Growth hormone deficient patients are characterised by extracellular volume deficit. When treatment with somatropin is initiated, this deficit is corrected. Fluid retention with peripheral oedema may occur especially in adults. Mild arthralgia, muscle pain and paraesthesia may also occur, but are usually self-limiting. The symptoms are usually transient, dose dependent and may require transient dose reduction.
In uncommon (≥ 1/1,000 to < 1/100) and rare (≥ 1/10,000 to < 1/1,000) cases children may experience the following side effects: Injection site reaction; Injection site pain; Headache; Arthralgia and myalgia; Peripheral oedema; Rash.
In children with Turner syndrome increased growth of hands and feet has been reported during Norditropin therapy.
A tendency for increased incidence of otitis media and otitis external in Turner syndrome patients treated with high doses of Norditropin has been observed in two open-label randomised clinical trials. However, the increase in ear infections did not result in more ear operations/tube insertions compared to the lower dose group in the trial.
Adults may experience the following: Very common effects (≥ 1/10): Peripheral oedema.
Common effects (≥ 1/100 to < 1/10): Headache and paraesthesia; Arthralgia, joint stiffness and myalgia.
Uncommon effects (≥ 1/1,000 to < 1/100): Carpal tunnel syndrome; Injection site reaction and injection site pain; Pruritus; Muscle stiffness; Type 2 diabetes mellitus.
In rare (< 1 in 1,000) cases the following side effects may occur in children and adults: Generalised hypersensitivity reactions.
Formation of antibodies directed against somatropin has rarely been observed during Norditropin therapy.
Increase in blood alkaline phosphatase level may be seen during treatment with Norditropin.