FDA label 8c997923-e8fe-401f-a458-aad94f13a180
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
- d6d1afeb-55d6-494c-9226-e6ad4232a7cf
- SPL ID
- 8c997923-e8fe-401f-a458-aad94f13a180
- Version
- 6
- Effective date
- 2010-11-04
- 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 03:00:21
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 | 8c997923-e8fe-401f-a458-aad94f13a180 | id | |
| spl set id | d6d1afeb-55d6-494c-9226-e6ad4232a7cf | set_id |
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
WARNINGS Metopirone may induce acute adrenal insufficiency in patients with reduced adrenal secretory capacity.
Adverse reactions cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
adverse reactions
ADVERSE REACTIONS Cardiovascular System: Hypotension Gastrointestinal System: Nausea, vomiting, abdominal discomfort or pain. Central Nervous System: Headache, dizziness, sedation. Dermatologic System: Allergic rash. Hematologic System: Rarely, decreased white blood cell count or bone marrow depression.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.