Fosrenol
- Generic Name: lanthanum carbonate chewable tablets
- Brand Name: Fosrenol
Fosrenol (Lanthanum Carbonate Chewable Tablets) side effects drug center
Fosrenol Side Effects Center
What Is Fosrenol?
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.
What Are Side Effects of Fosrenol?
Common side effects of Fosrenol include:
- nausea,
- vomiting,
- stomach pain,
- dizziness,
- diarrhea, or
- constipation
Dosage for Fosrenol
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.
What Drugs, Substances, or Supplements Interact with Fosrenol?
Other drugs may affect Fosrenol. Tell your doctor all prescription and over-the-counter medications and supplements you use.
Fosrenol During Pregnancy and Breastfeeding
Fosrenol is not recommended for use during pregnancy. It is unknown if this drug passes into breast milk. Consult your doctor before breastfeeding.
Additional Information
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.
Fosrenol Consumer Information
Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
This medicine may cause severe bowel obstruction or a perforation (a hole or tear) in your intestines.
Call your doctor at once if you have:
- severe stomach pain, bloating, or tenderness;
- fever, chills, nausea, vomiting, loss of appetite;
- severe constipation; or
- bleeding from your rectum or blood in your stools;
Common side effects may include:
- nausea, vomiting;
- diarrhea; 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
The following adverse reactions are discussed in greater detail in other sections of the labeling:
- Gastrointestinal Adverse Effects [see WARNINGS AND PRECAUTIONS]
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.
In double-blind, placebo-controlled studies where a total of 180 and 95 patients with ESRD were randomized to FOSRENOL chewable tablet and placebo, respectively, for 4 to 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 to 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-label clinical trials, which included 1,215 patients treated with FOSRENOL and 944 with alternative therapy. Fourteen percent (14%) of patients treated with FOSRENOL 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.
Cases of constipation, intestinal perforation, intestinal obstruction, ileus, subileus, dyspepsia, allergic skin reactions, hypophosphatemia, and tooth injury while chewing the tablet have been reported.
Read the entire FDA prescribing information for Fosrenol (Lanthanum Carbonate Chewable Tablets)
&Copy; 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.