warnings
WARNINGS: NOT FOR INJECTION INTO THE EYE. Sensitivity to topically applied aminoglycosides may occur in some patients. If a sensitivity reaction to Tobramycin Ophthalmic Solution occurs, discontinue use.
Tobramycin
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
- Brand name
- Tobramycin
- Generic name
- TOBRAMYCIN
- Manufacturer
- Proficient Rx LP
- Product type
- HUMAN PRESCRIPTION DRUG
- SPL set ID
- d8235017-cb52-44d4-a6e6-6ee3f00c47d2
- SPL ID
- 6458f461-e408-4dcc-b7c3-f8fb9fbcb31d
- Version
- 4
- Effective date
- 2022-07-01
- Source export date
- 2026-09-28
- Source partition
- 12
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0012-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-09-28/663999d0fe1757c1e2cd13a4799d76d875f663e0bc57701092264ebe7febfc18/drug-label-0012-of-0014.json.zip
- Source manifest SHA-256
- cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
- Import run
- 20260929T050834Z
- Imported at
- 2026-09-29 06:29:50
| Harmonized routes |
|---|
| OPHTHALMIC |
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 |
|---|---|---|---|
| application applno | ANDA | 064052 | derived:openfda.application_number |
| application number | ANDA064052 | openfda.application_number | |
| brand name | Tobramycin | openfda.brand_name | |
| generic name | TOBRAMYCIN | openfda.generic_name | |
| manufacturer name | Proficient Rx LP | openfda.manufacturer_name | |
| ndc | package | 63187-024-05 | openfda.package_ndc |
| ndc | product | 63187-024 | openfda.product_ndc |
| ndc11 | package | 63187002405 | derived:openfda.package_ndc |
| rxcui | 313415 | openfda.rxcui | |
| spl id | 6458f461-e408-4dcc-b7c3-f8fb9fbcb31d | id | |
| spl set id | d8235017-cb52-44d4-a6e6-6ee3f00c47d2 | set_id | |
| unii | VZ8RRZ51VK | openfda.unii |
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 reactions to tobramycin ophthalmic solution is localized ocular toxicity and hypersensitivity, including lid itching and swelling, and conjunctival erythema. These reactions occur in less than three of 100 patients treated with tobramycin. Similar reactions may occur with the topical use of other aminoglycoside antibiotics. Other adverse reactions have not been reported from tobramycin therapy; however, if topical ocular tobramycin is administered concomitantly with systemic aminoglycoside antibiotics, care should be taken to monitor the total serum concentration.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.