Short answer: In the label's 6-month placebo-controlled trial in adults, the most common Norditropin side effects were peripheral edema (42% vs 8% on placebo), edema (25% vs 0%), joint pain (19% vs 15%), leg edema (15% vs 4%) and muscle pain (15% vs 8%). In children, the label lists headache, sore throat, ear infection and fever among the most frequent. There is no boxed warning.
What Norditropin is approved for: Norditropin is approved for children with growth failure from growth hormone deficiency, short stature with Noonan syndrome or Turner syndrome, being born small for gestational age without catch-up growth by age 2 to 4, idiopathic short stature (height SDS below -2.25), or growth failure from Prader-Willi syndrome. It is also approved to replace growth hormone in adults with growth hormone deficiency (section 1).
Source
NORDITROPIN (somatropin) injection, for subcutaneous use, prescribing information and Patient Information. Novo Nordisk. DailyMed, version published July 25, 2025. DailyMed setid 1058e17c-9261-459c-a3e6-fae38d196c14
No. The current Norditropin 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 Norditropin.
| Adverse Reactions | Placebo (N=52) % | Norditropin (N=53) % |
|---|---|---|
| Peripheral Edema | 8 | 42 |
| Edema | 0 | 25 |
| Arthralgia | 15 | 19 |
| Leg Edema | 4 | 15 |
| Myalgia | 8 | 15 |
| Infection (non-viral) | 8 | 13 |
| Paraesthesia | 6 | 11 |
| Skeletal Pain | 2 | 11 |
| Headache | 6 | 9 |
| Bronchitis | 0 | 9 |
| Flu-like symptoms | 4 | 8 |
| Hypertension | 2 | 8 |
| Gastroenteritis | 8 | 8 |
| Other Non-Classifiable Disorders (excludes accidental injury) | 6 | 8 |
| Increased sweating | 2 | 8 |
| Glucose tolerance abnormal | 2 | 6 |
| Laryngitis | 6 | 6 |
| Type 2 diabetes mellitus | 0 | 5 |
Adults whose growth hormone deficiency began in adulthood: 53 on Norditropin and 52 on placebo for 6 months.
Children with growth hormone deficiency: in an open-label study at 0.025, 0.05 and 0.1 mg/kg/day, the most frequent reactions were headache, sore throat (pharyngitis), middle ear infection (otitis media) and fever, with no clinically significant differences between the three doses.
Noonan syndrome (21 children, 0.033 or 0.066 mg/kg/day, 11 years of follow-up): most frequent were upper respiratory infection, gastroenteritis, ear infection and influenza. Scoliosis was reported in 1 child on the lower dose and 4 on the higher dose.
Turner syndrome: most frequent were flu-like illness, middle and outer ear infections, upper respiratory infection, gastroenteritis, eczema and impaired fasting glucose, more often at the highest doses. Three patients had excessive growth of the hands or feet at high doses, and two had worsening of existing scoliosis at 0.045 mg/kg/day.
Small for gestational age (53 children treated up to 13 years): increased fasting blood glucose after 1 year in 4 children on 0.067 mg/kg/day and 2 on 0.033 mg/kg/day. One child had disproportionate growth of the lower jaw and one developed a mole (melanocytic nevus), both on 0.067 mg/kg/day.
In two placebo-controlled trials of 522 critically ill adults in intensive care without growth hormone deficiency, deaths were 42% on somatropin (5.3–8 mg/day) vs 19% on placebo.
Reported after approval: serious allergic reactions including anaphylaxis and angioedema, more or larger moles, hypothyroidism, breast growth in males (gynecomastia), high blood sugar, slipped capital femoral epiphysis and osteonecrosis in children, pancreatitis, and leukemia in a small number of children with growth hormone deficiency.
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. It is contraindicated in them, and the safety of continuing it in people who become critically ill has not been established.
Sudden death in children with Prader-Willi syndrome. Sudden 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. They are checked for airway problems first, and treatment is interrupted if snoring starts or worsens or sleep apnea appears.
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. Somatropin may lower insulin sensitivity, especially at higher doses, and can unmask glucose intolerance or diabetes. New type 2 diabetes has been reported. 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. It resolved after stopping or lowering the dose. Eye exams are done before and during treatment, and Turner syndrome may raise the risk.
Severe allergic reactions. Anaphylaxis and angioedema have been reported with somatropins after approval. The label says prompt medical attention should be sought if an allergic reaction occurs.
Fluid retention in adults. Swelling, joint pain, muscle pain and nerve compression such as carpal tunnel syndrome may frequently occur in adults. These are usually temporary and dose dependent.
Low cortisol. People with or at risk of pituitary hormone deficiencies 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, including with Norditropin. A child who starts limping or has 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 in children and adults, with possibly greater risk in children and in girls with Turner syndrome. It is considered in anyone with persistent severe stomach pain.
Fat loss at injection sites. Injecting in the same spot for a long time can cause tissue atrophy, so injection sites are rotated.
Lab tests. Phosphorus, alkaline phosphatase, parathyroid hormone and IGF-I levels may rise.
Who should not use it. People with acute critical illness, children with Prader-Willi syndrome who are severely obese or have severe breathing problems, active cancer, allergy to Norditropin or its ingredients, active proliferative or severe non-proliferative diabetic eye disease, and children whose growth plates have closed.
From the Patient Information leaflet that comes with Norditropin:
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.