Note: This document contains side effect information about iopamidol. Some dosage forms listed on this page may not apply to the brand name Isovue-M-300.

Applies to iopamidol: injection solution.

Serious side effects of Isovue-M-300

Along with its needed effects, iopamidol (the active ingredient contained in Isovue-M-300) 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 iopamidol:

Less common

• Arm, back, or jaw pain
• blurred vision
• chest pain or discomfort
• chest tightness or heaviness
• confusion
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• fast or irregular heartbeat
• feeling of warmth
• hives
• lightheadedness, dizziness, or fainting
• nausea
• redness of the face, neck, arms, and occasionally, upper chest
• slow or irregular heartbeat
• sudden sweating
• trouble breathing
• unusual tiredness or weakness

Less common or rare

• Blue lips and fingernails
• changes in skin color
• chills
• coughing that sometimes produces a pink frothy sputum
• decrease in the frequency of urination
• decrease in urine volume
• difficulty in passing urine (dribbling)
• dizziness
• fainting
• fast, pounding, or irregular heartbeat or pulse
• fever
• headache
• hives or welts, itching, or skin rash
• increased sweating
• nervousness
• numbness or tingling in the face, arms, or legs
• pain or discomfort in the arms, jaw, back, or neck
• pain, tenderness, or swelling of the foot or leg
• painful urination
• pale skin
• pounding in the ears
• redness of the skin
• severe, unusual tiredness or weakness
• trouble speaking, thinking, or walking
• vomiting

Rare

• Double vision
• inability to move the arms, legs, or facial muscles
• pain in the chest, groin, or legs, especially the calves
• severe, sudden headache
• slow speech
• slurred speech
• sudden loss of coordination
• sudden, severe weakness or numbness in the arm or leg
• vision changes

Incidence not known

• 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
• change in consciousness
• heart stops
• loss of consciousness
• no breathing
• no pulse or blood pressure
• no sensation in the legs
• not able to pass urine
• seizures
• unable to move the legs

Other side effects of Isovue-M-300

Some side effects of iopamidol 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 or rare

• Bad, unusual, or unpleasant (after) taste
• change in taste
• discouragement
• disturbed color perception
• feeling sad or empty
• halos around lights
• irritability
• loss of appetite
• loss of interest or pleasure
• loss of vision
• night blindness
• overbright appearance of lights
• stuffy nose
• trouble concentrating
• trouble sleeping
• tunnel vision
• weight loss

Incidence not known

• Burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• burning, dry, or itching eyes
• discharge or excessive tearing
• general feeling of discomfort or illness
• loss of memory
• problems with memory
• redness, pain, or swelling of the eye, eyelid, or inner lining of the eyelid
• runny nose
• sneezing
• stomach cramps
• trembling or shaking of the hands or feet

For Healthcare Professionals

Applies to iopamidol: injectable solution, intrathecal solution.

General

The most commonly reported adverse reactions after oral administration of this drug are vomiting and diarrhea.

If administered intrathecally, the most frequently reported adverse reactions are headache, nausea, vomiting, and musculoskeletal pain . These reactions are usually mild to moderate, occur 1 to 10 hours after injection (almost all occurring within 24 hours), and usually disappearing within 24 hours.^[Ref]

Gastrointestinal

Very common (10% or more): Nausea

Common (1% to 10%): Vomiting

Uncommon (0.1% to 1%): Anorexia, diarrhea, abdominal discomfort, dry mouth

Frequency not reported:Severe retching and choking, abdominal cramps (may occur as a consequence of the procedure), salivary hypersecretion, salivary gland enlargement, rectal hemorrhage, dysphagia, heartburn^[Ref]

Cardiovascular

Common (1% to 10%): Extrasystoles, atrial fibrillation, ventricular tachycardia, ventricular fibrillation

Uncommon (0.1% to 1%): Tachycardia, hypotension, hypertension, myocardial ischemia, circulatory collapse, ST-segment depression bigeminy extrasystoles, angina pectoris, bradycardia, transient ischemic attack, thrombophlebitis, flushing, bradycardia

Frequency not reported: Arterial spasm, vasodilation, chest pain, cardiopulmonary arrest, myocardial infarction, arterial thrombosis, displacement of arterial plaques, venous thrombosis, dissection of the coronary vessels, transient sinus arrest, cerebral hematomas, petechiae, cardiorespiratory arrest, pallor, electrocardiogram change including ST segment depression, cyanosis, syncope^[Ref]

Nervous system

Common (1% to 10%): Pain (2.8%), burning sensation (1.4%)

Uncommon (0.1% to 1%): Vasovagal reaction, tingling in arms, grimace, faintness, headache, taste alterations

Rare (less than 0.1%): Paresthesia

Frequency not reported: Dizziness, temporary cortical blindness, temporary amnesia, convulsions, paralysis, coma, depressed level of consciousness or loss of consciousness, restlessness, meningismus, meningitis like reaction, meningitis, agitation, abnormal coordination, involuntary movements, paraplegia, encephalopathy, hypoesthesia, somnolence, numbness, emotional stress, motor seizures, facial neuralgia, drowsiness^[Ref]

Other

Common (1% to 10%): Hot flashes (1.5%), warmth (1.1%)

Uncommon (0.1% to 1%): Fever, chills, feeling cold

Frequency not reported: Tremors, malaise, pain, rigors, shivering, hypothermia, tinnitus^[Ref]

Dermatologic

Uncommon (0.1% to 1%): Rash, urticaria, pruritus, excessive sweating, erythema

Very rare (less than 0.01%): Muco-cutaneous syndromes, including Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell syndrome), erythema multiforme, inflammation, skin necrosis

Frequency not reported: Erythematous swelling, facial edema, skin necrosis, bullous eruption, exanthema, skin cold/clammy^[Ref]

Genitourinary

Uncommon (0.1% to 1%): Urinary retention

Frequency not reported: Urogenital pain, hematuria, osmotic nephrosis of proximal tubular cells, neurogenic bladder^[Ref]

Musculoskeletal

Uncommon (0.1% to 1%): Back spasm, back pain

Rare (less than 0.1%): Muscle spasm

Frequency not reported: Involuntary leg movement, musculoskeletal pain, musculoskeletal weakness muscle cramps, myalgia, myopathy, backache, neck stiffness, leg sciatic pain, radicular irritation,cold extremities, shoulder pain, leg cramps^[Ref]

Ocular

Uncommon (0.1% to 1%): Visual disturbances

Frequency not reported: Periorbital edema, watery itchy eyes, lacrimation, conjunctivitis, conjunctival chemosis with infection, transient blindness, photophobia, mydriasis, oculogyric crisis^[Ref]

Renal

Uncommon (0.1% to 1%): Acute renal failure

Frequency not reported: Abnormal renal function, transient changes in hepatorenal chemistry tests^[Ref]

Respiratory

Uncommon (0.1% to 1%): Throat constriction, dyspnea, pulmonary edema, nasal congestions, asthma, bronchospasm

Frequency not reported: Increased cough, sneezing, asthma, apnea, laryngeal edema, chest tightness/pain, rhinitis, brachial plexus palsy following axillary artery injections, respiratory arrest, respiratory failure, acute respiratory distress syndrome, Apnea Laryngeal edema, pharyngitis^[Ref]

Endocrine

Frequency not reported: Thyroid function tests indicative of hypothyroidism or transient thyroid suppression in adults and pediatric patients (including infants)^[Ref]

Hematologic

Frequency not reported: Neutropenia, thrombocytopenia^[Ref]

Hypersensitivity

Frequency not reported: Anaphylactoid reaction (characterized by cardiovascular, respiratory and cutaneous symptoms), anaphylaxis reaction^[Ref]

Local

Frequency not reported: Injection site pain usually due to extravasation, hemorrhage or pseudoaneurysms at the puncture site^[Ref]

Psychiatric

Frequency not reported: Confusion, paroniria, hallucinations^[Ref]