FDA label 4a5d2b9d-b3ef-4313-b8e6-7a0bb08e272b

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
231800d1-4be5-4a74-aa00-37782108c4e3
SPL ID
4a5d2b9d-b3ef-4313-b8e6-7a0bb08e272b
Version
2
Effective date
2010-06-03
Source export date
2026-10-12
Source partition
2
Source file
https://download.open.fda.gov/drug/label/drug-label-0002-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/4760f38f2bcb10aa20ddbadb42b270d31e9f2a8024440d3af3dec8d11feb92ec/drug-label-0002-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 01:29:41

Warnings cross-check#

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

Warnings sections page 1 of 1 · 1 matching rows.

warnings

WARNINGS SEVERE ADVERSE EVENTS-INADVERTENT INTRATHECAL ADMINISTRATION Severe adverse reactions have been reported due to the inadvertent intrathecal administration of iodinated contrast media that are not indicated for intrathecal use. These serious adverse reactions include: death, convulsions, cerebral hemorrhage, coma, paralysis, arachnoiditis, acute renal failure, cardiac arrest, seizures, rhabdomyolysis, hyperthermia, and brain edema. Special attention must be given to insure that this drug product is not administered intrathecally. Serious or fatal reactions have been associated with the parenteral administration of radiopaque media. It is important that a course of action be carefully planned in advance for the treatment of possible serious reactions with oral use of HYPAQUE solutions. (See Precautions .) Usage in Pregnancy The safety of orally administered HYPAQUE solutions during pregnancy has not been established. Therefore, before administration of the drug to women of childbearing potential, the benefit to the patient should be carefully weighed against the possible risk to the fetus. In addition, most authorities consider elective contrast radiography of the abdomen contraindicated during pregnancy.

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 There have been few reported cases of adverse reactions with orally administered solutions of water-soluble contrast agents. Because of their osmotic effect, such solutions tend to exert cathartic action, but this is generally considered an advantage. Nausea, vomiting, or slight diarrhea may occasionally occur, particularly when the medium is used in a high concentration or large volume. Urticaria has been observed in a few patients; presumably the condition was caused by allergy to the contrast medium and it was readily alleviated by antihistamine therapy. Because small amounts of the medium may be absorbed, the possibility of systemic reactions should be considered, particularly in cases of perforation.

Reported adverse events (FAERS/openFDA)#

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