Research information only, not medical advice. In the paediatric trials that supported its former FDA approval, sermorelin's most common side effect was a transient injection-site reaction — pain, redness or swelling — in about 16% of patients. Its US-approved products were withdrawn in 2008, so there is no current FDA labelling.
Sermorelin is a GHRH analogue that was formerly FDA-approved (Geref) for paediatric growth-hormone deficiency; both US products were withdrawn in 2008 as a business decision, not for safety, and it is now available only through compounding. In the paediatric registration programme, the most common treatment-related adverse effect was a self-limited, transient injection-site reaction (pain, redness and/or swelling) in roughly 16% of patients (Prakash & Goa review). Because there is no current FDA label, this is the best-documented safety data; research information, not medical advice.
For the full evidence base, clinical trials, and regulatory status, see the Sermorelin research overview . Related: sermorelin before and after .
Sources
Frequently asked questions
- What are the side effects of sermorelin?
- The best-documented effect is a transient injection-site reaction (pain, redness or swelling) in about 16% of patients in the paediatric trials that supported its former approval.
- Is sermorelin FDA-approved?
- Not currently. Its US-approved products (Geref) were withdrawn in 2008 as a business decision; sermorelin is now available only through compounding pharmacies, with no current FDA labelling.
Updated · sourced to primary documents