Short answer: In the first 6 months of the label's blinded adult studies, Humatrope raised edema (17% vs 4% on placebo) and peripheral edema (12% vs 0%), with muscle and joint pain early on that tended to pass or ease with dose changes. In children, the label's tables show more ear infections, scoliosis and joint pain than in untreated or placebo groups. There is no boxed warning.
What Humatrope is approved for: Humatrope is approved for children with growth failure from growth hormone deficiency, short stature with Turner syndrome, idiopathic short stature (height SDS below -2.25), short stature or growth failure in SHOX deficiency, or being born small for gestational age without catch-up growth by age 2 to 4. It is also approved to replace growth hormone in adults with growth hormone deficiency (section 1).
Source
HUMATROPE (somatropin) for injection, for subcutaneous use, prescribing information. Eli Lilly. DailyMed, version published September 2, 2026. DailyMed setid a774e1ae-3997-49ee-8b0e-99a2b315d409
No. The current Humatrope 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 Humatrope.
| Adverse Reaction | Placebo 6 mo. then Humatrope 12 mo. (n=44) | Humatrope 18 mo. (n=52) |
|---|---|---|
| Edema | 11% | 21% |
| Arthralgia | 14% | 17% |
| Paresthesia | 14% | 17% |
| Myalgia | 9% | 14% |
| Pain | 14% | 14% |
| Peripheral edema | 18% | 12% |
| Headache | 7% | 8% |
| Hypertension | 5% | 8% |
| Joint disorder | 2% | 6% |
| Rhinitis | 11% | 13% |
| Back pain | 9% | 10% |
| Acne | 0% | 6% |
| Surgical procedure | 2% | 6% |
| Flu syndrome | 7% | 4% |
Adults whose growth hormone deficiency began in adulthood. The first column is people who had 6 months of placebo then 12 months of Humatrope; the second had Humatrope for all 18 months. In the first 6 months alone, edema was 17% vs 4% on placebo and peripheral edema 12% vs 0%.
| Adverse Reaction | Placebo (n=31) | Humatrope (n=37) |
|---|---|---|
| Scoliosis | 13% | 19% |
| Otitis media | 7% | 16% |
| Hyperlipidemia | 3% | 8% |
| Gynecomastia | 3% | 5% |
| Hip pain | 0 | 3% |
| Arthralgia | 3% | 11% |
| Arthrosis | 7% | 11% |
| Myalgia | 13% | 24% |
| Hypertension | 0 | 3% |
Children with idiopathic short stature on 0.22 mg/kg/week until adult height (mean 3.7 years on Humatrope, 3.3 years on placebo).
Children with growth hormone deficiency (314 children, 0.06 mg/kg 3 times a week for up to 8 years, no comparison group), Table 2: hypothyroidism 25%, allergic reaction 11%, joint pain 6%, bone disorder 4%, edema 4%, injection site pain or reaction 4%, neoplasm or tumor 2%, heart and blood vessel disorders 1%, thyroid disorders 1%, and intracranial hypertension in 1 child.
Turner syndrome (Table 3, Humatrope 0.3 mg/kg/week vs untreated): surgical procedure 45% vs 27%, middle ear infection (otitis media) 43% vs 26%, ear disorders 18% vs 5%.
SHOX deficiency (Table 5, Humatrope vs untreated): scoliosis 47% vs 0%, joint pain 11% vs 8%, gynecomastia 8% vs 0% (males only), excessive number of moles 7% vs 0%. IGF-I rose above 2 SD at least once in 37% vs 0%.
Small for gestational age (193 children): 6 had impaired fasting glucose at year 2, and one stopped Humatrope at month 15 because of it. At study end, 20-25% had IGF-I SDS above +2.
Adults: 2 of 113 developed carpal tunnel syndrome after starting maintenance without a low-dose lead-in; it eased after a lower dose. In adults treated as children, AST elevations were 13% vs 0% on placebo in the first 6 months.
Reported after approval: serious allergic reactions including anaphylaxis and angioedema, headaches (common in children, occasional in adults), more or larger moles, gynecomastia, pancreatitis, new type 2 diabetes, osteonecrosis in children, 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 (42% vs 19% on placebo in two trials of 522 intensive care patients) 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.
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. Humatrope is not approved for growth failure from Prader-Willi syndrome.
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.
Severe allergic reactions. Anaphylaxis and angioedema have been reported with somatropins after approval. Humatrope cartridges are not used in people allergic to metacresol or glycerin in the diluent.
Fluid retention. Swelling, joint pain, muscle pain and nerve compression such as carpal tunnel syndrome may frequently occur. 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. 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 who develops 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 somatropin or its ingredients, active proliferative or severe non-proliferative diabetic eye disease, and children whose growth plates have closed.
From the Patient Counseling Information (section 17); the label has Instructions for Use but no separate Patient Information leaflet that comes with Humatrope:
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.