warnings
WARNINGS Epinastine HCl ophthalmic solution, 0.05% is for topical ophthalmic use only and not for injection or oral use.
FDA label 4f395d6b-25dc-4776-adb5-831f471e5483
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
- 59196755-2d19-4e96-9689-05d21a284135
- SPL ID
- 4f395d6b-25dc-4776-adb5-831f471e5483
- Version
- 3
- Effective date
- 2015-01-08
- Source export date
- 2026-10-12
- Source partition
- 5
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0005-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-10-12/13cbfcd236c665f0ee69e2d9141331148dcdff45d1679c92f029cfba27dd74a2/drug-label-0005-of-0014.json.zip
- Source manifest SHA-256
- 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
- Import run
- 20261013T011858Z
- Imported at
- 2026-10-13 01:42:31
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 | 4f395d6b-25dc-4776-adb5-831f471e5483 | id | |
| spl set id | 59196755-2d19-4e96-9689-05d21a284135 | 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 The most frequently reported ocular adverse events occurring in approximately 1 - 10% of patients were burning sensation in the eye, folliculosis, hyperemia, and pruritus. The most frequently reported non-ocular adverse events were infection (cold symptoms and upper respiratory infections) seen in approximately 10% of patients, and headache, rhinitis, sinusitis, increased cough, and pharyngitis seen in approximately 1 - 3% of patients. Some of these events were similar to the underlying disease being studied.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.