Adverse reactions : תופעות לוואי

4.8 Undesirable Effects
The most commonly reported adverse drug reaction in clinical trials with iron sucrose was dysgeusia, which occurred with a rate of 4.5 events per 100 subjects. The most important serious adverse drug reactions associated with iron sucrose are hypersensitivity reactions, which occurred with a rate of 0.25 events per 100 subjects in clinical trials.
Anaphylactoid/anaphylactic reactions were reported only in the post-marketing setting (estimated as rare); fatalities have been reported. See section 4.4.
The adverse drug reactions reported after the administration of iron sucrose in 4,064 subjects in clinical trials as well as those reported from the post-marketing setting are presented in the table below.

System Organ        Common (≥1/100,      Uncommon               Rare              Frequency not Class               <1/10)               (≥1/1,000, <1/100)     (≥1/10,000,       known1) <1/1,000)
Immune system                            Hypersensitivity                         Anaphylactoid/ disorders                                                                         anaphylactic reactions,
angioedema
Nervous system      Dysgeusia            Headache, dizziness,   Syncope,          Depressed level disorders                                paraesthesia,          somnolence        of consciousness, hypoaesthesia                            confusional state,
loss of consciousness,
anxiety, tremor
Cardiac disorders                                               Palpitations      Bradycardia, Tachycardia,
Kounis syndrome
Vascular            Hypotension,         Flushing, phlebitis                      Circulatory disorders           hypertension                                                   collapse, thrombophlebitis
Respiratory,                              Dyspneoa                                 Bronchospasm thoracic and mediastinal disorders
Renal and urinary                                                Chromaturia disorders
Gastrointestinal    Nausea                Vomiting, abdominal disorders                                 pain, diarrhoea,
constipation
Skin and                                  Pruritus, rash                           Urticaria, subcutaneous                                                                       erythema tissue disorders
Musculoskeletal                           Muscle spasm,
and connective                            myalgia, arthralgia,
tissue disorders                          pain in extremity,
back pain
General disorders   Injection             Chills, asthenia,      Chest pain,       Cold sweat, and                 /infusion             fatigue, oedema        hyperdrosis       malaise, pallor, administration      site reaction (2)     peripheral, pain       pyrexia           influenza like site conditions                                                                    illness3) Investigations                            Alanine                Blood lactate aminotransferase       dehydrogenase increased, aspartate   increased aminotransferase increased, gamma- glutamyltransferase increased, serum ferritin increased
1)
Spontaneous reports from the post-marketing setting; estimated as rare 2)
The most frequently reported are: injection/infusion site pain, -extravasation, - irritation, -reaction, -discolouration, - haematoma, -pruritus.
3)
Onset may vary from a few hours to several days.


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/