Ultravist Injection Side Effects

Please note - some side effects for Ultravist Injection may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Ultravist Injection Side Effects - for the Professional

Ultravist Injection

For demographics, see CLINICAL TRIALS section.

The following table of incidence of reactions is based upon controlled clinical trials in which Ultravist Injection was compared with nonionic contrast agents (iohexol, iopamidol, ioversol) in 1367 patients. This listing includes all reported adverse reactions regardless of attribution.

Adverse reactions are listed by body system and in decreasing order of occurrence greater than 0.5% in the iopromide group.

One or more adverse reactions were recorded in 229 of 708 (32%) patients during the clinical trials, coincidental with the administration of Ultravist Injection or within the defined duration of the study follow-up period (24 - 72 hours). The incidence and type of adverse reactions were similar to those of the studied nonionic comparators (iohexol, iopamidol, ioversol) used in the clinical trials. Also, as with other contrast agents, Ultravist Injection is often associated with sensations of warmth and/or pain. The incidence is similar to the other nonionic contrast comparators.

Serious, life-threatening and fatal reactions have been associated with the administration of iodine-containing contrast media, including Ultravist Injection. In clinical trials 7/708 patients given Ultravist Injection and 4/659 given a comparator died 5 days or later after drug administration. Also, 8/708 patients given Ultravist Injection and 4/659 given a comparator had serious adverse events. Rare reports of death due to anaphylaxis and thrombosis have been documented during foreign postmarketing surveillance.

The following adverse reactions were observed in ≤0.5% of the subjects receiving Ultravist Injection:

BODY: abdominal pain, asthenia, chills, dry mouth, edema of the face, fever, malaise, neck pain; CARDIOVASCULAR: AV block (complete), bradycardia, coronary thrombosis, hypoxia, peripheral vascular disorder, pulmonary hypertension, sweating increase, syncope, vascular anomaly, ventricular extrasystoles; DIGESTIVE: constipation, diarrhea, dyspepsia, salivation increase, sore throat; INJECTION SITE REACTIONS: edema, erythema, rash; METABOLIC: excessive thirst; MUSCULOSKELETAL: arthralgia, myasthenia; NERVOUS SYSTEM: agitation, anxiety; convulsion, depression, emotional lability, hypertonia, hypesthesia, incoordination, insomnia, neuropathy, speech disorder, tremor; RESPIRATORY: apnea, asthma, cough increased, pharyngitis, respiratory disorder (unspecified); SKIN AND APPENDAGES: pruritus, rash; SPECIAL SENSES: visual field defect; UROGENITAL: dysmenorrhea, kidney pain.

Additional adverse events reported in foreign postmarketing surveillance and other trials with the use of Ultravist Injection include: apparent hypersensitivity reactions, congestive heart failure, tachycardia, ventricular fibrillation, hemopericardium, aphasia, tongue paralysis, amnesia, hypotonia, mydriasis, lacrimation disorder, hematuria, renal failure, and skin discoloration.

Pediatrics: For demographics, see PEDIATRIC USE section.

The overall character, quality, and severity of adverse reactions in pediatric patients is similar to that reported in adult populations from domestic and foreign postmarketing surveillance and other information. Additional adverse reactions reported in pediatric patients from foreign marketing surveillance or other information are: epistaxis, angioedema, migraine, joint disorder (effusion), muscle cramps, mucous membrane disorder (mucosal swelling), conjunctivitis, hypoxia, fixed eruptions, vertigo, diabetes insipidus, and brain edema.

OVERDOSAGE

The adverse effects of overdosage are life-threatening and affect mainly the pulmonary and cardiovascular systems. Treatment of an overdosage is directed toward the support of all vital functions, and prompt institution of symptomatic therapy.

Ultravist Injection binds negligibly to plasma or serum protein and can, therefore, be dialyzed.

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