Sodium Chloride Tablet side effects: what 73,092 FDA adverse event reports show

Sodium Chloride Tablet · Sodium Chloride · 1,243 reaction terms · 301,614 drug–reaction co-reports · data 2026-09-14

Drug class

Not stated in label

Brand names

Sodium Chloride

openFDA label

Who reports

73,092 reports · 80% serious · 6,303 with death outcome · 58% female

openFDA FAERS counts, all years, deduplication not applied

Used for

for the preparation of normal isotonic solution of sodium chloride as an electrolyte replenisher for the prevention of heat cramps due to excessive perspiration any alternative use as directed by a physician

FDA label, Indications and Usage

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

Reporting / coding artifact 6Lab value / disease marker 3No label text to screen 31

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, for the 300 most-reported drugs, adjusted for age band), and flags pairs whose reports are unusually skewed by sex or come mostly from consumers. Each row also shows the PRR against the other drugs of the same FDA class, which removes most confounding by the condition being treated, and a calibrated p-value: on validation, known non-causes average an ROR of about 2, so significance is judged against that empirical null (✓ = p < 0.05 after calibration). 1,203 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
Vaginal flatulence	117	178.2 141.4–224.7ROR 178.5 · calibrated p 2e-9 ✓	107.7 EB05 92.3 · IC025 +5.9 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious n=117 · ♀ 100% (drug 58%)	no trial arm names this drug
Device wireless communication issue	80	135.0 103.4–176.2ROR 135.2 · calibrated p 2e-8 ✓	89.7 EB05 74.4 · IC025 +5.5 3/3 methods agree	Reporting / coding artifact	100% consumer	no trial arm names this drug
Sleep disorder therapy	52	111.0 80.6–153.0ROR 111.1 · calibrated p 1e-7 ✓	77.7 EB05 61.6 · IC025 +5.1 3/3 methods agree	Reporting / coding artifact	serious n=52 · ♀ 0% (drug 58%) · 100% clinician	no trial arm names this drug
Deafness permanent	53	105.2 76.7–144.2ROR 105.3 · calibrated p 2e-7 ✓	74.9 EB05 59.4 · IC025 +5.0 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious n=53	no trial arm names this drug
Device maintenance issue	119	76.6 62.5–93.8ROR 76.7 · calibrated p 1e-6 ✓	59.9 EB05 51.4 · IC025 +5.3 3/3 methods agree	Reporting / coding artifact	serious n=47 · 100% consumer	no trial arm names this drug
Infusion site discharge	298	60.4 53.3–68.5ROR 60.7 · calibrated p 4e-6 ✓	49.8 EB05 45.2 · IC025 +5.3 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious n=180 · 88% consumer	no trial arm names this drug
Wound infection pseudomonas	53	58.6 43.6–78.7ROR 58.6 · calibrated p 8e-6 ✓	47.9 EB05 38.0 · IC025 +4.6 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious n=53 · ♀ 100% (drug 58%) · 100% clinician	no trial arm names this drug
Granulocyte count decreased	297	57.3 50.6–64.8ROR 57.5 · calibrated p 6e-6 ✓	47.6 EB05 43.2 · IC025 +5.3 3/3 methods agree	Lab value / disease marker	serious n=297	no trial arm names this drug
Analgesic therapy	49	54.4 40.0–73.8ROR 54.4 · calibrated p 1e-5 ✓	45.0 EB05 35.4 · IC025 +4.5 3/3 methods agree	Reporting / coding artifact	serious n=49 · ♀ 0% (drug 58%) · 100% clinician	no trial arm names this drug
Myelosuppression	5,168	51.3 49.8–52.8ROR 55.1 · calibrated p 7e-6 ✓	43.5 EB05 42.5 · IC025 +5.4 3/3 methods agree	No label text to screen label has no adverse-reaction text	age-adj. PRR 44.9 · serious PRR 31.2 · 92% clinician	no trial arm names this drug
Infective pulmonary exacerbation of cystic fibrosis	779	47.4 43.9–51.1ROR 47.9 · calibrated p 2e-5 ✓	40.7 EB05 38.3 · IC025 +5.2 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious n=711	no trial arm names this drug
Ejection fraction	77	43.4 34.1–55.2ROR 43.4 · calibrated p 4e-5 ✓	37.4 EB05 30.9 · IC025 +4.6 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious n=77 · ♀ 100% (drug 58%)	no trial arm names this drug
Cystic fibrosis respiratory infection suppression	118	43.2 35.6–52.4ROR 43.3 · calibrated p 4e-5 ✓	37.4 EB05 32.1 · IC025 +4.7 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious n=118 · 76% consumer	no trial arm names this drug
Sensitisation	97	41.5 33.5–51.3ROR 41.5 · calibrated p 5e-5 ✓	36.1 EB05 30.4 · IC025 +4.6 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious n=97 · ♀ 100% (drug 58%)	no trial arm names this drug
Appendicolith	48	41.4 30.6–56.0ROR 41.4 · calibrated p 6e-5 ✓	35.7 EB05 28.0 · IC025 +4.3 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious n=48 · ♀ 0% (drug 58%) · 100% clinician	no trial arm names this drug
Osmotic demyelination syndrome	93	41.1 33.1–51.1ROR 41.2 · calibrated p 5e-5 ✓	35.8 EB05 30.1 · IC025 +4.6 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious n=93 · 100% clinician	no trial arm names this drug
Device infusion issue	288	38.1 33.7–43.1ROR 38.3 · calibrated p 7e-5 ✓	33.6 EB05 30.5 · IC025 +4.8 3/3 methods agree	Reporting / coding artifact	serious n=164 · 81% consumer	no trial arm names this drug
Infusion site haemorrhage	370	36.9 33.1–41.1ROR 37.0 · calibrated p 8e-5 ✓	32.7 EB05 30.0 · IC025 +4.8 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious n=187 · 82% consumer	no trial arm names this drug
Infusion site irritation	139	36.0 30.2–43.0ROR 36.1 · calibrated p 1e-4 ✓	31.9 EB05 27.7 · IC025 +4.6 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious n=52 · ♀ 82% (drug 58%) · 100% consumer	no trial arm names this drug
Infusion site discomfort	108	33.8 27.7–41.2ROR 33.8 · calibrated p 2e-4 ✓	30.1 EB05 25.7 · IC025 +4.4 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious n=61 · 73% consumer	no trial arm names this drug
Endocrine ophthalmopathy	85	32.8 26.2–41.0ROR 32.8 · calibrated p 2e-4 ✓	29.3 EB05 24.4 · IC025 +4.3 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious n=85	no trial arm names this drug
Interleukin level increased	52	30.9 23.2–41.1ROR 30.9 · calibrated p 3e-4 ✓	27.7 EB05 21.9 · IC025 +4.0 3/3 methods agree	Lab value / disease marker	serious n=52 · ♀ 0% (drug 58%) · 100% clinician	no trial arm names this drug
Cystic fibrosis	527	29.9 27.4–32.7ROR 30.1 · calibrated p 3e-4 ✓	27.1 EB05 25.2 · IC025 +4.6 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious n=510	no trial arm names this drug
Infusion site induration	133	29.5 24.7–35.3ROR 29.6 · calibrated p 3e-4 ✓	26.7 EB05 23.1 · IC025 +4.3 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious n=45 · ♀ 81% (drug 58%) · 100% consumer	no trial arm names this drug
Infusion site mass	98	28.9 23.5–35.6ROR 28.9 · calibrated p 4e-4 ✓	26.2 EB05 22.1 · IC025 +4.2 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious n=55 · ♀ 82% (drug 58%) · 100% consumer	no trial arm names this drug
Infusion site discolouration	79	28.9 22.9–36.4ROR 28.9 · calibrated p 4e-4 ✓	26.1 EB05 21.7 · IC025 +4.1 3/3 methods agree	No label text to screen label has no adverse-reaction text	100% consumer	no trial arm names this drug
Infusion site inflammation	61	28.4 21.8–37.0ROR 28.4 · calibrated p 4e-4 ✓	25.7 EB05 20.7 · IC025 +4.0 3/3 methods agree	No label text to screen label has no adverse-reaction text	100% consumer	no trial arm names this drug
Infusion site pain	1,145	28.2 26.5–29.9ROR 28.6 · calibrated p 3e-4 ✓	25.7 EB05 24.5 · IC025 +4.6 3/3 methods agree	No label text to screen label has no adverse-reaction text	age-adj. PRR 17.6 · serious n=494 · 80% consumer	no trial arm names this drug
Infusion site swelling	545	27.8 25.4–30.3ROR 28.0 · calibrated p 4e-4 ✓	25.3 EB05 23.6 · IC025 +4.5 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious n=263 · 76% consumer	no trial arm names this drug
Acidosis hyperchloraemic	52	27.7 20.8–36.8ROR 27.7 · calibrated p 5e-4 ✓	25.1 EB05 19.9 · IC025 +3.9 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious n=51 · ♀ 0% (drug 58%) · 100% clinician	no trial arm names this drug
Infusion site warmth	106	27.6 22.6–33.7ROR 27.7 · calibrated p 5e-4 ✓	25.2 EB05 21.4 · IC025 +4.2 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious n=46 · 100% consumer	no trial arm names this drug
Infusion site erythema	703	26.5 24.5–28.6ROR 26.7 · calibrated p 5e-4 ✓	24.3 EB05 22.8 · IC025 +4.5 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious n=325 · 81% consumer	no trial arm names this drug
Infusion site pruritus	258	25.8 22.7–29.3ROR 25.9 · calibrated p 6e-4 ✓	23.7 EB05 21.4 · IC025 +4.3 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious n=157 · ♀ 80% (drug 58%) · 79% consumer	no trial arm names this drug
Infusion site infection	182	25.0 21.5–29.0ROR 25.0 · calibrated p 7e-4 ✓	23.0 EB05 20.3 · IC025 +4.2 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious n=85 · ♀ 81% (drug 58%) · 82% consumer	no trial arm names this drug
Infusion site bruising	167	24.4 20.8–28.5ROR 24.4 · calibrated p 8e-4 ✓	22.5 EB05 19.7 · IC025 +4.1 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious n=115 · ♀ 81% (drug 58%) · 70% consumer	no trial arm names this drug
Infusion site rash	105	23.9 19.6–29.1ROR 23.9 · calibrated p 9e-4 ✓	22.0 EB05 18.7 · IC025 +4.0 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious n=68	no trial arm names this drug
Hereditary angioedema	806	23.8 22.1–25.5ROR 24.0 · calibrated p 8e-4 ✓	22.0 EB05 20.7 · IC025 +4.3 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 16.8 · ♀ 85% (drug 58%)	no trial arm names this drug
Incorrect product formulation administered	63	23.1 17.9–29.9ROR 23.1 · calibrated p 0.001 ✓	21.3 EB05 17.3 · IC025 +3.8 3/3 methods agree	Reporting / coding artifact	♀ 100% (drug 58%) · 100% consumer	no trial arm names this drug
Female genital tract fistula	127	22.8 19.0–27.3ROR 22.8 · calibrated p 0.001 ✓	21.1 EB05 18.2 · IC025 +4.0 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious n=126 · ♀ 100% (drug 58%)	no trial arm names this drug
Blood fibrinogen decreased	75	20.5 16.2–25.9ROR 20.5 · calibrated p 0.002 ✓	19.1 EB05 15.7 · IC025 +3.7 3/3 methods agree	Lab value / disease marker	serious n=75	no trial arm names this drug

Clinical concept groups

MedDRA splits one clinical problem across several terms (e.g. "neutropenia", "neutrophil count decreased", "agranulocytosis"), which dilutes term-level signals. These rows count reports with any term in a concept group (an exact union, not a sum), compared with all other drugs. Groups are hand-built and listed in the methods.

Concept	Reports	PRR 95% CI	Reading
Hyponatraemia	1,434	5.24.9–5.5	signal
Neutropenia / agranulocytosis	3,493	4.14.0–4.2	signal
Thrombocytopenia	2,146	2.82.7–2.9	signal
Serious infection	7,328	2.72.7–2.8	signal
Liver injury	2,405	2.32.2–2.4	signal
Anaemia	2,333	2.22.2–2.3	signal
Anaphylaxis / angioedema	929	2.12.0–2.3	signal
Kidney injury	2,913	1.81.8–1.9	raised
Severe cutaneous reaction	434	1.71.5–1.8	raised
Gi bleeding	1,046	1.61.5–1.7	raised
Interstitial lung disease	533	1.61.5–1.7	raised
Opportunistic infection	746	1.61.5–1.7	raised
Arrhythmia / qt	1,058	1.61.5–1.7	raised
Fall / fracture	1,988	1.51.4–1.6	raised
Venous thromboembolism	1,127	1.51.4–1.6	raised
Seizure	975	1.41.3–1.5	raised

Trial evidence (ClinicalTrials.gov)

ClinicalTrials.gov returned results-bearing trials mentioning Sodium Chloride Tablet only as a background or rescue medication (NCT04518410, NCT06059846); no trial listing it as the tested intervention was cached, so no trial cross-check is shown.

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
Nausea	5,254	1.9 1.9–2.0ROR 2.0 · calibrated p 0.936	1.9 EB05 1.9 · IC025 +0.9	No label text to screen label has no adverse-reaction text	age-adj. PRR 1.8 · serious PRR 2.2	no trial arm names this drug
Myelosuppression	5,168	51.3 49.8–52.8ROR 55.1 · calibrated p 7e-6 ✓	43.5 EB05 42.5 · IC025 +5.4 3/3 methods agree	No label text to screen label has no adverse-reaction text	age-adj. PRR 44.9 · serious PRR 31.2 · 92% clinician	no trial arm names this drug
Dyspnoea (shortness of breath)	4,604	2.3 2.3–2.4ROR 2.4 · calibrated p 0.841	2.3 EB05 2.3 · IC025 +1.2 3/3 methods agree	No label text to screen label has no adverse-reaction text	age-adj. PRR 2.1 · serious PRR 2.0	no trial arm names this drug
Off label use (used outside approved label)	4,546	1.5 1.5–1.5ROR 1.5 · calibrated p 0.666	1.5 EB05 1.5 · IC025 +0.5	Reporting / coding artifact	age-adj. PRR 1.4 · serious PRR 1.7	no trial arm names this drug
Headache	4,257	2.0 1.9–2.0ROR 2.0 · calibrated p 0.952	1.9 EB05 1.9 · IC025 +0.9	No label text to screen label has no adverse-reaction text	age-adj. PRR 1.5 · serious PRR 1.9	no trial arm names this drug
Pyrexia (fever)	4,195	3.5 3.4–3.6ROR 3.7 · calibrated p 0.448	3.5 EB05 3.4 · IC025 +1.7 3/3 methods agree	No label text to screen label has no adverse-reaction text	age-adj. PRR 3.1 · serious PRR 2.8	no trial arm names this drug
Fatigue (tiredness)	4,058	1.5 1.5–1.5ROR 1.5 · calibrated p 0.661	1.5 EB05 1.5 · IC025 +0.5	No label text to screen label has no adverse-reaction text	age-adj. PRR 1.3 · serious PRR 1.5	no trial arm names this drug
Vomiting	3,746	2.3 2.2–2.4ROR 2.4 · calibrated p 0.870	2.3 EB05 2.2 · IC025 +1.1 3/3 methods agree	No label text to screen label has no adverse-reaction text	age-adj. PRR 2.1 · serious PRR 2.1	no trial arm names this drug
Diarrhoea (diarrhea)	3,610	1.6 1.6–1.7ROR 1.6 · calibrated p 0.734	1.6 EB05 1.6 · IC025 +0.6	No label text to screen label has no adverse-reaction text	age-adj. PRR 1.4 · serious PRR 1.6	no trial arm names this drug
Pneumonia (lung infection)	3,366	3.0 2.9–3.1ROR 3.1 · calibrated p 0.594	3.0 EB05 2.9 · IC025 +1.5 3/3 methods agree	No label text to screen label has no adverse-reaction text	age-adj. PRR 2.6 · serious PRR 2.2	no trial arm names this drug
Pain	2,881	1.3 1.3–1.4ROR 1.4 · calibrated p 0.547	1.3 EB05 1.3 · IC025 +0.4	No label text to screen label has no adverse-reaction text	age-adj. PRR 1.3 · serious PRR 1.2	no trial arm names this drug
White blood cell count decreased	2,854	7.7 7.4–8.0ROR 8.0 · calibrated p 0.067	7.5 EB05 7.3 · IC025 +2.9 3/3 methods agree	Lab value / disease marker	age-adj. PRR 8.0 · serious PRR 7.5	no trial arm names this drug
Cough	2,526	2.6 2.5–2.7ROR 2.7 · calibrated p 0.748	2.6 EB05 2.5 · IC025 +1.3 3/3 methods agree	No label text to screen label has no adverse-reaction text	age-adj. PRR 2.1 · serious PRR 2.5	no trial arm names this drug
Drug ineffective (drug did not work)	2,431	0.5 0.5–0.5ROR 0.5 · calibrated p 0.052	0.5 EB05 0.5 · IC025 -1.0 PRR-only: not supported by EBGM or IC	Reporting / coding artifact	age-adj. PRR 0.6 · serious PRR 0.9	no trial arm names this drug
Dizziness	2,375	1.4 1.3–1.4ROR 1.4 · calibrated p 0.563	1.4 EB05 1.3 · IC025 +0.4	No label text to screen label has no adverse-reaction text	age-adj. PRR 1.2 · serious PRR 1.4	no trial arm names this drug

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.

✓ A hand-written Bradford Hill causality assessment exists for this drug: Methotrexate Sodium ↔ Rheumatoid Arthritis.

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 Sodium Chloride Tablet?

In FDA FAERS, the most frequently co-reported reaction terms for Sodium Chloride Tablet are nausea, myelosuppression, dyspnoea, headache, pyrexia, fatigue. 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 Sodium Chloride Tablet have an FDA boxed warning?

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

Do FAERS signals prove that Sodium Chloride Tablet 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 31195e8f-d4de-9e37-e063-6294a90a4156, effective 20250324; matched on openfda.generic_name.exact:"SODIUM CHLORIDE TABLET")
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, 1,243 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
ClinicalTrials.gov API v2 (query SODIUM CHLORIDE TABLET, results-bearing studies sorted by enrollment)

Page generated 2026-10-14. 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.