Iothalamate Side Effects
For the Consumer
Applies to iothalamate: injection solution, intravenous solution, urethral 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 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.
- 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.
- A very bad skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis) may happen. It 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 iothalamate: injectable solution
Common (1% to 10%): Pruritus, urticarial, face edema
Uncommon (0.1% to 1%): Erythema, rash
Rare (less than 0.1%): Angioedema, diaphoresis
Frequency not reported: Ecchymosis and tissue necrosis[Ref]
Common (1% to 10%): Nausea, vomiting
Rare (0.01% to 0.1%): Diarrhea, dry mouth, tongue edema
Very rare (less than 0.01%): Dysphagia[Ref]
Common (1% to 10%): Anaphylactoid reactions
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]
Rarely, these allergic-type reactions can progress into anaphylaxis with loss of consciousness and coma and severe cardiovascular disturbances.[Ref]
Common (1% to 10%): Rhinitis
Uncommon (0.1% to 1%): Coughing, dyspnea
Rare (0.01% to 0.1%): Larynx edema
Very rare (less than 0.01%): Apnea, bronchospasm[Ref]
Uncommon (0.1% to 1%): Hypotension
Rare (0.01% to 0.1%): Thrombophlebitis, tachycardia, ventricular fibrillation, pallor, vasodilation, cyanosis
Very rare (less than 0.01%): Disseminated intravascular coagulation resulting in death; arrhythmia; bradycardia; cardiac arrest, circulatory failure; abnormal ECG; heart block; phlebitis
Frequency not reported: Generalized vasodilation, flushing and venospasm; occasionally thrombosis; severe cardiovascular responses include rare cases of hypotensive shock, coronary insufficiency, cardiac arrhythmia, fibrillation and arrest; extravasation with burning pain; hematomas; vascular constriction due to injection rate; thrombosis[Ref]
These severe reactions are usually reversible with prompt and appropriate management; however, fatalities have occurred.[Ref]
Uncommon (0.1% to 1%): Thyroid function tests indicative of hypothyroidism or transient thyroid suppression in adults and pediatric patients (including infants)[Ref]
Uncommon (0.1% to 1%): Periorbital edema
Rare (0.01% to 0.1%): Conjunctivitis
Very rare (less than 0.01%): Vision disorders[Ref]
Rare (less than 0.1%): Injection side reaction[Ref]
Rare (0.01% to 0.1%): Dizziness; paraesthesia; taste perversion
Very rare (less than 0.01%): Agitation, coma, convulsions, dyskinesia, paralysis, tremor, somnolence
Frequency not reported: Aphasia; syncope, paresis; paralysis resulting from spinal cord injury and pathology associated with syndrome of transverse myelitis; visual field losses which are usually transient but may be permanent; coma and death; headache, trembling, shaking, numbness[Ref]
Very rare (less than 0.01%): Urinary incontinence[Ref]
Very rare (less than 0.01%): Thirst[Ref]
Very rare (less than 0.01%): Involuntary muscle contractions, myalgia, leg pain
Frequency not reported: Spasm[Ref]
Very common (10% or more): Hot flushes, pain
Rare (0.01% to 0.1%): Malaise
Very rare (less than 0.01%): Edema, abnormal crying
Frequency not reported: Chills without fever and lightheadedness[Ref]
Very rare (less than 0.01%): Anxiety[Ref]
Very rare (less than 0.01%): Acute renal failure, decrease in renal function
Frequency not reported: Temporary renal shutdown or other nephropathy[Ref]
Frequency not reported: Red blood cell clumping and agglutination, crenation and interference in clot formation[Ref]
1. "Product Information. Conray (iothalamate)." Mallinckrodt Medical Inc, St. Louis, MO.
2. Cerner Multum, Inc. "Australian Product Information." O 0
3. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
Some side effects of iothalamate may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.
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