Drug · FAERS side-effect profile with label screen

Balanced Salt Enriched side effects: what 367 FDA adverse event reports show

Balanced Salt Solution Enriched With Bicarbonate, Dextrose, And Glutathione · 11 reaction terms · 182 drug–reaction co-reports · data 2026-09-14

Drug class

Not stated in label

Label matched

Balanced Salt Solution Enriched With Bicarbonate, Dextrose, And Glutathione (Bss Plus)

closest FDA label found for this product string; brand list suppressed because the label is a related product, not an exact match

Who reports

367 reports · 82% serious · 1 with death outcome · 57% female

openFDA FAERS counts, all years, deduplication not applied

Used for

BSS PLUS is indicated for use as an intraocular irrigating solution during intraocular surgical procedures involving perfusion of the eye.

FDA label, Indications and Usage

What it is

DESCRIPTION: BSS PLUS ® is a sterile intraocular irrigating solution for use during all intraocular surgical procedures, including those requiring a relatively long intraocular perfusion time .

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 8 strongest signals

Reporting / coding artifact 4Lab value / disease marker 1No label text to screen 3

What the badges mean

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.
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.
No label text to screen No validated FDA label was retrievable for this product, so the screen could not run. Disproportionality only.

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. 3 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
Eye inflammation	19	115.3 74.4–178.7ROR 121.5 · χ² 2,037 / p <1e-300	103.4 EB05 70.0 · IC025 +4.1 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious n=15	no trial data cached
Product preparation error	18	49.7 31.7–78.0ROR 52.2 · χ² 811 / p 1e-178	47.3 EB05 31.7 · IC025 +3.6 3/3 methods agree	Reporting / coding artifact	serious n=1	no trial data cached
Post procedural complication	15	44.6 27.1–73.2ROR 46.4 · χ² 596 / p 6e-132	42.3 EB05 27.2 · IC025 +3.3 3/3 methods agree	Reporting / coding artifact	serious PRR 15.9	no trial data cached
Intraocular pressure increased (raised eye pressure)	9	40.1 21.0–76.4ROR 41.1 · χ² 305 / p 1e-68	37.1 EB05 20.9 · IC025 +2.6 3/3 methods agree	Lab value / disease marker	serious PRR 32.5	no trial data cached
Visual acuity reduced	18	30.7 19.6–48.2ROR 32.3 · χ² 489 / p 1e-108	29.8 EB05 20.0 · IC025 +3.3 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 29.2	no trial data cached
Pharmaceutical product complaint	11	23.9 13.3–42.7ROR 24.6 · χ² 219 / p 8e-50	22.8 EB05 13.2 · IC025 +2.6 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 19.8	no trial data cached
Wrong technique in product usage process	70	19.8 16.0–24.5ROR 24.2 · χ² 1,243 / p 1e-272	19.7 EB05 16.1 · IC025 +3.7 3/3 methods agree	Reporting / coding artifact	serious PRR 74.7 · 90% clinician	no trial data cached
Wrong technique in drug usage process	10	15.5 8.4–28.6ROR 15.9 · χ² 122 / p 1e-28	13.9 EB05 6.9 · IC025 +2.1 3/3 methods agree	Reporting / coding artifact	serious PRR 29.0	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
Wrong technique in product usage process	70	19.8 16.0–24.5ROR 24.2 · χ² 1,243 / p 1e-272	19.7 EB05 16.1 · IC025 +3.7 3/3 methods agree	Reporting / coding artifact	serious PRR 74.7 · 90% clinician	no trial data cached
Eye inflammation	19	115.3 74.4–178.7ROR 121.5 · χ² 2,037 / p <1e-300	103.4 EB05 70.0 · IC025 +4.1 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious n=15	no trial data cached
Visual acuity reduced	18	30.7 19.6–48.2ROR 32.3 · χ² 489 / p 1e-108	29.8 EB05 20.0 · IC025 +3.3 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 29.2	no trial data cached
Product preparation error	18	49.7 31.7–78.0ROR 52.2 · χ² 811 / p 1e-178	47.3 EB05 31.7 · IC025 +3.6 3/3 methods agree	Reporting / coding artifact	serious n=1	no trial data cached
Post procedural complication	15	44.6 27.1–73.2ROR 46.4 · χ² 596 / p 6e-132	42.3 EB05 27.2 · IC025 +3.3 3/3 methods agree	Reporting / coding artifact	serious PRR 15.9	no trial data cached
Pharmaceutical product complaint	11	23.9 13.3–42.7ROR 24.6 · χ² 219 / p 8e-50	22.8 EB05 13.2 · IC025 +2.6 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 19.8	no trial data cached
Wrong technique in drug usage process	10	15.5 8.4–28.6ROR 15.9 · χ² 122 / p 1e-28	13.9 EB05 6.9 · IC025 +2.1 3/3 methods agree	Reporting / coding artifact	serious PRR 29.0	no trial data cached
Intraocular pressure increased (raised eye pressure)	9	40.1 21.0–76.4ROR 41.1 · χ² 305 / p 1e-68	37.1 EB05 20.9 · IC025 +2.6 3/3 methods agree	Lab value / disease marker	serious PRR 32.5	no trial data cached
Uveitis	4	16.9 6.4–44.9ROR 17.1 · χ² 45 / p 9e-12	11.0 EB05 3.3 · IC025 +0.8 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 12.7	no trial data cached
Eyelid oedema	4	19.5 7.4–51.8ROR 19.7 · χ² 53 / p 2e-13	13.5 EB05 3.7 · IC025 +0.9 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 15.1	no trial data cached
Retinal detachment	4	24.9 9.4–65.9ROR 25.1 · χ² 69 / p 4e-17	18.7 EB05 4.9 · IC025 +1.0 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 17.7	no trial data cached

Unlabeled candidate signals

Every screened signal with n ≥ 20 was either labeled, an indication term, or an artifact pattern — no unlabeled candidate stood out in the top signals.

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 Balanced Salt Enriched?

In FDA FAERS, the most frequently co-reported reaction terms for Balanced Salt Enriched are eye inflammation, visual acuity reduced, pharmaceutical product complaint, intraocular pressure increased, uveitis, eyelid oedema. 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 Balanced Salt Enriched have an FDA boxed warning?

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

Do FAERS signals prove that Balanced Salt Enriched 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 f69655c5-cf32-6461-e00e-3a5c4a761344, effective 20240125; matched on openfda.generic_name.exact:"BALANCED SALT SOLUTION ENRICHED WITH BICARBONATE, DEXTROSE, AND GLUTATHIONE")
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, 11 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.