Skip to main content
PlainMeds

What the label lists and what reports show

Polymyxin b and trimethoprim side effects

Polymyxin b and trimethoprim's FDA label lists its adverse reactions in its own words. FAERS holds 153 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 pruritus (21 reports).

  • Generic listed

Check it at the source: the polymyxin b and trimethoprim FDA label on DailyMed (effective January 6, 2026, Bausch & Lomb Incorporated); the FDA FAERS public dashboard.

What does the label list?

From the label: adverse reactions

The most frequent adverse reaction to polymyxin B sulfate and trimethoprim ophthalmic solution is local irritation consisting of increased redness, burning, stinging, and/or itching. This may occur on instillation, within 48 hours, or at any time with extended use. There are also multiple reports of hypersensitivity reactions consisting of lid edema, itching, increased redness, tearing, and/or circumocular rash. Stevens-Johnson Syndrome/Toxic Epidermal Necrolysis (SJS/TEN) and anaphylaxis have been reported. Photosensitivity has been reported in patients taking oral trimethoprim. 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 January 6, 2026 (SPL set 87999254-1857-4d3c-817a-cb8f6a5b0cf7), via openFDA; the full label on DailyMed

What do FAERS reports show?

153 reports list polymyxin b and trimethoprim among the medicines taken, each a report of something that happened, not proof the medicine caused it; 3 are coded as a death and 16 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 19 reactions below, 1 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

  • Eye Pruritus21
  • Ocular Hyperaemia21
  • Eye Irritation19
  • Eye Swelling18
  • Pain12
  • Eye Pain11
  • Eye Discharge10
  • Lacrimation Increased10
  • Drug Hypersensitivity9
  • Drug Ineffective (a use or a product term, not a reaction)9
  • Fatigue9
  • Pruritus9
  • Rash (named in the label)9
  • Vision Blurred9
  • Diarrhoea8
  • Off Label Use (a use or a product term, not a reaction)8
  • Product Dose Omission Issue (a use or a product term, not a reaction)8
  • Burning Sensation7
  • Inappropriate Schedule Of Product Administration (a use or a product term, not a reaction)7
  • Arthralgia6
  • Condition Aggravated (a use or a product term, not a reaction)6
  • Conjunctivitis (a use or a product term, not a reaction)6
  • Erythema6
  • Eyelid Margin Crusting6
  • Instillation Site Irritation6

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

What next?

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