Oxilan
Doctors: Clinton Should Recover Fully From Clot »
"Jan. 2, 2013 -- Medical experts say Secretary of State Hillary Clinton is extremely lucky that her medical team found the blood clot they are now treating with blood thinners.
The rare clot in a vein between her brain and skull was di"...
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Oxilan
Oxilan Side Effects Center
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) »
Additional Oxilan Information
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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