Fluorescein Sodium side effects: what 677 FDA adverse event reports show

Fluorescein Sodium · 15 reaction terms · 332 drug–reaction co-reports · data 2026-09-14

Drug class

Diagnostic Dye

FDA label (Established Pharmacologic Class)

Who reports

677 reports · 97% serious · 36 with death outcome · 49% 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 14 strongest signals

Labeled adverse reaction 1Labeled (related wording) 2Lab value / disease marker 1Not in label — unassessed 10

What the badges mean

Labeled adverse reaction The exact term appears in the label's warnings or adverse-reactions sections: a known, expected effect. The FAERS signal confirms the label rather than discovering anything.
Labeled (related wording) The label describes this effect under different wording (e.g. 'neutropenia' for 'neutrophil count decreased'). Treated as known.
Lab value / disease marker A laboratory result, investigation or disease-activity marker (antibody positive, CRP abnormal, swollen joint count) not described in the label. These usually mirror the monitored disease or testing protocol rather than a drug effect; not screened further.
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. 1 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
Anaphylactic shock	81	98.2 80.0–120.5ROR 111.4 · χ² 7,681 / p <1e-300	95.7 EB05 79.5 · IC025 +5.6 3/3 methods agree	Not in label — unassessed	serious PRR 57.9 · 97% clinician	no trial data cached
Cold sweat	23	40.4 27.0–60.4ROR 41.8 · χ² 845 / p 5e-186	39.2 EB05 27.5 · IC025 +3.8 3/3 methods agree	Not in label — unassessed	serious PRR 36.2	no trial data cached
Circulatory collapse	15	27.2 16.5–44.8ROR 27.8 · χ² 353 / p 6e-79	26.3 EB05 16.9 · IC025 +3.0 3/3 methods agree	Not in label — unassessed	serious PRR 16.2	no trial data cached
Cyanosis (blue skin from low oxygen)	11	21.6 12.0–38.9ROR 22.0 · χ² 196 / p 7e-45	20.6 EB05 11.7 · IC025 +2.5 3/3 methods agree	Not in label — unassessed	serious PRR 13.7	no trial data cached
Visual acuity reduced	21	19.4 12.8–29.6ROR 20.0 · χ² 349 / p 3e-78	19.0 EB05 13.0 · IC025 +3.0 3/3 methods agree	Not in label — unassessed	serious PRR 15.6	no trial data cached
Sneezing	13	18.0 10.5–30.9ROR 18.3 · χ² 192 / p 5e-44	17.2 EB05 10.0 · IC025 +2.5 3/3 methods agree	Not in label — unassessed	serious PRR 26.8	no trial data cached
Shock	13	17.7 10.3–30.3ROR 18.0 · χ² 188 / p 4e-43	16.8 EB05 9.7 · IC025 +2.5 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 10.6	no trial data cached
Mydriasis	6	14.5 6.5–32.2ROR 14.6 · χ² 63 / p 1e-15	10.9 EB05 4.2 · IC025 +1.4 3/3 methods agree	Not in label — unassessed	serious PRR 11.2	no trial data cached
Hypoaesthesia oral	7	14.4 6.9–30.1ROR 14.5 · χ² 74 / p 3e-18	11.4 EB05 4.8 · IC025 +1.6 3/3 methods agree	Not in label — unassessed	serious PRR 15.7	no trial data cached
Pallor	12	13.6 7.8–23.9ROR 13.9 · χ² 128 / p 5e-30	12.2 EB05 6.6 · IC025 +2.2 3/3 methods agree	Not in label — unassessed	serious PRR 10.6	no trial data cached
Chest discomfort	44	13.4 10.0–17.8ROR 14.2 · χ² 493 / p 1e-109	13.1 EB05 10.0 · IC025 +3.1 3/3 methods agree	Not in label — unassessed	serious PRR 11.9 · 93% clinician	no trial data cached
Loss of consciousness	55	13.3 10.3–17.1ROR 14.4 · χ² 616 / p 2e-136	13.1 EB05 10.3 · IC025 +3.1 3/3 methods agree	Labeled (related wording) related wording	serious PRR 8.2	no trial data cached
Anaphylactic reaction (severe allergic reaction)	23	13.0 8.7–19.4ROR 13.4 · χ² 243 / p 5e-55	12.3 EB05 8.3 · IC025 +2.7 3/3 methods agree	Labeled (related wording) related wording	serious PRR 7.9 · 90% clinician	no trial data cached
Intraocular pressure increased (raised eye pressure)	5	12.1 5.0–28.9ROR 12.1 · χ² 40 / p 1e-10	7.9 EB05 3.1 · IC025 +1.0 3/3 methods agree	Lab value / disease marker	serious PRR 10.6	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
Anaphylactic shock	81	98.2 80.0–120.5ROR 111.4 · χ² 7,681 / p <1e-300	95.7 EB05 79.5 · IC025 +5.6 3/3 methods agree	Not in label — unassessed	serious PRR 57.9 · 97% clinician	no trial data cached
Loss of consciousness	55	13.3 10.3–17.1ROR 14.4 · χ² 616 / p 2e-136	13.1 EB05 10.3 · IC025 +3.1 3/3 methods agree	Labeled (related wording) related wording	serious PRR 8.2	no trial data cached
Chest discomfort	44	13.4 10.0–17.8ROR 14.2 · χ² 493 / p 1e-109	13.1 EB05 10.0 · IC025 +3.1 3/3 methods agree	Not in label — unassessed	serious PRR 11.9 · 93% clinician	no trial data cached
Anaphylactic reaction (severe allergic reaction)	23	13.0 8.7–19.4ROR 13.4 · χ² 243 / p 5e-55	12.3 EB05 8.3 · IC025 +2.7 3/3 methods agree	Labeled (related wording) related wording	serious PRR 7.9 · 90% clinician	no trial data cached
Cold sweat	23	40.4 27.0–60.4ROR 41.8 · χ² 845 / p 5e-186	39.2 EB05 27.5 · IC025 +3.8 3/3 methods agree	Not in label — unassessed	serious PRR 36.2	no trial data cached
Visual acuity reduced	21	19.4 12.8–29.6ROR 20.0 · χ² 349 / p 3e-78	19.0 EB05 13.0 · IC025 +3.0 3/3 methods agree	Not in label — unassessed	serious PRR 15.6	no trial data cached
Circulatory collapse	15	27.2 16.5–44.8ROR 27.8 · χ² 353 / p 6e-79	26.3 EB05 16.9 · IC025 +3.0 3/3 methods agree	Not in label — unassessed	serious PRR 16.2	no trial data cached
Shock	13	17.7 10.3–30.3ROR 18.0 · χ² 188 / p 4e-43	16.8 EB05 9.7 · IC025 +2.5 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 10.6	no trial data cached
Sneezing	13	18.0 10.5–30.9ROR 18.3 · χ² 192 / p 5e-44	17.2 EB05 10.0 · IC025 +2.5 3/3 methods agree	Not in label — unassessed	serious PRR 26.8	no trial data cached
Pallor	12	13.6 7.8–23.9ROR 13.9 · χ² 128 / p 5e-30	12.2 EB05 6.6 · IC025 +2.2 3/3 methods agree	Not in label — unassessed	serious PRR 10.6	no trial data cached
Cyanosis (blue skin from low oxygen)	11	21.6 12.0–38.9ROR 22.0 · χ² 196 / p 7e-45	20.6 EB05 11.7 · IC025 +2.5 3/3 methods agree	Not in label — unassessed	serious PRR 13.7	no trial data cached
Hypoaesthesia oral	7	14.4 6.9–30.1ROR 14.5 · χ² 74 / p 3e-18	11.4 EB05 4.8 · IC025 +1.6 3/3 methods agree	Not in label — unassessed	serious PRR 15.7	no trial data cached
Mydriasis	6	14.5 6.5–32.2ROR 14.6 · χ² 63 / p 1e-15	10.9 EB05 4.2 · IC025 +1.4 3/3 methods agree	Not in label — unassessed	serious PRR 11.2	no trial data cached
Intraocular pressure increased (raised eye pressure)	5	12.1 5.0–28.9ROR 12.1 · χ² 40 / p 1e-10	7.9 EB05 3.1 · IC025 +1.0 3/3 methods agree	Lab value / disease marker	serious PRR 10.6	no trial data cached
Toxic skin eruption	3	9.2 3.0–28.4ROR 9.2 · χ² 14 / p 7e-5	4.8 EB05 1.7 · IC025 +0.0	Not in label — unassessed	serious PRR 5.5	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.

Anaphylactic shock — n=81, PRR 98.2
Cold sweat — n=23, PRR 40.4
Visual acuity reduced — n=21, PRR 19.4
Chest discomfort — n=44, PRR 13.4

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 anaphylactic shock, loss of consciousness, chest discomfort, anaphylactic reaction, cold sweat, visual acuity reduced. 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, 15 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.