Somatropin

Somatropin binds to dimeric GH receptors located within the cell membranes of target tissue cells. This interaction results in intracellular signal transduction and subsequent induction of transcription and translation of GH-dependent proteins including IGF-1, IGF BP-3 and acid-labile subunit.

• NORDITROPIN is a recombinant human growth hormone indicated for: • Pediatric : Treatment of pediatric patients with growth failure due to inadequate secretion of endogenous growth hormone (GH), short stature associated with Noonan syndrome, short stature associated with Turner syndrome, short stature born small for gestational age (SGA) with no catch-up growth by age 2 to 4 years, Idiopathic Short Stature (ISS), and growth failure due to Prader-Willi Syndrome ( 1.1 ) • Adult : Replacement of endogenous GH in adults with growth hormone deficiency ( 1.2 ) 1.1 Pediatric Patients NORDITROPIN is indicated for the treatment of pediatric patients with: • growth failure due to inadequate secretion of endogenous growth hormone (GH), • short stature associated with Noonan syndrome, • short stature associated with Turner syndrome, • short stature born small for gestational age (SGA) with no catch-up growth by age 2 years to 4 years of age, • Idiopathic Short Stature (ISS), height standard deviation score (SDS) <-2.25, and associated with growth rates unlikely to permit attainment of adult height in the normal range, • growth failure due to Prader-Willi syndrome (PWS).

• NORDITROPIN is contraindicated in patients with: • Acute critical illness after open heart surgery, abdominal surgery or multiple accidental trauma, or those with acute respiratory failure due to the risk of increased mortality with use of pharmacologic doses of somatropin [see Warnings and Precautions (5.1) ]. • Pediatric patients with Prader-Willi syndrome who are severely obese, have a history of upper airway obstruction or sleep apnea, or have severe respiratory impairment due to the risk of sudden death [see Warnings and Precautions (5.2) ].contraindicated

• Administer by subcutaneous injection to the back of upper arm, abdomen, buttock, or thigh with regular rotation of injection sites ( 2.1 ) • Pediatric Dosage - divide the calculated weekly dosage into equal doses given either 6, or 7 days per week o GHD: 0.17 mg/kg/week to 0.24 mg/kg/week( 2.2 ) o Noonan Syndrome: Up to 0.46 mg/kg/week ( 2.2 ) o Turner Syndrome: Up to 0.47 mg/kg/week ( 2.2 ) o SGA: Up to 0.47 mg/kg/week ( 2.2 ) o ISS: Up to 0.47 mg/kg/week ( 2.2 ) o Prader-Willi Syndrome: 0.24 mg/kg/week ( 2.2 ) o Adult Dosage: Either of the following two dosing regimens may be used: o Non-weight based dosing: Initiate with a dose of approximately 0.2 mg/day (range, 0.15 mg/day-0.3 mg/day) and increase the dose every 1-2 months by increments of approximately 0.1 mg/day-0.2 mg/day, according to individual patient requirements ( 2.3 ) o Weight-based dosing (Not recommended for obese patients): Initiate at 0.004 mg/kg daily and increase the dose according to individual patient requirements to a maximum of 0.016 mg/kg daily ( 2.3 ) 2.1 Administration and Use Instructions • Therapy with NORDITROPIN should be supervised by a physician who is experienced in the diagnosis and management of patients with the conditions for which NORDITROPIN is indicated [see Indications and Usage (1) ]. • Fundoscopic examination should be performed routinely before initiating treatment with NORDITROPIN to exclude preexisting papilledema, and periodically thereafter [see Warnings and Precautions (5.5) ].

• Increased Risk of Neoplasms : Second neoplasms have occurred in childhood cancer survivors. Monitor patients with preexisting tumors for progression or recurrence. ( 5.3 ) • Glucose Intolerance and Diabetes Mellitus : NORDITROPIN may decrease insulin sensitivity, particularly at higher doses. Monitor glucose levels periodically in all patients receiving NORDITROPIN, especially in patients with existing diabetes mellitus or at risk for development. ( 5.4 ) • Intracranial Hypertension (IH) : Has been reported usually within 8 weeks of initiation. Perform fundoscopic examinations prior to initiation and periodically thereafter. If papilledema occurs, stop treatment. ( 5.5 ) • Severe Hypersensitivity : Serious hypersensitivity reactions may occur. In the event of an allergic reaction, seek prompt medical attention. ( 5.6 ) • Fluid Retention : May occur in adults and may be dose dependent. ( 5.7 ) • Hypoadrenalism : Monitor patients for reduced serum cortisol levels and/or need for glucocorticoid dose increases in those with known hypoadrenalism. ( 5.8 ) • Hypothyroidism : Monitor thyroid function periodically as hypothyroidism may occur or worsen after initiation of somatropin. ( 5.9 ) • Slipped Capital Femoral Epiphysis in Pediatric Patients : May occur; evaluate patients with onset of a limp or hip/knee pain. ( 5.10 ) • Progression of Preexisting Scoliosis in Pediatric Patients : Monitor patients with scoliosis for progression. ( 5.11 ) • Pancreatitis : Has been reported; consider pancreatitis in patients with abdominal pain, especially pediatric patients.

The following important adverse reactions are also described elsewhere in the labeling: • Increased mortality in patients with acute critical illness [see Warnings and Precautions (5.1) ] • Sudden death in children with Prader-Willi syndrome [see Warnings and Precautions (5.2) ] • Neoplasms [see Warnings and Precautions (5.3) ] • Glucose intolerance and diabetes mellitus [see Warnings and Precautions (5.4) ] • Intracranial hypertension [see Warnings and Precautions (5.5) ] • Severe hypersensitivity [see Warnings and Precautions (5.6) ] • Fluid retention [see Warnings and Precautions (5.7) ] • Hypoadrenalism [see Warnings and Precautions (5.8) ] • Hypothyroidism [see Warnings and Precautions (5.9) ] • Slipped capital femoral epiphysis in pediatric patients [see Warnings and Precautions (5.10) ] • Progression of preexisting scoliosis in pediatric patients [see Warnings and Precautions (5.11) ] • Pancreatitis [see Warnings and Precautions (5.12) ] • Lipoatrophy [see Warnings and Precautions (5.13) ] Common adverse reactions in adult and pediatric patients include: upper respiratory infection, fever, pharyngitis, headache, otitis media, edema, arthralgia, paresthesia, myalgia, peripheral edema, flu syndrome, and impaired glucose tolerance. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Novo Nordisk at 1-888-NOVO-444 (1-888-668-6444) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

8.1 Pregnancy Risk Summary Limited available data with somatropin use in pregnant women are insufficient to determine a drug-associated risk of adverse developmental outcomes. In animal reproduction studies, there was no evidence of fetal or neonatal harm when pregnant rats were administered subcutaneous NORDITROPIN during organogenesis or during lactation at doses approximately 10-times higher than the maximal clinical dose of 0.016 mg/kg, based on body surface area (see Data). The estimated background risk of birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. Data Animal Data In an embryo-fetal development study, NORDITROPIN was administered via subcutaneous injection to pregnant rats from gestation Day 6 to 17, corresponding with the period of organogenesis. NORDITROPIN did not adversely affect fetal viability or developmental outcomes at maternal doses that were approximately 10-times the clinical dose of 0.016 mg/kg, based on body surface area. In a pre- and post-natal development study in pregnant rats, NORDITROPIN was administered from gestation Day 17 through lactation Day 21 (weaning).

Metabolism

Absorption - Somatropin has been studied following subcutaneous and intravenous administration in adult healthy subjects and GHD patients. A single dose administration of 4 mg NORDITROPIN in healthy subjects (n=26) with suppressed endogenous growth hormone resulted in a mean (SD) C max of 34.9 (10.4) ng/mL after approximately 3.0 hours.

Short-term overdosage could lead initially to hypoglycemia and subsequently to hyperglycemia. Overdose with somatropin is likely to cause fluid retention. Long-term overdosage could result in signs and symptoms of gigantism and/or acromegaly consistent with the known effects of excess growth hormone .

• Oct 16, 1986BLABLA019640Lilly
• May 25, 1995BLABLA019774Ferring
• Aug 24, 1995BLABLA020280Pharmacia
• Aug 23, 1996BLABLA020604Emd Serono
• Jun 20, 2000BLABLA021148Novo Nordisk Inc
• May 30, 2006BLABLA021426Sandoz

Reference statistics from the openFDA drug-shortage dataset. For a live view, consult the FDA database directly. Not clinical guidance.

• Norditropin, Injection, 30 mg/3 mL (NDC 0169-7703-21)To be discontinued
  Sponsor: Novo Nordisk, Inc.
  Updated Nov 14, 2025

1. 1Drug Dose Omission By Device17,45524%
2. 2Device Leakage10,15714%
3. 3Device Breakage9,08913%
4. 4Device Mechanical Issue7,25110%
5. 5Device Information Output Issue6,0428.5%
6. 6Device Issue5,4157.6%
7. 7Wrong Technique In Device Usage Process4,8906.8%
8. 8Injection Site Pain3,6405.1%
9. 9Poor Quality Device Used3,2054.5%
10. 10Device Use Error3,1314.4%
11. 11Incorrect Dose Administered2,7863.9%
12. 12Device Physical Property Issue2,7553.9%
13. 13Device Use Issue2,7263.8%
14. 14Incorrect Dose Administered By Device2,7263.8%
15. 15Device Malfunction2,3013.2%

Recent PubMed references pinned to Somatropin as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

• Growth hormone therapy after hematopoietic cell transplantation in childhood: a nationwide survey and longitudinal cohort study.
  Frontiers in endocrinology · 2026 · Shimomura M, Kawaguchi H, Inoue E, et al.
  PMID 42244940DOI 10.3389/fendo.2026.1831711
• Growth hormone therapy and near-final height in SHOX deficiency and turner syndrome: a real-world single-center retrospective cohort study.
  European journal of pediatrics · 2026 · Oktay MA, Döğer E, Uğurlu AK, et al.
  PMID 42243538DOI 10.1007/s00431-026-07135-7
• Treatment with long-acting growth hormone: effectiveness and safety.
  Frontiers in endocrinology · 2026 · Basile L, Cannarella R, Condorelli RA, et al.
  PMID 42238247DOI 10.3389/fendo.2026.1818944
• Speckle-tracking echocardiography reveals the synergistic impact of GH/IGF-1 excess and metabolic dysregulation on cardiac dysfunction in acromegaly.
  Pituitary · 2026 · Chen M, Zhang P, He W, et al.
  PMID 42213228DOI 10.1007/s11102-026-01684-8
• Can long-acting growth hormone improve adherence in pediatric growth hormone deficiency?
  Endocrine · 2026 · Rodaro C, Tamaro G, Fachin A, et al.
  PMID 42209878DOI 10.1007/s12020-026-04661-0
• Is Somatrogon different? 6-month clinical outcomes and follow-up data in Turkish children transitioned from Somatropin to Somatrogon.
  Growth hormone & IGF research : official journal of the Growth Hormone Research Society and the International IGF Research Society · 2026 · Atas N, Kılçık RD, Melik FÇ, et al.
  PMID 42190542DOI 10.1016/j.ghir.2026.101705
• Growth Hormone-Mediated Diabetic Ketoacidosis: A Rare Presentation of Acromegaly.
  Acta medica (Hradec Kralove) · 2026 · Polamuang W, Angsuwatcharakorn T, Santisukwongchote S, et al.
  PMID 42186927DOI 10.14712/18059694.2026.14
• Prevalence and patterns of biochemical discordance in patients with surgically treated acromegaly.
  Pituitary · 2026 · Pennlund A, Olsson Bontell T, Skoglund T, et al.
  PMID 42177388DOI 10.1007/s11102-026-01694-6

The 10 most recently updated of 813 ClinicalTrials.gov registrations naming Somatropin as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• AAVrh10-PCCA Gene Therapy for Propionic Acidemia
  Not yet recruiting · Phase 1 · Interventional · 9 enrolled · Mayo Clinic
  NCT07643844updated 2026-06-12
• A Research Study to Compare Somapacitan Once a Week With Norditropin® Once a Day in Children Who Need Help to Grow
  Active not recruiting · Phase 3 · Interventional · 412 enrolled · Novo Nordisk A/S
  NCT05330325updated 2026-06-12
• Growth Hormone Administration and the Human Immune System
  Completed · Phase 1 · Interventional · 66 enrolled · National Institute on Aging (NIA)
  NCT00663611updated 2026-06-12
• A Study to Follow Patients With Adult Growth Hormone Deficiency (AGHD) Treated With Sogroya® for Long Term Safety Information
  Enrolling by invitation · Observational · 400 enrolled · Novo Nordisk A/S
  NCT05718570updated 2026-06-12
• ACRODAT Prospective Evaluation Study
  Completed · Observational · 500 enrolled · University of Aarhus
  NCT04349839updated 2026-06-11
• GB06 Phase III Trial for Pediatric Growth Hormone Deficiency
  Recruiting · Phase 3 · Interventional · 192 enrolled · Kexing Biopharm Co., Ltd.
  NCT07553351updated 2026-06-10
• A Research Study in Children Born Small and Who Stayed Small. Treatment is Somapacitan Once a Week Compared to Norditropin® Once a Day
  Active not recruiting · Phase 2 · Interventional · 62 enrolled · Novo Nordisk A/S
  NCT03878446updated 2026-06-10
• Phase 3 Study of LUM-201 in Children With Growth Hormone Deficiency
  Recruiting · Phase 3 · Interventional · 150 enrolled · Lumos Pharma
  NCT06948214updated 2026-06-09
• A Study to Learn About Somatrogon in Patients With Pediatric Growth Hormone Deficiency (p GHD) in India.
  Recruiting · Observational · 50 enrolled · Pfizer
  NCT06587035updated 2026-06-05
• Albright Hereditary Osteodystrophy: Natural History, Growth, and Cognitive/Behavioral Assessments
  Active not recruiting · Interventional · 600 enrolled · Connecticut Children's Medical Center
  NCT00209235updated 2026-06-02

Frequently asked questions

How does Somatropin work?

Somatropin binds to dimeric GH receptors located within the cell membranes of target tissue cells. This interaction results in intracellular signal transduction and subsequent induction of transcription and translation of GH-dependent proteins including IGF-1, IGF BP-3 and acid-labile subunit.

What is Somatropin used for?

According to FDA labeling, Somatropin carries indications including: NORDITROPIN is a recombinant human growth hormone indicated for: • Pediatric : Treatment of pediatric patients with growth failure due to inadequate secretion of endogenous growth hormone (GH), short stature associated with Noonan syndrome, short stature associated with Turner syndrome, short stature born small for gestational age (SGA) with no catch-up growth by age 2 to 4 years, Idiopathic Short Stature (ISS), and growth failure due to Prader-Willi Syndrome ( 1.1 ) • Adult : Replacement of endogenous GH in adults with growth hormone deficiency ( 1.2 ) 1.1 Pediatric Patients NORDITROPIN is indicated for the treatment of pediatric patients with: • growth failure due to inadequate secretion of endogenous growth hormone (GH), • short stature associated with Noonan syndrome, • short stature associated with Turner syndrome, • short stature born small for gestational age (SGA) with no catch-up growth by age 2 years to 4 years of age, • Idiopathic Short Stature (ISS), height standard deviation score (SDS) <-2.25, and associated with growth rates unlikely to permit attainment of adult height in the normal range, • growth failure due to Prader-Willi syndrome (PWS).. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Somatropin?

Somatropin is classified as Somatropin and somatropin agonists, Recombinant Human Growth Hormone, Growth Hormone Receptor Agonists, Pituitary Hormone Receptor Agonists, Bone Formation Stimulation, Increased Erythroid Cell Production, Increased Lipolysis, Increased Protein Synthesis.

What are the brand names for Somatropin?

Somatropin is marketed under brand names including Genotropin, Humatrope, Norditropin, Nutropin, Omnitrope, Saizen, Serostim, Zomacton.

What are the contraindications for Somatropin?

Somatropin labeling lists contraindications including: NORDITROPIN is contraindicated in patients with: • Acute critical illness after open heart surgery, abdominal surgery or multiple accidental trauma, or those with acute respiratory failure due to the risk of increased mortality with use of pharmacologic doses of somatropin [see Warnings and Precautions (5.1) ]. • Pediatric patients with Prader-Willi syndrome who are severely obese, have a history of upper airway obstruction or sleep apnea, or have severe respiratory impairment due to the risk of sudden death [see Warnings and Precautions (5.2) ].. Always consult the full prescribing information and a clinician.