General The use of iodinated contrast media may cause untoward side effects. They are usually mild to moderate and transient in nature. However, severe and life-threatening reactions sometimes leading to death have been reported. In most cases, reactions occur within minutes of dosing but at times reactions may occur at later time.
Anaphylaxis (anaphylactoid/hypersensitivity reactions) may manifest with various symptoms, and rarely does any one patient develop all the symptoms. Typically, in 1 to 15 min (but rarely after as long as 2 h), the patient complains of feeling abnormal, agitation, flushing, feeling hot, sweating increased, dizziness, increased lacrimation, rhinitis, palpitations, paresthesia, pruritus, sore throat and throat tightness, dysphagia, cough, sneezing, urticaria, erythema, mild localised oedema, angioneurotic oedema and dyspnoea due to glottic/laryngeal/pharyngeal oedema and/or spasm manifesting with wheezing, and bronchospasm.
Nausea, vomiting, abdominal pain, and diarrhoea are also reported. These reactions, which can occur independently of the dose administered or the route of administration, may represent the first signs of circulatory collapse. Administration of the contrast medium must be discontinued immediately and, if needed, appropriate specific treatment urgently initiated via venous access.
Severe reactions involving the cardiovascular system, such as vasodilatation, with pronounced hypotension, tachycardia, dyspnoea, agitation, cyanosis and loss of consciousness progressing to respiratory and/or cardiac arrest may result in death.
These events can occur rapidly and require full and aggressive cardio-pulmonary resuscitation. Primary circulatory collapse can occur as the only and/or initial presentation without respiratory symptoms or without other signs or symptoms outlined above.
The adverse reactions reported in clinical trials among 4,903 adult patients and from post- marketing surveillance are represented in the tables below by frequency and classified by MedDRA system organ class. Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
1 Intravascular administration Adult patients involved in clinical trials with intravascular administration of Iomeprol were 4,739. Adults Adverse Reactions Clinical Trials Post-marketing Surveillance System Organ Class Common (≥1/100 t o <1/10) Uncommon (≥1/1000 to <1/100) Rare (≥1/10,000 to <1/1000) Frequency unknown* Blood and lymphatic system disorders Thrombocytopenia, Haemolytic anaemia Immune system disorders Anaphylactoid reaction Endocrine disorders Hyperthyroidism Psychiatric disorders Anxiety Confusional state Nervous system disorders Headache Dizziness Presyncope Coma Transient ischaemic attack Paralysis Adverse Reactions Clinical Trials Post-marketing Surveillance System Organ Class Common (≥1/100 t o <1/10) Uncommon (≥1/1000 to <1/100) Rare (≥1/10,000 to <1/1000) Frequency unknown* Syncope Convulsion Loss of consciousness Dysarthria Paraesthesia Amnesia Somnolence Taste abnormality Contrast induced encephalopathy*** Eye disorders Blindness transient Visual disturbance Conjunctivitis Lacrimation increased Photopsia Cardiac disorders Bradycardia Tachycardia Extrasystoles Cardiac arrest Myocardial infarction Cardiac failure Angina pectoris Arrhythmia Ventricular or atrial fibrillation Atrioventricular block Vascular disorders Hypertension Hypotension Circulatory collapse or shock Flushing Pallor Cyanosis Coronary artery thrombosis Coronary artery embolism Vasospasm**** Ischemia**** Respiratory, thoracic and mediastinal disorders Dyspnoea Respiratory arrest Acute respiratory distress syndrome (ARDS) Pulmonary oedema Laryngeal oedema Pharyngeal oedema Bronchospasm Asthma Cough Pharynx discomfort Laryngeal discomfort Rhinitis Dysphonia Gastrointestinal disorders Nausea Diarrhoea Adverse Reactions Clinical Trials Post-marketing Surveillance System Organ Class Common (≥1/100 t o <1/10) Uncommon (≥1/1000 to <1/100) Rare (≥1/10,000 to <1/1000) Frequency unknown* Vomiting Abdominal pain Salivary hypersecretion Dysphagia Salivary gland enlargement Skin and subcutaneous tissue disorders Erythema Urticaria Pruritus Rash Acute generalized exanthematous pustulosis Angioedema Sweating increased Stevens-Johnson’s syndrome Toxic epidermal necrolysis Erythema multiforme Drug Reaction with Eosinophilia and Systemic Symptoms Musculoskeletal and connective tissue disorder Back pain Arthralgia Renal and urinary disorders Acute kidney injury ***** General disorders and administration site conditions Feeling hot Chest pain Injection site warmth and pain Asthenia Rigors Pyrexia Injection site reaction** Coldness local Malaise Thirst Investigations Blood creatinine increased Electrocardiogram ST segment elevation Electrocardiogram abnormal * Since the reactions were not observed during clinical trials with 4,739 patients, best estimate is that their relative occurrence is rare (≥1/10,000 to <1/1000).
The most appropriate MedDRA term is used to describe a certain reaction and its symptoms and related conditions. ** Injection site reactions comprise injection site pain and swelling. In the majority of cases they are due to extravasation of contrast medium.
These reactions are usually transient and result in recovery without sequelae. Cases of extravasation with inflammation, skin necrosis and even development of compartment syndrome have been reported. *** Encephalopathy may manifest with symptoms and signs of neurological dysfunction such as headache, visual disturbance, cortical blindness, confusion, seizures, loss of coordination, hemiparesis, aphasia, unconsciousness, coma, brain oedema.
**** Vasospasm and consequent ischaemia have been observed during intra-arterial injections of contrast medium, in particular after coronary and cerebral angiography often procedurally related and possibly triggered by the tip of the catheter or excess catheter pressure ***** Transient renal failure […]