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Tetraferric tricitrate decahydrate
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- Active ingredient
- Tetraferric Tricitrate Decahydrate 210 mg
- Other brand name
- Drug classes
- Parenteral Iron Replacement, Phosphate Binder
- Dosage form
- Tablet, Film Coated
- Route
- Oral
- Prescription status
- Rx (prescription)
- Pregnancy
- See Pregnancy Use Section
- Lactation
- See Lactation Use Section
- Marketed in the U.S.
- Since 2025
- Label revision date
- June 23, 2024
- FDA Insert
- Prescribing information, PDF file
- Active ingredient
- Tetraferric Tricitrate Decahydrate 210 mg
- Other brand name
- Drug classes
- Parenteral Iron Replacement, Phosphate Binder
- Dosage form
- Tablet, Film Coated
- Route
- Oral
- Prescription status
- Rx (prescription)
- CSA schedule
- Not a scheduled drug
- Pregnancy
- See Pregnancy Use Section
- Lactation
- See Lactation Use Section
- Marketed in the U.S.
- Since 2025
- Label revision date
- June 23, 2024
- Manufacturer
- Mylan Pharmaceuticals Inc.
- Registration number
- NDA205874
- NDC root
- 0378-2895
- FDA Insert
- Prescribing information, PDF file
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Drug Overview
Ferric citrate is a medication that serves two main purposes: it acts as a phosphate binder and provides iron replacement. It is specifically used to help control high phosphorus levels in adults with chronic kidney disease who are on dialysis, as well as to treat iron deficiency anemia in those not on dialysis.
The way ferric citrate works is by binding to dietary phosphate in the gastrointestinal (GI) tract, forming an insoluble compound that is then excreted in the stool, which helps lower serum phosphate levels. Additionally, it provides ferric iron, which is converted to ferrous iron in the GI tract and then absorbed into the bloodstream, where it can be used to produce hemoglobin, the protein in red blood cells that carries oxygen.
Uses
Ferric citrate tablets serve two important purposes for adults dealing with chronic kidney disease. First, if you are on dialysis, these tablets help control the levels of phosphorus in your blood. High phosphorus levels can be a concern for those with kidney issues, and managing them is crucial for your overall health.
Additionally, if you have chronic kidney disease but are not on dialysis, ferric citrate tablets can be used to treat iron deficiency anemia. This condition occurs when your body lacks enough iron, which is essential for producing healthy red blood cells. By taking these tablets, you can help restore your iron levels and improve your energy and well-being.
Dosage and Administration
If you have hyperphosphatemia (high phosphorus levels) due to chronic kidney disease and are on dialysis, you will start with a dose of 2 tablets taken by mouth three times a day with your meals. Your doctor may adjust this dose by adding or removing 1 to 2 tablets as needed to keep your phosphorus levels within the target range. You can take a maximum of 12 tablets each day, and any changes to your dose can be made at intervals of one week or longer.
For those with iron deficiency anemia (low iron levels) who are not on dialysis due to chronic kidney disease, the starting dose is 1 tablet taken orally three times a day with meals. Similar to the previous condition, your doctor will adjust your dose as necessary to help you reach and maintain your hemoglobin (a protein in red blood cells that carries oxygen) goals, with a maximum of 12 tablets daily.
What to Avoid
If you have iron overload syndromes, such as hemochromatosis, you should avoid using this medication. Iron overload syndromes occur when your body absorbs too much iron, which can lead to serious health issues.
It's important to be cautious with medications that can be misused or abused. Always follow your healthcare provider's instructions and discuss any concerns you may have about dependence (a condition where your body becomes reliant on a substance) or misuse. If you have any questions about your treatment, don't hesitate to reach out to your healthcare professional for guidance.
Side Effects
You may experience some common side effects while using this medication, including discolored feces, diarrhea, constipation, nausea, vomiting, cough, abdominal pain, and elevated potassium levels (hyperkalemia). It's important to monitor for these reactions, as they can vary in severity.
Additionally, be aware of the risk of iron overload, which may require adjustments to your treatment. This condition can lead to serious health issues, so monitoring your iron levels is essential. Keep this medication out of reach of children, as accidental overdose of iron-containing products can be very dangerous. If an overdose occurs, seek medical help immediately.
Warnings and Precautions
It's important to be aware of some key warnings when using this product. If you are receiving intravenous iron, your doctor will monitor your ferritin and transferrin saturation (TSAT) levels to check for iron overload, which may require a dose adjustment or stopping the treatment. Additionally, keep this product out of reach of children, as accidental overdose of iron-containing products can be very dangerous and is a leading cause of poisoning in young children. If an overdose occurs, seek emergency help by calling a doctor or poison control center immediately.
Regular lab tests to monitor your ferritin and TSAT levels are necessary to ensure your safety while using this product. Always stay informed about these precautions to help protect your health and the health of those around you.
Overdose
If you take too much ferric citrate, there isn't much information available about what might happen, as there have been no reported cases of overdose in patients. However, it's important to be cautious, especially if you have chronic kidney disease. The highest amount studied in clinical trials was 2,520 mg of ferric iron, which is equivalent to 12 tablets of ferric citrate in one day. Taking more than this could lead to excessive iron buildup in your body, particularly if you are also receiving intravenous iron.
Signs of an overdose may include elevated iron levels, which can affect your liver. If you notice any unusual symptoms or suspect you have taken too much, it’s crucial to seek medical help immediately. Always consult your healthcare provider if you have concerns about your dosage or experience any adverse effects.
Pregnancy Use
There is currently no information available on the use of ferric citrate tablets during pregnancy, which means we cannot determine if they are associated with major birth defects or miscarriage. While animal studies have shown some concerns with other iron compounds, such as skeletal and brain malformations in neonatal mice, oral forms of iron have not demonstrated similar risks in other animal studies. However, it's important to note that taking too much iron during pregnancy can increase the risk of complications like miscarriage, gestational diabetes, and fetal malformations.
In the general U.S. population, the background risk of major birth defects is estimated to be between 2% and 4%, while the risk of miscarriage ranges from 15% to 20%. Adverse pregnancy outcomes can occur regardless of a mother's health or medication use. Additionally, the impact of ferric citrate on the absorption of vitamins and nutrients during pregnancy has not been studied, and your nutritional needs for vitamins and other nutrients are higher when you are pregnant. Always consult your healthcare provider before taking any medication or supplement during pregnancy.
Lactation Use
There is currently no information available about how ferric citrate affects breast milk, the breastfed child, or milk production in humans. However, studies in rats indicate that iron can transfer into milk through specific transporters. This means that if you take ferric citrate tablets while breastfeeding, your infant may be exposed to the substance.
When considering the use of ferric citrate, it's important to weigh the benefits of breastfeeding against your need for this medication and any potential risks to your child. Always consult with your healthcare provider to make the best decision for both you and your baby.
Pediatric Use
The safety and effectiveness of ferric citrate tablets for children have not been established, meaning there isn't enough research to confirm that it's safe for them to use. If your child is under 6 months old, it's important to note that they typically do not eat solid foods, which is when ferric citrate is recommended to be taken. This could put younger children at a higher risk of experiencing gastrointestinal (related to the stomach and intestines) side effects. Always consult with your child's healthcare provider before giving them any new medication.
Geriatric Use
Clinical studies involving ferric citrate tablets included a significant number of older adults, with 292 participants aged 65 and older, including 104 who were 75 and older. The findings from these studies suggest that older adults generally respond to ferric citrate in a similar way to younger patients, with no major differences noted in how well the medication is tolerated or its effectiveness.
As you consider treatment options, it's reassuring to know that the experiences of older adults in these studies did not reveal any unique concerns. However, it's always important to discuss any specific health conditions or medications you may be taking with your healthcare provider to ensure the best care tailored to your needs.
Renal Impairment
If you have kidney problems, it's important to know that there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the usual recommendations for monitoring or safety considerations related to renal impairment (kidney issues) are not provided.
Always consult your healthcare provider for personalized advice and to ensure that any medications you take are safe and appropriate for your kidney health. They can help you understand how your condition may affect your treatment plan.
Hepatic Impairment
If you have liver problems, it's important to know that there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the standard recommendations apply, but you should always consult your healthcare provider for personalized advice. They can help determine the best approach for your treatment and monitor your liver function as needed.
Make sure to keep your doctor informed about your liver health, as they may want to conduct regular tests to ensure your safety while using any medication. Your well-being is a priority, and your healthcare team is there to support you.
Drug Interactions
It's important to talk to your healthcare provider about any medications you are taking, as some drugs can interact with each other in ways that may affect their effectiveness or safety. If your doctor anticipates that a significant interaction might occur, they may suggest taking the medications at different times to minimize any potential issues.
Additionally, your healthcare provider might recommend monitoring how well the medications are working or checking the levels of certain drugs in your blood. This helps ensure that you receive the best possible care and that your treatment remains safe and effective. Always keep your healthcare team informed about all the medications and supplements you are using.
Storage and Handling
To ensure the best performance of your product, store it in a cool, dry place at a temperature between 20° to 25°C (68° to 77°F). It’s acceptable for the temperature to occasionally range from 15° to 30°C (59° to 86°F), but try to keep it within the recommended limits. Additionally, make sure to protect the product from moisture, as this can affect its quality and safety.
When handling the product, always do so with clean hands and in a clean environment to maintain its integrity. If you have any specific components that come with the product, ensure they are also stored and handled according to the same guidelines for optimal safety and effectiveness.
Additional Information
No further information is available.
FAQ
What is ferric citrate?
Ferric citrate is a phosphate binder and iron replacement product used to control serum phosphorus levels and treat iron deficiency anemia in patients with chronic kidney disease.
What are the indications for ferric citrate tablets?
Ferric citrate tablets are indicated for controlling serum phosphorus levels in adult patients with chronic kidney disease on dialysis and for treating iron deficiency anemia in those not on dialysis.
How does ferric citrate work?
Ferric citrate binds dietary phosphate in the gastrointestinal (GI) tract, precipitating it as insoluble ferric phosphate, which is excreted in stool, thus lowering serum phosphate levels.
What is the starting dose for ferric citrate in patients on dialysis?
The starting dose is 2 tablets taken orally 3 times per day with meals, adjustable by 1 to 2 tablets as needed, up to a maximum of 12 tablets daily.
What are the common side effects of ferric citrate?
Common side effects include discolored feces, diarrhea, constipation, nausea, vomiting, cough, abdominal pain, and hyperkalemia.
What should I do in case of an accidental overdose?
In case of accidental overdose, call a doctor or poison control center immediately, as iron overdose can be fatal, especially in children under 6 years of age.
Is ferric citrate safe to use during pregnancy?
There are no available data on the use of ferric citrate in pregnant women, and the potential risks are unknown. Consult your doctor for advice.
Can ferric citrate be taken with other medications?
Ferric citrate may interact with certain medications, such as doxycycline and ciprofloxacin. It's recommended to space their administration to avoid interactions.
How should ferric citrate be stored?
Store ferric citrate at 20° to 25°C (68° to 77°F), with excursions permitted to 15° to 30°C (59° to 86°F), and protect it from moisture.
What should I monitor while taking ferric citrate?
You should monitor ferritin and transferrin saturation (TSAT) levels to avoid iron overload and adjust the dose if necessary.
Packaging Info
The table below lists all NDC Code configurations of Ferric Citrate, the U.S. brand-name prescription product. Columns show Packaging, Formulation Type, and Active Ingredient Strength.
Details | ||||
|---|---|---|---|---|
| Tablet, Film Coated | 210 mg | ||
Product details Regulatory status — Marketed All current FDA data sets list this NDC as actively marketed. FDA record dates for this NDC:
Active ingredients
Inactive ingredients
| ||||
FDA Insert (PDF)
This is the full prescribing document for Ferric Citrate, submitted to the U.S. Food and Drug Administration (FDA). It contains official information for healthcare providers, including how to use the medication, possible side effects, and safety warnings.
Description
Ferric citrate is a phosphate binder and iron replacement product, chemically designated as iron (+3), x (1, 2, 3-propanetricarboxylic acid, 2-hydroxy-), y (H2O). Each tablet contains 210 mg of ferric iron, equivalent to 1 g of ferric citrate, and is formulated for oral administration. The tablets are film-coated, peach-colored, and oval-shaped, with the debossing “KX52” on one side.
Inactive ingredients include pregelatinized starch and calcium stearate. The film-coating comprises additional inactive components: hypromellose, titanium dioxide, triacetin, and color additives including FD&C Yellow #6/Sunset Yellow FCF Aluminum Lake, FD&C Red #40/Allura Red AC Aluminum Lake, and FD&C Blue #2/Indigo Carmine Aluminum Lake.
Uses and Indications
Ferric citrate tablets are indicated for the control of serum phosphorus levels in adult patients with chronic kidney disease who are on dialysis. Additionally, ferric citrate tablets serve as an iron replacement product for the treatment of iron deficiency anemia in adult patients with chronic kidney disease who are not on dialysis.
Limitations of Use: Ferric citrate tablets are specifically indicated for adult populations and are not recommended for use in pediatric patients.
Dosage and Administration
For the management of hyperphosphatemia in patients with chronic kidney disease on dialysis, the recommended starting dose is 2 tablets administered orally three times per day with meals. The dosage may be adjusted by 1 to 2 tablets as necessary to maintain serum phosphorus levels within the target range, with a maximum allowable dose of 12 tablets per day. Dose titration should occur at intervals of one week or longer, based on clinical response and laboratory results.
In the treatment of iron deficiency anemia in patients with chronic kidney disease not on dialysis, the initial dose is 1 tablet taken orally three times per day with meals. The dosage may be modified as required to achieve and sustain the hemoglobin target, with a maximum of 12 tablets per day. Regular monitoring of hemoglobin levels is recommended to guide dosage adjustments.
Contraindications
Use is contraindicated in patients with iron overload syndromes, such as hemochromatosis, due to the potential for exacerbating the condition.
Warnings and Precautions
Patients receiving intravenous iron therapy should be closely monitored for signs of iron overload. It is essential to regularly assess ferritin levels and transferrin saturation (TSAT) to ensure that iron levels remain within a safe range. In cases where iron overload is detected, a reduction in dosage or discontinuation of the intravenous iron may be necessary to prevent adverse effects.
Iron-containing products pose a significant risk of accidental overdose, particularly in children under the age of six. Healthcare professionals must emphasize the importance of keeping this product out of reach of children. In the event of an accidental overdose, immediate medical attention is critical. Patients or caregivers should be instructed to contact a healthcare provider or poison control center without delay.
Routine laboratory tests, specifically monitoring ferritin and TSAT, are recommended to manage and mitigate the risk of iron overload effectively. Regular evaluation of these parameters will aid in the safe administration of intravenous iron therapy.
Side Effects
Patients receiving treatment may experience a range of adverse reactions. The most common adverse reactions observed include discolored feces, diarrhea, constipation, nausea, vomiting, cough, abdominal pain, and hyperkalemia.
In addition to these common reactions, there are important considerations regarding iron overload. Patients should be monitored for ferritin and transferrin saturation (TSAT) levels, as iron overload may necessitate a reduction in dosage or discontinuation of intravenous iron therapy. Iron overload syndromes, such as hemochromatosis, have also been noted.
It is critical to highlight the risk of accidental overdose of iron-containing products, which is a leading cause of fatal poisoning in children under 6 years of age. Therefore, this product should be kept out of reach of children. In the event of an accidental overdose, it is imperative to contact a healthcare professional or poison control center immediately.
In clinical trials, there was one reported case of elevated iron levels in the liver, confirmed by biopsy, in a patient on dialysis who was administered intravenous iron and ferric citrate tablets. This underscores the importance of careful monitoring and management of iron levels in patients undergoing treatment.
Drug Interactions
When clinically significant drug interactions are anticipated, it is advisable to separate the timing of administration of the interacting medications. This approach may help mitigate potential adverse effects or diminished therapeutic efficacy.
Additionally, monitoring of clinical responses or blood levels of the concomitant medication is recommended. This practice ensures that any changes in drug effectiveness or safety can be promptly identified and addressed.
Packaging & NDC
The table below lists all NDC Code configurations of Ferric Citrate, the U.S. brand-name prescription product. Columns show Packaging, Formulation Type, and Active Ingredient Strength.
Details | ||||
|---|---|---|---|---|
| Tablet, Film Coated | 210 mg | ||
Product details Regulatory status — Marketed All current FDA data sets list this NDC as actively marketed. FDA record dates for this NDC:
Active ingredients
Inactive ingredients
| ||||
Pediatric Use
The safety and efficacy of ferric citrate tablets have not been established in pediatric patients. Special caution is advised for infants under 6 months of age, as they are unlikely to be consuming solid food and may be at greater risk of gastrointestinal toxicity due to the recommendation that ferric citrate tablets be taken with meals.
Geriatric Use
Clinical studies of ferric citrate tablets included 292 subjects aged 65 years and older, with 104 subjects aged 75 years and older. The overall clinical study experience has not identified any obvious differences in responses between elderly patients and younger patients regarding the tolerability or efficacy of ferric citrate tablets.
While no specific dosage adjustments are recommended based solely on age, healthcare providers should remain vigilant in monitoring geriatric patients for any potential adverse effects, given the variability in pharmacokinetics and pharmacodynamics that may occur in this population.
Pregnancy
There are no available data on the use of ferric citrate tablets in pregnant patients to inform a drug-associated risk of major birth defects and miscarriage. Animal reproduction studies have not been conducted with ferric citrate tablets; however, skeletal and encephalic malformations were observed in neonatal mice when ferric gluconate was administered intraperitoneally to gravid dams on gestation days 7-9. In contrast, oral administration of other ferric or ferrous compounds to gravid CD1-mice and Wistar-rats did not result in fetal malformations.
An overdose of iron in pregnant women may pose risks, including spontaneous abortion, gestational diabetes, and fetal malformation. The estimated background risk of major birth defects and miscarriage for the indicated population remains unknown. Adverse outcomes in pregnancy can occur regardless of maternal health or medication use. In the U.S. general population, the estimated background risks of major birth defects and miscarriage in clinically recognized pregnancies are 2 to 4% and 15 to 20%, respectively.
The effect of ferric citrate tablets on the absorption of vitamins and other nutrients has not been studied in pregnant women, yet it is important to note that the requirements for vitamins and other nutrients are increased during pregnancy. Healthcare professionals should consider these factors when prescribing ferric citrate tablets to women of childbearing potential and pregnant patients.
Lactation
There are no human data regarding the effect of ferric citrate in human milk, the effects on the breastfed child, or the effects on milk production. Data from rat studies have shown the transfer of iron into milk by divalent metal transporter-1 (DMT-1) and ferroportin-1 (FPN-1). Hence, there is a possibility of infant exposure when ferric citrate tablets are administered to a nursing woman.
The development and health benefits of breastfeeding should be considered along with the mother’s clinical need for ferric citrate tablets and any potential adverse effects on the breastfed child from ferric citrate tablets or from the underlying maternal condition.
Renal Impairment
Patients with renal impairment have not been specifically addressed in the available data regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as the lack of information necessitates careful clinical judgment and monitoring.
Hepatic Impairment
Patients with hepatic impairment have not been specifically studied in relation to the use of this medication. Consequently, there are no established dosage adjustments, special monitoring requirements, or precautions for individuals with compromised liver function. It is recommended that healthcare providers exercise caution when prescribing this medication to patients with hepatic impairment, given the lack of data on its safety and efficacy in this population. Regular monitoring of liver function may be prudent in these cases, although specific parameters are not defined in the available information.
Overdosage
In the event of an overdose of ferric citrate tablets, there is currently no available data specifically addressing the consequences of such an occurrence in patients. However, it is important to note that in individuals with chronic kidney disease, the maximum dose studied was 2,520 mg of ferric iron, which corresponds to the administration of 12 tablets of ferric citrate per day.
Excessive iron absorption from ferric citrate tablets may result in significantly elevated iron stores within the body, particularly when intravenous iron is administered concurrently. This potential for increased iron levels necessitates careful monitoring of iron status in patients receiving both ferric citrate and intravenous iron.
Clinical trials have documented at least one case of elevated liver iron levels, which was confirmed through biopsy, in a patient undergoing dialysis who was treated with both intravenous iron and ferric citrate tablets. This underscores the importance of vigilance in monitoring iron levels in patients at risk of iron overload.
In the case of suspected overdose, healthcare professionals should assess the patient's clinical status and consider appropriate management strategies, which may include monitoring serum iron levels and implementing measures to mitigate iron overload.
Nonclinical Toxicology
Data from carcinogenesis studies indicate that ferric citrate does not exhibit carcinogenic properties in mice and rats when administered via intramuscular or subcutaneous routes. Furthermore, ferric citrate has been shown to be non-mutagenic in the bacterial reverse mutation assay (Ames test) and does not induce clastogenic effects in the chromosomal aberration test conducted with Chinese hamster fibroblasts.
The potential of ferric citrate to impair reproductive performance or to induce fetal malformation has not been assessed.
Postmarketing Experience
No postmarketing experience details are available in the provided data.
Patient Counseling
Patients should be instructed to take ferric citrate tablets as directed, specifically with meals, to ensure optimal absorption and effectiveness. It is important for patients to adhere to their prescribed diets while using this medication, as dietary considerations can impact treatment outcomes.
Healthcare providers should also discuss the importance of timing when taking concomitant medications. Patients should be advised to dose these medications apart from ferric citrate tablets to avoid potential interactions that may affect the efficacy of either treatment.
Additionally, patients must be informed about the proper administration of ferric citrate tablets. They should be instructed to swallow the tablets whole and not to chew or crush them, as doing so may lead to discoloration of the mouth and teeth. This information is crucial for maintaining both the effectiveness of the medication and the patient's oral health.
Storage and Handling
The product is supplied in various package configurations, with specific NDC numbers available for identification. It should be stored at a temperature range of 20° to 25°C (68° to 77°F), with permissible excursions between 15° to 30°C (59° to 86°F). It is essential to protect the product from moisture to maintain its integrity and efficacy. Proper handling and storage conditions are crucial for ensuring the quality of the product throughout its shelf life.
Additional Clinical Information
No further data are available.
FDA Insert (PDF)
This document is the official FDA-approved prescribing information for Ferric Citrate as submitted by Mylan Pharmaceuticals Inc.. It includes detailed information about indications, dosage, contraindications, warnings, and clinical pharmacology.