Drug · FAERS side-effect profile with label screen
Sodium Sulfate, Potassium Sulfate,… side effects: what 4,351 FDA adverse event reports show
Drug class
Osmotic laxative
FDA label, Indications wording of the closest related product
Label matched
Sodium Sulfate, Potassium Sulfate, Magnesium Sulfate (Sodium Sulfate, Potassium Sulfate And Magnesium Sulfate)
closest FDA label found for this product string; brand list suppressed because the label is a related product, not an exact match
Who reports
4,351 reports · 14% serious · 31 with death outcome · 73% female
openFDA FAERS counts, all years, deduplication not applied
Used for
Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution is indicated for cleansing of the colon as a preparation for colonoscopy in adult and pediatric patients 12 years of age and older. Sodium Sulfate, Potassium Sulfate and Magnesium Su.
FDA label, Indications and Usage
What it is
Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution (for adults) is an osmotic laxative and is provided as two bottles each containing 6 ounces of solution. Each bottle contains: 17.5 grams sodium sulfate, 3.13 grams potassium sulfate, and 1.6 grams magnesium sulfate.
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 6Labeled (related wording) 4Likely indication confounding 2Reporting / coding artifact 2Lab value / disease marker 2Not in label — unassessed 24
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.
- Likely indication confounding The term appears in the label's indications: reports probably describe the disease being treated (or its progression), not a drug effect. Classic confounding by indication.
- 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. 21 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 |
|---|---|---|---|---|---|---|
| Retching | 150 | 34.2 29.2–40.1ROR 35.4 · χ² 4,774 / p <1e-300 | 33.8 EB05 29.5 · IC025 +4.7 3/3 methods agree | Not in label — unassessed | serious PRR 19.8 · 99% consumer | no trial data cached |
| Abdominal distension (bloating) | 393 | 18.3 16.6–20.1ROR 20.0 · χ² 6,409 / p <1e-300 | 18.2 EB05 16.7 · IC025 +4.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.9 · 98% consumer | no trial data cached |
| Vomiting | 1,637 | 16.9 16.2–17.5ROR 26.5 · χ² 24,910 / p <1e-300 | 16.8 EB05 16.1 · IC025 +4.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 7.0 · 97% consumer | no trial data cached |
| Feeling cold | 93 | 16.1 13.2–19.7ROR 16.4 · χ² 1,301 / p 4e-285 | 16.0 EB05 13.4 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious PRR 8.2 · 100% consumer | no trial data cached |
| Eructation (belching) | 50 | 12.7 9.6–16.7ROR 12.8 · χ² 526 / p 9e-117 | 12.4 EB05 9.7 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | 96% consumer | no trial data cached |
| Product preparation error | 46 | 10.7 8.0–14.3ROR 10.8 · χ² 395 / p 3e-88 | 10.3 EB05 7.9 · IC025 +2.8 3/3 methods agree | Reporting / coding artifact | serious n=4 · 98% consumer | no trial data cached |
| Abdominal pain | 377 | 7.8 7.1–8.6ROR 8.5 · χ² 2,259 / p <1e-300 | 7.8 EB05 7.1 · IC025 +2.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.3 · 96% consumer | no trial data cached |
| Nausea | 1,147 | 7.0 6.7–7.4ROR 9.2 · χ² 6,130 / p <1e-300 | 7.0 EB05 6.7 · IC025 +2.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.8 · 97% consumer | no trial data cached |
| Chills | 130 | 5.3 4.5–6.3ROR 5.5 · χ² 456 / p 2e-101 | 5.2 EB05 4.5 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 5.5 · 96% consumer | no trial data cached |
| Haematemesis (vomiting blood) | 26 | 4.9 3.4–7.2ROR 5.0 · χ² 78 / p 6e-19 | 4.6 EB05 3.3 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 7.0 · 92% consumer | no trial data cached |
| Flatulence (gas) | 57 | 4.9 3.8–6.3ROR 4.9 · χ² 171 / p 2e-39 | 4.7 EB05 3.7 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 5.6 · 96% consumer | no trial data cached |
| Gastrointestinal pain | 11 | 4.8 2.7–8.7ROR 4.9 · χ² 30 / p 2e-8 | 4.1 EB05 2.5 · IC025 +1.0 3/3 methods agree | Labeled (related wording) related wording | serious PRR 13.5 | no trial data cached |
| Tremor (shaking) | 161 | 4.7 4.0–5.4ROR 4.8 · χ² 464 / p 3e-103 | 4.6 EB05 4.0 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 5.7 · 94% consumer | no trial data cached |
| Abdominal pain upper | 194 | 4.6 4.0–5.2ROR 4.7 · χ² 539 / p 1e-119 | 4.5 EB05 4.0 · IC025 +1.9 3/3 methods agree | Labeled (related wording) related wording | serious PRR 3.4 · 98% consumer | no trial data cached |
| Blood potassium decreased | 28 | 4.5 3.1–6.5ROR 4.5 · χ² 72 / p 9e-18 | 4.2 EB05 3.1 · IC025 +1.4 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 17.1 · 85% consumer | no trial data cached |
| Blood sodium decreased | 17 | 4.4 2.7–7.0ROR 4.4 · χ² 41 / p 9e-11 | 3.9 EB05 2.6 · IC025 +1.2 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 15.3 | no trial data cached |
| Faeces discoloured | 19 | 4.2 2.7–6.6ROR 4.2 · χ² 44 / p 2e-11 | 3.9 EB05 2.6 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 9.5 | no trial data cached |
| Haemorrhoids | 17 | 4.2 2.6–6.7ROR 4.2 · χ² 38 / p 3e-10 | 3.8 EB05 2.5 · IC025 +1.1 3/3 methods agree | Not in label — unassessed | serious PRR 4.9 | no trial data cached |
| Cold sweat | 15 | 4.1 2.5–6.8ROR 4.1 · χ² 32 / p 7e-9 | 3.7 EB05 2.4 · IC025 +1.0 3/3 methods agree | Not in label — unassessed | serious PRR 3.3 | no trial data cached |
| Wrong technique in product usage process | 170 | 4.1 3.5–4.7ROR 4.2 · χ² 392 / p 1e-87 | 4.0 EB05 3.5 · IC025 +1.8 3/3 methods agree | Reporting / coding artifact | serious PRR 4.7 · 97% consumer | no trial data cached |
| Abdominal discomfort | 135 | 3.9 3.3–4.6ROR 4.0 · χ² 290 / p 3e-65 | 3.8 EB05 3.3 · IC025 +1.7 3/3 methods agree | Labeled (related wording) related wording | serious PRR 2.9 · 95% consumer | no trial data cached |
| Heart rate irregular | 17 | 3.6 2.2–5.8ROR 3.6 · χ² 29 / p 3e-8 | 3.3 EB05 2.2 · IC025 +0.9 3/3 methods agree | Not in label — unassessed | serious PRR 5.6 | no trial data cached |
| Presyncope (near-fainting) | 18 | 3.6 2.3–5.7ROR 3.6 · χ² 31 / p 1e-8 | 3.3 EB05 2.2 · IC025 +1.0 3/3 methods agree | Not in label — unassessed | serious PRR 6.2 | no trial data cached |
| Dehydration | 96 | 3.5 2.8–4.2ROR 3.5 · χ² 167 / p 2e-38 | 3.4 EB05 2.9 · IC025 +1.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 10.3 · 87% consumer | no trial data cached |
| Abdominal pain lower | 18 | 3.4 2.2–5.4ROR 3.4 · χ² 28 / p 5e-8 | 3.2 EB05 2.2 · IC025 +0.9 3/3 methods agree | Labeled (related wording) related wording | serious PRR 4.6 | no trial data cached |
| Dysgeusia (altered taste) | 53 | 3.4 2.6–4.5ROR 3.5 · χ² 89 / p 2e-21 | 3.3 EB05 2.7 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 2.9 · 98% consumer | no trial data cached |
| End stage renal disease | 13 | 3.4 2.0–5.9ROR 3.4 · χ² 20 / p 4e-6 | 3.1 EB05 2.0 · IC025 +0.7 | Not in label — unassessed | serious PRR 13.7 | no trial data cached |
| Urinary retention | 22 | 3.2 2.1–4.8ROR 3.2 · χ² 31 / p 1e-8 | 3.0 EB05 2.1 · IC025 +0.9 3/3 methods agree | Not in label — unassessed | serious PRR 11.8 · ♀ 41% (drug 73%) · 95% consumer | no trial data cached |
| Osteopenia | 10 | 3.2 1.7–5.9ROR 3.2 · χ² 13 / p 2e-4 | 2.8 EB05 1.7 · IC025 +0.4 | Not in label — unassessed | serious PRR 9.0 | no trial data cached |
| Anhedonia | 17 | 3.1 1.9–5.0ROR 3.1 · χ² 22 / p 1e-6 | 2.9 EB05 1.9 · IC025 +0.7 | Not in label — unassessed | serious PRR 11.4 | no trial data cached |
| Dyspepsia (indigestion) | 61 | 3.0 2.3–3.8ROR 3.0 · χ² 80 / p 2e-19 | 2.9 EB05 2.4 · IC025 +1.1 3/3 methods agree | Not in label — unassessed | serious PRR 7.1 · 88% consumer | no trial data cached |
| Blood glucose decreased | 29 | 2.9 2.0–4.2ROR 2.9 · χ² 34 / p 2e-9 | 2.8 EB05 2.1 · IC025 +0.9 3/3 methods agree | Lab value / disease marker | serious PRR 0.8 · 100% consumer | no trial data cached |
| Blood pressure increased | 91 | 2.9 2.3–3.5ROR 2.9 · χ² 109 / p 7e-26 | 2.8 EB05 2.4 · IC025 +1.2 3/3 methods agree | Lab value / disease marker | serious PRR 7.6 · 93% consumer | no trial data cached |
| Headache | 371 | 2.9 2.6–3.1ROR 3.0 · χ² 459 / p 4e-102 | 2.8 EB05 2.6 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 3.4 · 95% consumer | no trial data cached |
| Thirst | 10 | 2.7 1.5–5.0ROR 2.7 · χ² 9 / p 0.001 | 2.5 EB05 1.5 · IC025 +0.2 | Not in label — unassessed | – | no trial data cached |
| Chronic kidney disease | 41 | 2.6 1.9–3.5ROR 2.6 · χ² 38 / p 3e-10 | 2.5 EB05 1.9 · IC025 +0.8 | Not in label — unassessed | serious PRR 10.6 | no trial data cached |
| Rectal haemorrhage | 23 | 2.6 1.7–3.9ROR 2.6 · χ² 21 / p 3e-6 | 2.5 EB05 1.8 · IC025 +0.6 | Not in label — unassessed | serious PRR 4.3 · 91% consumer | no trial data cached |
| Hyperhidrosis (excessive sweating) | 68 | 2.5 2.0–3.2ROR 2.6 · χ² 62 / p 1e-15 | 2.5 EB05 2.1 · IC025 +0.9 3/3 methods agree | Not in label — unassessed | serious PRR 3.9 · 91% consumer | no trial data cached |
| Discomfort | 30 | 2.4 1.7–3.4ROR 2.4 · χ² 23 / p 9e-7 | 2.3 EB05 1.7 · IC025 +0.6 | Labeled adverse reaction exact term | serious PRR 5.1 · 81% consumer | no trial data cached |
| Haematochezia (blood in stool) | 26 | 2.3 1.5–3.3ROR 2.3 · χ² 17 / p 2e-5 | 2.2 EB05 1.6 · IC025 +0.5 | Not in label — unassessed | serious PRR 3.5 · 92% consumer | 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 |
|---|---|---|---|---|---|---|
| Vomiting | 1,637 | 16.9 16.2–17.5ROR 26.5 · χ² 24,910 / p <1e-300 | 16.8 EB05 16.1 · IC025 +4.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 7.0 · 97% consumer | no trial data cached |
| Nausea | 1,147 | 7.0 6.7–7.4ROR 9.2 · χ² 6,130 / p <1e-300 | 7.0 EB05 6.7 · IC025 +2.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.8 · 97% consumer | no trial data cached |
| Abdominal distension (bloating) | 393 | 18.3 16.6–20.1ROR 20.0 · χ² 6,409 / p <1e-300 | 18.2 EB05 16.7 · IC025 +4.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.9 · 98% consumer | no trial data cached |
| Abdominal pain | 377 | 7.8 7.1–8.6ROR 8.5 · χ² 2,259 / p <1e-300 | 7.8 EB05 7.1 · IC025 +2.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.3 · 96% consumer | no trial data cached |
| Headache | 371 | 2.9 2.6–3.1ROR 3.0 · χ² 459 / p 4e-102 | 2.8 EB05 2.6 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 3.4 · 95% consumer | no trial data cached |
| Abdominal pain upper | 194 | 4.6 4.0–5.2ROR 4.7 · χ² 539 / p 1e-119 | 4.5 EB05 4.0 · IC025 +1.9 3/3 methods agree | Labeled (related wording) related wording | serious PRR 3.4 · 98% consumer | no trial data cached |
| Wrong technique in product usage process | 170 | 4.1 3.5–4.7ROR 4.2 · χ² 392 / p 1e-87 | 4.0 EB05 3.5 · IC025 +1.8 3/3 methods agree | Reporting / coding artifact | serious PRR 4.7 · 97% consumer | no trial data cached |
| Tremor (shaking) | 161 | 4.7 4.0–5.4ROR 4.8 · χ² 464 / p 3e-103 | 4.6 EB05 4.0 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 5.7 · 94% consumer | no trial data cached |
| Retching | 150 | 34.2 29.2–40.1ROR 35.4 · χ² 4,774 / p <1e-300 | 33.8 EB05 29.5 · IC025 +4.7 3/3 methods agree | Not in label — unassessed | serious PRR 19.8 · 99% consumer | no trial data cached |
| Abdominal discomfort | 135 | 3.9 3.3–4.6ROR 4.0 · χ² 290 / p 3e-65 | 3.8 EB05 3.3 · IC025 +1.7 3/3 methods agree | Labeled (related wording) related wording | serious PRR 2.9 · 95% consumer | no trial data cached |
| Chills | 130 | 5.3 4.5–6.3ROR 5.5 · χ² 456 / p 2e-101 | 5.2 EB05 4.5 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 5.5 · 96% consumer | no trial data cached |
| Dehydration | 96 | 3.5 2.8–4.2ROR 3.5 · χ² 167 / p 2e-38 | 3.4 EB05 2.9 · IC025 +1.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 10.3 · 87% consumer | no trial data cached |
| Feeling cold | 93 | 16.1 13.2–19.7ROR 16.4 · χ² 1,301 / p 4e-285 | 16.0 EB05 13.4 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious PRR 8.2 · 100% consumer | no trial data cached |
| Blood pressure increased | 91 | 2.9 2.3–3.5ROR 2.9 · χ² 109 / p 7e-26 | 2.8 EB05 2.4 · IC025 +1.2 3/3 methods agree | Lab value / disease marker | serious PRR 7.6 · 93% consumer | no trial data cached |
| Hyperhidrosis (excessive sweating) | 68 | 2.5 2.0–3.2ROR 2.6 · χ² 62 / p 1e-15 | 2.5 EB05 2.1 · IC025 +0.9 3/3 methods agree | Not in label — unassessed | serious PRR 3.9 · 91% consumer | 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.
- Retching — n=150, PRR 34.2
- Feeling cold — n=93, PRR 16.1
- Eructation — n=50, PRR 12.7
- Chills — n=130, PRR 5.3
- Haematemesis — n=26, PRR 4.9
- Flatulence — n=57, PRR 4.9
- Tremor — n=161, PRR 4.7
- Dysgeusia — n=53, PRR 3.4
- Urinary retention — n=22, PRR 3.2
- Dyspepsia — n=61, PRR 3.0
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 Sulfate, Potassium Sulfate,…?
In FDA FAERS, the most frequently co-reported reaction terms for Sodium Sulfate, Potassium Sulfate,… are vomiting, nausea, abdominal distension, abdominal pain, headache, abdominal pain upper. 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 Sulfate, Potassium Sulfate,… have an FDA boxed warning?
No. The FDA label retrieved for Sodium Sulfate, Potassium Sulfate,… has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Sodium Sulfate, Potassium Sulfate,… 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 f269929e-c2ff-4288-9d3b-7770bcb5a498, effective 20260413; matched on
openfda.generic_name.exact:"SODIUM SULFATE, POTASSIUM SULFATE, MAGNESIUM SULFATE") - 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, 61 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.