octreotide 🐶 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 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

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 2100.92 14.26 653 59443 9723 63419203
Blood pressure systolic increased 1279.94 14.26 703 59393 46694 63382232
Body temperature decreased 1014.81 14.26 458 59638 19861 63409065
Malignant neoplasm progression 760.13 14.26 626 59470 81495 63347431
Inappropriate schedule of product administration 741.49 14.26 683 59413 103282 63325644
Blood pressure increased 735.39 14.26 834 59262 161228 63267698
Injection site mass 693.05 14.26 343 59753 18313 63410613
Injection site pain 633.18 14.26 694 59402 129106 63299820
Blood pressure diastolic decreased 486.72 14.26 290 59806 22416 63406510
Syringe issue 379.63 14.26 131 59965 2738 63426188
Blood growth hormone increased 377.79 14.26 88 60008 382 63428544
Heart rate decreased 317.83 14.26 296 59800 45264 63383662
Metastases to liver 296.43 14.26 216 59880 23423 63405503
Flatulence 274.50 14.26 242 59854 34460 63394466
Insulin-like growth factor increased 242.46 14.26 71 60025 848 63428078
Blood pressure diastolic increased 227.95 14.26 133 59963 9877 63419049
Blood chromogranin A increased 225.34 14.26 53 60043 242 63428684
Abdominal pain 224.40 14.26 698 59398 292758 63136168
Second primary malignancy 222.67 14.26 121 59975 7832 63421094
Carcinoid crisis 209.55 14.26 49 60047 217 63428709
Infusion related reaction 208.64 14.26 5 60091 245516 63183410
Abdominal distension 205.09 14.26 325 59771 86290 63342636
Hepatic lesion 201.00 14.26 96 60000 4729 63424197
Mass 191.73 14.26 135 59961 13865 63415061
Rheumatoid arthritis 186.88 14.26 14 60082 253805 63175121
Underdose 184.92 14.26 175 59921 27281 63401645
Stress 184.40 14.26 270 59826 66897 63362029
Cholelithiasis 178.45 14.26 214 59882 43711 63385215
Neoplasm progression 174.09 14.26 193 59903 36235 63392691
Contraindicated product administered 169.16 14.26 9 60087 217639 63211287
Blood pressure decreased 160.86 14.26 249 59847 64773 63364153
Diarrhoea 159.18 14.26 1188 58908 714178 62714748
Drug ineffective 158.37 14.26 488 59608 1044277 62384649
Diabetes mellitus 155.57 14.26 226 59870 55584 63373342
Drug intolerance 154.39 14.26 50 60046 308611 63120315
Injection site discomfort 153.88 14.26 79 60017 4551 63424375
Malaise 150.99 14.26 784 59312 415170 63013756
Toxicity to various agents 144.83 14.26 29 60067 247221 63181705
Weight decreased 144.56 14.26 581 59515 276217 63152709
Intestinal obstruction 143.00 14.26 161 59935 30738 63398188
Injection site haemorrhage 141.36 14.26 143 59953 24171 63404755
Condition aggravated 137.27 14.26 108 59988 402109 63026817
Glossodynia 137.12 14.26 8 60088 178868 63250058
Rash 134.61 14.26 202 59894 560669 62868257
Therapeutic product effect decreased 133.13 14.26 14 60082 193173 63235753
Arthropathy 130.49 14.26 31 60065 234761 63194165
Treatment failure 126.06 14.26 19 60077 199024 63229902
Off label use 121.39 14.26 289 59807 674173 62754753
Completed suicide 119.88 14.26 4 60092 145669 63283257
Flushing 114.94 14.26 233 59863 74854 63354072
Hand deformity 111.29 14.26 11 60085 159446 63269480
Hepatic neoplasm 110.59 14.26 48 60048 1888 63427038
Blood glucose decreased 108.80 14.26 116 59980 20836 63408090
Pericarditis 106.92 14.26 4 60092 131575 63297351
Insulin-like growth factor decreased 106.26 14.26 31 60065 365 63428561
Maternal exposure during pregnancy 105.89 14.26 38 60058 220024 63208902
Bowel movement irregularity 104.40 14.26 64 60032 5200 63423726
Nervousness 102.08 14.26 136 59960 30843 63398083
Blood pressure systolic decreased 100.51 14.26 71 60025 7326 63421600
Neoplasm 98.64 14.26 70 60026 7275 63421651
Acute kidney injury 98.59 14.26 64 60032 263351 63165575
Hypersensitivity 98.00 14.26 80 60016 292605 63136321
Neuroendocrine tumour 97.91 14.26 34 60062 724 63428202
Hepatic pain 95.40 14.26 50 60046 3006 63425920
Drug interaction 92.29 14.26 51 60045 229080 63199846
Intentional product use issue 88.77 14.26 9 60087 127883 63301043
Eating disorder 86.13 14.26 98 59998 18918 63410008
Exposure during pregnancy 85.47 14.26 21 60075 155526 63273400
Metastasis 85.14 14.26 56 60040 5141 63423785
Polyp 84.93 14.26 61 60035 6460 63422466
Pituitary tumour 83.28 14.26 32 60064 916 63428010
Abdominal pain upper 83.03 14.26 401 59695 206043 63222883
Pancreatic neuroendocrine tumour 82.44 14.26 26 60070 405 63428521
Carcinoid syndrome 81.94 14.26 20 60076 110 63428816
Back pain 78.35 14.26 472 59624 263673 63165253
Limb discomfort 77.97 14.26 117 59979 29599 63399327
Serum serotonin increased 77.57 14.26 21 60075 184 63428742
Carcinoid heart disease 77.20 14.26 15 60081 19 63428907
Faeces discoloured 76.49 14.26 91 60005 18418 63410508
Injection site hypersensitivity 76.17 14.26 38 60058 2059 63426867
Terminal state 76.02 14.26 39 60057 2243 63426683
Loss of personal independence in daily activities 75.61 14.26 4 60092 97286 63331640
Death 71.89 14.26 602 59494 373779 63055147
Drug hypersensitivity 69.51 14.26 117 59979 310570 63118356
Sinusitis 68.59 14.26 68 60028 226585 63202341
Overdose 68.37 14.26 13 60083 115065 63313861
Carcinoid tumour 68.24 14.26 22 60074 369 63428557
Hepatic enzyme increased 68.05 14.26 55 60041 202273 63226653
Feeling abnormal 66.06 14.26 297 59799 148095 63280831
Asthenia 63.41 14.26 597 59499 383007 63045919
Cough 62.83 14.26 483 59613 292260 63136666
Impaired healing 62.17 14.26 11 60085 102531 63326395
Hot flush 61.43 14.26 144 59952 51015 63377911
Injection site induration 60.57 14.26 58 60038 9168 63419758
Frequent bowel movements 59.48 14.26 90 60006 22932 63405994
Injection site swelling 59.42 14.26 136 59960 47436 63381490
Nephritic syndrome 59.03 14.26 19 60077 317 63428609
Blood glucose increased 59.00 14.26 194 59902 83562 63345364
Hypoglycaemia 58.40 14.26 156 59940 59909 63369017
Neutropenia 58.31 14.26 48 60048 174957 63253969
Hormone level abnormal 56.54 14.26 33 60063 2450 63426476
Therapeutic product effect incomplete 56.15 14.26 24 60072 125032 63303894
Blood glucose fluctuation 55.50 14.26 41 60055 4535 63424391
Blister 55.04 14.26 27 60069 129787 63299139
Drug abuse 53.31 14.26 4 60092 72514 63356412
Metastases to pancreas 53.08 14.26 17 60079 279 63428647
Rectal polyp 52.67 14.26 25 60071 1214 63427712
Intestinal haemorrhage 52.44 14.26 37 60059 3810 63425116
Blood growth hormone abnormal 51.99 14.26 11 60085 27 63428899
Musculoskeletal stiffness 50.72 14.26 60 60036 184558 63244368
Frustration tolerance decreased 49.84 14.26 46 60050 6942 63421984
Infection 48.77 14.26 89 60007 229084 63199842
Metastases to bone 48.49 14.26 78 60018 20941 63407985
Product dose omission issue 48.10 14.26 93 60003 234220 63194706
Steatorrhoea 48.00 14.26 18 60078 481 63428445
Asthma 47.66 14.26 31 60065 127530 63301396
Thyroid disorder 47.56 14.26 65 60031 15097 63413829
Groin pain 46.91 14.26 53 60043 10150 63418776
Urticaria 46.50 14.26 53 60043 165749 63263177
Product quality issue 46.42 14.26 104 59992 35761 63393165
Influenza 46.42 14.26 215 59881 108507 63320419
Injection site bruising 46.05 14.26 114 59982 41796 63387130
Intentional product misuse 45.82 14.26 3 60093 60914 63368012
Metastases to ovary 45.81 14.26 17 60079 441 63428485
Irritable bowel syndrome 45.50 14.26 11 60085 82401 63346525
Movement disorder 45.42 14.26 77 60019 21584 63407342
Psoriasis 45.36 14.26 13 60083 86944 63341982
Depressed mood 44.88 14.26 110 59986 40081 63388845
Hip fracture 44.52 14.26 91 60005 29383 63399543
Yellow skin 43.38 14.26 27 60069 2253 63426673
Proctalgia 43.15 14.26 40 60056 6070 63422856
Metastases to gastrointestinal tract 43.05 14.26 11 60085 75 63428851
Acne 42.63 14.26 78 60018 23215 63405711
Anxiety 42.29 14.26 351 59745 217190 63211736
Small intestinal obstruction 42.23 14.26 68 60028 18269 63410657
Angina bullosa haemorrhagica 41.87 14.26 12 60084 132 63428794
Adverse event 41.49 14.26 7 60089 67552 63361374
Hepatic mass 41.19 14.26 24 60072 1776 63427150
Productive cough 40.62 14.26 142 59954 63066 63365860
Neuroendocrine tumour of the lung 40.00 14.26 8 60088 13 63428913
Incorrect dose administered 39.65 14.26 136 59960 59832 63369094
Adverse drug reaction 39.63 14.26 13 60083 79701 63349225
Faeces pale 39.58 14.26 23 60073 1694 63427232
White blood cell count decreased 39.51 14.26 44 60052 139060 63289866
Hyponatraemia 39.40 14.26 29 60067 111871 63317055
Change of bowel habit 39.29 14.26 25 60071 2168 63426758
Heart rate increased 39.23 14.26 185 59911 94053 63334873
Febrile neutropenia 38.81 14.26 33 60063 118416 63310510
Seizure 38.72 14.26 41 60055 132593 63296333
Psychiatric symptom 38.45 14.26 35 60061 5188 63423738
Abdominal pain lower 38.45 14.26 79 60017 25599 63403327
Chikungunya virus infection 38.40 14.26 12 60084 181 63428745
Pruritus 38.25 14.26 194 59902 361259 63067667
Muscle swelling 37.73 14.26 15 60081 471 63428455
Blood growth hormone decreased 37.71 14.26 8 60088 20 63428906
5-hydroxyindolacetic acid increased 37.42 14.26 7 60089 6 63428920
Pituitary tumour recurrent 37.42 14.26 10 60086 83 63428843
Depressed level of consciousness 36.89 14.26 7 60089 62071 63366855
Musculoskeletal pain 36.85 14.26 179 59917 92098 63336828
Sciatic nerve injury 36.64 14.26 15 60081 509 63428417
Pollakiuria 36.14 14.26 81 60015 27856 63401070
Fall 36.07 14.26 546 59550 391788 63037138
Nasal discharge discolouration 36.06 14.26 24 60072 2247 63426679
Blood iron decreased 35.85 14.26 56 60040 14665 63414261
Joint swelling 35.74 14.26 174 59922 327492 63101434
Neuropathy peripheral 35.64 14.26 33 60063 113634 63315292
Brain neoplasm 35.61 14.26 31 60065 4335 63424591
Liver injury 35.59 14.26 7 60089 60513 63368413
Pancreatic disorder 35.53 14.26 25 60071 2563 63426363
C-reactive protein increased 35.39 14.26 23 60073 94684 63334242
Musculoskeletal discomfort 35.22 14.26 62 60034 17905 63411021
Alanine aminotransferase increased 35.12 14.26 28 60068 103742 63325184
Adenoma benign 35.03 14.26 17 60079 867 63428059
Gastrointestinal neoplasm 34.79 14.26 13 60083 344 63428582
Decreased appetite 34.79 14.26 377 59719 250675 63178251
Gait disturbance 34.76 14.26 294 59802 182884 63246042
Deep vein thrombosis 34.66 14.26 18 60078 83782 63345144
Injection site warmth 34.52 14.26 56 60040 15139 63413787
Ingrowing nail 34.42 14.26 24 60072 2425 63426501
Gallbladder disorder 34.36 14.26 63 60033 18779 63410147
Pancytopenia 34.28 14.26 25 60071 96908 63332018
Dizziness 34.16 14.26 584 59512 429341 62999585
Crying 33.99 14.26 71 60025 23272 63405654
Injection site hypoaesthesia 33.98 14.26 14 60082 483 63428443
Sensitisation 33.75 14.26 27 60069 3359 63425567
Sleep disorder due to general medical condition, insomnia type 32.99 14.26 5 60091 52212 63376714
Head banging 32.86 14.26 13 60083 403 63428523
Breast mass 32.81 14.26 39 60057 7883 63421043
Mobility decreased 32.60 14.26 40 60056 121119 63307807
Administration site abscess 32.32 14.26 7 60089 20 63428906
Unevaluable event 32.28 14.26 5 60091 51381 63377545
Illness 32.20 14.26 111 59985 48948 63379978
Fibromyalgia 32.20 14.26 18 60078 80402 63348524
Neuroendocrine carcinoma 32.18 14.26 11 60085 223 63428703
Bile duct stone 31.93 14.26 27 60069 3629 63425297
Pain in extremity 31.88 14.26 465 59631 331021 63097905
Metastases to eye 31.81 14.26 10 60086 154 63428772
Administration site induration 31.58 14.26 7 60089 23 63428903
Recurrent cancer 31.55 14.26 21 60075 1966 63426960
Metastases to abdominal cavity 31.54 14.26 13 60083 449 63428477
Buttock injury 31.47 14.26 11 60085 239 63428687
Medication error 30.85 14.26 6 60090 52278 63376648
Skin discolouration 30.65 14.26 92 60004 37736 63391190
Peripheral coldness 30.63 14.26 47 60049 12118 63416808
Respiratory rate increased 30.60 14.26 50 60046 13598 63415328
Administration site discharge 30.51 14.26 7 60089 28 63428898
Polydipsia 30.47 14.26 26 60070 3538 63425388
Facial asymmetry 30.46 14.26 15 60081 790 63428136
Nephrolithiasis 30.22 14.26 98 59998 41886 63387040
Body height increased 30.19 14.26 8 60088 64 63428862
Injection site cyst 30.08 14.26 8 60088 65 63428861
Haemorrhage 30.08 14.26 126 59970 60896 63368030
Wound 29.96 14.26 69 60027 163194 63265732
Injection site scar 29.92 14.26 16 60080 1002 63427924
Multiple sclerosis relapse 29.82 14.26 5 60091 48473 63380453
Blood glucose abnormal 29.68 14.26 37 60059 7855 63421071
Benign neoplasm of adrenal gland 29.58 14.26 7 60089 33 63428893
Hyperhidrosis 29.57 14.26 189 59907 107647 63321279
Cardio-respiratory arrest 29.41 14.26 10 60086 59949 63368977
Blood magnesium decreased 29.11 14.26 48 60048 13150 63415776
Electrocardiogram QT prolonged 29.08 14.26 10 60086 59520 63369406
Oxygen saturation decreased 28.63 14.26 25 60071 88560 63340366
Administration site odour 28.31 14.26 7 60089 41 63428885
Red blood cell sedimentation rate increased 28.27 14.26 4 60092 43978 63384948
Muscle contractions involuntary 28.04 14.26 21 60075 2371 63426555
Metastatic carcinoid tumour 28.00 14.26 6 60090 16 63428910
Pulmonary embolism 27.88 14.26 42 60054 116642 63312284
Ill-defined disorder 27.74 14.26 22 60074 81733 63347193
Anaphylactic reaction 27.63 14.26 14 60082 66086 63362840
Leukopenia 27.25 14.26 20 60076 77270 63351656
Liver abscess 26.84 14.26 22 60074 2832 63426094
Helicobacter infection 26.72 14.26 29 60067 92756 63336170
Furuncle 26.66 14.26 32 60064 6534 63422392
Metastases to fallopian tube 26.53 14.26 7 60089 55 63428871
Biliary obstruction 26.40 14.26 22 60074 2899 63426027
Contusion 25.95 14.26 236 59860 149808 63279118
Neuroendocrine carcinoma metastatic 25.81 14.26 9 60087 194 63428732
Injury 25.76 14.26 19 60077 73228 63355698
Urine odour abnormal 25.72 14.26 31 60065 6358 63422568
Metastases to breast 25.64 14.26 10 60086 298 63428628
Bone pain 25.52 14.26 111 59985 54530 63374396
Hallucination 25.44 14.26 10 60086 54807 63374119
Aspartate aminotransferase increased 25.14 14.26 29 60067 90248 63338678
Chronic obstructive pulmonary disease 25.14 14.26 14 60082 62672 63366254
Chondroma 24.74 14.26 6 60090 32 63428894
Hepatotoxicity 24.70 14.26 3 60093 37038 63391888
Thyroid mass 24.66 14.26 25 60071 4233 63424693
Rhinorrhoea 24.61 14.26 125 59971 65452 63363474
Postoperative wound infection 24.46 14.26 40 60056 10885 63418041
Cardiac failure congestive 24.36 14.26 31 60065 92402 63336524
Screaming 24.29 14.26 22 60074 3240 63425686
Dengue fever 24.18 14.26 12 60084 643 63428283
Injection site vesicles 24 14.26 21 60075 2956 63425970
Pancreatolithiasis 23.61 14.26 9 60087 252 63428674
Breast pain 23.59 14.26 35 60061 8763 63420163
Lactic acidosis 23.43 14.26 4 60092 38283 63390643
Bile output increased 23.22 14.26 6 60090 43 63428883
Swelling 23.15 14.26 159 59937 275219 63153707
Tumour compression 23.10 14.26 6 60090 44 63428882
Tonsillar inflammation 22.88 14.26 7 60089 98 63428828
Pulmonary fibrosis 22.59 14.26 5 60091 39804 63389122
Gout 22.48 14.26 43 60053 13228 63415698
Gastritis fungal 22.44 14.26 7 60089 105 63428821
Administration site haemorrhage 22.44 14.26 7 60089 105 63428821
Biliary colic 22.35 14.26 22 60074 3595 63425331
Muscle strain 22.30 14.26 33 60063 8241 63420685
Periarticular disorder 22.22 14.26 6 60090 52 63428874
Pregnancy 22.21 14.26 4 60092 36832 63392094
Product use in unapproved indication 22.10 14.26 263 59833 178817 63250109
No adverse event 21.94 14.26 6 60090 41399 63387527
Angioedema 21.85 14.26 9 60087 47956 63380970
Pain in jaw 21.78 14.26 7 60089 43489 63385437
Sedation 21.77 14.26 5 60091 38804 63390122
Soft tissue mass 21.72 14.26 9 60087 315 63428611
Metastases to pelvis 21.55 14.26 10 60086 461 63428465
Heart rate irregular 21.55 14.26 58 60038 22363 63406563
Pancreatic enlargement 21.54 14.26 6 60090 59 63428867
Dyspnoea 21.49 14.26 470 59626 660843 62768083
Plasma cell myeloma 21.44 14.26 4 60092 35901 63393025
Small intestine carcinoma 21.43 14.26 10 60086 467 63428459
Injection site inflammation 21.23 14.26 22 60074 3821 63425105
Zinc deficiency 21.10 14.26 6 60090 64 63428862
Diaphragmatic spasm 21.09 14.26 4 60092 4 63428922
Pancreatectomy 21.05 14.26 5 60091 24 63428902
Fear-related avoidance of activities 21.05 14.26 7 60089 130 63428796
Vulval disorder 20.95 14.26 12 60084 860 63428066
Blood gastrin increased 20.88 14.26 5 60091 25 63428901
Urine abnormality 20.38 14.26 29 60067 6990 63421936
Thrombocytopenia 20.33 14.26 74 60022 151083 63277843
Faeces soft 20.31 14.26 26 60070 5666 63423260
Feeling cold 20.21 14.26 59 60037 23829 63405097
Respiratory tract infection 20.20 14.26 7 60089 41476 63387450
Abdominal mass 20.12 14.26 19 60077 2951 63425975
Tumour pain 20.00 14.26 14 60082 1423 63427503
Bone cancer 19.96 14.26 14 60082 1428 63427498
Pallor 19.91 14.26 69 60027 30499 63398427
Suicide attempt 19.91 14.26 17 60079 60901 63368025
Pituitary enlargement 19.84 14.26 5 60091 32 63428894
Large intestine polyp 19.82 14.26 31 60065 8126 63420800
Hypothalamo-pituitary disorder 19.82 14.26 11 60085 742 63428184
Dysstasia 19.59 14.26 54 60042 21112 63407814
Metastases to peritoneum 19.55 14.26 20 60076 3422 63425504
Early satiety 19.47 14.26 12 60084 984 63427942
Metastases to uterus 19.23 14.26 6 60090 90 63428836
Drug-induced liver injury 19.23 14.26 7 60089 40215 63388711
Pancreatic carcinoma recurrent 19.17 14.26 6 60090 91 63428835
Gallbladder neoplasm 19.10 14.26 5 60091 38 63428888
Haemorrhoids 19.02 14.26 55 60041 22095 63406831
Cognitive disorder 18.96 14.26 15 60081 55800 63373126
Treatment noncompliance 18.70 14.26 6 60090 37319 63391607
Bartholinitis 18.66 14.26 5 60091 42 63428884
Lymphatic system neoplasm 18.66 14.26 5 60091 42 63428884
Obesity 18.62 14.26 3 60093 29949 63398977
Nasopharyngitis 18.58 14.26 341 59755 253916 63175010
Back injury 18.50 14.26 33 60063 9627 63419299
Coccydynia 18.32 14.26 14 60082 1629 63427297
Bite 18.31 14.26 9 60087 472 63428454
Gallbladder oedema 18.23 14.26 7 60089 200 63428726
Crystal arthropathy 18.12 14.26 8 60088 328 63428598
Rash maculo-papular 18.11 14.26 4 60092 31892 63397034
Spinal cord injury lumbar 17.97 14.26 5 60091 49 63428877
Abnormal faeces 17.96 14.26 24 60072 5456 63423470
Respiratory failure 17.92 14.26 44 60052 101814 63327112
Urine calcium/creatinine ratio increased 17.92 14.26 6 60090 114 63428812
Alopecia 17.87 14.26 219 59877 337317 63091609
Metastases to bladder 17.75 14.26 7 60089 215 63428711
Cardiac valve disease 17.72 14.26 21 60075 4231 63424695
Application site mass 17.70 14.26 5 60091 52 63428874
Pituitary tumour removal 17.64 14.26 4 60092 15 63428911
Thirst 17.37 14.26 40 60056 14001 63414925
Cyst 17.26 14.26 40 60056 14059 63414867
Carcinoid tumour of the small bowel 17.05 14.26 4 60092 18 63428908
Multiple endocrine neoplasia Type 1 17.05 14.26 4 60092 18 63428908
Myocardial infarction 16.92 14.26 44 60052 99849 63329077
Abortion spontaneous 16.91 14.26 12 60084 47183 63381743
Metastases to spine 16.88 14.26 18 60078 3231 63425695
Insulin-like growth factor abnormal 16.88 14.26 4 60092 19 63428907
Feeling hot 16.85 14.26 93 60003 50261 63378665
Confusional state 16.79 14.26 143 59953 236237 63192689
Respiratory disorder 16.75 14.26 8 60088 39074 63389852
Pneumonia aspiration 16.53 14.26 6 60090 34534 63394392
Endometrial cancer stage I 16.50 14.26 7 60089 260 63428666
Hypokinesia 16.47 14.26 39 60057 13897 63415029
Feeding disorder 16.46 14.26 38 60058 13324 63415602
Overweight 16.42 14.26 19 60077 3732 63425194
Spleen disorder 16.41 14.26 11 60085 1042 63427884
Fear 16.39 14.26 42 60054 15724 63413202
Tumour necrosis 16.35 14.26 10 60086 809 63428117
Body height decreased 16.27 14.26 32 60064 10046 63418880
Constipation 16.19 14.26 301 59795 224642 63204284
Polyuria 16.13 14.26 29 60067 8513 63420413
Memory impairment 16.03 14.26 160 59936 104098 63324828
Oropharyngeal pain 16.01 14.26 148 59948 94339 63334587
Rhabdomyolysis 15.98 14.26 11 60085 43940 63384986
Pituitary tumour benign 15.94 14.26 14 60082 1981 63426945
Musculoskeletal chest pain 15.89 14.26 50 60046 21033 63407893
Hyperglycaemia 15.84 14.26 80 60016 41787 63387139
Endocrine neoplasm 15.81 14.26 3 60093 3 63428923
Vasoactive intestinal polypeptide increased 15.81 14.26 3 60093 3 63428923
Pulse abnormal 15.78 14.26 15 60081 2349 63426577
Trichoglossia 15.74 14.26 7 60089 292 63428634
Gastrointestinal wall thickening 15.74 14.26 12 60084 1392 63427534
Metastases to oesophagus 15.69 14.26 4 60092 27 63428899
Labyrinthitis 15.68 14.26 15 60081 2368 63426558
Insulinoma 15.61 14.26 5 60091 82 63428844
Duodenal ulcer 15.51 14.26 27 60069 7729 63421197
Urethral caruncle 15.50 14.26 5 60091 84 63428842
Erythema 15.48 14.26 243 59853 175508 63253418
Metastases to lung 15.42 14.26 36 60060 12714 63416212
Fatigue 15.35 14.26 1005 59091 887023 62541903
Hyperdynamic left ventricle 15.35 14.26 6 60090 180 63428746
Dysuria 15.34 14.26 68 60028 33670 63395256
Hepatic cancer 15.24 14.26 20 60076 4467 63424459
Pancreatic neuroendocrine tumour metastatic 15.21 14.26 4 60092 31 63428895
Mesenteritis 15.20 14.26 7 60089 317 63428609
Lower respiratory tract infection 15.13 14.26 69 60027 132238 63296688
Short-bowel syndrome 14.97 14.26 8 60088 500 63428426
Arthropod bite 14.96 14.26 27 60069 7951 63420975
Neutrophil count decreased 14.77 14.26 19 60077 56387 63372539
Spinal pain 14.70 14.26 36 60060 13103 63415823
Abdominal neoplasm 14.69 14.26 7 60089 343 63428583
Dysphonia 14.65 14.26 86 60010 47528 63381398
Sepsis 14.61 14.26 85 60011 153038 63275888
Tricuspid valve stenosis 14.60 14.26 3 60093 6 63428920
Muscle neoplasm 14.58 14.26 4 60092 37 63428889
Metastases to lymph nodes 14.52 14.26 27 60069 8131 63420795
Empty sella syndrome 14.39 14.26 4 60092 39 63428887
Plasmablastic lymphoma 14.35 14.26 6 60090 215 63428711
Stomatitis 14.33 14.26 75 60021 138650 63290276

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 1423.27 15.08 455 42029 5710 34908737
Blood pressure systolic increased 1205.48 15.08 578 41906 22374 34892073
Body temperature decreased 964.55 15.08 417 42067 12617 34901830
Blood pressure increased 755.99 15.08 716 41768 87386 34827061
Injection site pain 669.26 15.08 475 42009 38530 34875917
Inappropriate schedule of product administration 542.69 15.08 511 41973 61785 34852662
Malignant neoplasm progression 521.90 15.08 587 41897 87459 34826988
Heart rate decreased 402.88 15.08 323 42161 31422 34883025
Blood pressure diastolic decreased 376.17 15.08 195 42289 8899 34905548
Metastases to liver 342.45 15.08 211 42273 13452 34900995
Injection site mass 314.67 15.08 156 42328 6470 34907977
Hepatic neoplasm 245.86 15.08 92 42392 1885 34912562
Blood growth hormone increased 212.03 15.08 56 42428 332 34914115
Blood chromogranin A increased 189.76 15.08 48 42436 233 34914214
Drug interaction 188.04 15.08 26 42458 225920 34688527
Second primary malignancy 185.46 15.08 117 42367 7769 34906678
Hepatic lesion 183.99 15.08 90 42394 3622 34910825
Abdominal pain 172.25 15.08 512 41972 163106 34751341
Syringe issue 171.92 15.08 99 42385 5565 34908882
Acute kidney injury 165.94 15.08 82 42402 304906 34609541
Insulin-like growth factor increased 162.46 15.08 60 42424 1183 34913264
Blood pressure diastolic increased 155.64 15.08 89 42395 4936 34909511
Flushing 154.93 15.08 194 42290 32226 34882221
Malaise 149.92 15.08 531 41953 185294 34729153
Injection site haemorrhage 149.12 15.08 111 42373 9657 34904790
Weight decreased 148.45 15.08 511 41973 175790 34738657
Diarrhoea 141.81 15.08 882 41602 389030 34525417
Carcinoid crisis 140.28 15.08 37 42447 218 34914229
Cholelithiasis 135.23 15.08 147 42337 21001 34893446
Toxicity to various agents 128.17 15.08 42 42442 200320 34714127
Abdominal distension 124.66 15.08 241 42243 58251 34856196
Pain 123.67 15.08 534 41950 204141 34710306
Intestinal obstruction 122.73 15.08 145 42339 22677 34891770
Flatulence 117.84 15.08 137 42347 21061 34893386
Stress 114.81 15.08 162 42322 30185 34884262
Underdose 108.29 15.08 107 42377 13673 34900774
Condition aggravated 105.37 15.08 51 42433 192145 34722302
Febrile neutropenia 102.11 15.08 21 42463 136828 34777619
Off label use 96.10 15.08 232 42252 419292 34495155
Neutropenia 91.55 15.08 38 42446 156740 34757707
Nasopharyngitis 90.21 15.08 236 42248 69732 34844715
Carcinoid syndrome 90.02 15.08 22 42462 90 34914357
Neoplasm 89.93 15.08 65 42419 5402 34909045
5-hydroxyindolacetic acid in urine increased 89.29 15.08 26 42458 231 34914216
Neoplasm progression 89.03 15.08 125 42359 23175 34891272
Blood pressure decreased 81.51 15.08 188 42296 51327 34863120
Injection site swelling 80.52 15.08 84 42400 11443 34903004
Biliary obstruction 75.44 15.08 45 42439 2700 34911747
Injection site discomfort 73.74 15.08 37 42447 1573 34912874
Hormone level abnormal 73.33 15.08 25 42459 386 34914061
Neuroendocrine tumour 71.34 15.08 29 42455 746 34913701
Blood mercury abnormal 69.63 15.08 21 42463 213 34914234
Pancytopenia 68.12 15.08 16 42468 95141 34819306
Pneumonia 67.05 15.08 222 42262 362405 34552042
Faeces soft 65.33 15.08 45 42439 3463 34910984
Metastasis 63.03 15.08 47 42437 4097 34910350
Blood glucose increased 62.73 15.08 201 42283 66517 34847930
Incorrect dose administered 59.88 15.08 144 42340 40371 34874076
Pancreatic neuroendocrine tumour 58.94 15.08 19 42465 244 34914203
Gait disturbance 58.18 15.08 231 42253 84909 34829538
Movement disorder 58.00 15.08 73 42411 12175 34902272
Fatigue 56.68 15.08 693 41791 369960 34544487
Discomfort 54.44 15.08 89 42395 18849 34895598
Serum serotonin increased 53.44 15.08 14 42470 80 34914367
Cardiac failure congestive 52.20 15.08 18 42466 83252 34831195
Heart rate increased 51.41 15.08 148 42336 46195 34868252
Pituitary tumour 51.31 15.08 21 42463 550 34913897
Atrial fibrillation 51.28 15.08 44 42440 122349 34792098
Eating disorder 50.43 15.08 56 42428 8184 34906263
Infusion related reaction 49.40 15.08 4 42480 53053 34861394
Back pain 49.31 15.08 284 42200 121505 34792942
Metastases to pancreas 48.96 15.08 17 42467 278 34914169
Hot flush 48.05 15.08 82 42402 17984 34896463
Thrombocytopenia 47.27 15.08 73 42411 156174 34758273
Blood test abnormal 47.26 15.08 50 42434 6921 34907526
Overdose 47.09 15.08 26 42458 91033 34823414
Steatorrhoea 45.99 15.08 21 42463 722 34913725
Rhinorrhoea 45.43 15.08 98 42386 25570 34888877
Respiratory rate increased 45.31 15.08 58 42426 9836 34904611
Hyponatraemia 45.15 15.08 22 42462 82669 34831778
Sepsis 44.71 15.08 84 42400 166477 34747970
Faecal volume decreased 44.49 15.08 13 42471 117 34914330
Myocardial infarction 44.39 15.08 49 42435 121036 34793411
Respiratory failure 44.31 15.08 40 42444 108532 34805915
Rhabdomyolysis 44.01 15.08 14 42470 68149 34846298
Metastases to bone 43.92 15.08 63 42421 11907 34902540
Heart rate irregular 43.70 15.08 73 42411 15734 34898713
Feeling cold 43.52 15.08 59 42425 10580 34903867
Bowel movement irregularity 43.30 15.08 33 42451 2972 34911475
Asthenia 42.93 15.08 471 42013 244780 34669667
Anaemia 42.91 15.08 143 42341 233192 34681255
Neuropathy peripheral 42.73 15.08 24 42460 83239 34831208
Acute myocardial infarction 42.70 15.08 7 42477 53712 34860735
Diaphragmatic spasm 41.47 15.08 12 42472 104 34914343
Intentional product misuse 40.95 15.08 4 42480 45607 34868840
Erythema 40.58 15.08 214 42270 88566 34825881
Mass 40.46 15.08 49 42435 7856 34906591
Peripheral swelling 39.55 15.08 191 42293 76350 34838097
Intentional product use issue 39.12 15.08 12 42472 59804 34854643
Influenza 39.07 15.08 141 42343 49525 34864922
Coronary artery disease 39.05 15.08 6 42478 48299 34866148
Cardiac arrest 38.55 15.08 36 42448 96123 34818324
Pain in extremity 37.66 15.08 273 42211 126240 34788207
Blood creatine phosphokinase increased 37.60 15.08 5 42479 44852 34869595
Low density lipoprotein decreased 37.43 15.08 21 42463 1122 34913325
Abdominal pain upper 36.65 15.08 178 42306 71312 34843135
Frequent bowel movements 36.62 15.08 60 42424 12727 34901720
Suicide attempt 36.27 15.08 3 42481 39113 34875334
Biliary colic 36.11 15.08 20 42464 1042 34913405
Musculoskeletal chest pain 36.09 15.08 52 42432 9866 34904581
Lacrimal disorder 35.90 15.08 14 42470 322 34914125
Foetal exposure during pregnancy 35.12 15.08 3 42481 38098 34876349
Feeling abnormal 35 15.08 161 42323 63074 34851373
Nerve degeneration 34.58 15.08 12 42472 196 34914251
Bone neoplasm 34.57 15.08 13 42471 270 34914177
Cardio-respiratory arrest 34.54 15.08 12 42472 55261 34859186
Hypoxia 34.36 15.08 12 42472 55083 34859364
Angioedema 34.29 15.08 3 42481 37371 34877076
5-hydroxyindolacetic acid increased 34.28 15.08 6 42478 0 34914447
Product dose omission issue 34.24 15.08 58 42426 119653 34794794
Drug ineffective 34.20 15.08 373 42111 456378 34458069
Blood glucose abnormal 33.95 15.08 39 42445 5913 34908534
Faeces discoloured 33.74 15.08 63 42421 14815 34899632
Product quality issue 33.60 15.08 68 42416 16967 34897480
Interstitial lung disease 33.23 15.08 19 42465 65263 34849184
Necrotising colitis 32.96 15.08 19 42465 1069 34913378
Blood glucose fluctuation 32.88 15.08 32 42452 4012 34910435
Metastases to lymph nodes 32.20 15.08 34 42450 4694 34909753
Neuroendocrine carcinoma metastatic 32.10 15.08 10 42474 114 34914333
Death 32.06 15.08 669 41815 397380 34517067
Nervousness 31.93 15.08 56 42428 12550 34901897
Blood growth hormone abnormal 31.86 15.08 6 42478 3 34914444
Nephrolithiasis 31.83 15.08 95 42389 30238 34884209
Carcinoid heart disease 31.69 15.08 7 42477 16 34914431
Musculoskeletal pain 31.57 15.08 98 42386 31865 34882582
Alanine aminotransferase increased 31.52 15.08 31 42453 80784 34833663
Hyperkalaemia 31.49 15.08 23 42461 69366 34845081
Oropharyngeal pain 30.72 15.08 104 42380 35381 34879066
Abnormal faeces 30.25 15.08 28 42456 3297 34911150
Intra-abdominal fluid collection 29.96 15.08 19 42465 1272 34913175
Terminal state 29.88 15.08 30 42454 3904 34910543
White blood cell count decreased 29.41 15.08 44 42440 95401 34819046
Abdominal discomfort 29.25 15.08 147 42337 59688 34854759
Musculoskeletal discomfort 28.92 15.08 42 42442 8026 34906421
Blood glucose decreased 28.72 15.08 55 42429 13182 34901265
Recurrent cancer 28.71 15.08 19 42465 1368 34913079
Suicidal ideation 28.47 15.08 7 42477 40381 34874066
Metastatic carcinoid tumour 28.05 15.08 6 42478 11 34914436
Deep vein thrombosis 27.87 15.08 23 42461 65225 34849222
Blood growth hormone decreased 27.84 15.08 7 42477 33 34914414
Yellow skin 27.74 15.08 22 42462 2100 34912347
Hepatic pain 27.73 15.08 19 42465 1449 34912998
Hepatic mass 27.19 15.08 17 42467 1110 34913337
Loss of personal independence in daily activities 27.10 15.08 4 42480 33175 34881272
Transfusion-related circulatory overload 26.74 15.08 11 42473 292 34914155
Rash 26.72 15.08 160 42324 222592 34691855
Contusion 26.71 15.08 101 42383 36263 34878184
Polyp 26.53 15.08 28 42456 3864 34910583
Renal mass 26.41 15.08 20 42464 1784 34912663
Seizure 26.28 15.08 55 42429 104802 34809645
Parathyroid hormone-related protein abnormal 26.24 15.08 6 42478 17 34914430
Hernia 26.14 15.08 44 42440 9539 34904908
Neutrophil count decreased 25.82 15.08 15 42469 51089 34863358
Blood potassium decreased 25.73 15.08 63 42421 17852 34896595
Sciatica 25.58 15.08 34 42450 5980 34908467
Concomitant disease aggravated 25.45 15.08 33 42451 5668 34908779
Pulse abnormal 25.44 15.08 17 42467 1244 34913203
Arthralgia 25.43 15.08 317 42167 169724 34744723
Blood creatinine increased 25.36 15.08 48 42436 94928 34819519
Intestinal intraepithelial lymphocytes increased 25.18 15.08 9 42475 161 34914286
Psoriasis 24.99 15.08 8 42476 38804 34875643
Product use in unapproved indication 24.96 15.08 235 42249 117264 34797183
Haematuria 24.87 15.08 15 42469 50051 34864396
Blood urine present 24.72 15.08 46 42438 10788 34903659
Expired product administered 24.51 15.08 25 42459 3316 34911131
Cardiac failure 24.47 15.08 46 42438 91202 34823245
Unevaluable event 24.27 15.08 5 42479 32585 34881862
Chronic kidney disease 23.99 15.08 10 42474 41200 34873247
Decreased appetite 23.94 15.08 308 42176 166084 34748363
Thyroid mass 23.81 15.08 12 42472 515 34913932
Respiratory arrest 23.80 15.08 3 42481 28040 34886407
Hernia pain 23.71 15.08 10 42474 283 34914164
Cortisol free urine increased 23.43 15.08 5 42479 9 34914438
Metastases to gastrointestinal tract 23.12 15.08 7 42477 72 34914375
Chest wall tumour 22.86 15.08 4 42480 0 34914447
Hypertrophic osteoarthropathy 22.62 15.08 7 42477 78 34914369
Injection site oedema 22.49 15.08 9 42475 222 34914225
Cryptitis 22.30 15.08 9 42475 227 34914220
Metastases to thorax 22.24 15.08 6 42478 39 34914408
Metastases to spine 22.05 15.08 21 42463 2563 34911884
Bite 21.71 15.08 7 42477 90 34914357
Neck mass 21.69 15.08 17 42467 1596 34912851
Metastases to oesophagus 21.66 15.08 5 42479 15 34914432
Intestinal metastasis 21.60 15.08 9 42475 247 34914200
Dizziness 21.52 15.08 379 42105 218142 34696305
Therapeutic product effect incomplete 21.35 15.08 18 42466 50523 34863924
Leukopenia 21.34 15.08 27 42457 62829 34851618
Septic shock 21.27 15.08 34 42450 71800 34842647
Mental status changes 20.98 15.08 10 42474 38073 34876374
Eating disorder symptom 20.96 15.08 5 42479 18 34914429
Lactic acidosis 20.96 15.08 8 42476 34764 34879683
Therapeutic product effect decreased 20.93 15.08 8 42476 34735 34879712
Body temperature increased 20.75 15.08 57 42427 17311 34897136
Anxiety 20.68 15.08 198 42286 99230 34815217
Dizziness postural 20.53 15.08 31 42453 6133 34908314
Device occlusion 20.51 15.08 32 42452 6513 34907934
Limb discomfort 20.49 15.08 43 42441 11004 34903443
Saliva altered 20.43 15.08 8 42476 186 34914261
Insulinoma 20.35 15.08 5 42479 21 34914426
Microvillous inclusion disease 20.20 15.08 8 42476 192 34914255
Pancreatic neoplasm 20.17 15.08 13 42471 895 34913552
Cardiogenic shock 20.00 15.08 4 42480 26614 34887833
Scan gallium abnormal 19.98 15.08 5 42479 23 34914424
Ventricular tachycardia 19.96 15.08 4 42480 26575 34887872
Rash maculo-papular 19.92 15.08 5 42479 28446 34886001
Encephalopathy 19.88 15.08 9 42475 35310 34879137
Somnolence 19.76 15.08 69 42415 111047 34803400
Metastases to pelvis 19.75 15.08 9 42475 308 34914139
Pyrexia 19.59 15.08 286 42198 332727 34581720
Eosinophilia 19.58 15.08 4 42480 26218 34888229
Labyrinthitis 19.56 15.08 13 42471 943 34913504
Treatment noncompliance 19.55 15.08 5 42479 28095 34886352
Blood iron decreased 19.54 15.08 28 42456 5285 34909162
Asthma 19.53 15.08 14 42470 42642 34871805
Metastases to lung 19.33 15.08 38 42446 9282 34905165
Disturbance in attention 19.28 15.08 4 42480 25941 34888506
Metastases to spleen 19.22 15.08 10 42474 459 34913988
Probiotic therapy 19.19 15.08 7 42477 133 34914314
Carcinoid tumour 18.85 15.08 8 42476 230 34914217
Injection site bruising 18.80 15.08 36 42448 8627 34905820
Cardiac valve disease 18.75 15.08 21 42463 3097 34911350
Respiratory distress 18.69 15.08 10 42474 35655 34878792
Metastases to eye 18.69 15.08 6 42478 76 34914371
Chills 18.68 15.08 165 42319 80878 34833569
Hallucination 18.67 15.08 21 42463 51477 34862970
Tumour marker increased 18.62 15.08 11 42473 648 34913799
Multiple organ dysfunction syndrome 18.48 15.08 41 42443 76525 34837922
Drug-induced liver injury 18.46 15.08 6 42478 28826 34885621
Depressed level of consciousness 18.42 15.08 15 42469 42826 34871621
Renal failure 18.27 15.08 89 42395 130468 34783979
Renal neoplasm 18.15 15.08 14 42470 1283 34913164
Hypotension 18.14 15.08 177 42307 221472 34692975
Ear discomfort 17.99 15.08 19 42465 2623 34911824
Productive cough 17.84 15.08 92 42392 37721 34876726
Product deposit 17.59 15.08 9 42475 399 34914048
Aggression 17.56 15.08 13 42471 38951 34875496
Apoptosis 17.52 15.08 9 42475 402 34914045
Staphylococcal infection 17.44 15.08 9 42475 32751 34881696
Pancreatic neuroendocrine tumour metastatic 17.40 15.08 6 42478 96 34914351
Acute respiratory distress syndrome 17.36 15.08 5 42479 25964 34888483
High frequency ablation 17.33 15.08 7 42477 177 34914270
Hepatic function abnormal 17.31 15.08 17 42467 44346 34870101
Faeces pale 17.18 15.08 14 42470 1389 34913058
Neuroendocrine tumour of the lung 17.14 15.08 3 42481 0 34914447
Sciatic nerve injury 17.12 15.08 6 42478 101 34914346
Injection site erosion 16.96 15.08 6 42478 104 34914343
Skin warm 16.95 15.08 17 42467 2210 34912237
Gastric hypomotility 16.80 15.08 6 42478 107 34914340
Injection site induration 16.75 15.08 19 42465 2841 34911606
Injection site hypersensitivity 16.49 15.08 8 42476 316 34914131
Gallbladder disorder 16.48 15.08 29 42455 6513 34907934
Ventricular fibrillation 16.13 15.08 4 42480 22950 34891497
Tubulointerstitial nephritis 16.13 15.08 3 42481 21021 34893426
Product prescribing error 16.11 15.08 4 42480 22923 34891524
Biliary tract infection 16.10 15.08 10 42474 645 34913802
Abdominal pain lower 16.06 15.08 38 42446 10533 34903914
Cough 16.06 15.08 264 42220 149876 34764571
Device toxicity 16.06 15.08 4 42480 18 34914429
Eructation 16.05 15.08 24 42460 4707 34909740
Blood cholesterol abnormal 16.03 15.08 15 42469 1791 34912656
Oncologic complication 15.97 15.08 8 42476 339 34914108
Groin pain 15.96 15.08 26 42458 5487 34908960
Hyperoxaluria 15.80 15.08 6 42478 128 34914319
Cytomegalovirus infection 15.77 15.08 6 42478 26129 34888318
Procedural pain 15.76 15.08 24 42460 4782 34909665
Procedural hypertension 15.74 15.08 5 42479 61 34914386
Anaphylactic reaction 15.59 15.08 10 42474 32291 34882156
Swelling of eyelid 15.57 15.08 12 42472 1099 34913348
Electrocardiogram T wave alternans 15.55 15.08 4 42480 21 34914426
Hair colour changes 15.53 15.08 15 42469 1862 34912585
Cerebral infarction 15.44 15.08 7 42477 27448 34886999
Plasma cell myeloma 15.40 15.08 17 42467 42020 34872427
Renal pain 15.38 15.08 19 42465 3109 34911338
Agitation 15.32 15.08 29 42455 57370 34857077
Glycosylated haemoglobin increased 15.31 15.08 39 42445 11321 34903126
Cerebral haemorrhage 15.31 15.08 12 42472 34925 34879522
Arthritis 15.30 15.08 77 42407 31269 34883178
Injection site inflammation 15.29 15.08 11 42473 907 34913540
Nasal congestion 15.27 15.08 62 42422 22995 34891452
Blood pressure fluctuation 15.25 15.08 66 42418 25183 34889264
Feeling hot 15.22 15.08 55 42429 19317 34895130
Nausea 15.08 15.08 529 41955 339379 34575068

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 2525.44 13.58 828 89179 12240 79642141
Blood pressure systolic increased 2320.29 13.58 1243 88764 65743 79588638
Body temperature decreased 1889.80 13.58 856 89151 31289 79623092
Blood pressure increased 1477.65 13.58 1485 88522 209875 79444506
Injection site pain 1141.15 13.58 1036 88971 128802 79525579
Inappropriate schedule of product administration 1094.33 13.58 1025 88982 132603 79521778
Malignant neoplasm progression 1056.18 13.58 1013 88994 134977 79519404
Injection site mass 874.67 13.58 436 89571 19748 79634633
Blood pressure diastolic decreased 821.85 13.58 479 89528 29737 79624644
Heart rate decreased 690.54 13.58 598 89409 69718 79584663
Metastases to liver 525.05 13.58 352 89655 27962 79626419
Blood growth hormone increased 467.73 13.58 118 89889 618 79653763
Hepatic lesion 391.75 13.58 180 89827 6779 79647602
Flatulence 361.07 13.58 334 89673 42390 79611991
Blood pressure diastolic increased 354.73 13.58 215 89792 14327 79640054
Insulin-like growth factor increased 330.09 13.58 111 89896 1775 79652606
Second primary malignancy 324.13 13.58 202 89805 14148 79640233
Abdominal pain 319.91 13.58 1066 88941 388503 79265878
Toxicity to various agents 311.91 13.58 51 89956 421489 79232892
Blood chromogranin A increased 306.74 13.58 78 89929 424 79653957
Carcinoid crisis 298.68 13.58 77 89930 446 79653935
Abdominal distension 295.55 13.58 504 89503 119146 79535235
Hepatic neoplasm 292.71 13.58 119 89888 3307 79651074
Stress 283.21 13.58 397 89610 79215 79575166
Injection site haemorrhage 277.35 13.58 239 89768 27631 79626750
Drug interaction 270.25 13.58 68 89939 415115 79239266
Acute kidney injury 260.10 13.58 131 89876 519273 79135108
Completed suicide 256.86 13.58 4 90003 245763 79408618
Cholelithiasis 251.91 13.58 304 89703 52360 79602021
Syringe issue 249.20 13.58 128 89879 6170 79648211
Weight decreased 241.60 13.58 914 89093 354284 79300097
Condition aggravated 239.69 13.58 134 89873 500990 79153391
Off label use 238.06 13.58 413 89594 906802 78747579
Diarrhoea 227.55 13.58 1733 88274 878756 78775625
Blood pressure decreased 227.36 13.58 405 89602 99061 79555320
Malaise 225.31 13.58 1120 88887 488749 79165632
Intestinal obstruction 225.07 13.58 260 89747 42760 79611621
Infusion related reaction 224.37 13.58 8 89999 230229 79424152
Injection site discomfort 207.32 13.58 106 89901 5060 79649321
Mass 205.35 13.58 165 89842 17307 79637074
Flushing 201.20 13.58 359 89648 87909 79566472
Neoplasm progression 190.13 13.58 262 89745 51420 79602961
Underdose 177.86 13.58 203 89804 32948 79621433
Drug abuse 164.50 13.58 4 90003 162687 79491694
Neoplasm 156.25 13.58 108 89899 9008 79645373
Synovitis 155.17 13.58 3 90004 150731 79503650
Drug ineffective 151.37 13.58 668 89339 1080245 78574136
Rheumatoid arthritis 147.94 13.58 28 89979 208442 79445939
Metastasis 143.24 13.58 92 89915 6788 79647593
Neutropenia 141.64 13.58 74 89933 287636 79366745
Diabetes mellitus 135.90 13.58 284 89723 78106 79576275
Carcinoid syndrome 135.09 13.58 34 89973 176 79654205
Neuroendocrine tumour 133.33 13.58 52 89955 1292 79653089
Blood glucose decreased 131.27 13.58 155 89852 26079 79628302
Therapeutic product effect decreased 129.95 13.58 16 89991 163847 79490534
Febrile neutropenia 128.40 13.58 50 89957 230949 79423432
Blood glucose increased 127.30 13.58 350 89657 114625 79539756
Eating disorder 125.25 13.58 135 89872 20562 79633819
Bowel movement irregularity 125.24 13.58 82 89925 6252 79648129
Contraindicated product administered 123.43 13.58 16 89991 157522 79496859
Nervousness 120.79 13.58 168 89839 33247 79621134
Injection site swelling 119.51 13.58 201 89806 46931 79607450
Back pain 119.21 13.58 666 89341 303514 79350867
Intentional product use issue 115.51 13.58 17 89990 152095 79502286
Overdose 110.72 13.58 35 89972 184171 79470210
Pancreatic neuroendocrine tumour 107.44 13.58 37 89970 638 79653743
Drug intolerance 106.70 13.58 85 89922 264034 79390347
Intentional overdose 105.62 13.58 3 90004 105957 79548424
Arthropathy 104.07 13.58 35 89972 177076 79477305
Pituitary tumour 102.87 13.58 42 89965 1180 79653201
Polyp 102.64 13.58 80 89927 8027 79646354
Rash 102.43 13.58 324 89683 578034 79076347
Movement disorder 101.45 13.58 139 89868 27120 79627261
Abdominal pain upper 101.27 13.58 510 89497 223309 79431072
Asthenia 98.62 13.58 945 89062 510744 79143637
Blood pressure systolic decreased 98.22 13.58 89 89918 10987 79643394
Carcinoid heart disease 96.93 13.58 21 89986 47 79654334
Hot flush 96.48 13.58 200 89807 54677 79599704
Fatigue 95.69 13.58 1525 88482 928202 78726179
5-hydroxyindolacetic acid in urine increased 95.49 13.58 27 89980 232 79654149
Treatment failure 94.56 13.58 37 89970 170449 79483932
Hepatic pain 93.66 13.58 58 89949 4014 79650367
Pancytopenia 93.54 13.58 35 89972 165710 79488671
Serum serotonin increased 93.33 13.58 28 89979 302 79654079
Hypersensitivity 93.25 13.58 95 89912 262144 79392237
Faeces discoloured 92.90 13.58 138 89869 28989 79625392
Loss of personal independence in daily activities 92.09 13.58 6 90001 102574 79551807
Hyponatraemia 90.09 13.58 44 89963 177804 79476577
Feeling abnormal 89.07 13.58 386 89621 158813 79495568
Insulin-like growth factor decreased 88.99 13.58 31 89976 554 79653827
Injection site hypersensitivity 87.55 13.58 43 89964 1882 79652499
Gait disturbance 86.36 13.58 462 89545 207044 79447337
Intentional product misuse 84.16 13.58 6 90001 95159 79559222
Nasopharyngitis 83.43 13.58 531 89476 253350 79401031
Glossodynia 82.13 13.58 10 89997 103327 79551054
Heart rate increased 82.08 13.58 311 89696 120413 79533968
Influenza 81.70 13.58 326 89681 129280 79525101
Cough 81.59 13.58 699 89308 366090 79288291
Pericarditis 80.65 13.58 11 89996 104225 79550156
Limb discomfort 80.50 13.58 138 89869 32712 79621669
Blood glucose fluctuation 80.42 13.58 64 89943 6618 79647763
Maternal exposure during pregnancy 80.17 13.58 27 89980 136511 79517870
Metastases to bone 78.29 13.58 116 89891 24311 79630070
Metastases to pancreas 77.82 13.58 28 89979 552 79653829
Frequent bowel movements 77.58 13.58 128 89879 29411 79624970
Hormone level abnormal 77.21 13.58 40 89967 1962 79652419
Steatorrhoea 75.30 13.58 31 89976 890 79653491
Biliary obstruction 74.57 13.58 53 89954 4621 79649760
Injection site induration 73.84 13.58 72 89935 9747 79644634
Hand deformity 73.59 13.58 14 89993 103905 79550476
Exposure during pregnancy 72.96 13.58 13 89994 101119 79553262
Incorrect dose administered 72.92 13.58 221 89786 76409 79577972
Terminal state 72.43 13.58 53 89954 4836 79649545
Cardio-respiratory arrest 71.97 13.58 17 89990 108493 79545888
Respiratory rate increased 71.28 13.58 104 89903 21496 79632885
Alanine aminotransferase increased 71.23 13.58 48 89959 162522 79491859
Blood mercury abnormal 71.16 13.58 21 89986 213 79654168
Product dose omission issue 70.83 13.58 106 89901 247431 79406950
Thrombocytopenia 70.78 13.58 119 89888 265140 79389241
Therapeutic product effect incomplete 70.29 13.58 36 89971 141609 79512772
Faeces soft 70.14 13.58 65 89942 8258 79646123
Nephrolithiasis 69.99 13.58 173 89834 53118 79601263
Musculoskeletal discomfort 69.11 13.58 98 89909 19737 79634644
5-hydroxyindolacetic acid increased 69.02 13.58 13 89994 8 79654373
Respiratory failure 68.41 13.58 62 89945 180849 79473532
Pain in extremity 66.07 13.58 665 89342 363873 79290508
Yellow skin 65.96 13.58 44 89963 3461 79650920
Musculoskeletal pain 65.74 13.58 259 89748 102095 79552286
Groin pain 64.96 13.58 77 89930 13003 79641378
Deep vein thrombosis 62.63 13.58 29 89978 120890 79533491
Cardiac failure congestive 62.44 13.58 42 89965 142360 79512021
Acute myocardial infarction 62.35 13.58 7 90000 77029 79577352
Blood glucose abnormal 62.32 13.58 68 89939 10498 79643883
Rhinorrhoea 61.98 13.58 208 89799 75866 79578515
Acne 61.15 13.58 110 89897 27080 79627301
Heart rate irregular 60.87 13.58 122 89885 32557 79621824
Diaphragmatic spasm 60.09 13.58 16 89991 107 79654274
Drug hypersensitivity 59.70 13.58 158 89849 298758 79355623
Blood iron decreased 59.39 13.58 80 89927 15354 79639027
Feeling cold 59.29 13.58 112 89895 28617 79625764
Angioedema 58.87 13.58 8 89999 76027 79578354
Hepatic enzyme increased 58.49 13.58 72 89935 182538 79471843
Blood growth hormone abnormal 57.77 13.58 13 89994 37 79654344
Asthma 57.70 13.58 41 89966 135054 79519327
Neuropathy peripheral 57.62 13.58 45 89962 141260 79513121
Anxiety 56.98 13.58 477 89530 248035 79406346
White blood cell count decreased 56.44 13.58 78 89929 188210 79466171
Recurrent cancer 56.03 13.58 36 89971 2657 79651724
Depressed level of consciousness 55.21 13.58 20 89987 96632 79557749
Acute respiratory failure 54.90 13.58 3 90004 59538 79594843
Sepsis 54.88 13.58 141 89866 269287 79385094
Dizziness 54.81 13.58 866 89141 525575 79128806
Injection site bruising 54.79 13.58 134 89873 40868 79613513
Blood growth hormone decreased 54.78 13.58 13 89994 50 79654331
Rhabdomyolysis 54.56 13.58 24 89983 103107 79551274
Cardiac arrest 53.92 13.58 69 89938 172027 79482354
Seizure 53.87 13.58 81 89926 188753 79465628
Carcinoid tumour 53.31 13.58 21 89986 536 79653845
Productive cough 53.11 13.58 219 89788 88112 79566269
Sinusitis 52.79 13.58 87 89920 195414 79458967
Psoriasis 52.09 13.58 18 89989 89569 79564812
Impaired healing 52.03 13.58 17 89990 87638 79566743
Oxygen saturation decreased 51.48 13.58 42 89965 129005 79525376
Abdominal pain lower 51.42 13.58 112 89895 31670 79622711
Neuroendocrine tumour of the lung 51.28 13.58 11 89996 23 79654358
Nephritic syndrome 51.21 13.58 19 89988 410 79653971
Pain 51.00 13.58 1094 88913 702708 78951673
Lactic acidosis 50.84 13.58 9 89998 70350 79584031
Anaphylactic reaction 50.14 13.58 16 89991 83727 79570654
Leukopenia 48.92 13.58 36 89971 116477 79537904
Myocardial infarction 48.73 13.58 83 89924 184046 79470335
Contusion 48.70 13.58 311 89696 148465 79505916
Musculoskeletal chest pain 47.98 13.58 94 89913 24670 79629711
Erythema 47.20 13.58 421 89586 222869 79431512
Ingrowing nail 47.08 13.58 33 89974 2814 79651567
Death 46.76 13.58 898 89109 565616 79088765
Hepatic mass 46.68 13.58 31 89976 2420 79651961
Anaemia 46.36 13.58 303 89704 444712 79209669
Faeces pale 46.03 13.58 33 89974 2917 79651464
Neuroendocrine carcinoma metastatic 45.99 13.58 17 89990 363 79654018
Hip fracture 45.95 13.58 105 89902 30656 79623725
Thyroid disorder 45.32 13.58 67 89940 14012 79640369
Unevaluable event 45.11 13.58 5 90002 55580 79598801
Metastases to gastrointestinal tract 44.96 13.58 13 89994 122 79654259
Drug-induced liver injury 44.55 13.58 10 89997 66107 79588274
Interstitial lung disease 44.48 13.58 37 89970 112563 79541818
Suicide attempt 44.34 13.58 19 89988 82913 79571468
Pancreatic disorder 44.00 13.58 34 89973 3368 79651013
Metastases to eye 43.92 13.58 15 89992 252 79654129
Hyperkalaemia 43.48 13.58 39 89968 114359 79540022
Abnormal faeces 43.39 13.58 48 89959 7523 79646858
C-reactive protein increased 43.31 13.58 49 89958 128978 79525403
Metastases to pelvis 43.23 13.58 19 89988 643 79653738
Gallbladder disorder 43.18 13.58 78 89929 19262 79635119
Blood creatine phosphokinase increased 42.56 13.58 11 89996 66079 79588302
Injection site scar 42.09 13.58 20 89987 813 79653568
Decreased appetite 41.73 13.58 579 89428 341839 79312542
Biliary colic 41.49 13.58 35 89972 3927 79650454
Rectal polyp 41.42 13.58 25 89982 1652 79652729
Hypoglycaemia 41.40 13.58 225 89782 101369 79553012
Medication error 41.29 13.58 13 89994 68629 79585752
Sedation 41.29 13.58 5 90002 51890 79602491
Frustration tolerance decreased 40.33 13.58 46 89961 7456 79646925
Red blood cell sedimentation rate increased 40.32 13.58 3 90004 45939 79608442
Fall 40.22 13.58 773 89234 486856 79167525
Faecal volume decreased 40.18 13.58 13 89994 183 79654198
Pulse abnormal 39.84 13.58 32 89975 3352 79651029
Metastases to ovary 39.66 13.58 15 89992 342 79654039
Sciatic nerve injury 39.28 13.58 17 89990 554 79653827
Oropharyngeal pain 39.18 13.58 234 89773 109119 79545262
Toxic epidermal necrolysis 38.87 13.58 3 90004 44578 79609803
Rash maculo-papular 38.77 13.58 8 89999 56070 79598311
Bile duct stone 38.36 13.58 39 89968 5550 79648831
Neutrophil count decreased 38.20 13.58 30 89977 93929 79560452
Bone pain 38.19 13.58 144 89863 55598 79598783
Low density lipoprotein decreased 37.58 13.58 21 89986 1200 79653181
Blister 37.31 13.58 48 89959 119428 79534953
Pneumonia 37.30 13.58 523 89484 659723 78994658
Intestinal haemorrhage 37.28 13.58 41 89966 6385 79647996
Hypoxia 37.12 13.58 37 89970 103206 79551175
Adverse event 36.95 13.58 11 89996 60203 79594178
Urticaria 36.87 13.58 98 89909 185103 79469278
Skin discolouration 36.85 13.58 116 89891 40918 79613463
Bite 36.78 13.58 16 89991 528 79653853
Hallucination 36.64 13.58 26 89981 85719 79568662
Change of bowel habit 36.63 13.58 28 89979 2729 79651652
Coronary artery disease 36.63 13.58 14 89993 65460 79588921
Nasal discharge discolouration 36.60 13.58 27 89980 2494 79651887
Pituitary tumour recurrent 36.33 13.58 12 89995 181 79654200
Respiratory arrest 36.26 13.58 10 89997 57540 79596841
Dyspnoea 35.96 13.58 717 89290 856308 78798073
Adverse drug reaction 35.83 13.58 15 89992 66377 79588004
Multiple sclerosis relapse 35.78 13.58 5 90002 46528 79607853
Cardiac valve disease 35.70 13.58 38 89969 5703 79648678
Respiratory tract infection 35.68 13.58 6 90001 48683 79605698
Metastases to lymph nodes 35.68 13.58 51 89956 10346 79644035
Blood urine present 35.54 13.58 76 89931 21221 79633160
Transfusion-related circulatory overload 35.41 13.58 14 89993 361 79654020
Treatment noncompliance 35.03 13.58 8 89999 52260 79602121
Renal neoplasm 34.91 13.58 24 89983 1984 79652397
Pollakiuria 34.90 13.58 107 89900 37210 79617171
Bone cancer 34.86 13.58 24 89983 1988 79652393
Metastases to oesophagus 34.53 13.58 8 89999 27 79654354
Infection 34.39 13.58 148 89859 241564 79412817
Electrocardiogram QT prolonged 34.12 13.58 31 89976 90355 79564026
Septic shock 33.74 13.58 54 89953 122747 79531634
Injection site hypoaesthesia 33.55 13.58 15 89992 529 79653852
Atrial fibrillation 33.43 13.58 113 89894 197773 79456608
Mental status changes 33.23 13.58 17 89990 66942 79587439
Hyperhidrosis 33.22 13.58 288 89719 151204 79503177
Gout 33.18 13.58 81 89926 24668 79629713
Stevens-Johnson syndrome 33.15 13.58 3 90004 39163 79615218
Abdominal mass 32.45 13.58 29 89978 3516 79650865
Eosinophilia 32.33 13.58 6 90001 45339 79609042
Insulinoma 32.21 13.58 10 89997 122 79654259
Renal mass 31.92 13.58 28 89979 3312 79651069
Muscle strain 31.52 13.58 46 89961 9509 79644872
Nerve degeneration 31.51 13.58 12 89995 279 79654102
Muscle injury 31.43 13.58 8 89999 48553 79605828
Peripheral coldness 31.40 13.58 61 89946 15909 79638472
Thyroid mass 31.40 13.58 30 89977 3960 79650421
Lacrimal disorder 31.28 13.58 14 89993 495 79653886
Urine odour abnormal 31.27 13.58 37 89970 6236 79648145
Labyrinthitis 31.09 13.58 26 89981 2882 79651499
Administration site abscess 31.09 13.58 7 90000 20 79654361
Hernia 30.95 13.58 63 89944 16996 79637385
Blood creatinine increased 30.89 13.58 82 89925 154975 79499406
Drug reaction with eosinophilia and systemic symptoms 30.87 13.58 17 89990 64227 79590154
Injection site cyst 30.70 13.58 9 89998 89 79654292
Chondroma 30.58 13.58 6 90001 6 79654375
Psychotic disorder 30.57 13.58 5 90002 41397 79612984
Sleep disorder due to general medical condition, insomnia type 30.55 13.58 6 90001 43550 79610831
Adenoma benign 30.52 13.58 18 89989 1140 79653241
Pulmonary embolism 30.39 13.58 96 89911 171558 79482823
Metabolic acidosis 30.33 13.58 29 89978 82500 79571881
Chills 30.27 13.58 295 89712 159939 79494442
Respiratory distress 30.19 13.58 14 89993 58325 79596056
Sensitisation 30.13 13.58 27 89980 3284 79651097
Proctalgia 29.92 13.58 46 89961 9955 79644426
Depressed mood 29.77 13.58 121 89886 48359 79606022
Tubulointerstitial nephritis 29.65 13.58 4 90003 38231 79616150
Back injury 29.53 13.58 47 89960 10476 79643905
Buttock injury 29.44 13.58 10 89997 165 79654216
Crying 29.40 13.58 74 89933 22969 79631412
Brain neoplasm 29.31 13.58 34 89973 5612 79648769
Prescribed overdose 29.29 13.58 4 90003 37879 79616502
Illness 29.29 13.58 117 89890 46394 79607987
Administration site discharge 29.28 13.58 7 90000 28 79654353
Pulmonary fibrosis 29.07 13.58 7 90000 44105 79610276
Transaminases increased 29.05 13.58 11 89996 51732 79602649
Acute respiratory distress syndrome 29.02 13.58 7 90000 44060 79610321
Neck mass 28.90 13.58 30 89977 4374 79650007
Administration site induration 28.71 13.58 7 90000 31 79654350
Hepatotoxicity 28.69 13.58 11 89996 51341 79603040
Cyst 28.61 13.58 54 89953 13786 79640595
Colitis ulcerative 28.51 13.58 3 90004 34739 79619642
Multiple organ dysfunction syndrome 28.45 13.58 58 89949 120188 79534193
Tumour marker increased 27.86 13.58 29 89978 4243 79650138
Administration site odour 27.85 13.58 7 90000 36 79654345
Injection site oedema 27.72 13.58 18 89989 1353 79653028
Blood potassium decreased 27.70 13.58 115 89892 46397 79607984
Feeling hot 27.58 13.58 137 89870 59597 79594784
Metastases to spine 27.56 13.58 29 89978 4295 79650086
Musculoskeletal stiffness 27.51 13.58 103 89904 174905 79479476
Liver abscess 27.39 13.58 34 89973 6020 79648361
Insulin-like growth factor abnormal 27.38 13.58 7 90000 39 79654342
Body temperature increased 27.38 13.58 111 89896 44309 79610072
Head banging 27.37 13.58 13 89994 528 79653853
Injection site warmth 27.24 13.58 55 89952 14752 79639629
Pituitary enlargement 27.21 13.58 8 89999 80 79654301
Liver injury 27.17 13.58 15 89992 56599 79597782
Angina bullosa haemorrhagica 27.16 13.58 10 89997 211 79654170
Metastases to lung 27.13 13.58 62 89945 18101 79636280
Aspartate aminotransferase increased 27.10 13.58 74 89933 138567 79515814
Ill-defined disorder 26.82 13.58 21 89986 65854 79588527
Benign neoplasm of adrenal gland 26.80 13.58 7 90000 43 79654338
Concomitant disease aggravated 26.75 13.58 51 89956 13116 79641265
Parathyroid hormone-related protein abnormal 26.68 13.58 6 90001 17 79654364
Pneumonia aspiration 26.45 13.58 22 89985 66945 79587436
Cardiac disorder 26.36 13.58 145 89862 65612 79588769
Osteonecrosis of jaw 26.33 13.58 8 89999 43218 79611163
Pneumocystis jirovecii pneumonia 26.19 13.58 3 90004 32505 79621876
Postoperative wound infection 26.09 13.58 50 89957 12911 79641470
Product quality issue 26.06 13.58 91 89916 33849 79620532
Breast mass 25.97 13.58 35 89972 6719 79647662
Injection site inflammation 25.94 13.58 27 89980 3949 79650432
Hypokalaemia 25.89 13.58 80 89927 143960 79510421
Hernia pain 25.74 13.58 12 89995 467 79653914
Gastrointestinal neoplasm 25.74 13.58 12 89995 467 79653914
Tumour pain 25.51 13.58 21 89986 2278 79652103
Intestinal intraepithelial lymphocytes increased 25.32 13.58 9 89998 171 79654210
Small intestinal obstruction 25.32 13.58 78 89929 27194 79627187
Metastases to fallopian tube 25.31 13.58 7 90000 55 79654326
Irritable bowel syndrome 25.14 13.58 20 89987 62221 79592160
Metastatic carcinoid tumour 25.10 13.58 6 90001 24 79654357
Hepatitis 25.01 13.58 16 89991 55711 79598670
Metastases to abdominal cavity 24.84 13.58 13 89994 651 79653730
Sciatica 24.58 13.58 88 89919 33134 79621247
Bone neoplasm 24.55 13.58 14 89993 832 79653549
Periarticular disorder 24.35 13.58 6 90001 28 79654353
Peripheral swelling 24.12 13.58 433 89574 269184 79385197
Metastases to thorax 24.10 13.58 9 89998 198 79654183
Administration site haemorrhage 23.99 13.58 7 90000 68 79654313
Cerebral haemorrhage 23.97 13.58 18 89989 57655 79596726
Abdominal rigidity 23.89 13.58 23 89984 3065 79651316
Crystal arthropathy 23.76 13.58 9 89998 206 79654175
Polydipsia 23.55 13.58 33 89974 6572 79647809
Product deposit 23.54 13.58 12 89995 569 79653812
Ventricular tachycardia 23.40 13.58 9 89998 41926 79612455
Intra-abdominal fluid collection 23.36 13.58 23 89984 3149 79651232
Injection site haematoma 23.29 13.58 28 89979 4799 79649582
Encephalopathy 23.27 13.58 25 89982 67372 79587009
Chikungunya virus infection 23.17 13.58 9 89998 221 79654160
Anaphylactic shock 23.16 13.58 6 90001 35990 79618391
Abdominal neoplasm 23.01 13.58 12 89995 597 79653784
Agranulocytosis 23.00 13.58 11 89996 45019 79609362
Accidental overdose 22.92 13.58 8 89999 39573 79614808
Glycosylated haemoglobin increased 22.66 13.58 60 89947 19200 79635181
Pallor 22.54 13.58 114 89893 49948 79604433
Hypothalamo-pituitary disorder 22.49 13.58 15 89992 1179 79653202
Facial asymmetry 22.19 13.58 13 89994 813 79653568
Hepatic function abnormal 22.18 13.58 30 89977 73077 79581304
Tumour compression 22.04 13.58 8 89999 162 79654219
Generalised tonic-clonic seizure 22.01 13.58 11 89996 43899 79610482
Psychiatric symptom 21.95 13.58 33 89974 7002 79647379
Bile output increased 21.94 13.58 6 90001 45 79654336
Drug withdrawal syndrome 21.93 13.58 6 90001 34712 79619669
Muscle swelling 21.92 13.58 13 89994 832 79653549
Myelosuppression 21.91 13.58 9 89998 40287 79614094
Mobility decreased 21.85 13.58 68 89939 122107 79532274
Chest injury 21.80 13.58 21 89986 2800 79651581
Tricuspid valve stenosis 21.78 13.58 5 90002 16 79654365
Concomitant disease progression 21.62 13.58 23 89984 3450 79650931
Confusional state 21.61 13.58 242 89765 317755 79336626
Nasal congestion 21.43 13.58 154 89853 76398 79577983
Fear-related avoidance of activities 21.41 13.58 7 90000 102 79654279
Pruritus 21.39 13.58 315 89692 394333 79260048
Hypotension 21.33 13.58 359 89648 439958 79214423
Metastases to breast 21.18 13.58 9 89998 280 79654101
Ventricular fibrillation 21.17 13.58 5 90002 31921 79622460
Cryptitis 20.92 13.58 9 89998 289 79654092
Endocrine neoplasm 20.92 13.58 4 90003 3 79654378
Hepatocellular injury 20.90 13.58 14 89993 47579 79606802
Staphylococcal infection 20.83 13.58 21 89986 58274 79596107
Renal failure 20.80 13.58 137 89870 200831 79453550
Drug dependence 20.76 13.58 10 89997 40759 79613622
Blood test abnormal 20.66 13.58 55 89952 17655 79636726
Cerebral infarction 20.65 13.58 13 89994 45663 79608718
Neutropenic sepsis 20.59 13.58 3 90004 27061 79627320
Pituitary tumour removal 20.53 13.58 5 90002 22 79654359
Renal pain 20.52 13.58 35 89972 8261 79646120
Lymphatic system neoplasm 20.50 13.58 6 90001 59 79654322
Ischaemic stroke 20.42 13.58 6 90001 33125 79621256
Plasma cell myeloma 20.42 13.58 18 89989 53241 79601140
Vasoactive intestinal polypeptide increased 20.38 13.58 4 90003 4 79654377
Hypertrophic osteoarthropathy 20.31 13.58 7 90000 121 79654260
Pancreatolithiasis 20.25 13.58 9 89998 313 79654068
COVID-19 pneumonia 20.18 13.58 4 90003 28845 79625536
Stomatitis 20.17 13.58 91 89916 146666 79507715
Pancreatic neuroendocrine tumour metastatic 20.15 13.58 7 90000 124 79654257
Haematuria 20.13 13.58 29 89978 68807 79585574
Muscle contractions involuntary 20.09 13.58 23 89984 3742 79650639
Liver function test abnormal 20.02 13.58 26 89981 64449 79589932
Urosepsis 20.01 13.58 3 90004 26492 79627889
Blood magnesium decreased 20 13.58 52 89955 16460 79637921
Skin sensitisation 19.96 13.58 13 89994 982 79653399
Product use in unapproved indication 19.95 13.58 395 89612 249964 79404417
International normalised ratio increased 19.92 13.58 41 89966 84680 79569701
Delirium 19.86 13.58 41 89966 84586 79569795
Microvillous inclusion disease 19.86 13.58 8 89999 217 79654164
Neurotoxicity 19.84 13.58 6 90001 32512 79621869
Adrenal insufficiency 19.82 13.58 4 90003 28483 79625898
Prostatomegaly 19.82 13.58 22 89985 3461 79650920
Pulmonary arterial hypertension 19.70 13.58 4 90003 28362 79626019
Suicidal ideation 19.65 13.58 35 89972 76305 79578076
Procedural pain 19.58 13.58 64 89943 23020 79631361
Scan gallium abnormal 19.54 13.58 5 90002 28 79654353
Presyncope 19.53 13.58 11 89996 41043 79613338
Body height increased 19.46 13.58 7 90000 138 79654243
Hyperglycaemia 19.40 13.58 141 89866 70194 79584187
Sluggishness 19.34 13.58 30 89977 6542 79647839
Screaming 19.28 13.58 23 89984 3910 79650471
Dysarthria 19.27 13.58 29 89978 67593 79586788
Tonsillar inflammation 19.27 13.58 7 90000 142 79654239
Bartholinitis 19.10 13.58 5 90002 31 79654350
Hypokinesia 19.10 13.58 56 89951 19004 79635377
Heart valve incompetence 19.09 13.58 21 89986 3270 79651111
Upper respiratory tract infection 19.09 13.58 47 89960 91121 79563260
Ligament sprain 19.05 13.58 45 89962 13419 79640962
Fibromyalgia 18.92 13.58 27 89980 64313 79590068
Metastases to peritoneum 18.90 13.58 24 89983 4348 79650033
Furuncle 18.85 13.58 32 89975 7522 79646859
Abortion spontaneous 18.83 13.58 5 90002 29502 79624879
Subdural haematoma 18.82 13.58 6 90001 31428 79622953
Probiotic therapy 18.78 13.58 7 90000 153 79654228
Serotonin syndrome 18.78 13.58 14 89993 45013 79609368
Coma 18.73 13.58 55 89952 100594 79553787
Arthropod bite 18.70 13.58 34 89973 8437 79645944
Hypersomnia 18.68 13.58 63 89944 23023 79631358
COVID-19 18.67 13.58 103 89904 157571 79496810
Status epilepticus 18.54 13.58 3 90004 25038 79629343
Injection site vesicles 18.52 13.58 20 89987 3052 79651329
Gallbladder neoplasm 18.51 13.58 6 90001 85 79654296
Spinal cord neoplasm 18.43 13.58 9 89998 389 79653992
Acute myeloid leukaemia 18.31 13.58 6 90001 30879 79623502
Mucosal inflammation 18.26 13.58 36 89971 75544 79578837
Empty sella syndrome 18.26 13.58 6 90001 89 79654292
Chronic kidney disease 18.25 13.58 29 89978 66125 79588256
Cytomegalovirus infection 18.12 13.58 13 89994 42631 79611750
Breast pain 18.03 13.58 33 89974 8232 79646149
Metastases to bladder 17.98 13.58 8 89999 279 79654102
Infrequent bowel movements 17.93 13.58 15 89992 1664 79652717
Chronic obstructive pulmonary disease 17.91 13.58 44 89963 85375 79569006
Somnolence 17.80 13.58 178 89829 238803 79415578
Flank pain 17.72 13.58 56 89951 19788 79634593
Limb injury 17.57 13.58 73 89934 29455 79624926
Anorectal discomfort 17.51 13.58 21 89986 3590 79650791
Neuroendocrine carcinoma 17.48 13.58 10 89997 598 79653783
Agitation 17.48 13.58 56 89951 99659 79554722
Rubber sensitivity 17.39 13.58 15 89992 1734 79652647
Somatostatin receptor scan abnormal 17.36 13.58 3 90004 0 79654381
Vulval disorder 17.33 13.58 10 89997 608 79653773
Haemorrhoids 17.33 13.58 72 89935 29056 79625325
Haemorrhage 17.31 13.58 168 89839 90950 79563431
Endometrial cancer stage I 17.30 13.58 7 90000 192 79654189
Face injury 17.26 13.58 21 89986 3643 79650738
Gastrointestinal wall thickening 17.26 13.58 18 89989 2639 79651742
Muscle spasms 17.19 13.58 285 89722 174445 79479936
Cognitive disorder 17.16 13.58 33 89974 69893 79584488
Eructation 17.14 13.58 38 89969 10871 79643510
Small intestine carcinoma 17.11 13.58 12 89995 1024 79653357
Blood cholesterol abnormal 17.10 13.58 20 89987 3330 79651051
Spleen disorder 17.06 13.58 15 89992 1779 79652602
Labelled drug-drug interaction medication error 17.06 13.58 5 90002 27645 79626736
Drug level increased 16.97 13.58 12 89995 39639 79614742
Dysstasia 16.83 13.58 69 89938 27677 79626704
Blood gastrin increased 16.74 13.58 5 90002 53 79654328
Cachexia 16.74 13.58 38 89969 11045 79643336
Fibrous dysplasia of bone 16.73 13.58 4 90003 16 79654365
Skin ulcer 16.65 13.58 22 89985 54128 79600253
Device issue 16.54 13.58 5 90002 27103 79627278
Scar 16.54 13.58 46 89961 15150 79639231
Hypertonic bladder 16.51 13.58 22 89985 4179 79650202
Diabetic ketoacidosis 16.43 13.58 9 89998 34113 79620268
Skin depigmentation 16.37 13.58 12 89995 1098 79653283
Device toxicity 16.35 13.58 4 90003 18 79654363
Dengue fever 16.32 13.58 11 89996 880 79653501
Muscle twitching 16.18 13.58 4 90003 24760 79629621
Product prescribing error 16.17 13.58 16 89991 44797 79609584
Helicobacter infection 16.16 13.58 34 89973 69670 79584711
Apoptosis 16.16 13.58 9 89998 511 79653870
Abdominal adhesions 16.06 13.58 20 89987 3553 79650828
Induration 15.98 13.58 15 89992 1937 79652444
Pituitary tumour benign 15.93 13.58 17 89990 2559 79651822
Injection site erosion 15.90 13.58 6 90001 136 79654245
Subarachnoid haemorrhage 15.89 13.58 4 90003 24461 79629920
Spinal cord injury lumbar 15.89 13.58 5 90002 64 79654317
Bronchiectasis 15.88 13.58 3 90004 22383 79631998
Factor V inhibition 15.82 13.58 8 89999 373 79654008
Intestinal metastasis 15.72 13.58 8 89999 378 79654003
Tension 15.70 13.58 22 89985 4382 79649999
Haemorrhage intracranial 15.68 13.58 5 90002 26188 79628193
Urine abnormality 15.68 13.58 31 89976 8188 79646193
Urine calcium/creatinine ratio increased 15.66 13.58 6 90001 142 79654239
Tachycardia 15.59 13.58 127 89880 177641 79476740
Hyperlipidaemia 15.59 13.58 5 90002 26088 79628293
Polyneuropathy 15.59 13.58 4 90003 24147 79630234
Excessive cerumen production 15.54 13.58 10 89997 740 79653641
Coccydynia 15.53 13.58 15 89992 2006 79652375
Cancer pain 15.52 13.58 24 89983 5221 79649160
Bone marrow failure 15.47 13.58 21 89986 51086 79603295
Injury 15.42 13.58 41 89966 77455 79576926
Aggression 15.37 13.58 21 89986 50937 79603444
Grip strength decreased 15.36 13.58 3 90004 21866 79632515
Cystitis 15.29 13.58 107 89900 52625 79601756
Multiple endocrine neoplasia 15.29 13.58 3 90004 3 79654378
Myocarditis 15.23 13.58 3 90004 21730 79632651
Urethral caruncle 15.22 13.58 5 90002 74 79654307
Cholestasis 15.19 13.58 22 89985 52087 79602294
Leukocytosis 15.13 13.58 16 89991 43439 79610942
Carcinoid tumour of the small bowel 15.07 13.58 7 90000 270 79654111
Device occlusion 15.03 13.58 38 89969 11828 79642553
No adverse event 14.96 13.58 12 89995 37180 79617201
Dystonia 14.90 13.58 3 90004 21396 79632985
Tricuspid valve disease 14.87 13.58 8 89999 424 79653957
Adrenal cyst 14.81 13.58 6 90001 165 79654216
Ear discomfort 14.75 13.58 31 89976 8552 79645829
Hemiparesis 14.71 13.58 10 89997 33723 79620658
Metastases to heart 14.65 13.58 7 90000 288 79654093
Zinc deficiency 14.65 13.58 6 90001 170 79654211
Feeding disorder 14.64 13.58 46 89961 16208 79638173
Cataract 14.61 13.58 120 89887 62000 79592381
Hypohidrosis 14.61 13.58 7 90000 290 79654091
Ataxia 14.60 13.58 5 90002 25034 79629347
Withdrawal syndrome 14.60 13.58 6 90001 26848 79627533
Obesity 14.55 13.58 11 89996 35114 79619267
Renal cyst 14.49 13.58 43 89964 14689 79639692
Injection site pustule 14.48 13.58 5 90002 87 79654294
High frequency ablation 14.47 13.58 7 90000 296 79654085
Swollen tongue 14.46 13.58 16 89991 42554 79611827
Gallbladder oedema 14.43 13.58 7 90000 298 79654083
Metastases to spleen 14.37 13.58 9 89998 635 79653746
Appendicitis 14.30 13.58 3 90004 20791 79633590
Bile output abnormal 14.29 13.58 4 90003 33 79654348
Rib fracture 14.28 13.58 66 89941 27881 79626500
Inguinal hernia 14.27 13.58 26 89981 6462 79647919
Ascites 14.20 13.58 139 89868 75423 79578958
Obstructive airways disorder 14.16 13.58 9 89998 31450 79622931
Emotional disorder 14.15 13.58 42 89965 14345 79640036
Respiratory disorder 14.02 13.58 18 89989 44838 79609543
Biliary tract infection 14.00 13.58 12 89995 1376 79653005
Dysuria 13.97 13.58 102 89905 50849 79603532
Cardiogenic shock 13.97 13.58 16 89991 41898 79612483
Gastritis fungal 13.97 13.58 6 90001 192 79654189
Sputum discoloured 13.93 13.58 55 89952 21688 79632693
Hallucination, visual 13.88 13.58 10 89997 32719 79621662
Disseminated intravascular coagulation 13.88 13.58 12 89995 35830 79618551
Pneumonitis 13.85 13.58 30 89977 60830 79593551
Toxic skin eruption 13.81 13.58 4 90003 22289 79632092
Tooth abscess 13.80 13.58 45 89962 16165 79638216
Kidney infection 13.78 13.58 55 89952 21796 79632585
Saliva altered 13.78 13.58 8 89999 492 79653889
Oncologic complication 13.69 13.58 7 90000 334 79654047
Blood follicle stimulating hormone increased 13.67 13.58 7 90000 335 79654046
Early satiety 13.62 13.58 12 89995 1427 79652954
Dizziness postural 13.61 13.58 36 89971 11513 79642868

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
MeSH PA D000970 Antineoplastic Agents
MeSH PA D018931 Antineoplastic Agents, Hormonal
MeSH PA D005765 Gastrointestinal Agents
CHEBI has role CHEBI:51060 hormone agonist

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 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 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 AMRYT 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 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 0078-0180 INJECTION, SOLUTION 50 ug INTRAVENOUS NDA 25 sections
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 0078-0181 INJECTION, SOLUTION 100 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
Sandostatin HUMAN PRESCRIPTION DRUG LABEL 1 0078-0182 INJECTION, SOLUTION 500 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 0641-6174 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 0641-6175 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 0641-6176 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 0641-6177 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 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 23155-685 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 23155-686 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 23155-687 INJECTION, SOLUTION 50 ug INTRAVENOUS ANDA 12 sections