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.
6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Risks Associated with Inadvertent Intrathecal Administration [see Warnings and Precautions (5.1) ] Hypersensitivity Reactions [see Warnings and Precautions (5.2) ] Contrast-Induced Kidney Injury [see Warnings and Precautions (5.3) ] Cardiovascular Adverse Reactions [see Warnings and Precautions (5.4) ] Thromboembolic Events [see Warnings and Precautions (5.5) ] Thyroid Dysfunction in Pediatric Patients 0 to 3 Years of Age [see Warnings and Precautions (5.8) ] Severe Cutaneous Adverse Reactions [see Warnings and Precautions (5.11) ] Most common adverse reactions (incidence greater than 0.5%) in adult patients after iodixanol injection: Discomfort, warmth, pain;
Cardiovascular: angina.
Gastrointestinal: diarrhea, nausea, vomiting.
Nervous System: agitation, anxiety, insomnia, nervousness, dizziness, headache, migraine, unusual skin sensations, sensory disturbance, fainting, sensation of spinning.
Skin: itchy rash, severe itching, hives.
Special Senses: Smell, taste, and vision alteration.
( 6.1 ) Pediatric patients experienced similar adverse reactions.
( 6.3 ) To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi USA, LLC at 1-800-551-7176 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Iodixanol is often associated with sensations of discomfort, warmth or pain.
5 WARNINGS AND PRECAUTIONS Hypersensitivity Reactions: Life-threatening or fatal reactions can occur.
Always have emergency equipment and trained personnel available.
( 5.2 ) Contrast-Induced Acute Kidney Injury: Acute injury including renal failure can occur.
Minimize dose and maintain adequate hydration to minimize risk.
( 5.3 ) Cardiovascular Adverse Reactions: Hemodynamic disturbances including shock and cardiac arrest may occur during or after administration.
Like all medications, Iodixanol 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: