"The U.S. Food and Drug Administration today notified Ranbaxy Laboratories, Ltd., that it is prohibited from manufacturing and distributing active pharmaceutical ingredients (APIs) from its facility in Toansa, India, for FDA-regulated drug product"...
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 Sermorelin Acetate (sermorelin) Side Effects Center for a complete guide to possible side effects
Concomitant glucocorticoid therapy may inhibit the response to Sermorelin.
Last reviewed on RxList: 7/16/2008
This monograph has been modified to include the generic and brand name in many instances.
Additional Sermorelin Acetate Information
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