FDA label 60c25adf-f33c-428c-af7c-d5fcd272c900
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
- SPL set ID
- b5f4f679-e624-4b91-8de5-3082c3036e53
- SPL ID
- 60c25adf-f33c-428c-af7c-d5fcd272c900
- Version
- 2
- Effective date
- 2009-09-14
- Source export date
- 2026-10-12
- 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/2026-10-12/a497e765d824a2e2aa9e88d5f0eea2aae9dcba363989e5f163395cda5c3c9dd8/drug-label-0011-of-0014.json.zip
- Source manifest SHA-256
- 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
- Import run
- 20261013T011858Z
- Imported at
- 2026-10-13 02:48:24
Harmonized identifier links#
Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.
| Type | Scope | Identifier | Source field |
|---|---|---|---|
| spl id | 60c25adf-f33c-428c-af7c-d5fcd272c900 | id | |
| spl set id | b5f4f679-e624-4b91-8de5-3082c3036e53 | set_id |
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
WARNINGS As with other I 131 containing agents, in order to decrease thyroid accumulation of I 131, block the thyroid gland with iodine. (See DOSAGE AND ADMINISTRATION section) During and following the injection, patients with known or suspected pheochromocytoma should be carefully monitored for hypertensive crises.
Adverse reactions cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
adverse reactions
ADVERSE REACTIONS Transient episodes of marked hypertension have been reported in patients after injection of Iobenguane Sulfate I 131. Some of these patients were on anti-hypertensives and others were not. Nausea, vomiting and sleepiness have been reported after injection of higher than the recommended doses of Iobenguane Sulfate I 131. The no effect level for these reactions has not been identified. An episode of fever, chills and hypotension has been reported. In clinical trials, no deaths have been attributed to the drug.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.