Drug · FAERS side-effect profile with label screen
Sevelamer Carbonate side effects: what 11,417 FDA adverse event reports show
Drug class
Not stated in label
Who reports
11,417 reports · 49% serious · 1,217 with death outcome · 48% female
openFDA FAERS counts, all years, deduplication not applied
Used for
Sevelamer carbonate tablets are indicated for the control of serum phosphorus in adults and children 6 years of age and older with chronic kidney disease (CKD) on dialysis. Sevelamer carbonate tablets are phosphate binder indicated for the control of serum phosphorus in adults and children 6 years of age and older with chronic kidney disease on dialysis. ( 1 )
FDA label, Indications and Usage
What it is
The active ingredient in sevelamer carbonate tablets is sevelamer carbonate, a polymeric amine that binds phosphate and is meant for oral administration. It was developed as a pharmaceutical alternative to sevelamer hydrochloride (Renagel ® ).
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 1Likely indication confounding 4Reporting / coding artifact 2Lab value / disease marker 6Not 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.
- 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. 967 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 |
|---|---|---|---|---|---|---|
| Crystal deposit intestine | 49 | 537.7 391.1–739.2ROR 540.0 · χ² 19,826 / p <1e-300 | 356.9 EB05 280.6 · IC025 +5.8 3/3 methods agree | Not in label — unassessed | serious n=48 · 98% clinician | no trial data cached |
| Ventricular hyperkinesia | 13 | 309.7 172.0–557.5ROR 310.0 · χ² 3,157 / p <1e-300 | 190.9 EB05 118.7 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious n=13 | no trial data cached |
| Chronic kidney disease-mineral and bone disorder | 86 | 159.5 128.1–198.7ROR 160.7 · χ² 12,306 / p <1e-300 | 142.1 EB05 118.6 · IC025 +6.0 3/3 methods agree | Not in label — unassessed | serious n=86 | no trial data cached |
| Hyperphosphataemia | 169 | 159.1 136.1–186.0ROR 161.5 · χ² 24,265 / p <1e-300 | 144.0 EB05 126.7 · IC025 +6.4 3/3 methods agree | Not in label — unassessed | serious n=57 | no trial data cached |
| Hyperparathyroidism secondary | 182 | 142.2 122.4–165.2ROR 144.5 · χ² 23,534 / p <1e-300 | 130.2 EB05 115.0 · IC025 +6.4 3/3 methods agree | Not in label — unassessed | serious n=182 | no trial data cached |
| Right atrial enlargement | 13 | 132.2 75.3–232.1ROR 132.4 · χ² 1,458 / p <1e-300 | 104.8 EB05 65.2 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious n=13 | no trial data cached |
| Hypochromasia | 13 | 129.3 73.7–226.9ROR 129.5 · χ² 1,427 / p <1e-300 | 102.9 EB05 64.0 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious n=13 | no trial data cached |
| Nephrogenic anaemia | 297 | 124.6 110.9–139.9ROR 127.9 · χ² 33,951 / p <1e-300 | 115.8 EB05 105.1 · IC025 +6.4 3/3 methods agree | Not in label — unassessed | serious n=297 | no trial data cached |
| Arteriovenous fistula site haemorrhage | 11 | 115.1 62.6–211.7ROR 115.2 · χ² 1,065 / p 6e-234 | 91.6 EB05 54.6 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious n=11 | no trial data cached |
| Left ventricular enlargement | 13 | 99.3 56.8–173.5ROR 99.4 · χ² 1,108 / p 3e-243 | 83.1 EB05 51.7 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious n=13 | no trial data cached |
| Mitral valve thickening | 13 | 90.2 51.7–157.3ROR 90.3 · χ² 1,009 / p 1e-221 | 76.6 EB05 47.7 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious n=13 | no trial data cached |
| Blood phosphorus abnormal | 18 | 73.9 46.1–118.3ROR 74.0 · χ² 1,175 / p 1e-257 | 66.3 EB05 44.3 · IC025 +3.8 3/3 methods agree | Likely indication confounding term in indications | serious n=6 | no trial data cached |
| End stage renal disease | 672 | 69.5 64.5–74.9ROR 73.8 · χ² 43,664 / p <1e-300 | 66.8 EB05 62.7 · IC025 +5.9 3/3 methods agree | Not in label — unassessed | serious PRR 78.5 | no trial data cached |
| Dialysis related complication | 11 | 58.2 32.0–106.1ROR 58.3 · χ² 545 / p 7e-121 | 51.7 EB05 30.8 · IC025 +3.0 3/3 methods agree | Reporting / coding artifact | serious n=9 | no trial data cached |
| Arteriovenous fistula thrombosis | 10 | 54.2 28.9–101.7ROR 54.3 · χ² 457 / p 1e-101 | 48.1 EB05 27.9 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious n=10 | no trial data cached |
| Blood phosphorus increased | 74 | 51.2 40.7–64.5ROR 51.5 · χ² 3,495 / p <1e-300 | 49.2 EB05 40.5 · IC025 +4.8 3/3 methods agree | Likely indication confounding term in indications | serious n=41 | no trial data cached |
| Left atrial enlargement | 14 | 49.5 29.1–84.2ROR 49.6 · χ² 601 / p 4e-133 | 45.4 EB05 28.8 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious n=14 | no trial data cached |
| Rebound acid hypersecretion | 70 | 42.9 33.8–54.3ROR 43.1 · χ² 2,755 / p <1e-300 | 41.5 EB05 33.9 · IC025 +4.6 3/3 methods agree | Not in label — unassessed | serious n=70 | no trial data cached |
| Mean platelet volume increased | 13 | 40.9 23.6–70.9ROR 41.0 · χ² 457 / p 1e-101 | 38.0 EB05 23.6 · IC025 +3.1 3/3 methods agree | Lab value / disease marker | serious n=13 | no trial data cached |
| Blood parathyroid hormone abnormal | 12 | 35.1 19.8–62.1ROR 35.1 · χ² 357 / p 6e-80 | 32.8 EB05 20.0 · IC025 +2.9 3/3 methods agree | Lab value / disease marker | serious n=4 | no trial data cached |
| Gastrointestinal mucosal disorder | 12 | 34.8 19.6–61.5ROR 34.8 · χ² 354 / p 3e-79 | 32.5 EB05 19.8 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious n=12 | no trial data cached |
| Rectal ulcer | 15 | 23.7 14.3–39.5ROR 23.7 · χ² 300 / p 2e-67 | 22.8 EB05 14.5 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious n=15 | no trial data cached |
| Constipation | 2,547 | 21.9 21.1–22.6ROR 27.8 · χ² 50,582 / p <1e-300 | 21.6 EB05 20.9 · IC025 +4.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.3 · 93% clinician | no trial data cached |
| Oral administration complication | 11 | 21.7 12.0–39.4ROR 21.8 · χ² 195 / p 1e-44 | 20.5 EB05 11.7 · IC025 +2.5 3/3 methods agree | Reporting / coding artifact | serious n=6 | no trial data cached |
| Large intestinal ulcer | 30 | 20.6 14.4–29.5ROR 20.6 · χ² 534 / p 2e-118 | 20.1 EB05 14.7 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious n=30 · 100% clinician | no trial data cached |
| Mucosal ulceration | 11 | 20.2 11.2–36.7ROR 20.3 · χ² 180 / p 2e-41 | 19.0 EB05 10.6 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious n=11 | no trial data cached |
| Renal transplant | 36 | 18.5 13.3–25.6ROR 18.5 · χ² 572 / p 1e-126 | 18.1 EB05 13.6 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious n=34 | no trial data cached |
| Blood parathyroid hormone increased | 29 | 18.4 12.8–26.5ROR 18.4 · χ² 455 / p 3e-101 | 18.0 EB05 13.0 · IC025 +3.2 3/3 methods agree | Lab value / disease marker | serious n=17 | no trial data cached |
| Calciphylaxis | 18 | 18.2 11.5–29.0ROR 18.3 · χ² 273 / p 1e-61 | 17.6 EB05 11.4 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious n=18 | no trial data cached |
| Hypervolaemia | 44 | 17.0 12.6–22.8ROR 17.0 · χ² 640 / p 2e-141 | 16.7 EB05 12.9 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious n=44 | no trial data cached |
| Blood calcium abnormal | 15 | 16.8 10.1–27.9ROR 16.8 · χ² 205 / p 8e-47 | 15.9 EB05 9.6 · IC025 +2.6 3/3 methods agree | Lab value / disease marker | serious n=12 | no trial data cached |
| Hypertensive heart disease | 17 | 16.7 10.4–26.9ROR 16.7 · χ² 234 / p 5e-53 | 16.0 EB05 10.1 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious n=17 | no trial data cached |
| Chronic kidney disease | 676 | 16.3 15.2–17.6ROR 17.3 · χ² 9,659 / p <1e-300 | 16.2 EB05 15.2 · IC025 +3.9 3/3 methods agree | Likely indication confounding term in indications | serious PRR 19.3 | no trial data cached |
| Dialysis | 125 | 16.3 13.7–19.4ROR 16.4 · χ² 1,761 / p <1e-300 | 16.1 EB05 13.8 · IC025 +3.6 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 18.1 | no trial data cached |
| Peritonitis bacterial | 82 | 15.1 12.1–18.7ROR 15.2 · χ² 1,055 / p 1e-231 | 14.9 EB05 12.3 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious PRR 17.4 · 94% clinician | no trial data cached |
| Nephrogenic systemic fibrosis | 24 | 14.5 9.7–21.7ROR 14.5 · χ² 286 / p 2e-64 | 13.9 EB05 9.5 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious n=24 | no trial data cached |
| Blood chloride increased | 13 | 13.9 8.1–24.1ROR 14.0 · χ² 142 / p 4e-33 | 12.6 EB05 7.0 · IC025 +2.3 3/3 methods agree | Lab value / disease marker | serious n=13 | no trial data cached |
| Skin induration | 15 | 13.4 8.1–22.3ROR 13.4 · χ² 159 / p 9e-37 | 12.3 EB05 7.2 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious n=15 | no trial data cached |
| Azotaemia | 27 | 12.4 8.5–18.2ROR 12.5 · χ² 271 / p 4e-61 | 11.8 EB05 8.2 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious n=26 | no trial data cached |
| Serum ferritin increased | 35 | 12.3 8.8–17.2ROR 12.3 · χ² 350 / p 2e-78 | 11.8 EB05 8.7 · IC025 +2.8 3/3 methods agree | Lab value / disease marker | serious n=28 · ♀ 27% (drug 48%) · 91% clinician | 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 | 2,547 | 21.9 21.1–22.6ROR 27.8 · χ² 50,582 / p <1e-300 | 21.6 EB05 20.9 · IC025 +4.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.3 · 93% clinician | no trial data cached |
| Diarrhoea (diarrhea) | 1,045 | 3.0 2.8–3.2ROR 3.2 · χ² 1,419 / p <1e-300 | 3.0 EB05 2.8 · IC025 +1.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 1.2 | no trial data cached |
| Pruritus (itching) | 1,009 | 4.9 4.6–5.2ROR 5.3 · χ² 3,188 / p <1e-300 | 4.9 EB05 4.6 · IC025 +2.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 1.3 · 93% clinician | no trial data cached |
| Nausea | 816 | 1.9 1.8–2.0ROR 2.0 · χ² 360 / p 1e-80 | 1.9 EB05 1.8 · IC025 +0.8 | Labeled adverse reaction exact term | serious PRR 1.3 | no trial data cached |
| Chronic kidney disease | 676 | 16.3 15.2–17.6ROR 17.3 · χ² 9,659 / p <1e-300 | 16.2 EB05 15.2 · IC025 +3.9 3/3 methods agree | Likely indication confounding term in indications | serious PRR 19.3 | no trial data cached |
| End stage renal disease | 672 | 69.5 64.5–74.9ROR 73.8 · χ² 43,664 / p <1e-300 | 66.8 EB05 62.7 · IC025 +5.9 3/3 methods agree | Not in label — unassessed | serious PRR 78.5 | no trial data cached |
| Renal failure (kidney failure) | 664 | 9.2 8.5–9.9ROR 9.7 · χ² 4,820 / p <1e-300 | 9.1 EB05 8.5 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious PRR 10.8 | no trial data cached |
| Death | 624 | 1.3 1.2–1.4ROR 1.3 · χ² 53 / p 2e-13 | 1.3 EB05 1.2 · IC025 +0.3 | Outcome field, not a reaction | serious PRR 1.6 | no trial data cached |
| Vomiting | 529 | 2.1 1.9–2.3ROR 2.1 · χ² 299 / p 3e-67 | 2.1 EB05 1.9 · IC025 +0.9 | Labeled adverse reaction exact term | serious PRR 1.3 | no trial data cached |
| Acute kidney injury (sudden kidney damage) | 514 | 6.2 5.7–6.8ROR 6.5 · χ² 2,252 / p <1e-300 | 6.2 EB05 5.7 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 7.3 | no trial data cached |
| Abdominal pain | 306 | 2.4 2.2–2.7ROR 2.5 · χ² 256 / p 8e-58 | 2.4 EB05 2.2 · IC025 +1.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 1.9 | no trial data cached |
| Nephrogenic anaemia | 297 | 124.6 110.9–139.9ROR 127.9 · χ² 33,951 / p <1e-300 | 115.8 EB05 105.1 · IC025 +6.4 3/3 methods agree | Not in label — unassessed | serious n=297 | no trial data cached |
| Dyspnoea (shortness of breath) | 292 | 0.9 0.8–1.1ROR 0.9 · χ² 1 / p 0.184 | 0.9 EB05 0.9 · IC025 -0.3 PRR-only: not supported by EBGM or IC | Not in label — unassessed | serious PRR 1.4 | no trial data cached |
| Fatigue (tiredness) | 264 | 0.6 0.6–0.7ROR 0.6 · χ² 62 / p 2e-15 | 0.6 EB05 0.6 · IC025 -0.9 PRR-only: not supported by EBGM or IC | Not in label — unassessed | serious PRR 1.1 | no trial data cached |
| Flatulence (gas) | 251 | 8.2 7.2–9.2ROR 8.3 · χ² 1,570 / p <1e-300 | 8.1 EB05 7.2 · IC025 +2.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 1.1 | 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.
- Crystal deposit intestine — n=49, PRR 537.7
- Chronic kidney disease-mineral and bone disorder — n=86, PRR 159.5
- Hyperphosphataemia — n=169, PRR 159.1
- Hyperparathyroidism secondary — n=182, PRR 142.2
- Nephrogenic anaemia — n=297, PRR 124.6
- End stage renal disease — n=672, PRR 69.5
- Rebound acid hypersecretion — n=70, PRR 42.9
- Large intestinal ulcer — n=30, PRR 20.6
- Renal transplant — n=36, PRR 18.5
- Hypervolaemia — n=44, PRR 17.0
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 Sevelamer Carbonate?
In FDA FAERS, the most frequently co-reported reaction terms for Sevelamer Carbonate are constipation, diarrhoea, pruritus, nausea, chronic kidney disease, end stage renal disease. 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 Sevelamer Carbonate have an FDA boxed warning?
No. The FDA label retrieved for Sevelamer Carbonate has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Sevelamer Carbonate 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 05b076d9-6516-4538-8e05-9709a677ed2f, effective 20240821; matched on
openfda.generic_name.exact:"SEVELAMER CARBONATE") - 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, 1,007 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.