octreotide ๐Ÿถ Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | 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 ยตM/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

Approvals:

DateAgencyCompanyOrphan
Oct. 21, 1988 FDA NOVARTIS
Aug. 21, 2020 PMDA Novartis Pharma K.K., Sandoz K.K.

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 1968.79 14.75 587 52882 6688 50544967
Blood pressure systolic increased 1180.48 14.75 627 52842 34822 50516833
Body temperature decreased 921.95 14.75 415 53054 15980 50535675
Malignant neoplasm progression 717.27 14.75 586 52883 67538 50484117
Inappropriate schedule of product administration 706.58 14.75 594 52875 71237 50480418
Blood pressure increased 635.99 14.75 742 52727 132390 50419265
Injection site mass 563.12 14.75 292 53177 15388 50536267
Injection site pain 503.71 14.75 603 52866 110421 50441234
Blood pressure diastolic decreased 448.43 14.75 257 53212 16524 50535131
Syringe issue 354.80 14.75 119 53350 2025 50549630
Blood growth hormone increased 348.43 14.75 83 53386 354 50551301
Heart rate decreased 279.04 14.75 262 53207 36235 50515420
Metastases to liver 265.53 14.75 198 53271 19906 50531749
Flatulence 263.52 14.75 231 53238 29227 50522428
Abdominal pain 231.98 14.75 659 52810 235569 50316086
Blood pressure diastolic increased 231.51 14.75 126 53343 7317 50544338
Insulin-like growth factor increased 221.05 14.75 66 53403 752 50550903
Blood chromogranin A increased 206.64 14.75 49 53420 204 50551451
Hepatic lesion 198.61 14.75 93 53376 3915 50547740
Abdominal distension 190.86 14.75 304 53165 72599 50479056
Carcinoid crisis 190.03 14.75 45 53424 186 50551469
Second primary malignancy 182.26 14.75 105 53364 6809 50544846
Underdose 175.30 14.75 156 53313 20122 50531533
Rheumatoid arthritis 167.82 14.75 12 53457 202538 50349117
Diarrhoea 154.97 14.75 1106 52363 587370 49964285
Drug ineffective 153.52 14.75 407 53062 818926 49732729
Stress 152.86 14.75 233 53236 53560 50498095
Mass 152.22 14.75 116 53353 12041 50539614
Toxicity to various agents 151.81 14.75 22 53447 212477 50339178
Blood pressure decreased 146.09 14.75 233 53236 55676 50495979
Neoplasm progression 144.56 14.75 166 53303 28991 50522664
Malaise 144.46 14.75 718 52751 334814 50216841
Weight decreased 138.43 14.75 530 52939 220715 50330940
Cholelithiasis 136.55 14.75 184 53285 37789 50513866
Contraindicated product administered 132.00 14.75 6 53463 148952 50402703
Condition aggravated 123.66 14.75 81 53388 296977 50254678
Intestinal obstruction 120.46 14.75 144 53325 26239 50525416
Off label use 119.29 14.75 199 53270 474227 50077428
Injection site discomfort 117.41 14.75 64 53405 3726 50547929
Rash 114.17 14.75 179 53290 437292 50114363
Drug intolerance 113.12 14.75 45 53424 219059 50332596
Injection site haemorrhage 108.29 14.75 123 53346 21223 50530432
Flushing 106.16 14.75 225 53244 66790 50484865
Acute kidney injury 105.04 14.75 55 53414 228003 50323652
Neoplasm 102.86 14.75 69 53400 5859 50545796
Diabetes mellitus 102.45 14.75 185 53284 48848 50502807
Bowel movement irregularity 101.23 14.75 59 53410 3909 50547746
Treatment failure 101.20 14.75 13 53456 137624 50414031
Hepatic neoplasm 100.70 14.75 45 53424 1697 50549958
Therapeutic product effect decreased 99.67 14.75 13 53456 136037 50415618
Drug interaction 96.66 14.75 45 53424 199576 50352079
Insulin-like growth factor decreased 95.98 14.75 29 53440 345 50551310
Blood pressure systolic decreased 92.91 14.75 64 53405 5675 50545980
Neuroendocrine tumour 92.43 14.75 31 53438 527 50551128
Glossodynia 92.43 14.75 8 53461 115561 50436094
Nervousness 88.93 14.75 127 53342 27524 50524131
Arthropathy 87.28 14.75 29 53440 157877 50393778
Pituitary tumour 82.71 14.75 32 53437 833 50550822
Hepatic pain 81.76 14.75 45 53424 2670 50548985
Abdominal pain upper 81.58 14.75 359 53110 158950 50392705
Metastasis 80.93 14.75 53 53416 4322 50547333
Blood glucose decreased 80.83 14.75 98 53371 18113 50533542
Maternal exposure during pregnancy 80.51 14.75 34 53435 159744 50391911
Frequent bowel movements 78.88 14.75 85 53384 13833 50537822
Carcinoid heart disease 78.46 14.75 15 53454 13 50551642
Eating disorder 75.13 14.75 87 53382 15322 50536333
Exposure during pregnancy 72.75 14.75 19 53450 120996 50430659
Carcinoid syndrome 72.56 14.75 18 53451 94 50551561
Neutropenia 70.61 14.75 34 53435 147931 50403724
Faeces discoloured 70.31 14.75 86 53383 16038 50535617
Pericarditis 70.24 14.75 3 53466 78686 50472969
Hand deformity 70.05 14.75 11 53458 100188 50451467
Intentional product use issue 68.43 14.75 3 53466 76915 50474740
Hypersensitivity 68.28 14.75 76 53393 215085 50336570
Pancreatic neuroendocrine tumour 68.23 14.75 21 53448 267 50551388
Overdose 67.38 14.75 12 53457 99715 50451940
Back pain 65.44 14.75 427 53042 219603 50332052
Serum serotonin increased 65.01 14.75 18 53451 153 50551502
Terminal state 63.62 14.75 35 53434 2075 50549580
Loss of personal independence in daily activities 61.45 14.75 3 53466 70047 50481608
Hormone level abnormal 57.60 14.75 33 53436 2116 50549539
Limb discomfort 57.49 14.75 97 53372 24260 50527395
Asthenia 57.27 14.75 551 52918 318491 50233164
Drug hypersensitivity 56.03 14.75 113 53356 250897 50300758
Therapeutic product effect incomplete 55.70 14.75 14 53455 91501 50460154
Carcinoid tumour 54.56 14.75 18 53451 290 50551365
Blood glucose increased 53.94 14.75 182 53287 71142 50480513
Feeling abnormal 53.36 14.75 268 53201 125224 50426431
Sinusitis 53.27 14.75 61 53408 170497 50381158
Blood growth hormone abnormal 51.08 14.75 11 53458 26 50551629
Metastases to pancreas 50.64 14.75 16 53453 223 50551432
Febrile neutropenia 50.44 14.75 20 53449 97647 50454008
Hypoglycaemia 49.96 14.75 147 53322 53434 50498221
Hot flush 49.91 14.75 130 53339 44039 50507616
Steatorrhoea 49.78 14.75 18 53451 386 50551269
Blood glucose fluctuation 48.49 14.75 38 53431 4108 50547547
Cough 48.46 14.75 427 53042 240837 50310818
Drug abuse 48.22 14.75 4 53465 59842 50491813
Product dose omission issue 47.06 14.75 76 53393 183762 50367893
Injection site hypersensitivity 46.54 14.75 27 53442 1773 50549882
Polyp 46.49 14.75 42 53427 5520 50546135
Movement disorder 45.35 14.75 73 53396 17559 50534096
Seizure 45.19 14.75 35 53434 117839 50433816
Death 44.84 14.75 533 52936 324846 50226809
Depressed mood 44.62 14.75 106 53363 33917 50517738
Product quality issue 43.60 14.75 99 53370 30759 50520896
Yellow skin 43.55 14.75 27 53442 2002 50549653
Hepatic enzyme increased 41.95 14.75 50 53419 137330 50414325
Impaired healing 41.84 14.75 11 53458 69775 50481880
Influenza 41.47 14.75 196 53273 89342 50462313
Hip fracture 40.95 14.75 87 53382 25844 50525811
Neuroendocrine tumour of the lung 40.81 14.75 8 53461 9 50551646
Angina bullosa haemorrhagica 40.57 14.75 12 53457 132 50551523
Productive cough 40.31 14.75 135 53334 52559 50499096
Metastases to bone 40.27 14.75 70 53399 17925 50533730
Faeces pale 40.24 14.75 23 53446 1468 50550187
Muscle swelling 39.33 14.75 15 53454 375 50551280
Psoriasis 39.29 14.75 12 53457 68988 50482667
Hyponatraemia 38.86 14.75 27 53442 96112 50455543
Pituitary tumour recurrent 38.59 14.75 10 53459 64 50551591
5-hydroxyindolacetic acid increased 38.48 14.75 7 53462 3 50551652
Acne 38.47 14.75 72 53397 19523 50532132
Injection site swelling 38.36 14.75 114 53355 41659 50509996
Metastases to gastrointestinal tract 38.33 14.75 10 53459 66 50551589
Sciatic nerve injury 38.18 14.75 15 53454 407 50551248
Intentional product misuse 38.00 14.75 3 53466 46731 50504924
Urticaria 37.62 14.75 49 53420 129512 50422143
Chikungunya virus infection 37.60 14.75 12 53457 173 50551482
Blood growth hormone decreased 36.83 14.75 8 53461 20 50551635
Groin pain 36.48 14.75 46 53423 8845 50542810
Injection site hypoaesthesia 36.05 14.75 14 53455 368 50551287
Injection site induration 35.34 14.75 44 53425 8353 50543302
Dizziness 35.16 14.75 537 52932 345832 50205823
Infection 35.13 14.75 82 53387 172872 50378783
White blood cell count decreased 35.08 14.75 43 53426 116679 50434976
Musculoskeletal stiffness 34.89 14.75 51 53418 128430 50423225
Pancytopenia 34.76 14.75 23 53446 84007 50467648
Pancreatic disorder 34.75 14.75 24 53445 2137 50549518
Deep vein thrombosis 34.71 14.75 17 53452 73287 50478368
Unevaluable event 34.70 14.75 4 53465 46062 50505593
Brain neoplasm 34.54 14.75 30 53439 3743 50547912
Gastrointestinal neoplasm 34.43 14.75 13 53456 316 50551339
Neuropathy peripheral 34.29 14.75 31 53438 96726 50454929
Heart rate increased 34.25 14.75 167 53302 77083 50474572
Asthma 33.64 14.75 27 53442 89310 50462345
Decreased appetite 33.53 14.75 342 53127 200581 50351074
Depressed level of consciousness 33.50 14.75 7 53462 51946 50499709
Psychiatric symptom 33.35 14.75 32 53437 4538 50547117
Blister 33.20 14.75 25 53444 85393 50466262
Metastases to eye 32.87 14.75 10 53459 122 50551533
Blood iron decreased 32.52 14.75 50 53419 11565 50540090
Hepatic mass 32.39 14.75 20 53449 1472 50550183
Adenoma benign 31.82 14.75 16 53453 788 50550867
Alanine aminotransferase increased 31.68 14.75 28 53441 88331 50463324
Crying 31.67 14.75 68 53401 20348 50531307
Facial asymmetry 31.60 14.75 15 53454 651 50551004
Thrombocytopenia 31.52 14.75 54 53415 127619 50424036
Head banging 31.50 14.75 13 53456 402 50551253
Pollakiuria 30.94 14.75 74 53395 23777 50527878
Anxiety 30.92 14.75 305 53164 177301 50374354
Body height increased 30.64 14.75 8 53461 53 50551602
Respiratory rate increased 30.47 14.75 48 53421 11337 50540318
Benign neoplasm of adrenal gland 30.15 14.75 7 53462 26 50551629
Adverse event 30.13 14.75 5 53464 43758 50507897
Metastases to ovary 30.13 14.75 12 53457 338 50551317
Bile duct stone 29.68 14.75 26 53443 3281 50548374
Electrocardiogram QT prolonged 29.58 14.75 9 53460 51877 50499778
Cardio-respiratory arrest 29.57 14.75 10 53459 53882 50497773
Recurrent cancer 29.40 14.75 20 53449 1737 50549918
Multiple sclerosis relapse 29.38 14.75 5 53464 42959 50508696
Pruritus 29.07 14.75 178 53291 283390 50268265
Adverse drug reaction 29.01 14.75 11 53458 55211 50496444
Contusion 28.72 14.75 210 53259 111973 50439682
Illness 28.51 14.75 73 53396 24467 50527188
Buttock injury 28.26 14.75 10 53459 201 50551454
Blood glucose abnormal 28.14 14.75 35 53434 6637 50545018
Metastases to abdominal cavity 28.10 14.75 12 53457 405 50551250
Anaphylactic reaction 28.02 14.75 11 53458 54044 50497611
Thyroid disorder 27.96 14.75 49 53420 12628 50539027
Gait disturbance 27.78 14.75 261 53208 149744 50401911
Breast mass 27.47 14.75 34 53435 6415 50545240
Metastatic carcinoid tumour 27.34 14.75 6 53463 16 50551639
Leukopenia 27.24 14.75 19 53450 67509 50484146
Administration site abscess 27.08 14.75 6 53463 17 50551638
Pulmonary embolism 27.00 14.75 41 53428 101663 50449992
Polydipsia 26.92 14.75 24 53445 3100 50548555
Fall 26.90 14.75 500 52969 334432 50217223
Cardiac failure congestive 26.51 14.75 30 53439 84352 50467303
Musculoskeletal pain 26.44 14.75 148 53321 72029 50479626
Administration site induration 26.35 14.75 6 53463 20 50551635
Incorrect dose administered 26.18 14.75 111 53358 48303 50503352
Injection site cyst 26.11 14.75 7 53462 52 50551603
Neuroendocrine carcinoma metastatic 26.05 14.75 9 53460 168 50551487
Biliary obstruction 25.99 14.75 21 53448 2372 50549283
Administration site discharge 25.90 14.75 6 53463 22 50551633
Chondroma 25.90 14.75 6 53463 22 50551633
Irritable bowel syndrome 25.80 14.75 11 53458 51430 50500225
Abdominal pain lower 25.57 14.75 65 53404 21691 50529964
Neuroendocrine carcinoma 25.47 14.75 9 53460 180 50551475
Metastases to breast 25.40 14.75 10 53459 273 50551382
Oxygen saturation decreased 25.32 14.75 24 53445 73224 50478431
Joint swelling 25.11 14.75 154 53315 245132 50306523
Pain in extremity 24.99 14.75 416 53053 272449 50279206
Pallor 24.90 14.75 67 53402 23132 50528523
Dyspnoea 24.61 14.75 419 53050 547189 50004466
Liver abscess 24.51 14.75 21 53448 2572 50549083
Chronic obstructive pulmonary disease 24.39 14.75 13 53456 53422 50498233
Product use in unapproved indication 24.25 14.75 207 53262 115612 50436043
Screaming 23.93 14.75 22 53447 2956 50548699
Rhabdomyolysis 23.68 14.75 6 53463 39021 50512634
Dengue fever 23.64 14.75 12 53457 603 50551052
Administration site odour 23.63 14.75 6 53463 35 50551620
Zinc deficiency 23.63 14.75 6 53463 35 50551620
Hallucination 23.36 14.75 10 53459 46647 50505008
Breast pain 23.30 14.75 34 53435 7510 50544145
Faeces soft 23.24 14.75 25 53444 4059 50547596
Hyperhidrosis 23.22 14.75 168 53301 89258 50462397
Tumour compression 23.21 14.75 6 53463 38 50551617
Small intestinal obstruction 23.20 14.75 52 53417 16016 50535639
Aspartate aminotransferase increased 23.15 14.75 29 53440 77969 50473686
Pain in jaw 23.14 14.75 6 53463 38422 50513233
Thyroid mass 23.03 14.75 23 53446 3425 50548230
Medication error 23.00 14.75 5 53464 36099 50515556
Metastases to pelvis 22.94 14.75 10 53459 355 50551300
C-reactive protein increased 22.72 14.75 22 53447 66452 50485203
Intestinal haemorrhage 22.70 14.75 22 53447 3158 50548497
Small intestine carcinoma 22.66 14.75 10 53459 366 50551289
Lactic acidosis 22.55 14.75 4 53465 33351 50518304
Tonsillar inflammation 22.32 14.75 7 53462 95 50551560
Gastritis fungal 22.19 14.75 7 53462 97 50551558
Vulval disorder 22.02 14.75 12 53457 698 50550957
Injection site bruising 22.01 14.75 87 53382 36681 50514974
Pancreatic enlargement 21.99 14.75 6 53463 48 50551607
Heart rate irregular 21.88 14.75 57 53412 19303 50532352
Dysstasia 21.74 14.75 54 53415 17765 50533890
Periarticular disorder 21.57 14.75 6 53463 52 50551603
Blood gastrin increased 21.45 14.75 5 53464 19 50551636
Nephritic syndrome 21.44 14.75 8 53461 188 50551467
Soft tissue mass 21.35 14.75 9 53460 294 50551361
Pancreatectomy 21.24 14.75 5 53464 20 50551635
Pregnancy 21.23 14.75 3 53466 29574 50522081
Memory impairment 21.13 14.75 150 53319 79210 50472445
Early satiety 21.08 14.75 12 53457 760 50550895
Bone cancer 21.03 14.75 14 53455 1173 50550482
Metastases to peritoneum 20.98 14.75 20 53449 2813 50548842
Proctalgia 20.71 14.75 26 53443 4977 50546678
No adverse event 20.69 14.75 5 53464 33573 50518082
Blood magnesium decreased 20.66 14.75 40 53429 11120 50540535
Plasma cell myeloma 20.65 14.75 4 53465 31318 50520337
Diaphragmatic spasm 20.65 14.75 4 53465 4 50551651
Tumour pain 20.58 14.75 14 53455 1216 50550439
Feeling hot 20.51 14.75 89 53380 39113 50512542
Pituitary enlargement 20.51 14.75 5 53464 24 50551631
Haemorrhoids 20.42 14.75 55 53414 18998 50532657
Sepsis 20.38 14.75 72 53397 132853 50418802
Injection site scar 20.02 14.75 12 53457 837 50550818
Large intestine polyp 19.74 14.75 31 53438 7301 50544354
Osteonecrosis of jaw 19.74 14.75 5 53464 32521 50519134
Feeding disorder 19.60 14.75 38 53431 10575 50541080
Thirst 19.51 14.75 38 53431 10612 50541043
Respiratory failure 19.50 14.75 42 53427 91139 50460516
Pancreatolithiasis 19.46 14.75 8 53461 245 50551410
Pancreatic carcinoma recurrent 19.44 14.75 6 53463 77 50551578
Insulin-like growth factor abnormal 19.38 14.75 4 53465 7 50551648
Bite 19.37 14.75 9 53460 372 50551283
Respiratory tract infection 19.28 14.75 5 53464 32012 50519643
Nephrolithiasis 19.11 14.75 80 53389 34613 50517042
Administration site haemorrhage 19.10 14.75 6 53463 82 50551573
Musculoskeletal discomfort 19.08 14.75 46 53423 14852 50536803
Myocardial infarction 19.05 14.75 41 53428 88986 50462669
Hepatotoxicity 18.99 14.75 3 53466 27223 50524432
Angioedema 18.98 14.75 8 53461 37668 50513987
Injection site inflammation 18.91 14.75 20 53449 3185 50548470
Red blood cell sedimentation rate increased 18.89 14.75 4 53465 29412 50522243
Sleep disorder due to general medical condition, insomnia type 18.77 14.75 5 53464 31442 50520213
Rectal polyp 18.65 14.75 12 53457 949 50550706
Biliary colic 18.63 14.75 20 53449 3239 50548416
Gallbladder neoplasm 18.55 14.75 5 53464 38 50551617
Anaemia 18.49 14.75 174 53295 252282 50299373
Lymphatic system neoplasm 18.44 14.75 5 53464 39 50551616
Metastases to fallopian tube 18.44 14.75 5 53464 39 50551616
Sciatica 18.35 14.75 57 53412 21325 50530330
Arthropod bite 18.31 14.75 27 53442 6018 50545637
Coccydynia 18.26 14.75 13 53456 1215 50550440
Application site mass 18.11 14.75 5 53464 42 50551613
Constipation 18.05 14.75 286 53183 185422 50366233
Sedation 18.02 14.75 5 53464 30605 50521050
Bile output increased 18.01 14.75 5 53464 43 50551612
Injection site warmth 17.96 14.75 43 53426 13823 50537832
Carcinoid tumour of the small bowel 17.88 14.75 4 53465 12 50551643
Abortion spontaneous 17.86 14.75 11 53458 41761 50509894
Suicide attempt 17.82 14.75 17 53452 51715 50499940
Spleen disorder 17.77 14.75 11 53458 813 50550842
Muscle strain 17.76 14.75 29 53440 7059 50544596
Overweight 17.75 14.75 19 53450 3067 50548588
Skin discolouration 17.63 14.75 75 53394 32682 50518973
Gallbladder oedema 17.58 14.75 7 53462 197 50551458
Tricuspid valve stenosis 17.56 14.75 3 53466 0 50551655
Endocrine neoplasm 17.56 14.75 3 53466 0 50551655
Gout 17.55 14.75 38 53431 11432 50540223
Hyperkalaemia 17.52 14.75 15 53454 48074 50503581
Helicobacter infection 17.51 14.75 16 53453 49686 50501969
Cardiac arrest 17.50 14.75 39 53430 83612 50468043
Sensitisation 17.43 14.75 14 53455 1568 50550087
Spinal cord injury lumbar 17.42 14.75 5 53464 49 50551606
Pancreatic neuroendocrine tumour metastatic 17.41 14.75 4 53465 14 50551641
BRASH syndrome 17.29 14.75 7 53462 206 50551449
Urine calcium/creatinine ratio increased 17.27 14.75 6 53463 114 50551541
Coronary artery disease 17.23 14.75 5 53464 29721 50521934
Multiple endocrine neoplasia Type 1 17.20 14.75 4 53465 15 50551640
Pituitary tumour removal 17.20 14.75 4 53465 15 50551640
Trichoglossia 17.01 14.75 7 53462 215 50551440
Hypothalamo-pituitary disorder 16.96 14.75 10 53459 677 50550978
Fear-related avoidance of activities 16.94 14.75 6 53463 121 50551534
Abdominal mass 16.85 14.75 17 53452 2562 50549093
Hepatic cancer 16.82 14.75 19 53450 3256 50548399
Pubic pain 16.74 14.75 5 53464 57 50551598
Fatigue 16.73 14.75 910 52559 706691 49844964
Frustration tolerance decreased 16.70 14.75 25 53444 5649 50546006
Haemorrhage 16.62 14.75 105 53364 53336 50498319
Pneumonia aspiration 16.58 14.75 6 53463 30998 50520657
Body height decreased 16.58 14.75 32 53437 8876 50542779
Ill-defined disorder 16.55 14.75 20 53449 54634 50497021
Nasopharyngitis 16.50 14.75 291 53178 192636 50359019
Back injury 16.43 14.75 28 53441 7057 50544598
Rash maculo-papular 16.35 14.75 4 53465 26637 50525018
Tumour necrosis 16.34 14.75 10 53459 724 50550931
Mobility decreased 16.14 14.75 38 53431 79910 50471745
Abnormal faeces 16.10 14.75 21 53448 4175 50547480
Pituitary tumour benign 15.98 14.75 14 53455 1767 50549888
Treatment noncompliance 15.85 14.75 6 53463 30144 50521511
Nasal discharge discolouration 15.84 14.75 13 53456 1501 50550154
Short-bowel syndrome 15.84 14.75 8 53461 398 50551257
Rhinorrhoea 15.83 14.75 101 53368 51482 50500173
Injury 15.80 14.75 17 53452 48908 50502747
Cognitive disorder 15.79 14.75 14 53455 44109 50507546
Transient global amnesia 15.71 14.75 8 53461 405 50551250
Gallbladder disorder 15.66 14.75 46 53423 16696 50534959
Fear 15.59 14.75 42 53427 14507 50537148
Pulse abnormal 15.55 14.75 14 53455 1831 50549824
Insulinoma 15.55 14.75 5 53464 74 50551581
Metastases to spine 15.53 14.75 17 53452 2814 50548841
Vasoactive intestinal polypeptide increased 15.49 14.75 3 53466 3 50551652
Metastases to uterus 15.42 14.75 5 53464 76 50551579
Labyrinthitis 15.35 14.75 15 53454 2176 50549479
Metastases to oesophagus 15.25 14.75 4 53465 27 50551628
Hypoxia 15.18 14.75 19 53450 51104 50500551
Respiratory disorder 15.11 14.75 7 53462 31180 50520475
Polyuria 15.03 14.75 27 53442 7094 50544561
Urethral caruncle 14.96 14.75 5 53464 84 50551571
Injection site vesicles 14.92 14.75 16 53453 2589 50549066
Hypokinesia 14.88 14.75 37 53432 12180 50539475

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 1327.25 15.34 409 37360 4274 29532484
Blood pressure systolic increased 1173.93 15.34 524 37245 16321 29520437
Body temperature decreased 857.14 15.34 367 37402 10297 29526461
Blood pressure increased 666.83 15.34 631 37138 73172 29463586
Injection site pain 603.09 15.34 423 37346 32023 29504735
Inappropriate schedule of product administration 538.19 15.34 449 37320 44023 29492735
Malignant neoplasm progression 518.62 15.34 551 37218 73308 29463450
Heart rate decreased 379.16 15.34 288 37481 24624 29512134
Blood pressure diastolic decreased 357.27 15.34 176 37593 6846 29529912
Metastases to liver 306.17 15.34 190 37579 11666 29525092
Injection site mass 296.32 15.34 143 37626 5312 29531446
Hepatic neoplasm 226.23 15.34 86 37683 1750 29535008
Blood chromogranin A increased 192.50 15.34 46 37723 157 29536601
Blood growth hormone increased 176.52 15.34 46 37723 242 29536516
Hepatic lesion 175.37 15.34 84 37685 3066 29533692
Abdominal pain 174.15 15.34 470 37299 134887 29401871
Drug interaction 169.99 15.34 25 37744 197360 29339398
Acute kidney injury 165.81 15.34 66 37703 265201 29271557
Syringe issue 160.90 15.34 84 37685 3694 29533064
Blood pressure diastolic increased 157.11 15.34 82 37687 3604 29533154
Second primary malignancy 151.99 15.34 99 37670 6606 29530152
Weight decreased 151.85 15.34 480 37289 150425 29386333
Malaise 150.96 15.34 497 37272 159105 29377653
Flushing 145.12 15.34 182 37587 28810 29507948
Diarrhoea 142.80 15.34 815 36954 331883 29204875
Insulin-like growth factor increased 136.73 15.34 52 37717 1059 29535699
Pain 123.87 15.34 489 37280 170943 29365815
Carcinoid crisis 122.14 15.34 33 37736 204 29536554
Abdominal distension 122.02 15.34 214 37555 45697 29491061
Stress 120.67 15.34 143 37626 21347 29515411
Cholelithiasis 117.88 15.34 132 37637 18540 29518218
Injection site haemorrhage 116.66 15.34 92 37677 8294 29528464
Flatulence 116.64 15.34 128 37641 17581 29519177
Toxicity to various agents 110.32 15.34 42 37727 173619 29363139
Intestinal obstruction 101.23 15.34 124 37645 19153 29517605
Underdose 96.45 15.34 96 37673 11773 29524985
Neoplasm 88.38 15.34 59 37710 4102 29532656
Febrile neutropenia 84.15 15.34 20 37749 112220 29424538
5-hydroxyindolacetic acid in urine increased 81.77 15.34 24 37745 208 29536550
Condition aggravated 80.94 15.34 43 37726 146252 29390506
Nasopharyngitis 80.35 15.34 211 37558 59454 29477304
Off label use 80.35 15.34 165 37604 300635 29236123
Neutropenia 80.08 15.34 34 37735 131677 29405081
Carcinoid syndrome 76.56 15.34 19 37750 79 29536679
Biliary obstruction 76.07 15.34 44 37725 2370 29534388
Injection site swelling 72.53 15.34 74 37695 9343 29527415
Hormone level abnormal 71.92 15.34 24 37745 328 29536430
Faeces soft 71.32 15.34 43 37726 2502 29534256
Pneumonia 70.11 15.34 195 37574 319977 29216781
Neuroendocrine tumour 67.22 15.34 27 37742 639 29536119
Injection site discomfort 66.92 15.34 33 37736 1284 29535474
Pancytopenia 66.02 15.34 13 37756 83155 29453603
Neoplasm progression 64.67 15.34 98 37671 18514 29518244
Blood mercury abnormal 62.49 15.34 19 37750 188 29536570
Metastasis 61.92 15.34 44 37725 3385 29533373
Discomfort 61.92 15.34 85 37684 14678 29522080
Fatigue 55.16 15.34 632 37137 316189 29220569
Blood glucose increased 54.92 15.34 183 37586 58801 29477957
Blood pressure decreased 54.38 15.34 154 37615 45323 29491435
Pancreatic neuroendocrine tumour 52.81 15.34 17 37752 206 29536552
Eating disorder 52.30 15.34 55 37714 7192 29529566
Gait disturbance 51.78 15.34 208 37561 73141 29463617
Cardiac failure congestive 51.14 15.34 17 37752 76564 29460194
Incorrect dose administered 51.02 15.34 123 37646 32861 29503897
Serum serotonin increased 48.16 15.34 13 37756 80 29536678
Steatorrhoea 46.36 15.34 21 37748 673 29536085
Movement disorder 46.06 15.34 61 37708 10176 29526582
Faecal volume decreased 45.43 15.34 13 37756 102 29536656
Drug ineffective 44.49 15.34 277 37492 362893 29173865
Peripheral swelling 44.37 15.34 180 37589 63559 29473199
Heart rate irregular 44.06 15.34 68 37701 13049 29523709
Erythema 43.81 15.34 202 37567 75404 29461354
Heart rate increased 43.78 15.34 129 37640 38809 29497949
Respiratory failure 43.61 15.34 36 37733 97095 29439663
Myocardial infarction 43.50 15.34 46 37723 110250 29426508
Rhabdomyolysis 43.31 15.34 12 37757 60796 29475962
Rhinorrhoea 43.12 15.34 89 37680 21430 29515328
Back pain 43.10 15.34 250 37519 102034 29434724
Atrial fibrillation 42.86 15.34 43 37726 105603 29431155
Diaphragmatic spasm 42.76 15.34 12 37757 87 29536671
Metastases to pancreas 42.66 15.34 15 37754 242 29536516
Pituitary tumour 42.30 15.34 18 37751 495 29536263
Bowel movement irregularity 41.78 15.34 30 37739 2346 29534412
Feeling cold 41.71 15.34 55 37714 9136 29527622
Hot flush 41.66 15.34 71 37698 14799 29521959
Infusion related reaction 41.52 15.34 4 37765 43882 29492876
Respiratory rate increased 40.90 15.34 53 37716 8655 29528103
Overdose 40.49 15.34 26 37743 79793 29456965
Asthenia 40.35 15.34 436 37333 214814 29321944
Thrombocytopenia 40.23 15.34 69 37700 134754 29402004
Sepsis 39.91 15.34 76 37693 142606 29394152
Acute myocardial infarction 39.65 15.34 7 37762 48431 29488327
Cardiac arrest 39.32 15.34 31 37738 85560 29451198
Anaemia 37.75 15.34 131 37638 200820 29335938
Blood creatine phosphokinase increased 37.68 15.34 4 37765 40640 29496118
Coronary artery disease 37.02 15.34 6 37763 44184 29492574
Frequent bowel movements 36.95 15.34 52 37717 9187 29527571
Neuropathy peripheral 36.21 15.34 23 37746 71004 29465754
Mass 36.12 15.34 45 37724 7066 29529692
Abdominal pain upper 36.10 15.34 164 37605 60829 29475929
Cardio-respiratory arrest 36.00 15.34 10 37759 50591 29486167
Lacrimal disorder 35.76 15.34 14 37755 309 29536449
Influenza 35.52 15.34 126 37643 41755 29495003
Blood test abnormal 35.17 15.34 40 37729 5709 29531049
Product dose omission issue 34.95 15.34 43 37726 96340 29440418
Hyponatraemia 34.34 15.34 22 37747 67611 29469147
Metastases to bone 34.21 15.34 52 37717 9846 29526912
5-hydroxyindolacetic acid increased 33.99 15.34 6 37763 0 29536758
Hyperkalaemia 33.96 15.34 18 37751 61374 29475384
Abdominal discomfort 33.90 15.34 136 37633 47767 29488991
Interstitial lung disease 33.31 15.34 16 37753 57702 29479056
Low density lipoprotein decreased 33.23 15.34 19 37750 1001 29535757
Suicide attempt 32.56 15.34 3 37766 34107 29502651
Nephrolithiasis 32.45 15.34 88 37681 25246 29511512
Foetal exposure during pregnancy 32.27 15.34 3 37766 33864 29502894
Abnormal faeces 31.98 15.34 27 37742 2678 29534080
Intra-abdominal fluid collection 31.66 15.34 19 37750 1096 29535662
Blood growth hormone abnormal 31.56 15.34 6 37763 3 29536755
Pain in extremity 31.48 15.34 245 37524 110188 29426570
Faeces discoloured 31.31 15.34 59 37710 13292 29523466
Nerve degeneration 31.26 15.34 11 37758 178 29536580
Hypoxia 30.79 15.34 11 37758 47368 29489390
Necrotising colitis 30.77 15.34 18 37751 990 29535768
Bone neoplasm 30.73 15.34 12 37757 263 29536495
Feeling abnormal 30.44 15.34 144 37625 54301 29482457
White blood cell count decreased 30.42 15.34 37 37732 83325 29453433
Musculoskeletal discomfort 30.42 15.34 39 37730 6302 29530456
Biliary colic 30.07 15.34 17 37752 876 29535882
Hepatic pain 30.01 15.34 19 37750 1206 29535552
Angioedema 29.95 15.34 3 37766 31912 29504846
Metastases to lymph nodes 29.90 15.34 31 37738 3986 29532772
Product quality issue 29.82 15.34 64 37705 15831 29520927
Alanine aminotransferase increased 29.77 15.34 28 37741 70916 29465842
Intentional product use issue 29.13 15.34 9 37760 42489 29494269
Blood glucose abnormal 28.80 15.34 34 37735 5049 29531709
Blood creatinine increased 28.76 15.34 40 37729 85062 29451696
Oropharyngeal pain 28.25 15.34 92 37677 29193 29507565
Metastatic carcinoid tumour 27.75 15.34 6 37763 11 29536747
Seizure 27.44 15.34 48 37721 93075 29443683
Blood glucose fluctuation 27.21 15.34 28 37741 3569 29533189
Nervousness 26.56 15.34 50 37719 11256 29525502
Decreased appetite 26.52 15.34 293 37476 145049 29391709
Carcinoid heart disease 26.49 15.34 6 37763 15 29536743
Hepatic mass 25.80 15.34 16 37753 979 29535779
Arthralgia 25.72 15.34 282 37487 139335 29397423
Hernia 24.86 15.34 41 37728 8317 29528441
Deep vein thrombosis 24.86 15.34 22 37747 57377 29479381
Renal failure 24.54 15.34 74 37695 118525 29418233
Suicidal ideation 24.43 15.34 7 37762 34709 29502049
Terminal state 24.29 15.34 26 37743 3468 29533290
Blood growth hormone decreased 24.17 15.34 6 37763 25 29536733
Hernia pain 24.16 15.34 10 37759 256 29536502
Metastases to gastrointestinal tract 23.82 15.34 7 37762 61 29536697
Neuroendocrine carcinoma metastatic 23.80 15.34 8 37761 112 29536646
Musculoskeletal chest pain 23.79 15.34 41 37728 8619 29528139
Psoriasis 23.62 15.34 6 37763 32221 29504537
Musculoskeletal pain 23.60 15.34 86 37683 28867 29507891
Recurrent cancer 23.50 15.34 16 37753 1149 29535609
Expired product administered 23.32 15.34 23 37746 2788 29533970
Metastases to thorax 23.28 15.34 6 37763 30 29536728
Cardiac failure 23.24 15.34 41 37728 79246 29457512
Cortisol free urine increased 23.19 15.34 5 37764 9 29536749
Blood glucose decreased 23.10 15.34 49 37720 12020 29524738
Unevaluable event 22.98 15.34 5 37764 29846 29506912
Mental status changes 22.88 15.34 8 37761 34919 29501839
Respiratory arrest 22.81 15.34 3 37766 25830 29510928
Chest wall tumour 22.66 15.34 4 37765 0 29536758
Dizziness postural 22.65 15.34 31 37738 5336 29531422
Hypertrophic osteoarthropathy 22.36 15.34 7 37762 77 29536681
Neutrophil count decreased 22.34 15.34 14 37755 43553 29493205
Metastases to spine 22.26 15.34 20 37749 2156 29534602
Swelling of eyelid 21.90 15.34 12 37757 582 29536176
Eating disorder symptom 21.67 15.34 5 37764 14 29536744
Parathyroid hormone-related protein abnormal 21.67 15.34 5 37764 14 29536744
Device occlusion 21.59 15.34 31 37738 5577 29531181
Haematuria 21.53 15.34 15 37754 44124 29492634
Blood urine present 21.51 15.34 42 37727 9713 29527045
Blood potassium decreased 21.51 15.34 56 37713 15678 29521080
Saliva altered 21.50 15.34 8 37761 153 29536605
Sciatica 21.49 15.34 29 37740 4925 29531833
Lactic acidosis 21.47 15.34 6 37763 30241 29506517
Metastases to oesophagus 21.41 15.34 5 37764 15 29536743
Chronic kidney disease 21.15 15.34 10 37759 36406 29500352
Injection site bruising 20.97 15.34 36 37733 7544 29529214
Death 20.94 15.34 578 37191 341506 29195252
Limb discomfort 20.86 15.34 41 37728 9527 29527231
Septic shock 20.54 15.34 30 37739 62530 29474228
Body temperature increased 20.31 15.34 52 37717 14413 29522345
Tumour marker increased 20.08 15.34 11 37758 533 29536225
Neck mass 20.06 15.34 16 37753 1465 29535293
Metastases to lung 20.04 15.34 36 37733 7819 29528939
Nausea 19.78 15.34 496 37273 288759 29247999
Therapeutic product effect incomplete 19.65 15.34 13 37756 39292 29497466
Blood pressure fluctuation 19.64 15.34 63 37706 19831 29516927
Product use in unapproved indication 19.60 15.34 183 37586 86692 29450066
Rash 19.57 15.34 152 37617 189667 29347091
Contusion 19.43 15.34 85 37684 31010 29505748
Ventricular tachycardia 19.05 15.34 3 37766 22571 29514187
Encephalopathy 18.85 15.34 8 37761 31035 29505723
Bite 18.84 15.34 6 37763 70 29536688
Leukopenia 18.59 15.34 26 37743 55177 29481581
Somnolence 18.45 15.34 60 37709 93895 29442863
Concomitant disease aggravated 18.41 15.34 27 37742 4951 29531807
Metastases to eye 18.40 15.34 6 37763 76 29536682
Yellow skin 18.39 15.34 17 37752 1901 29534857
Biliary tract infection 18.30 15.34 10 37759 482 29536276
Multiple organ dysfunction syndrome 18.16 15.34 33 37736 63083 29473675
Pancreatic neoplasm 18.04 15.34 12 37757 829 29535929
Intestinal metastasis 17.82 15.34 7 37762 156 29536602
Metastases to spleen 17.77 15.34 9 37760 371 29536387
Injection site hypersensitivity 17.76 15.34 8 37761 253 29536505
Pyrexia 17.63 15.34 260 37509 287362 29249396
Abdominal pain lower 17.62 15.34 36 37733 8602 29528156
Pancreatic neuroendocrine tumour metastatic 17.59 15.34 6 37763 88 29536670
Acute respiratory distress syndrome 17.33 15.34 4 37765 22931 29513827
High frequency ablation 17.30 15.34 7 37762 169 29536589
Therapeutic product effect decreased 17.24 15.34 8 37761 29443 29507315
Feeling hot 17.10 15.34 51 37718 15437 29521321
Gallbladder disorder 17.01 15.34 28 37741 5672 29531086
Neuroendocrine tumour of the lung 16.99 15.34 3 37766 0 29536758
Renal neoplasm 16.99 15.34 13 37756 1120 29535638
Thyroid mass 16.92 15.34 9 37760 411 29536347
Respiratory distress 16.90 15.34 10 37759 32096 29504662
Rash maculo-papular 16.90 15.34 5 37764 24284 29512474
Skin warm 16.90 15.34 16 37753 1844 29534914
Hair colour changes 16.86 15.34 15 37754 1596 29535162
Treatment noncompliance 16.84 15.34 5 37764 24222 29512536
Injection site oedema 16.64 15.34 7 37762 187 29536571
Eosinophilia 16.48 15.34 4 37765 22157 29514601
Chills 16.48 15.34 151 37618 71149 29465609
Transfusion-related circulatory overload 16.47 15.34 7 37762 192 29536566
Blood iron decreased 16.27 15.34 24 37745 4424 29532334
Productive cough 16.26 15.34 81 37688 31178 29505580
Depressed level of consciousness 16.18 15.34 14 37755 36928 29499830
Ear discomfort 16.18 15.34 17 37752 2220 29534538
Aggression 16.15 15.34 13 37756 35528 29501230
Hallucination 16.14 15.34 20 37749 44692 29492066
Arthritis 16.09 15.34 69 37700 24950 29511808
Rosacea 16.09 15.34 12 37757 995 29535763
Cardiac valve disease 16.05 15.34 19 37750 2829 29533929
Coma 16.04 15.34 16 37753 39434 29497324
Polyp 16.03 15.34 20 37749 3145 29533613
Pulse abnormal 16.02 15.34 12 37757 1001 29535757
Acne 16.02 15.34 36 37733 9184 29527574
Abdominal mass 15.95 15.34 13 37756 1227 29535531
Carcinoid tumour 15.94 15.34 7 37762 208 29536550
Drug-induced liver injury 15.93 15.34 4 37765 21651 29515107
Injection site induration 15.89 15.34 18 37751 2558 29534200
Fear of injection 15.88 15.34 11 37758 812 29535946
Hepatic function abnormal 15.88 15.34 16 37753 39243 29497515
Asthma 15.86 15.34 12 37757 33837 29502921
Device toxicity 15.86 15.34 4 37765 18 29536740
White coat hypertension 15.81 15.34 5 37764 57 29536701
Faeces pale 15.78 15.34 13 37756 1246 29535512
Labyrinthitis 15.77 15.34 11 37758 821 29535937
Disturbance in attention 15.68 15.34 4 37765 21420 29515338
Renal pain 15.64 15.34 18 37751 2601 29534157
Gastric hypomotility 15.57 15.34 5 37764 60 29536698
Hyperoxaluria 15.56 15.34 6 37763 127 29536631
Staphylococcal infection 15.55 15.34 9 37760 29231 29507527
Hypotension 15.52 15.34 166 37603 194188 29342570
Scan gallium abnormal 15.52 15.34 4 37765 20 29536738
Procedural hypertension 15.50 15.34 5 37764 61 29536697

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 2274.87 13.67 719 78629 8553 64410831
Blood pressure systolic increased 2172.39 13.67 1107 78241 48346 64371038
Body temperature decreased 1694.60 13.67 763 78585 25165 64394219
Blood pressure increased 1284.82 13.67 1305 78043 171247 64248137
Inappropriate schedule of product administration 1055.84 13.67 888 78460 91398 64327986
Malignant neoplasm progression 1012.17 13.67 946 78402 111925 64307459
Injection site pain 926.98 13.67 896 78452 110512 64308872
Blood pressure diastolic decreased 765.30 13.67 424 78924 21877 64397507
Injection site mass 712.09 13.67 371 78977 16899 64402485
Heart rate decreased 627.31 13.67 529 78819 54538 64364846
Metastases to liver 470.97 13.67 319 79029 23622 64395762
Blood growth hormone increased 417.53 13.67 106 79242 516 64418868
Hepatic lesion 378.83 13.67 171 79177 5653 64413731
Blood pressure diastolic increased 356.65 13.67 200 79148 10552 64408832
Flatulence 344.35 13.67 312 79036 35354 64384030
Abdominal pain 329.65 13.67 986 78362 311389 64107995
Toxicity to various agents 299.89 13.67 45 79303 363468 64055916
Blood chromogranin A increased 290.23 13.67 72 79276 313 64419071
Insulin-like growth factor increased 287.80 13.67 99 79249 1553 64417831
Abdominal distension 284.32 13.67 460 78888 95534 64323850
Hepatic neoplasm 271.24 13.67 112 79236 2965 64416419
Second primary malignancy 270.66 13.67 176 79172 12161 64407223
Acute kidney injury 269.60 13.67 108 79240 449132 63970252
Drug interaction 264.10 13.67 61 79287 362022 64057362
Carcinoid crisis 263.93 13.67 69 79279 385 64418999
Stress 254.27 13.67 342 79006 60192 64359192
Weight decreased 243.03 13.67 838 78510 284901 64134483
Diarrhoea 229.44 13.67 1595 77753 721109 63698275
Malaise 227.60 13.67 1027 78321 395220 64024164
Syringe issue 220.44 13.67 107 79241 4179 64415205
Off label use 206.64 13.67 287 79061 632519 63786865
Injection site haemorrhage 206.56 13.67 198 79150 24080 64395304
Condition aggravated 203.74 13.67 102 79246 372324 64047060
Cholelithiasis 200.14 13.67 263 79085 45243 64374141
Flushing 184.43 13.67 340 79008 78308 64341076
Intestinal obstruction 182.16 13.67 224 79124 36062 64383322
Blood pressure decreased 180.37 13.67 355 78993 85844 64333540
Infusion related reaction 179.08 13.67 5 79343 164462 64254922
Drug ineffective 163.71 13.67 512 78836 839735 63579649
Injection site discomfort 163.07 13.67 87 79261 4154 64415230
Mass 162.04 13.67 141 79207 15135 64404249
Neoplasm 153.47 13.67 100 79248 6931 64412453
Underdose 150.37 13.67 172 79176 25657 64393727
Drug abuse 144.18 13.67 4 79344 132370 64287014
Neutropenia 142.85 13.67 58 79290 239566 64179818
Neoplasm progression 141.70 13.67 211 79137 40753 64378631
Metastasis 131.70 13.67 84 79264 5611 64413773
Rheumatoid arthritis 131.53 13.67 22 79326 164272 64255112
Febrile neutropenia 128.20 13.67 36 79312 187621 64231763
Bowel movement irregularity 124.21 13.67 76 79272 4717 64414667
Carcinoid syndrome 121 13.67 30 79318 130 64419254
Neuroendocrine tumour 119.44 13.67 47 79301 1094 64418290
Eating disorder 118.88 13.67 124 79224 16681 64402703
Blood glucose increased 115.00 13.67 322 79026 97751 64321633
Synovitis 107.88 13.67 3 79345 99087 64320297
Nervousness 104.74 13.67 154 79194 29402 64389982
Overdose 102.86 13.67 34 79314 159532 64259852
Abdominal pain upper 101.10 13.67 455 78893 174575 64244809
Back pain 99.63 13.67 586 78762 249585 64169799
Blood glucose decreased 99.11 13.67 132 79216 22991 64396393
Frequent bowel movements 98.37 13.67 117 79231 18188 64401196
Diabetes mellitus 97.11 13.67 237 79111 66237 64353147
Pituitary tumour 96.61 13.67 40 79308 1066 64418318
Fatigue 95.47 13.67 1368 77980 747362 63672022
Carcinoid heart disease 94.22 13.67 20 79328 34 64419350
Pancytopenia 93.31 13.67 30 79318 143279 64276105
Therapeutic product effect decreased 93.30 13.67 15 79333 115336 64304048
Asthenia 91.12 13.67 864 78484 427180 63992204
Movement disorder 90.34 13.67 123 79225 21877 64397507
Contraindicated product administered 89.55 13.67 13 79335 107816 64311568
Faeces discoloured 88.21 13.67 132 79216 25597 64393787
5-hydroxyindolacetic acid in urine increased 86.90 13.67 25 79323 209 64419175
Hepatic pain 86.78 13.67 54 79294 3454 64415930
Blood pressure systolic decreased 86.73 13.67 78 79270 8742 64410642
Injection site swelling 84.86 13.67 169 79179 41184 64378200
Pancreatic neuroendocrine tumour 84.05 13.67 29 79319 459 64418925
Intentional product use issue 82.77 13.67 10 79338 95354 64324030
Serum serotonin increased 82.64 13.67 25 79323 253 64419131
Hot flush 82.04 13.67 178 79170 46057 64373327
Insulin-like growth factor decreased 80.25 13.67 29 79319 529 64418855
Hyponatraemia 78.92 13.67 42 79306 148297 64271087
Thrombocytopenia 78.38 13.67 96 79252 223705 64195679
Rash 77.68 13.67 296 79052 458253 63961131
Steatorrhoea 77.47 13.67 31 79317 755 64418629
Nasopharyngitis 77.17 13.67 458 78890 195615 64223769
Biliary obstruction 77.17 13.67 52 79296 3812 64415572
Hormone level abnormal 76.84 13.67 39 79309 1678 64417706
Faeces soft 76.54 13.67 61 79287 5794 64413590
Product dose omission issue 76.49 13.67 76 79272 194671 64224713
Loss of personal independence in daily activities 76.01 13.67 3 79345 72451 64346933
Influenza 74.76 13.67 294 79054 106237 64313147
Treatment failure 73.35 13.67 26 79322 116790 64302594
Feeling abnormal 73.16 13.67 342 79006 133260 64286124
Intentional product misuse 72.58 13.67 4 79344 72291 64347093
Metastases to pancreas 72.43 13.67 26 79322 465 64418919
Blood glucose fluctuation 71.42 13.67 59 79289 5896 64413488
Cardio-respiratory arrest 70.74 13.67 17 79331 98376 64321008
Respiratory failure 70.36 13.67 57 79291 161126 64258258
Gait disturbance 70.24 13.67 406 78942 171749 64247635
Drug intolerance 69.74 13.67 77 79271 187915 64231469
Heart rate increased 68.98 13.67 272 79076 98403 64320981
Respiratory rate increased 68.57 13.67 98 79250 18233 64401151
5-hydroxyindolacetic acid increased 68.53 13.67 13 79335 7 64419377
Cardiac arrest 67.85 13.67 54 79294 154010 64265374
Arthropathy 67.72 13.67 32 79316 120935 64298449
Therapeutic product effect incomplete 66.75 13.67 22 79326 103460 64315924
Alanine aminotransferase increased 66.05 13.67 45 79303 138986 64280398
Cardiac failure congestive 65.12 13.67 40 79308 130540 64288844
Terminal state 63.94 13.67 49 79299 4395 64414989
Cough 63.73 13.67 609 78739 301539 64117845
Rhabdomyolysis 63.72 13.67 17 79331 91709 64327675
Blood mercury abnormal 63.19 13.67 19 79329 188 64419196
Hypersensitivity 62.92 13.67 90 79258 196362 64223022
Heart rate irregular 62.31 13.67 117 79231 27296 64392088
Seizure 62.29 13.67 68 79280 166824 64252560
Metastases to bone 61.87 13.67 99 79249 20336 64399048
Diaphragmatic spasm 61.85 13.67 16 79332 85 64419299
Limb discomfort 61.79 13.67 116 79232 27059 64392325
Acute myocardial infarction 61.27 13.67 7 79341 69711 64349673
Exposure during pregnancy 60.82 13.67 11 79337 77664 64341720
Polyp 59.75 13.67 56 79292 6617 64412767
Incorrect dose administered 59.29 13.67 187 79161 60578 64358806
Pain 58.67 13.67 981 78367 552530 63866854
Deep vein thrombosis 58.60 13.67 28 79320 105154 64314230
Acne 58.15 13.67 103 79245 22978 64396406
Maternal exposure during pregnancy 57.41 13.67 23 79325 95861 64323523
Blood growth hormone abnormal 56.92 13.67 13 79335 36 64419348
Sepsis 56.22 13.67 125 79223 230216 64189168
Nephrolithiasis 55.73 13.67 148 79200 43535 64375849
Blood glucose abnormal 54.67 13.67 61 79287 8852 64410532
Hyperkalaemia 53.24 13.67 29 79319 101100 64318284
Yellow skin 53.19 13.67 38 79310 3061 64416323
Blood iron decreased 53.08 13.67 70 79278 12072 64407312
White blood cell count decreased 52.85 13.67 70 79278 157767 64261617
Angioedema 52.39 13.67 7 79341 61814 64357570
Injection site hypersensitivity 52.35 13.67 30 79318 1649 64417735
Myocardial infarction 52.08 13.67 77 79271 165744 64253640
Lactic acidosis 51.93 13.67 7 79341 61403 64357981
Pain in extremity 51.63 13.67 585 78763 302500 64116884
Neuroendocrine tumour of the lung 51 13.67 11 79337 21 64419363
Neuropathy peripheral 50.73 13.67 42 79306 117483 64301901
Productive cough 50.51 13.67 201 79147 73002 64346382
Anaemia 50.49 13.67 267 79081 378413 64040971
Dizziness 50.25 13.67 775 78573 429388 63989996
Depressed level of consciousness 49.64 13.67 19 79329 81417 64337967
Musculoskeletal discomfort 49.47 13.67 79 79269 16198 64403186
Blood growth hormone decreased 49.17 13.67 12 79336 48 64419336
Glossodynia 48.88 13.67 10 79338 64686 64354698
Groin pain 48.76 13.67 65 79283 11328 64408056
Pericarditis 48.63 13.67 9 79339 62507 64356877
Hypoxia 48.29 13.67 24 79324 88125 64331259
Rhinorrhoea 48.28 13.67 173 79175 59796 64359588
Musculoskeletal pain 48.12 13.67 213 79135 81081 64338303
Oxygen saturation decreased 47.89 13.67 37 79311 107139 64312245
Faeces pale 47.55 13.67 33 79315 2538 64416846
Recurrent cancer 47.55 13.67 32 79316 2341 64417043
Interstitial lung disease 47.26 13.67 31 79317 97701 64321683
Contusion 47.25 13.67 270 79078 113695 64305689
Anaphylactic reaction 47.18 13.67 13 79335 68651 64350733
Unevaluable event 47.16 13.67 4 79344 50485 64368899
Pneumonia 47.03 13.67 451 78897 559125 63860259
Leukopenia 46.46 13.67 34 79314 101208 64318176
Injection site induration 46.20 13.67 56 79292 8876 64410508
Feeling cold 45.28 13.67 94 79254 23584 64395800
Metastases to eye 45.10 13.67 15 79333 211 64419173
Erythema 44.96 13.67 388 78960 186682 64232702
Metastases to gastrointestinal tract 44.74 13.67 13 79335 113 64419271
Blood creatine phosphokinase increased 44.35 13.67 9 79339 58549 64360835
Coronary artery disease 44.31 13.67 10 79338 60423 64358961
Pancreatic disorder 43.44 13.67 33 79315 2921 64416463
Psoriasis 43.25 13.67 17 79331 71686 64347698
Hip fracture 43.21 13.67 100 79248 26999 64392385
Abnormal faeces 42.81 13.67 44 79304 5815 64413569
Decreased appetite 42.63 13.67 531 78817 280758 64138626
Drug hypersensitivity 42.49 13.67 150 79198 237665 64181719
Anxiety 42.44 13.67 408 78940 202241 64217143
Carcinoid tumour 41.85 13.67 17 79331 431 64418953
Faecal volume decreased 41.83 13.67 13 79335 145 64419239
Electrocardiogram QT prolonged 41.50 13.67 23 79325 79425 64339959
Abdominal pain lower 41.47 13.67 97 79251 26372 64393012
Sinusitis 40.01 13.67 74 79274 145854 64273530
Asthma 39.91 13.67 35 79313 95190 64324194
Pituitary tumour recurrent 39.53 13.67 12 79336 123 64419261
Suicide attempt 39.40 13.67 19 79329 70988 64348396
Hand deformity 39.34 13.67 14 79334 62757 64356627
Atrial fibrillation 39.20 13.67 96 79252 170993 64248391
Neuroendocrine carcinoma metastatic 38.73 13.67 15 79333 334 64419050
Drug-induced liver injury 36.75 13.67 7 79341 47636 64371748
Dyspnoea 36.73 13.67 643 78705 718031 63701353
Respiratory arrest 36.46 13.67 10 79338 52975 64366409
Hepatic enzyme increased 36.42 13.67 65 79283 129878 64289506
Hepatic mass 36.35 13.67 26 79322 2098 64417286
Injection site hypoaesthesia 36.29 13.67 15 79333 398 64418986
Musculoskeletal chest pain 36.18 13.67 81 79267 21398 64397986
Mental status changes 36.08 13.67 15 79333 61147 64358237
Septic shock 36.07 13.67 46 79302 105391 64313993
Pulmonary embolism 36.04 13.67 79 79269 146277 64273107
Death 35.90 13.67 811 78537 481894 63937490
Bite 35.77 13.67 15 79333 413 64418971
Bile duct stone 35.68 13.67 37 79311 4941 64414443
Feeling hot 35.29 13.67 130 79218 45533 64373851
C-reactive protein increased 35.03 13.67 39 79309 94870 64324514
Osteonecrosis of jaw 34.99 13.67 4 79344 39821 64379563
Metastases to oesophagus 34.81 13.67 8 79340 23 64419361
Sciatica 34.78 13.67 77 79271 20187 64399197
Sciatic nerve injury 34.70 13.67 15 79333 446 64418938
Renal neoplasm 34.48 13.67 23 79325 1658 64417726
Sedation 34.41 13.67 5 79343 41457 64377927
Multiple sclerosis relapse 34.05 13.67 5 79343 41130 64378254
Rash maculo-papular 34.04 13.67 8 79340 47018 64372366
Illness 33.94 13.67 80 79268 21858 64397526
Bone cancer 33.91 13.67 22 79326 1513 64417871
Injection site bruising 33.71 13.67 110 79238 36263 64383121
Blood creatinine increased 33.67 13.67 73 79275 135709 64283675
Metastases to lymph nodes 33.18 13.67 47 79301 8670 64410714
Biliary colic 32.96 13.67 30 79318 3414 64415970
Neutrophil count decreased 32.80 13.67 28 79320 77168 64342216
Low density lipoprotein decreased 32.71 13.67 19 79329 1071 64418313
Hallucination 32.68 13.67 25 79323 72763 64346621
Metastases to pelvis 32.47 13.67 15 79333 523 64418861
Impaired healing 32.32 13.67 17 79331 60456 64358928
Depressed mood 31.89 13.67 117 79231 40895 64378489
Medication error 31.56 13.67 11 79337 49955 64369429
Peripheral swelling 31.30 13.67 394 78954 208759 64210625
Stevens-Johnson syndrome 31.22 13.67 3 79345 34246 64385138
Pulse abnormal 31.19 13.67 26 79322 2631 64416753
Hernia 31.10 13.67 58 79290 13460 64405924
Metabolic acidosis 31.06 13.67 25 79323 70933 64348451
Oropharyngeal pain 30.78 13.67 201 79147 88666 64330718
Lacrimal disorder 30.61 13.67 14 79334 477 64418907
Respiratory distress 30.60 13.67 13 79335 52318 64367066
Abdominal mass 30.31 13.67 27 79321 2988 64416396
Treatment noncompliance 30.31 13.67 8 79340 43474 64375910
Chondroma 30.06 13.67 6 79342 6 64419378
Respiratory tract infection 29.93 13.67 5 79343 37402 64381982
Fall 29.93 13.67 697 78651 416129 64003255
Crying 29.72 13.67 72 79276 20018 64399366
Renal failure 29.57 13.67 119 79229 181569 64237815
Acute respiratory distress syndrome 29.45 13.67 6 79342 38929 64380455
Pituitary enlargement 29.30 13.67 8 79340 54 64419330
Psychotic disorder 29.09 13.67 4 79344 34574 64384810
Multiple organ dysfunction syndrome 29.08 13.67 50 79298 101363 64318021
Tumour marker increased 29.07 13.67 28 79320 3422 64415962
Eosinophilia 28.52 13.67 6 79342 38070 64381314
Blood urine present 28.50 13.67 67 79281 18273 64401111
Injection site scar 28.41 13.67 15 79333 701 64418683
Benign neoplasm of adrenal gland 28.30 13.67 7 79341 30 64419354
Urticaria 28.29 13.67 90 79258 147227 64272157
Metastases to ovary 28.15 13.67 11 79337 251 64419133
Adenoma benign 28.08 13.67 17 79331 1035 64418349
Injection site cyst 28.01 13.67 8 79340 65 64419319
Thyroid disorder 27.94 13.67 51 79297 11641 64407743
Drug reaction with eosinophilia and systemic symptoms 27.87 13.67 16 79332 54201 64365183
Transaminases increased 27.85 13.67 10 79338 44584 64374800
Nerve degeneration 27.79 13.67 11 79337 260 64419124
Red blood cell sedimentation rate increased 27.78 13.67 3 79345 31232 64388152
Cardiac valve disease 27.57 13.67 33 79315 5162 64414222
Brain neoplasm 27.57 13.67 32 79316 4846 64414538
Hypotension 27.48 13.67 318 79030 380656 64038728
Tumour pain 27.12 13.67 21 79327 1912 64417472
Neck mass 27.10 13.67 29 79319 4015 64415369
Angina bullosa haemorrhagica 27.01 13.67 10 79338 196 64419188
Head banging 26.98 13.67 13 79335 499 64418885
Hypoglycaemia 26.81 13.67 196 79152 89696 64329688
Metastatic carcinoid tumour 26.71 13.67 6 79342 15 64419369
Hypokalaemia 26.67 13.67 70 79278 121833 64297551
Generalised tonic-clonic seizure 26.54 13.67 8 79340 39849 64379535
Pollakiuria 26.26 13.67 92 79256 31438 64387946
Administration site induration 26.17 13.67 6 79342 17 64419367
Administration site abscess 26.17 13.67 6 79342 17 64419367
Aspartate aminotransferase increased 26.05 13.67 69 79279 119719 64299665
Metastases to spine 25.97 13.67 27 79321 3616 64415768
Hyperhidrosis 25.88 13.67 251 79097 124669 64294715
Pneumonia aspiration 25.79 13.67 21 79327 59250 64360134
Hernia pain 25.73 13.67 12 79336 428 64418956
Hepatitis 25.59 13.67 12 79336 45570 64373814
Gastrointestinal neoplasm 25.52 13.67 12 79336 436 64418948
Adverse drug reaction 25.47 13.67 12 79336 45452 64373932
Gallbladder disorder 25.15 13.67 61 79287 16969 64402415
Thyroid mass 25.04 13.67 25 79323 3192 64416192
Tubulointerstitial nephritis 25.03 13.67 4 79344 30905 64388479
Hepatotoxicity 24.89 13.67 9 79339 39953 64379431
Insulin-like growth factor abnormal 24.79 13.67 6 79342 23 64419361
Gout 24.77 13.67 70 79278 21343 64398041
Chills 24.71 13.67 268 79080 136996 64282388
Transfusion-related circulatory overload 24.71 13.67 10 79338 251 64419133
Metastases to thorax 24.52 13.67 9 79339 172 64419212
Adverse event 24.42 13.67 9 79339 39480 64379904
Administration site discharge 24.39 13.67 6 79342 25 64419359
Metastases to abdominal cavity 24.24 13.67 12 79336 489 64418895
Administration site odour 24.20 13.67 6 79342 26 64419358
Encephalopathy 24.18 13.67 22 79326 58797 64360587
Back injury 24.06 13.67 38 79310 7719 64411665
Liver abscess 23.95 13.67 31 79317 5249 64414135
Periarticular disorder 23.84 13.67 6 79342 28 64419356
Pneumocystis jirovecii pneumonia 23.72 13.67 3 79345 27631 64391753
Cerebral haemorrhage 23.64 13.67 17 79331 51073 64368311
Carcinoid tumour of the small bowel 23.49 13.67 7 79341 67 64419317
Chikungunya virus infection 23.47 13.67 9 79339 195 64419189
Labyrinthitis 23.46 13.67 22 79326 2601 64416783
Drug withdrawal syndrome 23.30 13.67 5 79343 31286 64388098
Blood potassium decreased 23.26 13.67 105 79243 40294 64379090
Pallor 23.23 13.67 102 79246 38679 64380705
Injection site inflammation 23.19 13.67 24 79324 3197 64416187
Facial asymmetry 23.17 13.67 13 79335 686 64418698
Agranulocytosis 23.16 13.67 9 79339 38220 64381164
Bone neoplasm 23.15 13.67 13 79335 687 64418697
Tricuspid valve stenosis 23.03 13.67 5 79343 10 64419374
Metastases to lung 22.89 13.67 55 79293 15209 64404175
Buttock injury 22.82 13.67 8 79340 133 64419251
Endocrine neoplasm 22.81 13.67 4 79344 0 64419384
Intra-abdominal fluid collection 22.80 13.67 22 79326 2695 64416689
Ingrowing nail 22.78 13.67 20 79328 2171 64417213
Injection site oedema 22.69 13.67 15 79333 1065 64418319
Coma 22.64 13.67 46 79302 87569 64331815
Muscle swelling 22.64 13.67 13 79335 717 64418667
Muscle strain 22.51 13.67 38 79310 8156 64411228
Body temperature increased 22.39 13.67 97 79251 36569 64382815
Dysarthria 22.37 13.67 24 79324 59382 64360002
Hepatocellular injury 22.34 13.67 14 79334 45221 64374163
Breast mass 22.27 13.67 30 79318 5280 64414104
Discomfort 22.23 13.67 173 79175 80705 64338679
Hepatic function abnormal 22.05 13.67 28 79320 64285 64355099
Subdural haematoma 21.90 13.67 4 79344 28050 64391334
Tumour compression 21.89 13.67 8 79340 151 64419233
Parathyroid hormone-related protein abnormal 21.85 13.67 5 79343 14 64419370
Lymphatic system neoplasm 21.79 13.67 6 79342 42 64419342
Administration site haemorrhage 21.66 13.67 6 79342 43 64419341
Polydipsia 21.59 13.67 31 79317 5790 64413594
Abdominal rigidity 21.54 13.67 21 79327 2606 64416778
Product quality issue 21.50 13.67 83 79265 29716 64389668
Insulinoma 21.48 13.67 7 79341 92 64419292
Nasal congestion 21.31 13.67 136 79212 59522 64359862
Metastases to peritoneum 21.28 13.67 24 79324 3523 64415861
Leukocytosis 21.08 13.67 10 79338 37730 64381654
Body height increased 21.08 13.67 7 79341 98 64419286
Chest injury 20.98 13.67 20 79328 2413 64416971
Cyst 20.98 13.67 46 79302 11981 64407403
Pancreatic neuroendocrine tumour metastatic 20.95 13.67 7 79341 100 64419284
International normalised ratio increased 20.94 13.67 41 79307 79126 64340258
Injection site haematoma 20.88 13.67 25 79323 3911 64415473
Ventricular tachycardia 20.87 13.67 8 79340 34257 64385127
Staphylococcal infection 20.78 13.67 19 79329 50659 64368725
Sluggishness 20.74 13.67 30 79318 5640 64413744
Hypothalamo-pituitary disorder 20.73 13.67 14 79334 1030 64418354
Ligament sprain 20.65 13.67 43 79305 10809 64408575
Blister 20.51 13.67 43 79305 80924 64338460
Cardiac disorder 20.40 13.67 128 79220 55688 64363696
Anaphylactic shock 20.35 13.67 6 79342 30322 64389062
Liver function test abnormal 20.22 13.67 26 79322 59375 64360009
Zinc deficiency 20.17 13.67 6 79342 57 64419327
Accidental overdose 20.16 13.67 8 79340 33549 64385835
Pituitary tumour removal 20.10 13.67 5 79343 22 64419362
Gastrointestinal haemorrhage 20.08 13.67 89 79259 132223 64287161
Haematuria 20.04 13.67 27 79321 60444 64358940
Vasoactive intestinal polypeptide increased 20.04 13.67 4 79344 4 64419380
Renal pain 20.04 13.67 33 79315 6941 64412443
Spinal cord neoplasm 19.92 13.67 9 79339 298 64419086
Cerebral infarction 19.86 13.67 13 79335 41031 64378353
Skin discolouration 19.82 13.67 91 79257 35164 64384220
Suicidal ideation 19.82 13.67 32 79316 66510 64352874
Pancreatolithiasis 19.78 13.67 9 79339 303 64419081
Hypertrophic osteoarthropathy 19.77 13.67 7 79341 120 64419264
Serotonin syndrome 19.62 13.67 12 79336 39270 64380114
Arthropod bite 19.58 13.67 32 79316 6689 64412695
Prostatomegaly 19.40 13.67 21 79327 2946 64416438
Tonsillar inflammation 19.36 13.67 7 79341 128 64419256
Product use in unapproved indication 19.33 13.67 315 79033 176303 64243081
Procedural pain 19.23 13.67 52 79296 15456 64403928
Agitation 19.13 13.67 51 79297 88316 64331068
Haemorrhoids 19.11 13.67 69 79279 23932 64395452
Cytomegalovirus infection 19.09 13.67 11 79337 37188 64382196
Infection 19.07 13.67 141 79207 184739 64234645
Ischaemic stroke 19.02 13.67 6 79342 29029 64390355
Pulmonary arterial hypertension 18.99 13.67 4 79344 25363 64394021
Renal mass 18.94 13.67 20 79328 2727 64416657
Empty sella syndrome 18.91 13.67 6 79342 72 64419312
Small intestine carcinoma 18.89 13.67 12 79336 796 64418588
Concomitant disease aggravated 18.85 13.67 43 79305 11499 64407885
Heart valve incompetence 18.67 13.67 20 79328 2773 64416611
Colitis ulcerative 18.60 13.67 3 79345 23025 64396359
Presyncope 18.55 13.67 10 79338 35079 64384305
Metastases to breast 18.53 13.67 8 79340 237 64419147
Vulval disorder 18.52 13.67 10 79338 489 64418895
Psychiatric symptom 18.45 13.67 30 79318 6243 64413141
Breast pain 18.42 13.67 32 79316 7029 64412355
Somnolence 18.39 13.67 161 79187 203484 64215900
Drug dependence 18.35 13.67 9 79339 33303 64386081
Glycosylated haemoglobin increased 18.17 13.67 52 79296 15967 64403417
Pulmonary fibrosis 18.15 13.67 7 79341 29871 64389513
Cachexia 18.10 13.67 37 79311 9180 64410204
Screaming 18.05 13.67 22 79326 3507 64415877
Plasma cell myeloma 18.04 13.67 18 79330 46057 64373327
Adrenal insufficiency 18.00 13.67 3 79345 22484 64396900
Spleen disorder 17.97 13.67 15 79333 1521 64417863
Dysstasia 17.85 13.67 66 79282 23149 64396235
Flank pain 17.83 13.67 52 79296 16137 64403247
Cancer pain 17.77 13.67 24 79324 4233 64415151
Concomitant disease progression 17.73 13.67 21 79327 3248 64416136
Drug level increased 17.71 13.67 10 79338 34186 64385198
Metastases to fallopian tube 17.68 13.67 5 79343 39 64419345
Blood test abnormal 17.68 13.67 45 79303 12898 64406486
Rubber sensitivity 17.67 13.67 14 79334 1318 64418066
Fear-related avoidance of activities 17.63 13.67 6 79342 91 64419293
Urosepsis 17.57 13.67 3 79345 22091 64397293
Blood gastrin increased 17.57 13.67 5 79343 40 64419344
Acute myeloid leukaemia 17.42 13.67 6 79342 27457 64391927
Limb injury 17.39 13.67 66 79282 23439 64395945
Ventricular fibrillation 17.39 13.67 4 79344 23856 64395528
Neurotoxicity 17.36 13.67 6 79342 27398 64391986
Coccydynia 17.35 13.67 14 79334 1353 64418031
Infrequent bowel movements 17.28 13.67 14 79334 1361 64418023
Cardiac failure 17.22 13.67 94 79254 132279 64287105
Chronic kidney disease 17.11 13.67 28 79320 57891 64361493
Biliary tract infection 17.11 13.67 12 79336 939 64418445
Somatostatin receptor scan abnormal 17.11 13.67 3 79345 0 64419384
Necrotising enterocolitis neonatal 17.11 13.67 3 79345 0 64419384
Status epilepticus 17.10 13.67 3 79345 21660 64397724
Intestinal haemorrhage 17.08 13.67 27 79321 5487 64413897
Bile output increased 17.05 13.67 5 79343 45 64419339
Respiratory depression 16.94 13.67 4 79344 23439 64395945
Hypersomnia 16.83 13.67 58 79290 19659 64399725
Abortion spontaneous 16.82 13.67 5 79343 25138 64394246
Bone pain 16.71 13.67 108 79240 47464 64371920
Memory impairment 16.69 13.67 170 79178 85512 64333872
Feeding disorder 16.64 13.67 44 79304 12905 64406479
Constipation 16.57 13.67 384 78964 228953 64190431
Skin sensitisation 16.54 13.67 11 79337 789 64418595
Delirium 16.49 13.67 38 79310 69156 64350228
Dengue fever 16.44 13.67 11 79337 797 64418587
Muscle injury 16.39 13.67 6 79342 26431 64392953
Pituitary tumour benign 16.36 13.67 17 79331 2276 64417108
Abdominal discomfort 16.32 13.67 315 79033 182007 64237377
Bone marrow failure 16.31 13.67 21 79327 47931 64371453
Musculoskeletal stiffness 16.30 13.67 87 79261 123119 64296265
Nasal discharge discolouration 16.24 13.67 15 79333 1739 64417645
Sleep disorder due to general medical condition, insomnia type 16.22 13.67 6 79342 26264 64393120
Therapy cessation 16.12 13.67 10 79338 32479 64386905
Device issue 16.10 13.67 4 79344 22644 64396740
Device toxicity 16.01 13.67 4 79344 18 64419366
Muscle spasms 15.98 13.67 253 79095 140770 64278614
Cholestasis 15.95 13.67 19 79329 44853 64374531
Spinal cord injury lumbar 15.91 13.67 5 79343 58 64419326
Confusional state 15.83 13.67 226 79122 260918 64158466
Epilepsy 15.72 13.67 11 79337 33520 64385864
Cystitis 15.68 13.67 98 79250 42577 64376807
Proctalgia 15.63 13.67 31 79317 7528 64411856
Dizziness postural 15.56 13.67 36 79312 9716 64409668
Haemorrhage intracranial 15.53 13.67 5 79343 23879 64395505
Dysphagia 15.51 13.67 73 79275 106739 64312645
Myelosuppression 15.48 13.67 5 79343 23825 64395559
Chronic obstructive pulmonary disease 15.38 13.67 41 79307 71007 64348377
Peripheral coldness 15.31 13.67 44 79304 13540 64405844
Face injury 15.30 13.67 19 79329 3086 64416298
Hypokinesia 15.21 13.67 50 79298 16546 64402838
Polyneuropathy 15.18 13.67 3 79345 19891 64399493
Early satiety 15.17 13.67 12 79336 1127 64418257
Urine calcium/creatinine ratio increased 15.15 13.67 6 79342 142 64419242
Hospitalisation 15.10 13.67 45 79303 75162 64344222
Diabetic ketoacidosis 15.07 13.67 9 79339 29836 64389548
Hemiparesis 15.05 13.67 9 79339 29818 64389566
Multiple endocrine neoplasia 15.03 13.67 3 79345 3 64419381
Liver operation 15.03 13.67 3 79345 3 64419381
Upper respiratory tract infection 15.02 13.67 43 79305 72742 64346642
Tachycardia 14.99 13.67 115 79233 149464 64269920
Excessive cerumen production 14.98 13.67 9 79339 540 64418844
Induration 14.97 13.67 14 79334 1650 64417734
Aggression 14.96 13.67 21 79327 46211 64373173
Tricuspid valve disease 14.95 13.67 8 79340 384 64419000
Gallbladder neoplasm 14.93 13.67 5 79343 72 64419312
Scan gallium abnormal 14.91 13.67 4 79344 25 64419359
Product deposit 14.82 13.67 8 79340 391 64418993
Kidney infection 14.81 13.67 52 79296 17786 64401598
Urethral caruncle 14.80 13.67 5 79343 74 64419310
Anorectal discomfort 14.78 13.67 18 79330 2867 64416517
Nephritic syndrome 14.77 13.67 7 79341 259 64419125
Pain in jaw 14.76 13.67 17 79331 40738 64378646
Eructation 14.74 13.67 34 79314 9157 64410227
Blood magnesium decreased 14.68 13.67 44 79304 13861 64405523
Injection site pustule 14.68 13.67 5 79343 76 64419308
Night sweats 14.66 13.67 85 79263 35961 64383423
Bartholinitis 14.65 13.67 4 79344 27 64419357
Hyperlipidaemia 14.61 13.67 5 79343 22971 64396413
Thermal burns of eye 14.56 13.67 5 79343 78 64419306
Toxic skin eruption 14.52 13.67 3 79345 19281 64400103
Sensitisation 14.50 13.67 14 79334 1717 64417667
Saliva altered 14.42 13.67 8 79340 413 64418971
Abdominal neoplasm 14.36 13.67 8 79340 416 64418968
Thyroid neoplasm 14.30 13.67 17 79331 2640 64416744
Coagulopathy 14.28 13.67 11 79337 31909 64387475
Ill-defined disorder 14.27 13.67 20 79328 44032 64375352
Abdominal adhesions 14.25 13.67 18 79330 2974 64416410
High frequency ablation 14.24 13.67 7 79341 281 64419103
Nausea 14.21 13.67 1136 78212 784664 63634720
Skin ulcer 14.20 13.67 20 79328 43954 64375430
Small intestinal obstruction 14.12 13.67 62 79286 23511 64395873
Fat tissue decreased 14.11 13.67 5 79343 86 64419298
Device occlusion 14.10 13.67 35 79313 9878 64409506
Rales 14.06 13.67 46 79302 15183 64404201
Ascites 14.04 13.67 127 79221 61874 64357510
Gallbladder oedema 14.01 13.67 7 79341 291 64419093
Bile acid malabsorption 13.99 13.67 6 79342 175 64419209
Pyrexia 13.96 13.67 554 78794 558090 63861294
Bile output abnormal 13.95 13.67 4 79344 33 64419351
Rectal polyp 13.91 13.67 12 79336 1272 64418112
No adverse event 13.88 13.67 9 79339 28552 64390832
Pubic pain 13.85 13.67 5 79343 91 64419293
Liver injury 13.79 13.67 10 79338 29922 64389462
Frustration tolerance decreased 13.74 13.67 26 79322 6099 64413285
Cataract 13.72 13.67 109 79239 51153 64368231
Ataxia 13.71 13.67 5 79343 22079 64397305
Labelled drug-drug interaction medication error 13.69 13.67 5 79343 22057 64397327
Prescribed overdose 13.68 13.67 4 79344 20327 64399057

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
FDA EPC N0000175904 Somatostatin Analog
CHEBI has role CHEBI:51060 hormone agonist
MeSH PA D000970 Antineoplastic Agents
MeSH PA D018931 Antineoplastic Agents, Hormonal
MeSH PA D005765 Gastrointestinal Agents

Drug Use (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




๐Ÿถ Veterinary Drug Use

None

๐Ÿถ 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 AMRYT 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 AMRYT 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 AMRYT 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 AMRYT 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 AMRYT 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

Orange Book exclusivity data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
EQ 20MG BASE MYCAPSSA AMRYT N208232 June 26, 2020 RX CAPSULE, DELAYED RELEASE ORAL June 26, 2023 NEW PRODUCT

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
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
CHEMBL408687 ChEMBL_ID

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Sandostatin HUMAN PRESCRIPTION DRUG LABEL 1 0078-0180 INJECTION, SOLUTION 50 ug INTRAVENOUS NDA 25 sections
Sandostatin HUMAN PRESCRIPTION DRUG LABEL 1 0078-0181 INJECTION, SOLUTION 100 ug INTRAVENOUS NDA 25 sections
Sandostatin HUMAN PRESCRIPTION DRUG LABEL 1 0078-0182 INJECTION, SOLUTION 500 ug INTRAVENOUS NDA 25 sections
Octreotide Acetate HUMAN PRESCRIPTION DRUG LABEL 1 0641-6174 INJECTION, SOLUTION 50 ug INTRAVENOUS ANDA 22 sections
Octreotide Acetate HUMAN PRESCRIPTION DRUG LABEL 1 0641-6175 INJECTION, SOLUTION 100 ug INTRAVENOUS ANDA 22 sections
Octreotide Acetate HUMAN PRESCRIPTION DRUG LABEL 1 0641-6176 INJECTION, SOLUTION 500 ug INTRAVENOUS ANDA 22 sections
Octreotide Acetate HUMAN PRESCRIPTION DRUG LABEL 1 0641-6177 INJECTION, SOLUTION 200 ug INTRAVENOUS ANDA 22 sections
Octreotide Acetate HUMAN PRESCRIPTION DRUG LABEL 1 0641-6178 INJECTION, SOLUTION 1000 ug INTRAVENOUS ANDA 22 sections
Octreotide Acetate HUMAN PRESCRIPTION DRUG LABEL 1 0703-3301 INJECTION, SOLUTION 50 ug INTRAVENOUS ANDA 23 sections
Octreotide Acetate HUMAN PRESCRIPTION DRUG LABEL 1 0703-3311 INJECTION, SOLUTION 100 ug INTRAVENOUS ANDA 23 sections
Octreotide Acetate HUMAN PRESCRIPTION DRUG LABEL 1 0703-3321 INJECTION, SOLUTION 500 ug INTRAVENOUS ANDA 23 sections
Octreotide Acetate HUMAN PRESCRIPTION DRUG LABEL 1 0703-3333 INJECTION, SOLUTION 200 ug INTRAVENOUS ANDA 23 sections
Octreotide Acetate HUMAN PRESCRIPTION DRUG LABEL 1 0703-3343 INJECTION, SOLUTION 1000 ug INTRAVENOUS ANDA 23 sections
OCTREOTIDE ACETATE HUMAN PRESCRIPTION DRUG LABEL 1 23155-685 INJECTION, SOLUTION 200 ug INTRAVENOUS ANDA 12 sections
OCTREOTIDE ACETATE HUMAN PRESCRIPTION DRUG LABEL 1 23155-686 INJECTION, SOLUTION 1000 ug INTRAVENOUS ANDA 12 sections
OCTREOTIDE ACETATE HUMAN PRESCRIPTION DRUG LABEL 1 23155-687 INJECTION, SOLUTION 50 ug INTRAVENOUS ANDA 12 sections
OCTREOTIDE ACETATE HUMAN PRESCRIPTION DRUG LABEL 1 23155-688 INJECTION, SOLUTION 100 ug INTRAVENOUS ANDA 12 sections
OCTREOTIDE ACETATE HUMAN PRESCRIPTION DRUG LABEL 1 23155-689 INJECTION, SOLUTION 500 ug INTRAVENOUS ANDA 12 sections
Octreotide Acetate HUMAN PRESCRIPTION DRUG LABEL 1 25021-451 INJECTION, SOLUTION 50 ug SUBCUTANEOUS ANDA 24 sections
Octreotide Acetate HUMAN PRESCRIPTION DRUG LABEL 1 25021-452 INJECTION, SOLUTION 100 ug SUBCUTANEOUS ANDA 24 sections
Octreotide Acetate HUMAN PRESCRIPTION DRUG LABEL 1 25021-453 INJECTION, SOLUTION 500 ug SUBCUTANEOUS ANDA 24 sections
Octreotide Acetate HUMAN PRESCRIPTION DRUG LABEL 1 25021-454 INJECTION, SOLUTION 200 ug SUBCUTANEOUS ANDA 24 sections
Octreotide Acetate HUMAN PRESCRIPTION DRUG LABEL 1 25021-455 INJECTION, SOLUTION 1000 ug SUBCUTANEOUS ANDA 24 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 26 sections
Octreotide HUMAN PRESCRIPTION DRUG LABEL 1 63323-376 INJECTION, SOLUTION 100 ug SUBCUTANEOUS ANDA 24 sections