FDA label cd61a40d-0314-a66f-2af0-b0e9ecf501e0

openFDA label record#

This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.

Verified complete openFDA source JSON (canonical bytes are SHA-256 checked before publication)

SPL set ID
9f703e6a-1636-492f-8b4f-e12abe969a99
SPL ID
cd61a40d-0314-a66f-2af0-b0e9ecf501e0
Version
6
Effective date
2018-01-06
Source export date
2026-10-12
Source partition
6
Source file
https://download.open.fda.gov/drug/label/drug-label-0006-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/b25dad4aaef9c88f0e827394a34fbbd1ce7d71422fa46b5d1e123befad498c1d/drug-label-0006-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 01:50:07

Adverse reactions cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

Adverse reactions sections page 1 of 1 · 1 matching rows.

adverse reactions

ADVERSE REACTIONS Sudden onset of bradycardia, hypotension, cardiac arrest and death have rarely been reported. Hypersensitivity reactions, which include sweating, flushing, pruritus, urticaria, skin rashes, arthralgia, respiratory distress, and circulatory collapse have occurred. Dizziness, syncope, hypotension, chills, fever, nausea, vomiting, and abdominal pain and tenderness are occasionally seen following instillation of the contrast medium. It should be kept in mind that the serious or anaphylactoid reactions that may occur with intravascular administration of radiopaque contrast agents are theoretically possible following administration by other routes.

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.