warnings and cautions
WARNINGS AND PRECAUTIONS None
FDA label cb45601b-173d-4390-bbd2-09476195dca3
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
- a05158b5-ae28-4889-881c-6a7883c96f4c
- SPL ID
- cb45601b-173d-4390-bbd2-09476195dca3
- Version
- 13
- Effective date
- 2021-10-14
- Source export date
- 2026-10-12
- Source partition
- 1
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0001-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-10-12/7928c8e8c6256620071a8b7e5b93eb8dfa543649c08d17a01ea02251012ba58c/drug-label-0001-of-0014.json.zip
- Source manifest SHA-256
- 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
- Import run
- 20261013T011858Z
- Imported at
- 2026-10-13 01:27:14
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 | cb45601b-173d-4390-bbd2-09476195dca3 | id | |
| spl set id | a05158b5-ae28-4889-881c-6a7883c96f4c | set_id |
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
Adverse reactions cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
adverse reactions
ADVERSE REACTIONS Post-marketing Experience • The following adverse events have been identified during post-marketing use of Engystol® Injection Solution. Because these events are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. • Allergic (hypersensitivity) skin reactions may occur in isolated cases. To report SUSPECTED ADVERSE REACTIONS, contact MediNatura. at 1.844.633.4628 or info@medinatura.com or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.