Fosrenol Side Effects

Generic Name: lanthanum carbonate

Please note - some side effects for Fosrenol may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Side Effects of Fosrenol - for the Consumer

Fosrenol

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Fosrenol:

Mild stomach pain; nausea; vomiting.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); severe or persistent constipation, diarrhea, nausea, stomach cramping or pain, or vomiting.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

Fosrenol Side Effects - for the Professional

Fosrenol

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).

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.

Side Effects by Body System - for Healthcare Professionals

Gastrointestinal

Gastrointestinal side effects (including nausea, vomiting, and diarrhea) were the most prominent reasons for discontinuation of therapy in clinical studies.

One study reported incidence of nausea and vomiting as high as 16% and 18%, respectively.

Gastrointestinal side effects have frequently included nausea (11%, compared to 5% with placebo), vomiting (9%, compared to 4% with placebo), abdominal pain (5%, compared to 0% with placebo), diarrhea (13% to 23%), and constipation (6% to 14%). Postmarketing gastrointestinal side effects have included dyspepsia.

Cardiovascular

Cardiovascular side effects have included hypotension (8% to 16%).

Respiratory

Respiratory side effects have included bronchitis (5%) and rhinitis (5% to 7%).

Other

Other side effects have included dialysis graft complication (3% to 26%), headache (5% to 21%), and dialysis graft occlusion (4% to 21%). Other side effects reported postmarketing have included tooth injury.

Metabolic

Metabolic side effects have included hypercalcemia (up to 4%). Metabolic side effects reported postmarketing have included hypophosphatemia and hypocalcemia (up to 5%).

Dermatologic

Dermatologic side effects reported postmarketing have included allergic skin reactions.

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