Recommended Topic Related To:

Fosrenol

"The U.S. Food and Drug Administration today approved Liposorber LA-15 System to treat pediatric patients with primary focal segmental glomerulosclerosis (FSGS) either before transplant, or after renal (kidney) transplantation in which there is re"...

Fosrenol

Fosrenol Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Fosrenol (lanthanum carbonate) 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. It prevents the body from absorbing phosphate, allowing it to be removed the body. Common side effects 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.

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.

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

SIDE EFFECTS: Nausea, vomiting, stomach pain, dizziness, diarrhea or constipation may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

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
(Adverse Reactions)

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 patients were randomized to FOSRENOL 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 4-6 Weeks

  FOSRENOL
%
(N=180)
Placebo
%
(N=95)
Nausea 11 5
Vomiting 9 4
Abdominal pain 5 0
* 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.

Postmarketing Experience

The following adverse reactions have been identified during post-approval use of FOSRENOL: constipation, dyspepsia, allergic skin reactions, hypophosphatemia, and tooth injury.

Read the entire FDA prescribing information for Fosrenol (Lanthanum Carbonate Chewable Tablets) »

A A A

Fosrenol - User Reviews

Fosrenol User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Fosrenol sorted by most helpful. Patient Discussions FAQs

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.


Women's Health

Find out what women really need.