Drug · FAERS side-effect profile with label screen
Calcium Acetate side effects: what 5,350 FDA adverse event reports show
Drug class
Phosphate binder
FDA label, Indications wording
Who reports
5,350 reports · 74% serious · 685 with death outcome · 52% female
openFDA FAERS counts, all years, deduplication not applied
Used for
Calcium acetate capsule is a phosphate binder indicated for the reduction of serum phosphorus in patients with end stage renal disease. ( 1 ) Calcium acetate capsule is a phosphate binder indicated to reduce serum phosphorus in patients with end stage renal disease (ESRD).
FDA label, Indications and Usage
What it is
Calcium acetate, USP acts as a phosphate binder.
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 2Likely indication confounding 2Reporting / coding artifact 1Lab value / disease marker 4Not in label — unassessed 31
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.
- 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. 298 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 |
|---|---|---|---|---|---|---|
| End stage renal disease | 436 | 94.9 86.7–104.0ROR 103.3 · χ² 39,496 / p <1e-300 | 92.3 EB05 85.3 · IC025 +6.2 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 72.2 | no trial data cached |
| Chronic kidney disease | 464 | 23.8 21.9–26.0ROR 26.0 · χ² 10,107 / p <1e-300 | 23.7 EB05 21.9 · IC025 +4.4 3/3 methods agree | Not in label — unassessed | serious PRR 18.8 | no trial data cached |
| Peritonitis bacterial | 49 | 19.1 14.5–25.3ROR 19.3 · χ² 821 / p 7e-181 | 18.9 EB05 14.9 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious PRR 14.6 | no trial data cached |
| Dialysis | 67 | 18.5 14.6–23.5ROR 18.7 · χ² 1,089 / p 4e-239 | 18.4 EB05 14.9 · IC025 +3.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 14.2 | no trial data cached |
| Hypercalcaemia | 55 | 17.5 13.5–22.8ROR 17.7 · χ² 838 / p 2e-184 | 17.3 EB05 13.8 · IC025 +3.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 13.8 · ♀ 73% (drug 52%) · 94% clinician | no trial data cached |
| Renal tubular necrosis | 43 | 17.2 12.8–23.2ROR 17.3 · χ² 637 / p 7e-141 | 17.0 EB05 13.1 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious PRR 13.4 | no trial data cached |
| Renal failure (kidney failure) | 484 | 14.2 13.1–15.5ROR 15.5 · χ² 5,949 / p <1e-300 | 14.2 EB05 13.1 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious PRR 11.1 | no trial data cached |
| Renal injury | 104 | 13.6 11.2–16.5ROR 13.9 · χ² 1,200 / p 3e-263 | 13.5 EB05 11.4 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious PRR 10.6 | no trial data cached |
| Nephropathy | 32 | 13.4 9.5–18.9ROR 13.5 · χ² 354 / p 3e-79 | 13.0 EB05 9.4 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious PRR 11.1 | no trial data cached |
| Hypocalcaemia (low calcium) | 63 | 13.1 10.3–16.8ROR 13.3 · χ² 691 / p 1e-152 | 12.9 EB05 10.4 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious PRR 10.1 | no trial data cached |
| Economic problem | 47 | 12.0 9.0–15.9ROR 12.1 · χ² 461 / p 2e-102 | 11.6 EB05 9.0 · IC025 +2.9 3/3 methods agree | Reporting / coding artifact | serious PRR 10.2 · ♀ 28% (drug 52%) | no trial data cached |
| Tubulointerstitial nephritis | 53 | 11.1 8.5–14.5ROR 11.2 · χ² 477 / p 6e-106 | 10.8 EB05 8.4 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious PRR 8.7 · 100% clinician | no trial data cached |
| Fluid overload | 39 | 10.4 7.6–14.2ROR 10.4 · χ² 320 / p 6e-72 | 9.9 EB05 7.4 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious PRR 9.1 | no trial data cached |
| Acute kidney injury (sudden kidney damage) | 378 | 9.7 8.8–10.7ROR 10.4 · χ² 2,970 / p <1e-300 | 9.7 EB05 8.9 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious PRR 7.6 | no trial data cached |
| Anhedonia | 65 | 9.6 7.6–12.3ROR 9.7 · χ² 494 / p 1e-109 | 9.3 EB05 7.5 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 8.3 · ♀ 29% (drug 52%) | no trial data cached |
| Hyperkalaemia (high potassium) | 82 | 9.2 7.4–11.4ROR 9.3 · χ² 592 / p 4e-131 | 8.9 EB05 7.4 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 7.3 | no trial data cached |
| Peritonitis | 48 | 9.1 6.9–12.1ROR 9.2 · χ² 337 / p 1e-75 | 8.6 EB05 6.7 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 6.9 | no trial data cached |
| Blood calcium decreased | 24 | 8.3 5.6–12.4ROR 8.4 · χ² 148 / p 3e-34 | 7.5 EB05 5.2 · IC025 +2.2 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 5.1 | no trial data cached |
| Blood potassium increased | 34 | 8.2 5.9–11.5ROR 8.3 · χ² 208 / p 2e-47 | 7.6 EB05 5.6 · IC025 +2.3 3/3 methods agree | Lab value / disease marker | serious PRR 6.1 | no trial data cached |
| Quality of life decreased | 27 | 7.9 5.4–11.5ROR 7.9 · χ² 155 / p 6e-36 | 7.1 EB05 5.1 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 7.6 · ♀ 26% (drug 52%) | no trial data cached |
| Arteriosclerosis | 18 | 7.5 4.7–11.9ROR 7.5 · χ² 95 / p 1e-22 | 6.5 EB05 4.3 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 6.0 | no trial data cached |
| Decreased activity | 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 | Not in label — unassessed | serious PRR 7.3 | no trial data cached |
| Blood urea increased | 25 | 5.8 3.9–8.6ROR 5.8 · χ² 95 / p 1e-22 | 5.3 EB05 3.8 · IC025 +1.7 3/3 methods agree | Lab value / disease marker | serious PRR 4.4 | no trial data cached |
| Flushing | 144 | 5.5 4.7–6.5ROR 5.7 · χ² 531 / p 7e-118 | 5.4 EB05 4.7 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 0.7 · ♀ 73% (drug 52%) · 92% consumer | no trial data cached |
| Atelectasis | 13 | 5.3 3.1–9.0ROR 5.3 · χ² 41 / p 9e-11 | 4.5 EB05 2.8 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 4.1 | no trial data cached |
| Mental status changes | 37 | 5.2 3.8–7.2ROR 5.2 · χ² 122 / p 1e-28 | 4.9 EB05 3.7 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 4.5 · ♀ 28% (drug 52%) · 91% clinician | no trial data cached |
| Deformity | 12 | 5.0 2.9–8.8ROR 5.0 · χ² 35 / p 2e-9 | 4.3 EB05 2.6 · IC025 +1.1 3/3 methods agree | Not in label — unassessed | serious PRR 4.5 | no trial data cached |
| Joint range of motion decreased | 17 | 5.0 3.1–8.0ROR 5.0 · χ² 50 / p 7e-13 | 4.4 EB05 2.9 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 4.7 | no trial data cached |
| Bacteraemia | 14 | 4.7 2.8–7.9ROR 4.7 · χ² 37 / p 7e-10 | 4.1 EB05 2.6 · IC025 +1.1 3/3 methods agree | Not in label — unassessed | serious PRR 3.7 | no trial data cached |
| Pulmonary oedema | 53 | 4.6 3.5–6.1ROR 4.7 · χ² 148 / p 3e-34 | 4.5 EB05 3.5 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 3.6 | no trial data cached |
| Electrolyte imbalance | 13 | 4.4 2.6–7.6ROR 4.4 · χ² 31 / p 1e-8 | 3.9 EB05 2.4 · IC025 +1.0 3/3 methods agree | Not in label — unassessed | serious PRR 3.6 | no trial data cached |
| Hyperlipidaemia | 13 | 4.3 2.5–7.3ROR 4.3 · χ² 29 / p 3e-8 | 3.7 EB05 2.4 · IC025 +1.0 3/3 methods agree | Not in label — unassessed | serious PRR 3.6 | no trial data cached |
| Fistula | 12 | 4.2 2.4–7.3ROR 4.2 · χ² 26 / p 2e-7 | 3.7 EB05 2.3 · IC025 +0.9 3/3 methods agree | Not in label — unassessed | serious PRR 3.1 | no trial data cached |
| Mitral valve incompetence | 12 | 4.2 2.4–7.3ROR 4.2 · χ² 26 / p 2e-7 | 3.6 EB05 2.3 · IC025 +0.9 3/3 methods agree | Not in label — unassessed | serious PRR 3.3 | no trial data cached |
| Ventricular extrasystoles | 11 | 4.1 2.3–7.5ROR 4.2 · χ² 23 / p 7e-7 | 3.6 EB05 2.2 · IC025 +0.8 3/3 methods agree | Not in label — unassessed | serious PRR 3.6 | no trial data cached |
| Blood creatinine increased | 69 | 4.1 3.3–5.2ROR 4.2 · χ² 161 / p 3e-37 | 4.0 EB05 3.3 · IC025 +1.6 3/3 methods agree | Lab value / disease marker | serious PRR 3.4 | no trial data cached |
| Scar | 18 | 4.1 2.6–6.5ROR 4.1 · χ² 39 / p 2e-10 | 3.8 EB05 2.5 · IC025 +1.1 3/3 methods agree | Not in label — unassessed | serious PRR 4.6 | no trial data cached |
| Haemoglobin decreased | 107 | 4.1 3.4–4.9ROR 4.1 · χ² 246 / p 9e-56 | 4.0 EB05 3.4 · IC025 +1.7 3/3 methods agree | Lab value / disease marker | serious PRR 3.3 | no trial data cached |
| Wrist fracture | 12 | 3.9 2.2–6.9ROR 3.9 · χ² 23 / p 7e-7 | 3.5 EB05 2.1 · IC025 +0.8 3/3 methods agree | Not in label — unassessed | serious PRR 3.6 | no trial data cached |
| Sepsis (blood infection) | 107 | 3.8 3.1–4.5ROR 3.8 · χ² 215 / p 7e-49 | 3.7 EB05 3.1 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 2.9 | 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 |
|---|---|---|---|---|---|---|
| Renal failure (kidney failure) | 484 | 14.2 13.1–15.5ROR 15.5 · χ² 5,949 / p <1e-300 | 14.2 EB05 13.1 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious PRR 11.1 | no trial data cached |
| Chronic kidney disease | 464 | 23.8 21.9–26.0ROR 26.0 · χ² 10,107 / p <1e-300 | 23.7 EB05 21.9 · IC025 +4.4 3/3 methods agree | Not in label — unassessed | serious PRR 18.8 | no trial data cached |
| End stage renal disease | 436 | 94.9 86.7–104.0ROR 103.3 · χ² 39,496 / p <1e-300 | 92.3 EB05 85.3 · IC025 +6.2 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 72.2 | no trial data cached |
| Acute kidney injury (sudden kidney damage) | 378 | 9.7 8.8–10.7ROR 10.4 · χ² 2,970 / p <1e-300 | 9.7 EB05 8.9 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious PRR 7.6 | no trial data cached |
| Diarrhoea (diarrhea) | 332 | 2.0 1.8–2.2ROR 2.1 · χ² 176 / p 2e-40 | 2.0 EB05 1.8 · IC025 +0.8 | Not in label — unassessed | serious PRR 1.3 | no trial data cached |
| Death | 243 | 1.1 1.0–1.2ROR 1.1 · χ² 2 / p 0.060 | 1.1 EB05 1.0 · IC025 -0.1 PRR-only: not supported by EBGM or IC | Outcome field, not a reaction | serious PRR 0.9 | no trial data cached |
| Pruritus (itching) | 168 | 1.7 1.5–2.0ROR 1.8 · χ² 53 / p 2e-13 | 1.7 EB05 1.5 · IC025 +0.5 | Labeled adverse reaction exact term | serious PRR 1.4 | no trial data cached |
| Anaemia (low red blood cells) | 153 | 3.1 2.7–3.7ROR 3.2 · χ² 223 / p 1e-50 | 3.1 EB05 2.7 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 2.5 | no trial data cached |
| Flushing | 144 | 5.5 4.7–6.5ROR 5.7 · χ² 531 / p 7e-118 | 5.4 EB05 4.7 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 0.7 · ♀ 73% (drug 52%) · 92% consumer | no trial data cached |
| Anxiety | 140 | 1.9 1.6–2.3ROR 1.9 · χ² 62 / p 2e-15 | 1.9 EB05 1.7 · IC025 +0.7 | Not in label — unassessed | serious PRR 2.0 | no trial data cached |
| Hypotension (low blood pressure) | 135 | 2.6 2.2–3.1ROR 2.7 · χ² 137 / p 6e-32 | 2.6 EB05 2.3 · IC025 +1.1 3/3 methods agree | Not in label — unassessed | serious PRR 2.2 | no trial data cached |
| Sepsis (blood infection) | 107 | 3.8 3.1–4.5ROR 3.8 · χ² 215 / p 7e-49 | 3.7 EB05 3.1 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 2.9 | no trial data cached |
| Haemoglobin decreased | 107 | 4.1 3.4–4.9ROR 4.1 · χ² 246 / p 9e-56 | 4.0 EB05 3.4 · IC025 +1.7 3/3 methods agree | Lab value / disease marker | serious PRR 3.3 | no trial data cached |
| Renal injury | 104 | 13.6 11.2–16.5ROR 13.9 · χ² 1,200 / p 3e-263 | 13.5 EB05 11.4 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious PRR 10.6 | no trial data cached |
| Emotional distress | 86 | 2.8 2.2–3.4ROR 2.8 · χ² 96 / p 5e-23 | 2.7 EB05 2.3 · IC025 +1.1 3/3 methods agree | Not in label — unassessed | serious PRR 2.4 | 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.
- Chronic kidney disease — n=464, PRR 23.8
- Peritonitis bacterial — n=49, PRR 19.1
- Renal tubular necrosis — n=43, PRR 17.2
- Renal failure — n=484, PRR 14.2
- Renal injury — n=104, PRR 13.6
- Nephropathy — n=32, PRR 13.4
- Hypocalcaemia — n=63, PRR 13.1
- Tubulointerstitial nephritis — n=53, PRR 11.1
- Fluid overload — n=39, PRR 10.4
- Acute kidney injury — n=378, PRR 9.7
✓ A hand-written Bradford Hill causality assessment exists for this drug: Medroxyprogesterone acetate ↔ Meningioma.
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 Calcium Acetate?
In FDA FAERS, the most frequently co-reported reaction terms for Calcium Acetate are renal failure, chronic kidney disease, end stage renal disease, acute kidney injury, diarrhoea, pruritus. 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 Calcium Acetate have an FDA boxed warning?
No. The FDA label retrieved for Calcium Acetate has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Calcium Acetate 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 35a6f515-dfe7-031c-e063-6294a90a5e95, effective 20250604; matched on
openfda.generic_name.exact:"CALCIUM ACETATE") - 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, 338 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.