"The U.S. Food and Drug Administration is alerting hospitals, health care professionals, and patients of a voluntary recall of all non-expired drug products produced and distributed for sterile use by Abrams Royal Compounding Pharmacy in Dallas, T"...
Sermorelin Acetate Side Effects Center
Medical Editor: John P. Cunha, DO, FACOEP
Sermorelin acetate is a human growth hormone-releasing hormone (GHRH or GRF) used for diagnostic evaluation of pituitary function and also for increasing growth in children. Off label usage may include acute or age-related growth hormone insufficiency. This medication is discontinued; generic versions may be available. Common side effects include injection site reactions (such as pain, swelling, or redness), headache, flushing, difficulty swallowing, dizziness, hyperactivity, sleepiness, and hives.
A dosage of 0.2 - 0.3 mcg of sermorelin acetate once daily at bedtime by subcutaneous injection is recommended. Sermorelin acetate may interact with glucocorticoids. Tell your doctor all medications and supplements you use. During pregnancy, sermorelin acetate should be used only if prescribed. It is unknown if this drug passes into breast milk. Consult your doctor before breastfeeding.
Our sermorelin acetate Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Sermorelin Acetate FDA Prescribing Information: Side Effects
A large proportion of patients develop anti- GRF antibodies at least once during treatment with Sermorelin. The significance of these antibodies is not clear and often a positive test at one growth assessment will become negative by the next assessment. The presence of antibodies does not appear to affect growth or appear to be related to a specific adverse reaction profile. No generalized allergic reactions to Sermorelin have been reported.
The most common treatment-related adverse event (occurring in about 1 patient in 6) is local injection reaction characterized by pain, swelling or redness. Of 350 patients exposed to Sermorelin in clinical trials, three discontinued therapy due to injection reactions. Other treatment-related adverse events had individual occurrence rates of less than 1% and include: headache, flushing, dysphagia, dizziness, hyperactivity, somnolence and urticaria.
When administered intravenously for diagnostic use, the following adverse reactions have been noted: flushing of the face, injection site pain, redness and/or swelling, nausea, headache, vomiting, dysgeusia, pallor and tightness in the chest.
Drug Abuse and Dependence
The clinical pharmacology suggests that Sermorelin is very unlikely to be associated with drug abuse or dependence and there have been no reports of this from clinical trials.
Read the entire FDA prescribing information for Sermorelin Acetate (Sermorelin)
Additional Sermorelin Acetate Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Find out what women really need.