Quick answers
- What is Potassium phosphate, monobasic potassium phosphate, dibasic injection, used for?
- The FDA-approved label (Potassium Phosphates, Amneal Pharmaceuticals Private Limited, December 31, 2024) says: “Potassium phosphates injection is indicated as a source of phosphorus: in intravenous fluids to correct hypophosphatemia in adults and pediatric patients when oral or enteral replacement is not possible, insufficient or contraindicated. for parenteral nutrition in adults and pediatric patients when oral or enteral nutrition is not possible, insufficient or contraindicated. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- What are the side effects of Potassium phosphate, monobasic potassium phosphate, dibasic injection,?
- The “Adverse Reactions” section of the FDA label (Potassium Phosphates, Amneal Pharmaceuticals Private Limited, December 31, 2024) begins: “The following clinically significant adverse reactions are described elsewhere in the labeling: Aluminum Toxicity [see Warnings and Precautions (5.5)] Hypomagnesemia [see Warnings and Precautions (5.6)] Vein Damage and Thrombosis [see Warnings and Precautions (5.7)] The following adverse reactions in Table 5 have been reported in clinical studies or post-marketing reports in patients receiving intravenously administered potassium phosphates.” … This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- What are the drug interactions of Potassium phosphate, monobasic potassium phosphate, dibasic injection,?
- The “Drug Interactions” section of the FDA label (Potassium Phosphates, Amneal Pharmaceuticals Private Limited, December 31, 2024) begins: “Use of Other Medications that Increase Potassium: Avoid use in patients receiving such products. If use cannot be avoided, closely monitor serum potassium concentrations.” … This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Potassium phosphate, monobasic potassium phosphate, dibasic injection, have a boxed warning?
- No. None of the 4 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Potassium phosphate, monobasic potassium phosphate, dibasic injection,?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Potassium phosphate, monobasic potassium phosphate, dibasic injection, been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Potassium phosphate, monobasic potassium phosphate, dibasic injection,?
- 4 companies list prescription products of Potassium phosphate, monobasic potassium phosphate, dibasic injection, in the FDA NDC Directory, including Amneal Pharmaceuticals Private Limited, American Regent, Inc. and Caplin Steriles Limited.
What Potassium phosphate, monobasic potassium phosphate, dibasic injection, is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
Potassium phosphates injection is indicated as a source of phosphorus: in intravenous fluids to correct hypophosphatemia in adults and pediatric patients when oral or enteral replacement is not possible, insufficient or contraindicated. for parenteral nutrition in adults and pediatric patients when oral or enteral nutrition is not possible, insufficient or contraindicated. …
— FDA label: Potassium Phosphates, Amneal Pharmaceuticals Private Limited, effective December 31, 2024. Read the full label on DailyMed →
Label quoted: the one for the most common form (solution, concentrate, intravenous), Potassium Phosphates, Amneal Pharmaceuticals Private Limited; it covers 3 products in the FDA NDC Directory. The side effects, interactions, dosage and pregnancy quotes below come from this same label.
The FDA has 4 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
0 of 4 FDA labels for this medicine have a boxed warning.
Potassium phosphate, monobasic potassium phosphate, dibasic injection, side effects
Quoted from the “Adverse Reactions” section of the FDA-approved label. Tell your doctor about any side effect that worries you.
The following clinically significant adverse reactions are described elsewhere in the labeling: Aluminum Toxicity [see Warnings and Precautions (5.5)] Hypomagnesemia [see Warnings and Precautions (5.6)] Vein Damage and Thrombosis [see Warnings and Precautions (5.7)] The following adverse reactions in Table 5 have been reported in clinical studies or post-marketing reports in patients receiving intravenously administered potassium phosphates.
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Because some of these reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Table 5: Adverse Reactions Reported in Clinical Studies or Post-marketing Reports with Intravenous Potassium Phosphates System Organ Class Adverse Reactions Metabolism and Nutrition Disorders pulmonary embolism due to pulmonary vascular precipitates [see Warnings and Precautions (5.2)], hyperkalemia [see Warnings and Precautions (5.3)], hyperphosphatemia [see Warnings and Precautions (5.4)], hypocalcemia [see Warnings and Precautions (5.5)], hypovolemia and osmotic diuresis Cardiac Disorders hypotension, arrhythmia, heart block, cardiac arrest, bradycardia, chest pain, ECG changes [see Warnings and Precautions (5.1)] and edema Respiratory, Thoracic and Mediastinal Disorders dyspnea [see Warnings and Precautions (5.2)] Renal and Urinary Disorders acute phosphate nephropathy (i.e., nephrocalcinosis with acute kidney injury), decreased urine output and transition to chronic kidney disease [see Warnings and Precautions (5.4)] Gastrointestinal Disorders diarrhea, stomach pain Musculoskeletal and Connective Tissue Disorders weakness Nervous System Disorders confusion, lethargy, paralysis, paresthesia Adverse reactions include hyperkalemia, hyperphosphatemia, hypocalcemia and hypomagnesemia. (6) To report SUSPECTED ADVERSE REACTIONS, contact Amneal Pharmaceuticals at 1-877-835-5472 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Table from the label
| System Organ Class | Adverse Reactions |
|---|---|
| Metabolism and Nutrition Disorders | pulmonary embolism due to pulmonary vascular precipitates [see Warnings and Precautions (5.2)], hyperkalemia [see Warnings and Precautions (5.3)], hyperphosphatemia [see Warnings and Precautions (5.4)], hypocalcemia [see Warnings and Precautions (5.5)], hypovolemia and osmotic diuresis |
| Cardiac Disorders | hypotension, arrhythmia, heart block, cardiac arrest, bradycardia, chest pain, ECG changes [see Warnings and Precautions (5.1)] and edema |
| Respiratory, Thoracic and Mediastinal Disorders | dyspnea [see Warnings and Precautions (5.2)] |
| Renal and Urinary Disorders | acute phosphate nephropathy (i.e., nephrocalcinosis with acute kidney injury), decreased urine output and transition to chronic kidney disease [see Warnings and Precautions (5.4)] |
| Gastrointestinal Disorders | diarrhea, stomach pain |
| Musculoskeletal and Connective Tissue Disorders | weakness |
| Nervous System Disorders | confusion, lethargy, paralysis, paresthesia |
— FDA label: Potassium Phosphates, Amneal Pharmaceuticals Private Limited, effective December 31, 2024. Read the full label on DailyMed →
Potassium phosphate, monobasic potassium phosphate, dibasic injection, drug interactions
Quoted from the “Drug Interactions” section of the FDA-approved label. Tell your pharmacist about every medicine, vitamin and herbal product you take.
Use of Other Medications that Increase Potassium: Avoid use in patients receiving such products. If use cannot be avoided, closely monitor serum potassium concentrations.
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(5.3, 7.1) 7.1 Other Products that Increase Serum Potassium Administration of potassium phosphates injection to patients treated concurrently or recently with products that increase serum potassium (e.g., potassium-sparing diuretics, ACE inhibitors, angiotensin II receptor antagonists, digoxin or the immunosuppressants tacrolimus and cyclosporine) increases the risk of severe and potentially fatal hyperkalemia, in particular in the presence of other risk factors for hyperkalemia [see Warnings and Precautions (5.3)]. Avoid use of potassium phosphates injection in patients receiving such products. If use cannot be avoided, closely monitor serum potassium concentrations [see Dosage and Administration (2.2, 2.4)].
— FDA label: Potassium Phosphates, Amneal Pharmaceuticals Private Limited, effective December 31, 2024. Read the full label on DailyMed →
Potassium phosphate, monobasic potassium phosphate, dibasic injection, dosage
Quoted from the “Dosage and Administration” section of the FDA-approved label. Your own dose is the one your doctor prescribes: do not change it on your own.
Administer intravenously only after dilution or admixing in a larger volume of fluid. (2.1) Potassium phosphates injection provides phosphorus 3 mmol/mL (potassium 4.4 mEq/mL). (2.2, 2.4) Monitor serum phosphorus, potassium, calcium and magnesium concentrations. (2.2, 2.4) See full prescribing information for instructions on preparation and administration.
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(2.1, 2.3) Recommended Dosage for Correction of Hypophosphatemia in Intravenous Fluids Potassium phosphates injection is only for administration to a patient with a serum potassium concentration less than 4 mEq/dL; otherwise, use an alternative source of phosphorus. (2.1) The dosage is dependent upon the individual needs of the patient and the contribution of phosphorus and potassium from other sources. (2.2) See full prescribing information for recommendations on initial or single dosing, repeated dosing, concentration and infusion rate. (2.1, 2.2) Recommended Dosage for Administration in Parenteral Nutrition Individualize the dosage based upon the patient’s clinical condition, nutritional requirements and the contribution of oral or enteral phosphorus and potassium intake. (2.4) See full prescribing information for recommendations for daily and maximum dosage. (2.4) 2.1 Preparation and Administration in Intravenous Fluids to Correct Hypophosphatemia Preparation Potassium phosphates injection is for intravenous infusion into a central or peripheral vein only after dilution. Using aseptic technique, withdraw the required amount from the vial and add to 0.9% Sodium Chloride Injection, USP (normal saline) or 5% Dextrose Injection, USP (D5W). For adults and pediatric patients 12 years of age and older a total volume of 100 mL or 250 mL is recommended. For pediatric patients less than 12 years of age, use the smallest recommended volume, considering daily fluid requirements and the maximum concentration for peripheral and central administration shown in Table 1. The concentration of the diluted solution should take into consideration the age of the patient, the amounts of phosphorus and potassium in the dose and is dependent upon whether administration will be through a peripheral or central venous catheter. The recommended maximum concentrations are shown in Table 1: Table 1: Maximum Recommended Concentration of Potassium Phosphates Injection by Age and Route of Administration (Peripheral vs. Central) Patient Population Peripheral Venous Catheter Central Venous Catheter Adults and Pediatric Patients 12 Years of Age and Older phosphorus 6.8 mmol/100 mL (potassium 10 mEq/100 mL) phosphorus 18 mmol/100 mL (potassium 26.4 mEq/100 mL) Pediatric Patients Less than 12 Years of Age phosphorus 0.27 mmol/10 mL (potassium 0.4 mEq/10 mL) phosphorus 0.55 mmol/10 mL (potassium 0.8 mEq/10 mL) Visually inspect the solution for particulate matter and discoloration before and after dilution and prior to administration. Do not administer unless solution is clear and seal on the vial is intact. Administration Check serum potassium and calcium concentrations prior to administration.
Table from the label
| Patient Population | Peripheral Venous Catheter | Central Venous Catheter |
|---|---|---|
| Adults and Pediatric Patients 12 Years of Age and Older | phosphorus 6.8 mmol/100 mL (potassium 10 mEq/100 mL) | phosphorus 18 mmol/100 mL (potassium 26.4 mEq/100 mL) |
| Pediatric Patients Less than 12 Years of Age | phosphorus 0.27 mmol/10 mL (potassium 0.4 mEq/10 mL) | phosphorus 0.55 mmol/10 mL (potassium 0.8 mEq/10 mL) |
— FDA label: Potassium Phosphates, Amneal Pharmaceuticals Private Limited, effective December 31, 2024. This is part of the section. Read the full label on DailyMed →
Potassium phosphate, monobasic potassium phosphate, dibasic injection, in pregnancy
Quoted from the pregnancy part of the FDA-approved label. Ask your doctor before you take any medicine while pregnant or planning a pregnancy.
Risk Summary Administration of the recommended dose of potassium phosphates injection is not expected to cause major birth defects, miscarriage or adverse maternal or fetal outcomes. Animal reproduction studies have not been conducted with potassium phosphates injection. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss or other adverse outcomes.
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In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Clinical Considerations Disease-associated Maternal and/or Embryo-Fetal Risk Phosphorus is an essential mineral element. Parenteral supplementation with potassium phosphates should be considered if a pregnant woman’s requirements cannot be fulfilled by oral or enteral intake.
— FDA label: Potassium Phosphates, Amneal Pharmaceuticals Private Limited, effective December 31, 2024. Read the full label on DailyMed →
When Potassium phosphate, monobasic potassium phosphate, dibasic injection, should not be used
Quoted from the “Contraindications” section of the FDA-approved label.
Potassium phosphates injection is contraindicated in patients with: Hyperkalemia [see Warning and Precautions (5.3)]. Severe renal impairment (eGFR less than 30 mL/min/1.73 m 2) or end stage renal disease [see Warning and Precautions (5.3)]. Hyperphosphatemia [see Warning and Precautions (5.4)]. Hypercalcemia or significant hypocalcemia [see Warning and Precautions (5.4)]. Hyperkalemia. (4) Hyperphosphatemia. (4) Hypercalcemia or significant hypocalcemia.
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(4) Severe renal impairment (eGFR less than 30 mL/min/1.73 m 2) or end stage renal disease. (4)
— FDA label: Potassium Phosphates, Amneal Pharmaceuticals Private Limited, effective December 31, 2024. Read the full label on DailyMed →
Potassium phosphate, monobasic potassium phosphate, dibasic injection, overdose
Quoted from the “Overdosage” section of the FDA-approved label. If someone may have taken too much, call Poison Help at 1-800-222-1222 (or 911 in an emergency).
Hyperphosphatemia Administration of excessive doses of intravenous potassium phosphates in intravenous fluids as a single-dose ranging from approximately 50 mmol to 270 mmol phosphorus and/or at rapid infusion rates (over 1 hour to 3 hours) has resulted in death, cardiac arrest, cardiac arrhythmia (including QT prolongation), hyperkalemia, hyperphosphatemia, seizures and tetany. Hyperphosphatemia is particularly a risk in patients with renal failure.
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Hyperphosphatemia leads in turn to hypocalcemia, which may be severe and to ectopic calcification, particularly in patients with initial hypercalcemia. Tissue calcification may cause hypotension and organ damage and result in acute renal failure. Hyperkalemia Excessive administration of phosphates given as potassium salts may also cause hyperkalemia. Manifestations of hyperkalemia include: Disturbances in cardiac conduction and arrhythmias, including bradycardia, heart block, asystole, ventricular tachycardia, ventricular fibrillation. Hypotension. Muscle weakness including paresthesia, muscular and respiratory paralysis. Management In the event of overdosage, discontinue infusions containing potassium phosphates immediately and institute general supportive measures, including ECG monitoring, laboratory monitoring and correction of serum electrolyte concentrations, especially potassium, phosphorus, calcium and magnesium.
— FDA label: Potassium Phosphates, Amneal Pharmaceuticals Private Limited, effective December 31, 2024. Read the full label on DailyMed →
Forms and how it is given
| Dosage forms | Solution, concentrate · Injection, solution · Injection, solution, concentrate · Injection |
|---|---|
| Route | Intravenous |
| Prescription products | 10 in the FDA NDC Directory |
| Brand names | Potassium Phosphates |
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Amneal Pharmaceuticals Private Limited5 products
- American Regent, Inc.3 products
- Caplin Steriles Limited3 products
- Amneal Pharmaceuticals LLC1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA218343 POTASSIUM PHOSPHATES IN 0.9% SODIUM CHLORIDE | Amneal | July 26, 2024 | — |
Generic approvals (3)
- ANDA216274Am Regent · October 2, 2023
- ANDA216344Amneal · October 10, 2023
- ANDA220373Caplin · March 12, 2026
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
| RxCUI (RxNorm) | 1928567, 1928569, 1928570, 2688947 |
|---|---|
| SPL set ID of the quoted label | 89136c51-a60b-4269-bd05-9489f060a734 |
| FDA labels (SPL) | 4 |
| FDA applications | NDA218343, 3 ANDA |
| Active ingredients (FDA) | POTASSIUM PHOSPHATE, DIBASIC / POTASSIUM PHOSPHATE, MONOBASIC |
Next steps
- Find a pharmacy near youAsk which price applies to you and whether your product is affected by a recall
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- Amneal Pharmaceuticals Private LimitedMaker or distributor
- American Regent, Inc.Maker or distributor
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Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Potassium Phosphates, Amneal Pharmaceuticals Private Limited, effective December 31, 2024; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →