Adverse reactions : תופעות לוואי

4.8 Undesirable effects
The subcutaneous administration of growth hormone may lead to loss or increase of adipose tissue as well as punctual haemorrhage and bruising at the injection site.
System Organ         Very Common Common                Uncommon                Rare           Very rare Class                (> 1/10)          (>1/100, <1/10) (>1/100. <1/1,000)      (>1/1,000,     (<1/10,000) <1/10,000)
Blood and                                              anemia lymphatic system disorders

Cardiac                                                tachycardia, (adult)     (children) disorders                                              hypertension             hypertension Ear and                                                vertigo labyrinth disorders
Endocrine                             hypothyroidism disorders
Eye disorders                                          papilloedema, diplopia 
Gastrointestinal                                       vomiting, abdominal diarrhea disorders                                              pain, flatulence, nausea
General            (adults)           (children)       weakness, injection disorders and      oedema, (adults)   oedema,          site atrophy, injection administration     peripheral         (children)       site hemorrhage, site conditions    oedema             peripheral       injection site mass, oedema,          hypertrophy injection site reactions,
asthenia
Immune system                         antibody disorders                             building
Investigations                                                                  renal function test abnormal

Metabolism and (adult) mild       (children)       hypoglycemia,                diabetes nutrition      hyperglycemia      glucose          hyperphosphatemia            mellitus type disorders                         tolerance                                     II impaired
Musculoskeletal (adults)          (children)       muscle atrophy, bone and connective   arthralgia;      arthralgia       pain, carpal tunnel tissue disorders (adults) myalgia (children)       syndrome myalgia          (children) Stiffness in
(adults)         the extremities
Stiffness in the extremities
Neoplasms                                          neoplasm malignant,                           (children) benign,                                            neoplasm                                      leukaemia malignant and unspecified
Nervous system (adult)            headache,        somnolence,                  neuropathy, disorders        headache,        hypertonia,      nystagmus                    intracranial (adult)          (adult) insomnia                              pressure paresthesia                                                    increased, (children) insomnia,
(children) paresthesia
Psychiatric                                           personality disorders disorders
Renal and                                             urinary incontinence, urinary disorders                                     haematuria, polyuria, urine frequency/pollakiuria,
urine abnormality
Reproductive                                          genital discharge,                         (children) system and breast                                     (adult) gynecomastia                       gynecomastia disorders
Skin and                                              lipodystrophy, skin subcutaneous                                          atrophy, dermatitis tissue disorders                                      exfoliative, urticaria, hirsutism, skin hypertrophy

Pancreatitis has been reported post-marketing during GH therapy (frequency unknown).Antibodies anti-somatropin: the protein somatropin may give rise to the formation of antibodies. Depending on the concerned product, these antibodies have been identified in a definite percentage of the treated population. Their binding capacity and their titers are generally low with no clinical consequence.
However, testing for antibodies to somatropin should be performed in case of absence of response to somatropin therapy.
Leukaemia: cases of leukaemia (very rare) have been reported in children with a GH deficiency, some of them being treated with somatropin and included in the post-marketing experience. However, there is no evidence of an increased risk of leukaemia without predisposition factors.

Slipped capital femoral epiphysis and Legg-Calve-Perthes disease have been reported in children treated with GH. Slipped capital femoral epiphysis occurs more frequently in case of endocrine disorders and Legg-Calve-Perthes is more frequent in case of short stature. But, it is unknown if these 2 pathologies are more frequent or not while treated with somatropin. A discomfort, a pain in the hip and/or the knee must evocate their diagnosis.
Other adverse drug reactions may be considered as class effect, as the hyperglycaemia due to the decrease in insulin-sensitivity, the decrease of free thyroxin level and the possible development of a benign intra-cranial hypertension.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.Any suspected adverse events should be reported to the Ministry of Health according to the National Regulation by using an online form: https://sideeffects.health.gov.il/