Drug · FAERS side-effect profile with label screen

Balanced Salt side effects: what 1,286 FDA adverse event reports show

Balanced Salt Solution · 28 reaction terms · 827 drug–reaction co-reports · data 2026-09-14

Drug class

Not stated in label

Label matched

Balanced Salt Solution (Bss)

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

Who reports

1,286 reports · 87% serious · 7 with death outcome · 55% female

openFDA FAERS counts, all years, deduplication not applied

Used for

For use as an extraocular and intraocular irrigating solution during ocular surgical procedure involving perfusion of the eye with an expected maximum duration of less than 60 minutes.

FDA label, Indications and Usage

What it is

DESCRIPTION BSS™ Sterile Irrigating Solution is a sterile balanced salt solution, each mL containing sodium chloride (NaCl) 0.64%, potassium chloride (KCl) 0.075%, calcium chloride dihydrate (.

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 23 strongest signals

Reporting / coding artifact 3Lab value / disease marker 1No label text to screen 19

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. 5 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	100	174.7 144.6–211.1ROR 189.3 · χ² 16,921 / p <1e-300	167.4 EB05 141.6 · IC025 +6.2 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious n=95	no trial data cached
Post procedural complication	79	67.2 54.3–83.3ROR 71.5 · χ² 5,071 / p <1e-300	65.9 EB05 54.6 · IC025 +5.2 3/3 methods agree	Reporting / coding artifact	serious PRR 42.6 · 94% clinician	no trial data cached
Intraocular pressure increased (raised eye pressure)	39	49.7 36.4–67.7ROR 51.2 · χ² 1,807 / p <1e-300	48.4 EB05 37.0 · IC025 +4.4 3/3 methods agree	Lab value / disease marker	serious PRR 45.9	no trial data cached
Uveitis	25	30.2 20.5–44.6ROR 30.8 · χ² 677 / p 2e-149	29.6 EB05 21.1 · IC025 +3.6 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 20.4	no trial data cached
Blindness unilateral	24	27.8 18.7–41.4ROR 28.3 · χ² 594 / p 2e-131	27.3 EB05 19.3 · IC025 +3.5 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 18.9 · ♀ 83% (drug 55%) · 92% clinician	no trial data cached
Visual acuity reduced	55	26.8 20.7–34.7ROR 28.0 · χ² 1,341 / p 6e-294	26.6 EB05 21.2 · IC025 +4.0 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 22.5 · 100% clinician	no trial data cached
Eye infection	16	23.3 14.3–37.9ROR 23.6 · χ² 319 / p 1e-71	22.6 EB05 14.7 · IC025 +3.0 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious n=9	no trial data cached
Conjunctivitis	25	22.2 15.1–32.8ROR 22.6 · χ² 485 / p 8e-108	21.8 EB05 15.5 · IC025 +3.3 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 27.2	no trial data cached
Retinal detachment	12	21.3 12.1–37.4ROR 21.5 · χ² 212 / p 2e-48	20.4 EB05 12.0 · IC025 +2.6 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 14.2	no trial data cached
Eye pain	70	20.7 16.5–26.0ROR 21.8 · χ² 1,294 / p 1e-283	20.6 EB05 16.8 · IC025 +3.8 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 30.6 · 91% clinician	no trial data cached
Vitreous floaters	12	20.1 11.4–35.3ROR 20.3 · χ² 199 / p 2e-45	19.2 EB05 11.1 · IC025 +2.5 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious n=8	no trial data cached
Ocular hyperaemia	45	15.7 11.8–20.9ROR 16.3 · χ² 606 / p 3e-134	15.5 EB05 12.0 · IC025 +3.3 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 29.8	no trial data cached
Ocular discomfort	10	15.0 8.1–27.9ROR 15.1 · χ² 117 / p 1e-27	13.3 EB05 6.6 · IC025 +2.1 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious n=9	no trial data cached
Inflammation	28	8.9 6.2–12.8ROR 9.1 · χ² 189 / p 3e-43	8.1 EB05 5.8 · IC025 +2.3 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 7.0 · ♀ 80% (drug 55%)	no trial data cached
Vision blurred (blurred vision)	74	8.8 7.1–11.0ROR 9.3 · χ² 510 / p 4e-113	8.5 EB05 7.0 · IC025 +2.7 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 7.8	no trial data cached
Pharmaceutical product complaint	14	8.7 5.1–14.6ROR 8.8 · χ² 88 / p 4e-21	7.2 EB05 4.4 · IC025 +1.9 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 4.0	no trial data cached
Lacrimation increased	14	7.6 4.5–12.9ROR 7.7 · χ² 74 / p 3e-18	6.4 EB05 3.9 · IC025 +1.7 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 13.1	no trial data cached
Visual impairment	54	7.2 5.5–9.3ROR 7.4 · χ² 282 / p 2e-63	6.8 EB05 5.4 · IC025 +2.3 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 8.0 · 98% clinician	no trial data cached
Eye irritation	22	6.4 4.3–9.7ROR 6.5 · χ² 96 / p 6e-23	5.7 EB05 4.0 · IC025 +1.8 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 16.4	no trial data cached
Circumstance or information capable of leading to medication error	13	6.3 3.7–10.9ROR 6.4 · χ² 53 / p 2e-13	5.3 EB05 3.3 · IC025 +1.5 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious n=10	no trial data cached
Medication error	18	5.3 3.3–8.4ROR 5.4 · χ² 59 / p 1e-14	4.7 EB05 3.2 · IC025 +1.5 3/3 methods agree	Reporting / coding artifact	serious PRR 5.3	no trial data cached
Blindness	12	4.8 2.7–8.4ROR 4.8 · χ² 33 / p 6e-9	4.1 EB05 2.5 · IC025 +1.1 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 3.3	no trial data cached
Product quality issue	39	4.7 3.5–6.4ROR 4.8 · χ² 111 / p 3e-26	4.5 EB05 3.4 · IC025 +1.6 3/3 methods agree	Reporting / coding artifact	serious PRR 8.0 · 95% clinician	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
Eye inflammation	100	174.7 144.6–211.1ROR 189.3 · χ² 16,921 / p <1e-300	167.4 EB05 141.6 · IC025 +6.2 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious n=95	no trial data cached
Post procedural complication	79	67.2 54.3–83.3ROR 71.5 · χ² 5,071 / p <1e-300	65.9 EB05 54.6 · IC025 +5.2 3/3 methods agree	Reporting / coding artifact	serious PRR 42.6 · 94% clinician	no trial data cached
Vision blurred (blurred vision)	74	8.8 7.1–11.0ROR 9.3 · χ² 510 / p 4e-113	8.5 EB05 7.0 · IC025 +2.7 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 7.8	no trial data cached
Eye pain	70	20.7 16.5–26.0ROR 21.8 · χ² 1,294 / p 1e-283	20.6 EB05 16.8 · IC025 +3.8 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 30.6 · 91% clinician	no trial data cached
Visual acuity reduced	55	26.8 20.7–34.7ROR 28.0 · χ² 1,341 / p 6e-294	26.6 EB05 21.2 · IC025 +4.0 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 22.5 · 100% clinician	no trial data cached
Visual impairment	54	7.2 5.5–9.3ROR 7.4 · χ² 282 / p 2e-63	6.8 EB05 5.4 · IC025 +2.3 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 8.0 · 98% clinician	no trial data cached
Ocular hyperaemia	45	15.7 11.8–20.9ROR 16.3 · χ² 606 / p 3e-134	15.5 EB05 12.0 · IC025 +3.3 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 29.8	no trial data cached
Product quality issue	39	4.7 3.5–6.4ROR 4.8 · χ² 111 / p 3e-26	4.5 EB05 3.4 · IC025 +1.6 3/3 methods agree	Reporting / coding artifact	serious PRR 8.0 · 95% clinician	no trial data cached
Intraocular pressure increased (raised eye pressure)	39	49.7 36.4–67.7ROR 51.2 · χ² 1,807 / p <1e-300	48.4 EB05 37.0 · IC025 +4.4 3/3 methods agree	Lab value / disease marker	serious PRR 45.9	no trial data cached
Inflammation	28	8.9 6.2–12.8ROR 9.1 · χ² 189 / p 3e-43	8.1 EB05 5.8 · IC025 +2.3 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 7.0 · ♀ 80% (drug 55%)	no trial data cached
Conjunctivitis	25	22.2 15.1–32.8ROR 22.6 · χ² 485 / p 8e-108	21.8 EB05 15.5 · IC025 +3.3 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 27.2	no trial data cached
Uveitis	25	30.2 20.5–44.6ROR 30.8 · χ² 677 / p 2e-149	29.6 EB05 21.1 · IC025 +3.6 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 20.4	no trial data cached
Blindness unilateral	24	27.8 18.7–41.4ROR 28.3 · χ² 594 / p 2e-131	27.3 EB05 19.3 · IC025 +3.5 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 18.9 · ♀ 83% (drug 55%) · 92% clinician	no trial data cached
Eye irritation	22	6.4 4.3–9.7ROR 6.5 · χ² 96 / p 6e-23	5.7 EB05 4.0 · IC025 +1.8 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 16.4	no trial data cached
Medication error	18	5.3 3.3–8.4ROR 5.4 · χ² 59 / p 1e-14	4.7 EB05 3.2 · IC025 +1.5 3/3 methods agree	Reporting / coding artifact	serious PRR 5.3	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?

In FDA FAERS, the most frequently co-reported reaction terms for Balanced Salt are eye inflammation, vision blurred, eye pain, visual acuity reduced, visual impairment, ocular hyperaemia. 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 have an FDA boxed warning?

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

Do FAERS signals prove that Balanced Salt 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 4bd4d59c-eb3b-4a5e-9eb7-ae95b0a92bea, effective 20240125; matched on openfda.generic_name.exact:"BALANCED SALT SOLUTION")
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, 28 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.