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tobradex

Pharmaranks rates Tobradex 3.4/5 for recall safety — an independent score from its FDA recall history and its manufacturer's record. Tobradex is a combination medicine containing Dexamethasone and Tobramycin.

Dexamethasone and Tobramycin · by Sandoz

68/100Limited · 1 source

Based on 1 source · Recall-safety score from FDA recall history — this product's own recalls and its manufacturer's record. Not an efficacy or quality rating. methodology →

Rated against independent regulatory sources·Last updated August 20, 2026·How we rate
Verified againstopenFDANIH DailyMedRxClass

Key facts

Active ingredient
Dexamethasone and Tobramycin
Form
Topical
Strength
Dexamethasone 0.1%; Tobramycin 0.3%
Type
Prescription (Rx)
Brand or generic
Brand-name
Manufacturer
Sandoz
Half-life
about 4 hours (how long it stays in your system)
What the pharmacy pays
~$0.23 per ml — not your price
FDA application
NDA050592

What is Tobradex?

From the FDA label:Tobramycin and dexamethasone ophthalmic suspension is a sterile, multiple dose antibiotic and steroid combination for topical ophthalmic use. The chemical structures for tobramycin and dexamethasone are presented below: Tobramycin Empirical Formula: C 18 H 37 N 5 O 9 Chemical Name: O -3-Amino-3-deoxy-α-D-glucopyranosyl-(1→4)- O -[2,6-diamino-2,3,6-trideoxy-α-D- ribo -hexopyranosyl-(1→6)]-2-deoxy-L-streptamine Molecular Weight: 467.52 Dexamethasone Empirical Formula: C 22 H 29 FO 5 Chemical Name: 9-Fluoro-11β,17,21-trihydroxy-16α-methylpregna-1,4-diene-3,20-dione Molecular Weight: 392.47 Each mL of tobramycin and dexamethasone ophthalmic suspension contains: Actives: tobramycin 0.3% (3 mg) and dexamethasone 0.1% (1 mg). Preservative: benzalkonium chloride 0.01%. Inactives: edetate disodium, hydroxyethyl cellulose, purified water, sodium chloride, sodium sulfate, sulfuric acid and/or sodium hydroxide (to adjust pH), and tyloxapol. tobramycin dexamethasone

How to use

One or two drops instilled into the conjunctival sac(s) every four to six hours. During the initial 24 to 48 hours, the dosage may be increased to one or two drops every two (2) hours. Frequency should be decreased gradually as warranted by improvement in clinical signs. Care should be taken not to discontinue therapy prematurely. Not more than 20 mL should be prescribed initially and the prescription should not be refilled without further evaluation as outlined in PRECAUTIONS above.

Side effects

Adverse reactions have occurred with steroid/anti-infective combination drugs which can be attributed to the steroid component, the anti-infective component, or the combination. Exact incidence figures are not available. The most frequent adverse reactions to topical ocular tobramycin (tobramycin ophthalmic solution 0.3%) are hypersensitivity and localized ocular toxicity, including lid itching and swelling, and conjunctival erythema. These reactions occur in less than 4% of patients. The reactions due to the steroid component are: elevation of IOP with possible development of glaucoma, and infrequent optic nerve damage; posterior subcapsular cataract formation; and delayed wound healing. Secondary Infection: The development of secondary infection has occurred after use of combinations containing steroids and antimicrobials. Fungal infections of the cornea are particularly prone to develop coincidentally with long-term applications of steroids. The possibility of fungal invasion must be considered in any persistent corneal ulceration where steroid treatment has been used. Secondary bacterial ocular infection following suppression of host responses also occurs. Postmarketing Experience: Additional adverse reactions identified from postmarketing use include anaphylactic reaction, erythema multiforme. The following additional adverse reactions have been reported with the…

Warnings

Important safety information

Sensitivity to topically applied aminoglycosides may occur in some patients. Severity of hypersensitivity reactions may vary from local effects to generalized reactions, such as erythema, itching, urticaria, skin rash, anaphylaxis, anaphylactoid reactions, or bullous reactions. If a sensitivity reaction does occur, discontinue use. Prolonged use of steroids may result in glaucoma, with damage to the optic nerve, defects in visual acuity and fields of vision, and posterior subcapsular cataract formation. Intraocular pressure (IOP) should be routinely monitored even though it may be difficult in pediatric patients and uncooperative patients. Prolonged use may suppress the host response and thus increase the hazard of secondary ocular infections. In acute purulent conditions and parasitic infections of the eye, steroids may mask infection or enhance existing infection. In those diseases causing thinning of the cornea or sclera, perforations have been known to occur with the use of topical steroids.

Who should not take Tobradex

Epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, varicella, and many other viral diseases of the cornea and conjunctiva. Mycobacterial infection of the eye. Fungal diseases of ocular structures. Hypersensitivity to a component of the medication.

How long does Dexamethasone and Tobramycin stay in your body?

The elimination half-life of dexamethasone and tobramycin is about 4 hours — the time it takes the body to clear about half of it. As a rule of thumb, a medicine is mostly gone after roughly 4 to 5 half-lives, though this varies from person to person with age and kidney or liver function. This is the plasma (terminal) elimination half-life — the label states the mean terminal half-life is 4 hours. Dexamethasone's anti-inflammatory/biologic effect lasts far longer than its blood levels (commonly cited biologic half-life ~36-54 hours), which is why it is dosed less often than the short plasma half-life implies; the drug is largely cleared from the blood within about a day (roughly 4-5 half-lives, ~1 day), but this clearance window is not the same as a drug-test detection window. Dexamethasone is ~77% protein-bound and metabolized by CYP3A4 (renal excretion is less than 10% of clearance), so strong CYP3A4 inhibitors/inducers can lengthen or shorten exposure. The manufacturer notes the effect of renal or hepatic impairment on its pharmacokinetics has not been formally studied.

This is general information, not medical advice. It doesn’t tell you when a drug test would read negative (tests detect substances for different, often longer, windows) or when it’s safe to take another dose — ask your pharmacist or prescriber. Source: HEMADY (dexamethasone) tablets — FDA label, Clinical Pharmacology (DailyMed).

Dosage forms

Topical

The forms currently marketed in the U.S., per the FDA National Drug Code Directory.

Ways to save

Ask for the generic

Same active ingredient, far cheaper. Is there a generic? →

Request a 90-day supply

Bulk fills usually lower the per-dose price vs monthly refills.

Use copay cards

Manufacturer copay cards & patient-assistance programs — especially for brand drugs.

Compare alternatives

A same-class option may cost less. See alternatives →

Frequently asked questions

How is Tobradex rated?
pharmaranks gives Tobradex a composite score of 3.4 out of 5, currently based on 1 weighted source (FDA regulatory recall-safety data weighted highest). See our methodology at /how-we-rate.
How much does Tobradex cost?
Nobody can tell you what you will pay — your price is set by your insurer's formulary, your deductible and the pharmacy's markup, and none of those are published. What IS published is what the pharmacy paid to acquire it: about $0.23 per ml, per the CMS NADAC survey. Treat that as the floor, not the quote — ask the pharmacist for the cash price as well as your copay, because for cheap generics the cash price often wins.
Is there a coupon or discount for Tobradex?
pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Tobradex. To pay less, ask your prescriber or pharmacist whether a generic equivalent exists, check the manufacturer's copay/savings card and patient-assistance program, and compare a pharmacy discount card against your insurance copay. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
Who makes Tobradex?
Tobradex is marketed by Sandoz. You can see Sandoz's full profile, rating, and other products on pharmaranks.
Is Tobradex a brand-name or generic drug?
Tobradex is a brand-name product with the active ingredient Dexamethasone and Tobramycin.
Is Tobradex available over the counter?
No. Tobradex is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
What forms does Tobradex come in?
Tobradex is currently marketed as topical, per the FDA's National Drug Code Directory.
Is Tobradex FDA-registered?
Tobradex is on record with the U.S. FDA under application number NDA050592. You can verify this on its official FDA label.
Has Tobradex been recalled by the FDA?
Tobradex has no FDA recalls recorded under its own application in the openFDA enforcement database. Its recall-safety score reflects its manufacturer's overall recall record. This is general reference, not medical advice — check the FDA recall database for the latest alerts.
Is Tobradex safe?
There's no single safe-or-not verdict. pharmaranks gives Tobradex a recall-safety score of 68/100, based on its FDA recall history (no recalls under its own FDA application) — not an efficacy or side-effect rating. Review its FDA-label side effects and warnings before use, and always consult a licensed professional.
What are the side effects of Tobradex?
Tobradex's side effects are taken directly from its FDA label. From the label: Adverse reactions have occurred with steroid/anti-infective combination drugs which can be attributed to the steroid component, the anti-infective component, or the combination. Exact incidence figures are not available.… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.

Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.

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tobradex

68/100