What the label lists and what reports show
Lanthanum side effects
Lanthanum's FDA label: “In controlled trials, the most common adverse reactions that were more frequent (≥5% difference vs.” FAERS holds 5,090 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is nausea (493 reports).
- Generic listed
Check it at the source: the lanthanum FDA label on DailyMed (effective December 31, 2024, Takeda Pharmaceuticals America, Inc.); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are possible or reasonably likely side effects of FOSRENOL?See " What is the most important information I should know about FOSRENOL? " The most common side effects of FOSRENOL include: nausea vomiting diarrhea stomach pain Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all the side effects of FOSRENOL. For more information, ask your healthcare provider or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Source: FDA drug label, Takeda Pharmaceuticals America, Inc., effective December 31, 2024 (SPL set f10776b2-2c25-4343-aabe-68f302e5cb54), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsIn controlled trials, the most common adverse reactions that were more frequent (≥5% difference vs.
From the label: adverse reactions, continuedThe following adverse reactions are discussed in greater detail in other sections of the labeling: Gastrointestinal Adverse Effects [see Warnings and Precautions (5.1) ] In controlled trials, the most common adverse reactions that were more frequent (≥5% difference vs. placebo) in FOSRENOL were nausea, vomiting, and abdominal pain. ( 6.1 ) The following adverse reactions have been identified during post-approval use of FOSRENOL: constipation, dyspepsia, allergic skin reactions, and tooth injury while chewing the tablet. ( 6.2 ) To report SUSPECTED ADVERSE REACTIONS, contact Takeda Pharmaceuticals U.S.A., Inc. at 1-877-TAKEDA-7 (1-877-825-3327) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Overall, the safety profile of FOSRENOL has been studied in over 5,200 subjects in completed clinical trials. The most common adverse reactions for FOSRENOL were gastrointestinal events, such as nausea, vomiting, and abdominal pain and they generally abated over time with continued dosing.
Source: FDA drug label, Takeda Pharmaceuticals America, Inc., effective December 31, 2024 (SPL set f10776b2-2c25-4343-aabe-68f302e5cb54), via openFDA; the full label on DailyMed
What do FAERS reports show?
5,090 reports list lanthanum among the medicines taken, each a report of something that happened, not proof the medicine caused it; 1,590 are coded as a death and 2,508 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 21 reactions below, 5 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Lanthanum: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions