Medical Editor: John P. Cunha, DO, FACOEP
- cough, and
- dark stools (related to the iron content).
The recommended starting dose of Auryxia is 2 tablets orally 3 times per day with meals. Auryxia may interact with other drugs. Tell your doctor all medications and supplements you use. Tell your doctor if you are pregnant or plan to become pregnant before using Auryxia. This drug may pass into breast milk. Consult your doctor before breastfeeding.
Our Auryxia (ferric citrate) 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.
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 adverse reaction rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Hyperphosphatemia In Chronic Kidney Disease On Dialysis
A total of 289 patients were treated with Auryxia and 149 patients were treated with active control (sevelamer carbonate and/or calcium acetate) during the 52-week, randomized, open-label, active control phase of a trial in patients on dialysis. A total of 322 patients were treated with Auryxia for up to 28 days in three short-term trials. Across these trials, 557 unique patients were treated with Auryxia; dosage regimens in these trials ranged from 210 mg to 2,520 mg of ferric iron per day, equivalent to 1 to 12 tablets of Auryxia.
Adverse reactions reported in more than 5% of patients treated with Auryxia in these trials included diarrhea (21%), discolored feces (19%), nausea (11%), constipation (8%), vomiting (7%), and cough (6%).
During the 52-week, active-control period, 61 patients (21%) on Auryxia discontinued study drug because of an adverse reaction, as compared to 21 patients (14%) in the active control arm. Patients who were previously intolerant to any of the active control treatments (calcium acetate and sevelamer carbonate) were not eligible to enroll in the study. Gastrointestinal adverse reactions were the most common reason for discontinuing Auryxia (14%).
Iron Deficiency Anemia In Chronic Kidney Disease Not On Dialysis
Across two trials, 190 patients with CKD-NDD were treated with Auryxia. This included a study of 117 patients treated with Auryxia and 116 patients treated with placebo in a 16-week, randomized, double-blind period and a study of 75 patients treated with Auryxia and 73 treated with placebo in a 12-week randomized double-blind period. Dosage regimens in these trials ranged from 210 mg to 2,520 mg of ferric iron per day, equivalent to 1 to 12 tablets of Auryxia.
Adverse reactions reported in at least 5% of patients treated with Auryxia in these trials are listed in Table 1.
Table 1: Adverse Reactions Reported in Two Clinical
Trials in at least 5% of patients receiving Auryxia
|Body System Adverse Reaction||Auryxia %
|Any Adverse Reaction||75||62|
|Metabolism and Nutrition Disorders|
During the 16-week, placebo-control trial, 12 patients (10%) on Auryxia discontinued study drug because of an adverse reaction, as compared to 10 patients (9%) in the placebo control arm. Diarrhea was the most common adverse reaction leading to discontinuation of Auryxia (2.6%).
Read the entire FDA prescribing information for Auryxia (Ferric Citrate Tablets)