Short answer: In the label's adult trials, the most common Genotropin side effects in the first 6 months were peripheral swelling (17.5% vs 5.1% on placebo), joint pain (17.3% vs 4.2%), upper respiratory infection (15.5% vs 14.5%), limb pain (14.7% vs 5.9%) and peripheral edema (10.8% vs 2.6%). The label says these fluid-retention effects came early, tended to pass and often eased with a lower dose.
What Genotropin is approved for: Genotropin is approved for children with growth failure from growth hormone deficiency, Prader-Willi syndrome, Turner syndrome, being born small for gestational age without catch-up growth by age 2, 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
GENOTROPIN (somatropin) for injection, for subcutaneous use, prescribing information. Pfizer. DailyMed, version published August 6, 2026. DailyMed setid ffebf88b-d257-4542-9808-74d9b7167765
No. The current Genotropin 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 Genotropin.
| Adverse Event | Placebo 0–6 mo. (n = 572) % | Genotropin 0–6 mo. (n = 573) % | Genotropin 6–12 mo. (n = 504) % | Genotropin 12–18 mo. (n = 63) % | Genotropin 18–24 mo. (n = 60) % |
|---|---|---|---|---|---|
| Swelling, peripheral | 5.1 | 17.5 | 5.6 | 0 | 1.7 |
| Arthralgia | 4.2 | 17.3 | 6.9 | 6.3 | 3.3 |
| Upper respiratory infection | 14.5 | 15.5 | 13.1 | 15.9 | 13.3 |
| Pain, extremities | 5.9 | 14.7 | 6.7 | 1.6 | 3.3 |
| Edema, peripheral | 2.6 | 10.8 | 3.0 | 0 | 0 |
| Paresthesia | 1.9 | 9.6 | 2.2 | 3.2 | 0 |
| Headache | 7.7 | 9.9 | 6.2 | 0 | 0 |
| Stiffness of extremities | 1.6 | 7.9 | 2.4 | 1.6 | 0 |
| Fatigue | 3.8 | 5.8 | 4.6 | 6.3 | 1.7 |
| Myalgia | 1.6 | 4.9 | 2.0 | 4.8 | 6.7 |
| Back pain | 4.4 | 2.8 | 3.4 | 4.8 | 5.0 |
Adults with growth hormone deficiency. Placebo figures come from the 6-month double-blind phase; later columns are the open-label phase on Genotropin. n is the number treated in each period, and % is the share who reported the event in that period. The label marks the 17.5% swelling figure as a significant increase over placebo (P≤.025).
In post-trial extension studies of 3,031 adults, diabetes developed in 12 (0.4%), all of whom had risk factors such as high HbA1c or marked obesity beforehand. 61 (2%) developed carpal tunnel symptoms, which eased after a lower dose or a break in treatment (52) or surgery (9).
In 273 children born small for gestational age: 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. No anti-hGH antibodies were found.
Children with idiopathic short stature: 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%).
Children with growth hormone deficiency infrequently had injection site reactions (pain or burning, lumps, rash, inflammation, pigmentation or bleeding), lipoatrophy, headache, blood in the urine, hypothyroidism and mild high blood sugar. In Prader-Willi syndrome trials, edema, aggressiveness, joint pain, benign intracranial hypertension, hair loss, headache and muscle pain were reported.
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. 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. 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 can 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.
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-I 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.
From the Warnings and Precautions (section 5); the label text has no separate Medication Guide that comes with Genotropin:
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.