Evigrade

Somatropin

AEMPS

Recombinant human growth hormone

ATC code: H01AC01

Brand names: Genotonorm, Norditropin, Saizen

Updated · Methodology

Indications

A

Growth hormone deficiency

First line

Confirmed growth hormone deficiency in children and adults, Turner syndrome, chronic kidney disease in children with growth failure, Prader-Willi syndrome, SHOX deficiency, and idiopathic short stature per criteria. Per SEEN 2022 and ES 2019, the indication requires two stimulation tests by an endocrinologist. Dose: children 0.025–0.05 mg/kg/day, adults 0.15–0.3 mg/day with gradual titration by IGF-1. Subcutaneous injections in the evening.

ICD-10: E23.0 · ICD-11: 5A61.3

Marketing claims without evidence base

The drug is promoted for these uses outside international guidelines. Each entry below is analyzed against AEMPS, FDA, EMA, Cochrane and major RCTs.

D

Anti-aging and longevity

Not recommended

Somatropin is heavily marketed in anti-aging clinics and the fitness industry as a rejuvenation, muscle-building, and fat-burning drug. In the US, EU, and Russia, prescribing it outside pediatrics and confirmed adult deficiency is prohibited. The Endocrine Society 2019, AACE 2019, and SEEN 2022 explicitly state: in people with normal GH secretion the drug does not work as a rejuvenator – the Rudman 1990 study cited by sellers showed transient lean-mass gain alongside edema, insulin resistance, and tumor risk. In athletes somatropin is on the WADA prohibited list. If prescribed for rejuvenation or quality of life without confirmed deficiency by two stimulation tests, consider getting a second opinion from an independent endocrinologist.

How to read tiers A–F
  • AStrong evidence – first or second line in international guidelines
  • BRecommended in selected cases
  • CStudy data contradict each other
  • DBenefit not proven, no documented harm
  • FDocumented harm, or risk without benefit

Mechanism of action

Somatropin is identical to endogenous pituitary growth hormone. Binds receptors in liver and peripheral tissues, triggers IGF-1 synthesis – the main mediator of anabolic effects: stimulates cartilage and bone growth at the epiphyses, increases protein synthesis and lipolysis. In adults maintains lean mass and bone density. Half-life 2–3 hours after subcutaneous injection; IGF-1 effect persists 24 hours.

Safety

Contraindications

  • Hypersensitivity to somatropin or excipients
  • Active malignancy
  • Closed epiphyses (for growth indication in children)
  • Acute critical illness (post-cardiac surgery, severe trauma, respiratory failure)
  • Proliferative diabetic retinopathy
  • Prader-Willi syndrome with severe obesity or respiratory failure

Serious adverse effects

  • Intracranial hypertension (especially in children during first weeks)
  • Scoliosis progression in growing children
  • Slipped capital femoral epiphysis in adolescents
  • Acute pancreatitis
  • Increased risk of tumor recurrence in patients with prior malignancy
  • Heart failure with excessive dosing

Common adverse effects

  • Injection-site reactions
  • Arthralgia and myalgia
  • Peripheral edema
  • Headache
  • Carpal tunnel syndrome
  • Insulin resistance with elevated glucose
  • Hypothyroidism

Pregnancy: can you take Somatropin?

Use in pregnancy is limited. In adult women, therapy is usually discontinued upon confirmed pregnancy. In hypopituitarism with hydrocortisone and L-thyroxine replacement, somatropin is managed individually with the endocrinologist.

Breastfeeding: can you take Somatropin?

Data limited. Hale L3. Somatropin is a large protein with negligible milk transfer and is destroyed in the infant's GI tract. If therapy is necessary, breastfeeding is usually compatible under endocrinologist supervision.

Reference information, not a clinical decision. Discuss feeding pauses or changes with your physician or an IBCLC.

Practical notes

Monitoring

IGF-1 at 1–2 months after start or dose change, then every 6–12 months. In children: growth velocity every 3–6 months, hand X-ray for bone age yearly. Fasting glucose and every 6–12 months. TSH and cortisol – screen for secondary thyroid and adrenal insufficiency (somatropin can mask these).

Timing and administration

Subcutaneously in the evening to mimic the physiological nocturnal peak. Rotate injection sites (abdomen, thigh, arm) – prevents lipodystrophy. Store at 2–8 °C.
Label mentions13 mentions

Verbatim lines from the interaction sections, in the language of the label

From this drug’s label

  • Moderateantidiabeticsclass named in the label
    «DRUG INTERACTIONS: Insulin and/or Other Hypoglycemic Agents: Dose adjustment of insulin or hypoglycemic agent may be required. ( 5.4 , 7 )»

    FDA, section 7 · Open on DailyMed

  • Moderatecorticosteroidesclass named in the label
    «El tratamiento concomitante con glucocorticoides inhibe el efecto promotor del crecimiento de los medicamentos que contienen somatropina. En los pacientes con deficiencia de hormona…»

    AEMPS, section 4.5 · Open on CIMA

  • Moderatecorticosteroidsclass named in the label
    «DRUG INTERACTIONS: Intervention: Carefully adjust glucocorticoid dosing in pediatric patients receiving glucocorticoid treatments to avoid both hypoadrenalism and an inhibitory effect on growth.»

    FDA, section 7 · Open on DailyMed

  • Moderateinsulinclass named in the label
    «DRUG INTERACTIONS: Insulin and/or Other Hypoglycemic Agents: Dose adjustment of insulin or hypoglycemic agent may be required. ( 5.4 , 7 )»

    FDA, section 7 · Open on DailyMed

  • antiepilépticosclass named in the label
    «Los datos de un estudio de interacción realizado en adultos con deficiencia de hormona de crecimiento, sugieren que la administración de somatropina puede aumentar el aclaramiento de compuestos…»

    AEMPS, section 4.5 · Open on CIMA

  • «Los datos de un estudio de interacción realizado en adultos con deficiencia de hormona de crecimiento, sugieren que la administración de somatropina puede aumentar el aclaramiento de compuestos…»

    AEMPS, section 4.5 · Open on CIMA

  • «DRUG INTERACTIONS: Examples: Cortisone acetate and prednisone may be effected more than others since conversion of these drugs to their biologically active metabolites is dependent on the activity of…»

    FDA, section 7 · Open on DailyMed

From other drugs’ labels

  • «Somatropina: Puede reducirse el efecto de la somatropina.»

    AEMPS, section 4.5 · Open on CIMA

  • ModerateGlimepiride
    «Drugs Affecting Glucose Metabolism: A number of medications affect glucose metabolism and may require glimepiride dose adjustment and particularly close monitoring for hypoglycemia or worsening…»

    FDA, section 7 · Open on DailyMed

  • «DRUG INTERACTIONS: Drugs: Atypical antipsychotics (e.g., olanzapine and clozapine), corticosteroids, danazol, diuretics, estrogens, glucagon, isoniazid, niacin, oral contraceptives, phenothiazines…»

    FDA, section 7 · Open on DailyMed

  • «Las sustancias que podrían disminuir la actividad reductora del nivel de glucosa en sangre incluyen corticoides, danazol, diazóxido, diuréticos, glucagón, isoniazida, derivados de la fenotiazina…»

    AEMPS, section 4.5 · Open on CIMA

  • «- Somatropina: el efecto puede verse atenuado por un tratamiento de larga duración.»

    AEMPS, section 4.5 · Open on CIMA

  • «DRUG INTERACTIONS: Examples: Atypical antipsychotics (e.g., olanzapine and clozapine), calcium channel antagonists, corticosteroids, danazol, diuretics, estrogens, glucagon, isoniazid, niacin, oral…»

    FDA, section 7 · Open on DailyMed

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Frequently asked

What is Somatropin used for?

Somatropin is evaluated for the following indications with varying evidence strength: Growth hormone deficiency (evidence tier A), Anti-aging and longevity (evidence tier D). See the full indication matrix with dosing and citations above on this page.

What are the side effects of Somatropin?

Common side effects of Somatropin (≥ 1 in 100): Injection-site reactions, Arthralgia and myalgia, Peripheral edema, Headache, Carpal tunnel syndrome, Insulin resistance with elevated glucose. See the Safety section for uncommon and serious reactions.

Is Somatropin safe during pregnancy?

Use in pregnancy is limited. In adult women, therapy is usually discontinued upon confirmed pregnancy. In hypopituitarism with hydrocortisone and L-thyroxine replacement, somatropin is managed individually with the endocrinologist.

Is Somatropin compatible with breastfeeding?

Data limited. Hale L3. Somatropin is a large protein with negligible milk transfer and is destroyed in the infant's GI tract. If therapy is necessary, breastfeeding is usually compatible under endocrinologist supervision.

Who should not take Somatropin?

Somatropin is contraindicated in: Hypersensitivity to somatropin or excipients; Active malignancy; Closed epiphyses (for growth indication in children); Acute critical illness (post-cardiac surgery, severe trauma, respiratory failure); Proliferative diabetic retinopathy. Full list in the Safety section.

Official sources

Direct links to regulator labels. Open in a new tab.

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