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 at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

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:

Constipation; diarrhea; headache; nausea; stomach pain; vomiting.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); dizziness; fainting; fatigue; unusual weakness.

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. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch .

Fosrenol Side Effects - for the Professional

Fosrenol

The most common adverse events for Fosrenol® were gastrointestinal events, such as nausea and vomiting and they generally abated over time with continued dosing.

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 events that were more frequent (≥5% difference) in the Fosrenol® group were nausea, vomiting, dialysis graft occlusion, and abdominal pain (Table 1).

The safety of Fosrenol® was studied in two long-term clinical trials that included 1215 patients treated with Fosrenol® and 943 with alternative therapy. Fourteen percent (14%) of patients in these comparative, open-label studies discontinued in the Fosrenol®-treated group due to adverse events. Gastrointestinal adverse events, such as nausea, diarrhea and vomiting, were the most common type of event leading to discontinuation.

The most common adverse events (≥ 5% in either treatment group) in both the long-term (2 year), open-label, active controlled, study of Fosrenol® vs. alternative therapy (Study A) and the 6-month, comparative study of Fosrenol® vs. calcium carbonate (Study B) are shown in Table 2. In Table 2, Study A events have been adjusted for mean exposure differences between treatment groups (with a mean exposure of 0.9 years on lanthanum and 1.3 years on alternative therapy). The adjustment for mean exposure was achieved by multiplying the observed adverse event rates in the alternative therapy group by 0.71.

Side Effects by Body System

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%).

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%),

Metabolic

Metabolic side effects have included hypercalcemia (up to 4%).

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