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Fosrenol

Last reviewed on RxList: 3/7/2016
Fosrenol Side Effects Center

Last reviewed on RxList 2/5/2016

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.

Fosrenol Consumer Information

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)

Fosrenol Professional 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 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.

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%).

Postmarketing Experience

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)

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© Fosrenol Patient Information is supplied by Cerner Multum, Inc. and Fosrenol Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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