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

Stem definitionDrug idCAS RN
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
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 1034.33 18.56 232 17073 3019 56271743
Insulin-like growth factor increased 576.78 18.56 114 17191 757 56274005
Product dose omission issue 552.92 18.56 475 16830 204278 56070484
Insulin-like growth factor decreased 492.56 18.56 88 17217 304 56274458
Wrong technique in device usage process 480.62 18.56 123 17182 2867 56271895
Device issue 428.83 18.56 181 17124 20925 56253837
Device information output issue 397.43 18.56 59 17246 25 56274737
Device leakage 372.01 18.56 119 17186 6256 56268506
Device mechanical issue 304.32 18.56 49 17256 69 56274693
Injection site pain 275.70 18.56 252 17053 116866 56157896
Device breakage 274.70 18.56 107 17198 10040 56264722
Blood thyroid stimulating hormone decreased 257.36 18.56 82 17223 4251 56270511
Incorrect dose administered 256.46 18.56 174 17131 52373 56222389
Growth retardation 231.00 18.56 57 17248 1138 56273624
Craniopharyngioma 228.64 18.56 40 17265 118 56274644
Device use issue 218.75 18.56 62 17243 2144 56272618
Headache 214.45 18.56 505 16800 558539 55716223
Scoliosis 212.33 18.56 80 17225 6853 56267909
Poor quality device used 208.29 18.56 58 17247 1878 56272884
Incorrect dose administered by device 169.75 18.56 58 17247 3742 56271020
Product prescribing error 158.39 18.56 95 17210 23091 56251671
Injection site bruising 140.63 18.56 107 17198 38414 56236348
Expired device used 110.76 18.56 26 17279 416 56274346
Device malfunction 109.89 18.56 66 17239 16070 56258692
Adenoidal hypertrophy 109.57 18.56 18 17287 31 56274731
Snoring 108.46 18.56 41 17264 3540 56271222
Epiphysiolysis 101.36 18.56 16 17289 18 56274744
Blood 25-hydroxycholecalciferol decreased 100.76 18.56 18 17287 62 56274700
Blood glucose increased 99.43 18.56 119 17186 75032 56199730
Blood triglycerides increased 98.78 18.56 55 17250 11622 56263140
Low density lipoprotein increased 98.36 18.56 44 17261 5830 56268932
Product storage error 97.70 18.56 57 17248 13156 56261606
Rheumatoid arthritis 97.20 18.56 5 17300 382599 55892163
Exposure via skin contact 96.86 18.56 22 17283 302 56274460
Thyroxine free decreased 90.99 18.56 24 17281 630 56274132
Blood creatinine decreased 90.68 18.56 40 17265 5126 56269636
Non-high-density lipoprotein cholesterol increased 88.87 18.56 18 17287 137 56274625
Glycosylated haemoglobin increased 87.44 18.56 50 17255 11115 56263647
Blood urea nitrogen/creatinine ratio increased 85.44 18.56 23 17282 654 56274108
High density lipoprotein decreased 79.10 18.56 27 17278 1735 56273027
Device power source issue 76.83 18.56 20 17285 498 56274264
Adrenocortical insufficiency acute 75.04 18.56 25 17280 1491 56273271
Weight increased 70.09 18.56 191 17114 229512 56045250
Sleep apnoea syndrome 66.89 18.56 59 17246 26002 56248760
Brain neoplasm 66.76 18.56 30 17275 4016 56270746
Vitamin D decreased 66.66 18.56 39 17266 9044 56265718
Papilloedema 66.02 18.56 29 17276 3678 56271084
Blood thyroid stimulating hormone increased 64.08 18.56 34 17271 6529 56268233
Meningioma 63.19 18.56 28 17277 3626 56271136
Idiopathic intracranial hypertension 62.32 18.56 25 17280 2529 56272233
Cortisol decreased 61.39 18.56 20 17285 1112 56273650
Bone density increased 60.61 18.56 17 17288 565 56274197
Blood growth hormone decreased 60.59 18.56 10 17295 18 56274744
Pituitary tumour recurrent 60.51 18.56 12 17293 81 56274681
Drug administered in wrong device 58.08 18.56 10 17295 26 56274736
Growing pains 57.07 18.56 9 17296 10 56274752
Tonsillar hypertrophy 52.89 18.56 17 17288 905 56273857
Liquid product physical issue 52.30 18.56 17 17288 938 56273824
Dyspnoea 51.63 18.56 64 17241 592513 55682249
Intracranial pressure increased 51.43 18.56 26 17279 4519 56270243
Toxicity to various agents 51.03 18.56 5 17300 224559 56050203
Injection site haemorrhage 50.56 18.56 47 17258 22154 56252608
Thyroxine free increased 50.01 18.56 16 17289 839 56273923
Infusion related reaction 49.23 18.56 4 17301 208927 56065835
Device failure 48.89 18.56 27 17278 5612 56269150
Blood follicle stimulating hormone increased 48.70 18.56 11 17294 147 56274615
Drug ineffective 48.46 18.56 135 17170 918854 55355908
Device defective 47.99 18.56 18 17287 1520 56273242
Blood corticotrophin decreased 47.60 18.56 12 17293 262 56274500
Increased appetite 47.54 18.56 31 17274 8704 56266058
Albumin globulin ratio increased 47.12 18.56 7 17298 3 56274759
Device use error 46.96 18.56 26 17279 5430 56269332
Pituitary tumour 45.53 18.56 15 17290 864 56273898
Osteochondrosis 45.28 18.56 16 17289 1140 56273622
Drug intolerance 44.70 18.56 13 17292 264805 56009957
Therapy cessation 44.20 18.56 48 17257 27216 56247546
Septo-optic dysplasia 42.53 18.56 6 17299 0 56274762
Medulloblastoma recurrent 42.51 18.56 9 17296 87 56274675
Thyroxine increased 42.36 18.56 13 17292 594 56274168
Drug interaction 42.03 18.56 7 17298 209748 56065014
Astrocytoma 41.97 18.56 9 17296 93 56274669
Blood prolactin decreased 41.44 18.56 8 17297 46 56274716
Pituitary tumour benign 40.66 18.56 17 17288 1911 56272851
Energy increased 40.61 18.56 18 17287 2332 56272430
Focal nodular hyperplasia 39.96 18.56 12 17293 509 56274253
Mood altered 39.91 18.56 33 17272 13322 56261440
Hypopituitarism 39.40 18.56 14 17291 1014 56273748
Blood glucose decreased 38.89 18.56 38 17267 19049 56255713
Cortisol increased 38.72 18.56 11 17294 383 56274379
Tonsillar disorder 38.60 18.56 14 17291 1076 56273686
Hepatic enzyme increased 38.44 18.56 4 17301 171380 56103382
Blood urea decreased 38.10 18.56 17 17288 2237 56272525
Hair growth abnormal 38.08 18.56 18 17287 2704 56272058
Menstruation irregular 38.03 18.56 24 17281 6372 56268390
Temperature intolerance 37.67 18.56 26 17279 8014 56266748
Hyponatraemic seizure 37.65 18.56 11 17294 424 56274338
Product use in unapproved indication 36.00 18.56 110 17195 140712 56134050
Reaction to preservatives 35.13 18.56 9 17296 210 56274552
Neutrophilic panniculitis 35.07 18.56 7 17298 49 56274713
Wrong device used 34.47 18.56 6 17299 17 56274745
Seizure 34.12 18.56 100 17205 125019 56149743
Blood insulin increased 33.79 18.56 8 17297 133 56274629
Tri-iodothyronine decreased 33.79 18.56 8 17297 133 56274629
Acute kidney injury 33.61 18.56 16 17289 240747 56034015
Neoplasm recurrence 33.57 18.56 16 17289 2448 56272314
Needle issue 33.47 18.56 25 17280 8713 56266049
General physical health deterioration 33.34 18.56 6 17299 170004 56104758
Growth hormone deficiency 33.24 18.56 8 17297 143 56274619
Wrong technique in product usage process 33.03 18.56 62 17243 58106 56216656
Hypothalamo-pituitary disorder 32.49 18.56 11 17294 689 56274073
Arthralgia 32.49 18.56 264 17041 501405 55773357
Drug hypersensitivity 31.76 18.56 23 17282 275182 55999580
Intercepted product prescribing error 31.50 18.56 8 17297 180 56274582
Alveolar rhabdomyosarcoma 31.31 18.56 6 17299 33 56274729
Osteochondroma 31.06 18.56 5 17300 7 56274755
Carbon dioxide decreased 30.98 18.56 14 17291 1898 56272864
Blood alkaline phosphatase decreased 30.96 18.56 12 17293 1108 56273654
Diabetes insipidus 30.71 18.56 15 17290 2422 56272340
Anion gap increased 30.45 18.56 13 17292 1538 56273224
Hypotension 30.14 18.56 20 17285 250488 56024274
Blood chloride increased 30.00 18.56 15 17290 2547 56272215
Abdominal discomfort 29.68 18.56 25 17280 277249 55997513
Dry skin 29.00 18.56 52 17253 47057 56227705
Gastrointestinal infection 28.94 18.56 22 17283 7872 56266890
Nausea 28.92 18.56 129 17176 764049 55510713
Otitis media 28.80 18.56 18 17287 4698 56270064
Device physical property issue 28.69 18.56 13 17292 1773 56272989
Glucose tolerance impaired 28.65 18.56 19 17286 5486 56269276
Poor quality product administered 28.25 18.56 15 17290 2884 56271878
Blood sodium increased 27.47 18.56 14 17291 2474 56272288
Lymphocyte count increased 27.00 18.56 15 17290 3152 56271610
Arthropathy 26.90 18.56 14 17291 200261 56074501
Stomatitis 26.62 18.56 3 17302 120807 56153955
Infantile haemangioma 26.30 18.56 6 17299 84 56274678
Oestradiol decreased 26.17 18.56 5 17300 27 56274735
Accidental exposure to product 26.16 18.56 35 17270 24612 56250150
Puberty 26.11 18.56 4 17301 3 56274759
Blood albumin increased 26.07 18.56 10 17295 898 56273864
Therapeutic product effect decreased 25.64 18.56 10 17295 169442 56105320
Underdose 25.62 18.56 34 17271 23723 56251039
Globulins decreased 25.52 18.56 7 17298 214 56274548
Precocious puberty 25.45 18.56 7 17298 216 56274546
Very low density lipoprotein increased 25.38 18.56 6 17299 99 56274663
Tri-iodothyronine free increased 25.36 18.56 7 17298 219 56274543
Hypoglycaemia 25.11 18.56 54 17251 55761 56219001
Total cholesterol/HDL ratio increased 24.95 18.56 6 17299 107 56274655
Medulloblastoma 24.69 18.56 5 17300 38 56274724
Pruritus 24.65 18.56 37 17268 316586 55958176
Malaise 24.53 18.56 195 17110 367665 55907097
Confusional state 24.52 18.56 17 17288 208138 56066624
Anaemia 24.16 18.56 28 17277 267483 56007279
Mean cell haemoglobin concentration decreased 24.07 18.56 14 17291 3209 56271553
Product quality issue 23.45 18.56 38 17267 31698 56243064
Growth accelerated 23.34 18.56 4 17301 10 56274752
Oesophageal disorder 23.30 18.56 12 17293 2168 56272594
Blister 23.26 18.56 3 17302 108884 56165878
Syringomyelia 23.06 18.56 6 17299 149 56274613
Glioma 22.87 18.56 7 17298 317 56274445
Blood alkaline phosphatase increased 22.71 18.56 42 17263 38903 56235859
Germ cell cancer 22.71 18.56 5 17300 59 56274703
Blood corticotrophin increased 22.56 18.56 5 17300 61 56274701
Nocturia 22.15 18.56 18 17287 7088 56267674
Thyroxine decreased 22.00 18.56 8 17297 619 56274143
Product dispensing error 21.84 18.56 20 17285 9244 56265518
Red cell distribution width increased 21.70 18.56 20 17285 9320 56265442
Neutropenia 21.32 18.56 11 17294 158156 56116606
Mood swings 21.27 18.56 26 17279 16721 56258041
Rathke's cleft cyst 21.26 18.56 3 17302 0 56274762
Bilateral breast buds 21.26 18.56 3 17302 0 56274762
Non-secretory adenoma of pituitary 21.26 18.56 3 17302 0 56274762
Anti-thyroid antibody positive 21.10 18.56 7 17298 412 56274350
Atrial fibrillation 21.00 18.56 4 17301 108893 56165869
Manufacturing product shipping issue 20.96 18.56 5 17300 86 56274676
Blood cholesterol increased 20.72 18.56 59 17246 72520 56202242
Hyperphagia 20.64 18.56 10 17295 1586 56273176
Insulin C-peptide decreased 20.58 18.56 4 17301 24 56274738
Pneumonia 20.43 18.56 61 17244 407037 55867725
Weight gain poor 20.07 18.56 8 17297 796 56273966
Blood luteinising hormone increased 20.06 18.56 5 17300 104 56274658
Cerebral cyst 20.06 18.56 6 17299 251 56274511
Carbon dioxide increased 20 18.56 9 17296 1208 56273554
Blood calcium increased 20.00 18.56 18 17287 8136 56266626
Mycobacterium chelonae infection 19.95 18.56 7 17298 488 56274274
Device dispensing error 19.84 18.56 5 17300 109 56274653
Endocrine ophthalmopathy 19.78 18.56 7 17298 501 56274261
Mean platelet volume increased 19.71 18.56 7 17298 506 56274256
Joint swelling 19.66 18.56 37 17268 289763 55984999
Carpal tunnel syndrome 19.61 18.56 26 17279 18118 56256644
Blood urea nitrogen/creatinine ratio decreased 19.57 18.56 4 17301 32 56274730
Neoplasm 19.51 18.56 16 17289 6385 56268377
Blood growth hormone abnormal 19.46 18.56 4 17301 33 56274729
Acanthosis nigricans 19.46 18.56 4 17301 33 56274729
Dehydroepiandrosterone decreased 19.19 18.56 3 17302 3 56274759
Infection 19.12 18.56 20 17285 200186 56074576
Tri-iodothyronine increased 18.71 18.56 5 17300 138 56274624

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 1794.89 19.30 366 21496 1098 31674384
Insulin-like growth factor increased 1035.36 19.30 224 21638 961 31674521
Product dose omission issue 952.34 19.30 694 21168 104892 31570590
Device issue 877.13 19.30 297 21565 8187 31667295
Wrong technique in device usage process 847.01 19.30 192 21670 1062 31674420
Device breakage 829.26 19.30 206 21656 1778 31673704
Device information output issue 699.44 19.30 113 21749 11 31675471
Injection site pain 632.19 19.30 356 21506 34278 31641204
Insulin-like growth factor decreased 579.25 19.30 108 21754 163 31675319
Device leakage 525.95 19.30 181 21681 5232 31670250
Growth retardation 461.49 19.30 125 21737 1557 31673925
Device mechanical issue 437.80 19.30 75 21787 42 31675440
Incorrect dose administered 395.04 19.30 267 21595 35485 31639997
Poor quality device used 377.57 19.30 93 21769 770 31674712
Headache 375.10 19.30 541 21321 183111 31492371
Incorrect dose administered by device 347.76 19.30 100 21762 1570 31673912
Craniopharyngioma 303.94 19.30 64 21798 233 31675249
Device use issue 291.90 19.30 66 21796 359 31675123
Product prescribing error 269.08 19.30 168 21694 19474 31656008
Scoliosis 264.43 19.30 90 21772 2509 31672973
Product storage error 250.52 19.30 114 21748 6952 31668530
Bone density increased 232.98 19.30 43 21819 59 31675423
Injection site bruising 198.65 19.30 101 21761 7874 31667608
Expired device used 195.99 19.30 34 21828 23 31675459
Blood creatinine decreased 155.54 19.30 62 21800 2717 31672765
Blood thyroid stimulating hormone decreased 152.39 19.30 55 21807 1828 31673654
Arthralgia 148.37 19.30 324 21538 151100 31524382
Thyroxine free decreased 146.72 19.30 35 21827 249 31675233
Osteochondrosis 140.13 19.30 43 21819 852 31674630
Adenoidal hypertrophy 139.82 19.30 30 21832 122 31675360
Device malfunction 138.91 19.30 84 21778 9182 31666300
Vitamin D decreased 136.06 19.30 58 21804 3019 31672463
Pituitary tumour benign 134.69 19.30 41 21821 790 31674692
Blood urea nitrogen/creatinine ratio increased 133.01 19.30 33 21829 282 31675200
Idiopathic intracranial hypertension 131.20 19.30 38 21824 612 31674870
Device power source issue 130.89 19.30 33 21829 303 31675179
Epiphysiolysis 121.19 19.30 25 21837 80 31675402
Acute kidney injury 117.49 19.30 25 21837 279689 31395793
Device use error 112.30 19.30 46 21816 2164 31673318
Toxicity to various agents 101.27 19.30 6 21856 181481 31494001
Device defective 99.49 19.30 30 21832 559 31674923
Injection site haemorrhage 98.11 19.30 67 21795 9018 31666464
Glioneuronal tumour 97.74 19.30 16 21846 3 31675479
Neoplasm recurrence 97.29 19.30 41 21821 2073 31673409
Papilloedema 96.64 19.30 43 21819 2483 31672999
Dyspnoea 96.62 19.30 59 21803 343420 31332062
Weight gain poor 90.51 19.30 31 21831 880 31674602
Hypotension 88.50 19.30 17 21845 204601 31470881
Wrong device used 87.80 19.30 15 21847 8 31675474
Epiphyses premature fusion 86.66 19.30 16 21846 22 31675460
Blood 25-hydroxycholecalciferol decreased 86.58 19.30 22 21840 209 31675273
Device failure 83.99 19.30 37 21825 2086 31673396
Drug interaction 82.77 19.30 21 21841 208522 31466960
Clear cell renal cell carcinoma 81.75 19.30 30 21832 1046 31674436
Sleep apnoea syndrome 81.11 19.30 81 21781 18544 31656938
Blood testosterone decreased 80.65 19.30 45 21817 4228 31671254
Pneumonia 79.42 19.30 69 21793 335243 31340239
Hepatoblastoma 77.75 19.30 15 21847 30 31675452
Acne 71.65 19.30 58 21804 10102 31665380
Increased appetite 71.39 19.30 48 21814 6296 31669186
Intracranial pressure increased 70.77 19.30 39 21823 3576 31671906
Thrombocytopenia 70.56 19.30 8 21854 142739 31532743
Device physical property issue 69.75 19.30 24 21838 691 31674791
Device dispensing error 69.31 19.30 14 21848 39 31675443
Underdose 68.55 19.30 62 21800 12545 31662937
Osteochondroma 67.56 19.30 12 21850 11 31675471
Exposure via skin contact 67.35 19.30 14 21848 47 31675435
High density lipoprotein decreased 67.27 19.30 36 21826 3114 31672368
Weight increased 67.25 19.30 165 21697 82782 31592700
Needle issue 66.89 19.30 43 21819 5230 31670252
Enuresis 64.28 19.30 31 21831 2153 31673329
Blood testosterone increased 64.19 19.30 25 21837 1029 31674453
Blood luteinising hormone decreased 63.34 19.30 15 21847 103 31675379
Brain neoplasm 63.27 19.30 34 21828 2966 31672516
Growing pains 62.80 19.30 10 21852 0 31675482
Migraine 62.34 19.30 62 21800 14118 31661364
Neutropenia 62.06 19.30 11 21851 140353 31535129
Lymphoproliferative disorder 61.97 19.30 32 21830 2573 31672909
Thyroxine increased 61.93 19.30 14 21848 76 31675406
Thyroxine decreased 60.79 19.30 15 21847 125 31675357
Snoring 60.66 19.30 33 21829 2950 31672532
Precocious puberty 60.37 19.30 15 21847 129 31675353
Delayed puberty 60.28 19.30 16 21846 183 31675299
Glycosylated haemoglobin increased 60.22 19.30 53 21809 10347 31665135
Wrong technique in product usage process 60.05 19.30 93 21769 33250 31642232
Bone density decreased 58.35 19.30 27 21835 1708 31673774
Device difficult to use 58.22 19.30 28 21834 1933 31673549
Blood thyroid stimulating hormone increased 58.04 19.30 34 21828 3503 31671979
Tonsillar hypertrophy 57.31 19.30 20 21842 601 31674881
Blood follicle stimulating hormone decreased 56.91 19.30 12 21850 44 31675438
Anaemia 56.72 19.30 39 21823 213483 31461999
Limb asymmetry 55.71 19.30 13 21849 83 31675399
Prescribed overdose 55.55 19.30 48 21814 9144 31666338
Sepsis 55.25 19.30 18 21844 151911 31523571
General physical health deterioration 54.46 19.30 7 21855 113428 31562054
Septo-optic dysplasia 53.93 19.30 9 21853 3 31675479
Product dispensing error 53.82 19.30 39 21823 5765 31669717
Attention deficit hyperactivity disorder 52.88 19.30 28 21834 2370 31673112
Blood glucose increased 52.15 19.30 124 21738 60959 31614523
Diarrhoea 52.08 19.30 103 21759 352306 31323176
Thyroxine free increased 51.76 19.30 15 21847 242 31675240
Pituitary tumour 51.70 19.30 18 21844 537 31674945
Confusional state 49.90 19.30 15 21847 133319 31542163
Tenosynovitis stenosans 49.80 19.30 9 21853 10 31675472
Non-high-density lipoprotein cholesterol increased 49.74 19.30 10 21852 27 31675455
Skin odour abnormal 49.68 19.30 20 21842 899 31674583
Focal segmental glomerulosclerosis 49.35 19.30 25 21837 1931 31673551
Therapy cessation 48.80 19.30 56 21806 14999 31660483
Meningioma 48.41 19.30 22 21840 1335 31674147
Injection site extravasation 47.93 19.30 27 21835 2583 31672899
Neurofibromatosis 47.70 19.30 8 21854 3 31675479
Bone development abnormal 47.35 19.30 10 21852 37 31675445
Globulins decreased 46.43 19.30 13 21849 184 31675298
Atrial fibrillation 45.97 19.30 11 21851 113772 31561710
Insulin resistance 45.88 19.30 17 21845 609 31674873
Liquid product physical issue 45.74 19.30 15 21847 371 31675111
Enchondromatosis 43.96 19.30 7 21855 0 31675482
Poor quality product administered 43.53 19.30 22 21840 1691 31673791
Completed suicide 43.07 19.30 6 21856 91508 31583974
Product use in unapproved indication 42.87 19.30 158 21704 99013 31576469
Pancytopenia 42.85 19.30 5 21857 87311 31588171
Blood testosterone free decreased 42.44 19.30 10 21852 67 31675415
Injection site discomfort 41.36 19.30 20 21842 1397 31674085
Stubbornness 41.14 19.30 8 21854 17 31675465
Renal failure 40.80 19.30 17 21845 123313 31552169
Respiratory failure 40.60 19.30 10 21852 101439 31574043
Red blood cell count increased 40.49 19.30 20 21842 1463 31674019
Acanthosis nigricans 38.95 19.30 11 21851 161 31675321
Blood insulin increased 38.74 19.30 13 21849 346 31675136
Growth hormone deficiency 37.71 19.30 12 21850 269 31675213
Obesity 37.18 19.30 42 21820 11058 31664424
No adverse event 37.10 19.30 56 21806 19569 31655913
Drug administered in wrong device 36.81 19.30 8 21854 35 31675447
Off label use 36.78 19.30 383 21479 346891 31328591
Pain in extremity 36.66 19.30 168 21694 116035 31559447
Gynaecomastia 36.54 19.30 38 21824 9116 31666366
Astrocytoma 36.22 19.30 11 21851 210 31675272
Strabismus 36.12 19.30 19 21843 1587 31673895
Haematocrit increased 35.86 19.30 20 21842 1877 31673605
Avulsion fracture 35.35 19.30 7 21855 17 31675465
Very low density lipoprotein increased 35.35 19.30 7 21855 17 31675465
Platelet count decreased 35.29 19.30 16 21846 110419 31565063
Blood albumin increased 35.14 19.30 14 21848 612 31674870
Abnormal behaviour 34.18 19.30 60 21802 23768 31651714
Injection site mass 34.18 19.30 30 21832 5834 31669648
Disease progression 34.15 19.30 10 21852 90454 31585028
Vitamin D deficiency 33.88 19.30 30 21832 5902 31669580
Cardiac failure 33.38 19.30 9 21853 85944 31589538
Osteosarcoma 33.28 19.30 11 21851 279 31675203
Pituitary tumour recurrent 33.16 19.30 8 21854 60 31675422
Pharyngitis streptococcal 32.66 19.30 20 21842 2233 31673249
Tendon calcification 32.60 19.30 8 21854 65 31675417
Low density lipoprotein increased 32.39 19.30 25 21837 4063 31671419
Anion gap increased 32.37 19.30 18 21844 1679 31673803
Mean cell haemoglobin decreased 31.89 19.30 17 21845 1459 31674023
Cardiac failure congestive 31.42 19.30 8 21854 79379 31596103
Adipomastia 31.40 19.30 5 21857 0 31675482
Pectus carinatum 31.40 19.30 5 21857 0 31675482
Gastrointestinal haemorrhage 31.39 19.30 9 21853 82540 31592942
Creutzfeldt-Jakob disease 31.12 19.30 7 21855 37 31675445
Blood alkaline phosphatase increased 30.96 19.30 65 21797 29388 31646094
Pulmonary embolism 30.86 19.30 9 21853 81637 31593845
Hyperkalaemia 30.80 19.30 4 21858 64347 31611135
Anger 30.41 19.30 38 21824 11115 31664367
Therapy interrupted 30.34 19.30 37 21825 10559 31664923
Mood swings 29.96 19.30 31 21831 7393 31668089
Phaeochromocytoma 29.78 19.30 9 21853 169 31675313
Acromegaly 29.69 19.30 7 21855 47 31675435
Septic shock 29.61 19.30 5 21857 66153 31609329
Device delivery system issue 29.58 19.30 11 21851 398 31675084
Carbon dioxide decreased 29.40 19.30 16 21846 1431 31674051
Crying 29.39 19.30 27 21835 5570 31669912
Neuropathy peripheral 29.22 19.30 8 21854 75641 31599841
Leukopenia 29.15 19.30 3 21859 57825 31617657
Breast mass 29.14 19.30 12 21850 572 31674910
Albumin globulin ratio increased 29.13 19.30 6 21856 19 31675463
Product quality issue 29.08 19.30 45 21817 16066 31659416
Epiphyses delayed fusion 29.05 19.30 5 21857 3 31675479
Interstitial lung disease 28.95 19.30 4 21858 61399 31614083
Fear of injection 28.70 19.30 15 21847 1236 31674246
Spinal deformity 28.51 19.30 11 21851 441 31675041
Cardiac arrest 28.29 19.30 13 21849 89049 31586433
Red cell distribution width increased 28.12 19.30 26 21836 5408 31670074
Diabetes insipidus 28.05 19.30 19 21843 2521 31672961
Growth failure 27.99 19.30 7 21855 62 31675420
Aggression 27.89 19.30 72 21790 37219 31638263
Blood triglycerides increased 27.88 19.30 40 21822 13357 31662125
Blood testosterone free increased 27.47 19.30 6 21856 27 31675455
Bradycardia 27.40 19.30 7 21855 69320 31606162
Intentional dose omission 26.37 19.30 19 21843 2783 31672699
Plasma cell myeloma 25.91 19.30 4 21858 56527 31618955
Aural polyp 25.59 19.30 5 21857 11 31675471
Mean cell volume decreased 25.52 19.30 14 21848 1272 31674210
Thirst 25.37 19.30 27 21835 6649 31668833
Mood altered 25.30 19.30 30 21832 8316 31667166
Dehydroepiandrosterone increased 25.12 19.30 4 21858 0 31675482
Temperature intolerance 24.99 19.30 19 21843 3020 31672462
Red cell distribution width decreased 24.94 19.30 8 21854 184 31675298
Apnoea 24.93 19.30 26 21836 6256 31669226
Blood sodium increased 24.71 19.30 18 21844 2681 31672801
Product preparation issue 24.54 19.30 9 21853 313 31675169
Haemoglobin increased 24.51 19.30 19 21843 3107 31672375
Polydipsia 24.51 19.30 20 21842 3520 31671962
Deep vein thrombosis 24.26 19.30 6 21856 60730 31614752
Blood parathyroid hormone increased 24.20 19.30 14 21848 1408 31674074
Blood growth hormone increased 24.12 19.30 9 21853 329 31675153
Osteonecrosis 23.97 19.30 38 21824 13846 31661636
Protein-losing gastroenteropathy 23.94 19.30 9 21853 336 31675146
Ear infection 23.80 19.30 30 21832 8851 31666631
Myocardial infarction 23.67 19.30 26 21836 113428 31562054
Blood calcium increased 23.59 19.30 19 21843 3283 31672199
Ependymoma malignant 23.57 19.30 5 21857 19 31675463
Viral infection 23.32 19.30 40 21822 15553 31659929
Chills 23.28 19.30 11 21851 74139 31601343
Blood urea decreased 23.23 19.30 12 21850 965 31674517
Gastroenteritis viral 23.18 19.30 25 21837 6252 31669230
Blood pressure decreased 22.98 19.30 3 21859 48088 31627394
Otitis media 22.94 19.30 17 21845 2599 31672883
Blood prolactin decreased 22.78 19.30 8 21854 245 31675237
Incorrect dosage administered 22.69 19.30 12 21850 1013 31674469
Medulloblastoma recurrent 22.65 19.30 6 21856 68 31675414
Hypothalamo-pituitary disorder 22.59 19.30 11 21851 780 31674702
Renal impairment 22.57 19.30 16 21846 86333 31589149
Blood alkaline phosphatase decreased 22.45 19.30 11 21851 791 31674691
Injection site swelling 22.29 19.30 31 21831 10056 31665426
Knee deformity 22.23 19.30 10 21852 592 31674890
Mean platelet volume decreased 21.95 19.30 9 21853 424 31675058
Encopresis 21.74 19.30 7 21855 163 31675319
Scarlet fever 21.49 19.30 6 21856 84 31675398
Lymphocyte count increased 21.32 19.30 17 21845 2896 31672586
C-reactive protein increased 21.07 19.30 4 21858 48646 31626836
Solar lentigo 20.83 19.30 9 21853 484 31674998
Nausea 20.77 19.30 126 21736 307821 31367661
Pulmonary oedema 20.74 19.30 3 21859 44499 31630983
Rheumatoid arthritis 20.56 19.30 4 21858 47805 31627677
Goitre 20.48 19.30 13 21849 1546 31673936
Multiple organ dysfunction syndrome 20.09 19.30 11 21851 68192 31607290
Dehydration 20.04 19.30 32 21830 119079 31556403
Empty sella syndrome 19.92 19.30 5 21857 45 31675437
Psoriasis 19.90 19.30 4 21858 46715 31628767
Hyperphagia 19.88 19.30 12 21850 1306 31674176
Blood chloride decreased 19.86 19.30 18 21844 3648 31671834
Hypopituitarism 19.82 19.30 14 21848 1987 31673495
Pruritus 19.79 19.30 35 21827 125132 31550350
Renal transplant 19.46 19.30 13 21849 1686 31673796

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 2746.82 17.38 574 29499 3638 70894733
Product dose omission issue 1504.34 17.38 1006 29067 216462 70681909
Insulin-like growth factor increased 1499.33 17.38 300 29773 1471 70896900
Wrong technique in device usage process 1291.11 17.38 297 29776 3071 70895300
Device information output issue 1153.94 17.38 173 29900 18 70898353
Device issue 1132.70 17.38 414 29659 23611 70874760
Insulin-like growth factor decreased 903.41 17.38 164 29909 415 70897956
Device breakage 848.20 17.38 264 29809 9134 70889237
Device leakage 838.08 17.38 261 29812 9047 70889324
Device mechanical issue 732.93 17.38 118 29955 88 70898283
Poor quality device used 594.84 17.38 145 29928 1953 70896418
Injection site pain 540.02 17.38 426 29647 117193 70781178
Device use issue 510.60 17.38 130 29943 2112 70896259
Product prescribing error 465.89 17.38 257 29816 38695 70859676
Craniopharyngioma 421.00 17.38 81 29992 309 70898062
Blood thyroid stimulating hormone decreased 376.31 17.38 125 29948 5329 70893042
Incorrect dose administered 372.91 17.38 272 29801 66447 70831924
Headache 354.44 17.38 766 29307 579639 70318732
Scoliosis 339.42 17.38 121 29952 6390 70891981
Growth retardation 321.69 17.38 85 29988 1607 70896764
Product storage error 319.37 17.38 145 29928 14396 70883975
Incorrect dose administered by device 291.61 17.38 98 29975 4331 70894040
Expired device used 284.39 17.38 57 30016 281 70898090
Bone density increased 257.68 17.38 59 30014 594 70897777
Injection site bruising 254.05 17.38 173 29900 37859 70860512
Blood creatinine decreased 232.91 17.38 95 29978 7254 70891117
Thyroxine free decreased 222.73 17.38 57 30016 945 70897426
Blood urea nitrogen/creatinine ratio increased 222.01 17.38 55 30018 794 70897577
Epiphysiolysis 217.83 17.38 38 30035 69 70898302
Device power source issue 203.24 17.38 51 30022 778 70897593
Adenoidal hypertrophy 202.56 17.38 38 30035 122 70898249
Vitamin D decreased 181.75 17.38 83 29990 8344 70890027
Blood 25-hydroxycholecalciferol decreased 179.47 17.38 39 30034 302 70898069
Blood glucose increased 163.95 17.38 210 29863 102772 70795599
Osteochondrosis 156.48 17.38 48 30025 1575 70896796
Device use error 154.07 17.38 69 30004 6627 70891744
Glycosylated haemoglobin increased 152.77 17.38 94 29979 17297 70881074
Papilloedema 146.28 17.38 64 30009 5814 70892557
Idiopathic intracranial hypertension 144.68 17.38 52 30021 2809 70895562
High density lipoprotein decreased 143.47 17.38 57 30016 4062 70894309
Device malfunction 142.30 17.38 93 29980 18991 70879380
Sleep apnoea syndrome 140.18 17.38 114 29959 32599 70865772
Device failure 137.04 17.38 61 30012 5774 70892597
Dyspnoea 133.60 17.38 81 29992 769979 70128392
Pituitary tumour benign 132.70 17.38 47 30026 2432 70895939
Neoplasm recurrence 131.93 17.38 53 30020 3888 70894483
Non-high-density lipoprotein cholesterol increased 130.23 17.38 28 30045 205 70898166
Low density lipoprotein increased 129.90 17.38 65 30008 8000 70890371
Toxicity to various agents 127.41 17.38 9 30064 382163 70516208
Blood triglycerides increased 125.47 17.38 87 29986 19577 70878794
Injection site haemorrhage 124.48 17.38 96 29977 25431 70872940
Snoring 124.00 17.38 54 30019 4850 70893521
Glioneuronal tumour 121.89 17.38 19 30054 8 70898363
Exposure via skin contact 120.83 17.38 27 30046 241 70898130
Blood thyroid stimulating hormone increased 118.20 17.38 62 30011 8417 70889954
Intracranial pressure increased 111.79 17.38 57 30016 7299 70891072
Hypotension 106.74 17.38 21 30052 404360 70494011
Blood testosterone decreased 105.64 17.38 39 30034 2274 70896097
Acute kidney injury 105.48 17.38 35 30038 474589 70423782
Wrong device used 105.38 17.38 17 30056 13 70898358
Device defective 105.34 17.38 35 30038 1491 70896880
Product use in unapproved indication 104.83 17.38 255 29818 207223 70691148
Rheumatoid arthritis 96.85 17.38 7 30066 291798 70606573
Growing pains 95.76 17.38 15 30058 7 70898364
Weight gain poor 94.58 17.38 28 30045 812 70897559
Tonsillar hypertrophy 93.14 17.38 31 30042 1328 70897043
Brain neoplasm 92.26 17.38 45 30028 5241 70893130
Drug interaction 92.26 17.38 24 30049 381417 70516954
Device physical property issue 91.18 17.38 35 30038 2274 70896097
Meningioma 91.14 17.38 41 30032 3977 70894394
Thyroxine free increased 88.94 17.38 29 30044 1164 70897207
Hepatoblastoma 88.52 17.38 16 30057 39 70898332
Septo-optic dysplasia 87.96 17.38 13 30060 0 70898371
Thyroxine increased 85.01 17.38 25 30048 708 70897663
Increased appetite 84.73 17.38 54 30019 10559 70887812
Needle issue 83.34 17.38 54 30019 10861 70887510
Epiphyses premature fusion 82.54 17.38 16 30057 64 70898307
Arthralgia 81.22 17.38 424 29649 502966 70395405
Device dispensing error 81.16 17.38 17 30056 108 70898263
Product dispensing error 78.65 17.38 54 30019 11954 70886417
Off label use 78.18 17.38 560 29513 742500 70155871
Pituitary tumour recurrent 77.41 17.38 17 30056 139 70898232
Clear cell renal cell carcinoma 77.09 17.38 31 30042 2279 70896092
Completed suicide 76.65 17.38 5 30068 227130 70671241
Weight increased 76.31 17.38 251 29822 242080 70656291
Adrenocortical insufficiency acute 76.13 17.38 32 30041 2634 70895737
Poor quality product administered 75.59 17.38 34 30039 3297 70895074
Blood testosterone increased 73.07 17.38 23 30050 823 70897548
Therapy cessation 72.21 17.38 80 29993 33596 70864775
Globulins decreased 71.60 17.38 19 30054 365 70898006
Liquid product physical issue 71.02 17.38 23 30050 903 70897468
Blood luteinising hormone decreased 70.42 17.38 16 30057 155 70898216
Pituitary tumour 69.99 17.38 24 30049 1127 70897244
General physical health deterioration 69.54 17.38 9 30064 236022 70662349
Wrong technique in product usage process 68.09 17.38 112 29961 68586 70829785
Pneumonia 67.23 17.38 93 29980 596139 70302232
Thyroxine decreased 66.30 17.38 21 30052 767 70897604
Albumin globulin ratio increased 65.41 17.38 11 30062 14 70898357
Precocious puberty 65.05 17.38 17 30056 307 70898064
Blood albumin increased 64.90 17.38 24 30049 1406 70896965
Neutropenia 64.43 17.38 15 30058 257141 70641230
Drug administered in wrong device 64.09 17.38 12 30061 38 70898333
Blood follicle stimulating hormone decreased 62.42 17.38 13 30060 80 70898291
Anaemia 62.31 17.38 48 30025 403375 70494996
Infusion related reaction 62.04 17.38 6 30067 197528 70700843
Diarrhoea 61.86 17.38 152 29921 783189 70115182
Confusional state 61.32 17.38 22 30051 284376 70613995
Anion gap increased 61.04 17.38 29 30044 3187 70895184
Blood urea decreased 60.97 17.38 28 30045 2849 70895522
Thrombocytopenia 59.79 17.38 14 30059 239096 70659275
Blood insulin increased 59.00 17.38 16 30057 335 70898036
Bone density decreased 57.79 17.38 44 30029 11430 70886941
Lymphoproliferative disorder 57.76 17.38 33 30040 5296 70893075
Blood alkaline phosphatase increased 56.10 17.38 94 29979 58427 70839944
Carbon dioxide decreased 55.39 17.38 27 30046 3139 70895232
Focal segmental glomerulosclerosis 55.09 17.38 27 30046 3177 70895194
Cortisol decreased 54.82 17.38 23 30050 1884 70896487
Energy increased 54.71 17.38 26 30047 2858 70895513
Mood altered 53.47 17.38 49 30024 16426 70881945
Device difficult to use 53.31 17.38 41 30032 10808 70887563
Blood prolactin decreased 53.05 17.38 14 30059 263 70898108
Astrocytoma 53.00 17.38 14 30059 264 70898107
Prescribed overdose 52.22 17.38 61 30012 27120 70871251
Blood testosterone free decreased 52.20 17.38 10 30063 37 70898334
Blood sodium increased 52.13 17.38 29 30044 4423 70893948
Atrial fibrillation 52.01 17.38 8 30065 184340 70714031
Medulloblastoma recurrent 51.35 17.38 12 30061 133 70898238
Osteosarcoma 51.34 17.38 15 30058 415 70897956
Blood corticotrophin decreased 51.30 17.38 15 30058 416 70897955
Blood follicle stimulating hormone increased 50.84 17.38 14 30059 311 70898060
Blood alkaline phosphatase decreased 50.20 17.38 21 30052 1708 70896663
Very low density lipoprotein increased 49.11 17.38 12 30061 163 70898208
Acromegaly 48.85 17.38 11 30062 102 70898269
Blood calcium increased 48.65 17.38 36 30037 8957 70889414
Enuresis 48.42 17.38 24 30049 2893 70895478
Nausea 48.39 17.38 192 29881 851896 70046475
Hypothalamo-pituitary disorder 48.31 17.38 18 30055 1077 70897294
Lymphocyte count increased 47.45 17.38 29 30044 5267 70893104
Growth hormone deficiency 47.39 17.38 14 30059 403 70897968
Red cell distribution width increased 47.03 17.38 42 30031 13615 70884756
Cortisol increased 45.41 17.38 14 30059 467 70897904
Mean cell haemoglobin decreased 45.05 17.38 28 30045 5240 70893131
Germ cell cancer 44.77 17.38 11 30062 153 70898218
Osteochondroma 44.71 17.38 8 30065 18 70898353
Acne 44.57 17.38 54 30019 24935 70873436
Red blood cell count increased 44.42 17.38 25 30048 3899 70894472
Blood chloride increased 44.07 17.38 27 30046 4926 70893445
Aggression 44.03 17.38 76 29997 48370 70850001
Pancytopenia 43.92 17.38 6 30067 151101 70747270
Strabismus 43.90 17.38 21 30052 2343 70896028
Blood testosterone free increased 43.59 17.38 7 30066 5 70898366
Device delivery system issue 43.52 17.38 14 30059 538 70897833
Blood growth hormone decreased 43.41 17.38 9 30064 54 70898317
Anger 42.91 17.38 43 30030 16089 70882282
Intentional dose omission 42.61 17.38 30 30043 6911 70891460
Pruritus 41.85 17.38 51 30022 345509 70552862
Drug intolerance 41.44 17.38 22 30051 225665 70672706
Tri-iodothyronine decreased 41.27 17.38 11 30062 215 70898156
Glucose tolerance impaired 40.82 17.38 29 30044 6777 70891594
Temperature intolerance 40.76 17.38 32 30041 8691 70889680
Injection site extravasation 40.69 17.38 32 30041 8714 70889657
Underdose 40.66 17.38 56 30017 29327 70869044
Malignant neoplasm progression 40.12 17.38 3 30070 121736 70776635
Contraindicated product administered 39.95 17.38 5 30068 134607 70763764
Blood glucose decreased 39.54 17.38 50 30023 24109 70874262
Bone development abnormal 39.33 17.38 8 30065 43 70898328
Insulin resistance 39.25 17.38 16 30057 1218 70897153
Abnormal behaviour 39.07 17.38 60 30013 34649 70863722
Hypopituitarism 38.84 17.38 21 30052 3029 70895342
Intercepted product prescribing error 38.59 17.38 11 30062 278 70898093
Drug ineffective 38.24 17.38 238 29835 939514 69958857
Mean cell haemoglobin concentration decreased 38.13 17.38 23 30050 4080 70894291
Hyperphagia 37.95 17.38 19 30054 2340 70896031
Mean platelet volume increased 37.91 17.38 15 30058 1057 70897314
Diabetes insipidus 37.86 17.38 24 30049 4647 70893724
Haematocrit increased 37.77 17.38 22 30051 3660 70894711
Stomatitis 37.59 17.38 5 30068 128506 70769865
Pulmonary embolism 37.26 17.38 10 30063 155857 70742514
Pleural effusion 36.94 17.38 6 30067 132858 70765513
Renal failure 36.87 17.38 17 30056 189053 70709318
Focal nodular hyperplasia 36.64 17.38 13 30060 676 70897695
Attention deficit hyperactivity disorder 36.46 17.38 20 30053 2967 70895404
Infantile haemangioma 36.44 17.38 6 30067 6 70898365
Respiratory failure 36.43 17.38 13 30060 168722 70729649
Tri-iodothyronine increased 36.32 17.38 10 30063 222 70898149
Seizure 35.84 17.38 160 29913 177802 70720569
Injection site discomfort 35.40 17.38 23 30050 4646 70893725
Therapeutic response unexpected 35.16 17.38 41 30032 18190 70880181
Tri-iodothyronine free increased 35.08 17.38 10 30063 253 70898118
Limb asymmetry 35.06 17.38 12 30061 560 70897811
Delayed puberty 34.89 17.38 9 30064 154 70898217
Platelet count decreased 34.79 17.38 16 30057 178206 70720165
Autism spectrum disorder 34.47 17.38 14 30059 1056 70897315
Gynaecomastia 33.99 17.38 26 30047 6797 70891574
Haemoglobin increased 33.84 17.38 24 30049 5591 70892780
Reaction to preservatives 33.53 17.38 9 30064 181 70898190
Blood cholesterol increased 33.18 17.38 80 29993 64524 70833847
Intentional product misuse 33.07 17.38 91 29982 79504 70818867
Hepatic enzyme increased 32.38 17.38 13 30060 156977 70741394
Blood prolactin increased 32.22 17.38 20 30053 3734 70894637
Hyponatraemic seizure 32.19 17.38 11 30062 511 70897860
Skin odour abnormal 32.17 17.38 16 30057 1943 70896428
Hypokalaemia 32.15 17.38 8 30065 131180 70767191
Sepsis 31.86 17.38 34 30039 244511 70653860
Pain in extremity 31.84 17.38 243 29830 327839 70570532
Cardiac failure congestive 31.79 17.38 9 30064 135448 70762923
Mood swings 31.77 17.38 39 30034 18247 70880124
Cardiac arrest 31.74 17.38 14 30059 159820 70738551
Bradycardia 31.72 17.38 7 30066 124608 70773763
Type 1 diabetes mellitus 31.67 17.38 24 30049 6190 70892181
Carbon dioxide increased 31.52 17.38 16 30057 2029 70896342
Dehydroepiandrosterone increased 31.48 17.38 5 30068 3 70898368
No adverse event 31.27 17.38 52 30021 32101 70866270
Cardiac failure 31.08 17.38 11 30062 143530 70754841
Astrocytoma, low grade 31.01 17.38 8 30065 137 70898234
Deep vein thrombosis 30.90 17.38 5 30068 111037 70787334
Vitamin D deficiency 30.88 17.38 32 30041 12455 70885916
Tendon calcification 30.85 17.38 8 30065 140 70898231
Tonsillar disorder 30.80 17.38 13 30060 1081 70897290
Interstitial lung disease 30.79 17.38 4 30069 104681 70793690
Drug hypersensitivity 30.44 17.38 40 30033 262419 70635952
Empty sella syndrome 30.43 17.38 7 30066 72 70898299
Maternal exposure during pregnancy 30.35 17.38 6 30067 115339 70783032
Alveolar rhabdomyosarcoma 29.86 17.38 6 30067 30 70898341
Systemic lupus erythematosus 29.71 17.38 4 30069 101898 70796473
Blood parathyroid hormone increased 29.71 17.38 18 30055 3219 70895152
Neutrophilic panniculitis 29.52 17.38 7 30066 83 70898288
Blood urea nitrogen/creatinine ratio decreased 29.52 17.38 7 30066 83 70898288
Blood growth hormone increased 29.38 17.38 11 30062 667 70897704
Cardio-respiratory arrest 29.24 17.38 4 30069 100673 70797698
Leukopenia 29.20 17.38 5 30068 106555 70791816
Product quality issue 29.16 17.38 49 30024 30512 70867859
Manufacturing product shipping issue 28.58 17.38 7 30066 96 70898275
Fall 27.77 17.38 96 29977 444000 70454371
Gastrointestinal haemorrhage 27.34 17.38 12 30061 137396 70760975
Crying 27.24 17.38 39 30034 21160 70877211
Septic shock 27.21 17.38 7 30066 112251 70786120
Protein-losing gastroenteropathy 27.18 17.38 10 30063 577 70897794
Talipes 27.18 17.38 7 30066 119 70898252
Medulloblastoma 27.07 17.38 7 30066 121 70898250
Pectus carinatum 27.07 17.38 4 30069 0 70898371
Puberty 27.07 17.38 4 30069 0 70898371
Rash 27.04 17.38 118 29955 510444 70387927
Neuropathy peripheral 27.01 17.38 10 30063 126886 70771485
Pre-existing condition improved 27.01 17.38 20 30053 4982 70893389
Blister 26.93 17.38 5 30068 100521 70797850
Blood chloride decreased 26.75 17.38 24 30049 7826 70890545
Otitis media 26.70 17.38 21 30052 5718 70892653
Migraine 26.52 17.38 79 29994 72159 70826212
Urinary tract infection 25.80 17.38 41 30032 248728 70649643
Eosinophil count increased 25.70 17.38 32 30041 15190 70883181
Syringomyelia 25.61 17.38 7 30066 151 70898220
Monocyte count increased 25.33 17.38 25 30048 9184 70889187
Chills 25.29 17.38 15 30058 144771 70753600
Neurofibromatosis 25.24 17.38 6 30067 72 70898299
Pituitary haemorrhage 25.13 17.38 8 30065 297 70898074
Thirst 25.06 17.38 31 30042 14618 70883753
Human epidermal growth factor receptor decreased 25.05 17.38 5 30068 24 70898347
Total cholesterol/HDL ratio decreased 25.05 17.38 5 30068 24 70898347
Blood corticotrophin increased 24.94 17.38 7 30066 167 70898204
Dehydroepiandrosterone decreased 24.88 17.38 5 30068 25 70898346
Gastrointestinal disorder 24.75 17.38 7 30066 105420 70792951
Therapeutic product effect decreased 24.72 17.38 15 30058 143003 70755368
Obesity 24.32 17.38 42 30031 26729 70871642
Intentional overdose 24.12 17.38 6 30067 98429 70799942
Stubbornness 24.00 17.38 8 30065 344 70898027
Incorrect dosage administered 23.90 17.38 14 30059 2353 70896018
Device operational issue 23.85 17.38 8 30065 351 70898020
Limb deformity 23.68 17.38 16 30057 3449 70894922
Blood pressure decreased 23.58 17.38 5 30068 91510 70806861
Bone sarcoma 23.30 17.38 6 30067 102 70898269
Blood immunoglobulin A increased 23.15 17.38 9 30064 605 70897766
Inability to afford medication 23.09 17.38 13 30060 2028 70896343
Hair growth abnormal 23.07 17.38 14 30059 2511 70895860
Dyspnoea exertional 23.05 17.38 3 30070 78427 70819944
Spinal deformity 23.03 17.38 10 30063 891 70897480
Blood 25-hydroxycholecalciferol increased 23.02 17.38 4 30069 7 70898364
Epiphyses delayed fusion 23.02 17.38 4 30069 7 70898364
Manufacturing product storage issue 23.02 17.38 4 30069 7 70898364
Productive cough 23.02 17.38 3 30070 78334 70820037
Phaeochromocytoma 22.99 17.38 9 30064 616 70897755
Total cholesterol/HDL ratio increased 22.55 17.38 7 30066 239 70898132
Mean cell volume decreased 22.47 17.38 17 30056 4373 70893998
Blood growth hormone abnormal 22.44 17.38 5 30068 44 70898327
Viral infection 22.41 17.38 50 30023 38341 70860030
Cholesteatoma 22.34 17.38 6 30067 121 70898250
Product dispensing issue 22.34 17.38 6 30067 121 70898250
Exposure during pregnancy 22.18 17.38 5 30068 87712 70810659
Vitamin B12 increased 21.89 17.38 9 30064 700 70897671
Enchondromatosis 21.77 17.38 5 30068 51 70898320
Avulsion fracture 21.76 17.38 7 30066 269 70898102
Product distribution issue 21.61 17.38 10 30063 1035 70897336
Joint swelling 21.60 17.38 47 30026 253164 70645207
Delirium 21.58 17.38 3 30070 74611 70823760
Anti-thyroid antibody positive 21.48 17.38 8 30065 478 70897893
Gastroenteritis viral 21.27 17.38 35 30038 21420 70876951
Loss of personal independence in daily activities 21.15 17.38 5 30068 84905 70813466
Blood sodium decreased 21.13 17.38 43 30030 30955 70867416
Renal impairment 21.08 17.38 18 30055 143919 70754452
Injection site mass 21.05 17.38 32 30041 18311 70880060
Hypoglycaemic seizure 21.04 17.38 9 30064 773 70897598
Plasma cell myeloma 21.04 17.38 3 30070 73198 70825173
Perthes disease 20.84 17.38 4 30069 15 70898356
Hypertrophic cardiomyopathy 20.82 17.38 12 30061 1958 70896413
Psoriasis 20.54 17.38 8 30065 98425 70799946
Chronic obstructive pulmonary disease 20.50 17.38 4 30069 77637 70820734
Primary hypogonadism 20.36 17.38 6 30067 171 70898200
Chest pain 20.32 17.38 48 30025 251212 70647159
Adipomastia 20.30 17.38 3 30070 0 70898371
Bilateral breast buds 20.30 17.38 3 30070 0 70898371
Rathke's cleft cyst 20.30 17.38 3 30070 0 70898371
Acquired syringomyelia 20.30 17.38 3 30070 0 70898371
Device electrical finding 20.20 17.38 6 30067 176 70898195
Chest discomfort 20.19 17.38 14 30059 124367 70774004
Glucocorticoid deficiency 20.13 17.38 8 30065 570 70897801
Ependymoma malignant 20.08 17.38 4 30069 19 70898352
Acanthosis nigricans 20.07 17.38 6 30067 180 70898191
Otitis media acute 20.07 17.38 10 30063 1219 70897152
C-reactive protein increased 19.94 17.38 11 30062 110506 70787865
Disease recurrence 19.77 17.38 47 30026 37556 70860815
Developmental hip dysplasia 19.73 17.38 6 30067 191 70898180
Glioblastoma 19.56 17.38 11 30062 1713 70896658
Thyroid hormones decreased 19.49 17.38 7 30066 377 70897994
Pharyngitis streptococcal 19.48 17.38 22 30051 9426 70888945
Multiple use of single-use product 19.46 17.38 8 30065 622 70897749
Arthropathy 19.38 17.38 21 30052 150036 70748335
Blood luteinising hormone increased 19.32 17.38 6 30067 205 70898166
Optic glioma 19.31 17.38 5 30068 87 70898284
Dysphagia 19.27 17.38 12 30061 112822 70785549
Dehydration 19.26 17.38 42 30031 226100 70672271
Neoplasm 19.25 17.38 20 30053 7804 70890567
Accidental exposure to product 19.22 17.38 39 30034 28012 70870359
Suicide attempt 19.18 17.38 5 30068 79505 70818866
Knee deformity 18.94 17.38 9 30064 989 70897382
Ascites 18.88 17.38 3 30070 67544 70830827
Aural polyp 18.80 17.38 5 30068 97 70898274
Erythema 18.76 17.38 35 30038 199528 70698843
High density lipoprotein increased 18.60 17.38 9 30064 1030 70897341
Cough 18.56 17.38 73 30000 325304 70573067
Coma 18.30 17.38 8 30065 91836 70806535
Pulmonary artery atresia 18.22 17.38 3 30070 3 70898368
Fear of injection 18.14 17.38 18 30055 6654 70891717
Oesophageal disorder 18.05 17.38 12 30061 2518 70895853
Lactic acidosis 17.93 17.38 3 30070 65021 70833350
Multiple organ dysfunction syndrome 17.90 17.38 12 30061 108503 70789868
Psoriatic arthropathy 17.83 17.38 3 30070 64768 70833603
LDL/HDL ratio increased 17.76 17.38 3 30070 4 70898367
Prolactin-producing pituitary tumour 17.59 17.38 5 30068 125 70898246
Mobility decreased 17.52 17.38 11 30062 102988 70795383
Encopresis 17.48 17.38 5 30068 128 70898243
Mean cell haemoglobin concentration increased 17.46 17.38 8 30065 810 70897561

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
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