Ioxaglate Side Effects
For the Consumer
Applies to ioxaglate: injection solution
What are some side effects that I need to call my doctor about right away?
WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:
- Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
- Signs of kidney problems like unable to pass urine, change in how much urine is passed, blood in the urine, or a big weight gain.
- Signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
- Stuffy nose.
- Shortness of breath.
- Blue or gray skin color.
- Chest pain or pressure or a fast heartbeat.
- A heartbeat that does not feel normal.
- Very bad dizziness or passing out.
- Weakness on 1 side of the body, trouble speaking or thinking, change in balance, drooping on one side of the face, or blurred eyesight.
- This drug may cause tissue damage if the drug leaks from the vein. Tell your nurse if you have any redness, burning, pain, swelling, blisters, skin sores, or leaking of fluid where the drug is going into your body.
- Very bad skin reactions (Stevens-Johnson syndrome/toxic epidermal necrolysis) may happen from 1 hour to several weeks after getting this drug. These skin reactions can cause very bad health problems that may not go away, and sometimes death. Get medical help right away if you have signs like red, swollen, blistered, or peeling skin (with or without fever); red or irritated eyes; or sores in your mouth, throat, nose, or eyes.
What are some other side effects of this drug?
All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:
- Feeling of warmth.
- Upset stomach or throwing up.
These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.
You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.
For Healthcare Professionals
Applies to ioxaglate: injectable solution
The most frequent adverse reactions are nausea, vomiting, facial flush and a feeling of body warmth. These reactions are usually of brief duration. In clinical trials, this drug produced less discomfort (pain and heat) up on injection than other contrast agents.[Ref]
Common (1% to 10%): Facial flushing
Uncommon (0.1% to 1%): Thrombosis
Rare (0.01% to 0.1%): Thrombophlebitis; severe cases of hypotensive shock, coronary insufficiency, cardiac arrhythmia, fibrillation and arrest
Very rare (less than 0.01%): Disseminated intravascular coagulation
Frequency not reported: Generalized vasodilation, flushing, venospasm. Vascular constriction due to injection rate. Cardiac decompensation, serious arrhythmias, myocardial ischemia or infarction may occur during coronary arteriography and left ventriculography.[Ref]
Common (1% to 10%): Nausea, vomiting[Ref]
Uncommon (0.1% to 1%): Thyroid function tests indicative of hypothyroidism or transient thyroid suppression in adults and pediatric patients (including infants)[Ref]
Frequency not reported: Extravasation with burning pain, hematomas, ecchymosis, tissue necrosis[Ref]
Frequency not reported: Dermal manifestations (urticaria with or without pruritus, erythema, maculopapular rash); dry mouth, sweating, conjunctival symptoms; facial, peripheral, and angioneurotic edema; symptoms related to the respiratory system include sneezing, nasal stuffiness, coughing, choking, dyspnea, chest tightness and wheezing, which may be initial manifestations of more severe and infrequent reactions including asthmatic attack, laryngospasm and bronchospasm with or without edema, pulmonary edema, apnea and cyanosis[Ref]
Frequency not reported: Headache, trembling, shaking, lightheadedness, spasm, convulsions, aphasia, syncope, paresis, paralysis resulting from spinal cord injury and pathology associated with the syndrome of transverse myelitis, visual field losses which are usually transient but may be permanent, coma, death[Ref]
Frequency not reported: Chills without fever, hyperthermia[Ref]
Frequency not reported: Temporary renal shutdown or other nephropathy[Ref]
1. "Product Information. Hexabrix 200 (ioxaglate)." Tyco Healthcare Group Canada Inc, Quebec City, IN.
Some side effects may not be reported. You may report them to the FDA.