Eligard Adverse Reactions

Adverse reactions seen with ELIGARD are mainly subject to the specific pharmacological action of leuprorelin acetate, namely increases and decreases in certain hormone levels. The most commonly reported adverse reactions are hot flashes, malaise, nausea and fatigue and transient local irritation at the site of injection. Mild or moderate hot flashes occur in approximately 58% of patients.
Tabulated list of adverse reactions: The following adverse events were reported during clinical trials with ELIGARD in patients with advanced prostate carcinoma. Adverse events are classified, by frequency, as very common (≥1/10), common (≥1/100, <1/10), uncommon (≥1/1,000, <1/100), rare (≥1/10,000, <1/1,000), and very rare (<1/10,000), not known (cannot be estimated from the available data). (See table.)

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Other adverse events which have been reported in general to occur with leuprorelin acetate treatment include peripheral oedema, pulmonary embolism, palpitations, myalgia, muscle weakness, an alteration in the skin sensation, chills, rash, amnesia and visual disturbances. Muscular atrophy has been observed with long term use of products in this class. Infarction of pre-existing pituitary apoplexy has been reported rarely after administration of both short and long acting GnRH agonists. There have been rare reports of thrombocytopenia and leucopenia. Changes in glucose tolerance have been reported.
Convulsions have been reported after GnRH agonist analogue administration (see Precautions).
Local adverse events reported after injection of ELIGARD are similar to the local adverse events associated with similar subcutaneously injected products. Generally, these localised adverse events following subcutaneous injection are mild and described as being of brief duration.
Anaphylactic/anaphylactoid reactions have been reported after GnRH agonist analogue administration.
Changes in Bone Density: Decreased bone density has been reported in the medical literature in men who have had orchiectomy or who have been treated with a GnRH analogue. It can be anticipated that long periods of treatment with leuprorelin may show increasing signs of osteoporosis. Regarding the increased risk for fractures owing to osteoporosis (see Precautions).
Exacerbation of signs and symptoms of the disease: Treatment with leuprorelin acetate can cause exacerbations of signs and symptoms of the disease during the first few weeks. If conditions such as vertebral metastases and/or urinary obstruction or haematuria are aggravated, neurological problems such as weakness and/or paraesthesia of the lower limbs or worsening of urinary symptoms may occur.