FDA label be53f85f-817d-4023-9124-867309cddcc0
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
- 6dc2e2de-4061-41dd-a35d-7d12507c517f
- SPL ID
- be53f85f-817d-4023-9124-867309cddcc0
- Version
- 2
- Effective date
- 2010-10-29
- Source export date
- 2026-10-12
- Source partition
- 13
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0013-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-10-12/b8dac220ac9fc8ffb4d86c6e00ece30169fc4575ca0cc92e5c9ce1a524fb0249/drug-label-0013-of-0014.json.zip
- Source manifest SHA-256
- 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
- Import run
- 20261013T011858Z
- Imported at
- 2026-10-13 03:03:27
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 | be53f85f-817d-4023-9124-867309cddcc0 | id | |
| spl set id | 6dc2e2de-4061-41dd-a35d-7d12507c517f | set_id |
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
WARNINGS Priscoline stimulates gastric secretion and may activate stress ulcers. Through this mechanism, it can produce significant hypochloremic alkalosis. Pretreatment of infants with antacids may prevent gastrointestinal bleeding. Patients should be observed closely for signs of systemic hypotension, and supportive therapy should be instituted if needed. In patients with mitral stenosis, parenterally administered Priscoline may produce a rise or fall in pulmonary artery pressure and total pulmonary resistance; therefore, it must be used with caution in patients with known or suspected mitral stenosis.
Adverse reactions cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
adverse reactions
ADVERSE REACTIONS The following adverse reactions have been observed, but there are insufficient data to support an estimate of their frequency: Cardiovascular : Hypotension, tachycardia, cardiac arrhythmias, hypertension, pulmonary hemorrhage. Digestive and Hepatic : Gastrointestinal hemorrhage, nausea, vomiting, diarrhea, hepatitis. Skin : Flushing, increased pilomotor activity with tingling or chilliness, rash. Hematologic : Thrombocytopenia, leukopenia. Renal : Edema, oliguria, hematuria.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.