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Iopromide Side Effects

Medically reviewed by Drugs.com. Last updated on Sep 20, 2020.

For the Consumer

Applies to iopromide: injection solution

Warning

Injection route (Solution)

Inadvertent intrathecal administration may cause death, convulsions, cerebral hemorrhage, coma, paralysis, arachnoiditis, acute renal failure, cardiac arrest, seizures, rhabdomyolysis, hyperthermia, and brain edema.

Side effects requiring immediate medical attention

Along with its needed effects, iopromide may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur while taking iopromide:

Less common

  • Bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site
  • chest pain
  • feeling faint, dizzy, or lightheadedness
  • feeling of warmth or heat
  • flushing or redness of the skin, especially on the face and neck
  • frequent strong or increased urge to urinate
  • headache
  • sweating

Rare

  • Bloating or swelling of the face, arms, hands, lower legs, or feet
  • bluish lips or skin
  • chest discomfort or tightness
  • convulsions
  • cough
  • decreased frequency or amount of urination
  • difficult or painful urination
  • difficulty breathing
  • excessive thirst
  • fever or chills
  • nausea or vomiting
  • noisy breathing
  • pain or discomfort in the arms, jaw, back, or neck
  • pale skin at injection site
  • irregular heartbeat
  • tingling of the hands or feet
  • unusual tiredness or weakness
  • unusual weight gain or loss

Incidence not known

  • Blistering, peeling, or loosening of the skin
  • bloody urine
  • blue lips and fingernails
  • coughing that sometimes produces a pink frothy sputum
  • diarrhea
  • difficult, fast, noisy breathing, sometimes with wheezing
  • difficulty with swallowing or sore throat
  • dilated neck veins
  • extreme fatigue
  • irregular breathing
  • joint or muscle pain
  • loss of appetite
  • lower back or side pain
  • nervousness
  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • red, irritated eyes
  • red skin lesions, often with a purple center
  • sensitivity to heat
  • skin rash, hives, or itching
  • sores, ulcers, or white spots in the mouth or on the lips
  • swelling of the face, fingers, feet, or lower legs
  • trouble sleeping

Side effects not requiring immediate medical attention

Some side effects of iopromide may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common

  • Change in taste
  • changes in vision
  • loss of taste

Rare

  • Abdominal or stomach discomfort or pain
  • acid or sour stomach
  • agitation
  • belching or passing of gas
  • body aches or pain
  • burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
  • difficulty with moving
  • dry mouth
  • excessive muscle tone
  • general feeling of discomfort or illness
  • lack of coordination
  • loss of strength or energy
  • muscle tension or tightness
  • sleepiness or unusual drowsiness
  • tender, swollen glands in the neck
  • voice changes

Incidence not known

  • Bigger, dilated, or enlarged pupils (black part of the eye)
  • burning, dry, or itching eyes
  • continuing ringing or buzzing or other unexplained noise in the ears
  • discharge, excessive tearing
  • feeling of constant movement of self or surroundings
  • headache, severe and throbbing
  • hearing loss
  • increased sensitivity of the eyes to light
  • redness, pain, or swelling of the eye, eyelid, or inner lining of the eyelid
  • sensation of spinning

For Healthcare Professionals

Applies to iopromide: injectable solution

General

The most important adverse events were anaphylactoid shock, contrast induced acute kidney injury, coma, cerebral infarction stroke, brain edema, convulsion, arrhythmia, cardiac arrest, myocardial ischemia, myocardial infarction, cardiac failure, bradycardia, cyanosis, hypotension, shock, dyspnea, pulmonary edema, respiratory insufficiency, and aspiration.[Ref]

Cardiovascular

Common (1% to 10%): Vasodilatation

Frequency not reported: Atrioventricular block (complete), bradycardia, ventricular extrasystole, coronary artery thrombosis, flushing, hypertension, hypotension, peripheral vascular disorder, vascular anomaly, myocardial ischemia, cardiac failure, cyanosis, shock

Postmarketing reports: Cardiac arrest, ventricular fibrillation, atrial fibrillation, tachycardia, palpitations, congestive heart failure, myocardial infarction, angina pectoris, vasospasm[Ref]

Dermatologic

Frequency not reported: Hyperhidrosis, face edema, erythema, pruritus, rash urticaria

Postmarketing reports: Angioedema, mild (e.g. rash, erythema, pruritus, urticaria, skin discoloration) to severe (e.g. Stevens-Johnson syndrome, toxic epidermal necrolysis) skin reactions, acute generalized exanthematous pustulosis (AGEP), drug reaction with eosinophilia and systemic symptoms (DRESS)[Ref]

Endocrine

Postmarketing reports: Hyperthyroidism, thyrotoxic crisis, hypothyroidism[Ref]

There are uncommon reports of hypothyroidism or transient thyroid suppression after iodinated contrast agents in patients of all ages, including infants. Some patients were treated for hypothyroidism.[Ref]

Gastrointestinal

Common (1% to 10%): Nausea, vomiting

Frequency not reported: Abdominal discomfort, abdominal pain, abdominal pain upper, constipation, diarrhea, dry mouth, dyspepsia, gastrointestinal disorder, gastrointestinal pain, salivation increased, stomach discomfort, rectal tenesmus

Postmarketing reports: Dysphagia, swelling of salivary glands, mucous membrane disorder/mucosal swelling (pediatric patients)[Ref]

Genitourinary

Common (1% to 10%): Urinary urgency

Frequency not reported: Dysuria, blood urea increased, urinary retention

Postmarketing reports: Hematuria[Ref]

Hypersensitivity

Postmarketing reports: Anaphylactoid reactions (including fatal cases), anaphylactoid shock, hypersensitivity[Ref]

Local

Common (1% to 10%): Injection site and infusion site reactions (hemorrhage, hematoma, pain, edema, erythema, rash)

Frequency not reported: Extravasation

Postmarketing reports: Compartment syndrome in case of extravasation, fixed eruptions (pediatric patients)[Ref]

Metabolic

Frequency not reported: Excessive thirst, blood lactate dehydrogenase increased, blood urea increased

Postmarketing reports: Diabetes insipidus (pediatric patients)[Ref]

Musculoskeletal

Common (1% to 10%): Back pain

Frequency not reported: Chills, arthralgia, musculoskeletal pain, myasthenia, neck pain, pain in extremity

Postmarketing reports: Joint disorder/effusion (pediatric patients), muscle cramps (pediatric patients)[Ref]

Nervous system

Common (1% to 10%): Headache, dysgeusia

Frequency not reported: Convulsion, dizziness, hypertonia, hypesthesia, incoordination, neuropathy, somnolence, speech disorder, tremor, paresthesia, syncope, cerebral infarction stroke, brain edema

Postmarketing reports: Vertigo, tinnitus, cerebral ischemia/infarction, paralysis, paresis, aphasia, coma, unconsciousness, amnesia, hypotonia, aggravation of myasthenia gravis symptoms, migraine (pediatric patients), brain edema (pediatric patients)[Ref]

Ocular

Common (1% to 10%): Abnormal vision

Frequency not reported: Visual field defect

Postmarketing reports: Mydriasis, lacrimation disorder, transient cortical blindness[Ref]

Psychiatric

Frequency not reported: Agitation, confusion, anxiety[Ref]

Renal

Frequency not reported: Renal pain, contrast-induced acute kidney injury

Postmarketing reports: Renal failure[Ref]

Respiratory

Frequency not reported: Asthma, apnea, cough increased, dyspnea, hypoxia, pharyngeal edema, pharyngitis, pleural effusion, pulmonary hypertension, respiratory disorder, sore throat, respiratory insufficiency, aspiration

Postmarketing reports: Laryngeal edema, laryngospasm, bronchospasm, pulmonary edema, acute respiratory distress syndrome, epistaxis (pediatric patients), hypoxia (pediatric patients)[Ref]

Hematologic

Frequency not reported: Hemoglobin increased, white blood cell count increased[Ref]

Immunologic

Postmarketing reports: Conjunctivitis (pediatric patients)[Ref]

Other

Common (1% to 10%): Chest pain, pain

Frequency not reported: Asthenia, chest discomfort, feeling hot, malaise, edema peripheral, pyrexia[Ref]

References

1. "Product Information. Ultravist (iopromide)." Berlex, Richmond, CA.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.