Chemical formula: C₁₇H₂₂I₃N₃O₈ Molecular mass: 777.089 g/mol PubChem compound: 3731
Animal studies have not indicated any harmful effects with respect to the course of pregnancy or on the health of the unborn or neonate. The safety of iomeprol in human pregnancy however has not been established. Therefore avoid in pregnancy unless there is no safer alternative.
Since, wherever possible, exposure to radiation should be avoided during pregnancy, the benefits of any X-ray examination, whether with or without contrast material, should for this reason alone be carefully weighed against the possible risk.
No human data exist concerning the excretion of iomeprol in breast milk. Animal studies have demonstrated that the excretion of iomeprol in breast milk is similar to that of other contrast agents and that these compounds are only minimally absorbed by the gastrointestinal tract of the young. Adverse effects on the nursing infant are therefore unlikely to occur.
Stopping breastfeeding is unnecessary.
Appropriate investigations and measures should be taken when exposing women of child-bearing potential to any X-ray examination, whether with or without contrast medium.
There is no known effect on the ability to drive and operate machines. After intrathecal administration, it is recommended that the patient should wait 24 hours before driving or operating machinery.
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.
Adult patients involved in clinical trials with intravascular administration of Iomeprol were 4,515.
Common (≥1/100 to <1/10)
Uncommon (≥1/1000 to <1/100)
Rare (≥1/10,000 to <1/1000)
Frequency unknown*
Frequency unknown*: Thrombocytopenia, Haemolytic anaemia
Frequency unknown*: Anaphylactoid reaction
Frequency unknown*: Anxiety, Confusional state
Uncommon: Headache, Dizziness
Rare: Presyncope
Frequency unknown*: Coma, Transient ischaemic attack, Paralysis, Syncope, Convulsion, Loss of consciousness, Dysarthria, Paraesthesia, Amnesia, Somnolence, Taste abnormality
Frequency unknown*: Blindness transient, Visual disturbance, Conjunctivitis, Lacrimation increased, Photopsia
Rare: Bradycardia, Tachycardia, Extrasystoles
Frequency unknown*: Cardiac arrest, Myocardial infarction, Cardiac failure, Angina pectoris, Arrhythmia, Ventricular or atrial fibrillation, Atrioventricular block, Palpitations, Cyanosis
Uncommon: Hypertension
Rare: Hypotension
Frequency unknown*: Circulatory collapse or shock, Hot flush, Flushing, Pallor
Uncommon: Dyspnoea
Frequency unknown*: Respiratory arrest, Acute respiratory distress syndrome (ARDS), Pulmonary oedema, Laryngeal oedema, Pharyngeal oedema, Bronchospasm, Asthma, Cough, Hyperventilation, Pharynx discomfort, Laryngeal discomfort, Rhinitis, Dysphonia
Uncommon: Nausea, Vomiting
Frequency unknown*: Diarrhoea, Abdominal pain, Salivary hypersecretion, Dysphagia, Salivary gland enlargement
Uncommon: Erythema, Urticaria, Pruritus
Rare: Rash
Frequency unknown*: Acute generalized exanthematous pustulosis, Angioedema, Cold sweat, Sweating increased
Rare: Back pain
Frequency unknown*: Arthralgia
Frequency unknown*: Renal failure
Feeling hot
Uncommon: Chest pain, Injection site warmth and pain
Rare: Asthenia, Rigors, Pyrexia
Frequency unknown*: Injection site reaction**, Coldness local, Fatigue, Malaise, Thirst
Rare: Blood creatinine increased
Frequency unknown*: Electrocardiogram ST segment elevation, Electrocardiogram abnormal
* Since the reactions were not observed during clinical trials with 4515 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.
Coronary artery thrombosis and coronary artery embolism have been reported as a complication of coronary catheterization procedures.
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.
As with other iodinated contrast media, very rare cases of mucocutaneous syndromes, including Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell syndrome) and erythema multiforme, have been reported following the administration of Iomeprol injection.
There is limited experience with paediatric patients. The clinical trial paediatric safety database comprises 167 patients.
The Iomeprol safety profile is similar in children and adults.
Adults patients involved in clinical trials with intrathecal administration of Iomeprol were 388.
The most frequently reported adverse reactions following intrathecal administration of Iomeprol are headache, dizziness, nausea, vomiting and back pain. These reactions are usually mild to moderate and transient in nature. Rarely, headache may persist for days. Most side effects occur some hours (3 to 6 hours) after the procedure, due to the distribution of the contrast medium in the CSF circulation from the site of administration to the intravascular space. Most reactions usually occur within 24 hours after injection.
Very common (≥1/10)
Common (≥1/100 to <1/10)
Uncommon (≥1/1000 to <1/100)
Frequency unknown*
Frequency unknown*: Anaphylactoid reaction
Very common: Headache
Common: Dizziness
Uncommon: Hypoaesthesia, Paraesthesia, Paraparesis, Loss of consciousness, Somnolence
Frequency unknown*: Epilepsy
Common: Hypertension
Uncommon: Hypotension, Flushing
Common: Nausea, Vomiting
Uncommon: Hyperhidrosis, Pruritus
Frequency unknown*: Rash
Common: Back pain, Pain in extremity
Uncommon: Musculoskeletal stiffness, Neck pain
Common: Injection site reaction**
Uncommon: Feeling hot, Pyrexia
* Since the reactions were not observed during clinical trials with 388 patients, best estimate is that their relative occurrence is uncommon (≥1/1000 to <1/100.
The most appropriate MedDRA term is used to describe a certain reaction and its symptoms and related conditions.
** Injection site reactions comprise application site pain, injection site discomfort, injection site pain and injection site warmth.
No adverse reactions were reported after intrathecal administration of Iomeprol both in clinical trials and in the post-marketing surveillance.
After injection of an iodinated contrast media in body cavities, contrast media are slowly absorbed from the area of administration into the systemic circulation and subsequently cleared by renal elimination.
Blood amylase increased is common following ERCP. Very rare cases of pancreatitis have been described.
The reactions reported in cases of arthrography and fistulography usually represent irritative manifestations superimposed on pre-existing conditions of tissue inflammation.
Hypersensitivity reactions are rare, generally mild and in the form of skin reactions. However, the possibility of severe anaphylactoid reactions cannot be excluded.
As with other iodinated contrast media, pelvic pain and malaise may occur after hysterosalpingography.
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. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme, Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
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