What the label lists and what reports show
Lonapegsomatropin side effects
Lonapegsomatropin's FDA label: “Most common adverse reactions (≥ 5%): viral infection, pyrexia, cough, nausea and vomiting, hemorrhage, diarrhea, abdominal pain, and arthralgia and arthritis ( 6.1 ).” FAERS holds 612 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 headache (67 reports).
- No generic listed
Check it at the source: the lonapegsomatropin FDA label on DailyMed (effective July 23, 2026); the FDA FAERS public dashboard.
What does the label list?
From the label: adverse reactionsMost common adverse reactions (≥ 5%): viral infection, pyrexia, cough, nausea and vomiting, hemorrhage, diarrhea, abdominal pain, and arthralgia and arthritis ( 6.1 ).
Table 2: Adverse Reactions Occurring in ≥ 5% SKYTROFA-Treated Pediatric Patients and More Frequently Than in Daily Somatropin-Treated Pediatric Patients (52 Weeks of Treatment)
| Adverse reactions | Daily Somatropin (N = 56) n (%) | SKYTROFA (N = 105) n (%) |
|---|---|---|
| Infection, viral | 6 (11%) | 16 (15%) |
| Pyrexia | 5 (9%) | 16 (15%) |
| Cough | 4 (7%) | 11 (11%) |
| Nausea and vomiting | 4 (7%) | 11 (11%) |
| Hemorrhage Hemorrhage in the SKYTROFA treatment group included epistaxis (3), contusion… | 1 (2%) | 7 (7%) |
| Diarrhea | 3 (5%) | 6 (6%) |
| Abdominal pain | 2 (4%) | 6 (6%) |
| Arthralgia and arthritis Arthralgia and arthritis in the SKYTROFA treatment group… | 1 (2%) | 6 (6%) |
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.
From the label: adverse reactions, continuedThe following important adverse reactions are described elsewhere in the labeling: Increased mortality in patients with acute critical illness [see Warnings and Precautions (5.1) ] Severe hypersensitivity [see Warnings and Precautions (5.2) ] Increased risk of 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) ] Fluid retention [see Warnings and Precautions (5.6) ] Hypoadrenalism [see Warnings and Precautions (5.7) ] Hypothyroidism [see Warnings and Precautions (5.8) ] Slipped capital femoral epiphysis in pediatric patients [see Warnings and Precautions (5.9) ] Progression of preexisting scoliosis in pediatric patients [see Warnings and Precautions (5.10) ] Pancreatitis [see Warnings and Precautions (5.11) ] Lipoatrophy [see Warnings and Precautions (5.12) ] Sudden death in pediatric patients with Prader-Willi syndrome [see Warnings and Precautions (5.13) ] Pediatric Patients: Most common adverse reactions (≥ 5%): viral infection, pyrexia, cough, nausea and vomiting, hemorrhage, diarrhea, abdominal pain, and arthralgia and arthritis ( 6.1 ). Adults: Most common adverse reaction (≥ 5%): edema peripheral ( 6.1 ).
Source: FDA drug label, Ascendis Pharma Endocrinology, Inc., effective July 23, 2026 (SPL set 9229f871-bc61-4ddc-8122-d126d40e36ac), via openFDA; the full label on DailyMed
What do FAERS reports show?
612 reports list lonapegsomatropin among the medicines taken, each a report of something that happened, not proof the medicine caused it; 0 are coded as a death and 15 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. Of the 20 reactions below, 7 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?
- Lonapegsomatropin: 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