Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Somatropin
Drug ID BADD_D02055
Description Human growth hormone (HGH), also known as somatotropin, is a peptide hormone that is synthesized and secreted by the somatotropic cells of the anterior pituitary gland.[A228183] Growth hormone plays an essential role in growth regulation during childhood as well as other basal metabolic functions, muscle and fat mass regulation, blood glucose level regulation, and lipid regulation in both children and adults.[A228183, L31508] Synthesized in a strain of _Escherichia coli_, recombinant HGH is a polypeptide hormone that contains 191 amino acid residues with a molecular weight of 22 kDa. It has an identical primary protein structure to endogenous human growth hormone.[A228188] Recombinant HGH has been commercially available since 1985 after its development by Genentech. [Somatrem] was the first available recombinant HGH and was largely replaced by somatropin, another form of recombinant HGH.[A228183] Growth hormone therapy is approved for various disorders of growth hormone deficiency, growth failure, or short stature including Turner syndrome, chronic renal insufficiency before transplantation, Prader-Willi syndrome, a history of fetal growth restriction, short stature homeobox (SHOX) haploinsufficiency, Noonan syndrome, idiopathic short stature, and adult- or childhood-onset growth hormone deficiency.[A228188] Recombinant growth hormone is available as a subcutaneous injection for children and adults under a wide variety of brand names.
Indications and Usage Somatotropin is indicated for the treatment of pediatric patients who have growth failure due to an inadequate secretion of endogenous growth hormone, short stature associated with Turner syndrome, Prader-Willi syndrome (PWS), idiopathic short stature (ISS), short stature or growth failure in short stature homeobox-containing gene (SHOX) deficiency, and short stature born small for gestational age (SGA).[L31513, L31518] It is indicated for the treatment of growth failure in children associated with chronic kidney disease up to the time of renal transplantation.[L31523] It is also indicated for adults with adult-onset growth hormone deficiency, either alone or associated with multiple hormone deficiencies (hypopituitarism), as a result of pituitary disease, hypothalamic disease, surgery, radiation therapy, or trauma. It is also used to treat childhood-onset growth hormone deficiency in adults due to congenital, genetic, acquired, or idiopathic causes.[L31518] Somatotropin is indicated for the treatment of wasting or cachexia in patients with human immunodeficiency virus (HIV) who are receiving antiretroviral therapy to increase lean body mass and body weight and improve physical endurance.[L31498] Somatotropin is indicated for the treatment of short bowel syndrome in adult patients receiving specialized nutritional support.[L31493]
Marketing Status approved; investigational
ATC Code H01AC01
DrugBank ID DB00052
KEGG ID D02691
MeSH ID D019382
PubChem ID Not Available
TTD Drug ID D09DMQ
NDC Product Code 0169-7703; 50242-075; 44087-3388; 55566-1901; 44087-0006; 0013-2653; 0013-2654; 0013-2655; 0002-8148; 0781-4004; 0169-7704; 0169-7705; 0002-8147; 0002-8149; 50242-931; 44087-0004; 44087-0005; 0013-2650; 0013-2652; 0781-3001; 0781-3004; 0013-2656; 68594-040; 44087-1088; 0169-7708; 0013-2646; 0013-2649; 0013-2651; 50242-076; 0013-2626; 0013-2657; 0013-2658; 50242-074; 62287-190; 44087-1005; 55566-1801
UNII NQX9KB6PCL
Synonyms Human Growth Hormone | Growth Hormone, Human | hGH (Human Growth Hormone) | Somatropin (Human) | Somatotropin (Human) | Somatropin | Serostim | Zomacton | Cryo-Tropin | Cryo Tropin | CryoTropin | Recombinant Human Growth Hormone (Mammalian) | r-hGH-M | r-hGH(m) | Humatrope | Umatrope | Maxomat | Norditropin | Norditropin Simplexx | Norditropine | Nutropin | Omnitrope | Saizen | Genotropin | Genotonorm
Chemical Information
Molecular Formula Not Available
CAS Registry Number 12629-01-5
SMILES Not Available
Chemical Structure
ADRs Induced by Drug
*The priority for ADR severity classification is based on FAERS assessment, followed by the most severe level in CTCAE rating. If neither is available, it will be displayed as 'Not available'.
**The 'Not Available' level is hidden by default and can be restored by clicking on the legend twice..
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Abdominal distension07.01.04.001--
Abdominal pain07.01.05.002--
Alopecia23.02.02.001--
Arthralgia15.01.02.001--
Arthritis15.01.01.001--
Arthropathy15.01.01.003--Not Available
Back pain15.03.04.005--
Breast enlargement21.05.04.001--Not Available
Breast pain21.05.05.003--
Bronchospasm10.01.03.012; 22.03.01.004--
Bursitis12.04.03.010; 15.04.01.001--Not Available
Chest pain22.12.02.003; 08.01.08.002; 02.02.02.011--Not Available
Chills08.01.09.001; 15.05.03.016--
Constipation07.02.02.001--
Crohn's disease10.02.01.005; 07.08.01.015--Not Available
Dehydration14.05.05.001--
Depression19.15.01.001--
Dermatitis bullous23.03.01.002--
Dizziness17.02.05.003; 02.11.04.006; 24.06.02.007--
Dry mouth07.06.01.002--
Dyspnoea02.11.05.003; 22.02.01.004--
Dysuria20.02.02.002--
Ear disorder04.03.01.001--Not Available
Face oedema23.04.01.004; 10.01.05.002; 08.01.07.003--
Fatigue08.01.01.002--
Flatulence07.01.04.002--
Fungal infection11.03.05.001--Not Available
Gastric ulcer07.04.03.002--
Gastrointestinal fistula07.11.05.001--
Generalised oedema14.05.06.007; 08.01.07.004--
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