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What the label lists and what reports show

Perfluorohexyloctane side effects

Perfluorohexyloctane's FDA label: “Most common ocular adverse reaction was blurred vision.” FAERS holds 1,914 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 irritation (241 reports).

  • No generic listed

Check it at the source: the perfluorohexyloctane FDA label on DailyMed (effective March 10, 2026, Bausch & Lomb Incorporated); the FDA FAERS public dashboard.

What does the label list?

From the label: adverse reactions

Most common ocular adverse reaction was blurred vision.

From the label: adverse reactions, continued

Most common ocular adverse reaction was blurred vision. Blurred vision was reported in less than 4% of individuals. ( 6.1 ) 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. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. In patients with DED, 614 patients received at least one dose of MIEBO in two randomized controlled clinical trials across 68 sites in the United States. The most common ocular adverse reaction was blurred vision. Blurred vision and conjunctival redness were reported in 1-3% of individuals. In four premarketing studies (three open-label [n=127], one randomized [n=24 treated with at least one dose of perfluorohexyloctane]) the most common adverse reaction was hypersensitivity.

Source: FDA drug label, Bausch & Lomb Incorporated, effective March 10, 2026 (SPL set 6b283c02-7df4-4c00-951b-555cddffe77c), via openFDA; the full label on DailyMed

What do FAERS reports show?

1,914 reports list perfluorohexyloctane among the medicines taken, each a report of something that happened, not proof the medicine caused it; 111 are coded as a death and 170 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 15 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

  • Inappropriate Schedule Of Product Administration (a use or a product term, not a reaction)265
  • Eye Irritation241
  • Vision Blurred239
  • Eye Pain231
  • Product Use Issue (a use or a product term, not a reaction)186
  • Product Delivery Mechanism Issue179
  • Drug Ineffective (a use or a product term, not a reaction)147
  • Product Use Complaint (a use or a product term, not a reaction)144
  • Circumstance Or Information Capable Of Leading To Medication Error (a use or a product term, not a reaction)142
  • Ocular Hyperaemia131
  • Dry Eye (a use or a product term, not a reaction)121
  • Accidental Exposure To Product118
  • Exposure Via Skin Contact118
  • Product Complaint109
  • Death (an outcome recorded in the report)106
  • Headache106
  • Intentional Product Use Issue (a use or a product term, not a reaction)96
  • Lacrimation Increased77
  • Wrong Technique In Product Usage Process (a use or a product term, not a reaction)77
  • Visual Impairment76
  • Burning Sensation73
  • Product Container Issue70
  • Product Knowledge Deficit65
  • Pain60
  • Product Dose Omission Issue (a use or a product term, not a reaction)60

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

What next?

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