What the label lists and what reports show
Calcium gluconate side effects
Calcium gluconate's FDA label: “The most common adverse events with Calcium Gluconate Injection are local soft tissue inflammation and necrosis, calcinosis cutis and calcification that are related to extravasation.” FAERS holds 11,976 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 pain (1,717 reports).
- Generic listed
Check it at the source: the calcium gluconate FDA label on DailyMed (effective May 6, 2024, Fresenius Kabi USA, LLC); the FDA FAERS public dashboard.
What does the label list?
From the label: adverse reactionsThe most common adverse events with Calcium Gluconate Injection are local soft tissue inflammation and necrosis, calcinosis cutis and calcification that are related to extravasation.
From the label: adverse reactions, continuedThe following serious adverse reactions are also described elsewhere in the labeling: Arrhythmias with Concomitant Cardiac Glycoside Use [see Warnings and Precautions ( 5.1 )] End-Organ Damage due to Intravascular Ceftriaxone-Calcium Precipitates [see Warnings and Precautions ( 5.2 )] Tissue Necrosis and Calcinosis [see Warnings and Precautions ( 5.3 )] Hypotension, Bradycardia, and Cardiac Arrhythmias [see Warnings and Precautions ( 5.4 )] Aluminum toxicity [see Warnings and Precautions ( 5.5 )] The following adverse reactions associated with the use of calcium gluconate were identified in the literature. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to estimate their frequency reliably or to establish a causal relationship to drug exposure. Cardiovascular: Vasodilation, decreased blood pressure, bradycardia, cardiac arrhythmia, syncope, cardiac arrest Administration site reactions: Local soft tissue inflammation, local necrosis, calcinosis cutis and calcification due to extravasation The most common adverse events with Calcium Gluconate Injection are local soft tissue inflammation and necrosis, calcinosis cutis and calcification that are related to extravasation. Other adverse events include vasodilation, decreased blood pressure, bradycardia, cardiac arrhythmia, syncope, and cardiac arrest. …
Source: FDA drug label, Fresenius Kabi USA, LLC, effective May 6, 2024 (SPL set 7f5101e0-abf9-4fcf-8986-c799e3333434), via openFDA; the full label on DailyMed
What do FAERS reports show?
11,976 reports list calcium gluconate among the medicines taken, each a report of something that happened, not proof the medicine caused it; 2,530 are coded as a death and 5,555 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. Of the 21 reactions below, 1 is 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 gluconate: 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