Adverse reactions : תופעות לוואי

4.8   Undesirable effects

The most common adverse reactions include gynecomastia, nausea/vomiting and fluid retention/oedema.

The most serious reactions are embolism, myocardial ischaemia , cardiac failure congestive and, angioedema.

Reported reactions arranged according to MedDRA System Organ System are the following:
System Organ           Very Common              Common           Frequency not Class                       ≥ 1/10          ≥ 1/100 to < 1/10  known (cannot be estimated from available data)
Blood and            Anaemia,             Thrombocytopenia lymphatic system Leukopenia disorders
Immune system                                                 Hypersensitivity disorders
Metabolism and       Fluid retention nutrition disorders
Psychiatric                                                   Confusional state, disorders                                                     Depression Nervous system                            Lethargy, Headache disorders
Cardiac disorders Cardiac failure         Myocardial          Myocardial congestive           infarction          ischaemia
Vascular                                  Embolism            Hypertension disorders
Gastrointestinal     Nausea and disorders            Vomiting*,
Diarrhoea*
Hepatobiliary        Hepatic function disorders            abnormal
Skin and                                                      Angioedema**, subcutaneous                                                  Dermatitis allergic tissue disorders
Musculoskeletal                                               Muscular weakness and connective tissue disorders
Reproductive         Gynaecomastia                            Erectile dysfunction system and breast disorders
General disorders                                             Injection site and                                                           thrombosis (IV administration                                                solution) site conditions
System Organ            Very Common                   Common              Frequency not Class                       ≥ 1/10                ≥ 1/100 to < 1/10      known (cannot be estimated from available data)
*Particularly during the first two weeks of treatment.
**Angioedema (Quincke oedema, larynx oedema) can occur. In many reported cases, including a fatal one, patients were concomitantly receiving ACE-inhibitors. Therapy with estramustine is to be immediately discontinued should angioedema occur.

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 (http://forms.gov.il/globaldata/getsequence/getsequence.aspx?formType=AdversEffectMedic @moh.health.gov.il ) or by email (adr@MOH.HEALTH.GOV.IL ).