90544082
Gastrointestinal wall thickening 20.36 15.14 15 66880 2122 90559430
Injection site hypertrophy 20.35 15.14 6 66889 96 90561456
Gallbladder neoplasm 20.33 15.14 5 66890 38 90561514
Chronic obstructive pulmonary disease 20.16 15.14 15 66880 73814 90487738
Oedema 20.00 15.14 78 66817 200217 90361335
Emotional disorder 19.94 15.14 38 66857 14959 90546593
Hallucination 19.89 15.14 12 66883 65947 90495605
Gastrooesophageal reflux disease 19.85 15.14 60 66835 166277 90395275
Cardio-respiratory arrest 19.73 15.14 11 66884 63129 90498423
Bite 19.71 15.14 9 66886 515 90561037
Gastrointestinal disorder 19.70 15.14 110 66785 256577 90304975
Crystal arthropathy 19.70 15.14 8 66887 343 90561209
Multiple sclerosis relapse 19.66 15.14 7 66888 52298 90509254
Hepatic cancer 19.62 15.14 21 66874 4860 90556692
Ovarian cyst 19.57 15.14 41 66854 17277 90544275
Product storage error 19.56 15.14 45 66850 20196 90541356
Head injury 19.56 15.14 59 66836 31129 90530423
Skin plaque 19.51 15.14 30 66865 9945 90551607
Lymphatic system neoplasm 19.48 15.14 5 66890 46 90561506
Abdominal mass 19.44 15.14 18 66877 3503 90558049
Metastases to lung 19.42 15.14 39 66856 15952 90545600
Upper respiratory tract infection 19.41 15.14 41 66854 128277 90433275
Metastases to uterus 19.38 15.14 6 66889 114 90561438
Calcinosis 19.35 15.14 16 66879 2679 90558873
Injection site nodule 19.33 15.14 20 66875 4453 90557099
Carcinoid tumour of the small bowel 19.31 15.14 4 66891 12 90561540
5-hydroxyindolacetic acid 19.31 15.14 4 66891 12 90561540
Discomfort 19.24 15.14 121 66774 274214 90287338
Urine calcium/creatinine ratio increased 19.24 15.14 6 66889 117 90561435
Ascites 19.23 15.14 78 66817 47662 90513890
Spinal cord injury lumbar 19.20 15.14 5 66890 49 90561503
Periarticular disorder 19.02 15.14 5 66890 51 90561501
Bone cancer 18.92 15.14 13 66882 1649 90559903
Metastases to bladder 18.91 15.14 7 66888 233 90561319
Vulval disorder 18.91 15.14 12 66883 1332 90560220
Hypersomnia 18.79 15.14 46 66849 21485 90540067
Faeces hard 18.73 15.14 17 66878 3225 90558327
Gallbladder oedema 18.72 15.14 7 66888 240 90561312
Exertional headache 18.64 15.14 3 66892 0 90561552
Rubber sensitivity 18.63 15.14 16 66879 2821 90558731
Spinal pain 18.61 15.14 38 66857 15729 90545823
Product quality issue 18.57 15.14 111 66784 79214 90482338
Hepatitis 18.52 15.14 15 66880 70724 90490828
Pituitary enlargement 18.51 15.14 5 66890 57 90561495
Metastases to spine 18.50 15.14 18 66877 3725 90557827
Coccydynia 18.42 15.14 14 66881 2077 90559475
Early satiety 18.41 15.14 12 66883 1395 90560157
Insulinoma 18.35 15.14 6 66889 137 90561415
Iliac artery occlusion 18.34 15.14 7 66888 254 90561298
Macular degeneration 18.33 15.14 3 66892 37967 90523585
Endometrial cancer stage I 18.32 15.14 7 66888 255 90561297
Injection site haematoma 18.24 15.14 24 66871 6898 90554654
Excessive cerumen production 18.13 15.14 9 66886 621 90560931
Spleen disorder 18.11 15.14 11 66884 1130 90560422
Plasma cell myeloma 18.06 15.14 4 66891 40824 90520728
Body height decreased 18.06 15.14 32 66863 11917 90549635
Arthropod bite 18.04 15.14 27 66868 8740 90552812
Multiple endocrine neoplasia Type 1 18.04 15.14 4 66891 18 90561534
Wrong technique in product usage process 17.96 15.14 102 66793 71469 90490083
Neck mass 17.95 15.14 18 66877 3864 90557688
Duodenal ulcer 17.67 15.14 28 66867 9524 90552028
Concomitant disease aggravated 17.61 15.14 31 66864 11487 90550065
Trichoglossia 17.57 15.14 8 66887 455 90561097
Rib fracture 17.52 15.14 51 66844 26384 90535168
Bile acid malabsorption 17.51 15.14 7 66888 288 90561264
Dyspnoea 17.49 15.14 506 66389 880449 89681103
Suicide attempt 17.35 15.14 18 66877 75381 90486171
Cyst 17.33 15.14 38 66857 16523 90545029
Functional gastrointestinal disorder 17.29 15.14 20 66875 5042 90556510
Urinary incontinence 17.27 15.14 64 66831 37502 90524050
Venous haemorrhage 17.15 15.14 7 66888 304 90561248
Ovarian cancer 17.12 15.14 23 66872 6744 90554808
Gastritis fungal 16.96 15.14 6 66889 175 90561377
Delirium 16.93 15.14 32 66863 104327 90457225
Musculoskeletal pain 16.85 15.14 197 66698 171054 90390498
Blood thyroid stimulating hormone decreased 16.85 15.14 21 66874 5719 90555833
Tumour necrosis 16.79 15.14 10 66885 991 90560561
Weight increased 16.66 15.14 213 66682 417714 90143838
Polyuria 16.63 15.14 28 66867 10012 90551540
Urethral caruncle 16.62 15.14 5 66890 86 90561466
Endocrine neoplasm 16.56 15.14 3 66892 3 90561549
Vasoactive intestinal polypeptide increased 16.56 15.14 3 66892 3 90561549
Aspartate aminotransferase increased 16.32 15.14 32 66863 102905 90458647
Cardiac failure congestive 16.25 15.14 30 66865 98664 90462888
Treatment noncompliance 16.18 15.14 9 66886 51718 90509834
Abdominal rigidity 16.16 15.14 14 66881 2498 90559054
Anger 16.11 15.14 33 66862 13687 90547865
Tenderness 16.08 15.14 50 66845 26818 90534734
Metastases to lymph nodes 16.02 15.14 30 66865 11659 90549893
Cortisol decreased 15.99 15.14 12 66883 1747 90559805
Zinc deficiency 15.91 15.14 5 66890 100 90561452
Hypoacusis 15.90 15.14 51 66844 27799 90533753
Onychomycosis 15.87 15.14 4 66891 37372 90524180
Lethargy 15.85 15.14 90 66805 63049 90498503
Flank pain 15.65 15.14 40 66855 19182 90542370
Abdominal neoplasm 15.61 15.14 7 66888 384 90561168
Pulse abnormal 15.58 15.14 15 66880 3064 90558488
Muscle neoplasm 15.57 15.14 4 66891 37 90561515
Concomitant disease progression 15.50 15.14 13 66882 2219 90559333
Endometriosis 15.45 15.14 21 66874 6227 90555325
Hospitalisation 15.43 15.14 46 66849 128054 90433498
Infrequent bowel movements 15.27 15.14 11 66884 1503 90560049
Iodine allergy 15.25 15.14 9 66886 877 90560675

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
Needle issue 1504.69 15.09 507 47488 8220 42565120
Blood pressure systolic increased 1232.83 15.09 610 47385 27358 42545982
Body temperature decreased 1030.06 15.09 440 47555 13973 42559367
Blood pressure increased 824.49 15.09 775 47220 101153 42472187
Injection site pain 650.96 15.09 531 47464 57267 42516073
Malignant neoplasm progression 527.05 15.09 629 47366 107771 42465569
Inappropriate schedule of product administration 442.32 15.09 542 47453 95360 42477980
Heart rate decreased 437.20 15.09 348 47647 36184 42537156
Blood pressure diastolic decreased 405.89 15.09 209 47786 10166 42563174
Metastases to liver 377.58 15.09 233 47762 16093 42557247
Injection site mass 336.16 15.09 173 47822 8402 42564938
Hepatic neoplasm 276.48 15.09 101 47894 2090 42571250
Blood growth hormone increased 264.44 15.09 73 47922 571 42572769
Insulin-like growth factor increased 223.83 15.09 80 47915 1551 42571789
Abdominal pain 195.10 15.09 562 47433 189909 42383431
Drug interaction 188.99 15.09 36 47959 266963 42306377
Injection site haemorrhage 187.46 15.09 133 47862 11603 42561737
Blood chromogranin A increased 186.02 15.09 48 47947 280 42573060
Second primary malignancy 182.47 15.09 121 47874 9454 42563886
Hepatic lesion 179.97 15.09 92 47903 4402 42568938
Malaise 178.16 15.09 584 47411 211572 42361768
Blood pressure diastolic increased 175.52 15.09 102 47893 6303 42567037
Weight decreased 175.12 15.09 573 47422 207375 42365965
Flushing 168.27 15.09 208 47787 36820 42536520
Syringe issue 167.60 15.09 110 47885 8446 42564894
Acute kidney injury 164.32 15.09 106 47889 367231 42206109
Cholelithiasis 160.89 15.09 163 47832 23183 42550157
Diarrhoea 145.95 15.09 951 47044 459898 42113442
Toxicity to various agents 142.10 15.09 41 47954 229095 42344245
Carcinoid crisis 140.17 15.09 37 47958 239 42573101
Pain 136.36 15.09 591 47404 244257 42329083
Abdominal distension 129.77 15.09 264 47731 71471 42501869
Febrile neutropenia 129.26 15.09 26 47969 185677 42387663
Flatulence 123.54 15.09 147 47848 25005 42548335
Intestinal obstruction 122.46 15.09 152 47843 27006 42546334
Neoplasm progression 119.21 15.09 155 47840 28845 42544495
Neutropenia 117.66 15.09 39 47956 199392 42373948
Stress 114.46 15.09 190 47805 44022 42529318
Nasopharyngitis 109.17 15.09 271 47724 83725 42489615
Underdose 106.93 15.09 112 47883 16554 42556786
Neoplasm 106.60 15.09 74 47921 6231 42567109
Blood pressure decreased 101.14 15.09 211 47784 58121 42515219
Condition aggravated 97.64 15.09 90 47905 260664 42312676
Carcinoid syndrome 90.36 15.09 22 47973 97 42573243
Off label use 86.62 15.09 398 47597 637937 41935403
Blood mercury abnormal 84.47 15.09 25 47970 257 42573083
Blood glucose increased 82.61 15.09 225 47770 73474 42499866
Gait disturbance 80.41 15.09 268 47727 97732 42475608
Biliary obstruction 79.51 15.09 48 47947 3181 42570159
Movement disorder 75.64 15.09 88 47907 14610 42558730
5-hydroxyindolacetic acid in urine increased 74.68 15.09 21 47974 177 42573163
Injection site swelling 73.32 15.09 93 47902 16880 42556460
Pneumonia 71.92 15.09 240 47755 421909 42151431
Hormone level abnormal 71.40 15.09 25 47970 455 42572885
Fatigue 69.45 15.09 772 47223 434869 42138471
Heart rate increased 68.28 15.09 171 47824 53084 42520256
Injection site discomfort 65.97 15.09 38 47957 2308 42571032
Faeces soft 65.63 15.09 50 47945 4862 42568478
Metastasis 65.32 15.09 49 47946 4656 42568684
Neuroendocrine tumour 64.89 15.09 28 47967 908 42572432
Heart rate irregular 64.72 15.09 85 47910 15965 42557375
5-hydroxyindolacetic acid increased 60.93 15.09 16 47979 101 42573239
Thrombocytopenia 60.74 15.09 75 47920 190204 42383136
Eating disorder 59.10 15.09 64 47931 9821 42563519
Back pain 56.94 15.09 312 47683 141464 42431876
Pancreatic neuroendocrine tumour 56.70 15.09 19 47976 301 42573039
Serum serotonin increased 56.54 15.09 15 47980 99 42573241
Pituitary tumour 55.74 15.09 22 47973 566 42572774
Pancytopenia 55.21 15.09 32 47963 117711 42455629
Faecal volume decreased 54.99 15.09 17 47978 205 42573135
Incorrect dose administered 54.68 15.09 157 47838 52817 42520523
Metastases to bone 54.48 15.09 75 47920 14734 42558606
Hyponatraemia 54.47 15.09 23 47972 101439 42471901
Hot flush 52.46 15.09 92 47903 22259 42551081
Electrocardiogram T wave alternans 52.19 15.09 14 47981 97 42573243
Overdose 51.68 15.09 27 47968 105237 42468103
Intentional product misuse 51.57 15.09 5 47990 61895 42511445
Polyp 50.98 15.09 42 47953 4572 42568768
Respiratory failure 50.56 15.09 42 47953 128090 42445250
Infusion related reaction 50.43 15.09 5 47990 60801 42512539
Blood cholesterol abnormal 50.23 15.09 30 47965 1949 42571391
Neuropathy peripheral 50.19 15.09 26 47969 101827 42471513
Transfusion-related circulatory overload 50.04 15.09 22 47973 747 42572593
Biliary colic 50.02 15.09 25 47970 1139 42572201
Asthenia 49.92 15.09 509 47486 280284 42293056
Cardiac failure congestive 48.25 15.09 18 47977 85584 42487756
Rhabdomyolysis 48.20 15.09 14 47981 78005 42495335
Atrial fibrillation 47.78 15.09 52 47943 139541 42433799
Low density lipoprotein decreased 47.34 15.09 25 47970 1279 42572061
Anaemia 47.17 15.09 160 47835 280118 42293222
Sepsis 46.25 15.09 97 47898 199237 42374103
Feeling abnormal 46.22 15.09 178 47817 69608 42503732
Contusion 45.84 15.09 127 47868 41858 42531482
Discomfort 45.76 15.09 93 47902 25126 42548214
Steatorrhoea 45.08 15.09 21 47974 818 42572522
Rhinorrhoea 44.91 15.09 106 47889 31688 42541652
Metastases to pancreas 44.65 15.09 17 47978 396 42572944
Intentional product use issue 44.17 15.09 13 47982 71820 42501520
Peripheral swelling 44.14 15.09 210 47785 90060 42483280
Rash 43.34 15.09 163 47832 276791 42296549
Influenza 43.17 15.09 161 47834 62014 42511326
Musculoskeletal chest pain 43.11 15.09 58 47937 11146 42562194
Metastases to spine 42.61 15.09 32 47963 3045 42570295
Diaphragmatic spasm 42.38 15.09 12 47983 104 42573236
Respiratory rate increased 42.16 15.09 57 47938 11005 42562335
Necrotising colitis 41.64 15.09 23 47972 1288 42572052
Feeling cold 40.82 15.09 61 47934 12912 42560428
Carcinoid heart disease 40.72 15.09 9 47986 23 42573317
Acute myocardial infarction 40.71 15.09 8 47987 58157 42515183
Suicide attempt 40.38 15.09 3 47992 46097 42527243
Nervousness 40.27 15.09 62 47933 13470 42559870
Product quality issue 39.90 15.09 72 47923 17810 42555530
Pain in extremity 39.75 15.09 298 47697 150306 42423034
Intestinal metastasis 39.65 15.09 15 47980 343 42572997
Blood test abnormal 39.63 15.09 60 47935 12846 42560494
Musculoskeletal pain 39.55 15.09 104 47891 33236 42540104
Blood glucose abnormal 39.28 15.09 44 47951 7009 42566331
Loss of personal independence in daily activities 39.04 15.09 5 47990 49811 42523529
Injection site oedema 38.98 15.09 15 47980 360 42572980
Foetal exposure during pregnancy 38.94 15.09 4 47991 47307 42526033
Drug ineffective 38.68 15.09 490 47505 629707 41943633
Coronary artery disease 38.43 15.09 7 47988 53713 42519627
Yellow skin 38.32 15.09 27 47968 2327 42571013
Blood glucose decreased 37.97 15.09 62 47933 14157 42559183
Anti factor V antibody 37.81 15.09 14 47981 301 42573039
Blood creatine phosphokinase increased 37.52 15.09 5 47990 48333 42525007
Faeces discoloured 37.32 15.09 68 47927 16946 42556394
Metastases to pelvis 37.05 15.09 15 47980 413 42572927
Bowel movement irregularity 36.92 15.09 31 47964 3465 42569875
Erythema 36.88 15.09 229 47766 108564 42464776
Angioedema 36.55 15.09 3 47992 42474 42530866
Mass 36.35 15.09 47 47948 8692 42564648
Abnormal faeces 35.66 15.09 32 47963 3909 42569431
Nerve degeneration 35.64 15.09 12 47983 193 42573147
Gastric hypomotility 35.03 15.09 12 47983 204 42573136
Abdominal pain upper 34.61 15.09 184 47811 82425 42490915
Sciatica 34.38 15.09 42 47953 7335 42566005
Dizziness 33.91 15.09 429 47566 248825 42324515
Asthma 33.64 15.09 14 47981 62300 42511040
Lacrimal disorder 33.43 15.09 13 47982 321 42573019
Death 32.96 15.09 727 47268 470458 42102882
Suicidal ideation 32.93 15.09 7 47988 48154 42525186
Hypoxia 32.65 15.09 19 47976 69767 42503573
Terminal state 32.51 15.09 32 47963 4391 42568949
Blood growth hormone abnormal 32.31 15.09 6 47989 3 42573337
Cardio-respiratory arrest 31.93 15.09 13 47982 58623 42514717
Metastases to thorax 31.78 15.09 9 47986 78 42573262
Blood glucose fluctuation 31.53 15.09 32 47963 4555 42568785
Psoriasis 31.37 15.09 8 47987 48596 42524744
Intra-abdominal fluid collection 31.09 15.09 20 47975 1483 42571857
Intestinal intraepithelial lymphocytes increased 31.02 15.09 11 47984 208 42573132
Interstitial lung disease 30.59 15.09 26 47969 78436 42494904
Neuroendocrine carcinoma metastatic 30.47 15.09 10 47985 148 42573192
Renal mass 30.38 15.09 22 47973 1980 42571360
Neutrophil count decreased 30.04 15.09 17 47978 63398 42509942
Somnolence 29.98 15.09 72 47923 141033 42432307
Hepatic pain 29.95 15.09 20 47975 1580 42571760
Needle track marks 29.51 15.09 8 47987 58 42573282
Recurrent cancer 29.14 15.09 20 47975 1653 42571687
Multiple organ dysfunction syndrome 29.12 15.09 40 47955 96995 42476345
Myocardial infarction 29.03 15.09 60 47935 123949 42449391
White blood cell count decreased 28.83 15.09 50 47945 110346 42462994
Decreased appetite 28.67 15.09 338 47657 192799 42380541
Arthralgia 28.64 15.09 355 47640 204883 42368457
Expired product administered 28.54 15.09 29 47966 4134 42569206
Blood urine present 28.45 15.09 49 47946 11684 42561656
Abdominal discomfort 28.43 15.09 163 47832 75092 42498248
Shunt malfunction 28.35 15.09 11 47984 270 42573070
Lactic acidosis 28.17 15.09 8 47987 45253 42528087
Metastases to lung 28.08 15.09 48 47947 11376 42561964
Cryptitis 27.98 15.09 11 47984 280 42573060
Labyrinthitis 27.92 15.09 16 47979 962 42572378
Pulse abnormal 27.79 15.09 18 47977 1350 42571990
Nephrolithiasis 27.78 15.09 98 47897 36732 42536608
Blood potassium decreased 27.75 15.09 67 47928 20317 42553023
Metastases to lymph nodes 27.71 15.09 34 47961 5964 42567376
Product storage error 27.64 15.09 47 47948 11093 42562247
Bone neoplasm 27.62 15.09 11 47984 290 42573050
Deep vein thrombosis 27.06 15.09 28 47967 76929 42496411
Therapeutic product effect incomplete 27.06 15.09 24 47971 70915 42502425
Blood follicle stimulating hormone increased 27.05 15.09 10 47985 214 42573126
Alanine aminotransferase increased 26.98 15.09 36 47959 88370 42484970
Cardiogenic shock 26.92 15.09 4 47991 35636 42537704
Viral diarrhoea 26.77 15.09 11 47984 315 42573025
Parathyroid hormone-related protein abnormal 26.70 15.09 6 47989 17 42573323
Frequent bowel movements 26.65 15.09 68 47927 21339 42552001
Gastrinoma 26.55 15.09 7 47988 45 42573295
Leukopenia 26.51 15.09 27 47968 74719 42498621
Septic shock 26.31 15.09 39 47956 91633 42481707
Microvillous inclusion disease 26.26 15.09 10 47985 233 42573107
Musculoskeletal discomfort 26.23 15.09 42 47953 9434 42563906
Hypoglycaemia 26.22 15.09 135 47860 59719 42513621
Inner ear disorder 26.22 15.09 10 47985 234 42573106
Therapeutic product effect decreased 26.14 15.09 6 47989 39144 42534196
Product dose omission issue 26 15.09 88 47907 154277 42419063
White coat hypertension 25.89 15.09 11 47984 343 42572997
Hyperoxaluria 25.85 15.09 9 47986 161 42573179
Insulinoma 25.74 15.09 6 47989 21 42573319
Groin pain 25.65 15.09 33 47962 6071 42567269
Cardiac failure 25.60 15.09 51 47944 106805 42466535
Hyperkalaemia 25.33 15.09 32 47963 80426 42492914
Carcinoid tumour 25.27 15.09 10 47985 259 42573081
Eructation 25.19 15.09 31 47964 5455 42567885
Blood pressure fluctuation 25.14 15.09 77 47918 26831 42546509
Tubulointerstitial nephritis 25.12 15.09 3 47992 31545 42541795
Hepatic mass 25.00 15.09 16 47979 1176 42572164
Vital functions abnormal 24.79 15.09 11 47984 382 42572958
Treatment noncompliance 24.70 15.09 6 47989 37666 42535674
Oropharyngeal pain 24.60 15.09 104 47891 42406 42530934
Adrenal cyst 24.60 15.09 9 47986 187 42573153
Hernia pain 24.31 15.09 10 47985 287 42573053
Bite 24.28 15.09 8 47987 120 42573220
Sedation 24.02 15.09 3 47992 30472 42542868
Hernia 23.96 15.09 44 47951 11029 42562311
Limb injury 23.90 15.09 51 47944 14254 42559086
Cardiac arrest 23.84 15.09 55 47940 109265 42464075
Cortisol free urine increased 23.81 15.09 5 47990 9 42573331
Concomitant disease aggravated 23.69 15.09 33 47962 6553 42566787
Body temperature increased 23.63 15.09 63 47932 20295 42553045
Injection site erosion 23.63 15.09 8 47987 131 42573209
Blood growth hormone decreased 23.55 15.09 6 47989 33 42573307
Anxiety 23.47 15.09 220 47775 118340 42455000
Blood creatinine increased 23.46 15.09 56 47939 109947 42463393
Unevaluable event 23.40 15.09 5 47990 34283 42539057
Drug-induced liver injury 23.39 15.09 7 47988 38266 42535074
Blood iron decreased 23.24 15.09 32 47963 6286 42567054
Chest wall tumour 23.16 15.09 4 47991 0 42573340
Oncologic complication 23.06 15.09 11 47984 452 42572888
Limb discomfort 23.06 15.09 47 47948 12720 42560620
Flank pain 22.99 15.09 35 47960 7528 42565812
Infrequent bowel movements 22.90 15.09 15 47980 1147 42572193
Hypertrophic osteoarthropathy 22.75 15.09 7 47988 83 42573257
Psychotic disorder 22.72 15.09 3 47992 29205 42544135
Haematuria 22.71 15.09 19 47976 57780 42515560
Cough 22.70 15.09 303 47692 177800 42395540
COVID-19 22.44 15.09 62 47933 115886 42457454
Anaphylactic reaction 22.43 15.09 10 47985 42733 42530607
Probiotic therapy 22.38 15.09 8 47987 155 42573185
Metastases to gastrointestinal tract 22.30 15.09 7 47988 89 42573251
Metastases to spleen 22.07 15.09 11 47984 498 42572842
Respiratory arrest 21.91 15.09 3 47992 28421 42544919
Mental status changes 21.87 15.09 10 47985 42105 42531235
Accidental overdose 21.82 15.09 3 47992 28327 42545013
Metastatic carcinoid tumour 21.61 15.09 6 47989 48 42573292
Cytomegalovirus infection 21.47 15.09 5 47990 32301 42541039
Ear congestion 21.40 15.09 12 47983 692 42572648
Encephalopathy 21.18 15.09 10 47985 41323 42532017
Disturbance in attention 21.12 15.09 4 47991 29862 42543478
Metastases to eye 21 15.09 7 47988 109 42573231
Rash maculo-papular 20.93 15.09 8 47987 37495 42535845
Prostatomegaly 20.81 15.09 30 47965 6147 42567193
Metastases to oesophagus 20.73 15.09 5 47990 21 42573319
Apoptosis 20.49 15.09 11 47984 582 42572758
Chills 20.37 15.09 178 47817 93888 42479452
Device toxicity 20.36 15.09 5 47990 23 42573317
Crystal arthropathy 20.33 15.09 6 47989 61 42573279
Product deposit 20.31 15.09 10 47985 441 42572899
Pancreatic neoplasm 20.24 15.09 13 47982 961 42572379
Scan gallium abnormal 20.19 15.09 5 47990 24 42573316
Pulmonary fibrosis 20.14 15.09 3 47992 26678 42546662
Respiratory distress 20.11 15.09 11 47984 41809 42531531
Saliva altered 20.01 15.09 8 47987 213 42573127
Breath odour 19.89 15.09 13 47982 990 42572350
Injection site induration 19.84 15.09 22 47973 3465 42569875
Depressed level of consciousness 19.82 15.09 15 47980 47955 42525385
Respiratory tract infection 19.78 15.09 3 47992 26319 42547021
Renal failure 19.68 15.09 89 47906 143637 42429703
Fibrous histiocytoma 19.40 15.09 9 47986 347 42572993
Tumour marker increased 19.38 15.09 12 47983 832 42572508
Ventricular fibrillation 19.36 15.09 5 47990 30118 42543222
Acute respiratory distress syndrome 19.34 15.09 5 47990 30103 42543237
Pyrexia 19.28 15.09 320 47675 393722 42179618
Glycosylated haemoglobin increased 19.24 15.09 44 47951 12880 42560460
Lumbar hernia 19.19 15.09 7 47988 144 42573196
Hallucination 19.03 15.09 22 47973 57485 42515855
Eating disorder symptom 18.98 15.09 5 47990 32 42573308
Hypotension 18.96 15.09 192 47803 257439 42315901
Injection site injury 18.89 15.09 9 47986 369 42572971
Device occlusion 18.82 15.09 34 47961 8416 42564924
Neck mass 18.70 15.09 16 47979 1834 42571506
Arterial occlusive disease 18.60 15.09 24 47971 4429 42568911
Ear discomfort 18.58 15.09 21 47974 3378 42569962
Nausea 18.58 15.09 581 47414 396218 42177122
Injection site inflammation 18.53 15.09 13 47982 1113 42572227
Cerebrospinal fluid leakage 18.52 15.09 11 47984 707 42572633
Sinus arrest 18.52 15.09 17 47978 2139 42571201
Skin exfoliation 18.48 15.09 12 47983 41541 42531799
Nightmare 18.45 15.09 3 47992 25009 42548331
Eosinophilia 18.39 15.09 7 47988 32892 42540448
Dizziness postural 18.18 15.09 32 47963 7763 42565577
Tongue haemorrhage 18.07 15.09 11 47984 740 42572600
Toxic epidermal necrolysis 18.05 15.09 4 47991 26746 42546594
Chronic kidney disease 17.99 15.09 16 47979 47225 42526115
Abdominal pain lower 17.82 15.09 41 47954 12051 42561289
High frequency ablation 17.77 15.09 7 47988 179 42573161
Upper respiratory tract infection 17.66 15.09 13 47982 42160 42531180
Renal neoplasm 17.51 15.09 14 47981 1461 42571879
Product prescribing error 17.43 15.09 4 47991 26108 42547232
Pancreatic polypeptide level decreased 17.37 15.09 3 47992 0 42573340
Neuroendocrine tumour of the lung 17.37 15.09 3 47992 0 42573340
Thyroid mass 17.24 15.09 11 47984 804 42572536
Abdominal neoplasm 17.21 15.09 9 47986 451 42572889
Haemoptysis 17.15 15.09 16 47979 46151 42527189
Arthritis 17.13 15.09 93 47902 41972 42531368
Neurotoxicity 17.09 15.09 3 47992 23648 42549692
Plasma cell myeloma 17.08 15.09 17 47978 47561 42525779
Pulmonary embolism 17.02 15.09 73 47922 119539 42453801
Anaphylactic shock 16.95 15.09 3 47992 23514 42549826
Seizure 16.90 15.09 74 47921 120487 42452853
Cerebral infarction 16.82 15.09 7 47988 31162 42542178
Hepatic function abnormal 16.77 15.09 20 47975 51547 42521793
Cardiac valve disease 16.75 15.09 20 47975 3411 42569929
Bone cancer 16.63 15.09 15 47980 1844 42571496
Bursitis infective 16.63 15.09 10 47985 658 42572682
Premature baby 16.59 15.09 3 47992 23150 42550190
Drug dependence 16.59 15.09 6 47989 29088 42544252
Delirium 16.41 15.09 21 47974 52498 42520842
Faeces pale 16.40 15.09 14 47981 1600 42571740
Skin warm 16.39 15.09 18 47977 2805 42570535
No adverse event 16.38 15.09 12 47983 39009 42534331
Coma 16.14 15.09 22 47973 53532 42519808
Procedural hypertension 16.12 15.09 5 47990 61 42573279
Cachexia 16.04 15.09 31 47964 8073 42565267
Sciatic nerve injury 15.95 15.09 6 47989 135 42573205
Rash pruritic 15.92 15.09 9 47986 33594 42539746
Pancreatic neuroendocrine tumour metastatic 15.91 15.09 6 47989 136 42573204
Injection site bruising 15.81 15.09 38 47957 11487 42561853
Acute myeloid leukaemia 15.70 15.09 3 47992 22253 42551087
Ischaemic stroke 15.68 15.09 3 47992 22230 42551110
Pneumonia aspiration 15.67 15.09 20 47975 50058 42523282
Medication error 15.54 15.09 9 47986 33145 42540195
Oxygen saturation decreased 15.38 15.09 31 47964 64656 42508684
Urine uric acid increased 15.29 15.09 3 47992 3 42573337
Staphylococcal infection 15.26 15.09 12 47983 37631 42535709
Bone pain 15.18 15.09 60 47935 23732 42549608
Tachypnoea 15.11 15.09 3 47992 21659 42551681

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
Needle issue 2857.57 13.89 931 99878 16909 110471581
Blood pressure systolic increased 2520.36 13.89 1314 99495 81677 110406813
Body temperature decreased 2101.24 13.89 902 99907 36033 110452457
Blood pressure increased 1725.80 13.89 1608 99201 256765 110231725
Injection site pain 1269.63 13.89 1150 99659 176772 110311718
Malignant neoplasm progression 1217.52 13.89 1114 99695 173453 110315037
Inappropriate schedule of product administration 1052.42 13.89 1103 99706 202534 110285956
Injection site mass 1001.51 13.89 476 100333 24137 110464353
Blood pressure diastolic decreased 908.18 13.89 504 100305 35381 110453109
Heart rate decreased 839.95 13.89 656 100153 82100 110406390
Metastases to liver 622.44 13.89 393 100416 34993 110453497
Blood growth hormone increased 561.63 13.89 141 100668 927 110487563
Insulin-like growth factor increased 417.22 13.89 132 100677 2164 110486326
Flatulence 416.88 13.89 360 100449 51789 110436701
Hepatic lesion 397.38 13.89 181 100628 8312 110480178
Abdominal pain 391.75 13.89 1190 99619 511799 109976691
Injection site haemorrhage 379.30 13.89 282 100527 32746 110455744
Blood pressure diastolic increased 366.47 13.89 223 100586 18584 110469906
Second primary malignancy 361.75 13.89 218 100591 17850 110470640
Hepatic neoplasm 346.21 13.89 131 100678 3736 110484754
Stress 329.40 13.89 442 100367 104906 110383584
Cholelithiasis 318.82 13.89 339 100470 63083 110425407
Abdominal distension 315.98 13.89 570 100239 174533 110313957
Carcinoid crisis 310.47 13.89 77 100732 478 110488012
Infusion related reaction 309.86 13.89 8 100801 381154 110107336
Blood chromogranin A increased 298.74 13.89 79 100730 654 110487836
Blood pressure decreased 294.84 13.89 439 100370 114652 110373838
Weight decreased 290.43 13.89 1012 99797 467045 110021445
Diarrhoea 278.85 13.89 1882 98927 1137623 109350867
Syringe issue 263.59 13.89 142 100667 9383 110479107
Toxicity to various agents 263.50 13.89 58 100751 480497 110007993
Intestinal obstruction 254.33 13.89 277 100532 52950 110435540
Flushing 247.73 13.89 385 100424 104351 110384139
Neoplasm progression 244.39 13.89 298 100511 64297 110424193
Malaise 238.58 13.89 1225 99584 670594 109817896
Condition aggravated 237.82 13.89 193 100616 734643 109753847
Drug interaction 235.69 13.89 81 100728 500102 109988388
Synovitis 233.89 13.89 3 100806 274089 110214401
Mass 226.24 13.89 168 100641 19462 110469028
Off label use 215.50 13.89 679 100130 1499506 108988984
Acute kidney injury 212.98 13.89 161 100648 635269 109853221
Injection site discomfort 211.01 13.89 110 100699 6797 110481693
Blood glucose increased 197.77 13.89 398 100411 132098 110356392
Completed suicide 197.24 13.89 5 100804 242376 110246114
Neoplasm 192.05 13.89 122 100687 10965 110477525
Metastasis 176.55 13.89 104 100705 8163 110480327
Back pain 175.31 13.89 736 100073 370260 110118230
Rheumatoid arthritis 172.79 13.89 32 100777 299581 110188909
Contraindicated product administered 170.83 13.89 15 100794 248252 110240238
Blood glucose decreased 166.85 13.89 168 100641 29320 110459170
Nervousness 166.04 13.89 186 100623 36665 110451825
Glossodynia 165.54 13.89 9 100800 221995 110266495
Therapeutic product effect decreased 164.79 13.89 16 100793 244300 110244190
Intentional product use issue 160.15 13.89 19 100790 247887 110240603
Diabetes mellitus 154.86 13.89 304 100505 99077 110389413
Pericarditis 154.17 13.89 12 100797 219102 110269388
Hand deformity 148.18 13.89 14 100795 218492 110269998
Rash 147.39 13.89 332 100477 820632 109667858
Arthropathy 147.15 13.89 40 100769 287482 110201008
Hot flush 146.78 13.89 236 100573 65800 110422690
Polyp 144.08 13.89 98 100711 9882 110478608
Injection site swelling 143.08 13.89 225 100584 61565 110426925
Drug abuse 143.05 13.89 4 100805 177407 110311083
Neuroendocrine tumour 142.93 13.89 54 100755 1533 110486957
Bowel movement irregularity 142 13.89 88 100721 7572 110480918
Neutropenia 140.01 13.89 84 100725 374536 110113954
Maternal exposure during pregnancy 139.10 13.89 31 100778 254852 110233638
Pancreatic neuroendocrine tumour 138.91 13.89 46 100763 877 110487613
Feeling abnormal 137.22 13.89 419 100390 180292 110308198
Carcinoid syndrome 135.45 13.89 35 100774 262 110488228
Febrile neutropenia 134.74 13.89 60 100749 316707 110171783
Drug intolerance 130.99 13.89 107 100702 406405 110082085
Hypersensitivity 126.90 13.89 109 100700 403889 110084601
Eating disorder 125.94 13.89 148 100661 30710 110457780
Impaired healing 124.79 13.89 16 100793 196701 110291789
Underdose 123.68 13.89 214 100595 63340 110425150
Fatigue 123.27 13.89 1667 99142 1214291 109274199
Hepatic pain 121.67 13.89 67 100742 4623 110483867
Faeces discoloured 120.95 13.89 152 100657 33796 110454694
Movement disorder 120.26 13.89 157 100652 36247 110452243
Asthenia 120.11 13.89 1053 99756 687946 109800544
Drug ineffective 119.41 13.89 855 99954 1519685 108968805
Pituitary tumour 117.81 13.89 44 100765 1209 110487281
Heart rate increased 117.23 13.89 342 100467 143492 110344998
Cough 116.05 13.89 769 100040 460872 110027618
Treatment failure 115.58 13.89 54 100755 277180 110211310
Injection site hypersensitivity 113.50 13.89 52 100757 2419 110486071
Carcinoid heart disease 113.18 13.89 24 100785 63 110488427
Serum serotonin increased 113.02 13.89 32 100777 350 110488140
Gait disturbance 109.52 13.89 523 100286 277685 110210805
Overdose 108.04 13.89 39 100770 233755 110254735
Asthma 107.06 13.89 47 100762 250244 110238246
Intentional overdose 106.77 13.89 3 100806 132498 110355992
Insulin-like growth factor decreased 106.25 13.89 34 100775 579 110487911
Exposure during pregnancy 105.27 13.89 14 100795 167410 110321080
Hepatic enzyme increased 105.18 13.89 83 100726 320809 110167681
Limb discomfort 104.77 13.89 156 100653 40698 110447792
Loss of personal independence in daily activities 103.35 13.89 9 100800 150011 110338479
Injection site induration 102.07 13.89 84 100725 11299 110477191
Influenza 100.56 13.89 361 100448 168740 110319750
Incorrect dose administered 99.86 13.89 262 100547 103379 110385111
Heart rate irregular 99.78 13.89 139 100670 34135 110454355
Blood pressure systolic decreased 99.76 13.89 89 100720 13352 110475138
Muscle injury 98.22 13.89 8 100801 140799 110347691
Terminal state 92.32 13.89 60 100749 5607 110482883
5-hydroxyindolacetic acid increased 92.06 13.89 22 100787 114 110488376
Hypoglycaemia 91.66 13.89 273 100536 115831 110372659
Therapeutic product effect incomplete 91.12 13.89 45 100764 223760 110264730
Metastases to bone 90.99 13.89 127 100682 31245 110457245
Death 90.43 13.89 1004 99805 697865 109790625
Blood mercury abnormal 89.69 13.89 25 100784 257 110488233
Nephrolithiasis 89.47 13.89 191 100618 66021 110422469
Liver injury 88.99 13.89 15 100794 150398 110338092
Intentional product misuse 88.81 13.89 9 100800 132895 110355595
Yellow skin 88.63 13.89 52 100757 4050 110484440
Blister 87.72 13.89 49 100760 227327 110261163
Blood glucose fluctuation 86.73 13.89 65 100744 7633 110480857
Irritable bowel syndrome 85.59 13.89 22 100787 164193 110324297
Drug hypersensitivity 85.15 13.89 179 100630 453911 110034579
Hyponatraemia 83.83 13.89 47 100762 217606 110270884
5-hydroxyindolacetic acid in urine increased 83.63 13.89 22 100787 178 110488312
Biliary obstruction 83.63 13.89 56 100753 5502 110482988
Hormone level abnormal 81.68 13.89 41 100768 2339 110486151
Musculoskeletal discomfort 81.64 13.89 104 100705 23434 110465056
Blood glucose abnormal 81.28 13.89 78 100731 12838 110475652
Abdominal pain lower 81.14 13.89 132 100677 37151 110451339
Faeces soft 80.77 13.89 73 100736 11137 110477353
Fibromyalgia 79.82 13.89 28 100781 170881 110317609
Carcinoid tumour 79.05 13.89 27 100782 568 110487922
Feeling cold 79 13.89 124 100685 33863 110454627
Acne 78.89 13.89 123 100686 33397 110455093
Rhinorrhoea 78.77 13.89 239 100570 102427 110386063
Groin pain 78.43 13.89 83 100726 15345 110473145
Steatorrhoea 77.46 13.89 31 100778 1030 110487460
Urticaria 75.90 13.89 108 100701 318749 110169741
Respiratory rate increased 74.93 13.89 103 100706 24980 110463510
Pain in extremity 74.38 13.89 724 100085 486394 110002096
Abnormal faeces 74.25 13.89 64 100745 9172 110479318
Sleep disorder due to general medical condition, insomnia type 73.69 13.89 6 100803 105637 110382853
Dizziness 73.65 13.89 965 99844 697228 109791262
Metastases to pancreas 73.12 13.89 27 100782 718 110487772
Fall 73.06 13.89 856 99953 602626 109885864
Ill-defined disorder 72.73 13.89 26 100783 156827 110331663
Drug-induced liver injury 70.97 13.89 12 100797 120055 110368435
Blood iron decreased 69.99 13.89 87 100722 19127 110469363
C-reactive protein increased 68.12 13.89 59 100750 217860 110270630
Pulmonary fibrosis 67.95 13.89 7 100802 102035 110386455
Obesity 67.73 13.89 11 100798 113340 110375150
Helicobacter infection 67.59 13.89 41 100768 181836 110306654
Abdominal pain upper 67.24 13.89 546 100263 348565 110139925
Productive cough 67.06 13.89 243 100566 114062 110374428
Psoriasis 66.99 13.89 22 100787 139971 110348519
Joint range of motion decreased 66.07 13.89 15 100794 121817 110366673
Thyroid disorder 65.31 13.89 79 100730 16890 110471600
Sinusitis 65.30 13.89 106 100703 296582 110191908
Recurrent cancer 65.17 13.89 40 100769 3383 110485107
Nasopharyngitis 64.58 13.89 595 100214 393766 110094724
Pancytopenia 64.01 13.89 58 100751 209555 110278935
Musculoskeletal chest pain 63.95 13.89 103 100706 28744 110459746
Prescribed overdose 63.89 13.89 4 100805 87577 110400913
Lip dry 63.80 13.89 8 100801 100075 110388415
Nephritic syndrome 63.41 13.89 22 100787 486 110488004
Diaphragmatic spasm 63.36 13.89 16 100793 108 110488382
Bone pain 63.08 13.89 165 100644 64968 110423522
Metastases to pelvis 62.57 13.89 25 100784 827 110487663
Pancreatic disorder 62.49 13.89 41 100768 3893 110484597
Angioedema 62.48 13.89 8 100801 98492 110389998
Ingrowing nail 61.80 13.89 38 100771 3224 110485266
Hip fracture 61.49 13.89 113 100696 35038 110453452
Blood growth hormone abnormal 61.07 13.89 13 100796 35 110488455
Grip strength decreased 60.53 13.89 3 100806 80171 110408319
Injection site bruising 60.39 13.89 140 100669 51123 110437367
Red blood cell sedimentation rate increased 58.89 13.89 3 100806 78299 110410191
Respiratory failure 58.44 13.89 66 100743 215266 110273224
Thrombocytopenia 57.73 13.89 147 100662 348738 110139752
Anxiety 57.67 13.89 523 100286 344555 110143935
Transfusion-related circulatory overload 57.31 13.89 24 100785 897 110487593
Medication error 57.08 13.89 13 100796 105353 110383137
Erythema 56.74 13.89 457 100352 290990 110197500
Biliary colic 56.71 13.89 41 100768 4556 110483934
Injury 56.61 13.89 47 100762 177218 110311272
Blood urine present 55.71 13.89 88 100721 24157 110464333
Stomatitis 55.40 13.89 101 100708 270141 110218349
Skin discolouration 54.58 13.89 131 100678 48915 110439575
Cardio-respiratory arrest 54.04 13.89 19 100790 115817 110372673
Adverse event 54.03 13.89 16 100793 108793 110379697
Labyrinthitis 53.79 13.89 34 100775 3028 110485462
Pain 53.69 13.89 1192 99617 953763 109534727
Oropharyngeal pain 53.67 13.89 255 100554 135021 110353469
Frustration tolerance decreased 53.57 13.89 52 100757 8679 110479811
Lactic acidosis 53.28 13.89 10 100799 92801 110395689
Infection 52.96 13.89 162 100647 362038 110126452
Acute myocardial infarction 52.66 13.89 7 100802 83770 110404720
Wheezing 52.66 13.89 95 100714 255135 110233355
Colitis ulcerative 52.31 13.89 5 100804 77358 110411132
Neuropathy peripheral 51.94 13.89 52 100757 179225 110309265
Alanine aminotransferase increased 51.33 13.89 55 100754 183718 110304772
Anaphylactic reaction 51.22 13.89 20 100789 114280 110374210
Faeces pale 50.93 13.89 34 100775 3323 110485167
Electrocardiogram T wave alternans 50.67 13.89 14 100795 139 110488351
Leukopenia 50.62 13.89 37 100772 148754 110339736
Neuroendocrine tumour of the lung 50.31 13.89 11 100798 35 110488455
Low density lipoprotein decreased 50.28 13.89 25 100784 1397 110487093
Blood cholesterol abnormal 49.87 13.89 35 100774 3711 110484779
Product deposit 49.40 13.89 20 100789 685 110487805
Mobility decreased 49.32 13.89 88 100721 237334 110251156
Gallbladder disorder 49.25 13.89 77 100732 20952 110467538
Pollakiuria 49.13 13.89 118 100691 44077 110444413
Metastases to spine 49.10 13.89 40 100769 5303 110483187
Cardiac disorder 48.90 13.89 167 100642 76113 110412377
Deep vein thrombosis 48.62 13.89 34 100775 139853 110348637
Cardiac valve disease 48.61 13.89 43 100766 6378 110482112
Adverse drug reaction 48.08 13.89 18 100791 105541 110382949
Pituitary tumour recurrent 47.81 13.89 14 100795 174 110488316
Faecal volume decreased 47.67 13.89 17 100792 408 110488082
Metastases to eye 47.51 13.89 16 100793 322 110488168
Chills 47.48 13.89 317 100492 190263 110298227
Intestinal haemorrhage 47.46 13.89 45 100764 7296 110481194
Bile duct stone 47.38 13.89 42 100767 6247 110482243
Cardiac failure congestive 47.04 13.89 41 100768 150959 110337531
Sciatic nerve injury 47.03 13.89 20 100789 777 110487713
Musculoskeletal stiffness 46.98 13.89 117 100692 279705 110208785
Neuroendocrine carcinoma metastatic 46.84 13.89 17 100792 430 110488060
Blood growth hormone decreased 46.52 13.89 11 100798 54 110488436
Rhabdomyolysis 46.34 13.89 26 100783 120375 110368115
Injection site scar 46.20 13.89 22 100787 1118 110487372
Hepatic mass 45.54 13.89 30 100779 2868 110485622
Injection site warmth 45.39 13.89 67 100742 17338 110471152
Hyperhidrosis 45.14 13.89 309 100500 186989 110301501
Brain neoplasm 45.13 13.89 41 100768 6296 110482194
Pancreatic neuroendocrine tumour metastatic 45.09 13.89 14 100795 215 110488275
Depressed level of consciousness 45.04 13.89 23 100786 112255 110376235
Injection site inflammation 44.44 13.89 36 100773 4735 110483755
Product dose omission issue 44.19 13.89 148 100661 321634 110166856
Cytokine release syndrome 43.89 13.89 6 100803 70300 110418190
Metastases to gastrointestinal tract 43.72 13.89 13 100796 171 110488319
Change of bowel habit 43.39 13.89 29 100780 2840 110485650
Sedation 43.38 13.89 6 100803 69677 110418813
Urine odour abnormal 43.33 13.89 43 100766 7372 110481118
Suicide attempt 43.27 13.89 20 100789 103374 110385116
Crystal arthropathy 43.13 13.89 14 100795 250 110488240
Nasal discharge discolouration 42.83 13.89 30 100779 3171 110485319
Bone cancer 42.33 13.89 27 100782 2443 110486047
Pulse abnormal 42.27 13.89 33 100776 4116 110484374
Injection site haematoma 42.06 13.89 36 100773 5110 110483380
Crying 41.85 13.89 80 100729 25548 110462942
Oxygen saturation decreased 41.63 13.89 49 100760 156933 110331557
Metastases to lung 41.43 13.89 75 100734 22988 110465502
Injection site oedema 41.37 13.89 24 100785 1830 110486660
Bite 41.30 13.89 17 100792 608 110487882
Joint swelling 41.14 13.89 236 100573 442609 110045881
Dry mouth 40.72 13.89 75 100734 199873 110288617
Respiratory tract infection 40.51 13.89 8 100801 71609 110416881
Anti factor V antibody 40.40 13.89 14 100795 308 110488182
Infrequent bowel movements 40.35 13.89 25 100784 2150 110486340
White blood cell count decreased 40.01 13.89 94 100715 229296 110259194
Rectal polyp 39.95 13.89 22 100787 1518 110486972
Muscle strain 39.65 13.89 50 100759 11152 110477338
Unevaluable event 39.59 13.89 4 100805 59223 110429267
Type 2 diabetes mellitus 39.28 13.89 63 100746 177169 110311321
Confusional state 39.25 13.89 258 100551 468422 110020068
Decreased appetite 39.08 13.89 630 100179 475216 110013274
Blood potassium decreased 38.74 13.89 123 100686 53991 110434499
Contusion 38.61 13.89 353 100456 233008 110255482
Nail disorder 38.50 13.89 4 100805 57931 110430559
Breast mass 38.23 13.89 42 100767 8099 110480391
Insulinoma 38.19 13.89 12 100797 192 110488298
Pneumonia 38.19 13.89 566 100243 876148 109612342
Depressed mood 37.99 13.89 132 100677 60677 110427813
Pruritus 37.96 13.89 343 100466 581217 109907273
Wound 37.83 13.89 100 100709 234337 110254153
Metastases to ovary 37.44 13.89 14 100795 386 110488104
Bartholinitis 37.29 13.89 9 100800 49 110488441
Renal mass 37.23 13.89 29 100780 3606 110484884
Hepatitis 36.80 13.89 18 100791 90036 110398454
Hypokinesia 36.72 13.89 69 100740 21757 110466733
Liver abscess 36.47 13.89 40 100769 7699 110480791
Illness 36.38 13.89 160 100649 82011 110406479
Body temperature increased 36.14 13.89 121 100688 54592 110433898
Limb injury 36.08 13.89 95 100714 37541 110450949
Blood creatine phosphokinase increased 35.82 13.89 11 100798 73066 110415424
Hernia 35.77 13.89 64 100745 19436 110469054
Lower limb fracture 35.77 13.89 12 100797 75336 110413154
Treatment noncompliance 35.75 13.89 11 100798 72979 110415511
Renal neoplasm 35.62 13.89 24 100785 2382 110486108
Tubulointerstitial nephritis 35.43 13.89 4 100805 54280 110434210
Interstitial lung disease 35.35 13.89 45 100764 139289 110349201
Adenoma benign 34.73 13.89 19 100790 1294 110487196
Postoperative wound infection 34.58 13.89 56 100753 15697 110472793
Nerve degeneration 34.21 13.89 12 100797 274 110488216
Peripheral coldness 34.21 13.89 61 100748 18479 110470011
Hyperglycaemia 34.18 13.89 161 100648 84929 110403561
Metastases to thorax 34.05 13.89 12 100797 278 110488212
Epilepsy 33.97 13.89 25 100784 100184 110388306
Neck mass 33.96 13.89 31 100778 4790 110483700
Delirium 33.85 13.89 44 100765 134981 110353509
Gout 33.74 13.89 91 100718 36475 110452015
Neuroendocrine carcinoma 33.58 13.89 16 100793 814 110487676
Intestinal metastasis 33.14 13.89 14 100795 535 110487955
Concomitant disease aggravated 33.01 13.89 56 100753 16308 110472182
Musculoskeletal pain 32.92 13.89 282 100527 182741 110305749
Gastrointestinal neoplasm 32.92 13.89 14 100795 544 110487946
Sepsis 32.83 13.89 170 100639 327176 110161314
Abdominal neoplasm 32.78 13.89 15 100794 696 110487794
Drug reaction with eosinophilia and systemic symptoms 32.66 13.89 17 100792 82078 110406412
Drug eruption 32.52 13.89 5 100804 53654 110434836
Metastases to lymph nodes 32.40 13.89 53 100756 14979 110473511
Intestinal intraepithelial lymphocytes increased 32.18 13.89 11 100798 232 110488258
Renal pain 31.89 13.89 42 100767 9775 110478715
Skin sensitisation 31.85 13.89 17 100792 1102 110487388
Sensitisation 31.83 13.89 28 100781 4123 110484367
Neutrophil count decreased 31.80 13.89 38 100771 120903 110367587
Stevens-Johnson syndrome 31.79 13.89 3 100806 46898 110441592
Metastases to oesophagus 31.68 13.89 8 100801 54 110488436
Insulin-like growth factor abnormal 31.68 13.89 8 100801 54 110488436
Small intestinal obstruction 31.59 13.89 82 100727 32131 110456359
Flank pain 31.56 13.89 67 100742 23063 110465427
Pallor 31.39 13.89 118 100691 56349 110432141
Bone erosion 31.34 13.89 3 100806 46368 110442122
Prostatomegaly 31.30 13.89 28 100781 4214 110484276
Septic shock 31.27 13.89 60 100749 157468 110331022
Hallucination 31.03 13.89 28 100781 101404 110387086
Benign neoplasm of adrenal gland 30.95 13.89 8 100801 60 110488430
Frequent bowel movements 30.84 13.89 138 100671 71252 110417238
Lower respiratory tract infection 30.57 13.89 116 100693 242990 110245500
Hypercholesterolaemia 30.36 13.89 23 100786 90814 110397676
Psychotic disorder 30.30 13.89 5 100804 50932 110437558
Wound infection 30.27 13.89 26 100783 96439 110392051
Lacrimal disorder 30.15 13.89 13 100796 523 110487967
Cyst 30.08 13.89 54 100755 16442 110472048
Injection site hypoaesthesia 30.05 13.89 14 100795 677 110487813
Coronary artery disease 29.79 13.89 14 100795 71676 110416814
Upper respiratory tract infection 29.74 13.89 46 100763 131282 110357208
Gastric hypomotility 29.74 13.89 11 100798 294 110488196
Head banging 29.42 13.89 13 100796 555 110487935
Angina bullosa haemorrhagica 29.34 13.89 10 100799 209 110488281
Proctalgia 29.02 13.89 47 100762 13175 110475315
Blood cholesterol increased 28.92 13.89 80 100729 184705 110303785
Cardiac arrest 28.74 13.89 88 100721 196665 110291825
Tooth abscess 28.67 13.89 57 100752 18732 110469758
Anaphylactic shock 28.65 13.89 6 100803 51540 110436950
Rash maculo-papular 28.60 13.89 16 100793 74206 110414284
Abdominal rigidity 28.57 13.89 25 100784 3655 110484835
Transaminases increased 28.55 13.89 11 100798 63379 110425111
Mental status changes 28.49 13.89 17 100792 76105 110412385
Glycosylated haemoglobin increased 28.36 13.89 65 100744 23554 110464936
No adverse event 28.34 13.89 16 100793 73823 110414667
Needle track marks 28.29 13.89 8 100801 87 110488403
Breast pain 28.28 13.89 40 100769 9960 110478530
Pancreatolithiasis 28.05 13.89 11 100798 346 110488144
Parathyroid hormone-related protein abnormal 27.96 13.89 6 100803 17 110488473
Eosinophilia 27.90 13.89 9 100800 57927 110430563
Nasal congestion 27.88 13.89 169 100640 98113 110390377
Intra-abdominal fluid collection 27.80 13.89 25 100784 3789 110484701
Hypoxia 27.80 13.89 47 100762 129468 110359022
Dyspnoea 27.70 13.89 783 100026 1106089 109382401
Shunt malfunction 27.67 13.89 11 100798 359 110488131
Abdominal mass 27.67 13.89 28 100781 4913 110483577
Metastases to neck 27.62 13.89 7 100802 48 110488442
Hernia pain 27.59 13.89 12 100797 493 110487997
Administration site abscess 27.23 13.89 6 100803 20 110488470
Tumour marker increased 27.11 13.89 28 100781 5032 110483458
Anaemia 27.07 13.89 344 100465 546742 109941748
Cryptitis 27.03 13.89 11 100798 382 110488108
Concomitant disease progression 26.98 13.89 24 100785 3586 110484904
Microvillous inclusion disease 26.97 13.89 10 100799 269 110488221
Seizure 26.88 13.89 107 100702 221078 110267412
Thyroid mass 26.87 13.89 28 100781 5085 110483405
Gingival abscess 26.75 13.89 15 100794 1072 110487418
Scar 26.71 13.89 52 100757 16829 110471661
Blood follicle stimulating hormone increased 26.55 13.89 11 100798 400 110488090
Induration 26.53 13.89 20 100789 2369 110486121
Vital functions abnormal 26.52 13.89 15 100794 1090 110487400
Respiratory arrest 26.45 13.89 10 100799 58289 110430201
Muscle contractions involuntary 26.39 13.89 26 100783 4418 110484072
Administration site discharge 26.18 13.89 6 100803 25 110488465
Metastases to fallopian tube 26.15 13.89 7 100802 61 110488429
Chondroma 26.07 13.89 5 100804 6 110488484
Hospitalisation 25.97 13.89 57 100752 142436 110346054
Feeding disorder 25.88 13.89 59 100750 21303 110467187
Pneumocystis jirovecii pneumonia 25.86 13.89 4 100805 42731 110445759
Multiple organ dysfunction syndrome 25.79 13.89 63 100746 151647 110336843
Head injury 25.68 13.89 92 100717 42925 110445565
Multiple sclerosis relapse 25.66 13.89 7 100802 50233 110438257
Buttock injury 25.56 13.89 9 100800 208 110488282
Metabolic acidosis 25.52 13.89 32 100777 99712 110388778
Bursitis 25.34 13.89 50 100759 129868 110358622
Tension 25.25 13.89 27 100782 5051 110483439
Myocardial infarction 25.24 13.89 90 100719 191993 110296497
Urine abnormality 25.15 13.89 36 100773 9060 110479430
Swelling 25.14 13.89 202 100607 350839 110137651
Chikungunya virus infection 25.08 13.89 9 100800 220 110488270
Hyperkalaemia 25.01 13.89 54 100755 135742 110352748
Dysuria 24.95 13.89 115 100694 60116 110428374
Arthropod bite 24.89 13.89 37 100772 9634 110478856
Tumour pain 24.75 13.89 21 100788 2946 110485544
Pituitary enlargement 24.74 13.89 8 100801 141 110488349
Skin exfoliation 24.72 13.89 26 100783 87625 110400865
Injection site cyst 24.69 13.89 8 100801 142 110488348
Administration site odour 24.66 13.89 6 100803 34 110488456
Dysstasia 24.55 13.89 76 100733 32910 110455580
Myelosuppression 24.42 13.89 30 100779 94310 110394180
Acute respiratory distress syndrome 24.34 13.89 9 100800 53189 110435301
Syncope 24.29 13.89 287 100522 202249 110286241
Migraine 24.20 13.89 78 100731 171574 110316916
Metastases to abdominal cavity 24.04 13.89 13 100796 865 110487625
Blood magnesium decreased 23.98 13.89 55 100754 19941 110468549
Nausea 23.94 13.89 1365 99444 1234325 109254165
Haemorrhage 23.92 13.89 173 100636 106519 110381971
Adrenal cyst 23.87 13.89 9 100800 254 110488236
5-hydroxyindolacetic acid in urine 23.61 13.89 5 100804 13 110488477
Polydipsia 23.61 13.89 32 100777 7656 110480834
Administration site haemorrhage 23.57 13.89 6 100803 42 110488448
Administration site induration 23.57 13.89 6 100803 42 110488448
Furuncle 23.52 13.89 34 100775 8634 110479856
Pulmonary embolism 23.45 13.89 108 100701 214366 110274124
Accidental overdose 23.33 13.89 9 100800 51825 110436665
Probiotic therapy 23.30 13.89 8 100801 171 110488319
Gastrointestinal wall thickening 23.02 13.89 22 100787 3601 110484889
Pneumonia aspiration 23.02 13.89 24 100785 81209 110407281
Excessive cerumen production 22.98 13.89 13 100796 945 110487545
Injection site erosion 22.96 13.89 8 100801 179 110488311
Facial asymmetry 22.83 13.89 13 100796 957 110487533
Viral diarrhoea 22.67 13.89 11 100798 583 110487907
Tricuspid valve stenosis 22.61 13.89 5 100804 17 110488473
Haemoglobin decreased 22.56 13.89 335 100474 248392 110240098
Tonsillar inflammation 22.55 13.89 8 100801 189 110488301
Inner ear disorder 22.54 13.89 12 100797 774 110487716
Blood creatinine increased 22.52 13.89 88 100721 182801 110305689
Urine viscosity increased 22.44 13.89 6 100803 52 110488438
Onychomycosis 22.44 13.89 4 100805 38527 110449963
Respiratory distress 22.31 13.89 18 100791 68856 110419634
Gastrinoma 22.24 13.89 6 100803 54 110488436
Hypersomnia 22.15 13.89 66 100743 27995 110460495
Oncologic complication 22.14 13.89 10 100799 450 110488040
X-ray abnormal 22.10 13.89 4 100805 38113 110450377
Endocrine neoplasm 21.77 13.89 4 100805 3 110488487
Metastatic carcinoid tumour 21.77 13.89 6 100803 59 110488431
Cachexia 21.73 13.89 41 100768 12964 110475526
Tumour compression 21.73 13.89 8 100801 211 110488279
Rib fracture 21.70 13.89 74 100735 33696 110454794
Respiratory disorder 21.49 13.89 20 100789 71362 110417128
Muscle swelling 21.48 13.89 13 100796 1072 110487418
Agranulocytosis 21.47 13.89 15 100794 61745 110426745
Device toxicity 21.41 13.89 5 100804 23 110488467
Fear-related avoidance of activities 21.36 13.89 7 100802 129 110488361
Neurotoxicity 21.33 13.89 6 100803 42201 110446289
COVID-19 pneumonia 21.32 13.89 4 100805 37139 110451351
Hypertrophic osteoarthropathy 21.31 13.89 7 100802 130 110488360
Injection site injury 21.27 13.89 13 100796 1091 110487399
Vasoactive intestinal polypeptide increased 21.24 13.89 4 100805 4 110488486
Emotional disorder 21.12 13.89 46 100763 16114 110472376
Serotonin syndrome 21.05 13.89 14 100795 59139 110429351
Iodine allergy 20.94 13.89 11 100798 690 110487800
Mesenteritis 20.82 13.89 9 100800 364 110488126
Hyperoxaluria 20.82 13.89 9 100800 364 110488126
Blood pressure fluctuation 20.80 13.89 128 100681 74696 110413794
Bronchiectasis 20.80 13.89 4 100805 36489 110452001
Metastases to breast 20.78 13.89 9 100800 366 110488124
Influenza like illness 20.78 13.89 145 100664 88267 110400223
Generalised tonic-clonic seizure 20.76 13.89 12 100797 54668 110433822
Periarticular disorder 20.75 13.89 5 100804 27 110488463
Renal cyst 20.71 13.89 49 100760 18123 110470367
Metastases to thyroid 20.68 13.89 6 100803 72 110488418
Eructation 20.68 13.89 42 100767 14015 110474475
Ventricular fibrillation 20.64 13.89 6 100803 41307 110447183
Lymphatic system neoplasm 20.61 13.89 6 100803 73 110488417
Scan gallium abnormal 20.60 13.89 5 100804 28 110488462
Apoptosis 20.58 13.89 11 100798 715 110487775
Psychiatric symptom 20.56 13.89 33 100776 9180 110479310
Gastroenteropancreatic neuroendocrine tumour disease 20.53 13.89 6 100803 74 110488416
Inguinal hernia 20.52 13.89 30 100779 7695 110480795
Spinal cord neoplasm 20.45 13.89 10 100799 539 110487951
Atrial fibrillation 20.44 13.89 124 100685 229518 110258972
Bone neoplasm 20.35 13.89 12 100797 943 110487547
Chest injury 20.35 13.89 20 100789 3389 110485101
Body height increased 20.07 13.89 7 100802 157 110488333
Lumbar hernia 19.91 13.89 7 100802 161 110488329
Gallbladder neoplasm 19.90 13.89 6 100803 83 110488407
Blood test abnormal 19.62 13.89 64 100745 28490 110460000
Sluggishness 19.55 13.89 29 100780 7538 110480952
Cortisol decreased 19.52 13.89 18 100791 2818 110485672
Night blindness 19.47 13.89 10 100799 599 110487891
Hypothalamo-pituitary disorder 19.46 13.89 18 100791 2828 110485662
Pituitary tumour benign 19.46 13.89 18 100791 2829 110485661
Gastrooesophageal reflux disease 19.45 13.89 91 100718 179885 110308605
Bile output increased 19.40 13.89 5 100804 37 110488453
Ascites 19.39 13.89 148 100661 92660 110395830
Heart valve incompetence 19.38 13.89 21 100788 3988 110484502
Screaming 19.23 13.89 23 100786 4858 110483632
Obstructive airways disorder 19.20 13.89 9 100800 46140 110442350
Constipation 19.18 13.89 444 100365 357342 110131148
Liver function test increased 19.12 13.89 32 100777 88516 110399974
Ligament sprain 19.05 13.89 44 100765 16024 110472466
White coat hypertension 19.05 13.89 13 100796 1318 110487172
Status epilepticus 19.00 13.89 3 100806 31568 110456922
Endometrial cancer stage I 18.96 13.89 7 100802 186 110488304
Feeling hot 18.88 13.89 145 100664 90961 110397529
Ischaemic stroke 18.85 13.89 7 100802 41256 110447234
Injection site hypertrophy 18.81 13.89 6 100803 101 110488389
Spleen disorder 18.81 13.89 15 100794 1929 110486561
Chronic obstructive pulmonary disease 18.81 13.89 45 100764 109113 110379377
Renal disorder 18.70 13.89 92 100717 49387 110439103
Prostate examination abnormal 18.68 13.89 7 100802 194 110488296
Myositis 18.63 13.89 3 100806 31113 110457377
Small intestine carcinoma 18.61 13.89 12 100797 1106 110487384
Breath odour 18.49 13.89 15 100794 1977 110486513
5-hydroxyindolacetic acid 18.47 13.89 4 100805 12 110488478
Device occlusion 18.46 13.89 42 100767 15143 110473347
Suicidal ideation 18.45 13.89 36 100773 93901 110394589
Faeces hard 18.39 13.89 21 100788 4225 110484265
Neutropenic sepsis 18.33 13.89 3 100806 30743 110457747
Hyperlipidaemia 18.30 13.89 5 100804 35843 110452647
Urosepsis 18.27 13.89 3 100806 30672 110457818
Metastases to bladder 18.25 13.89 8 100801 335 110488155
Acute myeloid leukaemia 18.21 13.89 6 100803 38104 110450386
Drug withdrawal syndrome 18.17 13.89 6 100803 38048 110450442
Alopecia 18.15 13.89 229 100580 364524 110123966
Kidney infection 18.15 13.89 58 100751 25541 110462949
Hypokalaemia 18.14 13.89 95 100714 182353 110306137
Swollen tongue 18.06 13.89 17 100792 60345 110428145
Adrenal insufficiency 18.05 13.89 8 100801 42382 110446108
Gallbladder enlargement 18.04 13.89 15 100794 2047 110486443
Pancreatic polypeptide level decreased 18.00 13.89 3 100806 0 110488490
Electrocardiogram QT prolonged 17.93 13.89 46 100763 108914 110379576
Rubber sensitivity 17.92 13.89 16 100793 2402 110486088
Gastric dilatation 17.92 13.89 15 100794 2066 110486424
Cataract 17.88 13.89 129 100680 79356 110409134
Tongue haemorrhage 17.79 13.89 12 100797 1193 110487297
Myocarditis 17.76 13.89 3 100806 30052 110458438
Sputum discoloured 17.75 13.89 61 100748 27884 110460606
Hypertonic bladder 17.72 13.89 23 100786 5279 110483211
Cancer pain 17.56 13.89 26 100783 6746 110481744
Dry eye 17.55 13.89 15 100794 55778 110432712
COVID-19 17.54 13.89 141 100668 244919 110243571
Cerebrospinal fluid leakage 17.50 13.89 15 100794 2133 110486357
Cerebral infarction 17.48 13.89 13 100796 51825 110436665
Face injury 17.43 13.89 21 100788 4471 110484019
Plasma cell myeloma 17.38 13.89 19 100790 62917 110425573
Cardiogenic shock 17.33 13.89 16 100793 57322 110431168
Polyneuropathy 17.24 13.89 4 100805 32008 110456482
Pituitary tumour removal 17.20 13.89 4 100805 18 110488472
Blood gastrin increased 17.16 13.89 5 100804 61 110488429
Cystitis 17.13 13.89 111 100698 65925 110422565
Abortion spontaneous 17.09 13.89 5 100804 34277 110454213
Procedural pain 17.09 13.89 71 100738 35494 110452996
Mucosal inflammation 17.07 13.89 39 100770 96102 110392388
Factor V inhibition 17.05 13.89 8 100801 393 110488097
Spinal cord injury lumbar 17.01 13.89 5 100804 63 110488427
Subdural haematoma 16.96 13.89 6 100803 36448 110452042
Abdominal adhesions 16.93 13.89 20 100789 4170 110484320
Encephalopathy 16.86 13.89 30 100779 81025 110407465
Fibrous dysplasia of bone 16.86 13.89 4 100805 20 110488470
Metastases to peritoneum 16.70 13.89 23 100786 5587 110482903
Eczema 16.68 13.89 25 100784 72268 110416222
Empty sella syndrome 16.67 13.89 6 100803 148 110488342
Urine calcium/creatinine ratio increased 16.63 13.89 6 100803 149 110488341
Sleep apnoea syndrome 16.58 13.89 77 100732 40370 110448120
Appendicitis 16.48 13.89 3 100806 28461 110460029
Urethral caruncle 16.47 13.89 5 100804 71 110488419
Cerebral haemorrhage 16.46 13.89 21 100788 64947 110423543
Metastases to spleen 16.42 13.89 10 100799 834 110487656
Accidental exposure to product 16.28 13.89 13 100796 49995 110438495
Dizziness postural 16.23 13.89 39 100770 14570 110473920
Finger deformity 16.18 13.89 5 100804 33087 110455403
Incisional hernia 16.18 13.89 16 100793 2731 110485759
Drug level increased 16.05 13.89 12 100797 47707 110440783
Hepatic function abnormal 16.04 13.89 36 100773 89259 110399231
Hepatic cancer 16.02 13.89 33 100776 11123 110477367
Multiple endocrine neoplasia 15.93 13.89 3 100806 3 110488487
Injection site vesicles 15.89 13.89 20 100789 4451 110484039
Dysarthria 15.87 13.89 33 100776 84088 110404402
Bile acid malabsorption 15.78 13.89 8 100801 466 110488024
Drug tolerance decreased 15.73 13.89 3 100806 27537 110460953
Tricuspid valve disease 15.72 13.89 8 100801 470 110488020
Vulval disorder 15.70 13.89 10 100799 903 110487587
Blood testosterone decreased 15.69 13.89 16 100793 2832 110485658
Muscle twitching 15.61 13.89 4 100805 29931 110458559
Anorectal discomfort 15.54 13.89 19 100790 4107 110484383
Aspartate aminotransferase increased 15.50 13.89 84 100725 159852 110328638
Thyroid neoplasm 15.45 13.89 17 100792 3284 110485206
Haemorrhoids 15.44 13.89 69 100740 35603 110452887
Subarachnoid haemorrhage 15.43 13.89 4 100805 29698 110458792
Hypohidrosis 15.41 13.89 7 100802 319 110488171
Skin plaque 15.40 13.89 35 100774 12610 110475880
Product use issue 15.39 13.89 196 100613 311499 110176991
Staphylococcal infection 15.36 13.89 25 100784 69919 110418571
Coccydynia 15.34 13.89 15 100794 2526 110485964
Eye contusion 15.31 13.89 16 100793 2916 110485574
Hypoacusis 15.17 13.89 68 100741 35123 110453367
Bile output abnormal 15.14 13.89 4 100805 33 110488457
Lung disorder 15.10 13.89 99 100710 179948 110308542
Drug dependence 15.07 13.89 14 100795 50006 110438484
Spinal pain 15.04 13.89 44 100765 18471 110470019
Osteonecrosis of jaw 14.99 13.89 13 100796 48004 110440486
Pancreatic enlargement 14.96 13.89 7 100802 342 110488148
Faecal volume increased 14.92 13.89 7 100802 344 110488146
Bladder disorder 14.89 13.89 32 100777 11105 110477385
Injection site pustule 14.88 13.89 5 100804 100 110488390
Inflammation 14.85 13.89 109 100700 193129 110295361
Hallucination, auditory 14.82 13.89 3 100806 26394 110462096
Hemiparesis 14.82 13.89 11 100798 43892 110444598
Peripancreatic fluid collection 14.78 13.89 5 100804 102 110488388
Trigeminal neuralgia 14.73 13.89 19 100790 4333 110484157
Skin depigmentation 14.73 13.89 11 100798 1285 110487205
Exertional headache 14.71 13.89 3 100806 6 110488484
Taste disorder 14.71 13.89 23 100786 65364 110423126
Neoplasm malignant 14.71 13.89 70 100739 37073 110451417
Ear discomfort 14.67 13.89 32 100777 11217 110477273
Gallbladder oedema 14.62 13.89 7 100802 360 110488130
High frequency ablation 14.57 13.89 7 100802 363 110488127
Saliva altered 14.55 13.89 8 100801 550 110487940
Venous haemorrhage 14.44 13.89 7 100802 370 110488120
Stoma complication 14.41 13.89 10 100799 1041 110487449
Dengue fever 14.41 13.89 11 100798 1328 110487162
Dystonia 14.35 13.89 3 100806 25802 110462688
Parotitis 14.34 13.89 16 100793 3137 110485353
Full blood count abnormal 14.32 13.89 18 100791 56034 110432456
Hepatocellular injury 14.31 13.89 15 100794 50627 110437863
Aspergillus infection 14.20 13.89 3 100806 25613 110462877
Dehydration 14.10 13.89 344 100465 279167 110209323
Iliac artery occlusion 14.08 13.89 7 100802 391 110488099
Leukocytosis 14.05 13.89 17 100792 53811 110434679
Glucose tolerance impaired 14.01 13.89 29 100780 9808 110478682
Somnolence 13.97 13.89 189 100620 297260 110191230
Biliary tract infection 13.97 13.89 12 100797 1712 110486778
Fibrous histiocytoma 13.95 13.89 9 100800 830 110487660
Gastrointestinal disorder 13.94 13.89 147 100662 241805 110246685
Ataxia 13.93 13.89 5 100804 30103 110458387

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC H01CB02 SYSTEMIC HORMONAL PREPARATIONS, EXCL. SEX HORMONES AND INSULINS
PITUITARY AND HYPOTHALAMIC HORMONES AND ANALOGUES
HYPOTHALAMIC HORMONES
Somatostatin and analogues
FDA MoA N0000000194 Somatostatin Receptor Agonists
MeSH PA D000970 Antineoplastic Agents
MeSH PA D005765 Gastrointestinal Agents
MeSH PA D018931 Antineoplastic Agents, Hormonal
FDA EPC N0000175904 Somatostatin Analog
CHEBI has role CHEBI:51060 hormone agonist
CHEBI has role CHEBI:35610 antineoplastic agent
CHEBI has role CHEBI:50503 laxative
CHEBI has role CHEBI:74518 anti-obesity agent

Related Drugs by ATC class:

H01CB Somatostatin and analogues 4 drugs
lanreotidepaltusotinepasireotidesomatostatin

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

DiseaseRelationSNOMED_IDDOID
Carcinoid syndrome indication 35868009
Acromegaly indication 74107003 DOID:2449
Congenital hyperinsulinism indication 360339005
Diarrhea from Pancreatic VIPoma indication
Irritable bowel syndrome off-label use 10743008 DOID:9778
Bleeding esophageal varices off-label use 17709002 DOID:112
Pancreatic fistula off-label use 25803005
Short bowel syndrome off-label use 26629001 DOID:10605
Gastrointestinal fistula off-label use 37831005
Islet cell hyperplasia off-label use 42681006 DOID:13317
Non-infective diarrhea off-label use 69980003
Postgastric surgery syndrome off-label use 80193009 DOID:8439
Chylothorax off-label use 83035003
Carcinoid crisis off-label use 237833006
Insulinoma off-label use 302822000 DOID:3892
Chemotherapy-Induced Diarrhea off-label use
Cirrhosis of liver contraindication 19943007 DOID:5082
Disorder of gallbladder contraindication 39621005 DOID:0060262
Hypothyroidism contraindication 40930008 DOID:1459
Renal failure syndrome contraindication 42399005 DOID:1074
Conduction disorder of the heart contraindication 44808001
Chronic heart failure contraindication 48447003
Bradycardia contraindication 48867003
Diabetes mellitus contraindication 73211009 DOID:9351
Hyperglycemia contraindication 80394007 DOID:4195
Intestinal obstruction contraindication 81060008 DOID:8437
Cobalamin deficiency contraindication 190634004
Hypoglycemic disorder contraindication 237630007
Calculus in biliary tract contraindication 266474003




🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 12.29 acidic
pKa2 12.92 acidic
pKa3 13.17 acidic
pKa4 13.77 acidic
pKa5 10.31 Basic
pKa6 7.03 Basic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
EQ 20MG BASE MYCAPSSA CHIESI N208232 June 26, 2020 RX CAPSULE, DELAYED RELEASE ORAL 11986529 Sept. 17, 2029 USE OF ORAL OCTREOTIDE FOR LONG-TERM MAINTENANCE TREATMENT IN ACROMEGALY PATIENTS WHO HAVE RESPONDED TO AND TOLERATED TREATMENT WITH OCTREOTIDE OR LANREOTIDE
EQ 20MG BASE MYCAPSSA CHIESI N208232 June 26, 2020 RX CAPSULE, DELAYED RELEASE ORAL 8535695 Sept. 17, 2029 USE OF ORAL OCTREOTIDE FOR LONG-TERM MAINTENANCE TREATMENT IN ACROMEGALY PATIENTS WHO HAVE RESPONDED TO AND TOLERATED TREATMENT WITH OCTREOTIDE OR LANREOTIDE
EQ 20MG BASE MYCAPSSA CHIESI N208232 June 26, 2020 RX CAPSULE, DELAYED RELEASE ORAL 10238709 Feb. 3, 2036 USE OF ORAL OCTREOTIDE FOR LONG-TERM MAINTENANCE TREATMENT IN ACROMEGALY PATIENTS WHO HAVE RESPONDED TO AND TOLERATED TREATMENT WITH OCTREOTIDE OR LANREOTIDE
EQ 20MG BASE MYCAPSSA CHIESI N208232 June 26, 2020 RX CAPSULE, DELAYED RELEASE ORAL 10695397 Feb. 3, 2036 USE OF ORAL OCTREOTIDE FOR LONG-TERM MAINTENANCE TREATMENT IN ACROMEGALY PATIENTS WHO HAVE RESPONDED TO AND TOLERATED TREATMENT WITH OCTREOTIDE OR LANREOTIDE
EQ 20MG BASE MYCAPSSA CHIESI N208232 June 26, 2020 RX CAPSULE, DELAYED RELEASE ORAL 11052126 Feb. 3, 2036 USE OF ORAL OCTREOTIDE FOR LONG-TERM MAINTENANCE TREATMENT IN ACROMEGALY PATIENTS WHO HAVE RESPONDED TO AND TOLERATED TREATMENT WITH OCTREOTIDE OR LANREOTIDE
EQ 20MG BASE MYCAPSSA CHIESI N208232 June 26, 2020 RX CAPSULE, DELAYED RELEASE ORAL 11338011 Feb. 3, 2036 USE OF ORAL OCTREOTIDE FOR LONG-TERM MAINTENANCE TREATMENT IN ACROMEGALY PATIENTS WHO HAVE RESPONDED TO AND TOLERATED TREATMENT WITH OCTREOTIDE OR LANREOTIDE
EQ 20MG BASE MYCAPSSA CHIESI N208232 June 26, 2020 RX CAPSULE, DELAYED RELEASE ORAL 11510963 Feb. 3, 2036 USE OF ORAL OCTREOTIDE FOR LONG-TERM MAINTENANCE TREATMENT IN ACROMEGALY PATIENTS WHO HAVE RESPONDED TO AND TOLERATED TREATMENT WITH OCTREOTIDE OR LANREOTIDE
EQ 20MG BASE MYCAPSSA CHIESI N208232 June 26, 2020 RX CAPSULE, DELAYED RELEASE ORAL 11857595 Feb. 3, 2036 USE OF ORAL OCTREOTIDE IN COMBINATION WITH A H2-RECEPTOR ANTAGONIST OR ANTACID FOR LONG-TERM MAINTENANCE TREATMENT IN ACROMEGALY PATIENTS WHO HAVE RESPONDED TO AND TOLERATED TREATMENT WITH OCTREOTIDE OR LANREOTIDE
EQ 20MG BASE MYCAPSSA CHIESI N208232 June 26, 2020 RX CAPSULE, DELAYED RELEASE ORAL 12246054 Feb. 3, 2036 USE OF ORAL OCTREOTIDE FOR LONG-TERM MAINTENANCE TREATMENT IN ACROMEGALY PATIENTS WHO HAVE RESPONDED TO AND TOLERATED TREATMENT WITH OCTREOTIDE OR LANREOTIDE
EQ 20MG BASE MYCAPSSA CHIESI N208232 June 26, 2020 RX CAPSULE, DELAYED RELEASE ORAL 12251418 Feb. 3, 2036 USE OF ORAL OCTREOTIDE FOR LONG-TERM MAINTENANCE TREATMENT IN ACROMEGALY PATIENTS WHO HAVE RESPONDED TO AND TOLERATED TREATMENT WITH OCTREOTIDE OR LANREOTIDE
EQ 7MG BASE/2.8ML (EQ 2.5MG BASE/ML) BYNFEZIA PEN SUN PHARM N213224 Sept. 27, 2024 RX SOLUTION SUBCUTANEOUS 11052196 Nov. 3, 2040 METHOD OF TREATING ACROMEGALY PATIENTS WHO HAVE HAD INADEQUATE RESPONSE TO OR CANNOT BE TREATED WITH SURGICAL RESECTION, PITUITARY IRRADIATION, AND BROMOCRIPTINE MESYLATE AT MAXIMALLY TOLERATED DOSES
EQ 7MG BASE/2.8ML (EQ 2.5MG BASE/ML) BYNFEZIA PEN SUN PHARM N213224 Sept. 27, 2024 RX SOLUTION SUBCUTANEOUS 11052196 Nov. 3, 2040 METHOD OF TREATING PROFUSE WATERY DIARRHEA ASSOCIATED WITH VASOACTIVE INTESTINAL PEPTIDE TUMORS (VIPOMAS)-SECRETING TUMORS
EQ 7MG BASE/2.8ML (EQ 2.5MG BASE/ML) BYNFEZIA PEN SUN PHARM N213224 Sept. 27, 2024 RX SOLUTION SUBCUTANEOUS 11052196 Nov. 3, 2040 METHOD OF TREATING SEVERE DIARRHEA AND FLUSHING EPISODES ASSOCIATED WITH METASTATIC CARCINOID TUMORS
EQ 7MG BASE/2.8ML (EQ 2.5MG BASE/ML) BYNFEZIA PEN SUN PHARM N213224 Sept. 27, 2024 RX SOLUTION SUBCUTANEOUS 11246991 Nov. 3, 2040 METHOD OF TREATING ACROMEGALY PATIENTS WHO HAVE HAD INADEQUATE RESPONSE TO OR CANNOT BE TREATED WITH SURGICAL RESECTION, PITUITARY IRRADIATION, AND BROMOCRIPTINE MESYLATE AT MAXIMALLY TOLERATED DOSES
EQ 7MG BASE/2.8ML (EQ 2.5MG BASE/ML) BYNFEZIA PEN SUN PHARM N213224 Sept. 27, 2024 RX SOLUTION SUBCUTANEOUS 11246991 Nov. 3, 2040 METHOD OF TREATING PROFUSE WATERY DIARRHEA ASSOCIATED WITH VASOACTIVE INTESTINAL PEPTIDE TUMORS (VIPOMAS)-SECRETING TUMORS
EQ 7MG BASE/2.8ML (EQ 2.5MG BASE/ML) BYNFEZIA PEN SUN PHARM N213224 Sept. 27, 2024 RX SOLUTION SUBCUTANEOUS 11246991 Nov. 3, 2040 METHOD OF TREATING SEVERE DIARRHEA AND FLUSHING EPISODES ASSOCIATED WITH METASTATIC CARCINOID TUMORS
EQ 7MG BASE/2.8ML (EQ 2.5MG BASE/ML) BYNFEZIA PEN SUN PHARM N213224 Sept. 27, 2024 RX SOLUTION SUBCUTANEOUS 11534553 Nov. 3, 2040 METHOD OF TREATING ACROMEGALY PATIENTS WHO HAVE HAD INADEQUATE RESPONSE TO OR CANNOT BE TREATED WITH SURGICAL RESECTION, PITUITARY IRRADIATION, AND BROMOCRIPTINE MESYLATE AT MAXIMALLY TOLERATED DOSES
EQ 7MG BASE/2.8ML (EQ 2.5MG BASE/ML) BYNFEZIA PEN SUN PHARM N213224 Sept. 27, 2024 RX SOLUTION SUBCUTANEOUS 11534553 Nov. 3, 2040 METHOD OF TREATING PROFUSE WATERY DIARRHEA ASSOCIATED WITH VASOACTIVE INTESTINAL PEPTIDE TUMORS (VIPOMAS)-SECRETING TUMORS
EQ 7MG BASE/2.8ML (EQ 2.5MG BASE/ML) BYNFEZIA PEN SUN PHARM N213224 Sept. 27, 2024 RX SOLUTION SUBCUTANEOUS 11534553 Nov. 3, 2040 METHOD OF TREATING SEVERE DIARRHEA AND FLUSHING EPISODES ASSOCIATED WITH METASTATIC CARCINOID TUMORS
EQ 20MG BASE MYCAPSSA CHIESI N208232 June 26, 2020 RX CAPSULE, DELAYED RELEASE ORAL 11141457 Dec. 28, 2040 USE OF ORAL OCTREOTIDE FOR LONG-TERM MAINTENANCE TREATMENT IN ACROMEGALY PATIENTS WHILE AVOIDING CONCOMITANT ADMINISTRATION OF LEVONORGESTREL
EQ 20MG BASE MYCAPSSA CHIESI N208232 June 26, 2020 RX CAPSULE, DELAYED RELEASE ORAL 11890316 Dec. 28, 2040 USE OF ORAL OCTREOTIDE FOR LONG-TERM MAINTENANCE TREATMENT IN ACROMEGALY PATIENTS WHILE AVOIDING CONCOMITANT ADMINISTRATION OF LEVONORGESTREL
EQ 7MG BASE/2.8ML (EQ 2.5MG BASE/ML) BYNFEZIA PEN SUN PHARM N213224 Sept. 27, 2024 RX SOLUTION SUBCUTANEOUS 12350475 Dec. 29, 2041 METHOD OF TREATING ACROMEGALY PATIENTS WHO HAVE HAD INADEQUATE RESPONSE TO OR CANNOT BE TREATED WITH SURGICAL RESECTION, PITUITARY IRRADIATION, AND BROMOCRIPTINE MESYLATE AT MAXIMALLY TOLERATED DOSES
EQ 7MG BASE/2.8ML (EQ 2.5MG BASE/ML) BYNFEZIA PEN SUN PHARM N213224 Sept. 27, 2024 RX SOLUTION SUBCUTANEOUS 12350475 Dec. 29, 2041 METHOD OF TREATING PROFUSE WATERY DIARRHEA ASSOCIATED WITH VASOACTIVE INTESTINAL PEPTIDE TUMORS (VIPOMAS)-SECRETING TUMORS
EQ 7MG BASE/2.8ML (EQ 2.5MG BASE/ML) BYNFEZIA PEN SUN PHARM N213224 Sept. 27, 2024 RX SOLUTION SUBCUTANEOUS 12350475 Dec. 29, 2041 METHOD OF TREATING SEVERE DIARRHEA AND FLUSHING EPISODES ASSOCIATED WITH METASTATIC CARCINOID TUMORS

Orange Book exclusivity data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
EQ 20MG BASE/VIAL OCTREOTIDE ACETATE MYLAN LABS LTD A216589 Dec. 12, 2025 RX INJECTABLE INJECTION July 27, 2026 COMPETITIVE GENERIC THERAPY
EQ 30MG BASE/VIAL OCTREOTIDE ACETATE MYLAN LABS LTD A216589 Dec. 12, 2025 RX INJECTABLE INJECTION July 27, 2026 COMPETITIVE GENERIC THERAPY
EQ 10MG BASE/VIAL OCTREOTIDE ACETATE MYLAN LABS LTD A216589 Dec. 12, 2025 RX INJECTABLE INJECTION Aug. 2, 2026 COMPETITIVE GENERIC THERAPY
EQ 20MG BASE MYCAPSSA CHIESI N208232 June 26, 2020 RX CAPSULE, DELAYED RELEASE ORAL June 26, 2027 LONG-TERM MAINTENANCE TREATMENT IN ACROMEGALY PATIENTS WHO HAVE RESPONDED TO AND TOLERATED TREATMENT WITH OCTREOTIDE OR LANREOTIDE

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])		Mechanism
action		Bioact sourceMoA source
Somatostatin receptor type 5 GPCR AGONIST IC50 8.52 WOMBAT-PK CHEMBL
Somatostatin receptor type 1 GPCR AGONIST Ki 6.65 CHEMBL CHEMBL
Somatostatin receptor type 2 GPCR AGONIST EC50 10.70 WOMBAT-PK CHEMBL
Somatostatin receptor type 3 GPCR AGONIST Ki 8.30 WOMBAT-PK CHEMBL
Somatostatin receptor type 4 GPCR AGONIST Ki 6.40 CHEMBL CHEMBL
Mu-type opioid receptor GPCR Ki 7.92 PDSP
Somatostatin receptor type 3 GPCR AGONIST Ki 7.80 IUPHAR
Somatostatin receptor type 5 GPCR AGONIST Ki 9.90 IUPHAR
Somatostatin receptor type 2 GPCR IC50 9.55 CHEMBL
Somatostatin receptor type 3 GPCR IC50 8.52 CHEMBL
Somatostatin receptor type 5 GPCR IC50 8.98 CHEMBL
Somatostatin receptor type 2 GPCR AGONIST Ki 8.70 IUPHAR

External reference:

IDSource
4019864 VUID
N0000147950 NUI
D00442 KEGG_DRUG
79517-01-4 SECONDARY_CAS_RN
4019472 VANDF
4019864 VANDF
C0028833 UMLSCUI
CHEBI:7726 CHEBI
CHEMBL1680 ChEMBL_ID
CHEMBL1200480 ChEMBL_ID
CHEMBL408687 ChEMBL_ID
D015282 MESH_DESCRIPTOR_UI
DB00104 DRUGBANK_ID
2055 IUPHAR_LIGAND_ID
5656 INN_ID
RWM8CCW8GP UNII
448601 PUBCHEM_CID
196457 RXNORM
1443 MMSL
36831 MMSL
5196 MMSL
67607 MMSL
d00370 MMSL
002107 NDDF
004012 NDDF
109053000 SNOMEDCT_US
109055007 SNOMEDCT_US
126155003 SNOMEDCT_US

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Sandostatin HUMAN PRESCRIPTION DRUG LABEL 1 0078-0180 INJECTION, SOLUTION 50 ug INTRAVENOUS NDA 31 sections
Sandostatin HUMAN PRESCRIPTION DRUG LABEL 1 0078-0181 INJECTION, SOLUTION 100 ug INTRAVENOUS NDA 31 sections
Sandostatin HUMAN PRESCRIPTION DRUG LABEL 1 0078-0182 INJECTION, SOLUTION 500 ug INTRAVENOUS NDA 31 sections
Octreotide Acetate HUMAN PRESCRIPTION DRUG LABEL 1 0641-6174 INJECTION, SOLUTION 50 ug INTRAVENOUS ANDA 25 sections
Octreotide Acetate HUMAN PRESCRIPTION DRUG LABEL 1 0641-6175 INJECTION, SOLUTION 100 ug INTRAVENOUS ANDA 25 sections
Octreotide Acetate HUMAN PRESCRIPTION DRUG LABEL 1 0641-6176 INJECTION, SOLUTION 500 ug INTRAVENOUS ANDA 25 sections
Octreotide Acetate HUMAN PRESCRIPTION DRUG LABEL 1 0641-6177 INJECTION, SOLUTION 200 ug INTRAVENOUS ANDA 25 sections
Octreotide Acetate HUMAN PRESCRIPTION DRUG LABEL 1 0641-6178 INJECTION, SOLUTION 1000 ug INTRAVENOUS ANDA 25 sections
Mycapssa HUMAN PRESCRIPTION DRUG LABEL 1 10122-550 CAPSULE, DELAYED RELEASE 20 mg ORAL NDA 35 sections
OCTREOTIDE ACETATE HUMAN PRESCRIPTION DRUG LABEL 1 23155-685 INJECTION, SOLUTION 200 ug INTRAVENOUS ANDA 17 sections
OCTREOTIDE ACETATE HUMAN PRESCRIPTION DRUG LABEL 1 23155-686 INJECTION, SOLUTION 1000 ug INTRAVENOUS ANDA 17 sections
OCTREOTIDE ACETATE HUMAN PRESCRIPTION DRUG LABEL 1 23155-687 INJECTION, SOLUTION 50 ug INTRAVENOUS ANDA 17 sections
OCTREOTIDE ACETATE HUMAN PRESCRIPTION DRUG LABEL 1 23155-688 INJECTION, SOLUTION 100 ug INTRAVENOUS ANDA 17 sections
OCTREOTIDE ACETATE HUMAN PRESCRIPTION DRUG LABEL 1 23155-689 INJECTION, SOLUTION 500 ug INTRAVENOUS ANDA 17 sections
Octreotide Acetate HUMAN PRESCRIPTION DRUG LABEL 1 25021-463 INJECTION, SOLUTION 50 ug SUBCUTANEOUS ANDA 29 sections
Octreotide Acetate HUMAN PRESCRIPTION DRUG LABEL 1 25021-464 INJECTION, SOLUTION 100 ug SUBCUTANEOUS ANDA 29 sections
Octreotide Acetate HUMAN PRESCRIPTION DRUG LABEL 1 25021-465 INJECTION, SOLUTION 500 ug SUBCUTANEOUS ANDA 29 sections
Octreotide Acetate HUMAN PRESCRIPTION DRUG LABEL 1 25021-466 INJECTION, SOLUTION 200 ug SUBCUTANEOUS ANDA 29 sections
Octreotide Acetate HUMAN PRESCRIPTION DRUG LABEL 1 25021-467 INJECTION, SOLUTION 1000 ug SUBCUTANEOUS ANDA 29 sections
OCTREOTIDE ACETATE HUMAN PRESCRIPTION DRUG LABEL 1 52958-046 INJECTION, SOLUTION 100 ug INTRAVENOUS ANDA 30 sections
Octreotide acetate HUMAN PRESCRIPTION DRUG LABEL 1 55648-632 INJECTION 1000 ug INTRAVENOUS ANDA 19 sections
Octreotide acetate HUMAN PRESCRIPTION DRUG LABEL 1 55648-633 INJECTION 100 ug INTRAVENOUS ANDA 19 sections
Octreotide acetate HUMAN PRESCRIPTION DRUG LABEL 1 55648-634 INJECTION 200 ug INTRAVENOUS ANDA 19 sections
Octreotide acetate HUMAN PRESCRIPTION DRUG LABEL 1 55648-635 INJECTION 500 ug INTRAVENOUS ANDA 19 sections
Octreotide acetate HUMAN PRESCRIPTION DRUG LABEL 1 55648-636 INJECTION 50 ug INTRAVENOUS ANDA 19 sections
BYNFEZIA Pen Human Prescription Drug Label 1 62756-452 INJECTION 2.50 mg SUBCUTANEOUS NDA 25 sections
Octreotide HUMAN PRESCRIPTION DRUG LABEL 1 63323-376 INJECTION, SOLUTION 100 ug SUBCUTANEOUS ANDA 27 sections
Octreotide HUMAN PRESCRIPTION DRUG LABEL 1 63323-376 INJECTION, SOLUTION 100 ug SUBCUTANEOUS ANDA 27 sections
Octreotide HUMAN PRESCRIPTION DRUG LABEL 1 63323-377 INJECTION, SOLUTION 500 ug SUBCUTANEOUS ANDA 27 sections
Octreotide HUMAN PRESCRIPTION DRUG LABEL 1 63323-377 INJECTION, SOLUTION 500 ug SUBCUTANEOUS ANDA 27 sections