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What the label lists and what reports show

Hydrocortisone and neomycin and polymyxin b side effects

Hydrocortisone and neomycin and polymyxin b's FDA label lists its adverse reactions in its own words. FAERS holds 279 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 ear discomfort (38 reports).

  • Generic listed

Check it at the source: the hydrocortisone and neomycin and polymyxin b FDA label on DailyMed (effective August 4, 2026, Preferred Pharmaceuticals, Inc.); the FDA FAERS public dashboard.

What does the label list?

From the label: adverse reactions

Neomycin occasionally causes skin sensitization. Ototoxicity and nephrotoxicity have also been reported (see ). Adverse reactions have occurred with topical use of antibiotic combinations including neomycin and polymyxin B. Exact incidence figures are not available since no denominator of treated patients is available. The reaction occurring most often is allergic sensitization. The following local adverse reactions have been reported with topical corticosteroids, especially under occlusive dressings: burning, itching, irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infection, skin atrophy, striae and miliaria. Stinging and burning have been reported rarely when this drug has gained access to the middle ear. …

Source: FDA drug label, Preferred Pharmaceuticals, Inc., effective August 4, 2026 (SPL set 5f17fae0-c6ea-452e-b84f-066caf2a95fc), via openFDA; the full label on DailyMed

What do FAERS reports show?

279 reports list hydrocortisone and neomycin and polymyxin b among the medicines taken, each a report of something that happened, not proof the medicine caused it; 3 are coded as a death and 17 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.

The 25 most reported reactions

  • Ear Discomfort38
  • Eye Irritation37
  • Ear Pain21
  • Pain21
  • Hypoacusis20
  • Incorrect Route Of Drug Administration19
  • Drug Ineffective (a use or a product term, not a reaction)18
  • Eye Pain18
  • Ocular Hyperaemia18
  • Accidental Exposure To Product17
  • Off Label Use (a use or a product term, not a reaction)17
  • Expired Product Administered (a use or a product term, not a reaction)15
  • Dizziness14
  • Drug Dispensing Error14
  • Incorrect Route Of Product Administration13
  • Tinnitus13
  • Medication Error (a use or a product term, not a reaction)12
  • Product Dose Omission Issue (a use or a product term, not a reaction)12
  • Wrong Product Administered11
  • Condition Aggravated (a use or a product term, not a reaction)10
  • Headache10
  • No Adverse Event (a use or a product term, not a reaction)10
  • Product Use In Unapproved Indication (a use or a product term, not a reaction)10
  • Pruritus10
  • Vision Blurred10

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

What next?

Hydrocortisone and neomycin and polymyxin b: the full record
label, generics, price, shortages, recalls
Side effects hub
the most reported medicines and reactions