Drug · FAERS side-effect profile with label screen
Sterile Water For side effects: what 5,101 FDA adverse event reports show
Drug class
Not stated in label
Label matched
Sterile Water For Injection (Sterile Water)
closest FDA label found for this product string; brand list suppressed because the label is a related product, not an exact match
Who reports
5,101 reports · 55% serious · 149 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. This parenteral preparation is indica.
FDA label, Indications and Usage
What it is
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 Water for Injec.
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
Labeled adverse reaction 1Labeled (related wording) 1Reporting / coding artifact 9Lab value / disease marker 2Not in label — unassessed 27
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.
- 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.
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. 173 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 | 576 | 238.6 220.4–258.3ROR 268.9 · χ² 128,558 / p <1e-300 | 223.7 EB05 208.8 · IC025 +7.4 3/3 methods agree | Not in label — unassessed | serious PRR 249.1 · ♀ 86% (drug 62%) | no trial data cached |
| Poor venous access | 85 | 34.1 27.6–42.2ROR 34.7 · χ² 2,678 / p <1e-300 | 33.6 EB05 28.0 · IC025 +4.5 3/3 methods agree | Not in label — unassessed | serious n=43 | no trial data cached |
| Myelosuppression | 218 | 26.5 23.3–30.2ROR 27.6 · χ² 5,298 / p <1e-300 | 26.3 EB05 23.5 · IC025 +4.4 3/3 methods agree | Not in label — unassessed | serious PRR 27.7 · 96% clinician | no trial data cached |
| Product packaging quantity issue | 52 | 19.7 15.0–25.8ROR 19.9 · χ² 899 / p 8e-198 | 19.5 EB05 15.4 · IC025 +3.6 3/3 methods agree | Reporting / coding artifact | ♀ 10% (drug 62%) | no trial data cached |
| Insurance issue | 69 | 19.2 15.2–24.3ROR 19.4 · χ² 1,166 / p 8e-256 | 19.0 EB05 15.5 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious PRR 37.9 | no trial data cached |
| Prescribed overdose | 72 | 15.3 12.2–19.3ROR 15.5 · χ² 948 / p 1e-208 | 15.2 EB05 12.4 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious PRR 25.9 · ♀ 87% (drug 62%) | no trial data cached |
| Infusion site pain | 46 | 14.9 11.1–19.8ROR 15.0 · χ² 579 / p 3e-128 | 14.6 EB05 11.3 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious n=18 | no trial data cached |
| Device related infection | 54 | 14.4 11.1–18.8ROR 14.6 · χ² 660 / p 9e-146 | 14.2 EB05 11.2 · IC025 +3.2 3/3 methods agree | Reporting / coding artifact | serious PRR 15.5 | no trial data cached |
| Pharyngitis streptococcal | 32 | 12.2 8.6–17.2ROR 12.3 · χ² 317 / p 4e-71 | 11.7 EB05 8.4 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious n=14 | no trial data cached |
| Poor quality product administered | 28 | 11.3 7.8–16.3ROR 11.3 · χ² 252 / p 6e-57 | 10.6 EB05 7.4 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious n=2 · ♀ 30% (drug 62%) | no trial data cached |
| Dermatitis contact | 28 | 10.2 7.0–14.7ROR 10.2 · χ² 222 / p 2e-50 | 9.4 EB05 6.6 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious n=18 · ♀ 85% (drug 62%) | no trial data cached |
| Weight fluctuation | 25 | 9.9 6.7–14.6ROR 9.9 · χ² 190 / p 1e-43 | 9.0 EB05 6.2 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious n=10 | no trial data cached |
| Gastroenteritis viral | 39 | 8.9 6.5–12.1ROR 8.9 · χ² 264 / p 1e-59 | 8.3 EB05 6.2 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 7.7 | no trial data cached |
| Respiratory tract infection | 48 | 7.6 5.7–10.1ROR 7.7 · χ² 269 / p 1e-60 | 7.2 EB05 5.6 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 6.5 | no trial data cached |
| Seasonal allergy | 26 | 7.6 5.2–11.1ROR 7.6 · χ² 142 / p 5e-33 | 6.8 EB05 4.8 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious n=18 · ♀ 100% (drug 62%) | no trial data cached |
| Product preparation error | 38 | 7.6 5.5–10.4ROR 7.6 · χ² 209 / p 9e-48 | 7.0 EB05 5.3 · IC025 +2.3 3/3 methods agree | Reporting / coding artifact | serious n=13 · 92% clinician | no trial data cached |
| Sinus congestion | 22 | 6.7 4.4–10.2ROR 6.7 · χ² 101 / p 5e-24 | 5.9 EB05 4.1 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious n=11 | no trial data cached |
| Ligament sprain | 16 | 6.7 4.1–10.9ROR 6.7 · χ² 72 / p 1e-17 | 5.7 EB05 3.7 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious n=9 | no trial data cached |
| Ear infection | 43 | 6.7 4.9–9.0ROR 6.7 · χ² 201 / p 5e-46 | 6.3 EB05 4.8 · IC025 +2.1 3/3 methods agree | Labeled (related wording) related wording | serious PRR 4.5 | no trial data cached |
| Pharyngeal oedema | 23 | 6.1 4.0–9.1ROR 6.1 · χ² 92 / p 4e-22 | 5.5 EB05 3.8 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 7.7 | no trial data cached |
| Bone marrow failure | 30 | 6.0 4.2–8.6ROR 6.1 · χ² 121 / p 2e-28 | 5.6 EB05 4.1 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 6.4 · 90% clinician | no trial data cached |
| Sinusitis | 148 | 5.9 5.1–6.9ROR 6.1 · χ² 603 / p 2e-133 | 5.8 EB05 5.1 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 5.5 | no trial data cached |
| Respiratory tract congestion | 22 | 5.7 3.7–8.6ROR 5.7 · χ² 80 / p 2e-19 | 5.1 EB05 3.6 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 3.1 | no trial data cached |
| Neutrophil count decreased | 56 | 5.7 4.4–7.4ROR 5.7 · χ² 212 / p 3e-48 | 5.4 EB05 4.3 · IC025 +2.0 3/3 methods agree | Lab value / disease marker | serious PRR 7.0 · 96% clinician | no trial data cached |
| Complication associated with device | 18 | 5.6 3.5–8.9ROR 5.6 · χ² 63 / p 8e-16 | 4.9 EB05 3.3 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 9.1 | no trial data cached |
| Sars-cov-2 test positive | 18 | 5.5 3.5–8.8ROR 5.6 · χ² 63 / p 1e-15 | 4.9 EB05 3.3 · IC025 +1.5 3/3 methods agree | Lab value / disease marker | serious n=9 | no trial data cached |
| Circumstance or information capable of leading to medication error | 43 | 5.3 3.9–7.1ROR 5.3 · χ² 145 / p 1e-33 | 5.0 EB05 3.9 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious n=4 · ♀ 19% (drug 62%) | no trial data cached |
| Bacteraemia | 15 | 5.2 3.2–8.7ROR 5.3 · χ² 47 / p 3e-12 | 4.6 EB05 2.9 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 5.6 | no trial data cached |
| Drug effect incomplete | 45 | 5.0 3.8–6.7ROR 5.1 · χ² 141 / p 8e-33 | 4.8 EB05 3.7 · IC025 +1.8 3/3 methods agree | Reporting / coding artifact | serious PRR 17.1 · 91% consumer | no trial data cached |
| Inappropriate schedule of product administration | 213 | 5.0 4.3–5.7ROR 5.1 · χ² 674 / p 8e-149 | 4.9 EB05 4.4 · IC025 +2.1 3/3 methods agree | Reporting / coding artifact | serious PRR 8.3 | no trial data cached |
| Illness | 119 | 4.9 4.1–5.8ROR 5.0 · χ² 364 / p 2e-81 | 4.8 EB05 4.1 · IC025 +2.0 3/3 methods agree | Reporting / coding artifact | serious PRR 5.7 | no trial data cached |
| Skin infection | 13 | 4.8 2.8–8.2ROR 4.8 · χ² 35 / p 1e-9 | 4.2 EB05 2.6 · IC025 +1.1 3/3 methods agree | Not in label — unassessed | serious PRR 3.2 | no trial data cached |
| Drug dispensing error | 18 | 4.8 3.0–7.6ROR 4.8 · χ² 50 / p 8e-13 | 4.3 EB05 2.9 · IC025 +1.3 3/3 methods agree | Reporting / coding artifact | serious n=5 | no trial data cached |
| Tenderness | 12 | 4.7 2.7–8.3ROR 4.7 · χ² 32 / p 9e-9 | 4.1 EB05 2.5 · IC025 +1.1 3/3 methods agree | Labeled adverse reaction exact term | serious n=5 | no trial data cached |
| Upper respiratory tract infection (cold/sinus infection) | 52 | 4.6 3.5–6.1ROR 4.7 · χ² 145 / p 1e-33 | 4.5 EB05 3.5 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 3.8 | no trial data cached |
| Infusion related reaction (reaction during infusion) | 74 | 4.6 3.7–5.8ROR 4.7 · χ² 206 / p 5e-47 | 4.5 EB05 3.7 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 4.3 | no trial data cached |
| Dyspnoea exertional | 42 | 4.6 3.4–6.2ROR 4.6 · χ² 115 / p 4e-27 | 4.4 EB05 3.4 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 4.9 | no trial data cached |
| Product availability issue | 25 | 4.6 3.1–6.8ROR 4.6 · χ² 67 / p 2e-16 | 4.3 EB05 3.0 · IC025 +1.4 3/3 methods agree | Reporting / coding artifact | serious PRR 6.8 | no trial data cached |
| Ear discomfort | 11 | 4.4 2.4–8.0ROR 4.4 · χ² 26 / p 2e-7 | 3.8 EB05 2.3 · IC025 +0.9 3/3 methods agree | Not in label — unassessed | serious n=8 | no trial data cached |
| Incorrect route of product administration | 18 | 4.4 2.8–7.0ROR 4.4 · χ² 44 / p 2e-11 | 4.0 EB05 2.7 · IC025 +1.2 3/3 methods agree | Reporting / coding artifact | serious PRR 2.6 | 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 |
|---|---|---|---|---|---|---|
| Hereditary angioedema | 576 | 238.6 220.4–258.3ROR 268.9 · χ² 128,558 / p <1e-300 | 223.7 EB05 208.8 · IC025 +7.4 3/3 methods agree | Not in label — unassessed | serious PRR 249.1 · ♀ 86% (drug 62%) | no trial data cached |
| Product dose omission issue | 250 | 3.6 3.2–4.1ROR 3.7 · χ² 475 / p 1e-105 | 3.6 EB05 3.2 · IC025 +1.6 3/3 methods agree | Reporting / coding artifact | serious PRR 8.8 | no trial data cached |
| Weight increased (weight gain) | 232 | 4.3 3.8–4.9ROR 4.4 · χ² 586 / p 8e-130 | 4.2 EB05 3.8 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 4.0 | no trial data cached |
| Pyrexia (fever) | 226 | 2.7 2.4–3.0ROR 2.8 · χ² 241 / p 1e-54 | 2.7 EB05 2.4 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 2.2 | no trial data cached |
| Weight decreased (weight loss) | 221 | 3.3 2.9–3.7ROR 3.4 · χ² 348 / p 7e-78 | 3.2 EB05 2.9 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 3.1 | no trial data cached |
| Myelosuppression | 218 | 26.5 23.3–30.2ROR 27.6 · χ² 5,298 / p <1e-300 | 26.3 EB05 23.5 · IC025 +4.4 3/3 methods agree | Not in label — unassessed | serious PRR 27.7 · 96% clinician | no trial data cached |
| Inappropriate schedule of product administration | 213 | 5.0 4.3–5.7ROR 5.1 · χ² 674 / p 8e-149 | 4.9 EB05 4.4 · IC025 +2.1 3/3 methods agree | Reporting / coding artifact | serious PRR 8.3 | no trial data cached |
| Cough | 166 | 2.4 2.1–2.8ROR 2.5 · χ² 141 / p 7e-33 | 2.4 EB05 2.1 · IC025 +1.0 3/3 methods agree | Not in label — unassessed | serious PRR 1.9 | no trial data cached |
| Nasopharyngitis (common cold) | 166 | 3.7 3.2–4.3ROR 3.8 · χ² 326 / p 3e-73 | 3.7 EB05 3.2 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 3.6 | no trial data cached |
| No adverse event | 159 | 3.7 3.2–4.3ROR 3.8 · χ² 311 / p 7e-70 | 3.6 EB05 3.2 · IC025 +1.6 3/3 methods agree | Reporting / coding artifact | serious PRR 1.6 · ♀ 38% (drug 62%) | no trial data cached |
| Covid-19 | 150 | 3.5 3.0–4.1ROR 3.6 · χ² 266 / p 5e-60 | 3.5 EB05 3.0 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 3.5 | no trial data cached |
| Sinusitis | 148 | 5.9 5.1–6.9ROR 6.1 · χ² 603 / p 2e-133 | 5.8 EB05 5.1 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 5.5 | no trial data cached |
| Illness | 119 | 4.9 4.1–5.8ROR 5.0 · χ² 364 / p 2e-81 | 4.8 EB05 4.1 · IC025 +2.0 3/3 methods agree | Reporting / coding artifact | serious PRR 5.7 | no trial data cached |
| Product use issue | 105 | 2.3 1.9–2.8ROR 2.3 · χ² 77 / p 7e-19 | 2.3 EB05 1.9 · IC025 +0.9 | Reporting / coding artifact | serious PRR 4.7 | no trial data cached |
| White blood cell count decreased | 97 | 3.7 3.0–4.5ROR 3.7 · χ² 187 / p 7e-43 | 3.6 EB05 3.1 · IC025 +1.5 3/3 methods agree | Lab value / disease marker | serious PRR 5.4 · 93% clinician | 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.
- Hereditary angioedema — n=576, PRR 238.6
- Poor venous access — n=85, PRR 34.1
- Myelosuppression — n=218, PRR 26.5
- Insurance issue — n=69, PRR 19.2
- Prescribed overdose — n=72, PRR 15.3
- Infusion site pain — n=46, PRR 14.9
- Pharyngitis streptococcal — n=32, PRR 12.2
- Poor quality product administered — n=28, PRR 11.3
- Dermatitis contact — n=28, PRR 10.2
- Weight fluctuation — n=25, PRR 9.9
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 For?
In FDA FAERS, the most frequently co-reported reaction terms for Sterile Water For are hereditary angioedema, weight increased, pyrexia, weight decreased, myelosuppression, 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 For have an FDA boxed warning?
No. The FDA label retrieved for Sterile Water For has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Sterile Water For 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 99e99a50-82d5-aff6-e053-2a95a90a8c56, effective 20250108; matched on
openfda.generic_name.exact:"STERILE WATER FOR INJECTION") - 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, 213 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.