Saizen Adverse Reactions

Up to 10% of patients may experience redness and itching at the site of injection.
Fluid retention is expected during growth hormone replacement therapy in adults. Oedema, joint swelling, arthralgias, myalgias and paresthesias may be clinical manifestations of fluid retention. However, these symptoms/signs are usually transient and dose dependent.
Adult patients with growth hormone deficiency, following diagnosis of growth hormone deficiency in childhood, reported side-effects less frequently than those with adult onset growth hormone deficiency.
Antibodies to Somatropin can form in some patients; the clinical significance of these antibodies is unknown, though to date the antibodies have been of low binding capacity and have not been associated with growth attenuation except in patients with gene deletions. In very rare instances, where short stature is due to deletion of the growth hormone gene complex, treatment with growth hormone may induce growth attenuating antibodies.
Pancreatitis has been reported in post-marketing studies during growth hormone therapy.
The adverse reactions reported as follows are classified according to frequency of occurrence as follows: Very Common >1/10; Common >1/100 - <1/10; Uncommon >1/1000 - <1/100; Rare >1/10000 - <1/1000; Very rare <1/10000.
Application site disorders: Common: Injection site reactions; localized lipoatrophy, which can be avoided by varying the site of injection.
Body as a whole - General disorders: Common (in adults) Uncommon (in children): Fluid retention: peripheral oedema, stiffness, arthralgia, myalgia, paresthesia.
Uncommon: Carpal tunnel syndrome.
CNS: Common: Isolated headache, carpal tunnel syndrome (in adults).
Uncommon: Idiopathic intracranial hypertension (benign intracranial hypertension), carpal tunnel syndrome (in paediatric patients).
Endocrine Disorders: Very rare: Hypothyroidism.
Musculo-skeletal disorders: Very rare: Slipped capital femoral epiphysis (Epiphysiolysis capitis femoris), or avascular necrosis of the femoral head.
Metabolism disorders: Insulin resistance can result in hyperinsulinism and in rare cases in hyperglycemia.
Immune system disorders: Frequency not known: Localised and generalised hypersensitivity reactions.
Reproductive system and breast disorders: Uncommon: Gynaecomastia.