warnings
WARNINGS NOT FOR INJECTION INTO THE EYE. If a hypersensitivity reaction to POLYTRIM occurs, discontinue use. POLYTRIM is not indicated for the prophylaxis or treatment of ophthalmia neonatorum.
FDA label b8660f8c-b1d1-4cbf-a6c1-03476b328f43
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
- 5ce95658-d2eb-4d35-b387-ded0d7e4a122
- SPL ID
- b8660f8c-b1d1-4cbf-a6c1-03476b328f43
- Version
- 10
- Effective date
- 2025-02-17
- Source export date
- 2026-10-12
- Source partition
- 3
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0003-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-10-12/f40eac55ff4c5d55c3d8bbc5766ea7e21e4196960cfb4703b96a406b491c0cd5/drug-label-0003-of-0014.json.zip
- Source manifest SHA-256
- 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
- Import run
- 20261013T011858Z
- Imported at
- 2026-10-13 01:31:27
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 | b8660f8c-b1d1-4cbf-a6c1-03476b328f43 | id | |
| spl set id | 5ce95658-d2eb-4d35-b387-ded0d7e4a122 | 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 frequent adverse reaction to POLYTRIM is local irritation consisting of increased redness, burning, stinging, and/or itching. This may occur on instillation, within 48 hours, or at any time with extended use. There are also multiple reports of hypersensitivity reactions consisting of lid edema, itching, increased redness, tearing, and/or circumocular rash. Stevens-Johnson Syndrome/Toxic Epidermal Necrolysis (SJS/TEN) and anaphylaxis have been reported. Photosensitivity has been reported in patients taking oral trimethoprim.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.