During clinical trials, the most common side effects of FOSRENOL^® were gastrointestinal, and included nausea, vomiting, and diarrhea. Nausea and vomiting generally lessened over time as patients continued with their treatment.

Patients who stopped treatment usually reported gastrointestinal side effects as the reason for stopping. Other side effects reported in trials included dialysis graft complications, headache, abdominal pain, and low blood pressure.

Although studies were not designed to detect differences in risk of bone fracture and mortality, there were no differences demonstrated in patients treated with FOSRENOL^® compared to alternative therapy for up to 3 years.

The duration of treatment exposure and time of observation in the clinical program were too short to conclude that FOSRENOL^® does not affect the risk of bone fracture or mortality beyond 3 years.

While lanthanum has been shown to accumulate in the GI tract, liver, and bone, in animals, the clinical significance in humans is unknown.

If you suffer from acute stomach ulcer, colon inflammation and colon ulcers, Crohn's disease, or bowel obstruction, it is important to know that patients with these conditions were not included in FOSRENOL^® clinical studies — please discuss with your doctor.

Don't take FOSRENOL^® if you are nursing or pregnant, or if you are under 18 years of age.