Chemical formula: C₁₇H₂₂I₃N₃O₈ Molecular mass: 777.085 g/mol PubChem compound: 65492
X-ray examination of women should if possible be conducted during the preovulation phase of the menstrual cycle and should be avoided during pregnancy; also, since it has not been demonstrated that iopamidol is safe for use in pregnant women, it should be administered only if the procedure is considered essential by the physician. Apart from radiation exposure of the foetus, benefit-risk consideration for iodine containing contrast agents should also take into account the sensitivity of the foetal thyroid towards iodine.
There are no or a limited amount of data from the use of iopamidol in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity. As a precautionary measure, it is preferable to avoid the use of iopamidol solution during pregnancy.
Iodine-containing X-ray contrast agents are excreted into the breast milk in low amounts. From animal experience, iopamidol is non toxic in animals after oral administration. From experience gained so far, harm to the nursing infant is unlikely to occur. Stopping breastfeeding is unnecessary.
No effects on fertility are anticipated due to the low absorption of iopamidol from the gastrointestinal tract following oral or rectal administration.
Reproduction studies performed in animals with Iopamidol administered parenterally revealed no evidence of impaired fertility. No studies have been performed in women.
There is no known effect on the ability to drive and operate machines. However, because of the risk of early reactions, driving or operating machinery is not advisable for one hour following the last intravascular injection.
Driving or operating machinery is not advisable for 6 hours following intrathecal administration.
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.
Anaphylaxis (anaphylactoid reactions/hypersensitivity) may manifest with: mild localized or more diffuse angioneurotic oedema, tongue oedema, laryngospasm or laryngeal oedema, dysphagia, pharyngitis and throat tightness, pharyngolaryngeal pain, cough, conjunctivitis, rhinitis, sneezing, feeling hot, sweating increased, asthenia, dizziness, pallor, dyspnoea, wheezing, bronchospasm, and moderate hypotension. Skin reactions may occur in the form of various types of rash, diffuse erythema, diffuse blisters, urticaria, and pruritus. These reactions, which occur irrespective of the dose administered and the route of administration, may represent the first signs of incipient state of shock. Administration of the contrast medium must be discontinued immediately and – if necessary – specific treatment initiated via a venous access.
Following intravascular administration, in most cases reactions occur within minutes of dosage. However, delayed reactions, usually involving skin, may occur, mostly within 2-3 days, more rarely within 7 days, after the administration of the contrast medium.
After intrathecal administration, most side effects occur with a delay of some hours due to the slow absorption from the site of administration and distribution to the whole body. Reactions usually occur within 24 hours after injection.
More 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 are classified by System Organ Class and frequency, using the following convention: Very common (≥1/10), Common (≥1/100 to <1/10), Uncommon (≥1/1,000 to <1/100), Rare (≥1/10,000 to <1/1,000), Very rare (<1/10,000), not known (cannot be estimated from the available data).
Frequency unknown: Thrombocytopenia
Frequency unknown: Anaphylaxis, Anaphylactoid reaction
Rare: Confusional state
Common: Headache
Uncommon: Dizziness, Taste alteration
Rare: Paraesthesia
Frequency unknown: Coma, Transient ischaemic attack, Syncope, Depressed level consciousness or loss of consciousness, Convulsion,
Frequency unknown: Transient blindness, Visual disturbance, Conjunctivitis, Photophobia
Uncommon: Cardiac dysrhythmias such as extrasystoles, atrial fibrillation, ventricular tachycardia and ventricular fibrillation*
Rare: Bradycardia
Frequency unknown: Myocardial ischaemia infarction, Cardiac failure, Cardio-respiratory arrest, Tachycardia
Uncommon: Hypotension, Hypertension, Flushing
Frequency unknown: Circulatory collapse or shock
Rare: Pulmonary oedema, Asthma, Bronchospasm
Frequency unknown: Respiratory arrest, Respiratory failure, Acute respiratory distress syndrome, Respiratory distress, Apnoea, Laryngeal oedema, Dyspnoea
Common: Nausea
Uncommon: Vomiting, Diarrhea, Abdominal pain, Dry mouth
Frequency unknown: Salivary hypersecretion, Salivary gland enlargement
Uncommon: Rash, Urticaria, Pruritus, Erythema, Sweating increased
Frequency unknown: Face oedema, muco-cutaneous syndrome**
Uncommon: Back pain
Rare: Muscle spasms
Frequency unknown: Musculoskeletal pain, Muscular weakness
Uncommon: Acute renal failure
Common: Feeling hot
Uncommon: Chest pain, Injection site pain***, Pyrexia, Feeling cold
Frequency unknown: Rigors, Pain, Malaise
Uncommon: Blood creatinine increased
Frequency unknown: Electrocardiogram change including ST Segment depression
* Cardiac reactions may occur consequences of the coronary catheterization procedural hazard: these complications include coronary artery thrombosis and coronary artery embolism.
** As with other iodinated contrast media, very rare cases of muco-cutaneous syndromes, including Stevens-Johnson syndrome, toxicepidermal necrolysis (Lyell syndrome) and erythema multiforme, have been reported following the administration of iopamidol
*** Injection site pain and swelling may occur. In the majority of cases it is due to extravasation of contrast medium. These reactions are usually transient and result in recovery without sequelae. However, inflammation and even skin necrosis have been seen on very rare occasions. In isolated reports extravasation led to the development of compartment syndrome
Frequency type and severity of adverse reactions in children are similar to those in adults.
Frequency unknown: Meningitis aseptic, Meningitis bacterial as consequence of the procedural hazard
Frequency unknown: Anaphylaxis, Anaphylactoid reaction**
Frequency unknown: Confusional state, Disorientation, Agitation, Restlessness
Very common: Headache
Frequency unknown: Coma, Paralysis, Convulsion, Syncope, Depressed level of consciousness or loss of consciousness, Meningism, Dizziness, Paraesthesia, Hypoaesthesia
Frequency unknown: Transient blindness
Frequency unknown: Arrhythmia
Common: Flushing
Frequency unknown: Hypertension
Frequency unknown: Respiratory arrest, Dyspnoea
Common: Nausea,Vomiting
Uncommon: Rash
Common: Back pain, Neck pain, Pain in extremity, Sensation of heaviness
Frequency unknown: Pyrexia, Malaise, Rigors
* Anaphylaxis (anaphylactoid reactions/hypersensitivity) may occur. Anaphylactoidreactions with circulatory disturbances such a severe blood pressure decrease leading to syncope or cardiac arrest and life threatening shock are much less common after intrathecal administration than after intravascular administration.
The majority of the reactions occur some hours after the contrast administration due to the slow absorption from the area of administration and distribution in the whole organism.
Blood amylase increased is common following ERCP. Very rare cases of pancreatitis have been described.
The reactions reported in cases of arthrography usually represent irritative manifestations superimposed on existing tissue inflammation.
Systemic hypersensitivity is rare, generally mild and in the form of skin reactions. However, the possibility of severe anaphylactoid reactions cannot be excluded.
The undesirable effects reported with iopamidol were, in general, non-serious, mild to moderate, transient and resolved spontaneously without residual effects.
Solutions of iodinated contrast media administered oral route or by enema can cause diarrhoea due to high osmolality of these solutions. Anaphylactoid reactions/hypersensitivity may manifest with: mild localized or more diffuse angioneurotic oedema, tongue oedema, laryngospasm or laryngeal oedema, pulmonary oedema, circulatory arrest, respiratory arrest, dysphagia, pharyngitis and throat tightness, pharyngolaryngeal pain, cough, conjunctivitis, rhinitis, sneezing, feeling hot, sweating increased, asthenia, dizziness, pallor, dyspnoea, wheezing, bronchospasm, and moderate hypotension. Skin reactions may occur in the form of various types of rash, diffuse erythema, diffuse blisters, urticaria, and pruritus. These reactions, which occur irrespective of the dose administered and the route of administration, may represent the first signs of incipient state of shock. Administration of the contrast medium must be discontinued immediately and – if necessary – specific treatment initiated via a venous access.
More severe reactions involving the cardiovascular system such as vasodilatation with pronounced hypotension, tachycardia, dyspnoea, agitation, cyanosis and loss of consciousness (syncope) may require emergency treatment.
In clinical trials, the most commonly reported adverse reactions are vomiting in adult patients (1.8%) and diarrhoea in paediatric patients (5.7%). These reactions have been reported mostly after oral administration of the contrast agent.
The adverse reactions are classified by System Organ Class and frequency, using the following convention: Very common (≥1/10), Common (≥1/100 to <1/10), Uncommon (≥1/1,000 to <1/100), Rare (≥1/10,000 to <1/1,000), Very rare (<1/10,000), Not known (cannot be estimated from the available data).
Adverse reactions derived from clinical trials in 269 adult patients who received iopamidol by either oral or rectal route of administration and from post-marketing spontaneous reporting are listed below.
Frequency not known: Anaphylactoid reaction
Uncommon: Hypotension
Frequency not known: Dyspnoea
Common: Vomiting
Uncommon: Diarrhoea, Abdominal discomfort
Frequency not known: Rash
The following adverse reactions derived from clinical trials conducted in 335 paediatric patients, who received iopamidol by either oral or rectal route of administration.
Common: Diarrhoea
Uncommon: Nausea, Vomiting
No cases were received as post-marketing spontaneous reporting.
No anaphylactoid reaction has been reported in children after oral or rectal administration of iopamidol however they have been reports of such reactions after parenteral administration of iopamidol.
Following oral administration of iopamidol, aspiration, manifested with coughing and possible pulmonary complications, has been reported.
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