Luprodex Adverse Reactions

Adverse events 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, nausea, malaise and fatigue and transient local irritation at the site of injection. Mild hot flashes occur in approximately 58% of patients.
The following adverse events are from literature. 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 2.)

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Other adverse events which have been reported in general are: peripheral oedema, pulmonary embolism, palpitations, myalgia, muscle weakness, an alteration in the skin sensation, chills, rash, amnesia and visual disturbances, muscular atrophy, pituitary apoplexy, thrombocytopenia, leucopenia, convulsions. Decreased bone density has been reported in literature who have been treated with GnRH analogues.
In men cases where a "tumour flare" occurs after leuprorelin acetate therapy, an exacerbation may occur in any symptoms or signs due to disease, for example, bone pain, urinary obstruction, weakness of the lower extremities and paraesthesia. These symptoms subside on continuation of therapy.
In women, adverse events are associated with hypo-estrogenism; the most frequently reported are hot flushes, mood swings including depression (occasionally severe), and vaginal dryness. Estrogen levels return to normal after treatment is discontinued.