Lanthanum Carbonate side effects: what 5,090 FDA adverse event reports show

Lanthanum Carbonate · 243 reaction terms · 14,443 drug–reaction co-reports · data 2026-09-14

Drug class

Phosphate binder

FDA label, Indications wording

Who reports

5,090 reports · 90% serious · 1,590 with death outcome · 35% female

openFDA FAERS counts, all years, deduplication not applied

Used for

Lanthanum carbonate chewable tablet is a phosphate binder indicated to reduce serum phosphate in patients with end-stage renal disease (ESRD). Management of elevated serum phosphorus levels in patients with ESRD usually includes all of the following: reduction in dietary intake of phosphate, removal of phosphate by dialysis, and reduction of intestinal phosphate absorption with phosphate binders.

FDA label, Indications and Usage

What it is

Lanthanum carbonate chewable tablet contains lanthanum carbonate dihydrate with molecular formula La 2 (CO 3 ) 3 .2H 2 O and molecular weight 457.8 (anhydrous mass). Lanthanum carbonate is described as white to off-white powder.

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 3Labeled (related wording) 1Likely indication confounding 2Reporting / coding artifact 3Lab value / disease marker 3Outcome field, not a reaction 1Not 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.
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.
Outcome field, not a reaction Death is a report outcome, not a reaction term. It is dominated by the underlying illness; see the seriousness profile and the boxed warning instead.
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. 203 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.

Show: hide coding/lab/outcome terms hide indication terms unlabeled only hide PRR-only

Reaction	Reports	PRR 95% CI · ROR · χ²/p	EBGM EB05 · IC025	Label screen	Serious-only & strata	Trial cross-check
Appendicitis	270	123.2 109.5–138.7ROR 130.1 · χ² 31,670 / p <1e-300	118.7 EB05 107.2 · IC025 +6.4 3/3 methods agree	Not in label — unassessed	serious PRR 77.9 · ♀ 4% (drug 35%) · 96% clinician	no trial data cached
Ventricular fibrillation	246	93.0 82.2–105.3ROR 97.7 · χ² 21,819 / p <1e-300	90.4 EB05 81.3 · IC025 +6.1 3/3 methods agree	Not in label — unassessed	serious PRR 58.5 · ♀ 4% (drug 35%) · 95% clinician	no trial data cached
Cardiogenic shock	259	76.1 67.5–85.8ROR 80.2 · χ² 18,794 / p <1e-300	74.4 EB05 67.1 · IC025 +5.8 3/3 methods agree	Not in label — unassessed	serious PRR 48.0 · ♀ 3% (drug 35%) · 96% clinician	no trial data cached
Multiple organ dysfunction syndrome	285	42.5 37.9–47.6ROR 45.0 · χ² 11,404 / p <1e-300	42.0 EB05 38.0 · IC025 +5.1 3/3 methods agree	Not in label — unassessed	serious PRR 27.0 · ♀ 3% (drug 35%) · 96% clinician	no trial data cached
End stage renal disease	178	40.2 34.8–46.5ROR 41.6 · χ² 6,703 / p <1e-300	39.7 EB05 35.0 · IC025 +4.9 3/3 methods agree	Likely indication confounding term in indications	serious PRR 25.5	no trial data cached
Ascites	280	39.6 35.3–44.4ROR 41.8 · χ² 10,405 / p <1e-300	39.1 EB05 35.4 · IC025 +5.0 3/3 methods agree	Not in label — unassessed	serious PRR 25.5 · ♀ 4% (drug 35%) · 95% clinician	no trial data cached
Incorrect route of product administration	156	38.6 33.0–45.1ROR 39.8 · χ² 5,626 / p <1e-300	38.1 EB05 33.3 · IC025 +4.8 3/3 methods agree	Reporting / coding artifact	serious PRR 49.1 · ♀ 7% (drug 35%) · 97% clinician	no trial data cached
Hyperlipidaemia	102	35.4 29.1–42.9ROR 36.1 · χ² 3,343 / p <1e-300	34.8 EB05 29.5 · IC025 +4.6 3/3 methods agree	Not in label — unassessed	serious PRR 24.8 · ♀ 10% (drug 35%) · 96% clinician	no trial data cached
Bacterial infection	157	35.1 30.1–41.0ROR 36.2 · χ² 5,130 / p <1e-300	34.7 EB05 30.4 · IC025 +4.7 3/3 methods agree	Not in label — unassessed	serious PRR 25.8 · ♀ 10% (drug 35%) · 95% clinician	no trial data cached
Aspiration	79	30.3 24.3–37.7ROR 30.7 · χ² 2,190 / p <1e-300	29.8 EB05 24.7 · IC025 +4.3 3/3 methods agree	Not in label — unassessed	serious PRR 19.8 · ♀ 12% (drug 35%)	no trial data cached
Ulcer	105	27.3 22.6–33.0ROR 27.9 · χ² 2,621 / p <1e-300	27.0 EB05 23.0 · IC025 +4.3 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 21.8 · ♀ 9% (drug 35%) · 93% clinician	no trial data cached
Neuralgia	150	25.6 21.9–30.0ROR 26.4 · χ² 3,508 / p <1e-300	25.4 EB05 22.2 · IC025 +4.3 3/3 methods agree	Not in label — unassessed	serious PRR 24.3 · ♀ 5% (drug 35%) · 95% clinician	no trial data cached
Gout	100	23.1 19.0–28.0ROR 23.5 · χ² 2,078 / p <1e-300	22.8 EB05 19.3 · IC025 +4.0 3/3 methods agree	Not in label — unassessed	serious PRR 22.3 · ♀ 7% (drug 35%) · 97% clinician	no trial data cached
Hyponatraemia (low sodium)	295	21.7 19.4–24.3ROR 23.0 · χ² 5,798 / p <1e-300	21.6 EB05 19.6 · IC025 +4.2 3/3 methods agree	Not in label — unassessed	serious PRR 14.2 · ♀ 3% (drug 35%) · 96% clinician	no trial data cached
Blood test abnormal	71	20.9 16.6–26.4ROR 21.2 · χ² 1,322 / p 1e-289	20.7 EB05 17.0 · IC025 +3.8 3/3 methods agree	Reporting / coding artifact	serious PRR 20.5 · ♀ 11% (drug 35%) · 94% clinician	no trial data cached
Peritonitis	99	19.8 16.3–24.1ROR 20.2 · χ² 1,740 / p <1e-300	19.6 EB05 16.6 · IC025 +3.8 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 12.7	no trial data cached
Hypercholesterolaemia	45	19.5 14.5–26.0ROR 19.6 · χ² 766 / p 5e-169	19.2 EB05 14.9 · IC025 +3.5 3/3 methods agree	Not in label — unassessed	serious PRR 13.2 · ♀ 5% (drug 35%) · 91% clinician	no trial data cached
Full blood count abnormal	47	18.4 13.9–24.5ROR 18.6 · χ² 755 / p 2e-166	18.2 EB05 14.2 · IC025 +3.5 3/3 methods agree	Lab value / disease marker	serious PRR 15.7 · ♀ 0% (drug 35%) · 96% clinician	no trial data cached
Ileus	53	17.8 13.6–23.3ROR 18.0 · χ² 821 / p 6e-181	17.6 EB05 14.0 · IC025 +3.5 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 11.5	no trial data cached
Micturition urgency	46	16.8 12.6–22.4ROR 16.9 · χ² 664 / p 8e-147	16.6 EB05 12.9 · IC025 +3.3 3/3 methods agree	Not in label — unassessed	serious PRR 17.8 · ♀ 0% (drug 35%) · 93% clinician	no trial data cached
Stress	281	16.2 14.4–18.1ROR 17.0 · χ² 3,978 / p <1e-300	16.1 EB05 14.6 · IC025 +3.8 3/3 methods agree	Not in label — unassessed	serious PRR 17.1 · ♀ 4% (drug 35%) · 95% clinician	no trial data cached
Sepsis (blood infection)	368	13.6 12.3–15.0ROR 14.6 · χ² 4,302 / p <1e-300	13.6 EB05 12.4 · IC025 +3.6 3/3 methods agree	Not in label — unassessed	serious PRR 8.8 · ♀ 14% (drug 35%) · 93% clinician	no trial data cached
Hypocalcaemia (low calcium)	62	13.6 10.6–17.4ROR 13.7 · χ² 708 / p 3e-156	13.4 EB05 10.7 · IC025 +3.2 3/3 methods agree	Not in label — unassessed	serious PRR 9.1 · 97% clinician	no trial data cached
Peritonitis bacterial	33	13.5 9.6–19.0ROR 13.6 · χ² 370 / p 1e-82	13.2 EB05 9.6 · IC025 +2.9 3/3 methods agree	Not in label — unassessed	serious PRR 8.7 · 91% clinician	no trial data cached
Chronic obstructive pulmonary disease	160	12.7 10.9–14.8ROR 13.1 · χ² 1,708 / p <1e-300	12.6 EB05 11.0 · IC025 +3.3 3/3 methods agree	Not in label — unassessed	serious PRR 9.5 · ♀ 9% (drug 35%) · 93% clinician	no trial data cached
Dialysis	43	12.5 9.3–16.8ROR 12.6 · χ² 442 / p 2e-98	12.1 EB05 9.2 · IC025 +3.0 3/3 methods agree	Likely indication confounding term in indications	serious PRR 8.2	no trial data cached
Blood cholesterol increased	140	12.4 10.5–14.6ROR 12.7 · χ² 1,455 / p <1e-300	12.3 EB05 10.6 · IC025 +3.3 3/3 methods agree	Lab value / disease marker	serious PRR 12.0 · ♀ 7% (drug 35%) · 96% clinician	no trial data cached
Abdominal distension (bloating)	309	12.3 11.0–13.7ROR 13.0 · χ² 3,196 / p <1e-300	12.2 EB05 11.1 · IC025 +3.4 3/3 methods agree	Not in label — unassessed	serious PRR 13.5 · ♀ 6% (drug 35%) · 93% clinician	no trial data cached
General physical health deterioration	334	12.0 10.8–13.3ROR 12.8 · χ² 3,368 / p <1e-300	11.9 EB05 10.9 · IC025 +3.4 3/3 methods agree	Reporting / coding artifact	serious PRR 9.0 · ♀ 12% (drug 35%) · 93% clinician	no trial data cached
Transaminases increased	60	11.2 8.7–14.3ROR 11.3 · χ² 544 / p 2e-120	10.9 EB05 8.6 · IC025 +2.9 3/3 methods agree	Labeled (related wording) related wording	serious PRR 7.6	no trial data cached
Coronary artery disease	74	10.0 8.0–12.6ROR 10.1 · χ² 591 / p 9e-131	9.7 EB05 7.9 · IC025 +2.9 3/3 methods agree	Not in label — unassessed	serious PRR 6.5 · ♀ 11% (drug 35%) · 93% clinician	no trial data cached
Prescribed overdose	45	9.6 7.2–12.8ROR 9.7 · χ² 338 / p 1e-75	9.1 EB05 7.0 · IC025 +2.6 3/3 methods agree	Not in label — unassessed	serious PRR 8.4	no trial data cached
Joint injury	48	9.3 7.0–12.3ROR 9.3 · χ² 345 / p 2e-77	8.8 EB05 6.8 · IC025 +2.6 3/3 methods agree	Not in label — unassessed	serious PRR 7.7 · ♀ 5% (drug 35%) · 94% clinician	no trial data cached
Sudden death	24	9.3 6.2–13.8ROR 9.3 · χ² 168 / p 8e-39	8.4 EB05 5.7 · IC025 +2.3 3/3 methods agree	Outcome field, not a reaction	serious PRR 5.9 · 96% clinician	no trial data cached
Cerebral infarction	54	9.1 7.0–11.9ROR 9.2 · χ² 382 / p 3e-85	8.7 EB05 6.9 · IC025 +2.6 3/3 methods agree	Not in label — unassessed	serious PRR 5.8	no trial data cached
Joint range of motion decreased	29	9.0 6.2–12.9ROR 9.0 · χ² 197 / p 5e-45	8.2 EB05 5.9 · IC025 +2.4 3/3 methods agree	Not in label — unassessed	serious PRR 7.1 · ♀ 59% (drug 35%)	no trial data cached
Blood calcium decreased	24	8.8 5.9–13.1ROR 8.8 · χ² 157 / p 2e-36	7.9 EB05 5.4 · IC025 +2.2 3/3 methods agree	Lab value / disease marker	serious PRR 5.6	no trial data cached
Cardiovascular disorder	54	8.7 6.7–11.4ROR 8.8 · χ² 361 / p 1e-80	8.3 EB05 6.5 · IC025 +2.6 3/3 methods agree	Not in label — unassessed	serious PRR 6.0 · ♀ 9% (drug 35%) · 92% clinician	no trial data cached
Diabetes mellitus	158	8.5 7.3–9.9ROR 8.8 · χ² 1,042 / p 6e-229	8.4 EB05 7.3 · IC025 +2.8 3/3 methods agree	Not in label — unassessed	serious PRR 5.9 · ♀ 5% (drug 35%) · 97% clinician	no trial data cached
Dry mouth	165	8.4 7.2–9.8ROR 8.7 · χ² 1,072 / p 3e-235	8.3 EB05 7.2 · IC025 +2.8 3/3 methods agree	Not in label — unassessed	serious PRR 10.7 · ♀ 5% (drug 35%) · 95% 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
Death	673	3.2 3.0–3.5ROR 3.6 · χ² 1,072 / p 2e-235	3.2 EB05 3.0 · IC025 +1.6 3/3 methods agree	Outcome field, not a reaction	serious PRR 2.1	no trial data cached
Nausea	493	2.6 2.4–2.8ROR 2.7 · χ² 492 / p 3e-109	2.6 EB05 2.4 · IC025 +1.2 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 2.9	no trial data cached
Vomiting	480	4.2 3.9–4.6ROR 4.6 · χ² 1,202 / p 1e-263	4.2 EB05 3.9 · IC025 +1.9 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 3.7	no trial data cached
Constipation	377	7.2 6.5–7.9ROR 7.7 · χ² 2,019 / p <1e-300	7.1 EB05 6.5 · IC025 +2.7 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 7.7 · ♀ 13% (drug 35%)	no trial data cached
Sepsis (blood infection)	368	13.6 12.3–15.0ROR 14.6 · χ² 4,302 / p <1e-300	13.6 EB05 12.4 · IC025 +3.6 3/3 methods agree	Not in label — unassessed	serious PRR 8.8 · ♀ 14% (drug 35%) · 93% clinician	no trial data cached
Abdominal pain	365	6.5 5.9–7.2ROR 6.9 · χ² 1,701 / p <1e-300	6.4 EB05 5.9 · IC025 +2.5 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 5.3 · 90% clinician	no trial data cached
General physical health deterioration	334	12.0 10.8–13.3ROR 12.8 · χ² 3,368 / p <1e-300	11.9 EB05 10.9 · IC025 +3.4 3/3 methods agree	Reporting / coding artifact	serious PRR 9.0 · ♀ 12% (drug 35%) · 93% clinician	no trial data cached
Abdominal distension (bloating)	309	12.3 11.0–13.7ROR 13.0 · χ² 3,196 / p <1e-300	12.2 EB05 11.1 · IC025 +3.4 3/3 methods agree	Not in label — unassessed	serious PRR 13.5 · ♀ 6% (drug 35%) · 93% clinician	no trial data cached
Hyponatraemia (low sodium)	295	21.7 19.4–24.3ROR 23.0 · χ² 5,798 / p <1e-300	21.6 EB05 19.6 · IC025 +4.2 3/3 methods agree	Not in label — unassessed	serious PRR 14.2 · ♀ 3% (drug 35%) · 96% clinician	no trial data cached
Multiple organ dysfunction syndrome	285	42.5 37.9–47.6ROR 45.0 · χ² 11,404 / p <1e-300	42.0 EB05 38.0 · IC025 +5.1 3/3 methods agree	Not in label — unassessed	serious PRR 27.0 · ♀ 3% (drug 35%) · 96% clinician	no trial data cached
Anaemia (low red blood cells)	282	6.1 5.4–6.8ROR 6.4 · χ² 1,205 / p 2e-264	6.0 EB05 5.5 · IC025 +2.4 3/3 methods agree	Not in label — unassessed	serious PRR 4.3 · 90% clinician	no trial data cached
Stress	281	16.2 14.4–18.1ROR 17.0 · χ² 3,978 / p <1e-300	16.1 EB05 14.6 · IC025 +3.8 3/3 methods agree	Not in label — unassessed	serious PRR 17.1 · ♀ 4% (drug 35%) · 95% clinician	no trial data cached
Ascites	280	39.6 35.3–44.4ROR 41.8 · χ² 10,405 / p <1e-300	39.1 EB05 35.4 · IC025 +5.0 3/3 methods agree	Not in label — unassessed	serious PRR 25.5 · ♀ 4% (drug 35%) · 95% clinician	no trial data cached
Appendicitis	270	123.2 109.5–138.7ROR 130.1 · χ² 31,670 / p <1e-300	118.7 EB05 107.2 · IC025 +6.4 3/3 methods agree	Not in label — unassessed	serious PRR 77.9 · ♀ 4% (drug 35%) · 96% clinician	no trial data cached
Cardiogenic shock	259	76.1 67.5–85.8ROR 80.2 · χ² 18,794 / p <1e-300	74.4 EB05 67.1 · IC025 +5.8 3/3 methods agree	Not in label — unassessed	serious PRR 48.0 · ♀ 3% (drug 35%) · 96% clinician	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.

Appendicitis — n=270, PRR 123.2
Ventricular fibrillation — n=246, PRR 93.0
Cardiogenic shock — n=259, PRR 76.1
Multiple organ dysfunction syndrome — n=285, PRR 42.5
Ascites — n=280, PRR 39.6
Hyperlipidaemia — n=102, PRR 35.4
Bacterial infection — n=157, PRR 35.1
Aspiration — n=79, PRR 30.3
Neuralgia — n=150, PRR 25.6
Gout — n=100, PRR 23.1

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 Lanthanum Carbonate?

In FDA FAERS, the most frequently co-reported reaction terms for Lanthanum Carbonate are nausea, vomiting, constipation, sepsis, abdominal pain, abdominal distension. 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 Lanthanum Carbonate have an FDA boxed warning?

No. The FDA label retrieved for Lanthanum Carbonate has no boxed warning; see the label's Warnings and Precautions for the recognised risks.

Do FAERS signals prove that Lanthanum 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 91556a42-5e16-4f86-bae9-a8cdd6b182a6, effective 20241107; matched on openfda.generic_name.exact:"LANTHANUM 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, field patient.drug.openfda.generic_name.exact, 243 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.