What the label lists and what reports show
Somatrogon side effects
Somatrogon's FDA label lists its adverse reactions in its own words. FAERS holds 1,211 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 injection site pain (789 reports).
- No generic listed
Check it at the source: the somatrogon FDA label on DailyMed (effective August 14, 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 NGENLA?NGENLA 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. • serious allergic reactions. Get medical help right away if your child has the following symptoms: o swelling of the face, lips, mouth, or tongue o trouble breathing o wheezing o severe itching o skin rashes, redness, or swelling o dizziness or fainting o fast heartbeat or pounding in the chest o sweating • 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 child’s healthcare provider will need to monitor your child for a return of cancer or a tumor. […]
Source: FDA drug label, Pfizer Laboratories Div Pfizer Inc, effective August 14, 2026 (SPL set 06dce529-b741-4a1b-8842-3ad77be6e308), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsThe following clinically significant 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 neoplasm [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 [see Warnings and Precautions (5.9) ] • Progression of preexisting scoliosis [see Warnings and Precautions (5.10) ] • Pancreatitis [see Warnings and Precautions (5.11) ] • Lipoatrophy [see Warnings and Precautions (5.12) ] …
Table 1 Adverse Reactions Occurring in ≥5% of NGENLA- or Somatropin-Treated Pediatric Patients (52 Weeks of Treatment)
| Adverse Drug Reactions | Daily Somatropin (N=115) n (%) | NGENLA (N=109) n (%) |
|---|---|---|
| Injection site reactions Injection site reactions included: injection site pain (39%… | 29 (25.2) | 46 (42.2) |
| Nasopharyngitis Nasopharyngitis included: rhinitis, pharyngitis, rhinitis allergic,… | 33 (28.7) | 36 (33) |
| Headache | 25 (21.7) | 18 (16.5) |
| Pyrexia | 17 (14.8) | 18 (16.5) |
| Anemia | 10 (8.7) | 10 (9.2) |
| Cough | 9 (7.8) | 9 (8.3) |
| Vomiting | 9 (7.8) | 8 (7.3) |
| Hypothyroidism | 3 (2.6) | 7 (6.4) |
| Abdominal pain | 8 (7.0) | 7 (6.4) |
| Rash | 7 (6.1) | 6 (5.5) |
| Oropharyngeal pain | 4 (3.5) | 6 (5.5) |
| Arthralgia | 8 (7.0) | 5 (4.6) |
| Otitis media | 10 (8.7) | 5 (4.6) |
| Tonsillitis | 6 (5.2) | 5 (4.6) |
| Bronchitis | 9 (7.8) | 3 (2.8) |
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, Pfizer Laboratories Div Pfizer Inc, effective August 14, 2026 (SPL set 06dce529-b741-4a1b-8842-3ad77be6e308), via openFDA; the full label on DailyMed
What do FAERS reports show?
1,211 reports list somatrogon among the medicines taken, each a report of something that happened, not proof the medicine caused it; 3 are coded as a death and 47 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 18 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?
- Somatrogon: 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