Common Adverse Reactions (for all indications for the use of iodine-containing radiocontrast agents)
Hypersensitivity reactions can occur regardless of the dose and mode of administration, mild symptoms may be harbingers of a serious anaphylactoid reaction / shock. In this case, the administration of the radiopaque means should be immediately stopped and, if necessary, the intravascular administration of specific therapeutic agents is started.
After the administration of the iodine-containing radiopaque agent, an insignificant transient increase in the serum creatinine concentration is observed, possibly the development of contrast-induced nephropathy.
Yodizm - a rare reaction to the introduction of iodine-containing radiocontrast agents, expressed in the increase and soreness of the salivary glands after a study of up to 10 days.
The incidence of adverse events is classified as follows: very often (≥ 1/10), often from (≥ 1/100 to <1/10), infrequently from (≥ 1/1000 to <1/100), rarely from (≥ 1 / 10,000 to <1/1000), very rarely from (<1/10000), the frequency is unknown (the frequency can not be determined from the available data).
Immune system disorders: rarely - hypersensitivity reactions (including dyspnea, rash, erythema, urticaria, pruritus, skin reactions, vasculitis, angioedema, laryngeal edema, laryngospasm, bronchospasm or noncardiogenic pulmonary edema) (reactions may occur immediately after injection or several days later); unknown - anaphylactic / anaphylactoid reaction, anaphylactic / anaphylactoid shock.
Disturbances from the nervous system: rarely - headache; very rarely - dysgeusia (transient sensation of a "metallic" taste in the oral cavity); unknown - faint.
Disorders from the cardiovascular system: rarely - aetiology.
Vascular disorders: very rarely - increased blood pressure, lower blood pressure.
Disorders from the gastrointestinal tract: infrequently - nausea; rarely vomiting; very rarely - diarrhea, pain / discomfort in the abdomen; unknown - an increase in the salivary glands.
General disorders and disorders at the site of administration: often - a feeling of heat; rarely - a fever; very rarely - chills.
Trauma, intoxication and complications of manipulation: unknown - iodism.
Intravascular administration (intraarterially and intravenously)
The nature of adverse reactions that occur with intra-arterial administration depends on the site of injection and the dose administered. Selective angiography and other procedures in which high concentrations of radiopaque means reach a particular organ may be accompanied by the development of complications in this organ.
Immune system disorders: unknown - severe skin reactions in the form of pustules or bullae.
Disorders from the endocrine system: unknown - thyrotoxicosis, transient hypothyroidism.
Disorders of the psyche: unknown - confusion of consciousness.
Impaired nervous system: rarely - dizziness; very rarely - convulsions, impaired consciousness, encephalopathy, stupor, disorders in the sensory sphere (including hypoesthesia), paresthesia, tremor; unknown - transient motor dysfunction (including speech disturbance, aphasia, dysarthria), transient memory loss, disorientation, coma and retrograde amnesia.
Disturbances on the part of the organ of sight: unknown - transient cortical blindness.
Hearing disorders and labyrinthine disorders: unknown - transient hearing loss.
Disorders from the cardiovascular system: rarely - arrhythmia (including bradycardia, tachycardia); very rarely - myocardial infarction; unknown - severe complications (including cardiac arrest, cardiac arrest and respiration), spasm of the coronary arteries, pain in the chest.
Vascular disorders: very rarely - "tides"; unknown - shock, arterial spasm, ischemia, thrombophlebitis and thrombosis.
Disturbances from the respiratory system, chest and mediastinal organs: rarely - cough; very rarely - shortness of breath, noncardiogenic pulmonary edema; unknown - severe symptoms and signs of respiratory disorders, bronchospasm, laryngospasm, attack of bronchial asthma.
Disorders from the gastrointestinal tract: rarely diarrhea; unknown - exacerbation of pancreatitis, acute pancreatitis.
Disturbances from the skin and subcutaneous tissues: unknown - bullous dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug rash, accompanied by eosinophilia and general symptoms, exacerbation of psoriasis.
Disturbances from musculoskeletal and connective tissue: unknown - arthralgia.
Disorders from the kidneys and urinary tract: rarely - a violation of kidney function, including acute renal failure.
General disorders and disorders at the site of administration: often - a feeling of heat; infrequently - pain and discomfort; rarely - asthenic condition (for example, malaise, fatigue); unknown - reactions at the injection site (including extravasation), back pain.
Intrathecal administration
In case of intrathecal administration, unwanted reactions can occur after several hours or even days after the diagnostic procedure. The frequency of adverse reactions is the same as after lumbar puncture.
Headache, nausea, vomiting or dizziness can be largely caused by a decrease in pressure in the subarachnoid space due to leakage of liquor through the puncture hole. To minimize the pressure drop, you must avoid removing too much cerebrospinal fluid.
Disorders of the psyche: unknown - confusion of consciousness.
Impaired nervous system: very often - headache (can be severe and prolonged); infrequently - aseptic meningitis (including chemical meningitis); rarely - convulsions,dizziness; unknown - abnormalities on the electroencephalogram, meningism, transient encephalopathy, including temporary memory loss, coma, stupor and retrograde amnesia, motor dysfunction (including speech disorders, aphasia, dysarthria), paresthesia, hypesthesia and impaired sensory function.
Disturbances on the part of the organ of sight: unknown - transient cortical blindness, photophobia.
Hearing disorders and labyrinthine disturbances: unknown - transient hearing loss.
Disorders from the gastrointestinal tract: often - nausea, vomiting.
Disturbances from musculoskeletal and connective tissue: rarely - pain in the neck, back pain; unknown - muscle spasms.
General disorders and disorders at the site of administration: rarely - pain in the limbs; unknown - reactions at the site of administration of the drug.
Intracavernal administration
Endoscopic retrograde cholangiopancreatography (ERCP)
Disorders from the gastrointestinal tract: often - pancreatitis, increased activity of amylase in the blood.
Oral administration
Disorders from the gastrointestinal tract: very often diarrhea; often - nausea, vomiting; infrequently - pain in the abdomen.
Hysterosalpingography (GHA)
Disorders from the gastrointestinal tract: very often - pain in the lower abdomen.
Arthrography
Disturbances from musculoskeletal and connective tissue: unknown - arthritis.
General disorders and disorders at the site of administration: very often - pain.
Gerniography
General disorders and disorders at the site of administration: unknown - the pain after the procedure.
Description of some unwanted reactions
There have been reports of thromboembolic complications in radiopaque cardioangiography and angiography of the cerebral, renal and peripheral arteries. The introduction of radiopaque means could contribute to the development of these complications. Cases of cardiac complications, including acute myocardial infarction, during or after coronary angiography with radiopaque enhancement are described. In elderly patients or in the presence of severe coronary artery disease, unstable angina and left ventricular dysfunction, the risk of cardiac complications is increased.
In very rare cases, the radiopaque can pass through the blood-brain barrier into the cerebral cortex,which can lead to the emergence of transient neurological reactions, in particular, convulsions, transient motor or sensory disturbances, confusion, loss of memory and encephalopathy.
Anaphylactoid reaction and shock can develop severe arterial hypotension and associated hypoxic encephalopathy, renal and hepatic insufficiency. In some cases, extravasation of radiopaque means there are local pain and swelling, but these symptoms are resolved without consequences. Cases of inflammation, tissue necrosis and the appearance of compartmental syndrome are described.
Pediatric Use
There have been reports of cases of transient hypothyroidism in children, including preterm and newborns, after the introduction of iodine-containing radiopaque agents. Premature babies are particularly sensitive to iodine effects. The case of transient hypothyroidism in a preterm child was reported. An adequate rehydration is necessary before and after the introduction of radiopaque means, this is especially important for young children. Nephrotoxic drugs should be discontinued.Reduced glomerular filtration, characteristic of young children, can also lead to a delayed removal of radiopaque substances.