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Fosrenol Side Effects Center
Medical Editor: John P. Cunha, DO, FACOEP
Fosrenol (lanthanum carbonate) prevents the body from absorbing phosphate, allowing it to be removed the body and is used for reducing phosphate levels in patients with end stage renal disease. High levels of phosphate can lead to complications with calcium absorption, resulting in serious medical problems. Common side effects of Fosrenol include nausea, vomiting, stomach pain, dizziness, diarrhea, or constipation.
The recommended initial total daily dose of Fosrenol is 1500 mg. Divide the total daily dose and take with or immediately after meals. The dose may be adjusted every 2-3 weeks until an acceptable serum phosphate level is reached. Other drugs may affect Fosrenol. Tell your doctor all prescription and over-the-counter medications and supplements you use. Fosrenol is not recommended for use during pregnancy. It is unknown if this drug passes into breast milk. Consult your doctor before breastfeeding.
Our Fosrenol (lanthanum carbonate) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What is Patient Information in Detail?
Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.
Fosrenol in Detail - Patient Information: Side Effects
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Stop using lanthanum carbonate and call your doctor at once if you have a serious side effect such as severe stomach pain or severe constipation.
Less serious side effects may include:
- nausea or vomiting;
- diarrhea or constipation; or
- stomach pain.
Read the entire detailed patient monograph for Fosrenol (Lanthanum Carbonate Chewable Tablets)
What is Patient Information Overview?
A concise overview of the drug for the patient or caregiver from First DataBank.
Fosrenol Overview - Patient Information: Side Effects
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Tell your doctor right away if any of these serious side effects occur: mental/mood changes, unusual muscle weakness.
Infrequently, serious blockage of the bowels may occur, which may sometimes require surgery or going to the hospital. This can occur especially in people with stomach/abdominal problems (such as abdominal surgery, colon cancer, chronic constipation, slow gut syndrome). Tell your doctor right away if you have severe or persistent stomach/abdominal pain, severe constipation, or persistent vomiting.
A very serious allergic reaction to this drug is unlikely, but get medical help right away if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Read the entire patient information overview for Fosrenol (Lanthanum Carbonate Chewable Tablets)
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Fosrenol FDA Prescribing Information: Side Effects
Overall, the safety profile of FOSRENOL has been studied in over 5200 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.
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in 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. In double-blind, placebo-controlled studies where a total of 180 and 95 ESRD patientswere randomized to FOSRENOL chewable tablet and placebo, respectively, for 4-6 weeks of treatment, the most common reactions that were more frequent ( ≥ 5% difference) in the FOSRENOL group were nausea, vomiting, and abdominal pain (Table 1).
Table 1: Adverse Reactions* That Were More Common on
FOSRENOL in Placebo- Controlled, Double-Blind Studies With Treatment Periods of
|* expressed as the event rate for each term|
In an open-label long-term 2 year extension study in 93 patients who had transitioned from other studies, resulting in a total of up to 6 years treatment, mean baseline values and changes in transaminases were similar to those observed in the earlier comparative studies, with little change during treatment.
The safety of FOSRENOL was studied in two long-term, open-labeled clinical trials, which included 1215 patients treated with FOSRENOL and 944 with alternative therapy. Fourteen percent (14%) of FOSRENOL treated patients discontinued treatment due to adverse events. Gastrointestinal adverse reactions, such as nausea, diarrhea and vomiting were the most common types of event leading to discontinuation.
In pooled active comparator controlled clinical trials, hypocalcemia was noted with an incidence of approximately 5% in both lanthanum and active comparator groups. A nonclinical study and a phase 1 study have shown reduced absorption of calcium in the intestine with lanthanum carbonate treatment.
In a crossover study in 72 healthy individuals comparing Fosrenol chewable tablets to Fosrenol oral powder, gastrointestinal adverse reactions such as nausea, diarrhea and vomiting were more common for the oral powder formulation (18%) than for the chewable tablets (7%).
The following adverse reactions have been identified during post-approval use of FOSRENOL. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure: constipation, dyspepsia, allergic skin reactions, hypophosphatemia, and tooth injury while chewing the tablet.
Read the entire FDA prescribing information for Fosrenol (Lanthanum Carbonate Chewable Tablets)
Additional Fosrenol Information
Fosrenol - User Reviews
Fosrenol User Reviews
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Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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