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 (canonical bytes are SHA-256 checked before publication)

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

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 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 sections page 1 of 1 · 1 matching rows.

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.