FDA label 40B89FD8-6514-7627-58CA-2A258B6B34A2
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
- 11bf60e0-d81d-4bd3-ac1b-376151d2754d
- SPL ID
- 40B89FD8-6514-7627-58CA-2A258B6B34A2
- Version
- 1
- Effective date
- 2006-07-03
- Source export date
- 2026-10-12
- Source partition
- 9
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0009-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-10-12/fb14b8f3d34b45230a84f851c029385f512adf3f002423a9b78d4f7ca626ecec/drug-label-0009-of-0014.json.zip
- Source manifest SHA-256
- 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
- Import run
- 20261013T011858Z
- Imported at
- 2026-10-13 02:23:38
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 | 40B89FD8-6514-7627-58CA-2A258B6B34A2 | id | |
| spl set id | 11bf60e0-d81d-4bd3-ac1b-376151d2754d | set_id |
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
WARNINGS With some nonsteroidal anti-inflammatory drugs, there exists the potential for increased bleeding time due to interference with thrombocyte aggregation. There have been reports that ocularly applied nonsteroidal anti-inflammatory drugs may cause increased bleeding of ocular tissues (including hyphemas) in conjunction with ocular surgery. There is the potential for cross-sensitivity to acetylsalicylic acid, phenylacetic acid derivatives, and other non-steroidal anti-inflammatory agents. Therefore, caution should be used when treating individuals who have previously exhibited sensitivities to these drugs.
Adverse reactions cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
adverse reactions
ADVERSE REACTIONS Ocular Transient burning and stinging was reported in 15% of patients with the use of topical diclofenac sodium ophthalmic solution, 0.1%. In cataract studies, keratitis occurred in 28% of patients receiving diclofenac sodium ophthalmic solution, 0.1%; however, most of the cases of keratitis occurred prior to drug therapy. Elevated intraocular pressure was reported in 15% of patients receiving diclofenac sodium ophthalmic solution, 0.1%. The following adverse reactions were reported in approximately 5% or less of the patients: abnormal vision, anterior chamber reaction, blurred vision, conjunctivitis, corneal deposits, corneal edema, corneal lesions, corneal opacity, discharge, injection, iritis, irritation, itching and ocular allergy. Systemic The following adverse reactions were reported in 3% or less of the patients: abdominal pain, asthenia, chills, dizziness, facial edema, fever, headache, insomnia, nausea, pain, rhinitis, viral infection, and vomiting.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.