Prescription medicine
Pegvisomant Brand names: Somavert
Pegvisomant (Somavert) is a prescription medicine with an FDA approval on record since 2003. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the pegvisomant FDA label on DailyMed (effective December 18, 2025, Pharmacia & Upjohn Company LLC); the BLA 21106 record on Drugs@FDA; every pegvisomant label on DailyMed.
Highlights of the record
FDA label of December 18, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageSOMAVERT is indicated for the treatment of acromegaly in patients who have had an inadequate response to surgery or radiation therapy, or for whom these therapies are not appropriate.
Forms and strengths
Kit.
On the market
- Earliest approval on file
- March 25, 2003 Somavert, Pharmacia; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 4,093 through July 30, 2026
What is pegvisomant used for?
From the label: indications and usageSOMAVERT is indicated for the treatment of acromegaly in patients who have had an inadequate response to surgery or radiation therapy, or for whom these therapies are not appropriate. The goal of treatment is to normalize serum insulin-like growth factor-1 (IGF-1) levels. SOMAVERT is a growth hormone receptor antagonist indicated for the treatment of acromegaly in patients who have had an inadequate response to surgery or radiation therapy, or for whom these therapies are not appropriate. The goal of treatment is to normalize serum insulin-like growth factor-1 (IGF-1) levels.
Source: FDA drug label (SOMAVERT), Pharmacia & Upjohn Company LLC, effective December 18, 2025 (SPL set 3cbb485b-6df1-49ce-8747-592b395b1988), via openFDA; the full label on DailyMed
Is there a generic for pegvisomant (Somavert)?
No generic pegvisomant is approved (Drugs@FDA, October 8, 2026).
- 2003 earliest approval on file
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do FAERS reports show for pegvisomant?
The FDA Adverse Event Reporting System holds 4,093 reports that list pegvisomant among the medicines taken, through July 30, 2026, 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.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Pegvisomant side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other