Adverse reactions : תופעות לוואי

4.8      Undesirable effects

Initial treatment with nafarelin acetate may cause transient exacerbation of endometriosis and chronic treatment may induce a menopausal state.
The following undesirable effects have been observed and reported during treatment of 282 adult patients with nafarelin acetate with the following frequencies: Very common (≥1/10); Common (≥1/100 to <1/10); Uncommon (≥1/1,000 to <1/100); Not known: Cannot be estimated from the available data.



               Adult population

MedDRA                              Frequency           Undesirable Effects System Organ Class
Immune system disorders             Common              Drug hypersensitivity (Chest pain, Dyspnoea,
Pruritus, Rash, Urticaria)

Endocrine disorders                 Common              Oestrogen deficiency Metabolism and nutrition            Very common         Weight increased disorders                           Common              Weight decreased Psychiatric disorders               Very common         Affect lability, Libido decreased
Common              Depression, Insomnia,
Libido increased
Nervous system disorders            Very common         Headache
Common              Paraesthesia
Vascular disorders                  Very common         Hot flush
Common              Hypertension,
Hypotension
Respiratory, thoracic and           Very common         Rhinitis mediastinal disorders
Skin and subcutaneous               Very common         Acne, Seborrhoea tissue disorders                    Common              Hirsutism
Uncommon            Alopecia
Musculoskeletal and                 Very common         Myalgia connective tissue disorders         Uncommon            Arthralgia
Reproductive system and             Very common         Breast atrophy, breast disorders                                        Vulvovaginal dryness Common              Artificial menopause,
Uterine haemorrhage
Uncommon            Breast enlargement,
Ovarian cyst
Not known           Ovarian hyperstimulation syndrome
General disorders and               Very common         Oedema administration site conditions
Investigations                      Common              Bone density decreased 

In addition to the above mentioned undesirable affects, migraine, blurred vision, palpitations, shortness of breath, increased levels of SGOT/SGPT and serum alkaline phosphatase have been reported but the frequencies are not known.

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. Healthcare professionals are asked to report any suspected adverse reactions by using an online formhttps://sideeffects.health.gov.il