Drug · FAERS side-effect profile with label screen
Sodium Phosphate side effects: what 1,718 FDA adverse event reports show
Drug class
Not stated in label
Who reports
1,718 reports · 95% serious · 414 with death outcome · 45% female
openFDA FAERS counts, all years, deduplication not applied
Used for
relieves occasional constipation this product generally produces bowel movement in 1 to 5 minutes
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 3Lab value / disease marker 6No 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 flags pairs whose reports are unusually skewed by sex or come mostly from consumers rather than clinicians. 105 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 |
|---|---|---|---|---|---|---|
| Appendicitis | 101 | 134.1 110.8–162.2ROR 142.4 · χ² 13,067 / p <1e-300 | 129.4 EB05 109.6 · IC025 +6.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 81.8 · ♀ 18% (drug 45%) · 98% clinician | no trial data cached |
| Ventricular fibrillation | 91 | 100.5 82.2–122.9ROR 106.1 · χ² 8,800 / p <1e-300 | 97.7 EB05 82.0 · IC025 +5.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 60.8 · ♀ 9% (drug 45%) · 97% clinician | no trial data cached |
| Cardiogenic shock | 107 | 92.2 76.7–110.9ROR 98.3 · χ² 9,496 / p <1e-300 | 90.1 EB05 76.6 · IC025 +5.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 55.6 · ♀ 21% (drug 45%) · 97% clinician | no trial data cached |
| Bacterial infection | 74 | 48.8 39.0–61.0ROR 51.0 · χ² 3,408 / p <1e-300 | 48.1 EB05 39.6 · IC025 +4.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 34.2 · 95% clinician | no trial data cached |
| Hyperlipidaemia | 46 | 47.0 35.3–62.6ROR 48.3 · χ² 2,019 / p <1e-300 | 46.0 EB05 35.9 · IC025 +4.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 31.4 · 96% clinician | no trial data cached |
| Ascites | 111 | 46.2 38.6–55.4ROR 49.4 · χ² 4,855 / p <1e-300 | 45.7 EB05 39.0 · IC025 +4.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 28.4 · ♀ 22% (drug 45%) · 95% clinician | no trial data cached |
| Multiple organ dysfunction syndrome | 105 | 46.1 38.3–55.5ROR 49.0 · χ² 4,576 / p <1e-300 | 45.6 EB05 38.7 · IC025 +4.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 27.9 · ♀ 12% (drug 45%) · 98% clinician | no trial data cached |
| Incorrect route of product administration | 63 | 45.9 36.0–58.5ROR 47.6 · χ² 2,716 / p <1e-300 | 45.2 EB05 36.6 · IC025 +4.7 3/3 methods agree | Reporting / coding artifact | serious PRR 55.6 · ♀ 11% (drug 45%) · 98% clinician | no trial data cached |
| Cytokine release syndrome | 57 | 36.6 28.4–47.3ROR 37.8 · χ² 1,935 / p <1e-300 | 36.1 EB05 28.9 · IC025 +4.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 22.5 · 98% clinician | no trial data cached |
| Blood test abnormal | 42 | 36.6 27.1–49.4ROR 37.5 · χ² 1,416 / p <1e-300 | 36.0 EB05 27.7 · IC025 +4.2 3/3 methods agree | Reporting / coding artifact | serious PRR 34.0 · 95% clinician | no trial data cached |
| End stage renal disease | 55 | 36.6 28.2–47.4ROR 37.7 · χ² 1,862 / p <1e-300 | 36.0 EB05 28.7 · IC025 +4.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 22.1 · 93% clinician | no trial data cached |
| Lymphocyte count decreased | 46 | 31.8 23.9–42.3ROR 32.7 · χ² 1,340 / p 1e-293 | 31.4 EB05 24.5 · IC025 +4.1 3/3 methods agree | Lab value / disease marker | serious PRR 23.1 · ♀ 18% (drug 45%) · 98% clinician | no trial data cached |
| Neuralgia | 62 | 31.3 24.5–40.0ROR 32.4 · χ² 1,785 / p <1e-300 | 30.9 EB05 25.0 · IC025 +4.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 28.2 · ♀ 19% (drug 45%) · 95% clinician | no trial data cached |
| Gout | 44 | 30.0 22.4–40.1ROR 30.7 · χ² 1,201 / p 2e-263 | 29.6 EB05 22.9 · IC025 +4.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 27.5 · 98% clinician | no trial data cached |
| Neutrophil count increased | 24 | 28.6 19.2–42.5ROR 29.0 · χ² 610 / p 6e-135 | 27.9 EB05 19.8 · IC025 +3.5 3/3 methods agree | Lab value / disease marker | serious PRR 19.1 · ♀ 17% (drug 45%) · 96% clinician | no trial data cached |
| Ulcer | 37 | 28.4 20.6–39.1ROR 29.0 · χ² 950 / p 8e-209 | 28.0 EB05 21.2 · IC025 +3.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 21.7 · 91% clinician | no trial data cached |
| Hyponatraemia (low sodium) | 116 | 25.2 21.2–30.1ROR 27.0 · χ² 2,678 / p <1e-300 | 25.1 EB05 21.5 · IC025 +4.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 15.7 · ♀ 16% (drug 45%) · 95% clinician | no trial data cached |
| Aspiration | 21 | 23.7 15.5–36.3ROR 24.0 · χ² 434 / p 1e-96 | 23.2 EB05 16.0 · IC025 +3.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 14.8 · ♀ 20% (drug 45%) · 100% clinician | no trial data cached |
| Blood urea increased | 32 | 23.2 16.5–32.8ROR 23.7 · χ² 658 / p 2e-145 | 22.9 EB05 17.0 · IC025 +3.5 3/3 methods agree | Lab value / disease marker | serious PRR 15.1 · 100% clinician | no trial data cached |
| Mucosal inflammation | 44 | 20.6 15.4–27.6ROR 21.2 · χ² 802 / p 8e-177 | 20.4 EB05 15.8 · IC025 +3.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 13.0 · 95% clinician | no trial data cached |
| Encephalopathy | 40 | 20.0 14.7–27.1ROR 20.4 · χ² 701 / p 8e-155 | 19.8 EB05 15.1 · IC025 +3.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 12.2 · ♀ 89% (drug 45%) · 98% clinician | no trial data cached |
| Blood cholesterol increased | 76 | 19.9 16.0–24.8ROR 20.8 · χ² 1,348 / p 3e-295 | 19.8 EB05 16.3 · IC025 +3.8 3/3 methods agree | Lab value / disease marker | serious PRR 18.1 · ♀ 25% (drug 45%) · 97% clinician | no trial data cached |
| Generalised oedema | 19 | 18.9 12.1–29.5ROR 19.1 · χ² 303 / p 3e-68 | 18.4 EB05 12.2 · IC025 +2.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 12.7 | no trial data cached |
| Febrile neutropenia | 96 | 17.7 14.6–21.5ROR 18.7 · χ² 1,500 / p <1e-300 | 17.6 EB05 14.9 · IC025 +3.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 10.8 · 99% clinician | no trial data cached |
| Full blood count abnormal | 15 | 17.4 10.5–28.8ROR 17.5 · χ² 215 / p 5e-49 | 16.7 EB05 10.2 · IC025 +2.6 3/3 methods agree | Lab value / disease marker | serious PRR 14.0 | no trial data cached |
| Sepsis (blood infection) | 153 | 16.8 14.4–19.5ROR 18.3 · χ² 2,260 / p <1e-300 | 16.7 EB05 14.6 · IC025 +3.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 10.2 · ♀ 21% (drug 45%) · 93% clinician | no trial data cached |
| Hypercholesterolaemia | 13 | 16.6 9.7–28.5ROR 16.7 · χ² 175 / p 3e-40 | 15.6 EB05 8.9 · IC025 +2.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 10.7 | no trial data cached |
| Stress | 96 | 16.3 13.4–19.8ROR 17.2 · χ² 1,367 / p 1e-299 | 16.2 EB05 13.7 · IC025 +3.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 16.3 · ♀ 8% (drug 45%) · 97% clinician | no trial data cached |
| Iron deficiency anaemia | 12 | 16.0 9.1–28.1ROR 16.1 · χ² 154 / p 1e-35 | 14.8 EB05 8.1 · IC025 +2.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 10.3 | no trial data cached |
| Chronic obstructive pulmonary disease | 66 | 15.5 12.2–19.6ROR 16.0 · χ² 880 / p 1e-193 | 15.3 EB05 12.4 · IC025 +3.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 11.0 · 95% clinician | no trial data cached |
| Hypoxia (low oxygen) | 44 | 15.3 11.5–20.5ROR 15.7 · χ² 575 / p 2e-127 | 15.1 EB05 11.6 · IC025 +3.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 9.5 · 95% clinician | no trial data cached |
| Clostridium difficile colitis | 13 | 15.0 8.7–25.7ROR 15.1 · χ² 156 / p 5e-36 | 13.8 EB05 7.8 · IC025 +2.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 9.3 | no trial data cached |
| Liver function test increased | 26 | 14.9 10.2–21.8ROR 15.1 · χ² 323 / p 1e-72 | 14.5 EB05 10.1 · IC025 +2.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 14.1 · 92% clinician | no trial data cached |
| Neurotoxicity | 21 | 14.8 9.7–22.6ROR 14.9 · χ² 256 / p 7e-58 | 14.2 EB05 9.4 · IC025 +2.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 9.1 · 90% clinician | no trial data cached |
| Blood creatinine increased | 79 | 14.8 11.9–18.3ROR 15.4 · χ² 1,001 / p 5e-220 | 14.6 EB05 12.1 · IC025 +3.4 3/3 methods agree | Lab value / disease marker | serious PRR 10.2 · 97% clinician | no trial data cached |
| Abdominal distension (bloating) | 125 | 14.7 12.4–17.4ROR 15.8 · χ² 1,587 / p <1e-300 | 14.6 EB05 12.6 · IC025 +3.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 15.6 · ♀ 24% (drug 45%) · 94% clinician | no trial data cached |
| Atelectasis | 11 | 13.9 7.7–25.0ROR 13.9 · χ² 119 / p 6e-28 | 12.2 EB05 6.4 · IC025 +2.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 8.5 | no trial data cached |
| Hypocalcaemia (low calcium) | 21 | 13.6 8.9–20.8ROR 13.7 · χ² 232 / p 9e-53 | 12.9 EB05 8.5 · IC025 +2.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 8.8 | no trial data cached |
| General physical health deterioration | 125 | 13.3 11.2–15.7ROR 14.3 · χ² 1,415 / p <1e-300 | 13.2 EB05 11.3 · IC025 +3.4 3/3 methods agree | Reporting / coding artifact | serious PRR 9.4 · ♀ 25% (drug 45%) · 94% clinician | no trial data cached |
| Oral candidiasis (oral thrush) | 14 | 13.1 7.8–22.2ROR 13.2 · χ² 145 / p 1e-33 | 11.9 EB05 6.8 · IC025 +2.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 11.2 | 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 |
|---|---|---|---|---|---|---|
| Constipation | 161 | 9.1 7.8–10.5ROR 9.9 · χ² 1,162 / p 6e-255 | 9.0 EB05 7.8 · IC025 +2.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 9.9 · 92% clinician | no trial data cached |
| Anaemia (low red blood cells) | 156 | 10.0 8.6–11.6ROR 10.9 · χ² 1,263 / p 7e-277 | 9.9 EB05 8.6 · IC025 +3.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 6.7 · 93% clinician | no trial data cached |
| Sepsis (blood infection) | 153 | 16.8 14.4–19.5ROR 18.3 · χ² 2,260 / p <1e-300 | 16.7 EB05 14.6 · IC025 +3.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 10.2 · ♀ 21% (drug 45%) · 93% clinician | no trial data cached |
| Abdominal pain | 143 | 7.5 6.4–8.8ROR 8.1 · χ² 809 / p 3e-178 | 7.4 EB05 6.4 · IC025 +2.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 6.0 · ♀ 22% (drug 45%) · 91% clinician | no trial data cached |
| General physical health deterioration | 125 | 13.3 11.2–15.7ROR 14.3 · χ² 1,415 / p <1e-300 | 13.2 EB05 11.3 · IC025 +3.4 3/3 methods agree | Reporting / coding artifact | serious PRR 9.4 · ♀ 25% (drug 45%) · 94% clinician | no trial data cached |
| Abdominal distension (bloating) | 125 | 14.7 12.4–17.4ROR 15.8 · χ² 1,587 / p <1e-300 | 14.6 EB05 12.6 · IC025 +3.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 15.6 · ♀ 24% (drug 45%) · 94% clinician | no trial data cached |
| Hyponatraemia (low sodium) | 116 | 25.2 21.2–30.1ROR 27.0 · χ² 2,678 / p <1e-300 | 25.1 EB05 21.5 · IC025 +4.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 15.7 · ♀ 16% (drug 45%) · 95% clinician | no trial data cached |
| Ascites | 111 | 46.2 38.6–55.4ROR 49.4 · χ² 4,855 / p <1e-300 | 45.7 EB05 39.0 · IC025 +4.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 28.4 · ♀ 22% (drug 45%) · 95% clinician | no trial data cached |
| Cardiogenic shock | 107 | 92.2 76.7–110.9ROR 98.3 · χ² 9,496 / p <1e-300 | 90.1 EB05 76.6 · IC025 +5.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 55.6 · ♀ 21% (drug 45%) · 97% clinician | no trial data cached |
| Multiple organ dysfunction syndrome | 105 | 46.1 38.3–55.5ROR 49.0 · χ² 4,576 / p <1e-300 | 45.6 EB05 38.7 · IC025 +4.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 27.9 · ♀ 12% (drug 45%) · 98% clinician | no trial data cached |
| Appendicitis | 101 | 134.1 110.8–162.2ROR 142.4 · χ² 13,067 / p <1e-300 | 129.4 EB05 109.6 · IC025 +6.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 81.8 · ♀ 18% (drug 45%) · 98% clinician | no trial data cached |
| Somnolence (drowsiness) | 97 | 5.9 4.9–7.1ROR 6.2 · χ² 393 / p 1e-87 | 5.7 EB05 4.8 · IC025 +2.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 5.9 · ♀ 22% (drug 45%) · 92% clinician | no trial data cached |
| Stress | 96 | 16.3 13.4–19.8ROR 17.2 · χ² 1,367 / p 1e-299 | 16.2 EB05 13.7 · IC025 +3.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 16.3 · ♀ 8% (drug 45%) · 97% clinician | no trial data cached |
| Febrile neutropenia | 96 | 17.7 14.6–21.5ROR 18.7 · χ² 1,500 / p <1e-300 | 17.6 EB05 14.9 · IC025 +3.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 10.8 · 99% clinician | no trial data cached |
| Ventricular fibrillation | 91 | 100.5 82.2–122.9ROR 106.1 · χ² 8,800 / p <1e-300 | 97.7 EB05 82.0 · IC025 +5.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 60.8 · ♀ 9% (drug 45%) · 97% clinician | 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 Sodium Phosphate?
In FDA FAERS, the most frequently co-reported reaction terms for Sodium Phosphate are constipation, anaemia, sepsis, abdominal pain, abdominal distension, hyponatraemia. 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 Phosphate have an FDA boxed warning?
No. The FDA label retrieved for Sodium Phosphate has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Sodium Phosphate 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 e3165538-75dd-4f0f-adc8-d4075de10f1e, effective 20241126; matched on
openfda.generic_name.exact:"SODIUM PHOSPHATE") - 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, 145 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.