Auryxia
- Generic Name: ferric citrate tablets
- Brand Name: Auryxia
- Drug Class: Iron Products
Auryxia (Ferric Citrate Tablets) side effects drug center
Auryxia Side Effects Center
What Is Auryxia?
Auryxia (ferric citrate) is a phosphate binder used for the control of serum phosphorus levels in patients with chronic kidney disease on dialysis.
What Are Side Effects of Auryxia?
Common side effects of Auryxia include:
- diarrhea,
- nausea,
- constipation,
- vomiting,
- cough, and
- dark stools (related to the iron content).
Dosage for Auryxia
The recommended starting dose of Auryxia is 2 tablets orally 3 times per day with meals.
What Drugs, Substances, or Supplements Interact with Auryxia?
Auryxia may interact with other drugs. Tell your doctor all medications and supplements you use.
Auryxia During Pregnancy and Breastfeeding
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.
Additional Information
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.
Auryxia 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.
Call your doctor at once if you have:
- severe stomach problems (pain, vomiting, diarrhea); or
- high potassium--nausea, weakness, tingly feeling, chest pain, irregular heartbeats, loss of movement.
Common side effects may include:
- diarrhea, constipation;
- darker color in your bowel movements;
- nausea, vomiting, stomach pain; or
- cough.
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 Auryxia (Ferric Citrate Tablets)
Auryxia Professional Information
SIDE EFFECTS
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 % (N=190) |
Placebo % (N=188) |
| Any Adverse Reaction | 75 | 62 |
| Metabolism and Nutrition Disorders | ||
| Hyperkalemia | 5 | 3 |
| Gastrointestinal Disorders | ||
| Discolored Feces | 22 | 0 |
| Diarrhea | 21 | 12 |
| Constipation | 18 | 10 |
| Nausea | 10 | 4 |
| Abdominal Pain | 5 | 2 |
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%).
DRUG INTERACTIONS
Table 2: Oral drugs that can be administered concomitantly with Auryxia
| Amlodipine | Metoprolol |
| Aspirin | Pravastatin |
| Atorvastatin | Propranolol |
| Calcitriol | Sitagliptin |
| Clopidogrel | Warfarin |
| Digoxin | |
| Diltiazem | |
| Doxercalciferol | |
| Enalapril | |
| Fluvastatin | |
| Glimepiride | |
| Levofloxacin | |
| Losartan | |
| Oral drugs that have to be separated from Auryxia and meals | |
| Dosing Recommendations | |
| Doxycycline | Take at least 1 hour before Auryxia |
| Ciprofloxacin | Take at least 2 hours before or after Auryxia |
Oral Medications Not Listed In Table 2
There are no empirical data on avoiding drug interactions between Auryxia and most concomitant oral drugs. For oral medications where a reduction in the bioavailability of that medication would have a clinically significant effect on its safety or efficacy, consider separation of the timing of the administration of the two drugs. The duration of separation depends upon the absorption characteristics of the medication concomitantly administered, such as the time to reach peak systemic levels and whether the drug is an immediate release or an extended release product. Consider monitoring clinical responses or blood levels of concomitant medications that have a narrow therapeutic range.
Read the entire FDA prescribing information for Auryxia (Ferric Citrate Tablets)
&Copy; Auryxia Patient Information is supplied by Cerner Multum, Inc. and Auryxia Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.