Short answer: In the label's adult trial, the most common Sogroya side effects more frequent than placebo were back pain (10% vs 3.3%), joint pain (6.7% vs 1.6%), indigestion (5% vs 3.3%), sleep problems and dizziness (4.2% each vs 1.6%). In children with growth hormone deficiency, the most common were colds (16.7%), headache (12.1%), pain in the arms or legs (9.8%) and fever (9.1%). There is no boxed warning.
What Sogroya is approved for: Sogroya is a once-weekly growth hormone analog approved for children aged 2.5 years and older with growth failure from growth hormone deficiency, short stature after being born small for gestational age with no catch-up growth by age 2, growth failure with Noonan syndrome, or idiopathic short stature. It is also approved to replace growth hormone in adults with growth hormone deficiency (section 1).
Source
SOGROYA (somapacitan-beco) injection, for subcutaneous use, prescribing information and Patient Information. Novo Nordisk. DailyMed, version published March 16, 2026. DailyMed setid eadd03b4-adc3-4b88-8a24-9d205c5b85aa
No. The current Sogroya label has no boxed warning.
These are the label's own numbers from the Adverse Reactions section. Where the label compares with placebo (a dummy treatment), both columns are shown, so you can see how much more often a reaction happened on Sogroya.
| Adverse Reactions | Placebo (N=61) % | Sogroya (N=120) % |
|---|---|---|
| Back pain | 3.3 | 10 |
| Arthralgia | 1.6 | 6.7 |
| Dyspepsia | 3.3 | 5 |
| Sleep disorder | 1.6 | 4.2 |
| Dizziness | 1.6 | 4.2 |
| Tonsillitis | 1.6 | 3.3 |
| Peripheral edema | 1.6 | 3.3 |
| Vomiting | 1.6 | 3.3 |
| Adrenal insufficiency | 1.6 | 3.3 |
| Hypertension | 1.6 | 3.3 |
| Blood creatine phosphokinase increase | 0 | 3.3 |
| Weight increased | 0 | 3.3 |
| Anemia | 0 | 2.5 |
# The table includes reactions reported at least 1% more often on Sogroya than on placebo. Adults with growth hormone deficiency in a 35-week double-blind trial.
| Adverse Reactions | Somatropin (N=68) % | Sogroya (N=132) % |
|---|---|---|
| Nasopharyngitis | 16.2 | 16.7 |
| Headache | 8.8 | 12.1 |
| Pyrexia | 11.8 | 9.1 |
| Pain in extremity | 2.9 | 9.8 |
| Injection site reaction | 5.9 | 6.1 |
| Diarrhea | 5.9 | 4.5 |
| Nausea/vomiting | 5.9 | 4.5 |
| Bronchitis | 7.4 | 3 |
Children with growth hormone deficiency who had not been treated before, Sogroya 0.16 mg/kg/week vs daily somatropin. Grouped terms: nasopharyngitis includes rhinitis, sore throat and sinusitis; injection site reaction includes bruising, pain, hematoma and swelling.
Small for gestational age (Table 3, Sogroya 0.24 mg/kg/week, N=69): nasopharyngitis 26%, respiratory tract infection 26%, fever 19%, cough 16%, ear infection 13%, diarrhea 10%, vomiting 10%, bronchitis 7%.
Noonan syndrome (Table 4, Sogroya N=49 vs somatropin N=28): respiratory tract infection 43% vs 29%, nasopharyngitis 29% vs 25%, diarrhea 22% vs 14%, ear infection 16% vs 14%, cough 14% vs 14%, vomiting 12% vs 11%, fever 10% vs 25%, headache 10% vs 7%.
Idiopathic short stature (Table 5, Sogroya N=59 vs somatropin N=28): respiratory tract infection 31% vs 29%, nasopharyngitis 22% vs 21%, ear infection 12% vs 7%, diarrhea 10% vs 25%, headache 10% vs 11%, injection site reaction 10% vs 7%.
Enlarged adenoids and tonsils needing surgery were reported in 1 child with SGA (1%) and 1 child with ISS (2%) in the first year; it resolved after the procedure.
In adults, more people on Sogroya moved from normal to raised phosphate (17.5% vs 4.9% on placebo) and creatine phosphokinase (9.2% vs 6.6%). These changes came and went and did not progress.
Reported after approval with somatropins: osteonecrosis (bone death) in children.
The Warnings and Precautions part of the label lists these. Each line gives the label's heading and what it means in plain words.
Acute critical illness. Higher death rates have been reported in critically ill people after open-heart or abdominal surgery, multiple injuries or acute respiratory failure given somatropin. Sogroya is contraindicated in them.
Severe allergic reactions. Anaphylaxis and angioedema have been reported with somatropin after approval. The label says prompt medical attention should be sought if an allergic reaction occurs.
Tumors. Active cancer can progress on somatropin, so any cancer must be inactive and its treatment complete first. Childhood cancer survivors treated with head or brain radiation had a higher risk of a second tumor, most often meningiomas. Moles are watched for growth or changes.
Blood sugar and diabetes. Growth hormone may lower insulin sensitivity, especially at higher doses. New type 2 diabetes has been reported, and undiagnosed pre-diabetes or diabetes may worsen. Glucose is checked periodically, and diabetes medicine doses may need adjusting.
Raised pressure in the skull. Intracranial hypertension with swelling of the optic nerve, vision changes, headache, nausea or vomiting has been reported, usually within the first 8 weeks. An eye exam is done before starting and periodically after, and treatment is stopped if optic nerve swelling appears.
Fluid retention. Swelling and nerve compression such as carpal tunnel syndrome or tingling were seen. These are usually temporary and dose dependent.
Low cortisol. People with or at risk of corticotropin deficiency may develop low cortisol or unmasked secondary adrenal insufficiency, and those already on steroid replacement may need higher doses.
Thyroid. Untreated hypothyroidism can blunt the response, and central hypothyroidism may appear or worsen during treatment, so thyroid tests are done periodically.
Hip problems in children. Slipped capital femoral epiphysis, sometimes with bone death (osteonecrosis), has been reported with somatropin. A child who starts limping or has persistent hip or knee pain is evaluated.
Scoliosis. Existing scoliosis can progress during rapid growth, so it is monitored, though somatropin has not been shown to cause more scoliosis.
Pancreatitis. Cases have been reported with somatropin, possibly more in children. It is considered in anyone with persistent severe stomach pain.
Fat changes at injection sites. Injecting in the same spot for a long time can cause fat buildup (lipohypertrophy) or fat loss (lipoatrophy), so sites are rotated.
Sudden death in children with Prader-Willi syndrome. Deaths have been reported after starting somatropin in children with Prader-Willi syndrome who had severe obesity, airway blockage or sleep apnea, or an unidentified respiratory infection. Sogroya is not approved for growth failure from genetically confirmed Prader-Willi syndrome.
Lab tests. Phosphorus and alkaline phosphatase have risen with somatropin, including Sogroya, and parathyroid hormone may rise.
Who should not use it. People with acute critical illness, allergy to Sogroya or its ingredients, children whose growth plates have closed, active cancer, active proliferative or severe non-proliferative diabetic eye disease, and children with Prader-Willi syndrome who are severely obese or have severe breathing problems.
From the Patient Information leaflet that comes with Sogroya:
Dose Track has a side-effect log. Each entry records the symptom, a severity (none, mild, moderate, severe or life-threatening), the date and an optional note, and can be tied to a specific dose or logged on its own. The history screen shows what you logged over time, which makes it easier to tell your prescriber when a reaction started and whether it is easing. The app records what you enter; it does not judge whether a symptom is serious. For anything on the label's call-your-doctor list, call your doctor.
This page is what the FDA label says, in plain words. It is not medical advice. Follow your prescriber, and ask them or your pharmacist about anything here.