Pharmacologic class (EPC) · 4 drug pages

Blood coagulation factor: adverse event reports filed with FDA

13,838 reports list a drug in this class as a suspect or interacting product, 2004–2026.

Read first · FDA's statement on these data

Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, a causal relationship cannot be established between product and reactions listed in a report. While a suspected relationship may exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product. Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product. openFDA, FDA

FDA adds: "There is no certainty that the reported event (adverse event or medication error) was actually due to the product. FDA does not require that a causal relationship between a product and event be proven, and reports do not always contain enough detail to properly evaluate an event." The information in these reports "cannot be used to estimate the incidence of these events."

Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

13,838
reports across the class: 0.1% of all reports; 2,002
reports, 12 months to June 2026: 2,419 in the 12 months before; 94.7%
marked serious by the reporter: 57.4% across all reports; 4
drugs with a page: brand and generic names counted separately

Blood coagulation factor is a pharmacologic class (an FDA Established Pharmacologic Class) with 4 drug pages on this site. Together those drugs are listed as a suspect or interacting product in 13,838 adverse event reports received by FDA, 0.1% of the database, from January 2004 to June 2026.

2,002 reports arrived in the 12 months to June 2026, down 17% from 2,419 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. 94.7% of the class's reports are marked serious, 32.2% record death among the outcomes and 55.6% record hospitalisation, as reported.

Across the class the reactions recorded most often are drug ineffective (26.5%), off label use (23.9%) and pain (21.8%). The class median share shown beside each term is the middle value across the member drugs; it is the comparison used on every drug page in this class.

The members table is 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."

Drugs in the class

Drug	Name type	Reports	Latest 12 months	Marked serious	Top term recorded
Calcium carbonate	generic	8,721	1,128	97.5%	Drug ineffective
Calcium gluconate	generic	2,347	340	96.3%	Drug ineffective
TumsCalcium carbonate	brand	1,696	413	77.8%	Drug ineffective
Calcium chloride	generic	1,074	121	95.5%	Drug ineffective

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."

Reports by month, five years

FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.

Reactions recorded across the class

share of class reports recording the termmedian drug in the class

Drug ineffectivethe medicine did not work as expected26.5%3,665
Off label useused for a purpose or in a way not on the label23.9%3,306
Painpain, site not specified21.8%3,020
Fatiguetiredness20.8%2,877
Rheumatoid arthritisrheumatoid arthritis, an inflammatory joint disease18.5%2,566
Vomitingbeing sick18.5%2,562
Dyspnoeashortness of breath18.5%2,555
Wheezingwheezing18.2%2,520
Condition aggravatedthe condition being treated got worse17.7%2,456
Nauseafeeling sick17.7%2,448
Psoriatic arthropathy17.5%2,425
Pemphigus17.4%2,405
Systemic lupus erythematosuslupus, an autoimmune disease17.2%2,383
Malaisegeneral feeling of being unwell16.8%2,330
Hypertensionhigh blood pressure16.8%2,327
Abdominal discomfortstomach discomfort16.3%2,258
Alopeciahair loss16.2%2,241
Mobility decreasedreduced ability to move about16.2%2,238
Headachehead pain16.1%2,230
Swellingswelling16.1%2,228
Glossodynia16.1%2,226
General physical health deteriorationgeneral decline in health16%2,216
Asthmaasthma16%2,213
Hand deformity15.8%2,191
Infusion related reactiona reaction during or soon after an infusion15.7%2,179

Solid bar: share of all class reports. Hollow bar: the median share across the 4 member drugs, the reference used on each member's page. One report can record several terms.

Outcomes, patients and reporters

Outcomes recorded

Death32.2%4,458

Life-threatening38%5,259

Hospitalisation (initial or prolonged)55.6%7,698

Disability31.1%4,304

Congenital anomaly12.5%1,726

Other serious81.1%11,228

Not serious5.3%729

Patient age

Under 21.3%173

2 to 110.8%110

12 to 170.9%131

18 to 4424.8%3,434

45 to 6416.2%2,239

65 to 7411.8%1,627

75 and over11.1%1,538

Age not given33.1%4,586

Who reported

Physician15.8%2,180

Pharmacist2.9%395

Other health professional61.2%8,462

Lawyer0%4

Consumer or non-health professional17.9%2,471

Not given2.4%326

Grey bar: all 20,646,523 reports in the database. Outcome flags are as the reporter set them and are not verified by FDA.

Questions about Blood coagulation factor reports

Which drugs are in the Blood coagulation factor class on this site?

Calcium carbonate, Calcium gluconate, Tums and Calcium chloride. Class membership comes from the pharmacologic class (EPC) on the drug's FDA label.

How many reports does the class have?

13,838 reports through June 2026, 2,002 of them in the latest 12 months. A report listing two drugs of the class counts once for each.

What reactions are recorded most often?

drug ineffective (26.5%), off label use (23.9%), pain (21.8%), fatigue (20.8%) and rheumatoid arthritis (18.5%).

Can the members table be used to rank the drugs?

No. 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." Drugs differ in how many people take them, in the conditions they treat, in time on the market and in how diligently reports are collected.

How do I report an adverse event?

Through FDA MedWatch (Form FDA 3500, or 1-800-FDA-1088) or to the manufacturer. See the guide on how to report.

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 class is the Established Pharmacologic Class most often attached to a drug's reports by openFDA's label harmonisation, or from the NDC Directory where reports carry none. 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.

Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.