What the label lists and what reports show
Somatropin side effects
Somatropin's FDA label lists its adverse reactions in its own words. FAERS holds 72,284 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is device leakage (10,550 reports).
- No generic listed
- A presentation discontinued
Check it at the source: the somatropin FDA label on DailyMed (effective August 20, 2026, Eli Lilly and Company); the FDA FAERS public dashboard.
What does the label list?
From the label: adverse reactionsThe following important adverse reactions are also described elsewhere in the labeling: Increased mortality in patients with acute critical illness [see Warnings and Precautions ( 5.1 )] Fatalities in children with Prader-Willi syndrome [see Warnings and Precautions ( 5.2 )] Neoplasms [see Warnings and Precautions ( 5.3 )] Glucose intolerance and diabetes mellitus [see Warnings and Precautions ( 5.4 )] Intracranial hypertension [see Warnings and Precautions ( 5.5 )] Severe hypersensitivity [see Warnings and Precautions ( 5.6 )] Fluid retention [see Warnings and Precautions ( 5.7 )] Hypoadrenalism [see Warnings and Precautions ( 5.8 )] Hypothyroidism [see Warnings and Precautions ( 5.9 )] Slipped capital femoral epiphysis in pediatric patients [see Warnings and Precautions ( 5.10 )] Progression of preexisting scoliosis in pediatric patients [see Warnings and Precautions ( 5.11 )] …
Table 6: Adverse Reactions with ≥5% Overall Occurrence in Adult-Onset Growth Hormone-Deficient Patients Treated with HUMATROPE for 18 Months as Compared with 6-Month Placebo and 12-Month HUMATROPE Exposure
| Adverse Reaction | 18 Months Exposure [Placebo (6 Months)/Humatrope (12 Months)] (n=44) | 18 Months Humatrope Exposure (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% |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
Source: FDA drug label, Eli Lilly and Company, effective August 20, 2026 (SPL set a774e1ae-3997-49ee-8b0e-99a2b315d409), via openFDA; the full label on DailyMed
What do FAERS reports show?
72,284 reports list somatropin among the medicines taken, each a report of something that happened, not proof the medicine caused it; 1,365 are coded as a death and 7,048 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Reports rose sharply in 2025 (11,518, against a median of 3,639 a year): FAERS counts follow reporting, which news, litigation and label changes can drive, not how often a reaction happens. Of the 19 reactions below, 2 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Somatropin: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions