PhosLo Side Effects
Generic Name: calcium acetate
Please note - some side effects for PhosLo may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.
Side Effects of PhosLo - for the Consumer
PhosLo
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using PhosLo:
Seek medical attention right away if any of these SEVERE side effects occur when using PhosLo:Nausea.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); confusion; constipation; fast, slow, or irregular heartbeat; increased thirst or urination; loss of appetite; loss of consciousness; mental or mood changes; muscle weakness; severe or persistent nausea; sluggishness; unusual tiredness; vomiting.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
TopPhosLo Side Effects - for the Professional
Phoslo
Hypercalcemia is discussed elsewhere [see Warnings and Precautions (5.1)].
Clinical Trial 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 rates in the clinical trials of another drug and may not reflect the rates observed in practice.
In clinical studies, calcium acetate has been generally well tolerated.
Phoslo® was studied in a 3-month, open-label, non-randomized study of 98 enrolled ESRD hemodialysis patients and in a two week double-blind, placebo-controlled, cross-over study with 69 enrolled ESRD hemodialysis patients. Adverse reactions (>2% on treatment) from these trials are presented in Table 1.
| Preferred Term | Total adverse reactions reported for calcium acetate n = 167 n (%) |
3-mo, open-label study of calcium acetate n = 98 n (%) |
Double-blind, placebo-controlled, cross-over study of calcium acetate n = 69 |
|
| Calcium acetate n (%) |
Placebo n (%) |
|||
| Nausea | 6 (3.6) | 6 (6.1) | 0 (0.0) | 0 (0.0) |
| Vomiting | 4 (2.4) | 4 (4.1) | 0 (0.0) | 0 (0.0) |
| Hypercalcemia | 21 (12.6) | 16 (16.3) | 5 (7.2) | 0 (0.0) |
Mild hypercalcemia may be asymptomatic or manifest itself as constipation, anorexia, neusea, and vomiting. More severe hypercalcemia is associated with confusion, delirium, stupor, and coma. Decreasing dialysate calcium concentration could reduce the incidence and severity of Phoslo®-induced hypercalcemia. Isolated cases of pruritus have been reported, which may represent allergic reactions.
Postmarketing Experience
Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to estimate their frequency or to establish a causal relationship to drug exposure.
The following additional adverse reactions have been identified during post-approval of calcium acetate: dizziness, edema, and weakness.
TopSide Effects by Body System - for Healthcare Professionals
Dermatologic
Dermatologic side effects have included pruritus.
Gastrointestinal
Gastrointestinal side effects associated with mild hypercalcemia (calcium levels greater than 10.5 mg/dl) have included constipation, anorexia, nausea and vomiting.
Nervous system
Nervous system side effects associated with severe hypercalcemia (calcium greater than 12 mg/dl) have included confusion, dizziness, weakness, delirium, stupor, and coma.
Metabolic
Metabolic side effects have included edema.
TopMore PhosLo resources
- PhosLo Advanced Consumer (Micromedex) - Includes Dosage Information
- PhosLo Concise Consumer Information (Cerner Multum)
- PhosLo MedFacts Consumer Leaflet (Wolters Kluwer)
- calcium acetate Concise Consumer Information (Cerner Multum)
- Eliphos Prescribing Information (FDA)
- Phoslo Prescribing Information (FDA)
- Phoslyra Prescribing Information (FDA)
- Phoslyra Solution MedFacts Consumer Leaflet (Wolters Kluwer)
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