Short answer: In the label's trials of children with growth hormone deficiency, the most common Omnitrope reactions were raised HbA1c (14% on the cartridge, 9% on the vial), eosinophilia (12% and 11%), hematoma or bruising (9% each) and hypothyroidism (16% on the vial). These pediatric trials had no placebo group. In adults, most side effects were mild, short-lived fluid retention such as swelling and joint pain.
What Omnitrope is approved for: Omnitrope is approved for children with growth failure from growth hormone deficiency, Prader-Willi syndrome, being born small for gestational age without catch-up growth by age 2, Turner syndrome, or idiopathic short stature (height SDS of -2.25 or below with open growth plates). It is also approved to replace growth hormone in adults with growth hormone deficiency that began in adulthood or childhood (section 1).
Source
OMNITROPE (somatropin) injection and for injection, for subcutaneous use, prescribing information and Instructions for Use. Sandoz. DailyMed, version published April 1, 2026. DailyMed setid 58d84ffa-4056-4e36-ad67-7bd4aef444a5
No. The current Omnitrope 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 Omnitrope.
| Adverse Event | n (%) |
|---|---|
| Elevated HbA1c | 12 (14%) |
| Eosinophilia | 10 (12%) |
| Hematoma | 8 (9%) |
Children with growth hormone deficiency treated with the Omnitrope cartridge, 86 patients. n is the number who reported the event during the study and % is the share. There was no placebo group.
| Adverse Event | n (%) |
|---|---|
| Hypothyroidism | 7 (16%) |
| Eosinophilia | 5 (11%) |
| Elevated HbA1c | 4 (9%) |
| Hematoma | 4 (9%) |
| Headache | 3 (7%) |
| Hypertriglyceridemia | 2 (5%) |
| Leg Pain | 2 (5%) |
Children with growth hormone deficiency treated with Omnitrope for injection (the vial), 44 patients. There was no placebo group.
Adults (Table 3, trials of another somatropin product in 1,145 adults with GHD), first 6 months vs placebo: peripheral swelling 17.5% vs 5.1%, joint pain 17.3% vs 4.2%, upper respiratory infection 15.5% vs 14.5%, limb pain 14.7% vs 5.9%, peripheral edema 10.8% vs 2.6%, tingling (paresthesia) 9.6% vs 1.9%, headache 9.9% vs 7.7%.
In post-trial extension studies of another somatropin product in 3,031 adults, diabetes developed in 12 (0.4%), all with risk factors beforehand, and 61 (2%) developed carpal tunnel symptoms, which eased after a lower dose or a break (52) or surgery (9).
Children born small for gestational age (273 patients, another somatropin product): mild short-lived high blood sugar, one case of benign intracranial hypertension, two of central precocious puberty, two of jaw prominence, and several of worsening scoliosis, injection site reactions and self-limited growth of pigmented moles.
Children with idiopathic short stature (another somatropin product): IGF-1 above +2 SD at least once in 1 (3%) untreated control, 10 (30%) on 0.23 mg/kg/week and 16 (38%) on 0.47 mg/kg/week; two or more times in a row in 0 (0%), 2 (7%) and 6 (14%).
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.
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 continuing it in people who become critically ill is weighed case by case.
Prader-Willi syndrome in children. 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 paused if snoring starts or worsens or sleep apnea appears.
Tumors. Childhood cancer survivors treated with head or brain radiation had a higher risk of a second tumor, most often meningiomas. People with past brain tumors are monitored for regrowth, and 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, and resolved after stopping or lowering the dose. Eye exams are done before and during treatment.
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. The label says fluid retention may frequently occur in adults: swelling, joint pain, muscle pain and nerve compression such as carpal tunnel syndrome. 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. People with Turner syndrome have thyroid function checked before starting, 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. 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.
Ear and heart issues in Turner syndrome. Somatropin may increase ear infections in Turner syndrome, and these patients are watched for heart and blood vessel problems such as stroke, aortic aneurysm or dissection and high blood pressure.
Fat loss at injection sites. Injecting in the same spot for a long time can cause tissue atrophy, which the label says can be avoided by rotating sites.
Lab tests. Phosphorus, alkaline phosphatase, parathyroid hormone and IGF-1 levels may rise.
Pancreatitis. Rare cases have been reported, with some evidence of greater risk in children, and girls with Turner syndrome may be at greater risk. It is considered in anyone, especially a child, with persistent severe stomach pain.
Benzyl alcohol. The 5 mg/1.5 mL cartridge and the diluent for the 5.8 mg vial contain benzyl alcohol, which has been linked to serious events and death, especially in children. A "gasping syndrome" has been tied to more than 99 mg/kg/day in newborns and low-birth-weight newborns.
From the Warnings and Precautions (section 5); the patient labeling for Omnitrope is Instructions for Use only that comes with Omnitrope:
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.