Yes, SKYTROFA is safe and effective when used as prescribed under medical supervision for growth hormone deficiency (GHD) in children and adults, although it also carries important risks and side effects which include viral infections, fever, cough, nausea, vomiting, diarrhea, stomach pain, bleeding, and joint pain or arthritis in children and swelling due to fluid build-up (edema) and low thyroid hormone (hypothyroidism).
The serious risks and warnings of SKYTROFA include:
Fluid retention: Excess fluid in the body can cause swelling in the hands and feet, joint or muscle pain, or nerve compression (carpal tunnel-like symptoms).
Intracranial hypertension: Increased pressure in the skull, presenting with headaches, visual changes, nausea, or vomiting.
Glucose changes: May decrease insulin sensitivity, potentially raising blood sugar levels or affecting diabetes management.
Endocrine impacts: Can unmask central hypoadrenalism or lower thyroid hormone levels, requiring regular lab monitoring.
Bone and joint issues: In children undergoing rapid growth, slipping of the hip bone growth plate (slipped capital femoral epiphysis) or worsening scoliosis can occur.
Other risks: Pancreatitis, severe allergic reactions, or potential tumor growth/recurrence.
Those who should NOT take SKYTROFA include:
Patients with an active cancer or tumor.
Children with closed bone growth plates.
Individuals with severe acute illness following open heart surgery, abdominal surgery, trauma, or acute breathing failure.
People with diabetic retinopathy (eye damage from diabetes)
Those with a known allergy to somatropin or SKYTROFA ingredients.
Severely obese children with Prader-Willi syndrome or severe breathing problems/sleep apnea.
SKYTROFA is approved for adults as well as children 1 year of age and older who weigh at least 25.4 lbs, by the U.S. Food and Drug Administration with growth hormone deficiency or (GHD).
SKYTROFA is used for the replacement of endogenous growth hormone in adults with GHD (as well as in pediatric patients aged 1 year and older who weigh at least 11.5 kg / 26 lbs).
SKYTROFA is a once weekly subcutaneous injection delivered via a dedicated auto-injector.
The FDA expanded the label to include adult GHD on July 28, 2025, following the Phase 3 foresiGHt clinical trial.
The side effects of SKYTROFA include viral infections, fever (pyrexia), cough, nausea and vomiting, diarrhea, stomach (abdominal) area pain, bleeding (hemorrhage), joint pain (arthralgia), and arthritis, as well as mild injection-site reactions in children.
And in adults the side effects of SKYTROFA include swelling due to fluid build-up (edema) and low thyroid hormone levels (hypothyroidism), along with joint pain, numbness, and dizziness.
Serious side effects of SKYTROFA include fluid retention, high blood sugar and diabetes, decreased hormone levels, intracranial hypertension, bone and spine issues in children, pancreatitis, tumor growth risk, severe allergic reactions and infection site tissue changes.
Fluid retention involves excess fluid in the body causing swelling in the hands and feet, joint or muscle pain, or carpal tunnel symptoms (burning or tingling).
High blood sugar and diabetes involve new or worsening high blood sugar levels or diabetes.
Decreased hormone levels involve drops in cortisol, (which causes extreme fatigue, dizziness, weakness, or skin darkening) or even drops in thyroid hormone.
Intracranial hypertension involves increased pressure inside your brain, leading to headaches, vision changes, or nausea.
Bone and spine issues in children involve slipped capital femoral epiphysis (hip or knee pain, or a limp that can lead to bone tissue damage/osteonecrosis) and the progression of scoliosis (curvening of the spine).
Pancreatitis involves severe and constant stomach pain, which can also be a sign of inflammation of the pancreas.
Tumor growth risk, involves increased risk of growth of an existing tumor/cancer or recurrence in pediatric brain/head radiation survivors.
Severe allergic reactions involve face, mouth, tongue, or throat swelling or difficulty breathing.
And injection site tissue changes include loss of fat or tissue weakness at the injection site which is minimized by rotating the injection spots.