Home FDA labels 77832854-ae5e-4662-bcce-c9a7f5e1be11 FDA label 77832854-ae5e-4662-bcce-c9a7f5e1be11 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 a1975215-25f1-4c5a-878d-bcbf5326bb92
SPL ID 77832854-ae5e-4662-bcce-c9a7f5e1be11
Version 8
Effective date 2016-09-30
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 02:48:28 Harmonized identifier links# Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.
Harmonized identifiers page 1 of 1 · 2 matching rows.
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 Hypersensitivity reactions including anaphylaxis, angioedema, urticaria, vasomotor disturbances, flushing, tingling, nausea, vomiting, and cramps may occur. Patients may have a sensation of warmth or the desire to defecate or urinate during or shortly following initiation of infusion.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.