What the label lists and what reports show
Somapacitan side effects
Somapacitan's FDA label lists its adverse reactions in its own words. FAERS holds 156 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 (14 reports).
- No generic listed
Check it at the source: the somapacitan FDA label on DailyMed (effective February 25, 2026); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are the possible side effects of SOGROYA?SOGROYA may cause serious side effects, including: • high risk of death in people who have critical illnesses because of heart or stomach surgery, trauma, or serious breathing (respiratory) problems. • increased risk of growth of cancer or a tumor that is already present and increased risk of the return of cancer or a tumor in people who were treated with radiation to the brain or head as children and who developed low growth hormone problems. Your or your child’s healthcare provider will need to monitor you or your child for a return of cancer or a tumor. Contact the healthcare provider if you or your child start to have sudden changes in behavior, headaches, vision problems, or changes in moles, birthmarks, or the color of your or your child’s skin. • new or worsening high blood sugar (hyperglycemia) or diabetes. […]
Source: FDA drug label, Novo Nordisk, effective February 25, 2026 (SPL set eadd03b4-adc3-4b88-8a24-9d205c5b85aa), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsThe following clinically significant adverse drug 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 …
A table the label prints in its adverse reactions section without a title; its column headings name the groups compared
| Adverse Reactions | Placebo (N=61) % | SOGROYA (N=120) % |
|---|---|---|
| Back pain | 3.3 | 10 |
| Arthralgia | 1.6 | 6.7 |
| Dyspepsia | 3.3 | 5 |
| Sleep disorder | 1.6 | 4.2 |
| Dizziness | 1.6 | 4.2 |
| Tonsillitis | 1.6 | 3.3 |
| Peripheral edema | 1.6 | 3.3 |
| Vomiting | 1.6 | 3.3 |
| Adrenal insufficiency | 1.6 | 3.3 |
| Hypertension | 1.6 | 3.3 |
| Blood creatine phosphokinase increase | 0 | 3.3 |
| Weight increased | 0 | 3.3 |
| Anemia | 0 | 2.5 |
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, Novo Nordisk, effective February 25, 2026 (SPL set eadd03b4-adc3-4b88-8a24-9d205c5b85aa), via openFDA; the full label on DailyMed
What do FAERS reports show?
156 reports list somapacitan among the medicines taken, each a report of something that happened, not proof the medicine caused it; 10 are coded as a death and 42 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 21 reactions below, 9 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.
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?
- Somapacitan: 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