What the label lists and what reports show
Pegvisomant side effects
Pegvisomant's FDA label: “Most common reported adverse reactions (>6%) are infection, pain, nausea, diarrhea, abnormal liver tests, flu syndrome, injection site reaction.” FAERS holds 4,093 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 (402 reports).
- No generic listed
Check it at the source: the pegvisomant FDA label on DailyMed (effective December 18, 2025, Pharmacia & Upjohn Company LLC); 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 SOMAVERT?SOMAVERT may cause serious side effects, including: • changes in your blood sugar leve l. Your healthcare provider may change your dose of diabetes medicine while you take SOMAVERT. • liver problems. Stop injecting SOMAVERT right away and call your healthcare provider if you have any of the following symptoms of liver problems: o yellowing of your eyes (jaundice) o dark, amber-colored urine o feeling very tired (fatigue or exhaustion) o nausea and vomiting o pain in your stomach (abdomen) o generalized swelling o bruising easily • skin thickening at your injection site that could lead to lumps (lipohypertrophy ) • allergic reactions. […]
Source: FDA drug label, Pharmacia & Upjohn Company LLC, effective December 18, 2025 (SPL set 3cbb485b-6df1-49ce-8747-592b395b1988), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsMost common reported adverse reactions (>6%) are infection, pain, nausea, diarrhea, abnormal liver tests, flu syndrome, injection site reaction.
From the label: adverse reactions, continuedClinically significant adverse reactions that appear in other section of the labeling include: • Hypoglycemia Associated with GH Lowering in Patients with Diabetes Mellitus [see Warnings and Precautions (5.1) ] • Liver Toxicity [see Warnings and Precautions (5.2) ] • Cross-Reactivity with GH Assays [see Warnings and Precautions (5.3) ] • Lipohypertrophy [see Warnings and Precautions (5.4) ] • Systemic Hypersensitivity [see Warnings and Precautions (5.5) ] Elevations of serum concentrations of ALT and AST greater than ten times the ULN were reported in two patients (0.8%) exposed to SOMAVERT in pre-approval clinical studies. One patient was rechallenged with SOMAVERT, and the recurrence of elevated transaminase levels suggested a probable causal relationship between administration of the drug and the elevation in liver enzymes. A liver biopsy performed on the second patient was consistent with chronic hepatitis of unknown etiology. In both patients, the transaminase elevations normalized after discontinuation of the drug. Elevations in ALT and AST levels were not associated with increased levels of TBIL and ALP, with the exception of two patients with minimal associated increases in ALP levels (i.e., less than 3 times ULN). …
Source: FDA drug label, Pharmacia & Upjohn Company LLC, effective December 18, 2025 (SPL set 3cbb485b-6df1-49ce-8747-592b395b1988), via openFDA; the full label on DailyMed
What do FAERS reports show?
4,093 reports list pegvisomant among the medicines taken, each a report of something that happened, not proof the medicine caused it; 318 are coded as a death and 800 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, 5 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?
- Pegvisomant: 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