Perfluorohexyloctane side effects: what 1,912 FDA adverse event reports show

Perfluorohexyloctane · Miebo · 56 reaction terms · 3,237 drug–reaction co-reports · data 2026-09-14

Drug class

Semifluorinated Alkane

FDA label (Established Pharmacologic Class)

Brand names

Miebo

openFDA label

Who reports

1,912 reports · 32% serious · 111 with death outcome · 83% female

openFDA FAERS counts, all years, deduplication not applied

Used for

MIEBO ® (perfluorohexyloctane ophthalmic solution) is indicated for the treatment of the signs and symptoms of dry eye disease (DED). MIEBO (perfluorohexyloctane ophthalmic solution) is a semifluorinated alkane indicated for treatment of the signs and symptoms of dry eye disease. ( 1 )

FDA label, Indications and Usage

What it is

MIEBO ® (perfluorohexyloctane ophthalmic solution) is a sterile, clear and colorless liquid containing 100% perfluorohexyloctane, for topical ophthalmic use. The active ingredient is 1,1,1,2,2,3,3,4,4,5,5,6,6-tridecafluorotetradecane and is a semifluorinated alkane.

FDA label, Description section

Boxed warning

None in the current label

How to read this page. FAERS is a spontaneous-reporting system: counts are not incidence rates and a signal is not proof of causation. Each reaction below is run through an automated screen — is the term in the FDA label (known), in the indications (the disease being treated), an administrative/coding term, or none of these (unlabeled)? That screen is mechanical text matching, not a causality assessment. The 30 hand-written Bradford Hill assessments are on the causality assessment page. Not medical advice.

Causality screen of the 40 strongest signals

Labeled (related wording) 1Likely indication confounding 1Reporting / coding artifact 18Not in label — unassessed 20

What the badges mean

Labeled (related wording) The label describes this effect under different wording (e.g. 'neutropenia' for 'neutrophil count decreased'). Treated as known.
Likely indication confounding The term appears in the label's indications: reports probably describe the disease being treated (or its progression), not a drug effect. Classic confounding by indication.
Reporting / coding artifact An administrative, monitoring or exposure term (product issue, off-label use, 'test normal', overdose...). Not a biological reaction; a high PRR here reflects how reports are coded.
Not in label — unassessed Not found in the label text, not an artifact pattern. This is a genuine candidate for a formal causality assessment (Bradford Hill / WHO-UMC); it has NOT had one here.

Strongest disproportionality signals

Flagged terms (PRR ≥ 2, χ² ≥ 4, n ≥ 10), ranked by PRR; infinite PRRs (no comparator reports) excluded. The EBGM column is a second, shrinkage-based estimate (MGPS) with its 5th percentile EB05 and the BCPNN IC025; a pair flagged by PRR alone is marked PRR-only and should be read as fragile. The strata column recomputes the PRR on serious reports only and flags pairs whose reports are unusually skewed by sex or come mostly from consumers rather than clinicians. 16 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.

Show: hide coding/lab/outcome terms hide indication terms unlabeled only hide PRR-only

Reaction	Reports	PRR 95% CI · ROR · χ²/p	EBGM EB05 · IC025	Label screen	Serious-only & strata	Trial cross-check
Product use complaint	144	102.7 87.7–120.3ROR 111.0 · χ² 14,280 / p <1e-300	100.4 EB05 87.4 · IC025 +6.0 3/3 methods agree	Reporting / coding artifact	serious n=36 · 98% consumer	no trial data cached
Exposure via skin contact	118	57.5 48.2–68.5ROR 61.2 · χ² 6,463 / p <1e-300	56.7 EB05 48.6 · IC025 +5.2 3/3 methods agree	Reporting / coding artifact	serious n=20 · 92% consumer	no trial data cached
Product packaging quantity issue	55	55.5 42.7–72.0ROR 57.1 · χ² 2,875 / p <1e-300	54.2 EB05 43.2 · IC025 +4.8 3/3 methods agree	Reporting / coding artifact	serious n=6 · 91% consumer	no trial data cached
Eye discharge	51	55.0 41.9–72.1ROR 56.4 · χ² 2,636 / p <1e-300	53.6 EB05 42.4 · IC025 +4.7 3/3 methods agree	Not in label — unassessed	serious n=6 · 73% consumer	no trial data cached
Ocular discomfort	50	50.7 38.5–66.7ROR 52.0 · χ² 2,375 / p <1e-300	49.5 EB05 39.1 · IC025 +4.6 3/3 methods agree	Not in label — unassessed	serious n=5 · 82% consumer	no trial data cached
Product complaint	109	48.1 40.0–57.7ROR 50.9 · χ² 4,959 / p <1e-300	47.5 EB05 40.5 · IC025 +5.0 3/3 methods agree	Reporting / coding artifact	serious n=22 · 96% consumer	no trial data cached
Eye irritation	241	47.6 42.3–53.5ROR 54.3 · χ² 10,920 / p <1e-300	47.2 EB05 42.4 · IC025 +5.2 3/3 methods agree	Not in label — unassessed	serious PRR 57.0 · 77% consumer	no trial data cached
Circumstance or information capable of leading to medication error	142	46.6 39.7–54.6ROR 50.2 · χ² 6,268 / p <1e-300	46.1 EB05 40.1 · IC025 +5.0 3/3 methods agree	Not in label — unassessed	serious n=30 · 98% consumer	no trial data cached
Eye pain	231	46.0 40.8–51.9ROR 52.2 · χ² 10,111 / p <1e-300	45.7 EB05 40.9 · IC025 +5.2 3/3 methods agree	Not in label — unassessed	serious PRR 22.5 · 85% consumer	no trial data cached
Inability to afford medication	31	34.6 24.4–49.1ROR 35.2 · χ² 977 / p 1e-214	33.9 EB05 25.0 · IC025 +3.9 3/3 methods agree	Not in label — unassessed	serious n=5 · 97% consumer	no trial data cached
Prescribed underdose	59	32.5 25.3–41.8ROR 33.5 · χ² 1,766 / p <1e-300	32.1 EB05 25.8 · IC025 +4.2 3/3 methods agree	Not in label — unassessed	serious PRR 54.6 · 97% consumer	no trial data cached
Ocular hyperaemia	131	30.8 26.1–36.3ROR 33.0 · χ² 3,745 / p <1e-300	30.6 EB05 26.4 · IC025 +4.5 3/3 methods agree	Not in label — unassessed	serious PRR 20.1 · 78% consumer	no trial data cached
Lacrimation increased	77	28.3 22.7–35.2ROR 29.4 · χ² 1,999 / p <1e-300	28.1 EB05 23.2 · IC025 +4.2 3/3 methods agree	Not in label — unassessed	serious PRR 24.3 · 82% consumer	no trial data cached
Dry eye	121	27.4 23.1–32.6ROR 29.2 · χ² 3,054 / p <1e-300	27.3 EB05 23.4 · IC025 +4.3 3/3 methods agree	Likely indication confounding term in indications	serious PRR 31.4 · 82% consumer	no trial data cached
Photophobia (light sensitivity)	41	24.1 17.8–32.6ROR 24.6 · χ² 884 / p 1e-194	23.8 EB05 18.3 · IC025 +3.7 3/3 methods agree	Not in label — unassessed	serious PRR 5.2 · 80% consumer	no trial data cached
Vision blurred (blurred vision)	239	19.2 17.1–21.6ROR 21.8 · χ² 4,125 / p <1e-300	19.1 EB05 17.2 · IC025 +4.0 3/3 methods agree	Labeled (related wording) related wording	serious PRR 14.5 · 84% consumer	no trial data cached
Inappropriate schedule of product administration	265	16.4 14.7–18.4ROR 18.9 · χ² 3,855 / p <1e-300	16.4 EB05 14.8 · IC025 +3.8 3/3 methods agree	Reporting / coding artifact	serious PRR 31.7 · 94% consumer	no trial data cached
Product dose omission in error	38	15.5 11.3–21.3ROR 15.8 · χ² 502 / p 2e-111	15.3 EB05 11.5 · IC025 +3.2 3/3 methods agree	Reporting / coding artifact	serious PRR 14.6 · 92% consumer	no trial data cached
Eye pruritus	43	14.3 10.6–19.2ROR 14.6 · χ² 519 / p 3e-115	14.1 EB05 10.8 · IC025 +3.1 3/3 methods agree	Not in label — unassessed	serious PRR 11.2 · 79% consumer	no trial data cached
Accidental exposure to product	118	13.0 10.9–15.4ROR 13.7 · χ² 1,294 / p 9e-284	12.9 EB05 11.0 · IC025 +3.3 3/3 methods agree	Reporting / coding artifact	serious PRR 45.0 · 92% consumer	no trial data cached
Eye swelling	43	12.8 9.5–17.1ROR 13.0 · χ² 454 / p 4e-101	12.5 EB05 9.5 · IC025 +3.0 3/3 methods agree	Not in label — unassessed	serious PRR 9.1 · 77% consumer	no trial data cached
Intentional product use issue	96	12.0 9.8–14.5ROR 12.5 · χ² 957 / p 2e-210	11.8 EB05 9.9 · IC025 +3.2 3/3 methods agree	Reporting / coding artifact	serious PRR 6.0 · 95% consumer	no trial data cached
Poor quality product administered	11	11.8 6.5–21.3ROR 11.9 · χ² 98 / p 2e-23	9.9 EB05 5.3 · IC025 +2.0 3/3 methods agree	Not in label — unassessed	serious n=3	no trial data cached
Burning sensation	73	11.4 9.1–14.3ROR 11.8 · χ² 685 / p 3e-151	11.2 EB05 9.1 · IC025 +3.0 3/3 methods agree	Not in label — unassessed	serious PRR 3.7 · 73% consumer	no trial data cached
Insurance issue	15	11.1 6.7–18.3ROR 11.2 · χ² 127 / p 7e-30	9.7 EB05 5.8 · IC025 +2.2 3/3 methods agree	Not in label — unassessed	serious PRR 8.3	no trial data cached
Product use issue	186	10.9 9.5–12.5ROR 12.0 · χ² 1,678 / p <1e-300	10.8 EB05 9.6 · IC025 +3.2 3/3 methods agree	Reporting / coding artifact	serious PRR 13.1 · 96% consumer	no trial data cached
Eye infection	11	10.8 6.0–19.4ROR 10.8 · χ² 88 / p 4e-21	8.8 EB05 4.8 · IC025 +1.9 3/3 methods agree	Not in label — unassessed	serious n=3	no trial data cached
Product prescribing issue	19	10.2 6.5–16.0ROR 10.3 · χ² 149 / p 1e-34	9.1 EB05 5.9 · IC025 +2.3 3/3 methods agree	Reporting / coding artifact	serious PRR 20.6	no trial data cached
Eye disorder	30	10.0 7.0–14.3ROR 10.2 · χ² 235 / p 2e-53	9.4 EB05 6.7 · IC025 +2.5 3/3 methods agree	Not in label — unassessed	serious PRR 5.2 · 90% consumer	no trial data cached
Eye haemorrhage	11	9.0 5.0–16.3ROR 9.1 · χ² 71 / p 2e-17	7.2 EB05 4.1 · IC025 +1.7 3/3 methods agree	Not in label — unassessed	serious PRR 11.7	no trial data cached
Therapy interrupted	53	8.4 6.5–11.0ROR 8.6 · χ² 340 / p 3e-76	8.0 EB05 6.3 · IC025 +2.5 3/3 methods agree	Reporting / coding artifact	serious PRR 13.2 · 98% consumer	no trial data cached
Product availability issue	16	7.8 4.8–12.7ROR 7.9 · χ² 89 / p 2e-21	6.7 EB05 4.2 · IC025 +1.9 3/3 methods agree	Reporting / coding artifact	serious PRR 3.7	no trial data cached
Glaucoma	12	6.8 3.9–12.0ROR 6.9 · χ² 54 / p 1e-13	5.6 EB05 3.4 · IC025 +1.5 3/3 methods agree	Not in label — unassessed	serious PRR 13.4	no trial data cached
Visual impairment	76	6.8 5.4–8.4ROR 7.0 · χ² 370 / p 9e-83	6.5 EB05 5.4 · IC025 +2.3 3/3 methods agree	Not in label — unassessed	serious PRR 6.1 · 88% consumer	no trial data cached
Surgery	30	5.7 4.0–8.1ROR 5.7 · χ² 111 / p 3e-26	5.2 EB05 3.8 · IC025 +1.8 3/3 methods agree	Reporting / coding artifact	serious PRR 11.8 · 86% consumer	no trial data cached
Product administration error	10	5.5 3.0–10.2ROR 5.5 · χ² 32 / p 6e-9	4.5 EB05 2.6 · IC025 +1.1 3/3 methods agree	Reporting / coding artifact	serious PRR 4.9	no trial data cached
Wrong technique in product usage process	77	4.2 3.4–5.2ROR 4.3 · χ² 185 / p 2e-42	4.1 EB05 3.4 · IC025 +1.7 3/3 methods agree	Reporting / coding artifact	serious PRR 9.5 · 93% consumer	no trial data cached
Intentional dose omission	10	4.0 2.2–7.4ROR 4.0 · χ² 20 / p 5e-6	3.5 EB05 2.0 · IC025 +0.7 3/3 methods agree	Reporting / coding artifact	serious PRR 6.0	no trial data cached
Product storage error	22	2.8 1.8–4.2ROR 2.8 · χ² 24 / p 6e-7	2.7 EB05 1.9 · IC025 +0.7	Reporting / coding artifact	serious PRR 7.4 · 86% consumer	no trial data cached
Product quality issue	31	2.5 1.8–3.6ROR 2.5 · χ² 27 / p 1e-7	2.5 EB05 1.8 · IC025 +0.7	Reporting / coding artifact	serious PRR 3.1 · 74% consumer	no trial data cached

Trial evidence (ClinicalTrials.gov)

Trial cross-check not yet run for this drug (ClinicalTrials.gov pull covers the 800 most-reported drugs first).

Most frequently reported reactions

By raw co-report count, regardless of disproportionality. Common terms here are often the illness itself or generic outcomes.

Reaction	Reports	PRR 95% CI · ROR · χ²/p	EBGM EB05 · IC025	Label screen	Serious-only & strata	Trial cross-check
Inappropriate schedule of product administration	265	16.4 14.7–18.4ROR 18.9 · χ² 3,855 / p <1e-300	16.4 EB05 14.8 · IC025 +3.8 3/3 methods agree	Reporting / coding artifact	serious PRR 31.7 · 94% consumer	no trial data cached
Eye irritation	241	47.6 42.3–53.5ROR 54.3 · χ² 10,920 / p <1e-300	47.2 EB05 42.4 · IC025 +5.2 3/3 methods agree	Not in label — unassessed	serious PRR 57.0 · 77% consumer	no trial data cached
Vision blurred (blurred vision)	239	19.2 17.1–21.6ROR 21.8 · χ² 4,125 / p <1e-300	19.1 EB05 17.2 · IC025 +4.0 3/3 methods agree	Labeled (related wording) related wording	serious PRR 14.5 · 84% consumer	no trial data cached
Eye pain	231	46.0 40.8–51.9ROR 52.2 · χ² 10,111 / p <1e-300	45.7 EB05 40.9 · IC025 +5.2 3/3 methods agree	Not in label — unassessed	serious PRR 22.5 · 85% consumer	no trial data cached
Product use issue	186	10.9 9.5–12.5ROR 12.0 · χ² 1,678 / p <1e-300	10.8 EB05 9.6 · IC025 +3.2 3/3 methods agree	Reporting / coding artifact	serious PRR 13.1 · 96% consumer	no trial data cached
Product use complaint	144	102.7 87.7–120.3ROR 111.0 · χ² 14,280 / p <1e-300	100.4 EB05 87.4 · IC025 +6.0 3/3 methods agree	Reporting / coding artifact	serious n=36 · 98% consumer	no trial data cached
Circumstance or information capable of leading to medication error	142	46.6 39.7–54.6ROR 50.2 · χ² 6,268 / p <1e-300	46.1 EB05 40.1 · IC025 +5.0 3/3 methods agree	Not in label — unassessed	serious n=30 · 98% consumer	no trial data cached
Ocular hyperaemia	131	30.8 26.1–36.3ROR 33.0 · χ² 3,745 / p <1e-300	30.6 EB05 26.4 · IC025 +4.5 3/3 methods agree	Not in label — unassessed	serious PRR 20.1 · 78% consumer	no trial data cached
Dry eye	121	27.4 23.1–32.6ROR 29.2 · χ² 3,054 / p <1e-300	27.3 EB05 23.4 · IC025 +4.3 3/3 methods agree	Likely indication confounding term in indications	serious PRR 31.4 · 82% consumer	no trial data cached
Accidental exposure to product	118	13.0 10.9–15.4ROR 13.7 · χ² 1,294 / p 9e-284	12.9 EB05 11.0 · IC025 +3.3 3/3 methods agree	Reporting / coding artifact	serious PRR 45.0 · 92% consumer	no trial data cached
Exposure via skin contact	118	57.5 48.2–68.5ROR 61.2 · χ² 6,463 / p <1e-300	56.7 EB05 48.6 · IC025 +5.2 3/3 methods agree	Reporting / coding artifact	serious n=20 · 92% consumer	no trial data cached
Product complaint	109	48.1 40.0–57.7ROR 50.9 · χ² 4,959 / p <1e-300	47.5 EB05 40.5 · IC025 +5.0 3/3 methods agree	Reporting / coding artifact	serious n=22 · 96% consumer	no trial data cached
Intentional product use issue	96	12.0 9.8–14.5ROR 12.5 · χ² 957 / p 2e-210	11.8 EB05 9.9 · IC025 +3.2 3/3 methods agree	Reporting / coding artifact	serious PRR 6.0 · 95% consumer	no trial data cached
Wrong technique in product usage process	77	4.2 3.4–5.2ROR 4.3 · χ² 185 / p 2e-42	4.1 EB05 3.4 · IC025 +1.7 3/3 methods agree	Reporting / coding artifact	serious PRR 9.5 · 93% consumer	no trial data cached
Lacrimation increased	77	28.3 22.7–35.2ROR 29.4 · χ² 1,999 / p <1e-300	28.1 EB05 23.2 · IC025 +4.2 3/3 methods agree	Not in label — unassessed	serious PRR 24.3 · 82% consumer	no trial data cached

Unlabeled candidate signals

These flagged terms were not found in the FDA label text and do not match an artifact pattern. They are the pairs that would merit a structured assessment (temporality, dose-response, biological plausibility, consistency across databases, trial or cohort evidence). The screen has not done that; string-matching misses label wording, and a strong PRR can still be stimulated reporting, co-medication, or the disease itself.

Eye discharge — n=51, PRR 55.0
Ocular discomfort — n=50, PRR 50.7
Eye irritation — n=241, PRR 47.6
Circumstance or information capable of leading to medication error — n=142, PRR 46.6
Eye pain — n=231, PRR 46.0
Inability to afford medication — n=31, PRR 34.6
Prescribed underdose — n=59, PRR 32.5
Ocular hyperaemia — n=131, PRR 30.8
Lacrimation increased — n=77, PRR 28.3
Photophobia — n=41, PRR 24.1

Want to assess one of these properly? The runbook describes the Bradford Hill / trial-evidence workflow used on the assessment page, and handoff_top1000_signals.csv lists the strongest unassessed pairs across all drugs.

Common questions

What are the most reported side effects of Perfluorohexyloctane?

In FDA FAERS, the most frequently co-reported reaction terms for Perfluorohexyloctane are eye irritation, vision blurred, eye pain, circumstance or information capable of leading to medication error, ocular hyperaemia, dry eye. These are report counts, not rates: FAERS has no denominator, reporting is voluntary and uneven, and a term can be reported because of the illness being treated rather than the drug.

Does Perfluorohexyloctane have an FDA boxed warning?

No. The FDA label retrieved for Perfluorohexyloctane has no boxed warning; see the label's Warnings and Precautions for the recognised risks.

Do FAERS signals prove that Perfluorohexyloctane causes these side effects?

No. A disproportionality signal (PRR, ROR) means a reaction is reported more often with this drug than with others in the database. That can reflect a real effect, but also the disease being treated, stimulated reporting after news or litigation, co-medications, or how reports are coded. Causality needs temporality, dose-response, biological plausibility, consistency across data sources and, ideally, trial or cohort evidence. This page screens each term against the FDA label and ClinicalTrials.gov results; it does not establish causation.

Sources & methods

FDA label via openFDA (set ID 6b283c02-7df4-4c00-951b-555cddffe77c, effective 20260310; matched on openfda.generic_name.exact:"PERFLUOROHEXYLOCTANE")
Bayesian shrinkage measures computed offline over all 1,317,300 cached pairs: BCPNN information component (IC, with Norén closed-form IC025) and MGPS empirical-Bayes geometric mean (EBGM, EB05) with a two-component gamma prior fitted by maximum marginal likelihood (α₁=0.57, β₁=0.02, α₂=1.42, β₂=0.70, w=0.17); unstratified
FAERS pair statistics from the OpenPV build of 2026-09-14 (openFDA count= aggregation, field patient.drug.openfda.generic_name.exact, 56 reaction terms, min 3 co-reports); PRR/ROR with 95% CI, chi-square with Yates correction
Serious-only and stratified counts (serious:1, patient.patientsex, primarysource.qualification) from openFDA count queries; serious-only PRR uses the drug serious report total and the term global serious total (N_serious=11,882,979); strata shown only when n ≥ 20
Seriousness and sex counts from openFDA count=serious, patient.patientsex, seriousnessdeath

Page generated 2026-10-08. Label and PubChem text are retrieved automatically and may lag the current label; always check the current prescribing information. OpenPV is a beta research tool of the Open Source Medicine Foundation.