What the label lists and what reports show

Dexamethasone and tobramycin side effects

Dexamethasone and tobramycin's FDA label lists its adverse reactions in its own words. FAERS holds 3,408 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is eye pain (257 reports).

Generic listed

Check it at the source: the dexamethasone and tobramycin FDA label on DailyMed (effective April 7, 2025, Sandoz Inc); the FDA FAERS public dashboard.

What does the label list?

From the label: adverse reactions
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. …

Source: FDA drug label, Sandoz Inc, effective April 7, 2025 (SPL set 05fd0c36-39b4-4a43-8490-eb8dfc0920ae), via openFDA; the full label on DailyMed

What do FAERS reports show?

3,408 reports list dexamethasone and tobramycin among the medicines taken, each a report of something that happened, not proof the medicine caused it; 153 are coded as a death and 892 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 21 reactions below, 3 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.

Reports received each year

The 25 most reported reactions

Eye Pain257
Off Label Use (a use or a product term, not a reaction)227
Vision Blurred188
Drug Ineffective (a use or a product term, not a reaction)185
Headache183
Ocular Hyperaemia177
Eye Irritation174
Nausea167
Fatigue164
Pain140
Dizziness139
Diarrhoea133
Dyspnoea123
Visual Impairment123
Anxiety109
Rash (named in the label)106
Intraocular Pressure Increased104
Hypersensitivity (named in the label)96
Condition Aggravated (a use or a product term, not a reaction)94
Eye Swelling93
Cataract (named in the label)92
Lacrimation Increased89
Asthenia87
Photophobia86
Pneumonia (a use or a product term, not a reaction)84

Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms

What next?

Dexamethasone and tobramycin: the full record: label, generics, price, shortages, recalls
Report a side effect to the FDA: MedWatch
Side effects hub: the most reported medicines and reactions