Adverse reactions : תופעות לוואי

4.8       Undesirable effects

4.8.1    Summary of the safety profile
The general safety profile of Ultravist is based on data obtained in pre-marketing studies in more than 3,900 patients and post-marketing studies in more than 74,000 patients, as well as on data from spontaneous reporting and the literature.

The most frequently reported undesirable effects (> 4%) in patients administered Ultravist are headaches, nausea and vasodilation.

The most serious undesirable effects that occur in patients administered Ultravist are as follows: anaphylactoid shock, respiratory arrest, bronchospasm, laryngeal oedema, pharyngeal oedema, asthma, coma, cerebral infarction, cerebrovascular accident, cerebral oedema, convulsions, arrhythmia, cardiac arrest, myocardial ischaemia, myocardial infarction, heart failure, bradycardia, cyanosis, hypotension, shock, dyspnoea, pulmonary oedema, respiratory failure and aspiration.

4.8.2    Summary table of undesirable effects

The undesirable effects observed with Ultravist are summarised in the table below. They are listed by System Organ Class (MedDRA version 13.0), the most appropriate MedDRA term being used to describe a specific reaction with its synonyms and related conditions.

Undesirable effects reported during clinical trials are classed according to their frequency, with frequency groups being defined according to the following convention:  common (≥ 1/100 to < 1/10),
uncommon (≥ 1/1,000 to < 1/100),
rare (≥ 1/10,000 to < 1/1,000).

The undesirable effects reported in the post-marketing period only, whose frequency could not be estimated, are listed under “unknown”.
Table 1: Undesirable effects reported in clinical trials or in the post-marketing period in patients treated with Ultravist

System organ       Common             Uncommon                       Rare             Frequency unknown class
Immune system                    Hypersensitivity/ disorders                        anaphylactoid reactions
(anaphylactoid shock§)*), respiratory arrest§)*),
bronchospasm*),
laryngeal*)/ pharyngeal*)/facial oedema, tongue oedema§),
laryngeal/pharyngeal spasm§), asthma§)*),
conjunctivitis§),
lacrimation§),
sneezing, cough,
mucosal oedema,
rhinitis§),
hoarseness§), throat irritation§, urticaria,
pruritus, angioedema)
Endocrine                                                                            Thyrotoxic crisis, thyroid disorders                                                                            disorders Psychiatric                                                Anxiety disorders
Nervous system   Dizziness,      Vasovagal reactions,                                Coma*), cerebral disorders        headaches,      confused state,                                     ischaemia/infarction*), dysgeusia       restlessness,                                       cerebrovascular paraesthesia/                                       accident*), cerebral hypoesthesia,                                       oedemaa)*), convulsions*), somnolence                                          transient loss of cortical visiona), loss of consciousness, agitation,
amnesia, tremor, speech disorders,
paresis/paralysis,
contrast media‑induced encephalopathy
Eye disorders    Vision disorder/ visual acuity disorder
Ear and                                                                              Hearing disorders labyrinth disorders
Cardiac          Chest pain/     Arrythmia*)               Cardiac arrest*),         Myocardial infarction*), disorders        discomfort                                myocardial ischaemia*),   heart failure*), palpitations              bradycardia*),
tachycardia, cyanosis*)
System organ         Common               Uncommon                 Rare    Frequency unknown class
Vascular           Hypertension,      Hypotension*)                       Shock*), thromboembolic disorders          vasodilation                                           eventsa), vasospasma) Respiratory,                          Dyspnoea*)                          Pulmonary oedema*), thoracic and                                                              respiratory failure*), mediastinal                                                               aspiration*) disorders
Gastrointestinal   Vomiting,          Abdominal pain                      Swallowing disorders, disorders          nausea                                                 swelling of the salivary glands, diarrhoea
Skin and                                                                  Bullous disorders (e.g.
subcutaneous                                                              Stevens-Johnson or Lyell tissue disorders                                                          syndrome), rash, erythema, hyperhidrosis,
acute generalised exanthematous pustulosis,
drug reaction with eosinophilia and systemic symptoms
Musculoskeletal                                                           Compartment syndrome and connective                                                            in the case of tissue disorders                                                          extravasationa) Renal and                                                                 Renal disordersa), acute urinary                                                                   kidney injurya) disorders
General            Pain, injection    Oedema                              Feeling faint, shivering, disorders and      site reactions                                         pallor administration     (of various site conditions    types such as pain, feeling of warmth§),
oedema§),
inflammation§)
, soft tissue lesions§) in the case of extravasation),
hot flushes
Investigations                                                            Fluctuation in body temperature
*) life-threatening and/or fatal cases have been reported a) during intravascular use only
§) identified only during post-marketing surveillance (frequency not known) 
Most reactions following use in body cavities occur a few hours after administration.

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