BENOXINATE: 79 Adverse Event Reports & Safety Profile
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Route: OPHTHALMIC · Manufacturer: Altaire Pharmaceuticals Inc. · FDA Application: 084149 · HUMAN PRESCRIPTION DRUG · FDA Label: Available
First Report: 20110527 · Latest Report: 20250218
What Are the Most Common BENOXINATE Side Effects?
All BENOXINATE Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Toxic anterior segment syndrome | 29 | 36.7% | 0 | 0 |
| Aqueous fibrin | 19 | 24.1% | 0 | 0 |
| Inflammation | 16 | 20.3% | 0 | 0 |
| Conjunctivitis | 13 | 16.5% | 0 | 0 |
| Hypopyon | 10 | 12.7% | 0 | 0 |
| Vitritis | 10 | 12.7% | 0 | 0 |
| Malaise | 9 | 11.4% | 0 | 8 |
| Bradycardia | 8 | 10.1% | 0 | 8 |
| Hypotension | 7 | 8.9% | 0 | 6 |
| Syncope | 7 | 8.9% | 0 | 6 |
| Cold sweat | 6 | 7.6% | 0 | 6 |
| Dizziness | 6 | 7.6% | 0 | 6 |
| Dyspnoea | 6 | 7.6% | 0 | 1 |
| Fall | 5 | 6.3% | 4 | 0 |
| Fatigue | 5 | 6.3% | 0 | 0 |
| Urticaria | 5 | 6.3% | 0 | 2 |
Who Reports BENOXINATE Side Effects? Age & Gender Data
Gender: 71.6% female, 28.4% male. Average age: 69.8 years. Most reports from: BE. View detailed demographics →
Is BENOXINATE Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2011 | 2 | 0 | 2 |
| 2013 | 2 | 0 | 0 |
| 2014 | 5 | 0 | 2 |
| 2016 | 1 | 0 | 1 |
| 2017 | 7 | 0 | 4 |
| 2019 | 3 | 0 | 2 |
| 2020 | 7 | 0 | 7 |
| 2021 | 3 | 0 | 0 |
| 2022 | 35 | 5 | 0 |
| 2023 | 1 | 0 | 1 |
| 2024 | 2 | 0 | 1 |
| 2025 | 1 | 0 | 1 |
What Is BENOXINATE Used For?
| Indication | Reports |
|---|---|
| Preoperative care | 25 |
| Product used for unknown indication | 25 |
| Local anaesthesia | 8 |
| Anaesthesia | 7 |
| Cataract operation | 5 |
Official FDA Label for BENOXINATE
Official prescribing information from the FDA-approved drug label.
Drug Description
Altafluor Benox (fluorescein sodium and benoxinate hydrochloride ophthalmic solution) 0.25%/0.4% is a sterile disclosing agent in combination with a short-acting ester anesthetic for topical ophthalmic use. Fluorescein sodium is represented by the following structural formula: C 20 H 10 Na 2 O 5 Mol. Wt.
376.27 Chemical Name: Spiro [isobenzofuran-1 (3 H ),9’-9[9 H ] xanthene]-3-one, 3’,6’ dihydroxy, disodium salt. Benoxinate hydrochloride is represented by the following structural formula: C 17 H 28 N 2 O 3
- HCl Mol. Wt.
344.88 Chemical Name: 2-(Diethylamino) etyl 4-amino-3-butoxybenzoate monohydrochloride. Each mL contains: Actives: fluorescein sodium 2.5 mg (0.25%) equivalent to fluorescein 2.2 mg (0.22%), benoxinate hydrochloride 4 mg (0.4%) equivalent to benoxinate 3.6 mg (0.36%); Inactives: povidone, hydrochloric acid, boric acid, sodium hydroxide, water for injection. Hydrochloric acid and/or sodium hydroxide may be added to adjust pH (4.3 – 5.3). Preservative: chlorobutanol 11mg (1.1%).
Fluorescein
Sodium and Benoxinate Hydrochloride Ophthalmic Solution USP, 0.25%/0.4% is a disclosing agent with rapid anesthetic action of short duration.
Fluorescein
Sodium is represented by the following structural formula.
Benoxinate
Hydrochloride is represented by the following structural formula:
FDA Approved Uses (Indications)
AND USAGE Fluorescein Sodium and Benoxinate Hydrochloride Ophthalmic Solution, 0.3%/0.4% is indicated for ophthalmic procedures in adult and pediatric patients requiring a disclosing agent in combination with a topical ophthalmic anesthetic agent.
Fluorescein
Sodium and Benoxinate Hydrochloride Ophthalmic Solution, 0.3%/0.4% is a combination of fluorescein sodium, a disclosing agent and benoxinate hydrochloride, a local ester anesthetic indicated for procedures in adult and pediatric patients requiring a disclosing agent in combination with a topical ophthalmic anesthetic. ( 1 )
Dosage & Administration
AND ADMINISTRATION Instill 1 to 2 drops of Altafluor Benox in the eye as needed.
Instill
1 to 2 drops topically in the eye as needed to achieve adequate anesthesia. ( 2 )
Contraindications
Fluorescein Sodium and Benoxinate Hydrochloride Ophthalmic Solution, 0.3%/0.4% is contraindicated in patients with known hypersensitivity to any component of this product. Known hypersensitivity to any component of this product. ( 4 )
Known Adverse Reactions
REACTIONS The following serious ocular adverse reactions are described elsewhere in the labeling:
- Corneal Toxicity [see Warnings and Precautions ( 5.1 )]
- Corneal Injury due to Insensitivity [see Warnings and Precautions ( 5.2 )] The following adverse reactions have been identified following use of Fluorescein Sodium and Benoxinate Hydrochloride Ophthalmic Solution, 0.3%/0.4%: ocular hyperemia, burning, stinging, eye irritation, blurred vision and punctate keratitis. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. The most common ocular adverse events are: stinging, burning and conjunctival redness. ( 6) To report SUSPECTED ADVERSE REACTIONS, contact Oceanside Pharmaceuticals at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Warnings
AND PRECAUTIONS Corneal Toxicity : Prolonged use or abuse may lead to corneal epithelial toxicity and manifest as epithelial defects which may progress to permanent corneal damage. ( Error! Hyperlink reference not valid. )
Corneal
Injury : Patients should not touch the eye for approximately 20 minutes after using anesthetic as accidental injuries can occur due to insensitivity of the eye. ( 5.2 )