Assessment of the Radio-contrast Media-Induced Self-Reported Adverse Drug Reactions in a Tertiary Care Hospital of North India: A Prospective Study.

Background: Radio-contrast media are the agents which are used on daily basis in the radiological practice for either diagnostic or therapeutic purpose. Currently used agents are considered to be safe but not devoid of side effects.

Objectives: Objectives of the study were to assess the incidence of adverse drug reactions (ADRs) in the patients who receive radiographic contrast media for computed tomography (CT) and intravenous pyelography (IVP), to stratify the ADRs into different types based on their time of appearance and as per their severity.

Materials And Methods: A prospective and observational study of 1-year duration was done on all the patients who received radio-contrast media (Iohexol) intravenously for CT and IVP in the radiodiagnosis department. Patients who experienced ADRs were recorded for the basic demographic characteristics and types of ADRs. Stratification of ADRs as per their severity was done using common terminology criteria for adverse events scale and Modified Hartwig and Siegel ADR Severity Assessment Scale, and casualty assessment was done using Naranjo's Algorithm.

Results: Out of the total 3522 patients who were included in the study, eight patients got 12 suspected ADRs with some of the patients having more than one type of ADR. The most frequent ADR was nausea and vomiting (25%), followed by fever, chills, or sweating. Incidence of ADRs was 0.23%. All the ADRs were acute and occurred within 30 min of contrast administration. As per the severity scales used, all the ADRs were mild (75%) to moderate (25%) in nature with none of the reactions to be severe. Causality assessment showed 87.5% of the reactions to be "probable" in nature.

Conclusion: Low osmolar nonionic radio contrast media are associated with very low incidence of ADRs in the North Indian population.