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What the label lists and what reports show

Gentamicin side effects

Gentamicin's FDA label: “The most frequently reported adverse reactions are ocular burning and irritation upon drug instillation, non-specific conjunctivitis, conjunctival epithelial defects and conjunctival hyperemia.” FAERS holds 15,709 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 acute kidney injury (1,204 reports).

  • Generic listed

Check it at the source: the gentamicin FDA label on DailyMed (effective July 22, 2024, Bausch & Lomb Incorporated); the FDA FAERS public dashboard.

What does the label list?

From the label: adverse reactions

The most frequently reported adverse reactions are ocular burning and irritation upon drug instillation, non-specific conjunctivitis, conjunctival epithelial defects and conjunctival hyperemia.

From the label: adverse reactions, continued

Bacterial and fungal corneal ulcers have developed during treatment with gentamicin ophthalmic preparations. The most frequently reported adverse reactions are ocular burning and irritation upon drug instillation, non-specific conjunctivitis, conjunctival epithelial defects and conjunctival hyperemia. Other adverse reactions which have occurred rarely are allergic reactions, thrombocytopenic purpura and hallucinations. To report SUSPECTED ADVERSE REACTIONS, contact Bausch & Lomb Incorporated at 1-800-553-5340 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Source: FDA drug label, Bausch & Lomb Incorporated, effective July 22, 2024 (SPL set 41d01350-5c4b-42fc-be5f-986ceec02bd3), via openFDA; the full label on DailyMed

What do FAERS reports show?

15,709 reports list gentamicin among the medicines taken, each a report of something that happened, not proof the medicine caused it; 2,829 are coded as a death and 7,428 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 17 reactions below, none is 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

  • Drug Ineffective (a use or a product term, not a reaction)1,248
  • Acute Kidney Injury1,204
  • Pyrexia898
  • Off Label Use (a use or a product term, not a reaction)870
  • Renal Failure707
  • Diarrhoea563
  • Sepsis507
  • Condition Aggravated (a use or a product term, not a reaction)504
  • Hypotension491
  • Nausea486
  • Renal Failure Acute463
  • Rash455
  • Pneumonia (a use or a product term, not a reaction)440
  • Product Use In Unapproved Indication (a use or a product term, not a reaction)426
  • Chronic Kidney Disease423
  • Drug Interaction (a use or a product term, not a reaction)418
  • Dyspnoea418
  • Fatigue410
  • Foetal Exposure During Pregnancy (a use or a product term, not a reaction)398
  • Maternal Exposure During Pregnancy (a use or a product term, not a reaction)395
  • Vomiting391
  • Premature Baby379
  • Septic Shock377
  • Pain366
  • Thrombocytopenia357

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

What next?

Gentamicin: the full record
label, generics, price, shortages, recalls
Side effects hub
the most reported medicines and reactions