Adverse reactions : תופעות לוואי

4.8 Undesirable effects
The most commonly reported adverse drug reaction in clinical trials with Venofer was dysgeusia, which occurred with a rate of 4.5 events per 100 subjects. The most important serious adverse drug reactions associated with Venofer 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 Venofer 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         Uncommon                    Rare             Frequency not Class                   (≥1/100,       (≥1/1,000, <1/100)          (≥1/10,000,      known1) <1/10)                                     <1/1,000)
Immune system                          Hypersensitivity                             Anaphylactoid/ disorders                                                                           anaphylactic reactions,
angioedema
Nervous system          Dysgeusia,     Headache, dizziness,        Syncope,         Depressed level disorders                              paraesthesia,               somnolence       of hypoaesthesia                                consciousness,
confusional
System Organ            Common         Uncommon                   Rare              Frequency not Class                   (≥1/100,       (≥1/1,000, <1/100)         (≥1/10,000,       known1) <1/10)                                    <1/1,000) state, loss of consciousness,
anxiety, tremor
Cardiac disorders                                                 Palpitations      Bradycardia, tachycardia,
Kounis syndrome
Vascular disorders Hypotension, Flushing, phlebitis                                 Circulatory hypertension                                                     collapse, thrombophlebitis
Respiratory,                                                                        Bronchospasm thoracic and                           Dyspnoea 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, myalgia,
and connective                         arthralgia, pain in tissue disorders                       extremity, back pain
General disorders Injection/           Chills, asthenia, fatigue, Chest pain,       Cold sweat, and administration infusion site       oedema peripheral,         hyperdrosis,      malaise, pallor, site conditions    reaction 2)         pain                       pyrexia           influenza like illness3)
Investigations                         Alanine                   Blood lactate aminotransferase          dehydrogenas increased, aspartate      e 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/