somatropin 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definitionDrug idCAS RN
growth hormone derivatives 4848 12629-01-5

Description:

MoleculeDescription

Synonyms:

  • somatropin
  • somatropine
  • human growth hormone
  • somatotropin (human)
  • omnitrope
  • somatropin recombinant
  • somatropin [rDNA origin]
A 191-amino acid polypeptide hormone secreted by the human adenohypophysis (PITUITARY GLAND, ANTERIOR), also known as GH or somatotropin. Synthetic growth hormone, termed somatropin, has replaced the natural form in therapeutic usage such as treatment of dwarfism in children with growth hormone deficiency.
  • Molecular weight: 22125.07
  • Formula: C990H1528N262O300S7
  • CLOGP:
  • LIPINSKI: None
  • HAC: None
  • HDO: None
  • TPSA: 9147.67
  • ALOGS:
  • ROTB: None

Drug dosage:

DoseUnitRoute
2 U P

ADMET properties:

None

Approvals:

DateAgencyCompanyOrphan
April 12, 2006 EMA SANDOZ GMBH
July 30, 1976 FDA SERONO

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
Drug dose omission by device 1732.96 18.29 378 18654 4423 63465567
Wrong technique in device usage process 820.56 18.29 195 18837 3403 63466587
Device mechanical issue 709.10 18.29 113 18919 149 63469841
Device information output issue 692.77 18.29 102 18930 39 63469951
Device leakage 671.09 18.29 191 18841 6905 63463085
Insulin-like growth factor increased 603.78 18.29 119 18913 800 63469190
Device breakage 563.45 18.29 187 18845 11355 63458635
Product dose omission issue 550.55 18.29 497 18535 233816 63236174
Device issue 546.25 18.29 221 18811 23560 63446430
Insulin-like growth factor decreased 500.48 18.29 89 18943 307 63469683
Poor quality device used 383.76 18.29 95 18937 1976 63468014
Device use issue 313.81 18.29 85 18947 2545 63467445
Injection site pain 303.15 18.29 275 18757 129525 63340465
Incorrect dose administered 276.77 18.29 190 18842 59778 63410212
Blood thyroid stimulating hormone decreased 254.73 18.29 82 18950 4508 63465482
Incorrect dose administered by device 246.72 18.29 79 18953 4269 63465721
Growth retardation 230.85 18.29 58 18974 1283 63468707
Craniopharyngioma 229.64 18.29 40 18992 118 63469872
Scoliosis 218.44 18.29 84 18948 7804 63462186
Headache 202.94 18.29 526 18506 632715 62837275
Product prescribing error 201.44 18.29 115 18917 26174 63443816
Expired device used 198.12 18.29 43 18989 486 63469504
Device power source issue 171.99 18.29 39 18993 546 63469444
Device malfunction 166.72 18.29 89 18943 17768 63452222
Injection site bruising 156.92 18.29 117 18915 41793 63428197
Snoring 120.81 18.29 46 18986 4156 63465834
Device physical property issue 111.85 18.29 36 18996 1976 63468014
Exposure via skin contact 108.33 18.29 25 19007 380 63469610
Adenoidal hypertrophy 106.68 18.29 18 19014 41 63469949
Device failure 104.88 18.29 46 18986 5965 63464025
Epiphysiolysis 103.65 18.29 17 19015 30 63469960
Blood 25-hydroxycholecalciferol decreased 101.21 18.29 18 19014 62 63469928
Blood glucose increased 99.41 18.29 124 18908 83632 63386358
Product storage error 97.62 18.29 59 18973 14897 63455093
Blood triglycerides increased 96.62 18.29 55 18977 12433 63457557
Low density lipoprotein increased 96.09 18.29 44 18988 6313 63463677
Device defective 92.52 18.29 31 19001 1931 63468059
Thyroxine free decreased 90.04 18.29 24 19008 674 63469316
Blood creatinine decreased 88.93 18.29 40 18992 5505 63464485
Non-high-density lipoprotein cholesterol increased 87.15 18.29 18 19014 157 63469833
Glycosylated haemoglobin increased 83.74 18.29 50 18982 12348 63457642
Blood urea nitrogen/creatinine ratio increased 83.56 18.29 23 19009 731 63469259
Brain neoplasm 78.08 18.29 34 18998 4332 63465658
High density lipoprotein decreased 74.27 18.29 27 19005 2143 63467847
Adrenocortical insufficiency acute 72.88 18.29 25 19007 1673 63468317
Injection site haemorrhage 69.66 18.29 58 18974 24256 63445734
Liquid product physical issue 69.20 18.29 22 19010 1160 63468830
Idiopathic intracranial hypertension 66.38 18.29 27 19005 2904 63467086
Sleep apnoea syndrome 66.37 18.29 61 18971 29072 63440918
Device use error 66.11 18.29 33 18999 5728 63464262
Vitamin D decreased 65.79 18.29 40 18992 10202 63459788
Papilloedema 64.89 18.29 29 19003 3931 63466059
Meningioma 62.22 18.29 28 19004 3857 63466133
Blood thyroid stimulating hormone increased 61.95 18.29 34 18998 7160 63462830
Weight increased 60.86 18.29 194 18838 260598 63209392
Blood growth hormone decreased 60.84 18.29 10 19022 18 63469972
Pituitary tumour recurrent 60.81 18.29 12 19020 81 63469909
Dyspnoea 60.12 18.29 66 18966 661247 62808743
Cortisol decreased 60.03 18.29 20 19012 1224 63468766
Infusion related reaction 58.08 18.29 4 19028 245517 63224473
Drug administered in wrong device 58.06 18.29 10 19022 27 63469963
Rheumatoid arthritis 57.61 18.29 5 19027 253814 63216176
Growing pains 57.30 18.29 9 19023 10 63469980
Septo-optic dysplasia 56.90 18.29 8 19024 0 63469990
Bone density increased 56.59 18.29 17 19015 741 63469249
Toxicity to various agents 55.76 18.29 5 19027 247245 63222745
Blood follicle stimulating hormone increased 54.10 18.29 12 19020 151 63469839
Tonsillar disorder 53.50 18.29 18 19014 1135 63468855
Drug ineffective 53.47 18.29 150 18882 1044615 62425375
Tonsillar hypertrophy 51.94 18.29 17 19015 984 63469006
Drug intolerance 50.39 18.29 15 19017 308646 63161344
Increased appetite 50.31 18.29 33 18999 9597 63460393
Thyroxine free increased 49.88 18.29 16 19016 868 63469122
Intracranial pressure increased 48.62 18.29 26 19006 5201 63464789
Device delivery system issue 47.87 18.29 15 19017 754 63469236
Mood altered 46.07 18.29 37 18995 14706 63455284
Hepatic enzyme increased 45.86 18.29 4 19028 202324 63267666
Blood corticotrophin decreased 45.15 18.29 12 19020 333 63469657
Medulloblastoma recurrent 44.96 18.29 9 19023 66 63469924
Pituitary tumour 44.78 18.29 15 19017 933 63469057
Astrocytoma 44.72 18.29 9 19023 68 63469922
Needle issue 43.41 18.29 31 19001 10345 63459645
Osteochondrosis 42.94 18.29 16 19016 1361 63468629
Albumin globulin ratio increased 42.81 18.29 7 19025 12 63469978
Device occlusion 42.75 18.29 27 19005 7360 63462630
Wrong technique in product usage process 42.53 18.29 71 18961 62269 63407721
Thyroxine increased 42.23 18.29 13 19019 616 63469374
Hyponatraemic seizure 42.18 18.29 12 19020 431 63469559
Hypopituitarism 41.97 18.29 15 19017 1133 63468857
Seizure 41.83 18.29 110 18922 132524 63337466
Blood prolactin decreased 41.50 18.29 8 19024 47 63469943
Therapy cessation 40.83 18.29 48 18984 30409 63439581
Intercepted product prescribing error 40.75 18.29 10 19022 200 63469790
Pituitary tumour benign 40.51 18.29 17 19015 1978 63468012
Blood glucose decreased 40.37 18.29 40 18992 20912 63449078
Focal nodular hyperplasia 39.18 18.29 12 19020 559 63469431
Energy increased 38.35 18.29 18 19014 2729 63467261
Drug hypersensitivity 38.10 18.29 23 19009 310664 63159326
Cortisol increased 38.07 18.29 11 19021 418 63469572
Wrong device used 37.78 18.29 7 19025 32 63469958
Wound 37.62 18.29 3 19029 163260 63306730
Acute kidney injury 37.53 18.29 16 19016 263399 63206591
Blood urea decreased 37.48 18.29 17 19015 2385 63467605
Hair growth abnormal 36.95 18.29 18 19014 2963 63467027
Menstruation irregular 36.58 18.29 24 19008 6980 63463010
Nausea 36.38 18.29 133 18899 854338 62615652
General physical health deterioration 36.28 18.29 8 19024 201394 63268596
Temperature intolerance 35.71 18.29 26 19006 8938 63461052
Neutrophilic panniculitis 35.25 18.29 7 19025 49 63469941
Reaction to preservatives 35.23 18.29 9 19023 213 63469777
Alveolar rhabdomyosarcoma 35.17 18.29 6 19026 15 63469975
Abdominal discomfort 35.01 18.29 27 19005 320858 63149132
Arthropathy 33.86 18.29 14 19018 234778 63235212
Blood insulin increased 33.77 18.29 8 19024 137 63469853
Hypotension 33.67 18.29 20 19012 272584 63197406
Tri-iodothyronine decreased 33.29 18.29 8 19024 146 63469844
Accidental exposure to product 33.16 18.29 41 18991 27364 63442626
Neoplasm recurrence 32.91 18.29 16 19016 2622 63467368
Drug interaction 32.50 18.29 14 19018 229117 63240873
Pruritus 31.73 18.29 37 18995 361416 63108574
Osteochondroma 31.19 18.29 5 19027 7 63469983
Stomatitis 30.74 18.29 3 19029 138722 63331268
Blood alkaline phosphatase decreased 30.40 18.29 12 19020 1193 63468797
Hypoglycaemia 30.27 18.29 60 18972 60005 63409985
Diabetes insipidus 30.01 18.29 15 19017 2610 63467380
Carbon dioxide decreased 29.93 18.29 14 19018 2107 63467883
Blood chloride increased 29.69 18.29 15 19017 2669 63467321
Confusional state 29.67 18.29 17 19015 236363 63233627
Otitis media 28.61 18.29 18 19014 4873 63465117
Device operational issue 28.38 18.29 8 19024 278 63469712
Gastrointestinal infection 28.38 18.29 23 19009 9258 63460732
Anion gap increased 28.35 18.29 13 19019 1869 63468121
Growth hormone deficiency 28.33 18.29 7 19025 144 63469846
Glucose tolerance impaired 28.32 18.29 20 19012 6557 63463433
Blister 28.26 18.29 3 19029 129811 63340179
Hypothalamo-pituitary disorder 28.14 18.29 10 19022 743 63469247
Anaemia 28.01 18.29 28 19004 293402 63176588
Device difficult to use 27.61 18.29 26 19006 12770 63457220
Poor quality product administered 27.40 18.29 15 19017 3141 63466849
Infantile haemangioma 27.16 18.29 6 19026 74 63469916
Therapeutic product effect decreased 27.08 18.29 12 19020 193175 63276815
Blood sodium increased 26.57 18.29 14 19018 2718 63467272
Oestradiol decreased 26.29 18.29 5 19027 27 63469963
Product dispensing error 26.28 18.29 23 19009 10282 63459708
Puberty 26.21 18.29 4 19028 3 63469987
Lymphocyte count increased 26.12 18.29 15 19017 3443 63466547
Therapeutic response unexpected 25.87 18.29 30 19002 18729 63451261
Blood albumin increased 25.68 18.29 10 19022 959 63469031
Tri-iodothyronine free increased 25.53 18.29 7 19025 219 63469771
Oesophageal disorder 25.49 18.29 13 19019 2360 63467630
Precocious puberty 25.47 18.29 7 19025 221 63469769
Underdose 25.38 18.29 36 18996 27420 63442570
Pneumonia 25.16 18.29 63 18969 456704 63013286
Astrocytoma, low grade 24.79 18.29 4 19028 6 63469984
Arthralgia 24.71 18.29 270 18762 569440 62900550
Product quality issue 24.66 18.29 41 18991 35824 63434166
Very low density lipoprotein increased 24.35 18.29 6 19026 122 63469868
Globulins decreased 24.33 18.29 7 19025 262 63469728
Joint swelling 24.23 18.29 38 18994 327628 63142362
Product use in unapproved indication 24.14 18.29 112 18920 178968 63291022
Total cholesterol/HDL ratio increased 23.82 18.29 6 19026 134 63469856
Growth accelerated 23.44 18.29 4 19028 10 63469980
Epiphyses premature fusion 23.33 18.29 5 19027 53 63469937
Glioma 23.13 18.29 7 19025 313 63469677
Syringomyelia 23.10 18.29 6 19026 152 63469838
Dry skin 23.06 18.29 52 18980 56835 63413155
Blood alkaline phosphatase increased 22.96 18.29 44 18988 42923 63427067
Mean cell haemoglobin concentration decreased 22.92 18.29 14 19018 3598 63466392
Rash 22.68 18.29 89 18943 560782 62909208
Germ cell cancer 22.32 18.29 5 19027 66 63469924
Atrial fibrillation 22.32 18.29 4 19028 116632 63353358
Blood corticotrophin increased 22.11 18.29 5 19027 69 63469921
Thyroxine decreased 21.88 18.29 8 19024 645 63469345
Malaise 21.78 18.29 205 18827 415749 63054241
Neutropenia 21.37 18.29 13 19019 174992 63294998
Rathke's cleft cyst 21.34 18.29 3 19029 0 63469990
Non-secretory adenoma of pituitary 21.34 18.29 3 19029 0 63469990
Bilateral breast buds 21.34 18.29 3 19029 0 63469990
Exposure during pregnancy 21.27 18.29 10 19022 155537 63314453
Anti-thyroid antibody positive 21.09 18.29 7 19025 423 63469567
Manufacturing product shipping issue 21.08 18.29 5 19027 86 63469904
Insulin C-peptide decreased 20.68 18.29 4 19028 24 63469966
Infection 20.59 18.29 23 19009 229150 63240840
Syringe issue 20.49 18.29 12 19020 2857 63467133
Nocturia 20.41 18.29 18 19014 8123 63461867
Primary hypothyroidism 20.28 18.29 5 19027 102 63469888
Blood luteinising hormone increased 20.19 18.29 5 19027 104 63469886
Platelet count decreased 20.13 18.29 5 19027 116117 63353873
Red cell distribution width increased 20.10 18.29 20 19012 10504 63459486
Diarrhoea 20.08 18.29 129 18903 715237 62754753
Pain 20.06 18.29 135 18897 740493 62729497
Mood swings 20.01 18.29 26 19006 18222 63451768
Mycobacterium chelonae infection 19.90 18.29 7 19025 505 63469485
Hyperphagia 19.85 18.29 10 19022 1769 63468221
Discomfort 19.65 18.29 13 19019 167361 63302629
Blood growth hormone abnormal 19.46 18.29 4 19028 34 63469956
Cerebral cyst 19.39 18.29 6 19026 289 63469701
Device dispensing error 19.39 18.29 5 19027 123 63469867
Mean platelet volume increased 19.36 18.29 7 19025 547 63469443
Medulloblastoma 19.35 18.29 4 19028 35 63469955
Carbon dioxide increased 19.32 18.29 9 19023 1341 63468649
Dehydroepiandrosterone decreased 19.26 18.29 3 19029 3 63469987
Weight gain poor 19.25 18.29 8 19024 908 63469082
Blood urea nitrogen/creatinine ratio decreased 19.06 18.29 4 19028 38 63469952
Osteosarcoma 18.98 18.29 5 19027 134 63469856
Acanthosis nigricans 18.70 18.29 4 19028 42 63469948
Tri-iodothyronine increased 18.47 18.29 5 19027 149 63469841
Teratoma 18.41 18.29 5 19027 151 63469839

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
Drug dose omission by device 2671.61 18.76 546 23307 1693 34931385
Device breakage 1300.46 18.76 304 23549 1996 34931082
Device information output issue 1153.81 18.76 185 23668 11 34933067
Wrong technique in device usage process 1135.90 18.76 252 23601 1260 34931818
Device issue 1081.08 18.76 359 23494 9418 34923660
Insulin-like growth factor increased 1032.58 18.76 225 23628 1018 34932060
Device leakage 937.72 18.76 293 23560 6282 34926796
Product dose omission issue 919.74 18.76 712 23141 118999 34814079
Device mechanical issue 805.06 18.76 137 23716 71 34933007
Injection site pain 699.95 18.76 395 23458 38610 34894468
Poor quality device used 640.57 18.76 145 23708 805 34932273
Insulin-like growth factor decreased 592.35 18.76 110 23743 163 34932915
Incorrect dose administered by device 445.88 18.76 124 23729 1734 34931344
Growth retardation 437.37 18.76 122 23731 1726 34931352
Device use issue 420.27 18.76 96 23757 558 34932520
Incorrect dose administered 411.30 18.76 286 23567 40229 34892849
Headache 365.28 18.76 557 23296 200078 34733000
Craniopharyngioma 298.44 18.76 63 23790 236 34932842
Product prescribing error 293.21 18.76 187 23666 22740 34910338
Expired device used 268.19 18.76 46 23807 27 34933051
Scoliosis 259.01 18.76 90 23763 2703 34930375
Product storage error 251.76 18.76 119 23734 8003 34925075
Bone density increased 233.43 18.76 43 23810 59 34933019
Injection site bruising 223.61 18.76 112 23741 8551 34924527
Device power source issue 213.66 18.76 50 23803 328 34932750
Device failure 210.47 18.76 74 23779 2302 34930776
Device malfunction 209.65 18.76 114 23739 10307 34922771
Device defective 201.67 18.76 55 23798 711 34932367
Device use error 199.09 18.76 71 23782 2304 34930774
Device physical property issue 191.52 18.76 54 23799 795 34932283
Blood creatinine decreased 152.78 18.76 62 23791 2879 34930199
Blood thyroid stimulating hormone decreased 151.33 18.76 55 23798 1886 34931192
Thyroxine free decreased 144.16 18.76 35 23818 274 34932804
Arthralgia 138.31 18.76 336 23517 169705 34763373
Adenoidal hypertrophy 136.62 18.76 30 23823 141 34932937
Osteochondrosis 135.53 18.76 44 23809 1066 34932012
Idiopathic intracranial hypertension 133.15 18.76 39 23814 662 34932416
Blood urea nitrogen/creatinine ratio increased 132.84 18.76 33 23820 287 34932791
Acute kidney injury 130.84 18.76 25 23828 304963 34628115
Vitamin D decreased 129.85 18.76 58 23795 3418 34929660
Pituitary tumour benign 128.55 18.76 40 23813 841 34932237
Epiphysiolysis 126.84 18.76 26 23827 81 34932997
Toxicity to various agents 109.27 18.76 7 23846 200355 34732723
Dyspnoea 107.72 18.76 62 23791 376720 34556358
Glioneuronal tumour 100.66 18.76 16 23837 0 34933078
Device delivery system issue 100.14 18.76 29 23824 472 34932606
Wrong device used 99.09 18.76 17 23836 10 34933068
Injection site haemorrhage 99.01 18.76 69 23784 9699 34923379
Neoplasm recurrence 98.56 18.76 42 23811 2207 34930871
Clear cell renal cell carcinoma 95.03 18.76 34 23819 1113 34931965
Papilloedema 94.14 18.76 43 23810 2670 34930408
Device difficult to use 91.44 18.76 43 23810 2854 34930224
Hypotension 89.14 18.76 21 23832 221628 34711450
Pneumonia 88.46 18.76 71 23782 362556 34570522
Weight gain poor 85.90 18.76 31 23822 1041 34932037
Exposure via skin contact 85.56 18.76 18 23835 66 34933012
Blood 25-hydroxycholecalciferol decreased 83.49 18.76 22 23831 247 34932831
Blood testosterone decreased 83.01 18.76 46 23807 4311 34928767
Epiphyses premature fusion 82.92 18.76 17 23836 53 34933025
Sleep apnoea syndrome 81.28 18.76 84 23769 20237 34912841
Hepatoblastoma 79.67 18.76 15 23838 25 34933053
Device dispensing error 78.76 18.76 16 23837 47 34933031
Liquid product physical issue 78.34 18.76 24 23829 478 34932600
Thrombocytopenia 78.10 18.76 8 23845 156239 34776839
Needle issue 78.02 18.76 50 23803 6115 34926963
Drug interaction 77.05 18.76 29 23824 225917 34707161
Growing pains 75.49 18.76 12 23841 0 34933078
Brain neoplasm 72.66 18.76 38 23815 3171 34929907
Lymphoproliferative disorder 72.14 18.76 36 23817 2723 34930355
Neutropenia 71.15 18.76 11 23842 156767 34776311
Intracranial pressure increased 70.57 18.76 40 23813 3915 34929163
Underdose 70.14 18.76 65 23788 13715 34919363
Acne 69.90 18.76 59 23794 11007 34922071
High density lipoprotein decreased 68.22 18.76 37 23816 3323 34929755
Wrong technique in product usage process 67.93 18.76 102 23751 35884 34897194
Osteochondroma 67.69 18.76 12 23841 11 34933067
Increased appetite 67.27 18.76 49 23804 7380 34925698
Anaemia 65.66 18.76 39 23814 233296 34699782
Blood testosterone increased 63.25 18.76 26 23827 1247 34931831
Blood luteinising hormone decreased 63.24 18.76 15 23838 105 34932973
Sepsis 62.68 18.76 18 23835 166543 34766535
Enuresis 62.40 18.76 31 23822 2322 34930756
Thyroxine increased 62.07 18.76 14 23839 76 34933002
Diarrhoea 61.22 18.76 108 23745 389804 34543274
General physical health deterioration 60.52 18.76 8 23845 128261 34804817
Septo-optic dysplasia 60.29 18.76 10 23843 3 34933075
Precocious puberty 59.92 18.76 15 23838 135 34932943
Snoring 57.44 18.76 33 23820 3313 34929765
Weight increased 57.27 18.76 166 23687 92867 34840211
Blood follicle stimulating hormone decreased 57.04 18.76 12 23841 44 34933034
Glycosylated haemoglobin increased 56.68 18.76 53 23800 11307 34921771
Bone density decreased 55.90 18.76 27 23826 1902 34931176
Confusional state 55.30 18.76 15 23838 144145 34788933
Pituitary tumour 55.25 18.76 19 23834 552 34932526
Thyroxine decreased 54.29 18.76 15 23838 204 34932874
Attention deficit hyperactivity disorder 54.25 18.76 29 23824 2530 34930548
Tonsillar hypertrophy 53.88 18.76 20 23833 728 34932350
Migraine 53.84 18.76 63 23790 17415 34915663
Delayed puberty 53.76 18.76 15 23838 212 34932866
Product dispensing error 53.70 18.76 40 23813 6234 34926844
No adverse event 53.62 18.76 72 23781 22855 34910223
Limb asymmetry 53.40 18.76 13 23840 103 34932975
Blood thyroid stimulating hormone increased 52.58 18.76 34 23819 4221 34928857
Acromegaly 52.14 18.76 11 23842 41 34933037
Prescribed overdose 51.83 18.76 49 23804 10598 34922480
Focal segmental glomerulosclerosis 51.70 18.76 26 23827 1999 34931079
Thyroxine free increased 51.13 18.76 15 23838 256 34932822
Injection site discomfort 51.13 18.76 24 23829 1586 34931492
Skin odour abnormal 50.55 18.76 21 23832 1035 34932043
Atrial fibrillation 50.33 18.76 11 23842 122382 34810696
Tenosynovitis stenosans 49.44 18.76 9 23844 11 34933067
Blood glucose increased 48.96 18.76 127 23726 66591 34866487
Insulin resistance 48.90 18.76 18 23835 640 34932438
Bone development abnormal 47.46 18.76 10 23843 37 34933041
Meningioma 47.44 18.76 22 23831 1414 34931664
Poor quality product administered 47.27 18.76 24 23829 1883 34931195
Drug administered in wrong device 47.25 18.76 10 23843 38 34933040
Pancytopenia 47.19 18.76 5 23848 95152 34837926
Completed suicide 46.59 18.76 6 23847 98162 34834916
Neurofibromatosis 45.85 18.76 8 23845 6 34933072
Injection site extravasation 45.19 18.76 27 23826 2915 34930163
Globulins decreased 45.15 18.76 13 23840 207 34932871
Respiratory failure 44.15 18.76 10 23843 108562 34824516
Renal failure 44.04 18.76 17 23836 130540 34802538
Enchondromatosis 44.04 18.76 7 23846 0 34933078
Therapy cessation 43.88 18.76 56 23797 16917 34916161
Disease progression 43.85 18.76 10 23843 108067 34825011
Device operational issue 43.58 18.76 12 23841 161 34932917
Blood testosterone free decreased 42.54 18.76 10 23843 67 34933011
Stubbornness 41.22 18.76 8 23845 17 34933061
Avulsion fracture 41.22 18.76 8 23845 17 34933061
Non-high-density lipoprotein cholesterol increased 41.15 18.76 11 23842 131 34932947
Red blood cell count increased 39.39 18.76 20 23833 1569 34931509
Blood insulin increased 38.84 18.76 13 23840 347 34932731
Acanthosis nigricans 38.51 18.76 11 23842 170 34932908
Platelet count decreased 38.09 18.76 17 23836 119700 34813378
Blood albumin increased 38.00 18.76 15 23838 647 34932431
Pleural effusion 36.33 18.76 6 23847 81540 34851538
Cardiac failure 35.92 18.76 9 23844 91239 34841839
Very low density lipoprotein increased 35.42 18.76 7 23846 17 34933061
Abnormal behaviour 35.17 18.76 62 23791 24907 34908171
Strabismus 34.97 18.76 19 23834 1712 34931366
Albumin globulin ratio increased 34.86 18.76 7 23846 19 34933059
Crying 34.46 18.76 30 23823 5832 34927246
Pain in extremity 34.45 18.76 174 23679 126339 34806739
Gastrointestinal haemorrhage 34.30 18.76 9 23844 88468 34844610
Haematocrit increased 34.05 18.76 20 23833 2093 34930985
Product use in unapproved indication 33.69 18.76 164 23689 117335 34815743
Gynaecomastia 33.54 18.76 38 23815 10142 34922936
Astrocytoma 33.54 18.76 10 23843 181 34932897
Osteosarcoma 33.29 18.76 11 23842 282 34932796
Injection site mass 33.22 18.76 31 23822 6595 34926483
Cardiac failure congestive 33.19 18.76 8 23845 83262 34849816
Neuropathy peripheral 33.18 18.76 8 23845 83255 34849823
Low density lipoprotein increased 32.95 18.76 26 23827 4410 34928668
Obesity 32.51 18.76 42 23811 12836 34920242
Tendon calcification 32.47 18.76 8 23845 67 34933011
Growth failure 32.47 18.76 8 23845 67 34933011
Device electrical finding 32.36 18.76 8 23845 68 34933010
Leukopenia 31.94 18.76 3 23850 62853 34870225
Cardiac arrest 31.63 18.76 13 23840 96146 34836932
Adipomastia 31.45 18.76 5 23848 0 34933078
Pectus carinatum 31.45 18.76 5 23848 0 34933078
Vitamin D deficiency 31.38 18.76 30 23823 6578 34926500
Protein-losing gastroenteropathy 31.25 18.76 11 23842 343 34932735
Creutzfeldt-Jakob disease 31.19 18.76 7 23846 37 34933041
Hyperkalaemia 31.15 18.76 5 23848 69384 34863694
Interstitial lung disease 30.94 18.76 4 23849 65278 34867800
Anion gap increased 30.69 18.76 18 23835 1878 34931200
Bradycardia 30.54 18.76 7 23846 75411 34857667
Septic shock 30.45 18.76 6 23847 71828 34861250
Product quality issue 30.31 18.76 47 23806 16988 34916090
Blood alkaline phosphatase increased 30.04 18.76 66 23787 31109 34901969
Pituitary tumour recurrent 29.80 18.76 8 23845 97 34932981
Mean cell haemoglobin decreased 29.75 18.76 17 23836 1689 34931389
Pharyngitis streptococcal 29.65 18.76 20 23833 2664 34930414
Product preparation issue 29.46 18.76 11 23842 407 34932671
Epiphyses delayed fusion 29.11 18.76 5 23848 3 34933075
Anger 28.82 18.76 38 23815 11846 34921232
Phaeochromocytoma 28.71 18.76 9 23844 194 34932884
Mood swings 28.63 18.76 31 23822 7870 34925208
Fear of injection 28.51 18.76 16 23837 1536 34931542
Hypothalamo-pituitary disorder 28.31 18.76 13 23840 817 34932261
Breast mass 28.20 18.76 12 23841 628 34932450
Pulmonary embolism 28.14 18.76 13 23840 89733 34843345
Viral infection 27.77 18.76 46 23807 17577 34915501
Carbon dioxide decreased 27.70 18.76 16 23837 1622 34931456
Spinal deformity 27.66 18.76 11 23842 484 34932594
Red cell distribution width increased 27.57 18.76 27 23826 6096 34926982
Blood testosterone free increased 27.54 18.76 6 23847 27 34933051
Therapy interrupted 27.52 18.76 40 23813 13657 34919421
Type 1 diabetes mellitus 27.50 18.76 23 23830 4235 34928843
Mood altered 27.12 18.76 32 23821 8920 34924158
Myocardial infarction 26.63 18.76 26 23827 121059 34812019
Blood triglycerides increased 26.51 18.76 40 23813 14119 34918959
Off label use 26.49 18.76 417 23436 419107 34513971
Aggression 26.36 18.76 72 23781 38892 34894186
Renal impairment 26.24 18.76 16 23837 94497 34838581
Blood parathyroid hormone increased 26.17 18.76 15 23838 1499 34931579
Diabetes insipidus 25.80 18.76 19 23834 2909 34930169
Nausea 25.75 18.76 132 23721 339776 34593302
Apnoea 25.65 18.76 27 23826 6637 34926441
Aural polyp 25.65 18.76 5 23848 11 34933067
Accidental exposure to product 25.16 18.76 37 23816 12765 34920313
Dehydroepiandrosterone increased 25.16 18.76 4 23849 0 34933078
Chills 25.01 18.76 12 23841 81031 34852047
Intentional dose omission 24.90 18.76 20 23833 3480 34929598
Red cell distribution width decreased 24.87 18.76 8 23845 188 34932890
Blood pressure decreased 24.79 18.76 3 23850 51512 34881566
Mean cell volume decreased 24.66 18.76 14 23839 1374 34931704
Deep vein thrombosis 24.60 18.76 7 23846 65241 34867837
C-reactive protein increased 24.05 18.76 4 23849 54094 34878984
Blood sodium increased 24.02 18.76 18 23835 2830 34930248
Ear infection 23.72 18.76 32 23821 10199 34922879
Ependymoma malignant 23.62 18.76 5 23848 19 34933059
Thirst 23.55 18.76 28 23825 7867 34925211
Pruritus 23.39 18.76 38 23815 141943 34791135
Haemoglobin increased 23.24 18.76 19 23834 3390 34929688
Temperature intolerance 23.17 18.76 19 23834 3403 34929675
Blood growth hormone increased 23.00 18.76 9 23844 379 34932699
Polydipsia 22.94 18.76 20 23833 3895 34929183
Medulloblastoma recurrent 22.88 18.76 6 23847 66 34933012
Autism spectrum disorder 22.75 18.76 16 23837 2280 34930798
Blood prolactin decreased 22.62 18.76 8 23845 253 34932825
Gastroenteritis viral 22.47 18.76 26 23827 7098 34925980
Blood urea decreased 22.44 18.76 12 23841 1047 34932031
Blood calcium increased 22.36 18.76 19 23834 3575 34929503
Pulmonary oedema 22.31 18.76 3 23850 47526 34885552
Osteonecrosis 22.30 18.76 38 23815 14852 34918226
Blood alkaline phosphatase decreased 22.15 18.76 11 23842 823 34932255
Treatment failure 21.79 18.76 3 23850 46694 34886384
Injury associated with device 21.78 18.76 12 23841 1111 34931967
Otitis media 21.69 18.76 17 23836 2855 34930223
Growth hormone deficiency 21.69 18.76 8 23845 286 34932792
Venous haemorrhage 21.60 18.76 5 23848 31 34933047
Knee deformity 21.34 18.76 10 23843 658 34932420
Mean platelet volume decreased 21.24 18.76 9 23844 466 34932612
Dehydration 21.21 18.76 35 23818 129934 34803144
Encopresis 21.20 18.76 7 23846 179 34932899
Multiple organ dysfunction syndrome 21.19 18.76 13 23840 76553 34856525
Seizure 21.08 18.76 133 23720 104724 34828354
Renal transplant 20.96 18.76 14 23839 1835 34931243
Injection site swelling 20.78 18.76 32 23821 11495 34921583
Cardio-respiratory arrest 20.71 18.76 6 23847 55267 34877811
Hypoxia 20.61 18.76 6 23847 55089 34877989
Incorrect dosage administered 20.44 18.76 12 23841 1254 34931824
Scarlet fever 20.31 18.76 6 23847 105 34932973
Arnold-Chiari malformation 20.24 18.76 8 23845 346 34932732
Delirium 20.12 18.76 3 23850 43988 34889090
Solar lentigo 19.99 18.76 9 23844 540 34932538
Goitre 19.73 18.76 13 23840 1665 34931413
Ascites 19.50 18.76 4 23849 46567 34886511
Blood chloride decreased 19.42 18.76 18 23835 3795 34929283
Lymphocyte count increased 19.34 18.76 17 23836 3348 34929730
Hyperphagia 19.15 18.76 12 23841 1411 34931667
Drug ineffective 18.97 18.76 210 23643 456541 34476537
Cholesteatoma 18.94 18.76 4 23849 15 34933063
Empty sella syndrome 18.90 18.76 5 23848 57 34933021
Chronic obstructive pulmonary disease 18.90 18.76 5 23848 48913 34884165
LDL/HDL ratio increased 18.87 18.76 3 23850 0 34933078
Device-device incompatibility 18.87 18.76 3 23850 0 34933078
Anti-transglutaminase antibody increased 18.87 18.76 3 23850 0 34933078
Non-secretory adenoma of pituitary 18.87 18.76 3 23850 0 34933078
Apnoeic attack 18.81 18.76 8 23845 418 34932660

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
Drug dose omission by device 4203.25 17.53 871 32451 5379 79705687
Wrong technique in device usage process 1902.55 17.53 420 32902 3608 79707458
Device information output issue 1899.86 17.53 285 33037 36 79711030
Device leakage 1534.49 17.53 430 32892 10426 79700640
Insulin-like growth factor increased 1526.45 17.53 307 33015 1579 79709487
Device breakage 1514.20 17.53 424 32898 10251 79700815
Product dose omission issue 1472.44 17.53 1038 32284 246499 79464567
Device mechanical issue 1467.05 17.53 235 33087 169 79710897
Device issue 1423.85 17.53 504 32818 26604 79684462
Poor quality device used 1022.16 17.53 228 33094 2057 79709009
Insulin-like growth factor decreased 923.63 17.53 167 33155 418 79710648
Device use issue 729.15 17.53 180 33142 2604 79708462
Injection site pain 632.23 17.53 484 32838 129354 79581712
Product prescribing error 543.75 17.53 297 33025 44516 79666550
Expired device used 448.87 17.53 86 33236 325 79710741
Incorrect dose administered by device 447.15 17.53 139 33183 4850 79706216
Craniopharyngioma 426.31 17.53 82 33240 318 79710748
Incorrect dose administered 406.57 17.53 301 33021 76329 79634737
Blood thyroid stimulating hormone decreased 372.32 17.53 125 33197 5591 79705475
Device power source issue 359.82 17.53 83 33239 880 79710186
Scoliosis 339.70 17.53 125 33197 7339 79703727
Headache 333.71 17.53 797 32525 652975 79058091
Product storage error 318.49 17.53 149 33173 16077 79694989
Growth retardation 311.26 17.53 85 33237 1858 79709208
Device failure 300.31 17.53 109 33213 6152 79704914
Injection site bruising 289.56 17.53 192 33130 40810 79670256
Device physical property issue 285.81 17.53 85 33237 2545 79708521
Device use error 261.92 17.53 102 33220 6999 79704067
Device malfunction 254.03 17.53 140 33182 21308 79689758
Bone density increased 244.52 17.53 59 33263 770 79710296
Blood creatinine decreased 228.47 17.53 95 33227 7730 79703336
Epiphysiolysis 226.68 17.53 40 33282 82 79710984
Thyroxine free decreased 219.99 17.53 57 33265 1010 79710056
Blood urea nitrogen/creatinine ratio increased 218.12 17.53 55 33267 870 79710196
Device defective 212.76 17.53 63 33259 1857 79709209
Adenoidal hypertrophy 196.20 17.53 38 33284 154 79710912
Blood 25-hydroxycholecalciferol decreased 174.92 17.53 39 33283 350 79710716
Vitamin D decreased 174.57 17.53 84 33238 9641 79701425
Blood glucose increased 160.18 17.53 218 33104 114757 79596309
Dyspnoea 152.00 17.53 85 33237 856940 78854126
Osteochondrosis 151.46 17.53 49 33273 1947 79709119
Idiopathic intracranial hypertension 150.44 17.53 55 33267 3167 79707899
Exposure via skin contact 148.02 17.53 33 33289 296 79710770
Glycosylated haemoglobin increased 145.20 17.53 94 33228 19166 79691900
Injection site haemorrhage 144.32 17.53 108 33214 27762 79683304
Papilloedema 143.57 17.53 64 33258 6169 79704897
Sleep apnoea syndrome 140.95 17.53 119 33203 36359 79674707
High density lipoprotein decreased 140.91 17.53 58 33264 4597 79706469
Toxicity to various agents 137.87 17.53 10 33312 421530 79289536
Pituitary tumour benign 135.39 17.53 48 33274 2528 79708538
Snoring 134.15 17.53 59 33263 5507 79705559
Neoplasm recurrence 132.65 17.53 54 33268 4160 79706906
Device delivery system issue 131.27 17.53 35 33287 696 79710370
Low density lipoprotein increased 129.59 17.53 66 33256 8556 79702510
Glioneuronal tumour 128.84 17.53 19 33303 0 79711066
Non-high-density lipoprotein cholesterol increased 125.31 17.53 29 33293 312 79710754
Blood triglycerides increased 121.30 17.53 87 33235 20953 79690113
Acute kidney injury 118.67 17.53 35 33287 519369 79191697
Wrong device used 116.53 17.53 20 33302 32 79711034
Brain neoplasm 111.23 17.53 52 33270 5594 79705472
Blood thyroid stimulating hormone increased 111.17 17.53 62 33260 9646 79701420
Liquid product physical issue 110.62 17.53 34 33288 1140 79709926
Hypotension 109.47 17.53 25 33297 440292 79270774
Blood testosterone decreased 108.84 17.53 40 33282 2337 79708729
Intracranial pressure increased 108.74 17.53 58 33264 8264 79702802
Needle issue 103.99 17.53 66 33256 13002 79698064
Growing pains 102.69 17.53 16 33306 7 79711059
Septo-optic dysplasia 101.72 17.53 15 33307 0 79711066
Device difficult to use 95.20 17.53 63 33259 13322 79697744
Device dispensing error 89.64 17.53 19 33303 131 79710935
Weight gain poor 89.43 17.53 28 33294 999 79710067
Hepatoblastoma 89.35 17.53 16 33306 37 79711029
Tonsillar hypertrophy 89.35 17.53 31 33291 1531 79709535
Meningioma 89.07 17.53 41 33281 4257 79706809
Epiphyses premature fusion 88.56 17.53 18 33304 98 79710968
Thyroxine free increased 88.43 17.53 29 33293 1203 79709863
Clear cell renal cell carcinoma 87.95 17.53 35 33287 2541 79708525
Increased appetite 86.70 17.53 57 33265 11921 79699145
Thyroxine increased 84.61 17.53 25 33297 731 79710335
Product use in unapproved indication 83.52 17.53 262 33060 250097 79460969
Completed suicide 82.73 17.53 5 33317 245762 79465304
Product dispensing error 81.43 17.53 57 33265 13206 79697860
Poor quality product administered 79.40 17.53 36 33286 3609 79707457
Pneumonia 77.98 17.53 97 33225 660149 79050917
Drug interaction 76.55 17.53 39 33283 415144 79295922
General physical health deterioration 76.05 17.53 12 33310 275226 79435840
Adrenocortical insufficiency acute 75.74 17.53 33 33289 3010 79708056
Wrong technique in product usage process 75.28 17.53 121 33201 73754 79637312
Pituitary tumour recurrent 74.05 17.53 17 33305 176 79710890
Drug administered in wrong device 73.90 17.53 14 33308 49 79711017
Infusion related reaction 73.68 17.53 6 33316 230231 79480835
Diarrhoea 73.68 17.53 162 33160 880327 78830739
Pituitary tumour 72.80 17.53 25 33297 1197 79709869
Blood testosterone increased 72.45 17.53 24 33298 1028 79710038
Anaemia 71.89 17.53 49 33273 444966 79266100
Acromegaly 71.87 17.53 15 33307 95 79710971
Confusional state 71.50 17.53 22 33300 317975 79393091
Blood luteinising hormone decreased 70.20 17.53 16 33306 160 79710906
Neutropenia 70.13 17.53 17 33305 287693 79423373
Globulins decreased 68.03 17.53 19 33303 452 79710614
Thrombocytopenia 68.02 17.53 14 33308 265245 79445821
Lymphoproliferative disorder 67.41 17.53 37 33285 5578 79705488
Albumin globulin ratio increased 67.24 17.53 12 33310 27 79711039
Arthralgia 66.98 17.53 438 32884 571365 79139701
Device operational issue 66.76 17.53 18 33304 374 79710692
Therapy cessation 66.05 17.53 80 33242 37482 79673584
Precocious puberty 64.74 17.53 17 33305 318 79710748
Thyroxine decreased 64.48 17.53 21 33301 852 79710214
Blood albumin increased 64.20 17.53 24 33298 1471 79709595
Weight increased 63.05 17.53 256 33066 277130 79433936
Rheumatoid arthritis 62.56 17.53 7 33315 208463 79502603
Nausea 61.27 17.53 201 33121 956995 78754071
Off label use 61.04 17.53 612 32710 906603 78804463
Blood urea decreased 59.58 17.53 28 33294 3047 79708019
Blood insulin increased 58.82 17.53 16 33306 344 79710722
Mood altered 58.43 17.53 53 33269 17794 79693272
Focal segmental glomerulosclerosis 57.53 17.53 28 33294 3293 79707773
Anion gap increased 57.43 17.53 29 33293 3691 79707375
Blood follicle stimulating hormone decreased 56.59 17.53 13 33309 135 79710931
Atrial fibrillation 56.09 17.53 8 33314 197878 79513188
Astrocytoma 55.78 17.53 14 33308 217 79710849
Blood alkaline phosphatase increased 55.17 17.53 97 33225 63567 79647499
Blood follicle stimulating hormone increased 54.95 17.53 15 33307 327 79710739
Medulloblastoma recurrent 53.39 17.53 12 33310 112 79710954
Pruritus 53.08 17.53 52 33270 394596 79316470
Osteosarcoma 53.08 17.53 15 33307 373 79710693
Carbon dioxide decreased 52.99 17.53 27 33295 3501 79707565
Blood prolactin decreased 52.81 17.53 14 33308 272 79710794
Drug ineffective 52.64 17.53 253 33069 1080660 78630406
Bone density decreased 52.48 17.53 44 33278 13303 79697763
Blood testosterone free decreased 52.35 17.53 10 33312 37 79711029
Cortisol decreased 52.26 17.53 23 33299 2149 79708917
Energy increased 51.88 17.53 26 33296 3256 79707810
Hypothalamo-pituitary disorder 50.66 17.53 19 33303 1175 79709891
Blood sodium increased 50.50 17.53 29 33293 4769 79706297
Drug intolerance 49.86 17.53 24 33298 264095 79446971
Blood alkaline phosphatase decreased 49.23 17.53 21 33301 1819 79709247
Pancytopenia 48.64 17.53 6 33316 165739 79545327
Contraindicated product administered 48.00 17.53 5 33317 157533 79553533
Blood corticotrophin decreased 47.54 17.53 15 33307 549 79710517
Very low density lipoprotein increased 46.83 17.53 12 33310 203 79710863
Enuresis 46.82 17.53 24 33298 3152 79707914
Device occlusion 46.41 17.53 39 33283 11827 79699239
Red cell distribution width increased 45.51 17.53 43 33279 15199 79695867
Type 1 diabetes mellitus 45.45 17.53 31 33291 6888 79704178
Malignant neoplasm progression 45.04 17.53 3 33319 135987 79575079
Osteochondroma 44.83 17.53 8 33314 18 79711048
Lymphocyte count increased 44.82 17.53 29 33293 5903 79705163
Acne 44.72 17.53 56 33266 27134 79683932
Insulin resistance 44.53 17.53 18 33304 1361 79709705
Blood calcium increased 44.48 17.53 36 33286 10364 79700702
Therapeutic response unexpected 44.40 17.53 48 33274 19898 79691168
Cortisol increased 43.89 17.53 14 33308 531 79710535
Stomatitis 43.84 17.53 5 33317 146752 79564314
Blood testosterone free increased 43.70 17.53 7 33315 5 79711061
No adverse event 43.59 17.53 65 33257 37127 79673939
Blood growth hormone decreased 43.54 17.53 9 33313 54 79711012
Blood chloride increased 43.43 17.53 27 33295 5129 79705937
Injection site discomfort 43.38 17.53 27 33295 5139 79705927
Germ cell cancer 43.33 17.53 11 33311 179 79710887
Aggression 43.32 17.53 77 33245 50881 79660185
Underdose 43.31 17.53 61 33261 33090 79677976
Red blood cell count increased 43.13 17.53 25 33297 4183 79706883
Anger 43.01 17.53 44 33278 17118 79693948
Strabismus 42.90 17.53 21 33301 2500 79708566
Tonsillar disorder 42.52 17.53 17 33305 1249 79709817
Intercepted product prescribing error 42.40 17.53 12 33310 300 79710766
Seizure 41.85 17.53 173 33149 188661 79522405
Mean cell haemoglobin decreased 41.15 17.53 28 33294 6196 79704870
Abnormal behaviour 40.34 17.53 62 33260 36359 79674707
Blood glucose decreased 39.94 17.53 52 33270 26182 79684884
Renal failure 39.89 17.53 17 33305 200951 79510115
Respiratory failure 39.77 17.53 13 33309 180898 79530168
Drug hypersensitivity 39.47 17.53 40 33282 298876 79412190
Bone development abnormal 39.45 17.53 8 33314 43 79711023
Glucose tolerance impaired 38.91 17.53 30 33292 8054 79703012
Intentional dose omission 38.72 17.53 31 33291 8786 79702280
Hepatic enzyme increased 38.62 17.53 14 33308 182596 79528470
Prescribed overdose 38.51 17.53 62 33260 37821 79673245
Astrocytoma, low grade 38.42 17.53 8 33314 50 79711016
Tri-iodothyronine decreased 38.27 17.53 11 33311 291 79710775
Injection site extravasation 38.27 17.53 32 33290 9637 79701429
Temperature intolerance 38.17 17.53 32 33290 9673 79701393
Sepsis 37.97 17.53 34 33288 269394 79441672
Protein-losing gastroenteropathy 37.96 17.53 13 33309 617 79710449
Device electrical finding 37.83 17.53 10 33312 192 79710874
Platelet count decreased 37.79 17.53 17 33305 194647 79516419
Arnold-Chiari malformation 37.78 17.53 10 33312 193 79710873
Attention deficit hyperactivity disorder 37.52 17.53 21 33301 3288 79707778
Mean platelet volume increased 37.48 17.53 15 33307 1105 79709961
Rash 37.19 17.53 121 33201 578237 79132829
Autism spectrum disorder 37.07 17.53 15 33307 1137 79709929
Hyperphagia 36.79 17.53 19 33303 2533 79708533
Hyperkalaemia 36.53 17.53 3 33319 114395 79596671
Systemic lupus erythematosus 36.50 17.53 4 33318 121145 79589921
Haematocrit increased 36.21 17.53 22 33300 4012 79707054
Mean cell haemoglobin concentration decreased 36.11 17.53 23 33299 4556 79706510
Reaction to preservatives 36.00 17.53 10 33312 233 79710833
Focal nodular hyperplasia 35.88 17.53 13 33309 729 79710337
Diabetes insipidus 35.67 17.53 24 33298 5213 79705853
Hyponatraemic seizure 35.59 17.53 12 33310 543 79710523
Tri-iodothyronine increased 35.45 17.53 10 33312 247 79710819
Maternal exposure during pregnancy 35.41 17.53 7 33315 136531 79574535
Tri-iodothyronine free increased 35.11 17.53 10 33312 256 79710810
Cardiac arrest 35.05 17.53 14 33308 172082 79538984
Bradycardia 35.05 17.53 7 33315 135550 79575516
Pulmonary embolism 34.90 17.53 14 33308 171640 79539426
Limb asymmetry 34.65 17.53 12 33310 589 79710477
Infantile haemangioma 34.44 17.53 6 33316 11 79711055
Cardiac failure 34.26 17.53 11 33311 154831 79556235
Hypokalaemia 34.13 17.53 9 33313 144031 79567035
Skin odour abnormal 33.96 17.53 17 33305 2124 79708942
Cardiac failure congestive 33.54 17.53 9 33313 142393 79568673
Blister 33.45 17.53 5 33317 119471 79591595
Interstitial lung disease 33.22 17.53 4 33318 112596 79598470
Alveolar rhabdomyosarcoma 33.18 17.53 6 33316 15 79711051
Pleural effusion 32.70 17.53 10 33312 145252 79565814
Haemoglobin increased 32.26 17.53 24 33298 6108 79704958
Deep vein thrombosis 31.77 17.53 6 33316 120913 79590153
Hypopituitarism 31.70 17.53 19 33303 3380 79707686
Gynaecomastia 31.61 17.53 26 33296 7655 79703411
Dehydroepiandrosterone increased 31.56 17.53 5 33317 3 79711063
Blood parathyroid hormone increased 31.47 17.53 19 33303 3426 79707640
Neuropathy peripheral 31.33 17.53 10 33312 141295 79569771
Blood prolactin increased 31.27 17.53 20 33302 3991 79707075
Vitamin D deficiency 31.15 17.53 34 33288 14245 79696821
Crying 30.99 17.53 43 33279 23000 79688066
Fall 30.65 17.53 103 33219 487526 79223540
Tendon calcification 30.55 17.53 8 33314 148 79710918
Carbon dioxide increased 30.36 17.53 16 33306 2224 79708842
Growth hormone deficiency 30.35 17.53 10 33312 421 79710645
Leukopenia 30.15 17.53 6 33316 116507 79594559
Gastrointestinal haemorrhage 30.11 17.53 12 33310 147707 79563359
Mood swings 29.63 17.53 39 33283 19841 79691225
Neutrophilic panniculitis 29.62 17.53 7 33315 83 79710983
Urinary tract infection 29.59 17.53 43 33279 274469 79436597
Intentional product misuse 29.31 17.53 97 33225 95068 79615998
Empty sella syndrome 29.25 17.53 7 33315 88 79710978
Delayed puberty 28.90 17.53 8 33314 184 79710882
Manufacturing product shipping issue 28.69 17.53 7 33315 96 79710970
Blood growth hormone increased 28.66 17.53 11 33311 725 79710341
Blood urea nitrogen/creatinine ratio decreased 28.55 17.53 7 33315 98 79710968
Product quality issue 28.47 17.53 51 33271 33889 79677177
Septic shock 28.47 17.53 8 33314 122793 79588273
Joint swelling 28.47 17.53 48 33274 288598 79422468
Pain in extremity 28.36 17.53 254 33068 364284 79346782
Gastrointestinal disorder 28.26 17.53 8 33314 122197 79588869
Product dispensing issue 28.15 17.53 8 33314 203 79710863
Chills 28.09 17.53 16 33306 160218 79550848
Therapeutic product effect decreased 27.83 17.53 17 33305 163846 79547220
Injection site mass 27.65 17.53 38 33284 20146 79690920
Pre-existing condition improved 27.55 17.53 21 33301 5542 79705524
Pectus carinatum 27.12 17.53 4 33318 0 79711066
Puberty 27.12 17.53 4 33318 0 79711066
Chest pain 26.88 17.53 48 33274 282256 79428810
Talipes 26.65 17.53 7 33315 131 79710935
Exposure during pregnancy 26.61 17.53 5 33317 101127 79609939
Arthropathy 26.60 17.53 21 33301 177090 79533976
Productive cough 26.40 17.53 3 33319 88328 79622738
Blood chloride decreased 26.21 17.53 24 33298 8153 79702913
Accidental exposure to product 26.19 17.53 47 33275 31275 79679791
Blood pressure decreased 25.99 17.53 5 33317 99461 79611605
Dyspnoea exertional 25.91 17.53 3 33319 87070 79623996
Otitis media 25.82 17.53 21 33301 6085 79704981
Viral infection 25.63 17.53 56 33266 42960 79668106
Avulsion fracture 25.51 17.53 8 33314 287 79710779
Blood cholesterol increased 25.48 17.53 85 33237 83635 79627431
C-reactive protein increased 25.46 17.53 11 33311 129016 79582050
Pituitary haemorrhage 25.09 17.53 8 33314 303 79710763
Loss of personal independence in daily activities 25.09 17.53 6 33316 102574 79608492
Delirium 24.98 17.53 3 33319 84624 79626442
Dehydroepiandrosterone decreased 24.96 17.53 5 33317 25 79711041
Human epidermal growth factor receptor decreased 24.79 17.53 5 33317 26 79711040
Renal impairment 24.60 17.53 18 33304 157765 79553301
Hair growth abnormal 24.52 17.53 15 33307 2769 79708297
Intentional device misuse 24.50 17.53 10 33312 775 79710291
Medulloblastoma 24.28 17.53 6 33316 87 79710979
Blood corticotrophin increased 24.15 17.53 7 33315 191 79710875
Inflammation 23.90 17.53 5 33317 93748 79617318
Bone sarcoma 23.79 17.53 6 33316 95 79710971
Syringomyelia 23.55 17.53 7 33315 209 79710857
Total cholesterol/HDL ratio decreased 23.40 17.53 5 33317 36 79711030
Limb deformity 23.38 17.53 16 33306 3574 79707492
Stubbornness 23.21 17.53 8 33314 387 79710679
Mobility decreased 23.19 17.53 11 33311 122164 79588902
Eosinophil count increased 23.12 17.53 32 33290 17073 79693993
Epiphyses delayed fusion 23.08 17.53 4 33318 7 79711059
Manufacturing product storage issue 23.08 17.53 4 33318 7 79711059
Chronic obstructive pulmonary disease 22.95 17.53 4 33318 85415 79625651
Blood 25-hydroxycholecalciferol increased 22.73 17.53 4 33318 8 79711058
Glucocorticoid deficiency 22.67 17.53 9 33313 649 79710417
Cough 22.67 17.53 78 33244 366711 79344355
Abdominal discomfort 22.65 17.53 44 33278 250683 79460383
Monocyte count increased 22.58 17.53 25 33297 10636 79700430
Phaeochromocytoma 22.55 17.53 9 33313 658 79710408
Psoriatic arthropathy 22.45 17.53 3 33319 77996 79633070
Blood growth hormone abnormal 22.41 17.53 5 33317 45 79711021
Arthritis 22.34 17.53 10 33312 114870 79596196
Spinal deformity 22.27 17.53 10 33312 980 79710086
Cholesteatoma 22.24 17.53 6 33316 125 79710941
Total cholesterol/HDL ratio increased 21.93 17.53 7 33315 266 79710800
Incorrect dosage administered 21.93 17.53 14 33308 2785 79708281
Enchondromatosis 21.85 17.53 5 33317 51 79711015
Cardio-respiratory arrest 21.81 17.53 9 33313 108501 79602565
Optic glioma 21.76 17.53 5 33317 52 79711014
Dysphagia 21.69 17.53 12 33310 122124 79588942
Hypertrophic cardiomyopathy 21.62 17.53 13 33309 2327 79708739
Ascites 21.53 17.53 3 33319 75559 79635507
Anti-thyroid antibody positive 21.36 17.53 8 33314 493 79710573
Erythema 21.22 17.53 38 33284 223252 79487814
Chest discomfort 21.19 17.53 16 33306 138028 79573038
Thirst 21.04 17.53 32 33290 18587 79692479
Intentional overdose 20.96 17.53 9 33313 105951 79605115
Perthes disease 20.90 17.53 4 33318 15 79711051
Mean cell volume decreased 20.89 17.53 17 33305 4930 79706136
High density lipoprotein increased 20.80 17.53 10 33312 1144 79709922
Coma 20.80 17.53 8 33314 100641 79610425
Disease progression 20.74 17.53 28 33294 184334 79526732
Hypoglycaemic seizure 20.72 17.53 9 33313 815 79710251
Blood sodium decreased 20.62 17.53 44 33278 33211 79677855
Renal cell carcinoma 20.49 17.53 19 33303 6559 79704507
Noonan syndrome 20.34 17.53 3 33319 0 79711066
Rathke's cleft cyst 20.34 17.53 3 33319 0 79711066
Device-device incompatibility 20.34 17.53 3 33319 0 79711066
Adipomastia 20.34 17.53 3 33319 0 79711066
Acquired syringomyelia 20.34 17.53 3 33319 0 79711066
Bilateral breast buds 20.34 17.53 3 33319 0 79711066
Fear of injection 20.27 17.53 20 33302 7454 79703612
Ependymoma malignant 20.14 17.53 4 33318 19 79711047
Primary hypogonadism 20.13 17.53 6 33316 181 79710885
Glioblastoma 20.10 17.53 11 33311 1649 79709417
Oesophageal disorder 20.05 17.53 13 33309 2654 79708412
Suicide attempt 19.99 17.53 5 33317 82927 79628139
Neurofibromatosis 19.94 17.53 6 33316 187 79710879
Glioma 19.68 17.53 8 33314 614 79710452
Acanthosis nigricans 19.61 17.53 6 33316 198 79710868
Inability to afford medication 19.59 17.53 13 33309 2760 79708306
Lactic acidosis 19.56 17.53 3 33319 70356 79640710
Developmental hip dysplasia 19.47 17.53 6 33316 203 79710863
Blood luteinising hormone increased 19.41 17.53 6 33316 205 79710861
Otitis media acute 19.41 17.53 10 33312 1327 79709739
Disease recurrence 19.35 17.53 51 33271 44058 79667008
Blood immunoglobulin A increased 19.20 17.53 9 33313 974 79710092
Gastroenteritis viral 19.17 17.53 36 33286 24795 79686271
Product distribution issue 19.11 17.53 10 33312 1370 79709696
Educational problem 19.08 17.53 7 33315 407 79710659
Apnoeic attack 19.06 17.53 8 33314 666 79710400
Obesity 19.00 17.53 44 33278 35081 79675985
Adenoidectomy 18.97 17.53 5 33317 95 79710971
Aural polyp 18.87 17.53 5 33317 97 79710969
Myocardial infarction 18.72 17.53 30 33292 184099 79526967
Hypoglycaemia 18.63 17.53 88 33234 101506 79609560
Thyroid hormones decreased 18.55 17.53 7 33315 440 79710626
Hypoxia 18.54 17.53 10 33312 103233 79607833
Migraine 18.46 17.53 79 33243 87414 79623652
Multiple organ dysfunction syndrome 18.38 17.53 14 33308 120232 79590834
Pulmonary artery atresia 18.26 17.53 3 33319 3 79711063
Pulmonary oedema 18.26 17.53 7 33315 88247 79622819
Hormone level abnormal 18.18 17.53 11 33311 1991 79709075
Liver disorder 18.18 17.53 4 33318 72413 79638653
Renal transplant 18.14 17.53 12 33310 2535 79708531
Infection 18.09 17.53 47 33275 241665 79469401
Tachycardia 18.04 17.53 29 33293 177739 79533327
Dehydration 18.02 17.53 49 33273 248138 79462928
Shunt malfunction 17.93 17.53 6 33316 265 79710801
Swelling 17.91 17.53 40 33282 216671 79494395
Pain 17.90 17.53 198 33124 703604 79007462
Prolactin-producing pituitary tumour 17.82 17.53 5 33317 121 79710945
Testicular germ cell cancer 17.80 17.53 3 33319 4 79711062
LDL/HDL ratio increased 17.80 17.53 3 33319 4 79711062
Rectal haemorrhage 17.63 17.53 5 33317 76295 79634771
Circumstance or information capable of leading to medication error 17.59 17.53 14 33308 3934 79707132

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC H01AC01 SYSTEMIC HORMONAL PREPARATIONS, EXCL. SEX HORMONES AND INSULINS
PITUITARY AND HYPOTHALAMIC HORMONES AND ANALOGUES
ANTERIOR PITUITARY LOBE HORMONES AND ANALOGUES
Somatropin and somatropin agonists
FDA CS M0028842 Human Growth Hormone
FDA EPC N0000175606 Recombinant Human Growth Hormone

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

DiseaseRelationSNOMED_IDDOID
Turner syndrome indication 38804009 DOID:3491
Prader-Willi syndrome indication 89392001 DOID:11983
Pituitary dwarfism indication 367460001 DOID:0060870
Severe growth hormone deficiency in adulthood indication 421684006
Growth retardation indication 444896005




🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

None

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])		Mechanism
action		Bioact sourceMoA source
Growth hormone receptor GPCR AGONIST DRUG LABEL DRUG LABEL

External reference:

IDSource
NQX9KB6PCL UNII
D02691 KEGG_DRUG
4020552 VUID
N0000148258 NUI
4020552 VANDF
C3714500 UMLSCUI
CHEMBL1201621 ChEMBL_ID
DB00052 DRUGBANK_ID
239 INN_ID
61148 RXNORM
5501 MMSL
82320 MMSL
d00577 MMSL
002104 NDDF
002106 NDDF
129495007 SNOMEDCT_US
395883003 SNOMEDCT_US
713492005 SNOMEDCT_US
D019382 MESH_DESCRIPTOR_UI
16132356 PUBCHEM_CID

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Norditropin HUMAN PRESCRIPTION DRUG LABEL 1 0169-7703 INJECTION, SOLUTION 30 mg SUBCUTANEOUS BLA 29 sections
Norditropin HUMAN PRESCRIPTION DRUG LABEL 1 0169-7703 INJECTION, SOLUTION 30 mg SUBCUTANEOUS BLA 29 sections
Norditropin HUMAN PRESCRIPTION DRUG LABEL 1 0169-7704 INJECTION, SOLUTION 5 mg SUBCUTANEOUS BLA 29 sections
Norditropin HUMAN PRESCRIPTION DRUG LABEL 1 0169-7704 INJECTION, SOLUTION 5 mg SUBCUTANEOUS BLA 29 sections
Norditropin HUMAN PRESCRIPTION DRUG LABEL 1 0169-7705 INJECTION, SOLUTION 10 mg SUBCUTANEOUS BLA 29 sections
Norditropin HUMAN PRESCRIPTION DRUG LABEL 1 0169-7705 INJECTION, SOLUTION 10 mg SUBCUTANEOUS BLA 29 sections
Norditropin HUMAN PRESCRIPTION DRUG LABEL 1 0169-7708 INJECTION, SOLUTION 15 mg SUBCUTANEOUS BLA 29 sections
Norditropin HUMAN PRESCRIPTION DRUG LABEL 1 0169-7708 INJECTION, SOLUTION 15 mg SUBCUTANEOUS BLA 29 sections
Omnitrope HUMAN PRESCRIPTION DRUG LABEL 1 0781-3001 INJECTION, SOLUTION 5 mg SUBCUTANEOUS BLA 26 sections
Omnitrope HUMAN PRESCRIPTION DRUG LABEL 1 0781-3004 INJECTION, SOLUTION 10 mg SUBCUTANEOUS BLA 26 sections
Nutropin AQ NuSpin 10 HUMAN PRESCRIPTION DRUG LABEL 1 50242-074 INJECTION, SOLUTION 10 mg SUBCUTANEOUS BLA 27 sections
Nutropin AQ NuSpin 5 HUMAN PRESCRIPTION DRUG LABEL 1 50242-075 INJECTION, SOLUTION 5 mg SUBCUTANEOUS BLA 27 sections
Nutropin AQ NuSpin 20 HUMAN PRESCRIPTION DRUG LABEL 1 50242-076 INJECTION, SOLUTION 20 mg SUBCUTANEOUS BLA 27 sections
Norditropin HUMAN PRESCRIPTION DRUG LABEL 1 54868-6146 INJECTION, SOLUTION 5 mg SUBCUTANEOUS NDA 25 sections