Adverse reactions : תופעות לוואי

4.8     Undesirable effects
Frequently (≥ 2%) reported adverse events during treatment with Decapeptyl 0.1 in clinical trials, either before or during co-administration with gonadotrophins, are listed in the table below. The most frequent adverse events are headache (27%), vaginal bleeding/spotting (24%), abdominal pain (15%), injection site inflammation (12%) and nausea (10%).

Mild to severe hot flushes and hyperhidrosis may occur which do not usually require discontinuation of therapy.

At the beginning of treatment with Decapeptyl 0.1, the combination with gonadotrophins may result in ovarian hyperstimulation syndrome. Ovarian enlargement, dyspnoea, pelvic and/or abdominal pain may be observed (refer to section 4.4 Special Warnings and Precautions for Use). Genital haemorrhage including menorrhagia and metrorrhagia may occur at the beginning of treatment with Decapeptyl 0.1.

Ovarian cysts have been reported to occur commonly (1%) during the initial phase of treatment with Decapeptyl 0.1.
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 0.1.

Single cases of allergic reactions, localized or generalized, have been reported after injection of Decapeptyl 0.1.

MedDRA System               Very common       Common (≥1/100 to        Uncommon (≥          Not known Organ Class                 (≥1/10)           <1/10)                   1/1,000 to <1/100)   (frequency cannot be estimated from the available data)
Infections and                                Upper respiratory infestations                                  tract infection,
pharyngitis
Immune system                                                                               Hypersensitivity disorders
Psychiatric disorders                                                  Mood changes,        Sleep disorder, depression           libido decreased
Nervous system disorder     Headache          Dizziness
Eye disorders                                                                               Visual impairment, vision blurred
Vascular disorders                            Hot flushes
Respiratory, thoracic and                                                                   Dyspnoea mediastinal disorders
Gastrointestinal            Abdominal pain,   Abdominal                                     Abdominal disorders                   nausea            distension, vomiting                          discomfort Skin and subcutaneous                                                                       Hyperhidrosis, tissue disorders                                                                            pruritus, rash, angioedema,
urticaria
Musculoskeletal and                           Back pain                                     Muscle spasms, connective tissue                                                                           arthralgia disorders
Pregnancy, puerperium                         Abortion and perinatal conditions
Reproductive system and     Vaginal           Pelvic pain, ovarian                          Ovarian breast disorders            haemorrhage       hyperstimulation                              enlargement, syndrome,                                     menorrhagia,
dysmenorrhoea,                                metrorrhagia,
ovarian cyst                                  vulvovaginal dryness,
dyspareunia, breast pain
General disorders and       Injection site    Injection site pain,                          Asthenia, injection administration site         inflammation      injection site                                site erythema conditions                                    reaction, fatigue,
influenza like illness
Investigations                                                                              Weight increased 

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/