Decapeptyl Adverse Reactions

Summary of safety profile: The most frequent adverse events are headache (27%), vaginal bleeding/spotting (24%), abdominal pain (15%), injection site inflammation (12%) and nausea (10%). Ovarian cysts have been reported to occur commonly (1%) during the initial phase of treatment with DECAPEPTYL.
Mild to severe hot flushes and hyperhidrosis may occur which do not usually require discontinuation of therapy.
At the beginning of treatment with DECAPEPTYL, the combination with gonadotrophins may result in ovarian hyperstimulation syndrome. When used for infertility treatment, ovarian hyperstimulation syndrome (see Precautions), ovarian enlargement, dyspnoea, pelvic and/or abdominal pain may be observed. Genital haemorrhage including menorrhagia and metrorrhagia may occur at the beginning of treatment with DECAPEPTYL.
During treatment with triptorelin some adverse reactions showed a general pattern of hypo-oestrogenic events related to pituitary-ovarian blockade such as sleep disorder, headache, mood altered, vulvovaginal dryness, dyspareunia and libido decreased.
Breast pain, muscle spasms, arthralgia, weight increased, nausea, abdominal pain, abdominal discomfort, asthenia and episodes of blurred vision and visual disturbances may occur during treatment with DECAPEPTYL.
Single cases of allergic reactions, localized or generalized, have been reported after injection of DECAPEPTYL. No anaphylactic reactions have been seen in clinical trials.
Tabulated summary of adverse reactions: Based on the frequency of adverse drug reactions reported in clinical trials with DECAPEPTYL in females for downregulation and prevention of premature LH surges (N=2,095). (See table.)

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