What the label lists and what reports show
Calcium chloride, icodextrin, magnesium chloride, sodium chloride and sodium lactate side effects
Calcium chloride, icodextrin, magnesium chloride, sodium chloride and sodium lactate's FDA label: “The most common adverse reaction (incidence > 5%) was rash.” FAERS holds 30,880 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is peritonitis (1,888 reports).
- No generic listed
Check it at the source: the calcium chloride, icodextrin, magnesium chloride, sodium chloride and sodium lactate FDA label on DailyMed (effective June 30, 2025); the FDA FAERS public dashboard.
What does the label list?
From the label: adverse reactionsThe most common adverse reaction (incidence > 5%) was rash.
Table 1 - Adverse Experiences in ≥5% of Patients and More Common on EXTRANEAL
| Reaction | EXTRANEAL N = 493 | Control N = 347 |
|---|---|---|
| Peritonitis | 26% | 25% |
| Upper respiratory infection | 15% | 13% |
| Hypertension | 13% | 8% |
| Rash | 10% | 5% |
| Headache | 9% | 7% |
| Abdominal Pain | 8% | 6% |
| Flu syndrome | 7% | 6% |
| Nausea | 7% | 5% |
| Cough increase | 7% | 4% |
| Edema | 6% | 5% |
| Accidental injury | 6% | 4% |
| Chest pain | 5% | 4% |
| Dyspepsia | 5% | 4% |
| Hyperglycemia | 5% | 4% |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedThe most common adverse reaction (incidence > 5%) was rash. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Vantive US Healthcare LLC at 1-855-857-0003 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience EXTRANEAL was originally studied in controlled clinical trials of 493 patients with kidney failure in patients requiring long-term kidney replacement therapy who received a single daily exchange of EXTRANEAL for the long dwell (8-to 16- hours). There were 215 patients exposed for at least 6 months and 155 patients exposed for at least one year. The population was 18-83 years of age, 56% male and 44% female, 73% Caucasian, 18% Black, 4% Asian, 3% Hispanic, and it included patients with the following comorbid conditions: 27% diabetes, 49% hypertension and 23% hypertensive nephropathy. Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in clinical trials of a drug cannot be compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The adverse reaction information from clinical trials does, however, provide a basis for identifying the adverse events that appear to be related to drug use and for approximating rates. Rash was the most frequently occurring EXTRANEAL-related adverse reaction (5.5%, EXTRANEAL; 1.7% Control). …
Source: FDA drug label, Vantive US Healthcare LLC, effective June 30, 2025 (SPL set d5b85158-b0d6-4855-9d07-8d1b3ad9ab71), via openFDA; the full label on DailyMed
What do FAERS reports show?
30,880 reports list calcium chloride, icodextrin, magnesium chloride, sodium chloride and sodium lactate among the medicines taken, each a report of something that happened, not proof the medicine caused it; 10,042 are coded as a death and 14,520 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Reports rose sharply in 2016 (3,141, against a median of 773 a year): FAERS counts follow reporting, which news, litigation and label changes can drive, not how often a reaction happens. Of the 24 reactions below, 10 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Calcium chloride, icodextrin, magnesium chloride, sodium chloride and sodium lactate: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions