Drug · FAERS side-effect profile with label screen
In Water For side effects: what 12,699 FDA adverse event reports show
Drug class
No validated FDA label found
Who reports
12,699 reports · 90% serious · 2,078 with death outcome · 60% female
openFDA FAERS counts, all years, deduplication not applied
Used for
—
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 1Lab value / disease marker 5No label text to screen 34
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. 1,107 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 |
|---|---|---|---|---|---|---|
| Normal labour | 107 | 5,446.5 3,670.9–8,080.9ROR 5,492.8 · χ² 132,864 / p <1e-300 | 1,023.0 EB05 870.4 · IC025 +7.2 3/3 methods agree | No label text to screen | serious n=107 · ♀ 100% (drug 60%) | not reported in cached trials |
| Vaginal flatulence | 153 | 1,672.6 1,335.7–2,094.4ROR 1,693.0 · χ² 125,285 / p <1e-300 | 747.9 EB05 653.6 · IC025 +7.5 3/3 methods agree | No label text to screen | serious n=153 · ♀ 100% (drug 60%) | not reported in cached trials |
| Mitochondrial dna mutation | 30 | 888.5 569.6–1,385.8ROR 890.6 · χ² 16,638 / p <1e-300 | 420.4 EB05 308.7 · IC025 +5.2 3/3 methods agree | No label text to screen | serious n=30 · ♀ 100% (drug 60%) | not reported in cached trials |
| Neonatal intestinal perforation | 12 | 814.4 407.4–1,628.2ROR 815.2 · χ² 5,968 / p <1e-300 | 291.2 EB05 177.5 · IC025 +3.6 3/3 methods agree | No label text to screen | serious n=12 | not reported in cached trials |
| Vascular resistance systemic increased | 10 | 397.3 199.1–792.9ROR 397.6 · χ² 2,867 / p <1e-300 | 198.9 EB05 115.5 · IC025 +3.2 3/3 methods agree | No label text to screen | serious n=10 | not reported in cached trials |
| Csf oligoclonal band present | 20 | 322.5 199.7–520.9ROR 323.1 · χ² 5,086 / p <1e-300 | 214.4 EB05 146.6 · IC025 +4.4 3/3 methods agree | Lab value / disease marker | serious n=20 · 90% clinician | not reported in cached trials |
| Delivery | 108 | 322.2 262.3–395.8ROR 324.9 · χ² 28,604 / p <1e-300 | 256.9 EB05 218.8 · IC025 +6.6 3/3 methods agree | No label text to screen | serious n=107 · ♀ 100% (drug 60%) | not reported in cached trials |
| Hypermagnesaemia | 81 | 239.0 189.4–301.6ROR 240.5 · χ² 16,535 / p <1e-300 | 198.8 EB05 165.1 · IC025 +6.2 3/3 methods agree | No label text to screen | serious n=77 · ♀ 89% (drug 60%) · 100% clinician | not reported in cached trials |
| Negative pressure pulmonary oedema | 11 | 221.2 117.9–415.2ROR 221.4 · χ² 1,933 / p <1e-300 | 146.1 EB05 87.0 · IC025 +3.3 3/3 methods agree | No label text to screen | serious n=11 | not reported in cached trials |
| Female genital tract fistula | 162 | 171.7 146.2–201.7ROR 173.9 · χ² 24,716 / p <1e-300 | 152.6 EB05 133.9 · IC025 +6.5 3/3 methods agree | No label text to screen | serious n=162 · ♀ 100% (drug 60%) | not reported in cached trials |
| Airway peak pressure increased | 13 | 154.6 87.5–272.9ROR 154.7 · χ² 1,674 / p <1e-300 | 117.4 EB05 73.0 · IC025 +3.6 3/3 methods agree | Lab value / disease marker | serious n=13 | not reported in cached trials |
| Pco2 increased | 49 | 121.1 90.7–161.8ROR 121.6 · χ² 5,322 / p <1e-300 | 108.1 EB05 85.0 · IC025 +5.3 3/3 methods agree | No label text to screen | serious n=49 · ♀ 100% (drug 60%) | not reported in cached trials |
| Neuromuscular blockade | 15 | 116.3 68.9–196.4ROR 116.5 · χ² 1,495 / p <1e-300 | 95.8 EB05 61.6 · IC025 +3.7 3/3 methods agree | No label text to screen | serious n=13 | not reported in cached trials |
| Radiculopathy | 164 | 109.5 93.6–128.2ROR 110.9 · χ² 16,425 / p <1e-300 | 101.5 EB05 89.1 · IC025 +6.0 3/3 methods agree | No label text to screen | serious n=164 · ♀ 97% (drug 60%) | NCT00170950: 2/5,757 (0.0%) on In Water For (serious AE) |
| Renal ischaemia | 32 | 103.4 72.4–147.8ROR 103.7 · χ² 2,956 / p <1e-300 | 92.1 EB05 68.3 · IC025 +4.7 3/3 methods agree | No label text to screen | serious n=32 · ♀ 100% (drug 60%) | not reported in cached trials |
| Po2 increased | 30 | 102.9 71.2–148.7ROR 103.1 · χ² 2,752 / p <1e-300 | 91.3 EB05 67.1 · IC025 +4.6 3/3 methods agree | No label text to screen | serious n=30 · ♀ 100% (drug 60%) | not reported in cached trials |
| Tachycardia foetal | 28 | 98.9 67.6–144.8ROR 99.1 · χ² 2,467 / p <1e-300 | 87.9 EB05 63.8 · IC025 +4.5 3/3 methods agree | No label text to screen | serious n=27 · ♀ 0% (drug 60%) · 100% clinician | not reported in cached trials |
| Chronic sinusitis | 204 | 95.1 82.7–109.4ROR 96.6 · χ² 17,861 / p <1e-300 | 89.2 EB05 79.4 · IC025 +6.0 3/3 methods agree | No label text to screen | serious n=205 · ♀ 100% (drug 60%) | NCT00170950: 1/5,740 (0.0%) on In Water For (serious AE) |
| Proctitis | 152 | 94.6 80.4–111.4ROR 95.8 · χ² 13,223 / p <1e-300 | 88.5 EB05 77.3 · IC025 +5.8 3/3 methods agree | No label text to screen | serious n=152 · ♀ 100% (drug 60%) | not reported in cached trials |
| Propofol infusion syndrome | 38 | 93.9 67.8–130.2ROR 94.2 · χ² 3,216 / p <1e-300 | 85.2 EB05 64.8 · IC025 +4.8 3/3 methods agree | No label text to screen | serious n=38 · ♀ 100% (drug 60%) | not reported in cached trials |
| Adrenal suppression | 45 | 93.0 68.9–125.5ROR 93.3 · χ² 3,789 / p <1e-300 | 85.0 EB05 66.1 · IC025 +5.0 3/3 methods agree | No label text to screen | serious n=45 · ♀ 0% (drug 60%) | not reported in cached trials |
| Blood magnesium increased | 46 | 88.6 65.9–119.1ROR 88.9 · χ² 3,695 / p <1e-300 | 81.3 EB05 63.4 · IC025 +5.0 3/3 methods agree | Lab value / disease marker | serious n=28 · ♀ 100% (drug 60%) · 100% clinician | NCT03914326: 1/4,825 (0.0%) on In Water For (serious AE) |
| Blood gases abnormal | 26 | 84.4 56.9–125.1ROR 84.5 · χ² 1,958 / p <1e-300 | 75.9 EB05 54.5 · IC025 +4.4 3/3 methods agree | Lab value / disease marker | serious n=26 · ♀ 100% (drug 60%) | not reported in cached trials |
| Apgar score low | 56 | 74.7 57.2–97.6ROR 75.0 · χ² 3,824 / p <1e-300 | 69.8 EB05 55.8 · IC025 +5.0 3/3 methods agree | No label text to screen | serious n=54 · 100% clinician | not reported in cached trials |
| Neuromuscular block prolonged | 15 | 69.4 41.4–116.3ROR 69.5 · χ² 906 / p 3e-199 | 61.6 EB05 39.7 · IC025 +3.5 3/3 methods agree | No label text to screen | serious n=12 | not reported in cached trials |
| Status asthmaticus | 19 | 68.3 43.2–108.1ROR 68.4 · χ² 1,146 / p 2e-251 | 61.7 EB05 41.8 · IC025 +3.9 3/3 methods agree | No label text to screen | serious n=19 | not reported in cached trials |
| Macular degeneration | 463 | 66.8 60.9–73.1ROR 69.2 · χ² 28,760 / p <1e-300 | 64.0 EB05 59.3 · IC025 +5.8 3/3 methods agree | No label text to screen | serious PRR 43.9 · ♀ 100% (drug 60%) | NCT03914326: 1/4,825 (0.0%) on In Water For (serious AE) |
| Respiratory tract infection bacterial | 19 | 65.2 41.2–103.0ROR 65.3 · χ² 1,093 / p 5e-240 | 59.2 EB05 40.0 · IC025 +3.8 3/3 methods agree | No label text to screen | serious n=19 | NCT03914326: 1/4,825 (0.0%) control (serious AE) |
| Hellp syndrome | 23 | 63.8 42.1–96.8ROR 63.9 · χ² 1,309 / p 7e-287 | 58.6 EB05 41.1 · IC025 +4.1 3/3 methods agree | No label text to screen | serious n=23 · ♀ 100% (drug 60%) · 100% clinician | not reported in cached trials |
| Pleocytosis | 20 | 59.0 37.8–92.2ROR 59.1 · χ² 1,046 / p 1e-229 | 54.2 EB05 37.1 · IC025 +3.8 3/3 methods agree | No label text to screen | serious n=20 | not reported in cached trials |
| Bradycardia foetal | 27 | 56.3 38.4–82.6ROR 56.4 · χ² 1,365 / p 4e-299 | 52.6 EB05 37.9 · IC025 +4.1 3/3 methods agree | No label text to screen | serious n=27 · 100% clinician | not reported in cached trials |
| Intraventricular haemorrhage neonatal | 16 | 55.9 34.0–92.0ROR 56.0 · χ² 782 / p 2e-172 | 51.0 EB05 33.3 · IC025 +3.5 3/3 methods agree | No label text to screen | serious n=16 | not reported in cached trials |
| Diabetes insipidus | 79 | 55.7 44.5–69.6ROR 56.0 · χ² 4,050 / p <1e-300 | 53.2 EB05 44.1 · IC025 +5.0 3/3 methods agree | No label text to screen | serious n=79 | not reported in cached trials |
| Blood ph decreased | 56 | 55.6 42.6–72.5ROR 55.8 · χ² 2,849 / p <1e-300 | 52.8 EB05 42.2 · IC025 +4.8 3/3 methods agree | Lab value / disease marker | serious n=56 · ♀ 100% (drug 60%) | not reported in cached trials |
| Neonatal infection | 11 | 54.1 29.7–98.7ROR 54.2 · χ² 505 / p 4e-112 | 48.3 EB05 28.8 · IC025 +3.0 3/3 methods agree | No label text to screen | serious n=11 | not reported in cached trials |
| Low birth weight baby | 249 | 53.4 47.1–60.5ROR 54.4 · χ² 12,351 / p <1e-300 | 51.5 EB05 46.4 · IC025 +5.3 3/3 methods agree | No label text to screen | serious PRR 33.2 · 98% clinician | not reported in cached trials |
| Maternal exposure during delivery | 30 | 52.6 36.6–75.6ROR 52.7 · χ² 1,422 / p <1e-300 | 49.5 EB05 36.3 · IC025 +4.2 3/3 methods agree | Reporting / coding artifact | serious n=25 · ♀ 100% (drug 60%) · 100% clinician | not reported in cached trials |
| Eclampsia | 11 | 51.5 28.3–93.8ROR 51.5 · χ² 480 / p 1e-106 | 46.2 EB05 27.5 · IC025 +3.0 3/3 methods agree | No label text to screen | serious n=11 | not reported in cached trials |
| Postpartum haemorrhage | 38 | 49.2 35.7–68.0ROR 49.4 · χ² 1,697 / p <1e-300 | 46.8 EB05 35.6 · IC025 +4.4 3/3 methods agree | No label text to screen | serious n=38 · ♀ 100% (drug 60%) · 100% clinician | not reported in cached trials |
| Foetal heart rate deceleration abnormality | 20 | 48.3 31.0–75.4ROR 48.4 · χ² 855 / p 3e-188 | 45.1 EB05 30.8 · IC025 +3.7 3/3 methods agree | No label text to screen | serious n=20 | not reported in cached trials |
Trial evidence (ClinicalTrials.gov)
✓ Trial adverse-event data found on ClinicalTrials.gov
Largest completed trials with posted results that list In Water For as a study intervention. The right-hand column of the signal table shows whether each FAERS term was also recorded in these trials, with a real denominator (5 of 40 signal terms matched).
- NCT00170950 — Avoiding Cardiovascular Events Through Combination Therapy in Patients Living With Systolic Hypertension (N=11506, PHASE3; 1077 AE terms posted; arms: Benazepril / Amlodipine; Benazepril / HCTZ)
- NCT03914326 — A Heart Disease Study of Semaglutide in Patients With Type 2 Diabetes (N=9651, PHASE3; 1622 AE terms posted; arms: Oral Semaglutide; Placebo)
Caveats: trial populations, doses and follow-up differ from the reporting population; AE terms are sponsor-coded and matched here by wording; absence from a trial list means the term was not reported above the sponsor's frequency threshold, not that it cannot occur.
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 |
|---|---|---|---|---|---|---|
| Drug ineffective (drug did not work) | 1,194 | 1.5 1.4–1.6ROR 1.5 · χ² 210 / p 6e-48 | 1.5 EB05 1.4 · IC025 +0.5 | Reporting / coding artifact | serious PRR 2.5 | not reported in cached trials |
| Nausea | 835 | 1.7 1.6–1.9ROR 1.8 · χ² 277 / p 2e-62 | 1.7 EB05 1.7 · IC025 +0.7 | No label text to screen | serious PRR 2.0 | NCT00170950: 9/5,740 (0.2%) on In Water For (serious AE) |
| Off label use (used outside approved label) | 829 | 1.6 1.5–1.7ROR 1.6 · χ² 182 / p 7e-42 | 1.6 EB05 1.5 · IC025 +0.5 | Reporting / coding artifact | serious PRR 1.7 | not reported in cached trials |
| Pyrexia (fever) | 787 | 3.8 3.5–4.0ROR 3.9 · χ² 1,615 / p <1e-300 | 3.7 EB05 3.5 · IC025 +1.8 3/3 methods agree | No label text to screen | serious PRR 2.9 | NCT00170950: 7/5,740 (0.1%) on In Water For (serious AE) |
| Maternal exposure during pregnancy | 749 | 14.1 13.2–15.2ROR 15.0 · χ² 9,091 / p <1e-300 | 14.0 EB05 13.2 · IC025 +3.7 3/3 methods agree | Reporting / coding artifact | serious PRR 10.5 · ♀ 97% (drug 60%) · 94% clinician | not reported in cached trials |
| Pain | 700 | 1.9 1.7–2.0ROR 1.9 · χ² 296 / p 1e-66 | 1.9 EB05 1.8 · IC025 +0.8 | No label text to screen | serious PRR 1.8 | NCT00170950: 21/5,740 (0.4%) on In Water For (serious AE) |
| Foetal exposure during pregnancy | 681 | 14.0 13.0–15.0ROR 14.7 · χ² 8,138 / p <1e-300 | 13.8 EB05 13.0 · IC025 +3.7 3/3 methods agree | Reporting / coding artifact | serious PRR 8.9 · 96% clinician | not reported in cached trials |
| Premature baby | 672 | 37.6 34.9–40.5ROR 39.6 · χ² 23,388 / p <1e-300 | 36.7 EB05 34.5 · IC025 +5.0 3/3 methods agree | No label text to screen | serious PRR 23.5 · 96% clinician | not reported in cached trials |
| Diarrhoea (diarrhea) | 638 | 1.6 1.5–1.8ROR 1.7 · χ² 163 / p 1e-37 | 1.6 EB05 1.5 · IC025 +0.6 | No label text to screen | serious PRR 1.7 | NCT00170950: 17/5,740 (0.3%) on In Water For (serious AE) |
| Dyspnoea (shortness of breath) | 593 | 1.7 1.6–1.9ROR 1.8 · χ² 188 / p 5e-43 | 1.7 EB05 1.6 · IC025 +0.7 | No label text to screen | serious PRR 1.4 | NCT00170950: 40/5,740 (0.7%) on In Water For (serious AE) |
| Anaemia (low red blood cells) | 557 | 4.8 4.5–5.2ROR 5.0 · χ² 1,699 / p <1e-300 | 4.8 EB05 4.5 · IC025 +2.1 3/3 methods agree | No label text to screen | serious PRR 3.4 | NCT00170950: 34/5,740 (0.6%) on In Water For (serious AE) |
| Hypotension (low blood pressure) | 556 | 4.6 4.2–5.0ROR 4.8 · χ² 1,571 / p <1e-300 | 4.6 EB05 4.3 · IC025 +2.1 3/3 methods agree | No label text to screen | serious PRR 3.3 | NCT00170950: 1/5,757 (0.0%) on In Water For (serious AE) |
| Vomiting | 522 | 1.8 1.7–2.0ROR 1.9 · χ² 204 / p 2e-46 | 1.8 EB05 1.7 · IC025 +0.7 | No label text to screen | serious PRR 1.7 | NCT00170950: 13/5,740 (0.2%) on In Water For (serious AE) |
| Pneumonia (lung infection) | 480 | 2.5 2.2–2.7ROR 2.5 · χ² 418 / p 3e-93 | 2.4 EB05 2.3 · IC025 +1.1 3/3 methods agree | No label text to screen | serious PRR 1.6 | NCT00170950: 1/5,740 (0.0%) on In Water For (serious AE) |
| Abdominal pain | 465 | 3.3 3.0–3.6ROR 3.4 · χ² 753 / p 4e-166 | 3.3 EB05 3.1 · IC025 +1.6 3/3 methods agree | No label text to screen | serious PRR 2.7 | NCT00170950: 21/5,740 (0.4%) on In Water For (serious AE) |
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 In Water For?
In FDA FAERS, the most frequently co-reported reaction terms for In Water For are nausea, pyrexia, pain, premature baby, diarrhoea, dyspnoea. 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 In Water For have an FDA boxed warning?
No validated FDA label could be retrieved for this product name, so this page cannot say.
Do FAERS signals prove that In 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
- No FDA label passed the name-validation check for this product string, so label-based screening was skipped
- 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, 1,147 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
IN WATER FOR, results-bearing studies sorted by enrollment)
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.