Calcium chloride: adverse event reports filed with FDA

1,074

reports as suspect product

0% of all reports · about 48 a year

121

reports, 12 months to June 2026

195 in the 12 months before

95.5%

marked serious by the reporter

94.7% across the class

21.6%

record death among outcomes, as reported

232 reports · not verified by FDA

Reports by month, five years

Reports by the month FDA received them. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.

By year received

2026 covers reports received through June 2026 only.

Reactions recorded in the reports

share of Calcium chloride reports recording the termmedian drug in blood coagulation factor

1. Drug ineffectivethe medicine did not work as expected25.6%275
2. Off label useused for a purpose or in a way not on the label21.1%227
3. Nauseafeeling sick19.8%213
4. Pemphigus17.7%190
5. Joint swellinga swollen joint16.2%174
6. Injurya physical injury16.1%173
7. Sleep disordera sleep problem15.7%169
8. Urticariahives15.4%165
9. Oedemaswelling from fluid15.3%164
10. Type 2 diabetes mellitustype 2 diabetes15.3%164
11. Ulcer haemorrhage15.3%164
12. Drug hypersensitivityan allergic-type reaction to a medicine15.1%162
13. Mobility decreasedreduced ability to move about15.1%162
14. Product use in unapproved indicationused for a purpose not on the label15%161
15. Condition aggravatedthe condition being treated got worse14.9%160
16. Pyrexiafever14.8%159
17. Psoriatic arthropathy14.5%156
18. Pericarditisinflammation of the sac around the heart14.3%154
19. Sinusitissinus infection14.3%154
20. Dyspnoeashortness of breath14.2%153
21. Pain in extremitypain in an arm or leg14.1%151
22. Liver injury14%150
23. Hypertensionhigh blood pressure12.8%138
24. Stomatitissore mouth12.8%137
25. Asthmaasthma12.5%134
26. Drug intolerancethe medicine was not tolerated12.3%132
27. Maternal exposure during pregnancythe mother took the medicine during pregnancy12.1%130
28. Gait disturbancedifficulty walking12%129
29. General physical health deteriorationgeneral decline in health11.7%126
30. Nasopharyngitisa cold11.5%124

Top 30 of 582 MedDRA preferred terms recorded across these reports, with a plain-language gloss where one is available. One report can record several terms. The hollow bar is the median share across the 4 drugs in the blood coagulation factor class; it describes the reports, not the patients. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

Outcomes recorded

Outcome flags as the reporter set them; a report can carry several, and "other serious" is FDA's own category for serious reports outside the named outcomes. Grey bar: all 13,838 reports in the class. FDA has not verified any outcome and states that the reports "cannot be used to estimate the incidence of these events."

Patients and reporters

Age and sex as stated in the report; the reporter's qualification is the primary source recorded by FDA. 17.2% of reports give the United States as the country of the event or reporter.

Reason for use recorded

The indication field is filled in by the reporter and is often blank; shares are of all 1,074 reports.

In context

Shares are of reports, not of patients treated. The number of people taking a product is not in the data, so none of these figures is a rate, and differences between columns reflect who takes a product, who reports and how long it has been sold. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

Other drugs in the blood coagulation factor class

Ordered by report count for navigation only. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic." A brand and its generic are separate rows because reporters name them separately.

Where this comes from. Counts are built from the openFDA Drug Adverse Event (FAERS) bulk export released 28 Sep 2026, which holds reports FDA received through 30 Jun 2026. Drug names are as reported, resolved to the brand or generic name on the FDA label where openFDA's harmonisation matched them; classes are the pharmacologic class (EPC) from the label and the National Drug Code Directory of 17 Sep 2026. A report counts here when it lists Calcium chloride as a suspect or interacting product; reports listing it only as a concomitant medication (1,973) are excluded. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.