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FDA label 25b1cde6-fe75-487b-9f68-54a41e27ffdd

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
cbac6335-6b1e-433f-a672-ad586572c531
SPL ID
25b1cde6-fe75-487b-9f68-54a41e27ffdd
Version
2
Effective date
2013-01-08
Source export date
2026-09-28
Source partition
11
Source file
https://download.open.fda.gov/drug/label/drug-label-0011-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/aa96b5a2be6b394393acd0090f6948bdf99e0e8e00666f81608929c8fa83db77/drug-label-0011-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 06:20:18

Boxed warning cross-check#

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boxed warning

NOT FOR INTRATHECAL USE

Warnings cross-check#

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warnings

WARNINGS Severe Adverse Events—Inadvertent Intrathecal Administration Serious 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 inadvertently administered intrathecally. The possibility exists for inadvertent administration into the intrathecal space during epidural administrations. Therefore, epidural administration procedures, such as pain management catheter placement, should not be performed with use of this product. General Apart from the possible adverse effects of diatrizoate meglumine, the hazards of the performance of a retrograde genitourinary procedure exist. These include such complications as hematuria, perforation of the ureter or bladder, introduction of infection into the genitourinary tract, and oliguria or anuria.

Adverse reactions cross-check#

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adverse reactions

ADVERSE REACTIONS The incidence of adverse reactions with diatrizoate meglumine is very low. Costovertebral angle tenderness, elevated temperature and flank pain have been reported in a few patients following use of the preparation for retrograde pyelography, as have nausea, sweating and flushing. Irritation of the urinary tract mucosa attributable to the contrast agent itself is not likely to occur. However, the technique of retrograde pyelography may be painful and may initiate pelvic, caliceal, or ureteral spasms with consequent renal colic. Since retrograde pyelography does not involve systemic administration of a contrast agent, the risk of severe reactions, which may occur with intravenous administration, is extremely remote. However, they should be kept in mind whenever a contrast agent is administered. Severe reactions may be manifested by edema of the face and glottis, respiratory distress, convulsions, or shock; such reactions may prove fatal unless promptly controlled by such emergency measures as maintenance of a clear airway and immediate use of oxygen and resuscitative drugs. Like other sensitivity phenomena, severe reactions are more likely to occur in patients with a personal or family history of bronchial asthma, significant allergies, drug reactions, or previous reactions to contrast agents.

Reported adverse events (FAERS/openFDA)#

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