FDA label 65e59e7a-0ec4-2a76-e053-2991aa0a0021

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: 01b6fbac-657b-49e6-9fb4-e4b046a6b3c5
SPL ID: 65e59e7a-0ec4-2a76-e053-2991aa0a0021
Version: 2
Effective date: 2018-02-23
Source export date: 2026-09-28
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/2026-09-28/9c7783846d422acb0c9e59457606951c785a7d28cc631c8cc4839d0dc7c55f39/drug-label-0001-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 05:13:28

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.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
spl id		65e59e7a-0ec4-2a76-e053-2991aa0a0021	id
spl set id		01b6fbac-657b-49e6-9fb4-e4b046a6b3c5	set_id

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 and cautions

5. WARNINGS AND PRECAUTIONS 5.1. Estradiol should not be administered in cases where undiagnosed vaginal bleeding is present; in cases with known, actual or suspected history of breast cancer; during current treatment for metastatic disease; with known or suspected estrogen-dependent neoplasia; with deep vein thrombosis, pulmonary embolism or any history of these conditions; active or recent arterial thromboembolic disease such as stroke or myocardial infarction; or with liver dysfunction or disease. 5.2 Use with caution in patients taking estrogen and/or progesterone therapy.

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

6. ADVERSE REACTIONS 6.1. None known. (see CONTRAINDICATIONS for hypersensitivity information).

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.