Lanthanum: Uses, Side Effects, Dosage - Drugvu

ℹ️ Compiled from public regulatory records · Last regulator revision: April 10, 2026🚩 Report this page

Lanthanum

Active ingredient

GB MHRACA Health Canada

Drug class: -
Availability: See label
Routes: Oral
Markets covered: 2
Products on record: 13

Overview

Lanthanum is an active pharmaceutical ingredient. The information below is compiled per regulator from the product labels on record, with direct links to the original documents.

Regulatory status by market

Market	Regulator	Products	Last revision
GB United Kingdom	MHRA	9	April 10, 2026
CA Canada	Health Canada	4	March 22, 2025

GBUnited Kingdom· MHRA

9 products

Uses

GBOfficial regulatory label· revised October 10, 2025[1]

Fosrenol is indicated as a phosphate binding agent for use in the control of hyperphosphataemia in chronic renal failure patients on haemodialysis or continuous ambulatory peritoneal dialysis (CAPD). 78 mmol/L in whom a low phosphate diet alone is insufficient to control serum phosphate levels.

How to take

CACanada· Health Canada

4 products

Uses

CAOfficial regulatory label· revised March 22, 2025[2]

NAT-LANTHANUM (lanthanum carbonate dihydrate) is indicated as a phosphate binding agent in patients with end stage renal disease on dialysis. The use of lanthanum carbonate in controlled clinical studies beyond 2 years is limited. The risk versus benefit from administration beyond two years should be carefully considered.
1 Pediatrics Pediatrics (<18 years of age): No data are available to Health Canada; therefore, Health Canada has not authorized an indication for pediatric use. 3% (159) were ≥75 years of age. No overall differences in safety or efficacy were observed between patients ≥65 years of age and younger patients.

How to take

Sources & citations

[1]MHRA (UK) · PL161890141 · revised October 10, 2025
[2]Health Canada (DPD) · 02498731 · revised March 22, 2025

Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.

Side effects & warnings

GBOfficial regulatory label· Adverse reactions· revised October 10, 2025[1]

The safety of lanthanum carbonate for use in patients has been examined in a number of clinical studies. 2).
The following convention was used for frequency of adverse drug reactions:
Very common (≥1/10); Common (≥1/100 to < 1/10); Uncommon (≥ 1/1,000 to < 1/100); Rare (≥1/10,000 to < 1/1,000); Very rare (< 1/10,000), not known (cannot be estimated from the available data). Infections and infestations Uncommon Gastroenteritis, laryngitis Blood and lymphatic system disorders Uncommon Eosinophilia Endocrine disorders Uncommon Hyperparathyroidism Metabolism and nutrition disorders Common Hypocalcaemia Uncommon Hypercalcaemia, hyperglycaemia, hyperphosphataemia, hypophosphataemia, anorexia, appetite increased Nervous system disorders Very Common Headache Uncommon Dizziness, taste alteration Ear and labyrinth disorders Uncommon Vertigo Gastrointestinal disorders* Very Common Abdominal pain, diarrhoea, nausea, vomiting Common Constipation, dyspepsia, flatulence, Uncommon Ileus, subileus, intestinal obstruction, irritable bowel syndrome, oesophagitis, stomatitis, loose stools, indigestion, gastrointestinal disorder (not otherwise specified), dry mouth, tooth disorder, eructation Rare Intestinal perforation Skin and subcutaneous tissue disorders Uncommon Alopecia, sweating increased Musculoskeletal and connective tissue disorders Uncommon Arthralgia, myalgia, osteoporosis General disorders and administration site conditions Uncommon Asthenia, chest pain, fatigue, malaise, peripheral oedema, pain, thirst.
Investigations Uncommon Blood aluminium increased, increase in GGT, increases in hepatic transaminases, alkaline phosphatase increased, weight decrease. 6%).
Post-marketing experience:
During post-approval use of Fosrenol, cases of allergic skin reactions (including skin rashes, urticaria and pruritus) have been reported which show a close temporal relationship to lanthanum carbonate therapy. In clinical trials, allergic skin reactions were seen in both Fosrenol and placebo/active comparator groups at a frequency of very common (≥1/10).
Although there have been a number of additional isolated reactions reported, none of these reactions are considered unexpected in this patient population. Transient QT changes have been observed but these were not associated with an increase of cardiac adverse events.
Paediatric population Frequency, type and severity of adverse reactions in children have not been fully established. In particular, uncertainty exists on the accumulation in bone and risk of growth retardation with treatment in children.
Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard.

GBOfficial regulatory label· Warnings and precautions· revised October 10, 2025[1]

Tissue deposition of lanthanum has been shown with Fosrenol in animal studies. 1). Cases of lanthanum deposition in gastrointestinal mucosa, mainly after long term use, have been reported. Lanthanum deposition in gastroduodenal mucosa is demonstrated endoscopically as whitish lesions of different sizes and shapes.
Also, various pathological features were identified in gastroduodenal mucosa with lanthanum deposition, such as chronic or active inflammation, glandular atrophy, regenerative changes, foveolar hyperplasia, intestinal metaplasia and neoplasia.
The use of Fosrenol in clinical studies beyond 2 years is currently limited. However, treatment of subjects with Fosrenol for up to 6 years has not demonstrated a change in the benefit/risk profile. 8). , constipation, diabetic gastroparesis) and when used with medications known to potentiate these effects.
During treatment with lanthanum carbonate, physicians and patients should remain alert for signs and symptoms of gastrointestinal disorders, especially constipation and abdominal pain/distension which may indicate bowel obstruction, ileus or subileus.
Treatment with lanthanum carbonate should be re-evaluated in patients who develop severe constipation or other severe gastrointestinal signs and symptoms. Patients with acute peptic ulcer, ulcerative colitis, Crohn’s disease, or bowel obstruction were not included in clinical studies with Fosrenol.
Patients with renal insufficiency may develop hypocalcaemia. Fosrenol does not contain calcium. Serum calcium levels should therefore be monitored at regular time intervals for this patient population and appropriate supplements given.
Lanthanum is not metabolised by liver enzymes but it is most likely excreted in the bile. 3). As the liver is the principal organ of elimination of absorbed lanthanum monitoring of liver function tests is recommended. Fosrenol should be discontinued if hypophosphataemia develops.
Abdominal x-rays of patients taking lanthanum carbonate may have a radio-opaque appearance typical of an imaging agent. Patients with rare glucose-galactose malabsorption should not take this medicine.

This is not medical advice. Consult a qualified healthcare professional.

Side effects & warnings

CAOfficial regulatory label· Adverse reactions· revised March 22, 2025[2]

1 Adverse Reaction Overview Gastrointestinal symptoms including, but not limited to, nausea, vomiting, abdominal cramps and diarrhea were observed in patients taking lanthanum carbonate. These symptoms were less frequent when taking NAT-LANTHANUM with or immediately after food.
2 Clinical Trial Adverse Reactions Clinical trials are conducted under very specific conditions. The adverse reaction rates observed in the clinical trials; therefore, may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug.
Adverse reaction information from clinical trials may be useful in identifying and approximating rates of adverse drug reactions in real-world use. In three placebo-controlled studies in end stage renal disease (ESRD) patients, the most common adverse events for lanthanum carbonate were gastrointestinal events such as nausea and vomiting, and they generally abated over time with continued dosing.
Adverse events that were more frequent (≥5% difference) in the lanthanum carbonate group are presented in Table 2. 0 WHOART = World Health Organization Adverse Reactions Thesaurus, NW = non-WHOART term developed by Sponsor for the clinical development program NAT-LANTHANUM Product Monograph Page 9 of 33 The safety of lanthanum carbonate was studied in two long-term clinical trials that included 1215 patients treated with lanthanum carbonate and 944 with alternative therapy.
Sixteen percent (16%) of patients in these comparative, open-label studies discontinued in the lanthanum carbonate-treated group due to adverse events. Gastrointestinal adverse events, such as nausea, diarrhea and vomiting, were the most common type of event leading to discontinuation.
The number of withdrawals and the most common adverse events (≥5% in either treatment group) in both the long-term (2 year), open-label, active-controlled, study of lanthanum carbonate vs. alternative therapy (Study A) and the 6-month, comparative study of lanthanum carbonate vs.
calcium carbonate (Study B) are shown in Table 3 and Table 4, respectively. 4 years on alternative therapy). 74. 72 mmol/L *Study A: Patients in the lanthanum carbonate group were titrated over a six-week period starting from a dose of 750 mg/day and then maintained on doses up to 3000 mg/day.
The alternative therapy group started the titration phase at their optimal dose and were subsequently maintained at their optimal dose with the allowance of switching/adding phosphate binders if they wished. **Study B: Patients in the lanthanum carbonate group were titrated from 375 mg/day up to their optimal dose and then maintained on doses up to 3000 mg/day.
The calcium carbonate group started the titration phase at their optimal dose and were maintained on doses up to 9000 mg/day. 9 mg/dL. Patients were allowed to switch phosphate binders throughout the study and could also take a combination of binders in order to achieve optimal phosphate control.
The dose range used in Study B was lanthanum carbonate 375 mg-3000 mg as elemental lanthanum and calcium carbonate 1500 mg-9000 mg elemental calcium. 1% and <5%), adverse drug reactions were reported: Blood and Lymphatic System Disorders: Eosinophilia Ear and Labyrinth Disorders: Vertigo Endocrine Disorders: Hyperparathyroidism Gastrointestinal Disorders: Dry mouth, dyspepsia, eructation, esophagitis, flatulence, gastrointestinal disorder NOS (not otherwise specified), indigestion, irritable bowel syndrome, loose stools, stomatitis, tooth disorder […]

CAOfficial regulatory label· Warnings and precautions· revised March 22, 2025[2]

, Gastrointestinal 08/2023 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. RECENT MAJOR LABEL CHANGES…………………………………………………………………………………………. 2 TABLE OF CONTENTS ..............................................................................................................
2 PART I: HEALTH PROFESSIONAL INFORMATION ...................................................................... 4 1 INDICATIONS ...............................................................................................................
4 2 CONTRAINDICATIONS ................................................................................................. 4 4 DOSAGE AND ADMINISTRATION ................................................................................. 5 5 OVERDOSAGE..............................................................................................................
5 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ................................. 5 7 WARNINGS AND PRECAUTIONS .................................................................................. 8 8 ADVERSE REACTIONS ..................................................................................................
11 NAT-LANTHANUM Product Monograph Page 3 of 33 9 DRUG INTERACTIONS ................................................................................................ 14 10 CLINICAL PHARMACOLOGY .......................................................................................
15 11 STORAGE, STABILITY AND DISPOSAL ......................................................................... 17 12 SPECIAL HANDLING INSTRUCTIONS ........................................................................... 17 PART II: SCIENTIFIC INFORMATION .......................................................................................
18 13 PHARMACEUTICAL INFORMATION ............................................................................ 18 14 CLINICAL TRIALS ........................................................................................................
25 15 MICROBIOLOGY ........................................................................................................ 25 16 NON-CLINICAL TOXICOLOGY .....................................................................................

This is not medical advice. Consult a qualified healthcare professional.