Drug · FAERS side-effect profile with label screen
Sterile Water side effects: what 4,285 FDA adverse event reports show
Drug class
Not stated in label
Who reports
4,285 reports · 55% serious · 123 with death outcome · 62% female
openFDA FAERS counts, all years, deduplication not applied
Used for
This parenteral preparation is indicated only for diluting or dissolving drugs for intravenous, intramuscular or subcutaneous injection, according to instructions of the manufacturer of the drug to be administered.
FDA label, Indications and Usage
What it is
DESCRIPTION This preparation is designed solely for parenteral use only after addition of drugs that require dilution or must be dissolved in an aqueous vehicle prior to injection. Sterile Wat.
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 40 strongest signals
Reporting / coding artifact 8Lab value / disease marker 2No label text to screen 30
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. 141 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
Show:
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Hereditary angioedema | 555 | 273.1 252.1–295.9ROR 313.6 · χ² 142,226 / p <1e-300 | 256.3 EB05 238.9 · IC025 +7.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 284.0 · ♀ 86% (drug 62%) | no trial data cached |
| Poor venous access | 79 | 37.7 30.3–47.0ROR 38.4 · χ² 2,768 / p <1e-300 | 37.1 EB05 30.8 · IC025 +4.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=41 | no trial data cached |
| Product packaging quantity issue | 51 | 23.0 17.5–30.2ROR 23.2 · χ² 1,045 / p 1e-229 | 22.7 EB05 17.9 · IC025 +3.8 3/3 methods agree | Reporting / coding artifact | ♀ 10% (drug 62%) | no trial data cached |
| Insurance issue | 67 | 22.2 17.5–28.1ROR 22.5 · χ² 1,328 / p 6e-291 | 21.9 EB05 17.9 · IC025 +3.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 43.4 | no trial data cached |
| Myelosuppression | 129 | 18.6 15.7–22.1ROR 19.2 · χ² 2,128 / p <1e-300 | 18.5 EB05 16.0 · IC025 +3.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 19.4 · 95% clinician | no trial data cached |
| Prescribed overdose | 72 | 18.3 14.5–23.0ROR 18.6 · χ² 1,155 / p 2e-253 | 18.1 EB05 14.9 · IC025 +3.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 30.7 · ♀ 87% (drug 62%) | no trial data cached |
| Device related infection | 48 | 15.3 11.5–20.2ROR 15.4 · χ² 624 / p 5e-138 | 15.1 EB05 11.7 · IC025 +3.3 3/3 methods agree | Reporting / coding artifact | serious PRR 16.4 · ♀ 83% (drug 62%) | no trial data cached |
| Infusion site pain | 36 | 13.8 10.0–19.2ROR 13.9 · χ² 415 / p 2e-92 | 13.5 EB05 10.0 · IC025 +3.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=16 | no trial data cached |
| Pharyngitis streptococcal | 29 | 13.1 9.1–18.9ROR 13.2 · χ² 312 / p 3e-70 | 12.7 EB05 9.0 · IC025 +2.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=13 | no trial data cached |
| Poor quality product administered | 27 | 13.0 8.9–18.9ROR 13.0 · χ² 285 / p 3e-64 | 12.4 EB05 8.6 · IC025 +2.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=2 · ♀ 31% (drug 62%) | no trial data cached |
| Dermatitis contact | 27 | 11.7 8.0–17.0ROR 11.7 · χ² 252 / p 5e-57 | 11.0 EB05 7.6 · IC025 +2.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=17 · ♀ 85% (drug 62%) | no trial data cached |
| Weight fluctuation | 23 | 10.8 7.2–16.3ROR 10.9 · χ² 195 / p 1e-44 | 10.0 EB05 6.7 · IC025 +2.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=9 | no trial data cached |
| Gastroenteritis viral | 36 | 9.7 7.0–13.5ROR 9.8 · χ² 273 / p 1e-61 | 9.2 EB05 6.8 · IC025 +2.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 8.6 | no trial data cached |
| Seasonal allergy | 24 | 8.3 5.6–12.4ROR 8.4 · χ² 147 / p 3e-34 | 7.5 EB05 5.2 · IC025 +2.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=17 · ♀ 95% (drug 62%) | no trial data cached |
| Respiratory tract infection | 39 | 7.4 5.4–10.1ROR 7.4 · χ² 208 / p 2e-47 | 6.9 EB05 5.2 · IC025 +2.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 6.8 | no trial data cached |
| Pharyngeal oedema | 23 | 7.2 4.8–10.9ROR 7.3 · χ² 117 / p 1e-27 | 6.4 EB05 4.5 · IC025 +2.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 9.1 | no trial data cached |
| Ear infection | 39 | 7.2 5.3–9.8ROR 7.3 · χ² 202 / p 4e-46 | 6.7 EB05 5.1 · IC025 +2.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 4.9 | no trial data cached |
| Product preparation error | 28 | 6.6 4.6–9.6ROR 6.7 · χ² 128 / p 6e-30 | 6.0 EB05 4.4 · IC025 +2.0 3/3 methods agree | Reporting / coding artifact | serious n=10 · 93% clinician | no trial data cached |
| Sars-cov-2 test positive | 18 | 6.6 4.2–10.5ROR 6.6 · χ² 80 / p 2e-19 | 5.7 EB05 3.8 · IC025 +1.7 3/3 methods agree | Lab value / disease marker | serious n=9 | no trial data cached |
| Sinusitis | 137 | 6.5 5.5–7.7ROR 6.7 · χ² 638 / p 4e-141 | 6.4 EB05 5.5 · IC025 +2.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 6.2 | no trial data cached |
| Ligament sprain | 13 | 6.5 3.7–11.1ROR 6.5 · χ² 55 / p 8e-14 | 5.4 EB05 3.3 · IC025 +1.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=7 | no trial data cached |
| Complication associated with device | 17 | 6.3 3.9–10.1ROR 6.3 · χ² 70 / p 2e-17 | 5.5 EB05 3.6 · IC025 +1.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 10.1 | no trial data cached |
| Drug effect incomplete | 45 | 6.0 4.5–8.0ROR 6.0 · χ² 182 / p 1e-41 | 5.7 EB05 4.4 · IC025 +2.0 3/3 methods agree | Reporting / coding artifact | serious PRR 20.3 · 91% consumer | no trial data cached |
| Respiratory tract congestion | 19 | 5.8 3.7–9.2ROR 5.9 · χ² 72 / p 1e-17 | 5.2 EB05 3.5 · IC025 +1.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 3.7 | no trial data cached |
| Sinus congestion | 16 | 5.8 3.5–9.4ROR 5.8 · χ² 59 / p 9e-15 | 5.0 EB05 3.3 · IC025 +1.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=8 | no trial data cached |
| Tenderness | 12 | 5.6 3.2–9.9ROR 5.6 · χ² 41 / p 7e-11 | 4.7 EB05 2.9 · IC025 +1.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=5 | no trial data cached |
| Inappropriate schedule of product administration | 201 | 5.6 4.9–6.4ROR 5.8 · χ² 754 / p 3e-166 | 5.5 EB05 4.9 · IC025 +2.2 3/3 methods agree | Reporting / coding artifact | serious PRR 9.3 | no trial data cached |
| Product availability issue | 25 | 5.5 3.7–8.1ROR 5.5 · χ² 87 / p 6e-21 | 5.0 EB05 3.6 · IC025 +1.7 3/3 methods agree | Reporting / coding artifact | serious PRR 8.1 | no trial data cached |
| Bacteraemia | 13 | 5.4 3.1–9.3ROR 5.4 · χ² 42 / p 4e-11 | 4.6 EB05 2.9 · IC025 +1.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 5.7 | no trial data cached |
| Ear discomfort | 11 | 5.3 2.9–9.5ROR 5.3 · χ² 34 / p 3e-9 | 4.4 EB05 2.6 · IC025 +1.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=8 | no trial data cached |
| Eye infection | 12 | 5.2 3.0–9.2ROR 5.3 · χ² 37 / p 6e-10 | 4.4 EB05 2.7 · IC025 +1.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=10 | no trial data cached |
| Upper respiratory tract infection (cold/sinus infection) | 47 | 5.0 3.8–6.6ROR 5.0 · χ² 146 / p 7e-34 | 4.8 EB05 3.7 · IC025 +1.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 4.2 | no trial data cached |
| Dyspnoea exertional | 38 | 5.0 3.6–6.8ROR 5.0 · χ² 116 / p 2e-27 | 4.7 EB05 3.6 · IC025 +1.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 5.7 | no trial data cached |
| Neutrophil count decreased | 41 | 5.0 3.7–6.7ROR 5.0 · χ² 126 / p 2e-29 | 4.7 EB05 3.6 · IC025 +1.7 3/3 methods agree | Lab value / disease marker | serious PRR 6.0 · 95% clinician | no trial data cached |
| Incorrect route of product administration | 17 | 5.0 3.1–8.0ROR 5.0 · χ² 50 / p 9e-13 | 4.4 EB05 2.9 · IC025 +1.3 3/3 methods agree | Reporting / coding artifact | serious PRR 3.0 | no trial data cached |
| Skin infection | 11 | 4.8 2.7–8.7ROR 4.8 · χ² 30 / p 3e-8 | 4.1 EB05 2.5 · IC025 +1.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 3.8 | no trial data cached |
| Infusion related reaction (reaction during infusion) | 65 | 4.8 3.8–6.1ROR 4.9 · χ² 193 / p 3e-44 | 4.7 EB05 3.8 · IC025 +1.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 4.5 | no trial data cached |
| Circumstance or information capable of leading to medication error | 33 | 4.8 3.4–6.8ROR 4.8 · χ² 96 / p 6e-23 | 4.5 EB05 3.4 · IC025 +1.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=3 · ♀ 19% (drug 62%) | no trial data cached |
| Weight increased (weight gain) | 217 | 4.8 4.2–5.4ROR 5.0 · χ² 649 / p 2e-143 | 4.7 EB05 4.2 · IC025 +2.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 4.5 | no trial data cached |
| Illness | 95 | 4.6 3.8–5.6ROR 4.7 · χ² 268 / p 2e-60 | 4.5 EB05 3.8 · IC025 +1.8 3/3 methods agree | Reporting / coding artifact | serious PRR 5.7 | 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 |
|---|---|---|---|---|---|---|
| Hereditary angioedema | 555 | 273.1 252.1–295.9ROR 313.6 · χ² 142,226 / p <1e-300 | 256.3 EB05 238.9 · IC025 +7.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 284.0 · ♀ 86% (drug 62%) | no trial data cached |
| Product dose omission issue | 237 | 4.1 3.6–4.6ROR 4.3 · χ² 554 / p 9e-123 | 4.0 EB05 3.6 · IC025 +1.8 3/3 methods agree | Reporting / coding artifact | serious PRR 10.0 | no trial data cached |
| Weight increased (weight gain) | 217 | 4.8 4.2–5.4ROR 5.0 · χ² 649 / p 2e-143 | 4.7 EB05 4.2 · IC025 +2.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 4.5 | no trial data cached |
| Weight decreased (weight loss) | 209 | 3.7 3.2–4.2ROR 3.8 · χ² 408 / p 6e-91 | 3.6 EB05 3.2 · IC025 +1.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 3.5 | no trial data cached |
| Inappropriate schedule of product administration | 201 | 5.6 4.9–6.4ROR 5.8 · χ² 754 / p 3e-166 | 5.5 EB05 4.9 · IC025 +2.2 3/3 methods agree | Reporting / coding artifact | serious PRR 9.3 | no trial data cached |
| Nasopharyngitis (common cold) | 146 | 3.9 3.3–4.5ROR 4.0 · χ² 310 / p 1e-69 | 3.8 EB05 3.3 · IC025 +1.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 4.0 | no trial data cached |
| Covid-19 | 144 | 4.0 3.4–4.7ROR 4.1 · χ² 321 / p 4e-72 | 3.9 EB05 3.4 · IC025 +1.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 4.0 | no trial data cached |
| Cough | 141 | 2.5 2.1–2.9ROR 2.5 · χ² 123 / p 7e-29 | 2.5 EB05 2.1 · IC025 +1.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 2.0 | no trial data cached |
| Sinusitis | 137 | 6.5 5.5–7.7ROR 6.7 · χ² 638 / p 4e-141 | 6.4 EB05 5.5 · IC025 +2.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 6.2 | no trial data cached |
| No adverse event | 134 | 3.7 3.1–4.4ROR 3.8 · χ² 263 / p 2e-59 | 3.7 EB05 3.2 · IC025 +1.6 3/3 methods agree | Reporting / coding artifact | serious PRR 1.9 · ♀ 36% (drug 62%) | no trial data cached |
| Myelosuppression | 129 | 18.6 15.7–22.1ROR 19.2 · χ² 2,128 / p <1e-300 | 18.5 EB05 16.0 · IC025 +3.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 19.4 · 95% clinician | no trial data cached |
| Product use issue | 101 | 2.6 2.2–3.2ROR 2.7 · χ² 102 / p 2e-24 | 2.6 EB05 2.2 · IC025 +1.1 3/3 methods agree | Reporting / coding artifact | serious PRR 5.3 | no trial data cached |
| Illness | 95 | 4.6 3.8–5.6ROR 4.7 · χ² 268 / p 2e-60 | 4.5 EB05 3.8 · IC025 +1.8 3/3 methods agree | Reporting / coding artifact | serious PRR 5.7 | no trial data cached |
| Influenza | 85 | 3.7 3.0–4.6ROR 3.8 · χ² 167 / p 2e-38 | 3.7 EB05 3.0 · IC025 +1.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 2.5 | no trial data cached |
| Chills | 82 | 3.4 2.8–4.2ROR 3.5 · χ² 139 / p 3e-32 | 3.4 EB05 2.8 · IC025 +1.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 3.2 | 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 Sterile Water?
In FDA FAERS, the most frequently co-reported reaction terms for Sterile Water are hereditary angioedema, weight increased, weight decreased, nasopharyngitis, covid-19, cough. 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 Sterile Water have an FDA boxed warning?
No. The FDA label retrieved for Sterile Water has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Sterile Water 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 74ed2a6f-824c-a1ff-e053-2a91aa0a57c0, effective 20250109; matched on
openfda.generic_name.exact:"STERILE WATER" AND openfda.product_type:"HUMAN PRESCRIPTION DRUG") - 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, fieldpatient.drug.openfda.generic_name.exact, 181 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.