Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
ADVERSE REACTIONS The most frequently reported adverse reactions following intrathecal administration of iopamidol are headache, nausea, vomiting, and musculoskeletal pain.
These reactions usually occur 1 to 10 hours after injection, almost all occurring within 24 hours.
They are usually mild to moderate in degree, lasting for a few hours and usually disappearing within 24 hours.
Rarely, headaches may be severe or persist for days.
Headache is often accompanied by nausea and vomiting, and tends to be more frequent and persistent in patients not optimally hydrated.
Backache, neck stiffness, numbness and paresthesias, leg or sciatic-type pain occurred less frequently, often in the form of a transient exacerbation of pre-existing symptomatology.
Transient alterations in vital signs may occur and their significance must be assessed on an individual basis.
The following table of incidence of reactions is based on clinical studies with Iopamidol Injection in about 686 patients.
Adverse Reactions Estimated Overall Incidence System > 1% ≤ 1% Body as a Whole headache (16.4%) pyrexia muscle weakness hot flashes malaise fatigue weakness Digestive nausea (7.3%) diarrhea vomiting (3.6%) heartburn Musculoskeletal back pain (2.2%) leg cramps leg pain (1.4%) sciatica neck pain (1.1%) cervicobrachial irritation meningeal irritation radicular irritation lumbosacral other musculoskeletal pain involuntary movement burning sensation Cardiovascular hypotension (1.1%) tachycardia hypertension chest pain Nervous none emotional stress dizziness paresthesia confusion hallucinations lightheadedness syncope numbness cold extremities ataxia irritability Urogenital none urinary retention Respiratory none dyspnea Skin and Appendages none rash Miscellaneous none injection site pain Other adverse effects reported in clinical literature for iopamidol include facial neuralgia, tinnitus, and sweating.
Major motor seizures have been reported in the clinical literature and since market introduction in the United States.
WARNINGS The need for myelographic examination should be carefully evaluated.
Iopamidol should be administered with caution in patients with increased intracranial pressure or suspicion of intracranial tumor, abscess or hematoma, those with a history of convulsive disorder, severe cardiovascular disease, chronic alcoholism, or multiple sclerosis, and elderly patients.
Particular attention must be given to state of hydration, concentration of medium, dose, and technique used in these patients.
Contrast media may promote sickling in individuals who are homozygous for sickle cell disease when injected intravenously or intra-arterially.
Although Iopamidol Injection is not injected intravascularly, measurable plasma levels are attained after intrathecal administration of iopamidol.
Like all medications, Iopamidol can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: