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Oxilan

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Oxilan

Oxilan

Oxilan Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Oxilan (ioxilan injection) is a diagnostic radiopaque media used for cerebral arteriography, coronary arteriography and left ventriculography, visceral angiography, aortography, peripheral arteriography, excretory urography, and contrast enhanced computed tomographic (CECT) imaging of the head and body. Common side effects include headache, fever, swelling at the injection site, chills, high blood pressure, irregular heart rate, nausea, vomiting, diarrhea, dizziness, rash, and itching.

The combination of volume and Oxilan concentration to be used should be carefully individualized accounting for factors such as age, body weight, size of the vessel and the rate of blood flow within the vessel. Oxilan may interact with other drugs. Tell your doctor all medications and supplements you use. During pregnancy, Oxilan should be used only if prescribed. It is unknown if this drug passes into breast milk. Consult your doctor before breastfeeding.

Our Oxilan (ioxilan injection) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Oxilan FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

For demographics, see Clinical Trials section.

The following table of incidence of reactions is based upon controlled clinical studies in which OXILAN® (ioxilan (ioxilan (ioxilan) ) ) was compared with a nonionic contrast agent (iohexol) in 531 patients. It includes all reported adverse events, regardless of attribution.

Adverse reactions are listed by body system and in decreasing order of occurrence greater than 0.5% in the OXILAN® (ioxilan (ioxilan (ioxilan) ) ) group.

Body System Adverse Event Ioxilan
(n = 531)
Comparator
(n = 542)
Body as a Whole Headache 19 (3.6%) 15 (2.8%)
Fever 9 (1.7%) 11 (2.0%)
Hematoma at Injection Site 4 (0.8%) 0 (0%)
Chills 3 (0.6%) 0 (0%)
Cardiovascular Angina Pectoris 7(1.3%) 11 (2.0%)
Hypertension 6(1.1%) 3 (0.6%)
Bradycardia 4(0.8%) 0 (0%)
Hypotension 5 (0.9%) 3 (0.6%)
Digestive Nausea 8 (1.5%) 7 (1.3%)
Diarrhea 5 (0.9%) 4(0.7%)
Nausea with Vomiting 5 (0.9%) 5 (0.9%)
Vomiting 3 (0.6%) 4(0.7%)
Nervous Dizziness 4(0.8%) 1 (0.2%)
Skin Urticaria 4(0.8%) 4(0.7%)
Rash 3 (0.6%) 4(0.7%)

One or more adverse reactions were reported in 76 of 531 (14.3%) of patients in the clinical trials, coincidental with the administration of OXILAN® (ioxilan (ioxilan (ioxilan) ) ) or within the study follow-up period of 24 to 72 hours. The incidence and type of adverse reactions were similar to those associated with the nonionic comparator (iohexol) used in the clinical trials. OXILAN® (ioxilan (ioxilan (ioxilan) ) ) , as do other iodinated contrast agents, often causes warmth and/or pain on injection. The rates are similar to that of the iohexol comparator.

Serious, life threatening and fatal reactions have been associated with the administration of iodine-containing contrast media. In all clinical trials 3/835 (0.3%) patients given OXILAN® (ioxilan (ioxilan (ioxilan) ) ) and 3/542 (0.6%) given iohexol died 4 days or later after drug administration. In the controlled trials 8/531 (1.5%) patients given OXILAN® (ioxilan (ioxilan (ioxilan) ) ) and 6/542 (1.1%) given iohexol had serious adverse events.

The following adverse reactions were observed ≤ 0.5% of patients receiving OXILAN® (ioxilan (ioxilan (ioxilan) ) ) Injection: BODY: allergic reaction, asthenia, chest and back pain, edema of the neck, facial edema, pain, peripheral edema; CARDIOVASCULAR: atrial fibrillation, syncope, tachycardia, vasodilation, ventricular extra systole; DIGESTIVE: anorexia, constipation, dyspepsia, dysphagia, Gl hemorrhage, ileus, liver failure; NERVOUS: hypotonia, nystagmus, paresthesia, somnolence, vertigo; RESPIRATORY: dyspnea, pharyngitis, rhinitis; SKIN: pruritus, sweating; SPECIAL SENSES: amblyopia, conjunctivitis, taste perversion, vision abnormality; UROGENITAL: anuria, dysuria, hematuria, infection of urinary tract, impairment of urination, kidney failure.

Additional adverse events reported in postmarketing surveillance with the use of OXILAN® (ioxilan (ioxilan (ioxilan) ) ) Injection include: bronchospasm.

Read the entire FDA prescribing information for Oxilan (Ioxilan) »

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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