Fluorescein side effects: what 237 FDA adverse event reports show

Fluorescein · 5 reaction terms · 50 drug–reaction co-reports · data 2026-09-14

Drug class

Diagnostic Dye

FDA label (Established Pharmacologic Class)

Who reports

237 reports · 82% serious · 14 with death outcome · 55% female

openFDA FAERS counts, all years, deduplication not applied

Used for

1. INDICATIONS & USAGE Fluoresecin Injection 10%, , (100 mg/mL) and Fluorescein Injection 25% (250 mg/mL) is indicated in diagnostic fluorescein angiography or angioscopy of the retina and iris vasculature. Fluorescein Injection, USP is indicated in diagnostic fluorescein angiography or angioscopy of the retina and iris vasculature. ( 1 )

FDA label, Indications and Usage

What it is

11. DESCRIPTION Fluorescein Injection, is a sterile solution for use intravenously as a diagnostic aid. It is a dark reddish orange solution with a pH of 8.3 to 9.8 and an osmolality of 572 to 858 mOsm/kg for the 10% and 1800 to 2200 mOsm/kg for the 25%.

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 3 strongest signals

Not in label — unassessed 3

What the badges mean

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. 2 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
Visual acuity reduced	31	82.0 59.0–113.8ROR 94.2 · χ² 2,401 / p <1e-300	78.1 EB05 57.6 · IC025 +4.6 3/3 methods agree	Not in label — unassessed	serious PRR 77.7 · 90% clinician	no trial data cached
Dermatitis contact	6	46.8 21.2–103.1ROR 48.0 · χ² 225 / p 4e-51	40.9 EB05 19.9 · IC025 +2.0 3/3 methods agree	Not in label — unassessed	serious n=6	no trial data cached
Vitreous floaters	5	45.4 19.1–108.2ROR 46.4 · χ² 175 / p 3e-40	38.6 EB05 17.1 · IC025 +1.6 3/3 methods agree	Not in label — unassessed	serious n=5	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
Visual acuity reduced	31	82.0 59.0–113.8ROR 94.2 · χ² 2,401 / p <1e-300	78.1 EB05 57.6 · IC025 +4.6 3/3 methods agree	Not in label — unassessed	serious PRR 77.7 · 90% clinician	no trial data cached
Dermatitis contact	6	46.8 21.2–103.1ROR 48.0 · χ² 225 / p 4e-51	40.9 EB05 19.9 · IC025 +2.0 3/3 methods agree	Not in label — unassessed	serious n=6	no trial data cached
Vitreous floaters	5	45.4 19.1–108.2ROR 46.4 · χ² 175 / p 3e-40	38.6 EB05 17.1 · IC025 +1.6 3/3 methods agree	Not in label — unassessed	serious n=5	no trial data cached
Eye haemorrhage	4	26.5 10.0–70.0ROR 26.9 · χ² 74 / p 3e-18	20.3 EB05 5.3 · IC025 +1.0 3/3 methods agree	Not in label — unassessed	serious PRR 20.9	no trial data cached
Retinal detachment	4	38.5 14.6–101.7ROR 39.1 · χ² 111 / p 3e-26	31.0 EB05 10.0 · IC025 +1.1 3/3 methods agree	Not in label — unassessed	serious PRR 27.4	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.

Visual acuity reduced — n=31, PRR 82.0

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 Fluorescein?

In FDA FAERS, the most frequently co-reported reaction terms for Fluorescein are visual acuity reduced, dermatitis contact, vitreous floaters, eye haemorrhage, retinal detachment. 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 Fluorescein have an FDA boxed warning?

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

Do FAERS signals prove that Fluorescein 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 0a2a65b1-dc88-445b-bfb7-53b2fd7bea2c, effective 20231025; matched on openfda.generic_name.exact:"FLUORESCEIN")
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, 5 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.